UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2013
¨ | 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 0-23155
SYNAGEVA BIOPHARMA CORP.
(Exact name of registrant as specified in its charter)
Delaware | 56-1808663 | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
128 Spring Street, Suite 520,
Lexington, MA 02421
(Address of principal executive offices, including zip code)
(781) 357-9900
Registrants telephone number, including area code
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 ¨
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No ¨
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ¨ | Accelerated filer | x | |||
Non-accelerated filer | ¨ (Do not check if a smaller reporting company) | Smaller reporting company | ¨ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ¨ No x
The number of shares outstanding of the registrants common stock as of May 1, 2013 was 27,268,539.
TABLE OF CONTENTS
Page | ||||||
PART I. |
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Item 1. |
3 | |||||
Consolidated Balance Sheets as of March 31, 2013 (Unaudited) and December 31, 2012 |
3 | |||||
Consolidated Statements of Operations (Unaudited) for the three months ended March 31, 2013 and 2012 |
4 | |||||
5 | ||||||
Consolidated Statements of Cash Flows (Unaudited) for the three months ended March 31, 2013 and 2012 |
6 | |||||
7 | ||||||
Item 2. |
Managements Discussion and Analysis of Financial Condition and Results of Operations |
16 | ||||
Item 3. |
23 | |||||
Item 4. |
23 | |||||
PART II. |
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Item 1. |
23 | |||||
Item 1A. |
23 | |||||
Item 5. |
37 | |||||
Item 6. |
37 | |||||
SIGNATURES | 39 |
2
Item 1. | Financial Statements |
CONSOLIDATED BALANCE SHEETS
(Unaudited and in thousands, except per share amounts)
March 31, 2013 |
December 31, 2012 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
$ | 53,762 | $ | 23,883 | ||||
Short-term investments |
255,180 | 195,070 | ||||||
Accounts receivable |
2,593 | 2,599 | ||||||
Prepaid expenses and other current assets |
8,229 | 3,555 | ||||||
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Total current assets |
319,764 | 225,107 | ||||||
Property and equipment, net |
7,276 | 4,012 | ||||||
Developed technology, net |
4,865 | 5,564 | ||||||
Goodwill |
8,535 | 8,535 | ||||||
Other assets |
713 | 38 | ||||||
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Total assets |
$ | 341,153 | $ | 243,256 | ||||
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Liabilities and Stockholders Equity |
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Current liabilities: |
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Accounts payable |
$ | 3,548 | $ | 2,576 | ||||
Accrued expenses |
4,629 | 5,112 | ||||||
Deferred revenue |
2,472 | 5,391 | ||||||
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Total current liabilities |
$ | 10,649 | $ | 13,079 | ||||
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Commitments and contingencies (Note 9) |
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Stockholders equity: |
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Common stock, par value $0.001; 60,000 shares authorized at March 31, 2013 and December 31, 2012; 27,187 and 24,467 shares issued and outstanding at March 31, 2013 and December 31, 2012, respectively |
27 | 24 | ||||||
Additional paid-in capital |
503,738 | 388,936 | ||||||
Accumulated other comprehensive loss |
12 | 6 | ||||||
Accumulated deficit |
(173,273 | ) | (158,789 | ) | ||||
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Total stockholders equity |
330,504 | 230,177 | ||||||
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Total liabilities and stockholders equity |
$ | 341,153 | $ | 243,256 | ||||
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The accompanying notes are an integral part of these financial statements.
3
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited and in thousands, except per share amounts)
Three Months Ended March 31, |
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2013 | 2012 | |||||||
Revenue: |
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Royalty revenue |
$ | 1,705 | $ | 1,449 | ||||
Collaboration and license revenue |
3,413 | 892 | ||||||
Other revenue |
| 56 | ||||||
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Total revenue |
5,118 | 2,397 | ||||||
Costs and expenses: |
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Research and development |
13,338 | 6,146 | ||||||
General and administrative |
5,654 | 2,920 | ||||||
Amortization of developed technology |
699 | 686 | ||||||
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Total costs and expenses |
19,691 | 9,752 | ||||||
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Loss from operations |
(14,573 | ) | (7,355 | ) | ||||
Interest income |
89 | 2 | ||||||
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Net loss |
$ | (14,484 | ) | $ | (7,353 | ) | ||
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Basic and diluted net loss per common share |
$ | (0.54 | ) | $ | (0.35 | ) | ||
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Weighted average shares used in basic and diluted per common share computations |
26,826 | 20,774 | ||||||
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The accompanying notes are an integral part of these financial statements.
4
STATEMENTS OF COMPREHENSIVE LOSS
(Unaudited and in thousands)
Three Months Ended March 31, |
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2013 | 2012 | |||||||
Consolidated | ||||||||
Net loss |
$ | (14,484 | ) | $ | (7,353 | ) | ||
Other comprehensive loss: |
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Fair market value adjustments of available for sale securities |
8 | | ||||||
Foreign currency translation adjustments |
(2 | ) | | |||||
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Total other comprehensive loss |
6 | | ||||||
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Comprehensive loss |
$ | (14,478 | ) | $ | (7,353 | ) | ||
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The accompanying notes are an integral part of these financial statements.
5
STATEMENTS OF CASH FLOWS
(Unaudited and in thousands)
Three Months Ended March 31, |
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2013 | 2012 | |||||||
Consolidated | ||||||||
Cash flows from operating activities |
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Net Loss |
$ | (14,484 | ) | $ | (7,353 | ) | ||
Adjustments: |
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Depreciation and amortization |
1,314 | 817 | ||||||
Stock compensation expense |
1,716 | 599 | ||||||
Amortization of discount on investments |
674 | | ||||||
Changes in assets and liabilities: |
||||||||
Accounts receivable |
6 | 380 | ||||||
Prepaid expenses, other current assets and other assets |
(2,482 | ) | 388 | |||||
Accounts payable |
(495 | ) | (10 | ) | ||||
Accrued expenses and other liabilities |
(481 | ) | (256 | ) | ||||
Deferred revenue |
(2,919 | ) | (565 | ) | ||||
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Net cash used in operating activities |
(17,151 | ) | (6,000 | ) | ||||
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Cash flows from investing activities |
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Purchase of available for sale investments |
(103,776 | ) | | |||||
Proceeds from sales and maturities available for sale investments |
43,000 | | ||||||
Capital expenditures |
(2,412 | ) | (199 | ) | ||||
Restricted cash |
(2,868 | ) | | |||||
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Net cash used in investing activities |
(66,056 | ) | (199 | ) | ||||
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Cash flows from financing activities |
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Proceeds from issuance of common stock, net of issuance costs |
111,055 | 84,600 | ||||||
Proceeds from exercise of stock options |
2,034 | 286 | ||||||
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Net cash provided by financing activities |
113,089 | 84,886 | ||||||
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Effect of exchange rate on cash |
(3 | ) | (1 | ) | ||||
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Net increase in cash and equivalents |
29,879 | 78,686 | ||||||
Cash and equivalents at the beginning of period |
23,883 | 60,232 | ||||||
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Cash and equivalents at the end of period |
$ | 53,762 | $ | 138,918 | ||||
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The accompanying notes are an integral part of these financial statements.
6
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except per share amounts or as otherwise indicated)
(Unaudited)
1. | Nature of the Business |
Synageva BioPharma Corp. (Synageva or the Company) is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of therapeutic products for patients with life-threatening rare diseases for which there is an unmet medical need. Synagevas lead program, sebelipase alfa, is a recombinant form of the human lysosomal acid lipase (LAL) enzyme currently under global clinical investigation for the treatment of patients with early onset and late onset LAL deficiency (LAL Deficiency), which is a rare, devastating disease that causes significant morbidity and mortality. Synageva has several protein therapeutics in its pipeline, including two enzyme replacement therapies for lysosomal storage disorders and additional programs for other serious genetic conditions for which there are currently no approved treatments. The most advanced of these other pipeline programs in SBC-103, an enzyme replacement therapy for the treatment of mucopolysaccharidosis IIIB (MPS IIIB), also known as Sanfilippo B syndrome. Synageva has not yet received approval to market sebelipase alfa and is not currently commercializing any other products.
The Companys business is subject to risks including those common to companies in the biopharmaceutical industry, such as the successful development of products, patient enrollment, clinical trial uncertainty, regulatory approval, fluctuations in operating results and financial risks, potential need for additional funding, protection of proprietary technology and patent risks, compliance with government regulations, dependence on key personnel, competition, technological and medical risks and management of growth.
The Company has incurred losses since inception and at March 31, 2013, had an accumulated deficit of $173.3 million. The Company expects to incur losses over the next several years as it continues to expand its drug discovery, development efforts and commercial activities. As a result of continuing losses, the Company may seek additional funding through a combination of public or private financing, collaborative relationships or other arrangements. The Company may not be able to obtain financing on acceptable terms, or at all, and the Company may not be able to enter into new collaboration or license agreements. If we are unable to obtain additional funding on a timely basis, whether through sales of debt or equity or through third-party collaboration or license arrangements, we may be required to curtail or terminate some or all of our development programs, including some or all of our drug candidates.
Through March 31, 2013, the Company funded its operations primarily from proceeds of the sale of stock, issuance of convertible notes, royalty proceeds and proceeds from government grants and collaboration agreements. On January 9, 2013, the Company announced the closing of a $117.5 million underwritten public offering of approximately 2.5 million shares of common stock at a price of $47.53. The Company received net proceeds of approximately $111.1 million from this offering. In addition to this offering, the Company received net proceeds of $192.7 million from two public equity offerings in fiscal 2012.
The Company intends to use the proceeds from these offerings for general corporate purposes, which may include working capital, capital expenditures, research and development expenditures, preclinical and clinical trial expenditures, commercial expenditures, acquisitions of new technologies or businesses that are complementary to our current technologies and business focus and investments. The Company expects that it will have sufficient cash and cash equivalents to sustain operations for more than two years.
2. | Summary of Significant Accounting Policies |
Basis of Presentation
The accompanying Financial Statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (SEC) for Quarterly Reports on Form 10-Q and do not include all of the information and note disclosures required by the accounting principles generally accepted in the United States of America (U.S. GAAP) for complete financial statements. The Financial Statements should therefore be read in conjunction with the Financial Statements and Notes thereto for the fiscal year ended December 31, 2012 included in the Companys Annual Report on Form 10-K filed with the SEC on March 14, 2013.
7
SYNAGEVA BIOPHARMA CORP.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except per share amounts or as otherwise indicated)
(Unaudited)
The accompanying Financial Statements have been prepared in accordance with U.S. GAAP, which requires management to make estimates and assumptions that affect amounts reported in the Financial Statements and accompanying disclosures. Although these estimates are based on the information reasonably available and actions that the Company may undertake in the future, actual results may be different from those estimates. The Financial Statements reflect all adjustments of a normal, recurring nature that are, in the opinion of management, necessary for a fair statement of results for these interim periods. The results of operations for the three months ended March 31, 2013 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2013.
Reverse Merger
On November 2, 2011, Trimeris, Inc., a Delaware corporation (Trimeris), closed a merger transaction (the Reverse Merger) with Synageva BioPharma Corp., a privately held Delaware corporation (Private Synageva), pursuant to an Agreement and Plan of Merger and Reorganization, dated as of June 13, 2011 (the Merger Agreement), by and among Trimeris, Private Synageva and Tesla Merger Sub, Inc., a wholly owned subsidiary of Trimeris (Merger Sub). Pursuant to the Merger Agreement, Private Synageva became a wholly owned subsidiary of Trimeris through a merger of Merger Sub with and into Private Synageva, and the former stockholders of Private Synageva received shares of Trimeris that constituted a majority of the outstanding shares of Trimeris. In connection with the Reverse Merger, Trimeris changed its name to Synageva BioPharma Corp.
The Reverse Merger was accounted for as a reverse acquisition under which Private Synageva was considered the acquirer of Trimeris.
Significant Accounting Policies
There have been no material changes to the Companys significant accounting policies during the three months ended March 31, 2013, as compared to the significant accounting policies disclosed in Note 2, Summary of Significant Accounting Policies, of the Companys financial statements included in the Annual Report on Form 10-K for the year ended December 31, 2012.
Recent Accounting Pronouncements
In February 2013, the Financial Accounting Standards Board issued an accounting standard update related to Comprehensive Income: Reporting of Amounts Reclassified Out of Accumulated Other Comprehensive Income. The revised standard requires companies to present information about reclassification adjustments from accumulated other comprehensive income in their annual financial statements in a single note or on the face of the financial statements. The Company adopted this standard in the first quarter of 2013 and presented this information in Note 6, Accumulated Other Comprehensive Income (Loss) to these condensed consolidated financial statements. The adoption of this standard did not have an impact on our financial position or results of operations.
Principles of Consolidation
Synagevas consolidated financial statements include the accounts of Synageva and its wholly owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.
8
SYNAGEVA BIOPHARMA CORP.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except per share amounts or as otherwise indicated)
(Unaudited)
3. | Fair Value of Financial Instruments |
Cash and Cash Equivalents
The Company considers all highly liquid investments with a remaining maturity at the date of purchase of 90 days or less to be cash equivalents. At March 31, 2013 and December 31, 2012, substantially all cash equivalents were U.S. treasury bills and amounts held in money market accounts at commercial banks.
Investments
All of the Companys investments were classified as available-for-sale at March 31, 2013 and December 31, 2012. The principal amounts of short-term investments are summarized in the tables below:
Less Than 12 Months to Maturity | ||||||||||||||||
Amortized Cost |
Unrealized Gains |
Unrealized Losses |
Fair Value | |||||||||||||
(in thousands) | ||||||||||||||||
Balance at March 31, 2013: |
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U.S. Treasury securities |
$ | 255,157 | $ | 23 | $ | | $ | 255,180 | ||||||||
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Total |
$ | 255,157 | $ | 23 | $ | | $ | 255,180 | ||||||||
Balance at December 31, 2012: |
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U.S. Treasury securities |
$ | 195,055 | $ | 15 | $ | | $ | 195,070 | ||||||||
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Total |
$ | 195,055 | $ | 15 | $ | | $ | 195,070 | ||||||||
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The Company completed an evaluation of its investments and determined that it did not have any other-than-temporary impairments as of March 31, 2013 or December 31, 2012.
Fair Value Measurements
Under current accounting standards, fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs.
The current accounting guidance also establishes a hierarchy to categorize how fair value is measured and which is based on three levels of inputs, of which the first two are considered observable and the last unobservable, as follows:
Level 1 |
Quoted prices in active markets for identical assets or liabilities. | |
Level 2 |
Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities, quoted prices in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities. | |
Level 3 |
Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
9
SYNAGEVA BIOPHARMA CORP.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except per share amounts or as otherwise indicated)
(Unaudited)
The following table presents information about the Companys financial assets and liabilities measured at fair value on a recurring basis as of March 31, 2013:
March 31, 2013 |
Quoted Price in Active Markets (Level 1) |
Significant Other Observable Inputs (Level 2) |
Significant Unobservable Inputs (Level 3) |
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Assets |
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Cash equivalents |
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Money market fund |
$ | 19,150 | $ | 19,150 | $ | | $ | | ||||||||
US treasury securities |
10,255 | 10,255 | | $ | | |||||||||||
Marketable securities |
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US treasury securities |
$ | 255,180 | $ | 255,180 | $ | | $ | | ||||||||
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Total |
$ | 284,585 | $ | 284,585 | $ | | $ | | ||||||||
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The following table presents information about the Companys financial assets and liabilities measured at fair value on a recurring basis as of December 31, 2012:
December 31, 2012 |
Quoted Price in Active Markets (Level 1) |
Significant Other Observable Inputs (Level 2) |
Significant Unobservable Inputs (Level 3) |
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Assets |
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Cash equivalents |
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Money market fund |
$ | 10,387 | $ | 10,387 | $ | | $ | | ||||||||
US treasury securities |
10,011 | 10,011 | | $ | | |||||||||||
Marketable securities |
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US treasury securities |
$ | 195,070 | $ | 195,070 | $ | | $ | | ||||||||
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Total |
$ | 215,468 | $ | 215,468 | $ | | $ | | ||||||||
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4. | Supplemental Balance Sheet Information |
Prepaid expenses and other current assets consist of the following:
March 31, 2013 |
December 31, 2012 |
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Prepaid clinical, manufacturing, and scientific costs |
$ | 3,264 | $ | 1,598 | ||||
Restricted cash short-term letters of credit (1) |
2,905 | 37 | ||||||
Interest receivable |
716 | 603 | ||||||
Prepaid insurance |
739 | 896 | ||||||
Other |
605 | 421 | ||||||
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$ | 8,229 | $ | 3,555 | |||||
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(1) | Restricted cash of $2.9 million at March 31, 2013 primarily relates to a short-term letter of credit associated with construction activities at our planned Lexington headquarters. |
10
SYNAGEVA BIOPHARMA CORP.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except per share amounts or as otherwise indicated)
(Unaudited)
Accrued expenses consist of the following:
March 31, 2013 |
December 31, 2012 |
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Accrued compensation, benefits and withholdings |
$ | 1,575 | $ | 1,862 | ||||
Clinical, manufacturing and scientific costs |
1,667 | 1,978 | ||||||
Professional fees |
714 | 685 | ||||||
Other |
673 | 587 | ||||||
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$ | 4,629 | $ | 5,112 | |||||
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5. | Share Based Payments |
The Companys stock-based compensation plans include the 1996 Stock Option Plan and the 2005 Stock Plan, as well as options outstanding under Trimeris, Inc.s 1993 Plan and 2007 Stock Incentive Plan. As part of the Reverse Merger, options outstanding under Trimeriss option plans were adjusted by the conversion ratio, and remain in existence as options in the combined entity. The Board of Directors has the authority to determine to whom options will be granted, the number of shares, the term, and the exercise price.
At the Companys annual meeting of stockholders held June 27, 2012, stockholders approved amendments to the 2005 Stock Plan to increase the number of shares of common stock available for issuance by 1.5 million shares, increasing the maximum number of shares that may be issued under the 2005 Stock Plan to approximately 3.5 million shares. Shares subject to outstanding awards under the 2005 Stock Plan totaled 2.0 million as of March 31, 2013.
In addition, at the Companys annual meeting of stockholders held June 27, 2012, stockholders approved the Employee Stock Purchase Plan (the ESPP), which allows eligible employees to use payroll deductions to purchase shares of the Companys common stock at a discount of 15%. The plan is considered a compensatory employee stock purchase plan, and will result in incremental stock-based compensation expense in future periods. Option periods under the ESPP will run from January 1 to June 30 and July 1 to December 31 of each year, with the first option period commencing in fiscal 2013.
Determining the Fair Value of Stock Options
The Company uses the Black-Scholes option pricing model to measure the fair value of its option awards. The fair value of each stock option grant was estimated on the date of grant using the Black-Scholes option-pricing model. The expected life assumption is based on the limited exercise historical experience at the Company, managements expectations based on the length of time that an employee will stay at the Company, the vesting period of four years and the contractual term of ten years. Volatility has been determined based on an analysis of reported data for a peer group of companies that granted options with substantially similar terms. The risk-free interest rate is based on the rate of U.S. Treasury zero coupon rate with a remaining term approximating the expected term used as the input to the Black-Scholes option pricing model.
Our Black-Scholes assumptions for options granted in the first three months of fiscal 2013 were consistent with those disclosed in Note 8, Share Based Payments, of the Companys financial statements included in the Annual Report on Form 10-K for the year ended December 31, 2012.
11
SYNAGEVA BIOPHARMA CORP.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except per share amounts or as otherwise indicated)
(Unaudited)
A summary of stock option activity under all equity plans for the three months ended March 31, 2013 is as follows:
Number of Shares |
Weighted Average Exercise Price |
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Outstanding at December 31, 2012 |
2,529 | $ | 25.06 | |||||
Options granted |
41 | 51.70 | ||||||
Options exercised |
(247 | ) | 8.23 | |||||
Options canceled or expired |
(29 | ) | 62.62 | |||||
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Outstanding at March 31, 2013 |
2,294 | $ | $26.87 | |||||
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The Company recognized stock-based compensation expense on all stock option awards for the three months ended March 31, 2013 and 2012, as follows:
Three Months Ended March 31, |
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2013 | 2012 | |||||||
Research and development |
$ | 664 | $ | 205 | ||||
General and administrative |
1,052 | 394 | ||||||
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$ | 1,716 | $ | 599 | |||||
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6. | Accumulated Other Comprehensive Income (Loss) |
The following table summarizes the changes in accumulated other comprehensive income (loss), net of tax by component:
Unrealized Gains on Available for Sale Securities |
Translation Adjustments |
Total | ||||||||||
Balance, as of December 31, 2012 |
15 | (9 | ) | 6 | ||||||||
Other comprehensive income (loss) before reclassifications |
8 | (2 | ) | 6 | ||||||||
Amounts reclassified from accumulated other comprehensive income (loss) |
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Net current period other comprehensive income (loss) |
8 | (2 | ) | 6 | ||||||||
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Balance, as of March 31, 2013 |
23 | (11 | ) | 12 |
Securities Available for Sale: Balances included within accumulated other comprehensive income (loss) related to unrealized holding gains (losses). There were no amounts reclassified from accumulated other comprehensive income (loss) during the three months ended March 31, 2013.
12
SYNAGEVA BIOPHARMA CORP.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except per share amounts or as otherwise indicated)
(Unaudited)
7. | Basic and Diluted Net Loss per Common Share |
Basic net loss per common share has been computed by dividing net loss by the weighted average number of shares outstanding during the period. Diluted net income per share, if applicable, has been computed by dividing diluted net income by the diluted number of shares outstanding during the period. Except where the result would be antidilutive to loss from continuing operations, diluted net loss per share has been computed assuming the exercise of stock options, as well as their related income tax effects.
The following table sets forth the computation of basic and diluted net loss per common share:
Three Months Ended March 31, |
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2013 | 2012 | |||||||
Numerator: |
||||||||
Net loss |
$ | (14,484 | ) | $ | (7,353 | ) | ||
Denominator |
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Weighted average common shares |
||||||||
Denominator for basic calculation |
26,826 | 20,744 | ||||||
Denominator for diluted calculation |
26,826 | 20,744 | ||||||
Net loss per share: |
||||||||
Basic |
$ | (0.54 | ) | $ | (0.35 | ) | ||
Diluted |
$ | (0.54 | ) | $ | (0.35 | ) |
The Companys potential dilutive securities which include stock options have been excluded from the computation of diluted net loss per share as the effect would be to reduce the net loss per share. Therefore, the weighted-average common stock outstanding used to calculate both basic and diluted net loss per share are the same. The following shares of potentially dilutive securities have been excluded from the computations of diluted weighted average shares outstanding as the effect of including such securities would be antidilutive (in thousands):
Three Months Ended March 31, |
||||||||
2013 | 2012 | |||||||
Options to purchase common stock |
2,294 | 2,304 |
8. | License Agreements and Collaborations |
Collaborations
In August 2011, the Company entered into a collaboration agreement with Mitsubishi Tanabe Pharma Corporation (Mitsubishi Tanabe) whereby the Company utilizes its proprietary expression technology for the development of a certain targeted compound. The agreement included an upfront development payment to the Company of $3.0 million, on-going reimbursement or funding of development costs, estimated during the initial development period to be approximately $1.5 million, and the potential for an additional payment of $3.0 million due upon the successful completion of the initial development.
In March 2012, the Company entered into a second agreement with Mitsubishi Tanabe to develop a second protein therapeutic. The agreement included an upfront license payment to the Company of $9.0 million and on-going reimbursement or funding of development costs, estimated during the initial development period to be approximately $0.8 million, as well as the potential for an additional payment of $3.0 million due upon successful completion of the initial development stage of the second program.
13
SYNAGEVA BIOPHARMA CORP.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except per share amounts or as otherwise indicated)
(Unaudited)
Under both agreements, Mitsubishi Tanabe has an option to obtain an exclusive royalty-bearing license, with the right to grant sublicenses, to further develop and commercialize the licensed compound that is the subject of the agreement (the Option). Additionally, upon exercise of the Option under the applicable agreement, the parties intend to negotiate a follow-on collaboration and license agreement that may include potential future development and commercial sales based milestone payments, and potential royalty payments. The Company determined that the Option is substantive as the decision to exercise is in the control of Mitsubishi Tanabe and is not essential to the functionality of the other deliverables in either agreement. Therefore, the Option was not considered to be a deliverable at the inception of either collaboration agreement. The Option terminates sixty days after the date the Joint Steering Committee (JSC) determines that the initial development met certain criteria.
The Company evaluated the collaboration agreements in order to determine whether the deliverables at the inception of the agreements: (i) the upfront license payments, (ii) the research services during the development periods, and (iii) the JSCs participation should be accounted for as a single unit or multiple units of accounting. The Company concluded that the upfront license payments do not have standalone value to Mitsubishi Tanabe because (i) Mitsubishi Tanabe does not have the ability to transfer or sublicense and (ii) the activities to be conducted during the development period are highly dependent on the Companys unique knowledge and understanding of its proprietary technology which is critical to optimizing the compounds. The Company determined that the JSC is a deliverable through the development period. In both agreements, the Company concluded that there are two units of accounting which are being delivered over the same performance period.
Revenue recognized under the first and second Mitsubishi Tanabe development programs totaled $0.5 million and $2.9 million for the three months ended March 31, 2013, respectively. For the three months ended March 31, 2012, collaboration revenue under the first development program totaled $0.9 million. Revenue is recognized using the proportional performance method. As of March 31, 2013, the deferred revenue balance includes $1.3 million and $1.2 million related to the first and second development programs, respectively.
9. | Commitments and Contingencies |
The Company accrues estimated liabilities for loss contingencies when it is probable that a liability has been incurred and the amount of the claim assessment or damages can be reasonably estimated. Synageva expenses legal fees, intellectual property related costs as they are incurred.
Occupancy Arrangements
On January 15, 2013, the Company entered into a lease agreement to accommodate the Companys continued growth and to relocate its corporate headquarters in Lexington, Massachusetts. The Company will occupy the location in stages as building modifications are completed. The Company currently anticipates that it will begin occupying a portion of the facility in May 2013. The initial lease term is for 77 months after the Company begins occupying the entire location, with an option to extend the lease term for two separate three year renewal periods. Future minimum lease payments for the Lexington lease are as follows:
Year Ending December 31, | ||||
2013 |
$ | 167 | ||
2014-2019 |
1,336 (per year | ) | ||
2020 |
334 |
10. | Subsequent Events |
On April 5, 2013, the Company, Shire Human Genetics Therapies, Inc. and its affiliates (Shire) and Cincinnati Childrens Hospital Research Foundation, an operating division of Childrens Hospital Medical
14
SYNAGEVA BIOPHARMA CORP.
NOTES TO THE FINANCIAL STATEMENTS
(In thousands, except per share amounts or as otherwise indicated)
(Unaudited)
Center, and their respective affiliates entered into a settlement agreement under which the parties settled the outstanding sebelipase alfa patent-related issues between them, including the revocation actions in the United Kingdom and France and the outstanding opposition in the European Patent Office.
Simultaneously with the execution of the settlement agreement, the Company entered into a sublicense agreement with Shire whereby the Company received exclusive, worldwide rights to multiple patents and patent applications owned by Cincinnati Childrens Hospital Research Foundation, and its affiliates, which had been exclusively licensed to, or co-owned with, Shire. The patents and patent applications cover the use of LAL including for the treatment of LAL Deficiency and atherosclerosis. These additional patents and patent applications complement the Companys existing and planned patent portfolio covering its LAL Deficiency program including patents and patent applications for composition of matter, methods of use, and manufacturing.
In exchange for the settlement and the rights acquired from Shire, the Company paid an upfront payment of $2.5 million, and will be obligated to make two sales-based milestones (each a low single-digit million dollar payment), and low, single-digit percentage tiered royalty payments on sales of sebelipase alfa in the U.S. and certain countries in Europe. The obligation to make tiered royalty payments is expected to expire in 2021. The Company will expense the $2.5 million upfront license payment as in-process research and development expense in the second quarter of fiscal 2013.
15
Item 2. | Managements Discussion and Analysis of Financial Condition and Results of Operations |
Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking statements as defined under federal securities laws. Many of these statements can be identified by the use of words such as believes, expects, anticipates, plans, may, will, projects, continues, estimates, potential, opportunity or the negative versions of these terms and other similar expressions. Our actual results or experience could differ significantly from the forward-looking statements. Factors that could cause or contribute to these differences include those discussed in Risk Factors, in Part II, Item 1A of this Quarterly Report on Form 10-Q. You should carefully consider that information before you make an investment decision.
We cannot guarantee any future results, levels of activity, performance or achievements. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this Quarterly Report on Form 10-Q as anticipated, believed, estimated or expected. The forward-looking statements contained in this Quarterly Report on Form 10-Q represent our estimates as of the date of this Quarterly Report on Form 10-Q (unless another date is indicated) and should not be relied upon as representing our expectations as of any other date. While we may elect to update these forward-looking statements, we specifically disclaim any obligation to do so.
The following discussion of our financial condition and results of operations should be read in conjunction with our Financial Statements and the related Notes thereto included elsewhere in this Quarterly Report on Form 10-Q.
Overview
We are a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of therapeutic products for patients with life-threatening rare diseases for which there is an unmet medical need. Our management team is experienced in the development and commercialization of drugs for diseases with small patient populations, including clinical and translational research, working with payors to establish reimbursement, and designing and building commercial organizations to reach highly specialized physicians to facilitate patient identification. Our lead program, sebelipase alfa, is a recombinant form of the human lysosomal acid lipase enzyme, or LAL, currently under global clinical investigation for the treatment of patients with early onset and late onset LAL deficiency, or LAL Deficiency, which is a rare, devastating disease that causes significant morbidity and mortality. We have several protein therapeutics in our pipeline, including two enzyme replacement therapies for lysosomal storage disorders and additional programs for other serious genetic conditions for which there are currently no approved treatments. The most advanced of these other pipeline programs is SBC-103, an enzyme replacement therapy for the treatment of mucopolysaccharidosis IIIB, or MPS IIIB, also known as Sanfilippo B syndrome. We have not yet received approval to market sebelipase alfa and are not currently commercializing any other products.
Financial Operations Overview
General
Our future operating results will depend on the progress of drug candidates currently in our research and development pipeline. The results of our operations will vary significantly from year-to-year and quarter-to-quarter and will depend largely on, among other factors, the cost and outcome of any preclinical development or clinical trials then being conducted.
A discussion of certain risks and uncertainties that could affect our liquidity, capital requirements and ability to raise additional funds is set forth under the section entitled Risk Factors in this Quarterly Report on Form 10-Q.
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Revenue
Royalty Revenue
Royalty revenues are recognized in the period earned, based on contract terms when reported sales are reliably measurable and collectability is reasonably assured. Royalty revenue relates to amounts earned from the sale of FUZEON by F. Hoffman-La Roche Ltd. (Roche). The FUZEON royalty stream was acquired in the Reverse Merger in the fourth quarter of fiscal 2011.
Collaboration and License Revenue
Collaboration and license revenue primarily relates to our collaboration agreements with Mitsubishi Tanabe whereby we utilize our proprietary expression technology in two development programs, in exchange for upfront license payments, funded development, and the potential for additional payments upon the successful completion of the development programs. Under the first program, which was entered into in August 2011, we received an upfront license payment of $3.0 million, on-going funding of development costs, and the potential for an additional payment of $3.0 million due upon the successful completion of the initial development. Additionally, we entered into a second agreement in March 2012, where we received an upfront license payment of $9.0 million, on-going funding of development costs, and the potential for an additional payment of $3.0 million due upon the successful completion of the initial development stage of the second program. We are recognizing revenue on consideration received under a proportional performance method. Under both agreements, Mitsubishi Tanabe has an option to obtain an exclusive royalty-bearing license, with the right to grant sublicenses, to further develop and commercialize the licensed compound. If Mitsubishi Tanabe exercises its option, the parties intend to negotiate a follow-on collaboration and license agreement that may include potential future development and commercial sales based milestone payments, and potential royalty payments.
Other Revenue
Other revenues relate to a National Institutes of Health (NIH) grant, which was completed in the first quarter of fiscal 2012.
Research and Development
We expense research and development costs as incurred. Research and development expense consists of costs incurred to discover, research and develop drug candidates, including personnel and facility-related expenses, outside contracted services including clinical trial costs, manufacturing and process development costs, research costs, outside consulting services and other external costs. Research and development expense includes any costs associated with generating collaboration or grant revenue.
General and Administrative
General and administrative expense consists primarily of salaries, stock-based compensation expense and other related costs for personnel in executive, business development, commercial, finance, human resource, legal, information technology, and support personnel functions. We also expense patent costs and expenses associated with maintaining our intellectual property as incurred. Other costs include facility costs not otherwise included in research and development expense, insurance, and professional fees for legal, accounting and commercial services.
Amortization of Developed Technology
We provide for the cost of amortization of developed technology, computed using an accelerated method based on the undiscounted cash flows received from the FUZEON royalty stream, in proportion to the estimated total undiscounted cash flows.
Interest Income, net
Interest income relates to interest earned on our cash equivalent and short-term investment balances.
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Results of Operations
Three Months Ended March 31, 2013 and 2012
Revenues
The following table presents total revenue for the three months ended March 31, 2013 and 2012, respectively (in thousands):
Three Months Ended March 31, |
||||||||||||||||
2013 | 2012 | $ Change | % Change | |||||||||||||
Royalty revenue |
$ | 1,705 | $ | 1,449 | $ | 256 | 18 | % | ||||||||
Collaboration and license revenue |
3,413 | 892 | 2,521 | 283 | ||||||||||||
Other revenue |
| 56 | (56 | ) | | |||||||||||
|
|
|
|
|
|
|||||||||||
Total revenue |
$ | 5,118 | $ | 2,397 | $ | 2,721 | 114 | % | ||||||||
|
|
|
|
|
|
Total revenues increased by approximately $2.7 million for the three months ended March 31, 2013, as compared to the comparable period of the prior year. The increase in revenues was the result of higher collaboration revenue and FUZEON royalty revenue.
Royalty revenues of $1.7 million relate to the royalty payment earned from Roche, based on total worldwide net sales of FUZEON. Collaboration and license revenue for the three months ended March 31, 2013 relates to revenue recognized from development programs with Mitsubishi Tanabe. For the three months ended March 31, 2013, we recognized $0.5 million and $2.9 million related to the first and second Mitsubishi Tanabe programs, respectively. For the three months ended March 31, 2012, collaboration and license revenue totaled $0.9 million primarily related to revenue recognized related to the first Mitsubishi Tanabe program. Other revenues relate to an NIH Grant, which totaled approximately $0.1 million for the three months ended March 31, 2012.
On an annualized basis, we expect FUZEON royalty revenues to decrease over time. As of March 31, 2013, our deferred revenue balance related to both of the Mitsubishi Tanabe collaboration agreements, totaled $2.5 million. We expect to recognize both the upfront payments and additional funded development payments related to both arrangements over the next year, in proportion to our performance under the arrangements.
Research and Development Expenses
Research and development expenses for the three months ended March 31, 2013 and 2012 are summarized as follows (in thousands):
Three Months Ended March 31, |
||||||||||||||||
2013 | 2012 | $ Change | % Change | |||||||||||||
Compensation and benefits-related |
$ | 3,738 | $ | 2,264 | $ | 1,474 | 65 | % | ||||||||
Clinical trials and manufacturing |
6,010 | 2,316 | 3,694 | 160 | ||||||||||||
Other development related external services |
1,497 | 797 | 700 | 88 | ||||||||||||
Facilities and related |
1,429 | 564 | 865 | 153 | ||||||||||||
Stock-based compensation expense |
664 | 205 | 459 | 224 | ||||||||||||
|
|
|
|
|
|
|||||||||||
Total research and development expense |
$ | 13,338 | $ | 6,146 | $ | 7,192 | 117 | % | ||||||||
|
|
|
|
|
|
Research and development expense increased by approximately $7.2 million, or 117%, to $13.3 million for the three months ended March 31, 2013, as compared to $6.1 million for the comparable prior year period. The increase in total research and development expense is due to increased clinical trial costs and manufacturing fees, as
18
well as other development related external services, associated with on-going development of sebelipase alfa and our pipeline programs and higher compensation expense from hiring additional staff to move the sebelipase alfa and pipeline programs forward. Additionally, for the three months ended March 31, 2013, research and development expense includes $0.7 million of stock-based compensation expense, compared to $0.2 million in the comparable prior year period. We expect research and development expense to continue to increase from those experienced in the first quarter as development activities for sebelipase alfa and our other pipeline programs continue.
General and Administrative Expenses
General and administrative expenses for the three months ended March 31, 2013 and 2012 are summarized as follows (in thousands):
Three Months Ended March 31, |
||||||||||||||||
2013 | 2012 | $ Change | % Change | |||||||||||||
Compensation and benefits-related |
$ | 2,478 | $ | 1,411 | $ | 1,067 | 76 | % | ||||||||
External and professional services |
2,010 | 970 | 1,040 | 107 | ||||||||||||
Facilities related and other |
114 | 145 | (31 | ) | (21 | ) | ||||||||||
Stock-based compensation expense |
1,052 | 394 | 658 | 167 | ||||||||||||
|
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|
|
|
|
|||||||||||
Total general and administrative expense |
$ | 5,654 | $ | 2,920 | $ | 2,734 | 94 | % | ||||||||
|
|
|
|
|
|
General and administrative expense increased by approximately $2.7 million, or 94%, to $5.7 million for the three months ended March 31, 2013 as compared to $2.9 million for the comparable prior year period. The increase was primarily due to higher compensation-related expenses of $1.1 million and increased stock-based compensation expense of $0.7 million, resulting from hiring additional staff to support expanded operations and increasing financial and legal costs associated with expanded operations and commercial preparations. Additionally, external fees and professional service costs increased $1.0 million period over period, primarily as a result of higher commercial related spending, higher public company costs, including insurance expense and higher professional service fees. We expect general and administrative expense to continue to increase in the future as our business grows.
Amortization of Developed Technology
Costs recognized for the amortization of developed technology for the three months ended March 31, 2013 and 2012 are summarized as follows (in thousands):
Three Months Ended March 31, |
||||||||||||||||
2013 | 2012 | $ Change | % Change | |||||||||||||
Amortization of developed technology |
699 | 686 | 13 | 2 | % | |||||||||||
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For both the three months ended March 31, 2013 and 2012, we recognized $0.7 million of amortization related to the developed technology acquired in the Reverse Merger.
Liquidity and Capital Resources
Sources of Liquidity
We have financed our operations to date primarily through the placement of our equity and debt securities and debt financings, and, to a lesser extent, license and royalty fees, upfront cash payments and research and development funding from collaborators, government grants and licensors. In November 2011, we acquired $50.1 million in cash as a result of the Reverse Merger with Trimeris. On January 10, 2012, we announced the closing of a $90.0 million underwritten public offering of approximately 3.6 million shares of our common stock at a price of $25.18 per share. We received net proceeds of approximately $84.6 million from this offering. In addition, on
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July 13, 2012, we announced the closing of a $115.0 million, second underwritten public offering of approximately 2.8 million shares of common stock at a price of $41.20 per share. We received net proceeds of approximately $108.1 million. On January 9, 2013, we announced the closing of a $117.5 million underwritten public offering of approximately 2.5 million shares of common stock at a price of $47.53 per share. We received net proceeds of approximately $111.1 million from this offering. We intend to use the net proceeds from these offerings for general corporate purposes, which may include working capital, capital expenditures, research and development expenditures, preclinical and clinical trial expenditures, commercial expenditures, acquisitions of new technologies or businesses that are complementary to our current technologies and business focus and investments.
We do not expect to generate any revenue from the direct sale of products currently in development for several years, if ever. As a result of our acquisition of Trimeris, we now receive royalties from the sale of FUZEON by Roche, which we expect to decrease over time. A significant portion of our revenues for the foreseeable future will be quarterly royalty payments from Roche based on sales of FUZEON, up-front license payments and funded research and development that we may receive under existing or new collaboration agreements, if any.
As of March 31, 2013, our principal sources of liquidity consisted of cash and cash equivalents and short-term investments of approximately $308.9 million. Our cash equivalents are highly liquid investments with a maturity of three months or less at date of purchase and consist of U.S. treasury bills and amounts held in money market funds.
Cash Flows
The use of our cash flows for operations has primarily consisted of salaries and wages for our employees, facility and facility-related costs for our office, laboratory, and manufacturing facilities, fees paid in connection with preclinical studies, clinical studies, outsourced manufacturing, laboratory supplies, consulting fees, commercial fees and legal fees. We expect that costs associated with clinical studies and manufacturing costs as well as commercial planning costs will increase in future periods as sebelipase alfa advances into further stages of clinical testing and our other preclinical candidates, including SBC-103, move forward in development.
Net cash used in operating activities was $17.2 million for the three months ended March 31, 2013, and was primarily the result of a net loss of $14.5 million, the drivers of which are discussed in further detail in Results of Operations. In addition, non-cash items and changes in certain operating assets and liabilities affected operating cash during the first quarter of fiscal 2013. Non-cash items partially offsetting net loss include depreciation of fixed assets of $0.6 million, amortization of developed technology of $0.7 million, stock-based compensation of $1.7 million, and the amortization of discount on available for sale investments of $0.7 million. Changes in operating assets and liabilities resulted in a net use of cash of $6.4 million, which was primarily the result of increased prepaid expenses and other assets of $2.5 million, decreased deferred revenue of $2.9 million and decreased accounts payable and accrued expenses of $1.0 million from December 31, 2012. The increase in prepaid expense and other assets was primarily driven by cash outlays for clinical and manufacturing activities. The decrease in deferred revenue in the period was primarily the result of the recognition of upfront license fees related to the Mitsubishi Tanabe development programs.
Net cash used in operating activities was $6.0 million for the three months ended March 31, 2012. Non-cash items partially offsetting net loss include depreciation of fixed assets of $0.1 million, amortization of developed technology of $0.7 million and stock-based compensation of $0.6 million. Changes in operating assets and liabilities resulted in a net use of cash of $0.1 million, which was primarily the result of a decrease in deferred revenue and accounts payable and accrued expenses of $0.6 million and $0.3 million from December 31, 2011, respectively. Sources of cash from changes in operating assets and liabilities included a net decrease of $0.4 million in accounts receivable and a net decrease of $0.4 million in prepaid expenses and other current assets. The decrease in deferred revenue in the period was primarily the result of revenue being recognized on the initial upfront license fee of $3.0 million from the initial Mitsubishi Tanabe development program.
We expect to continue to use cash in operations as we continue to seek to advance our pipeline programs through preclinical testing and clinical development. In addition, in the future, we may owe royalties and other contingent payments to our licensors based on the achievement of developmental milestones, product sales, and other specified objectives.
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Net cash used in investing activities totaled $66.1 million in the three months ended March 31, 2013, and was primarily a result of the purchase of available-for-sale investments of $103.8 million, partially offset by cash received from the maturity of available for sale investments totaling $43.0 million. Other uses of cash for investing activities included $2.9 million of restricted cash and $2.4 million for capital expenditures. The restricted cash outlay relates to a short-term letter of credit associated with construction activities at our planned headquarters in Lexington, MA. We anticipate cash spent on capital expenditures will continue to increase as we expand our internal production and development capabilities. In the corresponding period of the prior year, net cash used in investing activities totaled $0.2 million and related to capital expenditures.
Financing activities provided cash of approximately $113.1 million in the three months ended March 31, 2013, resulting from net cash received in secondary offerings of $111.1 million and proceeds from the exercise of stock options of $2.0 million. Financing activities provided cash of approximately $84.9 million for the three months ended March 31, 2012, resulting from net cash received in the secondary offering of $84.6 million and proceeds from the exercise of stock options of $0.3 million.
Funding Requirements
We have incurred significant losses since our inception. As of March 31, 2013, we had an accumulated deficit of approximately $173.3 million. Our cash and cash equivalents and investments balance at March 31, 2013 totaled $308.9 million. We expect to use our existing cash and cash equivalents and investments to continue our research and development programs and commercialization activities and to fulfill our planned operating goals. In particular, our currently planned operating and capital requirements include the need for working capital to support our research and development activities for sebelipase alfa and other preclinical candidates that we are seeking to develop, and to fund our general and administrative and commercial costs and expenses. We expect that we will have sufficient cash and cash equivalents to sustain operations for more than the next two years.
Our ability to finance our operations into the future and to generate revenues will depend heavily on our ability to obtain favorable results in the ongoing clinical trials of sebelipase alfa and to successfully develop and commercialize sebelipase alfa. We expect that our significant sources of cash flows from operations for the foreseeable future will be quarterly royalty payments from Roche based on sales of FUZEON and additional collaboration revenues, if any. Net sales of FUZEON by Roche have decreased in each of the last three years and are expected to continue to decline.
We may not be able to successfully enter into any new corporate collaborations and the timing, amount, and likelihood of us receiving additional payments under our current collaborations is highly uncertain. As a result, we cannot assure that we will attain any further funding from collaborations or licensing arrangements.
There are a number of factors that may adversely affect our planned future capital requirements and accelerate our need for additional financing, many of which are beyond our control, including the following:
| unanticipated costs in our research and development programs; |
| the timing, receipt and amount of payments, if any, from current and potential future collaborators; |
| the timing and amount of payments due to licensors of patent rights and technology used in our drug candidates; and |
| unplanned costs to prepare, file, prosecute, maintain and enforce patent claims and other patent-related costs, including litigation costs and technology license fees. |
We may seek additional funding through debt or equity financings. The fundraising environment for life science companies, in general, is highly volatile. Due to this and various other factors, including currently adverse general market conditions and the early-stage status of our development pipeline, additional funding may not be available on acceptable terms, if at all. In addition, the terms of any financing may be dilutive or otherwise adversely affect other rights of our stockholders. We also expect to seek additional funds through arrangements with collaborators, licensees or other third parties. These arrangements would generally require us to relinquish or
21
encumber rights to some of our technologies or drug candidates, and we may not be able to enter into such arrangements on acceptable terms, if at all. If we are unable to obtain additional funding on a timely basis, whether through sales of debt or equity or through third-party collaboration or license arrangements, we may be required to curtail or terminate some or all of our development programs, including some or all of our drug candidates.
Contractual Obligations and Requirements
As of March 31, 2013, our contractual obligations consisted primarily of operating leases for our headquarters and other facilities, contractual purchase obligations and to a lesser extent, minimum contractual payments on licensed technology.
On January 15, 2013, we entered into a lease agreement to accommodate our continued growth and to relocate our corporate headquarters in Lexington, Massachusetts. We will occupy the location in stages as building modifications are completed. We currently anticipate that we will begin occupying a portion of the facility in May 2013. The initial lease term is for 77 months after we begin occupying the entire location, with an option to extend the lease term for two separate three year renewal periods. Future minimum lease payments for the Lexington lease are as follows:
Year Ending December 31, | ||||
2013 |
$ | 167 | ||
2014-2019 |
1,336 (per year | ) | ||
2020 |
334 |
There have been no other significant changes to our contractual obligations and requirements during the three months ended March 31, 2013, as compared to those disclosed in Managements Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2013, which was filed with the SEC on March 14, 2013.
Off-Balance Sheet Arrangements
As of March 31, 2013, we did not have any off-balance sheet arrangements as defined in Item 303(a)(4)(ii) of SEC Regulation S-K.
Critical Accounting Policies and Estimates
In preparing our Financial Statements in accordance with accounting principles generally accepted in the U.S. and pursuant to the rules and regulations promulgated by the SEC, we make assumptions, judgments and estimates that can have a significant impact on our net income/loss and affect the reported amounts of certain assets, liabilities, revenue and expenses, and related disclosures. We base our assumptions, judgments and estimates on historical experience and various other factors that we believe to be reasonable under the circumstances. Actual results could differ materially from these estimates under different assumptions or conditions. On a regular basis, we evaluate our assumptions, judgments and estimates. We also discuss our critical accounting policies and estimates with the Audit Committee of our Board of Directors.
We believe that the assumptions, judgments and estimates involved in the revenue recognition, research and development expense, amortization of intangible assets, and income taxes have the greatest impact on our Financial Statements, so we consider these to be our critical accounting policies. Historically, our assumptions, judgments and estimates relative to our critical accounting policies have not differed materially from actual results.
There have been no significant changes to our critical accounting policies and estimates during the three months ended March 31, 2013, as compared to the critical accounting policies and estimates disclosed in Managements Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2012, which was filed with the SEC on March 14, 2013.
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Item 3. | Quantitative and Qualitative Disclosures About Market Risk |
Our market risks during the three months ended March 31, 2013 have not materially changed from those discussed in Part II, Item 7A, Quantitative and Qualitative Disclosures About Market Risk, of our Annual Report on Form 10-K for the year ended December 31, 2012, which was filed with the SEC on March 14, 2013.
Item 4. | Controls and Procedures |
We maintain disclosure controls and procedures designed to ensure that we are able to collect the information we are required to disclose in the reports we file with the Securities and Exchange Commission (SEC) and to process, summarize and disclose this information within the time periods specified in the rules and forms of the SEC. Based on the evaluation of our disclosure controls and procedures (as defined in the Securities Exchange Act of 1934, as amended, (the Exchange Act), Rules 13a-15(e) and 15d-15(e)) as of March 31, 2013, our Chief Executive Officer and Chief Financial Officer have concluded that such disclosure controls and procedures are effective to ensure that information required to be disclosed in our periodic reports filed under the Exchange Act is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions
There has been no change in our internal control over financial reporting that occurred during the quarter ended March 31, 2013 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Item 1. | Legal Proceedings. |
On April 5, 2013, we entered into a settlement agreement with Shire and Cincinnati Childrens Hospital Research Foundation, an operating division of Childrens Hospital Medical Center, and their respective affiliates under which the parties settled the outstanding sebelipase alfa patent-related issues between them, including revocation actions in the United Kingdom and France and the outstanding opposition in the European Patent Office.
Simultaneously with the execution of the settlement agreement, we entered into a sublicense agreement with Shire whereby we received exclusive, worldwide rights to multiple patents and patent applications owned by Cincinnati Childrens Hospital Research Foundation, and its affiliates, which had been exclusively licensed to, or co-owned with, Shire. The licensed patents and patent applications cover the use of LAL, including for the treatment of LAL Deficiency and atherosclerosis.
Item 1A. | Risk Factors. |
RISK FACTORS
Investing in our securities involves risk. Prior to making a decision about investing in our securities, you should carefully consider the specific risk factors discussed below and all of the other information contained or incorporated by reference to our Annual Report on Form 10-K for the year ended December 31, 2012, filed with the SEC on March 14, 2013. The risks and uncertainties we have described are not the only ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect our operations. If any of these risks were to occur, our business, financial condition or results of operations would likely suffer. In that event, the trading price of our common stock could decline, and you could lose all or part of your investment.
Risks Related to Our Business
We are largely dependent on the success of our leading product candidate, sebelipase alfa. All of our product candidates, including sebelipase alfa, are still in either preclinical or clinical development. Clinical trials of our product candidates may not be successful. If we are unable to commercialize sebelipase alfa, or experience significant delays in doing so, our business will be materially harmed.
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Our business prospects are largely dependent upon the successful development and commercialization of sebelipase alfa. We are currently enrolling patients in our global ARISE (Acid Lipase Replacement Investigating Safety and Efficacy) clinical trial, a randomized, double-blind, placebo-controlled Phase III trial of sebelipase alfa in children and adults with late onset LAL Deficiency. We are currently enrolling infants with early onset LAL Deficiency in a Phase II/III open-label trial with sebelipase alfa. Before we can commercialize product candidates, including sebelipase alfa, we need to:
| conduct substantial research and development; |
| undertake preclinical and clinical testing, sampling activity and other costly and time consuming measures; |
| scale-up manufacturing processes; and |
| pursue and obtain marketing and manufacturing approvals and, in some jurisdictions, pricing and reimbursement approvals. |
This process involves a high degree of risk and takes many years. Our product development efforts with respect to a product candidate may fail for many reasons, including:
| failure of the product candidate in preclinical studies; |
| failure of later trials to confirm positive results from earlier preclinical studies or clinical trials; |
| delays or difficulty enrolling patients in clinical trials, particularly for disease indications with small patient populations; |
| failure to identify a sufficient number of patients who meet the clinical trial enrollment criteria and/or who would support commercial launch and subsequent commercialization efforts; |
| patients exhibiting adverse reactions to the product candidate or indications of other safety concerns; |
| insufficient clinical trial data to support the effectiveness or superiority of the product candidate; |
| inability to manufacture sufficient quantities of the product candidate for development or commercialization activities in a timely and cost-efficient manner, if at all; |
| inability to produce, or sufficiently test the comparability of, drug materials derived from different manufacturing facilities operated by us or from processes run by our third party manufacturing partners which could impact our ability or timing with respect to receiving regulatory approval for our product candidates; |
| failure to obtain, or delays in obtaining, the required regulatory approvals for the product candidate, the facilities or the processes used to manufacture the product candidate; or |
| changes in the regulatory environment, including pricing and reimbursement, that make development of a new product or of an existing product for a new indication no longer desirable. |
Few research and development projects result in commercial products, and success in preclinical studies or early clinical trials often is not replicated in later studies.
We may decide to abandon development of a product candidate or service at any time, or we may be required to expend considerable resources repeating clinical trials or conducting additional trials, either of which would increase costs of development and delay any revenue from those programs.
In addition, a regulatory authority may deny or delay an approval because it is not satisfied with the structure or conduct of clinical trials or due to its assessment of the data we supply. A regulatory authority, for instance, may not believe that we have adequately addressed negative safety signals. Clinical data is subject to varied interpretations, and regulatory authorities may disagree with our assessments of data. In any such case, a regulatory authority could insist that we provide additional data, which could substantially delay or even prevent commercialization efforts, particularly if we are required to conduct additional pre-approval clinical studies.
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The results of our clinical trials may not prove sufficient to obtain regulatory approval of our product candidates, and subsequent trials may fail to replicate promising data seen in earlier preclinical studies and clinical trials.
Our Phase I/II study in adults with late onset LAL Deficiency completed enrollment in December 2011. Interim data from this study provided encouraging indications regarding safety and tolerability as well as effects consistent with preclinical findings and the known mechanism of action for LAL. We are currently enrolling the global ARISE clinical trial, a randomized, double-blind, placebo-controlled Phase III trial of sebelipase alfa in children and adults with CESD, the late onset form of LAL Deficiency. Our Phase II/III study in infants with early onset LAL Deficiency is currently on-going. We also are developing other product candidates for other rare diseases, including SBC-103 targeting a disease known as MPS IIIB, or Sanfilippo B. In February 2013, we presented preclinical data from the SBC-103 program that shows that dosing with SBC-103 reduces the accumulation of substrate in the brain of an MPS IIIB animal model.
Promising results in our preclinical studies or clinical trials may not be replicated in ongoing and future studies or trials, and final data analysis may differ from interim data analysis. Even if our additional trials of sebelipase alfa are conducted and completed as planned, the results may not prove sufficient to obtain regulatory approval. Success in preclinical testing does not ensure success in clinical trials, and success in early stage clinical trials does not ensure success in later clinical trials. Phase III clinical trials often fail to replicate encouraging results seen in preclinical studies and early clinical trials. We will incur substantial expenses moving our product candidates through stages of development, with no assurance that any of our product candidates will ultimately be commercialized. Future studies may, for example, indicate safety concerns that regulatory authorities view as unacceptable. Final data analysis of our completed, ongoing and future clinical trials may fail to demonstrate that our product candidates are sufficiently safe and effective for pursued indications. Any such failure could cause us to abandon a product candidate, substantially delay development of other product candidates, or require substantial expenditures to conduct additional trials. Both preclinical and clinical data are often susceptible to varying interpretations that may delay, limit or prevent regulatory approvals or commercialization. Any delay in, or termination of, our clinical trials would delay our obtaining regulatory approval of the affected product candidate and, consequently, our ability to commercialize that product candidate and potentially our other product candidates. Development and commercialization of therapies for rare diseases requires expenditure of significant funds with no assurance of success.
We may find it difficult to enroll patients in our clinical trials.
Sebelipase alfa is being developed to treat LAL Deficiency, which is very rare. Studies by investigators who screened various populations for a common mutation that causes LAL Deficiency indicate a prevalence range of 1:40,000 to 1:300,000 for late onset LAL Deficiency. There is no (or very little) prevalent population for early onset LAL Deficiency, since these infants rarely survive beyond the first year of life. Potential patients for our product candidates, including sebelipase alfa, may not be adequately diagnosed or identified with the diseases being targeted by our product candidates. We may not be able to initiate or continue clinical trials if we are unable to locate a sufficient number of eligible patients to participate in the clinical trials required by the FDA or other non-U.S. regulatory agencies. In addition, the process of finding and diagnosing patients may prove costly. We are currently enrolling patients in the ARISE trial, a randomized, double-blind, placebo-controlled Phase III trial of sebelipase alfa in children and adults with CESD, the late onset form of LAL Deficiency. We are currently enrolling infants with early onset LAL Deficiency, or Wolman disease, in a Phase II/III open-label trial with sebelipase alfa. Our inability to enroll a sufficient number of patients for any of our current or future clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether.
If our preclinical studies do not produce positive results, if our clinical trials are delayed or if serious side effects are identified during drug development, we may experience delays, incur additional costs and ultimately be unable to commercialize our product candidates.
Before obtaining regulatory approval for the sale of our product candidates, we must conduct, at our own expense, extensive preclinical tests to demonstrate the safety of our product candidates in animals, and clinical trials to demonstrate the safety and efficacy of our product candidates in humans. Preclinical and clinical testing is
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expensive, difficult to design and implement, and can take many years to complete. A failure of one or more preclinical studies or clinical trials can occur at any stage of testing. We may experience numerous unforeseen events during, or as a result of, preclinical testing and the clinical trial process, which could delay or prevent our receipt of regulatory approval for, or the commercialization of, our product candidates, including:
| our preclinical tests or clinical trials may produce negative or inconclusive results, and we may decide to conduct, or regulators may require, additional preclinical testing or clinical trials, or we may abandon projects that we expect to be promising; |
| a regulatory authority or institutional review board may not authorize us to commence a clinical trial or conduct a clinical trial at a prospective trial site; |
| conditions imposed on us by the FDA or any non-U.S. regulatory authority regarding the scope or design of our clinical trials may require us to resubmit our clinical trial protocols to institutional review boards for re-inspection due to changes in the regulatory environment; |
| the number of patients required for clinical trials may be larger than we anticipate or participants may drop out of clinical trials at a higher rate than we anticipate; |
| our third-party contractors or clinical investigators may fail to comply with regulatory requirements or fail to meet their contractual obligations to us in a timely manner or at all; |
| we might have to suspend or terminate one or more of our clinical trials if we, a regulatory authority or an institutional review board determine that the participants are being exposed to unacceptable health risks; |
| a regulatory authority or institutional review board may require that we hold, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements; |
| the cost of our clinical trials may be greater than we anticipate; |
| the supply or quality of our product candidates or other materials necessary to conduct our clinical trials may be insufficient or inadequate or we may not be able to reach agreements on acceptable terms with prospective contract manufacturing organizations; |
| we may not be able to reach agreements on acceptable terms with prospective clinical research organizations; or |
| the effects of our product candidates may not be the desired effects, may include undesirable side effects, or the product candidates may have other unexpected characteristics. |
If we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently contemplate or are unable to successfully complete our clinical trials or other testing or if the results of these trials or tests are not positive or are only modestly positive or if there are safety concerns, we may:
| be delayed in obtaining, or may not be able to obtain, marketing approval for one or more of our product candidates; |
| obtain approval for indications that are not as broad as intended or entirely different than those indications for which we sought approval; or |
| have the product removed from the market after obtaining marketing approval. |
Our product development costs will also increase if we experience delays in testing or approvals. We do not know whether any preclinical tests or clinical trials will be initiated as planned, will need to be restructured or will be completed on schedule, if at all. Significant preclinical or clinical trial delays could also shorten the patent protection period during which we may have the exclusive right to commercialize our product candidates. Such delays could allow our competitors to bring products to market before we do and impair our ability to commercialize our products or product candidates.
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We have neither obtained marketing approval, nor commercialized any of our current rare disease product candidates.
We have neither obtained marketing approval nor commercialized any of our current product candidates and do not expect to receive marketing approval or generate revenue from the direct sale of our products, including sebelipase alfa, for several years, if ever. We still have only limited experience in conducting clinical trials for sebelipase alfa even though we are currently enrolling patients in the ARISE trial, a randomized, double-blind, placebo-controlled Phase III trial of sebelipase alfa in children and adults with CESD, the late onset form of LAL Deficiency. We are also currently enrolling infants with early onset LAL Deficiency, or Wolman disease, in a Phase II/III open-label trial with sebelipase alfa. Additionally, we are conducting preclinical studies with other product candidates for various other indications. Our limited experience might prevent us from successfully designing or implementing a clinical trial for any of these diseases. We may not be able to demonstrate that our product candidates meet the appropriate standards for regulatory approval. If we are not successful in conducting and managing our preclinical development activities or clinical trials or obtaining regulatory approvals, we might not be able to commercialize our lead product candidates, or might be significantly delayed in doing so, which will materially harm our business.
If we infringe the rights of third parties we might have to forgo selling our future products, pay damages, or defend litigation.
If our product candidates, methods, processes, or other technologies infringe the proprietary rights of other parties, we could incur substantial costs and might have to:
| obtain rights or licenses from such third parties, which might not be available on commercially reasonable terms, if at all; |
| abandon an infringing product candidate; |
| redesign products or processes to avoid infringement; |
| stop using the subject matter claimed in the patents held by others; |
| pay damages; and/or |
| defend or initiate litigation or administrative proceedings which might be costly whether we win or lose, and which could result in a substantial diversion of financial and management resources. |
Any of these events could substantially harm our earnings, financial condition, and operations.
If the market opportunities for our product candidates are smaller than we believe they are, our revenues may be adversely affected and our business may suffer.
We focus our research and product development on treatments for rare diseases. Our projections of both the number of people who have these diseases, as well as the subset of people with these diseases who have the potential to benefit from treatment with our product candidates, are based on estimates. Currently, most reported estimates of the prevalence of these diseases are based on studies of small subsets of the population of specific geographic areas, which are then extrapolated to estimate the prevalence of the diseases in the broader world population. For example, studies estimate the prevalence of late onset LAL Deficiency between 1:40,000 and 1:300,000. These estimates may prove to be incorrect and new studies may change the estimated prevalence of these diseases.
The commercial success of any product candidate that we may develop, including sebelipase alfa, will depend upon the degree of market acceptance by physicians, patients, third party payors and others in the medical community.
Any future product that we may bring to the market, including sebelipase alfa, may not gain market acceptance by physicians, patients, third party payors and others in the medical community. If our products do not achieve an adequate level of acceptance, we may not generate significant product revenue and may not become profitable. The degree of market acceptance of these product candidates, if approved for commercial sale, will depend on a number of factors, including:
| the prevalence and severity of any side effects, including any limitations or warnings contained in a products approved labeling; |
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| the efficacy and potential advantages over alternative treatments; |
| relative convenience and ease of administration; |
| the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; |
| the strength of marketing and distribution support and timing of market introduction of competitive products; |
| publicity concerning our products or competing products and treatments; and |
| sufficient third party insurance coverage or reimbursement in the countries or geographies where patients live. |
Even if a potential product displays a favorable efficacy and safety profile in preclinical and clinical trials, market acceptance of the product will not be known until after it is launched. Our efforts to educate the medical community and third party payors on the benefits of the product candidates may require significant resources and may never be successful. Such efforts to educate the marketplace may require more resources than are required by the conventional technologies marketed by our competitors.
Uncertainties relating to third-party reimbursement and health care reform measures could limit payments or reimbursements for future products that we may develop could materially adversely affect our business.
In the U.S. and elsewhere, sales of prescription drugs depend in part on the consumers ability to obtain reimbursement for the cost of the drugs from third-party payors, such as private and government insurance programs. Third-party payors are increasingly challenging the prices charged for medical products and services, including those related to rare diseases, in an effort to promote cost containment measures and alternative health care delivery systems. Our prospects for achieving profitability will depend heavily upon the availability of adequate reimbursement for the use of our approved product candidates from governmental and other third party payors, both in the U.S. and in other markets. Reimbursement by a third party payor may depend upon a number of factors, including the third party payors determination that use of a product is:
| a covered benefit under its health plan; |
| safe, effective and medically necessary; |
| appropriate for the specific patient; |
| cost-effective; and |
| neither experimental nor investigational. |
Obtaining reimbursement approval for a product from each governmental or other third party payor is a time consuming and costly process that could require us to provide supporting scientific, clinical and cost effectiveness data for the use of our products to each payor. We may not be able to provide data sufficient to gain acceptance with respect to reimbursement or might need to conduct post-marketing studies in order to demonstrate the cost-effectiveness of any future products to such payors satisfaction. Such studies might require us to commit a significant amount of management time and financial and other resources. Even when a payor determines that a product is eligible for reimbursement, the payor may impose coverage limitations that preclude payment for some uses that are approved by the FDA or non-U.S. regulatory authorities. In addition, there is a risk that full reimbursement may not be available for high priced products. Moreover, eligibility for coverage does not imply that any product will be reimbursed in all cases or at a rate that allows us to make a profit or even cover our costs. Interim payments for new products, if applicable, may also not be sufficient to cover costs and may not be made permanent.
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We are exposed to product liability and preclinical and clinical liability risks which could place a substantial financial burden upon us, should we be sued, if we do not have adequate liability insurance or general insurance coverage for such a claim.
Our business exposes us to potential product liability and other liability risks that are inherent in the testing, manufacturing and marketing of products like ours. Foreign regulations may require us, as sponsor, to be liable for medical outcomes even if an adverse event is not directly related to our product candidate. In addition, the use in our clinical trials of pharmaceutical formulations and products that our potential collaborators may develop and the subsequent sale of these formulations or products by us or our potential collaborators may cause us to bear a portion or all of the product liability risks. As is common for companies sponsoring such clinical testing, we carry product liability insurance. The limit of this insurance may in some instances may be insufficient to offset a negative judgment or settlement payment. As a result, a successful liability claim or series of claims brought against us could have a material adverse effect on our business, financial condition and results of operations.
We are subject to regulations regarding the manufacturing of therapeutic proteins.
We are subject to ongoing periodic unannounced inspections by the FDA, corresponding state agencies or non-U.S. regulatory authorities to ensure strict compliance with current good manufacturing practice (cGMP) and other government regulations and corresponding foreign standards. The cGMP requirements govern quality control and documentation policies and procedures. Complying with cGMP and non-U.S. regulatory requirements will require that we expend time, money, and effort in production, recordkeeping, and quality control to assure that the product meets applicable specifications and other requirements. We must also pass a pre-approval inspection prior to regulatory approval. Failure to pass a pre-approval inspection might significantly delay FDA approval of our products. If we fail to comply with these requirements, we would be subject to possible regulatory action and might be limited in the jurisdictions in which we are permitted to sell our products. As a result, our business, financial condition, and results of operations might be materially harmed.
We currently manufacture the therapeutic protein products used in the production of sebelipase alfa; however, we have limited experience in manufacturing or procuring products in commercial quantities and our manufacturing system has never produced a product approved by regulatory authorities for commercial use. We may not be able to manufacture enough product to conduct clinical trials or for later commercialization at an acceptable cost or at all. We may not be able to produce, or sufficiently test the comparability of, drug materials derived from different manufacturing facilities operating by us or from processes run by our third party manufacturing partners, which could impact our ability or timing with respect to receiving regulatory approval for our product candidates.
Our current and anticipated future reliance on a limited number of third parties to complete the manufacturing process for our products exposes us to certain risks.
We currently rely on third parties to complete the manufacturing process, including purifying, finishing and filling our products. Our anticipated future reliance on a limited number of third-party manufacturers exposes us to the following risks:
| We might be unable to identify manufacturers on acceptable terms or at all because the number of potential manufacturers is limited and the FDA and other regulatory authorities must approve any replacement contractor. This approval would generally require new testing and compliance inspections. In addition, a new manufacturer would have to be educated in, or develop substantially equivalent processes for, production of our products after receipt of FDA approval, if any. |
| Our third-party manufacturers might be unable to formulate and manufacture the relevant drugs in the volume and of the quality required to meet our clinical and commercial needs, if any. |
| Our third-party contract manufacturers might not perform as agreed or might not remain in the contract manufacturing business for the time required to supply possible clinical trials or to successfully produce, store and distribute our products. |
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| Drug manufacturers are subject to ongoing periodic unannounced inspections by the regulatory, corresponding state agencies and non-U.S. regulatory authorities to ensure strict compliance with cGMP, and other government regulations and corresponding foreign standards. We do not have control over third-party manufacturers compliance with these regulations and standards. |
| If any third-party manufacturer makes improvements in the manufacturing process for the relevant products, we might not own, or might have to share, the intellectual property rights to the innovation with our licensors. |
| We might compete with other companies for access to these manufacturers facilities and might be subject to manufacturing delays if the manufacturers give other clients higher priority than us. |
Each of these risks could delay our clinical trials or the approval, if any, of our product candidates by the FDA or the commercialization of our product candidates and could result in higher costs or deprive us of potential product revenues. As a result, our business, financial condition, and results of operations might be materially harmed.
We face significant competition from other pharmaceutical and biotechnology companies. Our operating results will suffer if we fail to compete effectively.
The pharmaceutical and biotechnology industries are intensely competitive and subject to rapid and significant technological change. Our competitors include organizations such as major multinational pharmaceutical companies, established biotechnology companies and specialty pharmaceutical and generic drug companies. Many competitors have greater financial and other resources than we have, such as larger research and development staff, more extensive marketing, distribution, sales and manufacturing organizations and experience, more extensive clinical trial and regulatory experience, expertise in prosecution of intellectual property rights and access to development resources like personnel and technology. As a result, these companies may obtain regulatory approval more rapidly than we are able to and may be more effective in selling and marketing their products.
Our operations are subject to the economic, political, legal and business conditions in the countries in which we do business, and our failure to operate successfully or adapt to changes in these conditions could cause our operations to be limited or disrupted.
We have expanded our operations outside of the United States and expect to continue to do so in the future. Our current operations in foreign countries subject us to certain risks that could cause our operations to be limited or disrupted, including volatility in international economies, political instability, difficulties enforcing contractual and intellectual property rights, changes in laws, regulations or enforcement practices with respect to our business, compliance with tax, employment and labor laws, costs and difficulties in recruiting and retaining qualified managers and employees to manage and operate the business in local jurisdictions and costs and difficulties in managing and monitoring international operations.
Our business depends on protecting our intellectual property.
We are pursuing intellectual property protection for sebelipase alfa and other product candidates in the form of patent applications that have been and will continue to be filed in the U.S. and in other countries; however, there can be no assurance that patents will issue with the scope for which they are originally filed, if at all.
If we and our licensors do not obtain protection for our respective intellectual property rights and our products are not, or are no longer, protected by regulatory exclusivity protection, such as orphan drug protection, our competitors might be able to take advantage of our research, development, and manufacturing efforts to develop and commercialize competing drugs.
Our success, competitive position, and future revenues, if any, depend in part on our ability and the abilities of our licensors to obtain and maintain patent protection for our products, methods, processes, and other technologies, to preserve our trade secrets, to prevent third parties from infringing on our proprietary rights, and to operate without infringing on the proprietary rights of third parties. We currently hold various issued patents and exclusive rights to issued patents and own and have licenses to various patent applications, in each case in the U.S. as well as rights under foreign patents and patent applications. We anticipate filing additional patent applications both in the U.S. and in other countries, as appropriate. However, the patent process is subject to numerous risks and uncertainties, and there can be no assurance that we will be successful in protecting our products by obtaining and defending patents. These risks and uncertainties include the following:
| our patent rights might be challenged, invalidated, or circumvented, or otherwise might not provide any competitive advantage; |
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| our competitors, many of which have substantially greater resources than we do and many of which might make significant investments in competing technologies, might seek, or might already have obtained, patents that will limit, interfere with, or eliminate our ability to make, use, and sell our potential products either in the U.S. or in international markets; |
| as a matter of public policy regarding worldwide health concerns, there might be significant pressure on the U.S. government and other international governmental bodies to limit the scope of patent protection both inside and outside the U.S. for disease treatments that prove successful; and |
| countries other than the U.S. might have less restrictive patent laws than the U.S., giving foreign competitors the ability to exploit these laws to create, develop, and market competing products. |
In addition, the USPTO and patent offices in other jurisdictions have often required that patent applications concerning pharmaceutical and/or biotechnology-related inventions be limited or narrowed substantially to cover only the specific innovations exemplified in the patent application, thereby limiting the scope of protection against competitive challenges. Thus, even if we or our licensors are able to obtain patents, the patents might be substantially narrower than anticipated.
Patent and other intellectual property protection is crucial to the success of our business and prospects, and there is a risk that such protections will prove inadequate. Our business and prospects might be materially harmed if these protections prove insufficient.
On September 16, 2011, the Leahy-Smith America Invents Act, or the Leahy-Smith Act, was signed into law. The Leahy-Smith Act includes a number of significant changes to United States patent law, including provisions that affect the way patent applications will be prosecuted and may also affect patent litigation. The USPTO has issued regulations and procedures to govern administration of the Leahy-Smith Act, but many of the substantive changes to patent law associated with the Leahy-Smith Act have only recently become effective and other changes will not become effective until early 2013. Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business and financial condition.
We rely on trade secret protections through confidentiality agreements with our employees and third parties, and the breach of these agreements could adversely affect our business and prospects.
We rely on trade secrets, which we seek to protect, in part, through confidentiality and non-disclosure agreements with our employees, collaborators, suppliers, and other parties. There can be no assurance that these agreements will not be breached, that we would have adequate remedies for any such breach, or that our trade secrets will not otherwise become known to or independently developed by our competitors. We might be involved from time to time in litigation to determine the enforceability, scope, and validity of our proprietary rights. Any such litigation could result in substantial cost and divert managements attention from operations. If any of these events occurs, or we otherwise lose protection for our trade secrets or proprietary know-how, the value of this information may be greatly reduced.
We are dependent on certain license relationships.
We have licensed technology that is related to our proprietary expression technology from the University of Georgia, University of Minnesota and Pangenix. In addition, we obtained exclusive worldwide rights to multiple patents and patent applications covering the use of LAL for the treatment of LAL Deficiency and atherosclerosis from Shire and Cincinnati Childrens Hospital Research Foundation. We might enter into additional licenses in the future. Licenses to which we are a party contain, and we expect that any future licenses will contain, provisions requiring up-front, milestone, and royalty payments to licensors and other conditions to maintaining the license rights. If we fail to comply with our obligations under any such license, the applicable licensor may have the right to
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terminate the license on relatively short notice and as a result, we may not be able to commercialize drug candidates or technologies that were covered by the applicable license. Also, the milestone and other payments associated with these licenses will make it less profitable for us to develop our drug candidates.
We will be dependent on orphan drug status to commercialize sebelipase alfa and SBC-103. A competitor may receive orphan drug marketing authorization prior to us for the same indication for which we are seeking approval.
We expect to rely heavily on the orphan drug exclusivity for sebelipase alfa and SBC-103, which grants seven years of marketing exclusivity under the Federal Food, Drug, and Cosmetic Act, and up to 10 years of marketing exclusivity in Europe. While the orphan drug exclusivity for sebelipase alfa and SBC-103 will provide market exclusivity in the U.S., Europe, and other countries, we will not be able to exclude other companies from manufacturing and/or selling drugs using the same active ingredient for the same indication beyond that timeframe. Furthermore, the marketing exclusivity in Europe can be reduced from 10 years to six years if the initial designation criteria have significantly changed since the market authorization of the orphan drug. Even if we have orphan drug exclusivity for a particular drug indication, we cannot guarantee that another company also with orphan drug exclusivity will not receive marketing authorization for the same indication before we do. If that were to happen, our applications for that indication may not be approved until the competing companys period of exclusivity has expired. Even if we are the first to obtain marketing authorization for an orphan drug indication, there are circumstances under which a competing product may be approved for the same indication during the seven-year period of marketing exclusivity in the U.S., such as if the later product is shown to be clinically superior to our product, or if the later product is a different drug than sebelipase alfa or SBC-103. Further, the seven-year marketing exclusivity in the U.S. would not prevent competitors from obtaining approval of the same compound for other indications or the use of other types of drugs for the same use as the orphan drug.
If we are unable to retain and recruit qualified scientists and advisors, or if any of our key executives, key employees or key consultants discontinues his or her employment or consulting relationship with us, it may delay our development efforts or otherwise harm our business.
The loss of any of our key executives, employees or key consultants could impede the achievement of our research and development objectives. Furthermore, recruiting and retaining qualified scientific personnel to perform research and development work in the future is critical to our success. We may be unable to attract and retain personnel on acceptable terms given the competition among biotechnology, biopharmaceutical, and health care companies, universities, and non-profit research institutions for experienced scientists and other disciplines. Competition for employees may impact our ability to recruit and retain qualified personnel in the future. Certain of our officers, directors, scientific advisors, and/or consultants or certain of the officers, directors, scientific advisors, and/or consultants hereafter appointed may from time to time serve as officers, directors, scientific advisors, and/or consultants of other biopharmaceutical or biotechnology companies. We do not maintain key man insurance policies on any of our officers or employees. We currently have employment contracts with our Chief Executive Officer, Sanj K. Patel, and other executive officers which provide for certain severance benefits. Consistent with our current employment policies, all of our employees are employed at will and, therefore, each employee may leave our employment at any time. If we are unable to retain our existing employees, including qualified scientific personnel, and attract additional qualified candidates, our business and results of operations could be adversely affected. We are not aware of any key personnel who intend to retire or otherwise leave us in the near future.
We derive a significant portion of our income from royalties on sales of FUZEON. If FUZEON sales continue to decline, our business could suffer.
Royalties on sales of FUZEON are currently a significant source of revenue for us. FUZEON competes with numerous existing therapies for the treatment of HIV. From 2007 through 2012, overall FUZEON net sales reported by our commercialization partner Roche have declined, totaling $112.2 million, $88.4 million, $50.7 million and $41.3 million for fiscal 2009, 2010, 2011 and 2012, respectively. We cannot predict if or when sales levels for FUZEON will stabilize.
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Uncertainties relating to third-party reimbursement and health care reform measures could limit payments or reimbursements for FUZEON, which could adversely affect our business.
Currently, because of the high cost of the treatment of HIV, many state legislatures are reassessing reimbursement policies for this therapy. If third-party payor reimbursements for FUZEON are limited or reduced, our results of operations will be adversely affected. In addition, emphasis in the U.S. on the reduction of the overall costs of health care through managed care has increased and will continue to increase the pressure to reduce the prices of pharmaceutical products.
The wholesale acquisition cost of a one-year supply of FUZEON in the U.S. is approximately $32,500. A high drug price could also negatively affect patients ability to receive reimbursement coverage for FUZEON from third-party payors, such as private or government insurance programs. If Roche is unable to obtain and maintain reimbursement from a significant number of third-party payors, it would have a material adverse effect on our business, financial condition and results of operations.
Currently, FUZEON is covered by Medicaid in all 50 states in the U.S. In addition, the AIDS Drug Assistance Programs in all 50 states and a majority of private insurers provide some amount of access to FUZEON. However, there are reimbursement challenges remaining. Some of the payors require patients to meet minimum medical requirements, such as maintaining certain cell levels associated with HIV, to receive reimbursement. Other payors limit the number of patients to which they will provide reimbursement for FUZEON, and other payors may require co-payments by the patient in order to receive reimbursement for FUZEON that are significantly higher than those required for other anti-HIV drugs.
Several major pharmaceutical companies have offered to sell their anti-HIV drugs at or below cost to certain countries in Africa and Least Developed Countries (as defined by the United Nations), which could adversely affect the reimbursement climate of, and the prices that may be charged for, HIV medications in the U.S. and the rest of the world. Third-party payors could exert pressure for price reductions in the U.S. and the rest of the world based on these lower costs offered in Africa and Least Developed Countries. This price pressure could limit the price that Roche would be able to charge for FUZEON, thereby adversely affecting our results of operations
If the sale of FUZEON infringes the proprietary rights of third parties, we may need to obtain licenses, pay damages or defend litigation.
If the sale of FUZEON infringes the proprietary rights of third parties, we could incur substantial costs and may have to:
| obtain licenses, which might not be available on commercially reasonable terms, if at all; |
| pay damages; and/or |
| defend litigation or administrative proceedings which might be costly whether we win or lose, and which could result in a substantial diversion of financial and management resources. |
Any of these events could substantially harm our earnings, financial condition, and operations.
On November 20, 2007, Novartis filed a lawsuit against us and Roche and certain of its affiliated entities, alleging infringement of the 271 Patent, related to the manufacture, sale and offer for sale of FUZEON. On September 23, 2010, we entered into a settlement agreement (the Settlement Agreement) with Roche and Novartis settling the lawsuit and the lawsuit was dismissed with prejudice from the Eastern District of North Carolina on September 28, 2010. Under the terms of the Settlement Agreement, we, in collaboration with Roche, have the right to continue to sell FUZEON under a license to Novartis 271 Patent in exchange for the payment of royalties to Novartis on net sales of FUZEON. We will share responsibility for payment of these royalties equally with Roche.
We may pursue rapid expansion of our workforce or diversify our business strategy through mergers, acquisitions, licensing arrangement or other contractual arrangements with third parties which may require substantial resources and substantial amounts of time from members of our senior management and involve numerous risks.
We may spend substantial resources to hire additional employees or pursue acquisitions of new technologies or businesses that are complementary to our current technologies or business focus through mergers, acquisitions, licensing arrangement or other contractual arrangements with third parties. Acquisitions involve numerous risks,
33
including potential difficulties in the integration of acquired operations such as retaining key employees of the acquired business, integrating research and development programs, not meeting financial objectives, increased costs, undisclosed liabilities not covered by insurance or terms of acquisition, and diversion of managements attention and resources in connection with an acquisition. No assurance can be given as to our success in identifying, executing, and integrating acquisitions in the future.
Our success will depend in part on relationships with third parties. Any adverse changes in these relationships could adversely affect our business, financial condition, or results of operations.
Our success will be dependent on our ability to maintain and renew business relationships with third parties and to establish new business relationships. There can be no assurance that our management will be able to maintain such business relationships, or enter into or maintain new business contracts and other business relationships, on acceptable terms, if at all. The failure to maintain important business relationships could have a material adverse effect on our business, financial condition, or results of operations.
Our charter documents and indemnification agreements require us to indemnify our directors and officers to the fullest extent permitted by law, which may obligate us to make substantial payments and to incur significant insurance-related expenses.
Our charter documents require us to indemnify our directors and officers to the fullest extent permitted by law. This could require us, with some legally prescribed exceptions, to indemnify our directors and officers against any and all expenses, judgments, penalties, fines, and amounts reasonably paid in defense or settlement of an action, suit, or proceeding brought against any of them by reason of the fact that he or she is or was our director or officer. In addition, expenses incurred by a director or officer in defending any such action, suit, or proceeding must be paid by us in advance of the final disposition of that action, suit or proceeding if we receive an undertaking by the director or officer to repay us if it is ultimately determined that he or she is not entitled to be indemnified. We have also entered into indemnification agreements with each of our directors and officers. In furtherance of these indemnification obligations, we maintain directors and officers insurance in the amount of $30,000,000. For future renewals, if we are able to retain coverage, we may be required to pay a higher premium for our directors and officers insurance than in the past and/or the amount of its insurance coverage may be decreased.
Risks Relating Our Financial Position and Capital Requirements
We may be unable to raise the substantial additional capital that we will need to further develop and commercialize our products.
As is typical of biotechnology companies at our stage of development, our operations consume substantial amounts of cash and we will need substantial additional funds to further develop and commercialize our products.
While we will need to seek additional funding, we may not be able to obtain financing on acceptable terms, or at all. In addition, the terms of our financings may be dilutive to, or otherwise adversely affect, holders of our common stock. We may also seek additional funds through arrangements with collaborators or other third parties. These arrangements would generally require us to relinquish rights to some of our technologies, product candidates or products, and we may not be able to enter into such agreements, on acceptable terms, if at all. If we are unable to obtain additional funding on a timely basis, we may be required to curtail or terminate some or all of our development programs, including some or all of our product candidates.
We have incurred significant losses since our inception and anticipate that we will continue to incur losses for the foreseeable future. We are a clinical-stage company with limited historical revenues, which makes it difficult to assess our future viability.
We are a clinical-stage biopharmaceutical company. Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk. We expect our expenses to increase in connection with our efforts to seek approval for and commercialize sebelipase alfa and our research and development of our other product candidates, including but not limited to, SBC-103. As a result, we expect to continue to incur significant research and development and other expenses related to our ongoing operations for the foreseeable future. If any of our product candidates fail in clinical trials or do not gain regulatory approval, or if any of our product candidates, if approved, fail to achieve market acceptance, we may never become profitable. Even if we
34
achieve profitability in the future, we may not be able to sustain profitability in subsequent periods. Our prior losses, combined with expected future losses, have had and will continue to have an adverse effect on our stockholders equity and working capital.
Our ability to utilize Trimeris net operating loss and tax credit carryforwards in the future is subject to substantial limitations and may be further limited as a result of the Reverse Merger.
Federal and state income tax laws impose restrictions on the utilization of net operating loss (NOL) and tax credit carryforwards in the event that an ownership change occurs for tax purposes, as defined by Section 382 of the Internal Revenue Code of 1986, as amended (the Code). In general, an ownership change occurs when stockholders owning 5% or more of a loss corporation (a corporation entitled to use NOL or other loss carryforwards) have increased their aggregate ownership of stock in such corporation by more than 50 percentage points during any three-year period. If an ownership change occurs, Section 382 of the Code imposes an annual limitation on the amount of post-ownership change taxable income that may be offset with pre-ownership change NOLs of the loss corporation experiencing the ownership change. The annual limitation is calculated by multiplying the loss corporations value immediately before the ownership change by the greater of the long-term tax-exempt rate determined by the IRS in the month of the ownership change or the two preceding months. This annual limitation may be adjusted to reflect any unused annual limitation for prior years and certain recognized built-in gains and losses for the year. Section 383 of the Code also imposes a limitation on the amount of tax liability in any post-ownership change year that can be reduced by the loss corporations pre-ownership change tax credit carryforwards.
On November 2, 2011, we completed the Reverse Merger which resulted in an ownership change of Trimeris. Trimeris previously experienced an ownership change in 2008. Accordingly, our ability to utilize Trimeris NOL and tax credit carryforwards may be substantially limited. These limitations could, in turn, result in increased future tax payments for us, which could have a material adverse effect on our business, financial condition.
Our management is required to devote substantial time to comply with public company regulations.
As a public company, we incur significant legal, accounting and other expenses. The Sarbanes-Oxley Act of 2002 (Sarbanes-Oxley), as well as rules implemented by the SEC and the NASDAQ Global Select Market, impose various requirements on public companies, including those related to corporate governance practices. Our management and other personnel will need to devote substantial time to these requirements. Certain members of our management do not have experience in addressing these requirements.
Sarbanes-Oxley requires, among other things, that we maintain effective internal controls for financial reporting and disclosure controls and procedures. In particular, we will be required to perform system and process evaluation and testing of our internal controls over financial reporting to allow management and our independent registered public accounting firm to report on the effectiveness of our internal controls over financial reporting, as required by Section 404 of Sarbanes-Oxley (Section 404). We will incur substantial accounting and related expenses to comply with Section 404. We may need to hire additional accounting and financial staff to satisfy the ongoing requirements of Section 404. Moreover, if we are not able to comply with the requirements of Section 404, or if we or our independent registered public accounting firm identifies deficiencies in our internal controls over financial reporting that are deemed to be material weaknesses, the market price of our stock could decline and we could be subject to sanctions or investigations by the NASDAQ Global Select Market, the SEC, or other regulatory authorities.
We rely on Roche to timely deliver important financial information relating to sales of FUZEON. In the event that this information is inaccurate, incomplete, or not timely, we will not be able to meet our financial reporting obligations as required by the SEC.
Under the Roche License Agreement, Roche has exclusive control over the flow of information relating to sales of FUZEON that we require to meet our SEC reporting obligations. Roche is required under the Roche License Agreement to provide us with timely and accurate financial data related to sales of FUZEON so that we may meet our reporting requirements under federal securities laws. In the event that Roche fails to provide us with timely and accurate information, we may incur significant liability with respect to the federal securities laws, our disclosure controls and procedures under Sarbanes-Oxley may be inadequate, and we may be forced to restate our financial statements, any of which could adversely affect the market price of our common stock.
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Changes in the estimated performance periods of our collaboration arrangements may negatively impact current period revenue.
We account for our collaboration arrangements under the proportional performance method, whereby the amount of revenue recognized in the current period is based on our performance compared to the total estimate to complete the project. If our estimates to complete change in future periods, our collaboration revenue may be reduced and could potentially be negative.
Risks Related to Ownership of Our Common Stock
The market price and trading volume of our common stock may be volatile.
The market price of our common stock could fluctuate significantly for many reasons, including the following factors:
| announcements of clinical or regulatory developments or technological innovations by us or our competitors, |
| changes in our relationship with our licensors and other strategic partners, |
| our quarterly operating results, |
| declines in sales of FUZEON, |
| developments in patent or other technology ownership rights, |
| public concern regarding the safety of our products, |
| additional funds may not be available on terms that are favorable to us and, in the case of equity financings, may result in dilution to our stock holders, |
| government regulation of drug pricing, and |
| general changes in the economy, the financial markets or the pharmaceutical or biotechnology industries. |
Additional factors beyond our control may also have an impact on the price of our stock. For example, to the extent that other large companies within our industry experience declines in their stock price, our stock price may decline as well. In addition, when the market price of a companys common stock drops significantly, stockholders often institute securities class action lawsuits against the company. A lawsuit against us could cause us to incur substantial costs and could divert the time and attention of our management and other resources.
Future sales of substantial amounts of our common stock, or the perception that such sales could occur, could adversely affect the market price of our common stock.
Future sales into the public market of substantial amounts of our common stock, or securities convertible or exchangeable into shares of our common stock, including shares of our common stock issued upon exercise of options and warrants, or perceptions that such sales could occur, could adversely affect the market price of our common stock and our ability to raise capital in the future.
Ownership of our common stock is highly concentrated, and it may prevent you and other stockholders from influencing significant corporate decisions and may result in conflicts of interest that could cause our stock price to decline.
Our executive officers and directors, together with their respective affiliates, beneficially own or control approximately 39% of our issued and outstanding common stock. Accordingly, these executive officers, directors and their affiliates, acting individually or as a group, have substantial influence over the outcome of a corporate action requiring stockholder approval, including the election of directors, any merger, consolidation or sale of all or substantially all of our assets or any other significant corporate transaction. These stockholders may also exert
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influence in delaying or preventing a change in control, even if such change in control would benefit our other stockholders. In addition, the significant concentration of stock ownership may adversely affect the market value of our common stock due to investors perception that conflicts of interest may exist or arise.
Anti-takeover provisions in our charter and bylaws may prevent or frustrate attempts by stockholders to change the board of directors or current management and could make a third-party acquisition of us difficult.
Our certificate of incorporation and bylaws contain provisions that may discourage, delay or prevent a merger, acquisition or other change in control that stockholders may consider favorable, including transactions in which stockholders might otherwise receive a premium for their shares. These provisions could limit the price that investors might be willing to pay in the future for shares of our common stock.
We have never declared or paid dividends on our common stock and do not anticipate paying dividends in the foreseeable future.
Our business requires significant funding, and we do not anticipate paying any cash dividends on our common stock in the foreseeable future.
Item 5. | Other Information. |
None.
Item 6. | Exhibits. |
10.1 | Bioprocessing Services Agreement, between Synageva BioPharma Corp. and FUJIFILM Diosynth Biotechnologies U.S.A. Inc., dated January 22, 2013 | |
10.2 | Exclusive Sublicense Agreement, between Shire AG and Synageva BioPharma Corp., dated April 5, 2013 | |
10.3 | Lease, between the Trustees of Hayden Office Trust and Synageva BioPharma Corp., dated January 15, 2013. | |
31.1 | Certification of Chief Executive Officer pursuant to Rules 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended. | |
31.2 | Certification of Chief Financial Officer pursuant to Rules 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended. | |
32.1 | Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. This Certification accompanies this report and shall not, except to the extent required by the Sarbanes-Oxley Act of 2002, be deemed filed for purposes of §18 of the Securities Exchange Act of 1934, as amended. | |
101.INS* | XBRL Instance Document | |
101.SCH* | XBRL Taxonomy Extension Schema Document | |
101.CAL* | XBRL Taxonomy Extension Calculation Document | |
101.DEF* | XBRL Taxonomy Extension Definition Linkbase | |
101.LAB* | XBRL Taxonomy Extension Labels Linkbase Document | |
101.PRE* | XBRL Taxonomy Extension Presentation Link Document |
* | Furnished herewith and not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. |
| Portions of this exhibit have been omitted pursuant to a request for confidential treatment filed with the SEC. The confidential portions have been filed separately with the SEC pursuant to the confidential treatment request. |
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Attached as Exhibit 101 to this report are documents formatted in XBRL (Extensible Business Reporting Language). Users of this data are advised that, pursuant to Rule 406T of Regulation S-T, the interactive data file is deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, is deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is otherwise not subject to liability under these sections.
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Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Synageva BioPharma Corp. | ||||||
Date: May 7, 2013 | By: | /s/ Sanj K. Patel | ||||
Sanj K. Patel | ||||||
President and Chief Executive Officer | ||||||
(Principal Executive Officer) | ||||||
Date: May 7, 2013 | By: | /s/ Carsten Boess | ||||
Carsten Boess | ||||||
Chief Financial Officer | ||||||
(Principal Financial Officer) |
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Exhibit Index
10.1 | Bioprocessing Services Agreement, between Synageva BioPharma Corp. and FUJIFILM Diosynth Biotechnologies U.S.A. Inc., dated January 22, 2013 | |
10.2 | Exclusive Sublicense Agreement, between Shire AG and Synageva BioPharma Corp., dated April 5, 2013 | |
10.3 | Lease, between the Trustees of Hayden Office Trust and Synageva BioPharma Corp., dated January 15, 2013. | |
31.1 | Certification of Chief Executive Officer pursuant to Rules 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended. | |
31.2 | Certification of Chief Financial Officer pursuant to Rules 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended. | |
32.1 | Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. This Certification accompanies this report and shall not, except to the extent required by the Sarbanes-Oxley Act of 2002, be deemed filed for purposes of §18 of the Securities Exchange Act of 1934, as amended. | |
101.INS* | XBRL Instance Document | |
101.SCH* | XBRL Taxonomy Extension Schema Document | |
101.CAL* | XBRL Taxonomy Extension Calculation Document | |
101.DEF* | XBRL Taxonomy Extension Definition Linkbase | |
101.LAB* | XBRL Taxonomy Extension Labels Linkbase Document | |
101.PRE* | XBRL Taxonomy Extension Presentation Link Document |
* | Furnished herewith and not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. |
| Portions of this exhibit have been omitted pursuant to a request for confidential treatment filed with the SEC. The confidential portions have been filed separately with the SEC pursuant to the confidential treatment request. |
Attached as Exhibit 101 to this report are documents formatted in XBRL (Extensible Business Reporting Language). Users of this data are advised that, pursuant to Rule 406T of Regulation S-T, the interactive data file is deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, is deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is otherwise not subject to liability under these sections.
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EXECUTION COPY
Exhibit 10.1
BIOPROCESSING SERVICES AGREEMENT
This Bioprocessing Services Agreement dated January 22, 2013 (this Agreement) between Synageva BioPharma Corp., a Delaware corporation (Sponsor) having its principal place of business at 128 Spring Street, Suite 520, Lexington, Massachusetts 02421 and FUJIFILM Diosynth Biotechnologies U.S.A., Inc., a Delaware corporation (Diosynth), having its principal place of business at 101 J. Morris Commons Lane, Morrisville, NC 27560, (each a Party, collectively, the Parties).
Sponsor desires Diosynth to perform services in accordance with the terms of this Agreement and the Scope (as hereinafter defined) related to the production of the material as described in the relevant Scope of Work (Product) and Diosynth desires to perform such services;
In consideration of the above statements, which form part of this Agreement, and other good and valuable consideration, the sufficiency and receipt of which are hereby acknowledged, the Parties hereto agree as follows:
Definitions:
Agreement shall have the meaning set forth in the preamble.
Alliance Manager shall have the meaning set forth in Section 21(b).
Assumptions shall have the meaning set forth in Section 6(a).
Batch Packet shall mean a compilation of records, including but not limited to, executed process records, genealogy, certificate of analysis (COA) and associated Quality Control data, [*] Deviation Reports, Disposition of Product form, Restriction Summary and Facility Assessment memo.
cGMP shall have the meaning set forth in Section 3(a).
Change Order shall have the meaning set forth in Section 6(b).
Claim shall have the meaning set forth in Section 15(a).
Confidential Information shall have the meaning set forth in Section 7(d).
Diosynth Confidential Information shall have the meaning set forth in Section 7(b).
Diosynth Factor shall mean (a) Diosynths negligence or willful default or inaction, (b) Diosynths failure to comply with cGMP, or (c) the failure of the GMP Facility to comply with applicable laws.
Facilities shall mean Diosynths facilities located in North Carolina, including the GMP manufacturing plant (GMP Facility), the process development laboratories, the GMP warehouse, and the administrative building.
Impasse Notice shall have the meaning set forth in Section 6(b).
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Indemnified Party shall have the meaning set forth in Section 15(c).
Indemnity Claim shall have the meaning set forth in Section 15(c).
Joint Steering Committee shall have the meaning set forth in Section 21(a).
Loss shall have the meaning set forth in Section 15(a).
Modification shall have the meaning set forth in Section 6(a).
Non-Conforming Batch shall mean a cGMP Batch which: (i) has not been produced in accordance with cGMP; and/or (ii) does not meet the Product specification set out in the Product item specification.
Party or Parties shall have the meaning set forth in the preamble.
Process Consumables shall have the meaning set forth in the Scope.
Process Invention shall have the meaning set forth in Section 9(b).
Product shall have the meaning set forth in the preamble.
Product Invention shall have the meaning set forth in Section 9(b).
Program shall mean the services to be performed under this Agreement.
Program Invention shall have the meaning set forth in Section 9(a).
Program Price and Payment Schedule shall mean the schedule attached as Appendix 3 to this Agreement.
Quality Agreement shall mean the quality agreement attached as Appendix 2 to this Agreement.
Regulatory Authority shall mean any national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity with authority over the Manufacture, production, use or storage, transport, clinical testing, marketing, pricing or sale of Product, including the United States Food and Drug Administration (the FDA) or any successor agency or authority thereto, and the European Medicines Agency (the EMA), or any successor agency or authority thereto.
Scope shall mean the scope of work attached as Appendix 1 to this Agreement.
Sponsor shall have the meaning set forth in the preamble.
Sponsor Deliverables shall have the meaning set forth in the Scope.
Sponsor Confidential Information shall have the meaning set forth in Section 7(a).
Term shall have the meaning set forth in Section 20(a).
Work Output shall have the meaning set forth in Section 8(a).
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
CONFIDENTIAL | 2 |
Section 1.
Scope of Work/Performance of Program
a) | Diosynth will perform the Program for Sponsor in accordance with the terms and conditions of this Agreement, the Scope (attached as Appendix 1) and the Quality Agreement (attached as Appendix 2). Terms defined in the terms and conditions of this Agreement and the Scope and/or Quality Agreement shall have same meaning when used in the Scope or Quality Agreement. In the event of any conflict among the components of this Agreement and the Scope and/or Quality Agreement, the following order of precedence shall apply: |
1. | the terms and conditions of this Agreement; |
2. | the Quality Agreement; and |
3. | the Scope. |
b) | Sponsor shall perform its obligations as set forth in this Agreement (including the Scope) and the Quality Agreement, shall support and cooperate with the execution of the Program and shall not engage, or fail to engage, in any act, which may reasonably be expected to prevent or delay the successful execution of the Program. |
Section 2.
Sponsor Deliverables
a) | As further set forth in the Scope, Sponsor will timely provide Diosynth with Sponsor Deliverables (as defined in the Scope) at the Facilities. Sponsor acknowledges that the failure by Sponsor to provide Sponsor Deliverables within the timeframe set forth in the Scope may result in additional charges to Sponsor and a delay in meeting Program objectives. |
b) | Title to Sponsor Deliverables shall remain with Sponsor. Diosynth shall not sell, pledge, hypothecate, dispose of, or otherwise transfer any interest in Sponsor Deliverables except as otherwise provided in this Agreement, and shall use Sponsor Deliverables solely for purposes of performing the Program. Diosynth shall provide safe and secure storage conditions at the Facilities for Sponsor Deliverables while they are at the Facilities, shall store the Sponsor Deliverables in accordance with all applicable statutory and regulatory requirements and any storage guidelines provided by Sponsor and agreed upon by Diosynth and, upon termination of this Agreement, at the instruction of Sponsor, either return or destroy any unused Sponsor Deliverables at Sponsors expense. |
Section 3.
Compliance with Government Regulations
a) | Diosynth shall operate the GMP Facility as a compliant current Good Manufacturing Practices (cGMP) facility in accordance with 21 CFR Parts 11, 210, 211, 600, & 610, ICH Q7 GMP Guidance for Active Pharmaceutical Ingredients, and the EU GMP Guide, including any requirements provided for in the Quality Agreement for all aspects of manufacturing, testing, holding, packaging, labeling and delivery of the Product and/or intermediates produced for Sponsor. In addition, Diosynth shall perform the Program in compliance with statutory and regulatory requirements applicable to the Products clinical phase, including any other applicable regulations and/or guidance documents promulgated by any applicable Regulatory Authority. Diosynth shall not permit debarred |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
CONFIDENTIAL | 3 |
persons to participate in the Program. Diosynth shall undertake reasonable steps to prevent such participation. If Diosynth becomes aware of the debarment or threatened debarment of any person participating in the Program, Diosynth shall promptly so notify Sponsor. |
b) | Sponsor acknowledges that Diosynth has consulted with Sponsor in designing the Program in a manner consistent with current applicable regulatory guidelines. Notwithstanding the foregoing, except as set forth in Section 3(a), Diosynth does not warrant that the Program and/or the Program results will satisfy the requirements of any Regulatory Authority at the time of submission of Program results to such Regulatory Authority. As between the Parties, (i) Sponsor shall have the sole right and responsibility for determining regulatory strategy, decision and actions relating to the Program and the Product and, (ii) subject to each Partys contractual obligations under this Agreement, Diosynth shall have the sole right and responsibility for determining regulatory strategy, decision and actions to the extent relating to (A) the Facilities; (B) Diosynths quality systems; or (iii) any requirement imposed on Diosynth by a Regulatory Authority. Diosynth hereby represents that, to Diosynths knowledge, as of the Effective Date, no requirement imposed on Diosynth by a Regulatory Authority or any other commitments made by Diosynth shall delay or prevent Diosynth from performing the Program or otherwise complying with its obligations hereunder. |
c) | Should such applicable regulatory requirements change, Diosynth will promptly notify Sponsor of such change and the effect on the Program and Diosynth will use reasonable efforts to satisfy the new requirements. In the event that compliance with such new applicable regulatory requirements necessitates a change in the Scope, Diosynth will submit to Sponsor a Change Order, as herein after defined, in accordance with Section 6 of this Agreement. |
d) | Subject to this Section 3, in the event of a conflict in government regulations applicable to the performance of the Program, Sponsor and Diosynth will agree in good faith as to which regulations shall be followed by Diosynth in its performance of the Program. |
e) | If Diosynth receives any contact or communication from any Regulatory Authority relating in any way to the Program, Diosynth will (i) notify Sponsor and provide Sponsor with copies of any such communication within two (2) business days of its receipt of such communication and (ii) comply with all reasonable requests by Sponsor with respect to any actions to be taken or responses to be made to any such Regulatory Authority. Diosynth will promptly inform Sponsor in the event that any such Regulatory Authority takes any action against Diosynth for any reason that could be reasonably be expected to have an effect on Diosynths performance of the Program. Unless required by applicable laws or regulations, Diosynth will have no contact or communication with any such Regulatory Authority regarding the Product without the prior written consent of Sponsor, which consent will not be unreasonably withheld. |
f) | Diosynth shall secure and maintain in good order, at its sole cost and expense, such current governmental registrations, permits and licenses as are required by any Regulatory Authority in order for Diosynth to perform its obligations under this Agreement. |
g) | If Diosynth receives notice of action or threat of action with respect to its debarment during the Term of this Agreement (i) Diosynth shall so notify Sponsor immediately and (ii) Sponsor shall have the right to terminate this Agreement upon not less than ten (10) days written notice. |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
CONFIDENTIAL | 4 |
Section 4.
Facility Visits
The terms and conditions of Sponsor audit rights and rights to visit and inspect the Facilities are provided in the Quality Agreement.
Section 5.
Compensation
a) | Sponsor shall make the payments to Diosynth set forth in, and in accordance with, the Program Price and Payment Schedule. In addition, pursuant to the Scope, Sponsor agrees to pay Diosynth [*] for any Process Consumables purchased for the Program pursuant to the terms set forth in the Scope plus a fee equal [*] of such [*]. These amounts will be invoiced separately as they are incurred by Diosynth. Within thirty (30) days of completion of all Manufacturing under this Agreement, Sponsor will provide Diosynth with written notice specifying its preferred method of disposition for any remaining Process Consumables, the costs for which shall be borne solely by Sponsor. In specifying its preferred method for such disposition, Sponsor may choose from the following three options: |
1. | having Diosynth deliver remaining Process Consumables to Sponsor or a designated storage site; |
2. | having Diosynth deliver remaining Process Consumables to a destruction site; or |
3. | assigning ownership of remaining Process Consumables to Diosynth at no cost. |
In the event that Sponsor fails to provide written notice of its preferred method of disposition to Diosynth within the above thirty (30) day period, Diosynth will implement the second option specified above, the costs for which shall be borne solely by Sponsor.
b) | Subject to Section 5(d), payments are due thirty (30) calendar days from the date any invoice issued by Diosynth is received by Sponsor consistent with the Program Price and Payment Schedule. Unless Sponsor has advised Diosynth in good faith and in writing the specific basis for disputing an invoice, failure to pay an invoice within [*] from the date of invoice receipt may, at Diosynths election, constitute a material breach of this Agreement. Invoices will include a summary of all activities completed during the invoice period and a description of all Process Consumables purchased during the invoice period. |
c) | Diosynth has allocated resources to the Program that may be difficult or impractical to reallocate to other programs in the event of a material delay in the conduct of the Program that is reasonably attributable to Sponsor (a Sponsor Delay). In recognition of this, upon the occurrence of a Sponsor Delay, (i) Sponsor shall provide Diosynth with prompt written notice of same, (ii) Diosynth shall use reasonable efforts to reallocate resources to other programs and Sponsor and Diosynth shall negotiate in good faith a Change Order to compensate Diosynth for any idled personnel or capacity it is unable to reasonably reallocate to such other programs; and (iii) subject to subsection (ii), Sponsor agrees to pay the amounts set forth in and in accordance with the Change Order during such Sponsor Delay, including for completion of any components of the Program that are so delayed and not reallocated, for a period of [*]. Notwithstanding the foregoing, if Sponsor provides a notice of the occurrence of a Sponsor Delay within [*] prior to the scheduled commencement date for manufacturing activities and Diosynth is unable to reasonably reallocate the resources to be used in the Program to other programs, then (i) as |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Diosynths sole remedy for such Sponsor Delay, Sponsor shall pay Diosynth, upon receipt of Diosynths invoice, the following amounts: (A) if the notice of the occurrence of the Sponsor Delay is delivered by Sponsor on or between [*] and [*] days from the scheduled commencement date for manufacturing activities, an amount equal to [*] of the unbilled activities under the Manufacturing heading in the Program Price and Payment Schedule; (B) if the notice of the occurrence of the Sponsor Delay is delivered by Sponsor on or between [*] and [*] days from the scheduled commencement date for manufacturing activities, an amount equal to [*] of the unbilled activities under the Manufacturing heading in the Program Price and Payment Schedule; and (C) if the notice of the occurrence of a Sponsor Delay is delivered by Sponsor less than [*] from the scheduled commencement date for manufacturing activities, an amount equal to [*] of the unbilled activities under the Manufacturing heading in the Program Price and Payment Schedule; and (ii) Diosynth shall prepare in good faith and promptly provide to Sponsor a reasonable rescheduled date for the commencement of Sponsor manufacturing activities. Notwithstanding the foregoing, Sponsor Delays resulting in delays to commencement of manufacturing activities of [*] or more from the originally scheduled commencement date for such manufacturing activities shall be subject to the cancellation payments equal to [*] described in [*], less any delay payments already made by Sponsor. |
d) | Diosynth shall (i) use commercially reasonable efforts to complete disposition of each cGMP batch of Product (each, a Batch) within the period specified in the Quality Agreement, and (ii) provide Sponsors quality assurance department with a Batch Packet within ten (10) days of completion of disposition of each such Batch by Diosynth and (if appropriate) a recommendation for such Batch to be released. Within thirty (30) days after Sponsors receipt of such documentation, Sponsor shall review the Batch Packet to determine, to the extent ascertainable from such documentation, whether or not the Batch of Product covered by such Batch Packet conforms to the specifications set forth in the agreed specifications. |
e) | The following provisions shall apply if during disposition of a cGMP Batch or as a result of Sponsors review of the applicable Batch Packet, it is ascertained by either Party that such Batch is a Non-Conforming Batch: |
(i) | Diosynth or Sponsor, as the case may be, shall provide written notice of same to the other Party. |
(ii) | The Non-Conforming Batch shall not be delivered to Sponsor. |
(iii) | Diosynth shall use commercially reasonable efforts to manufacture a further Batch to replace the Non-Conforming Batch. |
(1) | If the Non-Conforming Batch arose other than as a result of a Diosynth Factor: |
(A) | Subject to Section 5(g), Sponsor shall be obliged to make payment for such Non-Conforming Batch in accordance with Section 5 and the applicable Program Price and Payment Schedule. |
(B) | If Sponsor wishes Diosynth to carry out additional work under the Program with respect to such Non-Conforming Batch, such additional work, including further manufacture, shall be carried out at a time to be agreed and subject to agreement of the price payable in respect of such further manufacture, such agreement to be recorded in a Change Order. |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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(2) | If the Non-Conforming Batch arose as a result of a Diosynth Factor, Diosynth shall undertake the manufacture of a further Batch under Section 5(e)(iii) to replace the Non-Conforming Batch at Diosynths cost and expense and as soon as reasonably practicable. |
(iv) | Unless otherwise agreed by the Parties in writing, Diosynth shall dispose of any Non-Conforming Batch that Diosynth is obligated to replace pursuant to Section 5(e)(iii) in accordance with all applicable laws, and such disposal shall be at Diosynths cost, if Diosynth was liable for the Non-Conforming Batch in accordance with Section 5(e)(iii)(2), and at Sponsors cost otherwise. |
Notwithstanding the foregoing, should any hidden or latent defects be discovered after the delivery of a Batch but in no event after [*] from the date the Batch is delivered, which defects could not reasonably be discovered during disposition within that period, then Sponsor shall promptly inform Diosynth. In the event that the Batch fails to comply with agreed upon specifications, and it is agreed by the Parties or established under the mechanism set out in Section 5(g) below that such failure was due to a Diosynth Factor, then Sponsor shall be entitled to the remedies under Section 5(e)(iii)(2) and (iv).
Notwithstanding anything to the contrary in this Agreement, the remedies set out in this Section 5(e) shall be Sponsors sole remedies in relation to a Non-Conforming Batch.
For the avoidance of doubt, if the Parties agree that an [*] Batch under a Scope of Work is to be carried out in accordance with cGMP, such [*] Batch shall not be treated as a GMP Batch for the purposes of this Section 5.
f) | If following the review of Batch Packet, it is ascertained by agreement of the Parties (or in the absence of such agreement, through arbitration pursuant to Section 14) that the Batch conforms to the specifications set forth in the agreed specifications and otherwise complies with the representations, warranties and covenants in Section 16(d) (a Conforming Batch), then Sponsor shall issue to Diosynth a certificate of compliance and Diosynth shall have no liability to Sponsor pursuant to Section 5(e)(iii) with respect to such Conforming Batch, and Sponsor shall pay for such Conforming Batch pursuant to Section 5. |
g) | In the event the Parties disagree in good faith as to whether a Batch of Product is a Conforming Batch or Non-Conforming Batch, the Parties shall agree to submit test samples for analysis to a mutually agreed upon independent third party GMP laboratory which is able to provide laboratory equipment and personnel that are qualified in the same manner as the Sponsor/ Diosynth facilities. The Parties hereby agree that a formal method transfer and qualification/validation must be completed by the third party laboratory prior to performing any testing related to a dispute resolution under Section 14. The costs of such independent laboratory shall be borne [*]; provided, however, that the Party that is determined to be correct in the dispute, shall be reimbursed by the other Party for its reasonable costs so incurred. The decision of such independent laboratory shall be in writing and shall be binding on both Parties unless there has been a manifest error on the face of the decision whereupon the Parties shall revert to the arbitration procedure set forth in Section 14. For the avoidance of doubt, the Parties will follow Diosynth quality procedures while accepting or rejecting the disputed Batch. |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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h) | The Parties hereby agree following the production of a certain number of Batches to be determined in good faith by the Parties, to discuss in good faith an amendment to the definition of Diosynth Factor to account for Diosynths increased level of understanding with respect to the manufacturing process necessary to produce such Batches. |
Section 6.
Change Orders
a) | The total budget for the Program specified in the Program Price and Payment Schedule, the individual budget components and the estimated durations specified in the Scope are subject to the Assumptions (as defined below) as well as the accuracy, timeliness and completeness of Sponsors Deliverables. Such Assumptions relate to the Program design and objectives, manpower requirements, timing, capital expenditure requirements, if any and other matters relating to the completion of the Program and are set forth in the Scope (Program Assumptions). Diosynth also assumes that Sponsor will cooperate and perform its obligations under this Agreement and the Scope in a timely manner, that no Force Majeure event will occur, and that there are no changes to any applicable laws, rules or regulations which materially affect the performance of the Program (the foregoing assumptions, together with the Program Assumptions, collectively, the Assumptions). In the event that any of the Assumptions require modification to this Agreement or the Program objectives cannot reasonably be achieved as a result of one or more of the Assumptions being materially incorrect (each being a Modification), the Scope may be amended as provided in paragraph b) of this Section 6. |
b) | In the event a Modification is identified by Sponsor or by Diosynth, the identifying Party shall notify the other Party in writing as soon as is reasonably possible. Diosynth shall provide Sponsor with a change order containing an estimate of the additional cost to Sponsor of such Modifications including any changes that may be necessary to the Program budget, activities and/or estimated duration as specified in the Scope (Change Order) within ten (10) business days of receiving such notice or providing such notice to Sponsor. Sponsor shall respond in writing to such Change Order within ten (10) business days of receiving such Change Order indicating whether or not it approves the proposed Change Order. Sponsor shall be deemed to have not approved the Change Order if Diosynth does not receive a written indication from Sponsor during such ten (10) day period. If Sponsor does not approve such Change Order, then Sponsor and Diosynth shall negotiate in good faith to agree on a Change Order that is mutually acceptable. If practicable, Diosynth shall continue work on the Program during any such negotiations, but shall not commence work with respect to the Change Order unless authorized in writing by Sponsor. If the Parties are unable to agree upon a Change Order within forty-five (45) days after issuance of the relevant Change Order, then Diosynth shall, if reasonably possible, perform the Scope without regard to the unresolved Change Order; provided, however, that the estimated timelines shall be adjusted to reflect any delay during the negotiation period. In the event that in Diosynths reasonable judgment such performance in not possible in accordance with the current Scope and Program Price and Payment Schedule, then Diosynth shall provide written notice to Sponsor of its inability to perform in the absence of an agreed upon Change Order (the Impasse Notice). Upon issuance of an Impasse Notice, either Party shall have the right to terminate this Agreement or the Program affected by such Change Order within thirty (30) days following the date of delivery of such Impasse Notice. |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
CONFIDENTIAL | 8 |
Section 7.
Confidential Information/Legal Proceedings
a) | During the Term of this Agreement and for five (5) years following the termination of this Agreement, Diosynth will hold in confidence and will not disclose, without Sponsors prior written permission, any Confidential Information pertaining to the Program or otherwise disclosed by Sponsor to Diosynth in connection with the Program (Sponsor Confidential Information) unless: (i) such disclosure is to an affiliate of Diosynth that is under an obligation to keep such information confidential comparable in scope to Diosynths obligation under this Section 7; (ii) such information is or becomes publicly available through no fault of Diosynth; (iii) such information is disclosed to Diosynth by a third party entitled to disclose it; (iv) such information is already known to Diosynth as shown by its prior written records; or, (v) such information is required by any law, rule, regulation, order decision, decree, subpoena or other legal process to be disclosed. If such disclosure is requested by legal process, Diosynth will use reasonable efforts to notify Sponsor of this request promptly prior to any disclosure to permit Sponsor to oppose such disclosure by appropriate legal action. Diosynth shall use reasonable precautions to protect the confidentiality of Sponsor Confidential Information comparable to precautions taken to protect its own proprietary information. |
b) | During the Term of this Agreement and for five (5) years following the termination of this Agreement, Sponsor will hold in confidence and not disclose, without Diosynths prior written permission, any Confidential Information pertaining to Diosynths performance of the Program disclosed by Diosynth to Sponsor (Diosynth Confidential Information) unless: (i) such disclosure is to an affiliate of Sponsor that is under a similar obligation to keep such information confidential; (ii) such information is or becomes publicly available through no fault of Sponsor; (iii) such information is disclosed by a third party entitled to disclose it; (iv) such information is already known to Sponsor as shown by its prior written records; or, (v) such information is required by any law, rule, regulation, order decision, decree, subpoena or other legal process to be disclosed. If such disclosure is requested by legal process, Sponsor will use reasonable efforts to notify Diosynth of this request promptly prior to any disclosure to permit Diosynth to oppose such disclosure by appropriate legal action. Sponsor shall use reasonable precautions to protect the confidentiality of Diosynth Confidential Information comparable to precautions taken to protect its own proprietary information. |
c) | If either Party shall be obliged to provide testimony or records with respect to the Confidential Information of the other in any legal or administrative proceeding, then the Party to whom the Confidential Information belongs shall reimburse the other Party for its out-of-pocket costs incurred in providing such testimony or records plus an hourly fee for its employees or representatives used to provide such testimony or records, which shall be based on the internal fully burdened costs of such employee or representative. |
d) | For both Parties, Confidential Information shall mean and include without limitation inventions, methods, plans, processes, specifications, characteristics, raw data, analyses, equipment design, trade secrets, costs, marketing, sales, and performance information, including patents and patent applications, grant applications, notes, and memoranda, whether in writing or presented, stored or maintained electronically, magnetically or by other means, which are disclosed by the disclosing Party to the recipient Party in writing or in other tangible form and whether or not marked confidential; provided, that, if disclosed orally (or in some other non-tangible form), the disclosing Party shall use reasonable efforts to identify such information as confidential to the recipient Party in writing within sixty (60) days of such oral disclosure. |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
CONFIDENTIAL | 9 |
e) | Upon the expiration or termination of this Agreement, to the extent requested by the disclosing Party, each recipient Party shall use all reasonable efforts to collect and return to the disclosing Party any and all data, notes, records, reports, and other electronic or written information, including any and all copies that may have been made thereof, that contain Confidential Information received from the disclosing Party; provided, that, each recipient Party shall be entitled to keep one archival copy of Confidential Information provided by the disclosing Party in its confidential files. |
Section 8.
Work Output
a) | All Information, data, documentation and reports produced by Diosynth in the conduct of the Program and/or all other cGMP documentation (Work Output) will be prepared by Diosynth using Diosynths standard format(s) unless otherwise specified in the Scope. |
b) | Sponsor will be supplied with copies of Work Output generated as a result of the Program as set forth in the Scope or Quality Agreement. Notwithstanding the foregoing, Diosynth shall not be obliged to supply all data generated but instead will supply relevant data to Sponsor and Sponsor will have access to all data generated in relation to the Program for on-site review either (i) during any audits or (ii) upon Sponsors written request. All Work Output and Product samples will be archived by Diosynth for a period of five (5) years following completion of the Program unless otherwise defined by the Program or required by applicable U.S. laws or regulations. Five (5) years after completion of the Program, Work Output and Product samples will be disposed by Diosynth or sent by Diosynth to Sponsor and a return fee will be charged, as specified in writing by Sponsor. Sponsor may elect to have the Work Output retained in the Diosynth archives for an additional period of time at additional cost to Sponsor. If Sponsor chooses to have Diosynth dispose of Work Output and Product samples, a disposal fee will be charged. Notwithstanding the foregoing, Diosynth will continue to retain such Work Output and Product samples as required by regulations and as may be required by law, pertaining to such activities as well as for archival purposes. In the absence of notice at the end of the applicable period, Diosynth shall send the Work Product to Sponsor at Sponsors cost and expense. |
Section 9.
Inventions and Patents
a) | Diosynth shall promptly and fully disclose to Sponsor any and all inventions, improvements, developments, original works of authorship or other intellectual property conceived, developed and/or reduced to practice, whether in whole or in part, by Diosynth in the course of the performance of the Program (collectively, Program Inventions). |
b) | All Program Inventions that relate to Diosynths general manufacturing and analytical methods and that are not specific to the Product or Sponsor Deliverables shall be Confidential Information of, and shall be solely owned by, Diosynth (collectively, Process Inventions). All other Program Inventions, including without limitation, any Program Inventions that are specific to the Product or the Sponsor Deliverables (collectively, Product Inventions) shall be Confidential Information of, and shall be solely owned by, Sponsor. Diosynth hereby agrees to assign, and does hereby assign, to Sponsor and its successors and assigns, without further consideration, its entire right, title and interest in any Product Inventions, whether or not patentable. If Sponsor requests and at Sponsors expense, Diosynth will execute any and all applications, assignments or other instruments |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
CONFIDENTIAL | 10 |
and give testimony which shall be necessary to apply for and obtain Letters of Patent of the US or of any foreign country with respect to any Product Inventions and Sponsor shall compensate Diosynth for the time devoted to such activities and reimburse it for expenses incurred. For Product Inventions assigned pursuant to this section, Sponsor shall provide Diosynth a royalty-free license necessary to perform the Program for the Term of this Agreement. |
Diosynth agrees to grant and hereby grants to Sponsor a perpetual, world-wide, royalty-free, sublicensable, exclusive license under all Process Inventions for use in connection with the Product. If Diosynth requests and at Diosynths expense, Sponsor will execute any and all applications, assignments or other instruments and give testimony which shall be necessary to apply for and obtain Letters of Patent of the US or of any foreign country with respect to any Process Inventions and Diosynth shall compensate Sponsor for the time devoted to such activities and reimburse it for expenses incurred.
c) | Diosynth reserves the right to use data during the course of the Program to support applications, assignments or other instruments necessary to apply for and obtain Letters of Patent of the U.S. or any foreign country with respect to Process Inventions so long as no information which Diosynth is required to keep confidential under this Agreement is disclosed in any such application, assignment, or other instrument. Diosynth shall notify Sponsor ninety (90) days in advance of intent to file such application, assignment or other instrument and Sponsor shall have the right to request that any Sponsor Confidential Information contained in any such application, assignment or other instrument be deleted therefrom. |
Section 10.
Independent Contractor
Diosynth shall perform the Program as an independent contractor of Sponsor and shall have complete and exclusive control over its facilities, equipment, employees and agents. The provisions of this Agreement shall not be construed to establish any form of partnership, agency or other joint venture of any kind between Diosynth and Sponsor, nor to constitute either Party as the agent, employee or legal representative of the other. All persons furnished by either Party to accomplish the intent of this Agreement shall be considered solely as the furnishing Partys employees or agents and the furnishing Party shall be solely responsible for compliance with all laws, rules and regulations involving, but not limited to, employment of labor, hours of labor, working conditions, workers compensation, payment of wages, and withholding and payment of applicable taxes, including, but not limited to income taxes, unemployment taxes, and social security taxes.
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
CONFIDENTIAL | 11 |
Section 11.
Insurance
a) | Diosynth shall secure and maintain in full force and effect throughout the performance of the Program policies of insurance with companies with an AM Best Rating of at least A-, VII or its equivalent for (a) workmens compensation with statutory limits, (b) general liability with combined single limits of not less than $5,000,000 per occurrence and $5,000,000 in the aggregate, (c) product liability with combined single limits of not less than $5,000,000 per occurrence and $5,000,000 in the aggregate and (d) property damage (including business interruption coverage) with limits equal to replacement value, and, in each case, having deductibles and other terms appropriate to the conduct of Diosynths business in Diosynths reasonable judgment. |
b) | Sponsor shall secure and maintain in full force and effect throughout the performance of the Program policies of insurance for (a) general liability and (b) product liability having policy limits, deductibles and other terms appropriate to the conduct of Sponsors business in Sponsors reasonable judgment. |
Section 12.
Delivery
Diosynth shall package for shipment and deliver Product, samples or other materials at Sponsors expense and in accordance with Sponsors full written and reasonable instructions with Sponsor bearing all packaging, shipping and insurance charges. Freight terms shall be Ex Works (Incoterms 2010) the GMP Facility. Title, possession, risk of loss, risk of damage and all forward costs and expenses shall pass to and be borne by Sponsor upon delivery. Diosynth shall retain representative samples of Product for record keeping, testing and regulatory purposes. Sponsor shall provide for shipping of each Batch of Product within thirty (30) calendar days of its issuance of certificate of compliance in accordance with Section 5(f), unless otherwise agreed between the Parties. In the event of any delay by Sponsor in issuance of the certificate of compliance or shipping of Product in accordance with this Section 12, the Parties acknowledge and agree that liability and risk of loss for each such shipment of Product shall automatically transfer to (and be assumed by) Sponsor effective upon expiration of sixty (60) days period since completion of manufacturing.
Section 13.
Default/Limitation of Warranty
a) | If Diosynth is in default of its material obligations under this Agreement, Sponsor shall promptly notify Diosynth in writing of any such default. Diosynth shall have a period of forty-five (45) days from the date of receipt of such notice within which to cure or, if a cure cannot reasonably be effected within such forty-five (45) day period, to deliver to Sponsor a plan for curing such breach that is reasonably sufficient to effect a cure as soon as practicable thereafter and to commence in good faith to cure such default in accordance with the plan within such forty-five (45) day period; provided, that, if the cure involves the supply to Sponsor of a replacement shipment of Product, the Parties will agree in good faith on a reasonable date by which Diosynth shall supply such Product. If Diosynth fails to so cure, or commence to cure, such breach, then this Agreement shall, at Sponsors option, immediately terminate. |
b) | If Sponsor is in default of its material obligations under this Agreement, Diosynth shall promptly notify Sponsor in writing of any such default. Sponsor shall have a period of forty-five (45) days from the date of receipt of such notice within which to cure such default |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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or, if a cure cannot reasonably be effected within such forty-five (45) day period, to deliver to Diosynth a plan for curing such breach that is reasonably sufficient to effect a cure as soon as practicable thereafter and to commence in good faith to cure such default in accordance with the plan within such forty-five (45) day period. If Sponsor fails to so cure, or commence to cure, such breach within the specified cure period, this Agreement may, at Diosynths option, immediately terminate. |
c) | Not withstanding anything herein to the contrary, EXCEPT AS SET FORTH IN SECTION 15, UNDER NO CIRCUMSTANCES SHALL EITHER PARTY BE ENTITLED TO INCIDENTAL, INDIRECT, CONSEQUENTIAL OR SPECIAL DAMAGES ARISING IN CONNECTION WITH THE DEFAULT OR BREACH OF ANY OBLIGATION OF THE OTHER PARTY UNDER THIS AGREEMENT, THE SCOPE OR ANY DOCUMENTS OR APPENDICES RELATED THERETO. EXCEPT FOR THE OBLIGATIONS OF DIOSYNTH UNDER SECTION 15(a), THE MAXIMUM LIABILITY OF DIOSYNTH FOR DAMAGES IN CONNECTION WITH A CLAIM RELATED TO THIS AGREEMENT, REGARDLESS OF THE CAUSE OF ACTION, [*]. |
d) | EXCEPT AS EXPRESSLY STATED HEREIN, NEITHER PARTY PROVIDES TO THE OTHER PARTY HERETO ANY WARRANTIES, EXPRESS OR IMPLIED, WITH RESPECT TO THE MATERIALS AND SERVICES PROVIDED HEREUNDER, AND ALL SUCH WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE ARE WAIVED. SUBJECT TO DIOSYNTHS OBLIGATIONS WITH RESPECT TO THE QUALITY OF THEIR SERVICES AS DESCRIBED HEREIN, INCLUDING THE APPLICABLE SCOPE OF WORK, QUALITY AGREEMENT OR OTHER AGREEMENT BETWEEN THE PARTIES, DIOSYNTH MAKES NO WARRANTIES THAT THE EXECUTION OF THE SCOPE WILL RESULT IN ANY SPECIFIC QUANTITY OR QUALITY OF PRODUCT. |
Section 14.
Dispute Resolution
a) | In the event any dispute shall arise between Sponsor and Diosynth with respect to any of the terms and conditions of this Agreement or the Program the senior executives of Sponsor and Diosynth shall meet as promptly as practicable after notice of such dispute to resolve in good faith such dispute. |
b) | If Sponsor and Diosynth are unable to satisfactorily resolve the dispute within thirty (30) days following referral to the senior executives, then such dispute shall be referred to mediation in accordance with the rules of the American Arbitration Association. The Parties shall participate in the mediation in a good faith attempt to settle the dispute. The mediation shall be held in Washington, D.C. |
c) | If mediation fails to resolve the dispute within forty-five (45) days of the initial meeting pursuant to Section 14 a) above, then such dispute shall be finally settled by an arbitrator in accordance with this Section 14. The arbitration will be held in Washington, D.C., and except as noted below, shall be conducted in accordance with the rules of the American Arbitration Association by a neutral arbitrator agreeable to both Parties. If the Parties do not agree on an arbitrator within thirty (30) days of the termination of the mediation as indicated by at least one of the Parties, the American Arbitration Association shall appoint an arbitrator to hear the case in accordance with its rules. The arbitrator shall have no |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
CONFIDENTIAL | 13 |
authority to award consequential, punitive or exemplary damages or to vary from or ignore the terms of this Agreement and shall be bound by controlling law. The Parties may seek judicial intervention for emergency relief, such as restraining orders and injunctions where appropriate. |
d) | Any decision by the arbitrator shall be binding upon the Parties and may be entered as final judgment in any court having jurisdiction. The cost of any arbitration proceeding shall be borne by the Parties as the arbitrator shall determine if the Parties have not otherwise agreed. The arbitrator shall render a final decision in writing to the Parties. |
Section 15.
Indemnification
a) | Diosynth shall indemnify Sponsor and its affiliates and their respective officers, directors and employees (Sponsor Indemnitees) from any loss, cost, damage or expense (Loss) from any lawsuit, action, claim, demand, assessment or proceeding made or brought by a third party (Claim) arising from or related to (i) the material breach of any representation or warranty by Diosynth under this Agreement; (ii) the failure of Diosynth to perform the Services in accordance with the Scope; (iii) the material breach by Diosynth of any applicable statute or regulation relating to the Program; or (iv) Diosynths negligence or intentional misconduct or inaction (including violation or non-performance of this Agreement); provided, that, if such Loss or Claim arises in whole or in part from Sponsors negligence or intentional misconduct or inaction, then the amount of the Loss that Diosynth shall indemnify Sponsor Indemnitees for pursuant to this Section 15 shall be reduced by an amount in proportion to the percentage of Sponsors responsibilities for such Loss determined by a court of competent jurisdiction in a final and non-appealable decision or in a binding settlement between the Parties. |
b) | Sponsor shall indemnify Diosynth and its affiliates and their respective officers, directors and employees (Diosynth Indemnitees) from any Claim or Loss arising from or related to: (i) the use by Sponsor of Sponsor Deliverables, Process Consumables, or the Product; (ii) the material breach of any representation or warranty by Sponsor under this Agreement; (iii) the infringement or alleged infringement of the intellectual property rights of a third party arising out of Diosynths use of any technical information, materials or know-how provided by Sponsor to Diosynth for Diosynths conduct of the Program in accordance with the Scope; or (iv) the negligence or intentional misconduct or inaction of Sponsor; provided, that, if such Loss or Claim arises in whole or in part from Diosynths negligence, gross negligence or intentional misconduct or inaction, then the amount of such Loss that Sponsor shall indemnify the Diosynth Indemnitees for pursuant to this Section 15 shall be reduced by an amount in proportion to the percentage of Diosynths responsibilities for such Loss as determined by a court of competent jurisdiction in a final and non-appealable decision or in a binding settlement between the Parties. |
c) | Upon receipt of notice of any Claim which may give rise to a right of indemnity from the other Party hereto, the Party seeking indemnification (the Indemnified Party) shall give written notice thereof to the other Party, (the Indemnifying Party) with a Claim for indemnity (Indemnity Claim). Any delay or failure to give notice shall not discharge the duty of the Indemnifying Party to indemnify except to the extent it is prejudiced by such delay or failure. Such Indemnity Claim shall indicate the nature of the Indemnity Claim and the basis therefore. Promptly after an Indemnity Claim is made for which the Indemnified Party seeks indemnity, the Indemnified Party shall permit the Indemnifying Party, at its option and expense, to assume the complete defense of such Indemnity |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
CONFIDENTIAL | 14 |
Claim; provided, that, (i) the Indemnified Party will have the right to participate in the defense of any such Indemnity Claim at its own cost and expense, (ii) the Indemnifying Party will conduct the defense of any such Indemnity Claim with due regard for the business interests and potential related liabilities of the Indemnified Party and (iii) the Indemnifying Party will, prior to making any settlement, consult with the Indemnified Party as to the terms of such settlement and receive approval thereof, not to be unreasonably withheld. The Indemnified Party shall have the right, at its election, to release and hold harmless the Indemnifying Party from its obligations hereunder with respect to such Indemnity Claim and assume the complete defense of the same in return for payment by the Indemnifying Party to the Indemnified Party of the amount of the Indemnifying Partys settlement offer. The Indemnifying Party will not, in defense of any such Indemnity Claim, except with the consent of the Indemnified Party, consent to the entry of any judgment or enter into any settlement which does not include as an unconditional term thereof, the giving by the claimant or plaintiff to the Indemnified Party of a release from all liability in respect thereof. After notice to the Indemnified Party of the Indemnifying Partys election to assume the defense of such Indemnity Claim, the Indemnifying Party shall be liable to the Indemnified Party for such legal or other expenses subsequently incurred by the Indemnified Party in connection with the defense thereof at the request of the Indemnifying Party. As to those Indemnity Claims with respect to which the Indemnifying Party does not elect to assume control of the defense, the Indemnified Party will afford the Indemnifying Party an opportunity to participate in such defense at the Indemnifying Partys own cost and expense, and will not settle or otherwise dispose of any of the same without the consent of the Indemnifying Party. |
Section 16.
Representations and Warranties
a) | Each Party represents and warrants to the other that it has the full right and authority to enter into this Agreement and to perform this Agreement in accordance with the terms and conditions set forth herein; this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against such Party in accordance with its terms except as enforceability may be limited by bankruptcy, fraudulent conveyance, insolvency, reorganization, moratorium and other laws relating to or affecting creditors rights generally and by general equitable principles; the execution, delivery and performance of this Agreement does not breach, violate, contravene or constitute a default under any contract or commitment to which such Party is a party or by which it is bound nor does the execution, delivery and performance of this Agreement by such Party violate any order, law or regulation of any court, governmental body or administrative or other agency having authority over it. Each Party represents and warrants to the other that neither it nor any of its officers, directors, or its employees performing services under this Agreement has been debarred, or convicted of a crime which could lead to debarment, under the Generic Drug Enforcement Act of 1992, 21 United States Code §§335(a) and (b). |
b) | Each Party represents and warrants to the other Party that it has obtained and will at all times during the term of this Agreement, hold and comply with all licenses, permits and authorizations necessary to perform this Agreement as now or hereafter required under any applicable statutes, laws, ordinances, rules and regulations of the United States and any applicable foreign, state, and local governments and governmental entities. |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
CONFIDENTIAL | 15 |
c) | Sponsor hereby represents and warrants to Diosynth that it has legal title and/or a valid license to the Sponsor Deliverables necessary to conduct the Program in accordance with the Scope. |
d) | Diosynth hereby represents and warrants to Sponsor that (i) Diosynth will operate the GMP Facility in compliance with cGMP in all aspects of manufacturing, testing, holding, packaging, labeling and preparation for shipping of the Product and will perform the Program in compliance with cGMP and that the Products will conform to the packaging instructions provided by Sponsor and agreed upon by Diosynth; (ii) Diosynth owns or lawfully controls the GMP Facility, and the GMP Facility shall be maintained in accordance with cGMP and in such condition as will allow Diosynth to manufacture the Product in compliance with cGMP; (iii) Diosynth has written agreements with all its employees involved in the performance of the Services, which agreements shall require that all discoveries and inventions conceived or reduced to practice by such employees in the conduct of the Services shall be promptly disclosed and assigned to Diosynth; and Diosynth has the right to assign to Sponsor its rights in and to all Product Inventions as provided in this Agreement; (iv) Diosynth is under no contractual or other obligation or restriction that is inconsistent with Diosynths performance of this Agreement; and (v) in performing this Agreement, Diosynth will comply with all applicable laws and perform the Program in compliance with applicable cGMP regulations, except as specified otherwise in this Agreement. |
Section 17.
Force Majeure
Either Party shall be excused from performing its respective obligations under this Agreement if its performance is delayed or prevented by any event beyond such Partys reasonable control, including, but not limited to, acts of God, fire, explosion, weather, disease, war, insurrection, civil strife, riots, government action, acts of terrorism or power failure; provided, that, such performance shall be excused only to the extent of and during such disability. The Party subject to such event shall promptly notify the other Party of the occurrence thereof and, if known, the expected duration. Any time specified or estimated for completion of performance in the Scope falling due during or subsequent to the occurrence of any or such events shall be automatically extended for a period of time to recover from such disability. Diosynth will promptly notify Sponsor if, by reason of any of the events referred to herein, Diosynth is unable to meet any such time for performance specified or estimated in the Scope. If any part of the Program is invalid as a result of such disability, Diosynth will, upon written request from Sponsor, but at Sponsors sole cost and expense, repeat that part of the Program affected by the disability.
Section 18.
Allocation of Resources
If delays in the agreed commencement or performance of the Program occur because of Sponsors request or inability to supply Diosynth with agreed Sponsor Deliverables or any information required to begin or perform the Program within thirty (30) days of such agreed time, Diosynth may reallocate resources being held for performance of the Program. In such event, Diosynth shall be relieved of its obligation to perform the Program as set forth in the Scope except that upon such delay being removed or remedied, Diosynth will use commercially reasonable efforts to allocate resources to performance of the Program as set forth in the Scope.
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
CONFIDENTIAL | 16 |
Section 19.
Use of Names
The Parties anticipate opportunities for joint or independent press releases or other announcements relating to the activities contemplated hereby. Notwithstanding the foregoing, neither Party shall use the name of the other Party or the names of the employees of the other Party in any advertising or sales promotional material or in any publication without prior written permission of such Party. Such consent may not be unreasonably withheld. This provision shall not restrict a Partys ability to use the other Partys name and to disclose the terms of this Agreement to the extent required by law or by the requirements of any nationally recognized securities exchange, quotation system or over-the-counter market on which such Party has its securities listed or traded. In the event that such disclosure is required as aforesaid, the disclosing Party shall make reasonable efforts to provide the other Party with notice beforehand and to coordinate with the other Party with respect to the wording and timing of any such disclosure.
Section 20.
Term/Termination
a) | This Agreement shall take effect on the date first written above and continue in effect, unless earlier terminated pursuant to this Section 20, until the completion of the Program (the Term). |
b) | In addition to the termination rights set forth in Section 13, Sponsor may at any time terminate this Agreement by giving forty-five (45) days written notice to Diosynth. In the event Sponsor elects to terminate for reasons other than pursuant to Section 13 or in the event that Diosynth terminates this Agreement pursuant to Section 13, then, as Diosynths sole remedy under this Agreement, Sponsor shall pay Diosynth upon receipt of Diosynths invoice, the following amounts: |
(i) | All amounts owed for services completed but not yet invoiced; plus |
(ii) | All unpaid costs incurred or committed for Process Consumables; plus |
(iii) | A termination fee to be paid on or before forty-five (45) days of the effective date of termination, calculated as follows: |
(A) [*] of any unbilled amounts set forth in the Program Price and Payment Schedule under all headings, other than Manufacturing; plus
(B) (1) If the effective date of termination is within [*] of the scheduled commencement date for manufacturing activities, but prior to the date that is [*] prior to the scheduled commencement for manufacturing activities, an amount equal to [*] of the unbilled activities under the Manufacturing heading in the Program Price and Payment Schedule (as amended to include any executed Change Orders); or
(B) (2) If the effective date of termination is within [*] of the scheduled commencement date for manufacturing activities, but prior to the date that is [*] prior to the scheduled commencement for manufacturing activities, an amount equal to [*] of the unbilled activities under the Manufacturing heading in the Program Price and Payment Schedule (as amended to include any executed Change Orders); or
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
CONFIDENTIAL | 17 |
(B) (3) If the effective date of termination is within [*] of the scheduled commencement date for manufacturing activities, but prior to the date that is [*] prior to the scheduled commencement for manufacturing activities, an amount equal to [*] of the unbilled activities under the Manufacturing heading in the Program Price and Payment Schedule (as amended to include any executed Change Orders); or
(B) (4) If the effective date of termination is within [*] of the scheduled commencement date for manufacturing activities, an amount equal to [*] of the unbilled activities under the Manufacturing heading in the Program Price and Payment Schedule (as amended to include any executed Change Orders).
c) | For the avoidance of doubt, the provisions of this Section 20 shall not apply to delays, including without limitation, Sponsor Delays, which are addressed in Section 5(c). For the avoidance of doubt, in the event of termination of this Agreement for any reason, (i) Diosynth will terminate all services in progress under the Program in an orderly manner as soon as practical and in accordance with a schedule agreed to by Sponsor, unless Sponsor specifies in the notice of termination that such services in progress should be completed, (ii) Diosynth will deliver to Sponsor any Sponsor Deliverables and Work Output in its possession or control and all Product Inventions developed through the date of termination or expiration, and (iii) Sponsor will pay Diosynth any monies due and owing Diosynth, up to the time of termination or expiration, for services actually performed and all authorized expenses actually incurred pursuant to Section 20(b). The termination of this Agreement for any reason shall relieve neither Party of its obligation to the other for obligations in respect of: (i) confidentiality of information; (ii) consents for advertising purposes and publications; (iii) indemnification; (iv) inventions and patents; (v) compensation for services performed and (vi) dispute resolution. |
Section 21.
Program Management.
a) Joint Steering Committee. Effective on the Effective Date, Sponsor and Diosynth shall establish a Joint Steering Committee (the Joint Steering Committee) comprised of an equal number of representatives designated by Sponsor and Diosynth.
b) | Alliance Managers. Each Party shall appoint one person to serve as an Alliance Manager (each, an Alliance Manager) with responsibility for overseeing the day-to-day activities of the Parties with respect to the Program and for being the primary point of contact between the Parties with respect to the Program. The Diosynth customer Project Leader will serve as the Diosynth Alliance Manager. The Alliance Managers shall report to the Joint Steering Committee. |
c) | Replacement of Joint Steering Committee Representatives and Alliance Managers. Each Party shall be free to replace its representative members on the Joint Steering Committee or its Alliance Manager with new appointees who have authority to act on behalf of such Party, on notice to the other Party. |
d) | Responsibilities of Joint Steering Committee. The Joint Steering Committee shall be responsible for overseeing and directing the Parties interaction and performance of their respective obligations under this Agreement. Without limiting the generality of the foregoing, its duties shall include: |
(i) | monitoring the performance of the Program; |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
CONFIDENTIAL | 18 |
(ii) | resolving disagreements that arise under the Agreement; and |
(iii) | determining the need for and terms of any Change Orders. |
e) | Meetings. The Joint Steering Committee shall meet at such times as the Joint Steering Committee determines to resolve issues arising hereunder and to perform its responsibilities under this Agreement; provided, that, the Joint Steering Committee shall meet not less than four (4) times per calendar year unless otherwise mutually agreed. Such meetings may be in person or by telephone as agreed by the Joint Steering Committee. To the extent that meetings are held in person, they shall alternate between the offices of the Parties unless the Parties agree otherwise. The Alliance Managers shall attend all meetings of the Joint Steering Committee. All decisions of the Joint Steering Committee shall be unanimous. The first meeting shall be held on or before January , 2013. |
f) | Administration. The chairperson of the Joint Steering Committee shall be designated every six (6) months on an alternating basis between the Parties. The initial chairperson will be selected by Diosynth. The chairperson shall be responsible for calling meetings, sending notices of meetings and for leading such meetings. |
g) | Minutes. Within fifteen (15) days after each Joint Steering Committee meeting, the Alliance Manager for the party whose representative chaired the Joint Steering Committee meeting shall prepare and distribute minutes of the meeting, which shall provide a description in reasonable detail of the discussions had at the meeting and a list of any actions, decisions or determinations approved by the Joint Steering Committee. Minutes shall be approved or disapproved and revised, as necessary, at the next meeting. Final minutes shall be distributed to the members of the Joint Steering Committee. |
h) | Dispute Resolution. In the event that the Joint Steering Committee cannot reach agreement with respect to any material issue, then the issue shall be resolved in accordance with the dispute resolution provisions in Section 14. |
i) | Limitations. The Joint Steering Committee is not empowered to amend the terms of this Agreement. |
Section 22.
Assignment
This Agreement shall not be assigned in whole or in part by either Party without the prior written consent of the other, which consent shall not be unreasonably withheld or delayed. Any attempt to assign this Agreement without such consent shall be void and of no effect. Notwithstanding the foregoing, either Party shall be entitled, without the prior written consent of the other Party, to assign all or any part of its rights under this Agreement to a purchaser of all or substantially all of its assets to which this Agreement relates, or an entity with which it may merge or sell its capital stock where it is not the surviving company; provided, that, the assignee agrees in writing to assume all obligations undertaken by its assignor in this Agreement. No assignment shall relieve the assigning Party of responsibility for the performance of any of its obligations hereunder. The terms of this Agreement shall inure to the benefit of successors and assigns.
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
CONFIDENTIAL | 19 |
Section 23.
Notice
All notices to be given as required in this Agreement shall be in writing and shall be delivered personally, sent by telecopies, or mailed either by a reputable overnight carrier or first class mail, postage prepaid to the Parties at the addresses set forth below or such other addresses as the Parties may designate in writing. Such notice shall be effective on the date sent, if delivered personally or sent by telecopier, the date after delivery if sent by overnight carrier and on the date received if mailed first class.
If to Sponsor:
Synageva BioPharma Corp.
128 Spring Street, Suite 520
Lexington, MA 02421
P: 781-357-9900
F: 781-357-9901
Attention: Legal Department
If to Diosynth:
President
Fujifilm Diosynth Biotechnologies
101 J. Morris Commons Lane
Morrisville, NC 27560
P: 919-337-4404
F: 919-337-0899
With copies to:
General Counsel
Fujifilm Diosynth Biotechnologies
Hexagon Tower
Blackley, Manchester, M9 8ES, United Kingdom
Facsimile No.: +44 161 721 5801
Assistant General Counsel
FUJIFILM Holdings America Corporation
200 Summit Lake Drive
Valhalla, New York 10595-1356
Fax: 914-789-8514
Section 24.
Choice of Law
This Agreement shall be construed and enforced in accordance with the laws of and in the venue of the State of Delaware except for its rules regarding conflict of laws.
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
CONFIDENTIAL | 20 |
Section 25.
Waiver/Severability
No waiver of any provision of this Agreement, whether by conduct or otherwise, in any one or more instances shall be deemed to be or be construed as a further or continuing waiver of any such provision, or of any other provision or condition of this Agreement. If any provisions hereof shall be determined to be invalid or unenforceable, the validity and effect of the other provisions of this Agreement shall not be affected thereby.
Section 26.
Nonsolicitation
For the term of this Agreement, and for twelve (12) months following termination of this Agreement, for any reason, neither Sponsor nor Diosynth nor any of their employees or agents shall, directly or indirectly, solicit, hire, or attempt to solicit or hire, any employees of the other who were involved in the Program, unless otherwise approved by the other Party. This provision shall not restrict either Party or its affiliates from advertising employment opportunities in any manner that does not directly target the other Party or its Affiliates.
Section 27.
Entire Agreement; Modification/Counterparts
a) | This instrument including the attached Appendices sets forth the entire agreement between the Parties hereto with respect to the performance of the Program by Diosynth for Sponsor and as such, supersedes all prior and contemporaneous negotiations, agreements, representations, understandings, and commitments with respect thereto and shall take precedence over all terms, conditions and provisions on any purchase order form or form of order acknowledgment or other document purporting to address the same subject matter. This Agreement shall not be waived, released, discharged, changed or modified in any manner except by an instrument signed by the duly authorized officers of each of the Parties hereto, which instrument shall make specific reference to this Agreement and shall express the plan or intention to modify same. |
b) | This Agreement may be executed in one or more counterparts each of which shall be deemed an original but all of which together shall constitute one and the same instrument. |
c) | This Agreement becomes effective and binding on both Parties on and as of the last date that the Parties hereto have executed this Agreement. Should terms contained herein be at variance with the terms and conditions specified in Sponsors written acceptance, then the terms and conditions contained herein take precedence. |
[Remainder of page intentionally left blank.]
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
CONFIDENTIAL | 21 |
Synageva BioPharma Corp. | FUJIFILM Diosynth Biotechnologies U.S.A., Inc. | |||||||
By: | /s/ Stephen Mahoney |
By: | /s/ Henrik Edeback | |||||
Name: | Stephen Mahoney |
Name: | Henrik Edeback | |||||
Title: | VP, General Counsel |
Title: | VP Finance | |||||
Date: | 1/22/13 |
Date: | 1/22/13 | |||||
FUJIFILM Diosynth Biotechnologies U.S.A., Inc. | ||||||||
By: | /s/ Stephen Spearman | |||||||
Name: | Stephen Spearman | |||||||
Title: | President | |||||||
Date: | 22 Jan 2013 |
[Signature page to Bioprocessing Services Agreement]
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
CONFIDENTIAL | 22 |
SOW Technology Transfer and Manufacture of SBC-102
APPENDIX 1
Scope of Work for Technology Transfer
and cGMP Manufacture of SBC-102
Drug Substance
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
CONFIDENTIAL | Page 1 of 20 |
SOW Technology Transfer and Manufacture of SBC-102
TABLE OF CONTENTS
1.0 |
PROGRAM DEFINITIONS |
3 | ||||
2.0 |
ACRONYMS |
5 | ||||
3.0 |
INTRODUCTION |
6 | ||||
4.0 |
SCOPE ASSUMPTIONS |
7 | ||||
5.0 |
SPONSOR DELIVERABLES |
8 | ||||
6.0 |
PROGRAM MANAGEMENT |
9 | ||||
7.0 |
[*] |
10 | ||||
8.0 |
TECHNOLOGY TRANSFER |
11 | ||||
9.0 |
PRODUCT RECOVERY AND PURIFICATION PROCESS TRANSFER |
11 | ||||
10.0 |
ANALYTICAL METHOD |
13 | ||||
11.0 |
DEMONSTRATION RUN |
14 | ||||
12.0 |
[*] AND FACILITY PREPARATION |
15 | ||||
13.0 |
[*] |
16 | ||||
14.0 |
CGMP MANUFACTURING |
17 | ||||
15.0 |
CURRENT PROCESS FLOW DIAGRAM |
19 | ||||
16.0 |
CURRENT CERTIFICATE OF ANALYSIS FOR EGG WHITES |
20 |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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SOW Technology Transfer and Manufacture of SBC-102
1.0 | PROGRAM DEFINITIONS |
The definitions listed below reflect terms used in this Scope.
Sponsor: | Synageva BioPharm (Synageva) with a place of business at 128 Spring Street Suite 520 Lexington, MA 02421 | |
Fujifilm Diosynth: | Fujifilm Diosynth Biotechnologies USA Inc. (Fujifilm Diosynth), with a place of business at 101 J. Morris Commons Lane Morrisville, North Carolina 27560. | |
Agreement: | The Bioprocessing Services Agreement, of which this Scope document is considered an attachment. (Also referred to herein as the BSA). | |
Bulk Drug Substance: | Drug Substance filled into bulk containers, using aseptic techniques, under a laminar flow hood. | |
cGMP: | Current Good Manufacturing Practices pursuant to (a) the U.S. Federal Food, Drug and Cosmetics Act as amended (21 USC 301 et seq.), (b) U.S. regulations in Title 21 of the U.S. Code of Federal Regulations Parts 210, 211, 600 and 610 (c) the EC Guide to Good Manufacturing Practice for Medicinal Intermediate Products, v.4, including relevant sections of DIR 2003/94/EC, and (d) International Conference on Harmonization (ICH) Guidance for Industry Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. | |
Drug Product: | The dosage form of SBC-102 in the final immediate packaging intended for clinical use. | |
[*]: | [*] run intended to execute the series of unit operations, in the specified order to evaluate whether or not the process for manufacturing Product in its entirety meets Product / process draft specifications. | |
In-Process Control: | Analytical testing performed by Quality Control during execution of the process to provide data for making process decisions. The manufacturing process is on hold during testing until results are obtained. | |
In-Process Testing: | Analytical testing performed on samples from the process, often after the process is finished, to provide data about performance of the process.
The manufacturing process is not on hold until results are obtained. Results of In-Process Testing are not used for making decisions during execution of the process; but can be used for batch decisions after execution of the process. | |
Item Specification: | A set of criteria to which a material must conform to be considered acceptable for its intended use. | |
Intermediate | Process fraction containing Product generated during the manufacturing prior to Bulk Drug Substance. | |
Manufacturing Process: | The detailed instructions used to produce the Product, which have been agreed by Fujifilm Diosynth and the Sponsor. | |
Process Consumables: | Process Consumables include any Process Consumable or Raw Material used in the manufacture of an intermediate or Drug Substance that do not by themselves participate in a chemical or biological reaction. Such other materials include: [*] | |
Process: | The manufacturing process consisting of three sub-processes: fermentation, product recovery, and purification. |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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SOW Technology Transfer and Manufacture of SBC-102
Product: | Recombinant form of the human Lysosomal Acid Lipase (LAL) enzyme known as SBC-102 | |
Program: | The services to be performed with respect to Product by Fujifilm Diosynth under the Agreement as more particularly detailed in this Scope. | |
Raw Materials: | Any ingredient intended for use in the manufacture of an intermediate or API, including those that may not appear in the final formulation. These include chemicals used directly and/or indirectly in the manufacturing process. | |
Reference Standard: | A substance that has been shown by an extensive set of analytical tests to be authentic material representative of the Product and process. | |
Scope: | This Appendix 1 Scope of work, which the Parties acknowledge is part of the Agreement. The scope is a component of the legal Agreement that specifies the Program design, information desired, estimated duration of the Program and all other matters pertinent to the completion of the Program. | |
Scope Assumptions: | Assumptions relating to the Program design, objectives, process assumptions, deliverables, resource requirements, timing, capital expenditure requirements (if any) and other matters relating to the completion of the Program as set forth in the Scope. | |
Technical Summary Report: |
Detailed reports to be provided to Synageva upon completion of the different sections of the Scope of work as detailed in Appendix 1 describing the experimental methods and justification for the process description, to include data from all experiments, and a preliminary rationale for each unit operation. The reports will also outline any additional work that needs to be performed to complete the Process and Product characterization and recommendations for the next stages, as appropriate. | |
Third Party: | Any organization other than Fujifilm Diosynth and Sponsor, selected by Fujifilm Diosynth or Sponsor to perform services related to manufacture and testing of the Product. |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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SOW Technology Transfer and Manufacture of SBC-102
2.0 | ACRONYMS |
API | Active Pharmaceutical Ingredient | |
BDS | Bulk Drug Substance | |
BLA | Biologics License Application | |
BOM | Bill of Materials | |
BSA | Bioprocessing Services Agreement | |
C of A | Certificate of Analysis | |
cGMP | current Good Manufacturing Practice | |
CMC | Chemistry, Manufacturing and Controls | |
CPL | Customer Project Leader | |
DNA | Deoxyribonucleic Acid | |
ELISA | Enzyme Linked Immuno-Sorbent Assay | |
FDA | Food and Drug Administration | |
HCP | Host Cell Protein | |
HPLC | High Pressure Liquid Chromatography | |
ICH | International Conference on Harmonization | |
IPC | In-Process Control | |
IPT | In-Process Test | |
L | Liters | |
QA | Quality Assurance | |
QC | Quality Control | |
SDS-PAGE | Sodium Dodecyl Sulfate Polyacrylamide Gel Electrophoresis | |
SEC | Size Exclusion Chromatography | |
SOP | Standard Operating Procedure | |
STM | Standard Test Method | |
TOC | Total Organic Carbon | |
UF/DF | Ultrafiltration and Diafiltration |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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SOW Technology Transfer and Manufacture of SBC-102
3.0 | INTRODUCTION |
The Sponsor has requested that Fujifilm Diosynth transfer the process and associated analytics for manufacture of SBC-102. SBC-102 is an enzyme replacement therapy for Lysosomal Acid Lipase (LAL) Deficiency, a lysosomal storage disorder. SBC-102 is a recombinant form of the human LAL enzyme. SBC-102 contains glycan structures that are specifically recognized and internalized by specific receptors into key target cells. In 2010, SBC-102 received orphan drug designation in both the US and EU.
SBC-102 is produced in the egg white of transgenic hens. SBC-102 will be recovered from the egg whites and purified. Synageva would like to establish a process that is capable of processing approximately [*] of egg whites containing Lysosomal Acid Lipase (rhLAL) at Fujifilm Diosynth. At this time, Synageva is requesting [*] manufacturing runs at the scale of [*] egg whites. The first manufacturing run may be executed as [*]
Note: | The ability to execute the [*] run is subject to business and quality agreement. An assessment of whether the [*] will be [*] run will be performed after the conclusion of the [*]. |
This Scope outlines activities for this program.
TECHNOLOGY TRANSFER
Process Transfer
| Product recovery process transfer |
| Purification process transfer |
Analytical
| Qualified method transfer to support technology transfer and manufacturing |
Demonstration Runs
| [*] product recovery and purification runs to be executed at approximately [*] of egg whites containing rhLAL in the process development laboratories. The actual volume of egg whites containing rhLAL will be determined based upon equipment and process scale factors. |
MANUFACTURING
[*]
| Procurement and testing of raw materials and process consumables |
| [*] and facility set-up, including qualification of necessary equipment, if required. |
cGMP Manufacturing Runs
| [*] at approximately [*] of egg whites containing rhLAL working scale. |
| Disposition of all lots of SBC-102 drug substance produced. |
Note: | The ability to execute the [*] manufacturing run as a [*] run is subject to business and quality agreement. After reviewing the results of the demonstration runs, the feasibility of the [*] manufacturing run to be executed as a [*] will be evaluated. If it is mutually agreed that the first manufacturing run will be executed as a [*], prior to execution of the run, both parties will agree to target success criteria for the run. In the event the target |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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SOW Technology Transfer and Manufacture of SBC-102
success criteria for the first are not met, the first run will be deemed an [*] and the Sponsor will be charged the [*] rate. Adjustments to the Scope, Price, and Payment Schedule will be managed via Change Order. |
Summary Reports
| Technology transfer activities summary report. |
| Manufacturing activities summary report. |
4.0 | SCOPE ASSUMPTIONS |
Assumptions for this Scope are listed below. If these Scope Assumptions change or prove to be invalid, the Program activities, Program price, and estimated duration will be modified accordingly.
1. | Any timeline provided is for planning purposes only and exhibits estimated durations for activities. Any delay to contract approval and/or Sponsor deliverables may subsequently delay other activities, including milestone completion dates. |
2. | All technology transferred to Fujifilm Diosynth by Sponsor will perform as represented by Sponsor and is suitable for its intended use. |
3. | All analytical samples collected during manufacturing will be stable under conditions recommended, to permit in process control testing. |
4. | [*]. |
5. | Standard Fujifilm Diosynth cleaning procedures are capable of degrading Product as demonstrated by [*]. |
6. | Any animal derived materials that are required for Product production have been evaluated for TSE / BSE risk and deemed suitable for human use. |
7. | The majority of the manufacturing process can be modified to fit equipment currently available at Fujifilm Diosynth. Processing steps that may require capital investment are the egg white thaw and the UFDF steps. A more detailed review of the programs equipment needs will be evaluated during the transfer. [*], the program price and timeline may be impacted. |
8. | Fujifilm Diosynth will employ [*] during performance of this Program as long as the equipment meets process requirements and appropriate cleaning and lack of carry-over from other products can be demonstrated. Where appropriate Fujfilm Diosynth will employ [*] to support manufacturing of SBC-102. The final equipment list is dependent on the manufacturing scale and will be established during transfer and [*]. If Synageva wishes to employ equipment [*] the manufacturing of SBC-102, or should [*] be required, the program price and timeline may be impacted. |
9. | [*] will be used for storage of buffers and in-process materials as appropriate. Fujifilm Diosynth will leverage existing stability information (e.g. bioburden, endotoxin) to support length of storage for process buffers and/or solutions. |
10. | Product recovery can be completed within [*], including cleaning. |
11. | Purification can be completed within [*], including awaiting QC eluate fraction results, cleaning and steaming. |
12. | Low-pressure [*] chromatography columns will be used for purification. |
13. | Sponsor will be responsible for performing any assays requiring the use of tissue cultures or animals. |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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SOW Technology Transfer and Manufacture of SBC-102
14. | Whenever possible, Raw Materials will be sourced as [*] from Fujifilm Diosynth approved vendors. Raw Materials will be released based on [*] C of A and ID testing only, with the exception of Critical Raw Materials which will be [*]. |
15. | [*] manufacturing runs at the [*] egg white scale are identified within the Scope. [*] of egg whites contains approximately [*]. At least [*] of the [*] manufacturing runs will be executed under [*] conditions. |
Note: The ability to execute the first manufacturing run [*] run is subject to business and quality agreement.
16. | The Sponsor will be responsible for all [*]. |
17. | Fujifilm Diosynth will use standard packing procedures for Product shipments. |
18. | Fujifilm Diosynths standard formats will be used for preparation of transfer and manufacturing documentation. |
5.0 | SPONSOR DELIVERABLES |
Sponsor will provide the following items at the following times:
Lysosomal Acid Lipase (rhLAL) Egg Whites
1. | All egg whites containing Lysosomal Acid Lipase (rhLAL) provided to Fujifilm Diosynth must be tested and found negative for [*]. Documentation to ensure that the material meets all agreed Certificate of Analysis specifications no less than [*] prior shipment of the material to Fujifilm Diosynth. |
2. | Lysosomal Acid Lipase (rhLAL) containing egg whites, sufficient to initiation transfer activities, will be delivered to Fujifilm Diosynth Process Development laboratories at least [*] prior to the start date for activities stated within the Scope. |
3. | Lysosomal Acid Lipase (rhLAL) containing egg whites for cGMP production will be delivered to Fujifilm Diosynth upon establishment of the receiving [*] in support of manufacturing activities. |
4. | Documentation to support receipt, acceptance, and release of Lysosomal Acid Lipase (rhLAL) containing egg whites in accordance to the receiving [*] for use in the manufacturing facility. |
Analytical
5. | Analytical test methods, qualification or validation protocols and reports for the methods to be transferred, and list of reagents required within [*] of the effective date of the Agreement. |
6. | Qualified reference standard to support process transfer and demonstration run within [*] of the effective date of the Agreement. |
Process
7. | Documentation to initiate transfer and establishment of the manufacturing process (including process development reports, historical data, current process specifications, list of materials and process consumables, and executed formulation and batch records or production protocols) not to exceed [*] of the effective date of the Agreement. |
8. | Bill of materials for GMP manufacturing with vendor catalogue numbers, material grade, and quantities for all process consumables not to exceed [*] of the effective date of the Agreement. |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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SOW Technology Transfer and Manufacture of SBC-102
Other
9. | Appointment of Alliance Manager authorized to represent and communicate with Fujifilm Diosynth on behalf of Sponsor. |
10. | Timely review and approval of all Fujifilm Diosynth documents submitted to Sponsor for approval, such as [*] and Sponsor-[*] (preferably within [*]). Review of documentation will be [*]. Comments from [*], if applicable, are to be provided cumulatively in one (1) document. |
11. | MSDS and [*] regarding the Product in support of [*] of the Product [*] prior to initiation of process transfer activities. |
12. | Timely updates on any results of [*], or otherwise acquired knowledge that might impact the [*]. |
6.0 | PROGRAM MANAGEMENT |
6.1 | Objectives |
1. | Fujifilm Diosynth will provide overall management of the Program according to the Scope and Agreement. |
6.2 | Activities |
1. | Fujifilm Diosynth will appoint a [*] to manage Program execution who will continuously evaluate the Program performance and will initiate discussions with Sponsor when Program-related issues arise. |
2. | The [*] will: |
| Manage Program performance as defined in the Agreement. |
| Serve as primary contact for the Program and communications with Sponsor and internal Fujifilm Diosynth project team members. |
| [*] work with Sponsor to determine what additional activities are required to support Sponsors Program and/or regulatory submissions. |
| [*] work with Sponsor to identify [*] Scope as defined, and determine and agree upon course of action according to the Agreement. |
| Conduct project meetings with Sponsor on a regular basis. Method of meeting (face-to-face, teleconference, etc.) and timing will be [*] and may vary depending on the needs of the Program and provide appropriate documentation and reporting to the team [*]. |
| Track Program progress against [*] |
| Facilitate the review and approve invoices with the Sponsor. |
6.3 | [*] |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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SOW Technology Transfer and Manufacture of SBC-102
7.0 | [*] |
7.1 | Objective |
1. | Perform [*]. |
2. | Establish requirements for [*]. |
3. | Perform [*]: |
| [*] requirements |
| [*] requirements |
Note: | [*] is required for all products [*]. [*] must be performed before any [*] |
7.2 | Activities |
1. | Review Sponsor process of [*]. |
2. | Review Sponsor supplied MSDS and [*] data to [*]. |
3. | Establish [*]. |
4. | Review [*] procedures for [*] and establish [*] requirements, if appropriate. |
5. | Perform [*] to assess [*] of Product and [*]. |
Note: | The joint project team will define the requirements of [*] for Product samples from [*]. |
6. | Establish [*] requirements and recommend [*] solutions to ensure product [*]. |
7. | Establish appropriate procedures and policies. |
8. | Establish [*] requirements. |
7.3 | [*] |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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SOW Technology Transfer and Manufacture of SBC-102
TECHNOLOGY TRANSFER
8.0 | TECHNOLOGY TRANSFER |
8.1 | Objective |
1. | Prepare Fujifilm Diosynth personnel and [*] to support transfer of the SBC-102 process into Fujifilm Diosynths [*]. |
8.2 | Activities |
1. | Receive and review existing process and analytical information from Sponsor in the form of raw data, manufacturing instructions, historical data and process development reports. |
2. | Establish an initial process consumable list and order materials required to support process development activities. |
3. | Based on process documentation provided by Sponsor, prepare [*] Fujifilm Diosynths manufacturing facility, including [*]. |
8.3 | [*] |
9.0 | PRODUCT RECOVERY AND PURIFICATION PROCESS TRANSFER |
9.1 | Objectives |
1. | Transfer the Sponsors product recovery and purification processes into Fujifilm Diosynths [*]. |
2. | Adapt current processes, as necessary, to assure fit with Fujifilm Diosynth manufacturing facilities and equipment. |
9.2 | Activities |
1. | Perform [*] recovery and purification transfer runs using Lysosomal Acid Lipase (rhLAL) containing egg whites supplied by the Sponsor. The target initial volume for each transfer [*] of egg whites. The initial volume for each transfer set will be finalized in the [*] to ensure that the [*] transfer runs yields information suitable to use in assessing the process and transfer. |
| [*] |
2. | Evaluate the suitability of the transferred process for scale-up and cGMP manufacturing at Fujifilm Diosynths RTP manufacturing facility. |
3. | Adapt, as necessary, unit operations to fit Fujifilm Diosynths manufacturing facilities and equipment. |
4. | Test [*]. |
5. | Determine [*] operations. |
6. | Evaluate [*] in the analytical methods section. |
7. | Test [*] to support cGMP manufacturing. |
8. | Evaluate [*] during cGMP manufacturing. |
9. | Generate [*] of transfer activities. |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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SOW Technology Transfer and Manufacture of SBC-102
9.3 | [*] |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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SOW Technology Transfer and Manufacture of SBC-102
10.0 | ANALYTICAL METHOD |
In the case of method transfer, the Sponsor has completed qualification or validation of product-specific methods to be used for cGMP purposes. Diosynth Fujifilm will review and analyze Sponsor provided method development/qualification/validation reports. Based upon the documentation, Fujifilm Diosynth will [*] each method to be transferred. In the case of method verification, Fujifilm Diosynth will [*] for each method to be verified. Fujifilm Diosynth expects that no more than [*] runs are sufficient to demonstrate that knowledgeable analysts can successfully execute a method [*]. [*] for each transfer/verification will be provided to the Sponsor and the transfer of a method [*]. If target acceptance criteria are not met during the execution of the [*] during or after the execution of the transfer protocol. Once the method transfer/verification protocol is successfully executed, [*] for verified methods) will be prepared to support cGMP activities.
Definitions used in this section include:
| Verify: Demonstrating that an USP compendial method, general Fujifilm Diosynth qualified or validated method or commercial testing kit (e.g., [*]) is suitable for use with the intended product. |
| Implement: Application of a Sponsors method at Fujifilm Diosynth [*]. Successful implementation of the method will be documented in a [*] at the completion of execution. |
| In-Process Control (IPC): Manufacturing decisions are based on the results of in-process control assays (e.g. methods used to determine protein concentration for column loading). |
| In-Process Test (IPT): [*]. This test provides a check that the process operates [*], as identified by transfer package. |
10.1 | Objective |
1. | Transfer Sponsors analytical methods and verify methods for use with Product as outlined in Table 1. |
10.2 | Activities |
1. | Transfer qualified analytical methods from Sponsor for cGMP In-Process Testing, In-Process Control, and Drug Substance / Drug Product release testing. |
2. | Implement analytical methods from Sponsor to [*]. |
3. | Verify that compendial methods are suitable for the intended purpose, meeting USP requirements [*]. |
4. | Verify [*]. |
5. | Prepare Program specific [*]. |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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SOW Technology Transfer and Manufacture of SBC-102
Table 1. SBC-102 Analytical Methods
Assay |
Purpose |
Application IPT: In Process Testing IPC: In Process Control DS: Drug Substance PD: Process Development |
Activity | |||
[*] | Concentration | [*] | Transfer Qualified Synageva Method | |||
[*] | Identity | [*] | Transfer Qualified Synageva Method | |||
[*] | Potency | [*] | Transfer Qualified Synageva Method | |||
[*] | Safety | [*] | Transfer Qualified Synageva Method | |||
[*] | Quality | [*] | Verify Fujifilm Diosynth Method | |||
[*] | Safety | [*] | Verify Fujifilm Diosynth Method | |||
[*] | Safety | [*] | Verify Fujifilm Diosynth Method | |||
[*] | Purity | [*] | Implement Synageva Method | |||
[*] | Purity | [*] | Implement Synageva Method |
10.3 | [*] |
11.0 | DEMONSTRATION RUN |
11.1 | Objectives |
1. | To perform [*] product recovery and purification runs using Lysosomal Acid Lipase containing egg whites supplied by the Sponsor. The target initial volume for each demonstration run is [*] of egg whites. The initial volume for each demonstration run will be finalized after the transfer runs to ensure that the [*] demonstration runs yields information suitable for assessing the process and scale-up. |
11.2 | Activities |
1. | Perform Product recovery. |
2. | Perform purification of Product. |
3. | Provide [*]. |
4. | Analyze purified Product alongside the reference standard using a [*] release methods. |
5. | Develop [*] parameters such as [*] and [*], and [*] as well as [*] Product specifications based on [*]. |
6. | Review demonstration run results and [*] determine the appropriate and subsequent activities. |
7. | Document demonstration run in [*] |
11.3 | [*] |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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SOW Technology Transfer and Manufacture of SBC-102
MANUFACTURING
12.0 | [*] AND FACILITY PREPARATION |
12.1 | Objectives |
1. | To [*]. |
2. | To procure and release Process Consumables to be used in the manufacture of Product. |
3. | To provide Quality Assurance and Quality Control support, as needed. |
12.2 | Activities |
Documentation
1. | Prepare and approve all necessary documentation, [*] for the manufacture of Product. |
2. | Establish [*] for Product and prepare and approve Product [*]. |
3. | Complete [*] changeover activities. |
Material Procurement and Testing
4. | Perform a quality audit of [*] suppliers of process materials including the rhLAL containing egg whites. |
5. | Procure, sample, test, and disposition Process Consumables to be utilized according to existing [*]. |
6. | Test [*] from Fujifilm Diosynth-approved vendors as per Fujifilm Diosynth procedures. |
7. | Perform sampling and submission of samples for testing to be [*], if necessary. |
Notes:
| Fujifilm Diosynth will acquire and release Process Consumables for an anticipated cGMP manufacturing campaign and [*]. Where possible, Fujifilm Diosynth will purchase [*] of a Process Consumable from approved vendor to [*]. Fujifilm Diosynth will procure Process Consumables for: |
| [*] complete manufacturing runs ([*] egg white scale). |
| [*] complete [*] run. |
| Where Fujifilm Diosynth [*] are not available, the assay methods for testing the materials may require development and qualification [*]. |
| Development and qualification of additional test methods for Raw Materials, if required, [*]. |
Set-up & Changeover
8. | Prepare facilities necessary for execution of the manufacturing processes including [*]. |
9. | Confirm [*] status and perform [*] as necessary. |
10. | Set-up all equipment necessary for execution of the process and testing. |
11. | Prepare and set-up software, as necessary. |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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SOW Technology Transfer and Manufacture of SBC-102
12.3 | [*] |
13.0 | [*] |
13.1 | Objectives |
1. | To execute an [*] consisting of the product recovery, and purification units of operation. These runs will verify [*] with manufacturing equipment. This run will be performed using [*] Process Consumables and [*] manufacturing suites, [*]. |
2. | To provide available purified Product to Sponsor |
3. | To test and correct any documentation [*]. |
Note: | The [*] is a critical element to confirm successful scale-up of the process by providing the opportunity to execute all process steps on intended [*] manufacturing equipment and to provide Fujifilm Diosynth manufacturing personnel hands on experience with the process. [*] is performed using [*] manufacturing documentation that is [*] operation. In the event of need for process modifications during the [*], Fujifilm Diosynth will [*] and procedures, then [*]. [*] to the process flow may be necessary. Fujifilm Diosynth will [*] only for [*] of one or more of units of operations (e.g. a chromatography step.) Fujifilm Diosynth will inform Sponsor of the modification as soon as possible. [*]. |
13.2 | Activities |
Manufacturing
1. | Perform the product recovery of approximately [*] of Lysosomal Acid Lipase (rhLAL) containing egg whites using [*]. |
2. | Perform the purification of Product recovered from the [*] of Lysosomal Acid Lipase (rhLAL) containing egg whites using [*]. |
3. | Collect samples for in-process testing according to [*]. |
4. | Clean equipment and facilities, and [*]. |
5. | Perform analytical testing [*] as required by the process. |
6. | Complete and review [*] production records. |
7. | Modify and update production records and submit [*]. |
8. | Make equipment adjustments, if necessary, before [*] campaign. |
Quality Control and [*]
9. | Perform in-process and release testing of Product produced from the [*] using [*] analytical documents. |
10. | Perform environmental monitoring and testing of cleaning samples. |
[*]
13. | Provide [*] oversight and support. |
14. | Perform [*], if necessary. |
15. | Evaluate [*]. |
16. | Make [*] adjustments, if necessary, before [*] campaign. |
17. | Host and provide [*]. |
[*]
18. | Provide [*], as needed. |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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SOW Technology Transfer and Manufacture of SBC-102
19. | Evaluate [*] manufacturing. |
20. | Perform [*], if necessary. |
Quality Assurance
21. | Provide compliance oversight for use of cGMP facility. |
22. | Review and approve modified and updated manufacturing documentation. |
13.3 | [*] |
14.0 | cGMP MANUFACTURING |
14.1 | Objectives |
1. | To manufacture [*] of Product in accordance with cGMP and [*] manufacturing documentation. |
2. | To provide Quality Assurance and Quality Control support as required. |
3. | To support Sponsors regulatory filing by providing [*] pertaining to work performed at Fujifilm Diosynth. |
Note: | The ability to execute the [*] is subject to business and quality agreement. After reviewing the results of the [*], the feasibility of the [*] will be evaluated. If it is mutually agreed that the [*], prior to execution of the run, both parties will agree to [*]. In the event the [*] for the [*] will be deemed an [*] and the Sponsor will be [*]. Adjustments to the Scope, Price, and Payment Schedule will be managed via Change Order. |
14.2 | Activities |
Manufacturing
1. | Perform [*] Product recoveries at [*] of Lysosomal Acid Lipase (rhLAL) containing egg whites using [*]. |
2. | Perform [*] purification of Product using [*] |
3. | Collect samples for in-process, release and stability testing according to [*]. |
4. | Clean equipment and facilities, and [*]. |
5. | Perform In-Process Control testing and/or In-Process Testing [*] as required by the process. |
6. | Review executed production records. |
7. | Participate in deviation closure and out-of-specification investigations, if any. |
Quality Control
8. | Perform In-Process Control testing for process steps according to [*]. |
9. | Perform release testing according to Product [*]. |
10. | Perform environmental monitoring and testing of cleaning samples. |
[*]
11. | Provide [*] support as needed. |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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SOW Technology Transfer and Manufacture of SBC-102
12. | Perform [*], if necessary. |
13. | Support [*] the process. |
14. | Support [*]. |
15. | Host and provide [*]. |
16. | Prepare [*]. |
[*]
17. | Provide [*], as necessary. |
18. | Support [*] the process. |
19. | Support [*]. |
20. | Evaluate [*] in comparison to [*]. |
21. | Perform [*], if necessary |
Quality Assurance
22. | Provide compliance oversight for cGMP manufacturing. |
23. | Issue [*] records. |
24. | Review [*] records. |
25. | Lead deviation closure and out-of-specification investigations, if any. |
26. | Disposition of Drug Substance to Sponsor in accordance with an established Quality Agreement specifying [*]. |
27. | Issue a Certificate of Analysis for Drug Substance. |
Regulatory support
28. | Prepare data and documents to support regulatory filing. |
29. | Perform [*] Fujifilm Diosynth [*], defining Fujifilm Diosynths [*]. |
30. | Maintain a copy [*] and updates/changes at Fujifilm Diosynth. |
14.3 | [*] |
Note - Quality Assurance will provide the batch packet to the client for release as per quality procedures. The batch packet consists of, but is not limited to, the following information.
| Completed disposition of manufactured product form |
| Completed batch genealogy |
| Completed and reviewed process records, including in-process results. |
| Certificate of Analysis |
| Facilities assessment memo |
| Quest Trackwise deviation report |
| Quest Trackwise restriction summary |
| Copies of all closed deviations associated with the batch. |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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SOW Technology Transfer and Manufacture of SBC-102
15.0 | CURRENT PROCESS FLOW DIAGRAM |
Attached is the Process Flow Diagram for the current process as represented by the Sponsor
[*]
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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SOW Technology Transfer and Manufacture of SBC-102
16.0 | CURRENT CERTIFICATE OF ANALYSIS FOR EGG WHITES |
Attached is the current Certificate of Analysis for the rhLAL containing Egg Whites.
[*]
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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FUJIFILM Diosynth Biotechnologies Synageva BioPharma Corp.
Clinical Material Manufacturing Quality Agreement
Table of Contents
General Information |
2 | |||
Signatures |
3 | |||
Quality Responsibilities Table |
4 | |||
Attachments |
9 | |||
Attachment A Release Documentation |
9 | |||
Attachment B Master Documents |
9 | |||
Attachment C Definitions |
9 |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Confidential | 1 of 10 |
FUJIFILM Diosynth Biotechnologies Synageva BioPharma Corp.
Clinical Material Manufacturing Quality Agreement
General Information
This Quality Agreement outlines the roles, responsibilities and time requirements with respect to the Quality Assurance of the Intermediate and/or Drug Substance produced by FUJIFILM Diosynth Biotechnologies U.S.A., Inc. (referred to in this Quality Agreement as Fujifilm Diosynth) for Synageva BioPharma Corp. (here within known as Sponsor) and fulfils the requirements as outlined in ICH Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. In addition, Fujifilm Diosynth may perform [*] as outlined within the Agreement. The drug substance covered by this Quality Agreement is <Sebelepase alfa SBC-102>.
The Quality Agreement is an appendix to the Bioprocessing Services Agreement (BSA) executed by Sponsor and Fujifilm Diosynth.
Unless otherwise defined specifically in this Quality Agreement, all general terms used herein will be interpreted in accordance with the definitions provided in the BSA. Any terms not so defined will be interpreted with the definitions so stated in ICH Q7 or 21 CFR Parts 210, 211, 600, & 610.
The Authorized Quality Representatives will resolve any disputes or conflicts relating to this Quality Agreement in a timely and equitable manner and in compliance with all applicable quality and regulatory requirements. Such resolutions shall be [*] by the Authorized Quality Representatives of each company. If any issue remains unresolved for more than twenty (20) business days, the senior corporate Quality officials from each company should be contacted to resolve this issue. In the event the parties fail to reach agreement on such issue within thirty (30) calendar days after notice is provided to the senior corporate Quality officials, then such dispute shall be resolved according to the provisions as detailed in the BSA.
All communication affecting the contents of this Quality Agreement will be between the Authorized Quality Representatives, as set forth below:
For Sponsor: | Mark Hazard, Quality Responsible Head | |
For Fujifilm Diosynth: | David Patterson, Sr. Vice President, Quality Operations |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Signatures
Sponsor Authorized Quality Assurance Representative
By: |
|
Date: |
| |||||||
(Signature) | ||||||||||
Name: | Mark Hazard | Tel.: | 706-286-8932 | |||||||
Email: | [*] | |||||||||
Address: | Synageva BioPharma Corp. | |||||||||
150 Ben Burton Rd | ||||||||||
Bogart, Ga. 30622 |
Fujifilm Diosynth Authorized Quality Assurance Representative
By: |
|
Date: |
| |||||
(Signature) | ||||||||
Name: | David Patterson | Tel.: | 919-337-4408 | |||||
Email: | [*] | |||||||
Address: | FUJIFILM Diosynth Biotechnologies U.S.A., Inc. | |||||||
101 J. Morris Commons Lane | ||||||||
Morrisville, North Carolina, USA, 27560 |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Confidential | 3 of 10 |
Quality Responsibilities Table
The responsible party is denoted by ü
Description |
Fujifilm Diosynth (time frame) |
Sponsor (time frame) | ||||
1 | Compliance | |||||
Operate under Current Good Manufacturing Practices pursuant to (a) the U.S. Federal Food, Drug and Cosmetics Act as amended (21 USC 301 et seq.), (b) U.S. regulations in Title 21 of the U.S. Code of Federal Regulations Parts 210, 211, 600 and 610 (c) the EC Guide to Good Manufacturing Practice for Medicinal Products, v.4, including relevant sections of DIR 2003/94/EC, and (d) International Conference on Harmonization (ICH) Guidance for Industry Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. | ü (at all times) |
|||||
Renegotiate the Quality Agreement | ü (as required) |
ü (as required) | ||||
Appoint an Authorized Quality Representative for resolution of disputes | ü (prior to approval of Quality Agreement) |
ü (prior to approval of Quality Agreement) | ||||
Give notification in event of Authorized Quality Representative change | ü (as required) |
ü (as required) | ||||
2 | Regulatory | |||||
Prepare and update Regulatory applications | ü | |||||
Provide information, as requested, to keep submissions current | ü | |||||
Provide copies of [*] relevant to work Fujifilm Diosynth performs for review and comment prior to submission to the [*] | ü | |||||
Provide comments on [*] section(s) prior to submission [*] | ü ([*] after receipt) |
|||||
Provide updates of [*] | ü (all [*] relevant to Fujifilm Diosynth process work) | |||||
Responsible for all reporting requirements with regard to manufacturing site registration that may be required to support Sponsor related activities | ü | |||||
Provide a Letter of Authorization (LOA) to reference site registration filing | ü (when requested) |
|||||
For clients with LOAs, provide [*] | ü | |||||
3 | Audits | |||||
3.1 Regulatory Inspections | ||||||
Provide notification of Regulatory Audits with Sponsor product impact | ü [*] |
|||||
Provide all Sponsor related regulatory observation response | ü [*] |
|||||
3.2 Sponsor Audits Entitled to one on-site GMP audit per [*] period | ||||||
Provide Notification to schedule audit not to exceed [*] | ü [*] | |||||
Schedule and support annual Sponsor Audits | ü |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Confidential | 4 of 10 |
Description |
Fujifilm Diosynth (time frame) |
Sponsor (time frame) | ||||
Provide written audit report | ü ([*] from completion of audit) | |||||
Provide written response to observations | ü ([*] from receipt of observations) |
|||||
3.3 For Cause Audits | ||||||
Provide notification to schedule For Cause Audit | ü (as required) | |||||
Schedule and support For Cause Audit | ü (scheduled at a mutually agreed upon time) |
|||||
4 | Complaint handling | |||||
Notify other party of any information coming into its possession concerning [*] | ü (within [*]) |
ü (within [*]) | ||||
Participate in the development of investigation plans | ü ([*] from Sponsor notification) | |||||
Investigate the issue to the extent that it relates to Fujifilm Diosynths activities and provide a written report | ü (Target [*] from date event observed) |
|||||
Approve Complaints [*] |
ü (Target [*] from date event observed) |
ü ([*] from receipt of complaint summary) | ||||
Determine how to address the information impacting the product quality and safety | ü | |||||
Communicate with regulatory authorities | ü | |||||
5 | Change Management | |||||
Communicate need for change to approved master documents (as defined in Attachment B) | ü | ü | ||||
Review proposed change for conformance to any regulatory commitments | ü ([*] from receipt of change summary) | |||||
Use [*] in controlled documents to track changes (review and approval according to Section 8) | ü | |||||
Use [*] for changes made to validated processes and/or systems | ü | |||||
6 | Facilities, Equipment, and Utilities Validation and Qualification | |||||
Maintain the qualified and/or validated state of equipment, facilities, and utilities including equipment supporting [*] | ü (on-going) |
|||||
7 | Consumables and Raw Materials | |||||
Determine suitable Process Consumables | ü | ü | ||||
Determine sources for identified Process Consumables | ü | |||||
Develop and approve test methods for Raw Materials | ü | ü [*] | ||||
Develop and approve [*] for Process Consumables | ü | ü [*] | ||||
Approve suppliers of Process Consumables | ü | ü [*] | ||||
Procure, store, sample and test Raw Materials according to approved [*] | ü |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Confidential | 5 of 10 |
Description |
Fujifilm Diosynth (time frame) |
Sponsor (time frame) | ||||
Release Process Consumables prior to use | ü | |||||
Audit supplier for [*] Process Consumables Provide summary of supplier audit to Fujifilm Diosynth |
ü (prior to receipt of material at Fujifilm Diosynth) | |||||
Use only the Process Consumables that are listed in the approved master controlled documents [*] | ü | |||||
Review supplier changes for compliance with regulatory filings and notify Sponsor | ü | |||||
7.1 Animal Derived Materials | ||||||
Source relevant Raw Materials from non-animal derived sources whenever possible | ü | |||||
Comply with U.S. and European regulations (EP, latest edition, Chapter 5.2.8, Minimizing the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products) | ü | |||||
Obtain Country of Origin certification and confirm source country is not a known BSE-contaminated country (in accord with 9CFR94.18) or by ensuring the processing methods are known to inactivate TSE agents, per CHMP guidelines | ü | |||||
Supply statement regarding process materials confirmed to be of animal origin as regards to TSE/BSE compliance and provide updates, as needed | ü (when requested) |
|||||
8 | Master Batch Records, Product Specification(s), Test Methods and Qualification/Validation Documentation | |||||
Author master documents (as defined in Attachment B) | ü (prior to start of first full scale run) |
|||||
Review master documents (as defined in Attachment B) | ü | ü (comments within [*] of receipt) | ||||
Approve master documents (as defined in Attachment B) | ü | ü (approval within [*] of receipt) | ||||
Revise master documents | ü (as required) |
|||||
Author transfer, qualification, and validations protocols | ü | |||||
Review transfer, qualification, and validations protocols [*] |
ü | ü (comments within [*] of receipt) | ||||
Approve, transfer, qualification, and validations protocols | ü | ü (approval within [*] of receipt) | ||||
Execute transfer, development, qualification and/or validation (as defined within the Scope of Work) | ü | |||||
Author transfer, qualification, and validations summary reports | ü | |||||
Review transfer, qualification, and validations summary reports [*] |
ü | ü (comments within [*] of receipt) |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Confidential | 6 of 10 |
Description |
Fujifilm Diosynth (time frame) |
Sponsor (time frame) | ||||
Approve transfer, qualification, and validations summary reports | ü | ü (approval within [*] of receipt) | ||||
9 | Manufacturing and Packaging of DS and/or Intermediates | |||||
The execution of manufacture, packaging, holding and labeling of DS in accordance with approved procedures | ü | |||||
10 | Quality Control Testing to Support cGMP Manufacture | |||||
Sample according to batch records or other approved document | ü | |||||
Test material using approved methods | ü | |||||
Compare results against Approved Specifications | ü | |||||
11 | Deviations and Out-of-Specification Results | |||||
Notification of Deviations with Potential Product Impact | ü ([*] from Fujifilm Diosynth QA notification) |
|||||
Notification of Significant Deviations and/or confirmed Out of Specification (OOS) Results | ([*] from Fujifilm Diosynth QA classification) | |||||
Participate in the development of investigation plans | ü ([*] from Sponsor notification) | |||||
Complete the investigation into Deviations or/and OOSs | ü ([*] from date event observed, or prior to execution of next campaign) |
|||||
Approve Deviation and / or OOS | ü ([*] from date event observed, or prior to execution of next campaign) |
|||||
Approve Deviations with potential product impact and OOSs [*] |
ü ([*] from receipt of deviation summary) | |||||
12 | Batch Disposition and Release | |||||
Prepare a Batch Packet (as defined in Attachment A), providing [*] and OOSs are approved | ü ([*] from date of manufacture) |
|||||
Disposition Intermediate and /or Drug Substance, providing [*] and OOSs are approved | ü ([*] from date of manufacture) |
|||||
Release Intermediate and /or Drug Substance. Issue a Certificate of Conformance (COC), or similar | ü ([*] from receipt of batch packet) | |||||
Maintain original batch records | ü (minimum of [*]) |
|||||
Make records [*] | ü (in a timeframe mutually agreed upon) |
|||||
13 | Storage, Delivery and Shipment | |||||
Store materials under appropriate conditions | ü | |||||
Provide information on required shipping conditions | ü |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Confidential | 7 of 10 |
Description |
Fujifilm Diosynth (time frame) |
Sponsor (time frame) | ||||
Authorize delivery of released Intermediate and/or Drug Substance | ü | |||||
Deliver released Intermediate and /or Drug Substance to Sponsors nominated courier | ü | |||||
14 | Person-in-the-Plant | |||||
Adhere to applicable Fujifilm Diosynth procedures | ü (at all times) | |||||
15 | QA Retain Samples of Intermediates and Drug Substance | |||||
Store sufficient quantity ([*] amount needed for release testing, [*]) of QA Retain for the purposes of fulfilling the regulatory reserve requirement | ü (minimum of [*] from date of manufacture) |
|||||
16 | Use of Subcontractors | |||||
Use subcontractors that meet the requirements for Approved Suppliers | ü | |||||
Approve the use of subcontractors, prior to use, for testing [*] | ü | ü | ||||
Through the use of Fujifilm Diosynth Quality systems, participate in any investigations and corrective actions that occur at the subcontractor | ü | ü | ||||
17 | Returned Goods | |||||
Handle return materials using a cGMP compliant system | ü | |||||
18 | [*] (when applicable, as detailed in the Scope) |
|||||
[*] using approved methods | ü | |||||
Compare results against approved specifications | ü | |||||
Issue a Certificate of Analysis | ü ([*] from receipt of samples) |
|||||
19 | Stability Testing and Expiration Period (when applicable) | |||||
Author stability protocols | ü | |||||
Review stability protocols | ü | ü (comments within [*] of receipt) | ||||
Approve stability protocols | ü | ü (approval within [*] of receipt) | ||||
Carry out stability program in accordance with approved protocols and ICH guidelines | ü | |||||
Test stability samples using approved methods | ü | |||||
Provide copies of results following each time point | ü ([*] from completion of testing, not to exceed [*] from scheduled pull date) |
|||||
Establish Expiry or Retest Period | ü |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Confidential | 8 of 10 |
Attachments
Attachment A Batch Packet Documentation
Relevant documentation to be transferred to Sponsor to facilitate the release of a Batch. This packet consists of copies of: [*]
Attachment B Master Documents
Master Documents include:
Master Batch Records
Master Formulation Records
Test Methods
Forms
Item Specifications
Stability Protocols
Qualification/Validation Documents
Master Documents requiring Sponsor [*]
Attachment C Definitions
API | Active Pharmaceutical Ingredient, may be used interchangeably with Drug Substance. | |
Approved Supplier | A supplier who has met minimum approval standards and who has been approved to provide required items or services that may impact product quality. | |
Authorized Quality Representatives | An individual named within the Quality Agreement with the authority to resolve any disputes or conflicts relating to this Quality Agreement in a timely and equitable manner and in compliance with all applicable quality and regulatory requirements. | |
Batch | A specific quantity of material produced in a process or fraction of a process. Batches are defined as the material represented at the end of the intermediate processing steps or the material represented at the end of the processing step for API. | |
cGMP | Current Good Manufacturing Practices pursuant to (a) the U.S. Federal Food, Drug and Cosmetics Act as amended (21 USC 301 et seq.), (b) U.S. regulations in Title 21 of the U.S. Code of Federal Regulations Parts 210, 211, 600 and 610 (c) the EC Guide to Good Manufacturing Practice for Medicinal Products, v.4, including relevant sections of DIR 2003/94/EC, and (d) International Conference on Harmonization (ICH) Guidance for Industry Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Confidential | 9 of 10 |
Critical Raw Materials | Raw materials comprise final formulation components and / or that combine structurally or chemically with the therapeutic protein. | |
Deviation | An unplanned event requiring investigation which 1) may affect the quality or compliance status of the product, process materials, equipment or facility involved or 2) may not be in alignment with regulatory submissions. | |
Disposition | A recommendation given by Fujifilm Diosynth Quality on the suitability of the Intermediate or Drug Substance for further processing. | |
Drug Product | The dosage form in the final immediate packaging intended for clinical use. | |
Drug Substance or DS | Any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the Drug Product. Such substances are intended to furnish pharmacological activity or other direct effect on the diagnosis, cure mitigation, treatment, or prevention of disease or to affect the structure and function of the body. | |
Process Consumables | Process Consumables include any disposable equipment or equipment parts or Raw Material used in the manufacture of an intermediate or Drug Substance that do not themselves participate in a chemical or biological reaction. Such other materials include: [*]. | |
Product | Any (a) API/Drug Substance, or (b) Drug Product comprised of API/Drug Substance, or (c) intermediate(s) of (a) or (b) , in each case as specified in the applicable Scope. | |
Raw Material | Any ingredient intended for use in the manufacture of an intermediate or API, including those that may not appear in the final formulation. These include chemicals used directly and/or indirectly in the manufacturing process. | |
Statement of Compliance | A Fujifilm Diosynth QA Disposition of Product Statement stating that a specific Batch of Drug Substance complies with all Product, GMP and regulatory requirements and is signed by an authorized representative of Fujifilm Diosynth. | |
Test Methods | Methods used for QC testing, including Standard Test Methods and Compendial Methods. |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Confidential | 10 of 10 |
Appendix 3
Synageva SBC-102 Program Price
Activity |
Price | |||
Technology Transfer |
[ | *] | ||
[*] |
[ | *] | ||
[*] |
[ | *] | ||
Analytical Method Transfer |
[ | *] | ||
Demonstration Runs ([*]) |
[ | *] | ||
[*] |
[ | *] | ||
[*] Manufacturing ([*]) |
[ | *] | ||
cGMP [*] ([*]) |
[ | *] | ||
[*] |
[ | *] | ||
TOTAL |
[ | *] |
Optional Activity |
Price | |||
[*] |
[ | *] |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Synageva SBC-102 Payment Schedule
Activity/Milestone |
Payment | Credit | Net Payment | |||||||||
[*] |
[ | *] | [ | *] | ||||||||
[*] |
[ | *] | [ | *] | ||||||||
[*] |
[ | *] | [ | *] | ||||||||
[*] |
[ | *] | [ | *] | ||||||||
[*] |
[ | *] | [ | *] | ||||||||
[*] |
[ | *] | [ | *] | ||||||||
[*] |
[ | *] | [ | *] | ||||||||
[*] |
[ | *] | [ | *] | ||||||||
[*] |
[ | *] | [ | *] | ||||||||
[*] |
[ | *] | [ | *] | ||||||||
[*] |
[ | *] | [ | *] | ||||||||
[*] |
[ | *] | [ | *] | ||||||||
[*] |
[ | *] | [ | *] | ||||||||
[*] |
[ | *] | [ | *] | ||||||||
[*] |
[ | *] | [ | *] | [ | *] | ||||||
[*] |
[ | *] | [ | *] | ||||||||
[*] |
[ | *] | [ | *] | ||||||||
[*] |
[ | *] | [ | *] | ||||||||
[*] |
[ | *] | [ | *] | [ | *] | ||||||
[*] |
[ | *] | [ | *] | ||||||||
[*] |
[ | *] | [ | *] | ||||||||
[*] |
[ | *] | [ | *] | [ | *] | ||||||
[*] |
[ | *] | [ | *] | ||||||||
[*] |
[ | *] | [ | *] | ||||||||
[*] |
[ | *] | [ | *] | [ | *] | ||||||
[*] |
[ | *] | [ | *] | ||||||||
TOTAL |
[ | *] | [ | *] |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
-2-
Exhibit 10.2
Execution Version
EXCLUSIVE SUBLICENSE AGREEMENT
THIS EXCLUSIVE SUBLICENSE AGREEMENT (the Agreement) is made and effective as of April 5, 2013 (the Effective Date) by and between Shire AG, a company organized under the laws of Switzerland, having a principal place of business at Business Park Terre-Bonne, Bâtiment A1, CH. De Terre Bonne 1,1262 Eysins, Switzerland (Shire), and Synageva BioPharma Corp., a Delaware corporation having a principal place of business at 128 Spring Street, Suite 520, Lexington, Massachusetts 02421, USA (Synageva). Shire and Synageva are referred to herein individually as a Party or collectively as the Parties.
RECITALS
WHEREAS, Childrens Hospital Medical Center, d/b/a Cincinnati Childrens Hospital Medical Center (CHMC) owns certain patents related to lysosomal acid lipase that it has licensed to Shire pursuant to an Second Amended and Restated Exclusive License Agreement effective April 5, 2013 (the CHMC Agreement);
WHEREAS, Synageva has commenced an action against an Affiliate of CHMC in the Patents Court of the United Kingdom seeking, among other things, a declaration that the UK designation of one of such licensed patents is invalid and revocation of the UK designation of such patent (the UK Action);
WHEREAS, a third party filed an opposition with the European Patent Office to one of such licensed patents, for which oral proceedings have been held before the European Patent Office Opposition Division, a written decision of the proceedings has been published and a notice of appeal referred to the European Patent Office Board of Appeal (the EPO Opposition);
WHEREAS, Synageva and one of its Affiliates have commenced an action in the Tribunal de Grande Instance of Paris against CHMC and certain of its Affiliates seeking, among other things, revocation of the French designation of one of such licensed patents (the French Action and, together the UK Action and the EPO Opposition, the Actions);
WHEREAS, Shire has been defending the Actions on behalf of CHMC and its Affiliates;
WHEREAS, the Parties desire to settle the Actions pursuant to a settlement agreement among Shire, certain of its Affiliates, CHMC, certain of its Affiliates, and Synageva and certain of its Affiliates of even date herewith (the Settlement Agreement) under which Shire has agreed, among other things, to grant Synageva an exclusive sublicense under such licensed patents on the terms set forth herein; and
NOW, THEREFORE, in consideration of the mutual covenants and promises contained in this Agreement and other good and valuable consideration, Synageva and Shire agree as follows:
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
1
ARTICLE 1 - DEFINITIONS
In the terms defined and used herein, the singular shall include the plural and vice versa. Undefined terms in this Agreement (other than names of Parties and Article headings) which are set forth in upper case letters have the meanings established for such terms in the succeeding Sections of this Article 1.
1.1 Affiliate means, with respect to any person or entity, any other person or entity which controls, is controlled by or is under common control with such person or entity. Control means that one of the following conditions is met: (a) in the case of corporate entities, direct or indirect ownership of more than fifty percent (50%) of the stock or shares having the right to vote for the election of directors or otherwise to direct or cause the direction of management, and (b) in the case of non-corporate entities, direct or indirect ownership of more than fifty percent (50%) of the equity interest with the power to direct or cause the direction of the management of such non-corporate entities.
1.2 Commercially Reasonable Efforts means efforts that are not less than those efforts a Party makes with respect to other products in its portfolio at a similar stage of development or in a similar stage of product life, with similar developmental risk profiles, of similar market and commercial potential, taking into account the competitiveness of the market place, the proprietary position of the products, the regulatory structure involved, the profitability of the applicable products and other relevant factors, but, in any event, not less than the efforts that would be exerted by a reasonably prudent and diligent biopharmaceutical company similarly situated to such Party to accomplish similar objectives.
1.3 Confidential Information has the meaning set forth in Section 10.3 (Confidential Information).
1.4 Europe means the following countries only: United Kingdom, Germany, France, Italy and Spain.
1.5 Family 1 Patents means the United States and foreign patents and patent applications that are listed on Exhibit A hereto under the heading Family 1 Patents and any patents maturing from any of the foregoing that are patent applications, and any divisionals, continuations, continuations-in-part (solely to the extent that the claims in such continuations-in-part are directed to subject matter disclosed in the patents and patent applications listed in Exhibit A) or other applications sharing common priority with any of the foregoing anywhere in the world (and all resulting patents therefrom), any re-examinations, reissues, renewals, restorations, and extensions (including patent term adjustments, patent term extensions, supplemental protection certificates or the equivalent thereof) of any of such patents or patent applications, and any foreign counterparts of any of the foregoing (whether or not listed on Exhibit A).
1.6 Family 2 Patents means the United States and foreign patents and patent applications that are listed on Exhibit B hereto and any patents maturing from any of the foregoing that are patent applications, and any divisionals, continuations, continuations-in-part or other
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
2
applications sharing common priority with any of the foregoing anywhere in the world (and all resulting patents therefrom), any re-examinations, reissues, renewals, restorations, and extensions (including patent term adjustments, patent term extensions, supplemental protection certificates or the equivalent thereof) of any of such patents or patent applications, and any foreign counterparts of any of the foregoing (whether or not listed on Exhibit B).
1.7 Family 3 Patents means the United States and foreign patents and patent applications that are listed on Exhibit A hereto under the heading Family 3 Patents (which are jointly owned by Shire HGT and CHMC) and any patents maturing from any of the foregoing that are patent applications, and any divisionals, continuations, continuations-in-part (solely to the extent that the claims in such continuations-in-part are directed to subject matter disclosed in the patents and patent applications listed in Exhibit A) or other applications sharing common priority with any of the foregoing anywhere in the world (and all resulting patents therefrom), any re-examinations, reissues, renewals, restorations, and extensions (including patent term adjustments, patent term extensions, supplemental protection certificates or the equivalent thereof) of any of such patents or patent applications, and any foreign counterparts of any of the foregoing (whether or not listed on Exhibit A).
1.8 Family 4 Patents means the United States and foreign patents and patent applications that are listed on Exhibit A hereto under the heading Family 4 Patents and any patents maturing from any of the foregoing that are patent applications, and any divisionals, continuations, continuations-in-part (solely to the extent that the claims in such continuations-in-part are directed to subject matter disclosed in the patents and patent applications listed in Exhibit A) or other applications sharing common priority with any of the foregoing anywhere in the world (and all resulting patents therefrom), any re-examinations, reissues, renewals, restorations, and extensions (including patent term adjustments, patent term extensions, supplemental protection certificates or the equivalent thereof) of any of such patents or patent applications, and any foreign counterparts of any of the foregoing (whether or not listed on Exhibit A).
1.9 Field of Use means all uses.
1.10 First Commercial Sale means the first bona fide commercial sale of a Product by Synageva or one of its Affiliates or Sublicensees for use in the Field of Use within a country in the Territory following issuance of all applicable Regulatory Approvals required prior to commercial sale in such country.
1.11 GAAP means generally accepted accounting principles in the United States, consistently applied; provided that, to the extent that Synageva adopts International Financial Reporting Standards (IFRS), then GAAP means IFRS, consistently applied.
1.12 Government means the federal, state and/or local government(s) and regulatory bodies of any country or multinational governmental entities within the Territory.
1.13 Net Sales means the gross amount invoiced for commercial sales of Products, as applicable, in an arms length transaction by Synageva, its Affiliates or Sublicensees to Third Parties (Gross Sales), less the following deductions from such Gross Sales, which are actually incurred, allowed, accrued or specifically allocated:
(a) Normal and customary trade, cash and quantity discounts actually given, coupons actually taken, credits, price adjustments or allowances for damaged products, returns or rejections of products;
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
3
(b) Adjustments, allowances, credits, fees, reimbursements, chargeback payments and rebates (or the equivalent thereof) for the Products granted to group purchasing organizations, pharmacy benefit management companies, health maintenance organizations and any other providers of health insurance coverage, health care organizations (including hospitals), Third Party health care administrators or patient assistance or other similar programs, or to federal, state/provincial, local and other Governments, including their agencies, or to wholesalers, distributors or other trade customers;
(c) Reasonable and customary freight, shipping insurance and other transportation expenses directly related to the commercial sale of the Products (if actually borne by Synageva, its Affiliates or Sublicensees without reimbursement from any Third Party); and
(d) Sales, value-added taxes, excise taxes, tariffs and duties, and other taxes and Government charges directly related to the commercial sale, to the extent that such items are included in the gross sales of Products and actually borne by Synageva, its Affiliates or Sublicensees without reimbursement from any Third Party (but not including taxes assessed against the income derived from such commercial sale);
(e) Actual bad debt expense, provided that any actual bad debt expense deducted from Gross Sales that is later collected by Synageva will be included in Net Sales; and
(f) Any item substantially similar in character or substance to any of the foregoing permitted by GAAP prevailing at the time and customary in the pharmaceutical industry at the time.
The transfer of Products by Synageva, one of its Affiliates or Sublicensees to another Affiliate or Sublicensee shall not be considered a commercial sale. In the case of any sale for value, such as barter or counter-trade, of a Product, or part thereof, other than in an arms length transaction exclusively for cash, Net Sales shall be deemed to be the Net Sales at which substantially similar quantities of such Product are sold for cash in an arms length transaction in the relevant country.
For the avoidance of doubt, disposal or use of Products in clinical trials, as free samples, or under compassionate use, patient assistance, named patient use, or test marketing programs or non-registrational studies or other similar programs or studies where the Product is supplied without charge or at the actual manufacturing cost therefor (without allocation of indirect costs or any mark-up), shall not be considered a commercial sale or result in any Net Sales under this Section 1.13 (Net Sales). Nor shall any Products donated by a Synageva, its Affiliates or Sublicensees to non-profit institutions or Government agencies for non-commercial purpose result in any Net Sales. Similarly, any free Products which are supplied to a Third Party in
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
4
conjunction with the offer for sale, or sale of any Product (in an amount customary in the industry), will not result in any Net Sales of such free goods. The use of a Product by a Party, its Affiliates or Sublicensees for research and development purposes shall not result in any Net Sales. For clarity, there shall be no limit on the quantity of Products which may be used in clinical trials but the quantity of Products to be given away as free samples shall be such quantities common in the industry for this sort of product. Such amounts shall be determined from the books and records of Synageva maintained in accordance with GAAP.
In the event any Product is sold as part of a combination product (being a product containing both a Product and one or more active ingredients or a product in which both Product and one or more active ingredients are packaged), the Net Sales from the combination product, for the purposes of determining royalty payments, shall be determined by multiplying the Net Sales of the combination product (as defined in the standard Net Sales definition), during the applicable royalty period, by the fraction, A/(A+B), where A is the average per unit sale price of Product when sold separately as a stand-alone Product in finished form in the country in which the combination product is sold and B is the average per unit sale of the other active ingredients contained in the combination product when sold separately as stand-alone products in finished form in the country in which the combination product is sold, in each case during the applicable royalty reporting period or, if sales of stand-alone Product did not occur in such period, then in the most recent royalty reporting period in which arms length fair market sales of such Products, as applicable, occurred. In the event that such average sale price cannot be determined for the stand alone Products or the other products, Net Sales for the purposes of determining royalty payments shall be mutually agreed upon by the Parties based on the relative value contributed by each component.
1.14 Patents means the Family 1 Patents, Family 3 Patents and Family 4 Patents.
1.15 Patent Challenge means, with respect to a Party, such Party or any of its Affiliates either (a) participating as a named party in any action or proceeding (including any patent opposition or re-examination proceeding or inter partes review, post-grant review or derivation proceeding or third party observation), or otherwise asserting any claim, challenging or denying the validity or enforceability of any patent or patent application or any claim thereof, or (b) providing financial resources or information to any other person or entity with knowledge that such person or entity will use, or is reasonably likely to use, such financial resources or information to bring or prosecute (and such person or entity does in fact use such financial resources or information to bring or prosecute) any action or proceeding (including any patent opposition or re-examination proceeding or inter partes review, post-grant review or derivation proceeding) to challenge or deny the validity or enforceability of any of such patent or patent application or any claim thereof. For the avoidance of doubt, it is understood and agreed that the submission of prior art during the prosecution or maintenance of a patent or patent application or other activity reasonably intended to satisfy the duty of candor and good faith shall not be considered a Patent Challenge. Furthermore, statements regarding one or more of the Patents made by a Party in the course of prosecuting such Partys patent application (e.g. for the purpose of distinguishing an invention in such a patent application from one of the Patents) shall not be considered a Patent Challenge.
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
5
1.16 Product means lysosomal acid lipase.
1.17 Regulatory Approval means any approvals (including supplements, amendments, pre- and post-approvals and price approvals), licenses, registrations or authorizations (including any designations of an indication for a Product as an Orphan Product under the Orphan Drug Act or other equivalent legislation), howsoever called, of any Regulatory Authority, which are necessary for the distribution, importation, exportation, manufacture, production, use, storage, transport or clinical testing and/or sale of a Product in a regulatory jurisdiction. Regulatory Approval shall not include any site license for a manufacturing facility.
1.18 Regulatory Authority means the United States Federal Drug Administration (FDA) or any counterpart of the FDA outside the United States, or other national, supra-national, regional, state or local regulatory agency, department, bureau, commission, council, ethics committee, review board or other entity with authority over the distribution, importation, exportation, manufacture, production, use, storage, transport or clinical testing and/or sale of a Product hereunder.
1.19 Royalty-Bearing Patent means a Family 1 Patent issued in the United States or Europe (as such term is defined herein).
1.20 Royalty-Bearing Product means a Product, the use of which in the United States or Europe (as such term is defined herein) would, but for the sublicense granted herein, infringe one or more Valid Claim in one or more of the Royalty-Bearing Patents.
1.21 Royalty Term means, on a country-by-country basis in the United States and Europe (as such term is defined herein), the period commencing upon the First Commercial Sale of a Royalty-Bearing Product in such country and ending on the date on which all Royalty-Bearing Patents containing a Valid Claim covering the use of Products in such country have expired or otherwise ceased to have any Valid Claim.
1.22 Second Family 1 Patent means a second Family 1 Patent that issues in the United States and has a Valid Claim that (i) is identical to claim 65 of U.S. patent application Serial No. 11/653,147 as such application exists as of the Effective Date, which claim is attached to this Agreement as Exhibit D; or (ii) would, but for the sublicense granted to Synageva under Section 2.1 (Sublicense Grant), be infringed by each use of the Product to treat cholesterol ester storage disease (CESD) (also known as late onset lysosomal acid lipase deficiency) recited in the Indications and Usage section of the Products FDA-approved label.
1.23 Shire HGT means Shire Human Genetic Therapies, Inc.
1.24 Sublicensee means any entity other than an Affiliate to whom Synageva sublicenses the rights set forth in Section 2.1 (Sublicense Grant) in accordance with Section 2.4 (Sublicenses).
1.25 Synageva Product Patents means the United States and foreign patents and patent applications that are listed on Exhibit C hereto and any patents maturing from any of the foregoing that are patent applications, and any divisionals, continuations, continuations-in-part
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
6
(solely to the extent that the claims in such continuations-in-part are directed to subject matter disclosed in the patents and patent applications listed in Exhibit C) or other applications sharing common priority with any of the foregoing anywhere in the world (and all resulting patents therefrom), any re-examinations, reissues, renewals, restorations, and extensions (including patent term adjustments, patent term extensions, supplemental protection certificates or the equivalent thereof) of any of such patents or patent applications, and any foreign counterparts of any of the foregoing (whether or not listed on Exhibit C).
1.26 Term has the meaning given to it in Section 11.1 of this Agreement.
1.27 Territory means worldwide.
1.28 Third Party means any person or entity other than Shire and its Affiliates and Synageva and its Affiliates and Sublicensees.
1.29 United States or U.S. means the United States of America and its territories and possessions.
1.30 Valid Claim means a claim in an issued, unexpired Patent that (a) has not been finally cancelled, withdrawn, abandoned or rejected by an administrative agency or other body of competent jurisdiction (b) has not been revoked, held invalid, or declared unpatentable or unenforceable by a court or other body of competent jurisdiction that is unappealable or unappealed within the time allowed for appeal, (c) has not been rendered unenforceable through disclaimer or otherwise, or (d) is not lost through an interference proceeding. Notwithstanding the foregoing, and without limiting the rights of Shire set forth in Section 6.3 (Patent Challenges), if Synageva or one of its Affiliates engages in any Patent Challenge of any issued claim of a Royalty-Bearing Patent in breach of Section 6.3 (Patent Challenges) and Synageva determines to cure such breach as provided in Section 11.3.1 (Breach of Settlement Agreement or Upon Certain Patent Challenges) or Section 11.3.2(b) (Upon Certain Patent Challenges), then such claim shall nevertheless be considered a Valid Claim hereunder until such Royalty-Bearing Patent would have expired.
ARTICLE 2 - SUBLICENSE
2.1 Sublicense Grant. Subject to the reservation of rights in Section 2.2, Shire hereby grants Synageva and its Affiliates an exclusive (even as to Shire) sublicense under Shires license interest in and to the Patents to make, have made, use, offer to sell, sell and import and otherwise distribute Products (or any other product the making, having made, using, selling, offering to sell, or importation or other distribution of which would infringe the Patents but for such sublicense) in the Field of Use and in the Territory. Synageva and its Affiliates may grant any further sublicenses of the rights sublicensed hereunder only as provided in Section 2.4 (Sublicenses).
2.2 Reservation of Rights. Notwithstanding the foregoing, CHMC, on behalf of itself and its Affiliates and CHMCs and its Affiliates investigators, hereby reserves the right to utilize and practice the Patents for non-commercial, non-clinical research, testing, or educational purposes. All rights not specifically granted herein are reserved to Shire and no other right or license,
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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whether express or implied, is granted in any intellectual property rights owned or controlled by Shire, CHMC or any of their respective Affiliates. For clarity, Shire and its Affiliates shall have no reserved rights under the Patents and shall not practice the Patents during the Term other than in accordance with any statutory or common law infringement exemption, such as the exemption set forth in 35 U.S.C. 271(e)(1) or its equivalent outside of the United States.
2.3 Government Funding. The sublicense rights in this Agreement may be subject to certain rights of the United States federal and/or state or local Government(s) to the extent that the Patents were created or invented in the course of Government-funded research. Shire has no and CHMC has agreed that it has no knowledge of any such rights as of the Effective Date. In the event Shire becomes aware of such rights, Shire shall notify Synageva immediately. In the event of such notification, Synageva agrees to comply and cause its Affiliates to comply with all such requirements, including, without limitation, any of those set forth in 35 U.S.C. Section 200 et seq. and regulations pertaining thereto (or any successor statutes or regulations). If any term of this Agreement fails to conform with the foregoing statutes and regulations, the relevant term shall be unenforceable and subject to the severability provisions in Section 14.6 (Severability).
2.4 Sublicenses. Synageva may grant to one or more Third Parties further sublicenses under the rights granted to Synageva in Section 2.1 (Sublicense Grant) in connection with the license of other intellectual property rights owned or controlled by Synageva to such Sublicensee or in settlement of an infringement action in accordance with Section 8.4 (Synageva Infringement Suit), provided, however, that, in each case, Synageva shall remain responsible for the performance of any such Sublicensees under such rights to the same extent as if such activities were conducted by Synageva. It is understood and agreed that, except as may be otherwise agreed in writing between the Parties, Sublicensees shall have no rights under this Agreement except as specified herein, including without limitation Section 11.5 (Effect on Termination).
2.5 CHMC Agreement.
2.5.1 Generally. Shire will promptly notify Synageva of: (i) any event of which it becomes aware that adversely affects any right granted to Shire under the CHMC Agreement, which right is, in turn, sublicensed to Synageva pursuant to this Agreement, or (ii) receipt by Shire of any notice of breach or termination of the CHMC Agreement. Shire will not breach the CHMC Agreement (unless such breach results from an act of, or omission by, Synageva) and will take, or permit Synageva to take, all reasonable actions necessary to maintain and enforce Shires rights under the CHMC Agreement.
2.5.2 No Amendment. Without Synagevas prior written consent, Shire will not consent or agree to amend, modify or terminate the CHMC Agreement or take any action or exercise any right under the CHMC Agreement in a manner that (a) prevents it from continuing to grant the sublicense granted to Synageva under this Agreement, (b) adversely affects Synagevas rights or obligations under this Agreement with respect to such sublicensed intellectual property, or (c) is in contravention of its obligations under this Agreement.
2.5.3 Financial Obligations. Shire will be solely responsible for all royalty amounts or other consideration owed to CHMC or any Third Party pursuant to the CHMC Agreement.
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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ARTICLE 3 - DUE DILIGENCE
3.1 Diligence. Synageva shall use, or shall have its Affiliates use, Commercially Reasonable Efforts to develop and commercialize Products. Synageva shall provide, or shall have its Affiliates provide, directly to CHMC at the address set forth in Article 13, annual updates within thirty (30) days of December 31 for each year of the Term until the First Commercial Sale of a Product, each of which shall summarize the development, manufacturing and Regulatory Approval progress made in the previous year. Synageva shall, if requested by Shire, confirm to Shire in writing that such annual update has been provided to CHMC.
3.2 Notice. Synageva shall, or shall have its Sublicensees notify CHMC in writing promptly after receiving official notice of any Regulatory Approval for a Product.
ARTICLE 4 - PATENT PROSECUTION AND COSTS
4.1 Patent Prosecution and Maintenance of Family 3 Patents. Synageva will have the first right, using in-house or outside legal counsel selected by Synageva and approved by CHMC, such approval shall not be unreasonably withheld, to prepare, file, prosecute and maintain, at Synagevas own expense, the Family 3 Patents jointly in CHMCs and Synagevas name in the United States and in any other countries in the Territory. Synageva will deliver to CHMC complete drafts of all material submissions to patent authorities relating to the Family 3 Patents, including, without limitation, patent applications and amendments, and give CHMC a reasonable opportunity to comment on such documents prior to their filing. CHMC has agreed to provide any such comments promptly. Synageva will consider CHMCs comments and requests with regard to the preparation, filing, prosecution and/or maintenance of the Family 3 Patents in good faith. If CHMC and Synageva disagree on any matter relating to the Family 3 Patents, Synageva will have the final decision with respect to such matter. Synageva will provide CHMC copies of material documents provided to and received from such patent authorities relating to the Family 3 Patents.
4.2 CHMCs Election to Prosecute Family 3 Patents. Synageva will provide CHMC with sixty (60) days written notice of a decision by Synageva that it desires not to remain responsible for the prosecution or maintenance of any Family 3 Patents. CHMC may, upon such written notice, elect to assume, at CHMCs expense, the responsibilities and obligations to prosecute, and maintain such Family 3 Patents jointly in CHMCs and Synagevas name, in their respective countries. In such event, CHMC has agreed to use reasonable efforts to deliver to Synageva reasonably complete drafts of all material submissions to patent authorities relating to such Family 3 Patents, including, without limitation, patent applications and amendments, and, to the extent feasible, to give Synageva a reasonable opportunity to comment on such documents prior to their filing. Synageva will provide any such comments promptly. CHMC has agreed to consider Synagevas comments and requests with regard to the preparation, filing, prosecution and/or maintenance of such abandoned Family 3 Patents in good faith. However, the final decision with respect to such matter shall remain with CHMC. CHMC has agreed to provide Synageva copies of material documents provided to and received from such patent authorities relating to such Family 3 Patents.
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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4.3 Patent Prosecution and Maintenance of Family 2 Patents. Synageva will have the sole and exclusive right, but not the obligation, to prosecute and maintain (or abandon) the Family 2 Patents, which have been assigned by Shire to Synageva as of the Effective Date.
4.4 Patent Prosecution and Maintenance of Family 1 and Family 4 Patents. CHMC has retained the first right, using in-house or outside legal counsel selected by Synageva and approved by CHMC, to prepare, file, prosecute and maintain patents and patent applications in the Family 1 Patents and Family 4 Patents in its own name in the United States and in any other countries in the Territory. Notwithstanding the foregoing, CHMC has agreed to provide Synageva the sole and exclusive right to decide whether to file for an extension of the term of any Family 1 Patent or Family 4 Patent, and CHMC has agreed not to file for any such extension without Synagevas prior written consent. Synageva agrees to reimburse CHMC for its reasonably incurred legal and administrative costs associated with the filing, prosecution of the Family 1 Patents and Family 4 Patents (including, without limitation, reasonable outside attorneys fees, filing fees and maintenance fees) incurred under this Section within thirty (30) days after each receipt of CHMCs written statement of such expenses. CHMC has agreed to provide Synageva copies of material documents provided to and received from such patent authorities relating to the Family 1 Patents and Family 4 Patents. CHMC has agreed to provide Synageva with sixty (60) days written notice of a decision by CHMC that it desires not to remain responsible for the prosecution or maintenance of any Family 1 Patents or Family 4 Patents. Synageva may, upon such written notice, elect to assume, at Synagevas expense, the responsibilities and obligations to prosecute, and maintain in CHMCs name the abandoned Family 1 Patents or Family 4 Patents in their respective countries. Synageva will use reasonable efforts to deliver to CHMC reasonably complete drafts of all material submissions to patent authorities relating to the Family 1 Patents and Family 4 Patents for which it has assumed responsibility, including, without limitation, patent applications and amendments, and, to the extent feasible, to give CHMC a reasonable opportunity to comment on such documents prior to their filing. CHMC will provide any such comments promptly. Synageva will consider CHMCs comments and requests with regard to the preparation, filing, prosecution and/or maintenance of such abandoned Family 1 Patents and Family 4 Patents in good faith. However, the final decision with respect to such matter shall remain with Synageva. Synageva will also provide CHMC copies of material documents provided to or received from such patent authorities relating to the abandoned Family 1 Patents or Family 4 Patents.
4.5 Continuations-in-Part. Synageva will not, and CHMC has agreed not to, file a continuation-in-part of any Patent without the prior written consent of the other party.
ARTICLE 5 - PUBLICATION RIGHTS
CHMC reserves the right for itself and its Affiliates and investigators to present, publish or otherwise disseminate the results of its and their research on the inventions claimed in the Patents to the extent that such results do not contain Confidential Information of Synageva or any of its Affiliates. CHMC has agreed to submit copies of any abstract or manuscript proposed for written or oral presentation or publication regarding the inventions claimed in the Patents to Synageva at least sixty (60) days in advance of the submission or presentation or thirty (30) days in the case of an abstract. If Synageva does not, within sixty (60) days after receipt of the
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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manuscript or thirty (30) days in the case of an abstract, object in writing, CHMC may proceed with the presentation or publication. However, if Synageva notifies CHMC in writing within such period that it has a reasonable belief that such presentation or publication would reveal Confidential Information of Synageva or any of its Affiliates or a patentable invention for which patent applications are being filed under Article 4, and provides a written request to CHMC specifically identifying the information giving rise to the belief, then CHMC has agreed to consider Synagevas request in good faith and shall either remove such Confidential Information or not publish or present the information so identified by Synageva until such time as a patent application has been filed or the expiration of sixty (60) days after the date of submission of the manuscript or abstract to Synageva, whichever occurs first. Synageva shall keep all submissions made by CHMC hereunder confidential in accordance with Article 11 until such time as CHMC or its Affiliates or investigators make the applicable publication or presentation.
ARTICLE 6 - OWNERSHIP
6.1 Ownership.
6.1.1 CHMC is and shall remain (i) the sole owner of the Family 1 Patents and the Family 4 Patents and (ii) the joint owner of the Family 3 Patents. Synageva agrees to execute, and shall cause its Affiliates to execute, any additional documents and do all things reasonably necessary during the Term of this Agreement to vest and confirm all such rights in CHMC to the foregoing Patents and to facilitate the obtaining by CHMC of any desired legal protection in the same in any countries. Any documents or actions described in the preceding sentence shall be prepared, filed or taken at CHMCs expense, but Synageva or its Affiliate, as applicable, shall sign such documents and otherwise reasonably cooperate at no cost to CHMC.
6.1.2 Shire has assigned to Synageva sole ownership of Family 2 Patents and a joint ownership interest in the Family 3 Patents pursuant to a patent assignment executed as of the Effective Date pursuant to the Settlement Agreement. Synageva shall remain (i) the sole owner of the Family 2 Patents and (ii) the joint owner (with CHMC) of the Family 3 Patents. No rights under the Family 2 Patents or Family 3 Patents are granted to Shire under this Agreement.
6.2 Patent Marking. To the extent commercially feasible, Synageva will mark, and shall cause its Affiliates to mark, all Products with the number of each issued Patent(s) that cover(s) the Products. Any such marking will be in conformance with the patent laws and other laws of the country of manufacture, use or sale, as applicable.
6.3 Patent Challenges.
6.3.1 To the fullest extent permitted by law in the countries within the Territory, Synageva and its Affiliates shall not engage in a Patent Challenge of the Patents. In the event that Synageva or its Affiliates does engage in any such Patent Challenge, then Shire shall have the right to terminate this Agreement pursuant to Section 11.3.1 or 11.3.2, as applicable. The foregoing two sentences shall not apply (i) with respect to any Patent that Shire, CHMC or their respective Affiliates first asserts against Synageva, any of its Affiliates, Sublicensees, or users of the Product after the Effective Date, where the Patent Challenge is made in defense of such assertion, (ii) with respect to any Patent Challenge commenced by a Third Party that after the
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Effective Date acquires or is acquired by Synageva or its Affiliates or its or their business or assets, whether by stock purchase, merger, asset purchase or otherwise, but only with respect to Patent Challenges commenced by such Third Party prior to the execution of the purchase agreement or merger agreement pursuant to which such transaction is effected.
6.3.2 To the fullest extent permitted by law in the countries within the Territory, (i) Shire and its Affiliates shall not engage in any Patent Challenge of the Family 1 Patents, Family 2 Patents, Family 3 Patents or Family 4 Patents or any claim of a Synageva Product Patent directed to the manufacture, use or sale of a Product, and (ii) CHMC and its Affiliates shall not engage in any Patent Challenge of the Family 2 Patents. In the event that Shire or its Affiliates or CHMC or its Affiliates does engage in any such Patent Challenge, then the license granted in Section 2.1 (Sublicense Grant) shall become royalty-free and fully-paid and Synageva shall cease to owe any amounts to Shire pursuant to Article 7 (Payments). The foregoing two sentences shall not apply (i) with respect to any patent that Synageva or its Affiliates first assert against Shire or any of its Affiliates or against CHMC or any of its Affiliates after the Effective Date, where the Patent Challenge is made in defense of such assertion, (ii) with respect to any Patent Challenge commenced by a Third Party that after the Effective Date acquires or is acquired by Shire or its Affiliates or its or their business or assets, whether by stock purchase, merger, asset purchase or otherwise, but only with respect to Patent Challenges commenced by such Third Party prior to the execution of the purchase agreement or merger agreement pursuant to which such transaction is effected.
ARTICLE 7 - PAYMENTS
In consideration of the rights set forth herein, Synageva shall make the following payments to Shire:
7.1 Up-Front Fee. Synageva shall make the payment set forth in Section 7.1 (Fixed Payment) of the Settlement Agreement.
7.2 Milestone Payments. Synageva shall pay Shire the following non-refundable, non-creditable milestone payments within forty-five (45) days of the last day of the calendar quarter in which the achievement of each of the following events occurs: (i) [*] when cumulative Net Sales of all Products in the Territory reach [*]; and (ii) [*] when cumulative Net Sales of all Products in the Territory reach [*]. Synageva shall notify Shire within thirty (30) days of the achievement of each of the foregoing milestones. Each milestone payment by Synageva to Shire hereunder shall be payable only once, regardless of the level of Net Sales achieved by the Products.
7.3 Royalties.
7.3.1 Europe. During the Royalty Term, Synageva shall pay Shire tiered royalties on aggregate annual Net Sales of Royalty-Bearing Products used in Europe in a given calendar year at the following rates:
Aggregate Calendar Year Net Sales of Royalty-Bearing Products in Europe |
Royalty Rate | |||
The portion less than or equal to $[*] |
[*] | % | ||
The portion greater than $[*] and less than or equal to $[*] |
[*] | % | ||
The portion greater than $[*] |
[*] | % |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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By way of example only, if Synageva receives [*] in annual Net Sales of Royalty-Bearing Products in a calendar year in Europe, then the royalties payable by Synageva under Section 7.3.1 (Europe) during such calendar year would be calculated as follows:
[*]
7.3.2 United States. During the Royalty Term, Synageva shall pay Shire a [*] royalty on aggregate annual Net Sales of Royalty-Bearing Products used in the United States in a given calendar year until such time as a Second Family 1 Patent issues in the United States. Following the issuance of a Second Family 1 Patent and for the remainder of the Royalty Term in the United States, for so long as such Second Family 1 Patent remains in existence, Synageva shall pay Shire tiered royalties on annual Net Sales of Royalty-Bearing Products used in the United States in a given calendar year at the following rates:
Aggregate Calendar Year Net Sales of Royalty-Bearing Products in the United States After A |
Royalty Rate | |||
The portion less than or equal to $[*] |
[*] | % | ||
The portion greater than $[*] and less than or equal to $[*] |
[*] | % | ||
The portion greater than $[*] |
[*] | % |
If such a Second Family 1 Patent issues during a calendar year, Synageva shall pay Shire [*] royalty on aggregate Net Sales of Royalty-Bearing Products used in the United States in that calendar year up to the issuance of the Second Family 1 Patent. Following the issuance of the Second Family 1 Patent and for the remainder of that calendar year, Synageva shall pay Shire tiered royalties on those aggregate Net Sales of Royalty-Bearing Products used in the United States on or after the date of issuance of the Second Family 1 Patent at the tiered royalty rates set forth in this Section 7.3.2 (United States), and the tiered royalty rate will be calculated based on aggregate Net Sales of the Royalty-Bearing Products in the United States occurring after the date of issuance of the Second Family 1 Patent.
By way of example only, in a calendar year in which a Second Family 1 Patent has not issued, if Synageva receives [*] in aggregate annual Net Sales of Royalty-Bearing Products in such calendar year in the United States, then the royalties payable by Synageva under Section 7.3.2 (United States) during such calendar year would be calculated as follows:
[*]
By way of example only, if such a Second Family 1 Patent issues in the United States on July 1st of a given year, and Synageva receives [*] in aggregate Net Sales of the Royalty-Bearing Products from January 1st to June 30th of that year and an additional [*] in Net Sales of the Royalty-Bearing Products from July 1st to December 31st of that year, then the royalties payable by Synageva under the Section 7.3.2 (United States) during such calendar year would be calculated as follows:
[*]
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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7.3.3 Payment. Payments of royalties hereunder shall be made within sixty (60) days after the end of each calendar quarter and shall be accompanied by a report of Net Sales in sufficient detail to permit confirmation of the accuracy of the royalty payment made and progress towards achievement of the milestones set forth in Section 7.2 (Milestone Payments). Such report shall include, without limitation: (i) Gross Sales and Net Sales and the aggregate deductions taken from Gross Sales to arrive at the Net Sales calculation, both in the currency in which the relevant sale of the Product was invoiced and as translated into U.S. dollars, together with details of the conversion rates used for such currency translation, (ii) the royalties payable in U.S. dollars, and (iii) the method used to calculate the royalty.
7.4 Taxes and Other Fees. In addition to any other amounts due hereunder, Synageva shall pay all federal, state, municipal, foreign, and other Governmental excise, sales, use, property, customs, import, value added and other taxes, fees and levies of any nature that are assessed upon or with respect to the development, manufacture, use, offer, sale, license, distribution, export or import of Products or otherwise arising in connection with this Agreement, other than taxes based on Shires income. Synageva shall be entitled to deduct from amounts otherwise due and payable hereunder any withholding taxes with respect to amounts payable hereunder that are required to be withheld by Synageva. If Synageva is obliged to withhold taxes, Synageva shall secure and promptly send to Shire proof of such taxes, duties or other levies withheld and paid by Synageva for the benefit of Shire. Each Party agrees to cooperate with the other Party in claiming exemptions from such deductions or withholdings under any agreement or treaty from time to time in effect.
7.5 Payments; Currency. All payments under this Agreement shall be made by wire transfer as per the following instructions:
Bank: [*]
Bank Address: [*]
Account Name: [*]
Account No.: [*]
Swift Code: [*]
IBAN: [*]
Correspondent Bank: [*]
Correspondent Bank Swift Code: [*] (with separate cover message [*])
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Each wire transfer shall identify the obligation under this Agreement that the payment satisfies. All payments shall be made in U.S. dollars without set-off for currency conversion. With respect to Net Sales invoiced or expenses incurred in a currency other than U.S. dollars, the Net Sales invoiced or expenses incurred shall be converted into the U.S. Dollar equivalent using the average of the daily last price rate of exchange for such currencies for the relevant month published by the Wall Street Journal.
7.6 Unpaid Amounts; Interest. Any undisputed sums which have not been timely paid by Synageva shall accrue interest compounded daily from the original due date of each sum until the date of actual receipt of payment at two per cent (1%) above the Federal Funds Target Rate.
7.7 Records; Audit. Synageva shall maintain, and shall require its Affiliates to maintain, complete and accurate books and records containing all information necessary to ascertain and verify the accurate calculation consistent with GAAP of amounts payable to Shire hereunder. Synageva shall maintain such books and records for a period of at least five years after the end of the calendar year in which they were generated. Once per calendar year during the Term of this Agreement, Shire shall have the right to engage an independent accounting firm acceptable to Synageva to examine in confidence the relevant books and account as may be necessary to determine or verify the amounts of payments due and other obligations hereunder. Synageva shall make such books and records available, during normal business hours at the facility(ies) where such books and records are maintained. Each such examination shall be limited to pertinent books and records for any year ending not more than thirty-six (36) months prior to the date of request; provided that Shire shall not be permitted to audit the same period of time more than once. The independent accounting firm will prepare and provide to each Party a written report stating whether the reports submitted and amounts paid are correct or incorrect and the amounts of any discrepancies. Should the audit lead to the discovery of a discrepancy to Shires detriment, Synageva shall pay the amount of the discrepancy, plus interest, within thirty (30) days of Shires written notice with the findings of the inspection. Should the audit lead to the discovery of a discrepancy to Synagevas detriment, Shire shall pay the amount of the discrepancy, plus interest, within thirty (30) days of Synagevas written notice with the findings of the inspection. Shire shall pay the full cost of the inspection unless the discrepancy is equal to or greater than five percent (5%) to Shires detriment, in which case Synageva shall pay the reasonable cost charged by the independent accounting firm for such inspection at the time of payment of the discrepancy.
7.8 No Other Financial Obligations. Synageva has no financial obligations with respect to the Patents, the Product or the rights granted to Synageva under this Agreement and the Settlement Agreement other than as expressly set forth in this Agreement.
ARTICLE 8 - INFRINGEMENT
8.1 Notification. Synageva shall promptly report in writing to CHMC during the Term any infringement or suspected infringement within the Field of Use in the Territory of any Patent sublicensed hereunder of which it becomes aware and shall provide CHMC with all available evidence supporting such infringement or suspected infringement. CHMC has agreed to promptly report in writing to Synageva during the Term any infringement or suspected
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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infringement within the Field of Use in the Territory of any Patent sublicensed hereunder which it becomes aware and shall provide Synageva with all available evidence supporting such infringement or suspected infringement.
8.2 Joint Suit. If CHMC and Synageva agree in writing to jointly institute a suit or action against any party or entity who has infringed or is suspected of infringing any of the Patents sublicensed hereunder within the Field of Use in the Territory, then the suit will be brought in the name of both entities. CHMC and Synageva will agree in writing on who shall control the action and how costs and recoveries will be shared. If Synageva and CHMC agree that Synageva will control the action, then Synageva may, if it so desires, be represented by counsel of its own selection and at its own expense.
8.3 Allocations of Responsibility.
8.3.1 Absent written agreement as set forth above, CHMC has retained the first right, but not the obligation, at its own expense to initiate an infringement suit or other appropriate action against any third party who at any time has infringed or is suspected of infringing any of the Family 1 Patents or Family 4 Patents, and Synageva has the first right, but not the obligation, at its own expense to initiate an infringement suit or other appropriate action against any third party who at any time has infringed or is suspected of infringing any of the Family 3 Patents. CHMC has agreed to provide Synageva with an opportunity to make suggestions and comments regarding initiation of an action regarding the Family 1 Patents and Family 4 Patents, and Synageva will provide CHMC with an opportunity to make suggestions regarding initiation of an action regarding the Family 3 Patents.
8.3.2 Any infringement suit or action brought by Synageva pursuant to this Section 8.3 shall be governed by Section 8.4 and prosecuted at Synagevas own expense. Any infringement suit or action brought by CHMC shall be governed by Section 8.5 and prosecuted at CHMCs own expense; provided, however, if CHMC institutes such a suit or action, Synageva shall have the right, but not the obligation, to join and assume control of such suit or action, at its own expense upon written notice to CHMC, in which case Synageva will control such action or suit in accordance with Section 8.4.
8.3.3 In the event that CHMC does not, within three (3) months after becoming aware of the infringement of any of the Family 1 Patents or Family 4 Patents, secure cessation of the infringement or enter suit against the infringer, then Synageva shall have the right, but not the obligation, at its own expense to initiate an infringement suit against such infringer in accordance with Section 8.4. In the event that Synageva does not, within three (3) months after becoming aware of the infringement of any of the Family 3 Patents, secure cessation of the infringement, enter suit against the infringer or provide CHMC with evidence of the pendency of a bona fide negotiation for the acceptance by the infringer of a sublicense under the applicable Patents, then CHMC shall have the right, but not the obligation, at its own expense to initiate an infringement suit against such infringer in accordance with Section 8.5.
8.4 Synageva Infringement Suit. For any suit or action brought or controlled by Synageva pursuant to Section 8.3, Synageva will provide CHMC with an opportunity to make suggestions
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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and comments regarding such action; provided, however, that all final decisions shall be made by Synageva in its discretion. CHMC has agreed to join such a suit as a party at Synagevas request, provided that Synageva bears all of CHMCs litigation-related expenses and out-of-pocket expenses, including, without limitation, reasonable attorney fees. In any event, CHMC has agreed to offer reasonable assistance to Synageva in connection with such action at no charge to Synageva. After the Parties have been compensated for their costs in handling an action hereunder, any remaining damages, profits or awards of whatever nature whatsoever recovered from such action shall be treated as Net Sales under this Agreement. Synageva shall have no right or authority to settle or otherwise voluntarily dispose of any such action without CHMCs prior written consent, not to be unreasonably withheld, provided that Synageva may grant a sublicense as part of a settlement of such action without CHMCs prior written consent so long as any royalties and milestones are paid on Net Sales by the Sublicensee in accordance with this Agreement and the sublicense otherwise conforms to the requirements of Section 2.4 (Sublicenses).
8.5 CHMC Infringement Suit. For any suit or action brought or controlled by CHMC pursuant to Section 8.3, CHMC has agreed to provide Synageva with an opportunity to make suggestions and comments regarding such action; provided, however, that all final decisions shall be made by CHMC in its discretion. Synageva shall join such a suit as a party at CHMCs request, provided that CHMC bears all of Synagevas litigation-related expenses and out-of-pocket expenses, including, without limitation, reasonable attorney fees. In any event, Synageva shall offer reasonable assistance to CHMC in connection with such action at no charge to CHMC. After the Parties have been compensated for their costs in handling such an action any remaining damages, profits or awards of whatever nature whatsoever recovered from such an action shall be shared equally by CHMC and Synageva, and Synagevas share of such recovery shall be treated as Net Sales under this Agreement.
8.6 Abandonment of Suit. In the event that either CHMC or Synageva institutes a suit under this Article and then decides to abandon the suit, it will first provide timely written notice to the other Party of its intention to abandon the suit, and the other Party, if it wishes, may continue prosecution of such suit; provided, however, that the sharing of expenses and of any recovery in such suit will be agreed upon separately in good faith by the Parties taking into account their respective efforts in the prosecution.
8.7 Declaratory Judgment Actions. In the event that a declaratory judgment action is brought against Synageva, Shire or CHMC by a person or entity alleging invalidity or unenforceability, or non-infringement of the Patents, CHMC will have the first right, but not the obligation, to defend and take sole control of the action. In any event, however, CHMC has agreed to permit Synageva, in Synagevas sole discretion, to participate in such an action or to take control of the defense of the action, in each case, at Synagevas own expense. If controlling the defense, Synageva shall provide to CHMC, and CHMC has agreed to provide to Synageva, each document or a draft thereof pertaining to the declaratory judgment action, including, but not limited to, each communication with opposing counsel, pleadings, discovery requirements, or other court filings, as follows: (a) documents received from the court or opposing counsel shall be provided promptly after receipt; and (b) for a document to be served on opposing counsel or filed in court, a draft of such document shall be provided to the non-controlling Party sufficiently
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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in advance of its filing to allow for review and comment by the non-controlling Party. The controlling Party agrees to consider the non-controlling Partys comments in good faith but shall have the right to make all decisions in its sole discretion. Section 8.4 (Synageva Infringement Suit) and 8.5 (CHMC Infringement Suit) will govern counterclaims for infringement of the Patents brought in any such action and the allocation of any recoveries therefrom.
ARTICLE 9 - REPRESENTATIONS AND WARRANTIES; DISCLAIMER
9.1 Mutual Representations. Each Party represents and warrants to the other Party as follows as of the Effective Date:
9.1.1 Organization. Such Party is duly organized, validly existing and in good standing under the laws of the jurisdiction in which it is organized.
9.1.2 Authorization and Enforcement of Obligations. Such Party: (i) has the requisite power and authority and the legal right to enter into this Agreement and to perform its obligations and grant the rights granted by it hereunder and (ii) has taken all requisite action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. This Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against such Party in accordance with its terms.
9.1.3 Consents. All necessary consents, approvals and authorizations of all Governmental authorities and other persons or entities required to be obtained by such Party in connection with this Agreement have been obtained.
9.1.4 No Conflict. The execution and delivery of this Agreement and the performance of such Partys obligations hereunder: (i) do not conflict with or violate any requirement of applicable laws, regulations or orders of Governmental bodies, (ii) do not conflict with, or constitute a default under, any contractual obligation of such Party, and (iii) do not conflict with or result in a breach of any provision of the organizational documents of such Party.
9.2 Shire Representations. Shire represents and warrants to Synageva as follows as of the Effective Date:
9.2.1 Intellectual Property. Shire represents and warrants that: (a) Shire HGT exclusively owns all rights, title and interests in and to the Family 2 Patents; (b) Shire HGT owns a joint and undivided interest with CHMC in the Family 3 Patents, and to its knowledge no other person or entity has any right, title or interest in the Family 3 Patents; (c) to its knowledge, Shire AG is the sole and exclusive licensee under the Patents, subject to the retained rights of CHMC and the Government described herein; and (e) as of the Effective Date, neither Shire nor its Affiliates are currently developing any lysosomal acid lipase product.
9.2.2 Litigation. Except for the Actions, there are no actions, suits, proceedings or investigations pending against Shire or any of its Affiliates or, to Shires knowledge, threated against Shire or any of its Affiliates or pending or threatened against CHMC or any of CHMCs Affiliates before any court, Government or regulatory body, agency, commission, official or any
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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arbitrator that is reasonably expected to have an adverse effect on Shires ability to grant the rights granted to Synageva herein or otherwise consummate the transactions and perform the obligations contemplated hereby.
9.3 No Inconsistent Rights. Shire and its Affiliates have not, as of the Effective Date, and during the Term they will not, grant or transfer any rights in the Patents that are inconsistent with (or otherwise adversely affect) the rights granted to Synageva in this Agreement.
9.4 Disclaimer. Nothing in this Agreement shall be construed as:
9.4.1 A warranty or representation by Shire or CHMC as to the validity or scope of any Patent or that any pending patent applications under the Patents will issue;
9.4.2 An obligation of Shire or CHMC to bring or prosecute actions or suits against Third Parties for infringement, except as expressly provided otherwise in Article 8 hereof;
9.4.3 Granting by implication, estoppel or otherwise any licenses under patents of Shire other than the Patents; or
9.4.4 An obligation to furnish any technology, technological information or biological materials.
9.5 EXCEPT AS OTHERWISE EXPRESSLY SET FORTH HEREIN (OR IN THE SETTLEMENT AGREEMENT), SHIRE MAKES NO, AND HAS NOT MADE ANY, REPRESENTATIONS OR WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND ASSUMES NO RESPONSIBILITIES OR LIABILITY WHATSOEVER WITH RESPECT TO THE PATENTS OR THE USE, SALE OR OTHER DISPOSITION BY SYNAGEVA OR ITS AFFILIATES, VENDEES OR OTHER AGENTS OR TRANSFEREES OR END USERS OF PRODUCTS INCORPORATING OR MADE BY USE OF ANY PATENTS LICENSED UNDER THIS AGREEMENT. THE PATENTS ARE PROVIDED AS IS, WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESS OR IMPLIED. SYNAGEVA SHALL BE SOLELY RESPONSIBLE FOR ALL REPRESENTATIONS AND WARRANTIES THAT SYNAGEVA MAKES TO THIRD PARTIES WITH RESPECT TO ANY OF THE FOREGOING. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH HEREIN, SYNAGEVA MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AND PARTICULARLY SYNAGEVA DISCLAIMS ALL IMPLIED WARRANTIES OF TITLE, NON-INFRINGEMENT, MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO THE PRODUCT.
ARTICLE 10 - PUBLICITY; MARKS; CONFIDENTIALITY
10.1 Publicity. Synageva may issue a Form 8-K announcing the execution of this Agreement in substantially the form attached in Exhibit I to the Settlement Agreement. Neither Party shall make any further public press release or similar publicity announcement or disclosure regarding the existence of this Agreement or its terms and conditions without the other Partys prior
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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consent, not to be unreasonably withheld, unless such release is (i) required in order to comply with its obligations under the law, including the Securities Act of 1933 and the Securities Exchange Act of 1934, each as amended, and the rules and regulations of the Securities and Exchange Commission (the SEC) promulgated thereunder, or in order to comply with the listing standards or agreements of any national or international securities exchanges or The NASDAQ Stock Market or New York Stock Exchange or other similar laws of a government authority or (ii) consistent with information disclosed in prior public filings, press releases or other public statement properly made hereunder. The disclosing Party shall provide copies of any proposed disclosure reasonably in advance of such release or announcement for the non-disclosing Partys prior review and comment. The non-disclosing Party shall provide its comments, if any, on such announcement as soon as practicable.
10.2 Use of Names, Logos or Symbols. No rights are granted in or to the names, logos, trademarks or service marks of Shire, CHMC or their respective Affiliates (including, without limitation, the names Cincinnati Childrens Hospital Medical Center, CHMC, Cincinnati Childrens Research Foundation, CCRF, Shire, or Shire AG), or the physical likeness or names of any employees or investigators of Shire, CHMC or their respective Affiliates, or other symbols of Shire, CHMC or their respective Affiliates for any purpose without the prior written consent of Shire or CHMC, as applicable, other than as approved under Section 10.1 (Publicity) above.
10.3 Confidential Information. For purposes of this Agreement, Confidential Information means any non-public information or materials of a Party hereto which the other Party is provided or has access to hereunder that relate to the transmitting Partys or its licensors research or business, or the Patents, and which are either identified as confidential at the time of disclosure or should, under the circumstances, reasonably be expected to be confidential such as test data, samples, data, drawings, trade secrets, draft and final correspondence with the United States Patent and Trademark Office and other patent authorities, and the terms of this Agreement, but does not include materials or information that the receiving Party can, prior to its proposed use or disclosure, substantiate through written documentation: (a) is explicitly approved for release by the transmitting Party; (b) was already known by the receiving Party prior to receiving the information or material from the transmitting Party; (c) was lawfully disclosed to the receiving Party by a Third Party having the right to disclose it without an obligation of confidentiality; (d) was in the public domain at the time of disclosure or later become part of the public domain through no fault or breach of obligation by the receiving Party, its employees, or agents; or (e) was independently developed by the receiving Party without use of the disclosing Partys Confidential Information.
10.4 Confidentiality Obligations. Each Party agrees to maintain such Confidential Information received from the other Party in strict confidence, to use it only in a manner consistent with the purpose for which it was transmitted and to not disclose it to Third Parties except Third Parties who are counsel or who are employees, consultants or permitted contractors or subcontractors of the receiving Party who have a need to know, have been instructed that it is proprietary information and are under binding obligations to maintain its confidentiality at least as stringent as those set forth herein. Each Party agrees to take the same measures to protect the Confidential Information of the other Party that it takes to protect its own information of
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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comparable sensitivity, but in no event less than reasonable care. All materials transmitted between the Parties or accessed hereunder and containing Confidential Information shall remain the property of the transmitting Party and shall, along with all copies, summaries and other tangible manifestations thereof, be immediately returned upon termination or expiration of this Agreement or upon earlier reasonable request unless previously destroyed at the transmitting Partys request. Each Party will, upon the other Partys request, provide a written officers certificate certifying that it has so returned or destroyed the other Partys Confidential Information. Each Party shall be responsible for any breach of confidentiality hereunder by any of its Affiliates and employees. Each Party shall advise the other immediately in the event that it learns or has reason to believe that any person discloses or uses or intends to disclose or use such other Partys Confidential Information and will reasonably cooperate with the other Party to prevent or remedy the same.
10.5 Permitted Disclosures. Notwithstanding the foregoing, Shire and Synageva may each disclose Confidential Information (i) in order to comply with its obligations under the law, including the Securities Act of 1933 and the Securities Exchange Act of 1934, each as amended, and the rules and regulations of the SEC promulgated thereunder; (ii) in order to comply with the listing standards or agreements of any national or international securities exchange or The NASDAQ Stock Market or New York Stock Exchange or other similar laws of a governmental authority; (iii) to respond to an inquiry of a governmental authority or regulatory authority, specifically including but not limited to the U.S. National Institutes of Health and the U.S. Food and Drug Administration, as required by law; (iv) as necessary to enforce a Partys rights under this Agreement in a judicial, administrative or arbitration proceeding; or (v) to potential investors, acquirers or business partners of such party or its Affiliates who have been advised of the confidential nature of such information and who are bound by obligations of confidentiality substantially similar to those contained herein, provided that (except as to Section 10.5(iv)), the receiving Party shall, if reasonably possible, notify the other Party of the intended disclosure in advance, reasonably cooperate with the disclosing Partys effort to seek a protective order contesting or limiting the disclosure and limit its disclosure to that which is required for the foregoing purpose. It is understood and agreed that CHMC may also disclose the terms and conditions of this Agreement to the Government and its agents as necessary in connection with any Government funding related to the Patents.
10.6 Duration of Confidentiality Obligations. Notwithstanding the expiration or termination of this Agreement, the Parties respective confidentiality obligations shall continue in effect for five (5) years after the expiration or earlier termination of this Agreement.
10.7 Remedies. The Parties each acknowledge and agree that a breach of this Article 10 may cause irreparable harm to the non-breaching Party for which the award of money damages may be inadequate. The Parties therefore agree that in the event of any breach of this provision, the non-breaching Party shall be entitled to seek injunctive relief in addition to seeking any other remedy provided in this Agreement or available at law.
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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ARTICLE 11 - TERM AND TERMINATION
11.1 Term. The term of this Agreement shall begin on the Effective Date and extend until the expiration of the last to expire Patent, unless terminated earlier pursuant to Article 11 of this Agreement (Term).
11.2 For Convenience. Synageva may terminate this Agreement at any time by providing at least ninety (90) days written notice to Shire.
11.3 For Breach.
11.3.1 Breach of Settlement Agreement or Upon Certain Patent Challenges. Shire may terminate this Agreement at any time during the Term upon written notice by Shire if Synageva (i) breaches any of its obligations under Section 2.1 of the Settlement Agreement or (ii) is in breach of Section 6.3 (Patent Challenges) by engaging in a Patent Challenge of a Royalty-Bearing Patent of the nature described in Section 1.15(a), and Synageva has not cured such breach within fifteen (15) days after receiving written notice from Shire requesting that Synageva cure such breach. Synageva may cure a breach of Section 6.3 (Patent Challenges) by agreeing in writing that it will continue to pay Shire royalties in accordance with Section 7.3 (Royalties) for the remaining term of the Royalty-Bearing Patent in question, even if such Royalty-Bearing Patent is held to be invalid, unenforceable, or not infringed by the Product as a result of such Patent Challenge.
11.3.2 Upon Non-Payment or Upon Certain Patent Challenges.
(a) Upon Non-Payment. Shire may terminate this Agreement at any time during the Term upon written notice by Shire if Synageva breaches any of its payment obligations to Shire hereunder and Synageva has not cured such breach within thirty (30) days after receiving written notice from Shire identifying the nature and amount of such breach with specificity and requesting that Synageva cure such breach. In the event that there is a dispute between the Parties regarding whether Synageva is in such breach of any of its payment obligations to Shire hereunder and Synageva initiates an arbitration proceeding pursuant to Section 14.13 (Arbitration) to resolve such dispute within the foregoing cure period (or such longer period as may be agreed in writing between Shire and Synageva), then this Agreement shall not terminate during the pendency of such arbitration proceeding (i.e., the cure period will be tolled during the pendency of such proceeding until a final award is issued in such arbitration proceeding); provided that if any such final award is entered in such arbitration proceeding which determines that Synageva has breached any of its payment obligations to Shire hereunder and has failed to cure such breach or if Synageva admits in writing in such arbitration proceeding that it has breached any of its payment obligations to Shire hereunder and failed to cure such breach, then this Agreement shall terminate ten (10) days following entry of such final award or such written admission, unless Synageva cures such breach prior to the expiration of such ten (10) day period. Notwithstanding the foregoing, if Shire gives written notice to Synageva that Synageva has materially breached this Agreement in ways other than failing to pay amounts due to Shire under this Agreement and Synageva disputes such other claimed breaches, then even if Shire shall have given written notice to Synageva pursuant to this Section 11.3.2(a) of breach of any of its
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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payment obligations to Shire under this Agreement, then in lieu of the arbitration proceeding contemplated by Section 14.13 (Arbitration) with respect to such claimed breaches of its payment obligations, Synageva may, within the longest cure period available to Synageva under such written notices from Shire, file a single legal action in a court of competent jurisdiction to resolve the disputes with respect to both the claimed breaches of Synagevas payment obligations and the claimed other material breaches by Synageva. Should Synageva file such an action, the cure period for all such claimed breaches will be tolled in accordance with Section 11.3.3 (Other Material Breaches).
(b) Upon Certain Patent Challenges. Shire may terminate this Agreement at any time during the Term upon written notice by Shire if Synageva is in breach of Section 6.3 (Patent Challenges) by engaging in a Patent Challenge of a Royalty-Bearing Patent of the nature described in Section 1.15(b), and Synageva has not cured such breach within thirty (30) days after receiving written notice from Shire requesting that Synageva cure such breach or such longer period as Shire and Synageva may agree in writing. Synageva may cure such breach by agreeing in writing that it will continue to pay Shire royalties in accordance with Section 7.3 (Royalties) for the remaining term of the Royalty-Bearing Patent in question, even if such Royalty-Bearing Patent is held to be invalid, unenforceable, or not infringed by the Product as a result of such Patent Challenge. In the event that there is a dispute between the Parties regarding whether Synageva is in breach of Section 6.3 (Patent Challenges) by engaging in a Patent Challenge of the Royalty-Bearing Patents of the nature described in Section 1.15(b), and Synageva initiates a legal action against Shire in a court of competent jurisdiction to resolve such dispute within the foregoing thirty (30) day (or longer if agreed in writing) cure period, then this Agreement shall not terminate during the pendency of such legal action (i.e., the cure period will be tolled during the pendency of such legal action, including any appeals); provided that if Synageva is found in a final judgment or order by such court of competent jurisdiction, that is no longer subject to appellate review, to have breached this Section 6.3 by engaging in a Patent Challenge the Royalty-Bearing Patents of the nature described in Section 1.15(b), or if Synageva admits in writing in such legal action or any settlement agreement in respect thereof that it has so breached Section 6.3 and failed to cure such breach, then this Agreement shall terminate ten (10) business days following such final and no longer reviewable judgment or order, or such written admission, unless Synageva cures such breach prior to the expiration of such ten (10) business day period (or unless any such settlement agreement provides otherwise, in which case such settlement agreement shall control).
11.3.3 Other Material Breaches. Except as provided by Sections 11.3.1 or 11.3.2, this Agreement may be terminated at any time during the Term upon written notice by Shire if Synageva is in material breach of its obligations hereunder and has not cured such breach within ninety (90) days after receiving written notice from Shire requesting that Synageva cure the material breach; provided, however, that if any such breach is not reasonably curable within ninety (90) days and if a Synageva is making a bona fide effort to cure such breach, such termination shall be delayed for a time period to be agreed by both Parties, not to exceed an additional ninety (90) days, in order to permit Synageva a reasonable period of time to cure such breach; provided, further, that in the event that there is a dispute between the Parties regarding whether Synageva is in such claimed material breach of this Agreement or whether such claimed breach gives Shire the right to terminate this Agreement and Synageva initiates a legal action
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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against Shire in a court of competent jurisdiction to resolve such dispute within the foregoing cure period (or such longer period as may be agreed in writing by Shire and Synageva), then this Agreement shall not terminate during the pendency of such legal action (i.e., the cure period will be tolled during the pendency of such legal action, including any appeals); provided that if Synageva is found in a final judgment or order by such court of competent jurisdiction that is no longer subject to appellate review to have committed such material breach of this Agreement and failed to cure such breach or if Synageva admits in writing in such legal action or in any settlement agreement in respect thereof that it has committed such material breach of this Agreement and failed to cure such breach, then this Agreement shall terminate ten (10) business days following such final and no longer reviewable judgment or order, or such written admission, unless Synageva cures such breach prior to the expiration of such ten (10) business day period (or unless any such settlement agreement provides otherwise, in which case such settlement agreement shall control.
11.4 For Bankruptcy or Insolvency. Shire may also terminate this Agreement by written notice to Synageva upon Synagevas (i) becoming insolvent or otherwise unable to pay its debts as they become due (unless Synageva cures such condition within thirty (30) days after receipt of written notice of a claim of insolvency by Shire); (ii) making a general assignment for the benefit of its creditors; or (iii) becoming the subject of a voluntary or involuntary petition in bankruptcy or any voluntary or involuntary proceeding relating to receivership, liquidation, or composition for benefit of creditors under domestic or foreign bankruptcy or insolvency law.
11.5 Effect on Termination. Upon expiration or termination of this Agreement by either Party pursuant to any of the provisions of this Article 11 or by Shire pursuant to Section 6.3 (Patent Challenge), (a) the sublicense granted to Synageva under Article 2 (Sublicense) shall terminate, and (b) any Sublicensees shall become direct sublicensees of Shire on the terms and conditions of this Agreement; provided, however, that such Sublicensees agree in writing to abide by the terms and conditions of this Agreement and will pay directly to Shire all amounts due under this Agreement as a result of such Sublicensees Net Sales.
11.6 General Effect of Termination; Survival. Upon expiration or termination of this Agreement, neither Party shall be relieved of any obligations incurred prior to such termination, and the obligations of the Parties under the following provisions shall survive and continue to be enforceable: Articles 1, 5, 10, 12, 13, and 14, Sections 4.1, 4.2, 4.3, 6.1, 7.7, 9.5, 11.5, and 11.6. In addition, the obligations of the Parties under Section 6.3 (Patent Challenges) shall survive expiration of this Agreement, but shall not survive termination of this Agreement by either Party for any reason. Termination or expiration of this Agreement for any reason shall not preclude any Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement.
11.7 Termination of CHMC Agreement. In the event CHMC notifies Shire or Synageva that the CHMC Agreement has been terminated, Synageva shall (i) become a direct licensee of CHMC on the terms and conditions of this Agreement if Synageva is not then in material breach of this Agreement, and (ii) have no further financial obligations to Shire under Article 7 of this Agreement (except for financial obligations that had accrued up to and through the effective date of termination of the CHMC Agreement). Synageva hereby agrees in writing to abide by the
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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terms and conditions of this Agreement as well as any terms and conditions of the copy of the CHMC Agreement provided to Synageva applicable to Shire that are not set forth herein. Any such direct license shall not impose any representations, warranties, obligations or liabilities on CHMC that are not included in the CHMC Agreement.
ARTICLE 12 - INDEMNIFICATION; INSURANCE; LIMITATION OF LIABILITY
12.1 Indemnification by Synageva. Synageva will, at its sole expense, indemnify, defend and hold harmless Shire, CHMC, their respective Affiliates, and its and their directors, trustees, officers and employees (or any one of them) from and against any and all losses, damages, fees, liabilities, penalties or expenses (including, without limitation, reasonable attorneys fees) (collectively, Losses) incurred under any theory of liability, including, without limitation, tort, warranty or strict liability, resulting from claims, suits, actions, demands, judgments, or investigations (both Governmental and non-Governmental) brought by Third Parties (Third Party Claims), arising out of (i) the development, manufacture, use, commercialization, packaging, marketing, sale, license or other distribution or disposition by Synageva or its Affiliates of any Product hereunder, (ii) the material breach of any representation, warranty or covenant by Synageva or its Affiliates or any other term or condition contained in this Agreement, or (iii) the recklessness, negligence or intentional misconduct by Synageva or its Affiliates; except in each case to the extent that such Losses relate to intellectual property infringement claims or fall within the scope of Shires indemnification obligations set forth in Article 12.2.
12.2 Indemnification by Shire. Shire will, at its sole expense, indemnify, defend and hold harmless Synageva and its Affiliates and each of their respective directors, officers, and employees, from and against all Losses, to the extent resulting from any Third Party Claims, arising out of (i) the material breach of any representation, warranty or covenant by Shire or its Affiliate or any other term or condition contained in this Agreement or (ii) the recklessness, negligence or intentional misconduct by Shire or its Affiliates; except in each case to the extent that such Losses fall within the scope of Synagevas indemnification obligations set forth in Article 12.1.
12.3 Procedures. To receive indemnification from a Party who is responsible for indemnification as described above (Indemnifying Party), the Party seeking indemnification (Indemnitee) must: (i) notify the Indemnifying Party promptly of the assertion of any such claims against it (an Indemnifiable Claim); provided that any delay by the Indemnitee in giving notice to Indemnifying Party of an Indemnifiable Claim shall not affect the Indemnitees right to be indemnified for such Indemnifiable Claim except to the extent that Indemnifying Party is actually prejudiced in its ability to defend against such Indemnifiable Claim; and (ii) authorize and permit Indemnifying Party to conduct and exercise control of the defense and disposition of such claims; provided, however, that the Indemnifying Party agrees not to enter into any settlement or compromise of any claim or action in a manner that admits fault or imposes any restrictions or obligations upon an Indemnitee without that Indemnitees prior written consent, which shall not be unreasonably withheld.
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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12.4 Insurance. Each Party shall, during the Term of the Agreement, maintain insurance in an amount sufficient to cover its obligations under this Agreement, such amount being at least [*] per occurrence and [*] annual aggregate. Synageva shall provide CHMC a certificate evidencing such coverage from time to time upon CHMCs reasonable request. The amounts of insurance coverage required herein shall not be construed as creating any limitation on either Partys indemnification obligations under this Agreement.
12.5 Exclusion of Damages; Limitation of Liability. NEITHER PARTY NOR ITS RESPECTIVE AFFILIATES SHALL BE LIABLE TO ANY OTHER PARTY FOR SPECIAL, EXEMPLARY, INDIRECT, CONSEQUENTIAL OR PUNITIVE DAMAGES, WHETHER IN CONTRACT, WARRANTY, TORT, STRICT LIABILITY OR OTHERWISE, ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT , THE PATENTS OR THE PRODUCT, INCLUDING BUT NOT LIMITED TO DAMAGES MEASURING LOST PROFITS, GOODWILL OR BUSINESS OPPORTUNITIES, EVEN IF ADVISED IN ADVANCE OF THE POSSIBILITY OF SUCH DAMAGES. The limitation in this Section 12.5 shall not apply to limit either Partys liability under Section 2.5.2 (No Amendment), Section 9.3 (No Inconsistent Rights), Section 12.1 (Indemnification by Synageva) or Section 12.2 (Indemnification by Shire), Section 10.3 through 10.5 (Confidentiality), the last sentence of Section 2.2 (Reservation of Rights) or due to such Partys willful misconduct.
ARTICLE 13 - NOTICES
All notices and other communications to be given hereunder shall be in writing and personally delivered or sent by Federal Express or a similar reputable express courier (except that notices of breach or that otherwise materially affect the Parties rights hereunder must be sent by such express courier providing a tracking or return receipt delivery) addressed to the respective Parties at the following addresses, or such other address and/or individual as a Party shall designate in writing for such purpose:
If to Shire: | Shire AG | |
Business Park Terre-Bonne | ||
Bâtiment A1 | ||
CH. De Terre Bonne 1,1262 Eysins | ||
Switzerland | ||
ATTN: LEGAL DEPARTMENT | ||
If to Synageva: | Synageva BioPharma, Inc. | |
128 Spring Street, Suite 520 | ||
Lexington, Massachusetts 02421, U.S.A. | ||
ATTN: GENERAL COUNSEL | ||
If to CHMC: | Childrens Hospital Medical Center | |
Center for Technology Commercialization | ||
3333 Burnet Avenue, Mail Location 7032 | ||
Cincinnati, Ohio 45229-3039, U.S.A. | ||
ATTN: DIRECTOR |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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ARTICLE 14 - MISCELLANEOUS
14.1 Assignment. A Party shall not assign or transfer any of its rights or obligations under this Agreement without the prior written consent of the other Party. The foregoing notwithstanding, Synageva and Shire shall be entitled, without prior written consent of the other Party to assign all of their rights and obligations under this Agreement (i) to an Affiliate at any time, or (ii) to a successor entity by way of merger or acquisition of substantially all of the assets (which with respect to Shire shall specifically include all or substantially all of Shires interest in the CHMC Agreement) of such Party (whether by consolidation, sale of assets, or otherwise), or (iii) to any Third Party that acquires or is otherwise transferred all or substantially all of Synagevas assets related to the Licensed Product; provided, however, that in cases (i) through (iii), such Affiliate, successor entity or Third Party, as applicable, expressly assumes in writing those rights, duties and obligations under this Agreement. In the event any Party assigns its rights and obligations under this Agreement to an Affiliate or a Third Party, such assigning Party shall, promptly following such assignment, give written notice of such assignment to the other Party. Any assignment or transfer in contravention of the terms of this Agreement shall be null and void ab initio.
14.2 Bankruptcy. All rights and licenses now or hereafter granted under or pursuant to this Agreement, including Article 2 hereof, are rights to intellectual property (as defined in Section 101(35A) of Title 11 of the United States Code, as amended (such Title 11, the Bankruptcy Code)). Shire agrees not to interfere with Synagevas and its Affiliates exercise of rights and licenses to intellectual property licensed hereunder and embodiments thereof in accordance with this Agreement.
14.3 Export Laws. It is understood that the Parties are subject to United States laws and regulations controlling the export of technical data, computer software, laboratory prototypes and other commodities, and that its obligations hereunder are contingent on compliance with all applicable United States export laws and regulations. The transfer of certain technical data and/or commodities may require a license from the cognizant agency of the United States Government and/or written assurances by Synageva that Synageva and its Affiliates shall not export data or commodities to certain foreign countries without prior approval of such agency. Shire neither represents nor warrants that a license shall not be required nor that, if required, it shall be issued. In any event, Synageva specifically agrees not to export or re-export any information and/or technical data and/or Products in violation of any applicable laws and/or regulations.
14.4 Governing Law and Consent to Jurisdiction. This Agreement and any disputes, claims, arbitrations or legal actions arising under or related to this Agreement or the negotiations, performance, interpretation or enforcement thereof (whether sounding in contract, tort, statute or otherwise, and whether at law or in equity) thereto shall be governed by and construed in accordance with the laws of the State of New York without regard to the conflicts of law provisions thereof with the exception of sections 5-1401 and 5-1402 of New York General Obligations Law. Any action or proceeding arising out of or relating to this Agreement may be brought in the federal and state courts located in either Massachusetts or New York, and each Party hereby irrevocably submits to the non-exclusive jurisdiction of such courts in any such action or proceeding, waive any objection it may now or hereafter have to venue or to convenience of forum.
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
27
14.5 Force Majeure. Neither Party shall be liable for any default or delay in the performance of its obligations under this Agreement to the extent that such default or delay is caused, directly or indirectly, by acts of God, civil disturbance, war, fires, acts or orders of any Government agency or official, natural catastrophes, or any other circumstances beyond such Partys reasonable control. In any such event, the non-performing Party shall be excused from any further performance or observance of the obligation so affected only for as long as such circumstances prevail and such Party continues to use commercially reasonable efforts to recommence performance or observance as soon as practicable. Any Party whose performance is delayed or prevented by any cause or condition within the purview of this Section (Force Majeure) shall promptly notify the other Party thereof, the anticipated duration of the non-performance, and the action(s) being taken to overcome or mitigate the delay or failure to perform. Notwithstanding the foregoing, under no circumstances shall any delay or nonperformance be excused or forgiven (a) if the cause of the nonperformance could have been prevented or avoided by the exercise of reasonable diligence; (b) if the Party whose performance is delayed or prevented fails to use reasonable diligence to promptly overcome and mitigate the delay or failure to perform; or (c) if the nonperformance is caused by the negligence, intentional conduct or misconduct of the nonperforming Party. The Parties understand and agree that Governmental acts, orders or restrictions do not constitute excusing events hereunder if such acts, orders or restrictions are issued due to either Partys alleged failure to conform to applicable laws, regulations or other Governmental requirements.
14.6 Severability. The provisions set forth in this Agreement shall be considered to be severable and independent of each other. In the event that any provision of this Agreement shall be determined to be unenforceable by a court of competent jurisdiction, such determination shall not be deemed to affect the enforceability of any other provision and the Parties agree that any court making such a determination is hereby requested and empowered to modify such provision and to substitute for such unenforceable provision such limitation or provision of a maximum scope as the court then deems reasonable and judicially enforceable and the Parties agree that such substitute provision shall be as enforceable as if set forth initially in this Agreement. Any such substitute provision shall be applicable in which the original provision was determined to be unenforceable. However, in the event that such court declines to modify such provisions, then the Parties will in good faith negotiate a modification to the provision to the minimum extent necessary to render it valid and enforceable in conformity with the Parties intent as manifested herein.
14.7 Headings; Jointly Drafted Agreement. Headings used herein are for reference purposes only and neither limit nor amplify the terms and conditions herein. The Parties jointly prepared this Agreement, and no presumption or inference shall be applied as against either Party as the drafter hereof.
14.8 Independent Contractors. The relationship between Shire and Synageva created by this Agreement is solely that of independent contractors. This Agreement does not create any agency, distributorship, employee-employer, partnership, joint venture or similar business
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
28
relationship between the Parties. No Party is a legal representative of another Party, and no Party has the right to assume or create any obligation, representation, warranty or guarantee, express or implied, on behalf of another Party for any purpose whatsoever. Each Party shall use its own discretion and shall have complete and authoritative control over its employees and the details of performing its obligations under this Agreement.
14.9 Entire Agreement; Amendment; English Language. This Agreement, together with its Exhibits, which are hereby incorporated by reference, contains the full understanding of the Parties with respect to the subject matter hereof and supersedes all prior understandings and writings relating thereto. It may not be modified or amended except by a writing signed by both Parties identified as an amendment to this Agreement. In the event that a translation of this Agreement is prepared and signed by the Parties, this English language version shall be the official version and shall govern if there is a conflict between the two.
14.10 Waiver. The waiver by either Party of any right, claim, or breach by the other Party must be in written form and signed by the Party against whom the waiver is charged, and it shall not be construed as a waiver of any succeeding right, claim, or breach.
14.11 Counterparts. This Agreement may be executed in separate counterparts, each of which so executed and delivered shall constitute an original, but all such counterparts shall together constitute one and the same instrument. Any such counterpart may comprise one or more duplicates or duplicate signature pages any of which may be executed by less than all of the Parties, provided that each Party executes at least one such duplicate or duplicate signature page. Signatures delivered by facsimile or as attachments to emails shall be effective as originals.
14.12 No Third Party Beneficiaries. This Agreement shall be binding upon, and inure to the benefit of, the Parties and their successors and permitted assigns. It is not intended to and shall not confer any rights or remedies upon any other person or entity, except that any Indemnitees are intended third party beneficiaries of Article 12 hereof and may enforce those sections thereof that are for their benefit.
14.13 Arbitration. Any arbitration described in Section 11.3.2(a) hereof shall be administered by JAMS pursuant to its Comprehensive Arbitration Rules and Procedures, as in effect on the date of this Agreement (the Rules), and in accordance with the Expedited Procedures in those Rules, except as otherwise provided in this Section 14.13. The location of the arbitration shall be Boston, Massachusetts, and the language of the arbitration shall be English. Synageva shall initiate an arbitration by delivering a demand for arbitration to JAMS and shall serve a copy thereof upon Shire, pursuant to Rule 5 of the Rules. The arbitration shall be conducted before a panel of three (3) arbitrators, selected pursuant to this Section 14.13. Within ten (10) days after Synageva serves the demand for arbitration upon Shire, each Party shall select one (1) person to act as an arbitrator. Each Party-appointed arbitrator: (i) shall be neutral under the Rules, (ii) shall not have and, in the prior two (2) years shall not have had, any pending or anticipated material commercial or other business relationship with either Party or any of its Affiliates; and (iii) shall be an active or retired attorney, or a retired judge, in either case a member of the bar of the Commonwealth of Massachusetts or the State of New York with at least fifteen (15) years of experience in the negotiation of, or litigation with respect to, commercial contract disputes,
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
29
including (to the extent reasonably practicable after diligent effort) experience with matters in the pharmaceutical or biotechnology industry. The two Party-appointed arbitrators shall, within twenty one (21) days after the second of them being appointed, jointly select the third arbitrator, who shall act as the Chair, and such third arbitrator shall satisfy each of the requirements in clauses (i)-(iii) of the immediately preceding sentence, except that clause (iii) shall be modified to require at least twenty (20) years of such experience. If the arbitrators appointed by the Parties are unable or fail to agree upon the third arbitrator within the allotted time, the third arbitrator shall be appointed by JAMS in accordance with the Rules, except that any JAMS-appointed third arbitrator (who shall act as the chair) shall satisfy each of the requirements in clauses (i)-(iii) of the immediately preceding sentence. Within ten (10) days after the date of the establishment of the arbitration panel, Synageva shall submit to JAMS and serve upon Shire its notice of claim as described in Rule 9 of the Rules. Rule 17 of the Rules shall not apply to the arbitration, and the arbitration panel shall not permit any other pre-hearing discovery. Within seven (7) days thereafter, Shire shall submit to JAMS and serve upon Synageva its response, including any defenses and counterclaims, as described in Rule 9 of the Rules. Within 10 (10) days thereafter, Synageva shall submit to JAMS and serve upon Shire a response to any counterclaims, including any defenses, as described in Rule 9 of the Rules. The arbitration panel shall be empowered only to: (i) determine if Synageva breached any of its payment obligations to Shire under this Agreement as set forth in a written notice from Shire to Synageva describing such claimed breach and demanding that Synageva cure such breach, as described in Section 11.3.2(a) hereof; (ii) determine if Synageva cured such claimed breach; (iii) if Synageva did not cure such claimed breach, the amount of damages, if any, owed by Synageva to Shire as a result of such breach (as limited by Section 12.5 hereof). The final arbitral award shall allocate between the Parties as the arbitration panel deems equitable the compensation, costs and fees in connection with the arbitration described in Rules 24 and 31 of the Rules. The final award shall be a reasoned award. The award of the arbitration panel shall be final and binding upon the Parties, subject to Rules 24(j), 24(k) and 25 of the Rules, it being agreed that with respect to Rules 24(k) and 25 of the Rules, neither Party will institute an Optional Arbitration Appeal or judicial proceedings to modify or vacate such award.
[Signature page follows.]
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
30
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed by their properly and duly authorized officers or representatives as of the Effective Date.
SYNAGEVA BIOPHARMA CORP. | SHIRE AG | |||
/s/ Stephen Mahoney |
/s/ Iain Ward | |||
Signature | Signature | |||
Stephen Mahoney |
Iain Ward | |||
Printed Name | Printed Name | |||
General Counsel |
VP, Senior Counsel | |||
Title | Title |
CHMC has reviewed this Exclusive Sublicense Agreement, agrees that it is consistent with the terms of the CHMC Agreement, and hereby consents to Shires entry into this Agreement with Synageva. In addition, CHMC agrees that Synageva will be an intended third party beneficiary of the CHMC Agreement with the right to enforce the CHMC Agreement against CHMC.
Acknowledged and agreed:
CHILDRENS HOSPITAL MEDICAL CENTER |
/s/ Arnold W. Strauss |
Signature |
Arnold W. Strauss, M.D. |
Printed Name |
Director, CCEF |
Title |
[Signature Page to the Exclusive Sublicense Agreement]
Exhibit A
Family 1 Patents, Family 3 Patents and Family 4 Patents
Family 1 Patents | ||||||||||||||
Patent No |
Serial No |
Patent Title |
Country |
File Date |
Issue Date |
Status |
Tech ID | |||||||
60/180,362 | Enzyme Therapy for Atherosclerosis | US | 02/04/2000 | Expired | 1999-1220 | |||||||||
01906927.7 | Lipid Hydrolysis Therapy for Atherosclerosis and Related Diseases | Germany | 02/02/2001 | Issued | 1999-1220 | |||||||||
01906927.7 | Lipid Hydrolysis Therapy for Atherosclerosis and Related Diseases | Spain | 02/02/2001 | Issued | 1999-1220 | |||||||||
01906927.7 | Lipid Hydrolysis Therapy for Atherosclerosis and Related Diseases | Italy | 02/02/2001 | Issued | 1999-1220 | |||||||||
01906927.7 | Lipid Hydrolysis Therapy for Atherosclerosis and Related Diseases | France | 02/02/2001 | Issued | 1999-1220 | |||||||||
1267914 | 01906927.7 | Lipid Hydrolysis Therapy for Atherosclerosis and Related Diseases | European Union | 02/02/2001 | 04/29/2009 | Issued | 1999-1220 | |||||||
6849257 | 09/775,517 | Lipid Hydrolysis Therapy for Atherosclerosis and Related Diseases | US | 02/02/2001 | 02/01/2005 | Issued | 1999-1220 | |||||||
PI0108077-6 | Lipid Hydrolysis Therapy for Atherosclerosis and Related Diseases | Brazil | 02/02/2001 | Pending | 1999-1220 | |||||||||
2,398,995 | Lipid Hydrolysis Therapy for Atherosclerosis and Related Diseases | Canada | 02/02/2001 | Pending | 1999-1220 | |||||||||
PCT/US2001/03481 | Lipid Hydrolysis Therapy for Atherosclerosis and Related Diseases | PCT | 02/02/2001 | Expired | 1999-1220 | |||||||||
2001-556495 | Lipid Hydrolysis Therapy for Atherosclerosis and Related Diseases | Japan | 02/02/2001 | Abandoned | 1999-1220 | |||||||||
01906927.7 | Lipid Hydrolysis Therapy for Atherosclerosis and Related Diseases | United Kingdom | 02/02/2001 | Issued | 1999-1220 | |||||||||
10/776,797 | Lipid Hydrolysis Therapy for Atherosclerosis and Related Diseases | US | 02/11/2004 | Abandoned | 1999-1220 | |||||||||
12/683,265 | Gene-Based Lysosomal Acid Lipase Therapy for Atherosclerosis and Related Diseases | US | 01/06/2010 | Pending | 1999-1220 | |||||||||
11/653,147 | Gene-Based Lipid Hydrolysis Therapy for Atherosclerosis and Related Diseases | US | 01/12/2007 | Pending | 1999-1220 | |||||||||
Family 3 Patents | ||||||||||||||
Patent No |
Serial No |
Patent Title |
Country |
File Date |
Issue Date |
Status |
Tech ID | |||||||
PCT/US2012/025233 | Methods for Treating Lysosomal Acid Lipase Deficiency | PCT | 2/15/2012 | Pending | 2011-0202 | |||||||||
61/443,079 | Methods for Treating Lysosomal Acid Lipase Deficiency | US | 2/16/2011 | Expired | 2011-0202 |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Family 4 Patents | ||||||||||||||
Patent No |
Serial No |
Patent Title |
Country |
File Date |
Issue Date |
Status |
Tech ID | |||||||
60/715,036 | Lysosomal Acid Lipase Therapy for NASH and Related Diseases | US | 09/08/2005 | Expired | 2005-0504 | |||||||||
PCT/US2006/034044 | Lysosomal Acid Lipase Therapy for NAFLD and Related Diseases | PCT | 08/31/2006 | Expired | 2005-0504 | |||||||||
12/065,975 | Lysosomal Acid Lipase Therapy for NAFLD and Related Diseases | US | 08/04/2008 | Pending | 2005-0504 |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Exhibit B
Family 2 Patents
Serial No |
Patent Title |
Country | File Date | Status | ||||
PCT/US2012/025239 | Methods for Treating Lysosomal Acid Lipase Deficiency | PCT | 2/15/2012 | Pending | ||||
61/443,179 | Methods for Treating Lysosomal Acid Lipase Deficiency | US | 2/15/2011 | Pending |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Exhibit C
Synageva Product Patents
Publication |
Application Number |
Case Title |
Country/Region |
Filing Date |
Case Status |
Case | ||||||
2011242461 | LYSOSOMAL STORAGE DISEASE ENZYMES | Australia | 4/23/2011 | Pending | 079/AU | |||||||
112012027143-1 | LYSOSOMAL STORAGE DISEASE ENZYMES | Brazil | 4/23/2011 | Pending | 079/BR | |||||||
2,796,607 | LYSOSOMAL STORAGE DISEASE ENZYMES | Canada | 4/23/2011 | Pending | 079/CA | |||||||
201180031009.3 | LYSOSOMAL STORAGE DISEASE ENZYMES | China | 4/23/2011 | Pending | 079/CN | |||||||
11772834.5 | LYSOSOMAL STORAGE DISEASE ENZYMES | European Patent | 4/23/2011 | Pending | 079/EP | |||||||
8994/DELNP/2012 | LYSOSOMAL STORAGE DISEASE ENZYMES | India | 4/23/2011 | Pending | 079/IN | |||||||
PCT/US2011/033699 | LYSOSOMAL STORAGE DISEASE ENZYMES | Japan | 4/23/2011 | Pending | 079/JP | |||||||
KR 10-2012-7030540 | LYSOSOMAL STORAGE DISEASE ENZYMES | Korea (South) | 4/23/2011 | Pending | 079/KR | |||||||
MX/a/2012/012356 | LYSOSOMAL STORAGE DISEASE ENZYMES | Mexico | 4/23/2011 | Pending | 079/MX | |||||||
2012149936 | LYSOSOMAL STORAGE DISEASE ENZYMES | Russian Federation | 4/23/2011 | Pending | 079/RU | |||||||
13/642,790 | LYSOSOMAL STORAGE DISEASE ENZYMES | United States of America | 4/23/2011 | Pending | 079/US | |||||||
WO 2011/133960 | PCT/US2011/033699 | LYSOSOMAL STORAGE DISEASE ENZYMES/WO | International Patent-PCT | 4/23/2011 | Pending | 079/WO | ||||||
61/343,177 | LYSOSOMAL STORAGE DISEASE ENZYMES | United States of America | 4/23/2010 | Lapsed | 079P | |||||||
61/396,376 | LYSOSOMAL STORAGE DISEASE ENZYMES | United States of America | 5/26/2010 | Lapsed | 079PA | |||||||
61/456,014 | LYSOSOMAL STORAGE DISEASE ENZYMES | United States of America | 10/29/2010 | Lapsed | 079PB | |||||||
61/432,372 | LYSOSOMAL STORAGE DISEASE ENZYMES | United States of America | 1/13/2011 | Lapsed | 079PC | |||||||
20110103302 | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | Argentina | 9/9/2011 | Pending | 080/AR | |||||||
Not yet available | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | Australia | 9/9/2011 | Pending | 080/AU | |||||||
BR112013005673-8 | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | Brazil | 9/9/2011 | Pending | 080/BR | |||||||
Not yet available | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | Canada | 9/9/2011 | Pending | 080/CA | |||||||
00664-2013 | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | Chile | 9/9/2011 | Pending | 080/CL | |||||||
Not yet available | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | China | 9/9/2011 | Pending | 080/CN |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Publication |
Application Number |
Case Title |
Country/Region |
Filing |
Case Status |
Case | ||||||
Not yet available | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | Colombia | 9/9/2011 | Pending | 080/CO | |||||||
Not yet available | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | Egypt | 9/9/2011 | Pending | 080/EG | |||||||
Not yet available | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | European Patent | 9/9/2011 | To be filed by April 9, 2013 | 080/EP | |||||||
Not yet available | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | Indonesia | 9/9/2011 | To be filed by April 9, 2013 | 080/ID | |||||||
Not yet available | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | Israel | 9/9/2011 | Pending | 080/IL | |||||||
Not yet available | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | India | 9/9/2011 | Pending | 080/IN | |||||||
Not yet available | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | Japan | 9/9/2011 | Pending | 080/JP | |||||||
Not yet available | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | Korea (South) | 9/9/2011 | To be filed by April 9, 2013 | 080/KR | |||||||
MX/a/2013/002704 | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | Mexico | 9/9/2011 | Pending | 080/MX | |||||||
Not yet available | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | New Zealand | 9/9/2011 | To be filed by April 9, 2013 | 080/NZ | |||||||
2013110491 | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | Russian Federation | 9/9/2011 | Pending | 080/RU | |||||||
Not yet available | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | Singapore | 9/9/2011 | Pending | 080/SG | |||||||
1301001156 | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | Thailand | 9/9/2011 | Pending | 080/TH | |||||||
100132633 | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | Taiwan | 9/9/2011 | Pending | 080/TW |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Publication |
Application Number |
Case Title |
Country/Region |
Filing |
Case Status |
Case | ||||||
Not yet available | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | Ukraine | 9/9/2011 | To be filed by April 9, 2013 | 080/UA | |||||||
US 2012-0064055A1 | 13/229,558 | METHODS FOR TREATING LYSOSOMAL ACID LIPASE DEFICIENCY IN PATIENTS | United States of America | 9/9/2011 | Pending | 080/US | ||||||
WO 2012/050695 | PCT/US2011/051096 | METHODS FOR TREATING LYSOSOMAL ACID LIPASE DEFICIENCY IN PATIENTS | International Patent-PCT | 9/9/2011 | Pending | 080/WO | ||||||
61/403,011 | METHODS FOR TREATING WOLMAN DISEASE AND CHOLESTERYL ESTER STORAGE DISEASE | United States of America | 9/9/2010 | Lapsed | 080P/US | |||||||
PCT/US2013/28688 | TRUNCATED LYSOSOMAL ACID LIPASE | International Patent-PCT | 3/1/2013 | Pending | 085/WO | |||||||
61/605,850 | TRUNCATED LYSOSOMAL ACID LIPASE | United States of America | 3/2/2012 | Lapsed | 085P/US |
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Exhibit D
Second Family 1 Patent Claim
65. A method for treatment of cholesteryl ester storage disease in a mammal comprising the step of administering to the mammal a safe and effective amount of lysosomal acid lipase by intravenous infusion, wherein said administration step results in activity of said lysosomal acid lipase in the lysosomes of cells of the small intestine, or both the lysosomes of the cells of the small intestine and the lysosomes of the cells of the liver, wherein said activity is present in an amount sufficient to reduce cholesteryl ester and/or triglyceride storage in said small intestine or in both small intestine and liver; and wherein the lysosomal acid lipase comprises an oligosaccharide terminated N-acetylglycosylation residue comprising a mannose residue.
[*] = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
8
Exhibit 10.3
LEASE
33 HAYDEN AVENUE
LEXINGTON, MASSACHUSETTS
Lease Dated January 15, 2013
THIS INSTRUMENT IS AN INDENTURE OF LEASE in which the Landlord and the Tenant are the parties hereinafter named, and which relates to space in a certain building (the Building) known as, and with an address at, 33 Hayden Avenue, Lexington, Massachusetts 02421.
The parties to this Indenture of Lease hereby agree with each other as follows:
ARTICLE I
Reference Data
1.1 | Subjects Referred To |
Each reference in this Lease to any of the following subjects shall be construed to incorporate the data stated for that subject in this Article:
Landlord: | The Trustees of Hayden Office Trust under Declaration of Trust dated August 24, 1977 recorded with the Middlesex South Registry District of the Land Court as Document No. 560049, as amended and without personal liability. | |
Landlords Original Address: | c/o Boston Properties Limited Partnership Prudential Center 800 Boylston Street, Suite 1900 Boston, Massachusetts 02199-8103 | |
Landlords Construction Representatives: | Ken Chianca and Jon Randall | |
Tenant: | Synageva BioPharma Corp., a Delaware corporation | |
Tenants Original Address: | 128 Spring Street, Lexington, Massachusetts |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Tenants Email Address for Information Regarding Billings and Statements: | chris.heberlig@synageva.com | |
Tenants Construction Representative: | Chris Heberlig | |
Second Floor Premises and Third Floor Premises Estimated Commencement Date: | May 31, 2013 | |
Office/Laboratory Premises Estimated Commencement Date: | June 28, 2013 | |
[*] Premises Estimated Commencement Date: | August 1, 2013 | |
Second Floor Premises and Third Floor Premises Outside Completion Date: | July 1, 2013 | |
Office/Laboratory Premises Outside Completion Date: | October 1, 2013 | |
[*] Premises Outside Completion Date: | November 1, 2013 | |
Second Floor Premises and Third Floor Premises Commencement Date: | As defined in Section 2.4 of this Lease. | |
Office/Laboratory Premises Commencement Date: | As defined in Section 2.4 of this Lease. | |
[*] Premises Commencement Date: | As defined in Section 2.4 of this Lease. | |
Applicable Commencement Date: | The Second Floor Premises and Third Floor Premises Commencement Date as to the Second Floor Premises and the Third Floor Premises, the Office/Laboratory Premises Commencement Date as to the Office/Laboratory Premises, and the [*] Premises Commencement Date as to the [*] Premises. |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 2
Second Floor Premises and Third Floor Premises Rent Commencement Date: | The five (5) month anniversary of the Second Floor Premises and Third Floor Premises Commencement Date. | |
Office/Laboratory Premises Rent Commencement Date: | The five (5) month anniversary of the Office/Laboratory Premises Commencement Date. | |
[*] Premises Rent Commencement Date: | The five (5) month anniversary of the [*] Premises Commencement Date. | |
Original Term: | The period from the Second Floor Premises and Third Floor Premises Commencement Date through, if either is later than the Second Floor Premises and Third Floor Premises Commencement Date, the later of (i) the Office/Laboratory Premises Commencement Date, and (ii) the [*] Premises Commencement Date (the later of such dates being the Final Commencement Date), and then continuing thereafter for a period of seventy-seven (77) months from the Final Commencement Date (plus the partial month if any, immediately following the Final Commencement Date), unless extended or sooner terminated as provided in this Lease. | |
Tenant Demolition Plans Date: | N/A. | |
Tenant Construction Plans Date: | February 4, 2013 | |
Authorization to Proceed Date: | February 25, 2013 | |
Long Lead Item Submission Date: | January 14, 2013 | |
Long Lead Item Release Date: | January 28, 2013 | |
Extension Options: | Two (2) periods of three (3) years each as provided in and on the terms set forth in Section 2.4.1 hereof. |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 3
Term or Lease Term: | All references in this Lease to the Term or Lease Term shall mean the Original Term and if extended pursuant to Section 2.4.1, the Original Term as extended by the exercise of the applicable extension options unless otherwise specifically provided in this Lease. | |
The Site: | That certain parcel of land known as and numbered 33 Hayden Avenue, Lexington, Middlesex County, Massachusetts, being more particularly described in Exhibit A attached hereto. | |
The Building: | The Building known as and numbered 33 Hayden Avenue, Lexington, Massachusetts. | |
The Complex: | The Building together with all common areas, surface parking areas, the Site and all improvements (including landscaping) thereon and thereto. | |
Third Floor Premises: | The portion of the third floor of the Building labeled as the Third Floor Premises on the floor plans annexed hereto as Exhibit D and incorporated herein by reference. | |
Second Floor Premises: | The portion of the second floor of the Building labeled as the Second Floor Premises on the floor plans annexed hereto as Exhibit D and incorporated herein by reference, which portion of the Premises is solely for use of accommodating Tenants vertical penetrations from the Office/Laboratory Premises. | |
Office/Laboratory Premises: | The portion of the first floor of the Building labeled as the Office/Laboratory Premises on the floor plans annexed hereto as Exhibit D and incorporated herein by reference | |
[*] Premises: | The portion of the first floor of the Building labeled as the [*] Premises on the floor plans annexed hereto as Exhibit D and incorporated herein by reference. | |
Tenants Premises: | Collectively, the Second Floor Premises, the Third Floor Premises, the Office/Laboratory Premises and the [*] Premises. |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Number of Parking Spaces: | One hundred and seventy (170) spaces based upon a parking ratio of 3.3 parking spaces for each 1,000 square feet of rentable floor area leased by Tenant, subject to and in accordance with the provisions of Section 2.2.1 below. | |
Second Floor Premises and Third Floor Premises Annual Fixed Rent: | For the period from the Second Floor Premises and Third Floor Premises Commencement Date and continuing through the last day of the Original Term, at the annual rate of $746,184.96, being the product of (i) $25.92 and (ii) the Rentable Floor Area of the Second Floor Premises and the Third Floor Premises, provided, however, that Annual Fixed Rent shall not commence until the Second Floor Premises and Third Floor Premises Rent Commencement Date (hereinabove defined in this Section 1.1). | |
Office/Laboratory Premises Annual Fixed Rent: | For the period from the Office/Laboratory Premises Commencement Date and continuing through the last day of the Original Term, at the annual rate of $512,386.56, being the product of (i) $25.92 and (ii) the Rentable Floor Area of the Office/Laboratory Premises, provided, however, that Annual Fixed Rent shall not commence until the Office/Laboratory Premises Rent Commencement Date (hereinabove defined in this Section 1.1). | |
[*] Premises Annual Fixed Rent: | For the period from the [*] Premises Commencement Date and continuing through the last day of the Original Term, at the annual rate of $77,760.00, being the product of (i) $25.92 and (ii) the Rentable Floor Area of the [*] Premises, provided, however, that Annual Fixed Rent shall not commence until the [*] Premises Rent Commencement Date (hereinabove defined in this Section 1.1). |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Annual Fixed Rent for the Premises: | (a) During the Original Term, the annual sum of (i) the Second Floor Premises and Third Floor Premises Annual Fixed Rent, (ii) the Office/Laboratory Premises Fixed Rent, and (iii) the [*] Premises Fixed Rent.
(b) During an Extension Term, the annual rate and on the terms determined pursuant to Section 2.4.1. | |
Operating Expenses: | As provided in Section 2.6 hereof. | |
Real Estate Taxes: | As provided in Section 2.7 hereof. | |
Tenant Electricity: | Initially, as provided in Section 2.5 subject to adjustment as provided in Section 2.8 hereof. | |
Additional Rent: | All charges and other sums payable by Tenant as set forth in this Lease, in addition to Annual Fixed Rent. | |
Rentable Floor Area of the Premises: | 51,556 square feet | |
Rentable Floor Area of the Third Floor Premises: | 28,680 square feet. | |
Rentable Floor Area of the Second Floor Premises: | 108 square feet. | |
Rentable Floor Area of the Office/Laboratory Premises: | 19,768 square feet. | |
Rentable Floor Area of the [*] Premises: | 3,000 square feet. | |
Total Rentable Floor Area of the Building: | 80,872 square feet. | |
Permitted Use: | General office for purposes of the Third Floor Premises and the office portion of the Laboratory Premises, and with respect only and limited to the laboratory portion of the Office/Laboratory Premises and [*] Premises, general laboratory use provided |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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such use is ancillary, accessory, subordinate and in support of the office use of the Third Floor Premises and the office use of the office portion of the Office/Laboratory Premises, as the foregoing may from time to time be permitted under the Zoning By-Law of the Town of Lexington and subject to the provisions of Section 2.1.1 below. | ||
Broker(s): | CB Richard Ellis and Cushman & Wakefield | |
Security Deposit: | $675,000 subject to the provisions of Section 9.18 of this Lease. |
1.2 | Exhibits |
There are incorporated as part of this Lease:
Exhibit A | | Description of Site | ||
Exhibit B-1 | | Work Agreement | ||
Exhibit B-2 | | Space Plan | ||
Exhibit B-3 | | Tenant Matrix | ||
Exhibit B-4 | | Tenant Plan and Working Drawing Requirements | ||
Exhibit B-5 | | Landlords Common Area Work | ||
Exhibit C | | Landlords Services | ||
Exhibit D | | Floor Plans | ||
Exhibit E | | Form of Declaration Affixing the Commencement Date of Lease | ||
Exhibit F | | Broker Determination | ||
Exhibit G | | Form of Letter of Credit | ||
Exhibit H | | Form of Certificate of Insurance | ||
Exhibit I | | Permitted Hazardous Materials | ||
Exhibit J | | Option Space | ||
Exhibit K | | Data Center Requirements |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Exhibit L | | Tenants Signage | ||
Exhibit M | | Form of Construction Letter of Credit | ||
Exhibit N | | Designated Parking Spaces |
1.3 | Table of Articles and Sections |
ARTICLE I | 1 | |||||||
Reference Data |
1 | |||||||
1.1 | Subjects Referred To |
1 | ||||||
1.2 | Exhibits |
7 | ||||||
ARTICLE II | 10 | |||||||
Building, Premises, Term and Rent |
10 | |||||||
2.1 | The Premises |
10 | ||||||
2.2 | Rights to Use Common Facilities |
14 | ||||||
2.3 | Landlords Reservations |
16 | ||||||
2.4 | Habendum |
16 | ||||||
2.5 | Fixed Rent Payments |
18 | ||||||
2.6 | Operating Expenses |
19 | ||||||
2.7 | Real Estate Taxes |
24 | ||||||
2.8 | Tenant Electricity |
26 | ||||||
ARTICLE III | 28 | |||||||
Condition of Premises |
28 | |||||||
3.1 | Preparation of Premises |
28 | ||||||
ARTICLE IV | 28 | |||||||
Landlords Covenants; Interruptions and Delays |
28 | |||||||
4.1 | Landlord Covenants |
28 | ||||||
4.2 | Interruptions and Delays in Services and Repairs, etc |
29 | ||||||
ARTICLE V | 31 | |||||||
Tenants Covenants |
31 | |||||||
5.1 | Payments |
31 | ||||||
5.2 | Repair and Yield Up |
31 | ||||||
5.3 | Use |
32 | ||||||
5.4 | Obstructions; Items Visible from Exterior; Rules and Regulations |
34 | ||||||
5.5 | Safety Appliances |
34 | ||||||
5.6 | Assignment; Sublease |
34 | ||||||
5.7 | Right of Entry |
40 | ||||||
5.8 | Floor Load; Prevention of Vibration and Noise |
41 | ||||||
5.9 | Personal Property Taxes |
41 | ||||||
5.10 | Compliance with Laws |
41 | ||||||
5.11 | Payment of Litigation Expenses |
41 |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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5.12 | Alterations |
41 | ||||||
5.13 | Vendors |
44 | ||||||
5.14 | Patriot Act |
44 | ||||||
ARTICLE VI | 45 | |||||||
Casualty and Taking |
45 | |||||||
6.1 | Damage Resulting from Casualty |
45 | ||||||
6.2 | Uninsured Casualty |
47 | ||||||
6.3 | Rights of Termination for Taking |
47 | ||||||
6.4 | Award |
48 | ||||||
ARTICLE VII | 48 | |||||||
Default |
48 | |||||||
7.1 | Tenants Default |
48 | ||||||
7.2 | Landlords Default |
53 | ||||||
ARTICLE VIII | 53 | |||||||
Insurance and Indemnity |
53 | |||||||
8.1 | Tenants Indemnity |
53 | ||||||
8.2 | Tenants Risk |
55 | ||||||
8.3 | Tenants Commercial General Liability Insurance |
56 | ||||||
8.4 | Tenants Property Insurance |
56 | ||||||
8.5 | Tenants Other Insurance |
57 | ||||||
8.6 | Requirements for Tenants Insurance |
57 | ||||||
8.7 | Additional Insureds |
58 | ||||||
8.8 | Certificates of Insurance |
58 | ||||||
8.9 | Subtenants and Other Occupants |
58 | ||||||
8.10 | No Violation of Building Policies |
59 | ||||||
8.11 | Tenant to Pay Premium Increases |
59 | ||||||
8.12 | Landlords Insurance |
59 | ||||||
8.13 | Waiver of Subrogation |
60 | ||||||
8.14 | Tenants Work |
61 | ||||||
ARTICLE IX | 61 | |||||||
Miscellaneous Provisions |
61 | |||||||
9.1 | Waiver |
61 | ||||||
9.2 | Cumulative Remedies |
62 | ||||||
9.3 | Quiet Enjoyment |
62 | ||||||
9.4 | Notice to Mortgagee and Ground Lessor |
63 | ||||||
9.5 | Assignment of Rents |
63 | ||||||
9.6 | Surrender |
64 | ||||||
9.7 | Brokerage |
64 | ||||||
9.8 | Invalidity of Particular Provisions |
65 | ||||||
9.9 | Provisions Binding, Etc |
65 | ||||||
9.10 | Recording; Confidentiality |
65 | ||||||
9.11 | Notices |
66 | ||||||
9.12 | When Lease Becomes Binding and Authority |
66 |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 9
9.13 | Section Headings |
67 | ||||||
9.14 | Rights of Mortgagee |
67 | ||||||
9.15 | Status Reports and Financial Statements |
68 | ||||||
9.16 | Self-Help |
68 | ||||||
9.17 | Holding Over |
68 | ||||||
9.18 | Security Deposit |
69 | ||||||
9.19 | Late Payment |
70 | ||||||
9.20 | Tenants Payments |
71 | ||||||
9.21 | Waiver of Trial by Jury |
71 | ||||||
9.22 | Governing Law |
71 | ||||||
9.23 | Signage |
72 | ||||||
9.24 | Tenants Equipment |
72 |
ARTICLE II
Building, Premises, Term and Rent
2.1 | The Premises |
Landlord hereby demises and leases to Tenant, and Tenant hereby hires and accepts from Landlord, Tenants Premises in the Building excluding exterior faces of exterior walls, the common stairways and stairwells, elevators and elevator wells, fan rooms, electric and telephone closets, janitor closets, and pipes, ducts, conduits, wires and appurtenant fixtures serving exclusively, or in common, other parts of the Building, and if Tenants Premises includes less than the entire rentable area of any floor, excluding the common corridors, elevator lobbies and toilets located on such floor. Subject to temporary interruption resulting from fire, casualty, maintenance activity, the actions of governmental authorities and other conditions not reasonably within Landlords control, Tenant shall have access to the Premises 24 hours per day, 365 days per year. Such right of access shall be subject to such reasonable security procedures (e.g., presentation of building access card, guard desk sign-in, and the like) as may be adopted by Landlord from time to time.
Tenants Premises with such exclusions is hereinafter referred to as the Premises. The term Building means the Building identified on the first page, and which is the subject of this Lease; the term Site means all, and also any part of the Land described in Exhibit A, plus any additions or reductions thereto resulting from the change of any abutting street line and all parking areas and structures. The term Property means the Building and the Site. Landlord and Tenant hereby agree that the Rentable Floor Area of the Premises and the Rentable Floor Area of the Building are conclusive for all purposes hereunder and shall not be subject to re-measurement, unless and to the extent the physical boundaries of the Premises or the Building are physically altered.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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2.1.1 | Use Limitations. |
Tenant hereby covenants and agrees with Landlord that Tenant shall be responsible and obligated, at Tenants sole cost and expense, for obtaining and maintaining in full force and effect throughout the entire Term, all permits, approvals and licenses from time to time required by Legal Requirements (defined in Exhibit B-1) and all Hazardous Materials Laws (defined in Section 5.3) relating and applicable to the conduct and operation of the laboratory and [*] including, but not limited to, the use, storage, removal, transport and disposal and other handling of Hazardous Materials and the requirements imposed by the Lexington Board of Health and regulations under which it operates. The foregoing shall be in addition to the covenants and obligations of Tenant elsewhere set forth in this Lease including those set forth in Section 5.3 hereof. Tenant acknowledges, covenants and agrees that Landlord shall have no obligation, liability or other responsibility for performing or otherwise complying with any of the foregoing or for the commissioning of any of Tenants laboratory or other equipment and systems.
In addition, all lab coats and other laboratory clothing, goggles and other equipment of any nature shall only be worn and used within the confines of the Premises.
Further, in recognition of the fact that Tenant has deliveries and pick-ups related to the laboratory use of the Office/Laboratory Premises and [*] Premises that are not consistent with uses typically found in a first class office building, Tenant agrees that, in order to minimize conflict with the conduct of the Building as a first class office and laboratory building, and the multi-tenant office use of the remainder of the Building, all deliveries and pick-ups relating to (i) Tenants laboratory uses shall only enter the Building through the loading dock located on the north wing of the first floor of the Building (the Loading Dock); and (ii) Tenants [*] uses shall only enter the Building through the new exterior door entering directly to the [*]. In no event shall any deliveries or shipments go through the common areas of the Building. Tenant shall have access to the Loading Dock at all times except in case of emergency or Force Majeure.
2.1.2 | Tenants Expansion Rights. Landlord and Tenant acknowledge and agree that this Section 2.1.2 shall exclusively govern the rights of Tenant to lease the 28,680 square feet of space on the second floor of the Building shown on Exhibit J attached hereto (the Option Space). The parties agree that the Option Space is currently vacant and not under lease to another party. |
2.1.2.1 Tenants Initial Right of First Refusal.
(A) Subject to the provisions of this Section 2.1.2.1, Landlord agrees that with respect only to the initial lease of the Option Space during the Term of this Lease to a third party and provided that (i) there exists no uncured Event of Default (as
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 11
defined in Section 7.1) and there have been no more than two (2) Event of Default occurrences during the previous thirty-six (36) months of the Term, (ii) this Lease is still in full force and effect, and (iii) no assignment of this Lease or subleases of more than twenty percent (20%) of the Premises in the aggregate are then in effect (except for any assignment or sublease to a Permitted Transferee (as defined in Section 5.6.4)), then if Landlord either (A) submits a written proposal to any potential tenant (a Potential Tenant) and such proposal is accepted by the Potential Tenant, or (B) receives a written proposal or request for proposal from a Potential Tenant respecting the leasing of the Option Space which Landlord desires to accept (collectively called a Potential Tenant Leasing Proposal), then Landlord shall by written notice to Tenant offer the entire Option Space to Tenant under substantially the same terms and conditions as contained in the Potential Tenant Leasing Proposal (Landlords Submitted Offer). Said notice shall consist of two counterpart originals of a commitment to enter into an amendment to this Lease to incorporate such Option Space into the Premises demised under this Lease upon the terms set forth in Landlords Submitted Offer and otherwise on the terms of this Lease (provided that Landlord shall have no obligation to provide Tenant any construction allowance or the like or to perform any work to the Option Space except as expressly contained in the Landlords Submitted Offer).
(B) Tenant shall have the right to accept Landlords Submitted Offer by executing such two (2) counterpart original commitments to enter into such lease amendment and delivering to Landlord the same within ten (10) business days after Tenants receipt of Landlords Submitted Offer. Within ten (10) business days after Landlords receipt of such accepted commitment, Landlord shall deliver to Tenant two (2) counterpart originals of an amendment to this Lease, in form and substance reasonably acceptable to Landlord and Tenant, to incorporate the Option Space subject to Landlords Submitted Offer into the Premises demised under this Lease upon the terms and conditions of such accepted commitment. Within ten (10) business days after Tenants receipt of such amendment, Tenant shall execute both counterpart originals of such amendment and shall deliver the same to Landlord along with appropriate evidence of the authority of Tenant to enter into the transaction. If Tenant shall duly and timely comply with the foregoing, Landlord shall execute and return one (1) fully executed counterpart to Tenant.
(C) If at the expiration of ten (10) business days after Tenants receipt of Landlords Submitted Offer, Tenant shall not have accepted Landlords Submitted Offer by entering into such commitment and delivering the same to Landlord, or if Tenant shall so execute and deliver such commitment, but at the end of ten (10) business days after Tenants receipt of such lease amendment Tenant has not entered into such lease amendment and delivered the same to Landlord and/or has not complied with the provisions of subparagraph (B) above, time being of the essence in respect to all of the same, Landlord shall be free to lease the Option Space at no less than ninety-five percent (95%) of the economic terms contained
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 12
in the Landlords Submitted Offer and for an initial term which is not more than one (1) year shorter, nor greater than one (1) year longer, than the initial term contained in the Landlords Submitted Offer, without again offering such space to Tenant for lease except after initial leasing of the same as provided in Section 2.2.2.2 below.
2.1.2.2 Tenants Right of First Offer.
(A) Subject to the rights of any then-existing tenant of the Option Space to extend its term (whether or not pursuant to rights which exist in its lease), Landlord agrees that if at any time during the Term of this Lease after initial leasing of the Option Space (it being agreed that this Section 2.1.2.2 shall not apply with respect to the initial lease of the Option Space or with respect to any efforts to lease the Option Space during the final twenty four (24) months of the Term), Landlord intends to offer the Option Space for lease then, provided that, (i) there exists no uncured Event of Default and there have been no more than two (2) Event of Default occurrences during the previous thirty-six (36) months of the Term, (ii) this Lease is still in full force and effect, and (iii) no assignment of this Lease or subleases of more than twenty percent (20%) of the Premises in the aggregate are then in effect (except for any assignment or sublease to a Permitted Transferee), then Landlord shall give notice of the availability of such space to Tenant and the business terms which Landlord is willing to lease such space (Landlords ROFO Offer).
(B) Tenant shall have the right to accept Landlords ROFO Offer by giving Landlord notice (Tenants ROFO Exercise Notice) of Tenants acceptance within ten (10) business days after its receipt of Landlords ROFO Offer and, if so accepted, Landlord and Tenant shall endeavor to execute, within ten (10) business days after Tenants ROFO Exercise Notice, an amendment to this Lease incorporating the Option Space into the Premises upon the terms contained in Landlords ROFO Offer and otherwise as substantially the same terms and conditions as contained in this Lease (provided that Landlord shall have no obligation to provide to Tenant any construction allowance or the like or to perform any work to the Option Space except as expressly contained in the Landlords ROFO Offer and the term applicable to the Option Space shall be co-terminus with the Term of this Lease); provided, however, that the failure of the parties to so enter into such amendment with the aforesaid ten (10) business-day period shall not negate the exercise by Tenant of its rights under this Section 2.1.2.2 and Tenant shall be deemed to be leasing the Option Space on the terms and provisions set forth in Landlords ROFO Offer.
(C) If at the expiration of ten (10) business days after Tenants receipt of Landlords ROFO Offer, Tenant shall not have accepted Landlords ROFO Offer by timely delivering Tenant ROFO Exercise Notice, time being of the essence in respect to all of the same, Landlord shall be free to consummate a lease for the Option Space at no less than ninety-five percent (95%) of the economic terms
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 13
contained in the Landlords ROFO Offer without again offering such space to Tenant for lease; provided, however, if after so leasing the Option Space, the same shall thereafter become available for lease during the Term, the terms of this Section 2.1.2.2. shall again apply to such Option Space except during the last twenty four (24) months of the Term.
(D) If Tenant shall accept Landlords ROFO Offer as provided above and if, thereafter, the then occupant of the Option Space wrongfully fails to deliver possession of such space at the time when its tenancy is scheduled to expire, Landlord shall use reasonable efforts (which shall be limited to the commencement and prosecution thereafter of eviction proceedings within sixty (60) days after the date on which the hold-over commences, but which shall not require the taking of any appeal) to evict such occupant from the Option Space. In such event, commencement of the term of Tenants occupancy and lease of such Option Space shall, in the event of such holding over by such occupant, be deferred until possession of such additional space is delivered to Tenant. The failure of the then occupant of such space to so vacate shall not give Tenant any right to terminate this Lease or to deduct from, offset against or withhold Annual Fixed Rent or Additional Rent (or any portions thereof).
2.2 | Rights to Use Common Facilities |
Subject to Landlords right to change or alter any of the following in Landlords discretion as herein provided, Tenant shall have, as appurtenant to the Premises, the non-exclusive right to use in common with others, subject to reasonable rules of general applicability to tenants of the Building from time to time made by Landlord of which Tenant is given notice (a) the common lobbies, corridors, stairways, elevators and loading area of the Building, and the pipes, ducts, conduits, wires and appurtenant meters and equipment serving the Premises in common with others, (b) common walkways and driveways necessary for access to the Building, and (c) if the Premises include less than the entire rentable floor area of any floor, the common toilets, corridors and elevator lobby of such floor. Notwithstanding anything to the contrary herein, Landlord has no obligation to allow any particular telecommunication service provider to have access to the Building or to the Premises except as may be required by applicable law, and if Landlord permits such access, Landlord may condition such access upon the payment to Landlord by the service provider of fees assessed by Landlord in its sole discretion. Notwithstanding the prior sentence, Landlord agrees that the following telecommunications service providers shall have the right under this Lease to access and provide services to the Premises without further consent of Landlord: Comcast Business, Comcast Enterprise, XO Communications, Verizon, Lighttower, Towerstream, Windstream and EarthLink, but Tenant agrees to give Landlord prior notice of, and a copy of, any contract between Tenant and any such telecommunication provider. In no event shall Tenant or any such provider record any such contract or any memorandum thereof against Landlords title to the Building or Site. Subject to the limitations contained in Section 2.1.1 above, Tenant shall have the right, in common with others, to use the freight elevators and loading docks serving the Building on 24 hours per day, 365 days per year, subject to Landlords reasonable scheduling requirements and compliance with Legal Requirements, at no additional charge (other than as may be included in Operating Expenses).
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 14
2.2.1 | Tenants Parking |
In addition, Tenant shall have the right to use the Number of Parking Spaces (referred to in Section 1.1) of the parking area, in common with use by other tenants from time to time of the Complex; provided, however, Landlord shall not be obligated to furnish stalls or spaces in any parking area specifically designated for Tenants use; however two (2) of such spaces shall be designated exclusively for Tenants use as shown Requested Reserved Spaces on Exhibit N attached hereto (the Designated Spaces). Landlord shall have no responsibility for policing the use of, or enforcing Tenants right to exclusively use, the Designated Spaces. Tenant, at Tenants expense, may install signs indicating that the Designed Spaces are for the exclusive use of Tenant, subject to compliance with applicable Legal Requirements. Landlord may relocate the Designated Spaces elsewhere on the Property upon not less than thirty (30) days advance notice to Tenant provided such relocated spaces are comparable in size, desirability and distance from the Building as the Designated Spaces shown on Exhibit N. In the event that the Rentable Floor Area of the Premises decreases at any time during the Lease Term, the Number of Parking Spaces provided to Tenant hereunder shall be reduced proportionately. Tenant covenants and agrees that it and all persons claiming by, through and under it, shall at all times abide by all reasonable rules and regulations promulgated by Landlord with respect to the use of the parking areas on the Site. The parking privileges granted herein are non-transferable except to a permitted assignee or subtenant as provided in Section 5.6. Further, Landlord assumes no responsibility whatsoever for loss or damage due to fire, theft or otherwise to any automobile(s) parked on the Site or to any personal property therein, however caused, and Tenant covenants and agrees, upon request from Landlord from time to time, to notify its officers, employees, agents and invitees of such limitation of liability. Tenant acknowledges and agrees that a license only is hereby granted, and no bailment is intended or shall be created.
2.2.2 | Tenants Dumpster. |
Tenant, at Tenants expense, shall have a right to maintain a dumpster exclusively for its use at the rear of the Building subject to Tenants compliance with the following: Prior to installation, Tenant shall provide Landlord with a written description of the size, and design of the dumpster, as well as the intended use of the dumpster, and such shall be subject to Landlords prior approval, which shall not be unreasonably withheld; provided, however, in no event may be dumpster be used for storage or disposal of Hazardous Materials. Landlord reserves the right to require Tenant, at its cost, to install a concrete pad and/or other appurtenances, to the extent Landlord reasonably believes the same to be necessary in connection with the installation and use of the dumpster. Once
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 15
approved, such dumpster shall be (i) located behind the Building where reasonably designated by Landlord, (ii) emptied on a regular basis (not less than weekly), (iii) maintained in a neat and sanitary condition and shall not be used for the storage or disposal of Hazardous Materials, (iv) screened or fenced as reasonably required by Landlord, and (v) locked each evening to prevent unauthorized disposal therein by third parties. At Tenants expense, Tenant shall keep the areas around the dumpster free of trash and shall maintain and repair the dumpster and any appurtenances in good condition throughout the Term. Tenant shall remove the dumpster upon the expiration or earlier termination of the Term.
2.3 | Landlords Reservations |
Landlord reserves the right from time to time, without unreasonable interference with Tenants use: (a) to install, use, maintain, repair, replace and relocate for service to the Premises and other parts of the Building, or either, pipes, ducts, conduits, wires and appurtenant fixtures, wherever located in the Premises or Building, and (b) to alter or relocate any other common facility, provided that substitutions are substantially equivalent or better. Installations, replacements and relocations referred to in clause (a) above shall be located so far as practicable in the central core area of the Building, above ceiling surfaces, below floor surfaces or within perimeter walls of the Premises; provided that Landlord shall not reduce the Rentable Floor Area of the Premises in more than a de-minimus manner.
2.4 | Habendum |
Tenant shall have and hold (i) the Second Floor Premises and Third Floor Premises for a period commencing on (the Second Floor Premises and Third Floor Premises Commencement Date) the earlier of (a) that date on which the Third Floor Premises are ready for occupancy as defined in Exhibit B-1 hereof (but in no such event earlier than either of (1) April 1, 2013, or (2) the date which is thirty (30) days prior to the Office/Laboratory Premises Commencement Date (as the same occurs or is deemed to have occurred in accordance with the terms of this Lease)), or (b) that date on which Tenant commences occupancy of any portion of the Third Floor Premises for the Permitted Uses, (ii) the Office/Laboratory Premises for a period commencing on (the Office/Laboratory Premises Commencement Date) the earlier of (a) that date on which the Office/Laboratory Premises are ready for occupancy as defined in Exhibit B-1 hereof (but in no such event earlier than April 1, 2013), or (b) that date on which Tenant commences occupancy of any portion of the Office/Laboratory Premises for the Permitted Uses, and (iii) the [*] Premises for a period commencing on (the [*] Premises Commencement Date) the earlier of (a) that date on which the [*] Premises are ready for occupancy as defined in Exhibit B-1 hereof (but in no event such earlier than April 1, 2013), or (b) that date on which Tenant commences occupancy of any portion of the [*] Premises for the Permitted Uses. In each case, the Term shall continue for the Original Term unless sooner terminated as provided in Article VI or Article VII or unless extended as provided in Section 2.4.1.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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As soon as may be convenient after the date has been determined on which the Applicable Commencement Date commences as aforesaid, Landlord and Tenant agree to join with each other in the execution of a written Declaration, in the form of Exhibit E, in which the date on which the Applicable Commencement Date occurs as aforesaid and the Term of this Lease shall be stated. If Tenant shall fail to execute such Declaration, each Applicable Commencement Date and Lease Term shall be as reasonably determined by Landlord in accordance with the terms of this Lease.
2.4.1 | Extension Option |
(A) On the conditions (which conditions Landlord may waive by written notice to Tenant) that at the time of exercise of the then applicable option to extend (except with respect to subsection (iii) below) and at the commencement date of the then applicable extension option period (i) there exists no uncured Event of Default (defined in Section 7.1), (ii) this Lease is still in full force and effect, and (iii) no assignment of this Lease or subleases of more than thirty percent (30%) of the Premises in the aggregate (excluding an assignment or sublease to a Permitted Transferee) is in effect at the commencement of the applicable Extended Term (as defined below), then Tenant shall have the right to extend the Term hereof upon all the same terms, conditions, covenants and agreements herein contained (except for the Annual Fixed Rent which shall be adjusted during the option periods as hereinbelow set forth) for two (2) successive periods of three (3) years each as hereinafter set forth. Each option period is sometimes herein referred to as an Extended Term. Notwithstanding any implication to the contrary Landlord has no obligation to make any additional payment to Tenant in respect of any construction allowance or the like or to perform any work to the Premises as a result of the exercise by Tenant of any such option.
(B) (i) No earlier than one hundred and twenty (120) days prior to the earliest date on which Tenant may exercise the then applicable option to extend the Term as provided in subsection (B)(ii) below, Tenant may, but shall not be obligated, to deliver written notice to Landlord (Rent Quotation Notice), requesting Landlords quotation of a proposed Annual Fixed Rent for the next applicable Extended Term (Landlords Rent Quotation). Within thirty (30) days after Landlords receipt of the Rent Quotation Notice, Landlord shall provide Landlords quotation of a proposed Annual Fixed Rent for the next applicable Extended Term (Landlords Rent Quotation)
(ii) If Tenant desires to exercise the then applicable option to extend the Term, then Tenant shall give notice (the Exercise Notice) to Landlord, not earlier than twenty four (24) months nor later than fifteen (15) months prior to the expiration of the then Term of this Lease (as it may have been previously extended) exercising such option to extend. Promptly after Landlords receipt of the Exercise Notice, Landlord and Tenant shall use reasonable efforts to reach agreement on a determination of an Annual Fixed Rent for the then applicable
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Extended Term. If at the expiration of thirty (30) days after the date when Landlord receives the Exercise Notice (the Negotiation Period), Landlord and Tenant have not reached agreement on a determination of an Annual Fixed Rent for the then applicable Extended Term and executed a written instrument extending the Term of this Lease pursuant to such agreement, then Tenant shall have the right, for thirty (30) days following the expiration of the Negotiation Period, to make a request to Landlord for a broker determination (the Broker Determination) of the Prevailing Market Rent (as defined in Exhibit G) for the applicable Extended Term, which Broker Determination shall be made in the manner set forth in Exhibit F.
(iii) If Tenant timely shall have requested the Broker Determination, then the Annual Fixed Rent for the applicable Extended Term shall be the greater of (a) ninety-five percent (95%) of the Prevailing Market Rent as determined by the Broker Determination or (b) the Annual Fixed Rent in effect during the last twelve (12) month period of the Lease Term immediately prior to such Extended Term. If Tenant does not timely request the Broker Determination, then Annual Fixed Rent during the applicable Extended Term shall be equal to the greater of (a) Landlords Rent Quotation or (b) the Annual Fixed Rent in effect during the last twelve (12) month period of the Lease Term immediately prior to such Extended Term.
(C) Upon the giving of the Exercise Notice by Tenant to Landlord exercising Tenants then applicable option to extend the Lease Term in accordance with the provisions of either subsection (B) above, this Lease and the Lease Term hereof shall be extended, for the applicable Extended Term, without the necessity for the execution of any additional documents, except that Landlord and Tenant agree to enter into an instrument in writing setting forth the Annual Fixed Rent for the then applicable Extended Term but the failure to so enter into such a written instrument shall not negate the exercise of the applicable option to extend. Notwithstanding anything herein contained to the contrary, in no event shall Tenant have the right to exercise more than one extension option at a time and, further, Tenant shall not have the right to exercise its second extension option unless it has duly exercised its first extension option and in no event shall the Lease Term hereof be extended for more than six (6) years after the expiration of the Original Term hereof.
2.5 | Fixed Rent Payments |
Tenant agrees to pay to Landlord, (1)(a) on the applicable Rent Commencement Date (defined in Section 1.1 hereof) and thereafter monthly, in advance, on the first day of each and every calendar month during the Original Term, a sum equal to one twelfth (1/12th) of the applicable Annual Fixed Rent (sometimes hereinafter referred to as fixed rent) and (1)(b) on the applicable Commencement Date and thereafter monthly, in advance, on the first day of each and every calendar month during the Original Term, an amount estimated by Landlord from time to time to cover Tenants monthly payments for electricity under Section 2.8 hereinbelow and (2) on the first day of each and every
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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calendar month during each extension option period (if exercised), a sum equal to (a) one twelfth (1/12th) of the applicable Annual Fixed Rent as determined in Section 2.4.1 for the applicable extension option period plus (b) then applicable monthly electricity charges (subject to escalation for electricity as provided in Section 2.8 hereof). Until notice of some other designation is given, fixed rent and all other charges for which provision is herein made shall be paid by remittance to or for the order of Boston Properties Limited Partnership either (i) by mail to P.O. Box 3557, Boston, Massachusetts 02241-3557, (ii) by wire transfer to Bank of America in Dallas, Texas, Bank Routing Number 0260-0959-3 or (iii) by ACH transfer to Bank of America in Dallas, Texas, Bank Routing Number 111 000 012, and in the case of (ii) or (iii) referencing Account Number 3756454460, Account Name of Boston Properties, LP, Tenants name and the Property address. All remittances received by Boston Properties Limited Partnership, as Agents as aforesaid, or by any subsequently designated recipient, shall be treated as payment to Landlord.
Annual Fixed Rent for any partial month shall be paid by Tenant to Landlord at such rate on a pro rata basis, and, if the applicable Rent Commencement Date is a day other than the first day of a calendar month, the first payment of Annual Fixed Rent which Tenant shall make to Landlord shall be a payment equal to a proportionate part of such monthly Annual Fixed Rent for the partial month from the applicable Rent Commencement Date to the first day of the succeeding calendar month.
Additional Rent payable by Tenant on a monthly basis, as hereinafter provided, likewise shall be prorated, and the first payment on account thereof shall be determined in similar fashion but shall commence on the applicable Commencement Date; and other provisions of this Lease calling for monthly payments shall be read as incorporating this undertaking by Tenant.
Notwithstanding that the payment of Annual Fixed Rent payable by Tenant to Landlord shall not commence until the Rent Commencement Date, Tenant shall be subject to, and shall comply with, all other provisions of this Lease as and at the times provided in this Lease.
The Annual Fixed Rent and all other charges for which provision is herein made shall be paid by Tenant to Landlord, without offset, deduction or abatement except as otherwise specifically set forth in this Lease.
2.6 | Operating Expenses |
Landlords Operating Expenses means the cost of operation of the Building and the Site which shall exclude costs of special services rendered to tenants (including Tenant) for which a separate charge is made, but shall include, without limitation, the following: premiums for insurance carried with respect to the Building and the Site (including, without limitation, liability insurance, insurance against loss in case of fire or casualty and insurance of monthly installments of fixed rent and any Additional Rent which may be due under this Lease and other leases of space in the Building for not more than 12 months in the case of both fixed rent and Additional Rent and if there be any first
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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mortgage of the Property, including such insurance as may be required by the holder of such first mortgage); maintenance, repair and replacement of the transformer and related equipment and appurtenances which are to be installed as part of Landlords Work; compensation and all fringe benefits, workers compensation insurance premiums and payroll taxes paid to, for or with respect to all persons engaged in the operating, maintaining or cleaning of the Building or Site and consistent with other comparable buildings owned by Landlord or Landlords affiliates in the Boston West suburban market; water, sewer, electric, gas, oil and telephone charges (excluding utility charges separately chargeable to tenants for additional or special services); cost of building and cleaning supplies and equipment; cost of maintenance, cleaning and repairs (other than repairs not properly chargeable against income or reimbursed from contractors under guarantees); cost of snow removal and care of landscaping; payments under service contracts with independent contractors; management fees at reasonable rates for self managed buildings consistent with the type of occupancy and the service rendered not to exceed three percent (3%) of annual gross scheduled revenues for the Building; and all other reasonable and necessary expenses paid in connection with the operation, cleaning and maintenance of the Building and the Site and properly chargeable against income, provided, however, there shall be included (a) depreciation for capital expenditures made by Landlord during the Lease Term (i) to reduce Landlords Operating Expenses if Landlord shall have reasonably determined that the annual reduction in Landlords Operating Expenses shall exceed depreciation therefor or (ii) to comply with applicable laws, rules, regulations, requirements, statutes, ordinances, by-laws and court decisions of all public authorities which are enacted, or interpreted to apply to the Property, after the date of this Lease (the capital expenditures described in subsections (i) and (ii) being hereinafter referred to as Permitted Capital Expenditures); plus (b) in the case of both (i) and (ii) an interest factor, reasonably determined by Landlord, as being the interest rate then charged for long term mortgages by institutional lenders on like properties within the locality in which the Building is located; depreciation in the case of both (i) and (ii) shall be determined by dividing the original cost of such capital expenditure by the number of years of useful life of the capital item acquired and the useful life shall be reasonably determined by Landlord in accordance with generally accepted accounting principles and practices in effect at the time of acquisition of the capital item; provided, however, if Landlord reasonably concludes on the basis of engineering estimates that a particular capital expenditure will effect savings in other Landlords Operating Expenses, including, without limitation, energy related costs, and that such projected savings will, on an annual basis (Projected Annual Savings), exceed the annual depreciation therefor, then and in such event the amount of depreciation for such capital expenditure shall be increased to an amount equal to the Projected Annual Savings; and in such circumstance, the increased depreciation (in the amount of the Projected Annual Savings) shall be made for such period of time as it would take to fully amortize the cost of the item in question, together with interest thereon at the interest rate as aforesaid in equal monthly payments, each in the amount of 1/12th of the Projected Annual Savings, with such payment to be applied first to interest and the balance to principal.
Notwithstanding the foregoing, the following shall be excluded from Operating Expenses for the Property:
(1) | All capital expenditures and depreciation, except as otherwise explicitly provided in this Section 2.6; |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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(2) | Leasing fees or commissions, advertising and promotional expenses, legal fees, the cost of tenant improvements, build out allowances, moving expenses, assumption of rent under existing leases and other concessions incurred in connection with leasing space in the Building; |
(3) | Interest on indebtedness, debt amortization, ground rent, and refinancing costs for any mortgage or ground lease of the Building or the Site; |
(4) | Costs paid or incurred in connection with financings, refinancings or sales of any of Landlords interest in the Building or the Site; |
(5) | Costs incurred in performing work or furnishing services for any tenant (including Tenant), whether at such tenants or Landlords expense, to the extent that such work or services is in excess of any work or service that Landlord is obligated to furnish to Tenant at Landlords expense (e.g., if Landlord agrees to provide extra cleaning to another tenant, the cost thereof would be excluded since Landlord is not obligated to furnish extra cleaning to Tenant); |
(6) | The cost of any item or service to the extent to which Landlord is actually reimbursed or compensated by insurance, any tenant, or any third party; |
(7) | Any advertising, promotional or marketing expenses for the Building; |
(8) | The cost of any service or materials provided by any party related to Landlord, to the extent such costs exceed the reasonable cost for such service or materials absent such relationship in buildings similar to the Building in the vicinity of the Building; |
(9) | Penalties and interest for late payment of any obligations of Landlord, including, without limitation, taxes, insurance, equipment leases and other past due amounts; |
(10) | Unfunded contributions to operating expense reserves; |
(11) | Salaries or other compensation paid to employees above the grade of Building manager; |
(12) | The cost of remediation or removal of Hazardous Materials (as defined in Section 5.3) which are in or on the Building or on the Site as of the Effective Date to the extent required by Hazardous Materials Laws (as defined in Section 5.3) unless caused by Tenant or its contractors, subcontractors, agents, employees or invitees, but the foregoing shall not prohibit the inclusion of routine maintenance and monitoring costs); |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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(13) | Costs of repairs, replacements, alterations or improvements necessary to make the Building or the Site comply with applicable law as of the date of this Lease; |
(14) | The costs of correcting defects in the construction of tenant spaces that Landlord has agreed to make under this Lease or other leases affecting the Buildings; |
(15) | Costs caused by the gross negligence of Landlord; |
(16) | Costs and expenses (including legal expenses) of Landlords enforcement of any other lease in the Building; |
(17) | Costs resulting from Landlords breach of this Lease or any other lease of space in the Building; |
(18) | Rents due under ground leases; and |
(19) | Costs of applying and reporting for the Building or any part thereof to seek or maintain certification under the U.S. EPAs Energy Star® rating system, the U.S. Green Building Councils Leadership in Energy and Environmental Design (LEED) rating system or a similar system or standard. |
Operating Expenses Allocable to the Premises shall mean the same proportion of Landlords Operating Expenses for and pertaining to the Building and the Site as the Rentable Floor Area of the Premises bears to 100% of the Total Rentable Floor Area of the Building. The parties acknowledge that for purposes of determining the initial amounts due under this Section 2.6, the Operating Expenses Allocable to the Premises shall not be based upon the entire Rentable Floor Area of the Premises until the Final Commencement Date due to the varied delivery dates of certain portions of the Premises as contemplated hereunder, and as a result, the Operating Expenses Allocable to the Premises with respect to period from the Second Floor and Third Floor Premises Commencement Date through the Final Commencement Date shall be adjusted on a proportionate basis reflective of the Applicable Commencement Date of each such portion of the Premises.
Tenant shall pay to Landlord, as Additional Rent, with respect to any calendar year falling within the Term, or fraction of a calendar year falling within the Term at the beginning or end thereof, the Operating Expenses Allocable to the Premises. Such payments shall be made at the times and in the manner hereinafter provided in this Section 2.6. Tenant shall make payments monthly in the amount of one-twelfth (1/12) of the Operating Expenses Allocable to the Premises anticipated for the then current year at the time and in the fashion herein provided for the payment of Annual Fixed Rent for the Premises. The amount to be paid to Landlord shall be an amount reasonably estimated annually by Landlord to be sufficient to cover, in the aggregate, a sum equal to the Operating Expenses Allocable to the Premises for the then-applicable calendar year of the Term.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Not later than one hundred and twenty (120) days after the end of the first calendar year or fraction thereof ending December 31 and of each succeeding calendar year during the Term or fraction thereof at the end of the Term, Landlord shall render Tenant a statement (the Reconciliation Statement) in reasonable detail and according to usual accounting practices certified by a representative of Landlord, showing for the preceding calendar year or fraction thereof, as the case may be, Landlords Operating Expenses and Operating Expenses Allocable to the Premises. Said Reconciliation Statement to be rendered to Tenant shall also show for the preceding year or fraction thereof, as the case may be the amounts of Operating Expenses Allocable to the Premises already paid by Tenant as Additional Rent and the amount of Operating Expenses Allocable to the Premises remaining due from, or overpaid by, Tenant for the applicable calendar year or other period covered by the statement. Within thirty (30) days after the date of delivery of such statement, Tenant shall pay to Landlord the balance of the amounts, if any, required to be paid pursuant to the above provisions of this Section 2.6 with respect to the preceding year or fraction thereof, or Landlord shall credit any amounts overpaid by Tenant against (i) monthly installments of fixed rent next thereafter coming due or (ii) any sums then due from Tenant to Landlord under this Lease (or refund such portion of the overpayment as aforesaid if the Term has ended and there is no Event of Default hereunder).
2.6.1 | Tenants Audit Right. |
Subject to the provisions of this Section and provided that no Event of Default of Tenant exists, Tenant shall have the right to examine the correctness of the Landlords Reconciliation Statement or any item contained therein on the following terms:
1. Any request for examination in respect of any Operating Year (as defined hereinbelow) may be made by notice from Tenant to Landlord no more than ninety (90) days after the date (the Tenant Audit Notice Date) Landlord provides Tenant the Reconciliation Statement of the actual amount of the Landlords Operating Expenses in respect of such Operating Year (the Operating Expense Statement Date) and only if Tenant shall have fully paid such amount. Such notice shall set forth in reasonable detail the matters questioned. Any examination must be completed and the results communicated to Landlord no more than one hundred eighty (180) days after the Tenant Audit Notice Date. Operating Year shall mean a period of twelve (12) consecutive calendar months, commencing on the first day of January in each year, except that the first Operating Year of the Lease Term hereof shall be the period commencing on the Commencement Date and ending on the succeeding December 31, and the last Operating Year of the Lease Term hereof shall be the period commencing on January 1 of the calendar year in which the Lease Term ends, and ending with the date on which the Lease Term ends.
2. Tenant hereby acknowledges and agrees that Tenants sole right to contest the Reconciliation Statement shall be as expressly set forth in this Section. Tenant hereby waives any and all other rights provided pursuant to applicable laws to inspect Landlords
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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books and records and/or to contest the Reconciliation Statement. If Tenant shall fail to timely exercise Tenants right to inspect Landlords books and records as provided in this Section, or if Tenant shall fail to timely communicate to Landlord the results of Tenants examination as provided in this Section, with respect to any Operating Year, Landlords Reconciliation Statement shall be conclusive and binding on Tenant.
3. So much of Landlords books and records pertaining to the Landlords Operating Expenses for the specific matters questioned by Tenant for the Operating Year included in Landlords statement shall be made available to Tenant within a reasonable time after Landlord timely receives the notice from Tenant to make such examination pursuant to this Section, either electronically or during normal business hours at the offices where Landlord keeps such books and records or at another location, as determined by Landlord.
4. Tenant shall have the right to make such examination no more than once in respect of any Operating Year in which Landlord has given Tenant a statement of the Landlords Operating Expenses.
5. Such examination may be made only by a qualified employee of Tenant or a qualified independent certified public accounting firm approved by Landlord. No examination shall be conducted by an examiner who is to be compensated, in whole or in part, on a contingent fee basis.
6. As a condition to performing any such examination, Tenant and its examiners shall be required to execute and deliver to Landlord an agreement, in form acceptable to Landlord, agreeing to keep confidential any information which it discovers about Landlord or the Building in connection with such examination.
7. No subtenant shall have any right to conduct any such examination and no assignee may conduct any such examination with respect to any period during which the assignee was not in possession of the Premises.
8. All costs and expenses of any such examination shall be paid by Tenant except if such examination shows that the amount of the Landlords Operating Expenses payable by Tenant was overstated by more than five percent (5%), Landlord shall reimburse Tenant for the reasonable out-of-pocket costs and expenses incurred by Tenant in such examination, up to a maximum of Three Thousand Dollars ($3,000). Any portion of Landlords Operating Expenses which are determined to be improperly charged by Landlord with respect to the Operating Year for which such audit is conducted shall be promptly refunded by Landlord to Tenant.
2.7 | Real Estate Taxes |
Tenant shall pay to Landlord, as Additional Rent, with respect to any full Tax Year or fraction of a Tax Year falling within the Term, Landlords Tax Expenses Allocable to the Premises (as hereinafter defined) on or before the thirtieth (30th) day following receipt by Tenant of the certified statement referred to below in this Section 2.7. Not later than
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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ninety (90) days after Landlords Tax Expenses Allocable to the Premises are determined for the first such Tax Year or fraction thereof and for each succeeding Tax Year or fraction thereof during the Term, Landlord shall render Tenant a statement in reasonable detail certified by a representative of Landlord showing for the preceding year or fraction thereof, as the case may be, real estate taxes on the Building and the Site and abatements and refunds of any taxes and assessments. Expenditures for reasonable, out-of-pocket, legal fees and for other expenses incurred in seeking the tax refund or abatement may be charged against the tax refund or abatement before the adjustments are made for the Tax Year. Said statement to be rendered to Tenant shall also show for the preceding Tax Year or fraction thereof as the case may be the amounts of real estate taxes already paid by Tenant as Additional Rent, and the amount of real estate taxes remaining due from, or overpaid by, Tenant for the year or other period covered by the statement. Within thirty (30) days after the date of delivery of the foregoing statement, Tenant shall pay to Landlord the balance of the amounts, if any, required to be paid pursuant to the above provisions of this Section 2.7 with respect to the preceding Tax Year or fraction thereof, or Landlord shall credit any amounts due from it to Tenant pursuant to the provisions of this Section 2.7 against (i) monthly installments of fixed rent next thereafter coming due or (ii) any sums then due from Tenant to Landlord under this Lease (or refund such portion of the over-payment as aforesaid if the Term has ended and Tenant has no further obligation to Landlord).
Payments by Tenant on account of Landlords Tax Expenses Allocable to the Premises shall be made monthly at the time and in the fashion herein provided for the payment of Annual Fixed Rent. The monthly amount so to be paid to Landlord shall be one-twelfth of the yearly amount reasonably estimated by Landlord to be sufficient to provide Landlord, in the aggregate, with a sum equal to Landlords Tax Expense Allocable to the Premises, at least ten (10) days before the day on which such payments by Landlord would become delinquent.
To the extent that real estate taxes shall be payable to the taxing authority in installments with respect to periods less than a Tax Year, the foregoing statement shall be rendered and payments made on account of such installments.
Terms used herein are defined as follows:
(i) | Tax Year means the twelve-month period beginning July 1 each year during the Term or if the appropriate governmental tax fiscal period shall begin on any date other than July 1, such other date. |
(ii) | Landlords Tax Expenses Allocable to the Premises shall mean the same proportion of Landlords Tax Expenses for and pertaining to the Building and the Site as the Rentable Floor Area of the Premises bears to 100% of the Total Rentable Floor Area of the Building. |
(iii) | Landlords Tax Expenses with respect to any Tax Year means the aggregate real estate taxes on the Building and Site with respect to that Tax Year, reduced by any abatement receipts with respect to that Tax Year. |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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(iv) | Real estate taxes means all taxes and special assessments of every kind and nature and user fees and other like fees assessed by any governmental authority on the Building or Site which the Landlord shall become obligated to pay because of or in connection with the ownership, leasing or operation of the Site, the Building and the Property (including, without limitation, if applicable the excise prescribed by Mass Gen Laws Chapter 121A, Section 10 and amounts in excess thereof paid to the Town of Lexington pursuant to agreement between Landlord and the Town) and reasonable expenses of and fees for any formal or informal proceedings for negotiation or abatement of taxes (collectively, Abatement Expenses). The amount of special taxes or special assessments to be included shall be limited to the amount of the installment (plus any interest, other than penalty interest, payable thereon) of such special tax or special assessment required to be paid during the year in respect of which such taxes are being determined. There shall be excluded from such taxes all income, estate, succession, inheritance and transfer taxes; provided, however, that if at any time during the Term the present system of ad valorem taxation of real property shall be changed so that in lieu of, or in addition to, the whole or any part of the ad valorem tax on real property there shall be assessed on Landlord a capital levy or other tax on the gross rents received with respect to the Site or Building or Property, federal, state, county, municipal, or other local income, franchise, excise or similar tax, assessment, levy or charge (distinct from any now in effect in the jurisdiction in which the Property is located) measured by or based, in whole or in part, upon any such gross rents, then any and all of such taxes, assessments, levies or charges, to the extent so measured or based, shall be deemed to be included within the term real estate taxes but only to the extent that the same would be payable if the Site and Building were the only property of Landlord. |
2.8 | Tenant Electricity |
Tenant acknowledges that the Premises shall be separately sub-metered or check metered for electrical service (it being agreed that Landlord shall be responsible for the cost of such metering as to the Third Floor Premises and the cost of such metering as to the Office/Laboratory Premises and the [*] Premises shall be included in the cost of Landlords Additional Work (as defined in Exhibit B-1)).
Tenant shall pay for all charges for electric consumption in the Premises as reasonably determined by Landlord based on readings of such submeters or check meters, but without mark-up above actual cost, within thirty (30) days of Landlords invoice therefor, from time to time, but not more often than monthly. Notwithstanding the forgoing, upon written notice from Landlord, Tenant shall pay an estimate of such charges, as reasonably determined by Landlord from time to time, monthly at the same time and in the same
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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manner as payments of Annual Fixed Rent, with appropriate payment (or credit against future electric charges) to be made annually based upon Landlords revised estimates for the prior year. If at any time electric charges for the Premises are payable to the utility therefor, because of the installation of submeters or check meters or otherwise, Tenant shall pay such charges as they become due, in lieu of such payments to Landlord as described above. Also, in the event that there is located in the Premises a data center containing high density computing equipment, as defined in the U.S. EPAs Energy Star® rating system (Energy Star), Landlord may, at any time during the Term, require the installation in accordance with Energy Star of separate metering or check metering equipment (Tenant being responsible for the costs of any such meter or check meter and the installation and connectivity thereof), and Tenant shall pay to Landlord, as Additional Rent, all electric consumption on any such meter within thirty (30) days after being billed thereof by Landlord, in addition to other electric charges payable by Tenant under this Lease. Further, Tenant agrees to comply with the requirements of Exhibit K in connection with any data center (as defined in such Exhibit) operated in the Premises as well as the related installation of meters to record the related consumption of such data center.
Not later than ninety (90) days after the end of the first calendar year or fraction thereof ending December 31 and of each succeeding calendar year during the Term or fraction thereof at the end of the Term, Landlord shall render Tenant a reasonably detailed accounting certified by a representative of Landlord showing for the preceding calendar year, or fraction thereof, as the case may be, the costs of furnishing electricity to the Premises. Said statement to be rendered to Tenant also shall show for the preceding year or fraction thereof, as the case may be, the amount already paid by Tenant on account of electricity, and the amount remaining due from, or overpaid by, Tenant for the year or other period covered by the statement. Within thirty (30) days after the date of the delivery of such statement, Tenant shall pay to Landlord the balance of the amounts, if any required to be paid pursuant to the above provisions of this Section 2.8 with respect to the preceding year, or fraction thereof, or Landlord shall credit any amounts due from it to Tenant pursuant to the above provisions of this Section 2.8 against monthly installments of Annual Fixed Rent or Additional Rent next thereafter coming due unless the Lease Term has expired and Tenant has no other or further obligations to Landlord, in which case Landlord shall promptly refund such amount to Tenant.
Tenant acknowledges and agrees that its payments under this Section 2.8 relate solely with respect to electrical consumption in the Premises and that costs of electrical consumption with respect to the remainder of the Building and the Site, including common areas and facilities and exterior lighting, shall be included in Landlords Operating Expenses.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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ARTICLE III
Condition of Premises
3.1 | Preparation of Premises |
The condition of the Premises upon Landlords delivery along with any work to be performed by either Landlord or Tenant shall be as set forth in the Work Agreement attached hereto as Exhibit B-1 and made a part hereof. In addition, Landlord shall be responsible for (i) ensuring that the roof and structure of the Building, and the existing mechanical, electrical and HVAC systems are delivered in good working order on the Second Floor Premises and Third Floor Premises Commencement Date, and (ii) renovating the base building and common areas, including renovating the cafeteria and the lobby in the Building, as provided in Exhibit B-5 attached hereto and made a part hereof (Landlords Common Area Work) at Landlords expense, without inclusion of such costs of renovation in Operating Expenses.
Landlord represents to Tenant that (i) to the best of Landlords actual knowledge as of the date of this Lease, there are no Hazardous Materials in the Premises which are required to be removed or otherwise abated in accordance with applicable Hazardous Materials Laws except for certain mastic adhesive used on floor tiles and elsewhere which has been identified as potentially containing asbestos, which Landlord agrees to abate in accordance with the Hazardous Materials Laws as necessary for the performance of the Landlords Work, and (ii) the Landlords Work and the Landlords Common Area Work shall be performed in compliance with all Legal Requirements (as defined below).
ARTICLE IV
Landlords Covenants; Interruptions and Delays
4.1 | Landlord Covenants |
4.1.1 | Services Furnished by Landlord |
To furnish services, utilities, facilities and supplies set forth in Exhibit C equal to those customarily provided by landlords in high quality buildings in the Boston West Suburban Market subject to escalation reimbursement in accordance with Section 2.6.
4.1.2 | Additional Services Available to Tenant |
To furnish, at Tenants expense, reasonable additional Building operation services which are usual and customary in similar office buildings in the Boston West Suburban Market upon reasonable advance request of Tenant at reasonable and equitable rates from time to time established by Landlord. Tenant agrees to pay to Landlord, as Additional Rent, the cost of any such additional Building services requested by Tenant and for the cost of any additions, alterations, improvements or other work performed by Landlord in the Premises at the request of Tenant within thirty (30) days after being billed therefor.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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4.1.3 | Roof, Exterior Wall, Floor Slab and Common Facility Repairs |
Except for (a) normal and reasonable wear and use and (b) damage caused by fire and casualty and by eminent domain, and except as otherwise provided in Article VI (i) to make such repairs to the roof, exterior walls, floor slabs and common areas and facilities as may be necessary to keep them in serviceable condition and (ii) to maintain the Building (exclusive of Tenants responsibilities under this Lease) in a first class manner comparable to the maintenance of similar properties in the Boston West Suburban Market.
4.1.4 | Door Signs |
To provide and install, at Landlords expense, letters or numerals on the exterior doors to the Premises to identify Tenants official name and Building address; all such letters and numerals shall be in the building standard graphics and no others shall be used or permitted on the Premises.
4.1.5 | Compliance with Law |
Landlord at Landlords expense, shall be responsible for the work described in Exhibit B-1 and for the common areas of the Building which Landlord renovates in connection with the performance of the Landlords Work, complying as of the Third Floor Commencement Date with the requirements of the Federal Americans With Disabilities Act (the ADA) in effect on the Third Floor Commencement Date; provided, however, that notwithstanding the foregoing, Tenant at Tenants expense, shall be responsible for (i) any additions, alterations or improvements performed by or for Tenant or any assignee of subtenant of Tenant (Tenant Improvements) complying with the ADA and (ii) compliance with the ADA required because of Tenants Specific Use of the Premises (as defined below) or Tenant Improvements. The term Tenants Specific Use of the Premises as used in this Lease shall not refer to the general office use of the Premises, but shall refer to the specific products and operations Tenant and any assignee and subtenant of Tenant use in the Premises and the manner in which Tenant and any assignee and subtenant of Tenant use such products and conduct such operations.
4.2 | Interruptions and Delays in Services and Repairs, etc. |
Landlord shall not be liable to Tenant for any compensation or reduction of rent by reason of inconvenience or annoyance or for loss of business arising from the necessity of Landlord or its agents entering the Premises in compliance with Section 5.7 hereof or other applicable provisions of this Lease for any of the purposes in this Lease authorized, or for repairing the Premises or any portion of the Building however the necessity may occur. In case Landlord is prevented or delayed from making any repairs, alterations or improvements, or furnishing any services or performing any other covenant or duty to be
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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performed on Landlords part, by reason of any cause reasonably beyond Landlords control, including without limitation by reason of Force Majeure (as defined in Section 6.1 hereof), Landlord shall not be liable to Tenant therefor, nor, except as expressly otherwise provided in Article VI, shall Tenant be entitled to any abatement or reduction of rent by reason thereof, or right to terminate this Lease, nor shall the same give rise to a claim in Tenants favor that such failure constitutes actual or constructive, total or partial, eviction from the Premises.
Landlord reserves the right to stop any service or utility system, when necessary by reason of accident or emergency, or until necessary repairs have been completed; provided, however, that in each instance of stoppage, Landlord shall exercise reasonable diligence to eliminate the cause thereof. Except in case of emergency repairs, Landlord will give Tenant reasonable advance notice of any contemplated stoppage and will use reasonable efforts to avoid unnecessary inconvenience to Tenant by reason thereof.
4.3 | Tenant Self-Help. |
Landlord shall never be liable for any failure to make repairs which, under the provisions of this Lease, Landlord has undertaken to make unless:
(a) | Tenant has given notice to Landlord of the need to make such repairs, or of a condition in the Building or in the Premises requiring any repair for which Landlord is responsible; and |
(b) | Landlord has failed to commence to make such repairs within a reasonable time after receipt of such notice. |
In the event Landlord fails to make such repairs as are required of Landlord within thirty (30) days after written notice from Tenant to Landlord and to the holder of any mortgage on the Premises of which Landlord has given Tenant notice or of which Tenant has actual notice, specifying the nature of such repairs (or if such repairs are of the type which cannot be completed within thirty (30) days, then if Landlord or the holder of any such mortgage (at the option of such mortgagee) fails to (i) commence making such repairs within thirty (30) days after such written notice from Tenant and (ii) thereafter prosecute such repairs to completion with due diligence given the nature of such repairs), then thereafter at any time prior to Landlords or such mortgagees commencing such repairs or subsequent to Landlord or such mortgagee commencing such repairs if Landlord or such mortgagee has not prosecuted such repairs to completion with due diligence given the nature of such repairs, Tenant may, but need not, make such repairs and charge the reasonable cost thereof to Landlord; provided, however, that in the case of emergency repairs (i) such notice by Tenant to Landlord and such mortgagee need not be in writing (and may be given solely to Landlord by telephone notice to the Boston Properties Control Center at 877-297-8411with a confirmatory email to mwaldron@bostonproperties.com (it being agreed that such telephone and/or email contact information may be changed by Landlord on written notice to Tenant delivered in accordance with Section 9.11 below)), and (ii) Tenant may make such emergency repairs
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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and charge the reasonable cost thereof (together with interest thereon from the date of payment of such costs through the date of repayment at the rate of one and one-half percentage points over the then prevailing prime rate in Boston as set by Bank of America, N.A., or its successor (but in no event greater than the maximum rate permitted by applicable law) to Landlord if either Landlord or such mortgagee has not made such emergency repairs within a reasonable time after such notice. However, in no event shall Tenant have the right to offset against, withhold or deduct from Annual Fixed Rent or additional rent payable under this Lease for any reason relating to this Section 4.3.
For purposes of clarification, the provisions of this Section 4.3 are not intended to, and shall not be interpreted to, require Tenant to send Landlord a notice as a condition precedent to Landlords obligation to perform any maintenance, repair or replacement obligations of Landlord which exist under this Lease.
ARTICLE V
Tenants Covenants
Tenant covenants and agrees to the following during the Term and such further time as Tenant occupies any part of the Premises:
5.1 | Payments |
To pay when due all Annual Fixed Rent and Additional Rent and all charges for utility services rendered to the Premises (except as otherwise provided in Exhibit C) and, further, as Additional Rent, all charges for additional services rendered pursuant to Section 4.1.2. In the event Tenant pays any utilities for the Premises directly to the utility company or provider, Tenant shall grant Landlord access to Tenants account with such utility company or provider so that Landlord can review the utility bills relating to the Premises.
5.2 | Repair and Yield Up |
Except as otherwise provided in Article VI and Section 4.1.3, to keep the Premises in good order, repair and condition, reasonable wear and tear only excepted, and all glass in windows (except glass in exterior walls unless the damage thereto is attributable to Tenants negligence or misuse) and doors of the Premises whole and in good condition with glass of the same type and quality as that injured or broken, damage by fire or taking under the power of eminent domain only excepted, and at the expiration or termination of this Lease peaceably to yield up the Premises all construction, work, improvements, and all alterations and additions thereto in good order, repair and condition, reasonable wear and tear only excepted, first removing all goods and effects of Tenant (but in no event shall Tenant remove any lab equipment and casework, refrigeration units, generators, compressors, benches (other than moveable benches which are in no way affixed to the Premises other than connection to utilities such as compressed air, electricity and gas), hoods, or HVAC systems which was paid for in whole or in part by the Tenant Allowance unless required by Landlord as provided herein) and, to the extent specified
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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by Landlord by notice to Tenant given at least ten (10) days before such expiration or termination (unless otherwise specified by Landlord as set forth in Section 5.12 below), the wiring for Tenants computer, telephone and other communication systems and equipment whether located in the Premises or in any other portion of the Building, including all risers and, to the extent requested by Tenant and specified by Landlord for removal as set forth in Section 5.12 below (except such limitation shall not apply with respect to alterations performed by Tenant without Landlord consent), all alterations and additions made by Tenant and all partitions, and repairing any damage caused by such removal and restoring the Premises and leaving them clean and neat. Tenant shall not permit or commit any waste, and Tenant shall be responsible for the cost of repairs which may be made necessary by reason of damage to common areas in the Building or to the Site caused by Tenant, Tenants agents, contractors, employees, sublessees, licensees, concessionaires or invitees.
5.3 | Use |
To use the Premises for the Permitted Use only, and not to injure or deface the Premises, Building, the Site or any other part of the Complex nor to permit in the Premises or on the Site any auction sale, vending machine (except as permitted by Landlord and located in the cafeteria of the Building), or inflammable fluids or chemicals, or nuisance, or the emission from the Premises of any objectionable noise or odor, nor to permit in the Premises anything which will in any way result in the leakage of fluid or the growth of mold, and not to use or devote the Premises or any part thereof for any purpose other than the Permitted Uses, nor for any use thereof which is inconsistent with maintaining the Building as a first class office and laboratory building in the quality of its maintenance, use and occupancy, or which is improper, offensive, contrary to law or ordinance or liable to render necessary any alteration or addition to the Building.
Notwithstanding the foregoing, Tenant shall not, nor shall Tenant permit its employees, invitees, agents, independent contractors, contractors, assignees or subtenants to, keep, maintain, use or store any Hazardous Materials in the Premises (other than the Hazardous Materials listed in Exhibit I (and at no greater than the amounts and/or quantities specified therein) (Tenants Hazardous Materials), provided that the same shall at all times be brought upon, kept or used in accordance with all applicable Hazardous Materials Laws (hereinafter defined) and to the extent any alterations or additions, including, without limitation, installation of life/safety and/or monitoring systems, are required with respect to the Premises and/or the Building under Legal Requirements or Hazardous Materials Laws as a result of Tenants Hazardous Materials, Tenant, subject to the terms of this Lease, shall be solely responsible for performing and/or installing the same, at its cost, as a condition precedent to Tenants right to use, store or dispose of, such Hazardous Materials) unless the same are approved by Landlord, which approval shall not be unreasonably withheld, conditioned or delayed. Tenant shall deliver MSDS sheets (and proposed quantities) with all requests for approval of Hazardous Materials as required above, and shall be responsible for notifying all federal, state and local authorities (including the Town of Lexington Fire Department) of the use, storage and disposal of Hazardous Materials by Tenant to the extent required by applicable law. Landlord agrees to respond to such request for approval within ten (10) business days of
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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receipt of all of the foregoing. Tenant shall maintain at the Premises a list of all Hazardous Materials that the Tenant will keep, maintain, use or store at the Premises (the Hazardous Materials Schedule). On or before each anniversary of the Final Commencement Date, and on any earlier date during the 12-month period on which Tenant intends to add a new Hazardous Material or increase the quantity of any Hazardous Material to the Hazardous Materials Schedule, Tenant shall update the Hazardous Materials Schedule and deliver the same to Landlord for Landlords approval with respect to such new or increased Hazardous Materials as required above. The Hazardous Materials Schedule shall be reasonably available to the Landlord at the Premises upon the Landlords written request. Further, (i) Tenant shall not, nor shall Tenant permit its employees, invitees, agents, independent contractors, contractors, assignees or subtenants to, keep, use, maintain, or store Hazardous Materials (as hereinafter defined), or dispose of the same into the sewage or waste disposal system or otherwise, or engage in any activity, in violation of Hazardous Materials Laws (as hereinafter defined) which might produce or generate any substance which is or may hereafter be classified as a radioactive, hazardous material, waste or substance (collectively Hazardous Materials), under federal, state or local laws, rules and regulations or standards, including, without limitation, 42 U.S.C. Section 6901 et seq., 42 U.S.C. Section 9601 et seq., 42 U.S.C. Section 2601 et seq., 49 U.S.C. Section 1802 et seq. and Massachusetts General Laws, Chapter 21E, and the National Fire Protection Association NFPA 45: Standards of Fire Protection for Laboratories Using Chemicals, and the rules and regulations or standards promulgated under any of the foregoing, as such laws, rules and regulations may be amended from time to time (collectively Hazardous Materials Laws), (ii) Tenant shall immediately notify Landlord of any incident in, on or about the Premises, the Building or the Site that would require the filing of a notice, or reporting to any governmental entity, under any Hazardous Materials Laws, (iii) Tenant shall comply and shall cause its employees, invitees, agents, independent contractors, contractors, assignees and subtenants to comply with each of the foregoing and (iv) subject to the provisions of Section 5.7, Landlord shall have the right to make such inspections (including testing) as Landlord shall elect from time to time to determine that Tenant is complying with the foregoing.
Notwithstanding anything to the contrary contained in this Lease, prior to the expiration or earlier termination of the Term, Tenant shall clean and otherwise cause the Premises to be decommissioned in accordance with all applicable Hazardous Materials Laws and shall leave the Premises and the Building (and the piping, sewage or waste disposal system, supply lines, drains and storage containers and basins serving the same, and all exhaust or other ductwork) free of all chemicals, blood, blood products, germs, bacteria, viruses, biological products and other Hazardous Materials resulting from Tenants use or occupancy of the Premises. Without limiting the foregoing, upon expiration or earlier termination of the Lease, Tenant shall provide Landlord, at Tenants sole cost and expense, with a so-called Clean Certificate from a reputable, experienced third party environmental engineer or industrial hygienist, licensed to do business in the Commonwealth of Massachusetts, dated within thirty (30) days after the expiration or early termination of the Term certifying to the Landlord that (a) the Premises, the Building and the pipes, sewage or waste disposal system, supply lines, drains, storage
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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containers, basins, exhaust and ductwork are free from chemicals, blood, blood products, germs, bacteria, viruses, biological products and other Hazardous Materials, (b) the Premises, the Building and the pipes, sewage or waste disposal system, supply lines, drains, storage containers, ductwork and exhaust serving the Premises have been sanitized in accordance with applicable Hazardous Materials Laws, (c) any radioactive materials, biological or chemical safety cabinets located, storage rooms or the storage areas in the Premises have been emptied and decontaminated in accordance with applicable Hazardous Materials Laws. If Tenant fails to perform such obligations under this paragraph, without limiting any other right or remedy, Landlord may, on ten (10) business days prior written notice to Tenant perform such obligations at Tenants expense, and Tenant shall within thirty (30) days of demand reimburse Landlord for all reasonable out-of-pocket costs and expenses incurred by Landlord in connection with such work. Tenants obligations under this paragraph shall survive the expiration or earlier termination of this Lease.
5.4 | Obstructions; Items Visible from Exterior; Rules and Regulations |
Not to obstruct in any manner any portion of the Building not hereby leased or any portion thereof or of the Site used by Tenant in common with others; not without prior consent of Landlord to permit the painting or placing of any signs, curtains, blinds, shades, awnings, aerials or flagpoles, or the like, visible from outside the Premises; and to comply with all reasonable rules and regulations now or hereafter made by Landlord, of which Tenant has been given notice, for the care and use of the Building and Site and their facilities and approaches; Landlord shall not be liable to Tenant for the failure of other occupants of the Building to conform to such rules and regulations. Without in any way limiting Landlords approval rights, in no event shall Tenant have the right to construct or otherwise place on or over windows any shades, coverings of any nature or type or any darkening or light reducing or blocking materials and, in addition, in no event shall Tenant construct or place any equipment, furniture, fixtures or the like in front of any windows.
5.5 | Safety Appliances |
To keep the Premises equipped with all safety appliances required by any public authority because of any use made by Tenant other than normal office use, and to procure all licenses and permits so required because of such use and, if requested by Landlord, to do any work so required because of such use, it being understood that the foregoing provisions shall not be construed to broaden in any way Tenants Permitted Use.
5.6 | Assignment; Sublease |
Except as otherwise expressly provided herein, Tenant covenants and agrees that it shall not assign, mortgage, pledge, hypothecate or otherwise transfer this Lease and/or Tenants interest in this Lease or sublet (which term, without limitation, shall include granting of concessions, licenses or the like) the whole or any part of the Premises. If Tenant is not a publicly-traded corporation, an assignment, within the meaning of this Section 5.6, shall be deemed to include one or more sales or transfers of stock or
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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membership or partnership interests, by operation of law or otherwise, or the issuance of new stock or membership or partnership interests, by which an aggregate of more than fifty percent (50%) of Tenants stock or membership or partnership interests shall be vested in a party or parties who are not stockholders or members or partners as of the date hereof, but in all events subject to Tenants rights under Section 5.6.4 below. For the purpose of this Section 5.6, ownership of stock or membership or partnership interests shall be determined in accordance with the principles set forth in Section 544 of the Internal Revenue Code of 1986, as amended from time to time, or the corresponding provisions of any subsequent law. Subject to the provisions of Section 5.6.4 below, the merger or consolidation of Tenant into or with any other entity, or the sale of all or substantially all of its assets, shall be deemed to be an assignment within the meaning of this Section 5.6. Any assignment, mortgage, pledge, hypothecation, transfer or subletting not expressly permitted in or consented to by Landlord under Sections 5.6.1-5.6.6 shall, at Landlords election, be void; shall be of no force and effect; and shall confer no rights on or in favor of third parties. In addition, Landlord shall be entitled to seek specific performance of or other equitable relief with respect to the provisions hereof.
5.6.1 | Notwithstanding the provisions of Section 5.6 above, in the event Tenant desires to assign this Lease or to sublet the whole (but not part) of the Premises (no partial subletting being permitted other than as provided in Section 5.6.4 below), Tenant shall give Landlord notice (the Proposed Transfer Notice) of any proposed sublease or assignment, and said notice shall specify the provisions of the proposed assignment or subletting, including (a) the name and address of the proposed assignee or subtenant, (b) in the case of a proposed assignment or subletting pursuant to Section 5.6.3 below, such information as to the proposed assignees or proposed subtenants net worth and financial capability and standing as may reasonably be required for Landlord to make the determination referred to in said Section 5.6.3 (provided, however, that Landlord shall hold such information confidential having the right to release same to its officers, accountants, attorneys and mortgage lenders on a confidential basis), (c) all of the terms and provisions upon which the proposed assignment or subletting is to be made, (d) in the case of a proposed assignment or subletting pursuant to Section 5.6.3 below, all other information necessary to make the determination referred to in said Section 5.6.3 and (e) in the case of a proposed assignment or subletting pursuant to Section 5.6.4 below, such information as may be reasonably required by Landlord to determine that such proposed assignment or subletting complies with the requirements of said Section 5.6.4. |
5.6.2 | Landlord shall have the right at its sole option, to be exercised within thirty (30) days after receipt of Tenants Proposed Transfer Notice (the Acceptance Period), to terminate this Lease as of the date proposed commencement date of the assignment or sublease which is the such of the Proposed Transfer Notice; provided, however, that upon such termination date, all obligations relating to the period after such termination date (but not those relating to the period before such termination date) shall cease and promptly upon being billed therefor by Landlord, Tenant shall make final payment of all Annual Fixed Rent and |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Additional Rent due from Tenant through the termination date. In the event that Landlord shall not exercise its termination rights as aforesaid, or shall fail to give any or timely notice pursuant to this Section the provisions of Sections 5.6.3, 5.6.5 and 5.6.6 shall be applicable. This Section 5.6.2 shall not be applicable to an assignment or sublease pursuant to Section 5.6.4. |
5.6.3 | Notwithstanding the provisions of Section 5.6 above, but subject to the provisions of this Section 5.6.3 and the provisions of Sections 5.6.5 and 5.6.6 below, in the event that Landlord shall not have exercised the termination right as set forth in Section 5.6.2, or shall have failed to give any or timely notice under Section 5.6.2, then for a period of one hundred and eighty (180) days (i) after the receipt of Landlords notice stating that Landlord does not elect the termination right, or (ii) after the expiration of the Acceptance Period, in the event Landlord shall not give any or timely notice under Section 5.6.2 as the case may be, Tenant shall have the right to assign this Lease or sublet the Premises in accordance with the Proposed Transfer Notice provided that, in each instance, Tenant first obtains the express prior written consent of Landlord, which consent shall not be unreasonably withheld, conditioned or delayed. |
Without limiting the foregoing standard, Landlord shall not be deemed to be unreasonably withholding its consent to such a proposed assignment or subleasing if:
(a) | the proposed assignee or subtenant is a tenant in the Building or is in active negotiation with Landlord for premises in the Building or is not of a character consistent with the operation of a first class office and laboratory building (by way of example Landlord shall not be deemed to be unreasonably withholding its consent to an assignment or subleasing to any governmental or quasi-governmental agency), or |
(b) | the proposed assignee or subtenant is not of good character and reputation, or |
(c) | the proposed assignee or subtenant does not possess adequate financial capability to perform the Tenant obligations as and when due or required, or |
(d) | the assignee or subtenant proposes to use the Premises (or part thereof) for a purpose other than the purpose for which the Premises may be used as stated in Section 1.1 hereof, or |
(e) | the character of the business to be conducted or the proposed use of the Premises by the proposed subtenant or assignee shall (i) be likely to increase Landlords Operating Expenses beyond that which Landlord now incurs for use by Tenant and the proposed |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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subtenant or assignee and Tenant have not agreed in writing for the benefit of the Landlord to pay for such increase; (ii) be likely to increase the burden on elevators or other Building systems or equipment over the burden generated by normal and customary office and laboratory usage; or (iii) violate or be likely to violate any provisions or restrictions contained herein relating to the use or occupancy of the Premises, or |
(f) | there shall be existing an Event of Default (defined in Section 7.1) or there have been two (2) or more Event of Default occurrences during the Term, or |
(g) | any part of the rent payable under the proposed assignment or sublease shall be based in whole or in part on the income or profits derived from the Premises or if any proposed assignment or sublease shall potentially have any adverse effect on the real estate investment trust qualification requirements applicable to Landlord and its affiliates, or |
(h) | the holder of any mortgage or ground lease on property which includes the Premises does not approve of the proposed assignment or sublease despite Landlords reasonable efforts to obtain such approval, or |
(i) | due to the identity or business of a proposed assignee or subtenant, such approval would cause Landlord to be in violation of any covenant or restriction contained in any recorded agreement affecting space in the Building or the Property. |
If Landlord shall consent to the proposed assignment or subletting, as the case may be, then, in such event, Tenant may thereafter sublease (the whole but not part of the Premises) or assign pursuant to Tenants notice, as given hereunder; provided, however, that if such assignment or sublease shall not be executed and delivered to Landlord within one hundred and twenty (120) days after the date of Landlords consent, the consent shall be deemed null and void and the provisions of Section 5.6.1 shall be applicable.
5.6.4 | Notwithstanding the foregoing provisions of Sections 5.6, 5.6.2, 5.6.3 and 5.6.5, but subject to the provisions of Sections 5.6.1 and 5.6.6, Tenant shall have the right to assign this Lease or to sublet the Premises (in whole or in part) to any other entity (the Successor Entity) (i) which controls or is controlled by Tenant or Tenants parent corporation, or which is under common control with Tenant (each a Related Party), or (ii) which purchases all or substantially all of the assets of Tenant, or (iii) which purchases all or substantially all of the stock of (or other ownership or membership interests in) Tenant or (iv) which merges or combines with Tenant, provided that the entity to which this Lease is so assigned |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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or which so sublets the Premises has a credit worthiness (e.g. net assets on a pro forma basis using generally accepted accounting principles consistently applied and using the most recent financial statements) which is the same or better than the Tenant as of the date of this Lease (the foregoing transferees referred to, individually or collectively, as a Permitted Transferee) except that with respect to a transfer to a Related Party, the Related Party to which this Lease is so assigned or which so sublets the Premises has a credit worthiness when combined with that of Tenant (e.g. net assets on a pro forma basis using generally accepted accounting principles consistently applied and using the most recent financial statements) which is the same or better than the Tenant as of the date of this Lease. Except in cases of statutory merger, in which case the surviving entity in the merger shall be liable as the Tenant under this Lease, Tenant shall continue to remain fully liable under this Lease, on a joint and several basis with the Permitted Transferee. If any parent, affiliate or subsidiary of Tenant to which this Lease is assigned or the Premises sublet (in whole or in part) shall cease to be such a parent, affiliate or subsidiary, such cessation shall be considered an assignment or subletting requiring Landlords consent.
5.6.5 | In the case of any assignment or subleasing as to which Landlord may consent (other than an assignment or subletting permitted under Section 5.6.4 above) such consent shall be upon the express and further condition, covenant and agreement, and Tenant hereby covenants and agrees that, in addition to the Annual Fixed Rent, Additional Rent and other charges to be paid pursuant to this Lease, fifty percent (50%) of the Assignment/Sublease Profits (hereinafter defined), if any, shall be paid to Landlord. The Assignment/Sublease Profits shall be the excess, if any, of (a) the Assignment/Sublease Net Revenues as hereinafter defined after first deducting (b) the Annual Fixed Rent and Additional Rent and other charges provided in this Lease (provided, however, that for the purpose of calculating the Assignment/Sublease Profits in the case of a sublease of a portion of the Premises, appropriate prorations in the applicable Annual Fixed Rent, Additional Rent and other charges under this Lease shall be made based on the percentage of the Premises subleased and on the terms of the sublease). The Assignment/Sublease Net Revenues shall be the fixed rent, Additional Rent and all other charges and sums payable either initially or over the term of the sublease or assignment plus all other profits and increases to be derived by Tenant as a result of such subletting or assignment, less the reasonable costs of Tenant incurred in such subleasing or assignment (the definition of which shall be limited to brokerage commissions, reasonable out-of-pocket legal fees incurred in connection with such sublease or assignment, costs payable to Landlord under Section 5.6.6(B) below and alteration allowances, in each case actually paid), as set forth in a statement certified by an appropriate officer of Tenant and delivered to Landlord within thirty (30) days of the full execution of the sublease or assignment document, amortized over the term of the sublease or assignment. |
All payments of the Assignment/Sublease Profits due Landlord shall be made within thirty (30) days of receipt of same by Tenant.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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5.6.6 | (A) It shall be a condition of the validity of any assignment or subletting consented to under Section 5.6.3 above, or any assignment or subletting of right under Section 5.6.4 above, that both Tenant and the assignee or sublessee enter into a separate written instrument directly with Landlord in a form and containing terms and provisions reasonably required by Landlord, including, without limitation, the agreement of the assignee or sublessee to be bound directly to Landlord for all the obligations of the Tenant under this Lease (including any amendments or extensions thereof), including, without limitation, the obligation (a) to pay the rent and other amounts provided for under this Lease (but in the case of a partial subletting pursuant to Section 5.6.4, such subtenant shall agree on a pro rata basis to be so bound), (b) to comply with the provisions of Sections 5.6 through 5.6.6 hereof and (c) to indemnify the Landlord Parties (as defined in Section 8.13) as provided in Section 8.1 hereof. Such assignment or subletting shall not relieve the Tenant named herein of any of the obligations of the Tenant hereunder and Tenant shall remain fully and primarily liable therefor and the liability of Tenant and such assignee (or subtenant, as the case may be) shall be joint and several. Further, and notwithstanding the foregoing, the provisions hereof shall not constitute a recognition of the sublease or the subtenant thereunder, as the case may be, and at Landlords option, upon the termination or expiration of the Lease (whether such termination is based upon a cause beyond Tenants control, a default of Tenant, the agreement of Tenant and Landlord or any other reason), the sublease shall be terminated. |
(B) As Additional Rent, Tenant shall pay to Landlord as a fee for Landlords review of any proposed assignment or sublease requested by Tenant and the preparation of any associated documentation in connection therewith, within thirty (30) days after receipt of an invoice from Landlord, an amount equal to the sum of (i) $1,000.00 and/or (ii) reasonable out of pocket legal fees or other expenses incurred by Landlord in connection with such request; provided, however, that no such amounts shall be due to Landlord if Landlord exercises its rights under Section 5.6.2.
(C) If this Lease be assigned, or if the Premises or any part thereof be sublet or occupied by anyone other than Tenant, Landlord may upon prior notice to Tenant, at any time and from time to time, collect rent and other charges from the assignee, sublessee or occupant and apply the net amount collected to the rent and other charges herein reserved, but no such assignment, subletting, occupancy or collection shall be deemed a waiver of this covenant, or a waiver of the provisions of Sections 5.6 through 5.6.6 hereof, or the acceptance of the assignee, sublessee or occupant as a tenant or a release of Tenant from the further performance by Tenant of covenants on the part of Tenant herein contained, the Tenant herein named to remain primarily liable under this Lease.
(D) The consent by Landlord to an assignment or subletting under Section 5.6.3 above, or the consummation of an assignment or subletting of right under
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Section 5.6.4 above, shall in no way be construed to relieve Tenant from obtaining the express consent in writing of Landlord to any further assignment or subletting.
(E) On or after the occurrence of an Event of Default (defined in Section 7.1), Landlord shall be entitled to one hundred percent (100%) of any Assignment/Sublease Profits arising from and after the Event of Default.
(F) Without limiting Tenants obligations under Section 5.12, Tenant shall be responsible, at Tenants sole cost and expense, for performing all work necessary to comply with Legal Requirements and Insurance Requirements in connection with any assignment or subletting hereunder including, without limitation, any work in connection with such assignment or subletting.
5.7 | Right of Entry |
To permit Landlord and its agents to examine the Premises at (i) reasonable times and upon reasonable notice (which shall be at one (1) business days notice), (ii) accompanied by a representative of Tenant if Tenant so elects, and (iii) in compliance with Tenants reasonable security and safety requirements (established from time to time by Tenant and of which Landlord is given advance written notice) (clauses (i) through (iii) collectively, the Entry Requirements) and, if Landlord shall so elect, in compliance the Entry Requirements, (x) to make any repairs or replacements required of Landlord under this Lease or which Landlord may deem necessary, (y) to remove, at Tenants expense, any alterations, addition, signs, curtains, blinds, shades, awnings, aerials, flagpoles, or the like not consented to in writing, or (z) to show the Premises to (A) prospective tenants during the nine (9) months preceding expiration of the Term, and (B) prospective purchasers and mortgagees at all reasonable times. Notwithstanding the foregoing, the building superintendent and those individuals involved in the cleaning and regular daily maintenance of the Building shall not be subject to the Entry Requirements (except when entering the [*] and any other areas of the Premises shown as Restricted Areas as shown on Exhibit D attached hereto when such Entry Requirements shall apply); provided, however that in the event of entry by the building superintendent, Tenant shall have the right to have a representative of Tenant accompany the superintendent if Tenant so elects and such representative is made promptly available between the hours of 8:00 a.m. to 6:00 p.m. Monday through Friday (legal holidays in all cases excepted). Further notwithstanding anything in the foregoing to the contrary, in the event of an emergency that could cause damage to health, safety or property, Landlord shall use good faith efforts to follow Tenants Entry Requirements and in such event Landlord will be required to give only such notice that it in good faith believes is feasible under the circumstances and need not wait to be accompanied by Tenant or its employees or representatives (although these parties may still accompany Landlord if they are available and wish to do so).
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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5.8 | Floor Load; Prevention of Vibration and Noise |
Not to place a load upon the Premises exceeding an average rate of 100 pounds of live load per square foot of floor area (partitions shall be considered as part of the live load); and not to move any safe, vault or other heavy equipment in, about or out of the Premises except in such manner and at such time as Landlord shall in each instance authorize; Tenants business machines and mechanical equipment which cause vibration or noise that may be transmitted to the Building structure or to any other space in the Building shall be so installed, maintained and used by Tenant so as to eliminate such vibration or noise.
5.9 | Personal Property Taxes |
To pay promptly when due all taxes which may be imposed upon Tenants Property (as defined in Section 8.4 hereof) in the Premises to whomever assessed.
5.10 | Compliance with Laws |
To comply with all applicable Legal Requirements now or hereafter in force which shall impose a duty on Landlord or Tenant relating to or as a result of the use or occupancy of the Premises; provided that (i) Tenant shall not be required to make any alterations or additions to the structure, roof, exterior and load bearing walls, foundation, structural floor slabs and other structural elements of the Building unless the same are required by such Legal Requirements as a result of or in connection with Tenants use or occupancy of the Premises beyond normal use of space of this kind, and (ii) Tenant shall not be responsible for non-compliance with Legal Requirements which exists prior to the Applicable Commencement Date as to the applicable portion of the Premises unless compliance is necessitated by the particular use made of such portion of the Premises by Tenant (or subtenants or assignees) or alterations performed by or for the benefit of Tenant (or subtenants or assignees) with respect to the Premises. Tenant shall promptly pay all fines, penalties and damages that may arise out of or be imposed because of its failure to comply with the provisions of this Section 5.10.
5.11 | Payment of Litigation Expenses |
To pay as Additional Rent all reasonable costs, counsel and other fees incurred by Landlord in connection with the successful enforcement by Landlord of any obligations of Tenant under this Lease or in connection with any bankruptcy case involving Tenant or any guarantor.
5.12 | Alterations |
Tenant shall not make alterations and additions to Tenants Premises except in accordance with plans and specifications therefor first approved by Landlord, which approval shall not be unreasonably withheld. However, Landlords determination of matters relating to aesthetic issues relating to alterations, additions or improvements which are visible outside the Premises shall be in Landlords sole discretion. Without
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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limiting such standard Landlord shall not be deemed unreasonable for withholding approval of any alterations or additions (including, without limitation, any alterations or additions to be performed by Tenant under Article III) which (a) in Landlords opinion might adversely affect any structural or exterior element of the Building, any area or element outside of the Premises, or any facility or base building mechanical system serving any area of the Building outside of the Premises, or (b) involve or affect the exterior design, size, height, or other exterior dimensions of the Building or (c) will require unusual expense to readapt the Premises to normal office use on Lease termination or expiration or increase the cost of construction or of insurance or taxes on the Building or of the services called for by Section 4.1 unless Tenant first gives assurance acceptable to Landlord for payment of such increased cost and that such readaptation will be made prior to such termination or expiration without expense to Landlord, (d) enlarge the Rentable Floor Area of the Premises, or (e) are inconsistent, in Landlords judgment, with alterations satisfying Landlords standards for new alterations in the Building. Landlords review and approval of any such plans and specifications and consent to perform work described therein shall not be deemed an agreement by Landlord that such plans, specifications and work conform with applicable Legal Requirements and requirements of insurers of the Building and the other requirements of this Lease with respect to Tenants insurance obligations (herein called Insurance Requirements) nor deemed a waiver of Tenants obligations under this Lease with respect to applicable Legal Requirements and Insurance Requirements nor impose any liability or obligation upon Landlord with respect to the completeness, design sufficiency or compliance of such plans, specifications and work with applicable Legal Requirements and Insurance Requirements nor give right to any other parties. Further, Tenant acknowledges that Tenant is acting for its own benefit and account, and that Tenant shall not be acting as Landlords agent in performing any work in the Premises, accordingly, no contractor, subcontractor or supplier shall have a right to lien Landlords interest in the Property in connection with any such work. Within thirty (30) days after receipt of an invoice from Landlord, Tenant shall pay to Landlord as a fee for Landlords review of any work or plans (excluding any review respecting initial improvements performed pursuant to Article III hereof for which a fee has previously been paid but including any review of plans or work relating to any assignment or subletting), as Additional Rent, an amount equal to the sum of: (i) $150.00 per hour (not to exceed $3,000 with respect to each project provided the same relates only to typical office alterations (as opposed to alterations relating laboratory, [*] and similar uses (Non-Office Alterations), it being agreed that such expenses are not to exceed $7,000 with respect to Non-Office Alterations), plus (ii) reasonable third party expenses incurred by Landlord (and appropriate for the contemplated alteration) in connection with the review of Tenants plans and Tenants work. Except for any additions or alterations which Tenant expressly requests to remain in the Premises in Tenants notice seeking Landlords consent for the installation thereof (which notice shall specifically refer to this Section 5.12) and for which Landlord fails to specifically designate for removal in writing (the No-Removal Alterations), all alterations and additions shall be part of the Building unless and until Landlord shall specify the same for removal pursuant to Section 5.2. For purposes of clarifying the foregoing, in no event may Landlord require removal of the No-Removal Alterations pursuant to Section 5.2 above. All of Tenants alterations and additions and
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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installation of furnishings shall be coordinated with any work being performed by Landlord and in such manner as to maintain harmonious labor relations and not to damage the Buildings or Site or interfere with construction or operation of the Buildings and other improvements to the Site and, except for installation of furnishings, shall be performed by Landlords general contractor or by contractors or workers first approved by Landlord, which approval shall not be unreasonably withheld, conditioned or delayed. Except for work by Landlords general contractor, Tenant, before its work is started, shall secure all licenses and permits necessary therefor; deliver to Landlord a statement of the names of all its contractors and subcontractors and the estimated cost of all labor and material to be furnished by them and security satisfactory to Landlord protecting Landlord against liens arising out of the furnishing of such labor and material; and cause each contractor to carry insurance in accordance with Section 8.14 herein, and to deliver to Landlord certificates of all such insurance. Tenant shall also prepare and submit to Landlord a set of as-built plans, in both print and electronic forms, showing such work performed by Tenant to the Premises promptly after any such alterations, improvements or installations are substantially complete and promptly after any wiring or cabling for Tenants computer, telephone and other communications systems is installed by Tenant or Tenants contractor. Without limiting any of Tenants obligations hereunder, Tenant shall be responsible, as Additional Rent, for the costs of any alterations, additions or improvements in or to the Building that are required in order to comply with Legal Requirements as a result of any work performed by Tenant. Landlord shall have the right to provide such rules and regulations relative to the performance of any alterations, additions, improvements and installations by Tenant hereunder and Tenant shall abide by all such reasonable rules and regulations and shall cause all of its contractors to so abide including, without limitation, payment for the costs of using Building services. Tenant agrees to pay promptly when due the entire cost of any work done on the Premises by Tenant, its agents, employees, or independent contractors, and not to cause or permit any liens for labor or materials performed or furnished in connection therewith to attach to the Premises or the Buildings or the Site and immediately to discharge or bond over any such liens which may so attach. Tenant shall pay, as Additional Rent, 100% of any real estate taxes on the Complex which shall, at any time after commencement of the Term, result from any alteration, addition or improvement to the Premises made by Tenant. Tenant acknowledges and agrees that Landlord shall be the owner of any additions, alterations and improvements in the Premises or the Building to the extent paid for by Landlord.
Notwithstanding the terms of Section 5.12, Tenant shall have the right, without obtaining the prior consent of Landlord but upon prior notice to Landlord, to make alterations, additions or improvements to the Premises where:
(i) | the same are within the interior of the Premises within the Building, and do not affect the exterior of the Premises and the Building (including no signs on windows); |
(ii) | the same do not affect the roof, any structural element of the Building, the mechanical, electrical, plumbing, heating, ventilating, air-conditioning and fire protection systems of the Building; |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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(iii) | the cost of any individual alteration, addition or improvement shall not exceed $20,000 and the aggregate cost of said alterations, additions or improvements made by Tenant during the Lease Term shall not exceed $150,000 in cost (provided, however that costs of painting and carpeting within the Premises shall not apply towards either of such amounts); and |
(iv) | Tenant shall comply with the provisions of this Lease and if such work increases the cost of insurance or taxes or of services, Tenant shall pay for any such increase in cost; |
provided, however, that Tenant shall, within fifteen (15) days after the making of such changes, send to Landlord plans and specifications describing the same in reasonable detail and provided further that Landlord, by notice to Tenant given at least thirty (30) days prior to the expiration or earlier termination of the Lease Term, may require Tenant to restore the Premises to its condition prior to such alteration, addition or improvement at the expiration or earlier termination of the Lease Term.
5.13 | Vendors |
Any vendors engaged by Tenant to perform services in or to the Premises including, without limitation, janitorial contractors and moving contractors shall be coordinated with any work being performed by or for Landlord and in such manner as to maintain harmonious labor relations and not to damage the Building or the Property or interfere with Building construction or operation and shall be performed by vendors first approved by Landlord.
5.14 | Patriot Act |
As an inducement to Landlord to enter into this Lease, Tenant hereby represents and warrants that: (i) Tenant is not, nor is it owned or controlled directly or indirectly by, any person, group, entity or nation named on any list issued by the Office of Foreign Assets Control of the United States Department of the Treasury (OFAC) pursuant to Executive Order 13224 or any similar list or any law, order, rule or regulation or any Executive Order of the President of the United States as a terrorist, Specially Designated National and Blocked Person or other banned or blocked person (any such person, group, entity or nation being hereinafter referred to as a Prohibited Person); (ii) Tenant is not (nor is it owned, controlled, directly or indirectly, by any person, group, entity or nation which is) acting directly or indirectly for or on behalf of any Prohibited Person; and ((iii) from and after the effective date of the above-referenced Executive Order, Tenant (and any person, group, or entity which Tenant controls, directly or indirectly) has not conducted nor will conduct business nor has engaged nor will engage in any transaction or dealing with any Prohibited Person in violation of the U.S. Patriot Act or any OFAC rule or regulation, including without limitation any assignment of this Lease or any subletting of all or any portion of the Premises or the making or receiving of any contribution of funds, goods or services to or for the benefit of a Prohibited Person in violation of the U.S. Patriot Act or any OFAC rule or regulation. In connection with the foregoing, it is
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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expressly understood and agreed that (x) any breach by Tenant of the foregoing representations and warranties shall be deemed an immediate Event of Default by Tenant under Section 7.1 of this Lease (without the benefit of notice or grace) and shall be covered by the indemnity provisions of Section 8.1 below, and (y) the representations and warranties contained in this subsection shall be continuing in nature and shall survive the expiration or earlier termination of this Lease. Notwithstanding anything to the contrary contained herein, so long as (i) Tenant is a publicly-traded company whose shares are listed and traded on a United States national stock exchange, this subsection shall not apply to any person (including any entity) to the extent such persons interest in Tenant is as a shareholder of Tenant, and (ii) any entity which has an ownership interest in Tenant is a publicly-traded company whose shares are listed and traded on a United States national stock exchange, this subsection shall not apply to any person (including any entity) to the extent such persons interest in Tenant is as a shareholder of such entity which has an ownership interest in Tenant
ARTICLE VI
Casualty and Taking
6.1 | Damage Resulting from Casualty |
In case during the Lease Term the Building or the Site are damaged by fire or casualty and such fire or casualty damage cannot, in the ordinary course, reasonably be expected to be repaired within two hundred forty (240) days from the time that repair work would commence, Landlord may, at its election, terminate this Lease by notice given to Tenant within sixty (60) days after the date of such fire or other casualty, specifying the effective date of termination. The effective date of termination specified by Landlord shall not be less than thirty (30) days nor more than forty-five (45) days after the date of notice of such termination. Landlord will provide an estimate (the Restoration Estimate) to Tenant of the time period for the restoration of the Premises, Building and Site, as the case may be, within sixty (60) days following the date of such damage or casualty.
In case (i) the Premises are damaged by fire or casualty and the Restoration Estimate indicates that restoration thereto can not reasonably be expected to be substantially completed within two hundred and forty (240) days (and/or as to special work or work which requires long lead time then if such work cannot reasonably be expected to be repaired within such additional time as is reasonable under the circumstances given the nature of the work) from the time that repair work would commence, Tenant may, at its election, terminate this Lease by notice given to Landlord within thirty (30) days after receipt of the Restoration Estimate, specifying the effective date of termination. The effective date of termination specified by Tenant shall be not less than thirty (30) days nor more than forty-five (45) days after the date of notice of such termination. Further, in case during the last year of the Lease Term, the Premises are damaged by fire or casualty and the Restoration Estimate indicates that restoration thereto can not reasonably be expected to be substantially completed within, in the ordinary course, one hundred fifty (150) days (and/or as to special work or work which requires long lead time then if such work cannot reasonably be expected to be repaired within such additional time as is
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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reasonable under the circumstances given the nature of the work) from the time that repair work would commence, then either party may, at its election, terminate this Lease by notice given to the other within sixty (60) days after the date of such fire or other casualty, specifying the effective date of termination. The effective date of termination specified by such party shall be not less than thirty (30) days nor more than forty-five (45) days after the date of notice of such termination.
Unless terminated pursuant to the foregoing provisions, this Lease shall remain in full force and effect following any such damage subject, however, to the following provisions.
If the Building or the Site or any part thereof are damaged by fire or other casualty and this Lease is not so terminated, or Landlord or Tenant have no right to terminate this Lease, and in any such case the holder of any mortgage which includes the Building as a part of the mortgaged premises or any ground lessor of any ground lease which includes the Site as part of the demised premises allows the net insurance proceeds to be applied to the restoration of the Building (and/or the Site), Landlord shall, promptly after such damage and the determination of the net amount of insurance proceeds available, use due diligence to restore the Premises and the Building in the event of damage thereto (excluding Tenants Property (as defined in Section 8.4 hereof)), except as expressly provided in the immediately following paragraph of this Section 6.1) into substantially the condition which existed as of the completion of Landlords Work (excluding any FF&E (as defined in Section 8.4 below) and a just proportion of the Annual Fixed Rent, Tenants share of Operating Expenses and Tenants share of real estate taxes shall be abated according to the nature and extent of the injury to the Premises, until the Premises shall have been restored by Landlord substantially into such condition except for punch list items and long lead items. Notwithstanding anything herein contained to the contrary, Landlord shall not be obligated to expend for such repair and restoration any amount in excess of the net insurance proceeds.
Notwithstanding the foregoing, if Landlord is proceeding with the restoration of the Building and the Premises in accordance with the previous paragraph, Landlord shall also restore any alterations, additions or improvements within the Premises that are part of Tenants Property (excluding any FF&E) (x) which have previously been approved by Landlord in accordance with the terms and provisions of this Lease and (y) with respect to which Tenant has carried all risk insurance covering the loss or damage in accordance with Section 8.4 below and pays the proceeds of such insurance (or an amount equivalent thereto) to Landlord within ten (10) business days following Landlords written request; provided, however, that in no event shall Landlord be required to fund any insufficiency in the insurance proceeds (or equivalent amount) provided by Tenant with respect to such loss or damage (or to fund any of the costs of restoration in the absence of any payment by Tenant).
If such restoration is not completed within thirty (30) days after the date stated in Landlords Restoration Estimate, such period to be subject, however, to extension where the delay in completion of such work is due to Force Majeure, as defined hereinbelow,
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Tenant, as its sole and exclusive remedy, shall have the right to terminate this Lease at any time after the expiration of such period (as extended), which right shall continue until the restoration is substantially completed. Such termination shall be effective as of the thirtieth (30th) day after the date of receipt by Landlord of Tenants notice, with the same force and effect as if such date were the date originally established as the expiration date hereof unless, within thirty (30) days after Landlords receipt of Tenants notice, such restoration is substantially completed, in which case Tenants notice of termination shall be of no force and effect and this Lease and the Lease Term shall continue in full force and effect. When used herein, Force Majeure shall mean any prevention, delay or stoppage due to governmental regulation, strikes, lockouts, acts of God, acts of war, terrorists acts, civil commotions, unusual scarcity of or inability to obtain labor or materials, labor difficulties, casualty or other causes reasonably beyond Landlords control or attributable to Tenants action or inaction.
6.2 | Uninsured Casualty |
Notwithstanding anything to the contrary contained in this Lease, if the Building or the Premises shall be substantially damaged by fire or casualty as the result of a risk not covered by the forms of casualty insurance at the time maintained by Landlord or required to be maintained by Landlord hereunder, and such fire or casualty damage cannot, in the ordinary course, reasonably be expected to be repaired within ninety (90) days from the time that repair work would commence, Landlord may, at its election, terminate the Term of this Lease by notice to the Tenant given within sixty (60) days after such loss. If Landlord shall give such notice, then this Lease shall terminate as of the date of such notice with the same force and effect as if such date were the date originally established as the expiration date hereof.
6.3 | Rights of Termination for Taking |
If the entire Building, or such portion of the Premises as to render the balance (if reconstructed to the maximum extent practicable in the circumstances) unsuitable for Tenants purposes, shall be taken by condemnation or right of eminent domain, Landlord or Tenant shall have the right to terminate this Lease by notice to the other of its desire to do so, provided that such notice is given not later than thirty (30) days after Tenant has been deprived of possession. If either party shall give such notice, then this Lease shall terminate as of the date of such notice with the same force and effect as if such date were the date originally established as the expiration date hereof.
Further, if so much of the Building shall be so taken that continued operation of the Building would be uneconomic as a result of the taking, Landlord shall have the right to terminate this Lease by giving notice to Tenant of Landlords desire to do so not later than thirty (30) days after Tenant has been deprived of possession of the Premises (or such portion thereof as may be taken). If Landlord shall give such notice, then this Lease shall terminate as of the date of such notice with the same force and effect as if such date were the date originally established as the expiration date hereof.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Should any part of the Premises be so taken or condemned during the Lease Term hereof, and should this Lease not be terminated in accordance with the foregoing provisions, and the holder of any mortgage which includes the Premises as part of the mortgaged premises or any ground lessor of any ground lease which includes the Site as part of the demised premises allows the net condemnation proceeds to be applied to the restoration of the Building, Landlord agrees, after the determination of the net amount of condemnation proceeds available to Landlord, to use due diligence to put what may remain of the Premises into proper condition for use and occupation as nearly like the condition of the Premises prior to such taking as shall be practicable (excluding Tenants Property). Notwithstanding the foregoing, Landlord shall not be obligated to expend for such repair and restoration any amount in excess of the net condemnation proceeds made available to it.
If the Premises shall be affected by any exercise of the power of eminent domain, then the Annual Fixed Rent, Tenants share of operating costs and Tenants share of real estate taxes shall be justly and equitably abated and reduced according to the nature and extent of the loss of use thereof suffered by Tenant; and in case of a taking which permanently reduces the Rentable Floor Area of the Premises, a just proportion of the Annual Fixed Rent, Tenants share of Operating Expenses and Tenants share of real estate taxes shall be abated for the remainder of the Lease Term.
6.4 | Award |
Landlord shall have and hereby reserves to itself any and all rights to receive awards made for damages to the Premises, the Building, the Complex and the Site and the leasehold hereby created, or any one or more of them, accruing by reason of exercise of eminent domain or by reason of anything lawfully done in pursuance of public or other authority. Tenant hereby grants, releases and assigns to Landlord all Tenants rights to such awards, and covenants to execute and deliver such further assignments and assurances thereof as Landlord may from time to time request, and if Tenant shall fail to execute and deliver the same within fifteen (15) days after notice from Landlord.
Nothing contained herein shall be construed to prevent Tenant from prosecuting in any condemnation proceeding a claim for the value of any of Tenants Property installed in the Premises by Tenant at Tenants expense and for relocation and moving expenses, provided that such action and any resulting award shall not affect or diminish the amount of compensation otherwise recoverable by Landlord from the taking authority.
ARTICLE VII
Default
7.1 | Tenants Default |
(a) | If at any time subsequent to the date of this Lease any one or more of the following events (herein sometimes called an Event of Default) shall occur: |
(i) | Tenant shall fail to pay the fixed rent, Additional Rent or other charges for which provision is made herein on or before the date on which the same become due and payable, and the same continues for five (5) business days after notice from Landlord thereof; or |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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(ii) | Landlord having rightfully given the notice specified in subdivision (i) above twice in any calendar year, Tenant shall thereafter in the same calendar year fail to pay the fixed rent, Additional Rent or other charges on or before the date on which the same become due and payable; or |
(iii) | Tenant shall assign its interest in this Lease or sublet any portion of the Premises in violation of the requirements of Section 5.6 through 5.6.5 of this Lease; or |
(iv) | Tenant shall fail to perform or observe some term or condition of this Lease which, because of its character, would immediately jeopardize Landlords interest (such as, but without limitation, failure to maintain general liability insurance, or the employment of labor and contractors within the Premises which interfere with Landlords work, in violation of Exhibit B-1), and such failure continues for three business (3) days after notice from Landlord to Tenant thereof; or |
(v) | Tenant shall neglect or fail to perform or observe any other covenant herein contained on Tenants part to be performed or observed and Tenant shall fail to remedy the same within thirty (30) days after notice to Tenant specifying such neglect or failure, or if such failure is of such a nature that Tenant cannot reasonably remedy the same within such thirty (30) day period, Tenant shall fail to commence promptly to remedy the same and to prosecute such remedy to completion with diligence and continuity; or |
(vi) | Tenants leasehold interest in the Premises shall be taken on execution or by other process of law directed against Tenant; or |
(vii) | Tenant shall make an assignment for the benefit of creditors or shall file a voluntary petition in bankruptcy or shall be adjudicated bankrupt or insolvent, or shall file any petition or answer seeking any reorganization, arrangement, composition, readjustment, liquidation, dissolution or similar relief for itself under any present or future federal, state or other statute, law or regulation for the relief of debtors, or shall seek or consent to or acquiesce in the appointment of any trustee, receiver or liquidator of Tenant or of all or any substantial part of its properties, or shall admit in writing its inability to pay its debts generally as they become due; or |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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(viii) | A petition shall be filed against Tenant in bankruptcy or under any other law seeking any reorganization, arrangement, composition, readjustment, liquidation, dissolution, or similar relief under any present or future Federal, State or other statute, law or regulation and shall remain undismissed or unstayed for an aggregate of sixty (60) days (whether or not consecutive), or if any debtor in possession (whether or not Tenant) trustee, receiver or liquidator of Tenant or of all or any substantial part of its properties or of the Premises shall be appointed without the consent or acquiescence of Tenant and such appointment shall remain unvacated or unstayed for an aggregate of sixty (60) days (whether or not consecutive) then, and in any of said cases (notwithstanding any license of a former breach of covenant or waiver of the benefit hereof or consent in a former instance). |
Landlord lawfully may, immediately or at any time thereafter, and without demand or further notice terminate this Lease by notice to Tenant, specifying a date not less than fifteen (15) days after the giving of such notice on which this Lease shall terminate, and this Lease shall come to an end on the date specified therein as fully and completely as if such date were the date herein originally fixed for the expiration of the Lease Term (Tenant hereby waiving any rights of redemption), and Tenant will then quit and surrender the Premises to Landlord, but Tenant shall remain liable as hereinafter provided.
(b) | If this Lease shall have been terminated as provided in this Article, then Landlord may, without notice, re- enter the Premises, either by force, summary proceedings, ejectment or otherwise, and remove and dispossess Tenant and all other persons and any and all property from the same, as if this Lease had not been made, and Tenant hereby waives the service of notice of intention to re-enter or to institute legal proceedings to that end. |
(c) | In the event that this Lease is terminated under any of the provisions contained in Section 7.1 (a) or shall be otherwise terminated by breach of any obligation of Tenant, Tenant covenants and agrees forthwith to pay and be liable for, on the days originally fixed herein for the payment thereof, amounts equal to the several installments of rent and other charges reserved as they would, under the terms of this Lease, become due if this Lease had not been terminated or if Landlord had not entered or re-entered, as aforesaid, and whether the Premises be relet or remain vacant, in whole or in part, or relet for a period less than the remainder of the Term, and for the whole thereof, but in the event the Premises be relet by Landlord, Tenant shall be entitled to a credit in the net amount of rent and other charges received by Landlord in reletting, after deduction of all expenses incurred in reletting the Premises (including, without limitation, remodeling costs, brokerage fees and the like), and in collecting the rent in connection therewith, in the following manner: |
Amounts received by Landlord after reletting shall first be applied against such Landlords out-of-pocket expenses, until the same are recovered, and until such recovery, Tenant shall pay, as of each day when a payment would fall due under this Lease, the amount which Tenant is obligated to pay under the terms of this Lease (Tenants liability prior to any such reletting and such recovery not in any way to be diminished as a result of the fact that such reletting might be for a rent higher than the rent provided for in this Lease); when and if such expenses have been completely recovered, the amounts received from reletting by Landlord as have not previously been applied shall be credited against Tenants obligations as of each day when a payment would fall due under this Lease, and only the net amount thereof shall be payable by Tenant. Further, amounts received by Landlord from such reletting for any period shall be credited only against obligations of Tenant allocable to such period, and shall not be credited against obligations of Tenant hereunder accruing subsequent or prior to such period; nor shall any credit of any kind be due for any period after the date when the term of this Lease is scheduled to expire according to its terms.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Landlord agrees to use reasonable efforts to relet the Premises after Tenant vacates the same in the event this Lease is terminated based upon an Event of Default by Tenant hereunder. The marketing of the Premises in a manner similar to the manner in which Landlord markets other premises within Landlords control within the Building shall be deemed to have satisfied Landlords obligation to use reasonable efforts hereunder. In no event shall Landlord be required to (i) solicit or entertain negotiations with any other prospective tenant for the Premises until Landlord obtains full and complete possession of the Premises (including, without limitation, the final and unappealable legal right to relet the Premises free of any claim of Tenant), (ii) relet the Premises before leasing other vacant space in the Building, or (iii) lease the Premises for a rental less than the current fair market rent then prevailing for similar office and laboratory space in the Boston West suburban market.
(d) | (i) Landlord may elect, as an alternative, to have Tenant pay liquidated damages, which election may be made by notice given to Tenant at any time after such termination and whether or not Landlord shall have collected any damages as aforesaid, as liquidated final damages and in lieu of all other damages beyond the date of such notice. Upon such notice, Tenant shall promptly pay to Landlord, as liquidated damages, in addition to any damages collected or due from Tenant for any period prior to such notice and all out-of-pocket expenses which Landlord may have incurred with respect to the collection of such damages, such a sum as at the time of the giving of such notice represents the amount of the excess, if any, of the total rent and other benefits which would have accrued to Landlord under |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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this Lease from the date of such notice for what would be the then unexpired Lease Term if the Lease terms had been fully complied with by Tenant over and above the then cash rental value (in advance) of the Premises for the balance of the Lease Term.
(ii) For the purposes of this Article, if Landlord elects to require Tenant to pay damages in accordance with the immediately preceding paragraph, the total rent shall be computed by assuming that Tenants share of excess taxes, Tenants share of excess operating costs and Tenants share of excess electrical costs would be, for the balance of the unexpired Term from the date of such notice, the amount thereof (if any) for the immediately preceding annual period payable by Tenant to Landlord.
(e) | In case of any Event of Default, re-entry, dispossession by summary proceedings or otherwise, Landlord may (i) re-let the Premises or any part or parts thereof, either in the name of Landlord or otherwise, for a term or terms which may at Landlords option be equal to or less than or exceed the period which would otherwise have constituted the balance of the Term of this Lease and may grant concessions or free rent to the extent that Landlord considers advisable or necessary to re-let the same and (ii) may make such alterations, repairs and decorations in the Premises as Landlord in its sole judgment considers advisable or necessary for the purpose of reletting the Premises; and the making of such alterations, repairs and decorations shall not operate or be construed to release Tenant from liability hereunder as aforesaid. Subject to the provisions of Section 7.1(c) above, Landlord shall in no event be liable in any way whatsoever for failure to re-let the Premises, or, in the event that the Premises are re-let, for failure to collect the rent under re-letting. Tenant hereby expressly waives any and all rights of redemption granted by or under any present or future laws in the event of Tenant being evicted or dispossessed, or in the event of Landlord obtaining possession of the Premises, by reason of the violation by Tenant of any of the covenants and conditions of this Lease. |
(f) | The specified remedies to which Landlord may resort hereunder are not intended to be exclusive of any remedies or means of redress to which Landlord may at any time be entitled lawfully, and Landlord may invoke any remedy (including the remedy of specific performance) allowed at law or in equity as if specific remedies were not herein provided for. Further, nothing contained in this Lease shall limit or prejudice the right of Landlord to prove and obtain in proceedings for bankruptcy or insolvency by reason of the termination of this Lease, an amount equal to the maximum allowed by any statute or rule of law in effect at the time when, and governing the proceedings in which, the damages are to be proved, whether or not the amount be greater, equal to, or less than the amount of the loss or damages referred to above. |
(g) | In lieu of any other damages or indemnity and in lieu of the recovery by Landlord of all sums payable under all the foregoing provisions of this Section 7.1, |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Landlord may elect to collect from tenant, by notice to Tenant, at any time after this Lease is terminated under any of the provisions contained in this Article VII or otherwise terminated by breach of any obligation of Tenant and before such full recovery, and Tenant shall thereupon pay, as liquidated damages, an amount equal to the sum of the Annual Fixed Rent and all Additional Rent payable for the twelve (12) months ended next prior to the such termination plus the amount of Annual Fixed Rent and Additional Rent of any kind accrued and unpaid at the time of such election plus any and all expenses which the Landlord may have incurred for and with respect of the collection to any of such rent. |
7.2 | Landlords Default |
Landlord shall in no event be in default in the performance of any of Landlords obligations hereunder unless and until Landlord shall have failed to perform such obligations within thirty (30) days, or such additional time as is reasonably required to correct any such default, after notice by Tenant to Landlord properly specifying wherein Landlord has failed to perform any such obligation. Tenant shall not assert any right to deduct the cost of repairs or any monetary claim against the Landlord from rent thereafter due and payable, but shall look solely to the Landlord for satisfaction of such claim.
ARTICLE VIII
Insurance and Indemnity
8.1 | Tenants Indemnity |
(a) Indemnity. To the fullest extent permitted by law, Tenant agrees to indemnify and save harmless the Landlord Parties from and against all claims of whatever nature by a third party arising from or claimed to have arisen from (i) any act, omission or negligence of the Tenant Parties (as hereinafter defined); (ii) any accident, injury or damage whatsoever caused to any person, or to the property of any person, occurring in or about the Premises from the earlier of (A) the date on which any Tenant Party first enters the Premises for any reason or (B) the Commencement Date, and thereafter throughout and until the end of the Lease Term, and after the end of the Lease Term for so long after the end of the Lease Term as Tenant or anyone acting by, through or under Tenant is in occupancy of the Premises or any portion thereof; (iii) any accident, injury or damage whatsoever occurring outside the Premises but within the Building, or on common areas or the Complex, where such accident, injury or damage results, or is claimed to have resulted, from any act, omission or negligence on the part of any of the Tenant Parties; or (iv) any breach of this Lease by Tenant; provided, however, that in no event shall the aforesaid indemnity render Tenant responsible or liable for any loss or damage to fixtures, personal property or other property of Landlord to the extent claims are waived pursuant to Section 8.13 below. Tenant shall pay such indemnified amounts as they are incurred by the Landlord Parties. This indemnification shall not be construed to deny or reduce any other rights or obligations of indemnity that any of the Landlord Parties may
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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have under this Lease or the common law. Notwithstanding anything contained herein to the contrary, Tenant shall not be obligated to indemnify a Landlord Party for any claims to the extent that such Landlord Partys damages in fact result from such Landlord Partys negligence or willful misconduct.
(b) Breach. In the event that Tenant breaches any of its indemnity obligations hereunder or under any other contractual or common law indemnity: (i) Tenant shall pay to the Landlord Parties all liabilities, loss, cost, or expense (including reasonable attorneys fees) incurred as a result of said breach; and (ii) the Landlord Parties may deduct and offset from any amounts due to Tenant under this Lease any amounts owed by Tenant pursuant to this Section 8.1(b).
(c) No limitation. The indemnification obligations under this Section 8.1 shall not be limited in any way by any limitation on the amount or type of damages, compensation or benefits payable by or for Tenant or any subtenant or other occupant of the Premises under workers compensation acts, disability benefit acts, or other employee benefit acts. Tenant waives any immunity from or limitation on its indemnity or contribution liability to the Landlord Parties based upon such acts.
(d) Subtenants and other occupants. Tenant shall require its subtenants and other occupants of the Premises to provide similar indemnities to the Landlord Parties in a form reasonably acceptable to Landlord.
(e) Survival. The terms of this Section 8.1 shall survive any termination or expiration of this Lease.
(f) Costs. The foregoing indemnity and hold harmless agreement shall include indemnity for all costs, expenses and liabilities (including, without limitation, reasonable attorneys fees and disbursements) incurred by the Landlord Parties in connection with any such claim or any action or proceeding brought thereon, and the defense thereof. In addition, in the event that any action or proceeding shall be brought against one or more Landlord Parties by reason of any such claim, Tenant, upon request from the Landlord Party, shall resist and defend such action or proceeding on behalf of the Landlord Party by counsel appointed by Tenants insurer (if such claim is covered by insurance without reservation) or otherwise by counsel reasonably satisfactory to the Landlord Party. The Landlord Parties shall not be bound by any compromise or settlement of any such claim, action or proceeding without the prior written consent of such Landlord Parties.
8.1.1. | Landlords Indemnity. |
Subject to the limitations in Section 9.3 and in Section 8.2 and Section 8.13 of this Article, and to the extent not resulting from any act, omission, fault, negligence or misconduct of Tenant or its contractors, licensees, invitees, agents, servants or employees, Landlord agrees to indemnify and save harmless Tenant from and against any claim by a third party arising from any injury to any person occurring in the Premises or in the Complex after the date that possession of the Premises is first
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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delivered to Tenant and until the expiration or earlier termination of the Lease Term, to the extent such injury results from the negligence or willful misconduct of Landlord or Landlords employees, or from any breach or default by Landlord in the performance or observance of its covenants or obligations under this Lease; provided, however, that in no event shall the aforesaid indemnity render Landlord responsible or liable for any loss or damage to fixtures, personal property or other property of Tenant, and Landlord shall in no event be liable for any indirect or consequential damages. Tenant shall provide notice of any such third party claim to Landlord as soon as practicable. Landlord shall have the right, but not the duty, to defend the claim. The provisions of this Section shall not be applicable to (i) the holder of any mortgage now or hereafter on the Property or Building (whether or not such holder shall be a mortgagee in possession of or shall have exercised any rights under a conditional, collateral or other assignment of leases and/or rents respecting the Property or Building), or (ii) any person acquiring title as a result of, or subsequent to, a foreclosure of any such mortgage or a deed in lieu of foreclosure, except to the extent of liability insurance maintained by either of the foregoing.
8.2 | Tenants Risk |
Tenant agrees to use and occupy the Premises, and to use such other portions of the Building and the Complex as Tenant is given the right to use by this Lease at Tenants own risk. The Landlord Parties shall not be liable to the Tenant Parties for any damage, injury, loss, compensation, or claim (including, but not limited to, claims for the interruption of or loss to a Tenant Partys business) based on, arising out of or resulting from any cause whatsoever, including, but not limited to, repairs to any portion of the Premises or the Building or the Complex, any fire, robbery, theft, mysterious disappearance, or any other crime or casualty, the actions of any other tenants of the Building or of any other person or persons, or any leakage in any part or portion of the Premises or the Building or the Complex, or from water, rain or snow that may leak into, or flow from any part of the Premises or the Building or the Complex, or from drains, pipes or plumbing fixtures in the Building or the Complex. Any goods, property or personal effects stored or placed in or about the Premises shall be at the sole risk of the Tenant Party, and neither the Landlord Parties nor their insurers shall in any manner be held responsible therefor. The Landlord Parties shall not be responsible or liable to a Tenant Party, or to those claiming by, through or under a Tenant Party, for any loss or damage that may be occasioned by or through the acts or omissions of persons occupying adjoining premises or any part of the premises adjacent to or connecting with the Premises or any part of the Building or otherwise. Notwithstanding the foregoing, the Landlord Parties shall not be released from liability for any injury, loss, damages or liability to the extent arising from any negligence or willful misconduct of the Landlord Parties on or about the Premises; provided, however, in no event shall the Landlord Parties have any liability to a Tenant Party based on any loss with respect to or interruption in the operation of Tenants business. The provisions of this section shall be applicable to the fullest extent permitted by law, and until the expiration or earlier termination of the Lease Term, and during such further period as Tenant may use or be in occupancy of any part of the Premises or of the Building.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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8.3 | Tenants Commercial General Liability Insurance |
Tenant agrees to maintain in full force on or before the earlier of (i) the date on which any Tenant Party first enters the Premises for any reason or (ii) the Commencement Date, and thereafter throughout and until the end of the Lease Term, and after the end of the Lease Term for so long as Tenant or anyone acting by, through or under Tenant is in occupancy of the Premises or any portion thereafter, a policy of commercial general liability insurance, on an occurrence basis, issued on a form at least as broad as Insurance Services Office (ISO) Commercial General Liability Coverage occurrence form CG 00 01 10 01 or another Commercial General Liability occurrence form providing equivalent coverage. Such insurance shall include broad form contractual liability coverage, specifically covering but not limited to the indemnification obligations undertaken by Tenant in this Lease to the extent they are insurable. The minimum limits of liability of such insurance shall be [*]. In addition, in the event Tenant hosts a function in the Premises, Tenant agrees to obtain, and cause any persons or parties providing services for such function to obtain, the appropriate insurance coverages as determined by Landlord (including liquor liability coverage, if applicable) and provide Landlord with evidence of the same.
8.4 | Tenants Property Insurance |
Tenant shall maintain at all times during the Term of the Lease, and during such earlier time as Tenant may be performing work in or to the Premises or have property, fixtures, furniture, equipment, machinery, goods, supplies, wares or merchandise on the Premises, and containing thereafter so long as Tenant is in occupancy of any part of the Premises, business interruption insurance and insurance against loss or damage covered by the so-called all risk type insurance coverage with respect to Tenants property, fixtures, furniture, equipment (collectively, Tenants fixtures, furniture and equipment are referred to herein as the FF&E), machinery, goods, supplies, wares and merchandise, and all alterations, improvements and other modifications made by or on behalf of the Tenant in the Premises, and other property of Tenant located at the Premises, which are permitted to be removed by Tenant at the expiration or earlier termination of the Lease Term except to the extent paid for by Landlord (collectively Tenants Property). The business interruption insurance required by this Section 8.4 shall be in minimum amounts typically carried by prudent tenants engaged in similar operations, but in no event shall be in an amount less than the Annual Fixed Rent then in effect during any year during the Term, plus any Additional Rent due and payable for the immediately preceding year during the Term. The all risk insurance required by this section shall be in an amount at least equal to the full replacement cost of Tenants Property. In addition, during such time as Tenant is performing work in or to the Premises, Tenant, at Tenants expense, shall also maintain, or shall cause its contractor(s) to maintain, builders risk insurance for the full insurable value of such work. Landlord and such additional persons or entities as Landlord may reasonably request shall be named as loss payees, as their interests may appear, on the policy or policies required by this Lease. In the event of loss or damage covered by the all risk insurance required by this Lease, the responsibilities for repairing or restoring the loss or damage shall be determined in accordance with Article VI. To the extent that Landlord is obligated to pay for the repair or restoration of the loss
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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or damage covered by the policy, Landlord shall be paid the proceeds of the all risk insurance covering the loss or damage. To the extent Tenant is obligated to pay for the repair or restoration of the loss or damage, covered by the policy, Tenant shall be paid the proceeds of the all risk insurance covering the loss or damage. If both Landlord and Tenant are obligated to pay for the repair or restoration of the loss or damage covered by the policy, the insurance proceeds shall be paid to each of them in the pro rata proportion of their obligations to repair or restore the loss or damage. If the loss or damage is not repaired or restored (for example, if the Lease is terminated pursuant to Article VI), the insurance proceeds shall be paid to Landlord and Tenant in the pro rata proportion of their relative contributions to the cost of the leasehold improvements covered by the policy.
8.5 | Tenants Other Insurance |
Tenant agrees to maintain in full force on or before the earlier of (i) the date on which any Tenant Party first enters the Premises for any reason or (ii) the Commencement Date, and thereafter throughout the end of the Term, and after the end of the Term for so long after the end of the Term as Tenant or anyone acting by, through or under Tenant is in occupancy of the Premises or any portion thereafter, (1) comprehensive automobile liability insurance (covering any automobiles owned or operated by Tenant (if any)) issued on a form at least as broad as ISO Business Auto Coverage form CA 00 01 07 97 or other form providing equivalent coverage; (2) workers compensation insurance; and (3) employers liability insurance. Such automobile liability insurance, which shall be required only if automobiles are owned or operated by Tenant, shall be in an amount not less than [*].for each accident. Such workers compensation insurance shall carry minimum limits as defined by the law of the jurisdiction in which the Premises are located (as the same may be amended from time to time). Such employers liability insurance shall be in an amount not less than [*]. for each accident, [*].disease-policy limit, and [*].disease-each employee.
8.6 | Requirements for Tenants Insurance |
All insurance required to be maintained by Tenant pursuant to this Lease shall be maintained with responsible companies that are admitted to do business, and are in good standing in the Commonwealth of Massachusetts and that have a rating of at least A and are within a financial size category of not less than Class X in the most current Bests Key Rating Guide or such similar rating as may be reasonably selected by Landlord. All such insurance shall: (1) be acceptable in form and content to Landlord; (2) be primary and noncontributory; and (3) contain an endorsement prohibiting cancellation, failure to renew, reduction of amount of insurance, or change in coverage without the insurer first giving Landlord thirty (30) days prior written notice (by certified or registered mail, return receipt requested, or by fax or email) of such proposed action. No liability policy shall contain any deductible or self-insured retention greater than [*].and no property policy shall contain any deductible or self-insured retention greater than [*]. Such deductibles and self-insured retentions shall be deemed to be insurance for purposes of the waiver in Section 8.13 below. Landlord reserves the right from time to time to require Tenant to obtain higher minimum amounts of insurance
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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based on such limits as are customarily carried with respect to similar properties in the area in which the Premises are located. The minimum amounts of insurance required by this Lease shall not be reduced by the payment of claims or for any other reason. In the event Tenant shall fail to obtain or maintain any insurance meeting the requirements of this Article, or to deliver such policies or certificates as required by this Article, Landlord may, at its option, on ten (10) days notice to Tenant, procure such policies for the account of Tenant, and the cost thereof shall be paid to Landlord within five (5) business days after delivery to Tenant of bills therefor.
8.7 | Additional Insureds |
To the fullest extent permitted by law, the commercial general liability and auto insurance carried by Tenant pursuant to this Lease, and any additional liability insurance carried by Tenant pursuant to Section 8.3 of this Lease, shall name Landlord, Landlords managing agent, and such other persons as Landlord may reasonably request from time to time as additional insureds with respect to liability arising out of or related to this Lease or the operations of Tenant (collectively Additional Insureds). Such insurance shall provide primary coverage without contribution from any other insurance carried by or for the benefit of Landlord, Landlords managing agent, or other Additional Insureds. Such insurance shall also waive any right of subrogation against each Additional Insured.
8.8 | Certificates of Insurance |
On or before the earlier of (i) the date on which any Tenant Party first enters the Premises for any reason or (ii) the Commencement Date, Tenant shall furnish Landlord with certificates evidencing the insurance coverage required by this Lease, and renewal certificates shall be furnished to Landlord at least annually thereafter, and at least thirty (30) days prior to the expiration date of each policy for which a certificate was furnished (acceptable forms of such certificates as of the date hereof for liability and property insurance, respectively, are attached as Exhibit H, however, other forms may be acceptable). Failure by the Tenant to provide the certificates or letters required by this Section 8.8 shall not be deemed to be a waiver of the requirements in this Section 8.8. Upon request by Landlord, a true and complete copy of any insurance policy required by this Lease shall be delivered to Landlord within ten (10) days following Landlords request.
8.9 | Subtenants and Other Occupants |
Tenant shall require its subtenants and other occupants of the Premises to provide written documentation evidencing the obligation of such subtenant or other occupant to indemnify the Landlord Parties to the same extent that Tenant is required to indemnify the Landlord Parties pursuant to Section 8.1 above, and to maintain insurance that meets the requirements of this Article, and otherwise to comply with the requirements of this Article. Tenant shall require all such subtenants and occupants to supply certificates of insurance evidencing that the insurance requirements of this Article have been met and shall forward such certificates to Landlord on or before the earlier of (i) the date on which the subtenant or other occupant or any of their respective direct or indirect partners,
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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officers, shareholders, directors, members, trustees, beneficiaries, servants, employees, principals, contractors, licensees, agents, invitees or representatives first enters the Premises or (ii) the commencement of the sublease. Tenant shall be responsible for identifying and remedying any deficiencies in such certificates or policy provisions.
8.10 | No Violation of Building Policies |
Tenant shall not commit or permit any violation of the policies of fire, boiler, sprinkler, water damage or other insurance covering the Complex and/or the fixtures, equipment and property therein carried by Landlord, or do or permit anything to be done, or keep or permit anything to be kept, in the Premises, which in case of any of the foregoing (i) would result in termination of any such policies, (ii) would adversely affect Landlords right of recovery under any of such policies, or (iii) would result in reputable and independent insurance companies refusing to insure the Complex or the property of Landlord in amounts reasonably satisfactory to Landlord.
8.11 | Tenant to Pay Premium Increases |
If, to the extent caused by anything done, caused or permitted to be done, or omitted by Tenant (or its subtenant or other occupants of the Premises), the rates for liability, fire, boiler, sprinkler, water damage or other insurance on the Complex and equipment of Landlord or any other tenant or subtenant in the Building shall be higher than they otherwise would be, Tenant shall reimburse Landlord and/or the other tenants and subtenants in the Building for the additional insurance premiums thereafter paid by Landlord or by any of the other tenants and subtenants in the Building which shall have been charged because of the aforesaid reasons, such reimbursement to be made from time to time on Landlords demand.
8.12 | Landlords Insurance |
(a) Required insurance. Landlord shall maintain (i) insurance against loss or damage with respect to the Building on an all risk type insurance form, with customary exceptions, subject to such deductibles and self insured retentions as Landlord may determine, in an amount equal to at least the replacement value of the Building; (ii) insurance with respect to any improvements, alterations, and fixtures of Tenant located at the Premises to the extent paid for by Landlord and for all of Landlords Work (other than FF&E); (iii) workers compensation insurance at not less than the minimum limits required by the law of the jurisdiction in which the Premises are located (as the same may be amended from time to time), and (iv) commercial general liability insurance with respect to the Building in an amount not less than $5,000,000 per occurrence, with deductibles and self insured retentions as determined by Landlord. The cost of such insurance shall be treated as a part of Landlords Operating Expenses. Such insurance shall be maintained with an insurance company or companies selected by Landlord. Payment for losses thereunder shall be made solely to Landlord.
(b) Optional insurance. Landlord may maintain such additional insurance with respect to the Building and the Complex, including, without limitation, earthquake insurance,
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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terrorism insurance, flood insurance, liability insurance and/or rent insurance, as Landlord may in its sole discretion elect. Landlord may also maintain such other insurance as may from time to time be required by the holder of any mortgage on the Building or Property. The cost of all such additional insurance shall also be part of the Landlords Operating Expenses.
(c) Blanket and self-insurance. Any or all of Landlords insurance may be provided by blanket coverage maintained by Landlord or any affiliate of Landlord under its insurance program for its portfolio of properties, or by Landlord or any affiliate of Landlord under a program of self-insurance provided there is a financially responsible self-insurer, and in such event Landlords Operating Expenses shall include the portion of the reasonable cost of blanket insurance or self-insurance that is allocated to the Building.
(d) No obligation. Landlord shall not be obligated to insure, and shall not assume any liability of risk of loss for, Tenants Property, including any such property or work of Tenants subtenants or occupants. Landlord will also have no obligation to carry insurance against, nor be responsible for, any loss suffered by Tenant, subtenants or other occupants due to interruption of Tenants or any subtenants or occupants business.
8.13 | Waiver of Subrogation |
To the fullest extent permitted by law, the parties hereto waive and release any and all rights of recovery against the other, and agree not to seek to recover from the other or to make any claim against the other, and in the case of Landlord, against all Tenant Parties (hereinafter defined), and in the case of Tenant, against all Landlord Parties (hereinafter defined), for any loss or damage incurred by the waiving/releasing party to the extent such loss or damage is insured under any insurance policy required by this Lease or which would have been so insured had the party carried the insurance it was required to carry hereunder, provided that this waiver and release shall not apply to the commercial general liability insurance Landlord is required to carry by Section 8.12(a)(iv). Tenant shall obtain from its subtenants and other occupants of the Premises a similar waiver and release of claims against any or all of Tenant or Landlord. In addition, the parties hereto (and in the case of Tenant, its subtenants and other occupants of the Premises) shall procure an appropriate clause in, or endorsement on, any insurance policy required by this Lease pursuant to which the insurance company waives subrogation. The insurance policies required by this Lease shall contain no provision that would invalidate or restrict the parties waiver and release of the rights of recovery in this section. The parties hereto covenant that no insurer shall hold any right of subrogation against the parties hereto by virtue of such insurance policy.
The term Landlord Party or Landlord Parties shall mean Landlord, any affiliate of Landlord, Landlords managing agents for the Building, each mortgagee (if any), each ground lessor (if any), and each of their respective direct or indirect partners, officers, shareholders, directors, members, trustees, beneficiaries, servants, employees, principals, contractors, licensees, agents or representatives. For the purposes of this Lease, the term Tenant Party or Tenant Parties shall mean Tenant, any affiliate of Tenant, any
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permitted subtenant or any other permitted occupant of the Premises, and each of their respective direct or indirect partners, officers, shareholders, directors, members, trustees, beneficiaries, servants, employees, principals, contractors, licensees, agents, invitees or representatives.
8.14 | Tenants Work |
During such times as Tenant is performing work or having work or services performed in or to the Premises, Tenant shall require its contractors, and their subcontractors of all tiers, to obtain and maintain commercial general liability, automobile, workers compensation, employers liability, builders risk, and equipment/property insurance in such amounts and on such terms as are customarily required of such contractors and subcontractors on similar projects. The amounts and terms of all such insurance are subject to Landlords written approval, which approval shall not be unreasonably withheld. The commercial general liability and auto insurance carried by Tenants contractors and their subcontractors of all tiers pursuant to this section shall name Landlord, Landlords managing agent, and such other persons as Landlord may reasonably request from time to time as additional insureds with respect to liability arising out of or related to their work or services (collectively Additional Insureds). Such insurance shall provide primary coverage without contribution from any other insurance carried by or for the benefit of Landlord, Landlords managing agent, or other Additional Insureds. Such insurance shall also waive any right of subrogation against each Additional Insured. Tenant shall obtain and submit to Landlord, prior to the earlier of (i) the entry onto the Premises by such contractors or subcontractors or (ii) commencement of the work or services, certificates of insurance evidencing compliance with the requirements of this section.
ARTICLE IX
Miscellaneous Provisions
9.1 | Waiver |
Failure on the part of Landlord or Tenant to complain of any action or non-action on the part of the other, no matter how long the same may continue, shall never be a waiver by Tenant or Landlord, respectively, of any of its rights hereunder. Further, no waiver at any time of any of the provisions hereof by Landlord or Tenant shall be construed as a waiver of any of the other provisions hereof, and a waiver at any time of any of the provisions hereof shall not be construed as a waiver at any subsequent time of the same provisions. The consent or approval of Landlord or Tenant to or of any action by the other requiring such consent or approval shall not be construed to waive or render unnecessary Landlords or Tenants consent or approval to or of subsequent similar act by the other.
No payment by Tenant, or acceptance by Landlord, of a lesser amount than shall be due from Tenant to Landlord shall be treated otherwise than as a payment on account. The acceptance by Landlord of a check for a lesser amount with an endorsement or statement thereon, or upon any letter accompanying such check, that such lesser amount is payment in full, shall be given no effect, and Landlord may accept such check without prejudice to any other rights or remedies which Landlord may have against Tenant.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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9.2 | Cumulative Remedies |
Except as expressly provided in this Lease, the specific remedies to which Landlord may resort under the terms of this Lease are cumulative and are not intended to be exclusive of any other remedies or means of redress to which such party may be lawfully entitled in case of any breach or threatened breach by Tenant of any provisions of this Lease. In addition to the other remedies provided in this Lease, Landlord shall be entitled to the restraint by injunction of the violation or attempted or threatened violation of any of the covenants, conditions or provisions of this Lease or to a decree compelling specific performance of any such covenants, conditions or provisions.
9.3 | Quiet Enjoyment |
This Lease is subject and subordinate to all matters of record. Tenant, subject to the terms and provisions of this Lease on payment of the rent and observing, keeping and performing all of the terms and provisions of this Lease on Tenants part to be observed, kept and performed, shall lawfully, peaceably and quietly have, hold, occupy and enjoy the Premises during the Term (exclusive of any period during which Tenant is holding over after the termination or expiration of this Lease without the consent of Landlord), without hindrance or ejection by any persons lawfully claiming under Landlord to have title to the Premises superior to Tenant; the foregoing covenant of quiet enjoyment is in lieu of any other covenant, express or implied; and it is understood and agreed that this covenant and any and all other covenants of Landlord contained in this Lease shall be binding upon Landlord and Landlords successors, including ground or master lessees, only with respect to breaches occurring during Landlords or Landlords successors respective ownership of Landlords interest hereunder, as the case may be.
Further, Tenant specifically agrees to look solely to Landlords then equity interest in the Building at the time owned and the profits and proceeds thereof, or in which Landlord holds an interest as ground lessee, for recovery of any judgment from Landlord; it being specifically agreed that neither Landlord (original or successor), nor any partner in or of Landlord, nor any beneficiary of any Trust of which any person holding Landlords interest is trustee, nor any member, manager, partner, director or stockholder, nor Landlords managing agent, shall ever be personally liable for any such judgment, or for the payment of any monetary obligation to Tenant. The provision contained in the foregoing sentence is not intended to, and shall not, limit any right that Tenant might otherwise have to obtain injunctive relief against Landlord or Landlords successors in interest, or any action not involving the personal liability of Landlord (original or successor), any partner in or of Landlord, any successor trustee to the persons named herein as Landlord, or any beneficiary of any trust of which any person holding Landlords interest is trustee, or of any manager, member, partner, director or stockholder of Landlord or of Landlords managing agent to respond in monetary damages from Landlords assets other than Landlords equity interest aforesaid in the Building and the profits and proceeds thereof, but in no event shall Tenant have the right to terminate or
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cancel this Lease or to withhold rent or to set-off any claim or damages against rent as a result of any default by Landlord or breach by Landlord of its covenants or any warranties or promises hereunder, except in the case of a wrongful eviction of Tenant from the demised premises (constructive or actual) by Landlord continuing after notice to Landlord thereof and a reasonable opportunity for Landlord to cure the same. In no event shall Landlord or Tenant ever be liable to the other party for any indirect or consequential damages or loss of profits or the like suffered from whatever cause; provided that the foregoing shall not limit or alter any procedural right or remedy of Landlord under this Lease nor shall the same apply to the obligations of Tenant with respect to any hold over by Tenant after the expiration or earlier termination of this Lease. In the event that Landlord shall be determined to have acted unreasonably in withholding any consent or approval under this Lease, the sole recourse and remedy of Tenant in respect thereof shall be to specifically enforce Landlords obligation to grant such consent or approval, and in no event shall the Landlord be responsible for any damages of whatever nature in respect of its failure to give such consent or approval nor shall the same otherwise affect the obligations of Tenant under this Lease or act as any termination of this Lease.
9.4 | Notice to Mortgagee and Ground Lessor |
After receiving notice from any person, firm or other entity that it holds a mortgage which includes the Premises as part of the mortgaged premises, or that it is the ground lessor under a lease with Landlord, as ground lessee, which includes the Premises as a part of the demised premises, no notice from Tenant to Landlord shall be effective against such mortgage holder or ground lessor unless and until a copy of the same is given to such holder or ground lessor, and the curing of any of Landlords defaults by such holder or ground lessor within a reasonable time thereafter (including a reasonable time to obtain possession of the premises if the mortgagee or ground lessor elects to do so) shall be treated as performance by Landlord. For the purposes of this Section 9.4 or Section 9.14, the term mortgage includes a mortgage on a leasehold interest of Landlord (but not one on Tenants leasehold interest).
9.5 | Assignment of Rents |
With reference to any assignment by Landlord of Landlords interest in this Lease, or the rents payable hereunder, conditional in nature or otherwise, which assignment is made to the holder of a mortgage or ground lease on property which includes the Premises, Tenant agrees:
(a) | That the execution thereof by Landlord, and the acceptance thereof by the holder of such mortgage or the ground lessor, shall never be treated as an assumption by such holder or ground lessor of any of the obligations of Landlord hereunder, unless such holder, or ground lessor, shall, by notice sent to Tenant, specifically otherwise elect; and |
(b) | That, except as aforesaid, such holder or ground lessor shall be treated as having assumed Landlords obligations hereunder only upon foreclosure of such holders mortgage and the taking of possession of the Premises, or, in the case of a ground lessor, the assumption of Landlords position hereunder by such ground lessor. |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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In no event shall the acquisition of title to the Building and the land on which the same is located by a purchaser which, simultaneously therewith, leases the entire Building or such land back to the seller thereof be treated as an assumption by such purchaser-lessor, by operation of law or otherwise, of Landlords obligations hereunder, but Tenant shall look solely to such seller-lessee, and its successors from time to time in title, for performance of Landlords obligations hereunder subject to the provisions of Section 9.3 hereof. In any such event, this Lease shall be subject and subordinate to the lease to such purchaser provided that such purchaser agrees to recognize the right of Tenant to use and occupy the Premises upon the payment of rent and other charges payable by Tenant under this Lease and the performance by Tenant of Tenants obligations under this Lease and provided that Tenant agrees to attorn to such purchaser. For all purposes, such seller-lessee, and its successors in title, shall be the landlord hereunder unless and until Landlords position shall have been assumed by such purchaser-lessor.
9.6 | Surrender |
No act or thing done by Landlord during the Lease Term shall be deemed an acceptance of a surrender of the Premises, and no agreement to accept such surrender shall be valid, unless in writing signed by Landlord. No employee of Landlord or of Landlords agents shall have any power to accept the keys of the Premises prior to the termination of this Lease. The delivery of keys to any employee of Landlord or of Landlords agents shall not operate as a termination of the Lease or a surrender of the Premises.
9.7 | Brokerage |
(A) Tenant warrants and represents that Tenant has not dealt with any broker, finder or other agent in connection with the consummation of this Lease other than the Recognized Brokers, if any, designated in Section 1.1 hereof; and in the event any claim is made against the Landlord relative to dealings by Tenant with brokers, finders or other agents other than the Recognized Brokers, if any, designated in Section 1.1 hereof, Tenant shall defend the claim against Landlord with counsel of Tenants selection first approved by Landlord (which approval will not be unreasonably withheld) and save harmless and indemnify Landlord on account of loss, cost or damage which may arise by reason of such claim.
(B) Landlord warrants and represents that Landlord has not dealt with any broker, finder or other agent in connection with the consummation of this Lease other than the Recognized Brokers, if any, designated in Section 1.1 hereof; and in the event any claim is made against the Tenant relative to dealings by Landlord with brokers, finders or other agents other than the Recognized Brokers, if any, designated in Section 1.1 hereof, Landlord shall defend the claim against Tenant with counsel of Landlords selection first approved by Tenant (which approval will not be unreasonably withheld) and save harmless and indemnify Tenant on account of loss, cost or damage which may arise by reason of such claim. Landlord agrees that it shall be solely responsible for the payment of brokerage commissions to the Recognized Brokers for the Original Term of this Lease, if any, designated in Section 1.1 hereof.
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9.8 | Invalidity of Particular Provisions |
If any term or provision of this Lease, including but not limited to any waiver of contribution or claims, indemnity, obligation, or limitation of liability or of damages, or the application thereof to any person or circumstance shall, to any extent, be invalid or unenforceable, the remainder of this Lease, or the application of such term or provision to persons or circumstances other than those as to which it is held invalid or unenforceable, shall not be affected thereby, and each term and provision of this Lease shall be valid and be enforced to the fullest extent permitted by law.
9.9 | Provisions Binding, Etc. |
The obligations of this Lease shall run with the land, and except as herein otherwise provided, the terms hereof shall be binding upon and shall inure to the benefit of the successors and assigns, respectively, of Landlord and Tenant and, if Tenant shall be an individual, upon and to his heirs, executors, administrators, successors and assigns. Each term and each provision of this Lease to be performed by Tenant shall be construed to be both a covenant and a condition. The reference contained to successors and assigns of Tenant is not intended to constitute a consent to subletting or assignment by Tenant.
9.10 | Recording; Confidentiality |
Tenant agrees not to record the within Lease, but each party hereto agrees, on the request of the other, to execute a so-called Notice of Lease or short form lease in form recordable and complying with applicable law and reasonably satisfactory to both Landlords and Tenants attorneys. In no event shall such document set forth rent or other charges payable by Tenant under this Lease; and any such document shall expressly state that it is executed pursuant to the provisions contained in this Lease, and is not intended to vary the terms and conditions of this Lease.
Tenant agrees that this Lease and the terms contained herein will be treated as strictly confidential and except as required by law (or except with the written consent of Landlord) Tenant shall not disclose the same to any third party except for Tenants partners, lenders, accountants and attorneys who have been advised of the confidentiality provisions contained herein and agree to be bound by the same. Notwithstanding anything to the contrary contained in this Lease, Tenant and its affiliates may disclose this Lease and the terms hereof as required by any applicable regulation or law and as may be required by any stock exchange on which Tenant is listed. In the event Tenant is required by law to provide this Lease or disclose any of its terms, Tenant shall give Landlord prompt notice of such requirement prior to making disclosure so that Landlord may seek an appropriate protective order. If failing the entry of a protective order Tenant is compelled to make disclosure, Tenant shall only disclose portions of the Lease which Tenant is required to disclose and will exercise reasonable efforts to obtain assurance that confidential treatment will be accorded to the information so disclosed.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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9.11 | Notices |
Whenever, by the terms of this Lease, notice shall or may be given either to Landlord or to Tenant, such notice shall be in writing and shall be sent by overnight commercial courier or by registered or certified mail postage or delivery charges prepaid, as the case may be:
If intended for Landlord, addressed to Landlord at the address set forth in Article I of this Lease (or to such other address or addresses as may from time to time hereafter be designated by Landlord by like notice) with a copy to Landlord, Attention: Regional General Counsel.
If intended for Tenant, addressed to Tenant at the address set forth in Article I of this Lease except that from and after the Final Commencement Date the address of Tenant shall be the Premises (or to such other address or addresses as may from time to time hereafter be designated by Tenant by like notice) with a copy to Tenant, Attention: Legal.
Except as otherwise provided herein, all such notices shall be effective when received; provided, that (i) if receipt is refused, notice shall be effective upon the first occasion that such receipt is refused, (ii) if the notice is unable to be delivered due to a change of address of which no notice was given, notice shall be effective upon the date such delivery was attempted, (iii) if the notice address is a post office box number, notice shall be effective the day after such notice is sent as provided hereinabove or (iv) if the notice is to a foreign address, notice shall be effective two (2) days after such notice is sent as provided hereinabove.
Where provision is made for the attention of an individual or department, the notice shall be effective only if the wrapper in which such notice is sent is addressed to the attention of such individual or department.
Any notice given by an attorney on behalf of Landlord or by Landlords managing agent shall be considered as given by Landlord and shall be fully effective.
Time is of the essence with respect to any and all notices and periods for giving notice or taking any action thereto under this Lease.
9.12 | When Lease Becomes Binding and Authority |
Employees or agents of Landlord have no authority to make or agree to make a lease or any other agreement or undertaking in connection herewith. The submission of this document for examination and negotiation does not constitute an offer to lease, or a reservation of, or option for, the Premises, and this document shall become effective and binding only upon the execution and delivery hereof by both Landlord and Tenant. All negotiations, considerations, representations and understandings between Landlord and Tenant are incorporated herein and may be modified or altered only by written agreement
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between Landlord and Tenant, and no act or omission of any employee or agent of Landlord shall alter, change or modify any of the provisions hereof. Landlord and Tenant hereby represents and warrants to the other that all necessary action has been taken to enter this Lease and that the person signing this Lease on behalf of Landlord and Tenant has been duly authorized to do so.
9.13 | Section Headings |
The titles of the Articles throughout this Lease are for convenience and reference only, and the words contained therein shall in no way be held to explain, modify, amplify or aid in the interpretation, construction or meaning of the provisions of this Lease.
9.14 | Rights of Mortgagee |
Provided that Landlord delivers to Tenant a subordination, non-disturbance and attornment agreement in form and substance reasonably satisfactory to Landlord, Tenant and the holder of such mortgage, this Lease shall be subject and subordinate to any mortgage now or hereafter on the Site or the Building, or both, and to each advance made or hereafter to be made under any mortgage, and to all renewals, modifications, consolidations, replacements and extensions thereof and all substitutions therefor provided that the holder of such mortgage agrees to recognize the rights of Tenant under this Lease (including the right to use and occupy the Premises) upon the payment of rent and other charges payable by Tenant under this Lease and the performance by Tenant of Tenants obligations hereunder in which event Tenant shall agree to attorn to such holder and its successors as landlord. In furtherance of the foregoing, Tenant shall execute and deliver promptly such instruments of subordination, attornment and recognition as such mortgagee may reasonably request subject to receipt of such instruments of recognition from such mortgagee as Tenant may reasonably request. In the event that any mortgagee or its respective successor in title shall succeed to the interest of Landlord, then, this Lease shall nevertheless continue in full force and effect and Tenant shall and does hereby agree to attorn to such mortgagee or successor and to recognize such mortgagee or successor as its landlord. If any holder of a mortgage which includes the Premises, executed and recorded prior to the date of this Lease, shall so elect, this Lease and the rights of Tenant hereunder, shall be superior in right to the rights of such holder, with the same force and effect as if this Lease had been executed, delivered and recorded, or a statutory notice hereof recorded, prior to the execution, delivery and recording of any such mortgage. The election of any such holder shall become effective upon either notice from such holder to Tenant in the same fashion as notices from Landlord to Tenant are to be given hereunder or by the recording in the appropriate registry or recorders office of an instrument in which such holder subordinates its rights under such mortgage to this Lease. Landlord represents and warrants to Tenant that no outstanding mortgage encumbers the Premises as of the date of this Lease.
If in connection with obtaining financing a bank, insurance company, pension trust or other institutional lender shall request reasonable modifications in this Lease as a condition to such financing, Tenant will not unreasonably withhold, delay or condition its consent thereto, provided that such modifications do not increase the obligations of Tenant hereunder or adversely affect the leasehold interest hereby created.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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9.15 | Status Reports and Financial Statements |
Recognizing that Landlord may find it necessary to establish to third parties, such as accountants, banks, potential or existing mortgagees, potential purchasers or the like, the then current status of performance hereunder, Tenant, on the request of Landlord made from time to time, will promptly furnish to Landlord, or any existing or potential holder of any mortgage encumbering the Premises, the Building, the Site and/or the Complex or any potential purchaser of the Premises, the Building, the Site and/or the Complex, (each an Interested Party), a statement of the status of any matter pertaining to this Lease, including, without limitation, acknowledgments that (or the extent to which) each party is in compliance with its obligations under the terms of this Lease. In addition, Tenant shall deliver to Landlord, or any Interested Party designated by Landlord, financial statements of Tenant and any guarantor of Tenants obligations under this Lease, as reasonably requested by Landlord, including, but not limited to financial statements for the past three (3) years; provided, however that such requirement shall not apply for so long as the Tenant hereunder is a publicly-traded company whose shares are listed and traded on a United States national stock exchange. Any such status statement or financial statement delivered by Tenant pursuant to this Section 9.15 may be relied upon by any Interested Party.
9.16 | Self-Help |
If Tenant shall at any time default beyond any applicable notice and cure period (except expiration of such period shall not be required in the event of an emergency) in the performance of any obligation under this Lease, Landlord shall have the right, but shall not be obligated, to enter upon the Premises and to perform such obligation notwithstanding the fact that no specific provision for such substituted performance by Landlord is made in this Lease with respect to such default. In performing such obligation, Landlord may make any payment of money or perform any other act. All sums so paid by Landlord (together with interest at the rate of one and one-half percentage points over the then prevailing prime rate in Boston as set by Bank of America, N.A., or its successor (but in no event greater than the maximum rate permitted by applicable law) and all costs and expenses in connection with the performance of any such act by Landlord, shall be deemed to be Additional Rent under this Lease and shall be payable to Landlord immediately on demand. Landlord may exercise the foregoing rights without waiving any other of its rights or releasing Tenant from any of its obligations under this Lease.
9.17 | Holding Over |
Any holding over by Tenant after the expiration of the term of this Lease shall be treated as a tenancy at sufferance and shall be on the terms and conditions as set forth in this Lease, as far as applicable except that Tenant shall pay as a use and occupancy charge an amount equal to 150% of the Annual Fixed Rent and 100% of the Additional Rent
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calculated (on a daily basis) at the highest rate payable under the terms of this Lease for the first thirty (30) days of such holding over, and increasing to 200% of the Annual Fixed Rent and 100% of the Additional Rent calculated (on a daily basis) at the highest rate payable under the terms of this Lease thereafter, measured from the day on which Tenants holdover commences and terminating on the day on which Tenant vacates the Premises. In addition, Tenant shall save Landlord, its agents and employees harmless and will exonerate, defend and indemnify Landlord, its agents and employees from and against any and all damages which Landlord may suffer on account of Tenants holdover in the Premises after the expiration or prior termination of the term of this Lease; provided, however that Tenant shall not be liable for consequential damages in connection with such holding over until such holding over exceeds thirty (30) days from the expiration or earlier termination of the term of this Lease. Nothing in the foregoing nor any other term or provision of this Lease shall be deemed to permit Tenant to retain possession of the Premises or hold over in the Premises after the expiration or earlier termination of the Lease Term. All property which remains in the Building or the Premises after the expiration or termination of this Lease shall be conclusively deemed to be abandoned and may either be retained by Landlord as its property or sold or otherwise disposed of in such manner as Landlord may see fit. If any part thereof shall be sold, then Landlord may receive the proceeds of such sale and apply the same, at its option against the expenses of the sale, the cost of moving and storage, any arrears of rent or other charges payable hereunder by Tenant to Landlord and any damages to which Landlord may be entitled under this Lease and at law and in equity.
9.18 | Security Deposit |
Concurrently with the execution of this Lease, Tenant shall pay to Landlord a security deposit in the amount of Six Hundred and Seventy-Five Thousand Dollars ($675,000) and Landlord shall hold the same, throughout the Term of this Lease (including the Extended Term, if applicable), unless sooner returned to Tenant as provided in this Section 9.18, as security for the performance by Tenant of all obligations on the part of Tenant to be performed under this Lease. Such deposit shall be in the form of an irrevocable, unconditional, negotiable letter of credit (the Letter of Credit). The Letter of Credit shall (i) be issued by and drawn on a bank reasonably approved by Landlord and at a minimum having a long term issuer credit rating from Standard and Poors Professional Rating Service of A or a comparable rating from Moodys Professional Rating Service, (ii) be substantially in the form attached hereto as Exhibit G, (iii) permit one or more draws thereunder to be made accompanied only by certification by Landlord or Landlords managing agent that pursuant to the terms of this Lease, Landlord is entitled to draw upon such Letter of Credit, (iv) permit transfers at any time without charge, (v) permit presentment in Boston, Massachusetts and (vi) provide that any notices to Landlord be sent to the notice address provided for Landlord in this Lease. Landlord hereby approves Silicon Valley Bank as the initial issuer of the Letter of Credit. If the credit rating for the issuer of such Letter of Credit falls below the standard set forth in (i) above or if the financial condition of such issuer changes in any other material adverse way or if any trustee, receiver or liquidator shall be appointed for the issuer, Landlord shall have the right to require that Tenant provide a substitute letter of credit that complies in all respects with the requirements of this Section, and Tenants failure to
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provide the same within thirty (30) days following Landlords written demand therefor shall entitle Landlord to immediately draw upon the Letter of Credit. Any such Letter of Credit shall be for a term of one (1) year and shall provide for automatic renewals through the date which is sixty (60) days subsequent to the scheduled expiration date of this Lease (as the same may be extended). Any failure or refusal of the issuer to honor the Letter of Credit shall be at Tenants sole risk and shall not relieve Tenant of its obligation hereunder with regard to the security deposit. Upon the occurrence of any Event of Default, Landlord shall have the right from time to time without prejudice to any other remedy Landlord may have on account thereof, to draw on all or any portion of such deposit held as a Letter of Credit and to apply the proceeds of such Letter of Credit or any cash held as such deposit, or any part thereof, to Landlords damages arising from such Event of Default on the part of Tenant under the terms of this Lease. If Landlord so applies all or any portion of such deposit, Tenant shall within ten (10) days after notice from Landlord deposit cash with Landlord in an amount sufficient to restore such deposit to the full amount stated in this Section 9.18. While Landlord holds any cash deposit Landlord shall have no obligation to pay interest on the same and shall have the right to commingle the same with Landlords other funds. Neither the holder of a mortgage nor the Landlord in a ground lease on property which includes the Premises shall ever be responsible to Tenant for the return or application of any such deposit, whether or not it succeeds to the position of Landlord hereunder, unless such deposit shall have been received in hand by such holder or ground Landlord.
Tenant not then being in default beyond any applicable notice and cure period, Landlord shall return the deposit, or so much thereof as shall not have theretofore been applied in accordance with the terms of this Section 9.18, to Tenant on the expiration or earlier termination of the term of this Lease (as the same may have been extended) and surrender possession of the Premises by Tenant to Landlord in the condition required in the Lease at such time.
9.19 | Late Payment |
If Landlord shall not have received any payment or installment of Annual Fixed Rent or Additional Rent (the Outstanding Amount) on or before the date on which the same first becomes payable under this Lease (the Due Date), the amount of such payment or installment shall incur a late charge equal to the sum of: (a) five percent (5%) of the Outstanding Amount for administration and bookkeeping costs associated with the late payment and (b) interest on the Outstanding Amount from the Due Date through and including the date such payment or installment is received by Landlord, at a rate equal to the lesser of (i) the rate announced by Bank of America, N.A., (or its successor) from time to time as its prime or base rate (or if such rate is no longer available, a comparable rate reasonably selected by Landlord), plus two percent (2%), or (ii) the maximum applicable legal rate, if any. Such interest shall be deemed Additional Rent and shall be paid by Tenant to Landlord upon demand.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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9.20 | Tenants Payments |
Each and every payment and expenditure, other than Annual Fixed Rent, shall be deemed to be Additional Rent hereunder, whether or not the provisions requiring payment of such amounts specifically so state, and shall be payable, unless otherwise provided in this Lease, within ten (10) days after written demand by Landlord, and in the case of the non-payment of any such amount, Landlord shall have, in addition to all of its other rights and remedies, all the rights and remedies available to Landlord hereunder or by law in the case of non-payment of Annual Fixed Rent. Unless expressly otherwise provided in this Lease, the performance and observance by Tenant of all the terms, covenants and conditions of this Lease to be performed and observed by Tenant shall be at Tenants sole cost and expense. In the event that Tenant shall seek Landlords consent or approval under this Lease, then Tenant shall reimburse Landlord, upon demand, as Additional Rent, for all reasonable out-of-pocket costs and expenses, including legal and architectural costs and expenses, incurred by Landlord in processing such request, whether or not such consent or approval shall be given; provided, however the foregoing shall not limit the recovery of costs and expenses expressly identified in Sections 5.6 or 5.12 of this Lease). Notwithstanding anything in this Lease to the contrary, if Landlord or any affiliate of Landlord has elected to qualify as a real estate investment trust (REIT), any service required or permitted to be performed by Landlord pursuant to this Lease, the charge or cost of which may be treated as impermissible tenant service income under the laws governing a REIT, may be performed by a taxable REIT subsidiary that is affiliated with either Landlord or Landlords property manager, an independent contractor of Landlord or Landlords property manager (the Service Provider) so long as there is not a resulting material increase in Operating Expenses. If Tenant is subject to a charge under this Lease for any such service, then, at Landlords direction, Tenant will pay such charge either to Landlord for further payment to the Service Provider or directly to the Service Provider, and, in either case, (i) Landlord will credit such payment against Additional Rent due from Tenant under this Lease for such service, and (ii) such payment to the Service Provider will not relieve Landlord from any obligation under the Lease concerning the provisions of such service.
9.21 | Waiver of Trial by Jury |
To induce Landlord to enter into this Lease, Tenant hereby waives any right to trial by jury in any action, proceeding or counterclaim brought by either Landlord or Tenant on any matters whatsoever arising out of or any way connected with this Lease, the relationship of the Landlord and the Tenant, the Tenants use or occupancy of the Premises and/or any claim of injury or damage, including but not limited to, any summary process eviction action.
9.22 | Governing Law |
This Lease shall be governed exclusively by the provisions hereof and by the law of the Commonwealth of Massachusetts, as the same may from time to time exist.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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9.23 | Signage. |
For so long as (i) this Lease is in full force and effect, (ii) Tenant has neither assigned this Lease nor sublet more than thirty percent (30%) of the Rentable Floor Area of the Premises (except for an assignment or sublease to a Permitted Transferee), and (iii) there exists no uncured Event of Default hereunder, Tenant shall be permitted, at Tenants sole cost and expense (A) to erect one (1) sign on the exterior façade of the Building (the Façade Sign), and (B) on a non-exclusive basis, to be identified on the monument signs and building directories located on the Site and generally serving the Building (the Additional Signage), all subject to compliance with the provisions of this Section 9.23. In addition, during the Term Tenant may, at its sole cost and expense, install, remove, replace and maintain signage containing Tenants name at the main entry to the Premises subject to compliance with the remaining provisions of this Section 9.23.
All features and aspects of the signage described in the prior paragraph, including, without limitation, the design, lighting, components, location, color, size, proportion and method of installation of all signage described in this Section 9.23 shall be subject to the prior approval of Landlord (which approval shall not be unreasonably withheld or conditioned). Landlord hereby approves the signage shown on Exhibit L attached hereto to the extent the same identifies the features and aspects of the signage specifically identified in the prior sentence.
Such signage shall be further subject to compliance with the requirements of the Zoning By-Law of the Town of Lexington and all other applicable Legal Requirements, including, without limitation, Tenant obtaining all necessary permits and approvals therefor. Tenant acknowledges and agrees that Tenants right to signage pursuant to this Section 9.23 is not on an exclusive basis and that Landlord may grant other tenants in the Complex the right to maintain signage on the Complex and/or the Building. Tenant shall be responsible for maintaining all of its signage in good condition and repair throughout the Term.
In the event that at any time during the Term, Tenant ceases to meet the requirements described above, Tenant shall, upon Landlords written request and at Tenants sole cost and expense, remove Façade Sign and/or Additional Signage designated by Landlord for removal and restore any areas affected by the installation and subsequent removal of Tenants signage. In addition, Tenant shall be required, at its sole cost and expense, to remove all of the Tenants signage described in this Section 9.23 and restore any areas affected by the installation and subsequent removal of Tenants signage upon the expiration or earlier termination of the Term.
9.24 | Tenants Equipment |
(A) Subject to the terms and provisions of this Section 9.24, Tenant shall be permitted to install (x) telecommunications equipment, related receiving equipment, related cable connections and other related telecommunications equipment (collectively, the Telecom Equipment) and (y) HVAC equipment and any and all related equipment to accommodate Tenants excess HVAC requirements (collectively, the HVAC Unit) in a
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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location or locations on the rooftop the Building in an area to be mutually agreed upon the parties, provided that (i) such installation and the operation thereof shall not cause any interference with any existing communication equipment in the Complex, and (ii) such installation does not adversely affect the structural elements or the visual aesthetic of the Building as determined by Landlord in its reasonable discretion. Tenant shall have no right to license, sublease, assign or otherwise transfer its rights to install and use Telecom Equipment and the HVAC Unit (other than to an assignee or subtenant permitted or consented to under this Lease). Landlord hereby reserves the right (at its sole discretion) to install and to permit others to install, use and maintain telecommunications equipment, antennas and similar installations on the rooftop of the Building and elsewhere on the Site provided that such equipment, antennas and installations do not materially interfere with Tenants Equipment (as defined below).
(B) Subject to the provisions of this Section 9.24, Tenant shall have the right to install a generator, related connections and a diesel fuel tank or similar fuel storage compartment (collectively, the Generator) in an area on the Site to be mutually agreed upon by Landlord and Tenant (it being understood and agreed that the Generator may not be installed on the roof of the Building).
(C) Tenants use of the Telecom Equipment, the HVAC Unit and the Generator (collectively, the Tenants Equipment) shall be upon all of the conditions of the Lease, except as modified below:
(i) | It is understood and agreed that Tenant shall be responsible, at its sole cost and expense, for installing the Tenants Equipment. In addition to complying with the applicable construction provisions of this Lease, Tenant shall not install or operate any portion of the Tenants Equipment until Tenant shall have obtained Landlords prior written approval, which approval will not be unreasonably withheld, conditioned or delayed, of Tenants plans and specifications therefor. |
(ii) | Landlord shall have no obligation to provide any services to the Tenants Equipment, provided Tenant shall have the right to connect Tenants Equipment to existing base building utility systems, subject to Landlords right to reasonably approve such connections. Tenant shall, at its sole cost and expense and otherwise in accordance with the provisions of this Section 9.24, arrange for all utility services required for the operation of the Tenants Equipment. |
(iii) | Tenant shall have no right to make any changes, alterations or other improvements to the Tenants Equipment without Landlords prior written consent, which consent shall not be unreasonably withheld or delayed; provided, however, that Tenant shall have the right to maintain and make repairs to the Tenants Equipment. |
(iv) | Tenant shall be responsible for the cost of repairing any damage to the Complex caused by the installation, operation and removal of the Tenants Equipment. |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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(v) | Except for assignees of this Lease or subtenants of all or a portion of the Premises, no other person, firm or entity (including, without limitation, other tenants, licensees or occupants of the Complex) shall have the right to connect to the Tenants Equipment other than Tenant. |
(vi) | To the maximum extent permitted by law, Tenants use of the Tenants Equipment shall be at the sole risk of Tenant, and Landlord shall have no liability to Tenant in the event that the Tenants Equipment is damaged for any reason excluding Landlords or Landlords Partys negligent act or omission. |
(vii) | Unless requested by Landlord as provided in this Lease, in no event shall Tenant remove the Tenants Equipment at the expiration or earlier termination of the Term. |
(viii) | In addition to the indemnification provisions set forth in this Lease (which shall be applicable to the Tenants Equipment), Tenant shall, to the maximum extent permitted by law, indemnify, defend, and hold Landlord, its agents, contractors and employees harmless from any and all claims, losses, demands, actions or causes of actions suffered by any person, firm, corporation, or other entity arising from the installation, use or removal of the Tenants Equipment excluding Landlords or Landlords Partys negligent act or omission. |
(ix) | To the extent required in Landlords approval of such Tenants Equipment, Tenant shall, at its sole cost and expense, remove Tenants Equipment (or such elements of the same as Landlord shall designate) and restore any areas affected by the installation and subsequent removal of Tenants Equipment upon the expiration or earlier termination of the Term. |
(D) Tenant shall, at its sole cost and expense, secure and maintain in full force and effect the approvals of all governmental authorities and all permits required by governmental authorities having jurisdiction over such approvals for the Tenants Equipment, and shall provide Landlord with copies of such approvals and permits prior to commencing any work with respect thereto. Tenant shall be solely responsible for maintaining Tenants Equipment in compliance with applicable Legal Requirements (and Landlord assumes not risk with respect thereto). In addition, Tenant shall be solely responsible for all costs and expenses in connection with the installation, maintenance, use and removal of the Tenants Equipment. In connection therewith, Tenant shall provide Landlord with evidence on an annual basis of the existence of a maintenance contract for the Generator with a service provider reasonably acceptable to Landlord. Tenant shall not operate the Generator other than on a temporary basis for maintenance and testing or as required in the event of an emergency. Tenant shall immediately notify Landlord of any release or spill of fuel or other Hazardous Materials related to the Generator.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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EXECUTED as a sealed instrument in two or more counterparts each of which shall be deemed to be an original.
WITNESS: | LANDLORD: | |||||||
HAYDEN OFFICE TRUST | ||||||||
/s/ XXXX |
By: | /s/ XXXX | ||||||
, for the Trustees of Hayden Office Trust, pursuant to written delegation, but not individually | ||||||||
TENANT: | ||||||||
ATTEST: | SYNAGEVA BIOPHARMA CORP. | |||||||
By: | /s/ Chris Heberlig |
By: | /s/ Sanj K. Patel | |||||
Name: | Chris Heberlig |
Name: | Sanj K. Patel | |||||
Title: | (Secretary or Assistant Secretary) |
Title: | (President or Vice President) | |||||
Hereto duly authorized | ||||||||
By: | /s/ Carsten Boess | |||||||
Name: | Carsten Boess | |||||||
Title: | (Treasurer or Assistant Treasurer) | |||||||
Hereto duly authorized |
CORPORATE SEAL
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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EXHIBIT A
DESCRIPTION OF SITE
Those certain parcels of land (together with the buildings and improvements thereon) situated on the northeasterly side of Route 2 so-called, in Lexington, Middlesex County, Massachusetts being shown as Parcel 1 and Parcel 2 on a plan entitled Plan of Land in Lexington, Mass., dated March 19, 1964, by Albert A. Miller and Wilbur C. Nylander, Civil Engineers & Surveyors, recorded with Middlesex South District Deeds, Book 10511, Page 298, bounded and described as follows:
SOUTHWESTERLY |
by Route 2 as shown on said plan by two lines measuring respectively 80.34 feet and 970.47 feet; | |
NORTHWESTERLY |
by the 1974 State Highway Layout being a relocation of Spring Street, by two lines measuring respectively 159.76 feet and 54.99 feet; | |
NORTHERLY |
on a curved line by the junction of said relocated Spring Street and an access road also part of the 1964 State Highway Layout, all as shown on said plan, 57.08 feet; | |
NORTHEASTERLY |
by said access road as shown on said plan by three lines measuring respectively 231.55 feet, 647.54 feet and 7.13 feet; | |
NORTHEASTERLY and EASTERLY |
by the same by several lines measuring respectively 101.06 feet, 33.98 feet, 19.62 feet, 57.07 feet and 17.46 feet. |
Parcel 1 contains, according to said plan, 45/100 acres, Parcel 2 contains 5-89/100 acres, and both Parcels together contain according to said plan, 6.34 acres.
Said premises are subject to easements, agreements and restrictions of record, if any, to the extent in force and applicable.
For title see Deed recorded with said registry of Deeds in Book 15217, page 429.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Exhibit A
EXHIBIT B-1
WORK AGREEMENT
1.1 | Landlords Work. |
(A) | Plans and Construction Process. |
(1) | Landlords Third Floor Work. Attached to the Lease as Exhibit B-2 is a space plan prepared by Perkins Will (the Architect) dated January 4, 2013 (the Space Plan) and a Turn-Key Matrix as Exhibit B-3, showing the work to be performed by Landlord, at Landlords cost and expense (except as otherwise noted in the Turn-Key Matrix), in order to prepare the Third Floor Premises for Tenants occupancy (such work being hereinafter referred to as the Landlords Third Floor Work). |
(2) | Tenants Demolition Plans. The parties acknowledge that Tenant has delivered to Landlord a set of demolition plans (the Tenant Demolition Plans) identifying all demolition work to be performed by Landlord to prepare the Premises for the performance of the remaining elements of Landlords Work (the Demolition Work) and Landlord has approved the same. It is understood and agreed that Landlords approval under this Section was given solely for the benefit of Landlord, and neither Tenant nor any third party shall have the right to rely upon Landlords approval of the Tenant Demolition Plans for any other purpose whatsoever other than for satisfying the consent requirements under this Lease. Without limiting the foregoing, Tenant shall be responsible for all elements of the design of the Tenant Demolition Plans (including, without limitation, compliance with law, functionality of design, the structural integrity of the design, the configuration of the Premises), and Landlords approval of the Tenants Demolition Plans shall in no event relieve Tenant of the responsibility for such design. Notwithstanding the foregoing, the parties acknowledge and agree that as an accommodation to Tenant, Landlord entered into the contract with the Architect prior to the execution of this Lease for the preparation of the Tenant Demolition Plans (the Architects Contract), and as a result, in the event that the Tenant Demolition Plans contain errors or omissions by Architect or the work described therein is not designed in compliance with applicable laws, Landlord, upon request of Tenant (which shall be a right but not an obligation of Tenant), and at the expense of Tenant, shall enforce the obligations of the Architect under the Architects Contract for the benefit of Tenant (or if not prohibited by the Architects Contract, Landlord shall, upon Tenants request, assign the right to enforce the Architects Contract directly to Tenant so that Tenant may undertake enforcement of the same on its own behalf). Tenant shall |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 1
Exhibit B-1
pay any costs and expenses incurred by Landlord in enforcing the Architects Contract at the request of Tenant within ten (10) days of demand as a condition to Landlords obligation to so enforce the Architects Contract. In the event Landlord elects to enforce the Architects Contract and the same is not at the request of Tenant, Landlord shall do the same at Landlords expense. Tenant shall promptly revise the Tenant Demotion Plans to incorporate any comments thereon from the Town of Lexington so that the same may be approved by the Town of Lexington for issuance of a demolition permit. |
(3) | Landlords Additional Work. No later than the Tenant Construction Plans Date, Tenant shall deliver to Landlord a full set of construction plans and specifications (the Tenants Submission) containing all details for the work to be performed by Landlord to prepare the Second Floor Premises and the Office/Laboratory Premises (the Landlords Laboratory Work) and the [*] Premises (the Landlords [*] Work) for Tenants occupancy (collectively, the Landlords Laboratory Work and the Landlords [*] Work are referred to herein as the Landlords Additional Work), such plans and specifications to be prepared by Perkins Will and shall clearly delineate between the Landlords [*] Work and the Landlords Laboratory Work. Landlord shall have no responsibility for the installation or connection of Tenants computer, telephone, other communication equipment, systems or wiring. Such plans and specifications (the Plans) shall contain at least the information required by, and shall conform to the requirements of, Exhibit B-4. Landlord shall have no obligation to perform Landlords Additional Work until the Plans shall have been presented to it and approved by it. Provided that the Plans shall contain at least the information required by, and shall conform to the requirements of, Exhibit B-4, Landlord shall not unreasonably withhold or delay its approval of the Plans. However, Landlords determination of matters relating to alterations or changes visible outside the Premises shall be in Landlords sole discretion. As soon as practicable after the receipt of the Plans, Landlord shall notify Tenant as to whether Landlord approves the Plans and shall furnish to Tenant a written statement (the Cost Notice) of all costs of Landlords Additional Work, as well as costs of the Demolition Work solely as to the Second Floor Premises, the Office/Laboratory Premises and the [*] Premises (the Total Landlords Additional Work Cost). In connection with the foregoing, it is understood and agreed that Landlords approval under this Section is given solely for the benefit of Landlord, and neither Tenant nor any third party shall have the right to rely upon Landlords approval of the Plans for any other purpose whatsoever other than for satisfying the consent requirements under this Lease. Without limiting the foregoing, Tenant shall be responsible for all elements of the design of the Plans (including, without limitation, compliance with law, functionality of design, the structural integrity of the design, the configuration of the Premises and the placement of Tenants furniture, appliances and equipment), and |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 2
Exhibit B-1
Landlords approval of the Plans shall in no event relieve Tenant of the responsibility for such design. Notwithstanding the foregoing, the parties acknowledge and agree that as an accommodation to Tenant, Landlord entered into the Architects Contract with the Architect prior to the execution of this Lease for the preparation of the Plans, and as a result, in the event that the Plans contain errors or omissions by Architect or the work described therein is not designed in compliance with applicable laws, Landlord, upon request of Tenant (which shall be a right but not an obligation of Tenant), and at the expense of Tenant, shall enforce the obligations of the Architect under the Architects Contract for the benefit of Tenant (or if not prohibited by the Architects Contract, Landlord shall, upon Tenants request, assign the right to enforce the Architects Contract directly to Tenant so that Tenant may undertake enforcement of the same on its own behalf). Tenant shall pay any costs and expenses incurred by Landlord in so enforcing the Architects Contract at the request of Tenant within ten (10) days of demand as a condition to Landlords obligation to so enforce the Architects Contract. In the event Landlord elects to enforce the Architects Contract and the same is not at the request of Tenant, Landlord shall do the same at Landlords expense. Landlord has agreed not to charge a construction management fee with respect to Landlords Additional Work. |
(4) | Tenant Plan Excess Costs. To the extent the Total Landlords Additional Work Cost exceeds the Tenant Allowance set forth in Section 1.4 of this Work Agreement, such excess costs are hereinafter referred to as Tenant Plan Excess Costs and shall be paid by Tenant as Additional Rent in accordance with Section 1.5 of this Work Agreement. Tenant shall provide Landlord in writing, within five (5) business days of receipt by Tenant of Landlords Cost Notice, of either (i) its approval thereof and its authorization to Landlord to proceed with Landlords Additional Work in the event Landlord had no objection to the Plans, or (ii) changes in the Plans prepared by Tenants architect which shall be responsive to any objections raised by Landlord. In the event of the latter modification, Landlord shall, as soon as practicable after Landlord obtains price quotations for any changes in the Plans, notify Tenant in writing of all changes in the Cost Notice, the Total Landlords Additional Work Cost and the Tenant Plan Excess Costs resulting from said plan modifications and whether Landlord approves the revised Plans. Tenant shall, within five (5) business days after receipt of Landlords revised quotation either approve or disapprove of such revised quotation (the Initial Revised Quotation). If Tenant approves such revised quotation, the Cost Notice and the Total Landlords Additional Work Cost shall be modified as stated in Landlords written notice. If Tenant disapproves the Initial Revised Quotation, Tenant may further revise the Plans and the foregoing process shall be continued until any further revised Plans and further revised quotation are approved, but any period from and after the expiration of the initial five-day period for approval of the Initial Revised Quotation and continuing until the |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 3
Exhibit B-1
final revisions and approvals shall be deemed a Tenant Delay hereunder. Landlord agrees that the Landlords Additional Work, as well as the Demolition Work solely related to the Second Floor Premises, the Office/Laboratory Premises and the [*] Premises, shall be performed for not more than the amount stated in the Cost Notice, as modified (if applicable) by the amount stated in the approved Initial Revised Quotation, and to the extent the actual costs of performing such work exceeds the Total Landlords Additional Work Cost (as modified if applicable) (the Construction Cost Excess), Tenant shall not have any responsibility for the Construction Cost Excess except to the extent the Construction Cost Excess is a result of a (i) Change Order, (ii) Tenant Delay, or (iii) deficiencies in the Plans. |
(5) | Definition of Landlords Work. For the purposes of the Lease, the term Landlords Work shall mean all labor, materials and other work necessary for the construction of the improvements identified as Landlords Third Floor Work, the Demolition Work, and Landlords Additional Work; provided, however, that Landlord shall have no responsibility for the installation or connection of Tenants computer, telephone, other communication equipment, systems or wiring or licensing or operational permits for the Laboratory or the [*] Premises. |
(6) | Authorization to Proceed Date; Tenant Construction Plans Date; Long Lead Item Release Date. Tenant shall, on or before the Authorization to Proceed Date, give Landlord written authorization to proceed with Landlords Additional Work in accordance with Tenants approved Plans (Notice to Proceed). It is acknowledged and agreed that the Authorization to Proceed Date shall be extended in the event Tenant elects to revise the Plans after receipt of the Cost Notice, but any delay caused by exercise of such election shall be deemed a Tenant Delay. In addition, Tenant shall, on or before the Tenant Construction Plans Date, execute and deliver to Landlord any affidavits and documentation required in order to obtain all permits and approvals necessary for Landlord to commence and complete Landlords Work on a timely basis (Permit Documentation). Tenant shall, on or before the (i) the Long Lead Items Submission Date, notify Landlord of all Long Lead Items (as defined below) required for the performance of the Landlords Work, and (ii) Long Lead Item Release Date, give Landlord written authorization to proceed to purchase and/or contract for any items of work for which there is a long lead time in obtaining the materials therefor or which are specially or specifically manufactured, produced or milled for the work in or to the Premises and require additional time for receipt or installation (Long Lead Items). Notwithstanding the foregoing, Tenant acknowledges that (i) certain Long Lead Items may still delay completion of Landlords Work and thus result in a Tenant Delay even if Tenant does authorize them on or before the Long Lead Item Release Date, and (ii) any Long Lead Items which are identified in Tenants Plans after the Long Lead Item Release Date may delay completion of Landlords Work and thus result in a Tenant Delay. |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 4
Exhibit B-1
(7) | Change Orders. Tenant shall have the right, in accordance herewith, to submit for Landlords approval change proposals subsequent to Landlords approval of the Plans and Tenants approval of the Tenant Plan Excess Costs, if any (each, a Change Proposal). Landlord agrees to respond to any such Change Proposal within such time as is reasonably necessary (taking into consideration the information contained in such Change Proposal) after the submission thereof by Tenant, advising Tenant of any anticipated increase in costs (Change Order Costs) associated with such Change Proposal, as well as an estimate of any delay which would likely result in the completion of the Landlords Work if a Change Proposal is made pursuant thereto (Landlords Change Order Response). Tenant shall have the right to then approve or withdraw such Change Proposal within three (3) days after receipt of Landlords Change Order Response. If Tenant fails to respond to Landlords Change Order Response within such three (3) day period, such Change Proposal shall be deemed withdrawn. If Tenant approves such Change Proposal, then such Change Proposal shall be deemed a Change Order hereunder and if the Change Order is made, then the Change Order Costs associated with the Change Order shall be deemed additions to the Tenant Plan Excess Costs and shall be paid in the same manner as Tenant Plan Excess Costs are paid as set forth in Section 1.5 of this Work Agreement. |
(8) | Tenant Response to Requests for Information and Approvals. Except to the extent that another time period is expressly herein set forth, Tenant shall reasonably respond to any request from Landlord, Landlords architect, Landlords contractor and/or Landlords Construction Representative for approvals or information in connection with Landlords Work, within three (3) business days of Tenants receipt of such request. |
(9) | Time of the Essence. Time is of the essence in connection with Tenants and Landlords obligations under this Section 1.1. |
(B) | Tenant Delay. |
(1) | A Tenant Delay shall be defined as the following: |
(a) | Tenants failure to (i) deliver the Tenants Submission by the Tenant Construction Plans Date, (ii) notify Landlord of all Long Lead Items by the Long Lead Submission Date, (iii) give Landlord written authorization to proceed to purchase and/or contract for delivery of the Long Lead Items by the Long Lead Item Release Date, (iv) give authorization to Landlord to proceed with Landlords |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 5
Exhibit B-1
Additional Work on or before the Authorization to Proceed Date or (v) provide all required Permit Documentation to Landlord on or before the Authorization to Proceed Date; or |
(b) | Tenants failure timely to respond to any request from Landlord, Landlords architect, Landlords contractor and/or Landlords Construction Representative including, without limitation, within the time periods set forth in Section 1.1(A)(8) above; |
(c) | Tenants failure to pay the Tenant Plan Excess Costs when due in accordance with Section 1.5 of this Work Agreement; |
(d) | Any delay due to items of work for which there is a long lead time in obtaining the materials therefor or which are specially or specifically manufactured, produced or milled for the work in or to the Premises and require additional time for receipt or installation; |
(e) | Any delay due to changes, alterations or additions required or made by Tenant after Landlord approves Tenants Plans including, without limitation, Change Orders; or |
(f) | Any other delays caused by Tenant, Tenants contractors, architects, engineers or anyone else engaged by Tenant in connection with the preparation of the Premises for Tenants occupancy, including, without limitation, utility companies and other entities furnishing communications, data processing or other service, equipment, or furniture. |
(2) | Tenant Obligations with Respect to Tenant Delays. |
(a) | Tenant covenants that no Tenant Delay shall delay an Applicable Commencement Date or the obligation to pay Annual Fixed Rent or Additional Rent, regardless of the reason for such Tenant Delay or whether or not it is within the control of Tenant or any such employee. Landlords Work (or the applicable elements thereof) shall be deemed substantially completed as of the date when Landlords Work (or the applicable elements thereof) would have been substantially completed but for any Tenant Delays, as determined by Landlord in the exercise of its good faith business judgment. |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 6
Exhibit B-1
(b) | Tenant shall reimburse Landlord the amount, if any, by which the cost of Landlords Work is increased as the result of any Tenant Delay. |
(c) | Any amounts due from Tenant to Landlord under this Section 1.1(B)(2) shall be due and payable within fifteen (15) days of billing therefore (except that amounts due in connection with Change Orders shall be paid as provided in Section 1.5), and all such amounts shall be considered to be Additional Rent. Nothing contained in this Section 1.1(B)(2) shall limit or qualify or prejudice any other covenants, agreements, terms, provisions and conditions contained in the Lease. |
(C) | Substantial Completion of Landlords Work. |
(1) | Landlords Obligations. Subject to Tenant Delays and delays due to Force Majeure, as defined in Section 6.1 of the Lease, Landlord shall use reasonable speed and diligence to have (i) Landlords Third Floor Work substantially completed on or before the Third Floor Premises Estimated Commencement Date, (ii) Landlords Laboratory Work substantially completed on or before the Office/Laboratory Premises Estimated Commencement Date, and (iii) Landlords [*] Work substantially completed on or before the [*] Premises Estimated Commencement Date, but Tenant shall have no claim against Landlord for failure so to complete construction of Landlords Work in the Premises, except for the rights expressly specified in Section 1.2 of this Work Agreement. Landlord shall use reasonable efforts to notify Tenant in writing ten (10) days in advance of the date on which it expects (A) Landlords Third Floor Work to be substantially completed, (B) Landlords Laboratory Work to be substantially completed, and (C) Landlords [*] Work to be substantially completed. |
(2) | Definition of Substantial Completion. The applicable portion of the Premises shall be treated as having been substantially completed (and ready for occupancy for the purposes of Section 2.4 of the Lease) on the later of: |
(a) | The date on which the Landlords Work applicable to such portion of the Premises (i.e. Landlords Third Floor Work as to the Third Floor Premises, Landlords Laboratory Work as to the Office/Laboratory Premises and the Second Floor Premises, and Landlords [*] Work as to the [*] Premises) has been completed (or would have been completed except for Tenant Delays) except for minor items of work and adjustment of equipment and fixtures |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 7
Exhibit B-1
which can be completed after occupancy has been taken without causing substantial interference with Tenants use of such portion of the Premises (i.e. so-called punch list items), or |
(b) | The date when permission has been obtained from the applicable governmental authority, to the extent required by law, for occupancy by Tenant of such portion of the Premises for the Permitted Use, unless the failure to obtain such permission is due to a Tenant Delay; provided however, such condition shall be waived in the event Landlord is unable to obtain such permission solely as a result of the failure of Tenant to install fixtures, furniture or equipment which is the responsibility of Tenant or in the equipment any commissioning or licensing of the laboratory or [*] is a pre-condition to the grant of such permission. |
In the event of any dispute as to the date on which an element of Landlords Work has been substantially completed, the reasonable determination of Landlords architect as to such date shall be deemed conclusive and binding on both Landlord and Tenant.
(3) | Incomplete Work. Landlord shall complete as soon as conditions practically permit any incomplete items of Landlords Work, and Tenant shall cooperate with Landlord in providing access as may be required to complete such work in a normal manner. |
(4) | Early Access by Tenant. Landlord shall permit Tenant access for installing Tenants trade fixtures in portions of the Premises for a period of thirty (30) days prior to substantial completion when it can be done without material interference with remaining work or with the maintenance of harmonious labor relations. Any such access by Tenant shall be at upon all of the terms and conditions of the Lease (other than the payment of Annual Fixed Rent) and shall be at Tenants sole risk, and Landlord shall not be responsible for any injury to persons or damage to property resulting from such early access by Tenant. |
(5) | Prohibition on Access by Tenant Prior to Actual Substantial Completion. If, prior to the date that the Premises are in fact actually substantially complete, the Premises are deemed to be substantially complete as a result of a Tenant Delay (i.e. and the Commencement Date has therefore occurred), Tenant shall not (except with Landlords consent) be entitled to take possession of the Premises for the Permitted Use until the Premises are in fact actually substantially complete. |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 8
Exhibit B-1
1.2 | Outside Completion Dates |
(A) If Landlord shall have failed substantially to complete the Landlords Third Floor Work on or before the Second Floor Premises and Third Floor Premises Outside Completion Date as defined in Section 1.1 of the Lease (which date shall be extended automatically for such periods of time as Landlord is prevented from proceeding with or completing the same by reason of Force Majeure (as defined in Section 6.1 of the Lease) or any act or failure to act of Tenant which interferes with Landlords construction of the Landlords Work, without limiting Landlords other rights on account thereof), the Second Floor Premises and Third Floor Premises Annual Fixed Rent shall be abated from and after the Second Floor Premises and Third Floor Premises Rent Commencement Date by two (2) days for each day beyond Second Floor Premises and Third Floor Premises Outside Completion Date (as so extended) until the Landlord substantially completes the Landlords Third Floor Work.
(B) If Landlord shall have failed substantially to complete the Landlords Laboratory Work on or before the Office/Laboratory Premises Outside Completion Date as defined in Section 1.1 of the Lease (which date shall be extended automatically for such periods of time as Landlord is prevented from proceeding with or completing the same by reason of Force Majeure (as defined in Section 6.1 of the Lease) or any act or failure to act of Tenant which interferes with Landlords Work, without limiting Landlords other rights on account thereof), the Office/Laboratory Premises Annual Fixed Rent shall be abated from and after the Office/Laboratory Rent Commencement Date by two (2) days for each day beyond Office/Laboratory Premises Outside Completion Date (as so extended) until the Landlord substantially completes the Laboratory Work.
(C) If Landlord shall have failed substantially to complete the Landlords [*] Work on or before the [*] Premises Outside Completion Date as defined in Section 1.1 of the Lease (which date shall be extended automatically for such periods of time as Landlord is prevented from proceeding with or completing the same by reason of Force Majeure (as defined in Section 6.1 of the Lease) or any act or failure to act of Tenant which interferes with Landlords Work, without limiting Landlords other rights on account thereof), the [*] Premises Annual Fixed Rent shall be abated from and after the [*] Premises Rent Commencement Date by two (2) days for each day beyond [*] Premises Outside Completion Date (as so extended) until the Landlord substantially completes the [*] Work.
(D) Each day of Tenant Delay shall be deemed conclusively to cause an equivalent day of delay by Landlord in substantially completing the work to be done by Landlord pursuant to Section 1.1 of this Work Agreement, and thereby automatically extend for each such equivalent day of delay the date of the applicable Outside Completion Date.
(E) It is acknowledged and agreed that the remedies contained in this Section 1.2 shall not apply in the event that Landlord shall be unable to obtain permission from the
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 9
Exhibit B-1
applicable governmental authority for occupancy by Tenant of an applicable portion of the Premises for the Permitted Use if such permission is withheld by such governmental authority due to the fact that elements of the Landlords Work in other portions of the Premises have not been completed.
1.3 | Quality and Performance of Work |
All construction work required or permitted by the Lease shall be done in a good and workmanlike manner and in compliance with all applicable laws, ordinances, rules, regulations, statutes, by-laws, court decisions, and orders and requirements of all public authorities (Legal Requirements) and all Insurance Requirements (as defined in Section 5.12 of the Lease). All of Tenants work shall be coordinated with any work being performed by or for Landlord and in such manner as to maintain harmonious labor relations. Each party may inspect the work of the other at reasonable times and shall promptly give notice of observed defects. Each party authorizes the other to rely in connection with design and construction upon approval and other actions on the partys behalf by any Construction Representative of the party named in Section 1.1 of the Lease or any person hereafter designated in substitution or addition by notice to the party relying. Except to the extent to which Tenant shall have given Landlord notice of respects in which Landlord has not performed Landlords construction obligations under this Work Agreement (if any) not later than the end of the fiftieth (50th) week next beginning after the Final Commencement Date with respect to Landlords construction obligations under this Work Agreement, Tenant shall be deemed conclusively to have approved Landlords construction and shall have no claim that Landlord has failed to perform any of Landlords obligations under this Work Agreement (if any). Landlord agrees to correct or repair at its expense items which are then incomplete or do not conform to the work contemplated under the Plans and as to which, in either case, Tenant shall have given notice within such period to Landlord, as aforesaid.
1.4 | Special Allowance |
Landlord shall provide to Tenant a special allowance equal to One Million One Hundred and Ninety-Eight Thousand Six Hundred and Sixty-One Dollars ($1,198,661) (the Tenant Allowance). The Tenant Allowance shall be used and applied by Landlord solely on account of the cost of Landlords Additional Work and the costs of the Demolition Work to the extent related to the Second Floor Premises, the Office/Laboratory Premises and the [*] Premises. In no event shall Landlords obligations to pay, or reimburse Tenant, for any of such costs exceed the total Tenant Allowance. Notwithstanding the foregoing, Landlord shall be under no obligation to apply any portion of the Tenant Allowance for any purposes other than as provided in this Section 1.4. In addition, in the event that (i) Tenant is in default under the Lease beyond any applicable notice and cure period or (ii) there are any liens which are not bonded to the reasonable satisfaction of Landlord against Tenants interest in the Lease or against the Building or the Site arising out of any work performed by Tenant or any litigation in which Tenant is a party, then, from and after the date of such event (Event), Landlord shall have no further obligation to utilize any portion of the Tenant
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 10
Exhibit B-1
Allowance towards the costs permitted under this Section 1.4. Further, the Tenant Allowance shall only be applied towards the cost of Landlords Additional Work and the costs of the Demolition Work to the extent related to the Second Floor Premises, the Office/Laboratory Premises and the [*] Premises, and in no event shall Landlord be required to make application of any portion of the Tenant Allowance towards Tenants personal property, trade fixtures or moving expenses or on account of any supervisory fees, overhead, management fees or other payments to Tenant, or any partner or affiliate of Tenant. In the event that the costs of Landlords Additional Work and the costs of the Demolition Work to the extent related to the Second Floor Premises, the Office/Laboratory Premises and the [*] Premises are less than the Tenant Allowance, Tenant shall not be entitled to any payment or credit nor shall there be any application of the same toward Annual Fixed Rent or Additional Rent owed by Tenant under the Lease. Landlord shall have the right to immediately cease performance of the Landlords Work if an Event of Default occurs under this Lease.
1.5 | Payment of Tenant Plan Excess Costs |
To the extent, if any, that there are Tenant Plan Excess Costs, Tenant shall pay Landlord, as Additional Rent, within ten (10) days of billing therefor, from time to time during the performance of Landlords Work, in the proportion that such Tenant Plan Excess Costs bears to the Total Landlords Additional Work Cost, provided however, that if the Tenant Plan Excess Costs are the result of a Change Order, then Tenant shall pay to Landlord, as Additional Rent, at the time that Tenant approves such Change Order in accordance with Section 1.1(A)(7), all such Tenant Plan Excess Costs. In addition to any other rights or remedies of Landlord hereunder for Tenants failure timely to pay the Tenant Plan Excess Costs when required under this Section, the same shall constitute a Tenant Delay hereunder and/or Landlord may immediately (and without notice to Tenant) draw on the Construction Letter of Credit (as defined below) in an amount equal to the amount so due from Tenant.
1.6 | Construction Letter of Credit. |
Concurrently with its execution of this Lease, Tenant shall pay to Landlord a security deposit in the amount of [*]. as security for the payment of the Tenant Plan Excess Costs. Such deposit shall be in the form of an irrevocable, unconditional, negotiable letter of credit (the Construction Letter of Credit). The Construction Letter of Credit shall comply in all respects with the letter of credit requirements of Section 9.18 of the Lease and be substantially in the form attached hereto as Exhibit M. If the credit rating for the issuer of such Construction Letter of Credit falls below the standard set forth in (i) above or if the financial condition of such issuer changes in any other material adverse way or if any trustee, receiver or liquidator shall be appointed for the issuer, Landlord shall have the right to require that Tenant provide a substitute letter of credit that complies in all respects with the requirements of this Section 1.6, and Tenants failure to provide the same within thirty (30) days following Landlords written demand therefor shall entitle Landlord to immediately draw upon the Construction Letter of Credit. Any such Letter
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 11
Exhibit B-1
of Credit shall be for a term expiring December 1, 2013. Any failure or refusal of the issuer to honor the Letter of Credit shall be at Tenants sole risk and shall not relieve Tenant of its obligation hereunder with regard to the security deposit or the payment of the Tenant Plan Excess Costs. Upon the failure of Tenant to pay any portion of the Tenant Plan Excess Costs when due, Landlord shall have the immediate right from time to time, without prejudice to any other remedy Landlord may have on account thereof, to draw on such Construction Letter of Credit and to apply the amount of such draw to the Tenant Plan Excess Costs then due. Neither the holder of a mortgage nor the Landlord in a ground lease on property which includes the Premises shall ever be responsible to Tenant for the return or application of any such deposit, whether or not it succeeds to the position of Landlord hereunder, unless such deposit shall have been received in hand by such holder or ground Landlord.
Tenant not then being in default and having paid the entire amount of the Tenant Plan Excess Costs, Landlord shall return the Construction Letter of Credit to Tenant within thirty (30) days after the Final Commencement Date.
1.7 | Payment of Costs of Preparing Tenants Plans. |
Landlord has entered into a contract or contracts for the design of the Landlords Work, including the design work for the Tenant Demolition Plans (to the extent related to the Second Floor premises, the Office/Laboratory Premises and the [*] Premises) and the Plans. Notwithstanding the foregoing, Tenant agrees and acknowledges that it is responsible for all costs of preparing the Tenant Demolition Plans (to the extent related to the Second Floor Premises, the Office/Laboratory Premises and the [*] Premises) and the Plans (collectively, the Design Work), but Landlord agrees that Landlord shall (using the Tenant Allowance ) pay the applicable vendors and service providers for the Design Work after receiving written approvals from Tenant of invoices for such vendors and service providers and written direction to pay such invoices from Tenant. Landlord shall make payments due under such contracts, in accordance with the written direction of Tenant, within thirty (30) days of Landlords receipt of such direction. Landlord shall have no obligation or liability to Tenant based upon the performance or non-performance of the Design Work or any deficiency in the Design Work except with respect to Landlords enforcement obligations upon Tenants request identified in Section 1.1(A)(2) and (A)(3) above. Tenant hereby agrees that Tenant has the sole responsibility to the vendors and service providers for directing the content of the Design Work (subject to Landlords approval, which approval shall not be unreasonably withheld, conditioned, or delayed). The parties expressly agree that, for the purposes of the immediately preceding sentence, Landlord shall not be responsible to Tenant for: (i) Tenant, or Tenants agents, employees or contractors acting in any capacity, including, without limitation, while performing the owners obligations under any design contracts and/or while managing the performance of vendors and service providers under any design contracts, or (ii) any contractors, architects, or vendors providing any services under any design contract. Notwithstanding the foregoing, (i) Landlord shall have no liability to Tenant, and Tenant waives all claims against Landlord in respect to, the failure of the Design Work as shown
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 12
Exhibit B-1
on the Plans to comply with applicable Legal Requirements, and (ii) Tenant shall have no liability to Landlord, and Landlord waives all claims against Tenant in respect to, the failure of the Design Work as shown on the Plans to comply with applicable Legal Requirements, but the foregoing shall not in any way impair or waive claims of either party against the architects and/or engineers with respect to the Design Work. Without limiting the foregoing, and notwithstanding anything to the contrary in this Lease contained, any delays arising from the Design Work or the delivery of the Plans shall be considered to be a Tenant Delay, except to the extent that the same arises from either Landlords failure timely to pay any amount directed by Tenant as provided above.
If (i) Tenant is required to indemnify, defend and/or hold Landlord harmless pursuant to the provisions of this Section 1.7, and/or (ii) Tenant, in Tenants sole discretion, determines that any materials are defective or not according to the contract specifications, or any of the work performed under any design contract is defective or negligently performed, then Landlord shall, upon Tenants written request, take any actions Tenant may reasonably request to enforce Landlords rights under such design contract so as to require the vendor, service provider, or contractor in question to perform its obligations under such design contract and thereby minimize or eliminate Tenants risk or cost. To the extent not paid by the vendor, service provider or contractor, as applicable, Tenant shall, within thirty (30) days of billing therefor, reimburse Landlord for any out-of-pocket costs (including, without limitation, reasonable attorneys fees) which Landlord incurs as the result of any such request by Tenant.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 13
Exhibit B-1
EXHIBIT B-2
Space Plan
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 1
Exhibit B-2
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 2
Exhibit B-2
EXHIBIT B-3
Page 1 of 4
Boston Properties Synageva Tenant Work Letter 33 Hayden Ave Lex 3rd Floor
DELINEATION OF SYNAGEVA Third Floor TURN-KEY MATRIX
January 8, 2013
Element |
Description |
Turn Key |
Tenant | |||
Demo | Remove existing carpet/ wall base/VCT throughout suite On floor 3. | X | ||||
Remove existing 15/16ceiling grid located at different areas and Install 9/16 Fineline ceiling grid to match existing grid on floor 3. | X | |||||
Remove existing ceiling tiles that do not match USG Mars 3500 Clima Plus tile on floor 3_ | X | |||||
Remove existing offices/D/F/H not needed for new layout on floor 3. | X | |||||
Penetration work (floor slab/wall removal) related to MEP demo for first floor Lab penetrations. | X | |||||
Finish Carpentry | Supply and install upper and lower Plastic Laminate (Wilsonart or Nevamar) cabinets In coffee area | X | ||||
3126/3177 and Kitchen area 3142 on 3id floor as indicated on attached plan. Laminate Selection by Tenant. | ||||||
Supply and install closet pole and shelf in coat closet 3161and 3181. | X | |||||
Sand and paint existing exterior window sills throughout The 3d floor. | X | |||||
Doors & Frames | Install 8-6 high PM frames as shown on attached plan. | |||||
Install new paint grade doors with full-size glass insert. | X | |||||
Supply and install US10 Bronze Satin Finish passage and lockset hardware to match second floor building standard hardware. | X | |||||
Card readers and electrical hardware by tenant. | X | |||||
Drywall | Build new demising walls with insulation for /IT Room 3151 along with demising walls with insulation in conference rooms 3154 and 3187, install insulation in walls of Senior managers offices on floor 3 per attached plans. | X | ||||
Build new floor to ceiling (8x6) office walls per attached plan on floor 3. | X |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 1
Exhibit B-3
Element |
Description |
Turn Key |
Tenant | |||
Acoustic Ceilings | Supply and install new 2x2USG Mars Clima Plus ceiling tile #869851 on floor 3. | |||||
Supply and install Fineline Ultraline - 43500 9/16 14 reveal ceiling grid on floor 3. | ||||||
Flooring | Supply and install base building Shaw Commercial carpet ($18/YD installed). Carpet selected by tenant from LL supplied carpet books. | X | X | |||
Carpet above LL allowance will be at tenant expense. | X | |||||
Supply and install new VCT in coffee area 3126/3177 kitchen area 3142 electrical room 3153 A/3180 copy room 3182/3153 storage room 3162/3163 file room 3148/3140 computer storage 3149 pre-action room 3150 and server room 3151. Color selected by tenant. | X | |||||
Supply and install new Sohnsonite vinyl wall base throughout floor 3. | ||||||
Wall Finishes | Paint New And Existing Walls In Tenants Choice Of Color On Floor 3 | X | ||||
Paint new and existing door frames. Paint new and existing doors.. | X | |||||
Accent colored walls one per office in building standard paint. | ||||||
Equipment Specialties | Supply and install cubicles. | X | ||||
Heavy loading requirements. | ||||||
Fire extinguishers as required by code | X | |||||
Building standard signage in building directory in lobby. | ||||||
Branding and tenant signage Exterior signage | X | |||||
Existing exterior window shades will be cleaned and repaired as needed throughout 3rd fi. | X | |||||
Moveable wall system in conference room 3154. | ||||||
Fire Protection | Relocate/add semi recessed fire sprinlder heads to accommodate attached layout to meet code requirements on floor 3. | X | ||||
Supply and install new fire ham/strobe units to accommodate floor layout to meet code requirements on floor 3. | X | |||||
Pre-Action fire suppression system. | ||||||
Plumbing | Supply and install piping and sink in coffee stations 3126/3177 with point of use water heater. | X |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 2
Exhibit B-3
Element |
Description |
Turn Key |
Tenant | |||
HVAC | Supplemental cooling unit one (5 ton) for server room 3153 on floor 3, | |||||
Relocate/add new ductwork and diftbsers to accommodate new layout on floor 3. | X | |||||
New Fan Powered Boxes as needed to accommodate new floor layout on floor 3. | X | |||||
Electrical | Supply and install (2) duplex wall outlets In new offices/coffee station/conference rooms on floor 3. | X | ||||
Existing wall outlets ill remain In Place. | ||||||
Ceiling Motion Sensors throughout suite on floor 3 to meet energy code. | X | |||||
Wall switches (motion sensors) as needed to accommodate layout on floor 3. | X | |||||
Exit Signs/Fire Alarm devices as required by code on floor 3. | X | |||||
Dimmer switches (If Requested) | X | |||||
Supply and install new 2x2 or 2x4indirect light fixtures throughout floor 3. | X | |||||
Specialty lighting fixtures. | X | |||||
Provide electrical power to cubicle whips or power- pole | X | |||||
Telecom Security | Design/Install of Tel/Data/Furniture/AV. | X | ||||
Tel/Data Wiring/Equipment and Permit | X | |||||
Tenant Space Security System (If Required) | X | |||||
Design Services | Design For Turnkey Scope on 3rd Floor. | X | ||||
Life/Safety Engineering for Fire Protection & Fire Alarm Modification Required by Code On Floor 3, | X | |||||
Design Cost associated with tenant cost items. | X |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 3
Exhibit B-3
EXHIBIT B-4
TENANT PLAN AND WORKING DRAWING REQUIREMENTS
1. | Floor plan indicating location of partitions and doors (details required of partition and door types). |
2. | Location of standard electrical convenience outlets and telephone outlets. |
3. | Location and details of special electrical outlets; (e.g. Xerox), including voltage, amperage, phase and NEMA configuration of outlets. |
4. | Reflected ceiling plan showing layout of standard ceiling and lighting fixtures. Partitions to be shown lightly with switches located indicating fixtures to be controlled. |
5. | Locations and details of special ceiling conditions, lighting fixtures, speakers, etc. |
6. | Location and heat load in BTU/Hr. of all special air conditioning and ventilating requirements and all necessary HVAC mechanical drawings. |
7. | Location and details of special structural requirements, e.g., slab penetrations and areas with floor loadings exceeding a live load of 70 lbs./s.f. |
8. | Locations and details of all plumbing fixtures; sinks, drinking fountains, etc. |
9. | Location and specifications of floor coverings, e.g., vinyl tile, carpet, ceramic tile, etc. |
10. | Finish schedule plan indicating wall covering, paint or paneling with paint colors referenced to standard color system. |
11. | Details and specifications of special millwork, glass partitions, rolling doors and grilles, blackboards, shelves, etc. |
12. | Hardware schedule indicating door number keyed to plan, size, hardware required including butts, latchsets or locksets, closures, stops, and any special items such as thresholds, soundproofing, etc. Keying schedule is required. |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 1
Exhibit B-4
13. | Verified dimensions of all built-in equipment (file cabinets, lockers, plan files, etc.). |
14. | Location of any special soundproofing requirements. |
15. | All drawings to be uniform size (30 X 42) and shall incorporate the standard project electrical and plumbing symbols and be at a scale of 1/8 = 1 or larger. |
16. | Drawing submittal shall include the appropriate quantity required for Landlord to file for permit along with four half size sets and one full size set for Landlords review and use. |
17. | Provide all other information necessary to obtain all permits and approvals for Landlords Work. |
18. | Upon completion of the work, Tenant shall provide Landlord with two hard copies and one electronic CAD file of updated architectural and mechanical drawings to reflect all project sketches and changes. |
19. | As appropriate with respect to the applicable portion of the Premises, details related to lab casework, laboratory and [*] equipment and special mechanical, electrical and plumbing systems. |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 2
Exhibit B-4
EXHIBIT B-5
Install new building AHU (air handler unit) on roof for building HVAC distribution. A Variable Air Volume (VAV) system designed in accordance with local and ASHRAE requirements will be provided to serve the HVAC requirements. Performance criteria is provided in Exhibit C Landlord Services.
All rooftop and vertical distribution for office space associated with installation of AHU1 shall be included in the Capital Renovations.
Automatic temperature control system for the office space consisting of direct digital controls (DDC) and appurtenances.
Install two (2) new high efficiency boilers for building with a capacity of 1,500,000 BTUII input per unit.
Renovate lst floor lobby and café consistent with attached Plan.
Remove ACM floor mastic/floor tile and duct sealant and other ACM containing materials as may be present throughout the building in accordance with the terms of the lease.
Update existing atrium exhaust as necessary to conform to current building codes or as required by local authorities.
Repave parking lot with new stall markings. New markings will include up to eight (8) visitor spots at a mutually acceptable location or locations. Signage designating visitor spots will be at Landlords expense.
New electrical service will be installed in accordance with the latest edition of the National Electric Code. Power will be provided in sufficient capacity for Base Building MEP load and Common Area electric loads. In addition to Base Building loads, electrical power shall be designed to provide capacity consistent with Tenants requirements for the lab, [*] and Tenants special equipment. Tenant power shall be available in the Main Electrical Room for extension to each new electrical closet on each of the tenant floors.
The costs associated with supplying and installing the new transformer which is necessary to accommodate Tenants specific power requirements is a cost associated with the lab and [*] buildout and, as such, is included in the lab and [*] budget.
Base building signage will be replaced with code conforming signage.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 1
Exhibit B-5
Plan of renovation scope to café and lobby area. This plan is subject to modification in execution of final plans but will be consistent in scope. Café furniture by Landlord. Tenant furniture in lobby includes but is not limited to reception desk, team table and chairs and branding screens.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 2
Exhibit B-5
EXHIBIT C
LANDLORD SERVICES
I. | CLEANING |
Cleaning and janitorial services shall be provided as needed Monday through Friday, exclusive of holidays observed by cleaning company and Saturdays and Sundays.
A. | OFFICE AREAS |
Cleaning and janitorial services to be provided in the office areas shall include:
1. | Vacuuming, damp mopping of resilient floors and trash removal. |
2. | Dusting of horizontal surfaces within normal reach (tenant equipment to remain in place). |
3. | High dusting and dusting of vertical blinds to be rendered as needed. |
B. | LAVATORIES |
Cleaning and janitorial services to be provided in the common area lavatories of the building shall include:
1. | Dusting, damp mopping of resilient floors, trash removal, sanitizing of basins, bowls and urinals as well as cleaning of mirrors and bright work. |
2. | Refilling of soap, towel, tissue and sanitary dispensers to be rendered as necessary. |
3. | High dusting to be rendered as needed. |
C. | MAIN LOBBIES, ELEVATORS, STAIRWELLS AND COMMON CORRIDORS |
Cleaning and janitorial services to be provided in the common areas of the building shall include:
1. | Trash removal, vacuuming, dusting and damp mopping of resilient floors and cleaning and sanitizing of water fountains. |
2. | High dusting to be rendered as needed. |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 1
Exhibit C
D. | WINDOW CLEANING |
All exterior windows shall be washed on the inside and outside surfaces at frequency necessary to maintain a first class appearance.
II. | HVAC |
A. | Heating, ventilating and air conditioning equipment will be provided with sufficient capacity to accommodate a maximum population density of one (1) person per one hundred fifty (150) square feet of useable floor area served, and a combined lighting and standard electrical load of 3.0 watts per square foot of useable floor area. In the event Tenant introduces into the Premises personnel or equipment which overloads the systems ability to adequately perform its proper functions, Landlord shall so notify Tenant in writing and supplementary system(s) may be required and installed by Landlord at Tenants expense, if within fifteen (15) days Tenant has not modified its use so as not to cause such overload. |
Operating criteria of the basic system shall not be less than the following:
(i) | Cooling season indoor temperature of not in excess of 73 - 79 degrees Fahrenheit when outdoor temperature is 91 degrees Fahrenheit ambient. |
(ii) | Heating season minimum room temperature of 68 - 75 degrees Fahrenheit when outdoor temperature is 6 degrees Fahrenheit ambient. |
B. | Landlord shall provide heating, ventilating and air conditioning as normal seasonal changes may require during the hours of 8:00 a.m. to 6:00 p.m. Monday through Friday (legal holidays in all cases excepted). |
If Tenant shall require air conditioning (during the air conditioning season) or heating or ventilating during any other time period, Landlord shall use landlords best efforts to furnish such services for the area or areas specified by written request of Tenant delivered to the Building Superintendent or the Landlord before 3:00 p.m. of the business day preceding the extra usage. Landlord shall charge Tenant for such extra-hours usage at reasonable rates customary for first-class office buildings in the Boston Suburban market, and Tenant shall pay Landlord, as Additional Rent, upon receipt of billing therefor.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 2
Exhibit C
III. | ELECTRICAL SERVICES |
A. | Landlord shall provide electric power for a combined load of 3.0 watts per square foot of useable area for lighting and for office machines through standard receptacles for the typical office space. |
B. | In the event that Tenant has special equipment (such as computers and reproduction equipment) that requires either 3-phase electric power or any voltage other than 120 volts, or for any other usage in excess of 3.0 watts per square foot, Landlord may at its option require the installation of separate metering (Tenant being solely responsible for the costs of any such separate meter and the installation thereof) and direct billing to Tenant for the electric power required for any such special equipment. |
C. | Landlord will furnish and install, at Tenants expense, all replacement lighting tubes, lamps and ballasts required by Tenant. Landlord will clean lighting fixtures on a regularly scheduled basis at Tenants expense. |
IV. | ELEVATORS |
Provide passenger elevator service.
V. | WATER |
Provide hot water for lavatory purposes and cold water for drinking, lavatory and toilet purposes.
VI. | CARD ACCESS SYSTEM |
Landlord will provide a card access system at one entry door of the building.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 3
Exhibit C
EXHIBIT D
FLOOR PLAN
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 1
Exhibit D
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 2
Exhibit D
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 3
Exhibit D
EXHIBIT E
DECLARATION AFFIXING THE COMMENCEMENT DATE OF LEASE
THIS AGREEMENT made this day of , 20 , by and between [LANDLORD] (hereinafter Landlord) and [TENANT] (hereinafter Tenant).
W I T N E S S E T H T H A T:
1. This Agreement is made pursuant to Section [2.4] of that certain Lease dated [date], between Landlord and Tenant (the Lease).
2. It is hereby stipulated that the Lease Term commenced on [commencement date], (being the Commencement Date under the Lease), and shall end and expire on [expiration date], unless sooner terminated or extended, as provided for in the Lease.
WITNESS the execution hereof under seal by persons hereunto duly authorized, the date first above written.
LANDLORD: | ||||||||||
[INSERT LL SIGNATURE BLOCK] | ||||||||||
By: |
| |||||||||
Name: |
| |||||||||
Title: |
| |||||||||
TENANT: | ||||||||||
ATTEST: | [TENANT] | |||||||||
By: |
|
By: |
| |||||||
Name: |
|
Name: |
| |||||||
Title: |
|
Title: |
| |||||||
Hereunto duly authorized |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 1
Exhibit E
EXHIBIT F
BROKER DETERMINATION OF PREVAILING MARKET RENT
Where in the Lease to which this Exhibit is attached provision is made for a Broker Determination of Prevailing Market Rent, the following procedures and requirements shall apply:
1. | Tenants Request. Tenant shall send a notice to Landlord by the time set for such notice in the applicable section of the Lease, requesting a Broker Determination of the Prevailing Market Rent, which notice to be effective must (i) make explicit reference to the Lease and to the specific section of the Lease pursuant to which said request is being made, (ii) include the name of a broker selected by Tenant to act for Tenant, which broker shall be affiliated with a major Boston commercial real estate brokerage firm selected by Tenant and which broker shall have at least ten (10) years experience dealing in laboratory/office properties of a nature and type generally similar to the Building located in the Boston West Suburban Market, and (iii) explicitly state that Landlord is required to notify Tenant within thirty (30) days of an additional broker selected by Landlord. |
2. | Landlords Response. Within thirty (30) days after Landlords receipt of Tenants notice requesting the Broker Determination and stating the name of the broker selected by Tenant, Landlord shall give written notice to Tenant of Landlords selection of a broker having at least the affiliation and experience referred to above. |
3. | Selection of Third Broker. Within ten (10) days thereafter the two (2) brokers so selected shall select a third such broker also having at least the affiliation and experience referred to above. |
4. | Rental Value Determination. Within thirty (30) days after the selection of the third broker, the three (3) brokers so selected, by majority opinion, shall make a determination of the annual fair market rental value of the Premises for the period referred to in the Lease. Such annual fair market rental value determination (w) may include provision for annual increases in rent during said term if so determined, (x) shall take into account the office and laboratory nature of the Premises (y) shall take into account the as-is condition of the Premises, and (z) shall take account of, and be expressed in relation to, the tax and operating cost bases and provisions for paying for so-called tenant electricity as contained in the Lease. The brokers shall advise Landlord and Tenant in writing by the expiration of said thirty (30) day period of the annual fair market rental value which as so determined shall be referred to as the Prevailing Market Rent. |
5. | Resolution of Broker Deadlock. If the Brokers are unable to agree at least by majority on a determination of annual fair market rental value, then the brokers shall send a notice to Landlord and Tenant by the end of the thirty (30) day period for making said |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 1
Exhibit F
determination setting forth their individual determinations of annual fair market rental value, and the highest such determination and the lowest such determination shall be disregarded and the remaining determination shall be deemed to be the determination of annual fair market rental value and shall be referred to as the Prevailing Market Rent. |
6. | Costs. Each party shall pay the costs and expenses of the broker selected by it and each shall pay one half (1/2) of the costs and expenses of the Third Broker. |
7. | Failure to Select Broker or Failure of Broker to Serve. If Tenant shall have requested a Broker Determination and Landlord shall not have designated a broker within the time period provided therefor above, then Tenants Broker shall alone make the determination of Prevailing Market Rent in writing to Landlord and Tenant within thirty (30) days after the expiration of Landlords right to designate a broker hereunder. If Tenant and Landlord have both designated brokers but the two brokers so designated do not, within a period of fifteen (15) days after the appointment of the second broker, agree upon and designate the Third Broker willing so to act, the Tenant, the Landlord or either broker previously designated may request the Boston Bar Association (or such organization as may succeed to the Boston Bar Association) to designate the Third Broker willing so to act and a broker so appointed shall, for all purposes, have the same standing and powers as though he had been seasonably appointed by the brokers first appointed. In case of the inability or refusal to serve of any person designated as a broker, or in case any broker for any reason ceases to be such, a broker to fill such vacancy shall be appointed by the Tenant, the Landlord, the brokers first appointed or the Boston Bar Association as the case may be, whichever made the original appointment, or if the person who made the original appointment fails to fill such vacancy, upon application of any broker who continues to act or by the Landlord or Tenant such vacancy may be filled by the Boston Bar Association and any broker so appointed to fill such vacancy shall have the same standing and powers as though originally appointed. |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 2
Exhibit F
EXHIBIT G
FORM OF LETTER OF CREDIT
BENEFICIARY:
|
(INSERT COMPLETE NAME & ADDRESS) | |||||
|
||||||
|
AS LANDLORD
APPLICANT:
SYNAGEVA BIOPHARMA CORP.
128 SPRING STREET, SUITE 520
LEXINGTON, MA 02421
TENANT
AMOUNT: [*].
EXPIRATION DATE: (TBD - ONE YEAR FROM L/C ISSUANCE)
LOCATION: SANTA CLARA, CALIFORNIA
LADIES AND GENTLEMEN:
WE HEREBY ESTABLISH OUR IRREVOCABLE STANDBY LETTER OF CREDIT NO. SVBSF IN YOUR FAVOR. THIS LETTER OF CREDIT IS AVAILABLE BY SIGHT PAYMENT WITH OURSELVES ONLY AGAINST PRESENTATION AT THE BANKS OFFICE (AS DEFINED BELOW) OF THE FOLLOWING DOCUMENTS:
(1) | THE ORIGINAL OF THIS LETTER OF CREDIT AND ALL AMENDMENT (S), IF ANY. |
(2) | YOUR SIGHT DRAFT, IN WHOLE OR IN PART DRAWN ON US IN THE FORM ATTACHED HERETO AS EXHIBIT A. |
(3) | A DATED STATEMENT PURPORTEDLY SIGNED BY AN AUTHORIZED REPRESENTATIVE OF THE BENEFICIARY, FOLLOWED BY HIS/HER PRINTED NAME AND DESIGNATED TITLE, STATING ANY OF THE FOLLOWING WITH INSTRUCTIONS IN BRACKETS THEREIN COMPLIED WITH: |
(A.) | AN EVENT OF DEFAULT (AS DEFINED IN THE LEASE) HAS OCCURRED BY SYNAGEVA BIOPHARMA CORP., AS TENANT UNDER THAT CERTAIN LEASE AGREEMENT DATED [INSERT DATE] BY AND BETWEEN TENANT, AND |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 1
Exhibit G
BENEFICIARY, AS LANDLORD. FURTHERMORE THIS IS TO CERTIFY THAT: (I) LANDLORD HAS GIVEN WRITTEN NOTICE TO TENANT TO CURE THE DEFAULT AND SUCH DEFAULT HAS NOT BEEN CURED UP TO THIS DATE OF DRAWING UNDER THIS LETTER OF CREDIT AND ALL APPLICABLE CURE PERIODS (IF ANY) HAVE EXPIRED; AND (II) THE TERMS AND CONDITIONS OF THE LEASE AUTHORIZE LANDLORD TO NOW DRAW DOWN ON THE LETTER OF CREDIT. |
OR
(B.) | BENEFICIARY HAS RECEIVED A NOTICE FROM SILICON VALLEY BANK THAT ITS IRREVOCABLE LETTER OF CREDIT NUMBER SVBSF WILL NOT BE EXTENDED AND APPLICANT HAS FAILED TO PROVIDE A REPLACEMENT LETTER OF CREDIT SATISFACTORY TO BENEFICIARY WITHIN THIRTY (30) DAYS PRIOR TO THE CURRENT EXPIRATION DATE. |
THE LEASE MENTIONED ABOVE IS FOR IDENTIFICATION PURPOSES ONLY AND IS NOT INTENDED THAT SAID LEASE BE INCORPORATED HEREIN OR FORM PART OF THIS LETTER OF CREDIT.
PARTIAL AND MULTIPLE DRAWINGS ARE ALLOWED.
THIS LETTER OF CREDIT MUST ACCOMPANY ANY DRAWINGS HEREUNDER FOR ENDORSEMENT OF THE DRAWING AMOUNT AND WILL BE RETURNED TO BENEFICIARY UNLESS IT IS FULLY UTILIZED.
THIS LETTER OF CREDIT SHALL BE AUTOMATICALLY EXTENDED FOR AN ADDITIONAL PERIOD OF ONE YEAR, WITHOUT AMENDMENT, FROM THE PRESENT OR EACH FUTURE EXPIRATION DATE UNLESS AT LEAST THIRTY (30) DAYS PRIOR TO THE THEN CURRENT EXPIRATION DATE WE SEND YOU A NOTICE BY REGISTERED MAIL/OVERNIGHT COURIER SERVICE AT THE ADDRESS SET FORTH IN THE IN THE STANDBY L/C (OR SUCH OTHER ADDRESS AS BENEFICIARY MAY FROM TIME TO TIME DESIGNATE IN A NOTICE DELIVERED TO SILICON VALLEY BANK AT THE BANKS OFFICE) THAT THIS LETTER OF CREDIT WILL NOT BE EXTENDED BEYOND THE THEN-CURRENT EXPIRATION DATE. BUT IN ANY EVENT THIS LETTER OF CREDIT WILL NOT BE EXTENDED BEYOND
(MUST INSERT FINAL EXPIRY DATE PRIOR TO L/C ISSUANCE) WHICH SHALL BE THE FINAL EXPIRATION DATE OF THIS LETTER OF CREDIT.
THE DATE THIS LETTER OF CREDIT EXPIRES IN ACCORDANCE WITH THE ABOVE PROVISION IS THE FINAL EXPIRATION DATE. UPON THE OCCURRENCE OF THE FINAL EXPIRATION DATE THIS LETTER OF CREDIT SHALL FULLY AND FINALLY EXPIRE AND NO PRESENTATIONS MADE UNDER THIS LETTER OF CREDIT AFTER SUCH DATE WILL BE HONORED.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 2
Exhibit G
THIS LETTER OF CREDIT IS TRANSFERABLE ONE OR MORE TIMES BY THE ISSUING BANK, AT THE REQUEST OF THE BENEFICIARY, BUT IN EACH INSTANCE TO A SINGLE BENEFICIARY AND ONLY IN ITS ENTIRETY UP TO THE THEN AVAILABLE AMOUNT IN FAVOR OF ANY NOMINATED TRANSFEREE ASSUMING SUCH TRANSFER TO SUCH TRANSFEREE WOULD BE IN COMPLIANCE WITH THEN APPLICABLE LAW AND REGULATIONS, INCLUDING BUT NOT LIMITED TO THE REGULATIONS OF THE U.S. DEPARTMENT OF TREASURY AND U.S. DEPARTMENT OF COMMERCE. AT THE TIME OF TRANSFER, THE ORIGINAL LETTER OF CREDIT AND ORIGINAL AMENDMENT(S), IF ANY, MUST BE SURRENDERED TO US TOGETHER WITH OUR LETTER OF TRANSFER DOCUMENTATION (IN THE FORM OF EXHIBIT B ATTACHED HERETO) AND OUR TRANSFER FEE OF 1/4 OF 1% OF THE TRANSFER AMOUNT (MINIMUM $250.00), NOT TO EXCEED A MAXIMUM AMOUNT OF $500.00. THE CORRECTNESS OF THE SIGNATURE AND TITLE OF THE PERSON SIGNING THE TRANSFER FORM MUST BE VERIFIED BY BENEFICIARYS BANK. ANY TRANSFER OF THIS LETTER OF CREDIT MAY NOT CHANGE THE PLACE OF EXPIRATION OF THE LETTER OF CREDIT FROM OUR ABOVE-SPECIFIED OFFICE. EACH TRANSFER SHALL BE EVIDENCED BY OUR ENDORSEMENT ON THE REVERSE OF THE ORIGINAL LETTER OF CREDIT AND WE SHALL FORWARD THE ORIGINAL LETTER OF CREDIT TO THE TRANSFEREE.
DRAFT(S) AND DOCUMENTS MUST INDICATE THE NUMBER THIS LETTER OF CREDIT.
ALL DEMANDS FOR PAYMENT SHALL BE MADE BY PRESENTATION OF THE ORIGINAL APPROPRIATE DOCUMENTS DURING REGULAR BUSINESS HOURS ON A BUSINESS DAY AT OUR OFFICE (THE BANKS OFFICE) AT: SILICON VALLEY BANK, 3003 TASMAN DRIVE, MAIL SORT HF210, SANTA CLARA, CALIFORNIA 95054, ATTENTION: GLOBAL FINANCIAL SERVICES - STANDBY LETTER OF CREDIT DEPARTMENT; OR BY FACSIMILE TRANSMISSION AT: (408) 969-6510 OR (408) 496-2418 AND SIMULTANEOUSLY UNDER TELEPHONE ADVICE TO: (408) 654-6274 OR (408) 654-7716, ATTENTION: STANDBY LETTER OF CREDIT NEGOTIATION DEPARTMENT WITH ORIGINALS TO FOLLOW BY OVERNIGHT COURIER SERVICE, PROVIDED, HOWEVER, THE BANK WILL DETERMINE HONOR OR DISHONOR ON THE BASIS OF PRESENTATION BY FACSIMILE ALONE, AND WILL NOT EXAMINE THE ORIGINALS.
WE HEREBY ENGAGE WITH YOU THAT DRAFT(S) DRAWN AND/OR DOCUMENTS PRESENTED UNDER AND IN ACCORDANCE WITH THE TERMS AND CONDITIONS OF THIS LETTER OF CREDIT SHALL BE DULY HONORED UPON PRESENTATION TO SILICON VALLEY BANK, IF PRESENTED ON OR BEFORE THE EXPIRATION DATE OF THIS LETTER OF CREDIT.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 3
Exhibit G
IF ANY INSTRUCTIONS ACCOMPANYING A DRAWING UNDER THIS LETTER OF CREDIT REQUEST THAT PAYMENT IS TO BE MADE BY TRANSFER TO YOUR ACCOUNT WITH ANOTHER BANK, WE WILL ONLY EFFECT SUCH PAYMENT BY FED WIRE TO A U.S. REGULATED BANK, AND WE AND/OR SUCH OTHER BANK MAY RELY ON AN ACCOUNT NUMBER SPECIFIED IN SUCH INSTRUCTIONS EVEN IF THE NUMBER IDENTIFIES A PERSON OR ENTITY DIFFERENT FROM THE INTENDED PAYEE.
EXCEPT SO FAR AS OTHERWISE EXPRESSLY STATED HEREIN, THIS LETTER OF CREDIT IS SUBJECT TO THE INTERNATIONAL STANDBY PRACTICE ISP98, INTERNATIONAL CHAMBER OF COMMERCE, PUBLICATION NO. 590.
SILICON VALLEY BANK, | ||||
|
| |||
(FOR BANK USE ONLY) | (FOR BANK USE ONLY) |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 4
Exhibit G
EXHIBIT A
SIGHT DRAFT/BILL OF EXCHANGE
DATE: | REF. NO. | |||||||
AT SIGHT OF THIS BILL OF EXCHANGE | ||||||||
PAY TO THE ORDER OF | ||||||||
US$ | ||||||||
U.S. DOLLARS | ||||||||
DRAWN UNDER SILICON VALLEY BANK, SANTA CLARA, CALIFORNIA, | ||||||||
IRREVOCABLE STANDBY LETTER OF CREDIT NUMBER NO. SVBSF DATED , 20 |
||||||||
TO: SILICON VALLEY BANK | ||||||||
|
||||||||
3003 TASMAN DRIVE |
[INSERT NAME OF BENEFICIARY] |
|||||||
SANTA CLARA, CA 95054 |
||||||||
| ||||||||
Authorized Signature |
GUIDELINES TO PREPARE THE SIGHT DRAFT OR BILL OF EXCHANGE:
(vi) | DATE | INSERT ISSUANCE DATE OF DRAFT OR BILL OF EXCHANGE. | ||
(vii) | REF. NO. | INSERT YOUR REFERENCE NUMBER IF ANY. | ||
(viii) | PAY TO THE ORDER OF: INSERT NAME OF BENEFICIARY | |||
(ix) | US$ | INSERT AMOUNT OF DRAWING IN NUMERALS/FIGURES. | ||
(x) | U.S. DOLLARS INSERT AMOUNT OF DRAWING IN WORDS. | |||
(xi) | LETTER OF CREDIT NUMBER INSERT THE LAST DIGITS OF OUR STANDBY L/C NUMBER THAT PERTAINS TO THE DRAWING. | |||
(xii) | DATED | INSERT THE ISSUANCE DATE OF OUR STANDBY L/C. | ||
NOTE: | BENEFICIARY SHOULD ENDORSE THE BACK OF THE SIGHT DRAFT OR BILL OF EXCHANGE | |||
AS YOU WOULD A CHECK. |
IF YOU NEED FURTHER ASSISTANCE IN COMPLETING THIS SIGHT DRAFT OR BILL OF EXCHANGE, PLEASE CALL OUR L/C PAYMENT SECTION AND ASK FOR: ERICO NICOLAS AT (408) 654-7127 OR EVELIO BARAIRO AT (408) 654-3035 .
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 5
Exhibit G
EXHIBIT B
DATE:
TO: | SILICON VALLEY BANK | |||||||
3003 TASMAN DRIVE | RE: | IRREVOCABLE STANDBY LETTER OF CREDIT | ||||||
SANTA CLARA, CA 95054 | NO. ISSUED BY | |||||||
ATTN: | INTERNATIONAL DIVISION. | SILICON VALLEY BANK, SANTA CLARA | ||||||
STANDBY LETTERS OF CREDIT | L/C AMOUNT: |
GENTLEMEN:
FOR VALUE RECEIVED, THE UNDERSIGNED BENEFICIARY HEREBY IRREVOCABLY TRANSFERS TO:
(NAME OF TRANSFEREE)
(ADDRESS)
ALL RIGHTS OF THE UNDERSIGNED BENEFICIARY TO DRAW UNDER THE ABOVE LETTER OF CREDIT UP TO ITS AVAILABLE AMOUNT AS SHOWN ABOVE AS OF THE DATE OF THIS TRANSFER.
BY THIS TRANSFER, ALL RIGHTS OF THE UNDERSIGNED BENEFICIARY IN SUCH LETTER OF CREDIT ARE TRANSFERRED TO THE TRANSFEREE. TRANSFEREE SHALL HAVE THE SOLE RIGHTS AS BENEFICIARY THEREOF, INCLUDING SOLE RIGHTS RELATING TO ANY AMENDMENTS, WHETHER INCREASES OR EXTENSIONS OR OTHER AMENDMENTS, AND WHETHER NOW EXISTING OR HEREAFTER MADE. ALL AMENDMENTS ARE TO BE ADVISED DIRECT TO THE TRANSFEREE WITHOUT NECESSITY OF ANY CONSENT OF OR NOTICE TO THE UNDERSIGNED BENEFICIARY.
THE ORIGINAL OF SUCH LETTER OF CREDIT IS RETURNED HEREWITH, AND WE ASK YOU TO ENDORSE THE TRANSFER ON THE REVERSE THEREOF, AND FORWARD IT DIRECTLY TO THE TRANSFEREE WITH YOUR CUSTOMARY NOTICE OF TRANSFER.
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 6
Exhibit G
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 7
Exhibit G
EXHIBIT H
FORM OF CERTIFICATE OF INSURANCE
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 1
Exhibit H
ACORD CERTIFICATE OF LIABILITY INSURANCE | DATE (MM/DD/YYYY)
| |||||||||||||||||||
PRODUCER |
THIS CERTIFICATE IS ISSUED AS A MATTER OF INFORMATION ONLY AND CONFERS NO RIGHTS UPON THE CERTIFICATE HOLDER. THIS CERTIFICATE DOES NOT AMEND, EXTEND OR ALTER THE COVERAGE AFFORDED BY THE POLICIES BELOW. | |||||||||||||||||||
COMPANIES AFFORDING COVERAGE | ||||||||||||||||||||
109722-ALL-GL-05-07 | COMPANY A |
|||||||||||||||||||
INSURED | COMPANY B |
|||||||||||||||||||
COMPANY C |
||||||||||||||||||||
COMPANY D |
||||||||||||||||||||
COVERAGES This certificate supersedes and replaces any previously issued certificate. | ||||||||||||||||||||
THIS IS TO CERTIFY THAT THE POLICIES OF INSURANCE LISTED BELOW HAVE BEEN ISSUED TO THE INSURED NAMED ABOVE FOR THE POLICY PERIOD INDICATED. NOTWITHSTANDING ANY REQUIREMENT, TERM OR CONDITION OF ANY CONTRACT OR OTHER DOCUMENT WITH RESPECT TO WHICH THIS CERTIFICATE MAY BE ISSUED OR MAY PERTAIN, THE INSURANCE AFFORDED BY THE POLICIES DESCRIBED HEREIN IS SUBJECT TO ALL THE TERMS, EXCLUSIONS AND CONDITIONS OF SUCH POLICIES. AGGREGATE LIMITS SHOWN MAY HAVE BEEN REDUCED BY PAID CLAIMS. | ||||||||||||||||||||
CO LTR |
TYPE OF INSURANCE | POLICY NUMBER | POLICY EFFECTIVE DATE (MM/DD/YY) |
POLICY EXPIRATION DATE (MM/DD/YY) |
LIMITS | |||||||||||||||
GENERAL LIABILITY | GENERAL AGGREGATE | $ | ||||||||||||||||||
¨ COMMERCIAL GENERAL LIABILITY | PRODUCTS - COMP/OP AGG | $ | ||||||||||||||||||
¨¨ CLAIMS MADE ¨ OCCUR | PERSONAL & ADV INJURY | $ | ||||||||||||||||||
¨ OWNERS & CONTRACTORS PROT | EACH OCCURRENCE | $ | ||||||||||||||||||
¨ | FIRE DAMAGE (Any one fire) | $ | ||||||||||||||||||
¨ | MED EXP (Any one person) | $ | ||||||||||||||||||
AUTOMOBILE LIABILITY | COMBINED SINGLE LIMIT | $ | ||||||||||||||||||
¨ ANY AUTO | ||||||||||||||||||||
¨ ALL OWNED AUTOS | BODILY INJURY | $ | ||||||||||||||||||
¨ SCHEDULED AUTOS | (Per person) | |||||||||||||||||||
¨ HIRED AUTOS | BODILY INJURY | $ | ||||||||||||||||||
¨ NON-OWNED AUTOS | (Per accident) | |||||||||||||||||||
¨ | PROPERTY DAMAGE | $ | ||||||||||||||||||
¨ | ||||||||||||||||||||
GARAGE LIABILITY | AUTO ONLY - EA ACCIDENT | $ | ||||||||||||||||||
¨ ANY AUTO | OTHER THAN AUTO ONLY: | $ | ||||||||||||||||||
¨ | EACH ACCIDENT | $ | ||||||||||||||||||
¨ | AGGREGATE | $ | ||||||||||||||||||
EXCESS LIABILITY | EACH OCCURRENCE | $ | ||||||||||||||||||
¨ UMBRELLA FORM | AGGREGATE | $ | ||||||||||||||||||
¨ OTHER THAN UMBRELLA FORM | $ | |||||||||||||||||||
WORKERS COMPENSATION AND EMPLOYERS LIABILITY | x |
WC STATU- TORY LIMITS |
¨ | OTH- ER |
||||||||||||||||
EACH ACCIDENT | $ | |||||||||||||||||||
ANY PROPRIETOR/ PARTNER/EXECUTIVE OFFICER | ¨ INCL | DISEASE - POLICY LIMIT | $ | |||||||||||||||||
¨ EXCL | DISEASE - EACH EMPLOYEE | $ | ||||||||||||||||||
OTHER | ||||||||||||||||||||
DESCRIPTION OF OPERATIONS/LOCATIONS/VEHICLES/SPECIAL ITEMS | ||||||||||||||||||||
CERTIFICATE HOLDER | NYC-002611111-01 | CANCELLATION
|
||||||||||||||||||
SHOULD ANY OF THE ABOVE DESCRIBED POLICIES BE CANCELLED BEFORE THE EXPIRATION DATE THEREOF, THE INSURANCE COMPANY WILL ENDEAVOR TO MAIL 30 DAYS WRITTEN NOTICE TO THE CERTIFICATE HOLDER NAMED TO THE LEFT, BUT FAILURE TO MAIL SUCH NOTICE SHALL IMPOSE NO OBLIGATION OR LIABILITY OF ANY KIND UPON THE COMPANY, ITS AGENTS OR REPRESENTATIVES. | ||||||||||||||||||||
AUTHORIZED REPRESENTATIVE |
![]() | |||||||||||||||||||
Nancy Bartolino |
||||||||||||||||||||
ACORD 25 (11/05) | © ACORD CORPORATION 1988 |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 1
Exhibit H
![]() |
EVIDENCE OF PROPERTY INSURANCE | DATE (MM/DD/YYYY) |
THIS EVIDENCE OF PROPERTY INSURANCE IS ISSUED AS A MATTER OF INFORMATION ONLY AND CONFERS NO RIGHTS UPON THE ADDITIONAL INTEREST NAMED BELOW. THIS EVIDENCE OF PROPERTY INSURANCE DOES NOT AMEND, EXTEND OR ALTER THE COVERAGE AFFORDED BY THE POLICIES BELOW. | ||||||||||||||||
AGENCY | PHONE (A/C, No, Ext): |
COMPANY | ||||||||||||||
FAX (A/C, No): |
ADDRESS: |
|||||||||||||||
CODE: | SUB CODE: | |||||||||||||||
AGENCY CUSTOMER ID #: |
||||||||||||||||
INSURED | LOAN NUMBER | POLICY NUMBER | ||||||||||||||
EFFECTIVE DATE | EXPIRATION DATE |
CONTINUED UNTIL | ||||||||||||||
¨ | TERMINATED IF CHECKED | |||||||||||||||
THIS REPLACES PRIOR EVIDENCE DATED: | ||||||||||||||||
PROPERTY INFORMATION | ||||||||||||||
LOCATION/DESCRIPTION | ||||||||||||||
THE POLICIES OF INSURANCE LISTED BELOW HAVE BEEN ISSUED TO THE INSURED NAMED ABOVE FOR THE POLICY PERIOD INDICATED. NOTWITHSTANDING ANY REQUIREMENT, TERM OR CONDITION OF ANY CONTRACT OR OTHER DOCUMENT WITH RESPECT TO WHICH THIS EVIDENCE OF PROPERTY INSURANCE MAY BE ISSUED OR MAY PERTAIN, THE INSURANCE AFFORDED BY THE POLICIES DESCRIBED HEREIN IS SUBJECT TO ALL THE TERMS, EXCLUSIONS AND CONDITIONS OF SUCH POLICIES. LIMITS SHOWN MAY HAVE BEEN REDUCED BY PAID CLAIMS. |
COVERAGE INFORMATION | ||||||||||
COVERAGE / PERILS / FORMS | AMOUNT OF INSURANCE | DEDUCTIBLE | ||||||||
REMARKS (Including Special Conditions) | ||||||||||
CANCELLATION |
SHOULD ANY OF THE ABOVE DESCRIBED POLICIES BE CANCELLED BEFORE THE EXPIRATION DATE THEREOF, THE ISSUING INSURER WILL ENDEAVOR TO MAIL DAYS WRITTEN NOTICE TO THE ADDITIONAL INTEREST NAMED BELOW, BUT FAILURE TO MAIL SUCH NOTICE SHALL IMPOSE NO OBLIGATION OR LIABILITY OF ANY KIND UPON THE INSURER, ITS AGENTS OR REPRESENTATIVES. |
ADDITIONAL INTEREST | ||||||||||
NAME AND ADDRESS | ¨ | MORTGAGEE | ¨ | ADDITIONAL INSURED | ||||||
¨ | LOSS PAYEE | ¨ | ||||||||
LOAN # | ||||||||||
AUTHORIZED REPRESENTATIVE | ||||||||||
ACORD 27 (2006/07) | © ACORD CORPORATION 1993-2006. All rights reserved. | |||||||||
The ACORD name and logo are registered marks of ACORD |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 1
Exhibit H
EXHIBIT I
PERMITTED HAZARDOUS MATERIALS
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 1
Exhibit I
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
Page 2
Exhibit I
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Exhibit I
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Exhibit I
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Exhibit I
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Exhibit I
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Exhibit I
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Exhibit I
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Exhibit I
EXHIBIT J
PLAN OF OFFER SPACE
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Exhibit J
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Exhibit J
EXHIBIT K
DATA CENTER REQUIREMENTS
Data Center Definition:
| A Data Center is any space specifically designed and equipped to meet the needs of high density computing equipment such as server racks used for data storage and processing. |
| Typically these facilities require dedicated uninterruptible power supplies (UPS Systems) and cooling systems. |
| Data Center functions may include traditional enterprise services, on-demand enterprise services, high performance computing, internet facilities, and/or hosting facilities. |
| Often Data Centers are free-standing, mission-critical computing centers. |
| When a Data Center is located within a larger building, it usually has its own power and cooling systems. It is also common to have raised floor space to facilitate equipment cooling. |
| The Data Center space is intended for sophisticated computing and server functions; it should not be used to represent a server closet or computer training area. |
Where to Install a Meter and What Electricity Consumption Requires Metering:
| A meter installed to measure the electricity consumption for a Data Center should be installed, and the consumption recorded, at the output of the Uninterruptible Power Supply (UPS). Tenant shall provide Landlord with the consumption data month to month. |
| Many UPS systems already have energy consumption meters on them. In this case Tenant shall provide Landlord with the consumption data from this meter month to month. |
| If Tenants Data center does not have electricity consumption meter installed at the UPS output to the IT Equipment, Tenant shall install one to obtain the most accurate consumption data. |
| If the UPS system supports non-IT loads such as air conditioning equipment, such electricity consumption shall be excluded from being recorded; OR Tenant shall install a meter to facilitate deducting the consumption of such non-IT equipment from the total Data center electricity consumption meter. |
| If there is no UPS system in Tenants Data Center, an electricity consumption meter shall be installed to record the electricity consumption of all IT equipment, servers, computers, etc., excluding air conditioning equipment; |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Exhibit K
EXHIBIT L
TENANTS SIGNAGE
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Exhibit L
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Exhibit L
EXHIBIT M
FORM OF CONSTRUCTION LETTER OF CREDIT
BENEFICIARY:
|
(INSERT COMPLETE NAME & ADDRESS) | |||
|
||||
|
AS LANDLORD
APPLICANT:
SYNAGEVA BIOPHARMA CORP.
128 SPRING STREET, SUITE 520
LEXINGTON, MA 02421
TENANT
AMOUNT: |
[*]. | |
EXPIRATION DATE: |
(TBD - ONE YEAR FROM L/C ISSUANCE) |
LOCATION: SANTA CLARA, CALIFORNIA
LADIES AND GENTLEMEN:
WE HEREBY ESTABLISH OUR IRREVOCABLE STANDBY LETTER OF CREDIT NO. SVBSF IN YOUR FAVOR. THIS LETTER OF CREDIT IS AVAILABLE BY SIGHT PAYMENT WITH OURSELVES ONLY AGAINST PRESENTATION AT THE BANKS OFFICE (AS DEFINED BELOW) OF THE FOLLOWING DOCUMENTS:
(1) | THE ORIGINAL OF THIS LETTER OF CREDIT AND ALL AMENDMENT (S), IF ANY. |
(2) | YOUR SIGHT DRAFT, IN WHOLE OR IN PART DRAWN ON US IN THE FORM ATTACHED HERETO AS EXHIBIT A. |
(3) | A DATED STATEMENT PURPORTEDLY SIGNED BY AN AUTHORIZED REPRESENTATIVE OF THE BENEFICIARY, FOLLOWED BY HIS/HER PRINTED NAME AND DESIGNATED TITLE, STATING ANY OF THE FOLLOWING WITH INSTRUCTIONS IN BRACKETS THEREIN COMPLIED WITH: |
A. | AN EVENT OF DEFAULT (AS DEFINED IN THE LEASE) HAS OCCURRED BY SYNAGEVA BIOPHARMA CORP., AS TENANT UNDER THAT CERTAIN LEASE AGREEMENT DATED [INSERT DATE] BY AND BETWEEN TENANT, AND BENEFICIARY, AS LANDLORD. FURTHERMORE THIS IS TO CERTIFY THAT: (I) LANDLORD HAS GIVEN WRITTEN NOTICE TO TENANT TO CURE THE DEFAULT AND SUCH DEFAULT HAS NOT BEEN CURED UP TO THIS DATE OF DRAWING UNDER THIS LETTER OF CREDIT AND ALL APPLICABLE CURE PERIODS (IF ANY) HAVE EXPIRED; AND (II) THE TERMS AND CONDITIONS OF THE LEASE AUTHORIZE LANDLORD TO NOW DRAW DOWN ON THE LETTER OF CREDIT. |
OR
B. | BENEFICIARY HAS RECEIVED A NOTICE FROM SILICON VALLEY BANK THAT ITS IRREVOCABLE LETTER OF CREDIT NUMBER SVBSF WILL NOT BE |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Exhibit M
EXTENDED AND APPLICANT HAS FAILED TO PROVIDE A REPLACEMENT LETTER OF CREDIT SATISFACTORY TO BENEFICIARY WITHIN THIRTY (30) DAYS PRIOR TO THE CURRENT EXPIRATION DATE. |
THE LEASE MENTIONED ABOVE IS FOR IDENTIFICATION PURPOSES ONLY AND IS NOT INTENDED THAT SAID LEASE BE INCORPORATED HEREIN OR FORM PART OF THIS LETTER OF CREDIT.
PARTIAL AND MULTIPLE DRAWINGS ARE ALLOWED.
THIS LETTER OF CREDIT MUST ACCOMPANY ANY DRAWINGS HEREUNDER FOR ENDORSEMENT OF THE DRAWING AMOUNT AND WILL BE RETURNED TO BENEFICIARY UNLESS IT IS FULLY UTILIZED.
THIS LETTER OF CREDIT SHALL TERMINATE ON
(MUST INSERT FINAL EXPIRY DATE PRIOR TO L/C ISSUANCE) WHICH SHALL BE THE FINAL EXPIRATION DATE OF THIS LETTER OF CREDIT.
THE DATE THIS LETTER OF CREDIT EXPIRES IN ACCORDANCE WITH THE ABOVE PROVISION IS THE FINAL EXPIRATION DATE. UPON THE OCCURRENCE OF THE FINAL EXPIRATION DATE THIS LETTER OF CREDIT SHALL FULLY AND FINALLY EXPIRE AND NO PRESENTATIONS MADE UNDER THIS LETTER OF CREDIT AFTER SUCH DATE WILL BE HONORED.
DRAFT(S) AND DOCUMENTS MUST INDICATE THE NUMBER THIS LETTER OF CREDIT.
ALL DEMANDS FOR PAYMENT SHALL BE MADE BY PRESENTATION OF THE ORIGINAL APPROPRIATE DOCUMENTS DURING REGULAR BUSINESS HOURS ON A BUSINESS DAY AT OUR OFFICE (THE BANKS OFFICE) AT: SILICON VALLEY BANK, 3003 TASMAN DRIVE, MAIL SORT HF210, SANTA CLARA, CALIFORNIA 95054, ATTENTION: GLOBAL FINANCIAL SERVICES - STANDBY LETTER OF CREDIT DEPARTMENT; OR BY FACSIMILE TRANSMISSION AT: (408) 969-6510 OR (408) 496-2418 AND SIMULTANEOUSLY UNDER TELEPHONE ADVICE TO: (408) 654-6274 OR (408) 654-7716, ATTENTION: STANDBY LETTER OF CREDIT NEGOTIATION DEPARTMENT WITH ORIGINALS TO FOLLOW BY OVERNIGHT COURIER SERVICE, PROVIDED, HOWEVER, THE BANK WILL DETERMINE HONOR OR DISHONOR ON THE BASIS OF PRESENTATION BY FACSIMILE ALONE, AND WILL NOT EXAMINE THE ORIGINALS.
WE HEREBY ENGAGE WITH YOU THAT DRAFT(S) DRAWN AND/OR DOCUMENTS PRESENTED UNDER AND IN ACCORDANCE WITH THE TERMS AND CONDITIONS OF THIS LETTER OF CREDIT SHALL BE DULY HONORED UPON PRESENTATION TO SILICON VALLEY BANK, IF PRESENTED ON OR BEFORE THE EXPIRATION DATE OF THIS LETTER OF CREDIT.
IF ANY INSTRUCTIONS ACCOMPANYING A DRAWING UNDER THIS LETTER OF CREDIT REQUEST THAT PAYMENT IS TO BE MADE BY TRANSFER TO YOUR
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Exhibit M
ACCOUNT WITH ANOTHER BANK, WE WILL ONLY EFFECT SUCH PAYMENT BY FED WIRE TO A U.S. REGULATED BANK, AND WE AND/OR SUCH OTHER BANK MAY RELY ON AN ACCOUNT NUMBER SPECIFIED IN SUCH INSTRUCTIONS EVEN IF THE NUMBER IDENTIFIES A PERSON OR ENTITY DIFFERENT FROM THE INTENDED PAYEE.
EXCEPT SO FAR AS OTHERWISE EXPRESSLY STATED HEREIN, THIS LETTER OF CREDIT IS SUBJECT TO THE INTERNATIONAL STANDBY PRACTICE ISP98, INTERNATIONAL CHAMBER OF COMMERCE, PUBLICATION NO. 590.
SILICON VALLEY BANK, | ||||
|
| |||
(FOR BANK USE ONLY) | (FOR BANK USE ONLY) |
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Exhibit M
EXHIBIT A
SIGHT DRAFT/BILL OF EXCHANGE
DATE: | REF. NO. | |||||||
AT SIGHT OF THIS BILL OF EXCHANGE | ||||||||
PAY TO THE ORDER OF | ||||||||
US$ | ||||||||
U.S. DOLLARS | ||||||||
DRAWN UNDER SILICON VALLEY BANK, SANTA CLARA, CALIFORNIA, | ||||||||
IRREVOCABLE STANDBY LETTER OF CREDIT NUMBER NO. SVBSF DATED , 20 |
||||||||
TO: SILICON VALLEY BANK | ||||||||
|
||||||||
3003 TASMAN DRIVE |
[INSERT NAME OF BENEFICIARY] |
|||||||
SANTA CLARA, CA 95054 |
||||||||
| ||||||||
Authorized Signature |
GUIDELINES TO PREPARE THE SIGHT DRAFT OR BILL OF EXCHANGE:
1. | DATE INSERT ISSUANCE DATE OF DRAFT OR BILL OF EXCHANGE. | |||
2. | REF. NO. | INSERT YOUR REFERENCE NUMBER IF ANY. | ||
3. | PAY TO THE ORDER OF: INSERT NAME OF BENEFICIARY | |||
4. | US$ | INSERT AMOUNT OF DRAWING IN NUMERALS/FIGURES. | ||
5. | U.S. DOLLARS | INSERT AMOUNT OF DRAWING IN WORDS. | ||
6. | LETTER OF CREDIT NUMBER INSERT THE LAST DIGITS OF OUR STANDBY L/C NUMBER THAT PERTAINS TO THE DRAWING. | |||
7. | DATED INSERT THE ISSUANCE DATE OF OUR STANDBY L/C. |
NOTE: BENEFICIARY SHOULD ENDORSE THE BACK OF THE SIGHT DRAFT OR BILL OF EXCHANGE AS YOU WOULD A CHECK.
IF YOU NEED FURTHER ASSISTANCE IN COMPLETING THIS SIGHT DRAFT OR BILL OF EXCHANGE, PLEASE CALL OUR L/C PAYMENT SECTION AND ASK FOR: ERICO NICOLAS AT (408) 654-7127 OR EVELIO BARAIRO AT (408) 654-3035 .
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Exhibit M
Exhibit N
Designated Parking Spaces
[*] | = | Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Securities and Exchange Commission. |
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Exhibit M
Exhibit 31.1
Section 302 Certification
CERTIFICATION
I, Sanj K. Patel, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Synageva BioPharma Corp.;
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 registrants 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 registrants 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 registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of registrants 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 registrants 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 registrants internal controls over financial reporting. |
Dated: May 7, 2013
/s/ Sanj K. Patel |
Sanj K. Patel, President and Chief Executive Officer |
Exhibit 31.2
Section 302 Certification
CERTIFICATION
I, Carsten Boess, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Synageva BioPharma Corp.;
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 registrants 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 registrants 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 registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and |
5. The registrants other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of registrants 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 registrants 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 registrants internal controls over financial reporting. |
Dated: May 7, 2013
/s/ Carsten Boess |
Carsten Boess, Chief Financial Officer |
Exhibit 32.1
CERTIFICATION PURSUANT TO
SECTION 1350, CHAPTER 63 OF TITLE 18, UNITED STATES CODE,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002*
Pursuant to Section 1350, Chapter 63 of Title 18, United States Code, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, each of the undersigned, as principal executive officer and principal financial officer of Synageva BioPharma Corp. (the Company), does hereby certify that to such officers knowledge:
(1) the Companys Form 10-Q for the period ended March 31, 2013 fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) the information contained in the Companys Form 10-Q for the period ended March 31, 2013 fairly presents, in all material respects, the financial condition and results of operations of the Company.
/s/ Sanj K. Patel |
Sanj K. Patel President and Chief Executive Officer |
/s/ Carsten Boess |
Carsten Boess Chief Financial Officer |
Date: May 7, 2013 |
* | A signed original of this written statement required by Section 906 of the Sarbanes-Oxley Act of 2002 has been provided to Synageva BioPharma Corp. and will be retained by Synageva BioPharma Corp. and provided to the Securities and Exchange Commission or its staff upon request. |
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