Table of Contents

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended March 31, 2015

 

OR

 

o          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: 001-35890

 

OVASCIENCE, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

45-1472564

(State or other jurisdiction of

 

(I.R.S. Employer

incorporation or organization)

 

Identification No.)

 

215 First Street, Suite 240

 

 

Cambridge, Massachusetts

 

02142

(Address of principal executive offices)

 

(Zip Code)

 

617-500-2802

(Registrant’s telephone number, including area code)

 

 

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

 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.  Yes  x   No  o

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, 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  x   No  o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer  o

 

Accelerated filer  x

 

 

 

Non-accelerated filer  o

 

Smaller reporting company  o

(Do not check if a smaller reporting company)

 

 

 

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

 

As of May 6, 2015, there were 27,194,884 shares of the registrant’s Common Stock, par value $0.001 per share, outstanding.

 

 

 



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OVASCIENCE, INC.

Quarterly Report on Form 10-Q

For the Quarterly Period Ended March 31, 2015

INDEX

 

 

 

 

Page

 

 

 

 

 

Part I. Financial Information

 

 

 

 

 

 

Item 1.

Financial Statements (Unaudited)

 

3

 

 

 

 

 

Condensed Consolidated Balance Sheets

 

3

 

 

 

 

 

Condensed Consolidated Statements of Operations and Comprehensive Loss

 

4

 

 

 

 

 

Condensed Consolidated Statements of Cash Flows

 

5

 

 

 

 

 

Notes to Unaudited, Condensed Consolidated Financial Statements

 

6

 

 

 

 

Item 2.

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

 

13

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

 

19

 

 

 

 

Item 4.

Controls and Procedures

 

19

 

 

 

 

 

Part II. Other Information

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

19

 

 

 

 

Item 1A.

Risk Factors

 

20

 

 

 

 

Item 6.

Exhibits

 

20

 

 

 

 

Signatures

 

20

 

 

 

Exhibit Index

 

21

 

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Table of Contents

 

Part I.                                     Financial Information

 

Item 1.                                  Financial Statements

 

OvaScience, Inc.

Condensed Consolidated Balance Sheets

(Unaudited)

(In thousands, except share and per share data)

 

 

 

As of March 31,

 

As of December 31,

 

 

 

2015

 

2014

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

134,698

 

$

6,414

 

Short-term investments

 

34,641

 

53,817

 

Prepaid expenses and other current assets

 

1,886

 

1,647

 

Restricted cash

 

109

 

 

Total current assets

 

171,334

 

61,878

 

Property and equipment, net

 

4,159

 

3,367

 

Investment in joint venture

 

196

 

 

Restricted cash

 

88

 

197

 

Other long-term assets

 

 

130

 

Total assets

 

$

175,777

 

$

65,572

 

Liabilities and stockholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

2,493

 

$

2,520

 

Accrued expenses and other current liabilities

 

4,116

 

7,654

 

Total current liabilities

 

6,609

 

10,174

 

Other non-current liabilities

 

74

 

73

 

Total liabilities

 

6,683

 

10,247

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

Preferred stock, $0.001 par value; 5,000,000 shares authorized, no shares issued and outstanding

 

 

 

Common stock, $0.001 par value; 100,000,000 shares authorized; 27,194,884 and 24,413,666 shares issued at March 31, 2015 and December 31, 2014, respectively; 27,030,370 and 24,084,637 shares outstanding at March 31, 2015 and December 31, 2014, respectively

 

27

 

24

 

Additional paid-in capital

 

280,972

 

150,025

 

Accumulated other comprehensive loss

 

(1

)

(26

)

Accumulated deficit

 

(111,904

)

(94,698

)

Total stockholders’ equity

 

169,094

 

55,325

 

Total liabilities and stockholders’ equity

 

$

175,777

 

$

65,572

 

 

See accompanying notes.

 

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OvaScience, Inc.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

(In thousands, except per share data)

 

 

 

Three Months Ended
March 31,

 

 

 

2015

 

2014

 

 

 

 

 

 

 

Revenues

 

$

15

 

$

 

Costs and expenses:

 

 

 

 

 

Costs of revenues

 

35

 

 

Research and development

 

5,747

 

4,652

 

Selling, general and administrative

 

11,046

 

2,998

 

Total costs and expenses

 

16,828

 

7,650

 

Loss from operations

 

(16,813

)

(7,650

)

Interest income (expense), net

 

44

 

(57

)

Other income (expense), net

 

34

 

(10

)

Loss from equity method investment

 

(471

)

(97

)

Net loss

 

$

(17,206

)

$

(7,814

)

Net loss per share—basic and diluted

 

$

(0.65

)

$

(0.41

)

Weighted average number of shares used in net loss per share—basic and diluted

 

26,588

 

19,214

 

 

 

 

 

 

 

Net loss

 

$

(17,206

)

$

(7,814

)

Other comprehensive loss:

 

 

 

 

 

Unrealized gains (losses) on available-for-sale securities

 

25

 

(13

)

Comprehensive loss

 

$

(17,181

)

$

(7,827

)

 

See accompanying notes.

 

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OvaScience, Inc.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(In thousands)

 

 

 

Three Months Ended
March 31,

 

 

 

2015

 

2014

 

Cash flows from operating activities:

 

 

 

 

 

Net loss

 

$

(17,206

)

$

(7,814

)

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

 

 

 

 

 

Depreciation and amortization

 

227

 

66

 

Amortization of premium on debt securities

 

171

 

149

 

Stock-based compensation expense

 

6,367

 

867

 

Net loss on equity method investment

 

471

 

97

 

Changes in operating assets and liabilities:

 

 

 

 

 

Prepaid expenses and other assets

 

(239

)

45

 

Accounts payable

 

(657

)

1,401

 

Accrued expenses and other non-current liabilities

 

(3,528

)

228

 

Net cash used in operating activities

 

(14,394

)

(4,961

)

Cash flows from investing activities:

 

 

 

 

 

Investment in joint venture

 

(750

)

(1,500

)

Purchases of property, plant and equipment

 

(389

)

 

Maturities of short-term investments

 

19,030

 

4,714

 

Sales of short-term investments

 

 

4,415

 

Purchases of short-term investments

 

 

(16,273

)

Net cash provided by (used in) investing activities

 

17,891

 

(8,644

)

Cash flows from financing activities:

 

 

 

 

 

Net proceeds from the issuance of common stock

 

124,063

 

51,661

 

Issuances of common stock under benefit plans, net of withholding taxes paid

 

724

 

 

Net cash provided by financing activities

 

124,787

 

51,661

 

Net increase in cash and cash equivalents

 

128,284

 

38,056

 

Cash and cash equivalents at beginning of period

 

6,414

 

18,078

 

Cash and cash equivalents at end of period

 

$

134,698

 

$

56,134

 

 

See accompanying notes.

 

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OvaScience, Inc.

Notes to Unaudited, Condensed Consolidated Financial Statements

 

1.                                       Organization and basis of presentation

 

OvaScience, Inc., incorporated on April 5, 2011 as a Delaware corporation, is a global fertility company developing proprietary potential treatments for female infertility based on recent scientific discoveries about the existence of egg precursor cells. As used in these condensed consolidated financial statements, the terms “OvaScience,” “we,” “us,” and “our” refer to the business of OvaScience, Inc. and its wholly owned subsidiaries. Our operations to date have been limited to organizing and staffing our company, business planning, raising capital, acquiring and developing our technology, identifying potential fertility treatments, developing the AUGMENT treatment, launching the AUGMENT treatment in select international in vitro fertilization (IVF) clinics, researching and developing the OvaPrime treatment and the OvaTure treatment, and determining the regulatory and development path for our fertility treatments. We have commenced our planned principal operations but have not generated any significant revenues to date.

 

We are subject to a number of risks similar to other life science companies in the development stage, including, but not limited to, the need to obtain adequate additional funding, possible failure to provide our treatments to IVF clinics to gain clinical experience in select countries outside of the United States, the need to obtain marketing approval for certain of our treatments, competitors developing new technological innovations, and the need to successfully commercialize and gain market acceptance of our treatments and protection of proprietary technology. If we do not successfully commercialize our treatments, we will be unable to generate treatment revenue or achieve profitability. As of March 31, 2015 we had an accumulated deficit of approximately $111.9 million.

 

Liquidity

 

We have incurred annual net operating losses in each year since our inception. We have generated limited treatment revenues related to our primary business purpose and have financed our operations primarily through private placements of our preferred stock and common stock. We have launched one fertility treatment, the AUGMENT treatment, in select international IVF clinics and have two potential treatments in development.  We have devoted substantially all of our financial resources and efforts to the launch of the AUGMENT treatment, raising capital and research and development. We expect to continue to incur significant expenses and operating losses for at least the next several years.

 

2.                                       Basis of presentation and significant accounting policies

 

Unaudited interim financial data

 

The accompanying unaudited condensed consolidated balance sheet as of March 31, 2015, the statements of operations and comprehensive loss for the three months ended March 31, 2015 and 2014, and the statements of cash flows for the three months ended March 31, 2015 and 2014, and the related interim information contained within the notes to the financial statements, have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission for interim financial information. Accordingly, they do not include all of the information and the notes required by U.S. generally accepted accounting principles for complete financial statements. In the opinion of management, the unaudited interim financial statements reflect all adjustments, consisting of normal and recurring adjustments, necessary for the fair presentation of our financial position at March 31, 2015, results of our operations for the three months ended March 31, 2015 and 2014 and our cash flows for the three months ended March 31, 2015 and 2014. The results for the three months ended March 31, 2015 are not necessarily indicative of future results.

 

Principles of consolidation

 

These condensed consolidated financial statements include the accounts of OvaScience and the accounts of our wholly-owned subsidiaries. All intercompany transactions have been eliminated in consolidation.

 

Use of estimates

 

These condensed consolidated financial statements are presented in conformity with U.S. generally accepted accounting principles, which require management to make estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. Actual results could differ from such estimates.

 

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Selling, general and administrative costs

 

We expense selling, general and administrative costs as incurred. Selling, general and administrative costs consist of ongoing costs to run our daily operations and internal costs to support the international launch of the AUGMENT SM  Centers of Excellence (“ACE”) access program for the AUGMENT treatment.

 

Net loss per share

 

Basic and diluted net loss per common share is calculated by dividing net loss applicable to common stockholders by the weighted average number of common shares outstanding during the period. Potentially dilutive shares, including outstanding stock options and unvested restricted stock, are only included in the calculation of diluted net loss per share when their effect is dilutive.

 

The amounts in the table below were excluded from the calculation of diluted net loss per share, prior to the use of the treasury stock method, due to their anti-dilutive effect (in thousands):

 

 

 

As of March 31,

 

 

 

2015

 

2014

 

Outstanding stock options and restricted stock units

 

3,943

 

2,225

 

Unvested founders’ stock

 

165

 

823

 

Total

 

4,108

 

3,048

 

 

Summary of significant accounting policies

 

Our other significant accounting policies are described in Note 2, “Summary of Significant Accounting Policies,” in our Annual Report on Form 10-K for the year ended December 31, 2014.

 

3.                                      OvaXon joint venture

 

In December 2013, we entered into a joint venture with Intrexon Corporation (“Intrexon”) to leverage Intrexon’s synthetic biology technology platform and OvaScience’s technology relating to egg precursor, or EggPC SM , cells to create new applications to prevent inherited diseases for human and animal health. We and Intrexon formed OvaXon, LLC (“OvaXon”) to conduct the joint venture. Each party contributed $1.5 million of cash to OvaXon, each has a 50% equity interest and research and development costs and profits will be split accordingly. Each party will also have 50% control over OvaXon and any disputes between us and Intrexon will be resolved through arbitration, if necessary.

 

We have recorded losses from equity method investments related to OvaXon of $0.5 million and $0.1 million for the three months ended March 31, 2015 and 2014, respectively. As of December 31, 2014, OvaXon had incurred expenses in excess of the initial investment. The additional expense incurred is included within accrued expenses on our balance sheet, as we had the intent to fund the joint venture in the future. Each party contributed an additional $0.8 million in January 2015.

 

We consider OvaXon a variable interest entity. OvaXon does not have a primary beneficiary as both OvaScience and Intrexon have equal ability to direct the activities of OvaXon through membership in a Joint Steering Committee and an Intellectual Property Committee and 50% voting rights. OvaXon has been accounted for under the equity method and is not consolidated. This analysis and conclusion will be updated annually to reflect any changes in ownership or control over OvaXon.

 

4.                                       Fair value

 

The fair value of our financial assets and liabilities reflects our estimate of amounts that we would have received in connection with the sale of such assets or paid in connection with the transfer of such liabilities in an orderly transaction between market participants at the measurement date. In connection with measuring the fair value of our assets and liabilities, we seek to maximize the use of observable inputs (market data obtained from independent sources) and to minimize the use of unobservable inputs (our assumptions about how market participants would price assets and liabilities). We use the following fair value hierarchy to classify assets and liabilities based on the observable inputs and unobservable inputs we used to value our assets and liabilities:

 

·                   Level 1—quoted prices (unadjusted) in active markets for identical assets or liabilities.

 

·                   Level 2—quoted prices for similar assets and liabilities in active markets or inputs that are observable for the asset or liability, either directly or indirectly through market corroboration, for substantially the full term of the financial instrument.

 

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·                   Level 3—unobservable inputs based on our assumptions used to measure assets and liabilities at fair value.

 

For fixed income securities, we reference pricing data supplied by our custodial agent and nationally known pricing vendors, using a variety of daily data sources, largely readily-available market data and broker quotes. The prices provided by third-party pricing services are validated by reviewing their pricing methods and obtaining market values from other pricing sources. After completing these validation procedures, we did not adjust or override any fair value measurements provided by the pricing services as of March 31, 2015 or December 31, 2014.

 

We review investments for other-than-temporary impairment whenever the fair value of an investment is less than the amortized cost and evidence indicates that an investment’s carrying amount is not recoverable within a reasonable period of time. To determine whether an impairment is other-than-temporary, we consider the intent to sell, or whether it is more likely than not that we will be required to sell the investment before recovery of the investment’s amortized cost basis. Evidence considered in this assessment includes reasons for the impairment, compliance with our investment policy, the severity and the duration of the impairment and changes in value subsequent to year end. As of March 31, 2015 and December 31, 2014, there were no investments with a fair value that was significantly lower than the amortized cost basis or any investments that had been in an unrealized loss position for a significant period.

 

The following tables provide our assets and liabilities that are measured at fair value on a recurring basis as of March 31, 2015 and December 31, 2014 (in thousands):

 

Description

 

Balance as of
March 31, 2015

 

Level 1

 

Level 2

 

Level 3

 

Assets:

 

 

 

 

 

 

 

 

 

Cash and money market funds

 

$

 134,698

 

$

 134,698

 

$

 —

 

$

 —

 

Corporate debt securities (including commercial paper)

 

34,641

 

 

34,641

 

 

Total assets

 

$

 169,339

 

$

 134,698

 

$

 34,641

 

$

 —

 

 

 

 

 

 

 

 

 

 

 

Description

 

Balance as of
December 31, 2014

 

Level 1

 

Level 2

 

Level 3

 

Assets:

 

 

 

 

 

 

 

 

 

Cash and money market funds

 

$

6,414

 

$

6,414

 

$

 

$

 

Corporate debt securities (including commercial paper)

 

53,817

 

 

53,817

 

 

Total assets

 

$

60,231

 

$

6,414

 

$

53,817

 

$

 

 

Cash and cash equivalents, prepaid expenses, accounts payable and accrued expenses are carried at amounts that approximate fair value due to their short-term maturities.

 

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5.                                       Cash, cash equivalents and short-term investments

 

The following tables summarize our cash, cash equivalents and short-term investments at March 31, 2015 and December 31, 2014 (in thousands):

 

March 31, 2015

 

Amortized Cost

 

Gross Unrealized
Gains

 

Gross Unrealized
Losses

 

Fair Value

 

Cash and money market funds

 

$

134,698

 

$

 

$

 

$

134,698

 

Corporate debt securities

 

 

 

 

 

 

 

 

 

Due in one year or less

 

34,642

 

5

 

(6

)

34,641

 

Total

 

$

169,340

 

$

5

 

$

(6

)

$

169,339

 

Reported as:

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

134,698

 

$

 

$

 

$

134,698

 

Short-term investments

 

34,642

 

5

 

(6

)

34,641

 

Total

 

$

169,340

 

$

5

 

$

(6

)

$

169,339

 

 

 

 

 

 

 

 

 

 

 

December 31, 2014

 

Amortized Cost

 

Gross Unrealized
Gains

 

Gross Unrealized
Losses

 

Fair Value

 

Cash and money market funds

 

$

6,414

 

$

 

$

 

$

6,414

 

Corporate debt securities

 

 

 

 

 

 

 

 

 

Due in one year or less

 

53,843

 

2

 

(28

)

53,817

 

Total

 

$

60,257

 

$

2

 

$

(28

)

$

60,231

 

Reported as:

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

6,414

 

$

 

$

 

$

6,414

 

Short-term investments

 

53,843

 

2

 

(28

)

53,817

 

Total

 

$

60,257

 

$

2

 

$

(28

)

$

60,231

 

 

At March 31, 2015 and December 31, 2014 we held twelve and thirty-two debt securities that had been in an unrealized loss position for less than 12 months, respectively. We held no investments that had been in a continuous unrealized loss position for 12 months or longer. At March 31, 2015 and December 31, 2014 the aggregate fair value of these securities was $13.2 million and $44.2 million, respectively. We evaluated our securities for other-than-temporary impairments based on quantitative and qualitative factors, and we considered the decline in market value for the twelve debt securities as of March 31, 2015 to be primarily attributable to current economic and market conditions. We will likely not be required to sell these securities, and we do not intend to sell these securities before the recovery of their amortized cost bases, which recovery is expected within the next 12 months. Based on our analysis, we do not consider these investments to be other-than-temporarily impaired as of March 31, 2015.

 

As of March 31, 2015, we held $5.4 million in financial institution debt securities and other corporate debt securities located in Canada and the United Kingdom. As of December 31, 2014, we held $7.5 million in financial institution debt securities and other corporate debt securities located in Canada, the United Kingdom, and France. Based on our analysis, we do not consider these investments to be other-than-temporarily impaired as of March 31, 2015.

 

We had no realized gains or losses or other-than-temporary impairments on our short-term investments for the three months ended March 31, 2015. We had immaterial realized gains and no losses or other-than-temporary impairments on our short-term investments for the three months ended March 31, 2014.

 

6.                                       Property and equipment

 

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

 

 

 

As of March 31,

 

As of December 31,

 

 

 

2015

 

2014

 

Laboratory equipment

 

$

5,089

 

$

4,093

 

Furniture

 

207

 

207

 

Computer equipment

 

7

 

7

 

Leasehold improvements

 

199

 

198

 

Total property and equipment, gross

 

5,502

 

4,505

 

Less: accumulated depreciation

 

(1,343

)

(1,138

)

Total property and equipment, net

 

$

4,159

 

$

3,367

 

 

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We recorded depreciation and amortization expense of $0.2 million and $0.1 million for the three months ended March 31, 2015 and 2014, respectively.

 

7.                                       Common stock

 

In January 2015, we issued and sold in an underwritten public offering an aggregate of 2,645,000 shares of our common stock at $50 per share, which included 345,000 shares that represented the full exercise of an option to purchase additional shares granted to the underwriters in connection with the offering. The shares included in this offering were registered under the Securities Act of 1933, as amended, or the Securities Act, pursuant to a registration statement on Form S-3 (File No. 333-200040) that the Securities and Exchange Commission declared effective on November 21, 2014. The offering resulted in $124.1 million of net proceeds, after deducting underwriting discounts and commissions and other offering expenses payable by us.

 

In March 2014, we issued and sold in a public offering an aggregate of 5,518,630 shares of our common stock at $10.00 per share, which included 518,630 shares that represented the partial exercise of an overallotment option granted to the underwriters in connection with the offering. The shares included in this offering were registered under the Securities Act of 1933, as amended, pursuant to a registration statement Form S-3 (File No. 333-190939) that the Securities and Exchange Commission declared effective on September 10, 2013. The offering resulted in $51.7 million of net proceeds, after deducting underwriting discounts and commissions and other offering expenses payable by us.

 

8.                                       Stock-based compensation

 

Founders’ stock

 

A summary of our Founders’ stock activity and related information is as follows:

 

 

 

Shares

 

Unvested at December 31, 2014

 

329,021

 

Granted

 

 

Vested

 

(164,515

)

Unvested at March 31, 2015

 

164,506

 

 

We record stock-based compensation expense for the common stock subject to repurchase based on the grant date intrinsic value for employees and the vesting date intrinsic value for non-employees. All of the restricted shares were issued at fair value.

 

Stock options

 

A summary of our stock option activity and related information is as follows:

 

 

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

Weighted

 

Average

 

 

 

 

 

 

 

average

 

Remaining

 

Aggregate

 

 

 

 

 

exercise

 

contractual

 

intrinsic

 

 

 

 

 

price per

 

Term

 

value

 

 

 

Shares

 

share

 

(years)

 

(in thousands)

 

 

 

 

 

 

 

 

 

 

 

Outstanding at December 31, 2014

 

3,628,628

 

$

16.01

 

9.11

 

$

102,355

 

Granted

 

419,500

 

42.10

 

 

 

 

 

Exercised

 

(130,690

)

6.91

 

 

 

 

 

Forfeited

 

(5,000

)

32.36

 

 

 

 

 

Cancelled

 

(4,006

)

11.30

 

 

 

 

 

Outstanding at March 31, 2015

 

3,908,432

 

19.10

 

9.02

 

64,178

 

Exercisable at March 31, 2015

 

698,661

 

8.94

 

7.99

 

18,016

 

Vested and expected to vest at March 31, 2015

 

2,598,271

 

18.63

 

8.95

 

44,097

 

 

The total intrinsic value (the amount by which the fair market value exceeded the exercise price) of stock options exercised was $4.9 million for the three months ended March 31, 2015.

 

The fair value of each stock-based option award is estimated on the grant date using the Black-Scholes option pricing model using the following assumptions:

 

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Three months ended March 31,

 

 

 

2015

 

2014

 

Risk-free interest rate

 

1.6% - 1.9%

 

1.6% - 1.8%

 

Dividend yield

 

 

 

Volatility

 

75%

 

78% - 84%

 

Expected term (years)

 

6.0 - 9.9

 

5.3 - 5.8

 

 

As of March 31, 2015, we had approximately $26.1 million of total unrecognized compensation cost, net of estimated forfeitures, related to unvested stock options, which we expect to recognize over a weighted-average period of 3.31 years.

 

During the three months ended March 31, 2015, we granted options to purchase 419,500 shares of our common stock at weighted average grant date fair values of $25.03 per share and with weighted average exercise prices of $42.10 per share. During the three months ended March 31, 2014, we granted options to purchase 377,098 shares of our common stock at weighted average grant date fair values of $7.06 and with weighted average exercise prices of $10.09 per share.

 

Restricted stock units

 

We granted restricted stock units (“RSUs”) to our Chief Executive Officer in December 2014 and 2012. The RSUs issued at each date included a service-based award that vests evenly over eight quarters and a performance-based award that vests in two one-year tranches upon the achievement of certain performance conditions for the respective year, as determined by our board of directors. The grant date fair value of the service-based awards is based on the closing price of our common stock on the award date and the stock-based compensation expense for these service-based awards are recognized on a straight-line basis over the vesting period. The grant date fair value of the performance-based awards is based on the closing price of our common stock on the date that the performance criteria is established for each tranche and communicated to our Chief Executive Officer and the stock-based compensation for these performance-based awards is recognized over the requisite service period.

 

The following table summarizes the December 9, 2014 award.

 

 

 

 

 

 

 

RSUs Vested

 

 

 

Number of

 

Grant Date

 

as of March

 

Award Type

 

RSUs Granted

 

Fair Value

 

31, 2015

 

 

 

 

 

 

 

 

 

Service-based

 

30,902

 

$

 32.36

 

3,862

 

Performance-based - Year 1

 

11,588

 

$

 43.47

 

 

Performance-based - Year 2

 

11,588

 

$

 —

 

 

 

The number of RSUs granted for the 2014 performance award is reflective of the maximum number of RSUs that can be earned, if the board of directors determines the performance criteria were achieved at 150%. On March 29, 2015 our board of directors established the 2015 performance criteria for the first tranche of the performance-based award and communicated the performance criteria to our Chief Executive Officer. The grant date stock price of these performance-based RSUs was $43.47 per share. As of March 31, 2015, we have determined that certain of the performance criteria are probable of achievement and we are recognizing the related expense for these awards over the requisite service period.

 

The following table summarizes the December 5, 2012 award.

 

 

 

 

 

 

 

RSUs Vested

 

 

 

Number of

 

Grant Date

 

as of March

 

Award Type

 

RSUs Granted

 

Fair Value

 

31, 2015

 

 

 

 

 

 

 

 

 

Service-based

 

128,205

 

$

7.80

 

128,205

 

Performance-based - Year 1

 

32,052

 

$

10.00

 

19,230

 

Performance-based - Year 2

 

32,051

 

$

8.75

 

32,051

 

 

The number of RSUs granted for the 2012 performance award is reflective of the maximum number of RSUs that can be earned, if the board of directors determined the performance criteria were achieved at 100%. On March 20, 2013 our board of directors

 

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established the 2013 performance criteria for the first tranche of the performance-based award and communicated the performance criteria to our Chief Executive Officer. In December 2013, certain of the performance criteria were met resulting in a partial vesting of the first tranche award. On February 7, 2014 our board of directors established the 2014 performance criteria for the second tranche of the performance-based award and communicated the performance criteria to our Chief Executive Officer. In December 2014 our board of directors determined that all of the performance criteria had been met resulting in the full vesting of the second tranche award.

 

The following expense has been recorded for the RSUs.

 

 

 

Expense Recorded in

 

 

 

March 31,

 

 

 

2015

 

2014

 

 

 

(in 000s)

 

December 9, 2014

 

 

 

 

 

Service-based

 

$

120

 

$

 

Performance-based

 

$

2

 

$

 

 

 

$

122

 

$

 

December 5, 2012

 

 

 

 

 

Service-based

 

$

 

$

119

 

Performance-based

 

$

 

$

45

 

 

 

$

 

$

164

 

 

As of March 31, 2015, we had approximately $1.2 million of total unrecognized compensation cost, net of estimated forfeitures, related to unvested restricted stock units, which we expect to recognize over a weighted-average period of 1.47 years.

 

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

 

This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties. The statements contained in this Quarterly Report on Form 10-Q that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Without limiting the foregoing, the words “may,” “shall,” “will,” “should,” “could,” “expects,” “plans,” “intends,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” “target,” “goal”, “seek”, “likely,” “hope” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. All forward-looking statements included in this Quarterly Report on Form 10-Q are based on information available to us up to, and including, the date of this document, and we expressly disclaim any obligation to update any such forward-looking statements to reflect events or circumstances that arise after the date hereof. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of certain important factors, including those set forth in this Item 2 — “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” as well as under the heading “Risk Factors” contained in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2014 and elsewhere in this Quarterly Report on Form 10-Q. You should carefully review those factors and also carefully review the risks outlined in other documents that we file from time to time with the Securities and Exchange Commission, or SEC.

 

Overview

 

OvaScience is a global fertility company focused on the discovery, development, and commercialization of new treatment options. More women around the world are waiting to start families. However, fertility decreases with age. A major cause of infertility, especially in older women, is poor egg health, which is linked to a reduction in the number of functioning mitochondria. Accordingly, women throughout the world are increasingly seeking new treatment options for infertility. The current standard of treatment for infertility is in vitro fertilization, or IVF, but it fails approximately 70% of the time.

 

Our patented technology is based on egg precursor, or EggPC SM , cells, which are immature egg cells found in the protective outer lining of a woman’s own ovaries. These immature egg cells have the ability to grow into fresh, young, healthy eggs. The discovery of EggPC cells countered a long-held medical belief that women are born with a set number of eggs, thereby enabling new fertility treatment options.

 

Our portfolio of fertility treatment options uses proprietary methods to identify and isolate EggPC cells from a woman’s ovarian tissue. By applying our EggPC technology platform in unique ways, we are developing and commercializing new fertility treatment options that are designed to improve egg health and revolutionize IVF.

 

Our first treatment, the AUGMENT SM  treatment, has been launched in select international IVF clinics, and we anticipate that we will introduce the AUGMENT treatment into new international regions in 2015. The AUGMENT treatment is not available in the United States. This treatment is specifically designed to improve egg health by supplementing a mitochondrial deficiency and may, in turn, improve IVF. With the AUGMENT treatment, energy-producing mitochondria from a woman’s own EggPC cells are added to the woman’s mature eggs during the IVF process to supplement the existing mitochondria. We expect 1,000 AUGMENT treatment cycles will be in process by the end of 2015. We have set this target to ensure that we are building a high-quality and scalable operating process to support our future fertility treatment portfolio.

 

The OvaPrime SM  treatment is a potential fertility treatment that could enable a woman to increase her egg reserve. The OvaPrime treatment is designed to replenish a woman’s egg reserve by transferring a patient’s EggPC cells from the protective ovarian lining back into the patient’s own ovaries where they may mature into fertilizable eggs during the IVF process. We reported large animal proof-of-concept studies in 2014 and plan to optimize the process and introduce the OvaPrime treatment to patients in at least one international region outside of the United States by the end of 2015.

 

The OvaTure SM  treatment is a potential next-generation IVF treatment that could help a woman produce healthy, young, fertilizable eggs without the need for hormone injections. The OvaTure treatment seeks to mature a woman’s own EggPC cells into eggs outside her body. This potential treatment may be an option for women with compromised eggs, who are unable to make eggs, or who may be unwilling or unable to undergo hormone hyperstimulation, such as women diagnosed with cancer. We established human preclinical proof-of-concept in 2014 by demonstrating that human EggPC cells can be matured into eggs outside of the body, and we plan to optimize the process and define the development pathway for the OvaTure treatment in 2015.

 

We believe our EggPC technology has the potential to make significant advances in the field of fertility because it is designed to address poor egg health and embryo quality due to age and other causes. We believe our EggPC technology could improve IVF by:

 

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Increasing live birth rates and reducing the number of IVF cycles.   By improving egg health, we believe we may increase the percentage of live births and reduce the number of IVF cycles required.

 

Reducing the incidence of multiple births.   By generating higher quality eggs, we believe our EggPC technology may allow for the transfer of fewer embryos per IVF cycle and, as a result, lower the incidence of multiple births and the associated complications.

 

Lowering the overall cost of the IVF process.   If we reduce the number of IVF cycles required for a live birth and the incidence of multiple births, we believe our fertility treatment options may also lower the overall costs associated with the IVF process.

 

Replenishing the ovary for women who make too few or no eggs.   Our OvaPrime treatment is designed to replenish a woman’s egg reserve by transferring a patient’s EggPC cells from the protective ovarian lining back into the patient’s own ovaries where they may mature into fertilizable eggs during the IVF process.

 

Reducing the need for hormonal hyperstimulation.   We are designing our OvaTure treatment to mature EggPC cells into fertilizable eggs in vitro, or outside the body. If successful, the OvaTure treatment could reduce, or possibly eliminate, the need for hormonal hyperstimulation for the maturation of multiple oocytes prior to egg retrieval in the IVF process.

 

Preventing inherited diseases.   OvaXon SM  is a joint venture with Intrexon Corporation, or Intrexon, which is focused on developing new applications to prevent the transmission of inherited diseases using our EggPC cells technology and Intrexon’s synthetic biology and high throughput platform for applications in human and animal health.

 

The AUGMENT Treatment

 

We have launched the AUGMENT treatment in select international IVF clinics and anticipate that we will introduce the AUGMENT treatment into new international regions in 2015. Initial positive clinical experiences with the AUGMENT treatment were presented in poster sessions at the Society for Reproductive Investigation (SRI) 62nd Annual Meeting in March 2015 by two IVF specialists who are offering the AUGMENT treatment in their practices, Robert F. Casper, M.D., F.R.C.S.(C), Medical Director of TCART Fertility Partners of Toronto, Canada, and Kutluk Oktay, M.D., F.A.C.O.G, of Gen-art IVF in Ankara, Turkey. Both doctors reported ongoing clinical pregnancies in women who had poor embryo development and failed to have a successful pregnancy after multiple IVF cycles and embryo transfers. The AUGMENT treatment is not available in the United States. As part of the AUGMENT treatment, a woman’s eggs may be revitalized by injecting mitochondria from her own EggPC cells into her egg during IVF. This has the potential to improve egg health and may, in turn, offer the potential for improved IVF.

 

The AUGMENT treatment complements the existing standard of practice for an IVF cycle. Prior to hormone hyperstimulation, a small ovarian tissue biopsy is taken by the patient’s doctor. Our proprietary process identifies and isolates the patient’s own EggPC cells, and then the patient’s own mitochondria from these EggPC cells are isolated. The patient’s own mitochondria are then injected into her egg at the time of intracytoplasmic sperm injection, or ICSI.

 

We expect 1,000 AUGMENT treatment cycles will be in process by the end of 2015. The AUGMENT treatment cycle begins upon our receipt of the patient’s tissue. We expect to receive payment before processing tissue and defer revenue until we deliver the mitochondria to the clinic.

 

We continue to target major international regions for the AUGMENT treatment that combine elements of the following key criteria:

 

·                   Key opinion leaders

 

·                   High volume IVF clinics

 

·                   High quality IVF labs

 

·                   Out-of-pocket pay and high average cost per cycle

 

·                   Donor egg restrictions

 

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Recent Developments

 

On April 29, 2015, our Board of Directors appointed John Sexton, Ph.D., the President of New York University (NYU), to our Board to serve as a Class II Director with a term expiring at the 2017 annual meeting of stockholders.

 

Critical Accounting Policies and Significant Judgments and Estimates

 

The discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of our condensed consolidated financial statements requires us to make judgments, estimates and assumptions that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. We evaluate our estimates, on an ongoing basis, including those related to accrued expenses and assumptions in the valuation of stock-based compensation. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable in the circumstances. Actual results could differ from those estimates.

 

Refer to Part II, Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our Annual Report on Form 10-K for the year ended December 31, 2014 for a discussion of our critical accounting policies and estimates.

 

There were no significant changes to our critical accounting policies and estimates in the three months ended March 31, 2015.

 

We have irrevocably elected not to follow the extended transition period available to emerging growth companies provided for in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards.

 

Results of Operations

 

The following table summarizes our results of operations for the three months ended March 31, 2015 and 2014, together with the change in these items in thousands of dollars and as a percentage (dollars in thousands):

 

 

 

 

 

2015 / 2014

 

 

 

Three Months Ended,

 

Comparison

 

 

 

March 31,

 

Increase / (Decrease)

 

 

 

2015

 

2014

 

$

 

%

 

Revenues

 

$

15

 

$

 

$

15

 

100

%

Costs of revenues

 

35

 

 

35

 

100

%

Research and development expenses

 

5,747

 

4,652

 

1,095

 

24

%

Selling, general and administrative expenses

 

11,046

 

2,998

 

8,048

 

268

%

Interest income (expense), net

 

44

 

(57

)

101

 

-177

%

Other income (expense), net

 

34

 

(10

)

44

 

-440

%

Loss from equity method investment

 

471

 

97

 

374

 

386

%

Net Loss

 

$

17,206

 

$

7,814

 

$

9,392

 

120

%

 

Revenues

 

We commenced our first commercial AUGMENT treatment in December 2014 and recorded $15.0 thousand of treatment revenues in the first quarter of 2015 for that AUGMENT cycle. During the three months ended March 31, 2015, we continued to transition certain of our ACE clinics to commercial centers and, as anticipated, began performing limited commercial AUGMENT treatment cycles, for which we received cash and expect to recognize the associated revenue over the coming quarters. The AUGMENT treatment cycle begins upon our receipt of the patient’s tissue. We expect to receive payment before processing tissue and defer treatment revenues until we deliver the mitochondria to the clinic. Based on our experiences to date, the period from receipt of the patient’s tissue to recording revenue is expected to range between 30 and 120 days, the typical timeframe required to perform an IVF cycle. Accordingly, we do not expect to have significant revenue or deferred revenue until the second half of 2015, and we expect that a majority of this revenue and deferred revenue will be recorded in the fourth quarter. Our ability to generate revenue in the near-term will depend on the number of commercial AUGMENT treatment cycles our ACE clinics perform and the treatment prices charged. We expect that the commercial ramp of the AUGMENT treatment during 2015 will depend upon the successful transition of ACE clinics to commercial operations, the addition of new ACE clinics and the results from ACE clinic experience as they become available.

 

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Costs of Revenues

 

To provide our AUGMENT treatment we establish laboratories and hire scientific personnel to process the patient tissue. Therefore, we expect the cost of processing an AUGMENT treatment to decline as these fixed costs will be allocated over a larger number of treatments as we continue our commercial launch. Our costs of revenues include the cost of processing patient tissue that corresponds to treatment revenues for the reporting period. We recorded initial revenues related to the AUGMENT treatment and corresponding costs of revenues during the first quarter of 2015. We did not have costs of revenues in Q1 2014.

 

Research and Development Expense

 

The $1.1 million, or 24%, increase in our research and development expense for the three months ended March 31, 2015 as compared to the three months ended March 31, 2014 was primarily attributable to:

 

·                   An increase of $2.2 million in stock-based compensation expense. The increase was primarily driven by certain mark-to-market adjustments of Founders’ stock for an additional $1.9 million.

·                   The additional costs were offset by a net $0.8 million decrease in license fees, resulting from a decrease of $1.0 million for the milestone that became due in 2014 upon completion of our public offering in 2014 and did not recur in 2015, which were offset by $0.2 million for a milestone incurred as a result of our first commercial AUGMENT treatment.

 

We expect research and development expense to increase if our programs successfully advance. We do not believe that the historical costs are indicative of the future costs associated with these programs nor do they represent what any other future treatment program we initiate may cost. Due to the variability in the length of time and scope of activities necessary to develop a fertility treatment and uncertainties related to cost estimates and our ability to commercialize and/or obtain marketing approval for our treatments, accurate and meaningful estimates of the total costs required to bring our treatments to market are not available.

 

Because of the risks inherent in discovery and development, we cannot reasonably estimate or know:

 

·                   The nature, timing and estimated costs of the efforts necessary to complete the development of our programs;

·                   The anticipated completion dates of these programs; or

·                   The period in which material net cash inflows are expected to commence, if at all, from the programs described above and any potential future treatments.

 

Selling, General and Administrative Expense

 

Selling, general and administrative costs consist of ongoing costs to run our operations and continue to support the expanding international availability of the ACE access program for the AUGMENT treatment. The $8.0 million, or 268%, increase in selling, general and administrative expense for the three months ended March 31, 2015 as compared to the three months ended March 31, 2014 was primarily due to:

 

·                   An increase of $4.5 million for employee compensation and related benefits, including stock-based compensation expense. The increase was primarily driven by the hiring of new selling, general and administrative personnel and $1.1 million in stock-based compensation expense related to Founders’ stock requiring mark-to-market accounting treatment.

·                   An increase of $1.7 million in ACE access program set-up costs including travel and facilities costs.

·                   An increase of $1.4 million in additional consulting, legal and marketing expenses as we continue to focus on the expanding international availability of the AUGMENT treatment.

·                   An increase of $0.4 million in facilities and other administrative costs.

 

Interest Income (Expense), Net

 

In the three months ended March 31, 2015 there was immaterial interest income, net related to short-term investments. Interest expense, net was $0.1 million for the three months ended March 31, 2014 which included $0.3 million of short term investment amortization and interest expense incurred to record the final installment payment due to Intrexon at fair value offset by $0.2 million of interest income.

 

Loss from Equity Method Investment

 

Loss from equity method investment was $0.5 million and $0.1 million for the three months ended March 31, 2015 and 2014, respectively. The losses result from our OvaXon joint venture established in December 2013.

 

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Liquidity and Capital Resources

 

Sources of Liquidity

 

We have generated limited AUGMENT treatment revenue to date. We have relied on the proceeds from sales of equity securities to fund our operations. Our short-term investments primarily trade in liquid markets, and the average days to maturity of our portfolio as of March 31, 2015 are less than six months. Because our fertility treatments are in various stages of development and the outcome of these efforts is uncertain, we cannot estimate the actual amounts necessary to successfully complete the development and commercialization of our treatments or whether or when we may achieve profitability.

 

Our significant capital resources are as follows (in thousands):

 

 

 

March 31,

 

December 31,

 

 

 

2015

 

2014

 

Cash, cash equivalents and short-term investments

 

$

169,339

 

$

60,231

 

Working capital

 

164,725

 

51,704

 

 

 

 

Three Months Ended,

 

 

 

March 31,

 

 

 

2015

 

2014

 

Cash (used in) provided by:

 

 

 

 

 

Operating activities

 

$

(14,394

)

$

(4,961

)

Investing activities

 

17,891

 

(8,644

)

Capital expenditures (included in investing activities above)

 

(389

)

 

Financing activities

 

124,787

 

51,661

 

 

Cash Flows

 

Cash used in operating activities in both of the periods presented was primarily driven by our net loss. Cash flows from operations can vary significantly due to various factors, including changes in the net loss and the timing of disbursements made for accounts payable and accruals.

 

Cash used in investing activities for the three months ended March 31, 2015 included a $0.8 million investment in a joint venture and capital expenditures of $0.4 million, which were offset by $19.0 million of proceeds from maturities of short-term investments. Capital expenditures in the three months ended March 31, 2015 primarily consisted of laboratory equipment.

 

Cash used in investing activities for the three months ended March 31, 2014 included the purchase of and proceeds from maturities of short-term investments and $4.4 million in sales of short-term investments. Our investing activities for the three months ended March 31, 2014 included $1.5 million investment in a joint venture.

 

Net cash provided by financing activities for the three months ended March 31, 2015 was primarily the result of an underwritten public offering of an aggregate of 2,645,000 shares of common stock at a price per share of $50.00 resulting in net proceeds of $124.1 million. Stock option exercises and issuances of common stock resulted in net proceeds of $0.7 million.

 

Net cash provided by financing activities for the three months ended March 31, 2014 was primarily the result of a underwritten public offering of an aggregate of 5,518,630 shares of common stock at a price per share of $10.00 resulting in net proceeds of $51.7 million.

 

We may need substantial additional funds to support our planned operations and commercialization strategy. We expect our existing cash, cash equivalents and short-term investments of $169.3 million at March 31, 2015 will enable us to fund our current operating plan at least into 2017. We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our treatments, and the extent to which we may enter into collaborations with third parties for development and commercialization of our treatments, we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the development of our current treatments in development. Our future capital requirements will depend on many factors, including:

 

·                   our success in expanding to new ACE clinics in other major regions of the world, transitioning ACE clinics to commercial centers and significantly increasing the number of patients receiving the AUGMENT treatment;

 

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·                   our success in optimizing and introducing the OvaPrime treatment to international IVF clinics;

 

·                   the costs associated with the expansion of foreign operations and building out our international commercial infrastructure, including establishing and staffing an international headquarters and other international subsidiaries;

 

·                   the costs associated with establishing a domestic and international sales, marketing, manufacturing and distribution infrastructure to commercialize the AUGMENT treatment and any potential fertility treatment we successfully develop;

 

·                   the pricing of the AUGMENT treatment and resulting revenues, as well as any future revenues we receive from our potential fertility treatments;

 

·                   the costs of continuing the optimization of the OvaTure treatment and our success in defining a development pathway;

 

·                   the costs of any clinical trials of potential fertility treatments;

 

·                   the costs involved in collaborating with Intrexon through the OvaXon joint venture to create new applications to prevent inherited diseases for human and animal health;

 

·                   following any applicable regulatory process in the United States and abroad, including the premarketing and marketing approval requirements, to which any of our potential fertility treatments may be subject;

 

·                   following any regulatory or institutional review board review of our potential fertility treatments that are subject to such review;

 

·                   preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;

 

·                   establishing collaborations and partnerships on favorable terms, if at all; and

 

·                   developing, acquiring or in-licensing other potential fertility treatments and technologies.

 

Until such time, if ever, as we can generate sufficient revenues from the AUGMENT treatment or our potential fertility treatments to become profitable, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. We do not have any committed external source of funds. In addition, we may elect to raise additional funds even before we need them if the conditions for raising capital are favorable. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of common stockholders. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or treatments or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our fertility treatment development or future commercialization efforts or grant rights to develop and market treatments that we would otherwise prefer to develop and market ourselves.

 

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 under SEC rules.

 

Contractual Obligations

 

There have been no material changes to our contractual obligations set forth under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Contractual Obligations” in our Annual Report on Form 10-K for the year ended December 31, 2014.

 

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Recently Adopted Accounting Standards

 

There are no recently issued accounting standards that have a material impact on us for the periods presented.

 

Item 3.                                  Quantitative and Qualitative Disclosures About Market Risk

 

Our interest income is sensitive to changes in the general level of U.S. interest rates, particularly since a significant portion of our investments are in money market funds and corporate obligations. We do not enter into investments for trading or speculative purposes. We maintain our cash, cash equivalents and short-term investments with a high quality, accredited financial institution. Our marketable securities are subject to interest rate risk and will fall in value if market interest rates increase.

 

A hypothetical 100 basis point increase in interest rates would result in an approximately $0.1 million decrease in the fair value of our investments as of March 31, 2015, as compared to an approximately $0.2 million decrease as of December 31, 2014. We have the ability to hold our fixed income investments until maturity and, therefore, we do not expect our operating results or cash flows to be affected to any significant degree by the effect of a change in market interest rates on our investments.

 

Item 4.                                  Controls and Procedures

 

Evaluation of Disclosure 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 March 31, 2015. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. 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. Based on the evaluation of our disclosure controls and procedures as of March 31, 2015, our principal executive officer and principal financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

 

Changes in Internal Controls.   No change in our internal control over financial reporting occurred during the fiscal quarter ended March 31, 2015 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

Part II.                                Other Information

 

Item 1.                                  Legal Proceedings

 

On September 16, 2013, a purported shareholder class action, styled Meriam Ratner v. OvaScience, Inc., et al., was filed in the United States District Court for the District of Massachusetts, naming us and certain of our officers as defendants. The lawsuit alleges that we made material misrepresentations and/or omissions of material fact relating to the qualification of AUGMENT as a 361 HCT/P in our public disclosures during the period from February 25, 2013 through September 10, 2013, in violation of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated thereunder. On February 2, 2014, we and certain of our officers, as defendants, filed a motion to dismiss with the District Court. On February 3, 2014, plaintiff Meriam Ratner voluntarily dismissed the suit without prejudice.

 

On June 6, 2014, this purported shareholder class action was re-filed by the plaintiff in the United States District Court for the District of Massachusetts, naming us and certain of our officers as defendants. The lawsuit includes the same allegations as were included in the action filed on September 16, 2013. The plaintiff filed an amended complaint on October 31, 2014. As amended, the complaint seeks certification of a class of purchasers of our stock during the period February 25, 2013 through September 10, 2013. The plaintiff seeks unspecified monetary damages on behalf of the putative class and an award of costs and expenses, including attorney’s fees. On December 16, 2014, we moved to dismiss the complaint. The court has not yet ruled on that motion. We believe that this action is without merit and intend to defend it vigorously. At this time, no assessment can be made as to the likely outcome of this lawsuit or whether the outcome will be material to us.

 

19



Table of Contents

 

We are not party to any other litigation in any court and management is not aware of any contemplated proceeding by any governmental authority against the Company.

 

Item 1A.                         Risk Factors

 

You should carefully review and consider the information regarding certain factors that could materially affect our business, financial condition or future results set forth under Item 1A. (Risk Factors) in our Annual Report on Form 10-K for the fiscal year ended December 31, 2014. There have been no material changes from the factors disclosed in our 2014 Annual Report on Form 10-K, although we may disclose changes to such factors or disclose additional factors from time to time in our future filings with the Securities and Exchange Commission.

 

Item 6.                                  Exhibits

 

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

 

Signatures

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

OVASCIENCE, INC.

 

 

 

 

 

By:

/s/ Michelle Dipp, M.D., Ph.D.

 

 

Name:

Michelle Dipp, M.D., Ph.D.

Date: May 11, 2015

 

Title:

Chief Executive Officer (Principal Executive Officer)

 

 

 

 

 

 

 

 

 

By:

/s/ Jeffrey Young

 

 

Name:

Jeffrey Young

Date: May 11, 2015

 

Title:

Chief Financial Officer (Principal Accounting and Financial Officer)

 

20



Table of Contents

 

Exhibit Index

 

Exhibit

 

Description

 

 

 

10.1

 

Amended and Restated Non-Employee Director Compensation Policy of the Registrant (effective March 3, 2015) (incorporated by reference to Exhibit 10.34 of the Registrant’s Annual Report on Form 10-K filed March 16, 2015 (File No. 001-35890)).

 

 

 

10.2*

 

Exclusive License Agreement, dated June 27, 2011, between the Registrant and the General Hospital Corporation.

 

 

 

10.3*

 

Amendment No. 1 to the Exclusive License Agreement, dated September 27, 2011, between the Registrant and the General Hospital Corporation.

 

 

 

31.1

 

Certification of Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 by Principal Executive Officer.

 

 

 

31.2

 

Certification of Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 by Principal Financial Officer.

 

 

 

32.1

 

Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, by Principal Executive Officer.

 

 

 

32.2

 

Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, by Principal Financial Officer.

 

 

 

101.INS

 

XBRL Instance Document

 

 

 

101.SCH

 

XBRL Taxonomy Extension Schema Document

 

 

 

101.CAL

 

XBRL Taxonomy Extension Calculation Linkbase Document

 

 

 

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase Document

 

 

 

101.LAB

 

XBRL Taxonomy Extension Label Linkbase Document

 

 

 

101.PRE

 

XBRL Taxonomy Presentation Linkbase Document

 


*      Refiled with terms that were disclosed by the Registrant subsequent to the grant of confidential treatment.

 

21


Exhibit 10.2

 

THE GENERAL HOSPITAL CORPORATION

 

EXCLUSIVE LICENSE AGREEMENT

 

MGH Agreement No: A209968
MGH Case Nos: 02595 and 21131

 

This Exclusive License Agreement (“Agreement”) is made as of the 27 th  day of June, 2011 (“Effective Date”), by and between OvaScience, Inc ., a Delaware corporation, having a principal place of business at The Prudential Tower, 800 Boylston Street, Suite 1555, Boston, MA 02199 (“Company”) and The General Hospital Corporation , d/b/a Massachusetts General Hospital, a not-for-profit Massachusetts corporation, with a principal place of business at 55 Fruit Street, Boston, Massachusetts 02114 (“Hospital”), each referred to herein individually as a “Party” and collectively as the “Parties”.

 

RECITALS

 

Hospital, as a center for patient care, research and education, is the owner of certain Patent Rights (defined below) and desires to grant a license of those Patent Rights to Company in order to benefit the public by disseminating the results of its research via the commercial development, manufacture, distribution and use of Products and Processes (defined below).

 

Company has the capability to commercially develop, manufacture, distribute and use Products and Processes for public use and benefit and desires to license such Patent Rights.

 

For good and valuable consideration, the sufficiency of which is hereby acknowledged, the Parties hereby agree as follows:

 

1.  CERTAIN DEFINITIONS

 

As used in this Agreement, the following terms shall have the following meanings, unless the context requires otherwise.

 

1.1                                Affiliate ” with respect to either Party shall mean any corporation or other legal entity other than that Party, in whatever country organized, that controls, is controlled by or is under common control with that Party.  The term “control” shall mean (i) in the case of Company, direct or indirect ownership of fifty percent (50%) or more of the voting securities having the right to elect directors, or the power, direct or indirect, to cause the direction of management and policies, whether by contract or otherwise and (ii) in the case of Hospital, the power, direct or indirect, to elect or appoint fifty percent (50%) or more of the directors or trustees, or to cause direction of management and policies, whether through the ownership of voting securities, by contract or otherwise.

 

1.2                                Claim ” shall mean any pending or issued claim of any Patent Right that has not been abandoned or permanently revoked, nor held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction that is unappealable or unappealed in the time allowed for appeal.

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

1



 

CONFIDENTIAL TREATMENT REQUESTED

 

1.3                                Clinical End User ” shall mean those fertility clinics and medical practices that purchase and/or use Products and/or Processes for patients (end users) pursuant to agreements with Company or any of its Affiliates or Sublicensees.

 

1.4                                Clinical Proof of Concept ” shall mean the completion of a clinical study conducted by or on behalf of Company or any of its Affiliates or Sublicensees using a Product or Process, consisting of a minimum of [***] women patients, in which the average pregnancy rate (as measured by fetal heart beat) of all women in such study is at least [***] percent ([***]%) above the average pregnancy rate via fresh embryo transfer in the most recent National SART Clinic Summary Report for the age group adjusted average, as a result of the use of such Product or Process.

 

1.5                                Distributor ” shall mean any third party entity to whom Company or any of its Affiliates or Sublicensees has granted, express or implied, the right to distribute any Product or Process pursuant to Section 2.1(b)(ii).

 

1.6                                First Commercial Sale ” shall mean the initial Sale anywhere in the applicable License Territory of a Product or Process that is either (a) to any party that is not part of a clinical study sponsored by Company or any of its Affiliates or Sublicensees, or (b) not used or intended to be used for a patient enrolled in a clinical study sponsored by Company or any of its Affiliates or Sublicensees; and provided Company or any of its Affiliates or Sublicensees has either (i) received all approvals from the FDA or other equivalent regulatory authority necessary for the commercial marketing of such Product or Process or (ii) completed enrollment and treatment of at least [***] women in a Clinical Proof of Concept study.

 

1.7                                License Field ” shall mean human female fertility and shall specifically exclude (a) treatments of menopause associated symptoms or diseases other than treatments of infertility; (b) treatments to delay menopause or menopause associated symptoms or diseases other than treatments of infertility; (c) diagnostics; (d) research tools, or any other field not specifically set forth herein.

 

1.8                                License Territory ” shall mean worldwide.

 

1.9                                Net Sales ” shall be calculated as set forth in this Section 1.9.

 

(a)                                  Subject to the conditions set forth below, “Net Sales” shall mean:

 

(i)                                      the gross amount billed or invoiced, or if no bill or invoice is issued the amount received, whichever is greatest, by Company and its Affiliates and Sublicensees for or on account of Sales of Products and/or Processes; provided that , with respect to the sale and/or use of Products and/or Processes by Clinical End Users (in their capacities as Clinical End Users), the amounts paid by Clinical End Users to Company, its Affiliates and Sublicensees shall be considered gross amounts billed or invoiced for purposes of calculating Net Sales and the amounts billed or invoiced by Clinical End Users to fertility patients (or such patients’ insurers or other third party payers) shall be excluded from the calculation of Net Sales;

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

2



 

CONFIDENTIAL TREATMENT REQUESTED

 

(ii)                                   less the following amounts:

 

(A)                                to the extent separately stated on the applicable bill or invoice, actually paid by Company and its Affiliates and Sublicensees in effecting such Sale:

 

1.                                       amounts repaid or credited by reason of rejection or return of applicable Products or Processes;

 

2.                                       reasonable and customary trade, quantity or cash rebates or discounts to the extent allowed and taken;

 

3.                                       amounts for outbound transportation, insurance, handling and shipping, but only to the extent separately invoiced in a manner that clearly specifies the charges applicable to the applicable Products; and

 

4.                                       taxes, customs duties and other governmental charges levied on or measured by Sales of Products or Processes, to the extent separately invoiced, whether paid by or on behalf of Company so long as Company’s price is reduced thereby, but not franchise or income taxes of any kind whatsoever.

 

(B)                                the gross amount received by Company and its Affiliates and Sublicensees for or on account of Sales of Products and Processes to Hospital and Hospital’s Affiliates.

 

(C)                                gross amounts billed or invoiced by Company and its Affiliates and Sublicensees in prior periods for or on account of Sales of Products and Processes that are not received within [***] months of billing or invoicing and are charged off or written off as uncollectable, such amounts not to exceed [***] percent ([***]%) of gross amounts billed or invoiced.

 

(b)                                  Specifically excluded from the definition of “Net Sales” are amounts attributable to any Sale of any Product or Process between or among Company and any Company Affiliate and/or Sublicensee, unless the transferee is the end purchaser, user or consumer of such Product or Process.

 

(c)                                   No deductions shall be made for any commissions paid to any individuals or for any costs or expenses of collections.

 

(d)                                  Net Sales shall be deemed to have occurred and the applicable Product or Process “Sold” on the earliest of the date of billing, invoicing, delivery or payment or the due date for payment.

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

3



 

CONFIDENTIAL TREATMENT REQUESTED

 

(e)                                   If any Product or Process is Sold for non-cash consideration, Net Sales shall be calculated based on the average cash amount charged to independent third parties for the Product or Process during the same Reporting Period or, in the absence of such transactions, on the fair market value of the Product or Process.  Non-cash consideration that could affect any payment due to Hospital hereunder shall not be accepted without the prior written consent of Hospital.  In addition, Company shall not grant discounts on Sales of Products or Processes in exchange for any consideration other than the Sale price of such Products or Processes without the prior written consent of Hospital.

 

(f)                                    Notwithstanding the foregoing, if Company or any of its Affiliates (or Sublicensees for which Net Sales are not established pursuant to clause (a)(i) above, if any) use and/or sell Products and/or Processes as a Clinical End User, such use and/or sale shall be deemed a Sale and Net Sales based on such Sale shall be deemed to be an amount determined as follows:

 

(i)                                      the average Net Sales amount resulting from equivalent uses and/or sales of Products and/or Processes by independent third party Clinical End Users during the same Reporting Period; or

 

(ii)                                   in the absence of transactions referenced in clause (f)(i) above, the Parties shall first discuss an alternative Net Sales amount to use until such time, if ever, there are independent third party Clinical End User transactions that can be used to calculate imputed Net Sales.  Absent agreement on an alternative Net Sales amount, a royalty in the amount of [***] dollars ($[***]) shall be payable (during the royalty term specified in Section 10.1) on each use and/or sale by Company or its Affiliates (or Sublicensees for which Net Sales are not established pursuant to clause (a)(i) above, if any) in lieu of the royalty amount calculated in Section 4.5(a) until such time, if ever, as there are independent third party Clinical End User transactions that can be used to calculate Net Sales in accordance clause (f)(i) above.

 

(iii)                                The Net Sales or royalty determined in accordance with the foregoing clauses (f)(i) and (f)(ii) shall be in lieu of any other calculation of Net Sales or royalties, as applicable, based on such use and/or sale.

 

1.10                         Patent Rights ” shall mean, inclusively, the U.S. Patent Applications listed in Appendix A and/or the equivalent of such application, including any divisional, continuation (including claims of continuations-in-part only to the extent entirely supported by the specification of the application on which such continuations-in-part are based), foreign counterpart patent application, Letters Patent and/or the equivalent thereof issuing thereon, and/or reissue, reexamination or extension thereof, or supplementary protection certificate or patents of addition relating thereto.

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

4



 

CONFIDENTIAL TREATMENT REQUESTED

 

 

1.11                         Process ” shall mean any process, method or service the use or performance of which, in whole or in part:

 

(a)                                  absent the license granted hereunder would infringe, or is covered by, one or more Claims of Patent Rights; or

 

(b)                                  employs, is based upon or is derived from Technological Information.

 

1.12                         Product ” shall mean any article, device or composition, the manufacture, use, or sale of which, in whole or in part:

 

(a)                                  absent the license granted hereunder would infringe, or is covered by, one or more Claims of Patent Rights; or

 

(b)                                  employs, is based upon or is derived from Technological Information.

 

1.13                         Reporting Period ” shall mean each three month period ending March 31, June 30, September 30 and December 31.

 

1.14                         Sell ” (and “Sale” and “Sold” as the case may be) shall mean to sell or have sold, to lease or have leased, to import or have imported or otherwise to transfer or have transferred a Product or Process for valuable consideration (in the form of cash or otherwise), and further in the case of a Process to use or perform such Process for the benefit of a third party for valuable consideration (in the form of cash or otherwise).

 

1.15                         Sublicense Income ” shall mean consideration in any form received by Company and/or Company’s Affiliate(s) in connection with or otherwise attributable to a grant of a sublicense or any other right, license, privilege or immunity (regardless of whether such grantee is a “Sublicensee” as defined in this Agreement) to make, have made, use, have used, Sell or have Sold Products or Processes, but excluding consideration included within Net Sales.  Sublicense Income shall include without limitation any license signing fee, license maintenance fee, unearned portion of any minimum royalty payment, distribution or joint marketing fee, research and development funding solely to the extent exceeding the reasonable cost (including reasonable allocations of overhead) of performing such research and development, funding for training in the use of Products and Processes solely to the extent exceeding reasonable cost-based funding (including without limitation travel costs and costs of training materials) and any consideration received for an equity interest in, extension of credit to or other investment in Company or Company’s Affiliates to the extent such consideration exceeds the fair market value of the equity or other interest received as determined by agreement of the Parties or by an independent appraiser mutually agreeable to the Parties (but shall exclude such consideration not exceeding fair market value).

 

1.16                         Sublicensee ” shall mean any sublicensee of rights granted in accordance with Section 2.1 (a)(ii).  For purpose of this Agreement, a Distributor of a Product or Process shall not be included in the definition of Sublicensee unless such Distributor (i) is granted any right to make, have made, use or have used Products or Processes in accordance with Section 2.1(a)(ii), or (ii) has agreed to pay to Company or its Affiliate(s) royalties on such Distributor’s sales of Products

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

5



 

CONFIDENTIAL TREATMENT REQUESTED

 

or Processes, in which case such Distributor shall be a Sublicensee for all purposes of this Agreement.

 

1.17                         Technological Information ” shall mean research data, designs, formulae, process information and other information pertaining to the invention(s) claimed in the Patent Rights which is created by Dr. Tilly and owned by Hospital and is not confidential information of or otherwise obligated to any third party and which Dr. Tilly knows as of the Effective Date and reasonably believes is necessary in order for Company to utilize the licenses granted hereunder, as further described in Appendix D .  Company agrees to treat all Technological Information in accordance with the provisions of Appendix E .

 

2.  LICENSE

 

2.1                                Grant of License .

 

(a)                                  Subject to the terms of this Agreement and Hospital’s rights in Patent Rights, Hospital hereby grants to Company in the License Field in the License Territory:

 

(i)                                      an exclusive, royalty-bearing license under its rights in Patent Rights to make, have made, use, have used, Sell and have Sold Products and Processes; and

 

(ii)                                   the right to grant sublicenses under the rights granted in Section 2.1 (a)(i) to Sublicensees, provided that in each case Company shall be responsible for the performance of any obligations of Sublicensees relevant to this Agreement as if such performance were carried out by Company itself, including, without limitation, the payment of any royalties or other payments provided for hereunder, regardless of whether the terms of any sublicense provide for such amounts to be paid by the Sublicensee directly to Hospital.

 

(iii)                                the nonexclusive right to use Technological Information disclosed by Hospital to Company hereunder in accordance with this Agreement.

 

(b)                                  The license granted in Section 2.1 (a) above includes:

 

(i)                                      the right to grant to Clinical End Users and to final purchasers, users or consumers of Products or Processes the right to use such purchased Products or Processes in a method coming within the scope of Patent Rights within the License Field and License Territory; and

 

(ii)                                   the right to grant a Distributor the right to Sell (but not to make, have made, use or have used) such Products and/or Processes for or on behalf of Company, its Affiliates and Sublicensees in a manner consistent with this Agreement.

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

6



 

CONFIDENTIAL TREATMENT REQUESTED

 

(c)                                   The foregoing license grant shall include the grant of such license to any Affiliate of Company, provided that such Affiliate shall assume the same obligations as those of Company and be subject to the same terms and conditions hereunder; and further provided that Company shall be responsible for the performance of all of such obligations and for compliance with all of such terms and conditions by Affiliate.  Company shall provide to Hospital a fully signed, non-redacted copy of each agreement with each Affiliate that assumes the aforesaid obligations, including all exhibits, attachments and related documents and any amendments, within [***] days of request by Hospital.

 

2.2                                Sublicenses .  Each sublicense granted hereunder shall be consistent with and comply with all terms of this Agreement and shall incorporate terms and conditions sufficient to enable Company to comply with this Agreement and shall provide that Hospital is a third party beneficiary of the terms thereof directed to enabling Company’s compliance with this Agreement.  Company shall notify Hospital, in confidence, of its (or any of its Sublicensees’) intent to enter into a sublicense agreement, and shall provide Hospital with the name of prospective Sublicensee at least [***] days prior to the execution of a sublicense.  Company shall provide to Hospital a fully signed non-redacted copy of all sublicense agreements (including further sublicenses entered into by Sublicensees) and amendments thereto, including all exhibits, attachments and related documents, within [***] days of executing the same; provided that Hospital shall not disclose any such sublicense agreement to any third party, shall not use such sublicense agreements for any purpose other than monitoring Company’s compliance with this Agreement and shall limit access to such sublicense agreements to Hospital personnel with a need for such access for the foregoing monitoring purpose.  Upon termination of this Agreement or any license granted hereunder for any reason, any sublicenses shall be addressed in accordance with Section 10.7.  Any sublicense which is not in accordance with the forgoing provisions shall be null and void.

 

2.3                                Retained Rights; Requirements .  Any and all licenses granted hereunder are subject to:

 

(a)                                  the right of Hospital and Hospital’s Affiliates as listed in Appendix F to make and to use the subject matter described and/or claimed in the Patent Rights for research and educational purposes; and

 

(b)                                  The right of Hospital and Hospital’s Affiliates as listed in Appendix F to purchase Products and Processes from Company or any of its Affiliates or Sublicensees for use by Hospital and such listed Affiliates as Clinical End Users at a cost reasonably similar to other Clinical End Users in the Northeast region, subject to supply terms and conditions to be reasonably negotiated upon Hospital’s request; and

 

(c)                                   for Patent Rights supported by federal funding, the rights, conditions and limitations imposed by U.S. law ( see 35 U.S.C. § 202 et seq . and regulations pertaining thereto), including without limitation:

 

(i)                                      the royalty-free non-exclusive license granted to the U.S. government; and

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

7



 

CONFIDENTIAL TREATMENT REQUESTED

 

(ii)                                   the requirement that any Products used or sold in the United States shall be manufactured substantially in the United States.

 

2.4                                No Additional Rights .  It is understood that nothing in this Agreement shall be construed to grant Company or any of its Affiliates a license, express or implied, under any patent owned solely or jointly by Hospital other than the Patent Rights expressly licensed hereunder.  Hospital shall have the right to license any Patent Rights to any other party for any purpose outside of the License Field or the License Territory.

 

2.5                                Disclosure of Technological Information .  At Company’s request prior to execution of this Agreement, Hospital (through Dr. Tilly) shall use reasonable efforts to disclose in confidence within [***] days after execution of this Agreement the Technological Information licensed hereunder.

 

3.  DUE DILIGENCE OBLIGATIONS

 

3.1                                Diligence Requirements .  Company shall use, and shall cause its Affiliates and Sublicensees, as applicable, to use, commercially reasonable efforts to develop and make available to the public Products and Processes throughout the License Territory in the License Field.  Such efforts shall include achieving the following objectives within the time periods designated below following the Effective Date:

 

(a)                                  Pre-Sales Requirements.

 

(i)                                      Company shall use commercially reasonable efforts to carry out development of Products and/or Processes in accordance with development plans mutually agreed by the Parties through their Steering Committee representatives.

 

(ii)                                   Company shall secure venture capital or other equity financing of at least $[***] within [***] months following the Effective Date.

 

(iii)                                Company shall identify one or more study site(s) for a Clinical Proof of Concept study with [***] months following the Effective Date.

 

(iv)                               Provide written report to Hospital detailing regulatory strategy for developing a Product or Process within [***] months following the Effective Date.

 

(v)                                  Enroll the first patient in a Clinical Proof of Concept study within [***] months following the Effective Date.

 

(vi)                               Complete a Clinical Proof of Concept study within [***] months following the Effective Date, provided that, this milestone shall be deemed achieved by the completion of a study prospectively intended to demonstrate Clinical Proof of Concept whether or not Clinical Proof of Concept is achieved with such study.

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

8



 

CONFIDENTIAL TREATMENT REQUESTED

 

(vii)                            Achieve a First Commercial Sale within [***] months following the Effective Date.

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

9



 

CONFIDENTIAL TREATMENT REQUESTED

 

(b)                                  Post Sales Requirements .

 

(i)                                      Following the First Commercial Sale in any country in the License Territory, Company shall directly or through its Affiliates and/or Sublicensees make continuing Sales in such country without any elapsed time period of [***] or more in which such Sales do not occur.

 

(ii)                                   Company shall directly or through an Affiliate or Sublicensee make such First Commercial Sale within the following countries and regions in the License Territory within [***] years after the Effective Date of this Agreement: (a) Canada, Mexico, Argentina, Brazil, Australia, New Zealand and Japan and (b) at least [***] of the following countries:  the U.K., France, Germany, Italy and Spain.

 

Achievement of the foregoing objectives shall be deemed to satisfy Company’s obligations to use commercially reasonable efforts under this Section 3.1.  Section 3.1(a) above may be updated or modified from time to time by the Steering Committee, and any such update or modification shall be documented in the minutes of the applicable Steering Committee meeting and may be updated hereto through a written amendment.

 

3.2                                Diligence Failures .  If Company fails to fulfill any of its obligations under Section 3.1(b) with respect to any of the countries listed in Section 3.1(b)(ii)(a) or with respect to at least [***] of the countries listed in Section 3.1(b)(ii)(b) in any material respect, then, subject to the notice and cure provisions of Section 10.4, Hospital may treat such failure as a default and, at Hospital’s option, may, solely with respect to the country(ies) to which such failure relates, either convert the License under 2(a)(i) to non-exclusive or terminate this Agreement and/or any license granted hereunder in accordance with Section 10.4.  For the avoidance of doubt, Hospital shall not, based on Company’s failure to fulfill it obligations under Section 3.1(b), have the right to terminate this Agreement or Company’s licenses hereunder, or convert Company’s licenses hereunder to non-exclusive, with respect to countries in which Company satisfies its obligations under Section 3.1 (b).  In addition, if Company, together with its Affiliates, Sublicensees and Clinical End Users, ceases all development and commercialization activities with respect to all Products and Processes for more than [***], Hospital may treat such failure as a default and, at Hospital’s option, may either convert the License under 2(a)(i) to non-exclusive or terminate this Agreement and/or any license granted hereunder in accordance with Section 10.4.

 

3.3                                Diligence Reports .  Company shall provide all reports with respect to its obligations under Section 3.1 as set forth in Section 5.

 

4.  PAYMENTS AND ROYALTIES

 

4.1                                License Issue Fee .  Company shall pay Hospital a non-refundable license issue fee in the amount of [***] dollars ($[***]) upon execution of this Agreement.

 

4.2                                Patent Cost Reimbursement .  Company shall reimburse Hospital for all costs associated with the preparation, filing, prosecution and maintenance of all Patent Rights (“Patent Costs”).

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

10


 


 

CONFIDENTIAL TREATMENT REQUESTED

 

As of the Effective Date, Hospital has incurred approximately [***] Dollars ($[***]) in Patent Costs, which amount Company shall pay to Hospital based upon the following schedule:

 

 

·                   $[***] within [***] days of the Effective Date

·                   $[***] on the [***] anniversary of the Effective Date

·                   [***] on the [***] anniversary of the Effective Date

 

Company shall pay to Hospital, or at Hospital’s request directly to patent counsel, all other Patent Costs within [***] days of Company’s receipt of an invoice for such Patent Costs either from Hospital or Hospital’s patent counsel.  Hospital shall instruct patent counsel to provide copies to Hospital for Hospital’s administrative files of all invoices detailing Patent Costs which are sent directly to Company.

 

4.3          Annual License Fee; Annual Maintenance Fee .

 

(a)                                  Annual License Fee .  Company shall pay to Hospital the non-refundable amount of [***] Dollars ($[***]) as an annual license fee (the “Annual License Fee”) within [***] days after each of the first (1 st ) and second (2 nd ) anniversaries of the Effective Date.

 

The first [***] Dollars ($[***]) of the Annual License Fees shall be creditable against royalties subsequently due on Net Sales amounts made during the [***] and [***] calendar years following the Effective Date, if any, but shall not be credited against royalties due on Net Sales made in any other subsequent year.

 

(b)                                  Annual Maintenance Fee .  Beginning on the third (3 rd ) anniversary of the Effective Date, Company shall pay the amount of [***] Dollars ($[***]) as an annual maintenance fee (the “Annual Maintenance Fee”) to Hospital within [***] days after each anniversary of the Effective Date.  The Annual Maintenance Fee shall be non-refundable and non-creditable against royalties.

 

4.4          Milestone Payments .  In addition to the payments set forth in Sections 4.1 through 4.3 above, Company shall pay Hospital milestone payments as follows:

 

(a)                                  [***] Dollars ($[***]) within [***] days of [***]; and

 

(b)                                  [***] Dollars ($[***]) within [***] days of [***]; and

 

(c)                                   [***] Dollars ($[***]) for the first calendar year in which Net Sales amounts equal or exceed [***] Dollars ($[***]); and

 

(d)                                  [***] Dollars ($[***]) for the first calendar year in which Net Sales amounts equal or exceed [***] Dollars ($[***]); and

 

(e)                                   [***] Dollars ($[***]) for the first calendar year in which Net Sales amounts equal or exceed [***] Dollars ($[***]); and

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

(f)                                    [***] Dollars ($[***]) for the first calendar year in which Net Sales amounts equal or exceed [***] Dollars ($[***]); and

 

(g)                                   [***] Dollars ($ [***]) for the first calendar year in which Net Sales amounts equal or exceed [***] Dollars ($[***]); and

 

(h)                                  [***] Dollars ($[***]) for the first calendar year in which Net Sales amounts equal or exceed [***] Dollars ($[***]); and

 

(i)                                      [***] Dollars ($[***]) for the first calendar year in which Net Sales amounts equal or exceed [***] Dollars ($[***]).

 

For the avoidance of doubt, should the milestone described in clause (b) above be achieved before the milestone in clause (a) above is achieved, the milestone payments described in clause (a) will be due and payable concurrently with the milestone payment described in clause (b), and should Net Sales amounts be equal to or greater than more than one of the above as yet to be achieved milestones in any given calendar year, all such milestones first achieved in such calendar year shall be due for that calendar year.

 

All payments due to Hospital under this Section 4.4 shall be due and payable by Company within [***] days after the end of each Reporting Period, and shall be accompanied by a report as set forth in Sections 5.2 and 5.3.

 

The milestone payments set forth in this Section 4.4 shall each be payable no more than once.

 

4.5          Royalties and Sublicense Income .

 

(a)                                  Beginning with the First Commercial Sale in any country in the License Territory, Company shall pay Hospital during the term of any license granted under Section 2.1(a)(i), a royalty of [***] percent ([***]%) of the Net Sales amounts of all Products and Processes.  In the event that Company reasonably determines that royalty payments to one or more third parties are required in order to avoid potential infringement of third party patent rights, Company shall notify Hospital via Hospital’s Executive Director, Research Ventures and Licensing promptly following Company’s decision to pursue a license from the applicable third party and, if such payments are in excess of [***] Percent ([***]%) of Net Sales, Company may offset a total of [***] Percent ([***]%) of such third-party payments that are in excess of [***] Percent ([***]%) of Net Sales against any royalty payments that are due under this Section 4.5(a) to Hospital in the same Reporting Period, provided that in no event shall the royalty payments under this Section 4.5(a), when aggregated with any other offsets and credits allowed under this Agreement, be reduced by more than [***] Percent ([***]%) in any Reporting Period.  Without limiting the foregoing, in connection with providing notification to Hospital of Company’s intent to pursue a third party license, Company shall provide an explanation of its rationale for pursuing the license.  In the event that Hospital notifies Company that Hospital has concerns regarding

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

Company’s determination to seek such license, the Steering Committee shall be convened to review the determination.  Failing satisfactory resolution from the Steering Committee the matter shall be discussed between Company CEO or Chairman and the Hospital’s Executive Director, Research Ventures and Licensing; provided that, Company’s CEO shall have final decision-making authority with respect to such matter and Company shall not be required to delay obtaining the proposed third party license for more than [***] days in total as a result of the foregoing Steering Committee and executive consultation process.

 

(b)                                  Company shall pay Hospital [***] percent ([***]%) of any and all Sublicense Income received prior to the third anniversary of the Effective Date, and [***] percent ([***]%) of any and all Sublicense Income received on or after the third anniversary of the Effective Date.

 

(c)                                   All payments due to Hospital under this Section 4.5 shall be due and payable by Company within [***] days after the end of each Reporting Period, and shall be accompanied by a report as set forth in Sections 5.3 and 5.4.

 

4.6          Liquidity Event Milestone Fee .  Company shall pay Hospital One Million Dollars ($1,000,000.00) (the “Liquidity Event Fee”), within [***] days following the first to occur of either:

 

(a)                                  The closing of the first underwritten public offering of Company’s securities (an “IPO”), provided that , if the proceeds to the Company from such IPO are less than [***] Dollars ($[***]), Company shall pay [***] percent ([***]%) of such proceeds to Hospital within [***] days following such closing and thereafter on each anniversary of such closing shall pay to Hospital the lesser of [***] percent ([***]%) of such proceeds or the payment amount that, when combined with prior payments pursuant to this Section 4.6(a), would equal [***] Dollars ($[***]); or

 

(b)                                  The closing of the first to occur of any of the following transactions (each a “Change of Control”):

 

(i)                                      a sale, conveyance or other disposition of all or substantially all of the assets of the Company (other than to an Affiliate of Company as part of a reorganization or restructuring); or

 

(ii)                                   a merger or consolidation of Company with or into any other entity, unless the stockholders of Company immediately before the transaction own fifty percent (50%) or more of the voting or capital stock of the acquiring or surviving corporation following the transaction;

 

provided that , if the proceeds to the Company of such Change of Control are less than [***] Dollars ($[***]), Company shall pay to Hospital [***] Dollars ($[***]) within [***] days following such Change of Control and thereafter shall pay to Hospital [***] Cents ($[***]) on each of the first three anniversaries of such Change of Control.

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

Provided , however , that this Section 4.6 shall terminate upon the full payment of the Liquidity Event Fee.

 

4.7          Form of Payment .  All payments due under this Agreement shall be drawn on a United States bank and shall be payable in United States dollars.  Each payment shall reference this Agreement and its Agreement Number and identify the obligation under this Agreement that the payment satisfies.  Conversion of foreign currency to U.S. dollars shall be made at the conversion rate existing in the United States, as reported in The Wall Street Journal, on the last working day of the applicable Reporting Period.  Such payments shall be without deduction of exchange, collection or other charges, and, specifically, without deduction of withholding or similar taxes or other government imposed fees or taxes, except as legally required or permitted in the definition of Net Sales.

 

Checks for all payments due to the Hospital under this Agreement shall be made payable to the Hospital and addressed as set forth below:

 

Massachusetts General Hospital

BOA-Lockbox Services

PCSR Lockbox #[***]

MA5-527-02-07

2 Morrissey Blvd

Dorchester, MA 02125

Reference Agreement #: A 209968

 

Payments via wire transfer should be made as follows:

 

ACH Credit: ABA # 011-000-138

Federal Reserve Wire: ABA#026-009-593

SWIFT Code: BOFAUS3N

Account #[***]

Massachusetts General Hospital

Bank of America

100 Federal Street

Boston, MA 02110

Reference Agreement #: A 209968

 

4.8          Overdue Payments .  The payments due under this Agreement shall, if overdue, bear interest beginning on the first day following the Reporting Period to which such payment was incurred and until payment thereof at a per annum rate equal to two percent (2%) above the prime rate in effect on the due date as reported by The Wall Street Journal, such interest rate being compounded on the last day of each Reporting Period, not to exceed the maximum permitted by law.  Any such overdue payments when made shall be accompanied by all interest so accrued.  Said interest and the payment and acceptance thereof shall not preclude Hospital from exercising any other rights it may have as a consequence of the lateness of any payment.

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

14



 

CONFIDENTIAL TREATMENT REQUESTED

 

5.  REPORTS, RECORDS, AND STEERING COMMITTEE

 

5.1          Diligence Reports .  Within [***] days after the end of each calendar year until such time as a First Commercial Sale has been achieved in the United States and the objectives set forth in Section 3.1 (b) have been achieved, Company shall report in writing to Hospital on progress made toward such objectives during such preceding 12 month period, including, without limitation, progress on research and development, status of applications for regulatory approvals, manufacturing, sublicensing and the number of sublicenses entered into and marketing.

 

5.2          Milestone Achievement Notification .  Company shall, along with delivering payment as set forth in Section 4.7, report to Hospital the dates on which it achieves the milestones set forth in Section 4.4 within [***] days after the Reporting Period during which each such milestone was achieved.

 

5.3          Sales Reports .  Company shall report to Hospital the date on which it achieves the First Commercial Sale in each country of the License Territory within [***] days of each such occurrence.  Following the First Commercial Sale, Company shall deliver reports to Hospital within [***] days after the end of each Reporting Period.  Each report under this Section 5.3 shall have substantially the format outlined in Appendix B , shall be certified as correct by an officer of Company and shall contain at least the following information (or as otherwise determined by the Steering Committee) as may be pertinent to a royalty accounting hereunder for the immediately preceding Reporting Period:

 

(a)                                  the number of Products and Processes Sold by Company, its Affiliates and Sublicensees in each of (i) the United States, (ii) the European Union, (iii) Japan and (iv) all other countries in aggregate (each of (i), (ii), (iii) and (iv), a “Reporting Territory”);

 

(b)                                  the amounts billed, invoiced and received by Company, its Affiliates and Sublicensees for each Product and Process, in each Reporting Territory, and total billings or payments due or made for all Products and Processes;

 

(c)                                   calculation of Net Sales for the applicable Reporting Period in each Reporting Territory, including an itemized listing of permitted offsets and deductions;

 

(d)                                  total royalties payable on Net Sales in U.S. dollars, together with the exchange rates used for conversion; and

 

(e)                                   any other payments due to Hospital under this Agreement.

 

If no amounts are due to Hospital for any Reporting Period, the report shall so state.

 

5.4          Sublicense Income Reports .  Company shall, along with delivering payment as set forth in Section 4.7, report to Hospital within [***] days after the end of each Reporting Period the amount of all Sublicense Income received by Company during such Reporting Period, and Company’s calculation of the amount due and paid to Hospital from such income, including an itemized listing of the source of income comprising such consideration, and the name and

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

address of each entity making such payments in substantially the format outlined in Appendix C .

 

5.5          Audit Rights .  Company shall maintain, and shall cause each of its Affiliates and Sublicensees to maintain, complete and accurate records relating to the rights and obligations under this Agreement and any amounts payable to Hospital in relation to this Agreement, which records shall contain sufficient information to permit Hospital and its representatives to confirm the accuracy of any payments and reports delivered to Hospital and compliance in all other respects with this Agreement.  Company shall retain and make available, and shall require each of its Affiliates and Sublicensees to retain and make available, such records for at least [***] years following the end of the calendar year to which they pertain, to Hospital and/or its representatives and upon at least [***] days’ advance written notice, for inspection during normal business hours, to verify any reports and payments made and/or compliance in other respects under this Agreement.  If any examination conducted by Hospital or its representatives pursuant to the provisions of this Section show an underreporting or underpayment of [***] percent ([***]%) or more in any calendar year due to Hospital hereunder, then, subject to Company’s right to discuss or dispute the results of such examination, Company shall bear the full cost of such audit and shall remit any amounts due to Hospital (including interest due in accordance with Section 4.8) within [***] days of receiving notice thereof from Hospital.

 

5.6          Steering Committee .

 

(a)                                  Purpose .  Company and Hospital will establish a steering committee (“Steering Committee”) to facilitate the exchange of information regarding the progress of the Company on research and development, regulatory approvals, manufacturing, sublicensing, marketing and sale of Products and the status of any sponsored research projects thereunder, new uses, Technological Information and or new technology as applicable.  The Steering Committee shall review and discuss Company’s development plans, including Company’s timeline for conducting clinical trials with respect to Products and/or Processes, which Company and Hospital anticipate will commence within approximately [***] months following the Effective Date, and Company shall consider recommendations made by the Steering Committee regarding the commercialization of Products and/or Processes, including potential markets beyond those set forth in Section 3.1(b)(ii) in which Company may pursue commercialization.

 

(b)                                  Membership .  Company will appoint at least [***] but not more than [***]members and Hospital will appoint at least [***] but not more than [***] members each to the Steering Committee.  A Party may replace any of its members at any time.

 

(c)           Meetings .  The Steering Committee will meet quarterly, or as otherwise determined by the committee, in person during the Term of the License until such time as the First Commercial Sale has been achieved or as otherwise determined by the Steering Committee.  The schedule and location for meetings will be agreed upon by the Parties in advance, provided that the first such meeting shall

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

occur within [***] days after the Effective Date and thereafter such meetings shall occur no later than [***] days after the end of each calendar quarter.  The first meeting of the Steering Committee will focus on discussions to facilitate the Company’s formulation of preliminary development plans.  The Steering Committee will use reasonable efforts to generate a written summary describing the details of the information exchanged and topics discussed at each Steering Committee meeting and disseminated to the Parties.

 

6.  PATENT PROSECUTION AND MAINTENANCE

 

6.1          Prosecution .  Hospital shall be responsible for the preparation, filing, prosecution and maintenance of all patent applications and patents included in Patent Rights.  Company shall reimburse Hospital for Patent Costs incurred by Hospital relating thereto in accordance with Section 4.2; provided that .  Hospital and Company shall discuss and agree in advance on the countries in which Hospital will prosecute the Patent Rights, so that Company may elect in advance, pursuant to Section 6.3, not to pay costs for any countries in which Company does not desire to fund such prosecution.

 

6.2          Copies of Documents .  With respect to any Patent Right licensed hereunder, Hospital shall instruct the patent counsel prosecuting such Patent Right to (i) copy Company on patent prosecution documents that are received from or filed with the United States Patent and Trademark Office and foreign equivalent, as applicable; (ii) if requested by Company, provide Company with copies of draft submissions to the USPTO prior to filing; and (iii) give consideration to the comments and requests of Company or its patent counsel.

 

6.3          Company’s Election Not to Proceed .  Company may elect to surrender any patent or patent application in Patent Rights in any country upon [***] days advance written notice to Hospital.  Such notice shall relieve Company from the obligation to pay for future Patent Costs but shall not relieve Company from responsibility to pay Patent Costs incurred prior to the expiration of the [***] day notice period.  Such U.S. or foreign patent application or patent shall thereupon cease to be a Patent Right hereunder, Company shall have no further rights therein and Hospital shall be free to license its rights to that particular U.S. or foreign patent application or patent to any other party on any terms.

 

6.4          Confidentiality of Prosecution and Maintenance Information .  Company agrees to treat all information related to prosecution and maintenance of Patent Rights as Confidential Information in accordance with the provisions of Appendix E .

 

7.  THIRD PARTY INFRINGEMENT AND LEGAL ACTIONS

 

7.1          Hospital Right to Prosecute .  Hospital will protect its Patent Rights from infringement and prosecute infringers when, in its sole judgment, such action may be reasonably necessary, proper and justified.  If Company shall have supplied Hospital with written evidence demonstrating to Hospital’s reasonable satisfaction prima facie infringement of a claim of a Patent Right in the License Field in the License Territory by a third party which poses a material threat to Company’s rights under this Agreement, Company may by notice request Hospital to

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

17



 

CONFIDENTIAL TREATMENT REQUESTED

 

take steps to protect such Patent Right.  Hospital shall notify Company within [***] days of the receipt of such notice whether Hospital intends to prosecute the alleged infringement.  If Hospital notifies Company that it intends to so prosecute, Hospital shall, within [***] months of its notice to Company either (i) cause such infringement to terminate, or (ii) initiate legal proceedings against the infringer.

 

7.2          Company Right to Prosecute .  In the event Hospital notifies Company that Hospital does not intend to prosecute infringement identified under Section 7.1, Company may, upon notice to Hospital, initiate legal proceedings against the infringer at Company’s expense with respect to a claim of a Patent Right in the License Field in the License Territory.  Before commencing such action, Company and, as applicable, any Affiliate, shall consult with Hospital, concerning, among other things, Company’s standing to bring suit, the advisability of bringing suit, the selection of counsel and the jurisdiction for such action and shall consider the views of Hospital regarding the proposed action, including without limitation with respect to potential effects on the public interest.  Company shall be responsible for all costs, expenses and liabilities in connection with any such action and shall indemnify and hold Hospital harmless therefrom, regardless of whether Hospital is a party-plaintiff, except for the expense of any independent counsel retained by Hospital in accordance with Section 7.5 below.

 

7.3          Hospital Joined as Party-Plaintiff .  If Company elects to commence an action as described in Section 7.2 above, Hospital shall have, in its sole discretion, the option to join such action as a party-plaintiff.  If joinder of Hospital as a party-plaintiff is necessary or desirable in order for Company to bring or maintain such action or to prove damages in such action, and Company requests that Hospital be joined, Hospital may either, in its sole discretion, permit itself to be joined as a party-plaintiff at the sole expense of Company, or assign to Company all of Hospital’s right, title and interest in and to the Patent Right which is the subject of such action (subject to all of Hospital’s obligations to the government under law and any other rights that others may have in such Patent Right).  If Hospital makes such an assignment, such action by Company shall thereafter be brought or continued without Hospital as a party; provided, however, that Hospital shall continue to have all rights of prosecution and maintenance with respect to Patent Rights and Company shall continue to meet all of its obligations under this Agreement as if the assigned Patent Right were still licensed to Company hereunder.

 

7.4          Notice of Actions; Settlement .  Company shall promptly inform Hospital of any action or suit relating to Patent Rights and shall not enter into any settlement, consent judgment or other voluntary final disposition of any action relating to Patent Rights, including but not limited to appeals, without the prior written consent of Hospital.

 

7.5          Cooperation .  Each Party agrees to cooperate reasonably in any action under Section 7 which is controlled by the other Party, provided that the controlling Party reimburses the cooperating Party for any costs and expenses incurred by the cooperating Party in connection with providing such assistance, except for the expense of any independent counsel retained by the cooperating Party in accordance with this Section 7.5.  Such controlling Party shall keep the cooperating Party informed of the progress of such proceedings and shall make its counsel available to the cooperating Party.  The cooperating Party shall also be entitled to independent

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

counsel in such proceedings but at its own expense, said expense to be offset against any damages received by the Party bringing suit in accordance with Section 7.6.

 

7.6          Recovery .  Any award paid by third parties as the result of such proceedings (whether by way of settlement or otherwise) shall first be applied to reimbursement of any legal fees and expenses incurred by either Party and then the remainder shall be divided between the Parties as follows:

 

(i)                                      Company shall receive an amount equal to its lost profits or a reasonable royalty on the infringing sales, or whichever measure of damages the court shall have applied; and

 

(ii)                                   Hospital shall receive an amount equal to the royalties and other amounts that Company would have paid to Hospital if Company had Sold the infringing Products and Services rather than the infringer; and

 

(iii)                                the balance, if any, remaining after Company and Hospital have been compensated under Section 7.6(a) shall be shall be shared [***] percent ([***]%) to the controlling party and [***] percent ([***]%) to the cooperating party.

 

8.  INDEMNIFICATION AND INSURANCE

 

8.1          Indemnification .

 

(a)                                  Company shall indemnify, defend and hold harmless Hospital and its Affiliates and their respective trustees, directors, officers, medical and professional staff, employees, and agents and their respective successors, heirs and assigns (the “Indemnitees”), against any liability, damage, loss or expense (including reasonable attorney’s fees and expenses of litigation) incurred by or imposed upon the Indemnitees or any one of them in connection with any claims, suits, actions, demands or judgments arising out of any theory of product liability (including, but not limited to, actions in the form of contract, tort, warranty, or strict liability) concerning any product, process or service made, used, or sold or performed pursuant to any right or license granted under this Agreement.

 

(b)                                  With respect to Patent Cost Reimbursement under Section 4.2, Company agrees to indemnify, defend and hold Hospital harmless from and against any and all Patent Costs and costs of collection arising from the failure of Company to timely pay such Patent Costs.

 

(c)                                   Company agrees, at its own expense, to provide attorneys reasonably acceptable to the Hospital to defend against any actions brought or filed against any party indemnified hereunder with respect to the subject of indemnity contained herein, whether or not such actions are rightfully brought; provided, however, that any Indemnitee shall have the right to retain its own counsel, at the expense of Company, if representation of such Indemnitee by counsel retained by Company

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

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CONFIDENTIAL TREATMENT REQUESTED

 

would be inappropriate because of conflict of interests of such Indemnitee and any other party represented by such counsel.  Company agrees to keep Hospital informed of the progress in the defense and disposition of such claim and to consult with Hospital prior to any proposed settlement.

 

(d)                                  This section 8.1 shall survive expiration or termination of this Agreement.

 

8.2          Insurance .

 

(a)                                  Beginning at such time as any such product, process or service is being commercially distributed, sold, leased or otherwise transferred, or performed or used (other than for the purpose of obtaining regulatory approvals), by Company, an Affiliate or Sublicensee, Company shall, at its sole cost and expense, procure and maintain commercial general liability insurance in amounts not less than $[***] per incident and $[***] annual aggregate and naming the Indemnitees as additional insureds.  Such commercial general liability insurance shall provide product liability coverage and shall not have a Contractual Liability Limitation Endorsement.  If Company elects to self-insure all or part of the limits described above (including deductibles or retentions which are in excess of $[***] annual aggregate) such self-insurance program must be acceptable to the Hospital and the Risk Management Foundation.  The minimum amounts of insurance coverage required under this Section 8.2 shall not be construed to create a limit of Company’s liability with respect to its indemnification under Section 8.1 of this Agreement.

 

(b)                                  Company shall provide Hospital with written evidence of such insurance upon request of Hospital.  Company shall provide Hospital with written notice at least [***] days prior to the cancellation, non-renewal or material change in such insurance; if Company does not obtain replacement insurance providing comparable coverage prior to the expiration of such [***] day period, Hospital shall have the right to terminate this Agreement effective at the end of such [***] day period without notice or any additional waiting periods.

 

(c)                                   Company shall maintain such commercial general liability insurance beyond the expiration or termination of this Agreement during (i) the period that any such product, process, or service is being commercially distributed, sold, leased or otherwise transferred, or performed or used (other than for the purpose of obtaining regulatory approvals), by Company or by a licensee, affiliate or agent of Company and (ii) a reasonable period after the period referred to in (c) (i) above which in no event shall be less than [***] years.

 

(d)                                  This section 8.2 shall survive expiration or termination of this Agreement.

 

9.  DISCLAIMER OF WARRANTIES; LIMITATION OF LIABILITY

 

9.1          Title to Patent Rights .  To the best knowledge of Hospital’s Office of Research, Ventures and Licensing, Hospital is the owner by assignment from Dr. Jonathan Tilly and Dr. Joshua

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

20


 


 

CONFIDENTIAL TREATMENT REQUESTED

 

Johnson of the Patent Rights and has the authority to enter into this Agreement and license the Patent Rights to Company hereunder.

 

9.2                                No Warranties .  HOSPITAL MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, CONCERNING THE PATENT RIGHTS AND THE RIGHTS GRANTED HEREUNDER, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT, VALIDITY OF PATENT RIGHTS CLAIMS, WHETHER ISSUED OR PENDING, AND THE ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE, AND HEREBY DISCLAIMS THE SAME.  SPECIFICALLY, AND NOT TO LIMIT THE FOREGOING, HOSPITAL MAKES NO WARRANTY OR REPRESENTATION (i) REGARDING THE VALIDITY OR SCOPE OF ANY OF THE CLAIM(S), WHETHER ISSUED OR PENDING, OF ANY OF THE PATENT RIGHTS, AND (ii) THAT THE EXPLOITATION OF THE PATENT RIGHTS OR ANY PRODUCT WILL NOT INFRINGE ANY PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF HOSPITAL OR OF ANY THIRD PARTY.

 

9.3                                Limitation of Liability .  IN NO EVENT SHALL EITHER PARTY OR ANY OF ITS AFFILIATES OR ANY OF THEIR RESPECTIVE TRUSTEES, DIRECTORS, OFFICERS, MEDICAL AND PROFESSIONAL STAFF, EMPLOYEES AND AGENTS BE LIABLE TO THE OTHER PARTY OR ANY OF ITS AFFILIATES FOR INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND ARISING IN ANY WAY OUT OF THIS AGREEMENT OR THE LICENSE RIGHTS GRANTED HEREUNDER, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, INCLUDING WITHOUT LIMITATION SUCH DAMAGES THAT ARE ECONOMIC DAMAGES OR INJURY TO PROPERTY OR LOST PROFITS, REGARDLESS OF WHETHER SUCH PARTY SHALL BE ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE POSSIBILITY OF THE FOREGOING; PROVIDED, HOWEVER, NOTHING IN THIS SECTION 9.3 SHALL BE CONSTRUED TO LIMIT COMPANY’S OBLIGATION TO INDEMNIFY HOSPITAL UNDER SECTION 8 OF THIS AGREEMENT.

 

10.  TERM AND TERMINATION

 

10.1                         Term .  The term of this Agreement shall commence on the Effective Date and shall remain in effect on a Product-by-Product, Process-by-Process and country-by-country basis until the date on which all Claims that cover the applicable Product or Process in the applicable country have expired or been abandoned, unless this Agreement is terminated earlier in accordance with any of the other provisions of Section 10.  Following expiration of this Agreement with respect to a Product or Process in a particular country, as described in the prior sentence, the licenses and rights granted to Company pursuant to Section 2.1 shall remain in effect on a perpetual, royalty-free and non-exclusive basis.

 

10.2                         Termination for Failure to Pay .  If Company fails to make any payment due hereunder, Hospital shall have the right to terminate this Agreement upon [***] days written notice, unless Company makes such payments plus any interest due, as set forth in Section 4.7, within said [***] day notice period.  If payments are not made, Hospital may immediately terminate this

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

21



 

Agreement at the end of said [***] day period.  Company shall be entitled to only one such cure period in a calendar year; for a second failure to make payment on time, Hospital shall have the right to terminate this Agreement immediately upon written notice.  Notwithstanding the foregoing, if Company in good faith disputes a payment obligation asserted by Hospital, then, providing Company shall make said disputed payment and Hospital shall place said payment in escrow, such termination right shall be tolled until after such dispute is resolved, and this Agreement shall not terminate based on such dispute if Company pays all amounts ultimately determined to be due within [***] days following the resolution of such dispute in accordance with Section 12.8.

 

10.3                         Termination for Insurance and Insolvency .

 

(a)                                  Insurance .  Hospital shall have the right to terminate this Agreement in accordance with Section 8.2(b) if Company fails to maintain the insurance required by Section 8.2.

 

(b)                                  Insolvency and other Bankruptcy Related Events .  Hospital shall have the right to terminate this Agreement immediately upon written notice to Company with no further notice obligation or opportunity to cure if Company: (i) shall make an assignment for the benefit of creditors; or (ii) or shall have a petition in bankruptcy filed for or against it (provided that in the case of a petition in bankruptcy filed against it, Hospital shall not have the right to terminate this Agreement if such petition is dismissed within sixty (60) days following the filing of such petition).

 

10.4                         Termination for Non-Financial Default .  If Company, any of its Affiliates or any Sublicensee shall materially default in the performance of any of its other obligations under this Agreement not otherwise covered by the provisions of Section 10.2 and 10.3, and if such material default has not been cured within [***] days after notice by Hospital in writing of such default, Hospital may immediately terminate this Agreement, and/or any license granted hereunder with respect to the country or countries in which such default has occurred, at the end of said [***] day cure period.  Hospital shall also have the right to terminate this Agreement and/or any such license immediately, upon written notice, in the event of [***] or more material defaults in any [***] year period even if cured within such [***] day period

 

10.5                         Challenging Validity .  During the term of this Agreement, Company shall not challenge, and shall restrict Affiliates and Sublicensees from challenging the validity of the Patent Rights and in the event of any breach of this provision by Company Hospital shall have the right to terminate this Agreement and any license granted hereunder immediately.  In addition, if the Patent Rights are upheld Company shall reimburse Hospital for its legal costs and expenses incurred in defending any such challenge by Company or its Affiliates in any country in which Company and its Affiliates retain a license to such Patent Rights under this Agreement.

 

10.6                         Termination by Company .  Company shall have the right to terminate this Agreement by giving ninety (90) days advance written notice to Hospital and upon such termination shall immediately cease all use and Sales of Products and Processes, subject to Section 10.9.

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

22



 

CONFIDENTIAL TREATMENT REQUESTED

 

10.7                         Effect of Termination on Sublicenses .  Any sublicenses granted by Company under this Agreement shall provide for assignment to Hospital of Company’s interest therein, upon termination (but not expiration) of this Agreement or upon termination of any license hereunder under which such sublicense has been granted.  Upon assignment of any such sublicense to Hospital upon termination, the rights granted to the Sublicensee in such sublicense shall survive; provided that , (a) Hospital shall not be obligated to accept the assignment of any such sublicense if the Sublicensee is then in material default of any of the obligations required to be imposed on Sublicensees pursuant to this Agreement and (b) Hospital shall not have any liability for Company’s obligations pursuant to the sublicense beyond Hospital’s obligations with respect to the sublicensed rights under this Agreement.

 

10.8                         Effects of Termination of Agreement .  Upon termination of this Agreement or any of the licenses hereunder for any reason, final reports in accordance with Section 5 shall be submitted to Hospital and all royalties and other payments, including without limitation any unreimbursed Patent Costs, accrued or due to Hospital as of the termination date shall become immediately payable.  Company shall cease, and shall cause its Affiliates and require its Sublicensees to cease under any sublicense granted by Company under this Agreement, all Sales and uses of Products and Processes upon such termination (but not expiration), subject to Sections 10.7 and 10.9.  The termination or expiration of this Agreement or any license granted hereunder shall not relieve Company, its Affiliates or Sublicensees of obligations arising before such termination or expiration.

 

10.9                         Inventory .  Upon early termination of this Agreement other than for Company default, Company, Company Affiliates and Sublicensees may complete and sell any work-in-progress and inventory of Products that exist as of the effective date of termination, provided that (i) Company pays Hospital the applicable running royalty or other amounts due on such Net Sales amounts in accordance with the terms and conditions of this Agreement, and (ii) Company, Company Affiliates and Sublicensees shall be permitted, but are not required to complete and sell all work-in-progress and inventory of Products within [***] months after the effective date of termination.  Upon expiration of this Agreement, Company shall pay to Hospital the royalties set forth in Section 4.5(a) for post-termination Sales pursuant to this Section 10.9 of any Product that was in inventory or was a work-in-progress on the date of termination of this Agreement.

 

11.  COMPLIANCE WITH LAW

 

11.1                         Compliance .  Company shall have the sole obligation for compliance with, and shall ensure that any Affiliates and Sublicensees comply with, all government statutes and regulations that relate to Products and Processes, including, but not limited to, those of the Food and Drug Administration and the Export Administration, as amended, and any applicable laws and regulations of any other country in the License Territory.  Company agrees that it shall be solely responsible for obtaining any necessary licenses to export, re-export, or import Products or Processes covered by Patent Rights and/or Confidential Information.  Company shall indemnify and hold harmless Hospital for any breach of Company’s obligations under this Section 11.1.

 

11.2                         Patent Numbers .  Company shall cause all Products sold in the United States to be marked with all applicable U.S. Patent Numbers, to the extent required by United States law.

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

23



 

CONFIDENTIAL TREATMENT REQUESTED

 

Company shall similarly cause all Products shipped to or sold in any other country to be marked in such a manner as to conform with the patent laws and practices of such country.

 

12.  MISCELLANEOUS

 

12.1                         Entire Agreement .  This Agreement and the Exclusive Option Agreement between the Parties of even date herewith constitute the entire understanding between the Parties with respect to the subject matter hereof.

 

12.2                         Notices .  Any notices, reports, waivers, correspondences or other communications required under or pertaining to this Agreement shall be in writing and shall be delivered by hand, or sent by a reputable overnight mail service (e.g., Federal Express), or by first class mail (certified or registered), or by facsimile confirmed by one of the foregoing methods, to the other Party.  Notices will be deemed effective (a) three (3) working days after deposit, postage prepaid, if mailed, (b) the next day if sent by overnight mail, or (c) the same day if sent by facsimile and confirmed as set forth above or delivered by hand.  Unless changed in writing in accordance with this Section, the notice address for Hospital shall be as follows:

 

Executive Director, Research Ventures and Licensing
Massachusetts General Hospital
101 Huntington Avenue, 4
th  Floor
Boston, MA 02199

 

Fax No. (617) 954-9361

 

12.3                         Amendment; Waiver .  This Agreement may be amended and any of its terms or conditions may be waived only by a written instrument executed by an authorized signatory of the Parties or, in the case of a waiver, by the Party waiving compliance.  The failure of either Party at any time or times to require performance of any provision hereof shall in no manner affect its rights at a later time to enforce the same.  No waiver by either Party of any condition or term shall be deemed as a further or continuing waiver of such condition or term or of any other condition or term.

 

12.4                         Binding Effect .  This Agreement shall be binding upon and inure to the benefit of and be enforceable by the Parties hereto and their respective permitted successors and assigns.

 

12.5                         Assignment .  Company shall not assign this Agreement or any of its rights or obligations under this Agreement without the prior written consent of Hospital; provided, however, that no such consent will be required to assign this Agreement to an Affiliate of Company, to a successor to all or substantially all of the Company’s business to which this Agreement pertains or to a purchaser of all or substantially all of the Company’s assets related to this Agreement, so long as such Affiliate, successor or purchaser shall agree in writing to be bound by all of the terms and conditions hereof prior to such assignment.  Company shall notify Hospital in writing of any such assignment and provide a copy of all assignment documents and related agreements to Hospital within [***] days of such assignment.  Failure of an assignee to agree to be bound by the terms hereof or failure of Company to notify Hospital and provide copies of assignment

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

24



 

CONFIDENTIAL TREATMENT REQUESTED

 

documentation shall, if not cured as permitted by Section 10.4, be grounds for termination of this Agreement for default.

 

12.6                         Force Majeure .  Neither Party shall be responsible for delays resulting from causes beyond the reasonable control of such Party, including without limitation fire, explosion, flood, war, sabotage, strike or riot, provided that the nonperforming Party uses commercially reasonable efforts to avoid or remove such causes of nonperformance and continues performance under this Agreement with reasonable dispatch whenever such causes are removed.

 

12.7                         Use of Name .  Neither Party shall use the name of the other Party or of any trustee, director, officer, staff member, employee, student or agent of the other Party or any adaptation thereof in any advertising, promotional or sales literature, publicity or in any document employed to obtain funds or financing without the prior written approval of the Party or individual whose name is to be used.  For Hospital, such approval shall be obtained from Hospital’s VP of Public Affairs.  Notwithstanding the forgoing, this shall not prohibit Company from stating the factual existence of this Agreement and its Terms.

 

12.8                         Governing Law .  This Agreement shall be governed by and construed and interpreted in accordance with the laws of the Commonwealth of Massachusetts, excluding with respect to conflict of laws, except that questions affecting the construction and effect of any patent shall be determined by the law of the country in which the patent shall have been granted.  Each Party agrees to submit to the exclusive jurisdiction of the Superior Court for Suffolk County, Massachusetts, and the United States District Court for the District of Massachusetts with respect to any claim, suit or action in law or equity arising in any way out of this Agreement or the subject matter hereof.

 

12.9                         Board Observer .  Hospital shall be entitled to have one representative of Hospital (the “Hospital Observer”) attend all regularly held and special meetings of the Board of Directors of Company (the “Board”) in a nonvoting observer capacity and to receive notice of all meetings of the Board, and Company shall give such Hospital Observer copies of all notices, minutes, consents and other material that it provides to its directors at or about the same time as delivered to such directors; provided, however, that: (a) Company reserves the right to exclude the Hospital Observer from any meeting or portion thereof of the Board or from access to any material or portion thereof if Company reasonably believes that such exclusion or withholding of information with respect thereto is reasonably necessary (i) to preserve attorney-client privilege, (ii) in the event the Board intends to discuss or vote upon any circumstances or matters where there is a material actual or material potential conflict of interest between Company and Hospital, including without limitation any discussion of the Parties’ rights and obligations under this Agreement, or (iii) to comply with the terms and conditions of confidentiality agreements with third parties; (b) the Hospital Observer shall be an Executive Director, Director, or Sr. Business Strategy & Licensing Manager from Hospital’s Office of Research Ventures & Licensing; the identity of the Hospital Observer shall be subject to the approval of Company’s Board, which approval shall not to be unreasonably withheld or delayed; and (c) the Hospital, on behalf of Hospital Observer, shall enter into a confidentiality agreement with Company in form and substance reasonably satisfactory to Company requiring the Hospital and Hospital Observer to maintain the confidentiality of Company information disclosed to the Hospital Observer.

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

25



 

CONFIDENTIAL TREATMENT REQUESTED

 

Hospital’s right under this Section 12.9 shall expire upon the earlier of (A) the closing of the initial public offering of Company’s capital stock, (B) a Change of Control or (C) if the investors in a Series B preferred stock sale (or a subsequent round ) by the Company object to the continuation of the Hospital Observer, the initial closing of such Series B preferred stock sale, provided the Parties shall agree on alternative arrangements to keep Hospital informed of the activities of the Company above the current reporting requirements.

 

12.10                  Hospital Policies .  Company acknowledges that Hospital’s employees and medical and professional staff members and the employees and staff members of Hospital’s Affiliates are subject to the applicable policies of Hospital and such Affiliates, including, without limitation, policies regarding conflicts of interest, intellectual property and other matters.  Company shall provide Hospital with any agreement it proposes to enter into with any employee or staff member of Hospital or any of Hospital’s Affiliates relating to the subject matter of this Agreement for Hospital’s prior review and shall not enter into any oral or written agreement with such employee or staff member which conflicts with any such policy.  Hospital shall provide Company, at Company’s request, with copies of any such policies applicable to any such employee or staff member.

 

12.11                  Severability .  If any provision(s) of this Agreement are or become invalid, are ruled illegal by any court of competent jurisdiction or are deemed unenforceable under then current applicable law from time to time in effect during the term hereof, it is the intention of the Parties that the remainder of this Agreement shall not be affected thereby.  It is further the intention of the Parties that in lieu of each such provision which is invalid, illegal or unenforceable, there be substituted or added as part of this Agreement a provision which shall be as similar as possible in economic and business objectives as intended by the Parties to such invalid, illegal or enforceable provision, but shall be valid, legal and enforceable.

 

12.12                  Survival .  In addition to any specific survival references in this Agreement, Sections 1, 2.4, 4.2, 4.7, 4.8, 5.3, 5.4, 5.5, 6.4, 8.1, 8.2, 9.2, 9.3, 10.7, 10.8, 10.9, 12.1, 12.2, 12.3, 12.4, 12.7, 12.8, 12.10, 12.11, 12.12, 12.13, and 12.14 shall survive termination or expiration of this Agreement.  Any other rights, responsibilities, obligations, covenants and warranties which by their nature should survive this Agreement shall similarly survive and remain in effect.

 

12.13                  Interpretation .  The Parties hereto are sophisticated, have had the opportunity to consult legal counsel with respect to this transaction and hereby waive any presumptions of any statutory or common law rule relating to the interpretation of contracts against the drafter.

 

12.14                  Headings .  All headings are for convenience only and shall not affect the meaning of any provision of this Agreement.

 

[ Remainder of page intentionally left blank ]

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

26



 

CONFIDENTIAL TREATMENT REQUESTED

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date first written above.

 

OVASCIENCE, INC.

 

THE GENERAL HOSPITAL CORPORATION, D/B/A MASSACHUSETTS GENERAL HOSPITAL

 

 

 

BY:

/s/ Michelle Dipp

 

BY:

/s/ Rebecca Menapace

 

Name: Michelle Dipp

 

 

Name: Rebecca Menapace

 

 

 

 

 

 

 

TITLE:

CEO OvaScience

 

TITLE:

Director, Research & Licensing

 

 

 

Research Ventures & Licensing

 

 

 

DATE:

June 27, 2011

 

 

 

 

DATE:

6/27/11

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

27


 


 

CONFIDENTIAL TREATMENT REQUESTED

 

Appendix A

 

DESCRIPTION OF PATENT RIGHTS

 

ID

 

Title

 

Assignee

 

Status

 

Type

 

CTRY

 

Serial #

 

Filing Date

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

28



 

Appendix B
SALES REPORTS

 

AGREEMENT INCOME REPORT

Royalty Income

 

 

[MGH][BWH] Agreement #-

 

Licensee -

 

Sub-Licensee -

 

 

Separate reports must be filed for:

 

1.                                       Each Product sold.

2.                                       Each country of sale, if different deductions or royalty rates apply.

 

Product Name:

 

Report Time Period:

 

 

From

mm/dd/yyyy

 

To

mm/dd/yyyy

 

 

Country of Sale

 

 

 

 

 

 

 

 

 

 

 

Quantity Sold

 

 

 

 

 

 

 

 

 

 

 

Gross Sales (USD)

$

 

$

 

$

 

 

 

 

 

 

Exchange Rate

 

 

 

 

 

 

Deductions (Itemize)

 

Please list each deduction separately.  Use same definition as appears in Agreement and include the contract paragraph as a reference (Std Section 1.17(a)(ii) line item deductions listed below).

 

A1.

 

 

 

 

 

A2.

 

 

 

 

 

A3.

 

 

 

 

 

A4.

 

 

 

 

 

B.

 

 

 

 

 

 

 

 

 

 

 

Total Deductions

(                                  )

 

(                                  )

 

(                                       )

 

 

 

 

 

 

Net Sales

 

 

 

 

 

 

 

 

 

 

 

Royalty Percentage

 

 

 

 

 

 

 

 

 

 

 

Credits (itemize)

(                                  )

 

(                                  )

 

(                                       )

 

 

 

 

 

 

Royalties Due

$

 

$

 

$

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

29



 

CONFIDENTIAL TREATMENT REQUESTED

 

PLEASE ATTACH DETAIL SALES REPORTS AS REQUIRED

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

30



 

CONFIDENTIAL TREATMENT REQUESTED

 

Appendix D

 

AGREEMENT INCOME REPORT

Sublicense Income

 

[MGH][BWH] Agreement #-

 

Licensee -

 

Sub-Licensee -

 

 

Separate reports must be filed for Payments associated with each Product:

 

Product Name:

 

 

Report Time Period:

 

From

mm/dd/yyyy

 

 

 

 

To

mm/dd/yyyy

 

 

Detailed Explanation of Payment

Required for “Other Payment”

 

Annual Fees/Minimum Royalties

$

 

 

 

 

 

 

Milestone Payments

$

 

 

 

 

 

 

Sublicense Fees and Royalties

$

 

 

 

 

 

 

Other Payment

$

 

 

 

 

 

 

Other Payment

$

 

 

 

 

 

 

Other Payment

$

 

 

 

 

 

 

TOTAL

$

 

 

 

PLEASE ATTACH DETAIL AS REQUIRED

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

31



 

Appendix D

 

DESCRIPTION OF TECHNOLOGICAL INFORMATION

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

32



 

CONFIDENTIAL TREATMENT REQUESTED

 

Appendix E

 

CONFIDENTIALITY TERMS AND CONDITIONS

 

1.                                       Definition of Confidential Information .  “Confidential Information” shall mean any information, including but not limited to data, techniques, protocols or results, or business, financial, commercial or technical information, disclosed by one Party (each a “Discloser” as applicable) to the other Party (each a “Recipient” as applicable) in connection with the terms of that certain Exclusive License Agreement dated                                            (the “License Agreement”) and identified as confidential at the time of disclosure (the “Purpose”).  Hospital’s Confidential Information shall also include all information disclosed by Hospital to Company in connection with the Patent Rights.  Capitalized terms used in this Appendix that are not otherwise defined herein have the meanings ascribed in the License Agreement to which this Appendix is attached and made a part thereof.

 

2.                                       Exclusions .  “Confidential Information” under this Agreement shall not include any information that (i) is or becomes publicly available through no wrongful act of Recipient; was known by Recipient prior to disclosure by Discloser, as evidenced by tangible records; (iii) becomes known to Recipient after disclosure from a third party having an apparent bona fide right to disclose it; (iv) is independently developed or discovered by Recipient without use of Discloser’s Confidential Information, as evidenced by tangible records; or (v) is disclosed to another party by Discloser without restriction on further disclosure.  The obligations of confidentiality and non-use set forth in this Agreement shall not apply with respect to any information that Recipient is required to disclose or produce pursuant to applicable law, court order or other valid legal process provided that Recipient promptly notifies Discloser prior to such required disclosure, discloses such information only to the extent so required and cooperates reasonably with Discloser’s efforts to contest or limit the scope of such disclosure.

 

3.                                       Permitted Purpose .  Recipient shall have the right to, and agrees that it will, use Discloser’s Confidential Information solely for the Purpose (as defined above), except as may be otherwise specified in a separate definitive written agreement negotiated and executed between the Parties.

 

4.                                       Restrictions .  For the term of the License Agreement and a period of [***] years thereafter (and indefinitely with respect to any individually identifiable health information disclosed by Hospital to Company, if any), each Recipient agrees that: (i) it will not use such Confidential Information for any purpose other than as specified herein, including without limitation for its own benefit or the benefit of any other person or entity; and (ii) it will use reasonable efforts (but no less than the efforts used to protect its own confidential and/or proprietary information of a similar nature) not to disclose such Confidential Information to any other person or entity except as expressly permitted hereunder.  Recipient may, however, disclose Discloser’s Confidential Information only on a need-to-know basis to its and its Affiliates employees, staff members and agents (“Receiving Individuals”) who are directly participating in the Purpose and who are informed of the confidential nature of such information, provided Recipient shall be responsible for compliance by Receiving Individuals with the terms of this Agreement and any breach thereof.  In addition, (a) Company may use and disclose

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

33



 

CONFIDENTIAL TREATMENT REQUESTED

 

Confidential Information of Hospital in accordance with the License Agreement as reasonably required for development, regulatory, manufacturing and commercialization activities with respect to Products and Processes, (b) Company may further make such disclosures as Company reasonably determines are required under applicable law or regulation, including without limitation applicable securities laws and regulations and the rules or regulations of any applicable securities exchange or Nasdaq, and (c) Company may make such disclosures of Confidential Information to Company’s and its Affiliates’ actual or potential directors, investors, funding sources, acquirers and licensees, provided that such recipient is bound to keep such information confidential substantially as provided herein.  Each Party further agrees not to use the name of the other Party or any of its Affiliates or any of their respective trustees, directors, officers, staff members, employees, students or agents in any advertising, promotional or sales literature, publicity or in any document employed to obtain funds or financing without the prior written approval of the Party or individual whose name is to be used, in the case of Hospital such approval to be given by the Public Affairs Department.  This Section 4 shall survive termination or expiration of this Agreement.

 

5.                                       Right to Disclose .  Discloser represents that to the best of its knowledge it has the right to disclose to each Recipient all of Discloser’s Confidential Information that will be disclosed hereunder.

 

6.                                       Ownership .  All Confidential Information disclosed pursuant to this Agreement, including without limitation all written and tangible forms thereof, shall be and remain the property of the Discloser.  Upon termination of this Agreement, if requested by Discloser, Recipient shall return or destroy at Discloser’s discretion all of Discloser’s Confidential Information, provided that Recipient shall be entitled to keep one copy of such Confidential Information in a secure location solely for the purpose of determining Recipient’s legal obligations hereunder or of excercising any rights of Recipient which survive such termination.

 

7.                                       No License .  Nothing in this Agreement shall be construed as granting or conferring, expressly or impliedly, any rights by license or otherwise, under any patent, copyright, or other intellectual property rights owned or controlled by Discloser relating to Confidential Information, except as specifically set forth in the License Agreement.

 

8.                                       Remedies .  Each Party acknowledges that any breach of this Agreement by it may cause irreparable harm to the other party and that each party is entitled to seek injunctive relief and any other remedy available at law or in equity.

 

9.                                       General .  These Confidentiality Terms and Conditions, along with the License Agreement, contain the entire understanding of the parties with respect to the subject matter hereof, and supersede any prior oral or written understandings between the parties relating to confidential treatment of information.  Sections 1, 2, 4, 6, 8 and 9 of these Confidentiality Terms and Conditions shall survive any expiration or termination of the License Agreement.

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

34



 

CONFIDENTIAL TREATMENT REQUESTED

 

Appendix F
HOSPITAL AND AFFILIATES

 

MASSACHUSETTS GENERAL HOSPITAL
BRIGHAM AND WOMEN’S HOSPITAL
NEWTON-WELLESLEY HOSPITAL

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

35


Exhibit 10.3

 

Amendment No. 1
To The
Exclusive License Agreement

 

This Amendment No. 1 (this “ Amendment ”) to the Exclusive License Agreement between OvaScience, Inc. (“ Company ”) and The General Hospital Corporation, (“ Hospital ”) dated June 27, 2011 (the “ Agreement ”), is effective as of September 7, 2011.  Capitalized terms used but not defined in this Amendment shall, unless the context otherwise requires, have the meanings specified in the Agreement.

 

WITNESSETH

 

WHEREAS, pursuant to Section 12.3 of the Agreement, the Agreement may be so amended with the written consent of Company and Hospital; and

 

WHEREAS, Hospital has entered into a Joint Invention Administration agreement (“JIA”) with the President and Fellows of Harvard College (“Harvard”) wherein Hospital is the exclusive agent to grant licenses to the certain patent rights in the field of ex-vivo human fertility.

 

WHEREAS, Company and Hospital desire to amend the Agreement.

 

NOW, THEREFORE, the Agreement is hereby amended as follows:

 

1.                                       Section 1.4 of the Agreement shall be deleted in its entirety and replaced by the following:

 

1.4                                Clinical Proof of Concept ” shall mean the completion of a clinical study conducted by or on behalf of Company or any of its Affiliates or Sublicensees of a Product or Process using the Hospital Patent Rights, consisting of a minimum of [***] women patients, in which the average pregnancy rate (as measured by fetal heart beat) of all women in such study is at least [***] percent ([***]%) above the average pregnancy rate via fresh embryo transfer in the most recent National SART Clinic Summary Report for the age group adjusted average, as a result of the use of such Product or Process.

 

2.                                       Section 1.10 of the Agreement shall be deleted in its entirety and replaced by the following:

 

1.10                         Patent Rights ” shall mean:

 

(a)                                  Hospital Patent Rights ” shall mean, inclusively, the U.S. Patent Applications listed in Appendix A and/or the equivalent of such application, including any divisional, continuation (including claims of continuations-in-part only to the extent entirely supported by the specification of the application on which such continuations-in-part are based), foreign counterpart patent application, Letters Patent and/or the equivalent thereof issuing thereon, and/or reissue, reexamination or extension thereof, or supplementary protection certificate or patents of addition relating thereto; and

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 



 

CONFIDENTIAL TREATMENT REQUESTED

 

(b)                                  Media Patent Rights ” shall mean, inclusively, the U.S. Patent Applications listed in Appendix A-1 and/or the equivalent of such application, including any divisional, continuation (including claims of continuations-in-part only to the extent entirely supported by the specification of the application on which such continuations-in-part are based), foreign counterpart patent application, Letters Patent and/or the equivalent thereof issuing thereon, and/or reissue, reexamination or extension thereof, or supplementary protection certificate or patents of addition relating thereto.

 

3.                                       A following new section 1.18 is hereby inserted immediately after Section 1.17 of the License.

 

1.18                         Limited Field ” shall mean ex-vivo human female fertility treatments and shall specifically exclude (a) treatments of menopause associated symptoms or diseases other than treatments of infertility; (b) treatments to delay menopause or menopause associated symptoms or diseases other than treatments of infertility; (c) diagnostics; (d) research tools, or any other field not specifically set forth herein.  For purposes of this definition, ex vivo human female fertility treatments shall be deemed to include the treatment of sperm in relation to in vitro fertilization treatments.

 

4.                                       The introductory clause of Section 2.1 (a) of the License is hereby deleted in its entirety and replaced by the following:

 

(a)                                  Subject to the terms of this Agreement and Hospital’s and Harvard’s respective rights in Patent Rights, Hospital hereby grants to Company in the License Field with respect to Hospital Patent Rights, and the Limited Field with respect to Media Patent Rights, in the License Territory:

 

5.                                       Section 2.1(a)(i) of the License is hereby deleted in its entirety and replaced by the following:

 

(i)                                      an exclusive, royalty-bearing license under Hospital’s and Harvard’s respective rights in Patent Rights to make, have made, use, have used, Sell and have Sold Products and Processes;

 

6.                                       Section 2.1(b)(i) of the License is hereby deleted in its entirety and replaced by the following:

 

(i)                                      the right to grant to Clinical End Users and to final purchasers, users or consumers of Products or Processes the right to use such purchased Products or Processes in a method coming within the scope of Hospital Patent Rights within the License Field and within the scope of Media Patent Rights within the Limited Field, in each case in the License Territory; and

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

2



 

CONFIDENTIAL TREATMENT REQUESTED

 

7.                                       Section 2.2 of the License is hereby deleted in its entirety and replaced by the following:

 

2.2                                Sublicenses .  Each sublicense granted hereunder shall be consistent with and comply with all terms of this Agreement and shall incorporate terms and conditions sufficient to enable Company to comply with this Agreement and shall provide that Hospital and Harvard are third party beneficiaries of the terms thereof directed to enabling Company’s compliance with this Agreement.  Company shall notify Hospital, in confidence, of its (or any of its Sublicensees’) intent to enter into a sublicense agreement, and shall provide Hospital with the name of prospective Sublicensee at least [***] days prior to the execution of a sublicense.  Company shall provide to Hospital a fully signed non-redacted copy of all sublicense agreements (including further sublicenses entered into by Sublicensees) and amendments thereto, including all exhibits, attachments and related documents, within [***] days of executing the same; provided that Hospital shall not disclose any such sublicense agreement to any third party other than Harvard, shall not use such sublicense agreements for any purpose other than monitoring Company’s compliance with this Agreement and shall limit access to such sublicense agreements to Hospital personnel with a need for such access for the foregoing monitoring purpose.  Upon termination of this Agreement or any license granted hereunder for any reason, any sublicenses shall be addressed in accordance with Section 10.7.  Any sublicense which is not in accordance with the forgoing provisions shall be null and void.

 

8.                                       A following new Section 2.3(d) is hereby inserted immediately after Section 2.3(c)(ii) of the License.

 

(d)                                  The right of Harvard, Hospital and Hospital’s Affiliates and academic, government and not-for-profit institutions to make and to use the subject matter described and/or claimed in the Media Patent Rights for research and educational purposes and not for the purpose of commercial manufacture, commercial marketing, commercial sale, commercial distribution or provision of services for a fee.  For the avoidance of doubt, nothing herein shall be construed as permitting any such institution or not-for-profit research organization to grant rights to any for-profit sponsor to Patent Rights within the scope of the license granted above.

 

9.                                       Section 2.4 of the License is hereby deleted in its entirety and replaced by the following:

 

2.4                                No Additional Rights .  It is understood that nothing in this Agreement shall be construed to grant Company or any of its Affiliates a license, express or implied, under any patent owned solely or jointly by Hospital or Harvard other than the Patent Rights expressly licensed hereunder.  Hospital shall have the right to license any Hospital Patent Rights to any other party for any purpose outside of the License Field or the License Territory.  Hospital and/or Harvard shall have the right to license any Media Patent Rights to any other party for any purpose outside of the Limited Field or the License Territory.

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

3



 

CONFIDENTIAL TREATMENT REQUESTED

 

10.                                Section 3.1 of the Agreement shall be deleted in its entirety and replaced by the following:

 

3.1                                Diligence Requirements .  Company shall use, and shall cause its Affiliates and Sublicensees, as applicable, to use, commercially reasonable efforts to develop and make available to the public Products and Processes throughout the License Territory in the License Field.  Such efforts shall include achieving the following objectives within the time periods designated below following the Effective Date:

 

(a)                                  Pre-Sales Requirements for Product and/or Processes using Hospital Patent Rights and/or Technological Information:

 

(i)                                      Company shall use commercially reasonable efforts to carry out development of Products and/or Processes in accordance with development plans mutually agreed by the Parties through their Steering Committee representatives.

 

(ii)                                   Company shall secure venture capital or other equity financing of at least $[***] within [***] months following the Effective Date.

 

(iii)                                Company shall identify one or more study site(s) for a Clinical Proof of Concept study with [***] months following the Effective Date.

 

(iv)                               Provide written report to Hospital detailing regulatory strategy for developing a Product or Process within [***] months following the Effective Date.

 

(v)                                  Enroll the first patient in a Clinical Proof of Concept study within [***] months following the Effective Date.

 

(vi)                               Complete a Clinical Proof of Concept study within [***] months following the Effective Date; provided that this milestone shall be deemed achieved by the completion of a study prospectively intended to demonstrate Clinical Proof of Concept whether or not Clinical Proof of Concept is achieved with such study.

 

(vii)                            Achieve a First Commercial Sale as it relates to Hospital Patent Rights or Technological Information within [***] months following the Effective Date.

 

(b)                                  Pre-Sales Requirements for Product and/or Processes using Media Patent Rights :

 

(i)                                      Initiate animal studies of a Product or Process using the Media Patent Rights within [***] months following the Effective Date.

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

4



 

CONFIDENTIAL TREATMENT REQUESTED

 

(ii)                                   Initiate human studies of a Product or Process using the Media Patent Rights within [***] months following the Effective Date.

 

(iii)                                Achieve First Commercial Sale of a Product or Process using the Media Patent Rights within [***] months of the Effective Date.

 

(c)                                   Post Sales Requirements .

 

(i)                                      Following the First Commercial Sale of a Product or Process in any country in the License Territory, Company shall directly or through its Affiliates and/or Sublicensees make continuing Sales of such Product or Process or a similar Product or Process in such country without any elapsed time period of [***] or more in which such Sales do not occur.

 

(ii)                                   Company shall directly or through an Affiliate or Sublicensee make such First Commercial Sale within the following countries and regions in the License Territory within [***] years after the Effective Date of this Agreement: (a) Canada, Mexico, Argentina, Brazil, Australia, New Zealand and Japan and (b) at least [***] of the following countries: the U.K., France, Germany, Italy and Spain.

 

Achievement of the foregoing objectives shall be deemed to satisfy Company’s obligations to use commercially reasonable efforts under this Section 3.1.  Sections 3.1(a) and (b) above may be updated or modified from time to time by the Steering Committee, and any such update or modification shall be documented in the minutes of the applicable Steering Committee meeting and may be updated hereto through a written amendment.

 

11.                                Section 3.2 of the Agreement shall be deleted in its entirety and replaced by the following:

 

3.2                                Diligence Failures .  If Company fails to fulfill any of its obligations under Section 3.1(c) with respect to any of the countries listed in Section 3.1(c)(ii)(a) or with respect to at least three of the countries listed in Section 3.1(c)(ii)(b) in any material respect, then, subject to the notice and cure provisions of Section 10.4, Hospital may treat such failure as a default and, at Hospital’s option, may, solely with respect to the country(-ies) to which such failure relates, either convert the License under 2(a)(i) to non-exclusive or terminate this Agreement and/or any license granted hereunder in accordance with Section 10.4.  For the avoidance of doubt, Hospital shall not, based on Company’s failure to fulfill it obligations under Section 3.1(c), have the right to terminate this Agreement or Company’s licenses hereunder, or convert Company’s licenses hereunder to non-exclusive, with respect to countries in which Company satisfies its obligations under Section 3.1(c).  In addition, if Company, together with its Affiliates, Sublicensees and Clinical End Users, ceases all development and commercialization activities with respect

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

5



 

CONFIDENTIAL TREATMENT REQUESTED

 

to all Products and Processes for more than [***], Hospital may treat such failure as a default and, at Hospital’s option, may either convert the License under 2(a)(i) to non-exclusive or terminate this Agreement and/or any license granted hereunder in accordance with Section 10.4.  If Company fails to fulfill any of its obligations under Section 3.1 (a) or 3.1(b), then, subject to the notice and cure provisions of Section 10.4, Hospital may treat such failure as a default and, at Hospital’s option, may, in the case of such failure with respect to Section 3.1 (a), solely with respect to the Hospital Patent Rights, or in the case of such failure with respect to Section 3.1(b), solely with respect to the Media Patent Rights, either convert the License under 2(a)(i) to non-exclusive with respect to the Hospital Patent Rights or Media Patent Rights, as applicable, or terminate any license granted hereunder with respect to the Hospital Patent Rights or Media Patent Rights, as applicable, in accordance with Section 10.4.  For the avoidance of doubt, Hospital shall not, based on Company’s failure to fulfill it obligations under Section 3.1 (a) or 3.1(b), have the right to terminate this Agreement or Company’s licenses hereunder, or convert Company’s licenses hereunder to non-exclusive, other than with respect to the Hospital Patent Rights or Media Patent Rights, as applicable.

 

12.                                A following new section 4.1 (a) is hereby inserted immediately after Section 4.1 of the License.

 

(a)                                  Media Patent Rights License Issue Fee .  Company shall pay Hospital an additional non-refundable license issue fee in the amount of [***] dollars ($[***]) upon the effective date of Amendment No. 1 to this Agreement for the grant of rights under the Media Patent Rights.

 

13.                                Section 4.2 of the Agreement shall be deleted in its entirety and replaced by the following:

 

4.2                                Patent Cost Reimbursement .  Company shall reimburse Hospital for all costs associated with the preparation, filing, prosecution and maintenance of all Patent Rights (“Patent Costs”).  As of the Effective Date, Hospital has incurred approximately [***] Dollars ($[***]) in Patent Costs with respect to Hospital Patent Rights.  As of the effective date of Amendment No. 1 to this Agreement, Hospital and Harvard have incurred approximately [***] Dollars ($[***]) in Patent Costs with respect to Media Patent Rights.  Company shall pay such amounts to Hospital based upon the following schedule:

 

·                   $[***] within [***] days of the Effective Date

·                   [***] within [***] days after the effective date of Amendment No. 1 to this Agreement

·                   $ [***] on the [***] anniversary of the Effective Date

·                   [***] on the [***] anniversary of the Effective Date

 

Company shall pay to Hospital, or at Hospital’s request directly to patent counsel, all other Patent Costs within [***] days of Company’s receipt of an invoice for such Patent

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

6



 

CONFIDENTIAL TREATMENT REQUESTED

 

Costs either from Hospital or Hospital’s patent counsel.  Hospital shall instruct patent counsel to provide copies to Hospital for Hospital’s administrative files of all invoices detailing Patent Costs which are sent directly to Company.

 

14.                                A following new section 4.3(c) is hereby inserted immediately after Section 4.3(b) of the License.

 

(c)  Media Patent Rights Annual License Fee .  Company shall pay to Hospital the non-refundable amount of [***] Dollars ($[***]) as an annual license fee for the grant of rights under the Media Patent Rights within [***] days after each anniversary of the Effective Date.

 

Each Media Patent Rights Annual License Fee shall be creditable against royalties subsequently due on Net Sales amounts from Products or Processes relying on the Media Patent Rights made in the same year as such fee is due, and against milestones subsequently due in the same year as such fee is due, but shall not be credited against royalties due on Net Sales made or milestones payable in any other subsequent year.  However, the first [***] Dollars ($[***]) of Media Patent Rights Annual License Fees shall be creditable against royalties subsequently due on Net Sales amounts made and milestones payable during the [***] and [***] calendar years following the Effective Date, if any, but shall not be credited against royalties due on Net Sales made or milestones payable in any other prior or subsequent year.

 

15.                                Section 4.4 of the Agreement shall be deleted in its entirety and replaced by the following:

 

4.4                                Milestone Payments .  In addition to the payments set forth in Sections 4.1 through 4.3 above, Company shall pay Hospital milestone payments as follows:

 

(a)                                  [***] Dollars ($[***]) within [***] days of [***]; and

 

(b)                                  [***] Dollars ($[***]) within [***] days of [***]; and

 

(c)                                   [***] Dollars ($[***]) within [***] days of [***]; and

 

(d)                                  [***] Dollars ($ [***]) within [***] days following the earlier of (i) [***] or (ii) [***] months after [***]; and

 

(e)                                   [***] Dollars ($[***]) for  the  first calendar year in which Net Sales amounts equal or exceed [***] Dollars ($[***]); and

 

(f)                                    [***] Dollars ($[***]) for the first calendar year in which Net Sales amounts equal or exceed [***] Dollars ($[***]); and

 

(g)                                   [***] Dollars ($[***]) for the first calendar year in which Net Sales amounts equal or exceed [***] Dollars ($[***]); and

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

7



 

CONFIDENTIAL TREATMENT REQUESTED

 

(h)                                  [***] Dollars ($[***]) for the first calendar year in which Net Sales amounts equal or exceed [***] Dollars ($[***]); and

 

(i)                                      [***] Dollars ($[***]) for the first calendar year in which Net Sales amounts equal or exceed [***] Dollars ($[***]); and

 

(j)                                     [***] Dollars ($[***]) for the first calendar year in which Net Sales amounts equal or exceed [***] Dollars ($[***]); and

 

(k)                                  [***] Dollars ($[***]) for the first calendar year in which Net Sales amounts equal or exceed [***] Dollars ($[***]).

 

For the avoidance of doubt, should the milestone described in clause (b) above be achieved before the milestone in clause (a) above is achieved, the milestone payments described in clause (a) will be due and payable concurrently with the milestone payment described in clause (b), and should the milestone described in clause (d) above be achieved before the milestone in clause (c) above is achieved, the milestone payments described in clause (c) will be due and payable concurrently with the milestone payment described in clause (d), and should Net Sales amounts be equal to or greater than more than one of the above as yet to be achieved milestones in any given calendar year, all such milestones first achieved in such calendar year shall be due for that calendar year.

 

All payments due to Hospital under this Section 4.4 shall be due and payable by Company within [***] days after the end of each Reporting Period, and shall be accompanied by a report as set forth in Sections 5.2 and 5.3.

 

The milestone payments set forth in this Section 4.4 shall each be payable no more than once.

 

16.                                Section 4.5(a) of the License is hereby deleted in its entirety and replaced by the following:

 

(a)                                  Beginning with the First Commercial Sale in any country in the License Territory, Company shall pay Hospital during the term of any license granted under Section 2.1(a)(i), a royalty of [***] percent ([***]%) of the Net Sales amounts of all Products and Processes.  In the event that Company reasonably determines that royalty payments to one or more third parties are required in order to avoid potential infringement of third party patent rights as a result of Sales of Products and/or Processes, Company shall notify Hospital via Hospital’s Executive Director, Research Ventures and Licensing promptly following Company’s decision to pursue a license from the applicable third party and, if such payments are in excess of [***] Percent ([***]%) of Net Sales, Company may offset a total of [***] Percent ([***]%) of such third-party payments that are in excess of [***] Percent ([***]%) of Net Sales against any royalty payments that are due under this Section 4.5(a) to Hospital in the same

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

8



 

CONFIDENTIAL TREATMENT REQUESTED

 

Reporting Period, provided that in no event shall the royalty payments under this Section 4.5(a), when aggregated with any other offsets and credits allowed under this Agreement, be reduced by more than [***] Percent ([***]%) in any Reporting Period.  Without limiting the foregoing, in connection with providing notification to Hospital of Company’s intent to pursue a third party license, Company shall provide an explanation of its rationale for pursuing the license.  In the event that Hospital notifies Company that Hospital has concerns regarding Company’s determination to seek such license, the Steering Committee shall be convened to review the determination.  Failing satisfactory resolution from the Steering Committee the matter shall be discussed between Company CEO or Chairman and the Hospital’s Executive Director, Research Ventures and Licensing; provided that, Company’s CEO shall have final decision-making authority with respect to such matter and Company shall not be required to delay obtaining the proposed third party license for more than [***] days in total as a result of the foregoing Steering Committee and executive consultation process.

 

17.                                The following new language shall be inserted after the final paragraph of Section 5.3 of the Agreement:

 

In addition to the above, in each such report, Company shall separately account (i) for royalties owed for Net Sales of Products and/or Processes covered solely by Media Patent Rights and solely by Hospital Patent Rights and (ii) for royalties owed for Net Sales of Products and/or Processes covered by both Media Patent Rights and Hospital Patent Rights.  Such reporting shall be of sufficient detail as to how the separate royalties were calculated in relation to (ii) above.  Absent the Company’s ability to accurately determine the royalties for each of the Hospital Patent Rights and Media Patent Rights as they relate to Products and/or Processes covered by both Media Patent Rights and Hospital Patent Rights, Company shall specify in its independent, good faith discretion the amount of such royalties attributable to the Media Patent Rights.

 

18.                                Section 5.4 of the Agreement shall be deleted in its entirety and replaced by the following:

 

5.4                                Sublicense Income Reports .  Company shall, along with delivering payment as set forth in Section 4.7, report to Hospital within [***] days after the end of each Reporting Period the amount of all Sublicense Income received by Company during such Reporting Period, and Company’s calculation of the amount due and paid to Hospital from such income, including an itemized listing of the source of income comprising such consideration, and the name and address of each entity making such payments in substantially the format outlined in Appendix C .  Additionally, Company shall separately account for Sublicense Income owed with respect to the Hospital Patent Rights and the Media Patent Rights.  Absent Company’s ability to accurately determine the Sublicense Income with respect to the each of the Hospital Patent Rights and Media

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

9



 

CONFIDENTIAL TREATMENT REQUESTED

 

Patent Rights, Company shall specify in its independent, good faith discretion the amount of such Sublicense income attributable to the Media Patent Rights.

 

19.                                Section 7.1 of the Agreement shall be deleted in its entirety and replaced by the following:

 

7.1                                Hospital Right to Prosecute .  Hospital will protect the Patent Rights from infringement and prosecute infringers when, in its sole judgment, such action may be reasonably necessary, proper and justified.  If Company shall have supplied Hospital with written evidence demonstrating to Hospital’s reasonable satisfaction prima facie infringement of a claim of a Hospital Patent Right in the License Field, or of a Media Patent Right in the Limited Field, in the License Territory by a third party which poses a material threat to Company’s rights under this Agreement, Company may by notice request Hospital to take steps to protect such Patent Right.  Hospital shall notify Company within [***] days of the receipt of such notice whether Hospital intends to prosecute the alleged infringement.  If Hospital notifies Company that it intends to so prosecute, Hospital shall, within [***] months of its notice to Company either (a) cause such infringement to terminate, or (b) initiate legal proceedings against the infringer.

 

20.                                Section 7.2 of the Agreement shall be deleted in its entirety and replaced by the following:

 

7.2                                Company Right to Prosecute .  In the event Hospital notifies Company that Hospital does not intend to prosecute infringement identified under Section 7.1, Company may, upon notice to Hospital, initiate legal proceedings against the infringer at Company’s expense with respect to a claim of a Hospital Patent Right in the License Field, or of a Media Patent Right in the Limited Field, in the License Territory.  Before commencing such action, Company and, as applicable, any Affiliate, shall consult with Hospital, concerning, among other things, Company’s standing to bring suit, the advisability of bringing suit, the selection of counsel and the jurisdiction for such action and shall consider the views of Hospital regarding the proposed action, including without limitation with respect to potential effects on the public interest.  Company shall be responsible for all costs, expenses and liabilities in connection with any such action and shall indemnify and hold Hospital and Harvard harmless therefrom, regardless of whether Hospital or Harvard is a party-plaintiff, except for the expense of any independent counsel retained by Hospital in accordance with Section 7.5 below.

 

21.                                Section 7.3 of the Agreement shall be deleted in its entirety and replaced by the following:

 

7.3                                Hospital and/or Harvard Joined as Party-Plaintiff .  If Company elects to commence an action as described in Section 7.2 above, Hospital and/or Harvard shall have, in its sole discretion, the option to join such action as a party-plaintiff.  If joinder of Hospital and/or Harvard as a party-plaintiff is necessary or desirable in order for Company to bring or maintain such action or to prove damages in such action, and

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

10



 

CONFIDENTIAL TREATMENT REQUESTED

 

Company requests that Hospital and/or Harvard be joined, Hospital and/or Harvard may either, in its sole discretion, permit itself to be joined as a party-plaintiff at the sole expense of Company, or assign to Company all of Hospital’s and/or Harvard’s right, title and interest in and to the Patent Right which is the subject of such action (subject to all  of Hospital’s and/or Harvard’s obligations to the government under law and any other rights that others may have in such Patent Right).  If Hospital and/or Harvard makes such an assignment, such action by Company shall thereafter be brought or continued without Hospital and/or Harvard as a party; provided, however, that Hospital and/or Harvard shall continue to have all rights of prosecution and maintenance with respect to Patent Rights and Company shall continue to meet all of its obligations under this Agreement as if the assigned Patent Right were still licensed to Company hereunder.

 

22.                                Section 7.4 of the Agreement shall be deleted in its entirety and replaced by the following:

 

7.4                                Notice of Actions; Settlement .  Company shall promptly inform Hospital of any action or suit relating to Patent Rights and shall not enter into any settlement, consent judgment or other voluntary final disposition of any action relating to Patent Rights, including but not limited to appeals, without the prior written consent of Hospital and/or Harvard, as applicable.

 

23.                                Section 8.1 of the Agreement shall be deleted in its entirety and replaced by the following:

 

8.1                                Indemnification .

 

(a)                                  Company shall indemnify, defend and hold harmless Hospital and Harvard and their Affiliates and their respective current or former trustees, directors, officers, medical and professional staff, governing  board  members, faculty, students, employees, and agents and their respective successors, heirs and assigns (the “ Indemnitees ”), against any liability, damage, loss or expense (including reasonable attorney’s fees and expenses of litigation) incurred by or imposed upon the Indemnitees or any one of them in connection with any claims, suits, actions, demands or judgments arising out of any theory of product liability (including, but not limited to, actions in the form of contract, tort, warranty, or strict liability) concerning any product, process or service made, used, or sold or performed pursuant to any right or license granted under this Agreement.

 

(b)                                  With respect to Patent Cost Reimbursement under Section 4.2, Company agrees to indemnify, defend and hold Hospital harmless from and against any and all Patent Costs and costs of collection arising from the failure of Company to timely pay such Patent Costs.

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

11



 

CONFIDENTIAL TREATMENT REQUESTED

 

(c)                                   Company agrees, at its own expense, to provide attorneys reasonably acceptable to the Hospital and/or Harvard to defend against any actions brought or filed against any party indemnified hereunder with respect to the subject of indemnity contained herein, whether  or  not  such actions are  rightfully  brought; provided, however, that any Indemnitee shall have the right to retain its own counsel, at the expense of Company, if representation of such Indemnitee by counsel retained by Company would be inappropriate because of conflict of interests of such Indemnitee and any other party represented by such counsel.  Company agrees to keep Hospital and/or Harvard informed of the progress in the defense and disposition of such claim and to consult with Hospital and/or Harvard prior to any proposed settlement.

 

(d)                                  This section 8.1 shall survive expiration or termination of this Agreement.

 

24.                                Section 9.2 of the Agreement shall be deleted in its entirety and replaced by the following:

 

9.2                                No Warranties .  NEITHER HOSPITAL NOR HARVARD MAKES ANY REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, CONCERNING THE PATENT RIGHTS AND THE RIGHTS GRANTED HEREUNDER, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE,  NONINFRINGEMENT, VALIDITY OF PATENT RIGHTS CLAIMS, WHETHER ISSUED OR PENDING, AND THE ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE, AND HEREBY DISCLAIMS THE SAME.  SPECIFICALLY, AND NOT TO LIMIT THE FOREGOING, NEITHER HOSPITAL NOR HARVARD MAKES ANY WARRANTY OR REPRESENTATION (a) REGARDING THE VALIDITY OR SCOPE OF ANY OF THE CLAIM(S), WHETHER ISSUED OR PENDING, OF ANY OF THE PATENT RIGHTS, AND (b) THAT THE EXPLOITATION OF THE PATENT RIGHTS OR ANY PRODUCT OR PROCESS WILL NOT INFRINGE ANY PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF HOSPITAL, HARVARD OR OF ANY THIRD PARTY.

 

25.                                Section 9.3 of the Agreement shall be deleted in its entirety and replaced by the following:

 

9.3                                Limitation of Liability .  IN NO EVENT SHALL EITHER PARTY OR HARVARD OR ANY OF THEIR RESPECTIVE AFFILIATES OR ANY OF THEIR RESPECTIVE TRUSTEES, DIRECTORS, OFFICERS, MEDICAL AND PROFESSIONAL STAFF, EMPLOYEES AND AGENTS BE LIABLE TO THE ANOTHER OR ANY OF ITS AFFILIATES FOR INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND ARISING IN ANY WAY OUT OF THIS AGREEMENT OR THE LICENSE RIGHTS GRANTED HEREUNDER, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY,

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

12



 

CONFIDENTIAL TREATMENT REQUESTED

 

INCLUDING WITHOUT LIMITATION SUCH DAMAGES THAT ARE ECONOMIC DAMAGES OR INJURY TO PROPERTY OR LOST PROFITS, REGARDLESS OF WHETHER SUCH ENTITY SHALL BE ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE POSSIBILITY OF THE FOREGOING; PROVIDED, HOWEVER, NOTHING IN THIS SECTION 9.3 SHALL BE CONSTRUED TO LIMIT COMPANY’S OBLIGATION TO INDEMNIFY HOSPITAL AND HARVARD UNDER SECTION 8 OF THIS AGREEMENT.

 

26.                                Section 10.5 of the Agreement shall be deleted in its entirety and replaced by the following:

 

10.5                         Challenging Validity .  During the term of this Agreement, Company shall not challenge, and shall restrict its Affiliates and Sublicensees from challenging the validity of the Patent Rights and, in the event of any breach of this provision by Company, Hospital shall have the right to terminate this Agreement and any license granted hereunder immediately.  In addition, if the Patent Rights are upheld, Company shall reimburse Hospital and Harvard for their legal costs and expenses incurred in defending any such challenge by Company or its Affiliates or Sublicensees  in any country in which Company and its Affiliates and Sublicensees retain a license to such Patent Rights under this Agreement.

 

27.                                Section 10.6 of the Agreement shall be deleted in its entirety and replaced by the following:

 

10.6                         Termination by Company .  Company shall have the right to terminate this Agreement in its entirety by giving ninety (90) days advance written notice to Hospital and upon such termination shall immediately cease all use and Sales of Products and Processes, subject to Section 10.9.  Company shall also have the right to terminate its license hereunder with respect to either the Hospital Patent Rights or the Media Patent Rights, but not both, by giving ninety (90) days advance written notice to Hospital and upon such termination shall immediately cease all use and Sales of Products and Processes using the Hospital Patent Rights or Media Patent Rights, as applicable, subject to Section 10.9.  Following such a termination with respect to the Hospital Patent Rights only, Sections 3.1 (a), and to the extent not already achieved or paid, Sections 4.3(a), 4.3(b), 4.4(a) and 4.4(b) shall no longer have any force or effect, but this Agreement shall otherwise remain in full force and effect.  Following such a termination with respect to the Media Patent Rights only, Sections 3.1 (b), and to the extent not already achieved or paid, Sections 4.3(c), 4.4(c) and 4.4(d) shall no longer have any force or effect, but this Agreement shall otherwise remain in full force and effect.

 

28.                                The last sentence of Section 11.1 of the Agreement shall be deleted in its entirety and replaced by the following:

 

Company shall indemnify and hold harmless Hospital and Harvard for any breach of Company’s obligations under this Section 11.1.

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the

Securities Exchange Act of 1934, as amended.

 

13



 

CONFIDENTIAL TREATMENT REQUESTED

 

29.                                The following language shall be added to Section 12.2:

 

Unless changed in writing in accordance with this Section, the notice address for Harvard shall be as follows:

 

Chief Technology Development Officer
Harvard Office of Technology Development
1350 Massachusetts Avenue
Holyoke Center, Suite 727E
Cambridge, MA 02138

 

Fax No. (617)495-9568

 

30.                                Section 12.7 of the Agreement shall be deleted in its entirety and replaced by the following:

 

12.7                         Use of Name .  Neither Party shall use the name of the other Party or Harvard or of any its Affiliates and their respective current or former trustees, directors, officers, medical and professional staff, governing board members, faculty, students, employees, and agents of the other Party or any adaptation thereof in any advertising, promotional or sales literature, publicity or in any document employed to obtain funds or financing without the prior written approval of the Party or individual whose name is to be used.  For Hospital, such approval shall be obtained from Hospital’s VP of Public Affairs.  Notwithstanding the forgoing, this shall not prohibit Company from stating the factual existence of this Agreement and its Terms.

 

31.                                Appendix A-1 attached to this Amendment is hereby inserted into the Agreement immediately following Appendix A of the Agreement.

 

32.                                Except as expressly modified by this amendment, all terms and conditions of the Agreement shall remain in full force and effect.

 

33.                                This Amendment may be executed by the parties hereto on separate counterparts each of which shall constitute an original but all of which together shall constitute one and the same instrument.

 

34.                                This Amendment shall be governed by the laws of The Commonwealth of Massachusetts.

 

IN WITNESS WHEREOF, the Parties have caused this Amendment to be executed by their duly authorized representatives as of the effective date first written above.

 

OVASCIENCE, INC.

 

THE GENERAL HOSPITAL CORPORATION, D/B/A MASSACHUSETTS GENERAL HOSPITAL

 

 

 

By:

/s/ Michelle Dipp

 

By:

/s/ Rebecca Menapace

 

Name:

 

 

Name:

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

14



 

CONFIDENTIAL TREATMENT REQUESTED

 

TITLE:

CEO, OvaScience

 

TITLE:

  /s/ Rebecca Menapace

 

 

 

 

Director, Research & Licensing

 

 

 

 

Research Ventures & Licensing

 

 

 

 

 

DATE:

9/7/11

 

DATE:

9/7/11

 

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

15



 

CONFIDENTIAL TREATMENT REQUESTED

 

Appendix A

 

DESCRIPTION OF HOSPITAL PATENT RIGHTS

 

ID

 

Title

 

Assignee

 

Status

 

Type

 

CTRY

 

Serial #

 

Filing
Date

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 

[***]

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

16



 

CONFIDENTIAL TREATMENT REQUESTED

 

Appendix A-1

 

DESCRIPTION OF MEDIA PATENT RIGHTS

 

[***]

[***]

 

[***]

 

[***]

 

[***]

 

 

 

 


Portions of the exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

17


EXHIBIT 31.1

 

Certification of Principal Executive Officer pursuant to Section 302
of the Sarbanes-Oxley Act of 2002 by Principal Executive Officer

 

I, Michelle Dipp, M.D., Ph.D., certify that:

 

1.     I have reviewed this Quarterly Report on Form 10-Q of OvaScience, 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 11, 2015

 

 

 

 

/s/ Michelle Dipp, M.D., Ph.D.

 

Michelle Dipp, M.D., Ph.D.

 

Chief Executive Officer

 

(Principal executive officer)

 


EXHIBIT 31.2

 

Certification of Principal Financial Officer pursuant to Section 302
of the Sarbanes-Oxley Act of 2002 by Principal Financial Officer

 

I, Jeffrey Young, certify that:

 

1.     I have reviewed this Quarterly Report on Form 10-Q of OvaScience, 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 11, 2015

 

 

 

/s/ Jeffrey Young

 

Jeffrey Young

 

Chief Financial Officer (Principal accounting and 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, by Chief Executive Officer

 

In connection with the Quarterly Report on Form 10-Q of OvaScience, Inc. (the “Company”) for the period ended March 31, 2015, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, Michelle Dipp, M.D., Ph.D., as Chief Executive Officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, that:

 

(1)   the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

 

(2)   the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Dated: May 11, 2015

 

 

 

 

/s/ Michelle Dipp, M.D., Ph.D.

 

Michelle Dipp, M.D., Ph.D.

 

Chief Executive Officer

 

(Principal executive officer)

 


EXHIBIT 32.2

 

Certification pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 by Principal Financial Officer

 

In connection with the Quarterly Report on Form 10-Q of OvaScience, Inc. (the “Company”) for the period ended March 31, 2015, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, Jeffrey Young, as principal financial officer of the Company, hereby certifies, pursuant to 18 U.S.C. Section 1350, that:

 

(1)   the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

 

(2)   the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Dated: May 11, 2015

 

 

/s/ Jeffrey Young

 

Jeffrey Young

 

Chief Financial Officer (Principal accounting and financial officer)