UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM 10-Q
(MARK ONE)
x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2013
o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the Transition Period from to
Commission File Number 000-50797
Momenta Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Its Charter)
Delaware |
|
04-3561634 |
(State or Other Jurisdiction of |
|
(I.R.S. Employer Identification No.) |
Incorporation or Organization) |
|
|
675 West Kendall Street, Cambridge, MA |
|
02142 |
(Address of Principal Executive Offices) |
|
(Zip Code) |
(617) 491-9700
(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 o
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 o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of large accelerated filer, accelerated filer, and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer x |
|
Accelerated filer o |
|
|
|
Non-accelerated filer o |
|
Smaller reporting company o |
(Do not check if a smaller reporting company) |
|
|
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x
Indicate the number of shares outstanding of each of the Registrants classes of Common Stock as of May 6, 2013.
Class |
|
Number of Shares |
Common Stock $0.0001 par value |
|
51,925,166 |
MOMENTA PHARMACEUTICALS, INC.
Our logo, trademarks and service marks are the property of Momenta Pharmaceuticals, Inc. Other trademarks or service marks appearing in this Quarterly Report on Form 10-Q are the property of their respective holders.
MOMENTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except per share amounts)
(unaudited)
|
|
March 31,
|
|
December 31, 2012 |
|
||
Assets |
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
43,288 |
|
$ |
52,990 |
|
Marketable securities |
|
280,916 |
|
287,613 |
|
||
Accounts receivable |
|
5,396 |
|
10,811 |
|
||
Unbilled revenue |
|
1,232 |
|
800 |
|
||
Prepaid expenses and other current assets |
|
3,639 |
|
4,953 |
|
||
|
|
|
|
|
|
||
Total current assets |
|
334,471 |
|
357,167 |
|
||
Property and equipment, net |
|
21,400 |
|
22,380 |
|
||
Restricted cash |
|
19,971 |
|
19,971 |
|
||
Intangible assets, net |
|
6,446 |
|
6,711 |
|
||
Other long-term assets |
|
400 |
|
400 |
|
||
|
|
|
|
|
|
||
Total assets |
|
$ |
382,688 |
|
$ |
406,629 |
|
|
|
|
|
|
|
||
Liabilities and Stockholders Equity |
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
||
Accounts payable |
|
$ |
3,643 |
|
$ |
3,580 |
|
Accrued expenses |
|
7,299 |
|
9,641 |
|
||
Deferred revenue |
|
4,576 |
|
4,426 |
|
||
Other current liabilities |
|
372 |
|
514 |
|
||
|
|
|
|
|
|
||
Total current liabilities |
|
15,890 |
|
18,161 |
|
||
Deferred revenue, net of current portion |
|
26,096 |
|
27,269 |
|
||
Other long-term liabilities |
|
657 |
|
712 |
|
||
|
|
|
|
|
|
||
Total liabilities |
|
42,643 |
|
46,142 |
|
||
Commitments and contingencies (Note 9) |
|
|
|
|
|
||
Stockholders Equity: |
|
|
|
|
|
||
Preferred stock, $0.01 par value per share; 5,000 shares authorized at March 31, 2013 and December 31, 2012, 100 shares of Series A Junior Participating Preferred Stock, $0.01 par value per share designated and no shares issued and outstanding |
|
|
|
|
|
||
Common stock, $0.0001 par value per share; 100,000 shares authorized at March 31, 2013 and December 31, 2012, 51,925 and 51,709 shares issued and outstanding at March 31, 2013 and December 31, 2012, respectively |
|
5 |
|
5 |
|
||
Additional paid-in capital |
|
526,161 |
|
522,422 |
|
||
Accumulated other comprehensive income |
|
46 |
|
111 |
|
||
Accumulated deficit |
|
(186,167 |
) |
(162,051 |
) |
||
|
|
|
|
|
|
||
Total stockholders equity |
|
340,045 |
|
360,487 |
|
||
|
|
|
|
|
|
||
Total liabilities and stockholders equity |
|
$ |
382,688 |
|
$ |
406,629 |
|
The accompanying notes are an integral part of these unaudited, condensed consolidated financial statements.
MOMENTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
(in thousands, except per share amounts)
(unaudited)
|
|
Three Months
|
|
||||
|
|
2013 |
|
2012 |
|
||
Collaboration revenues: |
|
|
|
|
|
||
Product revenue |
|
$ |
5,396 |
|
$ |
22,029 |
|
Research and development revenue |
|
2,207 |
|
2,199 |
|
||
Total collaboration revenue |
|
7,603 |
|
24,228 |
|
||
|
|
|
|
|
|
||
Operating expenses: |
|
|
|
|
|
||
Research and development* |
|
22,332 |
|
18,562 |
|
||
General and administrative* |
|
9,716 |
|
10,955 |
|
||
Total operating expenses |
|
32,048 |
|
29,517 |
|
||
|
|
|
|
|
|
||
Operating loss |
|
(24,445 |
) |
(5,289 |
) |
||
|
|
|
|
|
|
||
Other income (expense): |
|
|
|
|
|
||
Interest income |
|
269 |
|
307 |
|
||
Other income |
|
60 |
|
|
|
||
Total other income |
|
329 |
|
307 |
|
||
|
|
|
|
|
|
||
Net loss |
|
$ |
(24,116 |
) |
$ |
(4,982 |
) |
|
|
|
|
|
|
||
Basic and diluted net loss per share |
|
$ |
(0.48 |
) |
$ |
(0.10 |
) |
|
|
|
|
|
|
||
Shares used in computing basic and diluted net loss per share |
|
50,635 |
|
50,240 |
|
||
|
|
|
|
|
|
||
Comprehensive loss |
|
$ |
(24,181 |
) |
$ |
(4,875 |
) |
* Non-cash share-based compensation expense included in operating expenses is as follows:
Research and development |
|
$ |
1,123 |
|
$ |
1,355 |
|
General and administrative |
|
$ |
1,748 |
|
$ |
1,899 |
|
The accompanying notes are an integral part of these unaudited, condensed consolidated financial statements.
MOMENTA PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
(unaudited)
|
|
Three Months Ended March 31, |
|
||||
|
|
2013 |
|
2012 |
|
||
Cash Flows from Operating Activities: |
|
|
|
|
|
||
Net loss |
|
$ |
(24,116 |
) |
$ |
(4,982 |
) |
Adjustments to reconcile net loss to net cash (used in) provided by operating activities: |
|
|
|
|
|
||
Depreciation and amortization |
|
1,782 |
|
1,275 |
|
||
Share-based compensation expense |
|
2,871 |
|
3,254 |
|
||
Amortization of premium on investments |
|
849 |
|
513 |
|
||
Amortization of intangibles |
|
265 |
|
265 |
|
||
Loss on disposal of assets |
|
|
|
3 |
|
||
Changes in operating assets and liabilities: |
|
|
|
|
|
||
Accounts receivable |
|
5,415 |
|
5,799 |
|
||
Unbilled revenue |
|
(432 |
) |
1,652 |
|
||
Prepaid expenses and other current assets |
|
1,314 |
|
(525 |
) |
||
Accounts payable |
|
63 |
|
4,712 |
|
||
Accrued expenses |
|
(2,342 |
) |
(2,297 |
) |
||
Deferred revenue |
|
(1,023 |
) |
31,890 |
|
||
Other current liabilities |
|
(142 |
) |
202 |
|
||
Other long-term liabilities |
|
(55 |
) |
(64 |
) |
||
|
|
|
|
|
|
||
Net cash (used in) provided by operating activities |
|
(15,551 |
) |
41,697 |
|
||
|
|
|
|
|
|
||
Cash Flows from Investing Activities: |
|
|
|
|
|
||
Purchases of property and equipment |
|
(802 |
) |
(8,203 |
) |
||
Purchases of marketable securities |
|
(108,817 |
) |
(189,362 |
) |
||
Proceeds from maturities of marketable securities |
|
110,778 |
|
144,545 |
|
||
Proceeds from sales of marketable securities |
|
3,822 |
|
|
|
||
|
|
|
|
|
|
||
Net cash provided by (used in) investing activities |
|
4,981 |
|
(53,020 |
) |
||
|
|
|
|
|
|
||
Cash Flows from Financing Activities: |
|
|
|
|
|
||
Proceeds from issuance of common stock under stock plans |
|
868 |
|
735 |
|
||
|
|
|
|
|
|
||
Net cash provided by financing activities |
|
868 |
|
735 |
|
||
|
|
|
|
|
|
||
Decrease in cash and cash equivalents |
|
(9,702 |
) |
(10,588 |
) |
||
Cash and cash equivalents, beginning of period |
|
52,990 |
|
49,245 |
|
||
|
|
|
|
|
|
||
Cash and cash equivalents, end of period |
|
$ |
43,288 |
|
$ |
38,657 |
|
The accompanying notes are an integral part of these unaudited, condensed consolidated financial statements.
MOMENTA PHARMACEUTICALS, INC.
NOTES TO UNAUDITED, CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. The Company
Business
Momenta Pharmaceuticals, Inc. (the Company or Momenta) was incorporated in the state of Delaware in May 2001 and began operations in early 2002. Its facilities are located in Cambridge, Massachusetts. Momenta is a biotechnology company specializing in the structural characterization, process engineering and biologic systems analysis of complex molecules such as polysaccharides, polypeptides, and biologics (including proteins and antibodies). The Companys initial technology was built on the ability to characterize complex polysaccharides. Over the last decade, the Company has expanded its expertise into technologies that enable it to develop a diversified product portfolio of complex generics, biosimilars, and novel products. The Company presently derives all of its revenue from collaborations.
2. Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The Companys accompanying condensed consolidated financial statements are unaudited and have been prepared in accordance with accounting principles generally accepted in the United States of America, or GAAP, applicable to interim periods and, in the opinion of management, include all normal and recurring adjustments that are necessary to state fairly the results of operations for the reported periods. The Companys condensed consolidated financial statements have also been prepared on a basis substantially consistent with, and should be read in conjunction with, the Companys audited consolidated financial statements for the year ended December 31, 2012, which were included in the Companys Annual Report on Form 10-K that was filed with the Securities and Exchange Commission, or SEC, on February 28, 2013. The year-end condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. The results of the Companys operations for any interim period are not necessarily indicative of the results of the Companys operations for any other interim period or for a full fiscal year.
The accompanying condensed consolidated financial statements reflect the operations of the Company and the Companys wholly-owned subsidiary Momenta Pharmaceuticals Securities Corporation. All significant intercompany accounts and transactions have been eliminated.
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. On an ongoing basis, the Company evaluates its estimates and judgments, including those related to revenue recognition, accrued expenses, and share-based payments. The Company bases its estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities. Actual results could differ from those estimates.
Net Loss Per Common Share
The Company computes basic net loss per common share by dividing net loss by the weighted average number of common shares outstanding, which includes common stock issued as a result of public offerings, stock option exercises, stock purchased under the Companys employee stock purchase plan and vesting of shares of restricted common stock. The Company computes diluted net loss income per common share by dividing net loss by the weighted average number of common shares and potential shares from outstanding stock options and unvested restricted stock determined by applying the treasury stock method.
The following table presents anti-dilutive shares for the three months ended March 31, 2013 and March 31, 2012 (in thousands):
|
|
March 31, 2013 |
|
March 31, 2012 |
|
Weighted-average anti-dilutive shares related to: |
|
|
|
|
|
Outstanding stock options |
|
4,526 |
|
3,148 |
|
Restricted stock awards |
|
895 |
|
933 |
|
Since the Company had a net loss for all periods presented, the effect of all potentially dilutive securities is anti-dilutive. Accordingly, basic and diluted net loss per share is the same for the three months ended March 31, 2013 and 2012. Anti-dilutive shares comprise the impact of the number of shares that would have been dilutive had the Company had net income plus the number of common stock equivalents that would be anti-dilutive had the Company had net income. Furthermore, performance-based restricted common stock awards which vest based upon U.S. Food and Drug Administration, or FDA, approval for M356 in the United States were excluded from diluted shares outstanding as the vesting condition had not been met as of March 31, 2013.
Fair Value Measurements
The tables below present information about the Companys assets that are measured at fair value on a recurring basis at March 31, 2013 and December 31, 2012, and indicate the fair value hierarchy of the valuation techniques the Company utilized to determine such fair value. In general, fair values determined by Level 1 inputs utilize quoted prices (unadjusted) in active markets for identical assets or liabilities. Fair values determined by Level 2 inputs utilize data points that are observable, such as quoted prices (adjusted), interest rates and yield curves. Fair values determined by Level 3 inputs utilize unobservable data points for the asset or liability, and include situations where there is little, if any, market activity for the asset or liability. The fair value hierarchy level is determined by the lowest level of significant input. Financial assets measured at fair value on a recurring basis are summarized as follows (in thousands):
Description |
|
Balance as of
|
|
Quoted Prices in
|
|
Significant Other
|
|
Significant Other
|
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
$ |
38,848 |
|
$ |
38,848 |
|
$ |
|
|
$ |
|
|
Marketable securities: |
|
|
|
|
|
|
|
|
|
||||
U.S. Government-sponsored enterprise obligations |
|
67,788 |
|
|
|
67,788 |
|
|
|
||||
Corporate debt securities |
|
145,526 |
|
|
|
145,526 |
|
|
|
||||
Commercial paper obligations |
|
57,633 |
|
|
|
57,633 |
|
|
|
||||
Foreign government bonds |
|
9,969 |
|
|
|
9,969 |
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
319,764 |
|
$ |
38,848 |
|
$ |
280,916 |
|
$ |
|
|
Description |
|
Balance as of
|
|
Quoted Prices in
|
|
Significant Other
|
|
Significant Other
|
|
||||
Assets: |
|
|
|
|
|
|
|
|
|
||||
Cash equivalents |
|
$ |
47,940 |
|
$ |
47,940 |
|
$ |
|
|
$ |
|
|
Marketable securities: |
|
|
|
|
|
|
|
|
|
||||
U.S. Government-sponsored enterprise obligations |
|
51,225 |
|
|
|
51,225 |
|
|
|
||||
Corporate debt securities |
|
158,913 |
|
|
|
158,913 |
|
|
|
||||
Commercial paper obligations |
|
65,138 |
|
|
|
65,138 |
|
|
|
||||
Foreign government bonds |
|
12,337 |
|
|
|
12,337 |
|
|
|
||||
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
335,553 |
|
$ |
47,940 |
|
$ |
287,613 |
|
$ |
|
|
During the three months ended March 31, 2013, there were no transfers between Level 1 and Level 2 financial assets. The Company did not have any non-recurring fair value measurements on any assets or liabilities at March 31, 2013 and December 31, 2012. The carrying amounts reflected in the Companys condensed consolidated balance sheets for cash, accounts receivable, unbilled revenue, other current assets, accounts payable and accrued expenses approximate fair value due to their short-term maturities.
Cash, Cash Equivalents and Marketable Securities
The Company invests its cash in bank deposits, money market accounts, corporate debt securities, United States treasury obligations, commercial paper and United States government-sponsored enterprise securities in accordance with its investment policy. The Company has established guidelines relating to diversification and maturities that allow the Company to manage risk.
The Company invests its excess cash balances in short-term and long-term marketable debt securities. The Company classifies its investments in marketable debt securities as available-for-sale based on facts and circumstances present at the time it purchased the securities. The Company reports available-for-sale investments at fair value at each balance sheet date and includes any unrealized holding gains and losses (the adjustment to fair value) in accumulated other comprehensive income (loss), a component of stockholders equity. Realized gains and losses are determined using the specific identification method and are included in interest income. To determine whether an other-than-temporary
impairment exists, the Company considers whether it intends to sell the debt security and, if it does not intend to sell the debt security, it considers available evidence to assess whether it is more likely than not that it will be required to sell the security before the recovery of its amortized cost basis. The Company reviewed its investments with unrealized losses and concluded that no other-than-temporary impairment existed at March 31, 2013 as it has the ability and intent to hold these investments to maturity and it is not more likely than not that it will be required to sell the security before the recovery of its amortized cost basis. The Company did not record any impairment charges related to its marketable securities during the three months ended March 31, 2013 and 2012. The Companys marketable securities are classified as cash equivalents if the original maturity, from the date of purchase, is 90 days or less, and as marketable securities if the original maturity, from the date of purchase, is in excess of 90 days. The Companys cash equivalents are composed of money market funds.
The Companys financial assets have been initially valued at the transaction price and subsequently valued at the end of each reporting period, typically utilizing third-party pricing services or other market observable data. The pricing services utilize industry standard valuation models, including both income and market based approaches, and observable market inputs to determine value. These observable market inputs include reportable trades, benchmark yields, credit spreads, broker/dealer quotes, bids, offers, current spot rates and other industry and economic events. The Company validates the prices provided by its third-party pricing services by reviewing their pricing methods and matrices, obtaining market values from other pricing sources, analyzing pricing data in certain instances and confirming that the relevant markets are active. The Company did not adjust or override any fair value measurements provided by its pricing services as of March 31, 2013 and December 31, 2012.
The following tables summarize the Companys cash, cash equivalents and marketable securities at March 31, 2013 and December 31, 2012 (in thousands):
As of March 31, 2013 |
|
Amortized
|
|
Gross
|
|
Gross
|
|
Fair Value |
|
||||
Cash and money market funds |
|
$ |
43,288 |
|
$ |
|
|
$ |
|
|
$ |
43,288 |
|
U.S. Government-sponsored enterprise obligations |
|
|
|
|
|
|
|
|
|
||||
Due in one year or less |
|
4,253 |
|
3 |
|
|
|
4,256 |
|
||||
Due in two years or less |
|
63,526 |
|
18 |
|
(12 |
) |
63,532 |
|
||||
Corporate debt securities |
|
|
|
|
|
|
|
|
|
||||
Due in one year or less |
|
108,993 |
|
33 |
|
(39 |
) |
108,987 |
|
||||
Due in two years or less |
|
36,541 |
|
27 |
|
(29 |
) |
36,539 |
|
||||
Commercial paper obligations due in one year or less |
|
57,588 |
|
45 |
|
|
|
57,633 |
|
||||
Foreign government bonds |
|
|
|
|
|
|
|
|
|
||||
Due in one year or less |
|
8,366 |
|
1 |
|
(1 |
) |
8,366 |
|
||||
Due in two years or less |
|
1,603 |
|
|
|
|
|
1,603 |
|
||||
Total |
|
$ |
324,158 |
|
$ |
127 |
|
$ |
(81 |
) |
$ |
324,204 |
|
|
|
|
|
|
|
|
|
|
|
||||
Reported as: |
|
|
|
|
|
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
43,288 |
|
$ |
|
|
$ |
|
|
$ |
43,288 |
|
Marketable securities |
|
280,870 |
|
127 |
|
(81 |
) |
280,916 |
|
||||
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
324,158 |
|
$ |
127 |
|
$ |
(81 |
) |
$ |
324,204 |
|
As of December 31, 2012 |
|
Amortized
|
|
Gross
|
|
Gross
|
|
Fair Value |
|
||||
Cash and money market funds |
|
$ |
52,990 |
|
$ |
|
|
$ |
|
|
$ |
52,990 |
|
U.S. Government-sponsored enterprise obligations |
|
|
|
|
|
|
|
|
|
||||
Due in one year or less |
|
6,000 |
|
|
|
|
|
6,000 |
|
||||
Due in two years or less |
|
45,195 |
|
30 |
|
|
|
45,225 |
|
||||
Corporate debt securities |
|
|
|
|
|
|
|
|
|
||||
Due in one year or less |
|
76,500 |
|
19 |
|
(11 |
) |
76,508 |
|
||||
Due in two years or less |
|
82,363 |
|
72 |
|
(30 |
) |
82,405 |
|
||||
Commercial paper obligations due in one year or less |
|
65,104 |
|
34 |
|
|
|
65,138 |
|
||||
Foreign government bonds |
|
|
|
|
|
|
|
|
|
||||
Due in one year or less |
|
7,390 |
|
|
|
(1 |
) |
7,389 |
|
||||
Due in two years or less |
|
4,950 |
|
|
|
(2 |
) |
4,948 |
|
||||
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
340,492 |
|
$ |
155 |
|
$ |
(44 |
) |
$ |
340,603 |
|
|
|
|
|
|
|
|
|
|
|
||||
Reported as: |
|
|
|
|
|
|
|
|
|
||||
Cash and cash equivalents |
|
$ |
52,990 |
|
$ |
|
|
$ |
|
|
$ |
52,990 |
|
Marketable securities |
|
287,502 |
|
155 |
|
(44 |
) |
287,613 |
|
||||
|
|
|
|
|
|
|
|
|
|
||||
Total |
|
$ |
340,492 |
|
$ |
155 |
|
$ |
(44 |
) |
$ |
340,603 |
|
At March 31, 2013 and December 31, 2012, the Company held 28 marketable securities that were in a continuous unrealized loss position for less than one year. At March 31, 2013, the Company held one marketable security that was in a continuous unrealized loss position for fourteen months. At December 31, 2012, no marketable securities were in a continuous unrealized loss position for greater than one year.
The unrealized losses were caused by fluctuations in interest rates. The following table summarizes the aggregate fair value of these securities at March 31, 2013 and December 31, 2012 (in thousands):
|
|
As of March 31, 2013 |
|
As of December 31, 2012 |
|
||||||||
|
|
Aggregate
|
|
Unrealized
|
|
Aggregate
|
|
Unrealized
|
|
||||
U.S. Government-sponsored enterprise obligations |
|
$ |
39,822 |
|
$ |
(12 |
) |
$ |
|
|
$ |
|
|
Corporate debt securities |
|
$ |
84,402 |
|
$ |
(68 |
) |
$ |
83,529 |
|
$ |
(41 |
) |
Foreign government bonds |
|
$ |
6,657 |
|
$ |
(1 |
) |
$ |
8,445 |
|
$ |
(3 |
) |
Income Taxes
The Company generated U.S. taxable income during the years ended December 31, 2011 and 2010, and as a result, utilized $190.9 million and $26.3 million, respectively, of its available federal net operating loss carryforwards to offset this income. At December 31, 2012, the Company had federal and state net operating loss carryforwards of $41.4 million and $34.4 million, respectively, available to reduce future taxable income and which will expire at various dates through 2032. Of this amount, approximately $12.1 million of federal and state net operating loss carryforwards relate to stock option deductions for which the related tax benefit will be recognized in equity when realized. At December 31, 2012, the Company had federal and state research and development and other credit carryforwards of $4.9 million and $4.6 million, respectively, available to reduce future tax liabilities and which will expire at various dates beginning in 2017 through 2032.
As of December 31, 2012 and 2011, the Company had $2.9 million and $2.8 million of gross unrecognized tax benefits, respectively, of which $2.8 million and $2.7 million, respectively, if recognized, would not impact the Companys effective tax rate as there is a full valuation allowance on these credits.
Comprehensive Loss
Comprehensive loss is the change in equity of a company during a period from transactions and other events and circumstances, excluding transactions resulting from investments by owners and distributions to owners. Comprehensive loss includes net loss and the change in accumulated other comprehensive income (loss) for the period. Accumulated other comprehensive income (loss) consists entirely of unrealized gains and losses on available-for-sale marketable securities for all periods presented. See the unaudited condensed consolidated statements of comprehensive loss for relevant disclosures.
The following table summarizes the changes in accumulated other comprehensive income (loss) (in thousands):
|
|
Unrealized Gains
|
|
|
Balance as of December 31, 2012 |
|
$ |
111 |
|
Other comprehensive income (loss) before reclassifications |
|
(62 |
) |
|
Amounts reclassified from accumulated other comprehensive income (loss) |
|
(3 |
) |
|
Net current period other comprehensive income (loss) |
|
(65 |
) |
|
Balance as of March 31, 2013 |
|
$ |
46 |
|
The amounts reclassified from accumulated other comprehensive income (loss) represents realized gains on sales of marketable securities and are included in interest income in the consolidated statement of comprehensive loss.
3. Intangible Assets
As of March 31, 2013 and December 31, 2012, intangible assets, net of accumulated amortization, were as follows (in thousands):
|
|
|
|
As of March 31, 2013 |
|
As of December 31, 2012 |
|
||||||||
|
|
Weighted Average
|
|
Gross
|
|
Accumulated
|
|
Gross
|
|
Accumulated
|
|
||||
Core and developed technology |
|
10 |
|
$ |
10,257 |
|
$ |
(3,811 |
) |
$ |
10,257 |
|
$ |
(3,546 |
) |
Non-compete agreement |
|
2 |
|
170 |
|
(170 |
) |
170 |
|
(170 |
) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
||||
Total intangible assets |
|
10 |
|
$ |
10,427 |
|
$ |
(3,981 |
) |
$ |
10,427 |
|
$ |
(3,716 |
) |
The Companys intangible assets are described in Note 8, Related Party Transactions .
Amortization is computed using the straight-line method over the useful lives of the respective intangible assets as there is no other pattern of use that is reasonably estimable. Amortization expense was approximately $0.3 million for each of the three months ended March 31, 2013 and 2012.
The Company expects to incur amortization expense of appropriately $1.1 million per year for each of the next five years.
4. Restricted Cash
The Company designated $17.5 million as collateral for a security bond posted in the litigation against Amphastar Pharmaceuticals Inc., or Amphastar, Actavis, Inc., or Actavis (formerly Watson Pharmaceuticals Inc.), and International Medical Systems, Ltd. (a wholly owned subsidiary of Amphastar), as discussed within Note 9, Legal Contingencies . The $17.5 million is held in an escrow account by Hanover Insurance. The Company classified this restricted cash as long-term as the timing of a final decision in the Enoxaparin Sodium Injection patent litigation is not known.
The Company designated $2.5 million as collateral for a letter of credit related to the lease of office and laboratory space at its headquarters located at 675 West Kendall Street, Cambridge, Massachusetts. This balance will remain restricted through the remaining term of the lease which ends in April 2015. The Company will earn interest on the balance.
5. Collaboration and License Agreements
2003 Sandoz Collaboration
In November 2003, the Company entered into a collaboration and license agreement, or the 2003 Sandoz Collaboration, with Sandoz AG and Sandoz Inc. collectively, Sandoz, to jointly develop and commercialize Enoxaparin Sodium Injection, a generic version of Lovenox®, a low molecular weight heparin, or LMWH.
Under the 2003 Sandoz Collaboration, the Company granted Sandoz the exclusive right to manufacture, distribute and sell Enoxaparin Sodium Injection in the United States. The Company agreed to provide development and related services on a commercially reasonable basis, which included developing a manufacturing process to make Enoxaparin Sodium Injection, scaling up the process, contributing to the preparation of an Abbreviated New Drug Application, or ANDA, in Sandozs name to be filed with the FDA, further scaling up the manufacturing process to commercial scale, and related development of intellectual property. The Company has the right to participate in a joint steering committee which is responsible for overseeing development, legal and commercial activities and which approves the annual collaboration plan. Sandoz is responsible for commercialization activities and will exclusively distribute and market the product. The Company identified two significant deliverables in this arrangement consisting of: (i) a license and (ii) development and related services. The Company determined that the license did not meet the criteria for separation as it did not have stand-alone value apart from the development services, which are proprietary to the Company. Therefore, the Company determined that a single unit of accounting exists with respect to the 2003 Sandoz Collaboration.
In July 2010, the FDA granted marketing approval of the ANDA for Enoxaparin Sodium Injection filed by Sandoz. The Company is paid at cost for external costs incurred for development and related activities and is paid for full time equivalents, or FTEs, performing development and related services. The profit-share or royalties Sandoz is obligated to pay the Company under the 2003 Sandoz Collaboration differ depending on whether (i) there are no third-party competitors marketing an interchangeable generic version of Lovenox, or Lovenox-Equivalent Product (as defined in the 2003 Sandoz Collaboration), (ii) a Lovenox-Equivalent Product is being marketed by Sanofi-Aventis, which distributes the brand name Lovenox, or licensed by Sanofi-Aventis to another company to be sold as a generic drug, both known as authorized generics, or (iii) there is one or more third-party which is not Sanofi-Aventis marketing a Lovenox-Equivalent Product. Until October 2011, no third-party competitors were marketing a Lovenox-Equivalent Product; therefore, Sandoz paid the Company 45% of the contractual profits from the sale of Enoxaparin Sodium Injection. Profits on sales of Enoxaparin Sodium Injection are calculated by deducting from net sales the cost of goods sold and an allowance for selling, general and administrative costs, which is a contractual percentage of net sales. In October 2011, Sandoz confirmed that an authorized generic Lovenox-Equivalent Product was being marketed, which meant that Sandoz was obligated to pay the Company a royalty on its net sales of Enoxaparin Sodium Injection until the contractual profits from those net sales in a product year (July 1June 30) reached a certain threshold, which was achieved in December 2011, at which point the Company reverted back to receiving profit share revenue. Additionally, in October 2011, FDA approved the ANDA for the enoxaparin product of Actavis and Amphastar. In January 2012, following the Court of Appeals for the Federal Circuit granting a stay of the preliminary injunction previously issued against them by the United States District Court, Actavis announced that it and Amphastar intended to launch their enoxaparin product. Consequently, Sandoz is obligated to pay the Company a royalty on net sales in each post-launch contract year, which for net sales up to a pre-defined sales threshold is payable at a 10% rate, and for net sales above the sales threshold increases to 12%. The Company earned royalties of $5.4 million from Sandoz in the three months ended March 31, 2013 and hybrid profit share/royalties of $22.0 million from Sandoz during the three months ended March 31, 2012.
If certain milestones were achieved with respect to Enoxaparin Sodium Injection under certain circumstances, Sandoz agreed to make payments to the Company which would reach $55 million if all such milestones were achieved. Under the 2003 Sandoz Collaboration, in July 2010, upon the achievement of a regulatory milestone the Company earned and recognized $5.0 million in research and development revenue. In addition, no third-party competitors had marketed a Lovenox-Equivalent Product as of July 2011, the one year anniversary of the FDAs approval of Enoxaparin Sodium Injection. As a result, in the year ended December 31, 2011, the Company earned and recognized $10.0 million in product revenue upon the achievement of the commercial milestone. The Company is no longer eligible to receive milestones under the 2003 Sandoz Collaboration because the remaining milestones were contingent upon there being no third-party competitors marketing an interchangeable generic version of a Lovenox-Equivalent Product.
A portion of the development expenses and certain legal expenses, which in the aggregate have exceeded a specified amount, are offset against profit-sharing amounts, royalties and milestone payments. Sandoz also may offset a portion of any product liability costs and certain other expenses arising from patent litigation against any profit-sharing amounts, royalties and milestone payments.
The Company recognizes research and development revenue from FTE services and research and development revenue from external development costs upon completion of the performance requirements (i.e., as the services are performed and the reimbursable costs are incurred). Revenue from external development costs is recorded on a gross basis as the Company contracts directly with, manages the work of and is responsible for payments to third-party vendors for such development and related services, except with respect to any amounts due Sandoz for manufacturing raw material purchases, which are recorded on a net basis as an offset to the related development expense. There have been no such manufacturing raw material purchases since 2006.
2006 Sandoz Collaboration
In July 2006, the Company entered into a Stock Purchase Agreement and an Investor Rights Agreement with Novartis Pharma AG, and in June 2007, the Company and Sandoz AG executed a collaboration and license agreement, as amended, or the Second Sandoz Collaboration Agreement, related to the development and commercialization of M356, which is designed to be a generic version of Copaxone® (glatiramer acetate injection). Together, this series of agreements is referred to as the 2006 Sandoz Collaboration.
Pursuant to the terms of the Stock Purchase Agreement, the Company sold 4,708,679 shares of common stock to Novartis Pharma AG, an affiliate of Sandoz AG, at a per share price of $15.93 (the closing price of the Companys common stock on the NASDAQ Global Market was $13.05 on the date of the Stock Purchase Agreement) for an aggregate purchase price of $75.0 million, resulting in a paid premium of $13.6 million, which is being recognized in revenue on a straight-line basis over the estimated development period. In March 2013, the Company revised the estimate of the development period from approximately six years to approximately seven years due to a change in the period over which the Companys remaining performance obligations will occur. As a result of this change in estimate, the Companys net loss for the three months ended March 31, 2013 was $0.2 million more than had the estimate remained unchanged. The impact of this change in estimate on the Companys net loss per share for the three months ended March 31, 2013 was immaterial. The Company recognized research and development revenue relating to this paid premium of approximately $0.3 million and $0.5 million for the three months ended March 31, 2013 and 2012, respectively. The portion of the equity premium that is unearned at March 31, 2013 is included in deferred revenue.
Under the 2006 Sandoz Collaboration, the Company and Sandoz AG expanded the geographic markets for Enoxaparin Sodium Injection covered by the 2003 Sandoz Collaboration to include the European Union and further agreed to exclusively collaborate on the development and commercialization of M356 for sale in specified regions of the world. Each party has granted the other an exclusive license under its intellectual property rights to develop and commercialize such products for all medical indications in the relevant regions. The Company has agreed to provide development and related services which includes developing a manufacturing process to make the products, scaling up the process, contributing to the preparation of regulatory filings, further scaling up the manufacturing process to commercial scale, and related development of intellectual property. The Company has the right to participate in a joint steering committee, which is responsible for overseeing development, legal and commercial activities and which approves the annual collaboration plan. Sandoz AG is responsible for commercialization activities and will exclusively distribute and market any products covered by the 2006 Sandoz Collaboration. The Company identified two significant deliverables in this arrangement consisting of (i) a license and (ii) the development and related services. The Company determined that the license did not meet the criteria for separation as it does not have stand-alone value apart from the development services, which are proprietary to the Company. Therefore, the Company has determined that a single unit of accounting exists with respect to the 2006 Sandoz Collaboration.
The term of the Second Sandoz Collaboration Agreement extends throughout the development and commercialization of the products until the last sale of the products, unless earlier terminated by either party pursuant to the provisions of the Second Sandoz Collaboration Agreement. Sandoz AG has agreed to indemnify the Company for various claims, and a certain portion of such costs may be offset against certain future payments received by the Company.
Costs, including development costs and the cost of clinical studies, will be borne by the parties in varying proportions, depending on the type of expense and the related product. All commercialization responsibilities and costs will be borne by Sandoz AG. Under the 2006 Sandoz Collaboration, the Company is paid at cost for any external costs incurred in the development of products where development activities are funded solely by Sandoz AG or partly in proportion where development costs are shared between the Company and Sandoz AG. The Company also is paid at a contractually specified rate for FTEs performing development services where development activities are funded solely by Sandoz AG or partly by proportion where development costs are shared between the Company and Sandoz AG. Upon commercialization, the Company will earn a 50% profit share on worldwide net sales of M356. Additionally, the Company is eligible to receive up to $163.0 million in milestone payments upon the achievement of certain regulatory, commercial and sales-based milestones that include $10.0 million in regulatory milestones related to the approval by the FDA of M356 and $153.0 million in sales-based and commercial milestones. The Company has concluded that the regulatory milestones pursuant to its 2006 Sandoz Collaboration are substantive. The Company evaluated factors such as the scientific and regulatory risks that must be overcome to achieve the respective milestone, the level of effort and investment required and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment. Revenues from non-refundable regulatory milestones are recognized upon successful accomplishment of the milestones as research and development revenue. Sales-based and commercial milestones are accounted for as royalties and are recorded as revenue upon achievement of the milestone, assuming all other revenue recognition criteria are met. The Company has not earned and therefore has not recognized any milestone payments under this arrangement.
The Company recognizes research and development revenue from FTE services and research and development revenue from external development costs upon completion of the performance requirements (i.e., as the services are performed and the reimbursable costs are incurred). Revenue from external development costs is recorded on a gross basis as the Company contracts directly with, manages the work of and is responsible for payments to third-party vendors for such development and related services, except with respect to any amounts due Sandoz for shared development costs, which are recorded on a net basis. There were no shared development costs in the three months ended March 31, 2013 and 2012.
Baxter Agreement
In December 2011, the Company entered into a development, license and option agreement with Baxter International Inc., Baxter Healthcare Corporation and Baxter Healthcare SA, collectively, Baxter. The Company refers to this agreement as the Baxter Agreement. The Baxter Agreement became effective in February 2012, following expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act, as amended.
Under the Baxter Agreement, the Company agreed to collaborate, on a world-wide basis, on the development and commercialization of two biosimilar products, M923 and M834, indicated in the inflammatory and autoimmune therapeutic areas, or the initial products. In July 2012, Baxter selected a third biosimilar for inclusion in the collaboration known as M511, a monoclonal antibody for oncology. Baxter has the right until February 2015, to select up to three additional biosimilars to be included in the collaboration. The Company has initiated development of M511, a monoclonal antibody for oncology. The Company does not receive milestones related to the selection of additional products. The process for achieving milestones is as follows:
· Baxter selects an additional product to the collaboration and the Company initiates development.
· If the Company achieves pre-defined minimum development criteria related to the additional product, Baxter is given an option to exercise exclusive license rights.
· If Baxter exercises its exclusive license option to advance the product under the Baxter Agreement, the Company will earn a license payment.
· If the Company achieves pre-defined technical development criteria related to the initial product or additional product, the Company will earn a milestone payment.
· For the initial and additional products, if the Company either (a) submits an Investigational New Drug application, or IND, to the FDA or (b) is not required to file an IND, either referred to as the Transition Period, the Company will earn a milestone payment.
· Following the Transition Period, Baxter will assume responsibility for development of each biosimilar, and the Company has the potential to receive up to $300 million in regulatory milestones. These milestones are designed to reward the Company, on a sliding scale, for reducing the scope of the clinical activities required to develop each biosimilar.
Under the Baxter Agreement, each party has granted the other an exclusive license under its intellectual property rights to develop and commercialize designated products for all therapeutic indications. The Company has agreed to provide development and related services on a commercially reasonable basis through the Transition Period for each product, which include high-resolution analytics, characterization, and product and process development. Baxter is responsible for clinical development, manufacturing and commercialization activities and will exclusively distribute and market any products covered by the Baxter Agreement. The Company has the right to participate in a joint steering committee, consisting of an equal number of members from the Company and Baxter, to oversee and manage the development and commercialization of products under the collaboration. Costs, including development costs, payments to third parties for intellectual property licenses, and expenses for legal proceedings, including the patent exchange process pursuant to the Biologics Price Competition and Innovation Act of 2009, will be borne by the parties in varying proportions, depending on the type of expense and the stage of development. The Company has the option to participate, at its discretion, in a cost and profit share arrangement for the four additional products up to 30%. If the profit share is elected, the royalties payable would be reduced by up to nearly half. Absent a cost share arrangement, the Company will generally be responsible for research and process development costs prior to filing an IND, and the cost of in-human clinical trials, manufacturing in accordance with current good manufacturing practices and commercialization will be borne by Baxter.
In addition, the Company has agreed, for a period commencing six months following the effective date and ending on the earlier of (i) three years from the effective date of the Baxter Agreement (subject to certain limited time extensions as provided for in the Baxter Agreement) or (ii) the selection of the four additional products, to notify Baxter of bona fide offers from third parties to develop or commercialize a biosimilar that could be an additional product candidate. Following such notification, if Baxter does not select such proposed product or products for inclusion in the collaboration, the Company has the right to develop, manufacture, and commercialize such product or products on its own or with a third party. The Company also agreed to provide Baxter with a right of first negotiation with respect to collaborating in the development of a competing product for a period of three years following the effectiveness of an IND exemption or waiver or regulatory authority authorization to dose humans, subject to certain restrictions as outlined in the Baxter Agreement. Following the third anniversary of the effective date of the Baxter Agreement (subject to certain limited time extensions as provided for in the Baxter Agreement), the Company may develop, on its own or with a third party, any biosimilar product not named under the Baxter Agreement, subject to certain restrictions.
Under the terms of the Baxter Agreement, the Company received an initial cash payment of $33 million. The Company is eligible to receive from Baxter license payments totaling $28 million for the exercise of options with respect to the additional four product candidates that can be named under the Baxter Agreement, payments of $5 million each for extensions of the period during which such additional products may be selected, and a license payment of $7 million upon the achievement of pre-defined minimum development criteria, as defined in the agreement,
for M834 (a selected biosimilar). The Company is also eligible to receive from Baxter an aggregate of approximately $380 million in potential milestone payments, comprised of (i) up to $80 million in substantive milestone payments upon achievement of specified technical and development milestone events across the six product candidates, and (ii) regulatory milestones totaling up to $300 million, on a sliding scale, across the six product candidates where, based on the products regulatory application, there is a significant reduction in the scope of the clinical trial program required for regulatory approval. Two of the technical and development milestones were time-based and the total eligible milestones have been adjusted to correspond to current development plans. There are no other time-based milestones included in the Baxter Agreement. The technical and development milestones include (i) achievement of certain criteria that will ultimately drive commercial feasibility for manufacturing the products and (ii) acceptance by the FDA of an IND.
For the three products in development under the Baxter Agreement, if the Company achieves certain development and technical criteria, the Company could receive a total of up to $26 million in license payments and milestones in 2014.
In addition, if any of the six products are successfully developed and launched, Baxter will be required to pay to the Company royalties on net sales of licensed products worldwide, with a base royalty rate in the high single digits with the potential for significant tiered increases based on the number of competitors, the interchangeability of the product, and the sales tier for each product. The maximum royalty with all potential increases would be slightly more than double the base royalty.
The term of the collaboration shall continue throughout the development and commercialization of the products, on a product-by-product and country-by-country basis, until there is no remaining payment obligation with respect to a product in the relevant territory, unless earlier terminated by either party pursuant to the terms of the Baxter Agreement.
The Baxter Agreement may be terminated by:
· either party for breach by or bankruptcy of the other party;
· the Company in the event Baxter elects to terminate the Baxter Agreement with respect to both of the initial two products within a certain time period;
· Baxter for its convenience; or
· the Company in the event Baxter does not exercise commercially reasonable efforts to commercialize a product in the United States or other specified countries, provided that the Company also has certain rights to directly commercialize such product, as opposed to terminating the Baxter Agreement, in event of such a breach by Baxter.
In accordance with the Financial Accounting Standards Boards ASU No. 2009-13: Multiple-Deliverable Revenue Arrangements (Topic 615), the Company identified all of the deliverables at the inception of the Baxter Agreement. The deliverables were determined to include (i) the development and product licenses to the two initial biosimilars and the four additional biosimilars, (ii) the research and development services related to the two initial biosimilars and the four additional biosimilars and (iii) the Companys participation in a joint steering committee. The Company has determined that each of the license deliverables do not have stand-alone value apart from the related research and development services deliverables as there are no other vendors selling similar, competing products on a stand-alone basis, Baxter does not have the contractual right to resell the license, and Baxter is unable to use the license for its intended purpose without the Companys performance of research and development services. As such, the Company determined that separate units of accounting exist for each of the six licenses together with the related research and development services, as well as the joint steering committee with respect to this arrangement. The estimated selling prices for these units of accounting were determined based on similar license arrangements and the nature of the research and development services to be performed for Baxter and market rates for similar services. The arrangement consideration of $61 million, which includes the $33 million upfront payment and aggregate option payments of $28 million, was allocated to the units of accounting based on the relative selling price method. Of the $61 million, $10.3 million has been allocated to the first initial product license together with the related research and development services, $10.3 million to each of the four additional product licenses with the related research and development services, $9.4 million has been allocated to the second initial product license together with the related research and development services due to that products stage of development at the time the license was delivered, and $114,000 has been allocated to the joint steering committee unit of accounting. The Company will commence revenue recognition for each of the six units of accounting related to the products upon delivery of the related development and product license and will record this revenue on a straight-line basis over the applicable performance period during which the research and development services will be delivered. The Company will recognize the revenue related to the joint steering committee deliverable over the applicable performance period during which the research and development services will be delivered. The Company has determined that the performance period for each of the combined six units of accounting consisting of the products and related research and development services, begins upon delivery of the related development and product license and ends upon FDA approval of the related product. The Company has also determined that the applicable performance period for the joint steering committee deliverable begins upon delivery of the first development and product license and ends upon the latest date of FDA approval. The Company currently estimates that the performance period for the two initial products, considering their respective stage of development, is approximately five and seven years, respectively, and the period of performance for the joint steering committee is approximately nine years. In 2012, the Company commenced recognition of the revenue allocated to the two initial products but not for the four additional products as those licenses have not been delivered. The Company recognized
revenue relating to the amortized portion of the upfront payment of approximately $0.7 million and $0.6 million for the three months ended March 31, 2013 and 2012, respectively. The portion of the upfront payment that is unearned at March 31, 2013 is included in deferred revenue.
Any associated royalty or profit sharing payments will be considered contingent fees that will be recorded as earned in future periods. Baxters option to extend the naming period is considered to be substantive. As such, potential fees associated with the naming period extensions will be recognized in future periods if and when Baxter exercises its right to extend the naming period for any additional products.
The Company has concluded that certain of the technical and development milestones and all of the regulatory milestones pursuant to the Baxter Agreement are substantive. The Company evaluated factors such as the scientific and regulatory risks that must be overcome to achieve these milestones, the level of effort and investment required and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment. Revenues from non-refundable technical, development and regulatory milestones will be recognized upon successful accomplishment of the milestones as research and development revenue. The Company has not earned and therefore has not recognized any milestone payments under this arrangement.
Massachusetts Institute of Technology
The Company has an agreement dated November 1, 2002 with the Massachusetts Institute of Technology, or M.I.T., granting the Company various exclusive and non-exclusive worldwide licenses, with the right to grant sublicenses, under certain patents and patent applications relating to:
· methods and technologies for characterizing polysaccharides;
· certain heparins, heparinases and other enzymes; and
· synthesis methods.
In exchange for the licenses granted in the agreement, the Company has paid M.I.T. license maintenance fees, royalties on certain products and services covered by the licenses and sold by the Company or its affiliates or sublicensees, a percentage of certain other income received by the Company from corporate partners and sublicensees, and certain patent prosecution and maintenance costs.
The following table summarizes the license maintenance fees and royalties paid to M.I.T. and recorded in the three months ended March 31, 2013 and 2012 (in thousands):
|
|
For the Three
|
|
For the Three
|
|
||
License maintenance fees |
|
$ |
21 |
|
$ |
39 |
|
Royalties |
|
108 |
|
441 |
|
||
|
|
|
|
|
|
||
Total |
|
$ |
129 |
|
$ |
480 |
|
Beginning in 2013, the annual license maintenance obligations, which extend through the life of the patents, are approximately $0.1 million per year. The annual payments may be applied towards royalties payable to M.I.T. for that year for product sales, sublicensing of the patent rights or joint development revenue.
The Company is obligated to indemnify M.I.T. and related parties from losses arising from claims relating to the products, processes or services made, used, sold or performed pursuant to the agreements, unless the losses result from the indemnified parties gross negligence or willful misconduct.
The agreement expires upon the expiration or abandonment of all patents that issue and are licensed to the Company by M.I.T. under such agreement. The issued patents include over 30 United States patents and foreign counterparts of some of those. The Company expects that additional patents will issue from presently pending U.S. and foreign patent applications. Any such patent will have a term of 20 years from the filing date of the underlying application. M.I.T. may terminate the agreement immediately if the Company ceases to carry on its business, if any nonpayment by the Company is not cured within 60 days of written notice or the Company commits a material breach that is not cured within 90 days of written notice. The Company may terminate the agreement for any reason upon six months notice to M.I.T., and it can separately terminate the license under a certain subset of patent rights upon three months notice.
The Company granted Sandoz a sublicense under the agreement to certain of the patents and patent applications licensed to the Company. If M.I.T. converts the Companys exclusive licenses under this agreement to non-exclusive licenses due to the Companys failure to meet diligence
obligations, or if M.I.T. terminates this agreement, M.I.T. will honor the exclusive nature of the sublicense the Company granted to Sandoz so long as Sandoz continues to fulfill its obligations to the Company under the collaboration and license agreement the Company entered into with Sandoz and, if the Companys agreement with M.I.T. is terminated, Sandoz agrees to assume the Companys rights and obligations to M.I.T.
The Company previously had an exclusive patent license agreement dated October 31, 2002 with M.I.T granting the Company various licenses under certain patents solely related to the commercial sale or leasing of sequencing machines, including the performance of sequencing services. The Company terminated that agreement in January 2013. Nothing in the notice of termination impacts the agreement between the Company and M.I.T dated November 1, 2002.
6. Share-Based Payments
2004 Stock Incentive Plan
The Companys 2004 Stock Incentive Plan, as amended, allows for the granting of incentive and nonstatutory stock options, restricted stock awards, stock appreciation rights and other share-based awards to employees, officers, directors, consultants and advisors. At December 31, 2012, the Company was authorized to issue up to 15,343,534 shares of common stock with annual increases (to be added on the first day of the Companys fiscal years during the period beginning in fiscal year 2005 and ending on the second day of fiscal year 2013) equal to the lowest of (i) 1,974,393 shares, (ii) 5% of the then outstanding number of common shares or (iii) such other amount as the Board of Directors may authorize. At March 31, 2013, the Company had 5,034,813 shares available for grant under the 2004 Stock Incentive Plan.
Share-Based Compensation Expense
Total compensation cost for all share-based payment arrangements, including employee, director and consultant stock options, restricted stock and the Companys employee stock purchase plan for the three months ended March 31, 2013 and 2012 was $2.9 million and $3.3 million, respectively.
Share-based compensation expense related to outstanding employee stock option grants and the Companys employee stock purchase plan was $1.9 million and $1.8 million for the three months ended March 31, 2013 and 2012, respectively. During the three months ended March 31, 2013, the Company granted 1,128,646 stock options, of which 1,025,771 were granted in connection with annual merit awards and 102,875 were granted to new hires. The average grant date fair value of options granted was calculated using the Black-Scholes-Merton option-pricing model and the weighted average assumptions noted in the table below. The weighted average grant date fair value of option awards granted during the three months ended March 31, 2013 and 2012 was $7.21 and $9.37 per option, respectively.
The following tables summarize the weighted average assumptions the Company used in its fair value calculations at the date of grant:
|
|
Weighted Average Assumptions |
|
||||||
|
|
Stock Options |
|
Employee Stock Purchase Plan |
|
||||
|
|
For the Three
|
|
For the Three
|
|
For the Three
|
|
For the Three
|
|
Expected volatility |
|
62 |
% |
65 |
% |
64 |
% |
66 |
% |
Expected dividends |
|
|
|
|
|
|
|
|
|
Expected life (years) |
|
6.2 |
|
6.5 |
|
0.5 |
|
0.5 |
|
Risk-free interest rate |
|
1.4 |
% |
1.4 |
% |
0.1 |
% |
0.1 |
% |
At March 31, 2013, the total remaining unrecognized compensation cost related to nonvested stock option awards amounted to $15.7 million, including estimated forfeitures, which will be recognized over the weighted average remaining requisite service period of 3 years.
During the three months ended March 31, 2013, holders of options issued under the Companys stock plans exercised their right to acquire an aggregate of 51,749 shares of common stock. Additionally, during the three months ended March 31, 2013, the Company issued 38,626 shares of common stock to employees under the Companys employee stock purchase plan.
Restricted Stock Awards
The Company has also made awards of restricted common stock to employees, officers and directors. During the three months ended March 31, 2013, the Company awarded 140,300 shares of time-based restricted common stock to its officers in connection with its annual merit grant, 5,000 shares of time-based restricted common stock to a newly hired employee and 1,680 shares of performance-based restricted common stock to a newly hired employee. The time-based restricted common stock fully vests over the four years following the grant date. The performance condition that triggers vesting of the performance-based awards is the approval in the United States from the FDA for M356, the Companys second major generic program, provided that approval occurs on or before March 28, 2015. The Company has granted 856,510 shares of restricted common stock tied to this M356 performance
condition to its employees and officers that remain unvested at March 31, 2013. The awards of restricted common stock are generally forfeited if the employment relationship terminates with the Company prior to vesting.
The value of restricted stock awards is recognized as compensation cost in the Companys consolidated statements of comprehensive loss over each awards explicit or implicit service period. The Company estimates an awards implicit service period based on its best estimate of the period over which an awards vesting conditions will be achieved. The Company reevaluates these estimates on a quarterly basis and will recognize any remaining unrecognized compensation as of the date of an estimate revision over the revised remaining implicit service period. In March 2013, the Company revised the implicit service period for certain performance-based restricted stock awards due to a change in the expected vesting date. As a result of this change in estimate, the Companys net loss for the three months ended March 31, 2013 was $0.5 million less than had the estimate remained unchanged. The impact of this change in estimate on the Companys net loss per share for the three months ended March 31, 2013 was immaterial.
The Company recorded share-based compensation expense related to outstanding restricted stock awards, including the performance-based shares, because the Company determined that it was probable the performance condition would be achieved, of $0.9 million and $1.4 million for the three months ended March 31, 2013 and 2012, respectively. As of March 31, 2013, the total remaining unrecognized compensation cost related to nonvested restricted stock awards amounted to $8.5 million, which is expected to be recognized over the weighted average remaining requisite service period of 1.9 years.
A summary of the status of nonvested shares of restricted stock as of March 31, 2013 and the changes during the three months then ended are presented below (in thousands, except fair values):
|
|
Number of
|
|
Weighted
|
|
|
Nonvested at January 1, 2013 |
|
1,137 |
|
$ |
14.61 |
|
Granted |
|
146 |
|
12.58 |
|
|
Vested |
|
(58 |
) |
14.39 |
|
|
Forfeited |
|
(21 |
) |
14.60 |
|
|
|
|
|
|
|
|
|
Nonvested at March 31, 2013 |
|
1,204 |
|
$ |
14.37 |
|
Nonvested shares of restricted stock that have time-based or performance-based vesting schedules as of March 31, 2013 are summarized below:
Vesting Schedule |
|
Nonvested
|
|
Time-based |
|
347 |
|
Performance-based |
|
857 |
|
|
|
|
|
Nonvested at March 31, 2013 |
|
1,204 |
|
7. Tax Incentive Agreement
In March 2012, the Company entered into a Tax Incentive Agreement with the Massachusetts Life Sciences Center, or MLSC, under the MLSCs Life Sciences Tax Incentive Program, or the Program, to expand life sciences-related employment opportunities, promote health-related innovations and stimulate research and development, manufacturing and commercialization in the life sciences in the Commonwealth of Massachusetts. The Program was established in 2008 in order to incentivize life sciences companies to create new sustained jobs in Massachusetts. Under the Tax Incentive Agreement, companies receive an award from the MLSC upon attaining job creation commitment. Jobs must be maintained for at least five years, during which time a portion of the grant proceeds can be recovered by the Massachusetts Department of Revenue if the Company does not maintain its job creation commitments. As of December 31, 2012, the Company attained its job creation commitment and earned a $1.1 million job creation tax award and recognized one-fifth of the award as other income. The Company will recognize an equal portion of the award as other income over the five year period the Company maintains its job creation commitments. The unearned portion of the award is included in other liabilities in the consolidated balance sheet.
8. Related Party Transactions
In April 2007, the Company entered into an asset purchase agreement, or the Purchase Agreement, with Parivid, LLC, or Parivid, a provider of data integration and analysis services to the Company, and S. Raguram, the principal owner and Chief Technology Officer of Parivid. Parivid was considered to be a related party because a co-founder and member of the Companys Board of Directors is the brother of S. Raguram. Pursuant to the Purchase Agreement, the Company acquired patent rights, software, know-how and other intangible assets, and assumed certain specified liabilities of Parivid related to the acquired assets in exchange for $2.5 million in cash paid at closing and up to $11.0 million in
contingent milestone payments in a combination of cash and/or stock in the manner and on the terms and conditions set forth in the Purchase Agreement.
In July 2011, the Company entered into an Amendment to the Purchase Agreement where the parties agreed that a milestone payment would be made in cash rather than through the issuance of Company stock. In August 2011, the Company paid Parivid $6.7 million in cash, in lieu of stock, pursuant to this Amendment as consideration for the completion and satisfaction of a milestone related to the Enoxaparin Sodium Injection developed technology that was achieved in July 2011. The Company capitalized the payment as developed technology, which is included in intangible assets in the consolidated balance sheets. The developed technology is being amortized over the estimated useful life of the Enoxaparin Sodium Injection developed technology of approximately 10 years.
9. Commitments and Contingencies
Operating Leases
The Company leases office space and equipment under various operating lease agreements.
In September 2004, the Company entered into an agreement with Vertex Pharmaceuticals to lease 53,323 square feet of office and laboratory space located on the fourth and fifth floors at 675 West Kendall Street, Cambridge, Massachusetts, for an initial term of 80 months, or the West Kendall Sublease. In November 2005, the Company amended the West Kendall Sublease to lease an additional 25,131 square feet through April 2011. In April 2010, the Company exercised its right to extend the West Kendall Sublease for one additional term of 48 months, ending April 2015, or on such other earlier date as provided in accordance with the West Kendall Sublease. During the extension term, which commenced on May 1, 2011, annual rental payments increased by approximately $1.2 million over the previous annual rental rate.
In December 2011, the Company entered into an agreement to lease 68,575 square feet of office and laboratory space located on the first and second floors at 320 Bent Street, Cambridge, Massachusetts, for a term of approximately 18 months, or the First Bent Street Sublease. The Company gained access to the subleased space in December 2011 and, consequently, the Company commenced expensing the applicable rent on a straight-line basis beginning in December 2011. Annual rental payments due under the First Bent Street Sublease are approximately $2.3 million.
On February 5, 2013, the Company and BMR-Rogers Street LLC, or BMR, entered into a lease agreement, or the Second Bent Street Lease, pursuant to which the Company will lease 104,678 square feet of office and laboratory space located in the basement and first and second floors at 320 Bent Street, Cambridge, Massachusetts, or the Premises, beginning on September 1, 2013 and ending on August 31, 2016. Annual rental payments due under the Second Bent Street Lease will be approximately $6.1 million during the first lease year, $6.2 million during the second lease year and $6.3 million during the third lease year. The Company will be required to provide a security deposit in cash or in the form of a letter of credit in the amount of $0.7 million.
BMR has agreed to pay the Company a tenant improvement allowance of $0.7 million for certain improvements that the Company will construct to the Premises.
The Company has two consecutive options to extend the term of the Second Bent Street Lease for the Premises for one year each at the then-current fair market value. In addition, the Company has two additional consecutive options to extend the term of the Second Bent Street Lease for five years each for the office and laboratory space located in the basement portion of the Premises at the then-current fair market value.
Total operating lease commitments as of March 31, 2013 are as follows (in thousands):
|
|
Operating
|
|
|
April 1, 2013 December 31, 2013 |
|
$ |
6,855 |
|
2014 |
|
10,937 |
|
|
2015 |
|
7,870 |
|
|
2016 |
|
4,273 |
|
|
2017 |
|
62 |
|
|
|
|
|
|
|
Total future minimum lease payments |
|
$ |
29,997 |
|
Legal Contingencies
On August 28, 2008, Teva Pharmaceuticals Industries Ltd. and related entities, or Teva, and Yeda Research and Development Co., Ltd., or Yeda, filed suit against the Company and Sandoz in the United States Federal District Court in the Southern District of New York in response to the filing by Sandoz of the ANDA with a Paragraph IV certification for M356. The suit alleges infringement related to four of the seven Orange Book patents listed for Copaxone and seeks declaratory and injunctive relief that would prohibit the launch of the Companys product until the last to expire of these patents. The Company and Sandoz asserted defenses of non-infringement, invalidity and unenforceability and filed
counterclaims for declaratory judgments to have all seven of the Orange Book patents as well as two additional patents in the same patent family adjudicated in the present lawsuit. Another company, Mylan Inc., or Mylan, also has an ANDA for generic Copaxone under FDA review. In October 2009, Teva sued Mylan for patent infringement related to the Orange Book patents listed for Copaxone, and in October 2010, the court consolidated the Mylan case with the case against the Company and Sandoz. A trial on the issue of inequitable conduct occurred in July 2011 and the trial on the remaining issues occurred in September 2011 in the consolidated case. In June 2012, the Court issued its opinion and found all of the claims in the patents to be valid, enforceable and infringed. In July 2012, the Court issued a final order and permanent injunction prohibiting Sandoz and Mylan from infringing all of the patents in the suit. The Orange Book patents and one non-Orange book patent expire in May 2014 and one non-Orange Book patent expires in September 2015. In addition, the permanent injunction further restricts the FDA, pursuant to 35 U.S.C. section 271(e)(4)(A), from making the effective date of any final approval of the Sandoz or Mylan ANDA prior to the expiration of the Orange Book patents. In July 2012, the Company appealed the decision to the Court of Appeals for the Federal Circuit, or CAFC, and oral arguments were heard on May 7, 2013.
On December 10, 2009, in a separate action in the same court, Teva sued Sandoz, Novartis AG and the Company for patent infringement related to certain other non-Orange Book patents seeking declaratory and injunctive relief that would prohibit the launch of the Companys product until the last to expire of these patents as well as damages in the event that Sandoz has launched the product. In January 2010, the Company and Sandoz filed a motion to dismiss this second suit on several grounds, including the failure of Teva to state an actionable legal claim and lack of subject matter jurisdiction. The motion is pending and oral arguments are scheduled for May 13, 2013. The Company and Sandoz intends to defend this suit.
If the decision in the first suit is not reversed on appeal, or the Company is not successful in its second suit, the final approval and launch of M356 could be significantly delayed until expiration of the relevant patent rights which could impair its ability to commercialize M356 and the Companys business could be materially harmed. There are no damages being sought in the first suit, and at this time the Company believes a loss is not probable in the second. Litigation involves many risks and uncertainties, and there is no assurance that Novartis AG, Sandoz or the Company will prevail in either lawsuit.
On September 21, 2011, the Company and Sandoz sued Amphastar, Actavis and International Medical Systems, Ltd. (a wholly owned subsidiary of Amphastar) in the United States District Court for the District of Massachusetts for infringement of two of the Companys patents. Also in September, 2011, the Company filed a request for a temporary restraining order and preliminary injunction to prevent Amphastar, Actavis and International Medical Systems, Ltd. from selling their enoxaparin product in the United States. In October 2011, the court granted the Companys motion for a preliminary injunction and entered an order enjoining Amphastar, Actavis and International Medical Systems, Ltd. from advertising, offering for sale or selling their enoxaparin product in the United States until the conclusion of a trial on the merits and required the Company and Sandoz to post a security bond of $100 million in connection with the litigation. Amphastar, Actavis and International Medical Systems, Ltd. appealed the decision and in January 2012, the CAFC stayed the preliminary injunction. In August 2012, the CAFC issued a written opinion vacating the preliminary injunction and remanding the case to the District Court. In September 2012, the Company filed a petition with the CAFC for a rehearing by the full court en banc , which was denied. In January 2013, Amphastar and Actavis filed a motion for summary judgment in the District Court following the decision from the CAFC. The parties will commence briefing and oral arguments are currently scheduled for July 1, 2013. In February 2013, the Company filed a petition for a writ of certiorari for review of the CAFC decision by the United States Supreme Court and in April 2013 the Supreme Court requested a response from Amphastar which is due May 24, 2013. Review by the Supreme Court is discretionary and certiorari petitions are infrequently granted. The collateral for the security bond posted in the litigation remains outstanding. In the event that the Company is not successful in appealing the CAFC decision and loses the case at the District Court, and Amphastar and Actavis are able to prove they suffered damages as a result of the preliminary injunction, the Company could be liable for damages for up to $35 million of the security bond. In June 2012, Amphastar filed a motion to increase the amount of the security bond, which the Company and Sandoz have opposed.
While the Company intends to vigorously prosecute this action against Actavis and Amphastar, and believes that it can ultimately prove its case in court, this suit could last a number of years. As a result, potential recovery of lost profits and damages could await a final judgment after an appeal of a District Court decision. Litigation involves many risks and uncertainties, and there is no assurance that the Company or Sandoz will prevail in this patent enforcement suit.
Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations.
Our Managements Discussion and Analysis of Financial Condition and Results of Operations includes the identification of certain trends and other statements that may predict or anticipate future business or financial results. There are important factors that could cause our actual results to differ materially from those indicated. See Risk Factors in Item 1A of Part II of this Quarterly Report on Form 10-Q.
Statements contained or incorporated by reference in this Quarterly Report on Form 10-Q that are not based on historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements regarding future events and our future results are based on current expectations, estimates, forecasts, projections, intentions, goals, strategies, plans, prospects and the beliefs and assumptions of our management including, without limitation, our expectations regarding results of operations, general and administrative expenses, research and development expenses, current and future development and manufacturing efforts, regulatory filings, clinical trial results and the sufficiency of our cash for future operations. Forward-looking statements can be identified by terminology such as anticipate, believe, could, could increase the likelihood, hope, target, project, goals, potential, predict, might, estimate, expect, intend, is planned, may, should, will, will enable, would be expected, look forward, may provide, would or similar terms, variations of such terms or the negative of those terms.
We cannot assure investors that our assumptions and expectations will prove to have been correct. Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements. Such factors that could cause or contribute to such differences include those factors discussed below under Risk Factors in Item 1A of Part II of this Quarterly Report on Form 10-Q. We undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Business Overview
The Company
We are a biotechnology company specializing in the structural characterization, process engineering and biologic systems analysis of complex molecules such as polysaccharides, polypeptides, and biologics (including proteins and antibodies). Our initial technology was built on the ability to characterize complex polysaccharides. Over the last decade, we have expanded our expertise into technologies that enable us to develop a diversified product portfolio of complex generics, biosimilars and novel products. Our business strategy has been to develop both generic and novel products, and we are working with collaborators to develop and commercialize our complex generics and biosimilars. This strategy was validated by the marketing approval and commercial launch of Enoxaparin Sodium Injection, a generic version of Lovenox®, in July 2010. Since its launch through March 31, 2013, we have recorded Enoxaparin Sodium Injection product revenues of approximately $427 million, driven primarily by its initial status as a sole generic. We believe that our scientific capabilities, engineering approaches, intellectual property and regulatory strategies, and synergistic business model position us to develop and commercialize competitively differentiated products in our target areas of complex generics, biosimilars and novel products.
Our Programs
Our complex generics programs target marketed products that were originally approved by the United States Food and Drug Administration, or FDA, as New Drug Applications, or NDAs. Therefore, we have been able to access the existing 505(j) generic regulatory pathway and have submitted Abbreviated New Drug Applications, or ANDAs, for these products. Our first commercial product, Enoxaparin Sodium Injection, which has been developed and commercialized in collaboration with Sandoz Inc. and Sandoz AG, collectively Sandoz, affiliates of Novartis AG, received FDA marketing approval in July 2010 as a generic version of Lovenox® (enoxaparin sodium injection). Lovenox is a complex mixture of polysaccharide chains derived from naturally sourced heparin which is used to prevent and treat deep vein thrombosis, or DVT, and to support the treatment of acute coronary syndromes, or ACS. The Enoxaparin Sodium Injection ANDA submitted by Sandoz was the first ANDA for a generic Lovenox to be approved by FDA, validating our novel approaches to the structural characterization, process engineering and biologic systems analysis of complex molecules. From July 2010 through early October 2011, the Enoxaparin Sodium Injection marketed by Sandoz was the sole generic version of Lovenox, and consequently, under the terms of our collaborative agreement with Sandoz, we earned 45% profit share on Sandozs sales of Enoxaparin Sodium Injection. The product now faces other generic competitors and we receive a royalty on net sales, which have been significantly eroded by competitive pressures.
Our second complex generic product candidate, M356, is designed to be a generic version of Copaxone® (glatiramer acetate injection), a drug that is indicated for the reduction of the frequency of relapses in patients with relapsing-remitting multiple sclerosis, or RRMS. Copaxone consists of a synthetic mixture of polypeptide chains. With M356, we extended our core polysaccharide characterization and process engineering capabilities to develop capabilities for the structural characterization, process engineering and biologic systems analysis of this complex polypeptide mixture. We are also collaborating with Sandoz to develop and commercialize M356, and the Sandoz ANDA for M356 is currently under FDA review.
Our biosimilars program is targeted toward developing biosimilar versions of marketed therapeutic proteins, with a goal of obtaining FDA designation as interchangeable. The subset of biosimilars receiving an interchangeability designation are known as interchangeable biologics. In March 2010, an abbreviated regulatory process was codified in Section 351(k) of the Patient Protection and Affordable Care Act of 2010. This new pathway opens the market for biosimilar and interchangeable versions of a broad array of biologic therapeutics, including antibodies, cytokines, fusion proteins, hormones and blood factors. Forecasters predict a rapidly growing multi-billion dollar global market for these products. Most of these biologics are complex mixtures, and for several years we have been investing in developing novel approaches to the structural characterization, process engineering and analysis of the biologic activities of these products. In February 2012, FDA released three documents containing their preliminary guidelines for applications under the Section 351(k) pathway. These guidelines state that FDA will use a step-wise review that considers the totality-of-the-evidence in determining extent of the clinical development program. This approach puts a substantial emphasis on structural and functional characterization data in evaluating biosimilar products for approval. We believe the framework that the FDA has outlined in the draft guidance documents aligns with our strategy for biosimilars. Our goal is to engineer biologic products that will show minimal to no structural or functional differences from the reference brand product, thereby justifying a more selective and targeted approach to human clinical testing to support demonstration of interchangeability. In December 2011, we and Baxter International, Inc., Baxter Healthcare Corporation and Baxter Healthcare SA, collectively, Baxter, entered into a global collaboration and license agreement, or the Baxter Agreement, to develop and commercialize up to six biosimilars. The Baxter Agreement became effective in February 2012. Baxter is an established healthcare company with global product development, manufacturing and commercial capabilities.
Our novel products program leverages the capabilities and expertise of our complex generics and biosimilars programs to address unmet clinical needs. Our most advanced efforts have been in the area of polysaccharide mixtures. M402, in Phase 1 clinical development as a potential anti-cancer agent, is a novel heparan sulfate mimetic that binds to multiple growth factors, adhesion molecules and chemokines to inhibit tumor angiogenesis, progression, and metastasis. In addition to this development candidate, we are also seeking to discover and develop additional novel products. Our goal is to leverage the multi-targeting nature of complex mixture molecules to develop novel products which could positively modulate multiple pathways in a disease. We have built significant capabilities in biological characterization and engineering of proteins through our biosimilars platform that provide us with the potential to create unique and novel formulations of protein (including antibody) drug compositions for specific disease indications. To add to these capabilities, in December 2011 we acquired selected assets of Virdante Pharmaceuticals, Inc. relating to sialylation technology. Sialic acid is a type of sugar modification on selected proteins that is understood to regulate anti-inflammatory and immunomodulatory function. These assets add to our core ability to modify and engineer protein backbones to precisely regulate biological networks and develop novel biologic product candidates. We are applying our proprietary sialylation technology program to develop a sialylated plasma-derived intravenous immunoglobulin, or IVIG, product, or a recombinant sialylated Fc product. We are investigating both approaches, and expect to have data later this year that will guide our development efforts.
Our Collaborations
In 2003, we entered into a collaboration and license agreement, or the 2003 Sandoz Collaboration, with Sandoz N.V. and Sandoz Inc. to jointly develop, manufacture and commercialize Enoxaparin Sodium Injection in the United States. Sandoz N.V. later assigned its rights in the 2003 Sandoz Collaboration to Sandoz AG, an affiliate of Novartis Pharma AG. We refer to Sandoz AG and Sandoz Inc. together as Sandoz.
In 2006 and 2007, we entered into a series of agreements, including a Stock Purchase Agreement and an Investor Rights Agreement, with Novartis Pharma AG, and a collaboration and license agreement, as amended, or the Second Sandoz Collaboration Agreement, with Sandoz AG. Together, this series of agreements is referred to as the 2006 Sandoz Collaboration. Under the Second Sandoz Collaboration Agreement, we and Sandoz AG expanded the geographic markets for Enoxaparin Sodium Injection covered by the 2003 Sandoz Collaboration to include the European Union. Further, under the Second Sandoz Collaboration Agreement, we and Sandoz AG agreed to exclusively collaborate on the development and commercialization of M356, among other products. In connection with the 2006 Sandoz Collaboration, we sold 4,708,679 shares of common stock to Novartis Pharma AG at a per share price of $15.93 (the closing price of our common stock on the NASDAQ Global Market was $13.05 on the date of purchase) for an aggregate purchase price of $75.0 million, resulting in an equity premium of $13.6 million. As of March 31, 2013, Novartis AG owned approximately 9% of our outstanding common stock.
Prior to the launch of Enoxaparin Sodium Injection in 2010, the collaboration revenues derived from our 2003 Sandoz Collaboration and 2006 Sandoz Collaboration primarily consisted of amounts earned by us for reimbursement by Sandoz of research and development services and development costs. In July 2010, Sandoz began the commercial sale of Enoxaparin Sodium Injection. The profit-share or royalties Sandoz is obligated to pay us under the 2003 Sandoz Collaboration differ depending on whether (i) there are no third-party competitors marketing an interchangeable generic version of Lovenox, or Lovenox-Equivalent Product (as defined in the 2003 Sandoz Collaboration), (ii) a Lovenox-Equivalent Product is being marketed by Sanofi-Aventis, which distributes the brand name Lovenox, or licensed by Sanofi-Aventis to another company to be sold as a generic drug, both known as authorized generics, or (iii) there are one or more third-party competitors which are not Sanofi-Aventis marketing a Lovenox-Equivalent Product. From July 2010 through September 2011, no third-party competitor was marketing a Lovenox-Equivalent Product; therefore, during that period, Sandoz paid us 45% of the contractual profits from the sale of Enoxaparin Sodium Injection. In September 2011, FDA approved the ANDA for the enoxaparin product of Amphastar Pharmaceuticals, Inc. or Amphastar. In October 2011, Sandoz confirmed that an authorized generic Lovenox-Equivalent Product was being marketed, which meant that Sandoz was obligated to pay us a royalty on its net sales of Enoxaparin Sodium Injection until the contractual profits from those net sales in a product year (July 1June 30) reached a certain threshold. Upon the achievement of the contractual profit threshold in December 2011, Sandoz was obligated to pay us a profit share for the remainder of the product year. In January 2012, following the Court of Appeals for the Federal Circuit granting a
stay of the preliminary injunction previously issued against them by the United States District Court, Watson Pharmaceuticals, Inc. (now Actavis, Inc., or Actavis) and Amphastar launched their third-party competitor enoxaparin product. Consequently, in each product year, for net sales of Enoxaparin Sodium Injection up to a pre-defined sales threshold, Sandoz is obligated to pay us a royalty on net sales payable at a 10% rate, and for net sales above the sales threshold, payable at a 12% rate.
Certain development and legal expenses may reduce the amount of profit-share, royalty and milestone payments paid to us by Sandoz. Any product liability costs and certain other expenses arising from patent litigation may also reduce the amount of profit-share, royalty and milestone payments paid to us by Sandoz, but only up to 50% of these amounts due to us from Sandoz each quarter. Our contractual share of these development and legal expenses is subject to an annual adjustment at the end of each product year, and ends with the product year ending June 2015. The second annual adjustment of $3.9 million was recorded as a reduction in product revenue in the corresponding fiscal year.
In December 2011, we and Baxter entered into the Baxter Agreement under which we agreed to collaborate, on a world-wide basis, on the development and commercialization of up to six biosimilars. The Baxter Agreement became effective in February 2012. Baxter is an established healthcare company with global product development, manufacturing and commercial capabilities. To accelerate efforts in the biosimilars space and address this growing global market, we significantly increased the headcount and related operating expenses dedicated to our biosimilars program in 2012 and expect this trend to continue in 2013. We expect that the increase in operating expenses will be partially offset in future years by revenues from option fees and milestone payments under the Baxter Agreement, subject to achievement of technical and regulatory criteria. We have announced the following three products in development under the Baxter Agreement:
· M923, a biosimilar for a branded biologic indicated for autoimmune and inflammatory diseases, is our most advanced biosimilar. We are working toward a 2014 Investigational New Drug, or IND, submission.
· M834, also indicated for autoimmune and inflammatory diseases. We are working toward achievement of pre-defined minimum development criteria license payments in 2014.
· M511, a monoclonal antibody for oncology. We are working toward achievement of pre-defined minimum development criteria license payments in 2014.
As of March 31, 2013, we had an accumulated deficit of $186.2 million. To date, we have devoted substantially all of our capital resource expenditures to the research and development of our product candidates. In the second half of 2010, we began to derive revenue from our profit share on Sandozs commercial sale of Enoxaparin Sodium Injection. Due to the launch by Actavis and Amphastar of their enoxaparin product in January 2012, our enoxaparin product revenue has significantly decreased and we have been incurring operating losses. We expect that our return to profitability, if at all, will most likely come from the commercialization of our generic Copaxone product, which is subject to FDA approval and litigation that could delay the timing of the launch. Until generic Copaxone is approved, we expect to incur annual operating losses over the next several years as we expand our drug commercialization, development and discovery efforts. Additionally, we plan to continue to evaluate possible acquisitions or licensing of rights to additional technologies, products or assets that fit within our growth strategy. Accordingly, we will need to generate significant revenue to return to profitability.
Financial Operations Overview
Revenue
Our revenue has been primarily derived from our 2003 Sandoz Collaboration and 2006 Sandoz Collaboration. In 2012, we began recognizing revenue under the Baxter Agreement. In the near term, our current and future revenues are dependent upon the continued successful commercialization of Enoxaparin Sodium Injection, license fees and milestone payments earned under the Baxter Agreement and potential profit share payments and milestones from our 2006 Sandoz Collaboration. In the longer term, our revenue growth will depend upon the successful clinical development, regulatory approval and launch of new commercial products and the pursuit of external business development opportunities. We expect that any revenue we generate will fluctuate from quarter to quarter as a result of the amount and timing of revenue we earn under our collaborative or strategic relationships.
Research and Development
Research and development expenses consist of costs incurred in identifying, developing and testing product candidates. These expenses consist primarily of salaries and related expenses for personnel, license fees, consulting fees, nonclinical and clinical trial costs, contract research and manufacturing costs, and the costs of laboratory equipment and facilities. We expense research and development costs as incurred. Due to the variability in the length of time necessary to develop a product, the uncertainties related to the estimated cost of the projects and ultimate ability to obtain governmental approval for commercialization, accurate and meaningful estimates of the ultimate cost to bring our product candidates to market are not available.
Product Programs Complex Generics and Biosimilars
Enoxaparin Sodium InjectionGeneric Lovenox®
Enoxaparin Sodium Injection, our first product to receive marketing approval under an ANDA, is a generic version of Lovenox®. Lovenox is a complex drug consisting of a mixture of polysaccharide chains and is a widely-prescribed low molecular weight heparin, or LMWH, used for the prevention and treatment of DVT and to support the treatment of ACS. Lovenox is distributed worldwide by Sanofi-Aventis U.S. LLC, or Sanofi-Aventis, and is also known outside the United States as Clexane® and Klexane®. Under our 2003 Sandoz Collaboration, we work with Sandoz exclusively to develop, manufacture and commercialize Enoxaparin Sodium Injection in the United States. Sandoz is responsible for funding substantially all of the United States-related Enoxaparin Sodium Injection development, regulatory, legal and commercialization costs, other than legal expenses incurred by each party in connection with the patent suits filed against Teva Pharmaceutical Industries Ltd., or Teva, in December 2010 and Amphastar Pharmaceuticals, Inc., or Amphastar, Actavis, Inc., or Actavis, and International Medical Systems, Ltd. (a wholly owned subsidiary of Amphastar) in September 2011. In these cases, Momenta and Sandoz each bear their own legal expenses.
Sandoz submitted ANDAs in its name to the FDA for Enoxaparin Sodium Injection in syringe and vial forms, seeking approval to market Enoxaparin Sodium Injection in the United States. The ANDA for the syringe form of Enoxaparin Sodium Injection was approved in July 2010 and the ANDA for the vial form of Enoxaparin Sodium Injection was approved in December 2011.
In September 2011, we and Sandoz sued Amphastar, Actavis and International Medical Systems, Ltd. in the United States District Court for the District of Massachusetts for infringement of two of our patents. Also in September 2011, we filed a request for a temporary restraining order and preliminary injunction to prevent Amphastar, Actavis and International Medical Systems, Ltd. from selling their enoxaparin sodium product in the United States. In October 2011, the District Court granted our motion for a preliminary injunction and entered an order enjoining Amphastar, Actavis and International Medical Systems, Ltd. from advertising, offering for sale or selling their enoxaparin product in the United States until the conclusion of a trial on the merits and requiring us and Sandoz to post a security bond of $100 million in connection with the litigation. Amphastar, Actavis and International Medical Systems, Ltd. appealed the decision to the Court of Appeals for the Federal Circuit, or CAFC, and in January 2012, the CAFC stayed the preliminary injunction. In June 2012, Amphastar filed a motion to increase the amount of the security bond, which we and Sandoz have opposed. In August 2012, the CAFC issued a written opinion vacating the preliminary injunction and remanding the case to the District Court, holding that Amphastars use of our patented method for processing Enoxaparin Sodium Injection was protected by the safe harbor from patent infringement under federal patent law, 35 U.S.C. Section 271(e)(1). In September 2012, we filed a petition with the CAFC for rehearing by the full court en banc , which was denied. In January 2013, Amphastar and Actavis filed a motion for summary judgment in the District Court following the decision from the CAFC. The parties will commence briefing and oral arugments are currently scheduled for July 1, 2013. In February 2013, we filed a petition for a writ of certiorari for review of the CAFC decision by the United States Supreme Court and in April 2013 the Supreme Court requested a response from Amphastar which is due May 24, 2013. Review by the Supreme Court is discretionary and certiorari petitions are infrequently granted.
In December 2010, we sued Teva in the United States District Court for the District of Massachusetts for infringement of two of our patents. The patents claim methods of producing enoxaparin having specified quality attributes. In January 2013, Teva filed a motion for summary judgment in the District Court following the decision from the CAFC in the aforementioned case and oral arguments are scheduled for July 1, 2013.
M356Generic Copaxone® (glatiramer acetate injection)
M356 is designed to be a generic version of Copaxone ® (glatiramer acetate injection), a complex drug consisting of a synthetic mixture of polypeptide chains. Copaxone is indicated for the reduction of the frequency of relapses in patients with RRMS, a chronic disease of the central nervous system characterized by inflammation and neurodegeneration. In North America, Copaxone is marketed by Teva Neuroscience, Inc., which is a subsidiary of Teva. Under the Second Sandoz Collaboration Agreement, we and Sandoz AG agreed to exclusively collaborate on the development and commercialization of M356, among other products. Under the Second Sandoz Collaboration Agreement, costs, including development costs and the cost of clinical studies, will be borne by the parties in varying proportions, depending on the type of expense. For M356, we are generally responsible for all of the development costs in the United States. For M356 outside of the United States, we share development costs in proportion to our profit sharing interest. All commercialization responsibilities and costs will be borne by Sandoz AG worldwide as they are incurred for all products. We are reimbursed at cost for any external costs incurred in the development of products where development activities are funded solely by Sandoz AG or partly in proportion where development costs are shared between us and Sandoz AG. We are also paid at a contractually specified rate for FTEs performing development services where development activities are funded solely by Sandoz AG or partly by proportion where development costs are shared between us and Sandoz AG. The parties will share profits in varying proportions, depending on the product. Sandoz AG is responsible for funding all of the legal expenses incurred under the Second Sandoz Collaboration Agreement; however a portion of certain legal expenses will be offset against the profit-sharing amounts in proportion to our profit sharing interest.
In December 2007, Sandoz submitted to the FDA an ANDA seeking approval to market our joint product M356 in the United States containing a Paragraph IV certification. This is a certification by the ANDA applicant that the patent relating to the drug product that is the subject of the ANDA is invalid, unenforceable or will not be infringed. In July 2008, the FDA notified Sandoz that it had accepted the ANDA for review as of December 27, 2007. In addition, the FDAs published database indicates that the first substantially complete ANDA submitted for glatiramer acetate injection containing a Paragraph IV certification was filed on December 27, 2007, making Sandozs ANDA eligible for the grant of a
180-day generic exclusivity period upon approval. Under applicable laws, there are a number of ways an ANDA applicant may forfeit its 180-day exclusivity, including if the applicant fails to achieve at least tentative approval within 30 months after the date on which the ANDA is filed. Because tentative approval for the M356 ANDA was not received in the specified 30 months, the 180-day exclusivity period will be forfeited unless the exception to the forfeiture rule applies. We will not know whether the exception applies unless and until the FDA approves the ANDA. In the event we lose the patent case, we will be precluded from launching our product and we will forfeit the 180-day exclusivity. The review of Sandozs ANDA is ongoing. We and Sandoz are in regular communication with the FDA to address any additional questions or requests that it may have as it continues the review of Sandozs application.
Since 2008, Teva has filed four Citizen Petitions with FDA requesting FDA deny approval of any ANDA filed for generic Copaxone. The FDA has denied each of the Citizen Petitions. We anticipate Teva will continue to engage in activities that seek to challenge the approval of our M356 ANDA.
Subsequent to FDAs acceptance of the ANDA for review, in August 2008, Teva and related entities and Yeda Research and Development Co., Ltd., filed suit against us and Sandoz in the United States Federal District Court in the Southern District of New York. The suit alleges infringement related to four of the seven Orange Book patents listed for Copaxone. We and Sandoz asserted defenses of non-infringement, invalidity and unenforceability and filed counterclaims for declaratory judgments to have all seven of the Orange Book patents as well as two additional patents in the same patent family adjudicated in the present lawsuit. Another company, Mylan Inc., or Mylan, also has an ANDA for generic Copaxone under FDA review. In October 2009, Teva sued Mylan for patent infringement related to the Orange Book patents listed for Copaxone, and in October 2010, the court consolidated the Mylan case with the case against us and Sandoz. A trial on the issue of inequitable conduct occurred in July 2011 and the trial on the remaining issues occurred in September 2011 in the consolidated case. In June 2012, the Court issued its opinion and found all of the claims in the patents to be valid, enforceable and infringed. In July 2012, the Court issued a final order and permanent injunction prohibiting Sandoz and Mylan from infringing all of the patents in the suit. The Orange Book patents and one non-Orange book patent expire in May 2014 and one non-Orange Book patent expires in September 2015. In addition, the permanent injunction further restricts the FDA, pursuant to 35 U.S.C. Section 271(e)(4)(A), from making the effective date of any final approval of the Sandoz or Mylan ANDA prior to the expiration of the Orange Book patents. In July 2012, we appealed the decision to the CAFC, and oral arguments were heard on May 7, 2013.
In December 2009, in a separate action in the same court, Teva sued Sandoz, Novartis AG and us for patent infringement related to certain other non-Orange Book patents after Tevas motion to add those patents to the ongoing Paragraph IV litigation was denied. In January 2010, we and Sandoz filed a motion to dismiss this second suit on several grounds, including the failure of Teva to state an actionable legal claim and lack of subject matter jurisdiction. The motion is pending and oral argument is scheduled for May 13, 2013. We intend to defend this suit.
If the decision in the first suit is not reversed on appeal, or we are not successful in the second suit, the final approval and launch of M356 cannot occur until expiration of the relevant patent rights. Litigation involves many risks and uncertainties, and there is no assurance that Novartis AG, Sandoz or we will prevail in either lawsuit.
Biosimilars Program
We are also applying our technology platform to the development of biosimilar versions of marketed therapeutic proteins, with a goal of obtaining FDA designation as interchangeable. Therapeutic proteins represent a sizable segment of the United States drug market, with sales expected to be approximately $69 billion in 2013, according to Datamonitor. Given the inadequacies of standard technology, many of these therapeutic proteins have not been thoroughly characterized. Most of these products are complex glycoprotein mixtures, consisting of proteins that contain branched sugars that vary from molecule to molecule. These sugars can impart specific biological properties to the therapeutic protein and can often comprise a significant portion of the mass of the molecule. In addition to the structural characterization of several marketed therapeutic proteins, we are also advancing our structure-process capabilities as we further define the relationship between aspects of the manufacturing process and the structural composition of the final protein product. We believe that our investment in our analytics and characterization technology coupled with our investment in the science of better understanding the relationship of the biologic manufacturing process to structural composition provides us with the opportunity develop a competitive advantage for our future biosimilars or interchangeable biologic product candidates.
In December 2011, we and Baxter entered into the Baxter Agreement under which we agreed to collaborate, on a world-wide basis, on the development and commercialization of up to six biosimilars. The Baxter Agreement became effective in February 2012. We have announced the following three products in development under the Baxter Agreement:
· M923, a biosimilar for a branded biologic indicated for autoimmune and inflammatory diseases, is our most advanced biosimilar. We are working toward a 2014 IND submission.
· M834, also indicated for autoimmune and inflammatory diseases. We are working toward achievement of pre-defined minimum development criteria license payments in 2014.
· M511, a monoclonal antibody for oncology. We are working toward achievement of pre-defined minimum development criteria license payments in 2014.
Most protein drugs have been approved by the FDA under the Biologics License Application, or BLA, regulatory pathway. The BLA pathway was created to review and approve applications for biologic drugs that are typically produced from living systems. Until 2010, there was no abbreviated regulatory pathway for the approval of interchangeable or biosimilar versions of BLA-approved products in the United States; however, there have been guidelines for biosimilar products in the European Union for several years.
In March 2010, with the enactment of the Biologics Price Competition and Innovation Act of 2009, or BPCI, an abbreviated pathway for the approval of biosimilars and interchangeable biologics was created. The new abbreviated regulatory pathway establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as interchangeable, based on its similarity to an existing brand product.
Under the BPCI, an application for a biosimilar product cannot be approved by the FDA until 12 years after the original brand product was approved under a BLA. There are many biologics at this time for which this 12-year period has expired or is nearing expiration. We believe that scientific progress in the analysis and characterization of complex mixture drugs is likely to play a significant role in FDAs approval of biosimilar (including interchangeable) biologics in the years to come.
In December 2011, the FDA released its proposed biosimilar user fee program which includes a fee-based meeting process for consultation between applicants and the division of FDA responsible for reviewing biosimilar and interchangeable biologics applications under the new approval pathway. It contemplates well-defined meetings where the applicant can propose and submit analytic, physicochemical and biologic characterization data along with a proposed development plan. The proposed development plan may have a reduced scope of clinical development based on the nature and extent of the characterization data. There are defined time periods for meetings and written advice. In February 2012, the FDA published draft guidance documents for the development and registration of biosimilars and interchangeable biologics. The draft guidance documents indicate that the FDA will consider the totality of the evidence developed by an applicant in determining the nature and extent of the nonclinical and clinical requirements for a biosimilar or interchangeable biologic product.
The new law is complex and is only beginning to be interpreted and implemented by the FDA. As a result, we expect that its ultimate impact, implementation and meaning will be subject to uncertainty for years to come.
Product CandidatesNovel Products
Overview
Our novel products program uses the established characterization and process engineering capabilities from our complex generics and biosimilars programswith a focus on polysaccharides and therapeutic proteins.
M402
M402 is a novel heparan sulfate mimetic that binds to multiple growth factors, adhesion molecules, and chemokines to inhibit tumor angiogenesis, progression, and metastasis. The use of heparins to treat venous thrombosis in cancer patients has generated numerous reports of antitumor activity; however, the dose of these products has been limited by their anticoagulant activity. M402, which is derived from unfractionated heparin, has been engineered to have significantly reduced anticoagulant activity while preserving the relevant antitumor properties of heparin.
Researchers have conducted a series of nonclinical experiments using different pancreatic cancer models to test the hypothesis that M402 can modulate tumor progression and metastasis and enhance the efficacy of gemcitabine, a first-line standard of care chemotherapy treatment for pancreatic cancer. The nonclinical results showed that M402 in combination with gemcitabine prolonged survival and substantially lowered the incidence of metastasis, suggesting that M402 has the potential to complement conventional chemotherapy. We believe that M402s mechanism of action, by binding to multiple heparin binding factors involved in tumor growth and metastasis, creates the potential for M402 to contribute to efficacy in a broad range of cancers.
In April 2012, we initiated a Phase 1/2 proof-of-concept clinical study in patients with advanced metastatic pancreatic cancer. The trial consists of two parts and will evaluate the safety, potential efficacy, pharmacokinetics and pharmacodynamics of M402 in combination with nab-paclitaxel and gemcitabine (nab-paclitaxel was added to the trial design by a protocol amendment in April 2013). Part A is an open-label, multiple ascending dose escalation study. Dose escalation data from Part A are expected during the first half of 2014. Pending successful completion of this phase, we expect to initiate Part B of the trial, which will be a randomized, controlled study investigating the safety and antitumor activity of M402 administered in combination with nab-paclitaxel and gemcitabine, compared with nab-paclitaxel and gemcitabine.
Discovery Program
Many complex diseases are a result of multiple biological activities. We believe our core analytical tools may enable new insights into the biology of many diseases, which could lead to an enhanced understanding of the relative role of different biological targets and related cell-to-cell
signaling pathways. Our goal is to leverage this knowledge and the multi-targeting nature of complex mixture molecules to develop novel products which may positively modulate multiple pathways in a disease.
Sialylation Technology
We are applying our proprietary sialylation technology, a method to add sialic acid to proteins, to modify immunoglobulin G, or IgG, antibodies in IVIG, a drug that is currently used to treat autoimmune and inflammatory disease. Our objective is to further potentiate the anti-inflammatory activities of these antibodies and to potentially develop drugs with differentiated attributes such as enhanced efficacy and/or a wider therapeutic window that address autoimmune and inflammatory diseases. To date, we have made substantial progress in this program by demonstrating that sialylating Fc-linked glycans of IgG antibodies can enhance anti-inflammatory effects in a nonclinical model, consistent with the findings previously published by Dr. Jeffrey Ravetch of The Rockefeller University. In 2013, our first objective is to investigate the biology of sialylated IVIG to inform our selection of the indication to take forward into our initial clinical proof-of-concept trials . Our second objective is to define the product, or products, we will be advancing. We could apply our sialylation technology to develop a sialylated plasma-derived IVIG product, or a recombinant sialylated Fc product. We are investigating both approaches, and expect to have data later this year that will guide our development efforts.
Currently, IVIG is manufactured from large pools of human plasma. Increasing demand for IVIG products already exceeds available supply worldwide thus limiting broader clinical applications. Today, estimated global IVIG sales are $7 billion annually according to Health Advances. IVIG is approved in several indications primarily addressing inflammatory, infectious and immunodeficiency diseases, including primary immunodeficiency disease, idiopathic thrombocytopenic purpura, Kawasaki disease, chronic inflammatory demyelinating polyneuropathy, and multifocal motor neuropathy. IVIG is also being investigated for use in the treatment of Alzheimers disease and other neurological conditions.
General and Administrative
General and administrative expenses consist primarily of salaries and other related costs for personnel in executive, finance, legal, accounting, investor relations, information technology, business development and human resource functions. Other costs include royalty and license fees, facility and insurance costs not otherwise included in research and development expenses and professional fees for legal and accounting services and other general expenses.
Results of Operations
Three Months Ended March 31, 2013 and 2012
Collaboration Revenue
Collaboration revenue includes product revenue and research and development revenue earned under our collaborative arrangements. Product revenue consists of profit share, royalties and commercial milestones earned from Sandoz on sales of Enoxaparin Sodium Injection following its commercial launch in July 2010. During the three months ended March 31, 2013, we earned $5.4 million in royalties on Sandozs net sales of Enoxaparin Sodium Injection of $47 million. During the three months ended March 31, 2012, we earned $22.0 million in part on a profit share and in part on a royalty on Sandozs net sales of Enoxaparin Sodium Injection of $176 million. The decrease in our product revenue of $16.6 million, or 75%, from the 2012 period to the 2013 period is due to a change in the contractual basis of our earned product revenues from hybrid profit share / royalty to straight royalty following the January 2012 launch of a third-party competitors generic Lovenox®, as well as decreased unit sales due to lower market share, and lower prices in response to competitor pricing reductions on enoxaparin.
Research and development revenue consists of amounts earned by us under the 2003 Sandoz Collaboration and 2006 Sandoz Collaboration for reimbursement of research and development services and reimbursement of development costs, amounts earned by us under the 2006 Sandoz Collaboration for amortization of the equity premium, and amounts earned by us under the Baxter Agreement for amortization of an upfront payment. Research and development revenue was $2.2 million for each of the three months ended March 31, 2013 and 2012.
We expect research and development revenue earned by us under the 2003 Sandoz Collaboration and 2006 Sandoz Collaboration will be between $1.0 million and $2.0 million per quarter in 2013 and we will continue to recognize the $13.6 million equity premium under the 2006 Sandoz Collaboration at a rate of $0.3 million per quarter in 2013. We expect to continue to amortize the $33.0 million upfront payment from Baxter as we deliver research and development services for the two licensed biosimilars, with quarterly amortization of approximately $0.7 million in 2013.
There are a number of factors that make it difficult for us to predict the magnitude of future Enoxaparin Sodium Injection product revenue, including the impact of generic competition on the Sandoz market share; the pricing of products that compete with Enoxaparin Sodium Injection and other actions taken by our competitors; the inventory levels of Enoxaparin Sodium Injection maintained by wholesalers, distributors and other customers; the frequency of re-orders by existing customers and the change in estimates for product reserves. Accordingly, our Enoxaparin Sodium Injection product revenue in previous quarters may not be indicative of future Enoxaparin Sodium Injection product revenue. The change in Sandoz contractual payment terms, along with additional generic competition, has caused, and we expect will continue to cause, our future product revenue from Enoxaparin Sodium Injection to be significantly reduced compared to revenues earned during the products exclusivity period.
Research and Development Expense
Research and development expense for the three months ended March 31, 2013 was $22.3 million, compared with $18.6 million for the three months ended March 31, 2012. The increase of $3.7 million, or 20%, from the 2012 period to the 2013 period resulted primarily from increases of $1.7 million in personnel and related costs associated with our headcount growth to support our programs and $1.8 million in process development, manufacturing and third-party research costs related to our biosimilars and novel products programs and clinical trial expenses associated with our M402 Phase 1/2 clinical study.
The lengthy process of securing FDA approval for new drugs requires the expenditure of substantial resources. Any failure by us to obtain, or any delay in obtaining, regulatory approvals would materially adversely affect our product development efforts and our business overall. Accordingly, we cannot currently estimate with any degree of certainty the amount of time or money that we will be required to expend in the future on our product candidates prior to their regulatory approval, if such approval is ever granted. As a result of these uncertainties surrounding the timing and outcome of any approvals, we are currently unable to estimate when, if ever, our product candidates will generate revenues and cash flows.
The following table summarizes the primary components of our research and development external expenditures, including amortization of our intangible assets, for each of our principal commercial and development programs for the three months ended March 31, 2013 and 2012. The figures in the table include project expenditures incurred by us and reimbursed by our collaborative partner, but exclude project expenditures incurred by our collaborative partner. We do not maintain or evaluate, and therefore do not allocate, internal research and development costs on a project-by-project basis. Consequently, we do not analyze internal research and development costs by project in managing our research and development activities. Certain prior period amounts have been reclassified to conform to the current period presentation.
|
|
Research and Development Expense (in thousands) |
|
|||||||
Commercial and Development Programs (Status) |
|
Three Months
|
|
Three Months
|
|
Project Inception to
|
|
|||
|
|
|
|
|
|
|
|
|||
Enoxaparin Sodium Injection (ANDA approved July 2010) |
|
$ |
306 |
|
$ |
468 |
|
$ |
51,829 |
|
M356 (ANDA Filed) |
|
629 |
|
1,607 |
|
45,191 |
|
|||
M402 (Phase 1/2) |
|
1,035 |
|
593 |
|
15,440 |
|
|||
Biosimilars (Development) |
|
3,534 |
|
602 |
|
14,972 |
|
|||
Discovery programs |
|
392 |
|
256 |
|
|
|
|||
Research and development internal costs |
|
16,436 |
|
15,036 |
|
|
|
|||
|
|
|
|
|
|
|
|
|||
Total research and development expense |
|
$ |
22,332 |
|
$ |
18,562 |
|
|
|
|
The decrease of $0.2 million in external expenditures for Enoxaparin Sodium Injection from the 2012 period to the 2013 period was due to manufacturing activities assumed by Sandoz. The decrease of $1.0 million in M356 external expenditures from the 2012 period to the 2013 period was primarily due to timing of process development activities, manufacturing and third-party research costs. The increase of $0.4 million in M402 external expenditures from the 2012 period to the 2013 period was principally due to costs incurred in connection with our Phase 1/2 proof-of-concept clinical study. The increase of $2.9 million in biosimilars external expenditures from the 2012 period to the 2013 period was due to the timing of process development and third-party research costs to fund the build-out of our biologics infrastructure to support product development under our Baxter collaboration. Discovery program external expenditures increased by $0.1 million from the 2012 period to the 2013 period as due to funding of our sialylation technology program.
Research and development internal costs consist of compensation and other expense for research and development personnel, supplies and materials, facility costs and depreciation. The increase of $1.4 million from the 2012 period to the 2013 period was due to additional research and development headcount and related costs in support of our development programs.
General and Administrative
General and administrative expense for the three months ended March 31, 2013 was $9.7 million, compared to $11.0 million for the three months ended March 31, 2012. General and administrative expense decreased by $1.3 million, or 12%, from the 2012 period to the 2013 period due to decreases of $0.7 million in professional fees principally due to decreased legal fees relating to Enoxaparin Sodium Injection patent litigation and $0.7 million in royalty fees payable primarily to Massachusetts Institute of Technology, or M.I.T., due to reduced Enoxaparin Sodium Injection product revenue. These decreases were partially offset by an increase of $0.1 million in other professional fees.
Interest Income
Interest income on available-for-sale marketable securities was $0.3 million for each of the three months ended March 31, 2013 and 2012.
Other Income
Other income was $0.1 million and zero for the three months ended March 31, 2013 and 2012, respectively. The increase of $0.1 million from the 2012 period to the 2013 period was due to the commencement of income recognition related to a job creation tax award in the fourth quarter of 2012.
Liquidity and Capital Resources
We have financed our operations since inception primarily through the sale of equity securities, payments from our 2003 Sandoz Collaboration and 2006 Sandoz Collaboration, including profit share/royalty payments related to sales of Enoxaparin Sodium Injection, and borrowings from our lines of credit and capital lease obligations. Since our inception, we have received $406 million through private and public issuance of equity securities. As of March 31, 2013, we had received a cumulative total of $562 million from our 2003 Sandoz Collaboration and 2006 Sandoz Collaboration, a $33.0 million upfront payment under the Baxter Agreement, $4.0 million from debt financing, $9.2 million from capital lease obligations and $3.2 million from our landlord for leasehold improvements related to our corporate facility and additional funds from interest income. The January 2012 launch of a third-party competitors enoxaparin product triggered a change under the terms of our agreement with Sandoz in the basis of our product revenue from profit share to a royalty-based on Sandozs net sales of Enoxaparin Sodium Injection. This competition and the resulting contractual change has resulted in us incurring operating losses. We expect that our return to profitability, if at all, will most likely come from the commercialization of our generic Copaxone product, which is subject to FDA approval and litigation that could delay FDA approval. We expect to finance our current programs and planned operating requirements principally through our current cash, cash equivalents and marketable securities. We believe that these funds will be sufficient to meet our operating requirements through at least 2015. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and other important factors, and actual results could vary materially. We may, from time to time, seek additional funding through a combination of new collaborative agreements, strategic alliances and additional equity and debt financings or from other sources.
At March 31, 2013, we had $324.2 million in cash, cash equivalents and marketable securities and $5.4 million in accounts receivable. In addition, we also held approximately $20.0 million in restricted cash, of which $17.5 million serves as collateral for a security bond posted in the litigation against Actavis, Amphastar and International Medical Systems, Ltd. Our funds at March 31, 2013 were primarily invested in senior debt of government-sponsored enterprises, commercial paper, corporate debt securities and United States money market funds, directly or through managed funds, with remaining maturities of 24 months or less. Our cash is deposited in and invested through highly rated financial institutions in North America. The composition and mix of cash, cash equivalents and marketable securities may change frequently as a result of our evaluation of conditions in the financial markets, the maturity of specific investments, and our near term liquidity needs. We do not believe that our cash equivalents and marketable securities were subject to significant market risk at March 31, 2013.
During the three months ended March 31, 2013, our operating activities used cash of $15.6 million. During the three months ended March 31, 2012, our operating activities provided cash of $41.7 million. The cash provided by or used in operating activities generally approximates our net loss adjusted for non-cash items and changes in operating assets and liabilities.
For the three months ended March 31, 2013, our net loss adjusted for non-cash items was $18.3 million. For the three months ended March 31, 2013, non-cash items include share-based compensation of $2.9 million, depreciation and amortization of our property, equipment and intangible assets of $2.0 million and amortization of purchased premiums on our marketable securities of $0.8 million. In addition, the net change in our operating assets and liabilities provided cash of $2.8 million and resulted from: a decrease in accounts receivable of $5.4 million due to decreased unit sales resulting from to lower market share and lower prices in response to aggressive competitor pricing reductions; an increase in unbilled revenue of $0.4 million, due to higher reimbursable manufacturing activities for our M356 program; a decrease in prepaid expenses and other current assets of $1.3 million, primarily due to the receipt of a $1.1 million job creation tax award in the first quarter; a decrease in accrued expenses of $2.3 million primarily due to the payment of annual bonuses earned during 2012 and the timing of accrued payroll-related liabilities; a decrease in deferred revenue of $1.0 million, primarily due to the amortization of revenue related to the $33.0 million upfront payment made to us by Baxter in 2012 under our collaboration; and a decrease in other current liabilities of $0.1 million due to straight-line rent expense related to one of our facilities.
For the three months ended March 31, 2012, our net loss adjusted for non-cash items was $0.3 million. For the three months ended March 31, 2012, non-cash items include share-based compensation of $3.3 million, depreciation and amortization of our property, equipment and intangible assets of $1.5 million and amortization of purchased premiums on our marketable securities of $0.5 million. In addition, the net change in our operating assets and liabilities provided cash of $41.4 million and resulted from: a decrease in accounts receivable of $5.8 million, due to a contractual change in the basis of our Enoxaparin Sodium Injection product revenue from hybrid profit share / royalty to a straight royalty after January 2012, decreased unit sales due to lower market share, as well as lower prices in response to aggressive competitor pricing reductions; a decrease in unbilled revenue of $1.7 million, due to lower reimbursable manufacturing activities for our M356 program; an increase in prepaid expenses and other current assets of $0.5 million, primarily due to advance payments made for renewals of vendor maintenance agreements; an increase in accounts payable of $4.7 million, primarily due to the timing of payments to vendors for leasehold improvements and purchases of laboratory equipment; a decrease in accrued expenses of $2.3 million resulting from the payment of annual bonuses earned during 2011 and the timing of manufacturing activities for our M356 program; and an increase in deferred revenue of $31.9 million, primarily due to the receipt of a $33.0 million upfront payment made to us by Baxter in 2012 under our collaboration.
During the three months ended March 31, 2013, our investing activities provided cash of $5.0 million. In the three months ended March 31, 2013, we received $110.8 million from maturities of marketable securities and $3.8 million from sales of marketable securities. Additionally, during the first three months of 2013, we used $108.8 million of cash to purchase marketable securities and $0.8 million for the purchase of laboratory equipment and leasehold improvements.
During the three months ended March 31, 2012, our investing activities used cash of $53.0 million. In the three months ended March 31, 2012, we used $189.4 million of cash to purchase marketable securities and we received $144.5 million from maturities of marketable securities. During the first three months of 2012, we used $6.1 million for the purchase of laboratory equipment for our biosimilar and novel products programs and $2.1 million for leasehold improvements, furniture and computer equipment related to additional leased laboratory and office space.
During the three months ended March 31, 2013 and 2012, financing activities provided cash of $0.9 million and $0.7 million, respectively, in the form of net proceeds from stock option exercises and purchases of shares of our common stock through our employee stock purchase plan.
Contractual Obligations
Our major outstanding contractual obligations relate to license maintenance obligations including royalties payable to third parties and operating lease obligations. In February 2013, we and BMR-Rogers Street LLC entered into a lease agreement pursuant to which we will lease approximately 105,000 square feet of office and laboratory space located in the basement and first and second floors at 320 Bent Street, Cambridge, Massachusetts beginning on September 1, 2013 and ending on August 31, 2016. Annual rental payments due under this lease agreement will be approximately $2.0 million during 2013, $6.1 million during 2014, $6.2 million during 2015 and $4.2 million during 2016. In addition, we will be required to provide a security deposit in cash or in the form of a letter of credit in the amount of $0.7 million.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations are based on our consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of revenues and expenses during the reporting periods. Additionally, we are required to make estimates and judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities as of the balance sheet dates. On an on-going basis, we evaluate our estimates and judgments, including those related to revenue recognition, accrued expenses and share-based payments. We base our estimates on historical experience, known trends and events and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Please read Part II, Item 7 Managements Discussion and Analysis of Financial Condition and Results of Operations of our Annual Report on Form 10-K for the year ended December 31, 2012 for a discussion of our critical accounting policies and estimates.
Item 3. Quantitative and Qualitative Disclosures about Market Risk.
We are exposed to market risk related to changes in interest rates. Our current investment policy is to maintain an investment portfolio consisting mainly of United States money market, government-secured, and high-grade corporate securities, directly or through managed funds, with maturities of twenty-four months or less. Our cash is deposited in and invested through highly rated financial institutions in North America. Our marketable securities are subject to interest rate risk and will fall in value if market interest rates increase. However, due to the conservative nature of our investments, low prevailing market rates and relatively short effective maturities of debt instruments, interest rate risk is mitigated. If market interest rates were to increase immediately and uniformly by 10% from levels at March 31, 2013, we estimate that the fair value of our investment portfolio would decline by an immaterial amount. We do not own derivative financial instruments in our investment portfolio. Accordingly, we do not believe that there is any material market risk exposure with respect to derivative, foreign currency or other financial instruments that would require disclosure under this item.
Item 4. Controls and Procedures.
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2013. The term disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by the company in the reports that it files or submits under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commissions rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Securities Exchange Act of 1934, as amended, is accumulated and communicated to the companys management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Our management recognizes that any controls and procedures, no matter how well designed and
operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that, as of March 31, 2013, our disclosure controls and procedures were effective at the reasonable assurance level.
No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934, as amended) occurred during the three months ended March 31, 2013 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
On August 28, 2008, Teva and related entities, or Teva, and Yeda Research and Development Co., Ltd., or Yeda, filed suit against us and Sandoz in the United States Federal District Court in the Southern District of New York in response to the filing by Sandoz of the ANDA with a Paragraph IV certification for M356. The suit alleges infringement related to four of the seven Orange Book patents listed for Copaxone and seeks declaratory and injunctive relief that would prohibit the launch of our product until the last to expire of these patents. We and Sandoz asserted defenses of non-infringement, invalidity and unenforceability and filed counterclaims for declaratory judgments to have all seven of the Orange Book patents as well as two additional patents in the same patent family adjudicated in the present lawsuit. Another company, Mylan Inc., or Mylan, also has an ANDA for generic Copaxone under FDA review. In October 2009, Teva sued Mylan for patent infringement related to the Orange Book patents listed for Copaxone, and in October 2010, the Court consolidated the Mylan case with the case against us and Sandoz. A trial on the issue of inequitable conduct occurred in July 2011 and the trial on the remaining issues occurred in September 2011 in the consolidated case. In June 2012, the Court issued its opinion and found all of the claims in the patents to be valid, enforceable and infringed. In July 2012, the Court issued a final order and permanent injunction prohibiting Sandoz and Mylan from infringing all of the patents in the suit. The Orange Book patents and one non-Orange book patent expire in May 2014 and one non-Orange Book patent expires in September 2015. In addition, the permanent injunction further restricts the FDA, pursuant to 35 U.S.C. section 271(e)(4)(A), from making the effective date of any final approval of the Sandoz or Mylan ANDA prior to the expiration of the Orange Book patents. In July 2012, we appealed the decision to the CAFC, and oral arguments were heard on May 7, 2013.
On December 10, 2009, in a separate action in the same court, Teva sued Sandoz, Novartis AG and us for patent infringement related to certain other non-Orange Book patents seeking declaratory and injunctive relief that would prohibit the launch of our product until the last to expire of these patents as well as damages in the event that Sandoz has launched the product. In January 2010, we and Sandoz filed a motion to dismiss this second suit on several grounds, including the failure of Teva to state an actionable legal claim and lack of subject matter jurisdiction. The motion is pending and oral argument is scheduled for May 13, 2013. We intend to defend this suit.
If the decision in the first suit is not reversed on appeal, or we are not successful in the second suit, the final approval and launch of M356 cannot occur until expiration of the relevant patent rights. Litigation involves many risks and uncertainties, and there is no assurance that Novartis AG, Sandoz or we will prevail in either lawsuit.
On September 21, 2011, we and Sandoz sued Amphastar, Actavis, and International Medical Systems, Ltd. (a wholly owned subsidiary of Amphastar) in the United States District Court for the District of Massachusetts for infringement of two of our patents. Also in September, 2011, we filed a request for a temporary restraining order and preliminary injunction to prevent Amphastar, Actavis and International Medical Systems, Ltd. from selling their enoxaparin product in the United States. In October 2011, the District Court granted our motion for a preliminary injunction and entered an order enjoining Amphastar, Actavis and International Medical Systems, Ltd. from advertising, offering for sale or selling their enoxaparin sodium product in the United States until the conclusion of a trial on the merits and required us and Sandoz to post a security bond of $100 million in connection with the litigation. Amphastar, Actavis and International Medical Systems, Ltd. appealed the decision to the CAFC, and in January 2012, the CAFC stayed the preliminary injunction. In June 2012, Amphastar filed a motion to increase the amount of the security bond, which we and Sandoz have opposed. In August 2012, the CAFC issued a written opinion vacating the preliminary injunction and remanding the case to the District Court. In September 2012, we filed a petition with the CAFC for rehearing by the full court en banc , which was denied. In January 2013, Amphastar and Actavis filed a motion for summary judgment in the District Court following the decision from the CAFC. The parties will commence briefing and oral arguments are scheduled for July 1, 2013. In February 2013, we filed a petition for a writ of certiorari for review of the CAFC decision by the United States Supreme Court and in April 2013 the Supreme Court requested a response from Amphastar due May 24, 2013. Review by the Supreme Court is discretionary and certiorari petitions are infrequently granted.
While we intend to vigorously prosecute this action against Actavis and Amphastar, and we believe that we can ultimately prove our case in court, this suit could last a number of years. As a result, potential recovery of lost profits and damages could await a final judgment after an appeal of a District Court decision. Litigation involves many risks and uncertainties, and there is no assurance that we or Sandoz will prevail in this patent enforcement suit.
Investing in our stock involves a high degree of risk. You should carefully consider the risks and uncertainties and other important factors described below in addition to other information included or incorporated by reference in this Quarterly Report on Form 10-Q before purchasing our stock. If any of the following risks actually occur, our business, financial condition or results of operations would likely suffer.
Risks Relating to Our Business
We have incurred a cumulative loss since inception. If we do not generate significant revenue, we may not return to profitability.
We have incurred significant losses since our inception in May 2001. At March 31, 2013, our accumulated deficit was $186.2 million. We may incur annual operating losses over the next several years as we expand our drug commercialization, development and discovery efforts. In addition, we must successfully develop and obtain regulatory approval for our other drug candidates, and effectively manufacture, market and sell any drugs we successfully develop. Accordingly, we may not generate significant revenue in the longer term and, even if we do generate significant revenue, we may never achieve long term-profitability.
To be profitable, we and our collaborative partners must succeed in developing and commercializing drugs with significant market potential. This will require us and our collaborative partners to be successful in a range of challenging activities: developing product candidates; obtaining regulatory approval for product candidates through either existing or new regulatory approval pathways; clearing allegedly infringing patent rights; enforcing our patent rights; and manufacturing, distributing, marketing and selling products. Our potential profitability will also be adversely impacted by the entry of competitive products and, if so, the degree of the impact could be effected by whether the entry is before or after the launch of our products. We may never succeed in these activities and may never generate revenues that are significant.
Our current product revenue is dependent on the continued successful manufacture and commercialization of Enoxaparin Sodium Injection.
Our near-term ability to generate product revenue depends, in large part, on the continued successful commercialization of Enoxaparin Sodium Injection. This further depends, in large part, on Sandozs continued ability to manufacture and commercialize the product, maintain market share and compete with Lovenox brand competition as well as other generic competition.
Sandoz is facing increasing competition and pricing pressure from currently-approved generic competitors, which has and will continue to impact Sandoz net sales of Enoxaparin Sodium Injection, which will therefore impact our product revenue. Furthermore, other competitors may in the future receive approval to market generic enoxaparin products which will further impact product revenue to us.
Under these circumstances, the resulting market price for our Enoxaparin Sodium Injection product has decreased and may decrease further, and we have lost market share and may continue to lose market share for Enoxaparin Sodium Injection. All of this may further impact our revenue from Enoxaparin Sodium Injection and, as a result, our business, including our near-term financial results and our ability to fund future discovery and development programs, may suffer.
As a result of the District Court ruling in the ongoing patent litigation with Teva, absent a Court of Appeals decision in our favor, we may not be able to launch M356, if approved by the FDA, until September 2015.
In July 2012, the District Court issued a final order and permanent injunction prohibiting Sandoz and Mylan from infringing all of the patents in the suit. The Orange Book patents and one non-Orange book patent expire in May 2014 and one non-Orange Book patent expires in September 2015. In addition, the permanent injunction further restricts the FDA from making the effective date of any final approval of the Sandoz or Mylan ANDA prior to the expiration of the Orange Book patents. In July 2012, we appealed the decision to the Court of Appeals for the Federal Circuit and oral arguments were heard on May 7, 2013.
We and Sandoz intend to pursue this appeal and defend the other Copaxone-related litigation. However, if the decision is not reversed on appeal, then the final approval and launch of M356 cannot occur until expiration of the relevant patent rights, which could impair our ability to commercialize M356 and our business could be materially harmed.
If our patent litigation against Amphastar or Teva related to Enoxaparin Sodium Injection is not successful, we may be liable for damages. In addition, third parties may be able to commercialize a generic Lovenox product without risk of patent infringement damages, and our business may be materially harmed.
If we are not successful in the patent litigation against Amphastar and Actavis and do not succeed in obtaining injunctive relief or damages, the reduction in our revenue stream will be permanent and our ability to fund future discovery and development programs may suffer. Furthermore, in the event that we are not successful in appealing the CAFC decision and we lose the case in the District Court, and Amphastar and Actavis are able to prove they suffered damages as a result of the preliminary injunction having been in effect, then we could be liable for such
damages for up to $35 million of the security bond. This amount may be increased if Amphastar and Actavis are successful in their motion to increase the amount of the security bond.
In addition, if we are not successful in the patent case against Teva and do not succeed in obtaining injunctive relief, or damages for our lost profits due to infringing sales, and if Teva receives marketing approval, it will be able to commercialize a generic Lovenox. Under these circumstances, the resulting market price for our Enoxaparin Sodium Injection product may be lower and we may lose significant market share for Enoxaparin Sodium Injection. Consequently, our revenue would be reduced and our business, including our near-term financial results and our ability to fund future discovery and development programs, may suffer.
If efforts by manufacturers of branded products to delay or limit the use of generics or biosimilars are successful, our sales of generic and biosimilar products may suffer.
Many manufacturers of branded products have increasingly used legislative, regulatory and other means to delay regulatory approval and competition from manufacturers of generic drugs and could be expected to use similar tactics to delay competition from biosimilars. These efforts have included:
· settling patent lawsuits with generic or biosimilar companies, resulting in such patents remaining an obstacle for generic or biosimilar approval by others;
· settling paragraph IV patent litigation with generic companies to prevent the expiration of the 180-day generic marketing exclusivity period or to delay the triggering of such exclusivity period;
· submitting Citizen Petitions to request the FDA Commissioner to take administrative action with respect to prospective and submitted generic drug or biosimilar applications;
· appealing denials of Citizen Petitions in United States federal district courts and seeking injunctive relief to reverse approval of generic drug or biosimilar applications;
· conducting medical education with physicians, payors and regulators that claim that generic or biosimilar products are too complex for generic or biosimilar approval and influence potential market share;
· seeking state law restrictions on the substitution of generic and biosimilar products at the pharmacy without the intervention of a physician;
· seeking federal or state regulatory restrictions on the use of the same non-proprietary name as the reference brand product for a biosimilar or interchangeable biologic;
· seeking changes to the United States Pharmacopeia, an industry recognized compilation of drug and biologic standards;
· pursuing new patents for existing products or processes which could extend patent protection for a number of years or otherwise delay the launch of generic drugs or biosimilars; and
· attaching special patent extension amendments to unrelated federal legislation.
The FDAs practice is to rule within 180 days on Citizen Petitions that seek to prevent approval of an ANDA if the petition was filed after the Medicare Prescription Drug Improvement and Modernization Act of 2003, or MMA. If, at the end of the 180-day period, the ANDA is not ready for approval or rejection, then the FDA has typically denied and dismissed the petition without acting on the petition. Teva Neuroscience, Inc. has filed several Citizen Petitions regarding M356, all of which have been denied and dismissed. However, Teva may seek to file future petitions and may also seek reversal of the denial of a Citizen Petition in federal court. Other third parties may also file Citizen Petitions requesting that the FDA adopt specific approval standards for generic or biosimilar products. If the FDA grants future Citizen Petitions, we and Sandoz may be delayed in obtaining, or potentially unable to obtain, approval of the ANDA for M356 which would materially harm our business.
Further, some manufacturers of branded products have engaged in state-by-state initiatives to enact legislation that restricts the substitution of some branded drugs with generic drugs. If these efforts to delay or block competition are successful, we may be unable to sell our generic products, which could have a material adverse effect on our sales and profitability.
If other generic versions of our product candidates, including M356, are approved and successfully commercialized, our business would suffer.
We expect that certain of our product candidates may face intense and increasing competition from other manufacturers of generic and/or branded products. For example, in September 2009, Mylan announced that the FDA had accepted for filing its ANDA for generic Copaxone and in 2011 Synthon announced that it submitted an ANDA to the FDA for a generic Copaxone. Furthermore, as patents for branded products and related exclusivity periods expire, manufacturers of generic products may receive regulatory approval for generic equivalents and may be able to achieve significant market penetration. As this happens, or as branded manufacturers launch authorized generic versions of such products, market share, revenues and gross profit typically decline, in some cases, dramatically. If any of our generic product offerings, including M356, enter markets with a number of competitors, we may not achieve significant market share, revenues or gross profit. In addition, as other generic products are introduced to the markets in which we participate, the market share, revenues and gross profit of our generic products could decline.
If the market for a reference brand product, such as Copaxone, significantly declines, sales or potential sales of our generic and biosimilars product and product candidates may suffer and our business would be materially impacted.
Competition in the biotechnology industry is intense. Brand name products face competition on numerous fronts as technological advances are made or new products are introduced. As new products are approved that compete with the reference brand product to our generic product and generic or biosimilar product candidates, such as Copaxone, sales of the reference brand products may be significantly and adversely impacted and may render the reference brand product obsolete. In addition, brand companies may pursue life cycle management strategies that also impact our generic products.
We anticipate current injectable treatments commonly used to treat multiple sclerosis, including Copaxone, to experience competition from a number of novel drug products, including oral therapies. These novel drugs may offer patients a more convenient form of administration than Copaxone and may provide increased efficacy. In addition, in anticipation of increasing competition, Teva announced its plans to submit a Supplemental NDA to the FDA for marketing approval of a 3-times a week dose of Copaxone. If Tevas formulation is approved, this formulation would compete with our M356 product, if approved.
If the market for the reference brand product is impacted, we in turn may lose significant market share or market potential for our generic or biosimilar products and product candidates, and the value for our generic or biosimilar pipeline could be negatively impacted. As a result, our business, including our financial results and our ability to fund future discovery and development programs, would suffer.
If the raw materials, including unfractionated heparin, or UFH, used in our products become difficult to obtain, significantly increase in cost or become unavailable, we may be unable to produce our products and this would have a material adverse impact on our business.
We and our collaborative partners and vendors obtain certain raw materials, including UFH, from suppliers who in turn source the materials from other countries, including four suppliers in China. In 2008, due to the occurrence of adverse events associated with the use of UFH, there were global recalls of UFH products, including in the United States, putting our supply chain at risk. Based on investigation by the FDA into those adverse events, the FDA identified a heparin-like contaminant in the implicated UFH products and recommended that manufacturers and suppliers of UFH use additional tests to screen their UFH active pharmaceutical ingredient. We and our collaborative partner worked with the appropriate regulatory authorities to document and to demonstrate that our testing standards meet or exceed all requirements for testing and screening the supply of UFH active pharmaceutical ingredient. The FDA and other authorities have also placed restrictions on the import of some raw materials from China, and may in the future place additional restrictions and testing requirements on the use of raw materials, including UFH, in products intended for sale in the United States. As a result, the raw materials, including UFH, used in our products may become difficult to obtain, significantly increase in cost, or become unavailable to us. If any of these events occur, we and our collaborative partners may be unable to produce our products in sufficient quantities to meet the requirements for the commercial launch or demand for the product, which would have a material adverse impact on our business.
If we or our collaborative partners and other third parties are unable to satisfy FDA quality standards and related regulatory requirements, experience manufacturing difficulties or are unable to manufacture sufficient quantities of our products or product candidates, our development and commercialization efforts may be materially harmed.
We have limited personnel with experience in, and we do not own facilities for, manufacturing any products. We depend upon our collaborative partners and other third parties to provide raw materials meeting FDA quality standards and related regulatory requirements, manufacture the drug substance, produce the final drug product and provide certain analytical services with respect to our products and product candidates, including Enoxaparin Sodium Injection. We, our collaborative partners or our third-party contractors may have difficulty meeting FDA manufacturing requirements, including, but not limited to, reproducibility, validation and scale-up, and continued compliance with current good manufacturing practices requirements. In addition, events such as the contamination of UFH may have an adverse impact on the supply of starting or raw materials for some of our products and product candidates, and we, our collaborative partners or our third-party contractors may have difficulty producing products in the quantities necessary to meet FDA requirements or meet anticipated market demand. If we, our collaborative partners or our third-party manufacturers or suppliers are unable to satisfy the FDA manufacturing requirements for our products and product candidates, or are unable to produce our products in sufficient quantities to meet the requirements for the launch of the product or to meet market demand, our revenue and gross margins could be adversely affected, and could have a material adverse impact on our business.
Competition in the biotechnology and pharmaceutical industries is intense, and if we are unable to compete effectively, our financial results will suffer.
The markets in which we intend to compete are undergoing, and are expected to continue to undergo, rapid and significant technological change. We expect competition to intensify as technological advances are made or new biotechnology products are introduced. New developments by competitors may render our current or future product candidates and/or technologies non-competitive, obsolete or not economical. Our competitors products may be more efficacious or marketed and sold more effectively than any of our products.
Many of our competitors have:
· significantly greater financial, technical and human resources than we have at every stage of the discovery, development, manufacturing and commercialization process;
· more extensive experience in commercializing generic drugs, conducting nonclinical studies, conducting clinical trials, obtaining regulatory approvals, challenging patents and manufacturing and marketing pharmaceutical products;
· products that have been approved or are in late stages of development; and
· collaborative arrangements in our target markets with leading companies and/or research institutions.
If we successfully develop and obtain approval for our drug candidates, we will face competition based on many different factors, including:
· the safety and effectiveness of our products;
· with regard to our generic or biosimilar product candidates, the differential availability of clinical data and experience and willingness of physicians, payors and formularies to rely on biosimilarity data;
· the timing and scope of regulatory approvals for these products and regulatory opposition to any product approvals;
· the availability and cost of manufacturing, marketing, distribution and sales capabilities;
· the effectiveness of our marketing, distribution and sales capabilities;
· the price of our products;
· the availability and amount of third-party reimbursement for our products; and
· the strength of our patent position.
Our competitors may develop or commercialize products with significant advantages in regard to any of these factors. Our competitors may therefore be more successful in commercializing their products than we are, which could adversely affect our competitive position and business.
If we or our collaborators are unable to establish and maintain key customer distribution arrangements, sales of our products, and therefore revenue, would decline.
Generic pharmaceutical products are sold through various channels, including retail, mail order, and to hospitals through group purchasing organizations, or GPOs. As Enoxaparin Sodium Injection is primarily a hospital-based product, a large percentage of the revenue for Enoxaparin Sodium Injection is derived through contracts with GPOs. Currently, a relatively small number of GPOs control a substantial portion of generic pharmaceutical sales to hospital customers. In order to establish and maintain contracts with these GPOs, we believe that we, in collaboration with Sandoz, will need to maintain adequate drug supplies, remain price competitive, comply with FDA regulations and provide high-quality products. The GPOs with whom we or our collaborators have established contracts may also have relationships with our competitors and may decide to contract for or otherwise prefer products other than ours, limiting access of Enoxaparin Sodium Injection to certain hospital segments. Our sales could also be negatively affected by any rebates, discounts or fees that are required by our customers, including the GPOs, wholesalers, distributors, retail chains or mail order services, to gain and retain market acceptance for our products. We anticipate that M356 will be primarily distributed through retail channels and mail order services. If we or our collaborators are unable to establish and maintain distribution arrangements with all of these customers, sales of our products, our revenue and our profits would suffer.
Even if we receive approval to market our product candidates, the market may not be receptive to our product candidates upon their commercial introduction, which could adversely affect our ability to generate sufficient revenue from product sales to maintain or grow our business.
Even if our product candidates are successfully developed and approved for marketing, our success and growth will also depend upon the acceptance of our products by patients, physicians and third-party payors. Acceptance of our products will be a function of our products being clinically useful, being cost effective and demonstrating superior therapeutic effect with an acceptable side effect profile as compared to existing or future treatments. In addition, even if our products achieve market acceptance, we may not be able to maintain that market acceptance over time.
Factors that we believe will materially affect market acceptance of our product candidates under development include:
· the timing of our receipt of any marketing approvals, the terms of any approval and the countries in which approvals are obtained;
· the safety, efficacy and ease of administration of our products;
· the competitive pricing of our products;
· physician confidence in the safety and efficacy of complex generic products or biosimilars;
· the success and extent of our physician education and marketing programs;
· the clinical, medical affairs, sales, distribution and marketing efforts of competitors; and
· the availability and amount of government and third-party payor reimbursement.
If our products do not achieve market acceptance, we will not be able to generate sufficient revenue from product sales to maintain or grow our business.
We will require substantial funds and may require additional capital to execute our business plan and, if additional capital is not available, we may need to limit, scale back or cease our operations.
As of March 31, 2013, we had cash, cash equivalents and marketable securities totaling $324.2 million. For the three months ended March 31, 2013, we had a net loss of $24.1 million and cash used in operating activities of $15.6 million. We will continue to require substantial funds to conduct research and development, process development, manufacturing, nonclinical testing and clinical trials of our product candidates, as well as funds necessary to manufacture and market products that are approved for commercial sale. Because successful development of our drug candidates is uncertain, we are unable to estimate the actual funds we will require to complete research and development and commercialize our products under development. Our future capital requirements may vary depending on the following:
· the level of sales of Enoxaparin Sodium Injection;
· a final decision, after appeal, is issued in favor of Teva in its patent infringement litigation matters against us;
· the advancement of our product candidates and other development programs, including the timing and costs of obtaining regulatory approvals;
· the advancement of our biosimilar product candidates and receipt of license and milestone payments under our Baxter Agreement;
· the timing of FDA approval of the products of our competitors;
· the cost of litigation, including with Amphastar and Actavis relating to enoxaparin, that is not otherwise covered by our collaboration agreement, or potential patent litigation with others, as well as any damages, including possibly treble damages, that may be owed to third parties should we be unsuccessful in such litigation;
· the ability to enter into strategic collaborations;
· the continued progress in our research and development programs, including completion of our nonclinical studies and clinical trials;
· the potential acquisition and in-licensing of other technologies, products or assets; and
· the cost of manufacturing, marketing and sales activities, if any.
We expect to finance our current programs and planned operating requirements principally through our current cash, cash equivalents and marketable securities. We believe that these funds will be sufficient to meet our operating requirements through at least 2015. We may seek additional funding in the future and intend to do so through collaborative arrangements and public or private equity and debt financings or from other sources. Any additional capital raised through the sale of equity may dilute existing investors percentage ownership of our common stock. Capital raised through debt financing would require us to make periodic interest payments and may impose potentially restrictive covenants on the conduct of our business. Additional funds may not be available to us on acceptable terms or at all. In addition, the terms of any financing may adversely affect the holdings or the rights of our stockholders. If we are unable to obtain funding on a timely basis, we may be required to significantly curtail one or more of our research or development programs. We also could be required to seek funds through arrangements with collaborators or others that may require us to relinquish rights to some of our technologies, product candidates or products which we would otherwise pursue on our own.
If we are not able to retain our current management team or attract and retain qualified scientific, technical and business personnel, our business will suffer.
We are dependent on the members of our management team for our business success. Our employment arrangements with our executive officers are terminable by either party on short notice or no notice. We do not carry life insurance on the lives of any of our personnel. The loss of any of our executive officers would result in a significant loss in the knowledge and experience that we, as an organization, possess and could cause significant delays, or outright failure, in the development and approval of our product candidates. In addition, there is intense competition from numerous pharmaceutical and biotechnology companies, universities, governmental entities and other research institutions, for human resources, including management, in the technical fields in which we operate, and we may not be able to attract and retain qualified personnel necessary for the successful development and commercialization of our product candidates.
There is a substantial risk of product liability claims in our business. If our existing product liability insurance is insufficient, a product liability claim against us that exceeds the amount of our insurance coverage could adversely affect our business.
Our business exposes us to significant potential product liability risks that are inherent in the development, manufacturing and marketing of human therapeutic products. Product liability claims could delay or prevent completion of our development programs. If we succeed in marketing products, such claims could result in a recall of our products or a change in the approved indications for which they may be used. While we currently maintain product liability insurance coverage that we believe is adequate for our current operations, we cannot be sure that such coverage will be adequate to cover any incident or all incidents. Furthermore, clinical trial and product liability insurance is becoming increasingly expensive. As a result, we may be unable to maintain sufficient insurance at a reasonable cost to protect us against losses that could have a material adverse effect on our business. These liabilities could prevent or interfere with our product development and commercialization efforts.
As we evolve from a company primarily involved in drug discovery and development into one that is also involved in the commercialization of pharmaceutical products, we may have difficulty managing our growth and expanding our operations successfully.
As we advance our product candidates through the development process, we will need to expand our development, regulatory, manufacturing, quality, distribution, sales and marketing capabilities or contract with other organizations to provide these capabilities for us. As our operations expand, we expect that we will need to manage additional relationships with various collaborative partners, suppliers and other organizations. Our ability to manage our operations and growth requires us to continue to improve our operational, financial and management controls, reporting systems and procedures. For example, some jurisdictions, such as the District of Columbia, have imposed licensing requirements for sales representatives. In addition, the District of Columbia and the Commonwealth of Massachusetts, as well as the Federal government by way of the Sunshine Act provisions of the Patient Protection and Affordable Care Act of 2010, have established reporting requirements that would require public reporting of consulting and research fees to health care professionals. Because the reporting requirements vary in each jurisdiction, compliance will be complex and expensive and may create barriers to entering the commercialization phase. The need to build new systems as part of our growth could place a strain on our administrative and operational infrastructure. We may not be able to make improvements to our management information and control systems in an efficient or timely manner and may discover deficiencies in existing systems and controls. Such requirements may also impact our opportunities to collaborate with physicians at academic research centers as new restrictions on academic-industry relationships are put in place. In the past, collaborations between academia and industry have led to important new innovations, but the new laws may have an effect on these activities. While we cannot predict whether any legislative or regulatory changes will have negative or positive effects, they could have a material adverse effect on our business, financial condition and potential profitability.
We may acquire or make investments in companies or technologies that could have an adverse effect on our business, results of operations and financial condition or cash flows.
We may acquire or invest in companies, products and technologies. Such transactions involve a number of risks, including:
· we may find that the acquired company or assets does not further our business strategy, or that we overpaid for the company or assets, or that economic conditions change, all of which may generate a future impairment charge;
· difficulty integrating the operations and personnel of the acquired business, and difficulty retaining the key personnel of the acquired business;
· difficulty incorporating the acquired technologies;
· difficulties or failures with the performance of the acquired technologies or drug products;
· we may face product liability risks associated with the sale of the acquired companys products;
· disruption or diversion of managements attention by transition or integration issues and the complexity of managing diverse locations;
· difficulty maintaining uniform standards, internal controls, procedures and policies;
· the acquisition may result in litigation from terminated employees or third parties; and
· we may experience significant problems or liabilities associated with product quality, technology and legal contingencies.
These factors could have a material adverse effect on our business, results of operations and financial condition or cash flows, particularly in the case of a larger acquisition or multiple acquisitions in a short period of time. From time to time, we may enter into negotiations for acquisitions that are not ultimately consummated. Such negotiations could result in significant diversion of management time, as well as out-of-pocket costs.
The consideration paid in connection with an acquisition also affects our financial results. If we were to proceed with one or more significant acquisitions in which the consideration included cash, we could be required to use a substantial portion of our available cash to consummate any acquisition. To the extent we issue shares of stock or other rights to purchase stock, including options or other rights, existing stockholders may be diluted and earnings per share may decrease. In addition, acquisitions may result in the incurrence of debt, large one-time write-offs and restructuring charges. They may also result in goodwill and other intangible assets that are subject to impairment tests, which could result in future impairment charges.
Risks Relating to Development and Regulatory Approval
If we are not able to obtain regulatory approval for commercial sale of our generic product candidate, M356, as a therapeutic equivalent to Copaxone, our future results of operations will be adversely affected.
Our future results of operations depend to a significant degree on our ability to obtain regulatory approval for and commercialize M356. We will be required to demonstrate to the satisfaction of the FDA, among other things, that M356:
· contains the same active ingredients as Copaxone;
· is of the same dosage form, strength and route of administration as Copaxone, and has the same labeling as the approved labeling for Copaxone, with certain exceptions; and
· meets compendial or other applicable standards for strength, quality, purity and identity, including potency.
In addition, approval of a generic product generally requires demonstrating that the generic drug is bioequivalent to the reference listed drug upon which it is based, meaning that there are no significant differences with respect to the rate and extent to which the active ingredients are absorbed and become available at the site of drug action. However, the FDA may or may not waive the requirements for certain bioequivalence data (including clinical data) for certain drug products, including injectable solutions that have been shown to contain the same active and inactive ingredients in the same concentration as the reference listed drug.
Determination of therapeutic equivalence of M356 to Copaxone will be based, in part, on our demonstration of the chemical equivalence of our versions to their respective reference listed drugs. The FDA may not agree that we have adequately characterized M356 or that M356 and Copaxone are chemical equivalents. In that case, the FDA may require additional information, including nonclinical or clinical test results, to determine therapeutic equivalence or to confirm that any inactive ingredients or impurities do not compromise the products safety and efficacy. Provision of sufficient information for approval may be difficult, expensive and lengthy. We cannot predict whether M356 will receive FDA approval as therapeutically equivalent to Copaxone.
In the event that the FDA modifies its current standards for therapeutic equivalence with respect to generic versions of Copaxone, or requires us to conduct clinical trials or complete other lengthy procedures, the commercialization of M356 could be delayed or prevented or become more expensive. In addition, FDA is currently prohibited from granting final marketing approval until May 2014 as a result of ongoing patent litigation. Delays in any part of the process or our inability to obtain regulatory approval for M356 could adversely affect our operating results by restricting or significantly delaying our introduction of M356.
Although health care reform legislation that establishes a regulatory pathway for the approval by the FDA of biosimilars has been enacted, the standards for determining similarity or interchangeability for biosimilars are only just being implemented by the FDA. Therefore, substantial uncertainty remains about the potential value our proprietary technology platform can offer to biosimilars development programs.
The regulatory climate in the United States for follow-on versions of biologic and complex protein products remains uncertain, even following the recent enactment of legislation establishing a regulatory pathway for the approval of biosimilars. The new pathway contemplates approval of two categories of follow-on biologic products: (1) biosimilar products, which are highly similar to the existing brand product, notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences from the brand product and (2) interchangeable biologic products, which in addition to being biosimilar can be expected to produce the same clinical result in any given patient without an increase in risk due to switching from the brand product. Only interchangeable biosimilar products would be considered interchangeable at the retail pharmacy level without the intervention of a physician. The new legislation authorizes but does not require the FDA to establish standards or criteria for determining biosimilarity and interchangeability, and also authorizes the FDA to use its discretion to determine the nature and extent of product characterization, nonclinical testing and clinical testing on a product-by-product basis. Our competitive advantage in this area will depend on our success in demonstrating to the FDA that our analytics, biocharacterization and protein engineering platform technology provides a level of scientific assurance that facilitates determinations of interchangeability, reduces the need for expensive clinical or other testing, and raises the scientific quality requirements for our competitors to demonstrate that their products are highly similar to a brand product. Our ability to succeed will depend in part on our ability to invest in new programs and develop data in a timeframe that enables the FDA to consider our approach as the agency begins to implement the new law. In addition, the FDA will likely require significant new resources and expertise to review biosimilar applications, and the timeliness of the review and approval of our future applications could be adversely affected if there were a decline or even limited growth in FDA funding.
The new regulatory pathway also creates a number of additional obstacles to the approval and launch of biosimilar and interchangeable products, including:
· an obligation of the applicant to share, in confidence, the information in its abbreviated pathway application with the brand companys and patent owners counsel as a condition to using the new patent clearance process;
· the inclusion of multiple potential patent rights in the patent clearance process; and
· a grant to each brand company of 12 years of marketing exclusivity following the brand approval.
Furthermore, the new regulatory pathway creates the risk that the brand company, during its 12-year marketing exclusivity period, will develop and replace its product with a non-substitutable or modified product that may also qualify for an additional 12-year marketing exclusivity period, reducing the opportunity for substitution at the retail pharmacy level for interchangeable biosimilars Finally, the new legislation also creates the risk that, as brand and biosimilar companies gain experience with the new regulatory pathway, subsequent FDA determinations or court rulings could create additional areas for potential disputes and resulting delays in biosimilars approval.
In addition, there is reconsideration and legislative debate that could lead to the repeal or amendment of the new healthcare legislation. If the legislation is significantly amended or is repealed with respect to the biosimilar approval pathway, our opportunity to develop biosimilars (including interchangeable biologics) could be materially impaired and our business could be materially and adversely affected.
Even if we are able to obtain regulatory approval for our generic and interchangeable biologic product candidates as therapeutically equivalent or interchangeable, state pharmacy boards or agencies may conclude that our products are not substitutable at the pharmacy level for the reference listed drug. If our generic or interchangeable biologic products are not substitutable at the pharmacy level for their reference listed drugs, this could materially reduce sales of our products and our business would suffer.
Although the FDA may determine that a generic product is therapeutically equivalent to a brand product and provide it with an A rating in the FDAs Orange Book, this designation is not binding on state pharmacy boards or agencies. As a result, in states that do not deem our product
candidates therapeutically equivalent, physicians will be required to specifically prescribe a generic product alternative rather than have a routine substitution at the pharmacy level for the prescribed brand product. Should this occur with respect to one of our generic product candidates, it could materially reduce sales in those states which would substantially harm our business.
While a designation of interchangeability is a finding by the FDA that a biosimilar can be substituted at the pharmacy without physician intervention or prescription, brand pharmaceutical companies are lobbying state legislatures to enact physician prescription requirements, or in the absence of a prescription, physician and patient notification requirements, special labeling requirements and alternative naming requirements which if enacted could create barriers to substitution and adoption rates of interchangeable biologics as well as biosimilars. Should this occur with respect to one of our biosimilars or interchangeable biologic product candidates, and it is not determined to be unlawful or preempted by federal law, it could materially reduce sales in those states which would substantially harm our business.
If our nonclinical studies and clinical trials for our development candidates, including M402, are not successful, we will not be able to obtain regulatory approval for commercial sale of our novel or improved drug candidates.
To obtain regulatory approval for the commercial sale of our novel product candidates, we are required to demonstrate through nonclinical studies and clinical trials that our drug development candidates are safe and effective. Nonclinical studies and clinical trials of new development candidates are lengthy and expensive and the historical failure rate for development candidates is high.
A failure of one or more of our nonclinical studies or clinical trials can occur at any stage of testing. We may experience numerous unforeseen events during, or as a result of, nonclinical studies and clinical trials that could delay or prevent our ability to receive regulatory approval or commercialize M402 or our other drug candidates, including:
· regulators or institutional review boards may not authorize us to commence a clinical trial or conduct a clinical trial at a prospective trial site;
· our nonclinical studies or clinical trials may produce negative or inconclusive results, and we may be required to conduct additional nonclinical studies or clinical trials or we may abandon projects that we previously expected to be promising;
· enrollment in our clinical trials may be slower than we anticipate, resulting in significant delays, and participants may drop out of our clinical trials at a higher rate than we anticipate;
· we might have to suspend or terminate our clinical trials if the participants are being exposed to unacceptable health risks;
· regulators or institutional review boards may require that we hold, suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or if, in their opinion, participants are being exposed to unacceptable health risks;
· the cost of our clinical trials may be greater than we anticipate;
· the effects of our drug candidates may not be the desired effects or may include undesirable side effects or our product candidates may have other unexpected characteristics; and
· we may decide to modify or expand the clinical trials we are undertaking if new agents are introduced which influence current standard of care and medical practice, warranting a revision to our clinical development plan.
The results from nonclinical studies of a development candidate may not predict the results that will be obtained in human clinical trials. If we are required by regulatory authorities to conduct additional clinical trials or other testing of M402 or our other product candidates that we did not anticipate, if we are unable to successfully complete our clinical trials or other tests, or if the results of these trials are not positive or are only modestly positive, we may be delayed in obtaining marketing approval for our drug candidates or we may not be able to obtain marketing approval at all. Our product development costs will also increase if we experience delays in testing or approvals. Significant clinical trial delays could allow our competitors to bring products to market before we do and impair our ability to commercialize our products or potential products. If any of these events occur, our business will be materially harmed.
Failure to obtain regulatory approval in foreign jurisdictions would prevent us from marketing our products abroad.
We intend in the future to market our products, if approved, outside of the United States, either directly or through collaborative partners. In order to market our products in the European Union and many other foreign jurisdictions, we must obtain separate regulatory approvals and comply with the numerous and varying regulatory requirements of each jurisdiction. The approval procedure and requirements vary among countries, and can require, among other things, conducting additional testing in each jurisdiction. The time required to obtain approval abroad may differ from that required to obtain FDA approval. The foreign regulatory approval process may include all of the risks associated with
obtaining FDA approval, and we may not obtain foreign regulatory approvals on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries, and approval by one foreign regulatory authority does not ensure approval by regulatory authorities in any other foreign country or by the FDA. We and our collaborators may not be able to file for regulatory approvals and may not receive necessary approvals to commercialize our products in any market outside of the United States. The failure to obtain these approvals could materially adversely affect our business, financial condition, and results of operations.
Even if we obtain regulatory approvals, our marketed products will be subject to ongoing regulatory review. If we fail to comply with continuing United States and foreign regulations, we could lose our approvals to market products and our business would be seriously harmed.
Even after approval, any drugs or biological products we develop will be subject to ongoing regulatory review, including the review of clinical results which are reported after our products are made commercially available. Any regulatory approvals that we obtain for our product candidates may also be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the product candidate. In addition, the manufacturer and manufacturing facilities we use to produce any of our product candidates will be subject to periodic review and inspection by the FDA, or foreign equivalent, and other regulatory agencies. We will be required to report any serious and unexpected adverse experiences and certain quality problems with our products and make other periodic reports to the FDA. The discovery of any new or previously unknown problems with the product, manufacturer or facility may result in restrictions on the product or manufacturer or facility, including withdrawal of the product from the market. Certain changes to an approved product, including in the way it is manufactured or promoted, often require prior FDA approval before the product as modified may be marketed. If we fail to comply with applicable FDA regulatory requirements, we may be subject to fines, warning letters, civil penalties, refusal by the FDA to approve pending applications or supplements, suspension or withdrawal of regulatory approvals, product recalls and seizures, injunctions, operating restrictions, refusal to permit the import or export of products, and/or criminal prosecutions and penalties.
Similarly, our commercial activities will be subject to comprehensive compliance obligations under state and federal reimbursement, sunshine act, anti-kickback and government pricing regulations. If we make false price reports, fail to implement adequate compliance controls or our employees violate the laws and regulations governing relationships with health care providers, we could also be subject to substantial fines and penalties, criminal prosecution and debarment from participation in the Medicare, Medicaid, or other government reimbursement programs.
In addition, the FDAs policies may change and additional government regulations may be enacted that could prevent, limit, or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature, or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained and we may not achieve or sustain profitability, which would adversely affect our business.
If third-party payors do not adequately reimburse customers for any of our approved products, they might not be purchased or used, and our revenue and profits will not develop or increase.
Our revenue and profits 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 United States and in foreign 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 coverage and reimbursement approval for a product from each government 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 coverage and reimbursement. There is substantial uncertainty whether any particular payor will reimburse the use of any drug product incorporating new technology. 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 comparable authority. 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 our costs and may not be made permanent. Reimbursement rates may vary according to the use of the product and the clinical setting in which it is used, may be based on payments allowed for lower-cost products that are already reimbursed, may be incorporated into existing payments for other
products or services, and may reflect budgetary constraints and/or imperfections in Medicare, Medicaid or other data used to calculate these rates. Net prices for products may be reduced by mandatory discounts or rebates required by government health care programs or by any future relaxation of laws that restrict imports of certain medical products from countries where they may be sold at lower prices than in the United States.
There have been, and we expect that there will continue to be, federal and state proposals to constrain expenditures for medical products and services, which may affect payments for our products. The Centers for Medicare and Medicaid Services, or CMS, frequently change product descriptors, coverage policies, product and service codes, payment methodologies and reimbursement values. Third-party payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement rates, and both CMS and other third-party payors may have sufficient market power to demand significant price reductions. Due in part to actions by third-party payors, the health care industry is experiencing a trend toward containing or reducing costs through various means, including lowering reimbursement rates, limiting therapeutic class coverage and negotiating reduced payment schedules with service providers for drug products.
Our inability to promptly obtain coverage and profitable reimbursement rates from government-funded and private payors for our products could have a material adverse effect on our operating results and our overall financial condition.
Federal legislation will increase the pressure to reduce prices of pharmaceutical products paid for by Medicare or may otherwise seek to limit healthcare costs, either of which could adversely affect our revenue, if any.
The Medicare Modernization Act of 2003, or MMA, changed the way Medicare covers and reimburses for pharmaceutical products. The legislation introduced a new reimbursement methodology based on average sales prices for drugs that are used in hospital settings or under the direct supervision of a physician and, starting in 2006, expanded Medicare coverage for drug purchases by the elderly. In addition, the MMA requires the creation of formularies for self-administered drugs, and provides authority for limiting the number of drugs that will be covered in any therapeutic class and provides for plan sponsors to negotiate prices with manufacturers and suppliers of covered drugs. As a result of the MMA and the expansion of federal coverage of drug products, we expect continuing pressure to contain and reduce costs of pharmaceutical products. Cost reduction initiatives and other provisions of this legislation could decrease the coverage and price that we receive for our products and could materially adversely affect our operating results and overall financial condition. While the MMA generally applies only to drug benefits for Medicare beneficiaries, private payors often follow Medicare coverage policy and payment limitations in setting their own reimbursement policies and any reduction in coverage or payment that results from the MMA may result in a similar reduction in coverage or payments from private payors.
Furthermore, health care reform legislation was enacted in 2010 that could significantly change the United States health care system and the reimbursement of products. A primary goal of the law is to reduce or limit the growth of health care costs, which could change the market for pharmaceuticals and biological products.
The law contains provisions that will affect companies in the pharmaceutical industry and other healthcare-related industries by imposing additional costs and changes to business practices. Provisions affecting pharmaceutical companies include an increase to the mandatory rebates for drugs sold into the Medicaid program, an extension of the rebate requirement to drugs used in risk-based Medicaid managed care plans, an extension of mandatory discounts for drug products sold to certain critical access hospitals, cancer hospitals and other covered entities, and discounts and fees applicable to brand-name drugs. Although many of these provisions may not apply directly to us, they may change business practices in our industry and, assuming our products are approved for commercial sale, such changes could adversely impact our profitability.
Additionally, the new law establishes an abbreviated regulatory pathway for the approval of biosimilars and provides that brand biologic products may receive 12 years of market exclusivity, with a possible six-month extension for pediatric products. By creating a new approval pathway for biosimilars and adjusting reimbursement for biosimilars, the new law could promote the development and commercialization of biosimilars. However, given the uncertainty of how the law will be interpreted and implemented, the impact of the law on our strategy for biosimilars as well as novel biologics remains uncertain. Other provisions in the law, such as the comparative effectiveness provisions, may ultimately impact positively or negatively both brand and biosimilars products alike depending on an applicants clinical data, effectiveness and cost profile. If a brand product cannot be shown to provide a benefit over other therapies, then it might receive reduced coverage and reimbursement. While this might increase market share for biosimilars based on cost savings, it could also have the effect of reducing biosimilars market share.
The financial impact of this United States health care reform legislation over the next few years will depend on a number of factors, including but not limited to the issuance of implementation regulations and guidance and changes in sales volumes for products eligible for the new system of rebates, discounts and fees. Assuming our products are approved for commercial sale, the new legislation could also have a positive impact on us by increasing the aggregate number of persons with health care coverage in the United States and expanding the market for our products, but such increases, if any, are unlikely to be realized until approximately 2014 at the earliest.
The full effects of the United States health care reform legislation cannot be known until the new law is implemented through regulations or guidance issued by the CMS and other federal and state health care agencies. While we cannot predict whether any legislative or regulatory changes will have negative or positive effects, they could have a material adverse effect on our business, financial condition and potential profitability. In addition, litigation may prevent some or all of the legislation from taking effect. Consequently, there is uncertainty regarding implementation of the new legislation.
Foreign governments tend to impose strict price or reimbursement controls, which may adversely affect our revenue, if any.
In some foreign countries, particularly the countries of the European Union, the pricing and/or reimbursement of prescription pharmaceuticals are subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a product. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be adversely affected.
If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.
Our research and development involves, and may in the future involve, the use of hazardous materials and chemicals and certain radioactive materials and related equipment. If an accident occurs, we could be held liable for resulting damages, which could be substantial. We are also subject to numerous environmental, health and workplace safety laws and regulations, including those governing laboratory procedures, exposure to blood-borne pathogens and the handling of biohazardous materials. Insurance may not provide adequate coverage against potential liabilities and we do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us. Additional federal, state and local laws and regulations affecting our operations may be adopted in the future. We may incur substantial costs to comply with, and substantial fines or penalties if we violate, any of these laws or regulations.
The FDA has reported that it has a substantial backlog of ANDA filings that have resulted in significant delays in review and approval of applications. As a result, the review and potential approval of our application for M356 may be significantly delayed.
The FDA has reported that it has a substantial backlog of ANDA filings that have resulted in significant delays in the review and approval of ANDAs and amendments or supplements due to insufficient staffing and resources. Resource constraints have also resulted in significant delays in conducting ANDA-related pre-approval inspections. Enactment of user fee legislation in 2012 is expected to fund additional resources and the new legislation implements goals and metrics for application review to begin to address this backlog and the delays. Still, when an ANDA review requires coordination with the new drug offices of the FDA, the FDA is obligated to give priority to NDA and BLA applications that are subject to statutory review time periods as well. Until such time as resources are actually increased by the FDA, our applications and supplements may be subject to significant delays during their review cycles. In addition, if a user fee statute is enacted, we may become liable for fees that could be material to our earnings.
Risks Relating to Patents and Licenses
If we are not able to obtain and enforce patent protection for our discoveries, our ability to successfully commercialize our product candidates will be harmed and we may not be able to operate our business profitably.
Our success depends, in part, on our ability to protect proprietary methods and technologies that we develop under the patent and other intellectual property laws of the United States and other countries, so that we can prevent others from using our inventions and proprietary information. Because patent applications in the United States and many foreign jurisdictions are typically not published until 18 months after filing, or in some cases not at all, and because publications of discoveries in scientific literature lag behind actual discoveries, we cannot be certain that we were the first to make the inventions claimed in issued patents or pending patent applications, or that we were the first to file for protection of the inventions set forth in our patent applications. As a result, we may be required to obtain licenses under third- party patents to market our proposed products. If licenses are not available to us on acceptable terms, or at all, we will not be able to market the affected products.
Assuming the other requirements for patentability are met, currently, in the United States, the first to make the claimed invention is entitled to the patent, while outside the United States, the first to file a patent application is entitled to the patent. In March 2013, the United States will transition to a first inventor to file system in which, assuming the other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent. We may be subject to a third-party preissuance submission of prior art to the U.S. Patent and Trademark Office, or become involved in opposition, derivation, reexamination, inter partes review or interference proceedings challenging our patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights.
Our strategy depends on our ability to rapidly identify and seek patent protection for our discoveries. This process is expensive and time consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner.
Despite our efforts to protect our proprietary rights, unauthorized parties may be able to obtain and use information that we regard as proprietary. The issuance of a patent does not guarantee that it is valid or enforceable, so even if we obtain patents, they may not be valid or enforceable against third parties.
Our pending patent applications may not result in issued patents. The patent position of pharmaceutical or biotechnology companies, including ours, is generally uncertain and involves complex legal and factual considerations. The standards which the U.S. Patent and Trademark Office and its foreign counterparts use to grant patents are not always applied predictably or uniformly and can change. There is also no uniform,
worldwide policy regarding the subject matter and scope of claims granted or allowable in pharmaceutical or biotechnology patents. The laws of some foreign countries do not protect proprietary information to the same extent as the laws of the United States, and many companies have encountered significant problems and costs in protecting their proprietary information in these foreign countries.
Although we are aggressively pursuing patent applications on our innovative approaches to characterization and manufacture of complex generics, biosimilars and new drugs, there is presently uncertainty regarding the scope of the safe harbor from a patent infringement enforcement under federal patent law, 35 USC section 271(e)(1). This uncertainty may impair our ability to enforce certain of our patent rights and reduce the likelihood of enforcing certain of our patent rights to protect our innovations and our products. Accordingly, we do not know the degree of future protection for our proprietary rights or the breadth of claims allowed in any patents issued to us or to others.
The allowance of broader claims may increase the incidence and cost of patent interference proceedings and/or opposition proceedings, and the risk of infringement litigation. On the other hand, the allowance of narrower claims may limit the value of our proprietary rights. Our issued patents may not contain claims sufficiently broad to protect us against third parties with similar technologies or products, or provide us with any competitive advantage. Moreover, once they have issued, our patents and any patent for which we have licensed or may license rights may be challenged, narrowed, invalidated or circumvented. If our patents are invalidated or otherwise limited, other companies will be better able to develop products that compete with ours, which could adversely affect our competitive business position, business prospects and financial condition.
We also rely on trade secrets, know-how and technology, which are not protected by patents, to maintain our competitive position. If any trade secret, know-how or other technology not protected by a patent were to be disclosed to or independently developed by a competitor, our business and financial condition could be materially adversely affected.
Third parties may allege that we are infringing their intellectual property rights, forcing us to expend substantial resources in resulting litigation, the outcome of which would be uncertain. Any unfavorable outcome of such litigation could have a material adverse effect on our business, financial position and results of operations.
The issuance of our own patents does not guarantee that we have the right to practice the patented inventions. Third parties may have blocking patents that could be used to prevent us from marketing our own patented product and practicing our own patented technology.
If any party asserts that we are infringing its intellectual property rights or that our creation or use of proprietary technology infringes upon its intellectual property rights, we might be forced to incur expenses to respond to and litigate the claims. Furthermore, we may be ordered to pay damages, potentially including treble damages, if we are found to have willfully infringed a partys patent rights. In addition, if we are unsuccessful in litigation, or pending the outcome of litigation, a court could issue a temporary injunction or a permanent injunction preventing us from marketing and selling the patented drug or other technology for the life of the patent that we have allegedly or been deemed to have infringed. Litigation concerning intellectual property and proprietary technologies is widespread and can be protracted and expensive, and can distract management and other key personnel from performing their duties for us.
Any legal action against us or our collaborators claiming damages and seeking to enjoin any activities, including commercial activities relating to the affected products, and processes could, in addition to subjecting us to potential liability for damages, require us or our collaborators to obtain a license in order to continue to manufacture or market the affected products and processes. Any license required under any patent may not be made available on commercially acceptable terms, if at all. In addition, some licenses may be non-exclusive, and therefore, our competitors may have access to the same technology licensed to us.
If we fail to obtain a required license or are unable to design around a patent, we may be unable to effectively market some of our technology and products, which could limit our ability to generate revenue or achieve profitability and possibly prevent us from generating revenue sufficient to sustain our operations.
If we remain involved in patent litigation or other proceedings to determine or enforce our intellectual property rights, we could incur substantial costs which could adversely affect our business.
We may need to continue to resort to litigation to enforce a patent issued to us or to determine the scope and validity of a third-party patent or other proprietary rights such as trade secrets in jurisdictions where we intend to market our products, including the United States, the European Union, and many other foreign jurisdictions. The cost to us of any litigation or other proceeding relating to determining the validity of intellectual property rights, even if resolved in our favor, could be substantial and could divert our managements efforts. Some of our competitors may be able to sustain the costs of complex patent litigation more effectively than we can because they may have substantially greater resources. Moreover, the failure to obtain a favorable outcome in any litigation in a jurisdiction where there is a claim of patent infringement could significantly delay the marketing of our products in that particular jurisdiction. Counterclaims for damages and other relief may be triggered by such enforcement actions. The costs, uncertainties and counterclaims resulting from the initiation and continuation of any litigation could limit our ability to continue our operations.
We in-license a significant portion of our proprietary technologies and if we fail to comply with our obligations under any of the related agreements, we could lose license rights that are necessary to develop our product candidates.
We are a party to and rely on a number of in-license agreements with third parties, such as those with the Massachusetts Institute of Technology, that give us rights to intellectual property that is necessary for our business. In addition, we expect to enter into additional licenses in the future. Our current in-license arrangements impose various diligence, development, royalty and other obligations on us. If we breach our obligations with regard to our exclusive in-licenses, they could be converted to non-exclusive licenses or the agreements could be terminated, which would result in our being unable to develop, manufacture and sell products that are covered by the licensed technology.
Risks Relating to Our Dependence on Third Parties
The 2003 Sandoz Collaboration and 2006 Sandoz Collaboration are important to our business. If Sandoz fails to adequately perform under either collaboration, or if we or Sandoz terminate all or a portion of either collaboration, the development and commercialization of some of our drug candidates, including Enoxaparin Sodium Injection, would be delayed or terminated and our business would be adversely affected.
2003 Sandoz Collaboration
Either we or Sandoz may terminate the 2003 Sandoz Collaboration for material uncured breaches or certain events of bankruptcy or insolvency by the other party. Sandoz may also terminate the 2003 Sandoz Collaboration if the Enoxaparin Sodium Injection product or the market lacks commercial viability, if new laws or regulations are passed or court decisions rendered that substantially diminish our legal avenues for commercialization of Enoxaparin Sodium Injection, or, in multiple cases, if certain costs exceed mutually agreed upon limits. If the 2003 Sandoz Collaboration is terminated other than due to our uncured breach or bankruptcy, we will be granted an exclusive license under certain intellectual property of Sandoz to develop and commercialize Enoxaparin Sodium Injection in the United States. In that event, we would need to expand our internal capabilities or enter into another collaboration, which could cause significant delays that could prevent us from commercializing Enoxaparin Sodium Injection. If Sandoz terminates the 2003 Sandoz Collaboration due to our uncured breach or bankruptcy, Sandoz would retain the exclusive right to commercialize Enoxaparin Sodium Injection in the United States. In that event, we would no longer have any influence over the commercialization strategy of Enoxaparin Sodium Injection in the United States. In addition, Sandoz would retain its rights of first negotiation with respect to certain of our other products in certain circumstances and its rights of first refusal outside of the United States and the European Union.
Accordingly, if Sandoz terminates the 2003 Sandoz Collaboration, we may decide to discontinue the Enoxaparin Sodium Injection project, or our revenue may be reduced, any one of which could have a material adverse effect on our business.
2006 Sandoz Collaboration
Either we or Sandoz may terminate the Second Sandoz Collaboration Agreement for material uncured breaches or certain events of bankruptcy or insolvency by the other party. In addition, either we or Sandoz may terminate some of the products, on a product-by-product basis, if clinical trials are required. For some of the products, for any termination of the Second Sandoz Collaboration Agreement other than a termination by Sandoz due to our uncured breach or bankruptcy, or a termination by us alone due to the need for clinical trials, we will be granted an exclusive license under certain intellectual property of Sandoz to develop and commercialize the particular product. In that event, we would need to expand our internal capabilities or enter into another collaboration, which could cause significant delays that could prevent us from completing the development and commercialization of such product. For some products, if Sandoz terminates the Second Sandoz Collaboration Agreement due to our uncured breach or bankruptcy, or if there is a termination by us alone due to the need for clinical trials, Sandoz would retain the exclusive right to develop and commercialize the applicable product. In that event, we would no longer have any influence over the development or commercialization strategy of such product. In addition, for other products, if Sandoz terminates due to our uncured breach or bankruptcy, Sandoz retains a right to license certain of our intellectual property without the obligation to make any additional payments for such licenses. For certain products, if the Second Sandoz Collaboration Agreement is terminated other than due to our uncured breach or bankruptcy, neither party will have a license to the other partys intellectual property. In that event, we would need to expand our internal capabilities or enter into another collaboration, which could cause significant delays that could prevent us from completing the development and commercialization of such product. Accordingly, if the Second Sandoz Collaboration Agreement is terminated, our introduction of certain products may be significantly delayed, or our revenue may be significantly reduced either of which could have a material adverse effect on our business.
The Baxter Agreement is important to our business. If we or Baxter fail to adequately perform under the Agreement, or if we or Baxter terminate all or a portion of the Agreement, the development and commercialization of some of our biosimilar candidates would be delayed or terminated and our business would be adversely affected.
The Baxter Agreement may be terminated:
· by either party for breach by the other party (in whole or on a product by product or country-by-country basis);
· by either party for bankruptcy of the other party;
· by us in the event Baxter elects to terminate the Baxter Agreement with respect to both of the initial two products within a certain time period;
· by Baxter for its convenience (in whole or on a product by product basis);
· by us in the event Baxter does not exercise commercially reasonable efforts to commercialize a product in the United States or other specified countries, provided, that we also have certain rights to directly commercialize such product, as opposed to terminating the Baxter Agreement, in event of such a breach by Baxter; or
· by either party in the event there is a condition constituting force majeure for more than a certain consecutive number of days.
If the Baxter Agreement were terminated by Baxter for convenience or if Baxter elects to terminate the Baxter Agreement with respect to both of the initial two products in the specified time frame or if we terminate the Baxter Agreement for breach by Baxter, while we would have the right to research, develop, manufacture or commercialize the terminated products or license a third party to do so, we would need to expand our internal capabilities or enter into another collaboration, which could cause significant delays that could prevent us from commercializing our biosimilar candidates. In addition, we may need to seek additional financing to support the research, development and commercialization of the terminated products or alternatively we may decide to discontinue the terminated products, which could have a material adverse effect on our business. If Baxter terminates the Baxter Agreement due to our uncured breach, Baxter would retain the exclusive right to commercialize the terminated products on a world-wide basis, subject to certain payment obligations to us as outlined in the Agreement. In addition, depending upon the timing of the termination, we would no longer have any influence over or input into the clinical development strategy or/and the commercialization strategy or/and the legal strategy of the products in the territory.
We and our collaborative partners depend on third parties for the manufacture of products. If we encounter difficulties in our supply or manufacturing arrangements, our business may be materially adversely affected.
We have a limited number of personnel with experience in, and we do not own facilities for, manufacturing products. In addition, we do not have, and do not intend to develop, the ability to manufacture material for our clinical trials or at commercial scale. To develop our product candidates, apply for regulatory approvals and commercialize any products, we or our collaborative partners need to contract for or otherwise arrange for the necessary manufacturing facilities and capabilities. In order to generate revenue from the sales of Enoxaparin Sodium Injection, sufficient quantities of such product must also be produced in order to satisfy demand. If these contract manufacturers are unable to manufacture sufficient quantities of product, comply with regulatory requirements, or breach or terminate their manufacturing arrangements with us, the development and commercialization of the affected products or drug candidates could be delayed, which could have a material adverse effect on our business. In addition, any change in these manufacturers could be costly because the commercial terms of any new arrangement could be less favorable and because the expenses relating to the transfer of necessary technology and processes could be significant.
We have relied upon third parties to produce material for nonclinical and clinical studies and may continue to do so in the future. We cannot be certain that we will be able to obtain and/or maintain long-term supply and supply arrangements of those materials on acceptable terms, if at all. If we are unable to arrange for third-party manufacturing, or to do so on commercially reasonable terms, we may not be able to complete development of our products or market them.
In addition, the FDA and other regulatory authorities require that our products be manufactured according to current good manufacturing practices, or cGMP, regulations and that proper procedures are implemented to assure the quality of our sourcing of raw materials and the manufacture of our products. Any failure by us, our collaborative partners or our third-party manufacturers to comply with cGMP, and/or our failure to scale-up our manufacturing processes could lead to a delay in, or failure to obtain, regulatory approval. In addition, such failure could be the basis for action by the FDA to withdraw approvals for drug candidates previously granted to us and for other regulatory action, including product recall or seizure, fines, imposition of operating restrictions, total or partial suspension of production or injunctions. To the extent we rely on a third-party manufacturer, the risk of non-compliance with cGMPs may be greater and the ability to effect corrective actions for any such noncompliance may be compromised or delayed.
If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our product candidates, we may be unable to generate product revenue.
We do not have a sales organization and have no experience as a company in the sale, marketing or distribution of pharmaceutical products. There are risks involved with establishing our own sales and marketing capabilities, as well as entering into arrangements with third parties to perform these services. For example, developing a sales force is expensive and time consuming and could delay any product launch. In addition, to the extent that we enter into arrangements with third parties to perform sales, marketing or distribution services, we will have less control over sales of our products and our future revenue would depend heavily on the success of the efforts of these third parties.
General Company Related Risks
Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or remove our current management.
Provisions in our certificate of incorporation and our by-laws may delay or prevent an acquisition of us or a change in our management. In addition, these provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our board of directors. Because our board of directors is responsible for appointing the members of our management team, these provisions could in turn affect any attempt by our stockholders to replace current members of our management team. These provisions include:
· a classified board of directors;
· a prohibition on actions by our stockholders by written consent; and
· limitations on the removal of directors.
Moreover, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which prohibits a person who owns in excess of 15% of our outstanding voting stock from merging or combining with us for a period of three years after the date of the transaction in which the person acquired in excess of 15% of our outstanding voting stock, unless the merger or combination is approved in a prescribed manner. Finally, these provisions establish advance notice requirements for nominations for election to our board of directors or for proposing matters that can be acted upon at stockholder meetings. These provisions would apply even if the offer may be considered beneficial by some stockholders.
Our stock price may be volatile, and purchasers of our common stock could incur substantial losses.
The stock market in general and the market prices for securities of biotechnology companies in particular have experienced extreme volatility that often has been unrelated or disproportionate to the operating performance of these companies. The trading price of our common stock has been, and is likely to continue to be, volatile. Furthermore, our stock price could be subject to wide fluctuations in response to a variety of factors, including the following:
· failure to obtain FDA approval for the M356 ANDA or other announcements that indicated a material delay in the approval of the M356 ANDA;
· failure of Enoxaparin Sodium Injection to sustain commercial success or to meet expectations of securities analysts;
· failure to obtain clarity from the Court of Appeals for the Federal Circuit or Supreme Court regarding the appropriate scope of the safe harbor provisions from patent infringement;
· other adverse FDA decisions relating to our Enoxaparin Sodium Injection product or M356 program, including an FDA decision to require additional data, including requiring clinical trials, as a condition to M356 ANDA approval;
· litigation involving our company or our general industry or both, including litigation pertaining to the launch of our, our collaborative partners or our competitors products;
· a decision in favor of or against Teva or Amphastar and Actavis in the Companys material patent litigation suits, or a settlement related to any case;
· announcements by other companies regarding the status of their ANDAs for generic versions of Lovenox or Copaxone;
· FDA approval of other companies ANDAs for generic versions of Lovenox or Copaxone;
· marketing and/or launch of other companies generic versions of Lovenox or Copaxone;
· adverse FDA decisions regarding the development requirements for one or our biosimilar development candidates or failure of our other product applications to meet the requirements for regulatory review and/or approval;
· results or delays in our or our competitors clinical trials or regulatory filings;
· legislation is enacted that repeals the law enacting the biosimilar regulatory approval pathway or amends the law in a manner that is adverse to our biosimilar development strategy;
· failure to demonstrate therapeutic equivalence, biosimilarity or interchangeability with respect to our technology-enabled generic product candidates or biosimilars;
· demonstration of or failure to demonstrate the safety and efficacy for our novel product candidates;
· our inability to manufacture any products in conformance with cGMP or in sufficient quantities to meet the requirements for the commercial launch of the product or to meet market demand;
· failure of any of our product candidates, if approved, to achieve commercial success;
· the discovery of unexpected or increased incidence in patients adverse reactions to the use of our products or product candidates or indications of other safety concerns;
· developments or disputes concerning our patents or other proprietary rights;
· changes in estimates of our financial results or recommendations by securities analysts;
· termination of any of our product development and commercialization collaborations;
· significant acquisitions, strategic partnerships, joint ventures or capital commitments by us or our competitors;
· investors general perception of our company, our products, the economy and general market conditions;
· rapid or disorderly sales of stock by holders of significant amounts of our stock; or
· significant fluctuations in the price of securities generally or biotech company securities specifically.
If any of these factors causes an adverse effect on our business, results of operations or financial condition, the price of our common stock could fall and investors may not be able to sell their common stock at or above their respective purchase prices.
We could be subject to class action litigation due to stock price volatility, which, if it occurs, will distract our management and could result in substantial costs or large judgments against us.
The stock market in general has recently experienced extreme price and volume fluctuations. In addition, the market prices of securities of companies in the biotechnology industry have been extremely volatile and have experienced fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. These fluctuations could adversely affect the market price of our common stock. In the past, securities class action litigation has often been brought against companies following periods of volatility in the market prices of their securities. We may be the target of similar litigation in the future. Securities litigation could result in substantial costs and divert our managements attention and resources, which could cause serious harm to our business, operating results and financial condition.
10.1 |
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Sublease Agreement, dated February 5, 2013, by and between BMR-Rogers Street LLC and the Registrant |
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10.2 |
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First Amendment dated March 21, 2013 to the Sublease Agreement dated February 5, 2013 by and between BMR-Rogers Street LLC and the Registrant |
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31.1 |
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Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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31.2 |
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Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
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32.1 |
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Certifications of Chief Executive Officer and Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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101+ |
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The following materials from Registrants Quarterly Report on Form 10-Q for the period ended March 31, 2013, formatted in XBRL (Extensible Business Reporting Language): (i) the Condensed Consolidated Balance Sheets at March 31, 2013 and December 31, 2012, (ii) the Condensed Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2013 and March 31, 2012, (iii) the Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2013 and March 31, 2012, and (iv) Notes to Unaudited, Condensed Consolidated Financial Statements. |
+In accordance with Rule 406T of Regulation S-T, the XBRL-related information in Exhibit 101 to this Quarterly Report on Form 10-Q shall be deemed to be furnished and not filed.
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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Momenta Pharmaceuticals, Inc. |
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Date: May 10, 2013 |
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By: |
/s/ Craig A. Wheeler |
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Craig A. Wheeler, President and Chief Executive Officer |
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(Principal Executive Officer) |
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Date: May 10, 2013 |
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By: |
/s/ Richard P. Shea |
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Richard P. Shea, Senior Vice President and Chief Financial Officer |
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(Principal Financial and Accounting Officer) |
Exhibit 10.1
LEASE
by and between
BMR-ROGERS STREET LLC,
a Delaware limited liability company
and
MOMENTA PHARMACEUTICALS, INC.,
a Delaware corporation
Table of Contents
LEASE
THIS LEASE (this Lease ) is entered into as of this 5th day of February, 2013 (the Execution Date ), by and between BMR-ROGERS STREET LLC, a Delaware limited liability company ( Landlord ), and MOMENTA PHARMACEUTICALS, INC., a Delaware corporation ( Tenant ).
RECITALS
A. WHEREAS, pursuant to that certain ground lease dated as of March 30, 1999, by and among MBA-Rogers Street, LLC (as successor-in-interest to O&T Realty, LLC, and MBA-Cambridge, LLC (collectively, Initial Ground Lessor )), as landlord, and Rogers Street, LLC, a Delaware limited liability company ( Initial Ground Lessee ), as tenant, as such ground lease has been amended by that certain letter agreement dated as of July 29, 1999, between Initial Ground Lessor and Initial Ground Lessee, and that certain Agreement Regarding Arbitration and Lease Amendments dated as of December 15, 1999, by and between Initial Ground Lessor and Initial Ground Lessee, and as such ground lease has been assigned pursuant to that certain Assignment and Assumption of Ground Lease dated as of April 4, 2007, by and between Initial Ground Lessee and Landlord (collectively, and as the same may have been amended, amended and restated, supplemented or otherwise modified from time to time, the Ground Lease ), Landlord leases certain real property described on Exhibit A attached hereto (the Property ) and the improvements thereon located at 320 Bent Street, 301 Binney Street and 157 Sixth Street in Cambridge, Massachusetts, including the buildings located thereon. The Property consists of the parcel (the Bent Property ) underlying the building at 320 Bent Street in Cambridge, Massachusetts (the Bent Building ), and the parcel (the Binney Property ) underlying the buildings at 301 Binney Street (the Binney Building ) and 157 Sixth Street (together with the Binney Building, the Binney Buildings and, together with the Bent Building, the Buildings );
B. WHEREAS, Landlord wishes to lease to Tenant, and Tenant desires to lease from Landlord, certain premises (the Premises ) located in the basement level and on the first (1 st ) and second (2 nd ) floors of the Bent Building pursuant to the terms and conditions of this Lease, as detailed below.
AGREEMENT
NOW, THEREFORE, Landlord and Tenant, in consideration of the mutual promises contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, agree as follows:
1. Lease of Premises .
1.1 Effective on the Term Commencement Date (as defined below), Landlord hereby leases to Tenant, and Tenant hereby leases from Landlord, the Premises, as shown on Exhibit B attached hereto, including exclusive shafts, cable runs, mechanical spaces and rooftop areas, for use by Tenant in accordance with the Permitted Use (as defined below) and no other uses. The Bent Property and all landscaping, private drives and other improvements and appurtenances related thereto, including the Bent Building and the underground tunnel (the Tunnel ) that provides pedestrian access from the Bent Building to the parking garage located at the base of
the Binney Building (the Garage ), are hereinafter collectively referred to as the Bent Project . All portions of the Bent Project that are for the non-exclusive use of tenants of the Bent Building generally, including driveways, sidewalks, parking areas, landscaped areas, service corridors, loading docks, utility closets, chases, stairways, elevators, restrooms and lobbies, are hereinafter referred to as Common Area . As appurtenant to the Premises, Tenant shall have the right to use the Common Area in common with others entitled to use thereof. The Binney Property and all landscaping, private drives and other improvements and appurtenances related thereto, including the Binney Buildings, are hereinafter collectively referred to as the Binney Project . The Bent Project and the Binney Project are hereinafter collectively referred to as the Project .
2. Basic Lease Provisions . For convenience of the parties, certain basic provisions of this Lease are set forth herein. The provisions set forth herein are subject to the remaining terms and conditions of this Lease and are to be interpreted in light of such remaining terms and conditions.
2.1 This Lease shall take effect upon the Execution Date and, except as specifically otherwise provided within this Lease, each of the provisions hereof shall be binding upon and inure to the benefit of Landlord and Tenant from the date of execution and delivery hereof by all parties hereto.
2.2 In the definitions below, each current Rentable Area (as defined below) is expressed in rentable square footage. Rentable Area and Tenants Pro Rata Share are both subject to adjustment as provided in this Lease.
Definition or Provision |
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Means the Following (As of the Term
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Approximate Rentable Area of Premises |
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104,678 square feet |
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Approximate Rentable Area of Bent Building |
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195,198 square feet |
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Tenants Pro Rata Share of Bent Building |
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53.60% |
2.3 Initial monthly and annual installments of Base Rent for the Premises ( Base Rent ):
Dates |
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Square Feet of
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Base Rent per
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Monthly Base
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Annual Base
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Months 1-12 |
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104,678 |
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$ |
58.00 annually |
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$ |
505,943.67 |
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$ |
6,071,324.00 |
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Months 13-24 |
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104,678 |
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$ |
59.00 annually |
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$ |
514,666.83 |
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$ |
6,176,002.00 |
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Months 25-36 |
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104,678 |
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$ |
60.00 annually |
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$ |
523,390.00 |
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$ |
6,280,680.00 |
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2.4 Security Deposit: Seven Hundred Forty-Seven Thousand Six Hundred Thirty Dollars ($747,630).
2.5 Permitted Use: Office and laboratory use, including vivarium and process development laboratory uses, and uses customarily accessory thereto, in conformity with all federal, state, municipal and local laws, codes, ordinances, rules and regulations of Governmental Authorities (as defined below), or other governmental regulatory committees, agencies or governing bodies having jurisdiction over the Premises, the Buildings, the Property, the Project, Landlord or Tenant, including both statutory and common law and hazardous waste rules and regulations ( Applicable Laws )
2.6 |
Address for Rent Payment: |
BMR-Rogers Street LLC |
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P.O. Box 511247 |
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Los Angeles, California 90051-2997 |
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2.7 |
Address for Notices to Landlord: |
BMR-Rogers Street LLC |
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17190 Bernardo Center Drive |
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San Diego, California 92128 |
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Attn: Vice President, Real Estate Counsel |
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2.8 |
Address for Notices to Tenant: |
Momenta Pharmaceuticals, Inc. |
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675 West Kendall Street |
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Cambridge, Massachusetts 02142 |
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Attn: Cheryl M. Northrup, Esq. |
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2.9 |
Address for Invoices to Tenant: |
Momenta Pharmaceuticals, Inc. |
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675 West Kendall Street |
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Cambridge, Massachusetts 02142 |
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Attn: Richard Shea |
2.10 The following Exhibits are attached hereto and incorporated herein by reference:
Exhibit A |
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Property |
Exhibit B |
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Premises |
Exhibit C |
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[Intentionally omitted] |
Exhibit D |
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[Intentionally omitted] |
Exhibit E |
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Form of Letter of Credit |
Exhibit F |
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Rules and Regulations |
Exhibit G |
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Parking and Transportation Demand Management Plan Documents |
Exhibit H |
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Maintenance Matrix |
Exhibit I |
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[Intentionally omitted] |
Exhibit J |
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Tenants Personal Property |
Exhibit K |
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Form of Estoppel Certificate |
Exhibit L |
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Control Zone Area |
Exhibit M |
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Form of Ground Lessor NDA |
Exhibit N |
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Rooftop Installation Area |
Exhibit O |
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675 Kendall Space Plans |
Exhibit P |
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Vertex Sublease Premises |
Exhibit Q |
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Available ROFR Space |
Exhibit R |
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Generator Plans |
3. Term . The actual term of this Lease (as the same may be extended pursuant to Article 41 hereof, and as the same may be earlier terminated in accordance with this Lease, the Term ) shall commence on the Term Commencement Date (as identified in Section 4.1) and end on the date that is thirty-six (36) months after the Term Commencement Date (such date, the Term Expiration Date ), subject to earlier termination of this Lease as provided herein.
4. Possession and Commencement Date .
4.1 The Term Commencement Date shall be September 1, 2013, subject to Article 44 hereof. Failure by Tenant to obtain validation by any medical review board or other similar governmental licensing of the Premises required for the Permitted Use by Tenant shall not serve to extend the Term Commencement Date.
4.2 Landlord agrees to pay Tenant a tenant improvement allowance of Seven Hundred Forty-Seven Thousand Six Hundred Thirty Dollars ($747,630) (based upon Thirty Dollars ($30.00) per square foot of Rentable Area (as defined below) of the basement portion of the Premises only) (the TI Allowance ) upon the Term Commencement Date; provided that (a) Tenants work in the Premises ( Tenants Work ) has been completed as approved in the Consent to Sublease dated as of March 21, 2013 (the Consent ), by and among Landlord, Merck, Sharp & Dohme (f/k/a Schering Corporation) ( Merck ) and Tenant, and (b) the funding conditions that are set forth in the Consent have been satisfied. The TI Allowance may be applied to the costs of (v) construction, (w) all reasonable, out of pocket expenses incurred by Landlord in reviewing plans and specifications for Tenants Work and coordinating Tenants Work with the Bent Building facilities, up to a cap of Five Thousand Dollars ($5,000)), (x) space planning, architect, engineering and other related services performed by third parties unaffiliated with Tenant, (y) building permits and other taxes, fees, charges and levies by Governmental Authorities (as defined below) for permits or for inspections of Tenants Work and (z) costs and expenses for labor, material, equipment and fixtures. In no event shall the TI Allowance be used for (f) the cost of work that is not authorized by the Consent or otherwise approved in writing by Landlord, (g) payments to Tenant or any affiliates of Tenant, (h) the purchase of any furniture, personal property or other non-building system equipment, (i) costs resulting from any default by Tenant of its obligations under this Lease or (j) costs that are recoverable by Tenant from a third party (e.g., insurers, warrantors, or tortfeasors).
4.3 In no event shall any unused TI Allowance entitle Tenant to a credit against Rent payable under this Lease. Tenant shall deliver to Landlord (a) a certificate of occupancy for the Premises suitable for the Permitted Use and (b) a Certificate of Substantial Completion in the form of the American Institute of Architects document G704, executed by the project architect and the general contractor.
4.4 Prior to entering upon the Premises, Tenant shall furnish to Landlord evidence satisfactory to Landlord that insurance coverages required of Tenant under the provisions of
Article 23 are in effect, and such entry shall be subject to all the terms and conditions of this Lease.
5. Condition of Premises . Tenant acknowledges that neither Landlord nor any agent of Landlord has made any representation or warranty with respect to the condition of the Premises, the Buildings or the Project, or with respect to the suitability of the Premises, the Buildings or the Project for the conduct of Tenants business. Tenant acknowledges that (a) it is fully familiar with the condition of the Premises and agrees to take the same in its condition as is as of the Execution Date and (b) Landlord shall have no obligation to alter, repair or otherwise prepare the Premises for Tenants occupancy or to pay for or construct any improvements to the Premises, except with respect to payment of the TI Allowance and the ongoing performance of Landlords maintenance and repair obligations under the other provisions of this Lease. Tenants taking of possession of the Premises shall, except as otherwise agreed to in writing by Landlord and Tenant, conclusively establish that the Premises, the Buildings and the Project were at such time in good, sanitary and satisfactory condition and repair. Notwithstanding the foregoing, Landlord (x) represents, to the best of Landlords knowledge, that the Bent Project (excluding any areas for which a tenant assumed repair or maintenance obligations or obligations for compliance with Applicable Law under its lease) complies with Applicable Laws as of the date hereof, (y) agrees that all structural and Common Area components and base building systems (including heating, ventilating and air conditioning, electrical, life safety and plumbing) shall be in good working condition and suitable for the Permitted Use as of the Term Commencement Date and (z) agrees that the following shall comply with the Americans with Disabilities Act, 42 U.S.C. § 12101, et seq., and any state and local accessibility laws, codes, ordinances and rules (collectively, and together with regulations promulgated pursuant thereto, the ADA ) and the applicable building code: (i) with respect to the duration of the Term, the Common Area, and (ii) with respect to the time that Landlord delivers the Premises to Tenant, the Premises. Promptly after Landlord delivers to Tenant possession of those portions of the Premises that Tenant does not occupy as of the Execution Date, Tenant shall inspect such portions (and Landlord shall have the right to have a representative attend such inspection) and deliver to Landlord a punchlist specifying those aspects in which such portions of the Premises do not comply with the requirements of this Article.
6. Rentable Area .
6.1 The term Rentable Area shall reflect such areas as reasonably calculated by Landlords architect, as the same may be reasonably adjusted from time to time by Landlord in consultation with Landlords architect to reflect changes to the Premises, the Bent Building or the Bent Project, as applicable.
6.2 The Rentable Area of the Bent Building is generally determined by making separate calculations of Rentable Area applicable to each floor within the Bent Building and totaling the Rentable Area of all floors within the Bent Building. The Rentable Area of a floor is computed by measuring to the outside finished surface of the permanent outer Bent Building walls. The full area calculated as previously set forth is included as Rentable Area, without deduction for columns and projections or vertical penetrations, including stairs, elevator shafts, flues, pipe shafts, vertical ducts and the like, as well as such items enclosing walls.
6.3 The term Rentable Area , when applied to the Premises, is that area equal to the usable area of the Premises, plus an equitable allocation of Rentable Area within the Bent Building that is not then utilized or expected to be utilized as usable area, including that portion of the Bent Building devoted to corridors, equipment rooms, restrooms, elevator lobby, atrium and mailroom.
7. Rent .
7.1 Tenant shall pay to Landlord as Base Rent for the Premises, commencing on the Term Commencement Date, the sums set forth in Section 2.3 . Base Rent shall be paid in equal monthly installments as set forth in Section 2.3 , each in advance on the first (1 st ) day of each and every calendar month during the Term.
7.2 In addition to Base Rent, Tenant shall pay to Landlord as additional rent ( Additional Rent ) at times hereinafter specified in this Lease (a) Tenants Share (as defined below) of Operating Expenses (as defined below), (b) the Property Management Fee (as defined below) and (c) any other amounts that Tenant assumes or agrees to pay under the provisions of this Lease that are owed to Landlord, including any and all other sums that may become due pursuant to the provisions of this Lease by reason of any default of Tenant or failure on Tenants part to comply with the agreements, terms, covenants and conditions of this Lease to be performed by Tenant, after notice and the lapse of any applicable cure periods.
7.3 Base Rent and Additional Rent shall together be denominated Rent . Rent shall be paid to Landlord, without abatement (except as otherwise provided in Sections 14.4, 24.5 and 25.4 ), deduction or offset, in lawful money of the United States of America at the office of Landlord as set forth in Section 2.6 or to such other person or at such other place as Landlord may from time designate in writing. In the event the Term commences or ends on a day other than the first (1 st ) day of a calendar month, then the Rent for such fraction of a month shall be prorated for such period on the basis of the number of days of the Term that have elapsed in such month divided by the number of days in such month and shall be paid at the then-current rate for such fractional month.
8. [Intentionally omitted]
9. Operating Expenses .
9.1 As used herein, the term Operating Expenses shall mean:
(a) Government impositions, including property tax costs consisting of real and personal property taxes and assessments (including amounts due under any improvement bond upon the Bent Building or the Bent Project (including the parcel or parcels of real property upon which the Bent Building and areas serving the Bent Building are located)) or assessments in lieu thereof imposed by any federal, state, regional, local or municipal governmental authority, agency or subdivision (each, a Governmental Authority ), in each case to the extent assessed against the Bent Property and the Bent Building; taxes on or measured by gross rentals received from the rental of space in the Bent Project; taxes based on the square footage of the Premises, the Bent Building or the Bent Project, as well as any future utilities, surcharges or any other costs levied, assessed or imposed by, or at the direction of, or resulting from Applicable Laws or
interpretations thereof, promulgated by any Governmental Authority in connection with the use or occupancy of the Bent Project; taxes on this transaction or any document to which Tenant is a party creating or transferring an interest in the Premises; any fee for a business license to operate an office building; and any reasonable, out of pocket expenses, including the reasonable cost of attorneys or experts, reasonably incurred by Landlord in seeking reduction by the taxing authority of the applicable taxes, less tax refunds obtained as a result of an application for review thereof. With respect to any betterment assessments or other special assessments payable by Tenant pursuant to this Article, Landlord shall be deemed to have elected to pay the same over the longest period permitted by Applicable Law (regardless of whether Landlord actually elects to do so), and only the annual amount so payable (plus interest, if any, actually charged by the taxing authority) shall be included in taxes for any fiscal year. Operating Expenses shall not include any net income, franchise, capital stock, transfer, estate or inheritance taxes, or taxes that are the personal obligation of Tenant or of another tenant of the Bent Project; and
(b) All other costs of any kind paid or incurred by Landlord in connection with the operation or maintenance of the Bent Building and the Bent Project, which shall include costs of repairs and replacements to improvements within the Bent Project as appropriate to maintain the Bent Project as required hereunder; costs of utilities furnished to the Common Area; sewer fees; cable television; trash collection; cleaning, including windows; heating; ventilation; air-conditioning; maintenance of landscaping and grounds; maintenance of drives and parking areas, including costs related to maintaining the Tunnel; maintenance of the roof; security services and devices; building supplies; maintenance or replacement of equipment utilized for operation and maintenance of the Bent Project; license, permit and inspection fees; sales, use and excise taxes on goods and services purchased by Landlord in connection with the operation, maintenance or repair of the Bent Building or Bent Project systems and equipment; telephone, postage, stationery supplies and other expenses incurred in connection with the operation, maintenance or repair of the Bent Project; accounting, legal and other professional fees and expenses incurred in connection with the operation of the Bent Project; costs of furniture, draperies, carpeting, landscaping, snow removal and other customary and ordinary items of personal property provided by Landlord for use in Common Area or in the Bent Project office; Bent Project office rent or rental value at current market rates for a commercially reasonable amount of space, to the extent an office used for Bent Project operations is maintained at the Bent Project, plus commercially reasonable expenses for such office; capital expenditures (amortized over the useful life thereof, as reasonably determined by Landlord, in accordance with generally accepted accounting principles); costs of complying with Applicable Laws (except to the extent such costs are incurred to remedy non-compliance with Applicable Laws of which Landlord has knowledge as of the Execution Date (such knowledge is summarized in Landlords representation in Subsection 5(x) )); costs to keep the Bent Project in compliance with, or fees otherwise required under, any CC&Rs (as defined below); insurance premiums, including premiums for commercial general liability, property casualty, earthquake, terrorism and environmental coverages; portions of insured losses paid by Landlord as part of the deductible portion of a loss pursuant to the terms of insurance policies; service contracts; costs of services of independent contractors retained to do work of a nature referenced above; and costs of compensation (including employment taxes and fringe benefits) of all persons who perform regular and recurring duties connected with the day-to-day operation and maintenance of the Bent Project, its equipment, the adjacent walks, landscaped areas, drives and parking areas
(including the Tunnel), including janitors, floor waxers, window washers, watchmen, gardeners, sweepers, plow trucks and handymen.
(c) Notwithstanding the foregoing, Operating Expenses shall not include any of the following:
(i) Brokerage commissions or other costs incurred in leasing space in the Buildings;
(ii) Salaries of personnel not directly employed in the management or operation of the Bent Building or above the grade of general manager (it being understood that general manager shall mean the individual responsible for the maintenance and operation of the Bent Building, to the extent such persons time devoted to the Bent Building);
(iii) The cost of work done by Landlord for a particular tenant for which Landlord has the right to be reimbursed by such tenant;
(iv) [Intentionally omitted];
(v) Capital expenditures, depreciation and amortization, except that Operating Expenses for any given year shall include the annual amortization of capital expenditures incurred: (A) in replacing obsolete equipment, (B) for the primary purpose of reducing Operating Expenses, or (C) required by any Governmental Authority to comply with changes in Applicable Laws that take effect after the Execution Date or to ensure continued compliance with Applicable Laws in effect as of the Execution Date (excluding costs to remedy non-compliance with Applicable Laws that exists as of the Execution Date and of which non-compliance Landlord has knowledge as of such date), in each case amortized over the useful life thereof (as reasonably determined by Landlord in accordance with generally accepted accounting principles);
(vi) Interest on debt, amortization payments and other fees payable under any mortgage or mortgages, and rent under any ground or underlying lease or leases;
(vii) All items and services for which Tenant is separately charged, reimburses Landlord or pays third persons;
(viii) Advertising and promotional expenditures;
(ix) The costs of renovating or otherwise improving, decorating, painting or redecorating space for tenants or other occupants of the Buildings;
(x) Attorneys fees, costs and disbursements and other expenses incurred in connection with negotiations or disputes with tenants, other occupants, or prospective tenants or occupants;
(xi) Repairs or other work occasioned by fire, windstorm or other casualty (other than any deductible payable by Landlord under its insurance policies up to a maximum deductible of Twenty-Five Thousand Dollars ($25,000.00) for all insurance other than
flood insurance, and a maximum deductible of One Hundred Thousand Dollars ($100,000.00) for flood insurance) or by the exercise of eminent domain;
(xii) Landlords cost of services as well as fines or penalties for which Landlord is reimbursed by other tenants in the Bent Building (other than as part of operating expense payments);
(xiii) The costs of Signage (as defined below) identifying only Landlord or any specific tenants, except for the directory Signage in the Bent Building lobby;
(xiv) Expenses in connection with services or other benefits of a type are not provided to Tenant but that are provided to another tenant or occupant;
(xv) Any fines or penalties incurred due to violations by Landlord of any Applicable Law;
(xvi) The net (i.e., net of the reasonable costs of collection) amount recovered by Landlord under any warranty or service agreement from any contractor or service provider;
(xvii) The cost of testing, remediation or removal of Hazardous Materials (as defined below) that are present in the Bent Building as of the Execution Date; provided , however, that (A) with respect to the testing, remediation or removal of any material or substance that, as of the Execution Date, was not considered as a matter of law to be a Hazardous Material, but which is subsequently determined to be a Hazardous Material as a matter of law, the costs thereof shall be included in Operating Expenses, and (B) with respect to the cost of testing, remediation or removal of any Hazardous Materials that become present in the Bent Building after the Execution Date, the cost of testing, remediation or removal of the same shall be excluded from Operating Expenses if their presence has been caused by Landlord or its agents, contractors or employees; any other tenant of the Bent Building; or such tenants employees, agents, contractors or invitees;
(xviii) Landlords genera1 corporate overhead and general and administrative expenses (except to the extent of a commercially reasonable management fee);
(xix) Damages and penalties incurred due to violations by Landlord of the terms and conditions of this Lease (excluding costs of any cure or repair that may be required and that would otherwise be included in Operating Expenses under the terms of this Lease);
(xx) The cost of any electric service provided to any leased space in the Bent Building (i.e., other than to Common Areas);
(xxi) Costs incurred in the maintenance, repair and operation of the Garage;
(xxii) Costs incurred to remedy non-compliance (as of the Execution Date) of the Buildings with Applicable Laws, including penalties or damages incurred due to such non-compliance;
(xxiii) Costs arising from the gross negligence or willful misconduct of Landlord or its agents, contractors or employees;
(xxiv) Landlords charitable or political contributions;
(xxv) Costs of operating the business of the limited liability company or other entity that constitutes Landlord, as the same are distinguished from the costs of operating the Bent Building;
(xxvi) Any above-standard cleaning, including construction clean-up or special cleanings associated with parties/events and specific tenants requirements in excess of services provided to Tenant, including related trash collection, removal, hauling and dumping; and
(xxvii) Landlords legal costs (exceeding One Thousand Dollars ($1,000.00) in any one instance) in handling Landlords acceptance of any letter of credit security under any lease for space in the Bent Building, including any replacement or extension thereof.
(d) To the extent that Tenant uses more than Tenants Pro Rata Share of any item of Operating Expenses, Tenant shall pay Landlord for such excess in addition to Tenants obligation to pay Tenants Pro Rata Share of Operating Expenses (such excess, together with Tenants Pro Rata Share, Tenants Share ). To the extent that any other tenant of the Bent Building uses more than that tenants Pro Rata Share of any item of Operating Expenses, the cost of any such excess usage shall be excluded from Operating Expenses for the purposes of computing Tenants Pro Rata Share thereof.
9.2 Tenant shall pay to Landlord on the first (1 st ) day of each calendar month of the Term, as Additional Rent, (a) the Property Management Fee (as defined below) and (b) Landlords estimate of Tenants Share of Operating Expenses with respect to the Bent Building and the Bent Project, as applicable, for such month.
(a) The Property Management Fee shall equal three percent (3%) of Base Rent due from Tenant, and shall be payable at the same time as Operating Expenses.
(b) Within ninety (90) days after the conclusion of each calendar year (or such longer period as may be reasonably required by Landlord), Landlord shall furnish to Tenant a statement showing in reasonable detail the actual Operating Expenses and Tenants Share of Operating Expenses for the previous calendar year. Any additional sum due from Tenant to Landlord shall be due and payable within thirty (30) days after delivery of such statement to Tenant. If the amounts paid by Tenant pursuant to this Section exceed Tenants Share of Operating Expenses for the previous calendar year, then Landlord shall credit the difference against the Rent next due and owing from Tenant; provided that, if the Lease term has expired, Landlord shall accompany such statement with payment for the amount of such difference.
(c) Any amount due under this Section for any period that is less than a full month shall be prorated (based on the number of days in the actual month) for such fractional month.
9.3 Landlord may, from time to time, modify Landlords calculation and allocation procedures for Operating Expenses, so long as such modifications produce Dollar results substantially consistent with Landlords previous practice at the Project. Since the Project consists of multiple buildings, certain Operating Expenses may pertain to a particular building(s) and other Operating Expenses to the Project as a whole. Landlord reserves the right to allocate in a commercially reasonable manner any such costs applicable to any particular building within the Project to such building, and other such costs applicable to the Project to each of the Buildings in the Project (including the Bent Building), with the tenants in each of the Buildings being responsible for paying their respective proportionate shares of their buildings to the extent required under their leases. Landlord shall allocate such costs to the buildings (including the Bent Building) in a reasonable, non-discriminatory manner, and such allocation shall be binding on Tenant.
9.4 Landlords annual statement shall be final and binding upon Tenant unless Tenant, within ninety (90) days after Tenants receipt thereof, shall request in writing to review Landlords books and records regarding Operating Expenses, which request shall specify the particular items of such annual statement, if any, that Tenant believes to be in error, but Tenant need not allege any error in order to make such request if Tenant is not yet aware of any errors; provided that Tenant shall in all events pay the amount specified in Landlords annual statement, pending the results of the Independent Review (as defined herein) and determination of the Accountant(s) (as defined herein), as applicable and as each such term is defined below. If Tenant so requests, Landlord shall, not later than twenty (20) days after such request, provide Tenant with reasonable access to Landlords books and records to the extent relevant to determination of Operating Expenses, and such information as Landlord reasonably determines to be responsive to Tenants written inquiries. The review of Landlords books and records shall be performed only by an independent public accounting firm or other qualified real estate services firm hired by Tenant on an hourly basis and not on a contingent-fee basis (at Tenants sole cost and expense) and approved by Landlord (which approval Landlord shall not unreasonably withhold or delay), who shall audit and review such of Landlords books and records for the year in question as directly relate to the determination of Operating Expenses for such year (the Independent Review ). Landlord shall make such books and records available at the location where Landlord maintains them in the ordinary course of its business in the continental United States. Landlord need not provide copies of any books or records. Tenant shall commence the Independent Review within fifteen (15) days after the date Landlord has given Tenant access to Landlords books and records for the Independent Review. Tenant shall complete the Independent Review and notify Landlord in writing of Tenants specific objections to Landlords calculation of Operating Expenses (including Tenants accounting firms written statement of the basis, nature and amount of each proposed adjustment) no later than sixty (60) days after Landlord has first given Tenant access to Landlords books and records for the Independent Review. Landlord shall review the results of any such Independent Review. The parties shall endeavor to agree promptly and reasonably upon Operating Expenses taking into account the results of such Independent Review. If, as of sixty (60) days after Tenant has submitted the Independent Review to Landlord, the parties have not agreed on the appropriate adjustments to Operating Expenses, then the parties shall engage a mutually agreeable independent third party accountant with at least ten (10) years experience in commercial real estate accounting in the Cambridge, Massachusetts, area (the Accountant ). If the parties cannot agree on the Accountant, each shall within ten (10) days after such impasse appoint an
Accountant (different from the accountant and accounting firm that conducted the Independent Review) and, within ten (10) days after the appointment of both such Accountants, those two Accountants shall select a third (which cannot be the accountant and accounting firm that conducted the Independent Review). If either party fails to timely appoint an Accountant, then the Accountant the other party appoints shall be the sole Accountant. Within ten (10) days after appointment of the Accountant(s), Landlord and Tenant shall each simultaneously give the Accountants (with a copy to the other party) its determination of Operating Expenses, with such supporting data or information as each submitting party determines appropriate. Within ten (10) days after such submissions, the Accountants shall by majority vote select either Landlords or Tenants determination of Operating Expenses. The Accountants may not select or designate any other determination of Operating Expenses. The determination of the Accountant(s) shall bind the parties. If the parties agree or the Accountant(s) determine that the Operating Expenses actually paid by Tenant for the calendar year in question exceeded Tenants obligations for such calendar year, then Landlord shall, at Tenants option, either (a) so long as the Term has not expired or earlier terminated in accordance with the provisions hereof, credit the excess to the next succeeding installments of Rent or (b) pay the excess to Tenant within thirty (30) days after delivery of such results. If the parties agree or the Accountant(s) determine that Tenants payments of Operating Expenses for such calendar year were less than Tenants obligation for the calendar year, then Tenant shall pay the deficiency to Landlord within thirty (30) days after delivery of such results. If the Independent Review reveals or the Accountant(s) determine that the Operating Expenses billed to Tenant by Landlord and paid by Tenant to Landlord for the applicable calendar year in question exceeded by more than five percent (5%) what Tenant should have been billed during such calendar year, then Landlord shall pay the reasonable cost of the Independent Review and Accountant(s). In all other cases, Tenant shall pay such costs.
9.5 Tenant shall not be responsible for Operating Expenses attributable to the time period prior to the Term Commencement Date. Tenants responsibility for Tenants Share of Operating Expenses shall continue to the later of (a) the date of termination of the Lease, (b) the date Tenant has fully vacated the Premises and (c) as otherwise provided in Article 31 .
9.6 Operating Expenses for the calendar year in which Tenants obligation to share therein commences and for the calendar year in which such obligation ceases shall be prorated on an equitable basis reasonably determined by Landlord. Expenses such as taxes, assessments and insurance premiums that are incurred for an extended time period shall be equitably prorated based upon the time periods to which they apply so that the amounts attributed to the Premises relate in a reasonable manner to the time period wherein Tenant has an obligation to share in Operating Expenses.
9.7 Within ten (10) business days after the end of each calendar month, Tenant shall submit to Landlord an invoice, or, in the event an invoice is not available, an itemized list, of all costs and expenses that both (a) Tenant has incurred (either internally or by employing third parties) during the prior month and (b) for which Tenant reasonably believes it is entitled to reimbursements from Landlord pursuant to the terms of this Lease.
9.8 In the event that the Bent Building or Project is less than fully occupied, Tenant acknowledges that Landlord may extrapolate Operating Expenses that vary depending on the occupancy of the Bent Building or Project (as applicable) by dividing (a) the total cost of such
Operating Expenses by (b) the Rentable Area of the Bent Building or Project (as applicable) that is occupied, then multiplying (y) the resulting quotient by (z) ninety-five percent (95%) of the total Rentable Area of the Bent Building or Project (as applicable). Tenant shall pay Tenants Share of the product of (y) and (z), subject to adjustment as reasonably determined by Landlord; provided , however, that Landlord shall not recover more than one hundred percent (100%) of Operating Expenses.
10. Taxes on Tenants Property .
10.1 Tenant shall pay prior to delinquency any and all taxes levied against any personal property or trade fixtures placed by Tenant in or about the Premises.
10.2 If any such taxes on Tenants personal property or trade fixtures are levied against Landlord or Landlords property or, if the assessed valuation of the Bent Building, the Bent Property or the Bent Project is increased by inclusion therein of a value directly attributable (according to the invoices of the Assessment Department of the City of Cambridge) to Tenants personal property or trade fixtures, Landlord shall promptly notify Tenant thereof and, if Landlord, not sooner than ten (10) days after written notice to Tenant (unless such sum is required to be paid prior to such date), pays the taxes based upon any such increase in the assessed value of the Bent Building, the Bent Property or the Bent Project, then Tenant shall, upon demand, repay to Landlord the taxes so paid by Landlord. Such taxes shall exclude the amount, if any, that the assessed valuation of the Bent Building, the Bent Property or the Bent Project is increased by inclusion therein of a value directly attributable (according to the invoices of the Assessing Department of the City of Cambridge) to the personal property or trade fixtures of any other tenant of the Project.
10.3 If any improvements in or alterations to the Premises, whether owned by Landlord or Tenant and whether or not affixed to the real property so as to become a part thereof, are assessed for real property tax purposes at a valuation higher than the valuation at which improvements conforming to Landlords building standards (the Building Standard ) in other comparable spaces in the Bent Building are assessed, then the incremental real property taxes and assessments levied against Landlord or the Bent Building, the Bent Property or the Bent Project by reason of such excess assessed valuation shall be deemed to be taxes levied against personal property of Tenant and shall be governed by the provisions of Section 10.2 . Any such excess assessed valuation due to improvements in or alterations to space in the Bent Project leased by other tenants at the Bent Project shall not be included in Operating Expenses. If the records of the tax assessor are available and sufficiently detailed to serve as a basis for determining whether such Tenant improvements or alterations are assessed at a higher valuation than the Building Standard, then such records shall be binding on both Landlord and Tenant.
11. Security Deposit .
11.1 Tenant shall deposit with Landlord on or before the Term Commencement Date the sum set forth in Section 2.4 (the Security Deposit ), which sum shall be held by Landlord as security for the faithful performance by Tenant of all of the terms, covenants and conditions of this Lease to be kept and performed by Tenant during the period commencing on the Execution Date and ending upon the expiration or termination of Tenants obligations under this Lease. If
Tenant Defaults (as defined below) with respect to any provision of this Lease, including any provision relating to the payment of Rent, then Landlord may (but shall not be required to) use or apply such part (which may be the entirety) of the Security Deposit for the payment of any Rent or to cure any other such Default, or to compensate Landlord for any other amount that Landlord may be entitled to recover from Tenant under the terms of this Lease by reason of such Default. If any portion of the Security Deposit is so used or applied, then Tenant shall, within ten (10) business days following demand therefor, deposit cash with Landlord in an amount sufficient to restore the Security Deposit to its original amount, and Tenants failure to do so shall be a material breach of this Lease. The provisions of this Article shall survive the expiration or earlier termination of this Lease.
11.2 In the event of bankruptcy or other debtor-creditor proceedings against Tenant, the Security Deposit shall be deemed to be applied first to the payment of Rent and other charges due Landlord for all periods prior to the filing of such proceedings.
11.3 Landlord shall deliver to any purchaser of Landlords interest in the Premises the Security Deposit, and, upon such delivery, Landlord shall be discharged from any further liability with respect to such deposit. This provision shall also apply to any subsequent transfers.
11.4 So long as no Default exists, Tenant has not received written notice from Landlord that any failure of Tenant to act or any state of facts exists that (with the passage of time) could ripen into a Default; and Tenant surrenders the Premises to Landlord in the condition required by this Lease, then the Security Deposit, or any balance thereof, shall be returned to Tenant (or, at Landlords option, to the last assignee of Tenants interest hereunder) within thirty (30) days after the expiration or earlier termination of this Lease.
11.5 [Intentionally omitted]
11.6 If the Security Deposit shall be in cash, Landlord shall hold the Security Deposit in an account at a banking organization selected by Landlord; provided , however, that Landlord shall not be required to maintain a separate account for the Security Deposit, but may intermingle it with other funds of Landlord. Landlord shall be entitled to all interest and/or dividends, if any, accruing on the Security Deposit. Landlord shall not be required to credit Tenant with any interest for any period during which Landlord does not receive interest on the Security Deposit.
11.7 The Security Deposit shall initially be in the form of a letter of credit (the L/C Security ) as follows:
(a) Tenant shall provide Landlord, and maintain in full force and effect throughout the Term and until the date that is ninety (90) days after the then-current Term Expiration Date, a letter of credit in the form of Exhibit E issued by Silicon Valley Bank or another issuer reasonably satisfactory to Landlord, in the amount of the Security Deposit, with an initial term of at least one year. Landlord may require the L/C Security to be re-issued by a different issuer ( provided that Tenant may substitute a cash Security Deposit instead of causing the L/C Security to be re-issued by a different issuer) at any time during the Term if Landlord reasonably believes that the issuing bank of the L/C Security is or may soon become insolvent; provided , however, Landlord shall return the existing L/C Security to the existing issuer
immediately upon receipt of the substitute L/C Security or a cash Security Deposit. If any issuer of the L/C Security shall become insolvent or placed into FDIC receivership, then Tenant shall immediately deliver to Landlord (without the requirement of notice from Landlord) substitute L/C Security issued by an issuer reasonably satisfactory to Landlord, and otherwise conforming to the requirements set forth in this Article or, at the election of Tenant, a cash Security Deposit, and upon the delivery of either of the foregoing, Landlord shall immediately return the existing L/C Security to the issuer. As used herein with respect to the issuer of the L/C Security, insolvent shall mean the determination of insolvency as made by such issuers primary bank regulator (i.e., the state bank supervisor for state chartered banks; the OCC or OTS, respectively, for federally chartered banks or thrifts; or the Federal Reserve for its member banks). If, at the Term Expiration Date, any Rent remains uncalculated or unpaid, then Landlord shall with reasonable diligence complete any necessary calculations and forthwith deliver to Tenant an invoice therefor, accompanied by reasonable backup evidencing the amount of such unpaid Rent. If Tenant fails to pay the amount of such Rent before the earlier of (i) thirty (30) days after the delivery of such an invoice and (ii) the date that is thirty (30) days before the expiry date of the L/C Security, then Landlord may draw such unpaid amount from the L/C Security before returning same to Tenant. Tenant shall reimburse Landlords legal costs (as reasonably estimated by Landlords counsel, but in an amount not to exceed One Thousand Dollars ($1,000.00) in any one instance) in handling Landlords acceptance of L/C Security or its replacement or extension.
(b) If Tenant delivers to Landlord satisfactory L/C Security in place of the entire Security Deposit, Landlord shall remit to Tenant any cash Security Deposit Landlord previously held.
(c) Landlord may draw upon the L/C Security, and hold and apply the proceeds in the same manner and for the same purposes as the Security Deposit, if (i) an uncured Default (as defined below) exists, (ii) as of the date forty-five (45) days before any L/C Security expires (even if such scheduled expiry date is after the Term Expiration Date) Tenant has not delivered to Landlord an amendment or replacement for such L/C Security, meeting the requirements of this Section 11.7 , extending the expiry date to the earlier of (1) ninety (90) days after the then-current Term Expiration Date or (2) the date one year after the then-current expiry date of the L/C Security, (iii) the L/C Security provides for automatic renewals, Landlord reasonably requests in writing (with a copy of such request to Tenant) the issuer to confirm the current L/C Security expiry date, and the issuer fails to do so within ten (10) business days after delivery of such written request therefor, (iv) Tenant fails to pay (when and as Landlord reasonably requires in writing) any bank charges for Landlords transfer of the L/C Security or (v) the issuer of the L/C Security ceases, or announces that it will cease, to maintain an office in the city where Landlord may present drafts under the L/C Security as provided in the L/C Security (and fails to permit drawing upon the L/C Security by overnight courier or facsimile). This Section does not limit any other provisions of this Lease allowing Landlord to draw the L/C Security under specified circumstances.
(d) Tenant shall not seek to enjoin, prevent, or otherwise interfere with Landlords draw under L/C Security, even if it violates this Lease. Tenant acknowledges that the only effect of a wrongful draw would be to substitute a cash Security Deposit for L/C Security, causing Tenant no legally recognizable damage, provided that Landlord shall hold the proceeds of any draw in the same manner and for the same purposes as a cash Security Deposit. In the
event of a wrongful draw, the parties shall cooperate to allow Tenant to post replacement L/C Security simultaneously with the return to Tenant of the wrongfully drawn sums, and Landlord shall upon request confirm in writing to the issuer of the L/C Security that Landlords draw was erroneous. Landlord shall reimburse Tenant any reasonable, out of pocket expenses incurred by Tenant by reason of a wrongful draw within thirty (30) days after delivery of Tenants written demand therefor, accompanied by copies of third-party invoices evidencing the amount of such costs.
(e) If Landlord transfers its interest in the Premises, then Tenant shall at Tenants expense, within five (5) business days after receiving a request from Landlord, deliver (and, if the issuer requires, Landlord shall consent to) an amendment to the L/C Security naming Landlords grantee as substitute beneficiary. If the required Security Deposit changes while L/C Security is in force, then Tenant shall deliver (and, if the issuer requires, Landlord shall consent to) a corresponding amendment to the L/C Security.
12. Use .
12.1 Tenant shall not use the Premises, or permit or suffer the Premises to be used, for any purpose other than the Permitted Use without Landlords prior written consent, which consent Landlord may withhold in its sole and absolute discretion.
12.2 Tenant shall not use or occupy the Premises in violation of Applicable Laws; zoning ordinances; or the certificate of occupancy issued for the Bent Building or the Project, and shall, upon five (5) days written notice from Landlord, discontinue any use of the Premises that is declared or claimed by any Governmental Authority having jurisdiction to be a violation of any of the above ( provided , however, that Tenant shall have the right to appeal any such declaration or claim by any such Governmental Authority to the extent permitted by and in accordance with Applicable Laws, and may continue its use of the Premises while such appeal is pending, but only if such use will not result in any criminal or civil liability for Landlord; Tenant shall indemnify, save, defend (at Landlords option and with counsel reasonably acceptable to Landlord) and hold Landlord and its affiliates, employees, agents and contractors, and any lender, mortgagee or beneficiary (each, a Lender and, collectively with Landlord and its affiliates, employees, agents and contractors, the Landlord Indemnitees ) harmless from and against any demands, claims, liabilities, losses, costs, expenses, actions, causes of action, damages, suits or judgments, and all reasonable, out of pocket expenses (including reasonable attorneys fees, charges and disbursements, regardless of whether the applicable demand, claim, action, cause of action or suit is voluntarily withdrawn or dismissed) arising out of any such continued use). Tenant shall comply with any direction of any Governmental Authority having jurisdiction that shall, by reason of the nature of Tenants use or occupancy of the Premises, impose any duty upon Tenant or Landlord with respect to the Premises or with respect to the use or occupation thereof. Notwithstanding the foregoing or any other provision of this Lease to the contrary, if any alterations, additions or installations are required to be performed in the Premises pursuant to any Applicable Laws that are generally applicable to office space (i.e., as opposed to any such work that is required by reason of (a) the nature of Tenants use or occupancy of the Premises or (b) any work performed in the Premises by Tenant after the Term Commencement Date), then Landlord, not Tenant, shall be responsible for the performance of any such work.
12.3 Tenant shall not do or permit to be done anything that will invalidate or increase the cost of any fire, environmental, extended coverage or any other insurance policy covering the Buildings or the Project, and shall comply with all rules, orders, regulations and requirements of the insurers of the Buildings and the Project, and Tenant shall promptly, upon demand, reimburse Landlord for any additional premium charged for such policy by reason of Tenants failure to comply with the provisions of this Article. Landlord agrees that the Permitted Use of the Premises will not, per se , invalidate or increase the cost of any such insurance.
12.4 Tenant shall provide for the cleaning of the Premises as well as payment for the same, and Tenant shall keep all doors opening onto public corridors closed, except when in use for ingress and egress.
12.5 No additional locks or bolts of any kind shall be placed upon any of the doors or windows by Tenant, nor shall any changes be made to existing locks or the mechanisms thereof without Landlords prior written consent. Tenant shall, upon termination of this Lease, return to Landlord all keys to offices and restrooms either furnished to or otherwise procured by Tenant. In the event any key so furnished to Tenant is lost, Tenant shall pay to Landlord the cost of replacing the same or of changing the lock or locks opened by such lost key if Landlord shall deem it necessary to make such change.
12.6 No awnings or other projections shall be attached to any outside wall of the Bent Building. No curtains, blinds, shades or screens shall be attached to or hung in, or used in connection with, any window or door of the Premises other than Landlords standard window coverings. Neither the interior nor exterior of any windows shall be coated or otherwise sunscreened without Landlords prior written consent, nor shall any bottles, parcels or other articles be placed on the windowsills. No equipment, furniture or other items of personal property shall be placed on any exterior balcony without Landlords prior written consent.
12.7 No sign, advertisement or notice ( Signage ) shall be exhibited, painted or affixed by Tenant on any part of the Premises or the Buildings (other than in locations in the Premises not visible from outside the Premises when doors are closed) without Landlords prior written consent; provided , however, that Tenant shall be entitled to install prominent exterior Signage, subject to local law and zoning requirements and Landlords reasonable review and approval. All Signage shall conform to Landlords design criteria. For any Signage, Tenant shall, at Tenants own cost and expense, (a) acquire all permits for such Signage in compliance with Applicable Laws and (b) except as otherwise provided in this Section, design, fabricate, install and maintain such Signage in a first-class condition. Landlord shall reasonably cooperate with Tenants efforts to obtain any necessary governmental approvals for any exterior Signage of Tenant. Tenant shall be responsible for reimbursing Landlord for all reasonable costs incurred by Landlord in removing any of Tenants Signage upon the expiration or earlier termination of the Lease. Interior signs on entry doors to the Premises and the directory tablet shall not be deemed Signage for the purposes hereof; shall be inscribed, painted or affixed for Tenant by Landlord at Landlords sole cost and expense; and shall be of a size, color and type and be located in a place reasonably acceptable to Landlord. The directory tablet shall be provided exclusively for the display of the name and location of tenants only. Other than on floors exclusively occupied by Tenant, Tenant shall not place anything on the exterior of the corridor walls or corridor doors other than Landlords standard lettering. At Landlords option, Landlord may install any Tenant
Signage, and Tenant shall pay all reasonable, out of pocket costs associated with such installation within thirty (30) days after written demand therefor accompanied by copies of invoices evidencing the amount of such costs.
12.8 Tenant may only place equipment within the Premises with floor loading consistent with the Bent Buildings structural design unless Tenant obtains Landlords prior written approval. Tenant may place such equipment only in a location designed to carry the weight of such equipment. As of the Execution Date, the floor load capacity of the Premises is one hundred (100) pounds per square foot live load.
12.9 Tenant shall cause any equipment or machinery to be installed in the Premises so as to reasonably prevent sounds or vibrations therefrom from extending into the Common Area or other offices in the Bent Project.
12.10 Tenant shall not (a) do or permit anything to be done in or about the Premises that shall in any way obstruct or interfere with the rights of other tenants or occupants of the Project, or injure or annoy them, (b) use or allow the Premises to be used for immoral, unlawful or objectionable purposes, (c) cause, maintain or permit any nuisance or waste in, on or about the Project or (d) take any other action that would in Landlords reasonable determination in any manner adversely affect other tenants quiet use and enjoyment of their space or adversely impact their ability to conduct business in a professional and suitable work environment.
12.11 Except as expressly provided otherwise in Article 5 , Tenant shall be responsible for all liabilities, costs and expenses arising out of or in connection with the compliance of the Premises with the ADA, and Tenant shall indemnify, save, defend (at Landlords option and with counsel reasonably acceptable to Landlord) and hold the Landlord Indemnitees harmless from and against any demands, claims, liabilities, losses, costs, expenses, actions, causes of action, damages, suits or judgments, and all reasonable, out of pocket expenses (including reasonable attorneys fees, charges and disbursements, regardless of whether the applicable demand, claim, action, cause of action or suit is voluntarily withdrawn or dismissed) incurred in investigating or resisting the same (collectively, Claims ) arising out of any such failure of the Premises to comply with the ADA. This Section (as well as any other provisions of this Lease dealing with indemnification of the Landlord Indemnitees by Tenant shall be deemed to be modified in each case by the insertion in the appropriate place of the following: except as otherwise provided in Mass. G.L. Ter. Ed., C. 186, Section 15. The provisions of this Section shall survive the expiration or earlier termination of this Lease. Landlord shall be responsible for maintaining the Common Areas in compliance with the ADA ( provided that the costs of the same may be included in Operating Expenses to the extent permitted under this Lease).
12.12 Tenant shall establish and maintain, with respect to the Project and Tenants operations therein, a chemical safety program administered by a licensed, qualified individual in accordance with the requirements of the Massachusetts Water Resources Authority (the MWRA ) and any other applicable Governmental Authority. Tenant shall be solely responsible for all costs incurred in connection with such chemical safety program, and Tenant shall provide Landlord with such documentation as Landlord may reasonably require evidencing Tenants compliance with the requirements of (a) the MWRA and any other applicable Governmental Authority with respect to such chemical safety program and (b) this Section. Tenant shall obtain
and maintain during the Term (m) any permit required by the MWRA (the MWRA Permit ) and (n) a wastewater treatment operator license from the Commonwealth of Massachusetts with respect to Tenants use of the Acid Neutralization Tank (as defined in Section 16.10 ) in the Bent Building. Tenant shall not introduce anything into the Acid Neutralization Tank (x) in violation of the terms of the MWRA Permit, (y) in violation of Applicable Laws or (z) that would interfere with the proper functioning of the Acid Neutralization Tank. Landlord, at Tenants sole cost and expense, agrees to reasonably cooperate with Tenant in order to obtain the MWRA Permit and the wastewater treatment operator license. Tenant shall be solely responsible for any costs incurred pursuant to this Section.
13. Rules and Regulations, CC&Rs, Parking Facilities and Common Area .
13.1 Tenant shall have the non-exclusive right, in common with others, to use the Common Area in conjunction with Tenants use of the Premises for the Permitted Use, and such use of the Common Area and Tenants use of the Premises shall be subject to the rules and regulations adopted by Landlord and attached hereto as Exhibit F , together with such other reasonable and nondiscriminatory rules and regulations as are hereafter promulgated in writing by Landlord in its reasonable discretion (the Rules and Regulations ). Tenant shall faithfully observe and comply with the Rules and Regulations. Landlord shall not be responsible to Tenant for the violation or non-performance by any other tenant or any agent, employee or invitee thereof of any of the Rules and Regulations, but, upon the reasonable written request of Tenant from time to time, Landlord shall exercise reasonable efforts (short of litigation) to obtain compliance of other tenants in the Project with the rules and regulations agreed to by such tenants.
13.2 This Lease is subject to any recorded covenants, conditions or restrictions on the Project or Property as of the Execution Date (the CC&Rs ), as the same may be amended, amended and restated, supplemented or otherwise modified from time to time; provided that any such amendments, restatements, supplements or modifications do not materially modify Tenants rights or obligations hereunder. Tenant shall comply with the CC&Rs.
13.3 Tenant shall have a non-exclusive, irrevocable license to use Tenants Pro Rata Share of the parking facilities serving the Project (initially, Tenants Pro Rata Share of the parking facilities shall consist of eleven (11) parking spaces), which number shall increase or decrease in conjunction with changes to Tenants Pro Rata Share), which parking facilities are located in the Garage, in common on an unreserved basis with other tenants of the Project, during the Term at a cost of Two-Hundred Sixty Dollars ($260) per parking space per month, which amount may be increased or decreased by Landlord from time to time upon forty-five (45) days prior written notice from Landlord to Tenant to reflect then-current market rent for comparable parking lots and garages in the East Cambridge submarket, and which Tenant shall pay as Additional Rent simultaneously with payments of Base Rent.
13.4 Tenant agrees not to unreasonably overburden the parking facilities (i.e., shall not use more than Tenants Pro Rata Share of such parking facilities) and agrees to cooperate with Landlord and other tenants in the use of the parking facilities. Nothing in this Section, however, is intended to create an affirmative duty on Landlords part to monitor parking; provided, however, that, upon the written request of Tenant from time to time, Landlord shall use
commercially reasonable efforts (short of litigation) to ensure that Tenant may use the minimum number of parking spaces allocated to Tenant under Section 13.3 .
13.5 This Lease is subject to the Parking and Transportation Demand Management Plan for the Property dated May 2002 and the final decision related to the same dated May 24, 2002, both of which are attached hereto as Exhibit G (collectively and as the same may be amended hereafter, the PTDM ). Tenant shall, at its sole cost and expense, (a) discourage the use of single-occupancy vehicle commuting, (b) promote the use of alternative modes of transportation and/or alternative work hours, (c) provide employees with a commuter choice program to the maximum allowed transportation fringe benefits, and (d) comply with the tenant requirements in the PTDM, including the requirements set forth in the Public Transportation, Alternative Work Schedules, and Management sections thereof. Even if Tenant is not required to offer T-pass subsidies pursuant to the Public Transportation section of the PTDM, Tenant is hereby encouraged to offer the same to its employees. Tenant, at its sole cost and expense, shall comply with the reporting requirements set forth in the PTDM, insofar as the same apply to Tenant or are relevant to Tenants role in or contribution to the PTDM fulfillment requirements for the Bent Building or the Project, but not otherwise, at Landlords request. Any costs reasonably incurred by Landlord in connection with the PTDM shall be an Operating Expense.
13.6 Landlord reserves the right to modify the Common Area, including the right to add or remove exterior and interior landscaping and to subdivide real property, so long as the Common Area, as so modified, is at least functionally equivalent to the Common Area existing as of the Execution Date. Tenant acknowledges that Landlord specifically reserves the right to allow the exclusive use of corridors and restroom facilities located on specific floors to one or more tenants occupying such floors; provided , however, that Tenant shall not be deprived of the use of the corridors reasonably required to serve the Premises or of restroom facilities serving the floor upon which the Premises are located.
13.7 Subject to the terms of this Lease, including the Rules and Regulations, and the rights of other tenants of the Project, Tenant shall have the non-exclusive right to access the freight loading dock, at no additional cost.
14. Project Control by Landlord.
14.1 Landlord reserves full control over the Buildings and the Project to the extent not inconsistent with Tenants enjoyment of the Premises as provided by this Lease. This reservation includes Landlords right to subdivide the Project; convert the Bent Building and other buildings within the Project to condominium units; change the size of the Project by selling all or a portion of the Project or adding real property and any improvements thereon to the Project; grant easements and licenses to third parties; maintain or establish ownership of the Buildings separate from fee title to the Property; make additions to or reconstruct portions of the Buildings and the Project; install, use, maintain, repair, replace and relocate for service to the Premises and other parts of the Buildings or the Project pipes, ducts, conduits, wires and appurtenant fixtures, wherever located in the Premises, the Buildings or elsewhere at the Project; and alter or relocate any other Common Area or facility, including private drives, lobbies and entrances; provided , however, that such rights shall be exercised in a way that does not materially adversely affect
Tenants beneficial use and occupancy of the Premises, including the Permitted Use and Tenants access to the Premises.
14.2 Possession of areas of the Premises necessary for utilities, services, safety and operation of the Bent Building is reserved to Landlord, subject to Tenants rights of use and access as expressly provided in this Lease.
14.3 Tenant shall, at Landlords request, promptly execute such further commercially reasonable documents as may be reasonably appropriate to assist Landlord in the performance of its obligations hereunder; provided that Tenant need not execute any document that creates additional liability for Tenant or that materially adversely affects any of Tenants rights or obligations under this Lease.
14.4 Landlord may, at any and all reasonable times during non-business hours (or during business hours, if (a) with respect to Subsections 14.4(u) through 14.4 (y) , Tenant so requests, and (b) with respect to Subsection 14.4(z) , if Landlord so requests), and upon twenty-four (24) hours prior notice ( provided that no time restrictions shall apply or advance notice be required if an emergency immediately threatening life or property necessitates immediate entry), enter the Premises to (u) inspect the same and to determine whether Tenant is in compliance with its obligations hereunder, (v) supply any service Landlord is required to provide hereunder, (w) alter, improve, repair, preserve, protect or support any portion of the Buildings for which access to the Premises is reasonably necessary, provided , however, that access for alterations or improvements shall only be permitted when such alterations or improvements are required by Applicable Laws, (x) post notices of nonresponsibility, (y) access the telephone equipment, electrical substation and fire risers and (z) show the Premises to prospective purchasers or tenants during the final year of the Term. In connection with any such alteration, improvement or repair as described in Subsection 14.4(w) , Landlord may erect in the Premises or elsewhere in the Project scaffolding and other structures reasonably required for the alteration, improvement or repair work to be performed. Except as expressly provided below, in no event shall Tenants Rent abate as a result of Landlords activities pursuant to this Section; provided , however, that all such activities shall be conducted in such a manner so as to cause as little interference to Tenant as is reasonably possible. Notwithstanding anything to the contrary contained in this Lease, if (y) any of Landlords activities under this Article or (z) Landlords failure to provide utility or building services required to be provided by Landlord under this Lease (except to the extent that a failure to provide utilities results from the failure of the utility provider to provide utility service to the Project) shall, in either such case, substantially and adversely interfere with Tenants use of the Premises for the Permitted Use for a period of five (5) business days or longer, Tenants obligation to pay Base Rent, Operating Expenses and the Property Management Fee shall abate from and after the sixth (6 th ) business day of such interference until the end of the same with respect to the portion of the Premises so affected. Landlord shall at all times retain a key with which to unlock all of the doors in the Premises. If an emergency necessitates immediate access to the Premises, Landlord may use whatever force is necessary to enter the Premises, and any such entry to the Premises shall not constitute a forcible or unlawful entry to the Premises, a detainer of the Premises or an eviction of Tenant from the Premises or any portion thereof. Landlord shall, at its sole expense (other than those expenses that may properly be included in Operating Expenses), repair any damage to the Premises resulting from the exercise of its rights under this Section 14.4 , except in the event any damage has been directly or
indirectly caused as a result of or in connection with the acts or omissions of a Tenant Party (as defined below).
15. Quiet Enjoyment . So long as Tenant is not in Default under this Lease, Landlord covenants that Tenant may peacefully and quietly have, hold and enjoy the Premises, free from any claim by Landlord or persons claiming under Landlord, but subject to all of the terms and provisions hereof, provisions of Applicable Laws and rights of record to which this Lease is or may become subordinate. This covenant is in lieu of any other quiet enjoyment covenant, either express or implied.
16. Utilities and Services .
16.1 From and after the Term Commencement Date, Tenant shall pay for all water (including the cost to service, repair and replace reverse osmosis, de-ionized and other treated water systems and equipment), sewer, natural gas, heat, light, power, telephone, internet service, cable television, other telecommunications and other utilities supplied to the Premises, together with any fees, surcharges and taxes thereon. Landlord shall monitor the usage of such utilities by Tenant through the use of one or more submeters or check meters, and Landlord shall pay the cost of purchasing, installing and monitoring any related metering equipment, as necessary, at Landlords sole cost and expense.
16.2 Landlord shall not be liable for, nor shall any eviction of Tenant result from, Landlords failure to (a) furnish any utility or building service as required under this Lease (except as provided in Section 14.4 hereof), (b) obtain any permits for the Premises or the Bent Building as required under this Lease, (c) perform any of its repair or maintenance obligations under this Lease (except as provided in Section 14.4 hereof) or (d) satisfy any construction or reconstruction obligations of Landlord under this Lease, if such failure is caused by accident; breakage; repair; strike, lockout or other labor disturbance or labor dispute of any character; act of terrorism; shortage of materials, which shortage is not unique to Landlord or Tenant, as the case may be; governmental regulation, moratorium or other governmental action, inaction or delay; or other causes beyond Landlords control (but financial inability shall never constitute a cause beyond Landlords control) (collectively, Force Majeure ). In the event of such failure, Tenant shall not be entitled to termination of this Lease or (except as provided in Section 14.4 with respect to the furnishing of utilities or building services or the performance of Landlords repair or maintenance obligations under this Lease) any abatement or reduction of Rent, nor shall Tenant be relieved from the operation of any covenant or agreement of this Lease. Notwithstanding anything to the contrary contained in this Lease, Tenant shall not be liable for the failure to perform any of its repair and maintenance obligations under this Lease if such failure is caused by accident; breakage; repair; strike, lockout or other labor disturbance or labor dispute of any character; act of terrorism; shortage of materials, which shortage is not unique to Tenant; governmental regulation, moratorium or other governmental action, inaction or delay; or other causes beyond Tenants control (but financial inability shall never constitute a cause beyond Tenants control).
16.3 Tenant shall pay for, prior to delinquency of payment therefor, any utilities and services that may, at the election of Tenant or by requirement of law, be furnished to or be required to be furnished to the Premises during or, if Tenant occupies the Premises after the
expiration or earlier termination of the Term, after the Term, beyond those utilities provided by Landlord, including telephone, internet service, cable television and other telecommunications, together with any fees, surcharges and taxes thereon. Upon Landlords demand, utilities and services provided to the Premises that are separately metered shall be paid by Tenant directly to the supplier of such utilities or services.
16.4 Tenant shall not, without Landlords prior written consent, which consent shall not be unreasonably withheld, conditioned or delayed, use any device in the Premises (including data processing machines) that will in any way (a) increase the amount of ventilation, air exchange, gas, steam, electricity or water beyond the existing capacity of the Bent Building or the Bent Project as proportionately allocated to the Premises based upon Tenants Pro Rata Share of the Bent Building or Bent Project (as applicable) beyond the existing capacity of the Bent Building or the Bent Project (as applicable) as usually furnished or supplied for the Permitted Use or (b) exceed Tenants Pro Rata Share of the Bent Buildings or Bent Projects (as applicable) capacity to provide such utilities or services.
16.5 If Tenant shall require utilities or services in excess of those usually furnished or supplied for tenants in similar spaces in the Bent Building or the Bent Project by reason of Tenants equipment or extended hours of business operations, then Tenant shall first procure Landlords consent for the use thereof, which consent Landlord may condition upon the availability of such excess utilities or services but which shall not otherwise be unreasonably withheld, conditioned or delayed, and Tenant shall pay as Additional Rent an amount equal to the actual cost of providing such excess utilities and services.
16.6 Landlord shall provide water and sewer service in Common Area for lavatory and landscaping purposes only, which water shall be from the local municipal or similar source; provided , however, that if Landlord determines that Tenant requires, uses or consumes water provided to the Common Area for any purpose other than ordinary lavatory purposes, Landlord may install a water meter ( Tenant Water Meter ) and thereby measure Tenants water consumption for all purposes. Tenant shall pay Landlord for the costs of any Tenant Water Meter and the installation and maintenance thereof during the Term. If Landlord installs a Tenant Water Meter, Tenant shall pay for water consumed, as shown on such meter, as and when bills are rendered, in which event there shall be excluded from Operating Expenses the cost of all water service to the premises of other tenants of the Project. If Tenant fails to timely make such payments, Landlord may pay such charges and collect the same from Tenant. Any such costs or expenses incurred or payments made by Landlord for any of the reasons or purposes stated in this Section shall be deemed to be Additional Rent payable by Tenant and collectible by Landlord as such.
16.7 Landlord reserves the right to stop service of the elevator, plumbing, ventilation, air conditioning and utility systems, when Landlord reasonably deems necessary or desirable, due to accident, emergency or the need to make repairs, alterations or improvements, until such repairs, alterations or improvements shall have been completed, and, except as provided in Section 14.4 hereof, Landlord shall further have no responsibility or liability for failure to supply elevator facilities, plumbing, ventilation, air conditioning or utility service when prevented from doing so by Force Majeure; a failure by a third party to deliver gas, oil or another suitable fuel supply; or Landlords inability by exercise of reasonable diligence to obtain gas, oil or another
suitable fuel. Without limiting the foregoing, it is expressly understood and agreed that any covenants on Landlords part to furnish any service pursuant to any of the terms, covenants, conditions, provisions or agreements of this Lease, or to perform any act or thing for the benefit of Tenant, shall not be deemed breached if Landlord is unable to furnish or perform the same by virtue of Force Majeure.
16.8 For the Premises, Tenants and Landlords responsibilities for heating, ventilating and air conditioning systems shall be as set forth on Exhibit H hereto ( provided that Landlord shall be entitled to include its costs related to such responsibilities as Operating Expenses hereunder, except as otherwise provided in Article 9 ). Except as provided in Section 14.4 hereof, Landlord shall have no liability, and Tenant shall have no right or remedy, on account of any interruption or impairment in heating, ventilating and air conditioning services; provided that Landlord diligently endeavors to cure any such interruption or impairment.
16.9 For any utilities serving the Premises for which Tenant is billed directly by such utility provider, Tenant agrees to furnish to Landlord copies of invoices or statements for such utilities within thirty (30) days after Tenants receipt of Landlords written request therefor from time to time. In addition to the foregoing, (a) if Tenant elects to maintain any additional record of utility consumption at the Premises, Tenant shall provide Landlord a copy of any such additional record within thirty (30) days after Landlords written request therefor from time to time, and (b) Tenant shall retain and provide invoices or statements for utilities and records of utility consumption to Landlord as required by Applicable Laws. Tenant shall retain such invoices and statements from the utility provider and such additional records, if any, for at least sixty (60) months after receipt or preparation thereof, as the case may be, or for a longer period of time as required by Applicable Laws. Landlord shall have the right of access, during normal business hours and after reasonable advance notice to Tenant, to all utility meters and submeters serving the Premises in order to make readings of same from time to time. Tenant acknowledges that any utility information for the Premises, the Bent Building and the Project may be shared with third parties, including Landlords consultants and Governmental Authorities. The provisions of this Section shall survive the expiration or earlier termination of this Lease.
16.10 There currently exists a separate acid neutralization tank (the Acid Neutralization Tank ) located in the basement of the Bent Building that is connected to the Premises. Tenant shall have the exclusive right to use the Acid Neutralization Tank in accordance with Applicable Laws and subject to Tenant obtaining the MWRA Permit. Tenant shall pay all costs, charges and expenses in connection with or arising out of the operation, use, maintenance, repair or refurbishment of the Acid Neutralization Tank, including all clean-up costs relating to the Acid Neutralization Tank (collectively, Tank Costs ). The operation, use, maintenance, repair and refurbishment of the Acid Neutralization Tank shall be the sole responsibility of Tenant. In the event the Acid Neutralization Tank is damaged or repairs to the Acid Neutralization Tank are required as a result of the improper use of the Acid Neutralization Tank by Tenant, Tenant shall be responsible for the cost of any repairs or replacement required as a result of such improper use by Tenant. Tenant shall indemnify, save, defend (at Landlords option and with counsel reasonably acceptable to Landlord) and hold the Landlord Indemnitees harmless from and against any and all Claims, including (a) diminution in value of the Project or any portion thereof, (b) damages for the loss or restriction on use of rentable or usable space or of any amenity of the Project, (c) damages arising from any adverse impact on marketing of space in the
Project or any portion thereof and (d) sums paid in settlement of Claims that arise during or after the Term as a result of Tenants improper use of the Acid Neutralization Tank. This indemnification by Tenant includes costs incurred in connection with any investigation of site conditions or any clean-up, remediation, removal or restoration required by any Governmental Authority caused by Tenants improper use of the Acid Neutralization Tank.
17. Alterations .
17.1 Tenant shall make no alterations, additions or improvements in or to the Premises or engage in any construction, demolition, reconstruction, renovation, or other work (whether major or minor) of any kind in, at, or serving the Premises ( Alterations ) without Landlords prior written approval, which approval Landlord shall not unreasonably withhold, condition or delay; provided , however, that in the event any proposed Alteration affects (a) any structural portions of the Bent Building, including exterior walls, roof, foundation, foundation systems (including barriers and subslab systems), or core of the Bent Building, (b) the exterior of the Bent Building or (c) any Bent Building systems, including elevator, plumbing, air conditioning, heating, electrical, security, life safety and power, then Landlord may withhold its approval with respect thereto in its reasonable discretion. Tenant shall, in making any such Alterations, use only those architects, contractors, suppliers and mechanics of which Landlord has given prior written approval, which approval shall not be unreasonably withheld, conditioned, or delayed. In seeking Landlords approval, Tenant shall provide Landlord, at least fourteen (14) days in advance of any proposed construction, with plans, specifications, bid proposals, certified stamped engineering drawings and calculations by Tenants engineer of record or architect of record (including connections to the Bent Buildings structural system, modifications to the Bent Buildings envelope, non-structural penetrations in slabs or walls, and modifications or tie-ins to life safety systems), work contracts, requests for laydown areas and such other information concerning the nature and cost of the Alterations as Landlord may reasonably request. In no event shall Tenant use or Landlord be required to approve any architects, contractors, subcontractors or material suppliers that Landlord reasonably believes could cause labor disharmony. Notwithstanding the foregoing, Tenant may make strictly cosmetic changes to the Premises ( Cosmetic Alterations ) without Landlords consent; provided that (x) the cost of any Cosmetic Alterations does not exceed One Hundred Thousand Dollars ($100,000.00) in any one instance or Five Hundred Thousand Dollars ($500,000.00) annually, (y) such Cosmetic Alterations do not require a building permit and (z) such Cosmetic Alterations do not (i) require any structural or other substantial modifications to the Premises, (ii) require any changes to, or adversely affect, the Bent Building systems, (iii) affect the exterior of the Bent Building or (iv) trigger any requirement under Applicable Laws that would require Landlord to make any alteration or improvement to the Premises, the Bent Building or the Project. Tenant shall give Landlord at least ten (10) days prior written notice of any Cosmetic Alterations.
17.2 Tenant shall not construct or permit to be constructed partitions or other obstructions that might interfere with reasonable access to mechanical installation or service facilities of the Bent Building or with other tenants components located within the Bent Building, or unreasonably interfere with the moving of Landlords equipment to or from the enclosures containing such installations or facilities. At the time Landlord approves the plans for any such work by Tenant, Landlord shall identify any elements of Tenants proposed work that (to Landlords actual knowledge) will violate the requirements of the preceding sentence.
17.3 Tenant shall accomplish any work performed on the Premises or the Bent Building in such a manner as to permit any life safety systems to remain fully operable at all times, except as may be otherwise approved (in Landlords sole but reasonable discretion) in writing by Landlord.
17.4 Any work performed on the Premises, the Bent Building or the Bent Project by Tenant or Tenants contractors shall be done at such times and in such manner as Tenant may propose and Landlord shall approve, which approval shall not be unreasonably withheld, conditioned or delayed. Tenant covenants and agrees that all work done by Tenant or Tenants contractors shall be performed in full compliance with Applicable Laws. Within thirty (30) days after completion of any Alterations (other than Cosmetic Alterations), Tenant shall provide Landlord with complete as-built drawing print sets and electronic CADD files on disc (or files in such other current format in common use as Landlord reasonably approves or requires) showing any changes in the Premises.
17.5 Before commencing any Alterations, Tenant shall give Landlord at least fourteen (14) days prior written notice of the proposed commencement of such work. If any Alterations will cost in excess of One Million Dollars ($1,000,000) for any one project, Landlord may require, by written notice to Tenant at the time Landlord approves the plans and specifications for such Alterations, Tenant to obtain at its own cost and expense a completion and lien indemnity bond reasonably satisfactory to Landlord for such Alterations.
17.6 Tenant shall repair any damage to the Premises caused by Tenants removal of any property from the Premises. During any such restoration period, Tenant shall pay Rent to Landlord as provided herein as if such space were otherwise occupied by Tenant. The provisions of this Section shall survive the expiration or earlier termination of this Lease.
17.7 The Premises shall at all times remain the property of Landlord and shall be surrendered to Landlord upon the expiration or earlier termination of this Lease.
17.8 All Alterations, permanently attached equipment, additions and improvements attached to or built into the Premises, made by either of the Parties (including all floor and wall coverings, built-in cabinet work and paneling, sinks and related plumbing fixtures, laboratory benches, exterior venting fume hoods and walk-in freezers and refrigerators, ductwork, conduits, electrical panels and circuits), shall become the property of Landlord upon the expiration or earlier termination of the Term, and shall remain upon and be surrendered with the Premises as a part thereof, unless Landlord shall specify by written notice to Tenant, given contemporaneously with Landlords approval of the plans and specifications for any such work performed by or on behalf of Tenant, that such Alterations must be removed on or before the expiration or earlier termination of the Term, in which case Tenant shall so remove such Alterations.
17.9 Subject to Section 17.8 and except as to those items listed on Exhibit J attached hereto (which Exhibit J may be updated by Tenant from and after the Term Commencement Date, subject to Landlords written consent), all improvements installed by Tenant or at the direction of Tenant in and upon the Premises shall be and remain the property of Landlord and shall not be moved by Tenant at any time during the Term.
17.10 Notwithstanding any other provision of this Article to the contrary, in no event shall Tenant remove any improvement from the Premises as to which Landlord contributed payment without Landlords prior written consent, which consent Landlord may withhold in its sole and absolute discretion.
17.11 If Tenant shall fail to remove any of its effects from the Premises on or before the termination date of this Lease, then Landlord may, at its option, remove the same in any manner that Landlord shall choose and store such effects without liability to Tenant for loss thereof or damage thereto, and Tenant shall pay Landlord, upon demand, any costs and expenses incurred due to such removal and storage or Landlord may, at its sole option and without notice to Tenant, sell such property or any portion thereof at private sale and without legal process for such price as Landlord may obtain and apply the proceeds of such sale against any (a) amounts due by Tenant to Landlord under this Lease and (b) reasonable, out of pocket expenses incident to the removal, storage and sale of such personal property.
17.12 In the event Tenant performs Alterations, Tenant shall reimburse Landlord for its reasonable, out of pocket expenses, not to exceed Five Thousand Dollars ($5,000) for any one project, for plan review, coordination, scheduling and supervision thereof. Tenant shall reimburse Landlord for any reasonable, out of pocket extra expenses incurred by Landlord by reason of faulty work done by Tenant or its contractors, or by reason of delays caused by such work, or by reason of inadequate clean-up.
17.13 [Intentionally omitted]
17.14 Tenant shall take, and shall cause its contractors to take, commercially reasonable steps to protect the Premises during the performance of any Alterations, including covering or temporarily removing any window coverings so as to guard against dust, debris or damage.
17.15 Tenant shall require its contractors and subcontractors performing work on the Premises to name Landlord and its affiliates that are identified on a written notice to Tenant and Lenders as additional insureds on their respective insurance policies.
18. Repairs and Maintenance .
18.1 Subject to the terms of this Lease, (a) Landlord shall repair, maintain and, as necessary, replace the items that are identified in the column for Landlord Maintenance in Exhibit H hereto, and (b) Landlord shall provide the services identified in said column ( provided that Landlord shall be entitled to include its costs related to the aforementioned obligations as Operating Expenses hereunder, except as otherwise provided in Article 9 ).
18.2 Except for services of Landlord, if any, required by Section 18.1 , Tenant shall at Tenants sole cost and expense (a) be responsible for access and security to the Premises (rather than the Bent Building) and (b) maintain and keep the Premises and every part thereof in good condition and repair, damage thereto from ordinary wear and tear excepted, including the Acid Neutralization Tank and all laboratory systems, including the reverse osmosis, de-ionized and other treated water systems, vacuum, compressed air and laboratory gas. Tenant shall, upon the expiration or sooner termination of the Term, surrender the Premises to Landlord in as good a condition as when received, ordinary wear and tear, damage by casualty or eminent domain,
damage caused by the negligence or willful misconduct of Landlord, its agents, contractors, or employees; and damage resulting from the failure of Landlord to perform its obligations under this Lease in each case excepted and, subject to the foregoing, in substantially the same condition as existed on the Term Commencement Date; and shall, at Landlords request and Tenants sole cost and expense, remove all telephone and data systems, wiring and equipment from the Premises (but only to the extent installed by Tenant or Tenants employees, agents, contractors or invitees (each, a Tenant Party )), and repair any damage to the Premises caused thereby. Landlord shall have no obligation to alter, remodel, improve, repair, decorate or paint the Premises or any part thereof.
18.3 Except as provided in Section 14.4 hereof, Landlord shall not be liable for any failure to make any repairs or to perform any maintenance that is Landlords obligation pursuant to this Lease unless such failure shall persist for an unreasonable time after Tenant provides Landlord with written notice of the need of such repairs or maintenance. Tenant waives its rights under Applicable Laws now or hereafter in effect to make repairs at Landlords expense.
18.4 [Intentionally omitted]
18.5 This Article relates to repairs and maintenance arising in the ordinary course of operation of the Buildings and the Project. In the event of a casualty described in Article 24 , Article 24 shall apply in lieu of this Article. In the event of eminent domain, Article 25 shall apply in lieu of this Article.
18.6 Costs incurred by Landlord pursuant to this Article shall constitute Operating Expenses subject to the provisions of Section 14.4 hereof.
19. Liens.
19.1 Subject to the immediately succeeding sentence, Tenant shall keep the Premises, the Buildings and the Project free from any liens arising out of work or services performed, materials furnished or obligations incurred by Tenant. Tenant further covenants and agrees that any mechanics or materialmans lien filed against the Premises, the Buildings or the Project for work or services claimed to have been done for, or materials claimed to have been furnished to, or obligations incurred by Tenant shall be discharged or bonded by Tenant within twenty (20) days after Tenant is provided notice of the filing thereof, at Tenants sole cost and expense.
19.2 Should Tenant fail to discharge or bond against any lien of the nature described in Section 19.1 , Landlord may post a bond or otherwise provide security to eliminate the lien as a claim against title, and Tenant shall immediately reimburse Landlord for the reasonable, out of pocket costs thereof as Additional Rent. Tenant shall indemnify, save, defend (at Landlords option and with counsel reasonably acceptable to Landlord) and hold the Landlord Indemnitees harmless from and against any Claims arising from any such liens, including any administrative, court or other legal proceedings related to such liens.
19.3 In the event that Tenant leases or finances the acquisition of office equipment, furnishings or other personal property of a removable nature utilized by Tenant in the operation of Tenants business, Tenant warrants that any Uniform Commercial Code financing statement shall, upon its face or by exhibit thereto, indicate that such financing statement is applicable only
to removable personal property of Tenant located within the Premises. In no event shall the address of the Premises, the Buildings or the Project be furnished on a financing statement without qualifying language as to applicability of the lien only to removable personal property located in an identified suite leased by Tenant. Should any holder of a financing statement record or place of record a financing statement that reasonably appears to constitute a lien against any interest of Landlord or against equipment that may be located other than within the Premises, Tenant shall, within twenty (20) days after Tenant is provided notice of the filing such financing statement, cause (a) a copy of the Lender security agreement or other documents to which the financing statement pertains to be furnished to Landlord to facilitate Landlords ability to demonstrate that the lien of such financing statement is not applicable to Landlords interest and (b) Tenants Lender to amend such financing statement and any other documents of record to clarify that any liens imposed thereby are not applicable to any interest of Landlord in the Premises, the Buildings or the Project.
20. Estoppel Certificate . Each of Landlord and Tenant shall, within ten (10) days of receipt of written notice from the other, execute, acknowledge and deliver a statement in writing substantially in the form attached to this Lease as Exhibit K (as amended to the extent reasonably necessary), or on any other form reasonably requested by a proposed Lender, purchaser or third party with an interest in the Premises, (a) certifying that this Lease is unmodified and in full force and effect (or, if modified, stating the nature of such modification and certifying that this Lease as so modified is in full force and effect) and the dates to which rental and other charges are paid in advance, if any, (b) acknowledging that there are not, to the certifying partys knowledge, any uncured defaults on the part of the other party hereunder, or specifying such defaults if any are claimed, and (c) setting forth such further information with respect to this Lease or the Premises as may be reasonably requested thereon. Any such statement may be relied upon by any prospective purchaser, encumbrancer of all or any portion of the real property of which the Premises are a part, or other third party with an interest in the Premises or Tenant, as the case may be. Tenants failure to deliver any such statement within such the prescribed time, which failure continues for five (5) days after notice to Tenant thereof, shall, at Landlords option, constitute a Default (as defined below) under this Lease and, in any event, shall be binding upon Tenant that the Lease is in full force and effect and without modification except as may be represented by Landlord in any certificate prepared by Landlord and delivered to Tenant for execution; provided , however, that no such certificate shall have the effect of amending this Lease.
21. Hazardous Materials .
21.1 Tenant shall not cause or permit any Hazardous Materials (as defined below) to be brought upon, kept or used in or about the Premises, the Buildings or the Project in violation of Applicable Laws by any Tenant Party. If (a) Tenant breaches such obligation, (b) the presence of Hazardous Materials as a result of such a breach results in contamination of the Project, any portion thereof, or any adjacent property, (c) contamination of the Premises otherwise occurs during the Term or any extension or renewal hereof or holding over hereunder (other than if such contamination results from (i) migration of Hazardous Materials from outside the Premises not caused by a Tenant Party or (ii) to the extent such contamination is caused by Landlords gross negligence or willful misconduct) or (d) contamination of the Project occurs as a result of Hazardous Materials that are placed on or under or are released into the Project by a Tenant
Party, then Tenant shall indemnify, save, defend (at Landlords option and with counsel reasonably acceptable to Landlord) and hold the Landlord Indemnitees harmless from and against any and all Claims, including (w) diminution in value of the Project or any portion thereof, (x) damages for the loss or restriction on use of rentable or usable space or of any amenity of the Project, (y) damages arising from any adverse impact on marketing of space in the Project or any portion thereof and (z) sums paid in settlement of Claims that arise during or after the Term as a result of such breach or contamination. This indemnification by Tenant includes costs incurred in connection with any investigation of site conditions or any clean-up, remedial, removal or restoration work required by any Governmental Authority because of Hazardous Materials present in the air, soil or groundwater above, on or under or about the Project due to any of the events described in the second sentence of this Section. Without limiting the foregoing, if the presence of any Hazardous Materials in, on, under or about the Project, any portion thereof or any adjacent property caused or permitted by any Tenant Party results in any contamination of the Project, any portion thereof or any adjacent property, then Tenant shall promptly take all actions at its sole cost and expense as are necessary to return the Project, any portion thereof or any adjacent property to its respective condition existing prior to the time of such contamination; provided that Landlords written approval of such action shall first be obtained, which approval Landlord shall not unreasonably withhold, condition or delay; and provided , further, that it shall be reasonable for Landlord to withhold its consent if such actions could have a material adverse long-term or short-term effect on the Project, any portion thereof or any adjacent property. Notwithstanding the foregoing, Landlord shall indemnify, save, defend (at Tenants option and with counsel reasonably acceptable to Tenant) and hold the Tenant Parties harmless from and against any and all Claims resulting from the presence of Hazardous Materials (y) at the Project in violation of Applicable Laws as of the Execution Date, unless placed at the Project by a Tenant Party or having migrated to the Project as a result of the acts of a Tenant Party, or (z) released at, in, on, under or upon the Project by Landlord or its agents, contractors or employees.
21.2 Landlord acknowledges that it is not the intent of this Article to prohibit or unreasonably limit Tenant from operating its business for the Permitted Use. Tenant may operate its business according to the custom of Tenants industry so long as the use or presence of Hazardous Materials is strictly and properly monitored in accordance with Applicable Laws. As a material inducement to Landlord to allow Tenant to use Hazardous Materials in connection with its business, Tenant agrees to deliver to Landlord (a) a list identifying each type of Hazardous Material to be present at the Premises that is subject to regulation under any environmental Applicable Laws, (b) a list of any and all approvals or permits from Governmental Authorities required in connection with the presence of such Hazardous Material at the Premises and (c) correct and complete copies of (i) notices of violations of Applicable Laws related to Hazardous Materials at the Premises and (ii) plans relating to the installation of any storage tanks to be installed in, on, under or about the Bent Project by or on behalf of Tenant ( provided that installation of storage tanks shall only be permitted after Landlord has given Tenant its written consent to do so, which consent Landlord may withhold in its sole and absolute discretion with respect to underground storage tanks, but which consent Landlord shall not otherwise unreasonably withhold, condition, or delay) and closure plans or any other documents required by any and all Governmental Authorities for any storage tanks installed in, on, under or about the Bent Project by or on behalf of Tenant for the closure of any such storage tanks (collectively, Hazardous Materials Documents ). Tenant shall deliver to Landlord updated Hazardous
Materials Documents (l) no later than thirty (30) days prior to the initial occupancy of any portion of the Premises or the initial placement of equipment anywhere at the Project, (m) if there are any changes to the Hazardous Materials Documents, annually thereafter no later than December 31 of each year, and (n) thirty (30) days prior to the initiation by Tenant of any Alterations or changes in Tenants business that involve any material increase in the types or amounts of Hazardous Materials. For each type of Hazardous Material listed, the Hazardous Materials Documents shall include (t) the chemical name, (u) the material state (e.g., solid, liquid, gas or cryogen), (v) the concentration, (w) the storage amount (which may be a range or a maximum amount) and storage condition (e.g., in cabinets or not in cabinets), (x) the use amount and use condition (e.g., open use or closed use), (y) the location (e.g., room number or other identification) and (z) if known, the chemical abstract service number. Notwithstanding anything in this Section to the contrary, Tenant shall not be required to provide Landlord with any Hazardous Materials Documents containing information of a proprietary nature. Landlord may, at Landlords expense, cause the Hazardous Materials Documents to be reviewed by a person or firm qualified to analyze Hazardous Materials to confirm compliance with the provisions of this Lease and with Applicable Laws. In the event that a review of the Hazardous Materials Documents indicates non-compliance with this Lease or Applicable Laws, Tenant shall, at its expense, diligently take steps to bring its storage and use of Hazardous Materials into compliance.
21.3 [Intentionally omitted]
21.4 If Landlord reasonably believes that any Hazardous Materials have been released in violation of this Lease or Applicable Laws on the Project, Landlord shall have the right to conduct appropriate tests of the Project or any portion thereof. Landlords activities pursuant to this Section shall be conducted in such a manner as to minimize interference to Tenant to the extent reasonably possible. Tenant shall pay all reasonable, out of pocket costs of such tests if such tests reveal that Hazardous Materials exist at the Project in violation of Tenants obligations under this Lease.
21.5 If underground or other storage tanks storing Hazardous Materials installed or utilized by Tenant are located on the Premises, or are hereafter placed on the Premises by Tenant (or by any other party, if such storage tanks are utilized by Tenant), then Tenant shall monitor the storage tanks, maintain appropriate records, implement reporting procedures, properly close any underground storage tanks, and take or cause to be taken all other steps necessary or required concerning such tanks under Applicable Laws. Tenant shall have no responsibility or liability for underground or other storage tanks installed by anyone other than Tenant unless Tenant utilizes such tanks, in which case Tenants responsibility for such tanks shall be as set forth in this Section.
21.6 Tenant shall promptly report to Landlord any actual presence of mold or water intrusion at the Premises of which Tenant becomes aware or any suspected presence of the same; provided , however, that Tenant shall not be obligated to conduct special inspections on a routine basis outside of the normal conduct of its business related to the same.
21.7 Both Tenants obligations under Sections 21.1 and 21.4 and Tenants liabilities related to a breach of its obligations under any term of this Article shall survive the expiration or
earlier termination of the Lease. During any period of time needed by Tenant or Landlord after the termination of this Lease to complete the removal from the Premises of any Hazardous Materials for which Tenant is responsible pursuant to the terms of this Lease, Tenant shall be deemed a holdover tenant and subject to the provisions of Article 27 .
21.8 As used herein, the term Hazardous Material means any hazardous or toxic substance, material or waste that is or becomes regulated by any Governmental Authority.
21.9 Notwithstanding anything to the contrary in this Lease, Landlord shall, subject to the following provisions of this Section, have sole control over the allocation of fire control areas (as defined in the Uniform Building Code as adopted by the City of Cambridge (the UBC )) within the Bent Project for the storage of Hazardous Materials. In the exercise of such control, Landlord agrees that, during the Term (a) Tenant shall be entitled to the exclusive use of the two (2) control areas on the first (1 st ) floor of the Bent Building shown on Exhibit L attached hereto, (b) to the extent that any new tenant on the first (1 st ) floor of the Bent Building requires one (1) or more control areas, such tenant or Landlord will build out independent, self-contained control areas to satisfy that need in portions of the first (1 st ) floor of the Bent Building other than the Premises, and (c) provided that Tenant is the exclusive tenant on the second (2 nd ) floor of the Bent Building, Tenant shall be entitled to use all of the control areas located on such floor.
22. Odors and Exhaust.
Tenant acknowledges that Landlord would not enter into this Lease with Tenant unless Tenant assured Landlord that under no circumstances will any other occupants of the Buildings or the Project (including persons legally present in any outdoor areas of the Project) be subjected to odors or fumes (whether or not noxious), and that the Buildings and the Project will not be damaged by any exhaust, in each case from Tenants operations, including in Tenants vivarium. Landlord and Tenant therefore agree as follows:
22.1 Tenant shall not cause or permit (or conduct any activities that would cause) any release of any odors or fumes of any kind from the Premises.
22.2 If the Bent Building has a ventilation system that, in Landlords judgment, is adequate, suitable, and appropriate to vent the Premises in a manner that does not release odors affecting any indoor or outdoor part of the Project, Tenant shall vent the Premises through such system. If Landlord at any time determines that any existing ventilation system is inadequate, or if no ventilation system exists, Tenant shall in compliance with Applicable Laws vent all fumes and odors from the Premises (and remove odors from Tenants exhaust stream) as Landlord requires. The placement and configuration of all ventilation exhaust pipes, louvers and other equipment shall be subject to Landlords approval, which shall not be unreasonably withheld, conditioned or delayed. Tenant acknowledges Landlords legitimate desire to maintain the Project (indoor and outdoor areas) in an odor-free manner, and Landlord may require Tenant to abate and remove all odors in a manner that may go beyond the requirements of Applicable Laws.
22.3 Tenant shall, at Tenants sole cost and expense, provide odor eliminators and other devices (such as filters, air cleaners, scrubbers and whatever other equipment may in Landlords
reasonable judgment be necessary or appropriate from time to time) to completely remove, eliminate and abate any odors, fumes or other substances in Tenants exhaust stream that, in Landlords reasonable judgment, emanate from Tenants Premises. Any work Tenant performs under this Section shall constitute Alterations.
22.4 Tenants responsibility to remove, eliminate and abate odors, fumes and exhaust shall continue throughout the Term. Landlords approval of any Alterations or other work in the Premises shall not preclude Landlord from requiring reasonable additional measures to eliminate odors, fumes and other adverse impacts of Tenants exhaust stream (as Landlord may designate in Landlords reasonable discretion). Tenant shall, subject to Landlords review and approval (which shall not be unreasonably withheld, conditioned or delayed), (a) use the Bent Buildings exhaust system and (b) dilute any explosive gases emitted by Tenant into the Bent Buildings exhaust system in accordance with Applicable Laws and customary safety practices. Tenant shall install additional equipment as Landlord reasonably requires from time to time under the preceding two sentences. Such installations shall constitute Alterations.
22.5 If Tenant fails to install satisfactory odor control equipment within ten (10) business days after Landlords demand made at any time, then Landlord may, without limiting Landlords other rights and remedies, require Tenant to cease and suspend any operations in the Premises that, in Landlords reasonable determination, cause odors, fumes or exhaust. For example, if Landlord determines that Tenants production of a certain type of product causes odors, fumes or exhaust, and Tenant does not install satisfactory odor control equipment within ten (10) business days after Landlords request, then Landlord may require Tenant to stop producing such type of product in the Premises unless and until Tenant has installed odor control equipment satisfactory to Landlord.
23. Insurance; Waiver of Subrogation . Landlord shall maintain insurance for the Bent Building, the Bent Project and the Garage in amounts equal to full replacement cost thereof (exclusive of the costs of excavation, foundations and footings, and without reference to depreciation taken by Landlord upon its books or tax returns) providing protection against any peril generally included within the classification Fire and Extended Coverage, together with insurance against sprinkler damage, vandalism and malicious mischief, loss or failure of building equipment, rental loss during the period of repairs or rebuilding, workmens compensation insurance and fidelity bonds for employees employed to perform services. Landlord, subject to availability thereof, shall further insure, if Landlord deems it appropriate, coverage against flood, environmental hazard or earthquake. Notwithstanding the foregoing, Landlord may, but shall not be deemed required to, provide insurance for any improvements installed by Tenant or that are in addition to the standard improvements customarily furnished by Landlord, without regard to whether or not such are made a part of or are affixed to the Bent Building; provided , however, that if Landlord does not provide such insurance for such improvements installed by Tenant, then Operating Expenses shall not include the cost of any such insurance provided by Landlord with respect to such improvements by other tenants of the Project.
23.2 In addition, Landlord shall carry commercial general liability insurance with a single limit of not less than Two Million Dollars ($2,000,000) per occurrence for death or bodily injury, or property damage with respect to the Bent Project and Garage.
23.3 Tenant shall, at its own cost and expense, procure and maintain in effect, beginning on the Term Commencement Date and continuing throughout the Term (and occupancy by Tenant, if any, after termination of this Lease) commercial general liability insurance with limits of not less than One Million Dollars ($1,000,000) per occurrence and not less than Two Million Dollars ($2,000,000) in the aggregate for death or bodily injury and for property damage with respect to the Premises (including $100,000 fire legal liability (each loss)) and umbrella liability coverage with a limit of not less than Ten Million Dollars ($10,000,000) per occurrence and in the aggregate; and, after the Term Commencement Date, a Pollution/Environmental Policy covering the environmental risks of Tenants business with limits of not less than Three Million Dollars ($3,000,000) per occurrence and not less than Five Million Dollars ($5,000,000) in the aggregate, with respect to environmental contamination and pollution of the Premises caused by Tenant.
23.4 The insurance required to be purchased and maintained by Tenant pursuant to this Lease shall name Landlord, BioMed Realty, L.P., BioMed Realty Trust, Inc., and MBA-Rogers Street, LLC and their respective officers, directors, employees, agents, general partners, members, subsidiaries, affiliates and Lenders ( Landlord Parties ) as additional insureds. Such insurance shall be with companies authorized to do business in the state in which the Project is located and having a rating of not less than policyholder rating of A- and financial category rating of at least Class VIII in Bests Insurance Guide. Tenant shall obtain for Landlord from the insurance companies or cause the insurance companies to furnish certificates of coverage to Landlord. No such policy shall be cancelable or subject to reduction of coverage or other modification or cancellation unless the insurer shall endeavor to give thirty (30) days prior written notice to Landlord from the insurer; provided , however, that if the insurer is unwilling to provide such notice, Tenant shall provide such notice to Owner in accordance with the foregoing requirements. All such policies shall be written as primary policies, not contributing with and not in excess of the coverage that Landlord may carry. Tenants policy may be a blanket policy that specifically provides that the amount of insurance shall not be prejudiced by other losses covered by the policy. Tenant shall, at least three (3) days prior to the expiration of such policies, furnish Landlord with renewals or binders. Tenant agrees that if Tenant does not take out and maintain such insurance, which failure continues for more than two (2) business days after notice to Tenant thereof, Landlord may (but shall not be required to) procure such insurance on Tenants behalf and at its cost to be paid by Tenant as Additional Rent.
23.5 Tenant assumes the risk of damage to any fixtures, goods, inventory, merchandise, equipment and leasehold improvements, and Landlord shall not be liable for injury to Tenants business or any loss of income therefrom, relative to such damage, all as more particularly set forth within this Lease, except to the extent the same results from the gross negligence or willful misconduct of Landlord or its agents, contractors or employees. Tenant shall, at Tenants sole cost and expense, carry such insurance as Tenant desires for Tenants protection with respect to personal property of Tenant or business interruption.
23.6 In each instance where insurance is to name Landlord Parties as additional insureds, Tenant shall, upon Landlords written request, also designate and furnish certificates evidencing such Landlord Parties as additional insureds to (a) any Lender of Landlord holding a security interest in either of the Buildings, any portion of the Property or the Project, (b) the landlord under any lease whereunder Landlord is a tenant of the Property if the interest of
Landlord is or shall become that of a tenant under a ground lease rather than that of a fee owner and (c) any management company retained by Landlord to manage any portion of the Project; provided that, in each such case, Tenant has been given written notice of such party, including such partys name, address and interest in the Premises.
23.7 Landlord and Tenant each hereby waive any and all rights of recovery against the other or against the officers, directors, employees, agents, general partners, members, subsidiaries, affiliates and Lenders of the other on account of loss or damage occasioned by such waiving party or its property or the property of others under such waiving partys control, in each case to the extent that such loss or damage is insured against under any fire and extended coverage insurance policy that either Landlord or Tenant may have in force at the time of such loss or damage or would be insured against under any policy that such party is required to carry hereunder, regardless of whether such required insurance is actually in effect. Such waivers shall continue so long as their respective insurers so permit. Any termination of such a waiver shall be by advance written notice to the other party, containing a description of the circumstances hereinafter set forth in this Section. Landlord and Tenant, upon obtaining the policies of insurance required or permitted under this Lease, shall give notice to the insurance carrier or carriers that the foregoing mutual waiver of subrogation is contained in this Lease. If such policies shall not be obtainable with such waiver or shall be so obtainable only at a premium over that chargeable without such waiver, then the party seeking such policy shall notify the other in advance of such conditions, and the party so notified shall have ten (10) days thereafter to either (a) procure such insurance with companies reasonably satisfactory to the other party or (b) agree to pay such additional premium (in Tenants case, in the proportion that the area of the Premises bears to the insured area). If the parties do not accomplish either (a) or (b), then this Section shall have no effect during such time as such policies shall not be obtainable or the party in whose favor a waiver of subrogation is desired refuses to pay the additional premium. If such policies shall at any time be unobtainable, but shall be subsequently obtainable, then neither party shall be subsequently liable for a failure to obtain such insurance until a reasonable time after notification thereof by the other party. If the release of either Landlord or Tenant, as set forth in the first (1 st ) sentence of this Section, shall contravene Applicable Laws, then the liability of the party in question shall be deemed not released but shall be secondary to the other partys insurer.
23.8 Landlord may require insurance policy limits required under this Lease to be raised to conform with requirements of Landlords Lender or to bring coverage limits to levels then being required of new tenants within the Bent Project; provided that any such increased coverage limits are then customarily being required to be provided by tenants of properties comparable to the Project in the East Cambridge market.
23.9 Any costs incurred by Landlord pursuant to this Article shall constitute a portion of Operating Expenses.
24. Damage or Destruction .
24.1 In the event of a partial destruction of (a) the Premises, (b) the Common Area of the Bent Building or the Project or (c) the Garage ((a), (b) and (c) collectively, the Affected Areas ) by fire or other perils covered by extended coverage insurance and provided that (x) the
damage thereto is such that the Affected Areas may, in the ordinary course, be repaired, reconstructed or restored within a period of nine (9) months from the date of the happening of such casualty, (y) Landlord shall receive insurance proceeds sufficient to cover the cost of such repairs, reconstruction and restoration (except for any deductible amount provided by Landlords policy, which deductible amount shall be paid by Landlord and shall constitute an Operating Expense) and (z) such casualty was not deliberately caused by a Tenant Party, then Landlord shall commence and proceed diligently with the work of repair, reconstruction and restoration of the Affected Areas and this Lease shall continue in full force and effect.
24.2 In the event of any damage to or destruction of the Bent Building, the Bent Project or the Garage other than as described in Section 24.1 , Landlord may elect to repair, reconstruct and restore the Bent Building, the Bent Project or the Garage, as applicable, in which case this Lease shall continue in full force and effect. If Landlord elects not to repair, reconstruct and restore the Bent Building, the Bent Project or the Garage, as applicable, then this Lease shall terminate as of the date of such damage or destruction; provided , however, that if the Premises have not been damaged, then Landlord may terminate this Lease only if, reasonably simultaneously therewith, Landlord terminates the leases of all other tenants of the Project similarly affected. In the event of any damage or destruction (regardless of whether such damage is governed by Section 24.1 or this Section), if (a) in Landlords determination as set forth in the Damage Repair Estimate (as defined below), the Affected Areas cannot be repaired, reconstructed or restored within nine (9) months after the date of the Damage Repair Estimate, (b) subject to Section 24.6 , the Affected Areas are not actually repaired, reconstructed and restored within twelve (12) months after the date of the Damage Repair Estimate, or (c) the damage and destruction occurs within the last twelve (12) months of the then-current Term (and Tenant has not elected to extend the Term as provided herein), then Tenant shall have the right to terminate this Lease, effective as of the date of such damage or destruction, by delivering to Landlord its written notice of termination (a Termination Notice ) (y) with respect to Subsections 24.2(a) and (c) , no later than fifteen (15) days after Landlord delivers to Tenant Landlords Damage Repair Estimate and (z) with respect to Subsection 24.2(b) , no later than fifteen (15) days after such twelve (12) month period (as the same may be extended pursuant to Section 24.6 ) expires. If Tenant provides Landlord with a Termination Notice pursuant to Subsection 24.2(z) , Landlord shall have an additional thirty (30) days after receipt of such Termination Notice to complete the repair, reconstruction and restoration. If Landlord does not complete such repair, reconstruction and restoration within such thirty (30) day period, then Tenant may terminate this Lease by giving Landlord written notice within two (2) business days after the expiration of such thirty (30) day period. If Landlord does complete such repair, reconstruction and restoration within such thirty (30) day period, then this Lease shall continue in full force and effect.
24.3 As soon as reasonably practicable, but in any event within sixty (60) days following the date of damage or destruction, Landlord shall notify Tenant of Landlords good faith estimate of the period of time in which the repairs, reconstruction and restoration will be completed (the Damage Repair Estimate ), which estimate shall be based upon the opinion of a contractor reasonably selected by Landlord and experienced in comparable repair, reconstruction and restoration of similar buildings. Additionally, Landlord shall give written notice to Tenant within sixty (60) days following the date of damage or destruction of its election not to repair, reconstruct or restore the Bent Building, the Bent Project or the Garage, as applicable.
24.4 Upon any termination of this Lease under any of the provisions of this Article, the parties shall be released thereby without further obligation to the other from the date possession of the Premises is surrendered to Landlord, except with regard to (a) items occurring prior to the damage or destruction and (b) provisions of this Lease that, by their express terms, survive the expiration or earlier termination hereof. Notwithstanding the foregoing, any Rent that has been paid and is attributable to any period after the effective date of such termination shall be reimbursed to Tenant within thirty (30) days after demand by Tenant.
24.5 In the event of repair, reconstruction and restoration as provided in this Article, all Rent to be paid by Tenant under this Lease shall be abated proportionately based on the extent to which Tenants use of the Premises is impaired during the period of such repair, reconstruction or restoration. If only a portion of the Premises shall be impaired, but both (a) Tenant shall reasonably determine that it is uneconomical to continue operations in the remainder of the Premises during the period of reconstruction and (b) Landlords loss of rental insurance will cover the period of repair, reconstruction and restoration for the entire Premises, Tenants obligation to pay Base Rent, Operating Expenses and Property Management Fee shall abate for the entire Premises; provided that Tenant actually vacates the entire Premises during such period.
24.6 Notwithstanding anything to the contrary contained in this Article, should Landlord be delayed or prevented from completing the repair, reconstruction or restoration of the damage or destruction to the Premises after the occurrence of such damage or destruction by Force Majeure or delays caused by a Tenant Party, then the time for Landlord to commence or complete repairs, reconstruction and restoration shall be extended on a day-for-day basis; provided , however, that any delay by reason of Force Majeure shall not exceed ninety (90) days in the aggregate.
24.7 If Landlord is obligated to or elects to repair, reconstruct or restore as herein provided, then Landlord shall be obligated to make such repairs, reconstruction or restoration only with regard to (a) those portions of the Premises that were originally provided at Landlords expense or that Landlord has elected to insure as provided in Section 23.1 and (b) the Common Area portion of the Affected Areas. The repairs, reconstruction or restoration of improvements not originally provided by Landlord or insured by Landlord as provided in Section 23.1 or at Landlords expense shall be the obligation of Tenant. In the event Tenant has elected to upgrade certain improvements from the Building Standard, Landlord shall, upon the need for replacement due to an insured loss, provide only the Building Standard, unless Tenant again elects to upgrade such improvements and pay any incremental costs related thereto, except to the extent that excess insurance proceeds, if received, are adequate to provide such upgrades, in addition to providing for basic repairs, reconstruction and restoration of the Bent Building, the Bent Project and the Garage.
24.8 Notwithstanding anything to the contrary contained in this Article, each of Landlord and Tenant may elect to terminate this Lease if the damage resulting from any casualty covered under this Article occurs (a) during the thirteenth (13th) through the twenty-fourth (24th) months prior to the expiration of the Term and the Damage Repair Estimate indicates that more than six (6) months will be required for such repair, reconstruction or restoration, unless Tenant gives Landlord written notice within ten (10) business days after receipt of Landlords termination notice that Tenant will elect to exercise any option to extend the Term provided in
this Lease, (b) during the seventh (7th) through twelfth (12th) months prior to the expiration of the Term and the Damage Repair Estimate indicates that more than thirty (30) days will be required for such repair, reconstruction or restoration, unless Tenant has elected to extend the Term as provided herein, (c) during the last six (6) months of the Term unless Tenant has elected to extend the Term as provided herein or (d) to the extent that insurance proceeds are not available therefor other than by reason of the failure of Landlord to maintain the insurance required to be maintained by Landlord under this Lease.
24.9 Landlords obligation, should it elect or be obligated to repair, reconstruct or restore, shall be limited to the Affected Areas. Tenant shall, at its expense, replace or fully repair all of Tenants personal property and any Alterations installed by Tenant existing at the time of such damage or destruction. If Affected Areas are to be repaired, reconstructed or restored in accordance with the foregoing, Landlord shall make available to Tenant any portion of insurance proceeds it receives that are allocable to the Alterations constructed by Tenant pursuant to this Lease; provided Tenant is not then in Default under this Lease and has not received written notice from Landlord that any failure of Tenant to act or any state of facts (other than facts that exist as a result of the casualty at issue) exists that, in either such case, with the passage of time could ripen into a Default (and, in such case, Landlord shall release such proceeds forthwith after Tenant cures the matter set forth in Landlords Notice), and subject to the requirements of any Lender of Landlord.
25. Eminent Domain .
25.1 In the event (a) the whole of all Affected Areas or (b) such part thereof as shall substantially interfere with Tenants use and occupancy of the Premises for the Permitted Use shall be taken for any public or quasi-public purpose by any lawful power or authority by exercise of the right of appropriation, condemnation or eminent domain, or sold to prevent such taking, Tenant or Landlord may terminate this Lease effective as of the date possession is required to be surrendered to such authority, except with regard to (y) items occurring prior to the taking and (z) provisions of this Lease that, by their express terms, survive the expiration or earlier termination hereof.
25.2 In the event of a partial taking of (a) the Bent Building, the Bent Project or the Garage or (b) drives, walkways or parking areas serving the Bent Building or the Project for any public or quasi-public purpose by any lawful power or authority by exercise of right of appropriation, condemnation, or eminent domain, or sold to prevent such taking, then, without regard to whether any portion of the Premises occupied by Tenant was so taken, Landlord may elect to terminate this Lease (except with regard to (y) items occurring prior to the taking and (z) provisions of this Lease that, by their express terms, survive the expiration or earlier termination hereof) as of such taking if such taking is, in Landlords sole but reasonable opinion, of a material nature such as to make it uneconomical to continue use of the unappropriated portion for purposes of renting office or laboratory space.
25.3 Tenant shall be entitled to any award that is specifically awarded as compensation for (a) the taking of Tenants personal property, (b) the unamortized value of leasehold improvements or alterations that were installed at Tenants expense (i.e., net of the TI Allowance, as that term is defined in Section 4.2 ), but only to the extent of the portion of the unamortized
value that is attributable to the Term, and (c) the costs of Tenant moving to a new location. Except as set forth in the previous sentence, any award for such taking shall be the property of Landlord. Tenant shall be entitled to file a separate claim for an award in compensation for the items identified in this Section; provided , however, that Tenant shall not be entitled to file or pursue such a claim if any sum that may be awarded to Tenant may reduce any award amounts to which Landlord would be otherwise entitled.
25.4 If, upon any taking of the nature described in this Article, this Lease continues in effect, then Landlord shall promptly proceed to restore the Affected Areas to substantially their same condition prior to such partial taking. If less than the entirety of the Premises is restored as provided herein, the Rent and Tenants Proportionate Share shall be decreased proportionately to reflect the loss of any portion of the Premises no longer available to Tenant.
26. Surrender .
26.1 At least ten (10) days prior to Tenants surrender of possession of any part of the Premises, Tenant shall provide Landlord with (a) a facility decommissioning and Hazardous Materials closure plan for the Premises ( Exit Survey ) prepared by an independent third party reasonably acceptable to Landlord, (b) written evidence of all appropriate governmental releases obtained by Tenant in accordance with Applicable Laws, including laws pertaining to the surrender of the Premises, and (c) proof that the Premises have been decommissioned in accordance with American National Standards Institute ( ANSI ) Publication Z9.11-2008 (entitled Laboratory Decommissioning ) or any successor standards published by ANSI or any successor organization (or, if ANSI and its successors no longer exist, a similar entity publishing similar standards). In addition, Tenant agrees to remain responsible after the surrender of the Premises for the remediation of any recognized environmental conditions set forth in the Exit Survey (other than any matter for which Landlord is expressly responsible under the provisions of this Lease) and compliance with any recommendations set forth in the Exit Survey. Tenants obligations under this Section shall survive the expiration or earlier termination of the Lease.
26.2 No surrender of possession of any part of the Premises shall release Tenant from any of its obligations hereunder, unless such surrender is accepted in writing by Landlord.
26.3 The voluntary or other surrender of this Lease by Tenant shall not effect a merger with Landlords fee title or leasehold interest in the Premises, the Buildings, the Property or the Project, unless Landlord consents in writing, and shall, at Landlords option, operate as an assignment to Landlord of any or all subleases.
26.4 The voluntary or other surrender of any ground or other underlying lease that now exists or may hereafter be executed affecting all or any portion of the Project, or a mutual cancellation thereof or of Landlords interest therein by Landlord and its lessor, shall not effect a merger with Landlords fee title or leasehold interest in the Premises or all or any portion of the Project and shall, at the option of the successor to Landlords interest in all or any portion of the Project, operate as an assignment of this Lease by Landlord.
27. Holding Over.
27.1 If, with Landlords prior written consent, Tenant holds possession of all or any part of the Premises after the Term, Tenant shall become a tenant from month to month after the expiration or earlier termination of the Term, and in such case Tenant shall continue to pay (a) Base Rent in accordance with Article 7 and (b) any amounts for which Tenant would otherwise be liable under this Lease if the Lease were still in effect, including payments for Tenants Share of Operating Expenses. Any such month-to-month tenancy shall be subject to every other term, covenant and agreement contained herein.
27.2 Notwithstanding the foregoing, if Tenant remains in possession of the Premises after the expiration or earlier termination of the Term without Landlords prior written consent, (a) Tenant shall become a tenant at sufferance subject to the terms and conditions of this Lease, except that the monthly rent shall be equal to one hundred fifty percent (150%) of the Rent in effect during the last thirty (30) days of the Term, and (b) if such holdover continues for more than fifteen (15) days, Tenant shall be liable to Landlord for any and all damages suffered by Landlord as a result of such holdover, including any lost rent or consequential, special and indirect damages.
27.3 Acceptance by Landlord of Rent after the expiration or earlier termination of the Term shall not result in an extension, renewal or reinstatement of this Lease.
27.4 The foregoing provisions of this Article are in addition to and do not affect Landlords right of reentry or any other rights of Landlord hereunder or as otherwise provided by Applicable Laws.
28. Indemnification and Exculpation .
28.1 Tenant agrees to indemnify, save, defend (at Landlords option and with counsel reasonably acceptable to Landlord) and hold the Landlord Indemnitees harmless from and against any and all Claims arising from injury or death to any person or damage to any property occurring within or about the Premises, the Buildings, the Property or the Project arising directly or indirectly out of a Tenant Partys use or occupancy of the Premises or a breach or default by Tenant in the performance of any of its obligations hereunder, except to the extent caused by the negligence or willful misconduct of Landlord, its agents, contractors, or employees. Landlord agrees to indemnify, save, defend (at Tenants option and with counsel reasonably acceptable to Tenant) and hold Tenant and Tenants directors, officers, employees and agents harmless from and against any and all Claims arising from injury or death to any person or damage to any property caused by the gross negligence or willful misconduct of Landlord or Landlords agents, contractors or employees.
28.2 Notwithstanding anything in this Lease to the contrary, Landlord shall not be liable to Tenant for and Tenant assumes all risk of (a) damage or losses caused by fire, electrical malfunction, gas explosion or water damage of any type (including broken water lines, malfunctioning fire sprinkler systems, roof leaks or stoppages of lines), unless any such loss is due to Landlords gross negligence or willful disregard of written notice by Tenant of need for a repair that Landlord is responsible to make for an unreasonable period of time, and (b) damage to
personal property or scientific research, including loss of records kept by Tenant within the Premises. Tenant further waives any claim for injury to Tenants business or loss of income relating to any such damage or destruction of personal property as described in this Section. Notwithstanding anything in the foregoing or this Lease to the contrary, except (x) as otherwise expressly provided herein, (y) as may be provided by Applicable Laws or (z) in the event of Tenants breach of Article 21 or Section 26.1 , in no event shall Landlord or Tenant be liable to the other for any consequential, special or indirect damages arising out of this Lease.
28.3 Landlord shall not be liable for any damages arising from any act, omission or neglect of any other tenant in the Buildings or the Project, or of any other third party.
28.4 Tenant acknowledges that security devices and services, if any, while intended to deter crime, may not in given instances prevent theft or other criminal acts. Landlord shall not be liable for injuries or losses caused by criminal acts of third parties, and Tenant assumes the risk that any security device or service may malfunction or otherwise be circumvented by a criminal. If Tenant desires protection against such criminal acts, then Tenant shall, at Tenants sole cost and expense, obtain appropriate insurance coverage.
28.5 The provisions of this Article shall survive the expiration or earlier termination of this Lease.
29. Assignment or Subletting .
29.1 Except as hereinafter expressly permitted, Tenant shall not, either voluntarily or by operation of Applicable Laws, directly or indirectly sell, hypothecate, assign, pledge, encumber or otherwise transfer this Lease, or sublet the Premises (each, a Transfer ), without Landlords prior written consent, which consent shall not be unreasonably withheld, conditioned or delayed. Notwithstanding the foregoing, Tenant shall have the right to Transfer without Landlords prior written consent the Premises or any part thereof to any person that as of the date of determination is an affiliate of Tenant ( provided , however, that in the event of an assignment to any Tenants Affiliate (defined below), any subsequent sale or transfer of stock resulting in a change in voting control, or any other transaction(s) having the overall effect that such entity ceases to be Tenants Affiliate, which transaction is made primarily to enable Tenant to transfer the lessees interest in this Lease to the transferee without Landlords consent (and not for an independent business reason), shall be treated as if such sale or transfer or transaction(s) were, for all purposes, an assignment of this Lease governed by the provisions of this Article 29 ) or a successor to Tenant by merger, consolidation or purchase (collectively, Tenants Affiliate ), provided that Tenant shall notify Landlord in writing at least ten (10) days prior to the effectiveness of such Transfer (except to the extent that Tenant is prohibited from providing such notice in advance of the effectiveness of such Transfer by Applicable Laws or by any confidentiality agreement to which Tenant is a party, in which event Tenant shall notify Landlord in writing not later than five (5) days after the effective date of such Transfer) to Tenants Affiliate (an Exempt Transfer ) and otherwise comply with the requirements of this Lease regarding such Transfer; and provided , further, that the person that will be the tenant under this Lease after the Exempt Transfer has a net worth (as of the day immediately after the Exempt Transfer) that is equal to or greater than the net worth (as of the date of the Exempt Transfer) of the transferring Tenant. For purposes of Exempt Transfers, control requires both (a) owning
(directly or indirectly) more than fifty percent (50%) of the stock or other equity interests of another person and (b) possessing, directly or indirectly, the power to direct or cause the direction of the management and policies of such person. In no event shall Tenant perform a Transfer, other than an Exempt Transfer, to or with an entity that is a tenant at the Project or that is, as of the date of determination (or at any point in time during the six (6) months immediately prior thereto) in discussions or negotiations with Landlord or an affiliate of Landlord to lease premises at the Project or a property owned by Landlord or an affiliate of Landlord.
29.2 In the event Tenant desires to effect a Transfer, then, except as otherwise provided above with respect to any Exempt Transfer, at least thirty (30) but not more than ninety (90) days prior to the date when Tenant desires the assignment or sublease to be effective (the Transfer Date ), Tenant shall provide written notice to Landlord (the Transfer Notice ) containing information (including references) concerning the character of the proposed transferee, assignee or sublessee; the Transfer Date; any ownership or commercial relationship between Tenant and the proposed transferee, assignee or sublessee; and the consideration and all other material terms and conditions of the proposed Transfer, all in such detail as Landlord shall reasonably require by written notice to Tenant.
29.3 Landlord, in determining whether consent should be given to a proposed Transfer, may give consideration to (a) the financial strength of such transferee, assignee or sublessee (notwithstanding, but taking into account, Tenant remaining liable for Tenants performance), (b) any change in use that such transferee, assignee or sublessee proposes to make in the use of the Premises and (c) Landlords desire to exercise its rights under Section 29.8 to cancel this Lease. In no event shall Landlord be deemed to be unreasonable for declining to consent to a Transfer to a transferee, assignee or sublessee of poor reputation, lacking financial qualifications or seeking a change in the Permitted Use, or jeopardizing directly or indirectly the status of Landlord or any of Landlords affiliates as a Real Estate Investment Trust under the Internal Revenue Code of 1986 (as the same may be amended from time to time, the Revenue Code ). Notwithstanding anything contained in this Lease to the contrary, (w) no Transfer shall be consummated on any basis such that the rental or other amounts to be paid by the occupant, assignee, manager or other transferee thereunder would be based, in whole or in part, on the income or profits derived by the business activities of such occupant, assignee, manager or other transferee; (x) Tenant shall not furnish or render any services to an occupant, assignee, manager or other transferee with respect to whom transfer consideration is required to be paid, or manage or operate the Premises or any capital additions so transferred, with respect to which transfer consideration is being paid ( provided , however, that if Tenant subleases a portion of the Premises to any Tenants Affiliate or any joint venture entity in which Tenant has an equity interest, Tenant may provide to such subtenant customary office services such as shared use of phone or data equipment, receptionist services, shared use of kitchenette facilities and the like and charge such subtenant an amount reasonably approximating the cost to Tenant to provide such services without violating the provisions of this Subsection 29.3(x) ); (y) Tenant shall not consummate a Transfer with any person in which Landlord owns an interest, directly or indirectly (by applying constructive ownership rules set forth in Section 856(d)(5) of the Revenue Code); and (z) Tenant shall not consummate a Transfer with any person or in any manner that could cause any portion of the amounts received by Landlord pursuant to this Lease or any sublease, license or other arrangement for the right to use, occupy or possess any portion of the Premises to fail to qualify as rents from real property within the meaning of Section 856(d) of the Revenue Code, or any
similar or successor provision thereto or which could cause any other income of Landlord to fail to qualify as income described in Section 856(c)(2) of the Revenue Code. If Landlord denies consent to any proposed Transfer, the same shall be by written notice to Tenant setting forth the grounds for such denial.
29.4 The following are conditions precedent to a Transfer or to Landlord considering a request by Tenant to a Transfer:
(a) Tenant shall remain fully liable under this Lease during the unexpired Term;
(b) Tenant shall provide Landlord with evidence respecting the relevant business experience and financial responsibility and status of the proposed transferee, assignee or sublessee;
(c) Tenant shall reimburse Landlord for Landlords actual costs and expenses, including reasonable attorneys fees, charges and disbursements incurred in connection with the review, processing and documentation of such request, not to exceed Two Thousand Five Hundred Dollars ($2,500.00) in any one instance;
(d) Except with respect to an Exempt Transfer, if Tenants transfer of rights or sharing of the Premises provides for the receipt by, on behalf of or on account of Tenant of any consideration of any kind whatsoever (including a premium rental for a sublease or lump sum payment for an assignment, but excluding Tenants reasonable costs in marketing and subleasing the Premises, including any costs incurred by Tenant in preparing the Premises or any portion thereof for occupancy by the transferee) in excess of the rental and other charges due to Landlord under this Lease, Tenant shall pay fifty percent (50%) of all of such excess to Landlord, after making deductions for any reasonable marketing expenses, tenant improvement funds expended by Tenant, alterations, cash concessions, brokerage commissions, attorneys fees and free rent actually paid by Tenant. If such consideration consists of cash paid to Tenant, payment to Landlord shall be made upon receipt by Tenant of such cash payment;
(e) The proposed transferee, assignee or sublessee shall agree that, in the event Landlord gives such proposed transferee, assignee or sublessee notice that Tenant is in default under this Lease, such proposed transferee, assignee or sublessee shall thereafter make all payments otherwise due Tenant directly to Landlord, which payments shall be received by Landlord without any liability being incurred by Landlord, except to credit such payment against those due by Tenant under this Lease, and any such proposed transferee, assignee or sublessee shall agree to attorn to Landlord or its successors and assigns on the terms and conditions of the document effecting the Transfer should this Lease be terminated for any reason; provided , however, that in no event shall Landlord or its Lenders, successors or assigns be obligated to accept such attornment;
(f) Except with respect to an Exempt Transfer, Landlords consent to any such Transfer shall be effected on Landlords forms;
(g) Tenant shall not then be in Default hereunder and shall not have received written notice from Landlord that any failure of Tenant to act or any state of facts exists that with
the passage of time could ripen into a Default, unless Tenant cures the same prior to the effective date of the Transfer;
(h) Such proposed transferee, assignee or sublessees use of the Premises shall be the same as the Permitted Use;
(i) Landlord shall not be bound by any provision of any agreement pertaining to the Transfer, except for Landlords written consent to the same;
(j) Tenant shall pay all transfer and other taxes (including interest and penalties) assessed or payable for any Transfer;
(k) Landlords consent (or waiver of its rights) for any Transfer shall not waive Landlords right to consent to any later Transfer;
(l) Tenant shall deliver to Landlord one executed copy of any and all written instruments evidencing or relating to the Transfer; and
(m) A list of Hazardous Materials, certified by the proposed transferee, assignee or sublessee to be true and correct, that the proposed transferee, assignee or sublessee intends to use or store in the Premises. Additionally, Tenant shall deliver to Landlord, on or before the date any proposed transferee, assignee or sublessee takes occupancy of the Premises, all of the items relating to Hazardous Materials of such proposed transferee, assignee or sublessee as described in Section 21.2 .
29.5 Any Transfer that is not in compliance with the provisions of this Article shall be void and Landlord may elect to terminate this Lease if Tenant fails to rescind such Transfer within five (5) business days after Landlord notifies Tenant of Landlords intention to terminate.
29.6 The consent by Landlord to a Transfer shall not relieve Tenant or proposed transferee, assignee or sublessee from obtaining Landlords consent to any further Transfer, nor shall it release Tenant or any proposed transferee, assignee or sublessee of Tenant from full and primary liability under this Lease.
29.7 Notwithstanding any Transfer, Tenant shall remain fully and primarily liable for the payment of all Rent and other sums due or to become due hereunder, and for the full performance of all other terms, conditions and covenants to be kept and performed by Tenant. The acceptance of Rent or any other sum due hereunder, or the acceptance of performance of any other term, covenant or condition thereof, from any person or entity other than Tenant shall not be deemed a waiver of any of the provisions of this Lease or a consent to any Transfer.
29.8 If Tenant delivers to Landlord a Transfer Notice indicating a desire to transfer this Lease to a proposed transferee, assignee or sublessee other than pursuant to an Exempt Transfer, then Landlord shall have the option, exercisable by giving notice to Tenant at any time within ten (10) days after Landlords receipt of such Transfer Notice, to terminate this Lease as of the date specified in the Transfer Notice as the Transfer Date, except for those provisions that, by their express terms, survive the expiration or earlier termination hereof. If Landlord exercises such option, then Tenant shall have the right to withdraw such Transfer Notice by delivering to
Landlord written notice of such election within five (5) days after Landlords delivery of notice electing to exercise Landlords option to terminate this Lease. In the event Tenant withdraws the Transfer Notice as provided in this Section, this Lease shall continue in full force and effect. No failure of Landlord to exercise its option to terminate this Lease shall be deemed to be Landlords consent to a proposed Transfer.
29.9 If Tenant sublets the Premises or any portion thereof, Tenant hereby immediately and irrevocably assigns to Landlord, as security for Tenants obligations under this Lease, all rent from any such subletting, and appoints Landlord as assignee and attorney-in-fact for Tenant, and Landlord (or a receiver for Tenant appointed on Landlords application) may collect such rent and apply it toward Tenants obligations under this Lease; provided that, until the occurrence of a Default (as defined below) by Tenant, Tenant shall have the right to collect such rent.
30. Subordination and Attornment .
30.1 This Lease shall, subject to the following provisions of this Article 30 , be subject and subordinate to the lien of any mortgage, deed of trust, or lease in which Landlord is tenant now or hereafter in force against all or any portion of the Project and to all advances made or hereafter to be made upon the security thereof without the necessity of the execution and delivery of any further instruments on the part of Tenant to effectuate such subordination.
30.2 Notwithstanding the foregoing, Tenant shall execute and deliver upon demand such further commercially reasonable instrument or instruments evidencing such subordination of this Lease to the lien of any such mortgage or mortgages or deeds of trust or lease in which Landlord is tenant as may be required by Landlord, provided that the same shall not materially adversely affect any of Tenants rights or obligations under this Lease. If any such mortgagee, beneficiary or landlord under a lease wherein Landlord is tenant (each, a Mortgagee ) so elects, however, this Lease shall be deemed prior in lien to any such lease, mortgage, or deed of trust upon or including the Premises regardless of date and Tenant shall execute a statement in writing to such effect at Landlords request. Landlord represents that, as of the Execution Date, no party holds a mortgage or deed of trust on the Premises. Notwithstanding anything to the contrary contained in this Lease, Landlord agrees, within sixty (60) days after the Execution Date, to cause the lessor under the Ground Lease to execute, acknowledge and deliver to Tenant a non-disturbance agreement in the form of Exhibit M attached hereto. Landlord represents that nothing contained in the Ground Lease affects Landlords ability to materially fulfill its obligations to Tenant under this Lease.
30.3 Upon written request of Landlord and opportunity for Tenant to review, Tenant agrees to execute any Lease amendments not materially altering the terms of this Lease, if required by a mortgagee or beneficiary of a deed of trust encumbering real property of which the Premises constitute a part incident to the financing of the real property of which the Premises constitute a part.
30.4 In the event any proceedings are brought for foreclosure, or in the event of the exercise of the power of sale under any mortgage or deed of trust made by Landlord covering the Premises, Tenant shall at the election of the purchaser at such foreclosure or sale attorn to the purchaser upon any such foreclosure or sale and recognize such purchaser as Landlord under this
Lease, provided that such purchaser shall agree in writing not to disturb the occupancy of Tenant under all of the terms and conditions of this Lease.
30.5 Notwithstanding anything to the contrary contained in this Article, the obligation of Tenant to subordinate to any future mortgage, deed of trust, or lease shall be subject to the condition that the holder of any such mortgage or deed of trust or the lessor under any such lease shall enter into a commercially reasonable non-disturbance agreement that does not materially adversely affect any of the rights or obligations of Tenant under this Lease.
31. Defaults and Remedies .
31.1 Late payment by Tenant to Landlord of Rent and other sums due shall cause Landlord to incur costs not contemplated by this Lease, the exact amount of which shall be extremely difficult and impracticable to ascertain. Such costs include processing and accounting charges and late charges that may be imposed on Landlord by the terms of any mortgage or trust deed covering the Premises. Therefore, if any installment of Rent due from Tenant is not received by Landlord within three (3) business days after the date such payment is due, Tenant shall pay to Landlord (a) an additional sum of One Thousand Dollars ($1,000) as a late charge plus (b) interest at an annual rate (the Default Rate ) equal to the lesser of (i) the prime rate of interest charged from time to time by Bank of America, N.A., or its successor plus three percent (3%) per annum and (ii) the highest rate permitted by Applicable Laws. The parties agree that this late charge (including interest) represents a fair and reasonable estimate of the costs that Landlord shall incur by reason of late payment by Tenant and shall be payable as Additional Rent to Landlord due with the next installment of Rent or within five (5) business days after Landlords demand, whichever is earlier. Notwithstanding the foregoing, the first time, if any, in any calendar year that Tenant shall fail to pay any installment of Rent when due, the foregoing interest shall not accrue or become payable unless and until Tenant shall fail to pay such installment within five (5) days after Landlord notifies Tenant in writing of such non-payment. Landlords acceptance of any Additional Rent (including a late charge or any other amount hereunder) shall not be deemed an extension of the date that Rent is due or prevent Landlord from pursuing any other rights or remedies under this Lease, at law or in equity.
31.2 No payment by Tenant or receipt by Landlord of a lesser amount than the Rent payment herein stipulated shall be deemed to be other than on account of the Rent, nor shall any endorsement or statement on any check or any letter accompanying any check or payment as Rent be deemed an accord and satisfaction, and Landlord may accept such check or payment without prejudice to Landlords right to recover the balance of such Rent or pursue any other remedy provided in this Lease or in equity or at law. If a dispute shall arise as to any amount or sum of money to be paid by Tenant to Landlord hereunder, Tenant shall have the right to make payment under protest, such payment shall not be regarded as a voluntary payment, and there shall survive the right on the part of Tenant to institute suit for recovery of the payment paid under protest.
31.3 If Tenant fails to pay any sum of money required to be paid by it hereunder or fails to perform any other act on its part to be performed hereunder, in each case within the applicable cure period (if any) described in Section 31.4 , then Landlord may (but shall not be obligated to), without waiving or releasing Tenant from any obligations of Tenant, make such
payment or perform such act; provided that such failure by Tenant unreasonably interfered with the use of either of the Buildings or the Project by any other tenant or with the efficient operation of either of the Buildings or the Project, or resulted or could have resulted in a violation of Applicable Laws or the cancellation of an insurance policy maintained by Landlord. Notwithstanding the foregoing, in the event of an emergency, Landlord shall have the right to enter the Premises and act in accordance with its rights as provided elsewhere in this Lease. In addition to the late charge described in Section 31.1 , Tenant shall pay to Landlord as Additional Rent all sums so paid or incurred by Landlord, together with interest at the Default Rate, computed from the date such sums were paid or incurred.
31.4 The occurrence of any one or more of the following events shall constitute a Default hereunder by Tenant:
(a) Tenant abandons (rather than merely vacates) the Premises, other than to occupy the 675 Building. Tenant shall be deemed to have abandoned the Premises if Tenant vacates the Premises and fails to fulfill Tenants obligations with respect to the Premises as provided in this Lease;
(b) Tenant fails to make any payment of Rent, as and when due, or to satisfy its obligations under Article 19 , where such failure shall continue for a period of three (3) days after written notice thereof from Landlord to Tenant;
(c) Tenant fails to observe or perform any obligation or covenant contained herein (other than described in Sections 31.4(a) and 31.4(b) ) to be performed by Tenant, where such failure continues for a period of thirty (30) days after written notice thereof from Landlord to Tenant; provided that, if the nature of Tenants default is such that it reasonably requires more than thirty (30) days to cure, Tenant shall not be deemed to be in Default if Tenant commences such cure within such ten (10) day period and thereafter diligently prosecute the same to completion. Notwithstanding anything set forth herein to the contrary, such period shall automatically terminate if Landlord will be subject to criminal or civil liability because of Tenants failure to cure, even if Tenant has diligently prosecuted the same;
(d) Tenant makes an assignment for the benefit of creditors;
(e) A receiver, trustee or custodian is appointed to or does take title, possession or control of all or substantially all of Tenants assets and such appointment is not dismissed within sixty (60) days;
(f) Tenant files a voluntary petition under the United States Bankruptcy Code or any successor statute (as the same may be amended from time to time, the Bankruptcy Code ) or an order for relief is entered against Tenant pursuant to a voluntary or involuntary proceeding commenced under any chapter of the Bankruptcy Code;
(g) Any involuntary petition is filed against Tenant under any chapter of the Bankruptcy Code and is not dismissed within one hundred twenty (120) days;
(h) A default exists under the 675 Lease (as defined below) after the expiration of any applicable notice and cure periods;
(i) Tenant fails to deliver an estoppel certificate in accordance with Article 20 , which failure continues for five (5) business days after written notice thereof from Landlord to Tenant; or
(j) Tenants interest in this Lease is attached, executed upon or otherwise judicially seized and such action is not released within one hundred twenty (120) days of the action.
Notices given under this Section shall specify in reasonable detail the alleged default and shall demand that Tenant perform the provisions of this Lease or pay the Rent that is in arrears, as the case may be, within the applicable period of time, or quit the Premises. No such notice shall be deemed a forfeiture or a termination of this Lease unless Landlord elects otherwise in such notice.
31.5 In the event of a Default by Tenant, and at any time thereafter, with or without notice or demand and without limiting Landlord in the exercise of any right or remedy that Landlord may have, Landlord has the right to do any or all of the following:
(a) Halt any Alterations and order Tenants contractors, subcontractors, consultants, designers and material suppliers to stop work;
(b) Terminate Tenants right to possession of the Premises by written notice to Tenant or by any lawful means, in which case Tenant shall immediately surrender possession of the Premises to Landlord. In such event, Landlord shall have the immediate right to re-enter and remove all persons and property, and such property may be removed and stored in a public warehouse or elsewhere at the cost and for the account of Tenant, all without service of notice or resort to legal process and without being deemed guilty of trespass or becoming liable for any loss or damage that may be occasioned thereby; and
(c) Terminate this Lease, in which event Tenant shall immediately surrender possession of the Premises to Landlord. In such event, Landlord shall have the immediate right to re-enter and remove all persons and property, and such property may be removed and stored in a public warehouse or elsewhere at the cost and for the account of Tenant, all without service of notice or resort to legal process and without being deemed guilty of trespass or becoming liable for any loss or damage that may be occasioned thereby. In the event that Landlord shall elect to so terminate this Lease, then Landlord shall be entitled to recover from Tenant all damages incurred by Landlord by reason of Tenants default, including:
(i) The sum of:
A. The worth at the time of award of any unpaid Rent that had accrued at the time of such termination; plus
B. The worth at the time of award of the amount by which the unpaid Rent that would have accrued during the period commencing with termination of the Lease and ending at the time of award exceeds that portion of the loss of Landlords rental income from the Premises that Tenant proves could have been reasonably avoided; plus
C. The worth at the time of award of the amount by which the unpaid Rent for the balance of the Term after the time of award exceeds that portion of the loss of Landlords rental income from the Premises that Tenant proves could have been reasonably avoided; plus
D. Any other amount necessary to compensate Landlord for any expense incurred by Landlord as a result of such Default, including the cost of restoring the Premises to the condition required under the terms of this Lease, including any rent payments not otherwise chargeable to Tenant (e.g., during any free rent period or rent holiday); plus
E. At Landlords election, such other amounts in addition to or in lieu of the foregoing as may be permitted from time to time by Applicable Laws; or
(ii) At Landlords election, as minimum liquidated damages in addition to any (A) amounts paid or payable to Landlord pursuant to Section 31.5(c)(i)(A) prior to such election and (B) costs of restoring the Premises to the condition required under the terms of this Lease, an amount (the Election Amount ) equal to the positive difference (if any, and measured at the time of such termination) between (Y) the then-present value of the total Rent and other benefits that would have accrued to Landlord under this Lease for the remainder of the Term if Tenant had fully complied with the Lease minus (Z) the then-present cash rental value of the Premises as determined by Landlord for what would be the then-unexpired Term if the Lease remained in effect, with each such then-present value computed using the discount rate of the Federal Reserve Bank of San Francisco at the time of the award plus one (1) percentage point (the Discount Rate ). Landlord and Tenant agree that the Election Amount represents a reasonable forecast of the minimum damages expected to occur in the event of a breach, taking into account the uncertainty, time and cost of determining elements relevant to actual damages, such as fair market rent, time and costs that may be required to re-lease the Premises, and other factors; and that the Election Amount is not a penalty.
As used in Sections 31.5(c)(i)(A) and (B) , worth at the time of award shall be computed by allowing interest at the Default Rate. As used in Section 31.5(c)(i)(C) , the worth at the time of the award shall be computed by taking the present value of such amount, using the Discount Rate.
31.6 In addition to any other remedies available to Landlord at law or in equity and under this Lease, Landlord may continue this Lease in effect after Tenants Default and abandonment and recover Rent as it becomes due. If required by Applicable Laws, Landlord shall use reasonable efforts to relet the Premises. Any such obligation to relet will be subject to Landlords reasonable objectives of developing the Property in a harmonious manner with appropriate mixes of tenants, uses, floor areas, terms and the like. In attempting to relet the Premises, Landlord may make repairs, alterations, replacements and additions in or to the Premises and redecorate, remodel and paint the same to the extent reasonably deemed necessary or desirable by Landlord, and Tenant upon demand shall pay the reasonable cost of all of the foregoing, together with Landlords reasonable expenses of reletting. For purposes of this Section, the following acts by Landlord will not constitute the termination of Tenants right to possession of the Premises:
(a) Acts of maintenance or preservation or efforts to relet the Premises, including alterations, remodeling, redecorating, repairs, replacements or painting as Landlord shall consider advisable for the purpose of reletting the Premises or any part thereof; or
(b) The appointment of a receiver upon the initiative of Landlord to protect Landlords interest under this Lease or in the Premises.
Notwithstanding the foregoing, in the event of a Default by Tenant, Landlord may elect at any time to terminate this Lease and to recover damages to which Landlord is entitled.
31.7 If Landlord does not elect to terminate this Lease as provided in Section 31.5 , then Landlord may, from time to time, recover all Rent as it becomes due under this Lease. At any time thereafter, Landlord may elect to terminate this Lease and to recover damages to which Landlord is entitled.
31.8 In the event Landlord elects to terminate this Lease and relet the Premises, Landlord may execute any new lease in its own name. Tenant hereunder shall have no right or authority whatsoever to collect any Rent from such tenant. The proceeds of any such reletting shall be applied as follows:
(a) First, to the payment of any indebtedness other than Rent due hereunder from Tenant to Landlord, including storage charges or brokerage commissions owing from Tenant to Landlord as the result of such reletting;
(b) Second, to the payment of the reasonable, out of pocket costs and expenses of reletting the Premises, including (i) alterations and repairs that Landlord deems reasonably necessary and advisable and (ii) reasonable attorneys fees, charges and disbursements incurred by Landlord in connection with the retaking of the Premises and such reletting;
(c) Third, to the payment of Rent and other charges due and unpaid hereunder; and
(d) Fourth, to the payment of future Rent and other damages payable by Tenant under this Lease.
31.9 All of Landlords and Tenants rights, options and remedies hereunder shall be construed and held to be nonexclusive and cumulative. Each of Tenant and Landlord shall have the right to pursue any one or all of such remedies, or any other remedy or relief that may be provided by Applicable Laws, whether or not stated in this Lease. No waiver of any default of Tenant hereunder shall be implied from any acceptance by Landlord of any Rent or other payments due hereunder or any omission by Landlord or Tenant to take any action on account of such default if such default persists or is repeated, and no express waiver shall affect defaults other than as specified in such waiver. Any obligation imposed by Applicable Law upon Landlord to relet the Premises after any termination of this Lease shall be subject to the reasonable requirements of Landlord to (a) lease to high quality tenants on such terms as Landlord may from time to time deem appropriate in its discretion and (b) develop the Project in a harmonious manner with a mix of uses, tenants, floor areas, terms of tenancies, etc., as
determined by Landlord. Landlord shall not be obligated to relet the Premises to any party to whom Landlord or an affiliate of Landlord may desire to lease other available space in the Project or at another property owned by Landlord or an affiliate of Landlord.
31.10 Landlords termination of (a) this Lease or (b) Tenants right to possession of the Premises shall not relieve Tenant of any liability to Landlord that has previously accrued or that shall arise based upon events that occurred prior to the later to occur of (y) the date of Lease termination and (z) the date Tenant surrenders possession of the Premises.
31.11 To the extent permitted by Applicable Laws, Tenant waives any and all rights of redemption granted by or under any present or future Applicable Laws if Tenant is evicted or dispossessed for any cause, or if Landlord obtains possession of the Premises due to Tenants default hereunder or otherwise.
31.12 Landlord shall not be in default or liable for damages under this Lease unless Landlord fails to perform obligations required of Landlord within a reasonable time, but in no event shall such failure continue for more than thirty (30) days after written notice from Tenant specifying the nature of Landlords failure; provided , however, that if the nature of Landlords obligation is such that more than thirty (30) days are required for its performance, then Landlord shall not be in default if Landlord commences performance within such thirty (30) day period and thereafter diligently prosecutes the same to completion. In no event shall Tenant have the right to terminate or cancel this Lease or to withhold or abate rent or to set off any Claims against Rent as a result of any default or breach by Landlord of any of its covenants, obligations, representations, warranties or promises hereunder, except as may otherwise be expressly set forth in this Lease.
31.13 In the event of any default by Landlord, Tenant shall give notice by registered or certified mail to any (a) beneficiary of a deed of trust or (b) mortgagee under a mortgage covering the Premises or all or any portion of the Project and to any landlord of any lease of land upon or within which the Premises or all or any portion of the Project is located, and shall offer such beneficiary, mortgagee or landlord a reasonable opportunity to cure the default, including time to obtain possession of all or any portion of the Project by power of sale or a judicial action if such should prove necessary to effect a cure; provided that Landlord shall have furnished to Tenant in writing the names and addresses of all such persons who are to receive such notices.
32. Bankruptcy . In the event a debtor, trustee or debtor in possession under the Bankruptcy Code, or another person with similar rights, duties and powers under any other Applicable Laws, proposes to cure any default under this Lease or to assume or assign this Lease and is obliged to provide adequate assurance to Landlord that (a) a default shall be cured, (b) Landlord shall be compensated for its damages arising from any breach of this Lease and (c) future performance of Tenants obligations under this Lease shall occur, then such adequate assurances shall include any or all of the following, as designated by Landlord in its sole and absolute discretion:
32.1 Those acts specified in the Bankruptcy Code or other Applicable Laws as included within the meaning of adequate assurance, even if this Lease does not concern a shopping center or other facility described in such Applicable Laws;
32.2 A prompt cash payment to compensate Landlord for any monetary defaults or actual damages arising directly from a breach of this Lease;
32.3 A cash deposit in an amount at least equal to the then-current amount of the Security Deposit; or
32.4 The assumption or assignment of all of Tenants interest and obligations under this Lease.
33. Brokers .
33.1 Tenant represents and warrants that it has had no dealings with any real estate broker or agent in connection with the negotiation of this Lease other than CB Richard Ellis ( Broker ), and that it knows of no other real estate broker or agent that is or might be entitled to a commission in connection with this Lease. Landlord shall compensate Broker in relation to this Lease pursuant to a separate agreement between Landlord and Broker.
33.2 Tenant represents and warrants that no broker or agent has made any representation or warranty relied upon by Tenant in Tenants decision to enter into this Lease, other than as contained in this Lease.
33.3 Tenant acknowledges and agrees that the employment of brokers by Landlord is for the purpose of solicitation of offers of leases from prospective tenants and that no authority is granted to any broker to furnish any representation (written or oral) or warranty from Landlord unless expressly contained within this Lease. Landlord is executing this Lease in reliance upon Tenants representations, warranties and agreements contained within Sections 33.1 and 33.2 .
33.4 Tenant agrees to indemnify, save, defend (at Landlords option and with counsel reasonably acceptable to Landlord) and hold the Landlord Indemnitees harmless from any and all cost or liability for compensation claimed by any broker or agent, other than Broker, employed or engaged by Tenant or claiming to have been employed or engaged by Tenant. Landlord agrees to indemnify, save, defend (at Tenants option and with counsel reasonably acceptable to Tenant) and hold Tenant harmless from any and all cost or liability for compensation claimed by any broker or agent employed or engaged by Landlord or claiming to have been employed or engaged by Landlord.
34. Definition of Landlord . With regard to obligations imposed upon Landlord pursuant to this Lease, the term Landlord , as used in this Lease, shall refer only to Landlord or Landlords then-current successor-in-interest. In the event of any transfer, assignment or conveyance of Landlords interest in this Lease or in Landlords fee title to or leasehold interest in the Property, as applicable, Landlord herein named (and in case of any subsequent transfers or conveyances, the subsequent Landlord) shall be automatically freed and relieved, from and after the date of such transfer, assignment or conveyance, from all liability for the performance of any covenants or obligations contained in this Lease thereafter to be performed by Landlord and, without further agreement, the transferee, assignee or conveyee of Landlords in this Lease or in Landlords fee title to or leasehold interest in the Property, as applicable, shall be deemed to have assumed and agreed to observe and perform any and all covenants and obligations of Landlord hereunder during the tenure of its interest in the Lease or the Property. Landlord or any
subsequent Landlord may transfer its interest in the Premises or this Lease without Tenants consent.
35. Limitation of Landlords Liability .
35.1 If Landlord is in default under this Lease and, as a consequence, Tenant recovers a monetary judgment against Landlord, the judgment shall be satisfied only out of (a) the proceeds of sale received on execution of the judgment and levy against the right, title and interest of Landlord in the Bent Building and the Bent Project and any insurance proceeds payable with respect thereto, (b) rent or other income from such real property receivable by Landlord or (c) the consideration received by Landlord from the sale, financing, refinancing or other disposition of all or any part of Landlords right, title or interest in the Bent Building or the Bent Project.
35.2 Landlord shall not be personally liable for any deficiency under this Lease. If Landlord is a partnership or joint venture, then the partners of such partnership shall not be personally liable for Landlords obligations under this Lease, and no partner of Landlord shall be sued or named as a party in any suit or action, and service of process shall not be made against any partner of Landlord except as may be necessary to secure jurisdiction of the partnership or joint venture. If Landlord is a corporation, then the shareholders, directors, officers, employees and agents of such corporation shall not be personally liable for Landlords obligations under this Lease, and no shareholder, director, officer, employee or agent of Landlord shall be sued or named as a party in any suit or action, and service of process shall not be made against any shareholder, director, officer, employee or agent of Landlord. If Landlord is a limited liability company, then the members of such limited liability company shall not be personally liable for Landlords obligations under this Lease, and no member of Landlord shall be sued or named as a party in any suit or action, and service of process shall not be made against any member of Landlord except as may be necessary to secure jurisdiction of the limited liability company. No partner, shareholder, director, employee, member or agent of Landlord shall be required to answer or otherwise plead to any service of process, and no judgment shall be taken or writ of execution levied against any partner, shareholder, director, employee, member or agent of Landlord.
35.3 Each of the covenants and agreements of this Article shall be applicable to any covenant or agreement either expressly contained in this Lease or imposed by Applicable Laws and shall survive the expiration or earlier termination of this Lease.
36. Joint and Several Obligations . If more than one person or entity executes this Lease as Tenant, then:
36.1 Each of them is jointly and severally liable for the keeping, observing and performing of all of the terms, covenants, conditions, provisions and agreements of this Lease to be kept, observed or performed by Tenant; and
36.2 The term Tenant , as used in this Lease shall mean and include each of them, jointly and severally. The act of, notice from, notice to, refund to, or signature of any one or more of them with respect to the tenancy under this Lease, including any renewal, extension, expiration, termination or modification of this Lease, shall be binding upon each and all of the
persons executing this Lease as Tenant with the same force and effect as if each and all of them had so acted, so given or received such notice or refund, or so signed.
37. Representations .
37.1 Each of Landlord and Tenant (in this Section, the Representing Party ) guarantees, warrants and represents to the other party that (a) the Representing Party is duly incorporated or otherwise established or formed and validly existing under the laws of its state of incorporation, establishment or formation, (b) the Representing Party has and is duly qualified to do business in the state in which the Property is located, (c) the Representing Party has full corporate, partnership, trust, association or other appropriate power and authority to enter into this Lease and to perform all of its obligations hereunder, (d) each person (and all of the persons if more than one signs) signing this Lease on behalf of the Representing Party is duly and validly authorized to do so and (e) neither (i) the execution, delivery or performance of this Lease nor (ii) the consummation of the transactions contemplated hereby will violate or conflict with any provision of documents or instruments under which the Representing Party is constituted or to which the Representing Party is a party.
37.2 Landlord guarantees, warrants and represents that it is not a person or entity with whom U.S. persons or entities are restricted from doing business under regulations of the Office of Foreign Asset Control ( OFAC ) of the Department of the Treasury (including those named on OFACs Specially Designated and Blocked Persons List) or under any statute, executive order (including the September 24, 2001, Executive Order Blocking Property and Prohibiting Transactions with Persons Who Commit, Threaten to Commit, or Support Terrorism) or other similar governmental action.
37.3 Tenant guarantees, warrants and represents that it is not a person or entity with whom U.S. persons or entities are restricted from doing business under regulations of OFAC of the Department of the Treasury (including those named on OFACs Specially Designated and Blocked Persons List) or under any statute, executive order (including the September 24, 2001, Executive Order Blocking Property and Prohibiting Transactions with Persons Who Commit, Threaten to Commit, or Support Terrorism) or other similar governmental action.
38. Confidentiality .
38.1 Tenants Confidential Information means any non-public scientific, technical, trade, business or financial information developed for or possessed by Tenant that is treated by Tenant as confidential or proprietary, that is marked as confidential by Tenant and that is not generally known to the public. Landlords Confidential Information means any non-public scientific, technical, trade, business or financial information developed for or possessed by Landlord that is treated by Landlord as confidential or proprietary, that is marked as confidential by Landlord and that is not generally known to the public.
38.2 Landlord shall hold in strict confidence all of Tenants Confidential Information and shall not disclose to any other person any of Tenants Confidential Information. Landlord shall use Tenants Confidential Information solely for the purposes of administration of the Lease. In protecting Tenants Confidential Information, Landlord shall use the same degree of
care it uses for Landlords Confidential Information, but in no event less than a reasonable degree of care. Notwithstanding the foregoing, Tenants Confidential Information may be released by Landlord (x) if required by Applicable Laws or in any judicial proceeding; provided that Landlord has given Tenant reasonable notice of such requirement and the opportunity to contest the same, if feasible, (y) to Landlords attorneys, accountants, brokers and other bona fide consultants or advisers (with respect to this Lease only); provided such third parties agree to be bound by this Section and that non-public scientific information shall not be so shared, or (z) if required in connection with any legal proceeding between Landlord and Tenant with respect to this Lease; provided that the Landlord has given Tenant reasonable notice of such requirement and the opportunity to contest the same, if feasible.
38.3 Tenant shall hold in strict confidence all of Landlords Confidential Information and shall not disclose to any other person any of Landlords Confidential Information. Tenant shall use Landlords Confidential Information solely for the purposes of administration of the Lease. In protecting Landlords Confidential Information, Tenant shall use the same degree of care it uses for Tenants Confidential Information, but in no event less than a reasonable degree of care. Notwithstanding the foregoing, Landlords Confidential Information may be released by Tenant (x) if required by Applicable Laws or in any judicial proceeding; provided that Tenant has given Landlord reasonable notice of such requirement, if feasible, (y) to Tenants attorneys, accountants, brokers and other bona fide consultants or advisers (with respect to this Lease only); provided such third parties agree to be bound by this Section, or (z) if required in connection with any legal proceeding between Tenant and Landlord with respect to this Lease; provided that the Tenant has given Landlord reasonable notice of such requirement, if feasible.
38.4 Notwithstanding anything in this Article to the contrary, Tenant may file a description of this Lease, the Lease itself and any other material agreement or document related thereto in its public filings with the United States Securities and Exchange Commission, if required by such entity to do so.
39. Notices . Any notice, consent, demand, invoice, statement or other communication required or permitted to be given hereunder shall be in writing and shall be given by personal delivery or by overnight delivery with a reputable nationwide overnight delivery service. If given by personal delivery, any such notice, consent, demand, invoice, statement or other communication shall be deemed delivered upon receipt; if given by overnight delivery, shall be deemed delivered one business (1) day after deposit with a reputable nationwide overnight delivery service. Any notices given pursuant to this Lease shall be addressed to Landlord or Tenant, as the case may be, at the addresses shown in Sections 2.7 and 2.8 or 2.9 , respectively. Either party may, by notice to the other given pursuant to this Section, specify additional or different addresses for notice purposes.
40. Rooftop Installation Area .
40.1 Subject to the terms of this Article, Tenant may use the portion of the Bent Building that is cross-hatched on Exhibit N (the Rooftop Installation Area ) solely to operate, maintain, repair and replace rooftop antennae, mechanical equipment, communications antennas and other equipment installed by Tenant in the Rooftop Installation Area in accordance with this
Article ( Tenants Rooftop Equipment ). Tenants Rooftop Equipment shall be only for Tenants use of the Premises for the Permitted Use.
40.2 Tenant shall install Tenants Rooftop Equipment at its sole cost and expense, at such times and in such manner as Landlord may reasonably designate, and in accordance with this Article and the applicable provisions of this Lease regarding Alterations. Tenants Rooftop Equipment and the installation thereof shall be subject to Landlords prior written approval, which approval shall not be unreasonably withheld, conditioned or delayed. Among other reasons, Landlord may withhold approval if the installation or operation of Tenants Rooftop Equipment could reasonably be expected to damage the structural integrity of the Bent Building or to transmit vibrations or noise or cause other adverse effects beyond the Premises to an extent not customary in first class laboratory buildings, unless Tenant implements measures that are acceptable to Landlord in its reasonable discretion to avoid any such damage or transmission. Unless Landlord elects to require Tenant to remove Tenants Rooftop Equipment at the expiration of the Term by written notice to Tenant delivered at the time of Landlords written approval of Tenants Rooftop Equipment, such Rooftop Equipment shall become the property of Landlord upon the expiration or earlier termination of the Term.
40.3 Tenant shall comply with any roof or roof-related warranties. Tenant shall obtain a letter from Landlords roofing contractor within thirty (30) days after completion of any Tenant work on the rooftop stating that such work did not affect any such warranties, and Landlord shall reasonably cooperate with Tenant, at no cost to Landlord, in obtaining such letter. Tenant, at its sole cost and expense, shall inspect the Rooftop Installation Area at least annually, and correct any loose bolts, fittings or other appurtenances and repair any damage to the roof caused by the installation or operation of Tenants Rooftop Equipment. Tenant shall not permit the installation, maintenance or operation of Tenants Rooftop Equipment to violate any Applicable Laws or constitute a nuisance. Tenant shall pay Landlord within thirty (30) days after demand (a) all applicable taxes, charges, fees or impositions imposed on Landlord by Governmental Authorities as the result of Tenants use of the Rooftop Installation Areas in excess of those for which Landlord would otherwise be responsible for the use or installation of Tenants Rooftop Equipment and (b) the amount of any increase in Landlords insurance premiums as a result of the installation of Tenants Rooftop Equipment. Upon Tenants written request to Landlord, Landlord shall use commercially reasonable efforts to cause other tenants to remedy any interference in the operation of Tenants Rooftop Equipment caused by any such tenants equipment installed after the applicable piece of Tenants Rooftop Equipment; provided , however, that Landlord shall not be required to request that such tenants waive their rights under their respective leases.
40.4 If Tenants Equipment (a) causes physical damage to the structural integrity of the Bent Building, (b) interferes with any telecommunications, mechanical or other systems located at or near or servicing the Bent Building or the Bent Project that were installed prior to the installation of Tenants Rooftop Equipment, (c) interferes with any other service provided to other tenants in the Bent Building or the Bent Project by rooftop or penthouse installations that were installed prior to the installation of Tenants Rooftop Equipment or (d) interferes with any other tenants business, in each case in excess of that permissible under Federal Communications Commission regulations, then Tenant shall cooperate with Landlord to determine the source of the damage or interference and promptly repair such damage and eliminate such interference, in
each case at Tenants sole cost and expense, within ten (10) days after receipt of notice of such damage or interference (which notice may be oral; provided that Landlord also delivers to Tenant written notice of such damage or interference within twenty-four (24) hours after providing oral notice).
40.5 Landlord reserves the right to cause Tenant to relocate Tenants Rooftop Equipment to comparably functional space on the roof or in the penthouse of the Bent Building by giving Tenant prior written notice thereof. Landlord agrees to pay the reasonable costs thereof within thirty (30) days after delivery (consistent with Article 39 ) of Tenants invoice therefor. Tenant shall arrange for the relocation of Tenants Rooftop Equipment within sixty (60) days after receipt of Landlords notification of such relocation. In the event Tenant fails to arrange for relocation within such sixty (60)-day period, Landlord shall have the right to arrange for the relocation of Tenants Rooftop Equipment in a manner that does not unnecessarily interrupt or interfere with Tenants use of the Premises for the Permitted Use.
41. Options to Extend Term . Tenant shall have two (2) consecutive options (each, a Short-Term Renewal Option ) to extend the Term by one (1) year each as to the entire Premises (and no less than the entire Premises) upon the following terms and conditions. In addition, Tenant shall have two (2) consecutive options to extend the Term by five (5) years each as to the portion of the Premises located on the basement level of the Bent Building (each, a Long-Term Renewal Option and, together the Short-Term Renewal Options, each an Option and, collectively, the Options ) upon the following terms and conditions. For the avoidance of doubt, Tenant may exercise a Long-Term Renewal Option so that the related term would commence after the original Term or any other Option term. Tenant may only exercise a Short-Term Renewal Option, however, if such Option term would commence after the original Term or the other Short-Term Renewal Option term (in other words, Tenant may not exercise a Short-Term Renewal Option so that the related term would commence after a Long-Term Renewal Option term expires). Any extension of the Term pursuant to an Option shall be on all the same terms and conditions as this Lease, except as follows:
41.1 Base Rent at the commencement of each Option term shall equal the then-current fair market value for comparable office and laboratory space in the East Cambridge submarket of comparable age, quality, level of finish and proximity to amenities and public transit, subject to fair market escalations as determined at the time of the exercise of such option ( FMV ). Tenant may, no more than twelve (12) months prior to the date the Term is then scheduled to expire, request Landlords estimate of the FMV for the next Option term, and Tenants request shall specify whether Tenant desires Landlords estimate with respect to a Short-Term Renewal Option, a Long-Term Renewal Option, or both. Landlord shall, within fifteen (15) days after receipt of such request, give Tenant a written proposal of such FMV. If Tenant gives written notice to exercise an Option, such notice shall specify whether Tenant accepts Landlords proposed estimate of FMV, and the failure of Tenant expressly to indicate in such notice that Tenant accepts Landlords proposed estimate shall conclusively indicate that Tenant does not accept such proposed estimate. If Tenant does not accept the FMV, then the parties shall endeavor to agree upon the FMV, taking into account all relevant factors, including (a) the size of the Premises, (b) the length of the Option term, (c) rent in comparable buildings in the relevant submarket, including concessions offered to new tenants, such as free rent, tenant improvement allowances and moving allowances, (d) Tenants creditworthiness and (e) the quality and location
of the Bent Building and the Bent Project. In the event that the parties are unable to agree upon the FMV within thirty (30) days after Tenant notifies Landlord that Tenant is exercising an Option, then either party may request that the same be determined as follows: a senior officer of a nationally recognized leasing brokerage firm with local knowledge of the East Cambridge office, laboratory/research and development leasing submarket (the Baseball Arbitrator ) shall be selected and paid for jointly by Landlord and Tenant. If Landlord and Tenant are unable to agree upon the Baseball Arbitrator, then the same shall be designated by the local chapter of the American Arbitration Association or any successor organization thereto (the AAA ). The Baseball Arbitrator selected by the parties or designated by the AAA shall (y) have at least ten (10) years experience in the leasing of laboratory/research and development space in the East Cambridge submarket and (z) not have been employed or retained by either Landlord or Tenant or any affiliate of either for a period of at least ten (10) years prior to appointment pursuant hereto. Each of Landlord and Tenant shall submit to the Baseball Arbitrator and to the other party its determination of the FMV. The Baseball Arbitrator shall grant to Landlord and Tenant a hearing and the right to submit evidence. The Baseball Arbitrator shall determine which of the two (2) FMV determinations more closely represents the actual FMV. The arbitrator may not select any other FMV for the Premises other than one submitted by Landlord or Tenant. The FMV selected by the Baseball Arbitrator shall be binding upon Landlord and Tenant and shall serve as the basis for determination of Base Rent payable for the applicable Option term. If, as of the commencement date of an Option term, the amount of Base Rent payable during the Option term shall not have been determined, then, pending such determination, Tenant shall pay Base Rent equal to the Base Rent payable with respect to the last year of the then-current Term. After the final determination of Base Rent payable for the Option term, the parties shall promptly execute a written amendment to this Lease specifying the amount of Base Rent to be paid during the applicable Option term. Any failure of the parties to execute such amendment shall not affect the validity of the FMV determined pursuant to this Section.
41.2 No Option is assignable separate and apart from this Lease.
41.3 An Option is conditional upon Tenant giving Landlord written notice of its election to exercise such Option at least ten (10) months prior to the end of the expiration of the then-current Term. Time shall be of the essence as to Tenants exercise of an Option. Tenant assumes full responsibility for maintaining a record of the deadlines to exercise an Option. Tenant acknowledges that it would be inequitable to require Landlord to accept any exercise of an Option after the date provided for in this Section.
41.4 Notwithstanding anything contained in this Article to the contrary, Tenant shall not have the right to exercise an Option during the time commencing from the date Landlord delivers to Tenant a written notice that Tenant is in default under any provisions of this Lease and continuing until Tenant has cured the specified default.
41.5 All of Tenants rights under the provisions of an Option shall terminate and be of no further force or effect even after Tenants due and timely exercise of such Option if, after such exercise, but prior to the commencement date of the new term, (a) Tenant fails to pay to Landlord a monetary obligation of Tenant for a period of twenty (20) days after written notice from Landlord to Tenant, (b) Tenant fails to commence to cure a default (other than a monetary default) within thirty (30) days after the date Landlord gives notice to Tenant of such default or
(c) Tenant has defaulted under this Lease four (4) or more times and a service or late charge under Section 31.1 has become payable for any such default, regardless of whether Tenant has cured such defaults.
41.6 The period of time within which Tenant may exercise an Option shall not be extended or enlarged by reason of Tenants inability to exercise such Option because of the provisions of Sections 41.4 and 41.5 .
42. Early Termination . If Tenant has executed a lease (the 675 Lease ) with an affiliate of Landlord for the first (1 st ), second (2 nd ) and third (3 rd ) floors of the building located at 675 West Kendall Street in Cambridge, Massachusetts (the 675 Kendall Building ), which floors are shown on Exhibit O attached hereto (the 675 Premises ), and the 675 Lease is in addition to the space that Tenant currently subleases from Vertex Pharmaceuticals Incorporated at the 675 Kendall Building (as shown on Exhibit P attached hereto) whether or not such sublease is then in effect, then Tenant shall be entitled to exercise a one-time option to terminate this Lease (the Termination Option ) through written notice to Landlord no later than eight (8) months after the execution date for the 675 Lease. The termination of this Lease under the Termination Option shall be effective no earlier than the date of rent commencement under the 675 Lease. Notwithstanding the foregoing, Tenant shall not be entitled to exercise the Termination Option if, at the time of the exercise, a Default by Tenant is then continuing under this Lease. Notwithstanding the foregoing, the Termination Option shall not apply to any basement space in the Bent Building if Tenant has exercised any Long-Term Renewal Option or delivered a notice of intent to exercise any Long-Term Renewal Option for the same; rather, the Termination Option shall apply only to the portion of the Premises outside of the basement of the Bent Building. Upon any termination pursuant to this Section, this Lease shall be amended to reflect such termination.
43. 675 Kendall Building Right of First Refusal . The 675 Lease, if executed, shall contain a right of first refusal ( ROFR ) for Tenant as to any rentable premises on the fifth (5 th ) and sixth (6 th ) floors of the 675 Building (the Available ROFR Premises ), which floors are shown on Exhibit Q attached hereto; provided , however, that (a) the ROFR shall be subject to the rights of Genzyme Corporation and its successors and assigns in the Available ROFR Premises (the Genzyme Rights ), and (b) in no event shall Landlord be required to lease any Available ROFR Premises to Tenant for any period extending beyond the scheduled termination date of the 675 Lease, as the same may be extended pursuant to any option contained therein.
43.1 In the event that (a) the ROFR has not expired and is not subject to any exercised Genzyme Rights, (b) Landlord has received a written third-party proposal for any Available ROFR Premises (an Acceptable Proposal ) and (c) Landlord intends to lease such Available ROFR Premises on the terms and conditions of the Acceptable Proposal, Landlord shall provide written notice thereof to Tenant (the Notice of Offer ), which notice shall specify all of the terms and conditions set forth in such Acceptable Proposal other than the identity of the third party, and which Notice of Offer shall constitute an offer to lease such Available ROFR Premises to Tenant on such terms and conditions (except that, if the Acceptable Proposal calls for a lease expiration date later than the scheduled termination date of the 675 Lease, then the Notice of Offer shall be deemed to contain a lease expiration date that is the scheduled termination date of the 675 Lease). For the avoidance of doubt, in the event that the ROFR has not expired,
Landlord and Tenant agree that Landlord shall be prohibited from proceeding directly to lease negotiations and/or executing a lease with a third party in an effort to circumvent the ROFR without first receiving a written third-party proposal from such third party.
43.2 Within ten (10) business days following its receipt of a Notice of Offer, Tenant shall advise Landlord in writing whether Tenant elects to lease the Available ROFR Premises on the terms and conditions set forth in the Notice of Offer. If Tenant fails to notify Landlord of Tenants election within such ten (10) business day period, then Tenant shall be deemed to have elected not to lease the Available ROFR Premises upon the terms and conditions contained in the Notice of Offer.
43.3 If Tenant timely notifies Landlord that Tenant elects to lease the Available ROFR Premises on the terms and conditions set forth in the Notice of Offer, then Landlord shall lease the Available ROFR Premises to Tenant upon the terms and conditions set forth in the Notice of Offer.
43.4 If Tenant notifies Landlord that Tenant elects not to lease the Available ROFR Premises on the terms and conditions set forth in the Notice of Offer, or if Tenant fails to notify Landlord of Tenants election within the ten (10) business day period described above, then Landlord shall have the right to consummate the lease of the Available ROFR Premises on the same terms as set forth in the Notice of Offer following Tenants election (or deemed election) not to lease the Available ROFR Premises. If Landlord does not lease the Available ROFR Premises on the terms and conditions set forth in the Notice of Offer within two hundred forty (240) days after Tenants election (or deemed election) not to lease the Available ROFR Premises, then the ROFR shall be fully reinstated, and Landlord shall not thereafter lease the Available ROFR Premises without first complying with the procedures set forth in this Article.
43.5 Notwithstanding anything in this Article to the contrary, Tenant may not exercise the ROFR during such period of time that Tenant is in default (i.e., after notice to Tenant thereof but not requiring the expiration of the applicable cure period) under any provision of this Lease or the 675 Lease. Any attempted exercise of the ROFR during a period of time in which Tenant is so in default shall be void and of no effect. In addition, Tenant shall not be entitled to exercise the ROFR if (a) Landlord has given Tenant three (3) or more notices of monetary and/or material non-monetary defaults in accordance with this Lease or the 675 Lease, whether or not the defaults are cured, during the twelve (12) month period prior to the date on which Tenant seeks to exercise the ROFR, or (b) Tenant has subleased any portion of the 675 Premises (other than to an affiliate of Tenant).
43.6 Notwithstanding anything in this Lease or the 675 Lease to the contrary, Tenant shall not assign or transfer the ROFR, either separately or in conjunction with any assignment or transfer of Tenants interest in the Lease or the 675 Lease, without Landlords prior written consent, which consent Landlord may withhold in its sole and absolute discretion; provided , however, that Tenant shall be entitled to assign or transfer the ROFR in conjunction with any Exempt Transfer of Tenants interest in the Lease.
43.7 If Tenant exercises the ROFR, Landlord does not guarantee that the Available ROFR Premises will be available on the anticipated commencement date for the lease as to such
Premises due to a holdover by the then-existing occupants of the Available ROFR Premises or for any other reason beyond Landlords reasonable control.
43.8 Notwithstanding anything in this Lease or the 675 Lease to the contrary, the ROFR shall expire on the date that is two (2) years prior to the expiration of the term of the 675 Lease, as the same may be extended.
44. Merck Contingency . Notwithstanding anything in this Lease to the contrary, Landlords obligation to deliver the Premises by the Term Commencement Date is contingent upon Merck and all of Mercks subtenants and licensees other than Tenant (collectively, the Merck Tenants ) vacating the Premises no later than August 31, 2013. If the Merck Tenants do not timely vacate, then Landlord may delay the Term Commencement Date by written notice to Tenant until the Merck Tenants vacate the Premises, and the Term hereof shall be extended by one (1) day for every day that the Term Commencement Date is so extended.
45. Miscellaneous .
45.1 Landlord reserves the right to change the name of the Buildings or the Project in its sole discretion.
45.2 To induce Landlord to enter into this Lease, Tenant agrees that it shall promptly furnish to Landlord, from time to time (but not more than once in any calendar year), upon Landlords written request, the most recent year-end financial statements reflecting Tenants current financial condition audited by a nationally recognized accounting firm. Tenant shall, within ninety (90) days after the end of Tenants financial year, furnish Landlord with a certified copy of Tenants year-end financial statements for the previous year audited by a nationally recognized accounting firm. Tenant represents and warrants that all financial statements, records and information furnished by Tenant to Landlord in connection with this Lease are true, correct and complete in all respects. If audited financials are not otherwise prepared, unaudited financials complying with generally accepted accounting principles and certified by the chief financial officer of Tenant as true, correct and complete in all respects shall suffice for purposes of this Section. The provisions of this Section shall not apply at any time while Tenant is a corporation whose shares are traded on any nationally recognized stock exchange.
45.3 Where applicable in this Lease, the singular includes the plural and the masculine or neuter includes the masculine, feminine and neuter. The words include, includes, included and including shall mean include, etc., without limitation. The section headings of this Lease are not a part of this Lease and shall have no effect upon the construction or interpretation of any part hereof.
45.4 If either party commences a demand, claim, action, cause of action or suit against the other party arising out of or in connection with this Lease, then the substantially prevailing party shall be reimbursed by the other party for all reasonable costs and expenses, including reasonable attorneys fees and expenses, incurred by the substantially prevailing party in such action or proceeding and in any appeal in connection therewith (regardless of whether the applicable demand, claim, action, cause of action or suit is voluntarily withdrawn or dismissed).
45.5 Submission of this instrument for examination or signature by Tenant does not constitute a reservation of or option for a lease, and shall not be effective as a lease or otherwise until execution by and delivery to both Landlord and Tenant.
45.6 Time is of the essence with respect to the performance of every provision of this Lease in which time of performance is a factor.
45.7 Notwithstanding anything to the contrary contained in this Lease, but subject to the provisions of Section 14.4 hereof, Tenants obligations under this Lease are independent and shall not be conditioned upon performance by Landlord.
45.8 Whenever consent or approval of either party is required, that party shall not unreasonably withhold, condition or delay such consent or approval, except as may be expressly set forth to the contrary.
45.9 The terms of this Lease are intended by the parties as a final expression of their agreement with respect to the terms as are included herein, and may not be contradicted by evidence of any prior or contemporaneous agreement.
45.10 Any provision of this Lease that shall prove to be invalid, void or illegal shall in no way affect, impair or invalidate any other provision hereof, and all other provisions of this Lease shall remain in full force and effect and shall be interpreted as if the invalid, void or illegal provision did not exist.
45.11 At the written request of either party, Landlord and Tenant shall execute and acknowledge a short form or memorandum hereof. Within ten (10) days after receipt of written request from Landlord, Tenant shall execute a termination of any short form or memorandum of lease recorded with respect hereto. Neither party shall record this Lease. Tenant shall be responsible for the cost of recording any short form or memorandum of this Lease, including any transfer or other taxes incurred in connection with such recordation.
45.12 The language in all parts of this Lease shall be in all cases construed as a whole according to its fair meaning and not strictly for or against either Landlord or Tenant.
45.13 Each of the covenants, conditions and agreements herein contained shall inure to the benefit of and shall apply to and be binding upon the parties hereto and their respective heirs; legatees; devisees; executors; administrators; and permitted successors, assigns, sublessees. Nothing in this Section shall in any way alter the provisions of this Lease restricting assignment or subletting.
45.14 This Lease shall be governed by, construed and enforced in accordance with the laws of the state in which the Premises are located, without regard to such states conflict of law principles.
45.15 Each of Landlord and Tenant guarantees, warrants and represents to the other that the individual or individuals signing this Lease have the power, authority and legal capacity to sign this Lease on behalf of and to bind all entities, corporations, partnerships, limited liability
companies, joint venturers or other organizations and entities on whose behalf such individual or individuals have signed.
45.16 This Lease may be executed in one or more counterparts, each of which, when taken together, shall constitute one and the same document.
45.17 No provision of this Lease may be modified, amended or supplemented except by an agreement in writing signed by Landlord and Tenant. The waiver by either party of any breach by the other party of any term, covenant or condition herein contained shall not be deemed to be a waiver of any subsequent breach of the same or any other term, covenant or condition herein contained.
45.18 To the extent permitted by Applicable Laws, the parties waive trial by jury in any action, proceeding or counterclaim brought by the other party hereto related to matters arising out of or in any way connected with this Lease; the relationship between Landlord and Tenant; Tenants use or occupancy of the Premises; or any claim of injury or damage related to this Lease or the Premises.
46. Generator . Tenants use of the generators in the Bent Building shall be permitted as follows: (a) Tenant shall not be entitled to use Generator #1 identified in Exhibit R hereto, (b) Tenant shall be entitled to use all of the kilowatt capacity of Generator #2 identified in Exhibit R hereto, and (c) Tenant shall be entitled to utilize up to 300 kilowatts of the 450-kilowatt capacity of Generator #3 identified in Exhibit R hereto. In the event that Tenant requires additional standby power, Landlord will use commercially reasonable efforts (at no cost to Landlord) to facilitate efforts by Tenant to secure the same from one (1) or more of the tenants on the fourth (4 th ) floor of the Bent Building.
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IN WITNESS WHEREOF, the parties hereto have executed this Lease as a sealed Massachusetts instrument as of the date first above written.
LANDLORD : |
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BMR-ROGERS STREET LLC, |
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a Delaware limited liability company |
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/s/ Kevin M. Simonsen |
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Kevin M. Simonsen |
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VP, Real Estate Legal |
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TENANT : |
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MOMENTA PHARMACEUTICALS, INC., |
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a Delaware corporation |
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By: |
/s/ Richard P. Shea |
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Name: |
Richard P. Shea |
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Title: |
Senior Vice President and Chief Financial Officer |
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EXHIBIT A
PROPERTY
PARCEL ONE (304-322 Bent Street):
The land with the buildings thereon, situated in Cambridge, Middlesex County, Massachusetts, and shown as the parcel containing 40,000 square feet of land on a plan entitled Boston &. Albany R.R.- Cambridge land conveyed by B & A R.R. Co. to Stahleker Steel Corp., dated October 30,1945, and signed by L. J. Murphy, District Engineer and recorded with the Middlesex South District Registry of Deeds, Book 6944, Page 383, and bounded and described according to said plan, as follows:
NORTHEASTERLY: by Bent Street, 200 feet;
SOUTHEASTERLY: by land of the Boston & Albany R.R. Co., 200.02 feet;
SOUTHWESTERLY: by Rogers Street, 200 feet;
NORTHWESTERLY: by Fulkerson Street, formerly known as Ninth Street, 200.02 feet.
PARCEL TWO (301 Binney Street/157 Sixth Street):
a. Parcel 1 :
A certain parcel of land situated in Cambridge, in Middlesex County and Commonwealth of Massachusetts, bounded and described as follows:
NORTHWESTERLY: on Binney Street two hundred (200) feet, thence turning at right angles and running;
NORTHEASTERLY: along land shown on the plan hereinafter mentioned as belonging to Associates Transport, Inc., two hundred (200) feet to a point on the private way shown as Rogers Street on the plan hereinafter mentioned; thence turning at right angles and running;
SOUTHEASTERLY: on Rogers Street two hundred (200) feet to a point on Sixth Street; thence turning at right angles and running;
SOUTHWESTERLY: on Sixth Street two hundred (200) feet to the point of beginning.
Containing 40,000 square feet and being the parcel of land shown on the plan entitled Plan of Land in Cambridge, Mass. dated August 8, 1945, William S. Crocker, C.E., said plan being duly recorded with Middlesex South Registry District Deeds, Book 6893, Page 509; and also being the parcel of land shown on a plan
of land entitled Plan of Land in Cambridge, Mass. Property of Industrial Stainless Steel Inc. dated October 21,1960, Schofield Brothers, Reg. Land Surveyors, said plan being duly recorded with the Middlesex South Registry of Deeds as Plan Number 1664 of 1960 at Book 9706, Page End.
b. Parcel 2 :
A certain parcel of land with the buildings thereon situated in said Cambridge, bounded and described as follows:
NORTHERLY: by Rogers Street, three-hundred thirty-five and 27/100 (335.27) feet;
EASTERLY: by land now or formerly of Harry J . Dowd, two hundred and No/100 (200) feet;
SOUTHERLY: by Binney Street; and
WESTERLY: by Fulkerson Street.
Parcels 1 and 2 of Parcel Two together comprise Lots A, B, C and D as shown on a plan of land entitled Plan Showing Sub-division of Land in Cambridge, Massachusetts, dated July 29, 1940, Wm. H. McGinness C.E., said plan being duly recorded with the Middlesex South Registry of Deeds as Plan Number 1052 of 1940, at Book 6445, Page 394.
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EXHIBIT E
FORM OF LETTER OF CREDIT
IRREVOCABLE STANDBY LETTER OF CREDIT NO. SVBSF
DATE: , 2013
BENEFICIARY:
BMR-ROGERS STREET LLC
17190 BERNARDO CENTER DRIVE
SAN DIEGO, CA 92128
VICE-PRESIDENTREAL ESTATE COUNSEL
APPLICANT:
MOMENTA PHARMACEUTICALS, INC.
675 WEST KENDALL STREET
CAMBRIDGE, MA 02142
AMOUNT: US$ (U.S. DOLLARS AND NO/100)
EXPIRATION DATE: [ONE YEAR FROM ISSUANCE]
LOCATION: SANTA CLARA, CALIFORNIA
DEAR SIR/MADAM:
WE HEREBY ESTABLISH OUR IRREVOCABLE AND UNCONDITIONAL, EXCEPT FOR THE CONDITIONS EXPRESSLY SET FORTH HEREIN, STANDBY LETTER OF CREDIT NO. SVBSF IN FAVOR OF BENEFICIARY AVAILABLE BY BENEFICIARYS DRAFTS DRAWN ON US AT SIGHT AGAINST PRESENTATION, AS SET FORTH BELOW AT THE BANKS OFFICE (AS DEFINED BELOW) OR BY FACSIMILE TRANSMISSION AS SET FORTH BELOW, OF THE FOLLOWING DOCUMENTS ONLY:
1. THE ORIGINAL OF THIS LETTER OF CREDIT AND ALL AMENDMENT(S), IF ANY.
2. YOUR SIGHT DRAFT DRAWN ON US SUBSTANTIALLY IN THE FORM OF EXHIBIT A ATTACHED HERETO.
THE SIGHT DRAFT MUST BE SIGNED BY AN AUTHORIZED OFFICER OF BENEFICIARY FOLLOWED BY HIS/HER PRINTED NAME AND DESIGNATED TITLE. NO EVIDENCE OF AUTHORITY IS REQUIRED.
PARTIAL AND MULTIPLE DRAWINGS ARE ALLOWED. THIS LETTER OF CREDIT MUST ACCOMPANY ANY DRAWINGS HEREUNDER FOR ENDORSEMENT OF THE DRAWING AMOUNT AND WILL BE PROMPTLY RETURNED TO THE BENEFICIARY UNLESS IT IS FULLY UTILIZED.
THIS LETTER OF CREDIT SHALL BE AUTOMATICALLY EXTENDED FOR ADDITIONAL PERIODS OF ONE YEAR, WITHOUT THE NECESSITY OF AMENDMENT, FROM THE PRESENT AND EACH FUTURE EXPIRATION DATE UNLESS AT LEAST 90 DAYS PRIOR TO THE THEN CURRENT EXPIRATION DATE WE SEND YOU A NOTICE BY REGISTERED MAIL OR OVERNIGHT COURIER SERVICE AT THE ABOVE ADDRESS (OR SUCH OTHER ADDRESS AS BENEFICIARY SHALL SPECIFY BY WRITTEN NOTICE) THAT THIS LETTER OF CREDIT WILL NOT BE EXTENDED BEYOND THE CURRENT EXPIRATION DATE. IN NO EVENT SHALL THIS LETTER OF CREDIT BE AUTOMATICALLY EXTENDED BEYOND FEBRUARY 29, 2016 WHICH SHALL BE THE FINAL EXPIRATION DATE OF THIS LETTER OF CREDIT. IF ANY EXPIRATION DATE SHALL NOT FALL ON A BUSINESS DAY, THE EXPIRATION DATE SHALL BE THE NEXT SUCCEEDING BUSINESS DAY.
WE HEREBY AGREE TO CONFIRM THE EXPIRATION DATE IN WRITING UPON RECEIPT OF BENEFICIARYS WRITTEN REQUEST.
ALL DEMANDS FOR PAYMENT SHALL BE MADE BY PRESENTATION OF THE ORIGINAL SIGHT DRAFT AND LETTER OF CREDIT AND ALL AMENDMENTS, IF ANY, ON A BUSINESS DAY AT OUR OFFICE (THE BANKS OFFICE) AT: SILICON VALLEY BANK, 3003 TASMAN DRIVE, SANTA CLARA, CALIFORNIA 95054, ATTENTION: STANDBY LETTER OF CREDIT NEGOTIATION SECTION OR BY FACSIMILE TRANSMISSION AT: (408) 496-2418 OR: (408) 969-6510, ATTENTION: STANDBY LETTER OF CREDIT NEGOTIATION SECTION WITH ORIGINALS TO FOLLOW WITH REASONABLE PROMPTNESS THEREAFTER BY OVERNIGHT COURIER SERVICE OR OTHERWISE; PROVIDED, HOWEVER, THAT DELIVERY OF SUCH ORIGINALS SHALL NOT BE A CONDITION TO THE EFFECTIVENESS OF THE DRAW AND THE BANK WILL DETERMINE TO HONOR OR DISHONOR ON THE BASIS OF PRESENTATION BY FACSIMILE ALONE, AND WILL NOT EXAMINE THE ORIGINALS.
IF BENEFICIARY PRESENTS PROPER DRAWING DOCUMENTATION TO US ON OR BEFORE THE EXPIRATION DATE OF THIS LETTER OF CREDIT, THEN WE SHALL PAY ONLY FROM OUR OWN FUNDS UNDER THIS LETTER OF CREDIT AT OR BEFORE THE FOLLOWING TIME (THE PAYMENT DEADLINE): (A) IF PRESENTMENT IS MADE AT OR BEFORE NOON OF ANY BUSINESS DAY, THEN THE CLOSE OF THE NEXT BUSINESS DAY; AND (B) OTHERWISE, THE CLOSE OF THE SECOND BUSINESS DAY. WE WAIVE ANY RIGHT TO DELAY PAYMENT BEYOND THE PAYMENT DEADLINE. IF WE DETERMINE THAT DRAWING DOCUMENTATION IS NOT PROPER, THEN WE SHALL SO ADVISE BENEFICIARY IN WRITING, SPECIFYING ALL GROUNDS FOR OUR DETERMINATION, WITHIN TWO BUSINESS DAYS AFTER THE PAYMENT DEADLINE.
WE SHALL HAVE NO DUTY OR RIGHT TO INQUIRE INTO THE VALIDITY OF OR BASIS FOR ANY DRAW, AND WE WAIVE ANY DEFENSE BASED ON FRAUD OR CLAIM OF FRAUD.
NO AMENDMENT THAT ADVERSELY AFFECTS BENEFICIARY SHALL BE EFFECTIVE WITHOUT BENEFICIARYS WRITTEN CONSENT.
THIS LETTER OF CREDIT SHALL BE TRANSFERRED BY THE ISSUING BANK AT THE REQUEST OF THE BENEFICIARY ONE OR MORE TIMES BUT IN EACH INSTANCE TO A SINGLE BENEFICIARY AND ONLY IN ITS ENTIRETY UP TO THE THEN AVAILABLE AMOUNT IN FAVOR OF ANY DESIGNATED TRANSFEREE ASSUMING SUCH TRANSFER TO SUCH TRANSFEREE IS 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). OUR TRANSFER FEE OF ¼ OF 1% OF THE TRANSFER AMOUNT (MINIMUM $250.00) IS FOR THE ACCOUNT OF THE APPLICANT AND PAYMENT OF SUCH TRANSFER FEE IS NOT A CONDITION TO SUCH TRANSFER. ANY TRANSFER OF THIS LETTER OF CREDIT MAY NOT CHANGE THE PLACE OF EXPIRATION OF THE LETTER OF CREDIT FROM OUR ABOVE-SPECIFIED OFFICE. EACH TRANSFER SHALL BE EVIDENCED BY OUR ENDORSEMENT ON THE REVERSE OF THE ORIGINAL LETTER OF CREDIT TO REFLECT THE TRANSFER AND WE SHALL FORWARD THE ORIGINAL LETTER OF CREDIT TO THE TRANSFEREE.
WE IRREVOCABLY HEREBY AGREE WITH THE DRAWERS, ENDORSERS AND HOLDERS THAT THE DRAFTS DRAWN UNDER AND IN ACCORDANCE WITH THE TERMS AND CONDITIONS OF THIS LETTER OF CREDIT SHALL BE DULY HONORED UPON PRESENTATION TO THE DRAWEE, IF PRESENTED ON OR BEFORE THE EXPIRATION DATE OF THIS CREDIT IRRESPECTIVE OF ANY CLAIM BY ANY OTHER PERSON.
IF ANY INSTRUCTIONS ACCOMPANYING A DRAWING UNDER THIS LETTER OF CREDIT REQUEST THAT PAYMENT IS TO BE BY TRANSFER TO YOUR ACCOUNT WITH ANOTHER BANK, WE WILL ONLY EFFECT SUCH PAYMENT BY FED WIRE TO A U.S. REGULATED BANK, AND WE AND/OR SUCH
OTHER BANK MAY REASONABLY RELY ON AN ACCOUNT NUMBER SPECIFIED IN SUCH INSTRUCTIONS.
THIS LETTER OF CREDIT IS SUBJECT TO THE INTERNATIONAL STANDBY PRACTICES ISP98, INTERNATIONAL CHAMBER OF COMMERCE, PUBLICATION NO. 590; AND,TO THE EXTENT NOT INCONSISTENT WITH ISP98, ARTICLE 5 OF THE UNIFORM COMMERCIAL CODE OF THE STATE OF NEW YORK.
SILICON VALLEY BANK |
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EXHIBIT A
DATE: |
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A T SIGHT OF THIS DRAFT
P AY TO THE ORDER OF US$
USDOLLARS
DRAWN UNDER SILICON VALLEY BANK, SANTA CLARA, CALIFORNIA, STANDBY LETTER OF CREDIT NUMBER NO. DATED
T O: |
SILICON VALLEY BANK |
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3003 TASMAN DRIVE |
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SANTA CLARA, CA 95054 |
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Authorized Signature & Title |
GUIDELINES TO PREPARE THE DRAFT
1. DATE: ISSUANCE DATE OF DRAFT.
2. REF. NO.: BENEFICIARYS REFERENCE NUMBER, IF ANY.
3. PAY TO THE ORDER OF: NAME OF BENEFICIARY AS INDICATED IN THE L/C (MAKE SURE BENEFICIARY ENDORSES IT ON THE REVERSE SIDE).
4. US$: AMOUNT OF DRAWING IN FIGURES.
5. USDOLLARS: AMOUNT OF DRAWING IN WORDS.
6. LETTER OF CREDIT NUMBER: SILICON VALLEY BANKS STANDBY L/C NUMBER THAT PERTAINS TO THE DRAWING.
7. DATED: ISSUANCE DATE OF THE STANDBY L/C.
8. BENEFICIARYS NAME: NAME OF BENEFICIARY AS INDICATED IN THE L/C.
9. AUTHORIZED SIGNATURE: SIGNED BY AN AUTHORIZED SIGNER OF BENEFICIARY.
IF YOU NEED FURTHER ASSISTANCE IN COMPLETING THIS DRAFT, PLEASE CALL OUR L/C PAYMENT SECTION AT 408-654-6274 OR 408-654-7716 OR 408-654-5545 OR 408-654-7127 OR 408-654-3035.
EXHIBIT B
DATE:
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3003 TASMAN DRIVE |
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IRREVOCABLE STANDBY LETTER OF CREDIT |
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SILICON VALLEY BANK, SANTA CLARA |
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STANDBY LETTERS OF CREDIT |
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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 TO REFLECT THE TRANSFER AND FORWARD IT DIRECTLY TO THE TRANSFEREE WITH YOUR CUSTOMARY NOTICE OF TRANSFER.
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(SIGNATURE OF BENEFICIARY) |
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SIGNATURE AUTHENTICATED
The name(s), title(s), and signature(s) conform to that/those on file with us for the company and the signature(s) is/are authorized to execute this instrument.
We further confirm that the company has been identified applying the appropriate due diligence and enhanced due diligence as required by BSA and all its subsequent amendments.
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EXHIBIT F
RULES AND REGULATIONS
NOTHING IN THESE RULES AND REGULATIONS ( RULES AND REGULATIONS ) SHALL SUPPLANT ANY PROVISION OF THE LEASE. IN THE EVENT OF A CONFLICT OR INCONSISTENCY BETWEEN THESE RULES AND REGULATIONS AND THE LEASE, THE LEASE SHALL PREVAIL.
1. No Tenant Party shall encumber or obstruct the common entrances, lobbies, elevators, sidewalks and stairways of the Building(s) or the Project or use them for any purposes other than ingress or egress to and from the Building(s) or the Project.
2. Except as specifically provided in the Lease, no sign, placard, picture, advertisement, name or notice shall be installed or displayed on any part of the outside of the Premises or the Building(s) without Landlords prior written consent. Landlord shall have the right to remove, at Tenants sole cost and expense and without notice, any sign installed or displayed in violation of this rule.
3. If Landlord reasonably objects in writing to any curtains, blinds, shades, screens, hanging plants or other similar objects attached to or used in connection with any window or door of the Premises or placed on any windowsill, and (a) such window, door or windowsill is visible from the exterior of the Premises and (b) such curtain, blind, shade, screen, hanging plant or other object is not included in plans approved by Landlord, then Tenant shall promptly remove such curtains, blinds, shades, screens, hanging plants or other similar objects at its sole cost and expense.
4. No deliveries shall be made that reasonably impede or interfere with other tenants in or the operation of the Project. Movement of furniture, office equipment or any other large or bulky material(s) through the Common Area of the Bent Building shall be restricted to such hours as Landlord may designate and shall be subject to reasonable restrictions that Landlord may reasonably impose.
5. Tenant shall not place a load upon any floor of the Premises that exceeds the load per square foot that (a) such floor was designed to carry or (b) is allowed by Applicable Laws. Fixtures and equipment that cause noises or vibrations that may be transmitted to the structure of the Bent Building to such a degree as to be objectionable to other tenants shall be placed and maintained by Tenant, at Tenants sole cost and expense, on vibration eliminators or other devices sufficient to eliminate such noises and vibrations to levels reasonably acceptable to Landlord and the affected tenants of the Bent Project.
6. Tenant shall not use any method of heating or air conditioning other than that approved in writing by Landlord, which approval shall not be unreasonably withheld, conditioned, or delayed.
7. Tenant shall not install any radio, television or other antennae; cell or other communications equipment; or other devices on the roof or exterior walls of the Premises except
in accordance with the Lease. Tenant shall not interfere with radio, television or other digital or electronic communications at the Project or elsewhere.
8. Canvassing, peddling, soliciting and distributing handbills or any other written material within, on or around the Project (other than within the Premises) are prohibited. Tenant shall cooperate with Landlord to prevent such activities by any Tenant Party.
9. Tenant shall store all of its trash, garbage and Hazardous Materials in receptacles within its Premises or in receptacles designated by Landlord outside of the Premises. Tenant shall not place in any such receptacle any material that cannot be disposed of in the ordinary and customary manner of trash, garbage and Hazardous Materials disposal. Any Hazardous Materials transported through Common Area shall be held in secondary containment devices. Tenant shall be responsible, at its sole cost and expense, for Tenants removal of its trash, garbage and Hazardous Materials; provided , however, that Tenant is encouraged to participate in the waste removal and recycling program in place at the Project.
10. The Premises shall not be used for lodging or for any improper, immoral or objectionable purpose. No cooking shall be done or permitted in the Premises; provided , however, that Tenant may use (a) equipment approved in accordance with the requirements of insurance policies that Landlord or Tenant is required to purchase and maintain pursuant to the Lease for brewing coffee, tea, hot chocolate and similar beverages, (b) microwave ovens for employees use and (c) equipment shown on plans approved by Landlord; provided , further, that any such equipment and microwave ovens are used in accordance with Applicable Laws.
11. Tenant shall not, without Landlords prior written consent, use the name of the Project, if any, in connection with or in promoting or advertising Tenants business except as Tenants address.
12. Tenant shall comply with all safety, fire protection and evacuation procedures and regulations established by Landlord or any Governmental Authority.
13. Tenant assumes any and all responsibility for protecting the Premises from theft, robbery and pilferage, which responsibility includes keeping doors locked and other means of entry to the Premises closed.
14. Tenant shall not modify any locks to the Premises without Landlords prior written consent, which consent Landlord shall not unreasonably withhold, condition or delay. Tenant shall furnish Landlord with copies of keys, pass cards or similar devices for locks to the Premises.
15. Tenant shall cooperate and participate in all reasonable security programs affecting the Premises.
16. Tenant shall not permit any animals in the Project, other than for guide animals or for use in laboratory experiments.
17. Bicycles shall not be taken into the Building(s) except into areas designated by Landlord. Landlord agrees to designate one or more areas for the daytime storage of bicycles; provided that
Landlord may change the location of the designated areas from time to time in Landlords discretion.
18. The water and wash closets and other plumbing fixtures shall not be used for any purposes other than those for which they were constructed, and no sweepings, rubbish, rags or other substances shall be deposited therein.
19. Discharge of industrial sewage shall only be permitted if Tenant, at its sole expense, first obtains all necessary permits and licenses therefor from all applicable Governmental Authorities.
20. Smoking is prohibited inside the Buildings, but is permitted in designated outdoor areas of the Project.
21. The Projects hours of operation are currently 24 hours a day, seven days a week.
22. Tenant shall comply with all orders, requirements and conditions now or hereafter imposed by Applicable Laws or Landlord ( Waste Regulations ) regarding the collection, sorting, separation and recycling of waste products, garbage, refuse and trash generated by Tenant (collectively, Waste Products ), including (without limitation) the separation of Waste Products into receptacles reasonably approved by Landlord and the removal of such receptacles in accordance with any collection schedules prescribed by Waste Regulations.
23. Tenant, at Tenants sole cost and expense, shall cause the Premises to be exterminated on a monthly basis to Landlords reasonable satisfaction and shall cause all portions of the Premises used for the storage, preparation, service or consumption of food or beverages to be cleaned daily in a manner reasonably satisfactory to Landlord, and to be treated against infestation by insects, rodents and other vermin and pests whenever there is evidence of any infestation. Tenant shall not permit any person to enter the Premises or the Project for the purpose of providing such extermination services, unless such persons have been approved by Landlord, which approval shall not be unreasonably withheld, conditioned, or delayed. If requested by Landlord, Tenant shall, at Tenants sole cost and expense, store any refuse generated in the Premises by the consumption of food or beverages in a cold box or similar facility.
24. If Tenant desires to use any portion of the Common Area for a Tenant-related event, Tenant must notify Landlord in writing at least thirty (30) days prior to such event on the form attached as Attachment 1 to this Exhibit, which use shall be subject to Landlords prior written consent, not to be unreasonably withheld, conditioned or delayed. Notwithstanding anything in the Lease or the completed and executed Attachment to the contrary, Tenant shall be solely responsible for setting up and taking down any equipment or other materials required for the event, and shall promptly pick up any litter and report any property damage to Landlord related to the event. Any use of the Common Area pursuant to this Section shall be subject to the provisions of Article 28 of the Lease.
Landlord may waive any one or more of these Rules and Regulations for the benefit of Tenant or any other tenant, but no such waiver by Landlord shall be construed as a waiver of such Rules and Regulations in favor of Tenant or any other tenant, nor prevent Landlord from thereafter enforcing any such Rules and Regulations against any or all of the tenants of the
Project, including Tenant. These Rules and Regulations are in addition to, and shall not be construed to in any way modify or amend, in whole or in part, the terms covenants, agreements and conditions of the Lease. Landlord reserves the right to make such other and reasonable rules and regulations as, in its reasonable judgment, may from time to time be needed for safety and security, the care and cleanliness of the Project, or the preservation of good order therein; provided , however, that Tenant shall not be obligated to adhere to such additional rules or regulations until Landlord has provided Tenant with written notice thereof. Tenant agrees to abide by these Rules and Regulations and any reasonable additional rules and regulations issued or adopted by Landlord. Tenant shall be responsible for the observance of these Rules and Regulations by all Tenant Parties.
ATTACHMENT 1 TO EXHIBIT F
REQUEST FOR USE OF COMMON AREA
[TENANT LETTERHEAD]
VIA [ ]
[Date]
BMR-Rogers Street LLC
17190 Bernardo Center Drive
San Diego, California 92128
Attn: Senior Director, East Coast Operations
Re: Notice of Request to Use Common Area
To Whom It May Concern:
Momenta Pharmaceuticals, Inc., requests that it have use of the common area as described below:
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Open to the Public? |
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Food and/or Beverages? |
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If YES:
· will alcohol be served (Note: Proof of an insurance endorsement for serving alcohol must be provided) o YES o NO
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Other Amenities (tent, band, etc.): |
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Please let us know at your earliest convenience whether such use is approved.
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Sincerely, |
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To Be Completed by Landlord :
o APPROVED DENIED o
The following conditions apply to approval (if approved):
1.
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[LOGO] CITY OF CAMBRIDGE EXECUTIVE DEPARTMENT Robert W. Healy, City Manager Richard C. Rossi, Deputy City Manager PTDM Ordinance AMENDMENT FINAL DECISION Project: 301 Binney Street - 320 Bent Street Project Number: F-14, Amendment #3 Applicant Rogers Street, LLC. Contact: Daniel Winny Address: c/o Lyme Properties, 101 Main Street, 18th Floor, Cambridge, MA 02142 Date of Application: 4/11/02 Decision Deadline: 6/10/00 Date of Issue: 5/24/02 This form indicates the FINAL decision of the Parking and Transportation Demand Management Planning Officer with respect to the PTDM plan submitted for the project listed above. Please review the enclosed attachments, which include information about ongoing monitoring and reporting relative to this project. Decision: Approve (attachment: approval letter and copy of plan) El Approve with Conditions (attachment: letter of conditions and copy of plan) 0 Deny (attachment: reason for denial and copy of plan) Catherine E. Preston, AICP PTDM Planning Officer 795 Massachusetts Avenue, Cambridge, Massachusetts 02139 Voice: 617.349.4300 Fax:617.349.4307 TTY: 617.349.4242 Web: www.ci.cambridge.ma.us |
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[LOGO] CITY OF CAMBRIDGE EXECUTIVE DEPARTMENT Robert W. Healy, City Manager Richard C. Rossi, Deputy City Manager May 24, 2002 Daniel Winny Lyme Properties 101 Main Street, 18th Floor Cambridge, MA 02142 Dear Mr. Winny: The attached form indicates the final decision on the Parking and Transportation Demand Management plan for the project located at 301 Binney Street - 320 Bent Street. The final decision is an approval with conditions reflecting changes that must be made to your plan. This letter spells out the conditions that are placed on your plan, as well as recommendations for additional TDM programs that may improve your non-SOV mode split. The last section lays out more details about implementation of the monitoring and reporting program that is required as part of your plan. Plan Conditions The following conditions are placed on the PTDM plan for 301 Binney Street - 320 Bent Street: The revised plan does not address the mode split commitment, or appropriate TDM measures, for patrons of the retail and/or restaurant portions of the project. The SOV mode split commitments for non-employee trips are derived from the 1995 Nationwide Personal Transportation Survey (NPTS), adjusted for Cambridge Census Tracts. The NPTS SOV rate for restaurants nationwide is 25%. Using an adjustment factor of 0.770 (the ratio of SOV commuting rates in this Census tract to the National rates), we get a baseline restaurant patron mode split of 19% SOV. Similarly, the NPTS SOV rates for shopping trips nationwide is 46%. Using the same adjustment factor, we get a baseline retail patron mode split of 35%. Then, to both of these mode splits, we apply the standard 10% reduction, resulting in a 17% SOV mode split for restaurant patrons and a 32% SOV mode split for retail patrons. CONDITION: The mode split commitment for patrons of a restaurant shall be 17% SOV. The mode split commitment for patrons of a retail establishment shall be 32% SOV. If other non-office uses are proposed, the applicant shall consult the PTDM Planning Officer to determine the appropriate mode split commitment. 795 Massachusetts Avenue, Cambridge, Massachusetts 02139 Voice: 617.349.4300. Fax: 617.349.4307 TTY: 617.349.4242 Web: www.ci.cambridge.ma.us |
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[LOGO] CONDITION: Restaurant and retail tenants shall be required to emphasize the location's accessibility via transit in all advertising materials. In the event that the mode split for patrons of these uses is not met, additional reasonable measures shall be undertaken to meet this mode split. Additional Recommendations In addition to the conditions listed above, I am recommending the implementation of the following additional TDM measures. If the current plan fails to reach the stated mode split goal, implementing these programs will help to achieve that goal. Charge employees for the full cost of their parking directly. Implement financial incentives for walking and bicycling. Monitoring and Reporting Mode split information shall be monitored and reported annual. Driveway counts and parking utilization shall be reported every two years. If the certificate of occupancy is issued between September 1 and February 29, the monitoring shall take place during the months of September or October and be reported to the PTDM Planning Officer no later than November 30. If the certificate of occupancy is issued between March 1 and August 31, monitoring shall take place during the months of April or May and be reported to the PTDM Planning Officer no laterthan June 30. This will ensure that the monitoring captures a realistic assessment of the performance of the project, while giving time to compile the results and report them to the City. It is important to note that while approvals under the PTDM ordinance are transferable by and among private parties, this is contingent upon the new owner agreeing to continue to operate under the existing PTDM plan. Should the owner elect to transfer all or some portion ofthe project, Section 10.18.050 (g) of the PTDM ordinance would apply. I look forward to working with you in the future as you implement the elements of this plan. If you have any questions, please feel free to contact me by phone at 617-349-4673 or by email at cpreston@ci.cambridge.ma.us. Sincerely, Catherine E. Preston, AICP Catherine E. Preston, AICP Parking and Transportation Demand Management Officer cc: B. Rubenstein S. Rasmussen S. Clippinger J. Schrieber |
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PARKING AND TRANSPORTATION DEMAND MANAGEMENT PLAN PROPOSED RESEARCH AND DEVELOPMENT/RETAIL BUILDINGS 301 BINNEY STREET AND 320 BENT STREET CAMBRIDGE, MASSACHUSETTS Prepared for: ROGERS STREET, LLC Cambridge, MA May 2002 Prepared by: VANASSE & ASSOCIATES, INC. 10 New England Business Center Drive, Suite 314 Andover, MA 01810 (978) 474-8800 Copyright © 2002 by VAI All Rights Reserved |
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CONTENTS PARKING AND TRANSPORTATION DEMAND 1 MANAGEMENT PLAN 1 Project Description 1 Parking Demand Analysis 2 Travel Mode Split Commitment 2 Public Transportation 3 Bicycles and Walking 4 Ridesharing Program 4 Alternative Work Schedules 5 Management 5 Parking 6 Monitoring and Reporting 6 Corporate Officer Certification 7 PARKING GARAGE AND FIRST FLOOR PLANS (To be Provided under Separate Cover). |
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Page 1 of 2 City of Cambridge, Massachusetts 12/19/00 INTERDEPARTMENTAL PARKING FACILITY REGISTRATION FORM Application must include a signed and dated scale layout of the parking facility with lot lines, driveways, curb cuts, parking stalls, loading zones, building entrances/exits, pedestrian walkways, bicycle storage, etc. 3.) Name and address of property. owner: Rogers Street, LLC, C/O Lyme Properties, LLC 101 Main Street, 18th Floor, Cambridge, MA 02142 Telephone: 617-225-0909 4.) Name and address of parking facility operator: Rogers Street, LLC, C/O Lyme Properties, LLC 101 Main Street, 18th Floor, Cambridge, MA 02142 Telephone: 617-225-0909 5) Will any of the users be located off-site? Yes. No. If "yes, indicate name and address of off-site user(s): (company, residence, individual, or "general public") 6.) Type of Request: 7.) Type of Facility: 8.) Type of Use: New facility Lot Commercial (general public for a fee) Modified facility Garage Accessory2 (with a fee? Yes No) Principal (with a fee? Yes No) 932 Lab/Retail; 9.) Number of Parking Spaces Required by Zoning*: Minimum 503 Maximum Unlimited for Housing 10.) Number of Current and Proposed Parking Spaces by Type and User(s): Registered: Proposed: Proposed User(s): (Name of company, residence, or individual) Commercial (for a fee) Residential 41 37 Residents of proposed development (301 Binney Street/157 Sixth St.) Employee 195 466 Tenants of proposed development (301 Binney St. and 320 Bent St.) Customer/Client Included Visitor/Guest Included, Patient Student I hereby certify that all information supplied on this form is true, accurate and complete. I also certify that this information meets the requirements of Article 6 of the Cambridge Zoning Ordinance. Owner Signature & Title Date Operator Signature & Title Date. Print Name (Owner) & Title Print Name (Operator) & Title 1 For questions, contact the Assessing Department at 349-4343 or on the web at www2.ci.cambridge.ma.us/assessor/index.html. 2Accessory use parking only has non-commercial users who are located on-site.3 Principal use parking has a non-commercial user who is located off-site. 4 Parking requirements are described in Article 6 of the Cambridge Zoning Ordinance. Call Inspectional Services at 349-6100. Pre-existing off-street parking spaces are registered in the City parking inventory. Call the Traffic Department at 349-4745. APPLICATION IS NOT COMPLETE WITHOUT LAYOUT ATTACHED. 1.) Name and address of parking facility: Binney Street Garage 301 Binney Street, Cambridge, MA 02142 Telephone: 2.) Location of parking facility according to Assessing Department1: Block No. 31 Lot No.(s) 8, 12, and 13 |
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Page 2 of 2 FOR CITY OF CAMBRIDGE USE ONLY. DO NOT WRITE BELOW THIS LINE 12/19/00 Instructions: First department to receive application should confirm applicant has completed first page and understands that the required sign-offs may be conditional on others in order. After that department completes the tope line of this page and any possible sign-off(s), application should be forwarded to next department for sign-off. Each signing department must indicate the approved # of spaces under "parking tally plus any conditions. The Traffic Department can not sign-off on a building permit until parts 1), 2), and 4) below are signed. Zoning can not review a building permit application until Traffic has signed off. Licensing can not approve a parking license, if required, until parks 1), 2), 3), and 4) below are signed. Regarding the application for Parking Tally the following approvals must be received: Proposed: 1) Number of spaces registered in the parking inventory (info: 349-4745): Commercial Residential Other (employee, visitor, etc.) Registered: conditions: Signed Department of Traffic, Parking & Transportation Date 2) Facility has approved Parking & Transportation Demand Management Plan (info: 349-4745): Yes. No, not required. PTDM: conditions: Department Signed of Traffic, Parkins & Transportation Date 3) Facility has permit from Board of Zoning Signed Appeals (info: 349-6100): Yes, spaces valid until / / . BZA: conditions: No, not required. Inspectional Services Department Date 4) Facility has received a commercial parking Signed permit from the CPCC (info: 349-4745): Yes, spaces valid until /_/ CPCC: . conditions: No, not required. Department of Traffic, Parking & Transportation Date 5) Facility has received a parking license from the License Commission (info: 349-6100): q Yes, spaces valid until License: Garage & gasoline storage permit required. _/_/_. conditions: No, not required. Signed Cambridge License Commission Date To be completed by Inspectional Service or License Commission: Final Approved Number of Spaces For use by the Traffic Department: Final Parking Inventory Registration: Commercial Residential Other Exempt FORWARD COPIES TO: DEPARTMENT OF TRAFFIC, PARKING & TRANSPORTATION; INSPECTIONAL SERVICES DEPARTMENT; LICENSE COMMISSION; AND PARKING & TRANSPORTATION DEMAND MANAGEMENT OFFICER. |
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PARKING AND TRANSPORTATION DEMAND MANAGEMENT PLAN PROJECT DESCRIPTION The project site is located at 301 Binney Street and 320 Bent Street in Cambridge, Massachusetts. The existing project is permitted for 427,828 square foot (sf) gross floor area (gfa) of telecommunications space, 39,764 sf gfa of lab/research and development (R&D) space, and 41 apartment units (38,502 sf gfa); for a total of 506,094 sf GFA. A Parking and Transportation Demand Management (PTDM) plan for this existing project was approved on June 30, 2000 and amended on January 11, 2002. The building at 320 Bent Street is complete and a Certificate of Occupancy was issued on January 24, 2002. The garage and building at 301 Binney Street, including the houiing component whose address is 157 Sixth Street, are currently under construction. A PTDM amendment is now requested to reflect proposed changes in the uses, but not the total sf area of the project. The proposed new uses include 452,592 sf of R&D space, 17,500 sf of ancillary retail space, and 36,002 sf of residential space in the two buildings. The 301 Binney Street building will contain 289,852 sf of R&D space, 17,500 sf of retail space, and 36,002 .sf of residential space for a total of 343,354 sf. The 320 Bent Street building will contain 162,740 sf of R&D space. It should be noted that the aforementioned square footages are floor area gross as defined in the Cambridge Zoning Ordinance. Parking for both buildings will be provided in a 503-space private parking garage situated beneath the building located at 301 Binney Street. Access to the sites will be provided by way of Rogers Street, which is a private way. All truck access to the sites will be from Binney Street by way of Fulkerson Street and Sixth Street. Directional signs will be provided for trucks exiting the development on Rogers Street at Fulkerson Street and at Sixth Street to direct truck traffic to Binney Street from the project site. These signs will consist of a right-turn restriction for trucks exiting the development onto Fulkerson Street and a left-turn restriction for trucks exiting the development onto Sixth Street. The goal of these restrictions is to eliminate project-related truck traffic from the residential areas to the north o the development site. Figure 1 depicts the site location in relation to the existing roadway network. Detailed Traffic Impact Assessment/Interim Planning Overlay Petition (TIA/IPOP) Analyses were prepared by VAI for both 170 Fulkerson Street and 157 Sixth Street (as 320 Bent Street and 301 Binney Street were previously known) on behalf of Rogers Street, LLC in November 1999 and were subsequently certified by the City as complete. At that time, the 170 Fulkerson Street project (now 320 Bent Street) was to consist of the development of a 135,000 sf office/telecommunications building, with the 157 Sixth Street project (now 301 Binney Street) consisting of 185,000 sf of office/telecommunications space and 180,000 sf of biotechnology space. Parking was to be provided on-site by way of a 233-space private parking garage located beneath the 157 Sixth Street building. During the City approval process for the development sites, the 301 Binney Street site was ultimately approved for 360,000 sf of office/telecommunications space, with the 320 Bent Street site approved for 135,000 sf of |
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office/telecommunications space (the later increase in square footage from 495,000 sf to 506,094 sf is attributable to the housing units added as an amendment to the 301 Binney Street building permit in compliance with the requirements of the Larkin zoning amendment). Parking was reduced to 158 spaces in the originally approved PTDM plan for the projects. A new Traffic Impact Study/Special Permit Criteria Analysis TIS/SPCA) was prepared by VAI in April 2002 and submitted to the City of Cambridge for the proposed changes of use to the approved 301 Binney Street and 320 Bent Street development programs. The TIS/SPCA for the changes of use was Certified by the City as complete and reliable on April 30, 2002. PARKING DEMAND ANALYSIS A parking demand analysis was conducted for the development consistent with the vehicle-trip-generation calculations and travel mode split assumptions for project traffic as presented in the April 2002 TIS/SPCA. The analysis is based upon minimum City zoning requirements and is summarized in Table 1. Table 1 PARKING DEMAND ANALYSIS Type of Use Parking Space Ratio Number of Spaces Residential Use 1 per unit 37 (37 Apartments) R&D (Proposed 452,592 sf) General Retail (17,500 sf) TOTAL 1 per 1,050 sf 1 per 500 sf 431 503 35 Based upon the above analysis, the overall parking ratio for the development will be approximately 1 space per 1,006 sf (506,094 sf total space). Parking for the proposed development will be provided in a 503-space private parking garage situated beneath the building located at 301 Binney Street. TRAVEL MODE SPLIT COMMITMENT The 'travel mode split assumptions for the development were determined based on a review of 1990 U.S. Census Data and statistics compiled by the Metropolitan Area Planning Commission (MAPC). The travel mode split assumptions for the development were approved by the City of Cambridge Traffic,. Parking and Transportation Department and are summarized in Table 2. |
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Table 2 TRAVEL MODE SPLIT Mode of Travel Proposed Travel Mode Split R&D Center Residential and Retail Drive Alone 50 50 Rideshare 6 16 Transit 22 28 Bike 3 1 Walk 19 5 Other 0 0 TOTAL 100 100 Vehicle Occupancy Ratio 1.09 1.09 As shown in Table 2, the project proponent is committed to a 56 percent automobile mode split, which includes a 6 percent rideshare goal for the residential component of the project, and a 66 percent automobile mode split, which includes a 16 percent rideshare goal for the R&D and retail components of the project. The single-occupant vehicle (SOV) commitment is 50 percent for the entire development. The project proponent will monitor conditions to insure compliance with the mode split commitments. The monitoring and reporting system is documented later in this report. PUBLIC TRANSPORTATION The project site is ideally situated to take advantage of public transportation (transit) services in the area provided by the Massachusetts Bay Transit Authority (MBTA). The MBTA currently operates five public bus routes that serve the immediate vicinity of the project site. In addition, the Kendall Square Station on the Red Line and Lechmere Station on the Green Line are located within walking distance of the project site. Two shuttle bus services also operate in the vicinity of the project sites. The Galleria Shuttle originates in Kendall Square on Main Street and travels on Main Street, Galileo Galilei Way, Broadway, and Third Street, with connections to the Galleria Mall. The EZ-Ride shuttle originates from Cambridgeport and travels to North Station, with stops along Broadway, Kendall Square, Sixth Street, Third Street, and at Lechmere Station. The following measures will be implemented by the project proponent in order to encourage the use of public transportation by employees, residents and visitors of the planned development: MBTA bus and subway schedules will be available on-site MBTA passes will be sold on-site Tenants will be encouraged to provide 100 percent transit subsidies Employers will be encouraged to implement the Commuter Check program Rogers Street, LLC will join the other Lyme Properties affiliates at Kendall Square and Fort Washington Research Center in contributing to the EZ-Ride shuttle on a proportional basis upon full tenant occupancy of 320 Bent Street and subsequently 301 Binney Street. Lyme Properties will provide a covered bus shelter at an appropriate location on-site. In addition, Rogers Street, LLC will require tenants to offer 100 percent T-pass subsidies to their employees as long as University Park, Necco, Amgen, Biogen and Tech Square are required by the City of Cambridge to do the same. |
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Language in tenant leases will state that tenants should discourage the use of single-occupant vehicle commuting and promote the use of alternative modes of transportation and/or alternative work hours. In addition, language in the leases will encourage tenants to subsidize MBTA passes. At a minimum, tenants will be required to provide employees with the Commuter Choice program to the maximum allowed transportation fringe benefits. BICYCLES AND WALKING Bicycle spaces will be provided in a secured area within the 301 Binney Street parking garage. Rogers Street, LLC will provide 50 long-term bicycle spaces in the garage in addition to 29 bicycle spaces for short-term deliveries near entrances, as shown on the site plans. In addition, on-site shower facilities for employees will be provided as part of the required tenant or base building buildout. The overall site plan has been established with a sensitivity towards pedestrian access. The planned development has been designed to be handicapped accessible and sufficient illumination will be provided on-site. The project architect will work with the City of Cambridge Bicycle Coordinator to design long- and short-term bicycle parking and to ensure compliance with City standards. In addition, bicycle maps indicating the location of bicycle facilities in the area will be posted in a central location within the development to encourage bicycle commuting. At a minimum, the bicycle spaces will: Allow the frame and one wheel to be locked to the rack with a high security, U-shaped shackle lock if both wheels are left on the bicycle. Be securely anchored. Located near a main entrance lobby. Be covered. Each parking space must be accessible without moving another bicycle generally, allow for 2 feet by 6 feet for each bicycle parking space with a five foot aisle behind to allow room for maneuvering. Short-term bicycle parking will be provided convenient to the primary street level entrance. In order to encourage pedestrian access to the development and the community, the project proponent will reconstruct sidewalks along the project frontage on Binney Street, Fulkerson Street, Sixth Street, and the Rogers Street entrance in conjunction with the proposed project RIDESHARING PROGRAM Ridesharing refers to encouraging commuters to ride in vehicles with other commuters rather than drive alone to work. Given the number of employees in the area, a coordinated rideshare program could be very successful. The most common forms of ridesharing are carpools and vanpools. The benefits of such programs include less congestion, reduced fuel consumption, and better air quality. In conjunction with other Lyme Properties affiliates, Rogers Street, LLC will do the following: Join the local Charles River Transportation Management Association (CRTMA) who provide numerous services including: Computerized carpool/vanpool matching programs Guaranteed ride home program |
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Implement joint programs with area tenants, including an annual transportation fair to be held at least once a year. Provide a new employee information packet which will be distributed to all employees that will include information about the various TDM programs that are available and the ways in which employees can participate. Provide a quarterly bulletin or newsletter reminding employees about the programs and making them aware of any new or modified services. Coordinate with CARAVAN which leases commuter vans and provides administrative and organizational assistance. Provide preferential parking for car-poolers. Install commuter information centers or bulletin boards at one or more prominent location(s) in each of the subject buildings that would include up-to-date information about the various TDM programs that are available, as well as transit schedules and maps, ridematching forms, and promotional fliers. Provide a web site containing a variety of alternative mode information links which employees can use to find information about TDM programs or to obtain information from other sites (such as the MBTA or CARAVAN). Rogers Street, LLC will designate 47 spaces for car and vanpool parking on a preferential basis in the garage and will monitor their utilization and adequacy. In addition, Rogers Street, LLC will charge tenants for parking as additional rent independent of base building lease payments. ALTERNATIVE WORK SCHEDULES Flexible work hours allow employees to vary work schedules and reduces peak-hour traffic demands. Tenants of the development will be encouraged to implement flextime policies in order to reduce peak-hour traffic demands associated with the proposed project. Of all allowed uses in the Industry A-1 district, laboratory R&D provides the most flexible work hours. MANAGEMENT The project proponent will implement several management strategies designed to discourage the use of SOVs and encourage ridesharing and the use of alternative modes of transportation. The following strategies will be implemented by the property management team: Provide an on-site transportation coordinator. Join the CRTMA. Disseminate promotional materials to new employees on ridesharing and public transportation services. Provide preferential parking for carpoolers. Provide guaranteed ride home program (available through the TMA). Work with the City of Cambridge Office of Work Force Development to hire local residents. Promote an annual transportation awareness day. Develop a newsletter or email for employees in conjunction with the TMA promoting available Transportation Demand Management (TDM) programs. Install two electric vehicle charging stands. These strategies will be encouraged by tenants pursuant to lease rules and regulations. |
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PARKING An on-site parking supply of 1 space per 1,006 sf (506,094 sf total space) will be provided for residents, employees and visitors of the development. This parking ratio is sufficient to accommodate the anticipated parking demands associated with the planned development with implementation of an aggressive TDM program and incentives to use alternative modes of transportation as committed to by the project proponent herein. All of the proposed parking spaces will be accessory to the uses planned within the development, with no commercial spaces provided. In addition, Rogers Street, LLC will contract with Kendall Square/Cambridge Research Park for 145 spaces if the non-residential demand exceeds 466 spaces. Upon full occupancy by tenants, Lyme Properties will conduct bi-annual parking counts. If additional parking is warranted and Rogers Street, LLC can provide stacked or valet parking on-site, Rogers Street, LLC will amend the PTDM Plan and register the additional parking spaces. MONITORING AND REPORTING A monitoring program to document vehicle, pedestrian, and bicycle usage to the development will be provided to .the City of Cambridge on an annual basis. The monitoring program, including traffic counts and surveys, will provide detailed information on the travel modes used to travel to work and overall transportation characteristics. The monitoring program will include the following: Documentation on MBTA transit pass subsidies and carpooling (annually) Measured mode split (annually) Morning and evening peak-hour traffic counts at the site driveways (Rogers Street at Fulkerson Street and Rogers Street at Sixth Street) (every two years) Twenty-four-hour automatic traffic recorder (ATR) counts at the site driveways (Rogers Street, east of Fulkerson Street, and Rogers Street, west of Sixth Street) (every two years) Documentation relative to coordination with the City of Cambridge Office of Work Force Development to hire local residents. |
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This information will be provided to the City of Cambridge (based on date of certificate of occupancy), including recommendations to improve the PTDM program for the development, if necessary. In addition, initial employee surveys will be conducted in consultation with the CRTMA to identify employee commuter patterns and bring awareness to new employees of available TDM programs. In the event that the monitoring and reporting plans show that the SOV mode split goals are not being met, the applicant must make reasonable additional efforts to achieve the stated goals. CORPORATE OFFICER CERTIFICATION I hereby certify that the parking to be provided at this parking facility will be accessory to the uses within the planned development and that no commercial parking spaces will be provided. Should it be desired in the future to provide commercial parking within the facility, a commercial parking permit will be obtained from the City of Cambridge for each space to be used in such manner prior to their use as commercial spaces. Signed: Print Name: Title: Date: |
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City of Cambridge Community Development Department 344 Broadway, Cambridge, MA 02139 Attention: PTDM Planning Officer Parking and Transportation Demand Management Plan Property Transfer Form Name and Address of Transferee BME-Rogers Street LLC, 17140 Bernando Center Dr., Ste 222, San Diego, CA 92128 Telephone 858-485-9840 Name and Address of Approval Holder Lume Properties, 101 Main Street, Cambridge, MA 02142 Telephone 617-253-0909 Name and Address of Facility Rogers St. F-14 Amendment #3, 301 Binney St., 320 Bent St., Cambridge, MA 02142 Telephone Date of Current PTDM Plan Approval May 24, 2002. Instructions for Transferee: Complete either Section A or Section B within thirty (30) days of title transfer. Attach information about changes in use of the parking facility and associated building& If completing Section B, attach proposed revisions to approved plan. Section A I certify that I have reviewed and agree to implement the approved Parking and Transportation Demand Management plan for this facility. I understand the commitments made in the approved PTDM plan, including the commitment not to exceed a Single-Occupant Vehicle mode split of 50% for this facility. I understand that failure to implement the approved PTDM plan may result in enforcement actions per the Parking and Transportation Demand Management Ordinance. Section B I understand that the facility being transferred is subject to the Parking and Transportation Demand Management Ordinance. Having reviewed the approved PTDM plan, I believe that revisions to the approved plan are warranted and I am submitting a revised plan for approval. I understand that pending amendment of the approved plan or approval of a replacement plan, the approved plan is still in effect and I am responsible for its implementation. Transferee Signature and Title Date April 2000 |
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320 BENT The below CAM pool is the pool used to account for all expenses PREMISES= Includes all costs associated within the TENANT space BASE BUILDING = Includes all cost associated within the occupied building. MOMENTA MATRIX CAM POOL Account Landlord Maintenance Tenant Maintenance Utilities: Building Electricity x Premises Electricity x Building Gas x Base Building Plumbing System x Premises Plumbing System x Base Building HVAC Systems x Premises Gas x Building Water/Sewer x Premises Water/Sewer x Data/telecom cabling x Maintenance & Repairs Premises Bulbs/Ballasts x Premises Lighting Repairs x Premises Electrical Supplies x Premises Electrical Repairs x Premises Carpet/Floor Repairs x Premises Ceiling Repairs x Premises Computer Service x Base Building Electrical Supplies x Base Building Electrical Repairs x Base Building Environmental Repairs x Base Building Equipment Maintenance x Premises Equipment Rental x Base Building Equipment Rental x Exterior Repairs x Premises Fire Extinguisher x Base Building Fire Extinguiishers x Base Building General Repairs x Base Building Shared Generator #3 (See Attachment) x Tenant Dedicated Generator #2 (See Attachment) x Base Building loading dock/overhead doors x Base Building Glass Replacement x Premises Glass replacement x Base Building Key and Keycard Stock x Premises key and Keycard Access x Inspection Fees x Locksmith x Premises Maintenance Supplies x Base Building Maintenance Supplies x Premises Painting x Base Building Pest Control x Premises Pest Control x Premises Plumbing Repairs x Premises Plumbing Supplies x Acid Neutralization Tank / MWRA x Premises water heaters x Premises Reverse Osmosis System x Premises Vivarium x Tenant Glass wash/Autoclave x Base Building Sign Installation / Repairs x Premises Sign Repairs x Base Building Uniforms x Premises Janitorial: Contracted Service x Power Washing x Window Washing x HVAC Base Building Repairs (includes equipment on roof and within Premises if such equipment serves space other than Premises in addition to serving Premises) x Base Building Maintenance (includes equipment on roof and within Premises if such equipment serves space other than Premises in addition to serving Premises) x Tenant area heating system located within the Premises and exclusively serving the Premises x Tenant area cooling system located within the Premises and exclusively serving the Premises x Tenant area exhaust system located within the Premises and exclusively serving the Premises x Automatic temperature control system located within the Premises and exclusively serving the Premises x Tenant general exhaust and lab exhaust fans, duct and risers x Tenant supply and return air duct to AHUs in tenant area x Supplemental cooling systems dedicated to Tenant x Tenant compressed air (If applicable) x Tenant central vacuum system (If applicable) x Tenant fume hoods x |
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Landscape & Grounds Maintenance: Base Building Contracted Service x Interior of Premises Landscaping x Landscaping Repairs x Parking Lot Repairs x Shuttle x Premises Trash Removal x Premises Recycling x Vehicle Repairs & Maintenance x Lot and Landscape - Other x Snow Removal x Security & Life Safety: Base Building Contracted Security Service x Premises Constracted Security Services x Card access system for building entrances x Card access system for Tenant entrances and interior doors x Base Building Security Supplies x Base Building Life Safety Inspections x Base Building Fire & Life Safety - Repairs x Premises Fire & Life Safety - Repairs x Property Administrative: Cell Phones and Pagers x Consultant Fees x Computer Supplies & Repairs x Legal Fees x Licenses & permits x Office General x Office Rent x Office Supplies x Salaries & Related: Administrative Salaries x Administrative P/R Taxes & Related x Maintenance Salaries x Maintenance P/R Taxes & Related x Temporary Help x Management: Management Fee x Taxes: Real Property & School x Insurance: Boiler & Machinery Insurance x DIC Insurance x Liability Insurance x Property Insurance x Environmental Insurance x |
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MNTA Bent Street Personal Property Equipment Location Equipment Description Associated Utilities Mobile or Stationary Disposition Intent Basement, room B-9 Walk-in cold room -1 Elec, plumb, duct, alarms Stationary Remain Basement, room B-26 Cold room condensor Elec, plumb, duct, alarms Stationary Remain Basement, room B-34 Walk-in cold room -2 Elec, plumb, duct, alarms Stationary Remain Basement, room B-26 Cold room condensor Elec, plumb, duct, alarms Stationary Remain Basement, room B-12 Laminar flow hood Elec, plumb, duct, alarms Stationary Remain Basement, room B-2 Equipment utility panels Elec, plumb, duct, alarms Stationary Remain Basement, room B-2 Sump pump, pit & manifold Elect, plumb, hardware Stationary Remain Basement, all areas Piping, valves & fittings Plumbing Stationary Remain Basement, all areas Ducts, HVAC components Ductwork Stationary Remain Basement, all areas Fire protection systems Elec, plumb, duct, alarms Stationary Remain Basement, all areas Power wiring, panels, lighting Electrical Stationary Remain Basement, all areas Finishes, fixtures, walls, ceilings Architectural finishes Stationary Remain Basement, all areas Fixed furniture, casework Architectural finishes Stationary Remain Basement, all areas Low voltage wiring Electrical Stationary Remain Basement, all areas Utilities mounting hardware Elec, plumb, duct, alarms Stationary Remain Equipment Location Equipment Description Associated Utilities Mobile or Stationary Disposition Intent Basement, cage-1 Bulk N2 storage tanks Elec, plumb, alarms Mobile Remove Basement, room B-22 RO/DI water polishing vessels Plumbing Mobile Remove Basement, room B--2 Process equipment Elec, plumb, alarms Mobile Remove Basement, room B-51 NMR, consoles, components Elec, plumb, alarms Mobile Remove Basement, room B-53 NMR helium compressors Elec, plumb, alarms Mobile Remove Basement, room B-53 Freezers, refrigerators, misc. Elec, plumb, alarms Mobile Remove Basement, room B-1 Bio-safety cabinet Elec, plumb, alarms Mobile Remove Basement, room B-3 Bio-safety cabinet Elec, plumb, alarms Mobile Remove Basement, all areas Benchtop equipment Elec, plumb, alarms Mobile Remove Basement, all areas Lab gas manifolds, tanks Plumbing Mobile Remove Basement, all areas Furniture, storage cabinets N/A Mobile/stationary Remove Basement, all areas Process air filters, dryers Elec, plumb, alarms Mobile/stationary Remove Basement, all areas Process chemicals, waste Chemiicals Mobile Remove Basement, all areas Security systems Card readers, cameras, locks Stationary Remove Basement, all areas Ice machines Elec, plumb, alarms Mobile/stationary Remove Basement, all areas Printers, copiers, fax Elec, tele-data Mobile Remove Equipment Location Equipment Description Associated Utilities Mobile or Stationary Disposition Intent First floor, room 1157 fixed furniture, casework Elec, pumb, hardware Stationary Remain First floor, room 102 fixed furniture, reception Elec, tele-data Stationary Remain First floor, all areas finishes, fixtures, signage Architectural finishes Stationary Remain First floor, room all areas fixed furniture, cubicles Elec, tele-data Stationary Remain |
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MNTA Bent Street Personal Property Equipment Location Equipment Description Associated Utilities Mobile or Stationary Disposition Intent First floor, room 1154 Card access system Elec, tele-data Mobile Remove First flor, room 1102 Servers, tele-data equip Elec, tele-data Mobile Remove First floor, all areas Audio visual equipment Elect, tele-data Mobile Remove First floor, all areas Chairs, cabinets, stools N/A Mobile Remove First floor, all areas Work benches, desks N/A Mobile Remove First floor, all areas Printers, copiers, fax Elec, tele-data Mobile Remove First floor, all areas Coffee machines Elec, plumb Mobile Remove First floor, room 1118 Flammable cabinets N/A Mobile Remove First floor, room 1119 Waste compactor Plumbing (Comp air) Mobile Remove First floor, room 1119 Flammable cabinets N/A Mobile Remove First floor, room 1117 Storage racks N/A Mobile Remove First floor, room 1117 Pallet jacks N/A Mobile Remove Equipment Location Equipment Description Associated Utilities Mobile or Stationary Disposition Intent Second floor, all areas fixed furniture, casework Elec, pumb, hardware Stationary Remain Second floor, all areas finishes, fixtures, signage Architectural finishes Stationary Remain Second floor, all areas fixed furniture, cubicles Elec, tele-data Stationary Remain Second floor, all areas Low voltage alarm wiring Elec, tele-data Stationary Remain Second floor, all areas Ceilings, walls, doors Elec, pumb, hardware Stationary Remain Second floor, room 205 Bulk storage racks N/A Stationary Remain Second floor, room 231 MSA Oxygen monitor Elec, tele-data Stationary Remain Second floor, room 232 MSA Oxygen monitor Elec, tele-data Stationary Remain Second floor, room 261 MSA Oxygen monitor Elec, tele-data Stationary Remain Second floor, room 262 MSA Oxygen monitor Elec, tele-data Stationary Remain Second floor, room 265 MSA Oxygen monitor Elec, tele-data Stationary Remain Equipment Location Equipment Description Associated Utilities Mobile or Stationary Disposition Intent Second floor, all areas Printers, copiers, fax Elec, tele-data, Mobile Remove Second floor, all areas Coffee machines Elec, plumb Mobile Remove Second floor, all lab areas Water purifiers Elec, plumb Moblie Remove Second floor, all lab areas Benchtop equipment Elec, tele-data, plumb Mobile Remove Second floor, all lab areas Freezers, refrigerators, misc. Elec, plumb, alarms Mobile Remove Second floor, all lab areas Lab gas manifolds, tanks Plumbing Mobile Remove Second floor, all lab areas Lab furniture, storage cabs N/A Mobile/stationary Remove Second floor, all lab areas Process air filters, dryers Elec, plumb, alarms Mobile/stationary Remove Second floor, all lab areas Process chemicals, waste Chemiicals Mobile Remove Second floor, room 220 Bio-safety cabinets Elec, plumb, alarms Mobile/stationary Remove Second floor, room 223 Bio-safety cabinets Elec, plumb, alarms Mobile/stationary Remove Second floor, room 226 Tele-data equipment Elec, tele-data Mobile/stationary Remove Second floor, room 230 Bio-safety cabinets Elec, plumb, alarms Mobile/stationary Remove Second floor, room 266 Bio-safety cabinets Elec, plumb, alarms Mobile/stationary Remove Second floor, room 267 Bio-safety cabinets Elec, plumb, alarms Mobile/stationary Remove Second floor, room 268 Bio-safety cabinets Elec, plumb, alarms Mobile/stationary Remove Second floor, room 237 Bio-safety cabinets Elec, plumb, alarms Mobile/stationary Remove Second floor, room 237 Incubators Elec, plumb, alarms Mobile/stationary Remove Second floor, room 267 Incubators Elec, plumb, alarms Mobile/stationary Remove Second floor, room 268 Incubators Elec, plumb, alarms Mobile/stationary Remove Second floor, room 266 Incubators Elec, plumb, alarms Mobile/stationary Remove Second floor, room 230 Incubators Elec, plumb, alarms Mobile/stationary Remove |
EXHIBIT K
FORM OF ESTOPPEL CERTIFICATE
To: BMR-Rogers Street LLC
17190 Bernardo Center Drive
San Diego, California 92128
Attention: Vice President, Real Estate Counsel
BioMed Realty, L.P.
17190 Bernardo Center Drive
San Diego, California 92128
Re: Space in the Basement and on the First and Second Floors (the Premises ) at 320 Bent Street, Cambridge, Massachusetts (the Property )
The undersigned tenant ( Tenant ) hereby certifies to you as follows:
1. Tenant is a tenant at the Property under a lease (the Lease ) for the Premises dated as of February , 2013. The Lease has not been cancelled, modified, assigned, extended or amended [except as follows: [ ]], and there are no other agreements, written or oral, affecting or relating to Tenants lease of the Premises or any other space at the Property. The lease term expires on [ ], 20[ ].
2. Tenant took possession of the Premises, currently consisting of 105,000 rentable square feet, on [ ], 2013, and commenced to pay rent on the same date. Tenant has full possession of the Premises, has not assigned the Lease or sublet any part of the Premises, and does not hold the Premises under an assignment or sublease[, except as follows: [ ]].
3. All base rent, rent escalations and additional rent under the Lease have been paid through [ ], 20[ ]. There is no prepaid rent[, except $[ ]][, and the amount of security deposit is $[ ] [in cash][OR][in the form of a letter of credit]]. Tenant currently has no right to any future rent abatement under the Lease.
4. Base rent is currently payable in the amount of $[ ] per month.
5. Tenant is currently paying estimated payments of additional rent of $[ ] per month on account of real estate taxes, insurance, management fees and common area maintenance expenses.
6. All work to be performed for Tenant under the Lease has been performed as required under the Lease and has been accepted by Tenant[, except [ ]], and all allowances to be paid to Tenant, including allowances for tenant improvements, moving expenses or other items, have been paid.
7. The Lease is in full force and effect, free from default and free from any event that could become a default under the Lease, and Tenant has no claims against the landlord or
offsets or defenses against rent, and there are no disputes with the landlord. Tenant has received no notice of prior sale, transfer, assignment, hypothecation or pledge of the Lease or of the rents payable thereunder[, except [ ]].
8. Tenant has no rights or options to purchase the Property.
9. To Tenants knowledge, no hazardous wastes have been generated, treated, stored or disposed of by or on behalf of Tenant in, on or around the Premises or the Project in violation of any environmental laws.
10. The undersigned has executed this Estoppel Certificate with the knowledge and understanding that [INSERT NAME OF LANDLORD, PURCHASER OR LENDER, AS APPROPRIATE] or its assignee is acquiring the Property in reliance on this certificate and that the undersigned shall be bound by this certificate. The statements contained herein may be relied upon by [INSERT NAME OF PURCHASER OR LENDER, AS APPROPRIATE], BMR-Rogers Street LLC, MBA-Rogers Street, LLC, BioMed Realty, L.P., BioMed Realty Trust, Inc., and any mortgagee of the Property and their respective successors and assigns.
Any capitalized terms not defined herein shall have the respective meanings given in the Lease.
Dated this [ ] day of [ ], 20[ ].
MOMENTA PHARMACEUTICALS, INC., |
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EXHIBIT M
FORM OF GROUND LESSOR NDA
NONDISTURBANCE AND ATTORNMENT AGREEMENT
THIS AGREEMENT ( Agreement ), made this day of , 2013 between BMR-ROGERS STREET LLC, a Delaware limited liability company with offices at 17190 Bernardo Center Drive, San Diego, California ( Tenant ), MOMENTA PHARMACEUTICALS, INC., a Delaware corporation with offices at 675 West Kendall Street, Cambridge, Massachusetts ( Subtenant ) and MBA-ROGERS STREET, LLC, successor in interest to MBA-Cambridge, LLC and O&T Realty, LLC ( Ground Landlord ).
Background
A. Tenant has entered into a certain ground lease dated March 30, 1999, as amended by that certain letter dated July 29, 1999 and that certain Agreement Regarding Arbitration and Lease Amendments dated December 15, 1999, and as such ground lease has been assigned pursuant to that certain Assignment and Assumption of Ground Lease dated as of April 4, 2007 (collectively, and as the same may have been further amended, supplemented or otherwise modified, the Ground Lease ), with the Ground Lease covering, in part, the building known and numbered as 320 Bent Street, Cambridge, Massachusetts (the Building ) which Building is located on Ground Landlords property described in Exhibit 1 attached hereto (the Property ). A notice of said Ground Lease is recorded with the Middlesex (South) Registry of Deeds in Book 31460, Page 4.
B. Subtenant and Tenant have entered into a lease, a copy of which is attached as Exhibit 2 (the Sublease ) (provided that a copy of the Sublease shall not be attached to any counterpart of this Agreement to be recorded at the Registry of Deeds) for portions of the basement, first floor and second floor and ancillary shaft and penthouse space on other floors of the Building (the Premises ).
C. Ground Landlord has been requested by Tenant and Subtenant to enter into a nondisturbance agreement with Subtenant.
AGREEMENT
NOW, THEREFORE in consideration of the promises and the mutual covenants hereinafter contained, the parties hereto mutually covenant and agree as follows:
1. Ground Landlord consents to the execution and delivery of the Sublease. The provisions of this Agreement set forth in Sections 2 , 3 and 4 , below, shall take effect upon the Execution Date (as defined in the Sublease).
2. Effective as of the Execution Date, if the Ground Lease shall terminate before the expiration of the then-current term of the Sublease, unless such termination results from condemnation or fire or other catastrophe, the Sublease, if then in existence, shall continue with the same force and effect as if Ground Landlord as lessor and Subtenant as lessee had entered into a lease for a term equal to the then unexpired term of the Sublease, as of the termination of the Ground Lease, containing the same terms, covenants and conditions as those contained in the Sublease (except as hereinafter provided), including the rights of renewal therein.
3. Effective as of the Execution Date, any option which shall be or become vested in Subtenant to cancel the Sublease, because of default of Tenant, shall be ineffective unless Subtenant shall give Ground Landlord notice thereof, and Ground Landlord shall fail to cure such default within the time and in the manner Tenant would have been authorized to do had Tenant simultaneously received such notice. The provisions of this Subsection shall apply to any default occurring before or after the Sublease goes into effect.
4. Effective as of the Execution Date, from and after such termination of the Ground Lease and if Subtenants right of possession shall be preserved as aforesaid and Subtenant is not in default under the terms of the Sublease (beyond applicable notice and grace periods):
(a) Subtenant will attorn as tenant to Ground Landlord, and Ground Landlord will accept such attornment.
(b) Ground Landlord will have the same remedies by entry, action or otherwise for the nonperformance of any agreement contained in the Sublease for the recovery of rent, for the doing of any waste or for any cause of forfeiture, as Tenant had or would have had if the Ground Lease had not been terminated.
(c) From and after the time of such attornment, Subtenant shall have the same remedies against Ground Landlord for the breach of an agreement contained in the Sublease that Subtenant might have had against Tenant if the Ground Lease had not been terminated, except that Ground Landlord shall not be (i) liable for any act or omission of Tenant, except to the extent such act or omission continues after term initiation of the Ground Lease, (ii) subject to any offsets or defenses which Subtenant might have against Tenant, except to the extent such offsets or defenses relate to matters continuing after termination of the Ground Lease, (iii) bound by any rent or additional rent paid more than one month in advance of its due date which Subtenant might have paid in advance to Tenant, (iv) bound by any material amendment of the Sublease not consented to by Ground Landlord that results in a reduction in the amount of rent payable thereunder, or (v) liable for any security or tenant deposits held by or on behalf of any prior tenant (including Tenant) except to the extent actually received by Ground Landlord.
(d) Ground Landlord and Subtenant will enter into an agreement supplemental hereto containing the same terms and conditions as those contained in the Sublease but with such changes as may be necessary by reason of the substitution of Ground Landlord in the place and stead of Tenant as lessor.
5. The rights under this Agreement shall inure to the benefit of only Subtenant and those permitted assignees of Subtenant under the Sublease.
6. The term Ground Landlord as used in this Agreement means only the owner for the time being of the Premises, so that in the event of any sale of the Premises the predecessor owner shall be and hereby is entirely freed and relieved of all covenants and obligations of Ground Landlord hereunder provided that its successor assumes the same. The provisions of this Agreement, however, shall bind any subsequent owner of the Premises. The liability of Ground Landlord to Subtenant under this Agreement shall be limited to Ground Landlords interest in the Property and insurance, condemnation, and any sale proceeds therefrom.
7. If any defaults by Tenant shall occur under the Ground Lease, then (a) Ground Landlord shall, when the delivery of written notice to Tenant of the same is required under the Ground Lease, deliver simultaneous written notice of any such default to Subtenant, and (b) subject to the further conditions hereof, Subtenant may, but shall be under no obligation to, make payments to cure the same, and in such event Ground Landlord shall accept any sums so tendered if tendered prior to the expiration of any grace period, but Ground Landlord shall not be obligated to accept any payment which would have the effect of waiving any claim for damages which Ground Landlord may at any time have against Tenant or its successors in interest unless the payment by Subtenant shall be of the entire amount of such claim for damages whether or not then accrued.
8. Neither Subtenant nor its successors or assigns shall enter into any agreement which shall modify the rental terms of the Sublease without Ground Landlords prior written consent not to be unreasonably withheld or delayed. Any agreement made in contravention to the provisions of this Section shall be of no force or effect as to Ground Landlord.
9. Nothing in this Agreement contained shall be deemed or construed to modify any of the provisions of the Ground Lease as between Ground Landlord and Tenant or to waive any rights which Ground Landlord may now or hereafter have against Tenant by reason of the Ground Lease or anything connected therewith.
10. If any lease or tenancy shall come into existence between Ground Landlord and Subtenant pursuant to the provisions of Section 2 or Section 4 , the provisions of Section 6 shall apply to any liability imposed upon Ground Landlord by reason of such lease or tenancy.
11. This Agreement may not be modified orally or in any other manner than by an agreement in writing signed by all parties hereto or their respective successors in interest.
12. The covenants and agreements herein contained shall apply to, inure to the benefit of and be binding upon the parties hereto and upon their respective successors in interest and legal representatives except as otherwise hereinbefore provided.
13. This Agreement may be executed in counterpart and, when all counterpart documents are executed, the counterparts shall constitute a single binding instrument.
Executed under seal as of the date first written above.
GROUND LANDLORD: |
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MBA-ROGERS STREET, LLC |
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BMR-ROGERS STREET LLC |
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MOMENTA PHARMACEUTICALS, INC. |
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EXHIBIT 1
PROPERTY
Parcel One:
A certain parcel of land situated in Cambridge, in Middlesex County and Common-wealth of Massachusetts, bounded and described as follows:
NORTHWESTERLY: on Binney Street two hundred (200) feet, thence turning at right angles and running;
NORTHEASTERLY: along land shown on the plan hereinafter mentioned as belonging to Associates Transport, Inc., two hundred (200) feet to a point on the private way shown as Rogers Street on the plan hereinafter mentioned; thence turning at right angles and running;
SOUTHEASTERLY: on Rogers Street two hundred (200) feet to a point on Sixth Street; thence turning at right angles and running;
SOUTHWESTERLY: on Sixth Street two hundred (200) feet to the point of beginning.
Containing 40,000 square feet and being the parcel of land shown on the plan entitled Plan of Land in Cambridge, Mass. dated August 8, 1945. William S. Crocker, C. E., said plan being duly recorded with Middlesex South Registry District Deeds, Book 6893, Page 509; and also being the parcel of land shown on a plan of land entitled Plan of Land in Cambridge, Mass. Property of Industrial Stainless Steel Inc. dated October 21, 1960, Schofield Brothers, Reg. Land Surveyors, said plan being duly recorded with Middlesex South Registry of Deeds as Plan Number 1664 of 1960 at Book 9706, Page End.
Parcel Two:
A certain parcel of land with the buildings thereon situated in said Cambridge, bounded and described as follows:
NORTHERLY: by Rogers Street, three-hundred thirty-five and 27/100 (335.27) feet;
EASTERLY: by land now or formerly of Harry J. Dowd, two hundred and no/100 (200) feet;
SOUTHERLY: by Binney Street;
WESTERLY: by Fulkerson Street.
Parcels One and Two together comprise all of Lots A, B, C and D as shown on a plan of Land entitled Plan Showing Sub-division of land in Cambridge, Massachusetts, dated July 29, 1940, Wm. H. McGinness C. E., said plan being duly recorded with the Middlesex South Registry of Deeds as Plan Number 1052 of 1940, at Book 6445, Page 394.
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Exhibit 10.2
FIRST AMENDMENT TO LEASE
THIS FIRST AMENDMENT TO LEASE (this Amendment ) is entered into as of the 21st day of March, 2013, by and between BMR-ROGERS STREET LLC, a Delaware limited liability company ( Landlord ), and MOMENTA PHARMACEUTICALS, INC., a Delaware corporation ( Tenant ).
RECITALS
A. WHEREAS, Landlord and Tenant entered into that certain Lease dated as of February 5, 2013 (the Lease ), whereby Tenant leases certain premises (the Premises ) more fully described therein from Landlord in the building at 320 Bent Street, Cambridge, Massachusetts (the Bent Building ); and
B. WHEREAS, Landlord and Tenant desire to modify and amend the Lease only in the respects and on the conditions hereinafter stated.
AGREEMENT
NOW, THEREFORE, Landlord and Tenant, in consideration of the mutual promises contained herein and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, agree as follows:
1. Definitions . For purposes of this Amendment, capitalized terms shall have the meanings ascribed to them in the Lease unless otherwise defined herein. The Lease, as amended by this Amendment, is referred to herein as the Amended Lease .
2. Tenants Work .
a. Exhibit 1 to this Amendment shall be inserted at Exhibit C in the Lease and Exhibit 2 to this Amendment shall be inserted at Exhibit D in the Lease and the names for Exhibit C and Exhibit D as set forth in Section 2.10 of the Lease shall be revised to read as follows:
Exhibit C List of Plans and Specifications for Tenants Work Exhibit D Funding Conditions and Deliverables
b. The first sentence of Section 4.2 of the Lease is replaced with the following:
Landlord agrees to pay Tenant a tenant improvement allowance of Seven Hundred Forty-Seven Thousand Six Hundred Thirty Dollars ($747,630) (based upon Thirty Dollars ($30.00) per square foot of Rentable Area (as defined below) of the basement portion of the Premises only) (the TI Allowance ) upon the Term Commencement Date; provided that (a) Tenants work in the Premises ( Tenants Work ) has been completed in accordance
with the Landlord-approved list of plans and specifications attached hereto as Exhibit C , and (b) Tenant has satisfied the conditions and/or provided to Landlord the funding condition items listed on Exhibit D attached hereto, and Tenant has, in addition, furnished a statement setting forth the total amount of the TI Allowance requested.
c. Notwithstanding anything set forth in the Amended Lease to the contrary, Tenant shall have no obligation under the Amended Lease to remove any of the Tenants Work or the Agreed Alterations (defined below) upon the expiration or earlier termination of the Amended Lease; provided that nothing in this Subsection 2.c shall excuse Tenant from undertaking and completing the Agreed Alterations as required under Section 3 of this Amendment.
d. Clause (f) of the final sentence of Section 4.2 of the Lease is hereby amended by deleting the words authorized by the Consent or.
e. The second sentence of Section 4.3 of the Lease is hereby deleted.
f. The second sentence of Section 5 of the Lease is hereby amended by inserting the following language after the phrase in its condition as is as of the Execution Date:
( provided , however, that Tenant acknowledges and agrees that Merck, Sharp & Dohme Corp. (f/k/a Schering Corporation) ( Merck ) shall be entitled to complete the work in the Premises that is identified in the Surrender and Decommissioning Agreement dated as of March 21, 2013 that has been executed by Landlord and Merck after the Execution Date)
3. Alterations . Tenant hereby undertakes and agrees to complete the Alterations described on Exhibit 3 hereto (the Agreed Alterations ), and Landlord hereby consents to the completion by Tenant of the Agreed Alterations, subject to compliance with all of the provisions of the Lease, including, without limitation, Article 17 thereof, and subject to immaterial changes in the Agreed Alterations, as necessary, that shall be approved by Tenant. Landlord shall be under no obligation to pay for, or to contribute to, the cost of the Agreed Alterations, the Agreed Alterations shall not be considered part of Tenants Work, and the Agreed Alterations shall not be eligible for the TI Allowance under Section 4.2 of the Lease.
4. Non-Disturbance Agreement . The form of non-disturbance agreement attached to the Lease as Exhibit M is hereby deleted in its entirety and replaced with the form of non-disturance agreement attached hereto as Exhibit 4 , which form shall be deemed to be and to replace Exhibit M to the Lease, as hereby amended, for all purposes.
5. Broker . Tenant represents and warrants that it has not dealt with any broker, agent or other person in connection with this transaction and that no broker, agent or other person
brought about this transaction, other than CB Richard Ellis ( Broker ), and Tenant agrees to indemnify and hold Landlord harmless from and against any claims by Broker or any other broker, agent or other person, other than the Broker, claiming a commission or other form of compensation by virtue this Amendment. Landlord agrees to pay any commission that may be due to the Broker by reason of this Amendment. The provisions of this Section shall survive the expiration or earlier termination of the Amended Lease.
6. No Default . Tenant represents, warrants and covenants that, to the best of Tenants knowledge, Landlord and Tenant are not in default of any of their respective obligations under the Lease and no event has occurred that, with the passage of time or the giving of notice (or both) would constitute a default by either Landlord or Tenant thereunder.
7. Effect of Amendment . Landlord and Tenant acknowledge that the Lease is subject to certain contingencies more fully described therein, including, without limitation the so-called Merck Contingency set forth in Article 44 of the Lease. The parties agree that this Amendment shall be subject to all of the contingencies in the Lease. Subject to the foregoing, and except as modified by this Amendment, the Lease and all the covenants, agreements, terms, provisions and conditions thereof shall remain in full force and effect and are hereby ratified and affirmed. The covenants, agreements, terms, provisions and conditions contained in this Amendment shall bind and inure to the benefit of the parties hereto and their respective successors and, except as otherwise provided in the Lease, their respective assigns. In the event of any conflict between the terms contained in this Amendment and the Lease, the terms herein contained shall supersede and control the obligations and liabilities of the parties. From and after the date hereof, the term Lease as used in the Lease shall mean the Lease, as modified by this Amendment.
8. Miscellaneous . This Amendment becomes effective only upon execution and delivery hereof by Landlord and Tenant. The captions of the paragraphs and subparagraphs in this Amendment are inserted and included solely for convenience and shall not be considered or given any effect in construing the provisions hereof. All exhibits hereto are incorporated herein by reference. Submission of this instrument for examination or signature by Tenant does not constitute a reservation of or option for a lease, and shall not be effective as a lease, lease amendment or otherwise until execution by and delivery to both Landlord and Tenant.
9. Counterparts . This Amendment may be executed in one or more counterparts, each of which, when taken together, shall constitute one and the same document.
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IN WITNESS WHEREOF, Landlord and Tenant have hereunto set their hands as of the date and year first above written, and acknowledge that they possess the requisite authority to enter into this transaction and to execute this Amendment.
LANDLORD :
BMR-ROGERS STREET LLC, |
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a Delaware limited liability company |
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/s/ Kevin M. Simonsen |
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Kevin M. Simonsen |
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VP, Real Estate Legal |
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TENANT :
MOMENTA PHARMACEUTICALS, INC., |
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a Delaware corporation |
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/s/ Richard P. Shea |
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Richard P. Shea |
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Sr. Vice President and Chief Financial Officer |
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EXHIBIT 1
LIST OF PLANS AND SPECIFICATIONS FOR TENANTS WORK
See attached Drawings entitled New Process Development Lab, 320 Bent Street, Cambridge, MA 02142 prepared by Life Tek, Sci-X and AHA Consulting Engineers dated February 8, 2013, Sheet Numbers A-000, A-001, A-002, A-101, A-102, A-103, A-104, A-301, A-401, A-501, A-502, A-601, and A-801 for a Process Development Lab for Momenta Pharmaceuticals, consisting of thirteen (13) pages, with such changes thereto as may be approved in writing by Landlord and Tenant.
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EXHIBIT 2
FUNDING CONDITIONS AND DELIVERABLES
A. Evidence reasonably satisfactory to Landlord that (i) all of Tenants Work has been completed in all material respects in accordance with the plans and specifications therefor listed on Exhibit A to this Amendment and paid for in full (which shall be evidenced by the architects certificate of completion in the form of AIA Document G704-2000 and (i) the general contractors and (ii) each subcontractors and material suppliers, with a contract amount in excess of $100,000.00, final unconditional waivers and releases of liens, each in a form reasonably acceptable to Landlord and complying with applicable laws), (iii) any and all liens of record related to Tenants Work have either been discharged of record (by payment, bond, order of a court of competent jurisdiction or otherwise) or waived by the party filing such lien and (iv) no security interest against the Bent Building or the Project or any portion thereof relating to Tenants Work is outstanding;
B. Tenant has obtained a permanent certificate of occupancy from the City of Cambridge with respect to the Tenants Work along with any other certifications and approvals with respect to Tenants Work that may be required in connection with Tenants Work from any governmental authority and any board of fire underwriters or similar body for the use and occupancy of the Premises;
C. Certificates of insurance required by the Lease to be purchased and maintained by Tenant; and
D. Complete drawing print sets and electronic CAD files on disc of all contract documents for work performed by Tenants architect and engineers in relation to Tenants Work.
EXHIBIT 3
LIST OF AGREED ALTERATIONS
Tenant shall perform the following items:
Specific Requirement
Basement
1. Outside of cage 1: Repair O2 meter and sensor.
2. Storage Room 36: Remove unused chemical fume hood #3070.
3. Storage Room 35: Remove two (2) unused glass washers, stainless steel panels and copper coils.
4. Mechanical Room 29: Remove RO system and related ancillary equipment.
5. Laboratory Room 39: Remove barcode scanner and power supply.
6. Replace or repair bubbling sheet vinyl floor in laboratory near VH 0003.
Second Floor
1. Fermentation Room 246: Remove steam manifold and steam supply piping: cut and cap piping above ceiling.
2. Remove RO/DI wall mounted water treatment system.
3. Remove autoclave and stainless steel exhaust canopy.
4. Remove all wall mounted electrical disconnects and clips.
5. Cap floor drains and remove berms and patch.
6. Remove glass wash/autoclave and cap all utility feeds and drains.
7. Lab Support Room 268A: Remove glass wash and cap all utility feeds.
a. Remove fume hood and cut and cap utility feeds to above ceiling.
b. Remove cabinets, sink and countertop and cap all utilities and drain.
8. Hallway: Remove water sensor control panel and O2 level sensor.
Third Floor
1. Plumbing system (including PH Neutralization System): Cut and cap existing drains from 3 rd floor
space which empty into 2 nd floor system.
2. If applicable, cut and cap existing RO/DI use points from 3 rd floor system if currently connected to the 2 nd floor system.
EXHIBIT 4
NONDISTURBANCE AND ATTORNMENT AGREEMENT
THIS AGREEMENT ( Agreement ), made this day of , 2013 between BMR-ROGERS STREET LLC, a Delaware limited liability company with offices at 17190 Bernardo Center Drive, San Diego, California ( Tenant ), MOMENTA PHARMACEUTICALS, INC., a Delaware corporation with offices at 675 West Kendall Street, Cambridge, Massachusetts ( Subtenant ) and MBA-ROGERS STREET, LLC, successor in interest to MBA-Cambridge, LLC and O&T Realty, LLC ( Ground Landlord ).
Background
A. Tenant has entered into a certain ground lease dated March 30, 1999, as amended by that certain letter dated July 29, 1999 and that certain Agreement Regarding Arbitration and Lease Amendments dated December 15, 1999, and as such ground lease has been assigned pursuant to that certain Assignment and Assumption of Ground Lease dated as of April 4, 2007 (collectively, and as the same may have been further amended, supplemented or otherwise modified, the Ground Lease ), with the Ground Lease covering, in part, the building known and numbered as 320 Bent Street, Cambridge, Massachusetts (the Building ) which Building is located on Ground Landlords property described in Exhibit A attached hereto (the Property ). A notice of said Ground Lease is recorded with the Middlesex (South) Registry of Deeds in Book 31460, Page 4.
B. Subtenant and Tenant have entered into a lease and a first amendment to lease, copies of which are attached as Exhibit B (collectively, the Sublease ) (provided that a copy of the Sublease shall not be attached to any counterpart of this Agreement to be recorded at the Registry of Deeds) for portions of the basement, first floor and second floor and ancillary shaft and penthouse space on other floors of the Building (the Premises ).
C. Ground Landlord has been requested by Tenant and Subtenant to enter into a nondisturbance agreement with Subtenant.
AGREEMENT
NOW, T HEREFORE in consideration of the promises and the mutual covenants hereinafter contained, the parties hereto mutually covenant and agree as follows:
1. Ground Landlord consents to the execution and delivery of the Sublease. The provisions of this Agreement set forth in Sections 2 , 3 and 4 , below, shall take effect upon the Execution Date (as defined in the Sublease).
2. Effective as of the Execution Date, if the Ground Lease shall terminate before the expiration of the then-current term, unless such termination results from condemnation or fire or other catastrophe, the Sublease, if then in existence, shall continue with the same force and effect as if Ground Landlord as lessor and Subtenant as lessee had entered into a lease for a term equal to the then unexpired term of the Sublease, as of the termination of the Ground Lease, containing the same terms, covenants and conditions as those contained in the Sublease (except as hereinafter provided), including the rights of renewal therein.
3. (a) Intentionally Omitted.
(b) Effective as of the Execution Date, any option which shall be or become vested in Subtenant to cancel the Sublease, because of default of Tenant, shall be ineffective unless Subtenant shall give Ground Landlord notice thereof, and Ground Landlord shall fail to cure such default within the time and in the manner Tenant would have been authorized to do had Tenant simultaneously received such notice. The provisions of this Subsection shall apply to any default occurring before or after the Sublease goes into effect.
4. Effective as of the Execution Date, from and after such termination of the Ground Lease and if Subtenants right of possession shall be preserved as aforesaid and Subtenant is not in default under the terms of the Sublease (beyond applicable notice and grace periods):
(a) Subtenant will attorn as tenant to Ground Landlord, and Ground Landlord will accept such attornment.
(b) Ground Landlord will have the same remedies by entry, action or otherwise for the nonperformance of any agreement contained in the Sublease for the recovery of rent, for the doing of any waste or for any cause of forfeiture, as Tenant had or would have had if the Ground Lease had not been terminated.
(c) From and after the time of such attornment, Subtenant shall have the same remedies against Ground Landlord for the breach of an agreement contained in the Sublease that Subtenant might have had against Tenant if the Ground Lease had not been terminated, except that Ground Landlord shall not be (i) liable for any act or omission of Tenant, except to the extent such act or omission continues after term initiation of the Ground Lease, (ii) subject to any offsets or defenses which Subtenant might have against Tenant, except to the extent such offsets or defenses relate to matters continuing after termination of the Ground Lease, (iii) bound by any rent or additional rent paid more than one month in advance of its due date which Subtenant might have paid in advance to Tenant, (iv) bound by any material amendment of the Sublease not consented to by Ground Landlord that results in a reduction in the amount of rent payable thereunder, or (v) liable for any security or tenant deposits held by or on behalf of any prior tenant (including Tenant)
except to the extent actually received by Ground Landlord.
(d) Ground Landlord and Subtenant will enter into an agreement supplemental hereto containing the same terms and conditions as those contained in the Sublease but with such changes as may be necessary by reason of the substitution of Ground Landlord in the place and stead of Tenant as lessor.
5. The rights under this Agreement shall inure to the benefit of only Subtenant and those permitted assignees of Subtenant under the Sublease.
6. The term Ground Landlord as used in this Agreement means only the owner for the time being of the Premises, so that in the event of any sale of the Premises the predecessor owner shall be and hereby is entirely freed and relieved of all covenants and obligations of Ground Landlord hereunder provided that its successor assumes the same. The provisions of this Agreement, however, shall bind any subsequent owner of the Premises. The liability of Ground Landlord to Subtenant under this Agreement shall be limited to Ground Landlords interest in the Property and insurance, condemnation, and any sale proceeds therefrom.
7. If any defaults shall occur under the Ground Lease, then, subject to the further conditions hereof, Subtenant may, but shall be under no obligation to, make payments to cure the same, and in such event Ground Landlord shall accept any sums so tendered if tendered prior to the expiration of any grace period, but Ground Landlord shall not be obligated to accept any payment which would have the effect of waiving any claim for damages which Ground Landlord may at any time have against Tenant or its successors in interest unless the payment by Subtenant shall be of the entire amount of such claim for damages whether or not then accrued.
8. Neither Subtenant nor its successors or assigns shall enter into any agreement which shall modify the rental terms of the Sublease without Ground Landlords prior written consent not to be unreasonably withheld or delayed. Any agreement made in contravention to the provisions of this Section shall be of no force or effect as to Ground Landlord.
9. Nothing in this Agreement contained shall be deemed or construed to modify any of the provisions of the Ground Lease as between Ground Landlord and Tenant or to waive any rights which Ground Landlord may now or hereafter have against Tenant by reason of the Ground Lease or anything connected therewith.
10. If any lease or tenancy shall come into existence between Ground Landlord and Subtenant pursuant to the provisions of Section 2 or Section 4 , the provisions of Section 6 shall apply to any liability imposed upon Ground Landlord by reason of such lease or tenancy.
11. This Agreement may not be modified orally or in any other manner than by an agreement in writing signed by all parties hereto or their respective successors in interest.
12. The covenants and agreements herein contained shall apply to, inure to the benefit of and be binding upon the parties hereto and upon their respective successors in interest and legal representatives except as otherwise hereinbefore provided.
13. This Agreement may be executed in counterpart and, when all counterpart documents are executed, the counterparts shall constitute a single binding instrument.
Executed under seal as of the date first written above.
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TENANT: |
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SUBTENANT: |
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EXHIBIT A
PROPERTY
Parcel One:
A certain parcel of land situated in Cambridge, in Middlesex County and Common-wealth of Massachusetts, bounded and described as follows:
NORTHWESTERLY: on Binney Street two hundred (200) feet, thence turning at right angles and running;
NORTHEASTERLY: along land shown on the plan hereinafter mentioned as belonging to Associates Transport, Inc., two hundred (200) feet to a point on the private way shown as Rogers Street on the plan hereinafter mentioned; thence turning at right angles and running;
SOUTHEASTERLY: on Rogers Street two hundred (200) feet to a point on Sixth Street; thence turning at right angles and running;
SOUTHWESTERLY: on Sixth Street two hundred (200) feet to the point of beginning.
Containing 40,000 square feet and being the parcel of land shown on the plan entitled Plan of Land in Cambridge, Mass. dated August 8, 1945. William S. Crocker, C. E., said plan being duly recorded with Middlesex South Registry District Deeds, Book 6893, Page 509; and also being the parcel of land shown on a plan of land entitled Plan of Land in Cambridge, Mass. Property of Industrial Stainless Steel Inc. dated October 21, 1960, Schofield Brothers, Reg. Land Surveyors, said plan being duly recorded with Middlesex South Registry of Deeds as Plan Number 1664 of 1960 at Book 9706, Page End.
Parcel Two:
A certain parcel of land with the buildings thereon situated in said Cambridge, bounded and described as follows:
NORTHERLY: by Rogers Street, three-hundred thirty-five and 27/100 (335.27) feet;
EASTERLY: by land now or formerly of Harry J. Dowd, two hundred and no/100 (200) feet;
SOUTHERLY: by Binney Street;
WESTERLY: by Fulkerson Street.
Parcels One and Two together comprise all of Lots A, B, C and D as shown on a plan of Land entitled Plan Showing Sub-division of land in Cambridge, Massachusetts, dated July 29, 1940, Wm. H. McGinness C. E., said plan being duly recorded with the Middlesex South Registry of Deeds as Plan Number 1052 of 1940, at Book 6445, Page 394.
EXHIBIT B
SUBLEASE
See attached.
Exhibit 31.1
CERTIFICATION
I, Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals, Inc., certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Momenta Pharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The 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 the 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 control over financial reporting.
Dated: May 10, 2013 |
/s/ Craig A. Wheeler |
|
Craig A. Wheeler |
|
President and Chief Executive Officer |
Exhibit 31.2
CERTIFICATION
I, Richard P. Shea, Senior Vice President and Chief Financial Officer of Momenta Pharmaceuticals, Inc., certify that:
1. I have reviewed this Quarterly Report on Form 10-Q of Momenta Pharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The 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 the 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 control over financial reporting.
Dated: May 10, 2013 |
/s/ Richard P. Shea |
|
Richard P. Shea |
|
Senior Vice President and Chief Financial Officer |
Exhibit 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report on Form 10-Q of Momenta Pharmaceuticals, Inc. (the Company) for the period ended March 31, 2013 as filed with the Securities and Exchange Commission on the date hereof (the Report), the undersigned, Craig A. Wheeler, President and Chief Executive Officer of the Company, and Richard P. Shea, Senior Vice President and Chief Financial Officer of the Company, each hereby certifies, pursuant to 18 U.S.C. Section 1350, that:
(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Dated: May 10, 2013 |
/s/ Craig A. Wheeler |
|
Craig A. Wheeler |
|
President and Chief Executive Officer |
|
|
|
|
Dated: May 10, 2013 |
/s/ Richard P. Shea |
|
Richard P. Shea |
|
Senior Vice President and Chief Financial Officer |