0

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

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

For the quarterly period ended September 30, 2018

or

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

For the transition period from                      to                     

Commission File Number: 001-37609

MYOKARDIA, INC.

(Exact name of registrant as specified in its charter)

 

 

Delaware

 

44-5500552

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

333 Allerton Ave.

South San Francisco, CA

(Address of principal executive offices)

94080

(Zip Code)

(650) 741-0900

(Registrant’s 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   No 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files). Yes   No 

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

 

Large accelerated filer

 

  

Accelerated filer

 

Non-accelerated filer

 

  

  

Smaller reporting company

 

Emerging growth company    

 

 

 

 

 

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

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

The number of outstanding shares of the registrant’s common stock on November 5, 2018 were 40,270,711 shares.

 

 

 

 

 


 

MYOKARDIA, INC.

TABLE OF CONTENTS

 

 

Page

PART I—FINANCIAL INFORMATION

 

3

Item 1. Condensed Consolidated Financial Statements

 

3

Condensed Consolidated Balance Sheets as of September 30, 2018 and December 31, 2017 (unaudited)

 

3

Condensed Consolidated Statements of Operations and Comprehensive Loss for the three and nine months ended September 30, 2018 and 2017 (unaudited)

 

4

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2018 and 2017 (unaudited)

 

5

Notes to Condensed Consolidated Financial Statements (unaudited)

 

6

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

 

21

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

28

Item 4. Controls and Procedures

 

29

PART II—OTHER INFORMATION

 

30

Item 1. Legal Proceedings

 

30

Item 1A. Risk Factors

 

30

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

 

60

Item 3. Defaults Upon Senior Securities

 

60

Item 4. Mine Safety Disclosures

 

60

Item 5. Other Information

 

60

Item 6. Exhibits

 

61

EXHIBIT INDEX

 

61

SIGNATURES

 

62

 

 

2


 

PART I—FINANCI AL INFORMATION

 

 

Item 1.

Condensed Consolidated Financial Statements

MYOKARDIA, INC.

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

September 30,

2018

 

 

December 31,

2017

 

 

 

 

 

 

 

As Revised (Note 2)

 

Assets

 

 

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

335,279

 

 

$

224,571

 

Short-term investments

 

 

43,845

 

 

 

31,933

 

Receivable from collaboration partner

 

 

2,565

 

 

 

1,013

 

Prepaid expenses and other current assets

 

 

2,566

 

 

 

1,876

 

Total current assets

 

 

384,255

 

 

 

259,393

 

Property and equipment, net

 

 

4,905

 

 

 

3,147

 

Long-term investments

 

 

32,506

 

 

 

19,900

 

Restricted cash and other

 

 

2,312

 

 

 

368

 

Total assets

 

$

423,978

 

 

$

282,808

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

 

 

Accounts payable

 

$

2,454

 

 

$

2,301

 

Accrued liabilities

 

 

18,790

 

 

 

11,639

 

Prepayment from collaboration partner

 

 

10,943

 

 

 

4,432

 

Deferred revenue

 

 

12,400

 

 

 

33,558

 

Total current liabilities

 

 

44,587

 

 

 

51,930

 

Other long-term liabilities

 

 

54

 

 

 

202

 

Total liabilities

 

 

44,641

 

 

 

52,132

 

Commitments and contingencies (Note 6)

 

 

 

 

 

 

 

 

Stockholders’ equity

 

 

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 5,000,000 shares authorized; none

   issued and outstanding

 

 

 

 

 

 

Common stock, $0.0001 par value, 150,000,000 and 150,000,000

   shares authorized at September 30, 2018 and December 31, 2017,

   respectively; 40,240,530 and 35,812,791 shares issued and outstanding

   at September 30, 2018 and December 31, 2017, respectively

 

 

4

 

 

 

4

 

Additional paid-in capital

 

 

566,432

 

 

 

365,719

 

Accumulated other comprehensive loss

 

 

(222

)

 

 

(192

)

Accumulated deficit

 

 

(186,877

)

 

 

(134,855

)

Total stockholders’ equity

 

 

379,337

 

 

 

230,676

 

Total liabilities and stockholders’ equity

 

$

423,978

 

 

$

282,808

 

 

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

 

 

3


 

MYOKARDIA, INC.

Condensed Consolidated Statements of Operations and Comprehensive Loss

(In thousands, except share and per share amounts)

(Unaudited)

 

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

 

 

 

 

 

 

As Revised (Note 2)

 

 

 

 

 

 

As Revised (Note 2)

 

Collaboration and license revenue

 

$

9,188

 

 

$

3,077

 

 

$

21,158

 

 

$

8,488

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

15,910

 

 

 

14,361

 

 

 

49,746

 

 

 

39,967

 

General and administrative

 

 

10,957

 

 

 

5,884

 

 

 

27,182

 

 

 

16,442

 

Total operating expenses

 

 

26,867

 

 

 

20,245

 

 

 

76,928

 

 

 

56,409

 

Loss from operations

 

 

(17,679

)

 

 

(17,168

)

 

 

(55,770

)

 

 

(47,921

)

Interest and other income, net

 

 

1,890

 

 

 

447

 

 

 

3,748

 

 

 

977

 

Net loss

 

 

(15,789

)

 

 

(16,721

)

 

 

(52,022

)

 

 

(46,944

)

Other comprehensive gain (loss)

 

 

37

 

 

 

2

 

 

 

(30

)

 

 

60

 

Comprehensive loss

 

 

(15,752

)

 

 

(16,719

)

 

 

(52,052

)

 

 

(46,884

)

Net loss attributable to common stockholders

 

$

(15,789

)

 

$

(16,721

)

 

$

(52,022

)

 

$

(46,944

)

Net loss per share attributable to common stockholders, basic

   and diluted

 

$

(0.39

)

 

$

(0.50

)

 

$

(1.38

)

 

$

(1.47

)

Weighted average number of shares used to compute net loss

   per share attributable to common stockholders, basic and diluted

 

 

40,116,644

 

 

 

33,525,567

 

 

 

37,765,631

 

 

 

31,951,631

 

 

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

 

 

4


 

MYOKARDIA, INC.

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 

 

Nine Months Ended

September 30,

 

 

 

2018

 

 

2017

 

 

 

 

 

 

 

As Revised (Note 2)

 

Cash flow from operating activities:

 

 

 

 

 

 

 

 

Net loss

 

$

(52,022

)

 

$

(46,944

)

Adjustments to reconcile net loss to net cash (used in) provided by operating activities:

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

13,639

 

 

 

4,347

 

Depreciation

 

 

1,134

 

 

 

977

 

Amortization of premiums on investments

 

 

(127

)

 

 

62

 

Change in operating assets and liabilities:

 

 

 

 

 

 

 

 

Receivable from collaboration partner

 

 

(1,552

)

 

 

45,000

 

Prepaid expenses and other current assets

 

 

(690

)

 

 

(151

)

Other long-term assets

 

 

(87

)

 

 

(149

)

Accounts payable

 

 

357

 

 

 

228

 

Accrued liabilities

 

 

7,100

 

 

 

2,029

 

Prepayment from collaboration partner

 

 

6,511

 

 

 

 

Other long-term liabilities

 

 

(133

)

 

 

(118

)

Deferred revenue

 

 

(21,158

)

 

 

(8,488

)

Net cash (used in) operating activities

 

 

(47,028

)

 

 

(3,207

)

Cash flow from investing activities:

 

 

 

 

 

 

 

 

Purchases of investments

 

 

(48,421

)

 

 

(44,044

)

Sales of investments

 

 

8,000

 

 

 

4,000

 

Maturities of investments

 

 

16,000

 

 

 

 

Purchases of property and equipment

 

 

(3,017

)

 

 

(917

)

Net cash (used in) investing activities

 

 

(27,438

)

 

 

(40,961

)

Cash flow from financing activities:

 

 

 

 

 

 

 

 

Proceeds from issuance of common stock during follow-on offerings,

   net of issuance costs

 

 

182,450

 

 

 

133,925

 

Payments of financing-related costs

 

 

(587

)

 

 

(38

)

Proceeds from exercise of stock options and employee stock purchase plan

 

 

5,168

 

 

 

1,668

 

Net cash provided by financing activities

 

 

187,031

 

 

 

135,555

 

Net increase in cash, cash equivalents and restricted cash

 

 

112,565

 

 

 

91,387

 

Cash, cash equivalents and restricted cash, beginning of period

 

 

224,857

 

 

 

136,056

 

Cash, cash equivalents and restricted cash, end of period

 

$

337,422

 

 

$

227,443

 

Non-cash investing and financing activities:

 

 

 

 

 

 

 

 

Vesting of early exercised options and restricted stock

 

$

44

 

 

$

156

 

Unpaid financing-related costs

 

$

 

 

$

63

 

Unpaid portion of property and equipment purchases included in

   period-end accounts payable and accrued liabilities

 

$

158

 

 

$

38

 

 

 

 

 

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

 

 

 

 

5


 

MYOKARDIA, INC.

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

1. Organization

MyoKardia, Inc. (the “Company”) is a clinical-stage biopharmaceutical company pioneering a precision medicine approach to discover, develop and commercialize targeted therapies for the treatment of serious and neglected rare cardiovascular diseases. The Company’s initial focus is on the treatment of heritable cardiomyopathies, a group of rare, genetically driven forms of heart failure that result from biomechanical defects in cardiac muscle contraction. The Company has used its precision medicine platform to generate a robust pipeline of therapeutic programs for the chronic treatment of the two most common forms of heritable cardiomyopathy—hypertrophic cardiomyopathy (“HCM”), and dilated cardiomyopathy (“DCM”).  The Company was incorporated on June 8, 2012 in Delaware and its corporate headquarters and operations are located in South San Francisco, California.

 

Liquidity

 

The Company has incurred significant operating losses since inception and has an accumulated deficit of $186.9 million as of September 30, 2018. The Company has relied on its ability to fund its operations through private and public equity financings, and to a lesser extent through a license and collaboration arrangement with its collaboration partner, Sanofi S.A. (“Sanofi”) through its subsidiary, Aventis, Inc. The Company has not yet received regulatory approval to commercialize or sell any product and does not have customers. Management expects operating losses and negative operating cash flows to continue for the foreseeable future. As the Company continues to incur losses, the transition to profitability is dependent upon the successful development, approval, and commercialization of its products and product candidates and the achievement of a level of revenues adequate to support its cost structure. The Company’s ultimate success depends on the outcome of its research and development activities. The Company expects to incur additional losses and negative cash flows for the foreseeable future and it anticipates the need to raise additional capital to fully implement its business plan. The Company intends to raise such capital through the issuance of additional equity, debt and/or strategic alliances with partner companies.

 

On March 8, 2018, the Company filed a Registration Statement on Form S-3ASR (the “2018 Shelf Registration Statement”) covering the potential offering, issuance, and sale of an indeterminate amount of common stock, preferred stock, debt securities, warrants and/or units. In May 2018, the Company completed a follow-on offering under the 2018 Shelf Registration Statement pursuant to which the Company issued 3,750,000 shares of common stock at a price of $49.00 per share. In addition, in June 2018, the Company sold an additional 211,174 shares of common stock directly to the underwriters when they partially exercised their over-allotment option at the price of $49.00 per share. Consequently , the Company received proceeds totaling approximately $181.9 million from the offering, net of underwriting discounts and commissions and offering expenses, which includes approximately $9.7 million received due to the underwriters’ partial exercise of their over-allotment option.  

 

As of September 30, 2018, the Company had $411.6 million of cash, cash equivalents and short and long-term investments and management believes that these amounts will be sufficient to meet the Company’s anticipated operating and capital expenditure requirements for the twelve months following the date of this Form 10-Q. Management’s belief with respect to its ability to fund operations is based on estimates that are subject to risks and uncertainties. If actual results are different from management’s estimates, the Company may need to seek additional funding.

 

 

2. Basis of Presentation and Summary of Significant Accounting Policies

Basis of Presentation

The accompanying condensed consolidated financial statements are unaudited, include the Company’s accounts and those of its wholly-owned subsidiary and have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). All intercompany balances and transactions have been eliminated in consolidation. See “ Adopted Accounting Pronouncements – Revenue Recognition ” below for a discussion of certain revisions to prior period financial statements made in connection with the Company’s adoption of new revenue recognition guidance. See “ Adopted Accounting Pronouncements – Other” below for a discussion of a revisions to previous periods in the statement of cash flows, whereby restricted cash is included with cash and cash equivalents when reconciling the beginning of period and end of period total amounts.

The Company currently operates in one business segment, which is the identification, development and commercialization of therapies for the treatment of serious and neglected rare cardiovascular diseases and has a single reporting and operating unit. These interim statements, in the opinion of management, reflect all normal recurring adjustments necessary for the fair presentation of the Company’s financial position and results of operations for the interim periods ended September 30, 2018 and 2017.  

6


 

The results of operations for the interim periods are not necessa rily indicative of the results of operations to be expected for the full fiscal year or any interim period and should be read in conjunction with the audited financial statements for the year ended December 31, 2017 and the notes thereto, which are include d in the Company’s Annual Report on Form 10-K as of and for the year ended December 31, 2017. The significant accounting policies used in preparation of these condensed consolidated financial statements for the three and nine months ended September 30, 201 8 are consistent with those discussed in Note 2 to the consolidated financial statements in the Company’s 2017 Annual Report on Form 10-K and are updated below as necessary.

Reclassifications

The cash and cash equivalents on the condensed consolidated statements of cash flows for the nine months ended September 30, 2017 has been reclassified to include restricted cash to conform to the current period’s presentation. Such reclassification did not impact the Company’s net loss or financial position.

Use of Estimates

 

The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make certain estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, other comprehensive gain (loss) and the related disclosures.  On an ongoing basis, management evaluates its estimates, including estimates related to license and collaboration revenues, accrued clinical trial and manufacturing development expenses and stock-based compensation expense. Significant estimates in these condensed consolidated financial statements include estimates made in connection with accrued research and development expenses, stock-based compensation expense and revenue.  The Company bases its estimates on historical experience, known trends and other market-specific or other relevant factors that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions.

 

Significant accounting policies are described in Note 2 to the consolidated financial statements as of and for the year ended December 31, 2017 included in the Annual Report.  There have been no changes to the Company’s significant accounting policies during the nine months ended September 30, 2018, except as described below.

Adopted Accounting Pronouncements - Revenue Recognition

 

Effective January 1, 2018, the Company adopted Accounting Standards Codification Topic 606,  Revenue from Contracts with Customers  (“ASC 606”) using the full retrospective transition method.  This standard applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, certain collaboration arrangements and financial instruments.  Under ASC 606, the Company recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the Company expects to receive in exchange for those goods or services.  To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation.  The Company only applies the five-step model to contracts when it is probable that Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer.  At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct.  The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

Licenses of intellectual property :   Upon the inception of a Collaboration Agreement, if the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgement to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring proportional performance for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of proportional performance each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.  

Milestone payments :  At the inception of each arrangement that includes development, regulatory or commercial milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price. ASC 606 suggests two alternatives to use when estimating the amount of variable consideration: the expected value method and the most likely amount method. Under the expected value method, an entity considers the sum of

7


 

probability-weighted amounts in a range of possible consid eration amounts. Under the most likely amount method, an entity considers the single most likely amount in a range of possible consideration amounts. Whichever method is used, it should be consistently applied throughout the life of the contract; however, it is not necessary for the Company to use the same approach for all contracts. The Company expects to use the most likely amount method for development and regulatory milestone payments. If it is probable that a significant revenue reversal would not occu r, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis. The Company recognizes revenue when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, the Company re-evaluates the probability or achievement of each such milestone and any related constraint, and if necessary, adjusts its estimates of the overall transaction price. Any such adjustments are recorded on a cumulative catch- up basis, which would affect revenues and earnings in the period of adjustment.

Royalties :  For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from its collaboration arrangement.

Up-front payments and fees are recorded as deferred revenue upon receipt or when due and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts payable to the Company are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less.

Impact of Adoption – ASC 606

 

The Company entered into a license and collaboration agreement that became effective in August 2014, which is within the scope of ASC 606, under which it has licensed certain rights to its HCM-1 (which includes mavacamten and MYK-224), HCM-2 and DCM-1 (which includes MYK-491) programs to Sanofi and may enter into other such arrangements in the future. The terms of the arrangement include payment to the Company of one or more of the following: non-refundable, up-front license fees, development and regulatory and commercial milestone payments, and royalties on net sales of licensed products.

The Company has applied the five-step model of the new standard to the Company’s contract with Sanofi, as it is the only contract that will be impacted by the adoption of the new revenue standards. The Company has implemented the new revenue standards using the full retrospective transition method and has revised its comparative financial statements as if ASC 606 had been effective for those periods.

The following tables summarize the financial statement line items that were affected due to the Company’s implementation of ASC 606 (in thousands, except for share and per share amounts) :

 

Condensed Consolidated Balance Sheet

 

 

 

As of

December 31, 2017

 

 

 

As Originally

Reported

 

 

Effect of Change

 

 

As Revised

 

Deferred revenue - current

 

$

22,500

 

 

$

11,058

 

 

$

33,558

 

Accumulated deficit

 

$

(123,797

)

 

$

(11,058

)

 

$

(134,855

)

8


 

Condensed Consolidated Statement of Operations and Comprehensive Loss

 

 

 

Nine Months Ended

September 30, 2017

 

 

 

As Originally

Reported

 

 

Effect of Change

 

 

As Revised

 

Collaboration and license revenue

 

$

16,875

 

 

$

(8,387

)

 

$

8,488

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

39,967

 

 

 

 

 

 

39,967

 

General and administrative

 

 

16,442

 

 

 

 

 

 

16,442

 

Total operating expenses

 

 

56,409

 

 

 

 

 

 

56,409

 

Loss from operations

 

 

(39,534

)

 

 

(8,387

)

 

 

(47,921

)

Interest and other income, net

 

 

977

 

 

 

 

 

 

977

 

Net loss

 

 

(38,557

)

 

 

(8,387

)

 

 

(46,944

)

Other comprehensive (loss)

 

 

60

 

 

 

 

 

 

60

 

Comprehensive loss

 

 

(38,497

)

 

 

(8,387

)

 

 

(46,884

)

Net loss attributable to common stockholders

 

$

(38,557

)

 

$

(8,387

)

 

$

(46,944

)

Net loss per share attributable to common stockholders, basic and diluted

 

$

(1.21

)

 

$

(0.26

)

 

$

(1.47

)

Weighted average number of shares used to compute net loss per share

   attributable to common stockholders, basic and diluted

 

 

31,951,631

 

 

 

 

 

 

31,951,631

 

Condensed Consolidated Statement of Cash Flows

 

 

 

Nine Months Ended

September 30, 2017

 

 

 

As Originally

Reported

 

 

Effect of Change

 

 

As Revised

 

Net loss

 

$

(38,557

)

 

$

(8,387

)

 

$

(46,944

)

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

 

 

 

 

 

 

 

 

 

 

 

 

Deferred revenue

 

$

(16,875

)

 

$

8,387

 

 

$

(8,488

)

Cash, cash equivalents and restricted cash, beginning of period

 

$

135,797

 

 

$

259

 

 

$

136,056

 

Cash, cash equivalents and restricted cash, end of period

 

$

227,184

 

 

$

259

 

 

$

227,443

 

 

The change to net loss and deferred revenue in the condensed consolidated statement of cash flows, as revised above, reflects (i) the Company’s determination that the Sanofi continuation payment of $45.0 million received in January 2017 relates to three performance obligations that were previously accounted for as one combined unit of accounting and (ii) the result of the Company utilizing a cost-based input method to measure proportional performance for each interim period during the year ending December 31, 2017, instead of straight-line.

Impact of Adoption – ASU 2016-18

As discussed in “Adopted Accounting Pronouncements – Other” below, the change to cash, cash equivalents and restricted cash in the table above reflects the Company’s implementation of ASU 2016-18 whereby amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning of period and end of period total amounts shown on the statement of cash flows.  The Company implemented this change using a retrospective transition method.

 

9


 

The following table summarizes the cash balances that were affec ted due to the Company’s implementation of ASU 2016-18 (in thousands):

Condensed Consolidated Statement of Cash Flows

 

 

 

 

September 30, 2018

 

 

December 31, 2017

 

 

September 30, 2017

 

 

December 31, 2016

 

 

 

 

 

 

 

As Revised

 

 

As Revised

 

 

As Revised

 

Cash and cash equivalents

 

$

335,279

 

 

$

224,571

 

 

$

227,184

 

 

$

135,797

 

Restricted cash – noncurrent

 

 

2,143

 

 

 

286

 

 

 

259

 

 

 

259

 

Total cash, cash equivalents and restricted

   cash

 

$

337,422

 

 

$

224,857

 

 

$

227,443

 

 

$

136,056

 

Adopted Accounting Pronouncements – Other

In May 2017, the Financial Accounting Standards Board (“ FASB”) issued ASU No. 2017-09—Compensation—Stock Compensation (Topic 718): Scope of Modification Accounting. The amendments in this ASU provide guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting in Topic 718 to address diversity in practice. An entity should account for the effects of a modification unless all the three specified conditions are met. The current disclosure requirements in Topic 718 apply regardless of whether an entity is required to apply modification accounting under the amendments in this ASU. The amendments in this ASU are effective for all entities for annual periods, and interim periods within those annual periods, beginning after December 15, 2017, with early adoption permitted. The amendments in this ASU should be applied prospectively to an award modified on or after the adoption date. The adoption of this standard did not have a material impact on the Company’s consolidated financial statements .

In November 2016, the FASB issued ASU No. 2016-18 (Topic 230), Restricted Cash, Statement of Cash Flows . This ASU 2016-18 requires that a state ment of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Therefore, amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016-18 is effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years, with early adoption permitted. The amendments in this ASU should be applied using a retrospective transition method to each period presented. Other than the change in presentation in the accompanying consolidated statements of cash flows, the adoption of this guidance had no effect on the Company’s financial position, results of operations or liquidity.

Recent Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the FASB or other standard setting bodies and adopted by the Company as of the specified effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material impact on the Company’s consolidated financial statements upon adoption. Under the Jumpstart Our Business Startups Act of 2012, as amended (the “JOBS Act”), the Company meets the definition of an emerging growth company and has irrevocably elected to opt out of the extended transition period for complying with new or revised accounting standards pursuant to Section 107(b) of the JOBS Act.

In August 2018, the FASB issued ASU 2018-13 (Topic 820), Fair Value Measurement, which modifies the disclosure requirements in Topic 820 by removing requirements for disclosing (i) amounts of and reasons for transfers between the Level 1 and Level 2 hierarchies, (ii) the policy for timing of transfers between levels and (iii) the valuation processes for Level 3 fair value measurements. The ASU 2018-13 amendment also adds requirements for disclosure of changes in unrealized gains and losses for the period relating to Level 3 fair value measurements and other factors considered in the valuation of Level 3 investments. This amendment is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The Company has evaluated this amendment and it is not expected to have a material impact to the Company’s financial statements.

In July 2018, the FASB issued issued amendments ASU 2018-10, Codification Improvements, and ASU 2018-11, Targeted Improvements to the ASU No. 2016-02 (Topic 842), Leases previously issued in February 2016. These ASUs, taken together, modify lease accounting for lessees to increase transparency and comparability by recording lease assets and liabilities for operating leases and disclosing key information about leasing arrangements. These amendments are required to be implemented for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. The new lease standard originally required the adoption of the standard using the modified retrospective transition method; however, the July 2018 amendments provide entities with an additional (and optional) transition method to adopt the new lease standard. Under this transition method, an entity initially applies the new lease standard at the adoption date and recognizes a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption.

10


 

The amendments also provide lessors with a practical expedient, by class of underlying asset, to not separate nonlease components from the associated lease componen t and, instead, to account for those components as a single component if the nonlease components otherwise would be accounted for under the new revenue guidance (Topic 606) and certain criteria are met. If the nonlease component or components associated wi th the lease component are the predominant component of the combined component, an entity is required to account for the combined component in accordance with Topic 606. Otherwise, the entity must account for the combined component as an operating lease in accordance with Topic 842.

The Company will adopt the new standard on January 1, 2019 by recognizing a cumulative-effect adjustment to the opening balance of retained earnings as of that date. Although the Company anticipates recording leased assets and liabilities for its facilities in South San Francisco, the ultimate impact of adopting ASU 2016-02 and its amendments will depend on the Company’s lease portfolio as of the adoption date .   In addition, the Company is in the process of identifying and designing the appropriate changes to its accounting policies, business processes, and related internal controls to support recognition and disclosure requirements under ASC 842 and is implementing these changes over the remainder of 2018 .

In June 2018, the FASB issued ASU No. 2018-07 (Topic 718), Compensation – Stock Compensation .  The update represents an expansion of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. An entity should apply the requirements of Topic 718 to nonemployee awards except for specific guidance on inputs to an option pricing model and the attribution of cost (that is, the period of time over which share-based payment awards vest and the pattern of cost recognition over that period). The amendments specify that Topic 718 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. The amendments also clarify that Topic 718 does not apply to share-based payments used to effectively provide (1) financing to the issuer or (2) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under Topic 606, Revenue from Contracts with Customers.  The Company will adopt ASU 2018-17 in the first quarter of 2019 and it is not expected to have a material impact to the Company’s financial statements.

In February 2018, the FASB issued ASU No. 2018-05 (Topic 740) Income Taxes, Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin No. 118 .  The update provides guidance that gives entities the option to reclassify to retained earnings tax effects related to items in accumulated other comprehensive income (OCI) that the FASB refers to as having been stranded in accumulated OCI as a result of tax reform. Entities can early adopt the guidance in any interim or annual period for which financial statements have not yet been issued and apply it either (1) in the period of adoption or (2) retrospectively to each period in which the income tax effects of the Tax Cuts and Jobs Act related to items in accumulated OCI are recognized.  The Company will adopt ASU 2018-05 in the first quarter of 2019 utilizing the modified retrospective transition method. The adoption of this standard has not had and through the one-year period of adoption, is not expected to have a material impact to the Company’s financial statements.

 

 

3. Sanofi License and Collaboration Agreement

Sanofi (Aventis Inc.)

In August 2014, the Company entered into an exclusive License and Collaboration Agreement (“Collaboration Agreement”) with Aventis Inc., a wholly-owned subsidiary of Sanofi, for the research, development and potential commercialization of pharmaceutical products for the treatment, prevention and diagnosis of hypertrophic and dilated cardiomyopathy, as well as potential additional indications.  The Company has determined that Sanofi is a related party of the Company due to its close collaborative relationship and that it is the Company’s only partner.  In addition, Sanofi is a beneficial shareholder of the Company’s common stock.

Under the Collaboration Agreement, the Company granted Sanofi royalty-bearing licenses to develop and commercialize products resulting from its lead candidate programs HCM-1, HCM-2 and DCM-1. The licenses provide Sanofi with worldwide rights in the case of DCM-1 and rights outside the United States with respect to the HCM-1 and HCM-2 programs. The terms of the Collaboration Agreement also state that the Company is responsible for conducting research and development activities through early human efficacy studies for all three programs, except for specified research activities to be conducted by Sanofi.

Upon entering into this agreement, the Company received an up-front non-refundable cash payment of $35.0 million and Sanofi made an up-front equity purchase of $10.0 million (additional equity investments from Sanofi totaling $21.4 million were received subsequent to the effective date of the Collaboration Agreement). The Company was also eligible to receive additional payments and services, as follows: (1) a one-time, non-refundable payment of $25.0 million contingent upon submission of an Investigational New Drug (“IND”) application before certain regulatory authority(ies) for its DCM-1 program; (2) up to $45.0 million in funding from Sanofi of approved in-kind research and clinical activities; (3) a non-refundable continuation payment of $45.0 million contingent upon Sanofi’s notification of its decision to continue the agreement beyond December 31, 2016; and, (4) up to $15.0 million in research and development funding for the lead compound in each program if studies leading to proof-of-concept (“POC”) are extended beyond December 31, 2018.

11


 

During the fourth quarter of 2016, the Company submitted an I ND application to the U.S. Food and Drug Administration and as a result, the Company received the $25.0 million milestone payment from Sanofi.  

In December 2016, Sanofi provided notice to the Company of its election to continue the collaboration through December 31, 2018 pursuant to the terms of the Collaboration Agreement. In connection with Sanofi’s decision to continue the collaboration, the Company received the $45.0 million milestone payment.

The Company is also entitled to receive tiered royalties ranging from the mid-single digits to the mid-teens on net sales of certain HCM-1, HCM-2 and DCM-1 finished products outside the United States and on net sales of certain DCM-1 finished products in the United States. Sanofi is eligible to receive tiered royalties ranging from the mid-single digits to the low-teens on net sales of certain HCM-1 and HCM-2 finished products in the United States.

Revenue Recognition

The Company evaluated the Collaboration Agreement under ASC 606 and determined that it had the following performance obligations: (1) the licenses of intellectual property for each of the HCM-1, HCM-2 and DCM-1 programs, and (2) the performance of research and development services, including regulatory support, for each of the three programs.  The Company considered whether the licenses have standalone functionality and are capable of being distinct; however, given the fact that the research and development services are of such a specialized nature that can only be performed by the Company and Sanofi cannot benefit from the intellectual property licenses without the Company’s performance, the Company determined that the intellectual property licenses are not distinct from the research and development services and thus the license and research and development services for each program are combined into three separate performance obligations.

 

Contract Term

For revenue recognition purposes, the Company determined that the Collaboration Agreement is a period to period contract for which the Company had enforceable rights and obligations from inception through December 31, 2016.  Sanofi had the right to terminate the Collaboration Agreement prior to December 31, 2016 or to extend the contract term through December 31, 2018.  If Sanofi had elected to terminate the agreement, the termination would have had taken effect on December 31, 2016 and all licensed rights would have reverted to the Company. The Company did not have any obligation to reimburse Sanofi any portion of the payments received if Sanofi had terminated the agreement.

In December 2016, Sanofi elected to continue the Collaboration Agreement through an extended term ending December 31, 2018 and made the $45.0 million continuation payment to the Company. The Company determined that the extended term was to be treated as a separate contract because such an extension was not probable at the inception of the contract, the extension represents additional goods and services, and such activities are priced commensurate to the effort required and do not involve any significant discount. It was also concluded that the extended term provides the Company with enforceable rights and obligations for the two-year period ending December 31, 2018.  

Because Sanofi retains the option in the Collaboration Agreement to extend the arrangement, neither party is committed to perform and the contract does not have enforceable rights and obligations beyond December 31, 2018.

Transaction Price

The Company’s assessment of the transaction price included an analysis of amounts to which it expected to be entitled for providing goods or services to the customer which at contract inception consisted of the upfront cash payment, valued at $34.3 million, net of the fair value of $0.7 million allocated to the option provided to Sanofi to acquire equity, and variable consideration of $25.0 million, subject to an IND application. Sanofi paid the Company the $25.0 million milestone upon the Company’s application for the IND. In 2016, after the IND application was made and when the Company determined it was deemed probable that significant reversal in the amount of cumulative revenue recognized will not occur, the Company included this amount in the transaction price.  As of December 31, 2016, all performance obligations associated with the initial term were satisfied.       

The extended term (from January 1, 2017 to December 31, 2018) has a fixed fee of $45.0 million, paid by Sanofi contemporaneously with the notice of continuation of the contract.  The Company therefore determined that the transaction price for this extended term is $45.0 million.

12


 

As previously noted above, the Collaboration Agreement also includes up to $45.0 million in funding from Sanofi of approved in-kind research and clinical activities. Sanofi is the decisi on maker on how to provide these services and such services are used in the development of joint program technology which is co-owned by both parties. As such the Company concluded that these in-kind contributions do not constitute consideration paid by Sa nofi to the Company.  

Any consideration related to sales-based royalties will be recognized when the related sales occur and therefore have also been excluded from the transaction price.  

Methodology for Recognition

Since the Company has determined that the three performance obligations are satisfied over time, the Company has selected a single revenue recognition method that it believes most faithfully depicts the Company’s performance in transferring control of the services. ASC 606 allows entities to choose between two methods to measure progress toward complete satisfaction of a performance obligation:  

 

1. Output methods - recognize revenue on the basis of direct measurements of the value to the customer of the goods or services transferred to date relative to the remaining goods or services promised under the contract (e.g. surveys of performance completed to date, appraisals of results achieved, milestones reached, time elapsed, and units produced, or units delivered); or

2. Input methods - recognize revenue on the basis of the entity’s efforts or inputs to the satisfaction of a performance obligation (e.g., resources consumed, labor hours expended, costs incurred, or time elapsed) relative to the total expected inputs to the satisfaction of that performance obligation.

 

The Company concluded that it will utilize a cost-based input method to measure proportional performance and to calculate the corresponding amount of revenue to recognize. The Company believes this is the best measure of progress because other measures do not reflect how the Company executes its performance obligations under the contract with Sanofi. In applying the cost-based input methods of revenue recognition, the Company uses actual costs incurred relative to budgeted costs to fulfill the combined performance obligations. Revenue will be recognized based on actual costs incurred as a percentage of total actual and budgeted costs as the Company completes its performance obligations, which will be fulfilled by December 31, 2018. A cost-based input method of revenue recognition requires management to make estimates of costs to complete the Company’s performance obligations. In making such estimates, significant judgment is required to evaluate assumptions related to cost estimates. The cumulative effect of revisions to estimated costs to complete the Company’s performance obligations will be recorded in the period in which changes are identified and amounts can be reasonably estimated. A significant change in these assumptions and estimates could have a material impact on the timing and amount of revenue recognized in future periods.

 

For the nine months ended September 30, 2018 and 2017, the Company recognized $21.2 million and $8.5 million of license and collaboration revenue, respectively.  

 

The following table presents changes in the Company’s contract assets and liabilities, which excludes research and development reimbursements under the mavacamten registration program plan, for the nine months ended September 30, 2018 and 2017 (in thousands):

 

 

 

Nine Months Ended September 30, 2018

 

 

 

Balance at

Beginning of Period

 

 

Additions

 

 

Deductions

 

 

Balance at End

of Period

 

Contract liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Deferred revenue

 

$

33,558

 

 

$

 

 

$

(21,158

)

 

$

12,400

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Nine Months Ended September 30, 2017

 

 

 

Balance at

Beginning of Period

 

 

Additions

 

 

Deductions

 

 

Balance at End

of Period

 

Contract assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Receivable from collaboration partner

 

$

45,000

 

 

$

 

 

$

(45,000

)

 

$

 

Contract liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Deferred revenue

 

$

45,000

 

 

$

 

 

$

(8,488

)

 

$

36,512

 

 

13


 

Deferred revenue of $12.4 million as of September 30, 2018 consists of the $45.0 million continuation payment received in January 2017, less $11.4 million recognized in the year ended December 31, 2017 and $21.2 millio n recognized during the nine months ended September 30, 2018. The $12.4 million in deferred revenue will be recognized through December 31, 2018 as the performance obligations are satisfied.

Registration Program Plan and Pre-POC Cost Sharing

In addition to amounts due to the Company under the Collaboration Agreement, Sanofi is conditionally responsible for reimbursing the Company for (i) one half or more of the registration program plan (“RPP”) costs after clinical proof-of-concept is established for the lead compound under each of the HCM-1 and HCM-2 programs; and (ii)  if the Company has initiated a clinical trial of a compound under a proof-of-concept development plan and not terminated its development thereof and if another Additional Compound is identified as a development candidate for the same program, the Company is entitled to full reimbursement of pre-proof-of-concept (“pre-POC”) research and development costs on development candidates mutually identified as such Additional Compounds, with the objective of conducting IND-enabling studies and clinical trials on such candidate. An “Additional Compound” is a compound that qualifies as a secondary compound to the lead compound in each program. The estimated amount to be so reimbursed shall be provided by the Company in advance of the decision whether to initiate further development of such Additional Compounds and there is no contractual limit on the costs to be incurred by the Company and reimbursed by Sanofi. The Company has the right, but not the obligation to conduct development of Additional Compounds and Sanofi is entitled to terminate the agreement with respect to any program prior to the delivery by the Company to Sanofi of a final study report.

Effective October 2017, Sanofi is sharing RPP costs for the mavacamten program during the remainder of the contract term. Registration program costs are subject to review and approval by the Company and Sanofi and include amounts incurred relating to clinical trials, development and manufacturing of, and obtaining regulatory approvals for mavacamten, and include direct employee costs and direct out-of-pocket costs incurred, by or on behalf of a party, that are specifically identifiable or reasonably and directly allocable to those activities.

Pursuant to the Additional Compounds provisions of the Collaboration Agreement, in August 2018 Sanofi agreed to reimburse the Company for eligible costs it has incurred in the development of  the MYK-224 compound, which has been identified as an Additional Compound under the HCM-1 program. Eligible costs are subject to review and approval under the same procedures as under the RPP program; reimbursable costs consist of research and development activities agreed to by the Company and Sanofi that were negotiated and budgeted prior to the application for reimbursement. Under the Collaboration Agreement, Sanofi will continue to reimburse the Company for eligible MYK-224 identified and agreed to under the program, through proof-of-concept. Only one Additional Compound for each of the three programs is eligible for reimbursement under the Collaboration Agreement and only after a clinical trial of an initial compound under the program has been established and not terminated.

Accordingly, for the HCM-1 program, the Additional Compound MYK-224 was nominated and the Company invoiced Sanofi $2.6 million for costs incurred through September 30, 2018.

Estimated reimbursements are invoiced to Sanofi before each interim period based on budgeted amounts.  For the RPP program, these estimates consist of one half of the Company’s mavacamten development budget in excess of Sanofi’s mavacamten development budget each interim period. For the MYK-224 compound, these estimates consist of all of the Company’s research and development budget related to the compound for the forthcoming quarter. After each period end, a review of the actual expenses incurred is performed and any adjustments are carried forward to future invoices. Actual amounts received from Sanofi are applied to the applicable interim period to reduce the Company’s research and development expenses.  

The Company recorded a $2.6 million and $1.0 million  receivable for reimbursable RPP and MYK-224 expenses, as of September 30, 2018 and December 31, 2017 respectively, which are recorded as receivable from collaboration partner and included in current assets in the condensed consolidated balance sheets. As of September 30, 2018 and December 31, 2017, the Company has recorded $10.9 million and $4.4 million, respectively, as prepayments from collaboration partner, to apply to future research and development expenses. Prepayments from collaboration partner are included in current liabilities in the condensed consolidated balance sheets. The Company recorded $14.8 million and zero as reductions to research and development expenses for the nine months ended September 30, 2018 and 2017, respectively.

14


 

The following table presents the Sanofi research and development reimbursement receivables and related prepayment activity during the nine mont hs ended September 30, 2018 (in thousands):

 

Receivable from collaboration partner

 

 

 

 

Balance at January 1, 2018

 

$

1,013

 

Additions

 

 

2,565

 

Deductions

 

 

(1,013

)

Balance at September 30, 2018

 

$

2,565

 

 

 

 

 

 

Prepayment from collaboration partner

 

 

 

 

Balance at January 1, 2018

 

$

4,432

 

Additions for advance billings

 

 

2,565

 

Payments received from collaboration partner

 

 

18,734

 

Actual expenses incurred

 

 

(14,787

)

Balance at September 30, 2018

 

$

10,943

 

 

4. Fair Value Measurements

Financial assets and liabilities are recorded at fair value. The accounting guidance for fair value provides a framework for measuring fair value, clarifies the definition of fair value and expands disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows:

Level 1—Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date.

Level 2—Inputs other than quoted market prices included in Level 1 are either directly or indirectly observable for the asset or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life.

Level 3—Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model.

The following table sets forth the Company’s financial instruments that were measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands):

 

 

 

Fair Value Measurements at September 30, 2018

 

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

335,103

 

 

$

335,103

 

 

$

 

 

$

 

U.S. government agency obligations

 

 

28,672

 

 

 

 

 

 

28,672

 

 

 

 

Corporate securities

 

 

47,679

 

 

 

 

 

 

47,679

 

 

 

 

Total

 

$

411,454

 

 

$

335,103

 

 

$

76,351

 

 

$

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fair Value Measurements at December 31, 2017

 

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Money market funds

 

$

223,568

 

 

$

223,568

 

 

$

 

 

$

 

U.S. government agency obligations

 

 

27,878

 

 

 

 

 

 

27,878

 

 

 

 

Corporate securities

 

 

23,955

 

 

 

 

 

 

23,955

 

 

 

 

Total

 

$

275,401

 

 

$

223,568

 

 

$

51,833

 

 

$

 

15


 

 

The following table is a summary of amortized cost, unrealized gain and loss, and fair value of the Company’s marketable securities by contractual maturities (in thousands):

 

 

 

Fair Value Measurements at September 30, 2018

 

 

 

Amortized Cost

 

 

Unrealized Gain

 

 

Unrealized Loss

 

 

Fair Value

 

Cash equivalents (due within 90 days)

 

$

335,103

 

 

$

 

 

$

 

 

$

335,103

 

Short-term investments (due within one year)

 

 

43,949

 

 

 

 

 

 

(104

)

 

 

43,845

 

Long-term investments (due between one and two years)

 

 

32,619

 

 

 

 

 

 

(113

)

 

 

32,506

 

Total

 

$

411,671

 

 

$

 

 

$

(217

)

 

$

411,454

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fair   Value Measurements at December 31, 2017

 

 

 

Amortized Cost

 

 

Unrealized Gain

 

 

Unrealized Loss

 

 

Fair Value

 

Cash equivalents (due within 90 days)

 

$

223,568

 

 

$

 

 

$

 

 

$

223,568

 

Short-term investments (due within one year)

 

 

32,010

 

 

 

 

 

 

(77

)

 

 

31,933

 

Long-term investments (due between one and two years)

 

 

20,010

 

 

 

 

 

 

(110

)

 

 

19,900

 

Total

 

$

275,588

 

 

$

 

 

$

(187

)

 

$

275,401

 

 

 

5. Balance Sheet Components

Property and Equipment

Property and equipment consist of the following (in thousands):

 

 

 

September 30,

2018

 

 

December 31,

2017

 

Scientific equipment

 

$

8,558

 

 

$

5,935

 

Furniture and equipment

 

 

1,198

 

 

 

1,064

 

Capitalized software

 

 

278

 

 

 

278

 

Leasehold improvements

 

 

427

 

 

 

331

 

Total

 

 

10,461

 

 

 

7,608

 

Less: Accumulated depreciation

 

 

(5,556

)

 

 

(4,461

)

Property and equipment, net

 

$

4,905

 

 

$

3,147

 

 

Depreciation expense was $0.4 million and $0.4 million for the three months ended September 30, 2018 and 2017, respectively and $1.1 million and $1.0 million for the nine months ended September 30, 2018 and 2017, respectively.

Accrued Liabilities

Accrued liabilities consist of the following (in thousands):

 

 

 

September 30,

2018

 

 

December 31,

2017

 

Clinical research and development

 

$

11,233

 

 

$

5,981

 

Payroll-related liabilities

 

 

6,140

 

 

 

4,412

 

Other

 

 

1,417

 

 

 

1,246

 

Total accrued liabilities

 

$

18,790

 

 

$

11,639

 

 

 

16


 

6. Commitments and Contingencies

Purchase Commitments

The Company conducts product research and development programs through a combination of internal and collaborative programs that include, among others, arrangements with universities, contract research organizations and clinical research sites. The Company has contractual arrangements with these organizations; however, these contracts are generally cancelable on 30 days’ notice and the obligations under these contracts are largely based on services performed.

Facilities

In September 2018, the Company entered into a noncancelable operating lease (the “Lease”) for approximately 129,846 square feet of space in Brisbane, California (the “New Facility”). The date on which the Company will become responsible for paying rent under the Lease (the “Rent Commencement Date”) will be the date the premises are ready for occupancy, currently anticipated to be January 2020. The Lease expires 10 years after the Rent Commencement Date. The Lease grants the Company an option to extend the Lease for an additional 10-year period. Future minimum rental payments under the Lease during the 10-year term are $93.2 million in the aggregate. The Lease further provides that the Company is obligated to pay to the landlord certain costs, including taxes and operating expenses. As of September 30, 2018, the Lease term has not commenced as the Company did not have the right to use or control physical access to the New Facility.

In September 2018 t he Company provided a standby letter of credit of $1.9 million as security for its obligations under the Lease. This standby letter of credit together with standby letters on Existing Facilities (as defined below) are classified as long-term assets within restricted cash and other on the balance sheet.

The Company currently leases approximately 48,400 square feet of office and lab space in two separate facilities in South San Francisco, California (the “Existing Facilities”). All of the lease agreements associated with the Existing Facilities expire on or before January 2020. The Company does not plan to cancel the existing lease agreements for its Existing Facilities prior to their respective expiration dates.

Future annual minimum lease payments due under the new and existing operating leases at December 31 of each year are as follows (in thousands):

 

Year ending December 31:

 

Amount 1

 

2018 (three months)

 

$

531

 

2019

 

 

2,071

 

2020

 

 

5,454

 

2021

 

 

8,461

 

2022

 

 

8,757

 

Thereafter

 

 

70,508

 

Total

 

$

95,782

 

  

(1)  

The table above is prepared under the assumption that the Rent Commencement Date at the New Facility starts on January 1, 2020.

Rent expense for the three months ended September 30, 2018 and 2017 was $0.6 million and $0.3 million, respectively, and for the nine months ended September 30, 2018 and 2017 was $1.6 million and $1.0 million, respectively. The operating leases require the Company to share in prorated operating expenses and property taxes based upon actual amounts incurred; those amounts are not fixed for future periods and, therefore, are not included in the future commitments listed above.

17


 

Contingencies

From time to time, the Company may have contingent liabilities that arise in the ordinary course of business activities. The Company accrues for such a liability when it is probable that future expenditures will be made, and such expenditures can be reasonably estimated. There were no contingent liabilities requiring accrual or disclosure as of September 30, 2018 or December 31, 2017.

Guarantees and Indemnifications

The Company enters into standard indemnification arrangements in the ordinary course of business.

Pursuant to certain of these arrangements, the Company indemnifies, holds harmless, and agrees to reimburse the indemnified parties for losses suffered or incurred by the indemnified party, in connection with any trade secret, copyright, patent or other intellectual property infringement claim by any third-party with respect to the Company’s technology. The term of these indemnification arrangements is generally perpetual. The maximum potential amount of future payments the Company could be required to make under these agreements is not determinable because it involves claims that may be made against the Company in the future but have not yet been made.

The Company indemnifies its officers and directors for certain events or occurrences, subject to certain limits, while the officer or director is or was serving at the Company’s request in such capacity, as permitted under Delaware law and in accordance with its certificate of incorporation and bylaws, and agreements providing for indemnification entered into with its officers and directors. The term of the indemnification period lasts as long as an officer or director may be subject to any proceeding arising out of acts or omissions of such officer or director in such capacity.

The maximum amount of potential future indemnification of directors and officers is unlimited; however, the Company currently holds director and officer liability insurance. This insurance allows the transfer of risk associated with its exposure and may enable it to recover a portion of any future amounts paid.

The Company believes that the fair value of these indemnification obligations is minimal. Accordingly, the Company has not recognized any liabilities relating to these obligations for any period presented.

 

 

7. Stockholders’ Equity

 

On March 8, 2018 the Company filed the 2018 Shelf Registration Statement covering the potential offering, issuance, and sale of an indeterminate amount of common stock, preferred stock, debt securities, warrants and/or units. In May 2018, the Company completed a follow-on offering under the 2018 Shelf Registration Statement pursuant to which the Company issued 3,750,000 shares of common stock at a price of $49.00 per share. In June 2018, the Company sold an additional 211,174 shares of common stock directly to the underwriters when they partially exercised their over-allotment option at the price of $49.00 per share. In the period ending June 30, 2018, the Company received proceeds totaling approximately $181.9 million from the offering, net of underwriting discounts and commissions and offering expenses, which includes approximately $9.7 million received due to the underwriters’ partial exercise of their over-allotment option.

 

Common Stock Reserved for Issuance

The Company has reserved shares of common stock for issuance as follows:

 

 

 

September 30,

2018

 

 

December 31,

2017

 

Options and awards issued and outstanding

 

 

3,828,905

 

 

 

2,964,549

 

Shares available for issuance under 2015 Stock Option and Incentive Plan

 

 

977,948

 

 

 

863,538

 

Shares available for issuance under 2015 Employee Stock Purchase Plan

 

 

794,724

 

 

 

449,444

 

Total

 

 

5,601,577

 

 

 

4,277,531

 

 

 

18


 

8. Stock-Based Compensation

The Company classifies stock-based compensation expense in the accompanying condensed consolidated statements of operations and comprehensive loss based on the department to which a recipient belongs. The following table sets forth stock-based compensation expense related to equity awards granted to employees and consultants for all periods presented (in thousands):

 

 

 

Three   Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Research and development

 

$

2,042

 

 

$

713

 

 

$

5,683

 

 

$

1,913

 

General and administrative

 

 

3,184

 

 

 

888

 

 

 

7,956

 

 

 

2,434

 

Total

 

$

5,226

 

 

$

1,601

 

 

$

13,639

 

 

$

4,347

 

 

 

The following summarizes option and other equity award activity under the 2012 Equity Incentive Plan and 2015 Stock Option and Incentive Plan: 

 

 

 

Shares Subject to

 

 

Weighted Average

 

 

 

Outstanding

Options

 

 

Exercise Price

per Share

 

Balance at December 31, 2017

 

 

2,964,549

 

 

$

11.54

 

Options granted

 

 

1,305,721

 

 

 

52.12

 

Options exercised

 

 

(454,515

)

 

 

10.43

 

Options canceled/forfeited

 

 

(142,636

)

 

 

22.36

 

Balance at September 30, 2018

 

 

3,673,119

 

 

$

25.68

 

 

 

 

 

 

 

 

 

 

 

 

Shares Subject to

 

 

Weighted Average

 

 

 

Outstanding

Awards

 

 

Grant Date

Fair Value

 

Balance at December 31, 2017

 

 

 

 

$

 

Restricted stock units granted

 

 

161,076

 

 

 

52.76

 

Restricted stock units forfeited

 

 

(5,290

)

 

 

53.00

 

Balance at September 30, 2018

 

 

155,786

 

 

$

52.75

 

 

Restricted stock units (“ RSUs”) settle into shares of common stock upon vesting and the exercise price is the market price on the date of vesting .

 

Pursuant to the terms of the Company’s 2015 Employee Stock Purchase Plan (the “2015 ESPP”), on April 30, 2018, the Company issued 12,847 shares to participants in the 2015 ESPP in exchange for their contributions during the period from November 1, 2017 to April 30, 2018.

 

In relation to stock options and awards to purchase common stock that vest upon the achievement of performance criteria, there was zero and zero stock-based compensation expense recorded for the three months ended September 30, 2018 and 2017, respectively, and $193,000 and $174,000 in stock-based compensation expense was recorded for the nine months ended September 30, 2018 and 2017, respectively. The Company begins to recognize expenses related to these stock options and awards during the period upon concluding that certain performance criteria are considered probable.

 

 

19


 

9. Net Loss per Share Attributable to Common Stockholders

The following table sets forth the computation of basic and diluted net loss per share attributable to common stockholders (in thousands, except share and per share amounts):

 

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Numerator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(15,789

)

 

$

(16,721

)

 

$

(52,022

)

 

$

(46,944

)

Net loss attributable to common stockholders, basic and diluted

 

$

(15,789

)

 

$

(16,721

)

 

$

(52,022

)

 

$

(46,944

)

Denominator

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding

 

 

40,145,306

 

 

 

33,686,799

 

 

 

37,857,621

 

 

 

32,195,471

 

Less: weighted average shares subject to repurchase

 

 

(28,662

)

 

 

(161,232

)

 

 

(91,990

)

 

 

(243,840

)

Weighted average shares used to compute basic and diluted net

   loss per share

 

 

40,116,644

 

 

 

33,525,567

 

 

 

37,765,631

 

 

 

31,951,631

 

Net loss per share attributable to common stockholders, basic

   and diluted

 

$

(0.39

)

 

$

(0.50

)

 

$

(1.38

)

 

$

(1.47

)

 

The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share attributable to common stockholders for the periods presented because including them would have been antidilutive:

 

 

 

As of September 30,

 

 

 

2018

 

 

2017

 

Common stock subject to repurchase

 

 

17,095

 

 

 

127,524

 

Options and awards issued and outstanding

 

 

3,828,905

 

 

 

3,289,677

 

 

As of September 30, 2018, the Company has contributions from plan participants of $0.5 million under the 2015 ESPP, which if converted, would be equivalent to 11,766 shares based on 85% of the stock price at the beginning of the offering period. As of September 30, 2017, the Company had contributions from plan participants of $0.3 million under the 2015 Employee Stock Purchase Plan, which if converted, would have been equivalent to 25,668 shares based on 85% of the stock price at the beginning of the offering period.

 

10. Income taxes

On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (“Tax Act”) was signed into law making significant changes to the Internal Revenue Code. Changes include, but are not limited to, a corporate tax rate decrease from 35% to 21% effective for tax years beginning after December 31, 2017, the transition of U.S. international taxation from a worldwide tax system to a territorial system, and a one-time transition tax on the mandatory deemed repatriation of cumulative foreign earnings as of December 31, 2017. 

Also, on December 22, 2017, Staff Accounting Bulletin No. 118 (“SAB 118”) was issued to address the application of U.S. GAAP in situations when a registrant does not have the necessary information available, prepared, or analyzed (including computations) in reasonable detail to complete the accounting for certain income tax effects of the Act. For the nine months ended September 30, 2018, the Company noted no additional guidance or information that affects the provisional amounts initially recorded at zero for the transition tax and the remeasurement of the deferred tax assets for the year ended December 31, 2017. As a result, the Company recorded no adjustment to the transition tax and the remeasurement of the deferred tax assets. The Company will continue to monitor and analyze any additional guidance and information that may be issued by the federal and state tax authorities. Any subsequent adjustment to these amounts will be recorded to current tax expense in the 2018 interim period during which the analysis is complete. 

 

 

 

20


 

Item 2.

Management’s Discussion and Analysis o f Financial Condition and Results of Operation

You should read the following management’s discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated financial statements and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with our audited consolidated financial statements and notes thereto for the year ended December 31, 2017, included in our Annual Report on Form 10-K for the year ended December 31, 2017, filed with the U.S. Securities and Exchange Commission (SEC) on March 8, 2018 (the “Annual Report”).

Special note regarding forward-looking statements

This report contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those discussed in these forward-looking statements. The statements contained in this report that are not purely historical ar e forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended ( the “ Exchange Act”). Forward-looking statements are often identified by the use of words such as, but not limited to, “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “seek,” “should,” “strategy,” “target,” “will,” “would” and similar expressions or variations intended to identify forward-looking statements. These statements are based on the beliefs and assumptions of our management based on information currently available to management. Such forward-looking statements are subject to risks, uncertainties and other important factors that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified below and those discussed in the section titled “Risk Factors” included under Part II, Item 1A below. Furthermore, such forward-looking statements speak only as of the date of this report. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements.

Overview

We are a clinical-stage biopharmaceutical company pioneering a precision medicine approach to discover, develop and commercialize targeted therapies for the treatment of serious and neglected rare cardiovascular diseases. Our initial focus is on the treatment of heritable cardiomyopathies, a group of rare, genetically driven forms of heart failure that result from biomechanical defects in cardiac muscle contraction. We have generated a robust pipeline of therapeutic programs for the chronic treatment of the two most common forms of heritable cardiomyopathy—hypertrophic cardiomyopathy, or HCM, and dilated cardiomyopathy, or DCM.

We are currently enrolling patients into a pivotal Phase 3 clinical trial of mavacamten , our product candidate for the treatment of symptomatic, obstructive HCM (“oHCM”). Patients from the Phase 2 clinical study of mavacamten in oHCM are currently being enrolled in an open-label extension study intended to provide data on long-term exposure to mavacamten.  Mavacamten is also being evaluated in a randomized Phase 2 clinical trial for the treatment of symptomatic non-obstructive HCM (“nHCM”). Our second clinical-stage candidate, MYK-491, is currently being studied in a Phase 1b single-ascending dose clinical trial in patients with stable heart failure, based on results from a completed Phase 1 clinical trial in healthy volunteers. The protocol for the ongoing Phase 1b clinical study was recently modified to incorporate a Phase 2a multiple-ascending dose trial in patients with stable heart failure. Additionally, we are advancing multiple preclinical programs, focused on regulating or normalizing cardiac muscle contractility and relaxation .

Financial Overview

We have not generated net income from operations, and, as of September 30, 2018, had an accumulated deficit of $186.9 million, primarily as a result of research and development and general and administrative expenses. To date, all our revenue has been derived from non-refundable payments under the license and collaboration agreement we entered into with Aventis Inc., a wholly-owned subsidiary of Sanofi S.A. (“Sanofi”), in August 2014, which we refer to as the Collaboration Agreement, and we have not yet generated any revenue from product sales. We have never been profitable and have incurred net losses in each year since commencement of our operations. We expect to incur significant and increasing losses from operations for the foreseeable future, and we can provide no assurance that we will ever generate significant revenue or profits.

Through September 30, 2018, we have financed our operations through an initial public offering (“IPO”), three follow-on public offerings, private placements of redeemable convertible preferred stock and funds received in connection with the Collaboration Agreement with Sanofi.  We received net proceeds of $93.9 million from the sale of shares of our Series A, A-1 and B redeemable convertible preferred stock. On November 3, 2015, we completed our IPO of 6,253,125 shares of common stock at an offering price of $10.00 per share, resulting in net proceeds of approximately $55.6 million, after deducting underwriting discounts, commissions and offering costs. On October 3, 2016, we completed a follow-on public offering of 4,370,000 shares of common stock at an offering price of $15.00 per share, resulting in net proceeds of approximately $61.1 million, after deducting underwriting discounts, commissions and offering costs. On August 14, 2017, we completed our second follow-on public offering of 4,025,000 shares of common stock at an offering price of $35.50 per share, resulting in net proceeds of approximately $133.9 million, after deducting

21


 

underwriting discounts, commissions and offering costs. On May 25, 2018, we complete d our third follow-on public offering of 3,750,000 shares of common stock at an offering price of $49.00 per share, resulting in net proceeds of approximately $172.2 million, after deducting underwriting discounts, commissions and offering costs. On June 2 2, 2018, the underwriters partially exercised their over-allotment option, purchasing 211,147 shares of our common stock at an offering price of $49.00 per share, resulting in net proceeds of approximately $9.7 million, after deducting underwriting discoun ts, commissions and offering costs. Net proceeds of $181.9 million from these two closings are net of $0.6 million in offering costs. Included in the May 25, 2018 sale of common stock was a sale of 150,000 shares to Sanofi.

In connection with the Collaboration Agreement, we have received $135.4 million from Sanofi, consisting of a $35.0 million upfront payment, a $25.0 million milestone payment for the submission of an Investigational New Drug (“IND”) application for MYK-491 with the U.S. government’s Food and Drug Administration (“FDA”) in November 2016, a $45.0 million continuation payment from Sanofi in January 2017 and $30.4 million in reimbursements and prepayments for research and development costs under the development portion of our Collaboration Agreement. As of September 30, 2018, we had cash and cash equivalents of $335.3 million, short-term investments of $43.8 million and long-term investments of $32.5 million.

We have no manufacturing facilities and all of our manufacturing activities are contracted out to a third party. We currently utilize third-party clinical research organizations (“ CROs”) to carry out our clinical development and trials. We do not yet have a sales organization.

We expect to incur substantial expenditures in the foreseeable future for the advancement of our precision medicine platform, the development and potential commercialization of mavacamten and MYK-491, and the discovery, development and potential commercialization of any additional product candidates we may pursue. Specifically, we expect to continue to incur substantial expenses in connection with our ongoing clinical trials of mavacamten, including a Phase 3 pivotal trial in symptomatic oHCM, a Phase 2 clinical trial in symptomatic nHCM, and any additional clinical trials that we may conduct for mavacamten , as well as our ongoing clinical development activities for MYK-491.  We will need substantial additional funding to support operating activities as we advance mavacamten , MYK-491, and other potential product candidates through clinical development, seek regulatory approval and proceed to commercialization. Adequate funding may not be available to us on acceptable terms, or at all.

The research and development expenses incurred in the development and potential commercialization of mavacamten , MYK-491 and other product candidates are net of $7.7 million and $14.8 million in Sanofi research and development credits during the three and nine months ended September 30, 2018, respectively, as follows (in thousands):

 

 

 

Three Months Ended

September 30,

 

 

Nine Months Ended

September 30,

 

 

 

2018

 

 

2017

 

 

2018

 

 

2017

 

Mavacamten

 

$

7,371

 

 

$

7,920

 

 

$

22,189

 

 

$

20,344

 

MYK-491

 

 

3,045

 

 

 

2,778

 

 

 

8,724

 

 

 

8,174

 

Other

 

 

5,494

 

 

 

3,663

 

 

 

18,833

 

 

 

11,449

 

Total research and development expenses

 

$

15,910

 

 

$

14,361

 

 

$

49,746

 

 

$

39,967

 

 

Sanofi License and Collaboration Agreement

In August 2014, we entered into a Collaboration Agreement with Sanofi that covers three main research programs: our first program in HCM (referred to as HCM-1), a second program in HCM (referred to as HCM-2) and our first program in DCM (referred to as DCM-1).

Under the Collaboration Agreement, we are responsible for conducting research and development activities through early human efficacy studies, except for specified research activities to be conducted by Sanofi. Thereafter, we will lead worldwide development and U.S. commercial activities for the HCM-1 and HCM-2 programs, Sanofi will lead global development and commercial activities for DCM-1 and Sanofi will lead commercial activities for the HCM-1 and HCM-2 programs where it has commercialization rights outside of the U.S.  Sanofi also has the option to co-promote the HCM-1 and HCM-2 programs in the United States only in the event of a potential expanded cardiovascular disease indication outside of the genetically targeted indications. We have co-commercialization rights to DCM-1 in the United States, at our option.

We are entitled to receive tiered royalties ranging from the mid-single digits to the mid-teens on net sales of certain HCM-1, HCM-2 and DCM-1 finished products outside the United States and on net sales of certain DCM-1 finished products in the United States. Sanofi is eligible to receive tiered royalties ranging from the mid-single digits to the low-teens on net sales of certain HCM-1 and HCM-2 finished products in the United States.

22


 

Under the Collaboration Agreement, Sanofi agreed to provide upfront and milestone payments, equity investments and research and development support. As of September 30, 2018, we have received from Sanofi an initial non-refundable upfront cash payment of $35.0 million and equity investments of $10.0 million in exchange for Series A-1 redeemable convertible preferred stock, a $2 5.0 million milestone-based payment and a $45.0 million continuation payment. In addition, we have received equity funding outside of the original agreement of $5.0 million in exchange for Series B redeemable convertible preferred stock, $9.0 million in ex change for shares of our common stock in our IPO and $7.4 million in the May 2018 follow-on offering sale of common stock. We are also eligible to receive up to $45.0 million of approved in-kind research and clinical activities, for which eligibility expir es on December 31, 2018 .

Critical Accounting Policies and Significant Judgments and Estimates

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

Our significant accounting policies are fully described in Note 2 of our Annual Report.  We believe that the accounting policies discussed in our Annual Report are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates. There have been no changes to our significant accounting policies during the nine months ended September 30, 2018, except with respect to changes in our revenue recognition policy upon the adoption of ASU No. 2014-09 Revenue from Contracts with Customers (Topic 606) .

Components of Operating Results

Collaboration and License Revenue

We generate revenue from the Collaboration Agreement with Sanofi for the development and commercialization of products under the collaboration.

Operating Expense

Research and Development Expenses

Research and development expenses consist of salaries and benefits, including stock-based compensation, lab supplies and facility costs, and fees paid to CROs to conduct certain research and development activities on our behalf. Amounts incurred in connection with collaboration and license agreements are also included in research and development expense. Payments made prior to the receipt of goods or services are capitalized until the goods or services are received. Amounts shown are net of research and development reimbursement credits from Sanofi under the Collaboration Agreement.

General and Administrative Expenses

General and administrative expenses consist principally of salaries and benefits, including stock-based compensation, professional fees for legal, consulting, audit and tax services, market research, rent and other general operating expenses not otherwise classified as research and development expenses.

Interest and Other Income, Net

Interest and other income, net consists primarily of interest income earned on our cash and cash equivalents, short-term investments and long-term investments.

23


 

Results of Operations

Comparison of the Three-Month Periods Ended September 30, 2018 and 2017

The following table compares the operating results (in thousands):

 

 

 

Three Months Ended

September 30,

 

 

 

 

 

 

 

 

 

 

 

2018

 

 

2017

 

 

Increase/(Decrease)

 

 

 

 

 

 

 

As Revised (Note 2)

 

 

 

 

 

 

 

 

 

Collaboration and license revenue

 

$

9,188

 

 

$

3,077

 

 

$

6,111

 

 

 

199

%

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

15,910

 

 

 

14,361

 

 

 

1,549

 

 

 

11

%

General and administrative

 

 

10,957

 

 

 

5,884

 

 

 

5,073

 

 

 

86

%

Total operating expenses

 

 

26,867

 

 

 

20,245

 

 

 

6,622

 

 

 

33

%

Loss from operations

 

 

(17,679

)

 

 

(17,168

)

 

 

(511

)

 

 

3

%

Interest and other income, net

 

 

1,890

 

 

 

447

 

 

 

1,443

 

 

 

323

%

Net loss

 

$

(15,789

)

 

$

(16,721

)

 

$

932

 

 

 

(6)

%

Collaboration and License Revenue

Collaboration and license revenue increased $6.1 million, from $3.1 million to $9.2 million for the three months ended September 30, 2017 and 2018, respectively. The amounts for the periods ended September 30, 2017 and 2018 relate to revenue we recognized from the continuation payment of $45.0 million under the Collaboration Agreement. Revenues have been retroactively restated to reflect implementation of the ASU 606 revenue standard and as revised reflect a higher level of research and development efforts incurred and expected to be incurred in 2018 as compared to the same period in 2017.

 

Research and Development Expenses

Research and development expenses increased $1.5 million, or 11%, from $14.4 million for the three months ended September 30, 2017 to $15.9 million for the three months ended September 30, 2018. The increase in research and development expenses was primarily due to a $4.1 million increase in clinical expenses related to our mavacamten and MYK-491 clinical trials, a $2.1 million increase in personnel expenses as a result of an increase in employee headcount, a $1.3 million increase in stock compensation expense, a $0.6 million increase in consulting expense, a $0.5 million increase in contract research, chemistry and biology expenses on discovery and pre-clinical programs including HCM-2 and a back-up program for DCM-1 and a $0.5 million increase in facilities expenses.  Increases in research and development expenses were offset by zero and $7.7 million in research and development credits from Sanofi during the three months ended September 31, 2017 and 2018, respectively.

We expect research and development expenses to increase in future periods as we continue the development of our lead product candidate, mavacamten, in clinical trials as well as preclinical and subsequent clinical activities for our MYK-491, MYK-224, HCM-2, LUS-1, ACT-1, and other back-up programs. As product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials, we expect that our research and development expenses will increase substantially in the future.

General and Administrative Expenses

General and administrative expenses increased $5.1 million, or 86%, from $5.9 million for the three months ended September 30, 2017 to $11.0 million for the three months ended September 30, 2018. The increase in general and administrative expenses was primarily due to a $2.2 million increase in stock compensation expense, a $1.5 million increase in personnel expenses as a result of an increase in employee headcount, a $0.5 million increase in professional and consulting fees, a $0.4 million increase in office and facilities related expenses, and a $0.5 million increase in other miscellaneous expenses.  We expect general and administrative expenses to continue to increase in future periods in order to provide administrative support for our clinical development efforts, potential future commercialization of mavacamten and the ongoing and planned clinical development of MYK-491.

Interest and Other Income, Net

Interest and other income increased $1.4 million, or 323%, from $0.4 million for the three months ended September 30, 2017 to $1.9 million for the period ending September 30, 2018. The increase in interest income was primarily due to higher balances of cash,  cash equivalents and investments.

24


 

 

Comparison of the Nine-Month Periods Ended September 30, 2018 and 2017

The following table compares the operating results (in thousands):

 

 

 

Nine Months Ended

September 30,

 

 

 

 

 

 

 

 

 

 

 

2018

 

 

2017

 

 

Increase/(Decrease)

 

 

 

 

 

 

 

As Revised (Note 2)

 

 

 

 

 

 

 

 

 

Collaboration and license revenue

 

$

21,158

 

 

$

8,488

 

 

$

12,670

 

 

 

149

%

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

49,746

 

 

 

39,967

 

 

 

9,779

 

 

 

24

%

General and administrative

 

 

27,182

 

 

 

16,442

 

 

 

10,740

 

 

 

65

%

Total operating expenses

 

 

76,928

 

 

 

56,409

 

 

 

20,519

 

 

 

36

%

Loss from operations

 

 

(55,770

)

 

 

(47,921

)

 

 

(7,849

)

 

 

16

%

Interest and other income, net

 

 

3,748

 

 

 

977

 

 

 

2,771

 

 

 

284

%

Net loss

 

$

(52,022

)

 

$

(46,944

)

 

$

(5,078

)

 

 

11

%

Collaboration and License Revenue

Collaboration and license revenue increased $12.7 million, or 149%, from $8.5 million for the nine months ended September 30, 2017 to $21.2 million for the nine months ended September 30, 2018. The amounts for the periods ended September 30, 2017 and 2018 relate to revenue we recognized from the continuation payment of $45.0 million under the Collaboration Agreement. Revenues have been retroactively restated to reflect implementation of the ASU 606 revenue standard and as revised reflect a higher level of research and development efforts incurred and expected to be incurred in 2018 as compared to the same period in 2017.

Research and Development Expenses

Research and development expenses increased $9.7 million, or 24%, from $40.0 million for the nine months ended September 30, 2017 to $49.7 million for the nine months ended September 30, 2018. The increase in research and development expenses was primarily due to a $11.0 million increase in clinical expenses related to our mavacamten and MYK-491 clinical trials, a $4.7 million increase in personnel expenses as a result of an increase in employee headcount, a $3.8 million increase in stock compensation expense, a $2.4 million increase in consulting expense, a $1.5 million increase in contract research, chemistry and biology expenses on discovery and pre-clinical programs including HCM-2 and a back-up program for DCM-1, and a $1.2 million increase in facilities expenses.  Increases in research and development expenses were offset by zero and $14.8 million in research and development credits for the RPP and pre-proof-of-concept credits from Sanofi during the nine months ended September 31, 2017 and 2018, respectively.

We expect research and development expenses to increase in future periods as we continue the development of our lead product candidate, mavacamten, in clinical trials as well as preclinical and subsequent clinical activities for our MYK-491, MYK-224, HCM-2, LUS-1, ACT-1, and other back-up programs. As product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials, we expect that our research and development expenses will increase substantially in the future.

General and Administrative Expenses

General and administrative expenses increased $10.8 million, or 65%, from $16.4 million for the nine months ended September 30, 2017 to $27.2 million for the nine months ended September 30, 2018. The increase in general and administrative expenses was primarily due to a $5.5 million increase in stock compensation expense, a $2.8 million increase in personnel expenses as a result of an increase in employee headcount, a $1.1 million increase in facilities and office expenses, a $0.8 million increase in professional and consulting fees and a $0.6 million increase in other miscellaneous expenses.  We expect general and administrative expenses to continue to increase in future periods in order to provide administrative support for our clinical development efforts, potential future commercialization of mavacamten and the ongoing and planned clinical development of MYK-491.

Interest and Other Income, Net

Interest and other income increased $2.7 million, or 284%, from $1.0 million to $3.7 million for the nine months ended  September 30, 2017 and 2018, respectively.  The increase in interest income was primarily due due to higher balances of cash, cash equivalents and investments.

25


 

 

Liquidity and Capital Resources

Since our inception, we have financed our operations primarily through private placements of our equity securities, payments received in connection with the Collaboration Agreement, and our public offerings of common stock. A s of September 30, 2018, we had cash and cash equivalents of $335.3 million, short-term investments of $43.8 million and long-term investments of $32.5 million, w hich we believe will be sufficient to fund our planned operations through at least the next twelve months from the date of this filing.   To date, we have not generated any revenue from product sales. We do not know when, or if, we will generate any revenue from product sales and do not expect to generate significant revenue from product sales unless and until we obtain regulatory approval of and commercialize mavacamten , MYK-491 or other product candidates.

We expect that our existing cash and cash equivalents will provide sufficient funds to sustain operations through at least the next 12 months from the date of this filing based on our existing business plan. However, we expect to incur substantial expenditures in the foreseeable future for the advancement of our precision medicine platform, the development and potential commercialization of mavacamten and MYK-491, and the discovery, development and potential commercialization of any additional product candidates we may pursue. Specifically, we have incurred substantial expenses in connection with our clinical trials of mavacamten and expect to continue to incur substantial expenses in connection with our ongoing Phase 2 and Phase 3 clinical trial of mavacamten in HCM and any additional clinical trials that we may conduct, as well as our ongoing and planned clinical development activities for MYK-491. Furthermore, if our clinical trials for mavacamten are successful, or our other product candidates, including MYK-491, enter into late-stage clinical trials or more advanced discovery and development stages, we may need to raise additional capital in order to further advance our product candidates towards regulatory approval.

We will continue to require additional financing to develop our product candidates and fund operations for the foreseeable future through equity or debt financings, collaborative or other arrangements with corporate sources, or through other sources of financing. Adequate additional funding may not be available to us on acceptable terms or at all. Our failure to raise capital as and when needed could have a negative impact on our financial condition and our ability to pursue our business strategies. We anticipate that we will need to raise substantial additional capital, the requirements of which will depend on many factors, including:

 

the rate of progress and the costs of, and our ability to generate positive data from our ongoing and planned clinical trials of mavacamten and MYK-491;

 

our ability to receive additional payments from Sanofi pursuant to the Collaboration Agreement and the timing thereof;

 

the number of product candidates that we develop or intend to develop using our precision medicine platform;

 

the costs of research and preclinical studies to support the advancement of other product candidates into clinical development;

 

the timing of, and costs involved in, executing our clinical development plans, seeking and obtaining approvals from the FDA and comparable foreign regulatory authorities, including the potential by the FDA or comparable regulatory authorities to require that we perform more studies than those that we currently expect;

 

the costs of preparing to manufacture mavacamten on a larger scale, to manufacture MYK-491 for continued clinical development and to manufacture any additional product candidates we may identify for clinical development;

 

the costs of commercialization activities if mavacamten or any future product candidate is approved, including the formation of a sales force;

 

the degree and rate of market acceptance of any products launched by us or our partners;

 

the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;

 

our need and ability to hire additional personnel;

 

our ability to enter into additional collaboration, licensing, commercialization or other arrangements and the terms and timing of such arrangements; and

 

the emergence of competing technologies or other adverse market developments.

We may seek funds through borrowings or additional rounds of financing, including private or public equity or debt offerings and collaborative arrangements with corporate partners. If we raise additional funds by issuing equity securities, our stockholders may experience dilution. Any future debt financing into which we enter may impose upon us additional covenants that restrict our operations, including limitations on our ability to incur liens or additional debt, pay dividends, repurchase our common stock, make certain investments and engage in certain merger, consolidation or asset sale transactions. Any debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. If we are unable to raise additional funds when needed, we may be required to delay, reduce, or terminate some or all of our development programs and clinical trials.

26


 

Cash Flows

The following table sets forth the primary sources and uses of cash for each of the periods presented below (in thousands):

 

 

 

Nine Months Ended September 30,

 

 

 

2018

 

 

2017

 

 

 

 

 

 

 

As Revised (Note 2)

 

 

 

(in thousands)

 

Cash Flows from Continuing Operations:

 

 

 

 

 

 

 

 

Net cash (used in) operating activities

 

$

(47,028

)

 

$

(3,207

)

Net cash (used in) investing activities

 

 

(27,438

)

 

 

(40,961

)

Net cash provided by financing activities

 

 

187,031

 

 

 

135,555

 

Net increase in cash, cash equivalents and restricted cash

 

$

112,565

 

 

$

91,387

 

Cash Used in Operating Activities

Net cash used in operating activities for the nine months ended September 30, 2018 was $47.0 million, and was primarily due to the net loss for the period of $52.0 million, offset by non-cash stock-based compensation expense of $13.6 million and depreciation of $1.1 million, and was also affected by changes in operating assets and liabilities, primarily due to a decrease in deferred revenue of $21.2 million, an increase in prepayments from collaboration partner of $6.5 million and increase in accrued liabilities of $7.1 million.

Net cash used in operating activities for the nine months ended September 30, 2017 was $3.2 million, and was primarily due to the $45.0 million continuation payment received from Sanofi, partially offset by the net loss for the period of $46.9 million and stock-based compensation expense of $4.3 million and changes in operating assets and liabilities, including a decrease in deferred revenue of $16.9 million and an increase in accrued liabilities of $2.0 million.

Cash Used in Investing Activities

Cash used in investing activities for the nine months ended September 30, 2018 consisted primarily of purchases of investments of $48.4 million, offset by sales and maturities of investments of $8.0 million and $16.0 million, respectively. During the nine months ended September 30, 2018, we also had investments in equipment of $3.0 million.

Cash used in investing activities for the nine months ended September 30, 2017 consisted primarily of purchases of investments of $44.0 million and investments in equipment of $0.9 million, offset by sale of investments of $4.0 million.

Cash Provided by Financing Activities

Cash provided by financing activities for the nine months ended September 30, 2018 consisted of proceeds from the issuance of common stock in connection with a follow-on offering of $182.5 million, funds received as a result of common stock option exercise of $5.1 million, net of $0.6 million in payments for financing-related costs.

Cash provided by financing activities for the nine months ended September 30, 2017 consisted of net proceeds from the issuance of common stock in connection with a follow-on offering of $133.9 million and funds received as a result of common stock option exercise of $1.7 million.

Contractual Obligations and Other Commitments

There have been no material changes, other than that discussed below, outside the ordinary course of our business to our contractual obligations during the nine months ended September 30, 2018, as compared to those disclosed in our Annual Report.

In September 2018, we entered into a noncancelable operating lease (the “Lease”) for approximately 129,846 square feet of space in Brisbane, California (the “New Facility”). The date on which we will become responsible for paying rent under the Lease (the “Rent Commencement Date”) will be the date the premises are ready for occupancy, currently anticipated to be January 2020.  The Lease expires 10 years after the Rent Commencement Date. The Lease grants us an option to extend the Lease for an additional 10-year period. Future minimum rental payments under the Lease during the 10-year term are $93.2 million in the aggregate. The Lease further provides that we are obligated to pay to the landlord certain costs, including taxes and operating expenses. As of September 30, 2018, the Lease term has not commenced as we did not have the right to use or control physical access to the New Facility.  The Lease expires 10 years after the Rent Commencement Date.

27


 

The following table summarizes our contractual obligat ions under the new and existing operating leases as of September 30, 2018 (in thousands):

 

 

 

Payments due by period (1)

 

 

 

Less than

1 year (three

months)

 

 

1 to 3

years

 

 

4 to 5

years

 

 

After 5

years

 

 

Total

 

Lease obligations, net

 

$

531

 

 

$

15,986

 

 

$

17,820

 

 

$

61,444

 

 

$

95,782

 

 

(1)  

The table above is prepared under the assumption that the Rent Commencement Date at the New Facility starts on January 1, 2020.

Off-Balance Sheet Arrangements

Since our inception, we have not engaged in any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

Jumpstart Our Business Startups Act of 2012

The JOBS Act permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies. We are choosing to “opt out” of this provision and, as a result, we will comply with new or revised accounting standards as required when they are adopted. This decision to opt out of the extended transition period under the JOBS Act is irrevocable. See Note 2, Summary of Significant Accounting Policies, to our consolidated financial statements appearing in our Annual Report regarding recent accounting pronouncements and Note 2 of the Notes to Condensed Consolidated Financial Statements in this document for revisions to those policies.

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

The market risk inherent in our financial instruments represents the potential loss arising from adverse changes in interest rates or exchange rates. As of September 30, 2018, we had cash and cash equivalents of $335.3 million, consisting of interest-bearing money market accounts, short-term investments of $43.8 million, consisting of corporate securities, and long-term investments of $32.5 million, consisting of United States government agency obligations, which would be affected by changes in the general level of United States interest rates. However, due to the low- risk profile of our investments, an immediate 100 basis point change in interest rates would not have a material effect on the fair value of our cash and cash equivalents.

In addition, we are also exposed to foreign currency exchange rate risk inherent in our contracts with research institutions and contract research organizations as certain services are performed by them outside the United States. From time to time w e have payments due to an Australian vendor in foreign currency. A significant movement in the Australian dollar may have a material impact on our financial position in the future.

We do not believe that inflation, interest rate changes or exchange rate fluctuations had a significant impact on our results of operations for any periods presented.

28


 

Item 4.

Controls and Procedures

Evaluation of Disclosure Controls and Procedures

The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, 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 our management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Our disclosure controls and procedures are designed to provide reasonable assurance of achieving their control objectives.

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2018, the end of the period covered by this Quarterly Report on Form 10-Q. Based upon such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of such date.

Changes in Internal Control over Financial Reporting

There was no change in our internal control over financial reporting that occurred during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

 

29


 

PART II – OTHE R INFORMATION

Item 1.

Legal Proceedings

We are not currently a party to any material litigation or other material legal proceedings.

Item 1A.

RISK FACTORS

You should consider carefully the following risk factors, together with all the other information in this report, including our consolidated financial statements and notes thereto, and in our other public filings with the SEC.   The occurrence of any of the following risks could harm our business, financial condition, results of operations and/or growth prospects or cause our actual results to differ materially from those contained in forward-looking statements we have made in this report and those we may make from time to time. You should consider all of the risk factors described when evaluating our business.

Risks Related to Our Limited Operating History, Financial Condition and Capital Requirements

Our limited operating history may make it difficult for you to evaluate the success of our business to date and to assess our future viability.

We are an early-stage company. We were incorporated and commenced operations in June 2012. Our operations to date have been limited to organizing and staffing our company, business planning, raising capital, developing our technology, creating and expanding on our precision medicine platform, identifying potential product candidates, undertaking preclinical studies for our programs, completing our ongoing clinical trials for our most advanced product candidate, mavacamten, planning further clinical development of mavacamten and completing our ongoing clinical development of our second product candidate, MYK-491. We have not yet demonstrated our ability to successfully complete the clinical development of a product candidate, including the completion of any clinical trials designed to support the registration of a product candidate, obtain marketing approvals, manufacture a commercial scale medicine, or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful commercialization. Typically, it takes many years to develop a new medicine from the time it is discovered to when it is available for treating patients. Consequently, any predictions you make about our future success or viability may not be as accurate as they could be if we had a longer operating history.

In addition, as a new business, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors. We will need to transition from a company with a research and development focus to a company capable of supporting larger scale clinical development and commercial activities. If we are not successful in such a transition, our business, results and financial condition will be harmed.

We have a history of significant losses and may not achieve or sustain profitability and, as a result, you may lose all or part of your investment.

Our initial product candidates, mavacamten and MYK-491, are in various stages of clinical testing and we must successfully complete our ongoing clinical trials and conduct significant additional clinical trials before we can seek the regulatory approvals necessary to begin commercial sales of these or any other product candidates we may develop. We have incurred operating losses in each year since our inception due to costs incurred in connection with our research and development activities and general and administrative costs associated with our operations. Our net loss for the nine months ended September 30, 2018 and 2017 was   $52.0 and $46.9 million, respectively. As of September 30, 2018, we had an accumulated deficit of $186.9 million. We expect to incur increasing losses for several years as we continue our research activities and conduct development of, and seek regulatory approvals for, our initial product candidates, and commercialize any approved drugs. If our product candidates fail in clinical trials or do not gain regulatory approval, or if our product candidates do not achieve market acceptance, we will not be profitable. If we fail to become and remain profitable, or if we are unable to fund our continuing losses, you could lose all or part of your investment.

We have never generated any revenue from product sales and may never be profitable.

Our ability to generate revenue and achieve profitability depends on our ability, alone or with strategic collaborators, to successfully complete the development of, and obtain the regulatory approvals necessary to commercialize, our product candidates. We do not anticipate generating revenues from product sales for the foreseeable future, if ever. Our ability to generate future revenue from product sales depends heavily on our success in:

 

completing research and preclinical and clinical development of our product candidates;

 

seeking and obtaining regulatory approvals to market product candidates for which we complete clinical trials;

30


 

 

developing a sustainable, scalable, reproducible and trans ferable manufacturing process for our product candidates;

 

establishing and maintaining supply and manufacturing relationships with third parties that can provide adequate (in amount and quality) products and services to support clinical development and the market demand, if any, for our product candidates, if approved;

 

launching and commercializing product candidates for which we obtain regulatory approval, either through a collaboration or, if launched independently, by establishing a sales force, marketing and distribution infrastructure;

 

obtaining market acceptance of our product candidates and the use of precision medicine as a viable treatment option for cardiovascular diseases;

 

addressing any competing technological and market developments;

 

implementing additional internal systems and infrastructure, as needed;

 

identifying and validating new product candidates from our platform;

 

maintaining our existing collaboration agreement with Sanofi and negotiating favorable terms in any new collaboration, licensing or other arrangements into which we may enter;

 

maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how; and

 

attracting, hiring and retaining qualified personnel who are suitable to our culture and mission.

Even if one or more of the product candidates that we are developing is approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved product candidate. Our expenses could increase beyond our expectations if we are required by the U.S. Food and Drug Administration ( the “ FDA”) , the European Medicines Agency ( the “ EMA”) or other regulatory agencies, domestic or foreign, to perform clinical trials and other studies in addition to those that we currently anticipate. Even if we are able to generate revenues from the sale of any approved products, we may not become profitable and may need to obtain additional funding to continue operations.

We will need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations.

We are currently advancing mavacamten and MYK-491, our initial product candidates, through clinical development, and conducting preclinical discovery and development activities in our other programs. Drug development is expensive, and we expect our research and development expenses to increase substantially in connection with our ongoing activities, particularly as we advance our product candidates in clinical trials.

As of September 30, 2018, our cash and cash equivalents, including investments, were $411.6 million. We intend to use our cash and cash equivalents to fund the advancement of our mavacamten clinical development program, including our ongoing Phase 3 clinical trial in symptomatic oHCM patients and our planned additional clinical trials of mavacamten, the progression of MYK-491 through clinical proof-of-concept, our ongoing preclinical, discovery and research programs and the expansion of our platform, as well as for working capital and general corporate purposes. However, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private equity or debt financings, government or other third-party funding, marketing and distribution arrangements and other collaborations, strategic and licensing arrangements or a combination of these approaches. In any event, we will require additional capital to obtain regulatory approval for, and to commercialize, mavacamten , or any other product candidates we may identify and develop. Even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital if market conditions are favorable or if we have specific strategic considerations.

Our funding requirements and the timing of our need for additional capital are subject to change based on a number of factors, including:

 

the rate of progress and the cost of our ongoing and planned clinical trials of mavacamten and MYK-491;

 

our ability to successfully maintain our collaboration with Sanofi, and the amount and timing of any subsequent payments we may receive pursuant to the collaboration;

 

the number of product candidates that we intend to develop using our precision medicine platform;

31


 

 

the costs of research and preclinical studies to support the advancement of other product candidates into clinical development;

 

the timing of, and costs involved in, seeking and obtaining approvals from the FDA and comparable foreign regulatory authorities, including the potential by the FDA or comparable regulatory authorities to require that we perform more studies than those that we currently expect;

 

the costs of preparing to manufacture mavacamten on a larger scale, and to manufacture MYK-491 for further clinical development;

 

the costs of commercialization activities if mavacamten or any future product candidate is approved, including the formation of a sales force;

 

the degree and rate of market acceptance of any products launched by us or our partners;

 

the costs of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;

 

our need and ability to hire additional personnel;

 

our ability to enter into additional collaboration, licensing, commercialization or other arrangements and the terms and timing of such arrangements; and

 

the emergence of competing technologies or other adverse market developments.

Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates. In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all. Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares to decline. The sale of additional equity or convertible securities would dilute all of our stockholders. The incurrence of indebtedness would result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. We could also be required to seek funds through arrangements with collaborative partners or otherwise at a different stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.

If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs or the commercialization of any product candidates or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially and adversely affect our business, financial condition and results of operations.

Our reported financial results may be adversely affected by changes in accounting principles generally accepted in the U.S.

We prepare our financial statements in conformity with accounting principles generally accepted in the U.S. These accounting principles are subject to interpretation by the Financial Accounting Standards Board (“FASB”) and the Securities and Exchange Commission. A change in these policies or interpretations could have a significant effect on our reported financial results, may retroactively affect previously reported results, could cause unexpected financial reporting fluctuations, and may require us to make costly changes to our operational processes and accounting systems. In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers which supersedes nearly all existing U.S. GAAP revenue recognition guidance. The new standard and its amendments were effective January 1, 2018, and was implemented utilizing the full retrospective method. As a result, all consolidated results of operations and consolidated balance sheets were restated in the Company’s Form 10-Q for the three months ended March 31, 2018 and will continue to be for all periods presented. See “Note 2 – Summary of Significant Accounting Policies ” for additional discussion of the accounting changes.

32


 

Risks Related to Our Precision Medicine Platform and the Discovery and Development of Our Product Candidates

The precision medicine approach we are taking to discover and develop drugs for heritable cardiovascular diseases is novel and may never lead to marketable products.

We have concentrated our therapeutic product research and development efforts on the application of precision medicine to the treatment of heritable cardiovascular diseases, and our future success depends on the successful development of products based on our precision medicine platform and the continued development of this platform. We believe we are the first company to apply precision medicine to the treatment of cardiovascular disease, and neither we nor any other company has received regulatory approval to market therapeutics specifically targeting any form of heritable cardiomyopathy. The scientific discoveries that form the basis for our efforts to discover and develop product candidates are novel, and the scientific evidence to support the feasibility of developing product candidates based on these discoveries is both preliminary and limited. If we do not successfully develop and commercialize product candidates based upon our technological approach, we will not become profitable and the value of our common stock may decline.

Further, our focus solely on precision medicine for the development of drugs for heritable cardiomyopathies as opposed to multiple, more proven technologies for drug development increases the risks associated with the ownership of our common stock. If we are not successful in developing any product candidates using our precision medicine platform, we may be required to change the scope and direction of our product development activities. In that case, we may not be able to identify and implement successfully an alternative product development strategy, which would materially and adversely affect our business, financial condition and results of operations.

We depend heavily on the success of mavacamten and MYK-491, our initial product candidates. Other than mavacamten and MYK-491, all of our other programs are in discovery or preclinical development. Preclinical testing and clinical trials of our product candidates may not be successful. If we are unable to commercialize our product candidates or experience significant delays in doing so, our business will be materially harmed.

We have invested a significant portion of our efforts and financial resources in the identification of our initial product candidates, mavacamten for the treatment of hypertrophic card iomyopathy (“ HCM”) and MYK-491 for the treatment of dilated cardiomyopathy (“DCM”). We are currently evaluating mavacamten and MYK-491 in clinical trials, and, if these product candidates fail to demonstrate safety or efficacy in their respective target indications to the satisfaction of the FDA or other comparable regulatory authorities, we will need to identify and rely on other product candidates or target indications, or both, for clinical development. All of our other programs are still in discovery or preclinical development. Our ability to generate revenue from product sales, which we do not expect will occur for many years, if ever, will depend heavily on the successful development and eventual commercialization of mavacamten , MYK-491 or other product candidates that we may identify from our precision medicine platform.

The success of mavacamten , MYK-491 and any other product candidates that we discover and develop will depend on many factors, including the following:

 

timely and successful initiation of, enrollment in, and completion of, clinical trials, including our Phase 2 and Phase 3 clinical trials of mavacamten in HCM, our Phase 1b and Phase 2 clinical trials of MYK-491 in DCM and any additional clinical trials of these product candidates ;

 

achieving positive safety and efficacy data and desirable medicinal properties for our product candidates for the intended indications;

 

our ability to receive, and the timing of receipt of, any marketing approvals from applicable regulatory authorities;

 

establishing and maintaining manufacturing capabilities or making arrangements with third-party manufacturers for the manufacture of our product candidates for clinical trials and, if approved, for commercialization;

 

obtaining and maintaining patent and trade secret protection and non-patent exclusivity for our product candidates;

 

launching commercial sales of our products, if and when approved, whether alone or in collaboration with others;

 

acceptance of our products, if and when approved, by patients, the medical community and third-party payors;

 

effectively competing with other therapies;

 

a continued acceptable safety profile of our products following approval; and

 

enforcing and defending intellectual property rights and claims.  

If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays or an inability to successfully commercialize our product candidates, which would materially harm our business.

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Preclinical and clinical drug development involves a lengthy and expensive process with an uncertain outcome, and observations and results from earlier studies and trials may not be applicable or predictive in future clinical trials.

Preclinical and clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the preclinical development or clinical trial process. The results of preclinical studies and early clinical trials of our product candidates may not be predictive of the results of later-stage clinical trials. For example, although our preclinical observations and data generated from our Phase 1 and Phase 2 clinical trials of mavacamten support our hypothesis that mavacamten has the potential to reduce cardiac muscle contractility and our belief that such data have demonstrated clinical proof of mechanism in both HCM patients and healthy volunteers, we have not completed placebo controlled clinical trials of mavacamten in larger populations using the current dosing strategy, inclusion/exclusion criteria, and endpoints of EXPLORER-HCM. In addition, our precision medicine platform is based on a translational medicine approach. Translational medicine, or the application of basic scientific findings to develop therapeutics that promote human health, is subject to a number of inherent risks. In particular, scientific hypotheses formed from preclinical or early clinical observations may prove to be incorrect, and the data generated in animal models or observed in limited patient populations may be of limited value, and may not be applicable in clinical trials conducted under the controlled conditions required by applicable regulatory requirements and our protocols. The initial clinical data from our Phase 1 and Phase 2 clinical trials of mavacamten, as well as our Phase 1 clinical trial of MYK-491, are preliminary in nature, and the clinical development of mavacamten and MYK-491 is not complete. Early positive data may not be repeated or observed in ongoing or future trials involving our product candidates. Product candidates in later stages of clinical trials may fail to show the desired safety and efficacy traits despite having progressed through preclinical studies and initial clinical trials. There is a high failure rate for drugs and biologics proceeding through clinical trials, particularly in the field of cardiovascular medicine. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in clinical development even after achieving promising results in earlier studies, and any such setbacks in our clinical development could have a material adverse effect on our business and operating results.

We may encounter substantial delays in our clinical trials or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.

Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical trials to demonstrate the safety and efficacy of the product candidates in humans. Clinical testing is expensive, time-consuming and uncertain as to outcome. We cannot guarantee that any clinical trials will be conducted as planned or completed on schedule, if at all. A failure of one or more clinical trials can occur at any stage of testing. We may experience delays in our ongoing clinical trials and we do not know whether planned clinical trials will begin on time, need to be redesigned, enroll patients on time or be completed on schedule, if at all. Additionally, although we believe that our precision medicine approach should eliminate the need for mavacamten to undergo the large outcomes-based studies that are often required for cardiovascular drugs as a condition to regulatory approval by the FDA or other regulatory authorities, regulatory authorities may nevertheless require us to conduct additional trials or generate additional data, including potential trials studying the interaction of our product candidates with other therapeutics commonly administered in the patient populations we are seeking to treat, which would increase the time and cost of our clinical development process.  Furthermore, we will need to conduct larger clinical trials, and the FDA may subsequently require us to evaluate a larger number of patients than we presently anticipate, or to assess other endpoints besides those presently contemplated, in order to support regulatory approval.

Clinical trials can be delayed for a variety of reasons, including:

 

delays in reaching a consensus with regulatory agencies on trial design;

 

delays in reaching agreement on acceptable terms with prospective CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites;

 

delays in obtaining required Institutional Review Board (“ IRB”) approval at each clinical trial site;

 

delays in recruiting suitable patients to participate in our clinical trials;

 

imposition of a clinical hold by regulatory agencies, including after an inspection of our clinical trial operations or trial sites;

 

failure by our CROs, other third parties or us to adhere to clinical trial requirements;

 

failure by us or our CROs or other third-party contractors to perform clinical trials in accordance with the FDA’s good clinical practice (“ GCP”) requirements or applicable regulatory guidelines in other countries;

 

delays in the testing, validation, manufacturing and delivery of our product candidates to the clinical sites;

 

delays in having patients complete participation in a study or return for post-treatment follow-up;

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clinical trial sites deviating from a trial protocol or dropping out of a trial;

 

clinical trial subjects failing to comply with the trial regimen or dropping out of a trial;

 

adding new clinical trial sites;

 

failure to manufacture or supply sufficient quantities of product candidates for use in clinical trials;

 

occurrence of serious adverse events associated with the product candidate that are viewed to outweigh its potential benefits; or

 

changes in regulatory requirements and guidance that require amending or submitting new clinical protocols.

We could encounter delays if a clinica l trial is suspended or terminated by us, by the IRBs of the institutions in which such trials are being conducted, or suspension or termination is recommended by the Data Safety Monitoring Board for such trial or by the FDA or other regulatory authorities. Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a drug, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial.

Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA or other regulatory authorities. The FDA or other regulatory authorities may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected interpretation of the study. The FDA or other regulatory authorities may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of our marketing applications by the FDA or other regulatory authorities, as the case may be, and may ultimately lead to the denial of marketing approval of one or more of our product candidates.

Any inability to successfully complete preclinical and clinical development could result in additional costs to us or impair our ability to generate revenues from product sales, regulatory and commercialization milestones and royalties. In addition, if we make manufacturing or formulation changes to our product candidates, we may need to conduct additional studies to bridge our modified product candidates to earlier versions. Clinical trial delays could also shorten any periods during which we may have the exclusive right to commercialize our product candidates or allow our competitors to bring products to market before we do, which could impair our ability to successfully commercialize our product candidates and may harm our business and results of operations. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates.

If the results of our clinical trials are inconclusive or if there are safety concerns or adverse events associated with our product candidates, we may:

 

be delayed in obtaining marketing approval for our product candidates, if at all;

 

obtain approval for indications or patient populations that are not as broad as intended or desired;

 

obtain approval with labeling that includes significant restrictions on use or distribution of the drug;

 

require safety warnings in the label and/or require risk management plan post-approval;

 

be required to perform additional clinical trials to support approval or be subject to additional post-marketing testing requirements;

 

have regulatory authorities withdraw their approval of the product or impose restrictions on its distribution in the form of a modified risk evaluation and mitigation strategy (“ REMS”);

 

be subject to the addition of labeling statements, such as warnings or contraindications;

 

be sued; or

 

experience damage to our reputation.

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We may find it difficult to enroll patients in our clinical trials, which could delay or prevent clinical trials of our product candidates.

Identifying and qualifying patients to participate in clinical trials of our product candidates is critical to our success. The timing to commence and complete our clinical trials depends on the speed at which we can recruit patients to participate in testing our product candidates. If patients are unwilling to participate in our clinical trials because of a lack of familiarity with our approach to the treatment of cardiovascular diseases, negative publicity from adverse events in biotechnology or the fields of precision medicine or cardiovascular disease or for other reasons, including competitive clinical trials for similar patient populations, our timelines for recruiting patients, conducting clinical trials and obtaining regulatory approval of potential products may be delayed. These delays could result in increased costs, delays in advancing our product development, delays in testing the effectiveness of our technology or termination of our clinical trials altogether.

We may not be able to identify, recruit and enroll a sufficient number of patients, or those with required or desired characteristics to achieve diversity in a study, to complete our clinical trials in a timely manner. Patient enrollment is affected by factors including:

 

severity of the disease under investigation;

 

design of the clinical trial protocol;

 

size and nature of the patient population;

 

eligibility criteria for the clinical trial in question;

 

perceived risks and benefits of the product candidate under study in relation to other available therapies, including any new drugs that may be approved for the indications we are investigating;

 

proximity and availability of clinical trial sites for prospective patients;

 

availability of competing therapies and clinical trials;

 

efforts to facilitate timely enrollment in clinical trials;

 

patient referral practices of physicians; and

 

ability to monitor patients adequately during and after treatment.

In particular, each of the conditions in which we plan to evaluate our current product candidates is a rare genetic disorder with limited patient pools from which to draw for clinical trials. To date, the HCM and DCM patient populations have not been extensively evaluated in clinical trials. As a result, enrollment in our ongoing and planned clinical trials is difficult to predict and may take longer or cost more than we anticipate.

We plan to seek initial marketing approval in the United States. We may not be able to initiate or continue clinical trials if we cannot enroll a sufficient number of eligible patients to participate in the clinical trials required by the FDA or other regulatory agencies. Our ability to successfully initiate, enroll and complete a clinical trial in any foreign country is subject to numerous risks unique to conducting business in foreign countries, including:

 

difficulty in establishing or managing relationships with CROs and physicians;

 

different standards for the conduct of clinical trials;

 

our inability to locate qualified local consultants, physicians and partners; and

 

the potential burden of complying with a variety of foreign laws, medical standards and regulatory requirements, including the regulation of pharmaceutical and biotechnology products and treatment.

If we have difficulty enrolling a sufficient number of patients to conduct our clinical trials as planned, we may need to delay, limit or terminate ongoing or planned clinical trials, any of which would have an adverse effect on our business.

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We may not be successful in our efforts to identify or discover potential product candidates.

The success of our business depends primarily upon our ability to identify, develop and commercialize therapeutics for the treatment of genetic cardiovascular diseases based on our precision medicine approach. A key element of our strategy is to use our precision medicine platform to identify and study compounds that can be used to correct or offset the abnormal contraction caused by HCM and DCM. Our research programs may initially show promise in identifying potential product candidates, yet fail to yield product candidates for clinical development for a number of reasons, including:

 

the research methodology used may not be successful in identifying appropriate biomarkers or potential product candidates;

 

our initial hypotheses based on our preclinical or early clinical observations may not be supported by later clinical results;

 

potential product candidates may, on further study, be shown to have harmful side effects or may have other characteristics that may make the products unmarketable or unlikely to receive marketing approval; or

 

research programs to identify new product candidates require substantial technical, financial and human resources. We may choose to focus our efforts and resources on a potential product candidate that ultimately proves to be unsuccessful.

If we are unable to identify suitable compounds for preclinical and clinical development, we may be forced to abandon our development efforts for a research program or programs and we will not be able to obtain product revenues in future periods, which likely would result in significant harm to our financial position and adversely impact our stock price.

We may not be able to successfully use the Sarcomeric Human Cardiomyopathy Registry, or SHaRe, to identify or recruit patients for our clinical trials or to develop targeted precision therapeutics for the treatment of heritable cardiomyopathies.

We rely, and expect to continue to rely, on genetic and clinical data gathered through SHaRe to provide us with insight into risk profiles and disease progression in heritable cardiomyopathies. Although the body of information in SHaRe is growing, we may face challenges collecting additional data through SHaRe in the future for a variety of reasons, including:

 

insufficient funding to support the research necessary to generate patient data for SHaRe;

 

our failure to maintain existing relationships and establish new relationships with clinical investigators and research institutions whose activities support SHaRe and provide us with access to patient data;

 

our failure to maintain or increase interest in SHaRe within our target patient communities; and

 

third parties may generate competing databases to which we do not have access.

Additionally, the predictive value of the information generated through SHaRe to date may be limited. Although we expect to use these data to define and identify patient subgroups most likely to respond to our product candidates, our initial hypotheses regarding these data may prove to be incorrect, or our patient selection strategies based on our analysis of these data may fail to yield suitable patients for evaluation in our clinical trials or suitable indications and product candidates for clinical development.

Any of our product candidates may cause adverse effects or have other properties that could delay or prevent their regulatory approval, limit the scope of any approved label or market acceptance or result in other significant negative consequences following marketing approval, if any .

Adverse events or other unintended side effects or safety signals caused by our product candidates could cause us, IRBs or ethics committees, clinical trial sites or regulatory authorities to interrupt, delay or halt clinical trials and could result in the denial of regulatory approval. For example, through additional studies, we may determine that although mavacamten has been shown to be specific to striated muscle, which includes both skeletal and cardiac muscle, and selective for cardiac muscle, it may target myosin in skeletal muscle, which could result in unintended adverse effects. We have observed adverse events in our clinical trials of mavacamten . Results of our ongoing and planned trials could reveal a high and unacceptable severity and prevalence of these or other adverse events in subjects treated with our product candidates. Additionally, if the adverse events we have observed are deemed to be unacceptable or other unacceptable side effects or safety signals are observed in any ongoing or subsequent preclinical studies or clinical trials of our product candidates, our trials could be suspended or terminated and the FDA or comparable foreign regulatory authorities could order us to cease further development of or deny approval of our product candidates for any or all targeted indications. Any adverse effects encountered in our preclinical studies or clinical trials, whether or not drug-related, could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims.  Additionally, adverse effects may represent safety signals that could influence the benefit-risk assessment for further development or commercialization of a product candidate and may warrant further clinical or nonclinical investigation, consultation with health authorities, changes to product labeling or guidelines for its safe use, or other scientific or regulatory actions.  Any of these occurrences may harm our business, financial condition and prospects significantly.

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Further, if any of our future products, if and when approved for commercial sale, cause serious or unexpected adv erse events, a number of potentially significant negative consequences could result, including:

 

regulatory authorities may withdraw their approval of the product or impose restrictions on its distribution in the form of a REMS or provide a medication guide outlining the risks of such side effects for distribution to patients;

 

regulatory authorities may require the addition of labeling statements, such as warnings or contraindications;

 

we may be required to change the way the product is administered or conduct additional clinical trials;

 

we could be sued and held liable for harm caused to patients; or

 

our reputation may suffer.

Any of these events could prevent us or our partners from achieving or maintaining market acceptance of the affected product and could substantially increase the costs of commercializing our future products and impair our ability to generate revenues from the commercialization of these products.

Risks Related to Government Regulation

We currently do not have regulatory approval to market any of our product candidates. The regulatory approval processes of the FDA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.

The time required to obtain approval by the FDA, EMA and comparable foreign authorities is unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions. We have not obtained regulatory approval for any product candidate and it is possible that none of our existing product candidates or any product candidates we may seek to develop in the future will ever obtain regulatory approval.

Our product candidates could fail to receive regulatory approval for many reasons, including the following:

 

the FDA or comparable foreign regulatory authorities may disagree with the design or implementation of our clinical trials;

 

we may be unable to demonstrate to the satisfaction of the FDA or comparable foreign regulatory authorities that a product candidate is safe and effective for its proposed indication;

 

the results of clinical trials may not meet the level of statistical significance required by the FDA or comparable foreign regulatory authorities for approval;

 

we may be unable to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;

 

the FDA or comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;

 

the data collected from clinical trials of our product candidates may not be sufficient to support the submission of a New Drug Application (“ NDA”) or other submission or to obtain regulatory approval in the United States or elsewhere;

 

the FDA or comparable foreign regulatory authorities may find deficiencies with or fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; or

 

the approval policies or regulations of the FDA or comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.

This lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval to market mavacamten , MYK-491 or any other product candidate we may develop, which would significantly harm our business, results of operations and prospects.

In addition, even if we were to obtain approval, regulatory authorities may approve any of our product candidates for fewer or more limited indications than we request, may not approve the price we intend to charge for our products, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing scenarios could materially harm the commercial prospects for our product candidates.

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Even if we complete the necessary preclinical studies and clinical trials, we cannot predict when or if we will obtain regulatory approval to commercialize a product candida te or the approval may be for a more limited indication than we expect.

We cannot commercialize a product until the appropriate regulatory authorities have reviewed and approved the product candidate. Even if our product candidates demonstrate safety and efficacy in clinical trials, the regulatory agencies may not complete their review processes in a timely manner, or we may not be able to obtain regulatory approval. Additional delays may result if an FDA Advisory Committee or other regulatory authority recommends non-approval or restrictions on approval. In addition, we may experience delays or rejections based upon additional government regulation from future legislation or administrative action, or changes in regulatory agency policy during the period of product development, clinical trials and the review process. Regulatory agencies also may approve a treatment candidate for fewer or more limited indications than requested or may grant approval subject to the performance of post-marketing studies. In addition, regulatory agencies may not approve the labeling claims that are necessary or desirable for the successful commercialization of our treatment candidates. If we are unable to obtain regulatory approval for our product candidates for use in the treatment of heritable cardiomyopathies, our business may suffer.

Failure to obtain marketing approval in international jurisdictions would prevent our products from being marketed in such jurisdictions.

In order to market and sell our products in the European Union and many other jurisdictions, we or our third-party collaborators must obtain separate marketing approvals and comply with numerous and varying regulatory requirements. The approval procedure varies among countries and can involve additional testing. The time required to obtain approval may differ substantially from that required to obtain FDA approval. The regulatory approval process outside the United States generally includes all of the risks associated with obtaining FDA approval. In addition, in many countries outside the United States, it is required that the product be approved for reimbursement before the product can be approved for sale in that country. We or these third parties may not obtain approvals from regulatory authorities outside the United States on a timely basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by regulatory authorities in other countries or jurisdictions or by the FDA. However, the failure to obtain approval in one jurisdiction may negatively impact our ability to obtain approval in other jurisdictions. We may not be able to file for marketing approvals, and even if we do, we may not obtain necessary approvals to commercialize our medicines in any market.

Even if we receive regulatory approval for any of our product candidates, we will be subject to ongoing obligations and continued regulatory review, which may result in significant additional expense. Additionally, our product candidates, if approved, could be subject to labeling and other restrictions and market withdrawal and we may be subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our products.

Any product candidate for which we obtain marketing approval, along with the manufacturing processes, post-approval clinical data, labeling, advertising and promotional activities for such product, will be subject to extensive and ongoing regulatory requirements and review by the FDA and other regulatory authorities. These requirements include submissions of safety and other post-marketing information and reports, registration and listing requirements, current Good Manufacturing Practice (“ cGMP”) requirements relating to quality control, quality assurance and corresponding maintenance of records and documents, and requirements regarding the distribution of samples to physicians and recordkeeping. For example, the holder of an approved NDA is obligated to monitor and report adverse events and any failure of a product to meet the specifications in the NDA. The holder of an approved NDA must also submit new or supplemental applications and obtain FDA approval for certain changes to the approved product, product labeling or manufacturing process.

In addition, product manufacturers and their facilities are subject to payment of user fees and continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP and adherence to commitments made in the NDA and other marketing authorizations.

Even if marketing approval of a product candidate is granted, the approval may be subject to limitations on the indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the medicine.

The FDA closely regulates the post-approval marketing and promotion of medicines to ensure that they are marketed only for the approved indications and in accordance with the provisions of the approved labeling. The FDA imposes stringent restrictions on manufacturers’ communications regarding off-label use and if we do not market our medicines for their approved indications, we may be subject to enforcement action for off-label marketing.

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In addition, later discovery of previously unknown problems with our medicines, manufacturers or manufacturing processes, or failure to comply with regulatory requirements, may result in various nega tive consequences, including:

 

restrictions on the labeling, marketing or manufacturing of the product;

 

restrictions on distribution or use of the product;

 

requirements to conduct post-marketing clinical trials or holds on ongoing or planned clinical trials;

 

warning or untitled letters;

 

withdrawal of the medicines from the market;

 

refusal by the FDA or comparable foreign regulatory authorities to approve pending applications or supplements to approved applications that we submit;

 

mandatory or voluntary recalls;

 

fines, restitution or disgorgement of profits or revenue;

 

suspension or withdrawal of marketing approvals;

 

refusal to permit the import or export of our medicines;

 

product seizure or detention; and

 

injunctions or the imposition of civil or criminal penalties.

The FDA’s policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. 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, which would adversely affect our business, prospects and ability to achieve or sustain profitability.

Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. The occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates and generate revenues.

We may seek one or more special designations from regulatory authorities for our product candidates, including Breakthrough Therapy Designation, Fast Track Designation or Orphan Drug Designation. These designations may not lead to a faster development or regulatory review or approval process, and it does not increase the likelihood that our product candidates will receive marketing approval.

We may seek one or more special designations from regulatory authorities for our product candidates, including Breakthrough Therapy Designation, Fast Track Designation or Orphan Drug Designation.

A breakthrough therapy is defined as a product that is intended, alone or in combination with one or more other products, to treat a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the product may demonstrate substantial improvement over existing therapies on one or more clinically important endpoints, such as substantial treatment effects observed early in clinical development. For products that have been designated as breakthrough therapies, interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens. Products designated as breakthrough therapies by the FDA can also be eligible for accelerated approval. If a product is intended for the treatment of a serious or life-threatening condition and the product demonstrates the potential to address unmet medical needs for this condition, the product sponsor may apply for Fast Track Designation.

The FDA has broad discretion whether or not to grant these designations, so even if we believe a particular product candidate is eligible for a particular designation, we cannot assure you that the FDA would decide to grant it. Accordingly, even if we believe one of our product candidates meets the criteria for a designation, the FDA may disagree and instead determine not to make such designation. In any event, the receipt of a particular designation for a product candidate may not result in a faster development process, review or approval compared to products considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, even if one or more of our product candidates qualify as breakthrough therapies, the FDA may later decide that the products no longer meet the conditions for qualification and rescind the breakthrough designation. Further, the FDA may withdraw Fast Track Designation if it believes that the designation is no longer supported by data from a clinical development program.

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Regulator y authorities in some jurisdictions, including the United States and Europe, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a drug as an orphan drug if it is a drug intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectati on that the cost of developing the drug will be recovered from sales in the United States. In the United States, Orphan Drug Designation entitles a party to incentives such as tax advantages and user-fee waivers.  In April 2016, the FDA granted Orphan Drug Designation for mavacamten for use in the treatment of symptomatic obstructive HCM.

In addition, if a product that has Orphan Drug Designation subsequently receives the first approval for the disease for which it has such designation, the product is entitled to orphan drug exclusivity, which in the United States means that the FDA may not approve any other applications to market the same drug for the same indication for seven years, except in limited circumstances.  The exclusivity granted under any Orphan Drug Designations that we have received or may receive may not effectively protect the product candidate from competition.   Although we have received Orphan Drug Designation from the FDA for mavacamten for use in the treatment of symptomatic obstructive HCM, we may not be the first to obtain marketing approval of this drug for the orphan-designated indication due to the uncertainties associated with developing pharmaceutical products. In addition, exclusive marketing rights in the United States may be limited if we seek approval for an indication broader than the orphan-designated indication or may be lost if the FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs of patients with the rare disease or condition. Further, even if we obtain orphan drug exclusivity, that exclusivity may not effectively protect the product from competition because different drugs with different active moieties  can be approved for the same condition. Even after an orphan drug is approved, the FDA can subsequently approve another drug with the same active moiety for the same condition if the FDA concludes that the later drug is clinically superior, in that it is shown to be safer, more effective or makes a major contribution to patient care. Orphan Drug Designation neither shortens the development time or regulatory review time of a drug nor gives the drug any advantage in the regulatory review or approval process.  Any inability to secure or maintain Orphan Drug Designation or the exclusivity benefits of this designation would have an adverse impact on our ability to develop and commercialize our product candidates.

Risks Related to Our Reliance on Third Parties

We are substantially dependent upon our collaboration agreement with Sanofi for the development and eventual commercialization of mavacamten, MYK-224, MYK-491 and any product candidates from our HCM-2 program. If this collaboration is unsuccessful or is terminated, we may be unable to commercialize certain product candidates and we will not receive additional funding from this relationship .

We depend upon our license and collaboration agreement with Aventis Inc., a wholly-owned subsidiary of Sanofi S.A., which we refer to as the Collaboration Agreement, for financial and scientific resources related to the clinical development and commercialization of product candidates under our mavacamten , MYK-224, MYK-491 and HCM-2 programs. While Sanofi has obligations to fund various research and development activities under the collaboration and with respect to the commercialization of product candidates in selected territories under certain programs under the Collaboration Agreement, our ability to receive funding from this relationship will depend upon the ability and willingness of Sanofi to successfully meet its responsibilities under our Collaboration Agreement and continue the collaboration. We may not receive some or all of the financial and scientific resources that we currently expect to receive under our Collaboration Agreement.

Our ability to generate additional funding from our Collaboration Agreement may be impaired by several factors including:

 

Sanofi may shift its priorities and resources away from our programs due to a change in business strategies, or a merger, acquisition, sale or downsizing of its company or business unit;

 

Sanofi may cease development and commercialization activities in therapeutic areas which are the subject of our collaboration;

 

Sanofi may change the success criteria for a particular program or potential product candidate, thereby delaying or ceasing development of such program or candidate;

 

Sanofi may exercise its rights to terminate the collaboration; or

 

a dispute may arise between us and Sanofi concerning financial obligations or the research, development or commercialization of a program or product candidate, resulting in a delay in payments or termination of a program and possibly resulting in costly litigation or arbitration which may divert management attention and resources.

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Specifically, with respect to termination, the initial term of the research program under our Collaboration Agreement with Sanofi is set to end on December 31, 2018. At any time after December 31, 2018, Sanofi may, upon prior written notice to us, terminate the Collaboration Agreement for convenience in its entirety or on a region-by-region or program-by-program basis with respect to selected regions or programs. The Collaboration Agreement is also subject to termination by either party upon a material breach by the other party, subject to a notice and cure period, or upon a bankruptcy, insolvency or similar event affecting the other party.

If our Collaboration Agreement with Sanofi is terminated, then, depending on the event:

 

the development of our product candidates subject to the Collaboration Agreement may be terminated or significantly delayed;

 

our cash expenditures could increase significantly if it is necessary for us to hire additional employees and allocate internal resources to the development and commercialization of product candidates that were previously funded, or expected to be funded, by Sanofi;

 

we would bear all of the risks and costs related to the further development and commercialization of product candidates that were previously the subject of the Collaboration Agreement;

 

in order to fund further development and commercialization, we may need to seek out and establish alternative strategic collaborations with third-party partners, which may not be possible; or

 

we may not be able to do so on terms which are acceptable to us, in which case it may be necessary for us to limit the size or scope of one or more of our programs or increase our expenditures and seek additional funding by other means.

Any of these events would have a material adverse effect on our results of operations and financial condition.

We expect to rely on third parties to conduct some or all aspects of our protocol development, research and preclinical and clinical testing, and these third parties may not perform satisfactorily.

We do not expect to independently conduct all aspects of our protocol development, research and preclinical and clinical testing. We currently rely, and expect to continue to rely, on third parties with respect to these items.

Any of these third parties may terminate their engagements with us at any time. If we need to enter into alternative arrangements, it could delay our product development activities. Our reliance on these third parties for research and development activities will reduce our control over these activities but will not relieve us of our responsibility to ensure compliance with all required regulations and study protocols. For product candidates that we develop and commercialize on our own, we will remain responsible for ensuring that each of our preclinical studies and clinical trials are conducted in accordance with the study plan and protocols. We and our third-party contractors and CROs are required to comply with GCP regulations, which are regulations and guidelines enforced by the FDA, the Competent Authorities of the Member States of the European Economic Area (“ EEA”), and comparable foreign regulatory authorities for all products in clinical development. Regulatory authorities enforce these GCP requirements through periodic inspections of trial sponsors, principal investigators and trial sites. If we or any of our third-party contractors or CROs fail to comply with applicable GCP requirements, the clinical data generated in our clinical trials may be deemed unreliable and the FDA, EMA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials complies with GCP regulations. In addition, our clinical trials must be conducted with product produced under cGMP regulations. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process.

If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct our studies in accordance with regulatory requirements or our stated study plans and protocols, we will be delayed in completing, or may not be able to complete, the preclinical and clinical studies required to support future Investigational New Drug Application (IND) submissions and approval of our product candidates. Any of these events could lead to clinical study delays or failure to obtain regulatory approval, or impact our ability to successfully commercialize future products. Some of these events could be the basis for FDA action, including injunction, request for voluntary recall, seizure or total or partial suspension of production.

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We contract with third parties for the manufacture of our product candidates for preclinical and clinical testing and expect to continue to do so for commercialization. This reliance on third parties increases the risk that we will not have s ufficient quantities of our product candidates or medicines or that such supply will not be available to us at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.

We do not have any manufacturing facilities. We currently rely, and expect to continue to rely, on third-party manufacturers for the manufacture of our product candidates for preclinical and clinical testing and for the commercial supply of any of these product candidates for which we or our collaborators obtain marketing approval. To date, we have obtained materials for mavacamten for our clinical trials from third-party manufacturers, and we intend to rely on third-party manufacturers for our planned Phase 2 and Phase 3 clinical development activities for mavacamten and Phase 1b and Phase 2 clinical trials of MYK-491 . We do not have a long-term supply agreement with the third-party manufacturers, and we purchase our required drug supply on a purchase order basis. We may be unable to establish any agreements with third-party manufacturers or to do so on acceptable terms.  

Reliance on third-party manufacturers entails risks to which we would not be subject if we manufactured the product candidates ourselves, including:

 

the inability to negotiate or maintain manufacturing agreements with third parties under commercially reasonable terms;

 

reduced control as a result of using third-party manufacturers for all aspects of manufacturing activities;

 

reliance on the third party for regulatory compliance, quality assurance, and safety and pharmacovigilance reporting;

 

the possible breach of the manufacturing agreement by the third party;

 

the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us; and

 

disruptions to the operations of our third-party manufacturers or suppliers caused by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier.

The facilities used by our contract manufacturers to manufacture any of our future products must be evaluated by the FDA pursuant to inspections that will be conducted after we submit an NDA to the FDA. We do not control the manufacturing process of, and are completely dependent on, our contract manufacturing partners for compliance with the cGMP regulation for manufacture of both active drug substances and finished drug products. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others, they will not be able to secure and/or maintain regulatory approval for their manufacturing facilities or our marketing applications will not be approved. In addition, we have no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or a comparable foreign regulatory authority finds deficiencies with or does not approve these facilities for the manufacture of our product candidates or if it finds deficiencies or withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved. Third-party manufacturers may not be able to comply with cGMP regulations or similar regulatory requirements outside the United States. Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or voluntary recalls of product candidates or medicines, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of our medicines and harm our business and results of operations.

Any products that we may develop may compete with our other product candidates and products and the products of third parties for access to manufacturing facilities. There are a limited number of manufacturers that operate under cGMP regulations and that might be capable of manufacturing for us.

Any performance failure on the part of our existing or future manufacturers could delay clinical development or marketing approval. We do not currently have arrangements in place for a redundant supply of bulk drug substances. If any one of our current contract manufacturers cannot perform as agreed, we may be required to replace that manufacturer. Although we believe that there are several potential alternative manufacturers who could manufacture our product candidates, we may incur added costs and delays in identifying and qualifying any such replacement.

Our current and anticipated future dependence upon others for the manufacture of our product candidates or medicines may adversely affect our future profit margins and our ability to commercialize any medicines that receive marketing approval on a timely and competitive basis.

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Risks Related to Our Intellectual Property

If we are unable to obtain and maintain patent protection for our medicines and technology, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize medicines and technology similar or identical to ours, and our ability to successfully commercialize our medicines and technology may be adversely affected.

Our commercial success will depend, in part, on our ability to obtain and maintain patent protection in the United States and other countries with respect to our proprietary products and technology. We seek to protect our proprietary position by filing patent applications in the United States and abroad related to our novel technologies and medicines that are important to our business. To date, we own three issued United States patents that cover our proprietary technology or product candidates. We cannot be certain that we will secure any additional rights to any issued patents with claims that cover any of our proprietary technology or product candidates.

The patent prosecution 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. It is also possible that we will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection. Although we enter into non-disclosure and confidentiality agreements with parties who have access to patentable aspects of our research and development output, such as our employees, corporate collaborators, outside scientific collaborators, CROs, contract manufacturers, consultants, advisors and other third parties, any of these parties may breach the agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

In addition to seeking patents for some of our technology and medicines, we also rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain our competitive position. With respect to our proprietary molecularly targeted small molecule drugs, we consider trade secrets and know-how to be our primary intellectual property. Trade secrets and know-how can be difficult to protect. In particular, we anticipate that with respect to our precision medicine platform, these trade secrets and know-how will over time be disseminated within the industry through independent development, the publication of journal articles describing the methodology, and the movement of personnel skilled in the art from academic to industry scientific positions.

We seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, CROs, contract manufacturers, consultants, advisors and other third parties. We also enter into confidentiality and invention or patent assignment agreements with our employees and consultants. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor or other third party, we would have no right to prevent them from using that technology or information to compete with us. If any of our trade secrets were to be disclosed to or independently developed by a competitor or other third party, our competitive position would be harmed.

Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts.

Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. There is a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits, interferences, oppositions and  inter partes  reexamination proceedings before the U.S. Patent and Trademark Office, or the U.S. PTO, and corresponding foreign patent offices. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are pursuing development candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, the risk increases that our product candidates may be subject to claims of infringement of the patent rights of third parties.

Third parties may assert that we are employing their proprietary technology without authorization. There may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our product candidates. Because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that our product candidates may infringe. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents. If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of any of our product candidates, any molecules formed during the manufacturing process or any final product itself, the holders of any such patents may be able to block our ability to commercialize such product candidate unless we obtained a license under the applicable patents, or until such patents expire.

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Similarly, if any third-party patents were held by a court of competent jurisdiction to cover aspects of our formulations, processes for manufacture or methods of use, including combina tion therapy, the holders of any such patents may be able to block our ability to develop and commercialize the applicable product candidate unless we obtained a license or until such patent expires. In either case, such a license may not be available on c ommercially reasonable terms or at all.

Parties making claims against us may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize one or more of our product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business. In the event of a successful claim of infringement against us, we may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, pay royalties, redesign our infringing products or obtain one or more licenses from third parties, which may be impossible or require substantial time and monetary expenditure.

Parties making claims against us may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have material adverse effect on our ability to raise additional funds or otherwise have a material adverse effect on our business, results of operations, financial condition and prospects.

We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time-consuming and unsuccessful.

Competitors may infringe our patents or the patents of our licensors. To counter infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours or our licensors is not valid, is unenforceable and/or is not infringed, or may refuse to stop the other party from using the technology at issue on the grounds that our patents do not cover the technology in question. Interference proceedings provoked by third parties or brought by us may be necessary to determine the priority of inventions with respect to our patents or patent applications or those of our licensors. An adverse result in any litigation or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our patent applications at risk of not issuing.

An unfavorable outcome could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms. Our defense of litigation or interference proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees. We may not be able to prevent, alone or with our licensors, misappropriation of our intellectual property rights, particularly in countries where the laws may not protect those rights as fully as in the United States.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of our common stock.

We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property.

We may also be subject to claims that former employees, collaborators or other third parties have an ownership interest in our patents or other intellectual property. In the future, we may have ownership disputes arising, for example, from conflicting obligations of consultants or others who are involved in developing our product candidates. Litigation may be necessary to defend against these and other claims challenging inventorship or ownership. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a material adverse effect on our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

Issued patents covering our product candidates could be found invalid or unenforceable if challenged in court.

If we or one of our licensing partners initiated legal proceedings against a third party to enforce a patent covering one of our product candidates, the defendant could counterclaim that the patent covering our product candidate is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the U.S. PTO, or made a misleading statement, during prosecution. Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation.

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Such mechanisms include re-examination, post grant review, and equivalent proceedings in foreign jurisd ictions (e.g., opposition proceedings). Such proceedings could result in revocation or amendment to our patents in such a way that they no longer cover our product candidates. The outcome following legal assertions of invalidity and unenforceability is unp redictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invali dity and/or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our product candidates. Such a loss of patent protection would have a material adverse impact on our business.

We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.

As is common in the biotechnology and pharmaceutical industry, we employ individuals who were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees, consultants and independent contractors do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of any of our employee’s former employer or other third parties. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel, which could adversely impact our business. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees.

Risks Related to Commercialization and the Market for Our Product Candidates

If the market opportunities for our product candidates are smaller than we believe they are or if we are unable to market our products to expanded patient populations, our revenues may be adversely affected and our business may suffer.

We focus our research and product development efforts on treatments for heritable cardiomyopathies, and our targeted indications are rare genetic diseases. In particular, we estimate that approximately 630,000 people in the United States have a form of HCM, and that approximately 360,000 people in the United States have a form of genetic DCM. Our projections of both the number of people who have these diseases, as well as the subset of people with these diseases who have the potential to benefit from treatment with our product candidates, are based on estimates derived from primary research with physicians and payors, analysis of medical journals and peer-reviewed literature, the work of third-party consultants and other publicly- or non-publicly-available data sources. These estimates may prove to be incorrect and new studies may change the estimated incidence or prevalence of our targeted disease indications. The number of patients in the United States, Europe and elsewhere may turn out to be lower than expected, may not be otherwise amenable to treatment with our products, and new patients may become increasingly difficult to identify or gain access to, all of which would adversely affect our results of operations and our business.

Additionally, because the target patient populations of our product candidates are small, we must be able to successfully identify patients and achieve a significant market share to achieve or maintain profitability and growth. Although we plan to use SHaRe to identify and select patients who are suitable for treatment with our products, if approved, we may not be able to identify or target a sufficient number of patients through SHaRe or our sales and marketing efforts to achieve the necessary market share.

Even if any of our product candidates receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.

If any of our product candidates receive marketing approval, they may nonetheless fail to gain sufficient market acceptance by physicians, patients, healthcare payors and others in the medical community. For example, current cardiovascular disease treatments such as beta blockers, non-dihydropyridine calcium channel blockers and disopyramide are well-established in the medical community, and doctors may continue to rely on these treatments. If our product candidates do not achieve an adequate level of acceptance, we may not generate significant product revenues and we may not become profitable. The degree of market acceptance of our product candidates, if approved for commercial sale, will depend on a number of factors, including:

 

efficacy and potential advantages compared to alternative treatments;

 

the ability to offer our medicines for sale at competitive prices;

 

convenience and ease of administration compared to alternative treatments;

 

the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

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the strength of marketing and distribution support;

 

sufficient third-party coverage or reimbursement; and

 

the prevalence and severity of any side effects.

Any failure to achieve or maintain sufficient market acceptance of mavacamten , MYK-491 or any of our other product candidates, if approved, could significantly harm our business, prospects, financial condition and results of operations.

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 any revenues.

We have no experience marketing or selling our product candidates. To successfully commercialize any products that may result from our development programs, we will need to develop these capabilities, either on our own or with others. We may enter into collaborations with other entities to utilize their mature marketing and distribution capabilities, but we may be unable to enter into marketing agreements on favorable terms, if at all. If our future collaborations do not commit sufficient resources to commercialize our future products, if any, and we are unable to develop the necessary marketing capabilities on our own, we will be unable to generate sufficient product revenue to sustain our business. We will be competing with many companies that currently have extensive and well-funded marketing and sales operations. Without an internal team or the support of a third party to perform marketing and sales functions, we may be unable to compete successfully against these more established companies.

The insurance coverage and reimbursement status of newly-approved products targeting small patient populations is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue.

The availability and extent of reimbursement by governmental and private payors is essential for most patients to be able to afford expensive treatments, such as endothelin receptor antagonists used in the treatment of certain cardiovascular diseases. Sales of our product candidates will depend substantially, both domestically and abroad, on the extent to which the costs of our product candidates will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government health administration authorities, private health coverage insurers and other third-party payors. Additionally, therapies directed at small patient populations, such as our product candidates, may be more expensive, and reimbursement options for these therapies may be more limited. If reimbursement or coverage is not available, or is available only to limited levels, we may not be able to successfully commercialize our product candidates. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize a sufficient return on our investment.

There is significant uncertainty related to the insurance coverage and reimbursement of newly appro ved products and for products whose targeted patient populations are small. In the United States, the principal decisions about reimbursement for new medicines are typically made by the Centers for Medicare & Medicaid Services (“ CMS”), an agency within the U.S. Department of Health and Human Services, as CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare. Private payors tend to follow CMS to a substantial degree. It is difficult to predict what CMS or third-party payors will decide with respect to reimbursement and coverage for fundamentally novel products such as ours, as there is no body of established practices and precedents for these new products. Reimbursement agencies in Europe may be more conservative than CMS.

Outside the United States, international operations are generally subject to extensive governmental price controls and other market regulations, and we believe the increasing emphasis on cost-containment initiatives in Europe, Canada, and other countries may put pressure on the pricing and usage of our product candidates. In many countries, the prices of medical products are subject to varying price control mechanisms as part of national health systems. In general, the prices of medicines under such systems are substantially lower than in the United States. Other countries allow companies to fix their own prices for medicines, but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our product candidates. Accordingly, in markets outside the United States, the reimbursement for our products may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenues and profits.

Moreover, increasing efforts by governmental and third-party payors, in the United States and abroad, to cap or reduce healthcare costs may cause such organizations to limit both coverage and the level of reimbursement for new products approved and, as a result, they may not cover or provide adequate payment for our product candidates. We expect to experience pricing pressures in connection with the sale of any of our product candidates, due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs and surgical procedures and other treatments, has become very intense. As a result, increasingly high barriers are being erected to the entry of new products.

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Risk Related to Our Business and Industry

We may be subject to healthcare, health information privacy and security laws, regulation and enforcement, and our failure to comply with these laws could harm our results of operations and financial conditions.

Although we do not currently have any products on the market, if we obtain FDA approval for any of our product candidates and begin commercializing those products in the United States, our operations may be directly, or indirectly through our customers and third-party payors, subject to various U.S. federal and state fraud and abuse, patient privacy laws and other healthcare regulatory laws, and to additional healthcare, statutory and regulatory requirements and enforcement by foreign regulatory authorities in jurisdictions in which we conduct our business. Healthcare providers, physicians and others play a primary role in the recommendation and prescription of any products for which we obtain marketing approval. These laws may impact, among other things, our proposed sales, marketing and education programs and constrain the business of financial arrangements and relationships with healthcare providers, physicians and other parties through which we market, sell and distribute our products for which we obtain marketing approval. The laws that may affect our ability to operate include:

 

the U.S. federal Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or paying any remuneration (including any kickback, bribe, or certain rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under U.S. federal and state healthcare programs such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

 

the U.S. federal False Claims Act, which imposes civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the U.S. federal government, claims for payment or approval that are false or fraudulent or from knowingly making a false statement to avoid, decrease or conceal an obligation to pay money to the U.S. federal government. In addition, the government may assert that a claim including items and services resulting from a violation of the U.S. federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;

 

the U.S. federal Health Insurance Portability and Accountability Act of 1996 (“ HIPAA”) which imposes criminal and civil liability for knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, or knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false statement, in connection with the delivery of, or payment for, healthcare benefits, items or services; similar to the U.S. federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

 

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“ HITECH”) and its implementing regulations, and as amended again by the final HIPAA omnibus rule, Modifications to the HIPAA Privacy, Security, Enforcement and Breach Notification Rules Under HITECH and the Genetic Information Nondiscrimination Act; Other Modifications to the HIPAA Rules, published in January 2013, which imposes certain obligations, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information without appropriate authorization on covered entities subject to the rule, such as health plans, healthcare clearinghouses and healthcare providers as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information;

 

the U. S. Federal Food, Drug, and Cosmetic Act (“ FDCA”) which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices;

 

the U. S. legislation commonly referred to as the Physician Payments Sunshine Act, enacted as part of the ACA and its implementing regulations, which requires certain manufacturers of drugs, devices, biologics and medical supplies that are reimbursable under Medicare, Medicaid, or the Children’s Health Insurance Program to report annually to CMS, information related to payments and other transfers of value to physicians and teaching hospitals, as well as ownership and investment interests held by physicians  and their immediate family members;

 

Federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;

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analogous state laws and regulations, including: state anti-kickback and false claims laws, which may apply to our business practices, including but not limited to, research, distribution, sales and marketing arrangements and claims involving healthcare items or services reimbursed by any third-party payor, including private insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant complian ce guidance promulgated by the U.S. federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources; and state laws and regulations that require drug manufacturers to file reports relating to pricing and marketing information, which requires tracking gifts and other remuneration and items of value provided to healthcare professionals and entities, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts; and

 

European and other foreign law equivalents of each of the laws, including reporting requirements detailing interactions with and payments to healthcare providers.

In addition, regulators globally are also imposing greater monetary fines for privacy violations. For example, in 2016, the European Union adopted a new regulation governing data practices and privacy called the General Data Protection Regulation, or GDPR, which became effective on May 25, 2018. The GDPR applies to any company established in the European Union as well as to those outside the European Union if they collect and use personal data in connection with the offering goods or services to individuals in the European Union or the monitoring of their behavior. The GDPR enhances data protection obligations for processors and controllers of personal data, including, for example, special protections for “sensitive information” such as health and genetic information, expanded disclosures about how personal information is to be used, limitations on retention of information, mandatory data breach notification requirements and onerous new obligations on service providers. Non-compliance with the GDPR may result in monetary penalties of up to €20 million or 4% of worldwide revenue, whichever is higher. The GDPR and other changes in laws or regulations associated with the enhanced protection of certain types of personal data, such as healthcare data or other sensitive information, could greatly increase our cost of developing or commercializing our product candidates or impair our ability to collect data from patients resident in the European Union.

Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of the laws described above or any other governmental laws and regulations that may apply to us, we may be subject to significant penalties, including civil, criminal and administrative penalties, damages, fines, exclusion from U.S. government funded healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations. If any of the physicians or other providers or entities with whom we expect to do business is found not to be in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs and imprisonment. If any of the above occur, it could adversely affect our ability to operate our business and our results of operations.

We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.

Our competitors may develop drugs that are less expensive, safer, or more effective, which may diminish or eliminate the commercial success of any drugs that we may commercialize.

Our competitors may:

 

develop drug candidates and market drugs that are less expensive or more effective than our future drugs;

 

commercialize competing drugs before we or our partners can launch any drugs developed from our drug candidates;

 

initiate or withstand substantial price competition more successfully than we can;

 

have greater success in recruiting skilled scientific workers from the limited pool of available talent;

 

more effectively negotiate third-party licenses and strategic collaborations; and

 

take advantage of acquisition or other opportunities more readily than we can.

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We will compete for market share against large pharmaceutical and biotechnology compan ies and smaller companies that are collaborating with larger pharmaceutical companies, new companies, academic institutions, government agencies and other public and private research organizations. Many of these competitors, either alone or together with t heir partners, may develop new drug candidates that will compete with ours, as these competitors may, and in certain cases do, operate larger research and development programs or have substantially greater financial resources than we do. Our competitors ma y also have significantly greater experience in:

 

developing product candidates;

 

undertaking preclinical testing and clinical trials;

 

building relationships with key customers and opinion-leading physicians;

 

obtaining and maintaining FDA and other regulatory approvals of product candidates;

 

formulating and manufacturing drugs; and

 

launching, marketing and selling drugs.

If our competitors market drugs that are less expensive, safer or more effective than our potential drugs, or that reach the market sooner than our potential drugs, we may not achieve commercial success. In addition, the life sciences industry is characterized by rapid technological change. Because our research approach integrates many technologies, it may be difficult for us to stay abreast of the rapid changes in each technology. If we fail to stay at the forefront of technological change, we may be unable to compete effectively. Our competitors may render our technologies obsolete by advances in existing technological approaches or the development of new or different approaches, potentially eliminating the advantages in our drug discovery process that we believe we derive from our research approach and proprietary technologies.

Public opinion and heightened regulatory scrutiny of precision medicine for the treatment of cardiovascular disease may impact public perception of our product candidates or adversely affect our ability to conduct our business or obtain regulatory approvals for our product candidates.

Precision medicine remains a novel technology, particularly in the field of cardiovascular disease, with no products approved to date in the United States that are specifically targeted at correcting the underlying biomechanical defects in cardiac contractility associated with HCM and DCM. Public perception may be influenced by claims that these therapies are unproven or unsafe, and our product candidates may not gain the acceptance of the public or the medical community. In particular, our success will depend upon physicians, who specialize in the treatment of those diseases that our product candidates target, prescribing treatments that involve the use of our product candidates in lieu of, or in addition to, existing treatments they are already familiar with and for which greater clinical data may be available. More restrictive government regulations or negative public opinion could have an adverse effect on our business or financial condition and may delay or impair the development and commercialization of our product candidates or demand for any products we may develop. Adverse events in our clinical trials, even if not ultimately attributable to our product candidates, and the resulting publicity, could result in increased governmental regulation, unfavorable public perception, potential regulatory delays in the testing or approval of our product candidates, stricter labeling requirements for those product candidates that are approved and a decrease in demand for any such product candidates.

Healthcare legislative reform measures may have a material adverse effect on our business and results of operations.

In the United States, the EU, and other foreign jurisdictions, there have been a number of legislative and regulatory changes to the healthcare system that could affect our future results of operations. In particular, there have been and continue to be a number of initiatives at the United States federal and state levels that seek to reduce healthcare costs and improve the quality of healthcare. For example, ACA changes the way healthcare is financed by both governmental and private insurers and significantly impacts the U.S. pharmaceutical and biotechnology industries. ACA, among other things, subjects biologic products to potential competition by lower-cost biosimilars, addresses a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increases the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations, establishes annual fees and taxes on manufacturers of certain branded prescription drugs and biologic products, and a new Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 50% point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D.

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The new presidential administration has indicated that enacting change to the ACA is a legislative priority, and has alternatively discussed repealing and replacing the ACA. In January 2017, Congress voted to adopt a budget resolution for fiscal year 2017, that while not a law, is widely viewed as the first step toward the pa ssage of legislation that would repeal certain aspects of the ACA.  The 2017 Tax Reform Act includes a provision repealing the individual mandate, effective January 1, 2019.  Further, on January 20, 2017, U.S. President Donald Trump signed an Executive Ord er directing federal agencies with authorities and responsibilities under the ACA to waive, defer, grant exemptions from, or delay the implementation of any provision of the ACA that would impose a fiscal burden on states or a cost, fee, tax, penalty or re gulatory burden on individuals, healthcare providers, health insurers, or manufacturers of pharmaceuticals or medical devices. On October 13, 2017, President Trump signed an Executive Order terminating the cost-sharing subsidies that reimburse the insurers under the ACA.  Several state Attorneys General filed suit to stop the administration from terminating the subsidies, but their request for a restraining order was denied by a federal judge in California on October 25, 2017.  In addition, CMS has recently proposed regulations that would give states greater flexibility in setting benchmarks for insurers in the individual and small group marketplaces, which may have the effect of relaxing the essential health benefits required under the ACA for plans sold th rough these marketplaces.  Thus, there may be further action to repeal, replace, or modify the ACA. While any further legislative and regulatory changes will likely take time to develop, and may or may not have an impact on the regulatory regime to which w e are subject, we cannot predict the ultimate content, timing or effect of any healthcare reform legislation or the impact of potential legislation on us.

In addition, other legislative changes have been proposed and adopted in the United States since ACA was enacted. On August 2, 2011, the Budget Control Act of 2011, among other things, created measures for spending reductions by Congress. A Joint Select Committee on Deficit Reduction, tasked with recommending a targeted deficit reduction of at least $1.2 trillion for the years 2013 through 2021, was unable to reach required goals, thereby triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions of Medicare payments to providers of 2% per fiscal year. These reductions went into effect on April 1, 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2025 unless additional Congressional action is taken. On January 2, 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. These new laws may result in additional reductions in Medicare and other health care funding, which could have a material adverse effect on our customers and accordingly, our financial operations.

Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. For example, CMS may develop new payment and delivery models, such as bundled payment models. The U.S. federal government has set a goal of moving 50% of Medicare payments into these “Alternative Payment Models” by the end of 2018. In addition, recently there has been heightened governmental scrutiny over the manner in which drug manufacturers set prices for their commercial products.  We expect that additional U.S. federal healthcare reform measures will be adopted in the future, any of which could limit the amounts that the U.S. federal government will pay for healthcare products and services, which could result in reduced demand for our product candidates or additional pricing pressures.

Our future success depends on our ability to retain key employees and consultants, including our scientific advisors and founders, and to attract, retain and motivate qualified personnel.

We are highly dependent on our scientific advisors and founders and the principal members of our executive team, the loss of whose services may adversely impact the achievement of our objectives. While we have entered into employment agreements with each of our executive officers, any of them could leave our employment at any time, as all of our employees are “at will” employees. Recruiting and retaining other qualified employees, consultants and advisors for our business, including scientific and technical personnel, will also be critical to our success. There is currently a shortage of skilled executives and scientific experts in our industry, which is likely to continue. As a result, competition for skilled personnel is intense and the turnover rate can be high. We may not be able to attract and retain personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies, as well as from academic and research institutions, for individuals with similar skill sets. In addition, any failure of our programs to succeed in preclinical studies or clinical trials may make it more challenging to recruit and retain qualified personnel. The inability to recruit or the loss of the services of any executive, key employee, consultant or advisor may impede the progress of our research, development and commercialization objectives.

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We will need to expand our organization and we may experience difficulties in managing this growth, which could disrupt our operations.

As of September 30, 2018, we had 156 full-time employees. As we mature, we expect to expand our full-time employee base and to hire more consultants and contractors. Our management may need to divert a disproportionate amount of its attention away from our day-to-day activities and devote a substantial amount of time to managing these growth activities. We may not be able to effectively manage the expansion of our operations, which may result in weaknesses in our infrastructure, operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees. Our expected growth could require significant capital expenditures and may divert financial resources from other projects, such as the development of additional product candidates. If our management is unable to effectively manage our growth, our expenses may increase more than expected, our ability to generate and/or grow revenues could be reduced, and we may not be able to implement our business strategy. Our future financial performance and our ability to commercialize product candidates and compete effectively will depend, in part, on our ability to effectively manage any future growth.

We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.

Because we have limited financial and managerial resources, we focus on research programs and product candidates that we identify for specific indications. As a result, we may forego or delay pursuit of opportunities with other product candidates or for other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial medicines or profitable market opportunities. Our spending on current and future research and development programs and product candidates for specific indications may not yield any commercially viable medicines. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate.

Our anticipated international operations may expose us to business, regulatory, political, operational, financial, pricing and reimbursement and economic risks associated with doing business outside of the United States.

We have a wholly-owned Australian subsidiary through which we conduct clinical trials in Australia. Our business strategy also contemplates potential additional international operations as we seek to continue the development of mavacamten , MYK-491 and other product candidates that we have or may identify, seek regulatory approval for our product candidates, and commercialize any product candidates that are approved outside the United States. If any product candidates for which we have retained worldwide commercial rights are approved, we may hire sales representatives and conduct physician and patient group outreach activities outside of the United States. Doing business internationally involves a number of risks, including but not limited to:

 

multiple, conflicting, and changing laws and regulations such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements, and other governmental approvals, permits, and licenses;

 

failure by us to obtain and maintain regulatory approvals for the use of our products in various countries;

 

complexities and difficulties in obtaining protection for and enforcing our intellectual property rights;

 

difficulties in staffing and managing foreign operations;

 

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

 

limits in our ability to penetrate international markets;

 

financial risks, such as exposure to foreign currency exchange rate fluctuations and their impact on payments required in local currency;

 

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

 

certain expenses including, among others, expenses for travel, translation, and insurance; and

 

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

Any of these factors could significantly harm our future international expansion and operations and, consequently, our results of operations.

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If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.

We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. Our operations involve the use of hazardous and flammable materials, including chemicals and biological materials. Our operations also produce hazardous waste products. We generally contract with third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties.

Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials or other work-related injuries, this insurance may not provide adequate coverage against potential liabilities. In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or production efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

Our employees, independent contractors, principal investigators, CROs, consultants, vendors and collaboration partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could have a material adverse effect on our business.

We are exposed to the risk that our employees, independent contractors, principal investigators, CROs, consultants, vendors and collaboration partners may engage in fraudulent conduct or other illegal activities. Misconduct by these parties could include intentional, reckless and/or negligent conduct or unauthorized activities that violate: (i) the regulations of the FDA, EMA and other regulatory authorities, including those laws that require the reporting of true, complete and accurate information to such authorities; (ii) manufacturing standards; (iii) federal and state data privacy, security, fraud and abuse and other healthcare laws and regulations in the United States and abroad; or (iv) laws that require the reporting of true, complete and accurate financial information and data. In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Activities subject to these laws could also involve the improper use of information obtained in the course of clinical trials or creating fraudulent data in our preclinical studies or clinical trials, which could result in regulatory sanctions and cause serious harm to our reputation. It is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent misconduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with such laws or regulations. Additionally, we are subject to the risk that a person could allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business and results of operations, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, possible exclusion from participation in Medicare, Medicaid and other U.S. federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

Unfavorable global economic and political conditions could adversely affect our business, financial condition or results of operations.

Our ability to invest in and expand our business and meet our financial obligations, to attract and retain third-party contractors and collaboration partners and to raise additional capital depends on our operating and financial performance, which, in turn, is subject to numerous factors, including the prevailing economic and political conditions and financial, business and other factors beyond our control, such as the rate of unemployment, the number of uninsured persons in the United States, political influences and inflationary pressures. For example, an overall decrease in or loss of insurance coverage among individuals in the United States as a result of unemployment, underemployment or the potential repeal of certain provisions of the ACA, may decrease the demand for healthcare services and pharmaceuticals. If fewer patients are seeking medical care because they do not have insurance coverage, we may experience difficulties in any eventual commercialization of our product candidates and our business, results of operations, financial condition and cash flows could be adversely affected.

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In addition, our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets upon which biopharmaceu tical companies such as us are dependent for sources of capital. In the past, global financial crises have caused extreme volatility and disruptions in the capital and credit markets. A severe or prolonged economic downturn could result in a variety of ris ks to our business, including a reduced ability to raise additional capital when needed on acceptable terms, if at all, and weakened demand for our product candidates. A weak or declining economy could also strain our suppliers, possibly resulting in suppl y disruption. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business.

We or the third parties upon whom we depend may be adversely affected by earthquakes or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster.

Earthquakes or other natural disasters could severely disrupt our operations, and have a material adverse effect on our business, results of operations, financial condition and prospects. If a natural disaster, power outage or other event occurred that prevented us from using all or a significant portion of our headquarters, that damaged critical infrastructure, such as the manufacturing facilities of our third-party contract manufacturers, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time. The disaster recovery and business continuity plans we have in place currently are limited and are unlikely to prove adequate in the event of a serious disaster or similar event. We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which, particularly when taken together with our lack of earthquake insurance, could have a material adverse effect on our business.

Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any medicines that we may develop.

We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical trials and will face an even greater risk if we commercially sell any medicines that we may develop. If we cannot successfully defend ourselves against claims that our product candidates or medicines caused injuries, we could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

 

decreased demand for any product candidates or medicines that we may develop;

 

injury to our reputation and significant negative media attention;

 

withdrawal of clinical trial participants;

 

significant costs to defend the related litigation;

 

substantial monetary awards to trial participants or patients;

 

loss of revenue; and

 

the inability to commercialize mavacamten , MYK-491 or any other product candidates that we may develop.

Although we maintain product liability insurance, including coverage for clinical trials that we sponsor, it may not be adequate to cover all liabilities that we may incur. We anticipate that we will need to increase our insurance coverage as we commence additional clinical trials and if we successfully commercialize any product candidates. The market for insurance coverage is increasingly expensive, and the costs of insurance coverage will increase as our clinical programs increase in size. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise.

Our internal computer systems, or those of our third-party CROs or other contractors or consultants, may fail or suffer security breaches, which could result in a material disruption of our operations.

Despite the implementation of security measures, our internal computer systems and those of our third-party CROs and other contractors and consultants are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. While we have not experienced any such system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our programs. For example, the loss of clinical trial data for our product candidates could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach results in a loss of or damage to our data or applications or other data or applications relating to our technology or product candidates, or inappropriate disclosure of confidential or proprietary information, we could incur liabilities and experience delays or disruptions to various aspects of our operations, including our financial reporting and the development of our product candidates.

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Our ability t o utilize our net operating loss carryforwards and certain other tax attributes may be limited.

We have incurred substantial losses during our history and do not expect to become profitable in the near future. To the extent that we continue to generate taxable losses, unused losses will carry forward to offset future taxable income, if any, until suc h unused losses expire. Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended ( the “ Code”) if a corporation undergoes an “ownership change,” generally defined as a greater than 50 percentage point change (by value) in its equity owner ship over a rolling three-year period, the corporation’s ability to use its pre-change net operating loss carryforwards (“ NOLs”) and other pre-change tax attributes (such as research tax credits) to offset its post-change income or taxes may be limited. While we have determined that an ownership change occurred in April 2015 in connection with our Series B redeemable convertible preferred stock financing and in August 14, 2017 due to a subsequent stock offering, we do not believe that these ownership changes will result in the expiration of any of our existing NOLs prior to utilization. We may experience subsequent shifts in our stock ownership, some of which are outside our control. As a result, if we earn net taxable income, our ability to use our pre-change net operating loss carryforwards to offset U.S. federal taxable income may be subject to limitations, which could potentially result in increased future tax liability to us. In addition, at the state level, there may be periods during which the use of NOLs is suspended or otherwise limited, which could accelerate or permanently increase state taxes owed.

In addition, under the Tax Cuts and Jobs Act (the “Tax Act”), the amount of post 2017 NOLs that we are permitted to deduct in any taxable year is limited to 80% of our taxable income in such year, where taxable income is determined without regard to the NOL deduction itself.  The Tax Act generally eliminates the ability to carry back any NOL to prior taxable years, while allowing post 2017 unused NOLs to be carried forward indefinitely.  There is a risk that due to changes under the Tax Act, regulatory changes or other unforeseen reasons, our existing NOLs could expire or otherwise be unavailable to offset future income tax liabilities.

Risks Related to Our Common Stock

The market price of our common stock has been and may continue to be highly volatile.

The market price of our common stock has experienced volatility since our IPO in October 2015 and is likely to continue to be volatile. Our stock price could be subject to wide fluctuations in response to a variety of factors, including the following:

 

adverse results or delays in preclinical studies or clinical trials;

 

reports of adverse events in clinical trials of our product candidates or in other products for the treatment of cardiovascular diseases or clinical trials of such products;

 

inability to obtain additional funding;

 

any delay in filing an IND or NDA for any of our product candidates and any adverse development or perceived adverse development with respect to the FDA’s review of that IND or NDA;

 

failure to develop successfully and commercialize our product candidates;

 

any adverse developments relating to our Collaboration Agreement with Sanofi, or any failure to maintain our existing strategic collaborations or enter into new collaborations;

 

failure by us or our licensors and strategic collaborators to prosecute, maintain or enforce our intellectual property rights;

 

changes in laws or regulations applicable to future products;

 

inability to obtain adequate product supply for our product candidates or the inability to do so at acceptable prices;

 

adverse regulatory decisions affecting our product candidates or development programs;

 

introduction of new products, services or technologies by our competitors;

 

failure to meet or exceed financial projections we may provide to the public or to the investment community;

 

the perception of the pharmaceutical industry by the public, legislatures, regulators and the investment community;

 

announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us, our strategic collaboration partner or our competitors;

 

disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;

 

additions or departures of key scientific or management personnel;

 

significant lawsuits, including patent or stockholder litigation;

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changes in the market valuations of similar companies;

 

sales of our common stock by us or our stockholders in the future; and

 

trading volume of our common stock.

In addition, companies trading in the stock market in general, and The NASDAQ Global Select Market (“ NASDAQ”) in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance.  In the past, following periods of volatility in the market, securities class-action litigation has often been instituted against companies. Such litigation, if instituted against us, could result in substantial costs and diversion of management’s attention and resources, which could materially and adversely affect our business, financial condition, results of operations and growth prospects.

Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall.

Additional capital will be needed in the future to continue our planned operations. To the extent we raise additional capital by issuing equity securities, our stockholders may experience substantial dilution. We may sell common stock, convertible securities or other equity securities in one or more transactions at prices and in a manner we determine from time to time. If we sell common stock, convertible securities or other equity securities in more than one transaction, investors may be materially diluted by subsequent sales. These sales may also result in material dilution to our existing stockholders, and new investors could gain rights superior to our existing stockholders.

In addition, sales of a substantial number of shares of our outstanding common stock in the public market could occur at any time. These sales, or the perception in the market that the holders of a large number of shares of common stock intend to sell shares, could reduce the market price of our common stock. A substantial number of our outstanding shares of common stock are held by a relatively small number of stockholders who are not subject to restrictions on trading.  Sales by our stockholders of a substantial number of shares, or the expectation that such sales may occur, could significantly reduce the market price of our common stock.  

We have also registered all shares of our common stock subject to options or other equity awards issued or reserved for future issuance under our equity incentive plans. As a result, these shares will be eligible for sale in the public market to the extent permitted by any applicable vesting requirements and the exercise of options, and restrictions under applicable securities laws. In addition, our directors, executive officers and certain affiliates have established or may in the future establish programmed selling plans under Rule 10b5-1 of the Securities Exchange Act of 1934, as amended, for the purpose of effecting sales of our common stock.  If any of these events cause a large number of our shares to be sold in the public market, the sales could reduce the trading price of our common stock and impede our ability to raise future capital. If these additional shares are sold, or if it is perceived that they will be sold, in the public market, the trading price of our common stock could decline.

Pursuant to our 2015 Stock Option and Incentive Plan ( the “ 2015 Plan”), we are authorized to grant stock options and other equity-based awards to our employees, directors and consultants. Beginning on January 1, 2017, the number of shares available for future grant under the 2015 Plan will automatically increase each year by up to 4% of all shares of our capital stock outstanding as of December 31 of the prior calendar year, subject to the ability of our board of directors to take action to reduce the size of the increase in any given year. In addition, pursuant to our 2015 E mployee Stock Purchase Plan ( the “ 2015 ESPP”), we have initially reserved 255,000 shares for purchase by eligible employees. Beginning on January 1, 2017 and ending on January 1, 2025, the number of shares available for future issuance under the 2015 ESPP will automatically increase each year by up to the lesser of 3,000,000 shares of common stock or 1% of all shares of our capital stock outstanding as of December 31 of the prior calendar year, subject to the ability of our board of directors to take action to reduce the size of the increase in any given year. Currently, we plan to register the increased number of shares available for issuance under the 2015 Plan and the 2015 ESPP each year. If our board of directors elects to increase the number of shares available for future grant under these plans by the maximum amount each year, our stockholders may experience additional dilution, which could cause our stock price to fall.

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Our principal stockholders and management own a significant percentage of our stoc k and will be able to exert significant control over matters subject to stockholder approval.

As of September 30, 2018, our executive officers, directors, five percent or greater stockholders and their affiliates beneficially own approximately 33.2% of our outstanding voting stock. These stockholders will have the ability to influence us through their ownership positions. These stockholders may be able to determine all matters requiring stockholder approval. For example, these stockholders, acting together, may be able to control elections of directors, amendments of our organizational documents, or approval of any merger, sale of assets, or other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may believe are in your best interest as one of our stockholders.

We have broad discretion in the use of our cash and cash equivalents and may not use them effectively.

Our management has broad discretion in the application of our existing cash and cash equivalents, and you will not have the opportunity to assess whether our existing cash and cash equivalents are being used appropriately. Because of the number and variability of factors that will determine our use of our existing cash and cash equivalents, their ultimate use may vary substantially from their currently intended use. The failure by our management to apply these funds effectively could harm our business. Pending their use, we may invest our cash and cash equivalents in short-term, investment-grade, interest-bearing securities. These investments may not yield a favorable return to our stockholders.

If securities or industry analysts do not publish research, or publish inaccurate or unfavorable research, about our business, our stock price and trading volume could decline.

The trading market for our common stock will depend, in part, on the research and reports that securities or industry analysts publish about us or our business. Securities and industry analysts may not publish an adequate amount of research on our company, which may negatively impact the trading price for our stock. In addition, if one or more of the analysts who cover us downgrade our stock or publish inaccurate or unfavorable research about our business, our stock price would likely decline. Further, if our operating results fail to meet the forecasts of analysts, our stock price would likely decline. If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, demand for our stock could decrease, which might cause our stock price and trading volume to decline.

We are currently an “emerging growth company,” and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our common stock less attractive to investors.

We are an “emerging growth company,” as defined in the JOBS Act. For as long as we continue to be an emerging growth company, we may take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act of 2002 ( the “ Sarbanes-Oxley Act”), reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved. Based on the market value of our common stock held by non-affiliates as of June 30, 2018, we will no longer be an emerging growth company after December 31, 2018. Even after we no longer qualify as an emerging growth company, we could still qualify as a “smaller reporting company” which would allow us to take advantage of many of the same exemptions from disclosure requirements, including not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act (“Section 404”), and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements. We cannot predict if investors will find our common stock less attractive because we may rely on these exemptions. If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

Under the JOBS Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as those standards apply to private companies. We have irrevocably elected not to avail ourselves of this exemption from new or revised accounting standards and, therefore, are subject to the same new or revised accounting standards as other public companies that are not emerging growth companies.

We will continue to incur increased costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives.

As a public company, and particularly after we are no longer an emerging growth company, we incur and will continue to incur significant legal, accounting and other expenses that we did not incur as a private company. In addition, the Sarbanes-Oxley Act and rules subsequently implemented by the SEC and NASDAQ have imposed various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our management

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and other personnel will need to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time-consuming and c ostly. For example, we expect that these rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance.

Pursuant to Section 404, we are required to furnish a report by our management on our internal control over financial reporting with our Annual Report on Form 10-K for each fiscal year.  In addition, beginning with our Annual Report on Form 10-K for the fiscal year ending December 31, 2018,  we will be required to obtain an attestation report on internal control over financial reporting issued by our independent registered public accounting firm. To achieve compliance with Section 404 within the prescribed period, we are and will continue to be engaged in a process to document and evaluate our internal control over financial reporting, which is both costly and challenging. In this regard, we will need to continue to dedicate internal resources, engage outside consultants and adopt a detailed work plan to assess and document the adequacy of internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are functioning as documented and implement a continuous reporting and improvement process for internal control over financial reporting.

Despite our efforts, there is a risk that neither we nor our independent registered public accounting firm will be able to conclude within the prescribed timeframe that our internal control over financial reporting is effective as required by Section 404. This could impair our ability to produce timely and accurate consolidated financial statements and result in an adverse reaction in the financial markets due to a loss of confidence in the reliability of our consolidated financial statements.

Our operating results may fluctuate significantly or may fall below the expectations of investors or securities analysts, each of which may cause our stock price to fluctuate or decline.

Our quarterly and annual operating results may fluctuate significantly in the future, which makes it difficult to predict our future operating results. Our net loss and other operating results will be affected by numerous factors, many of which are outside of our control and may be difficult to predict, including:

 

variations in the level of expenses related to our clinical development programs, our precision medicine platform or our preclinical research and development programs;

 

the timing and success or failure of preclinical studies and clinical trials for our product candidates or competing product candidates;

 

our ability to obtain regulatory approval for our product candidates, and the timing and scope of any such approvals we may receive;

 

if any of our product candidates receives regulatory approval, the level of underlying demand for these product candidates and our ability to successfully commercialize any approved product;

 

addition or termination of clinical trials or funding support;

 

our execution of any new collaborative, licensing or similar arrangements, and the timing of payments we may make or receive under these arrangements.

 

any intellectual property infringement or other lawsuits in which we may become involved; and

 

regulatory developments affecting our product candidates or those of our competitors.

If our operating results fall below the expectations of investors or securities analysts, the price of our common stock could decline substantially. Furthermore, any fluctuations in our operating results may, in turn, cause the price of our stock to fluctuate substantially. Additionally, due to the unpredictability of our quarterly and annual operating results, we believe that period-to-period comparisons of our financial results are not necessarily meaningful and should not be relied upon as an indication of our future performance.

Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.

We have never declared or paid cash dividends on our capital stock. We currently intend to retain all of our future earnings, if any, to finance the growth and development of our business. In addition, the terms of any future debt agreements may preclude us from paying dividends. As a result, capital appreciation, if any, of our common stock will be your sole source of gain for the foreseeable future.

58


 

We could be subject to securities class action litigation.

In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because biotechnology and pharmaceutical companies have experienced significant stock price volatility in recent years. If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business.

Provisions in our amended and restated certificate of incorporation and amended and restated bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to acquire us or increase the cost of acquiring us, even if doing so would benefit our stockholders or remove our current management.

Our amended and restated certificate of incorporation, amended and restated bylaws and Delaware law contain provisions that may have the effect of delaying or preventing a change in control of us or changes in our management. Our amended and restated certificate of incorporation and amended and restated bylaws include provisions that:

 

authorize “blank check” preferred stock, which could be issued by our board of directors without stockholder approval and may contain voting, liquidation, dividend and other rights superior to our common stock;

 

create a classified board of directors whose members serve staggered three-year terms;

 

specify that special meetings of our stockholders can be called only by our board of directors, the chairperson of our board of directors, our chief executive officer or our president;

 

prohibit stockholder action by written consent;

 

establish an advance notice procedure for stockholder approvals to be brought before an annual meeting of our stockholders, including proposed nominations of persons for election to our board of directors;

 

provide that our directors may be removed only for cause and with the vote of the holders of 75% or more of our outstanding capital stock then entitled to vote at an election of directors;

 

provide that vacancies on our board of directors may be filled only by a majority of directors then in office, even if less than a quorum;

 

specify that no stockholder is permitted to cumulate votes at any election of directors;

 

expressly authorize our board of directors to modify, alter or repeal our amended and restated bylaws; and

 

require supermajority votes of the holders of our common stock to amend specified provisions of our amended and restated certificate of incorporation and amended and restated bylaws.

These provisions, alone or together, could delay or prevent hostile takeovers and changes in control or changes in our management.

In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which limits the ability of stockholders owning in excess of 15% of our outstanding voting stock to merge or combine with us.

Any provision of our amended and restated certificate of incorporation or amended and restated bylaws or Delaware law that has the effect of delaying or deterring a change in control could limit the opportunity for our stockholders to receive a premium for their shares of our common stock, and could also affect the price that some investors are willing to pay for our common stock.

59


 

Item 2.

Unregistered Sales of Equi ty Securities and Use of Proceeds

 

(a)

Recent Sales of Unregistered Equity Securities

None.

 

(b)

Use of Proceeds

Not applicable.

 

(c)

Issuer Repurchases of Company Equity Securities.

None.

Item 3.

Defaults Upon Senior Securities

None.

Item 4.

Mine Safety Disclosures

Not applicable.

Item 5.

Other Information

None.

60


 

Item 6.

Exhibits

The following exhibits are filed or furnished as part of this Quarterly Report on Form 10-Q:

EXHIBIT INDEX

 

Exhibit

Number

 

Exhibit Description

 

Incorporated by

Reference From

 

Date

 

Number

 

Filed

Herewith

 

 

 

 

 

 

 

 

 

 

 

   3.1

 

Restated Certificate of Incorporation.

 

10-Q

 

11/18/2015

 

3.1

 

 

 

 

 

 

 

 

 

 

 

 

 

   3.2

 

Amended and Restated Bylaws.

 

S-1/A

 

10/13/2015

 

3.4

 

 

 

 

 

 

 

 

 

 

 

 

 

   4.1

 

Specimen Common Stock Certificate.

 

S-1/A

 

10/19/2015

 

4.1

 

 

 

 

 

 

 

 

 

 

 

 

 

  10.1

 

Lease by and between the Registrant and HCP LS Brisbane, LLC dated September 13, 2018

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

  31.1

 

Certification of Principal Executive Officer Required Under Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended.

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

  31.2

 

Certification of Principal Financial Officer Required Under Rule 13a-14(a) and 15d-14(a) of the Securities Exchange Act of 1934, as amended.

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

  32.1*

 

Certification of Principal Executive Officer and Principal Financial Officer Required Under Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and 18 U.S.C. §1350.

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

101.INS

 

XBRL Instance Document.

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

101.SCH

 

XBRL Taxonomy Extension Schema Document.

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

101.CAL

 

XBRL Taxonomy Extension Calculation Linkbase Document.

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

101.DEF

 

XBRL Taxonomy Extension Definition Linkbase Document.

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

101.LAB

 

XBRL Taxonomy Extension Label Linkbase Document.

 

 

 

 

 

 

 

X

 

 

 

 

 

 

 

 

 

 

 

101.PRE

 

XBRL Taxonomy Extension Presentation Linkbase Document.

 

 

 

 

 

 

 

X

 

#

Represents management compensation plan, contract or arrangement.

*

The certification attached as Exhibit 32.1 that accompanies this Quarterly Report on Form 10-Q is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of MyoKardia, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in such filing.

61


 

SIGNA TURES

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.

 

Date: November 8, 2018

MYOKARDIA, INC.

 

 

 

 

 

By:

/s/ Tassos Gianakakos

 

 

 

Tassos Gianakakos

 

 

 

President, Chief Executive Officer

 

 

 

(Principal Executive Officer)

 

 

 

 

 

 

 

 

Date: November 8, 2018

By:

/s/ Taylor Harris

 

 

 

Taylor Harris

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

 

 

 

 

62

 

Exhibit 10.1

THE SHORE AT SIERRA POINT

 

LEASE

 

This Lease (the " Lease "), dated as of the date set forth in Section 1 of the Summary of Basic Lease Information (the " Summary "), below, is made by and between HCP LS BRISBANE, LLC, a Delaware limited liability company (" Landlord "), and MYOKARDIA, INC., a Delaware corporation (" Tenant ").

 

SUMMARY OF BASIC LEASE INFORMATION

 

TERMS OF LEASE DESCRIPTION

 

 

1.

Date: September 13 ,      2018

 

 

2.

Premises ( Article 1 ).

 

2.1 Building: That certain four-story building containing approximately 135,295 rentable square feet of space (" RSF "), known as Building D, located at: 1000 Sierra Point Boulevard Brisbane, California 94005

2.2 Premises: Approximately 129,846 RSF in the aggregate, comprised of all of the rentable area on the 1st, 2nd, 3rd and 4th floors of the Building, as further set forth in Exhibit A to the Lease.

 

 

3.

Lease Term ( Article 2 ).

 

3.1 Length of Term: Ten (10) years.

3.2 Lease Commencement Date: The date that the Premises are "Ready for  Occupancy" as defined in the Tenant Work Letter attached hereto as Exhibit B .

3.3 Lease Expiration Date: The day prior to the tenth (10th) anniversary of the Lease Commencement Date.

 

 

4.

Base Rent (Article 3):

 

 

 

Lease Year

 

 

Annualized

Base Rent

 

Monthly Installment

of Base Rent

 

Approximate Monthly Base

Rent per RSF

 

1 (months 1 – 8)

 

N/A

 

$340,845.75

 

$5.250

 

1 (months 9 – 12)

 

N/A

 

$681,691.50

 

$5.250

 

2

 

$8,460,765.36

 

$705,063.78

 

$5.430

 

1


 

 

3

 

$8,756,892.15

 

$729,741.01

 

$5.620

 

4

 

$9,063,383.37

 

$755,281.95

 

$5.817

 

5

 

$9,380,601.79

 

$781,716.82

 

$6.020

 

6

 

$9,708,922.85

 

$809,076.90

 

$6.231

 

7

 

$10,048,735.15

 

$837,394.60

 

$6.449

 

8

 

$10,400,440.88

 

$866,703.41

 

$6.675

 

9

 

$10,764,456.31

 

$897,038.03

 

$6.908

 

10

 

$11,141,212.29

 

$928,434.36

 

$7.150

 

*Note that for the first eight (8) months of the Lease Term, Tenant’s Base Rent obligation has been calculated as if the Premises contained only 50% of the rentable square feet of the Premises. Such calculation shall not affect Tenant’s right to use the entire Premises, or Tenant’s obligations under this Lease with respect to the entire Premises, including without limitation, Tenant’s obligation to pay Tenant’s Share of Direct Expenses with respect to the Premises which shall be as provided in Section 6 of this Summary, all in accordance with the terms and conditions of this Lease.

 

Address for Payment of Rent :

 

If by check, remittances should be mailed to:

HCP Life Sciences REIT File 51142

Los Angeles, CA 90074-1142

 

If by ACH, remit to:

HCP Life Sciences REIT Bank of America ABA: 121000358

Acct: 1235928034

 

If by Wire, remit to:

HCP Life Sciences REIT Bank of America ABA: 026009593

Acct: 1235928034

 

If by overnight mail, remit to:

Bank of America Lockbox Services Lockbox 51142

2706 Media Center Drive

Los Angeles, CA 90065-1733

 

 

 

 

2


 

 

 

5.

Tenant Improvement Allowance ( Exhibit B ): $150.00 per RSF of the Premises (i.e., $19,476,900.00 for the 129,846 RSF of the Premises).

 

6.

Tenant's Share ( Article 4 ): 95.97% (i.e., not including the ground floor fitness center that is provide for use of Tenant and other tenants of the Project).

 

7.

Permitted Use ( Article 5 ): The Premises shall be used only for general office, research and development, engineering, lab scale manufacturing and laboratory and vivarium uses, including, but not limited to, administrative offices and other lawful uses reasonably related to or incidental to such specified uses, all (i) consistent with first class life sciences projects in Brisbane, California (" First Class Life Sciences Projects "), and (ii) in compliance with, and subject to, applicable laws and the terms of this Lease.

 

8.

Letter of Credit ( Article 21 ): $1,856,868.71.

 

9.

Parking ( Article 28 ): The right to use up to 2.83 on-site parking spaces at the Project for each 1,000 RSF of the Premises, on an unreserved basis, subject to the terms of Article 28 of the Lease.

 

10.

Address of Tenant ( Section 29.18 ): Before the commencement of the Lease:

MyoKardia, Inc.

333 Allerton Avenue

South San Francisco, California 94080 Attention:  General Counsel

After the commencement of the Lease:

MyoKardia, Inc.

1000 Sierra Point Boulevard

Brisbane, California 94005

Attention: General Counsel

 

11.

Address of Landlord ( Section 29.18 ):See Section 29.18 of the Lease.

 

12.

Broker(s) ( Section 29.24 ):CBRE, Inc.

 

3


 

1. PREMISES, BUILDING, PROJECT, AND COMMON AREAS.

 

1.1 Premises, Building, Project and Common Areas .

 

1.1.1 The Premises . Landlord hereby leases to Tenant and Tenant hereby leases from Landlord the premises set forth in Section 2.2 of the Summary (the " Premises "). The outline of the Premises is set forth in Exhibit A attached hereto. The outline of the "Building" and the "Project," as those terms are defined in Section 1.1.2 below, are further depicted on the Site Plan attached hereto as Exhibit A . The parties hereto agree that the lease of the Premises is upon and subject to the terms, covenants and conditions herein set forth, and Tenant covenants as a material part of the consideration for this Lease to keep and perform each and all of such terms, covenants and conditions by it to be kept and performed. The parties hereto hereby acknowledge that the purpose of Exhibit A is to show the approximate location of the Premises only, and such Exhibit is not meant to constitute an agreement, representation or warranty as to the construction of the Premises, the precise area thereof or the specific location of the "Common Areas," as that term is defined in Section 1.1.3 , below, or the elements thereof or of the accessways to the Premises or the "Project," as that term is defined in Section 1.1.2 , below, and that the square footage of the Premises shall be as set forth in Section 2.1 of the Summary of Basic Lease Information. Except as specifically set forth in this Lease and in the Tenant Work Letter attached hereto as Exhibit B (the " Tenant Work Letter "), Landlord shall not be obligated to provide or pay for any improvement work or services related to the improvement of the Premises. Tenant also acknowledges that neither Landlord nor any agent of Landlord has made any representation or warranty regarding the condition of the Premises, the Building or the Project or with respect to the suitability of any of the foregoing for the conduct of Tenant's business, except as specifically set forth in this Lease and the Tenant Work Letter. Landlord shall deliver the Premises to Tenant in good, vacant, broom clean condition, in compliance with all laws, with the roof water-tight and shall cause the plumbing, electrical systems, fire sprinkler system, lighting, and all other building systems serving the Premises, including the Generator, in good operating condition and repair on or before the Lease Commencement Date, or such earlier date as Landlord and Tenant mutually agree. Landlord will be responsible for causing the exterior of the Building, the existing Building entrances, and all exterior Common Areas (including required striping and handicapped spaces in the parking areas) to be in compliance with ADA and parking requirements, to the extent required to allow the legal occupancy of the Premises or completion of the Tenant Improvements. Notwithstanding anything in this Lease to the contrary, in connection with the foregoing Landlord shall, at Landlord's sole cost and expense (which shall not be deemed an "Operating Expense," as that term is defined in Section 4.2.4), repair or replace any failed or inoperable portion of the HVAC and other mechanical, plumbing, electrical or other building systems serving the Premises during the first twelve (12) months of the initial Lease Term (" Warranty Period "), provided that the need to repair or replace was not caused by the misuse, misconduct, damage, destruction, omissions, and/or negligence of Tenant, its subtenants and/or assignees, if any, or any company which is acquired, sold or merged with Tenant (collectively, " Tenant Damage "), or by any modifications, Alterations or improvements constructed by or on behalf of Tenant (which shall not include the Tenant Improvements). Landlord shall coordinate such work with Tenant and shall utilize commercially reasonable efforts to perform the same in a manner designed to minimize interference with Tenant's use of the Premises. To the extent repairs which Landlord is required to make pursuant to this Section 1.1.1 are necessitated in part by Tenant Damage, then Tenant shall reimburse Landlord for an equitable proportion of the cost of such repair.

 

1.1.2 The Building and The Project . The Premises constitutes the space set forth in Section 2.1 of the Summary (the " Building "). The Building is part of an office/laboratory project currently known as "The Shore at Sierra Point." The term " Project ," as used in this Lease, shall mean (i) the Building and the Common Areas, (ii) the land (which is improved with landscaping, parking facilities and other improvements) upon which the Building and the Common Areas are located, (iii) the other office/laboratory buildings located at the Sierra Point complex, and the land upon which such adjacent office/laboratory buildings are located, and (iv) at Landlord's discretion, any additional real property, areas, land, buildings or other improvements added thereto outside of the Project (provided that any such additions do not increase Tenant's obligations under this Lease).

 

1.1.3 Common Areas . Tenant shall have the non-exclusive right to use in common with other tenants in the Project, and subject to the rules and regulations referred to in Article 5 of this Lease, those portions of the Project which are provided, from time to time, for use in common by Landlord, Tenant and any other tenants of the Project, which shall include the shipping and receiving area in the Building (such areas, together with such other

 

4


 

portions of the Project designated by Landlord, in its discretion, are collectively referred to herein as the " Common Areas "). Landlord shall maintain and operate the Common Areas, including all sprinkler and other systems serving the Common Areas, in a first class manner, and the use thereof shall be subject to such rules, regulations and restrictions as Landlord may reasonably make from time to time. Landlord reserves the right to close temporarily, make alterations or additions to, or change the location of elements of the Project and the Common Areas, provided that in connection therewith Landlord will use commercially reasonable efforts to minimize any interference with Tenant's use of and access to the Premises and parking areas. Landlord hereby acknowledges that as of the date of this Lease Landlord is planning to operate an amenities center in the Project for use by the tenants of the Project during the Lease Term, and in connection therewith Landlord agrees to utilize commercially reasonable efforts to operate and maintain such amenities center (which amenities center shall include a café) throughout the Lease Term; provided, however, Tenant nevertheless acknowledges herby that if despite such commercially reasonable efforts Landlord is unable for any reason to maintain continuous operation of the amenities center during the Lease Term, in no event shall such failure be deemed a default of the Lease, nor shall such failure impact the validity of this Lease and Landlord shall not be subject to any liability for such failure, provided that in such event Landlord shall utilize commercially reasonable efforts to provide replacement food services to Tenant (e.g., an on-site café in a different location or the routine scheduling of food trucks to the Project). Landlord shall take all commercially reasonable measures to prevent, to the extent practicable, any intrusion of odors, noise, or vibrations from the Common Area on the first floor of the Building to the Premises.

 

1.2 Rentable Square Feet of Premises . Tenant hereby acknowledges and agrees that Landlord shall have the one-time right during the Lease Term to remeasure the rentable square footage of the Premises and/or Building in accordance with the terms of this Section 1.2 . Any such remeasurement shall be determined in accordance with the standards set forth in ANSI Z65.1-2010, as promulgated by the Building Owners and Managers Association (the " BOMA Standard "), and subject to related guidelines applicable thereto. Landlord's space planner/architect shall certify any such remeasurement and shall provide reasonable documentation to Tenant for Tenant's review following such remeasurement. In the event that Landlord's space planner/architect determines that the rentable square footage of the Premises and/or Building are different from those set forth in this Lease, all amounts, percentages and figures appearing or referred to in this Lease based upon such amounts (including, without limitation, the amount of the Base Rent, Tenant Improvement Allowance, Additional Tenant Improvement Allowance, and Tenant's Share) shall be modified in accordance with such determination, provided that Landlord and Tenant hereby acknowledge and agree that the rentable square footage of the Premises shall not increase by more than one percent (1%) from the rentable square footage set forth in Section 2.2 of the Summary. If such determination is made, it will be confirmed in writing by Landlord to Tenant.

 

 

1.3

Right of First Offer .

 

1.3.1 Right of First Offer . Subject to the terms and conditions of this Section 1.3 , Landlord hereby grants to Tenant, commencing on the date of this Lease, an on-going right of first offer during the initial Lease Term with respect to any space in the last building to be constructed in the Project, which is currently anticipated to be Building A at the Project, with the address of 1800 Sierra Point Boulevard, if and when such building is completed by Landlord (the “ First Offer Space ”). Such right of first offer shall be subject and subordinate to the terms of any renewal right contained in any lease of the First Offer Space entered into by Landlord with a third party after Tenant's failure to exercise its right of first offer as provided in this Section 1.3 (the " Intervening Leases "). All such tenants under Intervening Leases, are collectively referred to as the " Superior Right Holders ".

 

1.3.2 Procedure for Lease .

 

1.3.2.1 Procedure for Offer . Subject to the terms hereof, Landlord shall notify Tenant (the “ First Offer Notice ”) prior to entering into any lease with a third party for the First Offer Space, which notice shall outline the base rent, allowance amounts if any, length of term, and other economic terms on which Landlord would be willing to lease the First Offer Space (as set forth in such proposal) to Tenant (the " Fundamental Terms "). Pursuant to such First Offer Notice, Landlord shall offer to lease to Tenant the applicable First Offer Space on the Fundamental Terms.

 

5


 

1.3.2.2 Procedure for Acceptance . If Tenant wishes to exercise Tenant’s right of first offer with respect to the First Offer Space described in the First Offer Notice, then within seven (7) business days after delivery of the First Offer Notice to Tenant, Tenant shall deliver notice to Landlord of Tenant’s irrevocable exercise of its right of first offer with respect to all of the First Offer Space described in the First Offer Notice on the Fundamental Terms provided for therein. If Tenant does not so notify Landlord within such seven (7) business day period of Tenant’s exercise of its first offer right, then Landlord shall be free to negotiate and enter into a lease for the First Offer Space to anyone whom it desires on any terms that Landlord desires, provided that, if Landlord has not entered into any such lease within one hundred eighty (180) days after the date of delivery of the First Offer Notice, then, prior to entering into any lease of such First Offer Space, Landlord shall first again offer such space to Tenant in accordance with the terms of this Section 1.3 , provided that, prior to the entering into a lease of such space on terms that are more than 10% more favorable to the tenant than those set forth in the First Offer Notice (as determined on a net effective present value basis), Landlord shall first deliver any other First Officer Notice to Tenant offering such space to Tenant on such reduced terms. Tenant shall respond to any such “re-offer” within five (5) days after delivery of such “re-offer” notice.

 

1.3.2.3 Construction In First Offer Space . Unless the Fundamental Terms provided to Tenant for the First Offer Space otherwise specify, Tenant shall take the First Offer Space in its "as is" condition, and Landlord shall not be obligated to provide or pay for any improvement of the First Offer Space. For the avoidance of doubt, if the Fundamental Terms include a tenant improvement allowance or a turn-key build out, Tenant shall receive the same allowance or turn-key build out, as applicable.

 

1.3.2.4 Lease of First Offer Space . If Tenant timely exercises Tenant’s right of first offer to lease First Offer Space as set forth herein, Tenant shall within fifteen (15) days after receipt of Landlord’s first draft of an amendment accurately setting forth the Fundamental Terms and not containing any new material terms, enter an amendment to this Lease (the “ First Offer Space Amendment ”) for such First Offer Space pursuant to this Section 1.3 . Tenant’s lease of such First Offer Space shall be upon the express terms set forth in the First Offer Notice, but otherwise upon the same general terms and conditions set forth in this Lease and this Section 1.3 . The First Offer Space Lease shall not contain the rights set forth in Section 2.2 , below, unless such rights were set forth in the First Offer Notice. The term of Tenant's lease of the First Offer Space shall commence on the date set forth in the First Offer Notice (provided that such commencement date shall in no event be earlier than the date of Landlord's delivery of the applicable First Offer Space to Tenant), and shall expire on the applicable date set forth in the First Offer Notice (the " First Offer Space Expiration Date ").

 

1.3.2.5 Limitation of Exercise of First Offer Right . The right to lease First Offer Space as provided in this Section 1.3 may not be exercised if, as of the date of the attempted exercise of the expansion option by Tenant, Tenant is in default under this Lease, beyond any applicable notice and cure period. The terms of this Section 1.3 shall be personal to the originally named Tenant hereunder (the " Original Tenant ") or a Permitted Transferee, and may not be exercised by any assignee, subtenant, or other Transferee of Original Tenant's interest in this Lease other than a Permitted Transferee. Tenant’s right of first offer shall be continuous during the initial Lease Term. Tenant’s rejection of any particular offer shall not relieve Landlord of its obligation to again offer the First Offer Space to Tenant any time the First Offer Space subsequently becomes available (provided that Tenant’s rights under this Section 1.3 shall be subject and subordinate to the renewal rights of any tenant under a lease entered into by Landlord after Tenant has declined or failed to respond to a First Offer Notice).

 

1.4 Right of Notice and Negotiation . Landlord is currently intending to construct up to three (3) additional buildings at the Project, known as Buildings A, B and C, to be located at 1800, 1600 and 1400, respectively, Sierra Point Boulevard consisting of approximately 100,000 square feet (Building A) and 140,000 square feet (each of Building B and C) (the " New Buildings "). Landlord agrees that prior to the earlier of (i) Landlord commencing construction of any New Building, or (ii) Landlord entering into a lease of space in any New Building, Landlord will provide Tenant written notice that either Landlord is intending to commence construction, or that Landlord is intending to enter into a lease, as applicable, which notice shall state the proposed approximate location, configuration and rentable square footage of the space and the date upon which it is expected to become available (the " New Building Notice "). For a period of fifteen (15) business days following the New Building Notice (the " Negotiation Period "), Landlord shall not enter into any lease of the applicable New Building (unless Tenant has indicated in writing that Tenant is not interested in leasing space in the New Building), and shall, upon Tenant's written request, negotiate in

 

6


 

good faith with Tenant with respect to a possible lease of the New Building, or a portion thereof, by Tenant. Notwithstanding the foregoing, Landlord's determination as to whether to lease any New Building or portion thereof to Tenant shall be made in Landlord's sole and absolute, but good faith, discretion. If Tenant indicates that it is not interested in leasing space in the New Building, or if Landlord and Tenant do not reach an agreement within the Negotiation Period, Landlord shall be free to lease space in the New Building to anyone Landlord desires, on any terms Landlord desires. Notwithstanding the foregoing, if Landlord has not commenced construction, or entered into a lease, of the New Building, as applicable, within six (6) months after the date of the New Building Notice, Landlord shall again be required to deliver a New Building Notice to Tenant on the terms of this Section 1.4 prior to commencing construction or leasing space in such New Building.

 

2. LEASE TERM; OPTION TERM.

 

2.1 Lease Term . The terms and provisions of this Lease shall be effective as of the date of this Lease. The term of this Lease (the " Lease Term ") shall be as set forth in Section 3.1 of the Summary, shall commence on the date set forth in Section 3.2 of the Summary (the " Lease Commencement Date "), and shall terminate on the date set forth in Section 3.3 of the Summary (the " Lease Expiration Date ") unless this Lease is sooner terminated as hereinafter provided. For purposes of this Lease, the term " Lease Year " shall mean each consecutive twelve (12) month period during the Lease Term. At any time during the Lease Term, Landlord may deliver to Tenant a notice in the form as set forth in Exhibit C , attached hereto, as a confirmation only of the information set forth therein, which Tenant shall execute and return to Landlord within five (5) days of receipt thereof. Notwithstanding the foregoing, if Landlord has not delivered possession of the Premises in the condition required by Section 1.1.1 , above, (1) on or before March 31, 2020, then, as Tenant’s sole remedy for such delay, the date Tenant is otherwise obligated to commence payment of rent shall be delayed by one day for each day that the delivery date is delayed beyond such date, or (2) June 30, 2020, then, Tenant shall also have the right to terminate this Lease by written notice thereof to Landlord, whereupon any monies previously paid by Tenant to Landlord shall be reimbursed to Tenant. The foregoing dates shall be extended to the extent of any delays in delivery of possession caused by (i) Tenant Delay, as provided in Section 1(j) of the Tenant Work Letter, or (ii) war, terrorism, acts of God, natural disaster, civil unrest, governmental strike or area-wide or industry-wide labor disputes, inability to obtain services, labor, or materials or reasonable substitutes therefor, or delays due to utility companies that are not the result of any action or inaction of Landlord (provided that any such delay in this item (ii) shall not extend any such date by more than ninety (90) days).

 

 

2.2

Option Term .

 

2.2.1 Option Right . Landlord hereby grants to the Original Tenant, and its "Permitted Assignees", as that term is defined in Section 14.8 , below, one (1) option to extend the Lease Term for a period of ten

(10) years (the " Option Term "), which option shall be irrevocably exercised only by written notice delivered by Tenant to Landlord not more than twelve (12) months nor less than nine (9) months prior to the expiration of the initial Lease Term, provided that the following conditions ( the " Option Conditions ") are satisfied: (i) as of the date of delivery of such notice, Tenant is not in default under this Lease, after the expiration of any applicable notice and cure period; (ii) Tenant has not previously been in default under this Lease, after the expiration of any applicable notice and cure period, more than twice in the twelve (12) month period prior to the date of Tenant's attempted exercise; and

(iii) the Lease then remains in full force and effect. Landlord may, at Landlord's option, exercised in Landlord's sole and absolute discretion, waive any of the Option Conditions in which case the option, if otherwise properly exercised by Tenant, shall remain in full force and effect. Upon the proper exercise of such option to extend, and provided that Tenant satisfies all of the Option Conditions (except those, if any, which are waived by Landlord), the Lease Term, as it applies to the Premises, shall be extended for a period of ten (10) years. The rights contained in this Section 2.2 shall be personal to Original Tenant and any Permitted Assignees, and may be exercised by Original Tenant or such Permitted Assignees (and not by any assignee, sublessee or other "Transferee," as that term is defined in Section 14.1 of this Lease, of Tenant's interest in this Lease).

 

2.2.2 Option Rent . The annual Rent payable by Tenant during the Option Term (the " Option Rent ") shall be equal to the "Fair Rental Value," as that term is defined below, for the Premises as of the commencement date of the Option Term. The " Fair Rental Value ," as used in this Lease, shall be equal to the annual rent per rentable square foot (including additional rent and considering any "base year" or "expense stop" applicable thereto), including all escalations, at which tenants (pursuant to leases consummated within the twelve (12) month

 

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period preceding the first day of the Option Term), are leasing non-sublease, non-encumbered, non-equity space which is not significantly greater or smaller in size than the subject space, with a comparable level of improvements (excluding any property that Tenant would be allowed to remove from the Premises at the termination of the Lease), for a comparable lease term, in an arm's length transaction, which comparable space is located in the "Comparable Buildings," as that term is defined in this Section 2.2.2 , below (transactions satisfying the foregoing criteria shall be known as the " Comparable Transactions "), taking into consideration the following concessions (the " Concessions "):

(a) rental abatement concessions, if any, being granted such tenants in connection with such comparable space; (b) tenant improvements or allowances provided or to be provided for such comparable space, and taking into account the value, if any, of the existing improvements in the subject space, such value to be based upon the age, condition, design, quality of finishes and layout of the improvements and the extent to which the same can be utilized by a general office/lab user other than Tenant; and (c) other reasonable monetary concessions being granted such tenants in connection with such comparable space; provided, however, that in calculating the Fair Rental Value, no consideration shall be given to the fact that Landlord is or is not required to pay a real estate brokerage commission in connection with Tenant's exercise of its right to extend the Lease Term, or the fact that landlords are or are not paying real estate brokerage commissions in connection with such comparable space. The Concessions shall be reflected in the effective rental rate (which effective rental rate shall take into consideration the total dollar value of such Concessions as amortized on a straight-line basis over the applicable term of the Comparable Transaction (in which case such Concessions evidenced in the effective rental rate shall not be granted to Tenant)) payable by Tenant. The term “ Comparable Buildings ” shall mean the Building and those other life sciences buildings which are comparable to the Building in terms of age (based upon the date of completion of construction or major renovation of to the building), quality of construction, level of services and amenities, size and appearance, and are located in Brisbane, California and the surrounding commercial area.

 

2.2.3 Determination of Option Rent . In the event Tenant timely and appropriately exercises an option to extend the Lease Term, Landlord shall notify Tenant of Landlord's determination of the Option Rent within thirty (30) days thereafter. If Tenant, on or before the date which is ten (10) days following the date upon which Tenant receives Landlord's determination of the Option Rent, in good faith objects to Landlord's determination of the Option Rent, then Landlord and Tenant shall attempt to agree upon the Option Rent using their best good-faith efforts. If Landlord and Tenant fail to reach agreement within ten (10) days following Tenant's objection to the Option Rent (the " Outside Agreement Date "), then Tenant shall have the right to withdraw its exercise of the option by delivering written notice thereof to Landlord within five (5) days thereafter, in which event Tenant's right to extend the Lease pursuant to this Section 2.2 shall be of no further force or effect. If Tenant does not withdraw its exercise of the extension option, each party shall make a separate determination of the Option Rent, as the case may be, within ten (10) days after the Outside Agreement Date, and such determinations shall be submitted to arbitration in accordance with Sections 2.2.3.1 through 2.2.3.7 , below. If Tenant fails to object to Landlord's determination of the Option Rent within the time period set forth herein, then Tenant shall be deemed to have objected to Landlord's determination of Option Rent.

 

2.2.3.1 Landlord and Tenant shall each appoint one arbitrator who shall be a real estate appraiser who shall have been active over the five (5) year period ending on the date of such appointment in the appraisal of other class A life sciences buildings located in the Brisbane market area. The determination of the arbitrators shall be limited solely to the issue of whether Landlord's or Tenant's submitted Option Rent is the closest to the actual Option Rent, taking into account the requirements of Section 2.2.2 of this Lease, as determined by the arbitrators. Each such arbitrator shall be appointed within fifteen (15) days after the Outside Agreement Date. Landlord and Tenant may consult with their selected arbitrators prior to appointment and may select an arbitrator who is favorable to their respective positions. The arbitrators so selected by Landlord and Tenant shall be deemed " Advocate Arbitrators ."

 

2.2.3.2 The two (2) Advocate Arbitrators so appointed shall be specifically required pursuant to an engagement letter within ten (10) days of the date of the appointment of the last appointed Advocate Arbitrator to agree upon and appoint a third arbitrator (" Neutral Arbitrator ") who shall be qualified under the same criteria set forth hereinabove for qualification of the two Advocate Arbitrators, except that neither the Landlord or Tenant or either parties' Advocate Arbitrator may, directly or indirectly, consult with the Neutral Arbitrator prior or subsequent to his or her appearance. The Neutral Arbitrator shall be retained via an engagement letter jointly prepared by Landlord's counsel and Tenant’s counsel.

 

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2.2.3.3 The three arbitrators shall, within thirty (30) days of the appointment of the Neutral Arbitrator, reach a decision as to whether the parties shall use Landlord's or Tenant's submitted Option Rent, and shall notify Landlord and Tenant thereof.

 

2.2.3.4 The  decision  of  the  majority  of  the  three  arbitrators  shall  be  binding upon

Landlord and Tenant.

 

2.2.3.5 If either Landlord or Tenant fails to appoint an Advocate Arbitrator within fifteen

(15) days after the Outside Agreement Date, then either party may petition the presiding judge of the Superior Court of San Mateo County to appoint such Advocate Arbitrator subject to the criteria in Section 2.2.3.1 of this Lease, or if he or she refuses to act, either party may petition any judge having jurisdiction over the parties to appoint such Advocate Arbitrator.

 

2.2.3.6 If the two (2) Advocate Arbitrators fail to agree upon and appoint the Neutral Arbitrator, then either party may petition the presiding judge of the Superior Court of San Mateo County to appoint the Neutral Arbitrator, subject to criteria in Section 2.2.3.1 of this Lease, or if he or she refuses to act, either party may petition any judge having jurisdiction over the parties to appoint such arbitrator.

 

2.2.3.7 The cost of the arbitration shall be paid by Landlord and Tenant equally.

 

2.2.3.8 In the event that the Option Rent shall not have been determined pursuant to the terms hereof prior to the commencement of the Option Term, Tenant shall be required to pay the Option Rent initially provided by Landlord to Tenant, and upon the final determination of the Option Rent, the payments made by Tenant shall be reconciled with the actual amounts of Option Rent due, and the appropriate party shall make any corresponding payment to the other party.

 

3. BASE RENT. Tenant shall pay, without prior notice or demand, to Landlord at the address set forth in Section 4 of the Summary, or, at Landlord's option, at such other place as Landlord may from time to time designate in writing, by a check for currency which, at the time of payment, is legal tender for private or public debts in the United States of America, base rent (" Base Rent ") as set forth in Section 4 of the Summary, payable in equal monthly installments as set forth in Section 4 of the Summary in advance on or before the first day of each and every calendar month during the Lease Term, without any setoff or deduction whatsoever. The Base Rent for the first full month of the Lease Term shall be paid six (6) months prior to the estimated Lease Commencement Date. If any Rent payment date (including the Lease Commencement Date) falls on a day of the month other than the first day of such month or if any payment of Rent is for a period which is shorter than one month, the Rent for any fractional month shall accrue on a daily basis for the period from the date such payment is due to the end of such calendar month or to the end of the Lease Term at a rate per day which is equal to 1/365 of the applicable annual Rent. All other payments or adjustments required to be made under the terms of this Lease that require proration on a time basis shall be prorated on the same basis.

 

4. ADDITIONAL RENT.

 

4.1 General Terms .

 

4.1.1 Direct Expenses; Additional Rent . In addition to paying the Base Rent specified in Article 3 of this Lease, Tenant shall pay " Tenant's Share " of the annual " Direct Expenses ," as those terms are defined in Sections 4.2.6 and 4.2.2 of this Lease, respectively, allocable to the Building as described in Section 4.3 . Such payments by Tenant, together with any and all other amounts payable by Tenant to Landlord pursuant to the terms of this Lease, are hereinafter collectively referred to as the " Additional Rent ", and the Base Rent and the Additional Rent are herein collectively referred to as " Rent ." All amounts due under this Article 4 as Additional Rent shall be payable for the same periods and in the same manner as the Base Rent. Without limitation on other obligations of Tenant which survive the expiration of the Lease Term, the obligations of Tenant to pay the Additional Rent provided for in this Article 4 shall survive the expiration of the Lease Term.

 

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4.1.2 Triple Net Lease . Landlord and Tenant acknowledge that, to the extent provided in this Lease, it is their intent and agreement that this Lease be a " TRIPLE NET " lease and that as such, the provisions contained in this Lease are intended to pass on to Tenant or reimburse Landlord for the costs and expenses reasonably associated with this Lease, the Building and the Project, and Tenant's operation therefrom to the extent provided in this Lease. To the extent such costs and expenses payable by Tenant cannot be charged directly to, and paid by, Tenant, such costs and expenses shall be paid by Landlord but reimbursed by Tenant as Additional Rent.

 

4.2 Definitions of Key Terms Relating to Additional Rent . As used in this Article 4 , the following terms shall have the meanings hereinafter set forth:

 

4.2.1 Intentionally Deleted.

 

4.2.2 " Direct Expenses " shall mean " Operating Expenses " and " Tax Expenses ."

 

4.2.3 " Expense Year " shall mean each calendar year in which any portion of the Lease Term falls, through and including the calendar year in which the Lease Term expires, provided that Landlord, upon notice to Tenant, may change the Expense Year from time to time to any other twelve (12) consecutive month period, and, in the event of any such change, Tenant's Share of Direct Expenses shall be equitably adjusted for any Expense Year involved in any such change.

 

4.2.4 " Operating Expenses " shall mean all expenses, costs and amounts of every kind and nature which Landlord pays or accrues during any Expense Year because of or in connection with the ownership, management, maintenance, security, repair, replacement, restoration or operation of the Project, or any portion thereof. Without limiting the generality of the foregoing, Operating Expenses shall specifically include any and all of the following: (i) the cost of supplying all utilities, the cost of operating, repairing and maintaining the utility, telephone, mechanical, sanitary, storm drainage, and elevator systems, and the cost of maintenance and service contracts in connection therewith; (ii) the cost of licenses, certificates, permits and inspections and the cost of contesting any governmental enactments which are reasonably likely to increase Operating Expenses during the Lease Term, and the costs incurred in connection with a governmentally mandated transportation system management program or similar program; (iii) the cost of all insurance carried by Landlord in connection with the Project and Premises as reasonably determined by Landlord; (iv) the cost of landscaping, relamping, and all supplies, tools, equipment and materials used in the operation, repair and maintenance of the Project, or any portion thereof; (v) the cost of parking area operation, repair, restoration, and maintenance; (vi) management and/or incentive fees, consulting fees, legal fees and accounting fees, of all contractors and consultants in connection with the management, operation, maintenance and repair of the Project; (vii) payments under any equipment rental agreements; (viii) subject to item (f), below, wages, salaries and other compensation and benefits, including taxes levied thereon, of all persons engaged in the operation, maintenance and security of the Project; (ix) costs under any easement pertaining to the sharing of costs by the Project; (x) operation, repair, maintenance and replacement of all systems and equipment and components thereof of the Project; (xi) the cost of janitorial, alarm, security and other services, replacement of wall and floor coverings, ceiling tiles and fixtures in Common Areas, maintenance and replacement of curbs and walkways, repair to roofs and re-roofing; (xii) amortization (including interest on the unamortized cost) over such period of time as Landlord shall reasonably determine, of the cost of acquiring or the rental expense of personal property used in the maintenance, operation and repair of the Project, or any portion thereof; (xiii) the cost of capital improvements or other costs incurred in connection with the Project (A) which are intended to effect economies in the operation or maintenance of the Project, or any portion thereof, or to reduce current or future Operating Expenses or to enhance the safety or security of the Project or its occupants, (B) which are required to comply with present or anticipated conservation programs, (C) which are replacements or modifications of nonstructural items located in the Common Areas required to keep the Common Areas in good order or condition, or (D) which are required under any governmental law or regulation; provided, however, that any capital expenditure shall be amortized (including reasonable interest on the amortized cost) over the reasonable useful life of such capital item; and (xiv) costs, fees, charges or assessments imposed by, or resulting from any mandate imposed on Landlord by, any federal, state or local government for fire and police protection, trash removal, community services, or other services which do not constitute "Tax Expenses" as that term is defined in Section 4.2.5 , below, and (xv) payments under any easement, license, operating agreement, declaration, restrictive covenant, or instrument pertaining to the sharing of costs by the Building, including, without limitation, any covenants, conditions and restrictions affecting the property, and reciprocal easement agreements affecting the property, any

 

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parking licenses, and any agreements with transit agencies affecting the Property (collectively, " Underlying Documents "). Notwithstanding the foregoing, for purposes of this Lease, Operating Expenses shall not, however, include:

 

(a) costs, including legal fees, space planners' fees, advertising and promotional expenses (except as otherwise set forth above), and brokerage fees incurred in connection with the original construction or development, or original or future leasing of the Project, and costs, including permit, license and inspection costs, incurred with respect to the installation of tenant improvements made for new tenants initially occupying space in the Project after the Lease Commencement Date or incurred in renovating or otherwise improving, decorating, painting or redecorating vacant space for tenants or other occupants of the Project (excluding, however, such costs relating to any common areas of the Project or parking facilities);

 

(b) except as set forth in items (xii), (xiii), and (xiv) above, depreciation, interest and principal payments on mortgages and other debt costs, if any, penalties and interest;

 

(c) costs for which the Landlord is reimbursed by any tenant or occupant of the Project or by insurance by its carrier or any tenant's carrier or by anyone else, electric power costs for which any tenant directly contracts with the local public service company and costs of utilities and services provided to other tenants that are not provided to Tenant;

 

(d) any bad debt loss, rent loss, or reserves for bad debts or rent loss or other reserves to the extent not used in the same year;

 

(e) costs associated with the operation of the business of the partnership or entity which constitutes the Landlord, as the same are distinguished from the costs of operation of the Project (which shall specifically include, but not be limited to, accounting costs associated with the operation of the Project). Costs associated with the operation of the business of the partnership or entity which constitutes the Landlord include costs of partnership accounting and legal matters, costs of defending any lawsuits with any mortgagee (except as the actions of the Tenant may be in issue), costs of selling, syndicating, financing, mortgaging or hypothecating any of the Landlord's interest in the Project, and costs incurred in connection with any disputes between Landlord and its employees, between Landlord and Project management, or between Landlord and other tenants or occupants;

 

(f) the wages and benefits of any employee who does not devote substantially all of his or her employed time to the Project unless such wages and benefits are prorated to reflect time spent on operating and managing the Project vis-a-vis time spent on matters unrelated to operating and managing the Project; provided, that in no event shall Operating Expenses for purposes of this Lease include wages and/or benefits attributable to personnel above the level of Project manager;

 

(g) amount paid as ground rental for the Project by the Landlord;

 

(h) except for a property management fee not to exceed three percent (3%) of gross revenues, overhead and profit increment paid to the Landlord, and any amounts paid to the Landlord or to subsidiaries or affiliates of the Landlord for services in the Project to the extent the same exceeds the costs of such services rendered by qualified, first-class unaffiliated third parties on a competitive basis;

 

(i) any compensation paid to clerks, attendants or other persons in commercial concessions operated by the Landlord (other than as direct reimbursement for costs which, if incurred directly by Landlord, would properly be included in Operating Expenses);

 

(j) rentals and other related expenses incurred in leasing air conditioning systems, elevators or other equipment which if purchased the cost of which would be excluded from Operating Expenses as a capital cost, except equipment not affixed to the Project which is used in providing engineering, janitorial or similar services and, further excepting from this exclusion such equipment rented or leased to remedy or ameliorate an emergency condition in the Project;

(a)

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(k) all items and services for which Tenant or any other tenant in the Project reimburses Landlord or which Landlord provides selectively to one or more tenants (other than Tenant) without reimbursement;

 

(l) any costs expressly excluded from Operating Expenses elsewhere in this Lease;

 

(m) rent for the amenities center or for any office space occupied by Project management personnel;

 

(n) costs arising from the gross negligence or willful misconduct of Landlord or its agents, employees or contractors in connection with this Lease;

 

(o) costs incurred to comply with laws relating to the removal or remediation of hazardous material (as defined under applicable law), and any costs of fines or penalties relating to the presence of hazardous material, in each case to the extent not brought into the Building or Premises by Tenant or any Tenant Parties;

 

(p) costs to correct any construction defect in the Project or to remedy any violation of a covenant, condition, restriction, underwriter's requirement or law that exists as of the Lease Commencement Date;

 

(q) capital costs occasioned by casualties or condemnation.

 

(r) legal fees, accountants’ fees (other than normal bookkeeping expenses) and other expenses incurred in connection with disputes of tenants or other occupants of the Project or associated with the enforcement of the terms of any leases with tenants or the defense of Landlord’s title to or interest in the Project or any part thereof;

 

(s) costs incurred due to a violation by Landlord or any other tenant of the Project of the terms and conditions of a lease; and

 

(t) self-insurance retentions and premiums for insurance coverage not customarily paid by tenants of similar projects in the vicinity of the Premises.

 

4.2.5 Taxes .

 

4.2.5.1 " Tax Expenses " shall mean all federal, state, county, or local governmental or municipal taxes, fees, charges or other impositions of every kind and nature, whether general, special, ordinary or extraordinary (including, without limitation, real estate taxes, general and special assessments, transit taxes, leasehold taxes or taxes based upon the receipt of rent, including gross receipts or sales taxes applicable to the receipt of rent, unless required to be paid by Tenant, personal property taxes imposed upon the fixtures, machinery, equipment, apparatus, systems and equipment, appurtenances, furniture and other personal property used in connection with the Project, or any portion thereof), which shall be paid or accrued during any Expense Year (without regard to any different fiscal year used by such governmental or municipal authority) because of or in connection with the ownership, leasing and operation of the Project, or any portion thereof.

 

4.2.5.2 Tax Expenses shall include, without limitation: (i) Any tax on the rent, right to rent or other income from the Project, or any portion thereof, or as against the business of leasing the Project, or any portion thereof; (ii) Any assessment, tax, fee, levy or charge in addition to, or in substitution, partially or totally, of any assessment, tax, fee, levy or charge previously included within the definition of real property tax; (iii) Any assessment, tax, fee, levy, or charge allocable to or measured by the area of the Premises or the Rent payable hereunder, including, without limitation, any business or gross income tax or excise tax with respect to the receipt of such rent, or upon or with respect to the possession, leasing, operating, management, maintenance, alteration, repair, use or occupancy by Tenant of the Premises, or any portion thereof; and (iv) Any assessment, tax, fee, levy or charge, upon this transaction or any document to which Tenant is a party, creating or transferring an interest or an estate in the Premises or the improvements thereon.

 

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4.2.5.3 Any costs and expenses (including, without limitation, reasonable attorneys' and consultants' fees) incurred in attempting to protest, reduce or minimize Tax Expenses shall be included in Tax Expenses in the Expense Year such expenses are incurred. Tax refunds shall be credited against Tax Expenses and refunded to Tenant regardless of when received, based on the Expense Year to which the refund is applicable, provided that in no event shall the amount to be refunded to Tenant for any such Expense Year exceed the total amount paid by Tenant as Additional Rent under this Article 4 for such Expense Year. If Tax Expenses for any period during the Lease Term or any extension thereof are increased after payment thereof for any reason, including, without limitation, error or reassessment by applicable governmental or municipal authorities, Tenant shall pay Landlord upon demand Tenant's Share of any such increased Tax Expenses. Notwithstanding anything to the contrary contained in this Section 4.2.5 , there shall be excluded from Tax Expenses (i) all excess profits taxes, franchise taxes, gift taxes, capital stock taxes, inheritance and succession taxes, transfer taxes, estate taxes, federal and state income taxes, and other taxes to the extent applicable to Landlord's net income (as opposed to rents, receipts or income attributable to operations at the Project), (ii) any items included as Operating Expenses, (iii) any items paid by Tenant under Section 4.5 of this Lease, (iv) assessments in excess of the amount which would be payable if such assessment expense were paid in installments over the longest permitted term; (v) taxes imposed on land and improvements other than the Project; and (vi) tax increases resulting from the improvement of any of the Project for the sole use of other occupants.

 

4.2.6 " Tenant's Share " shall mean the percentage set forth in Section 6 of the Summary.

 

4.3 Allocation of Direct Expenses . The parties acknowledge that the Building is a part of a multi- building project and that the costs and expenses incurred in connection with the Project (i.e., the Direct Expenses) should be shared between the Building and the other buildings in the Project. Accordingly, as set forth in Section 4.2 above, Direct Expenses (which consist of Operating Expenses and Tax Expenses) are determined annually for the Project as a whole, and a portion of the Direct Expenses, which portion shall be determined by Landlord on an equitable basis, shall be allocated to the Building (as opposed to other buildings in the Project). Such portion of Direct Expenses allocated to the Building shall include all Direct Expenses attributable solely to the Building and a pro rata portion of the Direct Expenses attributable to the Project as a whole, and shall not include Direct Expenses attributable solely to other buildings in the Project; provided, however, common amenities, such as the fitness center in the Building, shall be allocated to the Project as a whole (and not to the Building).

 

4.4 Calculation and Payment of Additional Rent . Commencing on the Lease Commencement Date, Tenant shall pay to Landlord, in the manner set forth in Section 4.4.1 , below, and as Additional Rent, Tenant's Share of Direct Expenses for each Expense Year during the Lease Term.

 

4.4.1 Statement of Actual Direct Expenses and Payment by Tenant . Landlord shall give to Tenant within five (5) months following the end of each Expense Year, a statement (the " Statement ") which shall state the Direct Expenses incurred or accrued for such preceding Expense Year, and which shall indicate the amount of Tenant's Share of Direct Expenses. Upon receipt of the Statement for each Expense Year commencing or ending during the Lease Term, Tenant shall pay, with its next installment of Base Rent due that is at least thirty (30) days thereafter, the full amount of Tenant's Share of Direct Expenses for such Expense Year, less the amounts, if any, paid during such Expense Year as " Estimated Direct Expenses ," as that term is defined in Section 4.4.2 , below, and if Tenant paid more as Estimated Direct Expenses than the actual Tenant's Share of Direct Expenses, Tenant shall receive a credit in the amount of Tenant's overpayment against Rent next due under this Lease. The failure of Landlord to timely furnish the Statement for any Expense Year shall not prejudice Landlord or Tenant from enforcing its rights under this Article 4 . Even though the Lease Term has expired and Tenant has vacated the Premises, when the final determination is made of Tenant's Share of Direct Expenses for the Expense Year in which this Lease terminates, Tenant shall immediately pay to Landlord such amount, and if Tenant paid more as Estimated Direct Expenses than the actual Tenant's Share of Direct Expenses, Landlord shall, within thirty (30) days, deliver a check payable to Tenant in the amount of the overpayment. The provisions of this Section 4.4.1 shall survive the expiration or earlier termination of the Lease Term. Notwithstanding the immediately preceding sentence, Tenant shall not be responsible for Tenant’s Share of any Direct Expenses attributable to any Expense Year which are first billed to Tenant more than two (2) calendar years after the earlier of the expiration of the applicable Expense Year or the Lease Expiration Date,

 

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provided that in any event Tenant shall be responsible for Tenant’s Share of Direct Expenses levied by any governmental authority or by any public utility companies at any time following the Lease Expiration Date which are attributable to any Expense Year (provided that Landlord delivers Tenant a bill for such amounts within two (2) years following Landlord’s receipt of the bill therefor).

 

4.4.2 Statement of Estimated Direct Expenses . In addition, Landlord shall give Tenant a yearly expense estimate statement (the " Estimate Statement ") which shall set forth Landlord's reasonable estimate (the " Estimate ") of what the total amount of Direct Expenses for the then-current Expense Year shall be and the estimated Tenant's Share of Direct Expenses (the " Estimated Direct Expenses "). The failure of Landlord to timely furnish the Estimate Statement for any Expense Year shall not preclude Landlord from enforcing its rights to collect any Estimated Direct Expenses under this Article 4 , nor shall Landlord be prohibited from revising any Estimate Statement or Estimated Direct Expenses theretofore delivered to the extent necessary. Thereafter, Tenant shall pay, with its next installment of Base Rent due that is at least thirty (30) days thereafter, a fraction of the Estimated Direct Expenses for the then-current Expense Year (reduced by any amounts paid pursuant to the last sentence of this Section 4.4.2 ). Such fraction shall have as its numerator the number of months which have elapsed in such current Expense Year, including the month of such payment, and twelve (12) as its denominator. Until a new Estimate Statement is furnished (which Landlord shall have the right to deliver to Tenant at any time), Tenant shall pay monthly, with the monthly Base Rent installments, an amount equal to one-twelfth (1/12) of the total Estimated Direct Expenses set forth in the previous Estimate Statement delivered by Landlord to Tenant.

 

4.5 Taxes and Other Charges for Which Tenant Is Directly Responsible . Tenant shall be liable for and shall pay ten (10) days before delinquency, taxes levied against Tenant's equipment, furniture, fixtures and any other personal property located in or about the Premises. If any such taxes on Tenant's equipment, furniture, fixtures and any other personal property are levied against Landlord or Landlord's property or if the assessed value of Landlord's property is increased by the inclusion therein of a value placed upon such equipment, furniture, fixtures or any other personal property and if Landlord pays the taxes based upon such increased assessment, which Landlord shall have the right to do regardless of the validity thereof but only under proper protest if requested by Tenant, Tenant shall upon demand repay to Landlord the taxes so levied against Landlord or the proportion of such taxes resulting from such increase in the assessment, as the case may be.

 

4.6 Landlord's Books and Records . Within one hundred twenty (120) days after receipt by Tenant of a Statement, if Tenant disputes the amount of Additional Rent set forth in the Statement, a member of Tenant's finance department, or an independent certified public accountant (which accountant is a member of a nationally recognized accounting firm and is not working on a contingency fee basis) (" Tenant's Accountant "), designated and paid for by Tenant, may, after reasonable notice to Landlord and at reasonable times, inspect Landlord's records with respect to the Statement at Landlord's offices, provided that there is no existing Event of Default and Tenant has paid all amounts required to be paid under the applicable Estimate Statement and Statement, as the case may be. In connection with such inspection, Tenant and Tenant's agents must agree in advance to follow Landlord's reasonable rules and procedures regarding inspections of Landlord's records, and shall execute a commercially reasonable confidentiality agreement regarding such inspection. Tenant's failure to dispute the amount of Additional Rent set forth in any Statement within one hundred twenty (120) days of Tenant's receipt of such Statement shall be deemed to be Tenant's approval of such Statement and Tenant, thereafter, waives the right or ability to dispute the amounts set forth in such Statement. If after such inspection, Tenant still disputes such Additional Rent, a determination as to the proper amount shall be made, at Tenant's expense, by an independent certified public accountant (the " Accountant ") selected by Landlord and subject to Tenant's reasonable approval; provided that if such Accountant determines that Direct Expenses were overstated by more than five percent (5%), then the cost of the Accountant and the cost of such determination shall be paid for by Landlord, and Landlord shall reimburse Tenant's the cost of the Tenant's Accountant (provided that such cost shall be a reasonable market cost for such services). Tenant hereby acknowledges that Tenant's sole right to inspect Landlord's books and records and to contest the amount of Direct Expenses payable by Tenant shall be as set forth in this Section 4.6 , and Tenant hereby waives any and all other rights pursuant to applicable law to inspect such books and records and/or to contest the amount of Direct Expenses payable by Tenant.

 

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5. USE OF PREMISES.

 

5.1 Permitted Use . Tenant shall use the Premises solely for the Permitted Use set forth in Section 7 of the Summary and Tenant shall not use or permit the Premises or the Project to be used for any other purpose or purposes whatsoever without the prior written consent of Landlord, which may be withheld in Landlord's sole discretion.

 

5.2 Prohibited Uses . Tenant further covenants and agrees that Tenant shall not use or permit any person or persons to use, the Premises or any part thereof for any use or purpose in violation of the laws of the United States of America, the State of California, or the ordinances, regulations or requirements of the local municipal or county governing body or other lawful authorities having jurisdiction over the Project) including, without limitation, any such laws, ordinances, regulations or requirements relating to hazardous materials or substances, as those terms are defined by applicable laws now or hereafter in effect. Landlord shall have the right to impose reasonable, nondiscriminatory and customary rules and regulations regarding the use of the Project that do not unreasonably interfere with Tenant’s use of the Premises, as reasonably deemed necessary by Landlord with respect to the orderly operation of the Project, and Tenant shall comply with such reasonable rules and regulations. Tenant shall not do or permit anything to be done in or about the Premises which will in any way obstruct or interfere with the rights of other tenants or occupants of the Building, or injure or annoy them or use or allow the Premises to be used for any improper, unlawful or objectionable purpose, nor shall Tenant cause, maintain or permit any nuisance in, on or about the Premises. Tenant shall comply with, and Tenant's rights and obligations under the Lease and Tenant's use of the Premises shall be subject and subordinate to, all recorded easements, covenants, conditions, and restrictions now or hereafter affecting the Project, so long as the same do not unreasonably interfere with Tenant’s use of the Premises or parking rights or materially increase Tenant’s obligations or decrease Tenant’s rights under this Lease.

 

 

5.3

Hazardous Materials .

 

5.3.1 Tenant's Obligations .

 

5.3.1.1 Prohibitions . As a material inducement to Landlord to enter into this Lease with Tenant, Tenant has fully and accurately completed Landlord’s Pre-Leasing Environmental Exposure Questionnaire (the " Environmental Questionnaire "), which is attached as Exhibit E . Tenant agrees that except for those chemicals or materials, and their respective quantities, specifically listed on the Environmental Questionnaire (as the same may be updated from time to time as provided below), neither Tenant nor Tenant’s employees, contractors and subcontractors of any tier, entities with a contractual relationship with Tenant (other than Landlord), or any entity acting as an agent or sub-agent of Tenant (collectively, " Tenant's Agents ") will produce, use, store or generate any "Hazardous Materials," as that term is defined below, on, under or about the Premises, nor cause any Hazardous Material to be brought upon, placed, stored, manufactured, generated, blended, handled, recycled, used or "Released," as that term is defined below, on, in, under or about the Premises. If any information provided to Landlord by Tenant on the Environmental Questionnaire, or otherwise relating to information concerning Hazardous Materials is intentionally false, incomplete, or misleading in any material respect, the same shall be deemed a default by Tenant under this Lease. Upon Landlord's request, or in the event of any material change in Tenant's use of Hazardous Materials in the Premises, Tenant shall deliver to Landlord an updated Environmental Questionnaire at least once a year. Tenant shall notify Landlord prior to using any Hazardous Materials in the Premises not described on the initial Environmental Questionnaire, and, to the extent such use would, in Landlord's reasonable judgment, cause a material increase in the risk of liability compared to the uses previously allowed in the Premises, such additional use shall be subject to Landlord's prior consent, which may be withheld in Landlord’s reasonable discretion. Tenant shall not install or permit Tenant's Agents to install any underground storage tank on the Premises. For purposes of this Lease, " Hazardous Materials " means all flammable explosives, petroleum and petroleum products, waste oil, radon, radioactive materials, toxic pollutants, asbestos, polychlorinated biphenyls (" PCBs "), medical waste, chemicals known to cause cancer or reproductive toxicity, pollutants, contaminants, hazardous wastes, toxic substances or related materials, including without limitation any chemical, element, compound, mixture, solution, substance, object, waste or any combination thereof, which is or may be hazardous to human health, safety or to the environment due to its radioactivity, ignitability, corrosiveness, reactivity, explosiveness, toxicity, carcinogenicity, infectiousness or other harmful or potentially harmful properties or effects, or defined as, regulated as or included in, the definition of "hazardous substances," "hazardous wastes," "hazardous materials," or "toxic substances" under any Environmental

 

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Laws. For purposes of this Lease, " Release " or " Released " or " Releases " shall mean any release, deposit, discharge, emission, leaking, spilling, seeping, migrating, injecting, pumping, pouring, emptying, escaping, dumping, disposing, or other movement of Hazardous Materials into the environment. Landlord acknowledges that Tenant will be installing and using fume hoods in the Premises and that emissions of Hazardous Materials into the air in compliance with all Environmental Laws shall not be considered Releases.

 

5.3.1.2 Notices to Landlord . Tenant shall notify Landlord in writing as soon as possible but in no event later than five (5) days after (i) the occurrence of any actual, alleged or threatened Release of any Hazardous Material in, on, under, from, about or in the vicinity of the Premises (whether past or present), regardless of the source or quantity of any such Release, or (ii) Tenant becomes aware of any regulatory actions, inquiries, inspections, investigations, directives, or any cleanup, compliance, enforcement or abatement proceedings (including any threatened or contemplated investigations or proceedings) relating to or potentially affecting the Premises, or

(iii) Tenant becomes aware of any claims by any person or entity relating to any Hazardous Materials in, on, under, from, about or in the vicinity of the Premises, whether relating to damage, contribution, cost recovery, compensation, loss or injury. Collectively, the matters set forth in clauses (i), (ii) and (iii) above are hereinafter referred to as " Hazardous Materials Claims ". Tenant shall promptly forward to Landlord copies of all orders, notices, permits, applications and other communications and reports in connection with any Hazardous Materials Claims. Additionally, Tenant shall promptly advise Landlord in writing of Tenant’s discovery of any occurrence or condition on, in, under or about the Premises that could subject Tenant or Landlord to any liability, or restrictions on ownership, occupancy, transferability or use of the Premises under any "Environmental Laws," as that term is defined below. Tenant shall not enter into any legal proceeding or other action, settlement, consent decree or other compromise with respect to any Hazardous Materials Claims without first notifying Landlord of Tenant’s intention to do so and affording Landlord the opportunity to join and participate, as a party if Landlord so elects, in such proceedings and in no event shall Tenant enter into any agreements which are binding on Landlord or the Premises without Landlord’s prior written consent. Landlord shall have the right to appear at and participate in, any and all legal or other administrative proceedings concerning any Hazardous Materials Claim. For purposes of this Lease, " Environmental Laws " means all applicable present and future laws relating to the protection of human health, safety, wildlife or the environment, including, without limitation, (i) all requirements pertaining to reporting, licensing, permitting, investigation and/or remediation of emissions, discharges, Releases, or threatened Releases of Hazardous Materials, whether solid, liquid, or gaseous in nature, into the air, surface water, groundwater, or land, or relating to the manufacture, processing, distribution, use, treatment, storage, disposal, transport, or handling of Hazardous Materials; and (ii) all requirements pertaining to the health and safety of employees or the public. Environmental Laws include, but are not limited to, the Comprehensive Environmental Response, Compensation and Liability Act of 1980, 42 USC § 9601, et seq., the Hazardous Materials Transportation Authorization Act of 1994, 49 USC § 5101, et seq., the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act of 1976, and Hazardous and Solid Waste Amendments of 1984, 42 USC § 6901, et seq., the Federal Water Pollution Control Act, as amended by the Clean Water Act of 1977, 33 USC § 1251, et seq., the Clean Air Act of 1966, 42 USC § 7401, et seq., the Toxic Substances Control Act of 1976, 15 USC § 2601, et seq., the Safe Drinking Water Act of 1974, 42 USC §§ 300f through 300j, the Occupational Safety and Health Act of 1970, as amended, 29 USC § 651 et seq., the Oil Pollution Act of 1990, 33 USC

§ 2701 et seq., the Emergency Planning and Community Right-To-Know Act of 1986, 42 USC § 11001 et seq., the National Environmental Policy Act of 1969, 42 USC § 4321 et seq., the Federal Insecticide, Fungicide and Rodenticide Act of 1947, 7 USC § 136 et seq., California Carpenter-Presley-Tanner Hazardous Substance Account Act, California Health & Safety Code §§ 25300 et seq., Hazardous Materials Release Response Plans and Inventory Act, California Health & Safety Code, §§ 25500 et seq., Underground Storage of Hazardous Substances provisions, California Health & Safety Code, §§ 25280 et seq., California Hazardous Waste Control Law, California Health & Safety Code, §§ 25100 et seq., and any other state or local law counterparts, as amended, as such applicable laws, are in effect as of the Lease Commencement Date, or thereafter adopted, published, or promulgated.

 

5.3.1.3 Releases of Hazardous Materials . If any Release of any Hazardous Material in, on, under, from or about the Premises shall occur at any time during the Lease by Tenant or Tenant's Agents, in addition to notifying Landlord as specified above, Tenant, at its own sole cost and expense, shall (i) immediately comply with any and all reporting requirements imposed pursuant to any and all Environmental Laws, (ii) provide a written certification to Landlord indicating that Tenant has complied with all applicable reporting requirements,

(iii) take any and all necessary investigation, corrective and remedial action in accordance with any and all applicable Environmental Laws, utilizing an environmental consultant approved by Landlord, all in accordance with the

 

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provisions and requirements of this Section 5.3 , including, without limitation, Section 5.3.4 , and (iv) take any such additional investigative, remedial and corrective actions as Landlord shall in its reasonable discretion deem necessary such that the Premises are remediated to the condition existing prior to such Release.

 

 

5.3.1.4

Indemnification .

 

5.3.1.4.1 In General . Without limiting in any way Tenant’s obligations under any other provision of this Lease, Tenant shall be solely responsible for and shall protect, defend, indemnify and hold the Landlord Parties harmless from and against any and all claims, judgments, losses, damages, costs, expenses, penalties, enforcement actions, taxes, fines, remedial actions, liabilities (including, without limitation, actual attorneys’ fees, litigation, arbitration and administrative proceeding costs, expert and consultant fees and laboratory costs) including, without limitation, consequential damages and sums paid in settlement of claims, which arise during or after the Lease Term, whether foreseeable or unforeseeable, that arise during or after the Lease Term in whole or in part, foreseeable or unforeseeable, directly or indirectly arising out of or attributable to the Release of Hazardous Materials in, on, under or about the Premises by Tenant or Tenant's Agents.

 

5.3.1.4.2 Limitations . Notwithstanding anything in Section 5.3.1.4 , above, to the contrary, Tenant's indemnity of Landlord as set forth in Section 5.3.1.4 , above, shall not be applicable to claims based upon Hazardous Materials not Released by Tenant or Tenant's Agents.

 

5.3.1.4.3 Landlord Indemnity . Under no circumstance shall Tenant be liable for, and Landlord shall indemnify, defend, protect and hold harmless Tenant and Tenant's Agents from and against, all losses, costs, claims, liabilities and damages (including attorneys’ and consultants’ fees) arising out of any Hazardous Materials that exist in, on or about the Project as of the date hereof, or Hazardous Material Released by Landlord or any Landlord Parties. Landlord will provide Tenant with any Hazardous Material reports relating to the Building that Landlord has in its immediate possession. The provision of such reports shall be for informational purposes only, and Landlord does not make any representation or warranty as to the correctness or completeness of any such reports.

 

5.3.1.5 Compliance with Environmental Laws . Without limiting the generality of Tenant’s obligation to comply with applicable laws as otherwise provided in this Lease, Tenant shall, at its sole cost and expense, comply with all Environmental Laws related to the use of Hazardous Materials by Tenant and Tenant’s Agents. Tenant shall obtain and maintain any and all necessary permits, licenses, certifications and approvals appropriate or required for the use, handling, storage, and disposal of any Hazardous Materials used, stored, generated, transported, handled, blended, or recycled by Tenant on the Premises. Landlord shall have a continuing right, without obligation, to require Tenant to obtain, and to review and inspect any and all such permits, licenses, certifications and approvals, together with copies of any and all Hazardous Materials management plans and programs, any and all Hazardous Materials risk management and pollution prevention programs, and any and all Hazardous Materials emergency response and employee training programs respecting Tenant’s use of Hazardous Materials. Upon request of Landlord, Tenant shall deliver to Landlord a narrative description explaining the nature and scope of Tenant’s activities involving Hazardous Materials and showing to Landlord’s satisfaction compliance with all Environmental Laws and the terms of this Lease.

 

 

5.3.2

Assurance of Performance .

 

5.3.2.1 Environmental Assessments In General . Landlord may, but shall not be required to, engage from time to time such contractors as Landlord determines to be appropriate (and which are reasonably acceptable to Tenant) to perform environmental assessments of a scope reasonably determined by Landlord (an " Environmental Assessment ") to ensure Tenant’s compliance with the requirements of this Lease with respect to Hazardous Materials.

 

5.3.2.2 Costs of Environmental Assessments . All costs and expenses incurred by Landlord in connection with any such Environmental Assessment initially shall be paid by Landlord; provided that if any such Environmental Assessment shows that Tenant has failed to comply with the provisions of this Section 5.3 ,then all of the costs and expenses of such Environmental Assessment shall be reimbursed by Tenant as Additional Rent within thirty (30) days after receipt of written demand therefor.

 

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5.3.3 Tenant’s Obligations upon Surrender . At the expiration or earlier termination of the Lease Term, Tenant, at Tenant’s sole cost and expense, shall: (i) cause an Environmental Assessment of the Premises to be conducted in accordance with Section 15.3 ; (ii) cause all Hazardous Materials brought onto the Premises by Tenant or Tenant's Agents to be removed from the Premises and disposed of in accordance with all Environmental Laws and as necessary to allow the Premises to be used for the purposes allowed as of the date of this Lease; and

(iii) cause to be removed all containers installed or used by Tenant or Tenant’s Agents to store any Hazardous Materials on the Premises, and cause to be repaired any damage to the Premises caused by such removal.

 

5.3.4 Clean-up .

 

5.3.4.1 Environmental Reports; Clean-Up . If any written report, including any report containing results of any Environmental Assessment (an " Environmental Report ") shall indicate (i) the presence of any Hazardous Materials as to which Tenant has a removal or remediation obligation under this Section 5.3 , and

(ii) that as a result of same, the investigation, characterization, monitoring, assessment, repair, closure, remediation, removal, or other clean-up (the " Clean-up ") of any Hazardous Materials is required, Tenant shall immediately prepare and submit to Landlord within thirty (30) days after receipt of the Environmental Report a comprehensive plan, subject to Landlord’s written approval, specifying the actions to be taken by Tenant to perform the Clean-up so that the Premises are restored to the conditions required by this Lease. Upon Landlord’s approval of the Clean-up plan, Tenant shall, at Tenant’s sole cost and expense, without limitation on any rights and remedies of Landlord under this Lease, immediately implement such plan with a consultant reasonably acceptable to Landlord and proceed to Clean-Up Hazardous Materials in accordance with all applicable laws. If, within thirty (30) days after receiving a copy of such Environmental Report, Tenant fails either (a) to complete such Clean-up, or (b) with respect to any Clean-up that cannot be completed within such thirty-day period, fails to proceed with diligence to prepare the Clean-up plan and complete the Clean-up as promptly as practicable, then Landlord shall have the right, but not the obligation, and without waiving any other rights under this Lease, to carry out any Clean-up recommended by the Environmental Report or required by any governmental authority having jurisdiction over the Premises, and recover all of the costs and expenses thereof from Tenant as Additional Rent, payable within ten (10) days after receipt of written demand therefor.

 

5.3.4.2 No Rent Abatement . Tenant shall continue to pay all Rent due or accruing under this Lease during any Clean-up, and shall not be entitled to any reduction, offset or deferral of any Base Rent or Additional Rent due or accruing under this Lease during any such Clean-up.

 

5.3.4.3 Surrender of Premises . Tenant shall complete any Clean-up prior to surrender of the Premises upon the expiration or earlier termination of this Lease.  Tenant shall obtain and deliver to Landlord a letter or other written determination from the overseeing governmental authority confirming that the Clean-up has been completed in accordance with all requirements of such governmental authority and that no further response action of any kind is required for the unrestricted use of the Premises (" Closure Letter "). Upon the expiration or earlier termination of this Lease, Tenant shall also be obligated to close all permits obtained in connection with Hazardous Materials used by Tenant or Tenant's Agents in accordance with applicable laws.

 

5.3.4.4 Failure to Timely Clean-Up . Should any Clean-up for which Tenant is responsible not be completed, or should Tenant not receive the Closure Letter and any governmental approvals required under Environmental Laws in conjunction with such Clean-up prior to the expiration or earlier termination of this Lease, then, commencing on the later of the termination of this Lease and three (3) business days after Landlord's delivery of notice of such failure and that it elects to treat such failure as a holdover, Tenant shall be liable to Landlord as a holdover tenant (as more particularly provided in Article 16 ) until Tenant has fully complied with its obligations under this Section 5.3 .

 

5.3.5 Confidentiality . Unless compelled to do so by applicable law, Tenant agrees that Tenant shall not disclose, discuss, disseminate or copy any information, data, findings, communications, conclusions and reports regarding the environmental condition of the Premises to any Person (other than Tenant’s consultants,

 

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attorneys, property managers, employees, shareholders and potential and actual investors, lenders, business and merger partners, subtenants and assignees that have a need to know such information), including any governmental authority, without the prior written consent of Landlord. In the event Tenant reasonably believes that disclosure is compelled by applicable law, it shall provide Landlord ten (10) days’ advance notice of disclosure of confidential information so that Landlord may attempt to obtain a protective order. Tenant may additionally release such information to bona fide prospective purchasers or lenders, subject to any such parties’ written agreement to be bound by the terms of this Section 5.3 .

 

5.3.6 Copies of Environmental Reports . Within thirty (30) days of receipt thereof, Tenant shall provide Landlord with a copy of any and all environmental assessments, audits, studies and reports regarding Tenant’s activities with respect to the Premises, or ground water beneath the Land, or the environmental condition or Clean-up thereof. Tenant shall be obligated to provide Landlord with a copy of such materials without regard to whether such materials are generated by Tenant or prepared for Tenant, or how Tenant comes into possession of such materials.

 

5.3.7 Signs, Response Plans, Etc . Tenant shall be responsible for posting on the Premises any signs required under applicable Environmental Laws with respect to the use of Hazardous Materials by Tenant or Tenant's Agents. Tenant shall also complete and file any business response plans or inventories required by any applicable laws. Tenant shall concurrently file a copy of any such business response plan or inventory with Landlord.

 

5.3.8 Survival . Each covenant, agreement, representation, warranty and indemnification made by Tenant set forth in this Section 5.3 shall survive the expiration or earlier termination of this Lease and shall remain effective until all of Tenant’s obligations under this Section 5.3 have been completely performed and satisfied.

 

6. SERVICES AND UTILITIES.

 

6.1 In General . Landlord will be responsible, at Tenant's sole cost and expense (subject to the terms  of Section 4.2.4 , above), for the furnishing of heating, ventilation and air-conditioning, electricity, and water services to the Premises. Landlord shall not provide janitorial or telephone services for the Premises. Tenant shall be solely responsible for performing all janitorial services and other cleaning of the Premises, all in compliance with applicable laws. The janitorial and cleaning of the Premises shall be adequate to maintain the Premises in a manner consistent with First Class Life Sciences Projects.

 

Tenant shall cooperate fully with Landlord at all times and abide by all reasonable regulations and requirements that Landlord may reasonably prescribe for the proper functioning and protection of the HVAC, electrical, mechanical and plumbing systems. Provided that Landlord agrees to provide and maintain and keep in continuous service utility connections to the Project, including electricity, water and sewage connections, Landlord shall have no obligation to provide any services or utilities (including process utilities) to the Building, including, but not limited to heating, ventilation and air-conditioning, electricity, water, telephone, janitorial and interior Building security services, except as set forth in this Section 6.1 , above.

 

6.2 Tenant Payment of Utilities Costs . After the Lease Commencement Date to the extent that any utilities (including without limitation, electricity, gas, sewer and water) to the Building are separately metered or sub- metered to the Premises, such utilities shall either be contracted for and paid directly by Tenant to the applicable utility provider, or reimbursed by Tenant to Landlord within thirty (30) days after billing. After the Lease Commencement Date, to the extent that any utilities (including without limitation, electricity, gas, sewer and water) to the Building are not separately metered to the Premises, then Tenant shall pay to Landlord, within thirty (30) days after billing, an equitable portion of the Building utility costs, based on Tenant's proportionate use thereof. The majority of utilities to the Building will be separately metered (or sub-metered) in the Premises. To the extent any utilities are not separately metered, Tenant shall be responsible for its equitable share of such utility costs.

 

6.3 Interruption of Use . Tenant agrees that Landlord shall not be liable for damages, by abatement of Rent or otherwise, for failure to furnish or delay in furnishing any service or utility (including, without limitation, telephone and telecommunication services, UPS services, or other laboratory services or utilities), or for any diminution in the quality or quantity thereof, when such failure or delay or diminution is occasioned, in whole or   in

 

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part, by breakage, repairs, replacements, or improvements, by any strike, lockout or other labor trouble, by inability to secure electricity, gas, water, or other fuel at the Building or Project after reasonable effort to do so, by any riot or other dangerous condition, emergency, accident or casualty whatsoever, by act or default of Tenant or other parties, or by any other cause; and such failures or delays or diminution shall never be deemed to constitute an eviction or disturbance of Tenant's use and possession of the Premises or relieve Tenant from paying Rent or performing any of its obligations under this Lease. Notwithstanding the foregoing, Landlord may be liable for damages to the extent caused by the negligence or willful misconduct of Landlord or the Landlord Parties, provided that Landlord shall not be liable under any circumstances for injury to, or interference with, Tenant's business, including, without limitation, loss of profits, however occurring, through or in connection with or incidental to a failure to furnish any of the services or utilities as set forth in this Article 6 .

 

6.4 Energy Performance Disclosure Information . Tenant hereby acknowledges that Landlord may be required to disclose certain information concerning the energy performance of the Building pursuant to California Public Resources Code Section 25402.10 and the regulations adopted pursuant thereto (collectively the " Energy Disclosure Requirements "). Tenant hereby acknowledges prior receipt of the Data Verification Checklist, as defined in the Energy Disclosure Requirements (the " Energy Disclosure Information "), and agrees that Landlord has timely complied in full with Landlord’s obligations under the Energy Disclosure Requirements. Tenant acknowledges and agrees that (i) Landlord makes no representation or warranty regarding the energy performance of the Building or the accuracy or completeness of the Energy Disclosure Information, (ii) the Energy Disclosure Information is for the current occupancy and use of the Building and that the energy performance of the Building may vary depending on future occupancy and/or use of the Building, and (iii) Landlord shall have no liability to Tenant for any errors or omissions in the Energy Disclosure Information. If and to the extent not prohibited by applicable laws, Tenant hereby waives any right Tenant may have to receive the Energy Disclosure Information, including, without limitation, any right Tenant may have to terminate this Lease as a result of Landlord’s failure to disclose such information. Further, Tenant hereby releases Landlord from any and all losses, costs, damages, expenses and/or liabilities relating to, arising out of and/or resulting from the Energy Disclosure Requirements, including, without limitation, any liabilities arising as a result of Landlord’s failure to disclose the Energy Disclosure Information to Tenant prior to the execution of this Lease. Tenant’s acknowledgment of the AS-IS condition of the Premises pursuant to the terms of this Lease shall be deemed to include the energy performance of the Building. Tenant further acknowledges that pursuant to the Energy Disclosure Requirements, Landlord may be required in the future to disclose information concerning Tenant’s energy usage to certain third parties, including, without limitation, prospective purchasers, lenders and tenants of the Building (the " Tenant Energy Use Disclosure "). Tenant hereby (A) consents to all such Tenant Energy Use Disclosures, and

(B) acknowledges that Landlord shall not be required to notify Tenant of any Tenant Energy Use Disclosure. Further, Tenant hereby releases Landlord from any and all losses, costs, damages, expenses and liabilities relating to, arising out of and/or resulting from any Tenant Energy Use Disclosure. The terms of this Section 6.3 shall survive the expiration or earlier termination of this Lease.

 

6.5 Generator . Commencing on the Lease Commencement Date, Tenant shall have the right to connect to the Building back-up generator, which Landlord shall install as part of Landlord’s Work (the " Generator "), for Tenant’s Share of the Generator’s capacity (after accounting for Building Common Area requirements) to provide back-up generator services to the Premises. During the Lease Term, Landlord shall maintain the Generator in good condition and repair, and Tenant shall be responsible for a share of the costs of such maintenance and repair based on the proportion of the Generator capacity allocated to the Premises. Notwithstanding the foregoing, Landlord shall not be liable for any damages whatsoever resulting from any failure in operation of the Generator, or the failure of the Generator to provide suitable or adequate back-up power to the Premises, including but not limited to, loss of profits, loss of rents or other revenues, loss of business opportunity, loss of goodwill or loss of use, in each case, however occurring, or loss to inventory, scientific research, scientific experiments, laboratory animals, products, specimens, samples, and/or scientific, business, accounting and other records of every kind and description kept at the Premises and any and all income derived or derivable therefrom.

 

6.6 Storage Room . Tenant shall have the right to utilize storage space in the storage room to be constructed by Landlord in the Building pursuant to Schedule 1 to Exhibit B (the " Storage Room "), for up to Tenant’s Share of the Storage Room's storage capacity, provided that Tenant shall be responsible for providing any equipment or modifications (e.g., (self-contained bunkers, dedicated exhaust, additional fire rating, etc.) to support Tenant's specific usage and Landlord shall demise by chain link fence Tenant's Share of the usable space of the Storage Room.

 

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During the Lease Term, Landlord shall maintain the Storage Room in good condition and repair, and Tenant shall be responsible for a share of the costs of such maintenance and repair based on the proportion of the capacity of the Storage Room allocated to Tenant's use (subject to the provisions of Section 4.2.4 above). Notwithstanding the foregoing, Landlord shall not be liable for any damages whatsoever resulting from any failure in operation of the Storage Room, or the failure of the Storage Room to provide suitable or adequate storage of Tenant's chemicals, including but not limited to, loss of profits, loss of rents or other revenues, loss of business opportunity, loss of goodwill or loss of use, in each case, however occurring, or loss to inventory, scientific research, scientific experiments, laboratory animals, products, specimens, samples, and/or scientific, business, accounting and other records of every kind and description kept at the Storage Room or the Premises and any and all income derived or derivable therefrom.

 

7. REPAIRS .

 

7.1 Tenant Repair Obligations . Tenant shall, throughout the Term, at its sole cost and expense, maintain, repair or replace as required, the Premises in a good standard of maintenance, repair and replacement as required, and in good and sanitary condition, all in accordance with the standards of First Class Life Sciences Projects, except for the Landlord Repair Obligations, whether or not such maintenance, repair, replacement or improvement is required in order to comply with applicable Laws (" Tenant's Repair Obligations "), including without limitation, all electrical facilities and equipment, including lighting fixtures, lamps, fans and any exhaust equipment and systems, electrical motors and all other appliances and equipment of every kind and nature located in the Premises; all communications systems serving the Premises; all of Tenant's security systems in or about or serving the Premises; Tenant's signage; interior demising walls and partitions (including painting and wall coverings), equipment, floors. Tenant shall additionally be responsible, at Tenant’s sole cost and expense, to furnish all expendables, including light bulbs, paper goods and soaps, used in the Premises.

 

7.2 Landlord Repair Obligations . Landlord shall be responsible, as a part of Operating Expenses, for repairs to and routine maintenance of the Building including without limitation: (1) exterior windows, window frames, window casements (including the repairing, resealing, cleaning and replacing of exterior windows); (2) exterior doors, door frames and door closers; (3) the Building (as opposed to the Premises) and Project plumbing, sewer, drainage, electrical, fire protection, life safety and security systems and equipment, existing heating, ventilation and air- conditioning systems, and all other mechanical and HVAC systems and equipment (collectively, the " Building Systems "), (4) the exterior glass, exterior walls, foundation and roof of the Building, the structural portions of the floors of the Building, including, without limitation, any painting, sealing, patching and waterproofing of exterior walls, and (5) repairs to the elevator in the Building and underground utilities, except to the extent that any such repairs are required due to the negligence or willful misconduct of Tenant (the " Landlord Repair Obligations "); provided, however, that if such repairs are due to the negligence or willful misconduct of Tenant, Landlord shall nevertheless make such repairs at Tenant's expense, or, if covered by Landlord's insurance, Tenant shall only be obligated to pay any deductible in connection therewith. Costs expended by Landlord in connection with the Landlord Repair Obligations shall be included in Operating Expenses to the extent allowed pursuant to the terms of Article 4 , above. Landlord shall cooperate with Tenant to enforce any warranties that Landlord holds that could reduce Tenant's maintenance obligations under this Lease.

 

7.3 Tenant's Right to Make Repairs . Notwithstanding any provision to the contrary contained in this Lease, if Tenant provides written notice to Landlord of an event or circumstance which requires the action of Landlord under this Lease with respect to repair and/or maintenance required in the Premises, including repairs to the portions of the Building located within the Premises that are Landlord’s responsibility under Section 7.4 (the " Base Building "), which event or circumstance with respect to the Base Building materially and adversely affects the conduct of Tenant’s business from the Premises, and Landlord fails to commence corrective action within a reasonable period of time, given the circumstances, after the receipt of such notice, but in any event not later than thirty (30) days after receipt of said notice (unless Landlord’s obligation cannot reasonably be performed within thirty (30) days, in which event Landlord shall be allowed additional time as is reasonably necessary to perform the obligation so long as Landlord begins performance within the initial thirty (30) days and diligently pursues performance to completion), or, in the event of an Emergency (as defined below), not later than five (5) business days after receipt of such notice, then Tenant shall have the right to undertake such actions as may be reasonably necessary to make such repairs if Landlord thereafter fails to commence corrective action within five (5) business days following Landlord's receipt of a second

 

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written notice from Tenant specifying that Tenant will undertake such actions if Landlord fails to timely do so (provided that such notice shall include the following language in bold, capitalized text: " IF LANDLORD FAILS TO COMMENCE THE REPAIRS DESCRIBED IN THIS LETTER WITHIN FIVE (5) BUSINESS DAYS FROM LANDLORD'S RECEIPT OF THIS LETTER, TENANT WILL PERFORM SUCH REPAIRS AT

LANDLORD'S EXPENSE "; provided, however, that in no event shall Tenant undertake any actions that could materially or adversely affect the Base Building. Notwithstanding the foregoing, in the event of an Emergency, no second written notice shall be required as long as Tenant advises Landlord in the first written notice of Tenant's intent to perform such Emergency repairs if Landlord does not commence the same within such five (5) business day period, utilizing the language required in second notices. If such action was required under the terms of this Lease to be taken by Landlord and was not commenced by Landlord within such five (5) business day period and thereafter diligently pursued to completion, then Tenant shall be entitled to prompt reimbursement by Landlord of the reasonable out-of- pocket third-party costs and expenses actually incurred by Tenant in taking such action. If Tenant undertakes such corrective actions pursuant to this Section 7.3 , then (a) the insurance and indemnity provisions set forth in this Lease shall apply to Tenant's performance of such corrective actions, (b) Tenant shall proceed in accordance with all applicable laws, (c) Tenant shall retain to perform such corrective actions only such reputable contractors and suppliers as are duly licensed and qualified, (d) Tenant shall effect such repairs in a good and workmanlike and commercially reasonable manner, (e) Tenant shall use new or like new materials, and (f) Tenant shall take reasonable efforts to minimize any material interference or impact on the other tenants and occupants of the Building. Promptly following completion of any work taken by Tenant pursuant to the terms of this Section 7.5, Tenant shall deliver a detailed invoice of the work completed, the materials used and the costs relating thereto, and Landlord shall reimburse Tenant the amounts expended by Tenant in connection with such work, provided that Landlord shall have the right to object if Landlord claims that such action did not have to be taken by Landlord pursuant to the terms of this Lease or that the charges are excessive (in which case Landlord shall pay the amount it contends would not have been excessive). For purposes of this Section 7.5 , an " Emergency " shall mean an event threatening immediate and material danger to people located in the Building or immediate, material damage to the Building, Base Building, or creating a realistic possibility of an immediate and material interference with, or immediate and material interruption of a material aspect of Tenant's business operations.

 

8. ADDITIONS AND ALTERATIONS.

 

8.1 Landlord's Consent to Alterations . Tenant may not make any improvements, alterations, additions or changes to the Premises or any mechanical, plumbing or HVAC facilities or systems pertaining to the Premises (collectively, the " Alterations ") without first procuring the prior written consent of Landlord to such Alterations, which consent shall be requested by Tenant not less than ten (10) business days prior to the commencement thereof, and which consent shall not be unreasonably withheld by Landlord, provided it shall be deemed reasonable for Landlord to withhold its consent to any Alteration which adversely affects the structural portions or the systems or equipment of the Building or is visible from the exterior of the Building. Notwithstanding the foregoing, Tenant shall be permitted to make Alterations following ten (10) business days' notice to Landlord (as to Alterations costing more than $10,000 only), but without Landlord's prior consent, to the extent that such Alterations

(i) do not affect the building systems or equipment (other than minor changes such as adding or relocating electrical outlets and thermostats), (ii) are not visible from the exterior of the Building, and (iii) cost less than $100,000.00 for a particular job of work. The construction of the Tenant Improvements to the Premises shall be governed by the terms of the Tenant Work Letter and not the terms of this Article 8 .

 

8.2 Manner of Construction . Landlord may impose, as a condition of its consent to any and all Alterations or repairs of the Premises or about the Premises, such requirements as Landlord in its reasonable discretion may deem desirable, including, but not limited to, the requirement that upon Landlord's request, Tenant shall, at Tenant's expense, remove such Alterations upon the expiration or any early termination of the Lease Term. Tenant shall construct such Alterations and perform such repairs in a good and workmanlike manner, in conformance with any and all applicable federal, state, county or municipal laws, rules and regulations and pursuant to a valid building permit, issued by the city in which the Building is located (or other applicable governmental authority). Tenant shall not use (and upon notice from Landlord shall cease using) contractors, services, workmen, labor, materials or equipment that, in Landlord's reasonable judgment, would disturb labor harmony with the workforce or trades engaged in performing other work, labor or services in or about the Building or the Common Areas. Upon completion of any Alterations, Tenant shall deliver to Landlord final lien waivers from all contractors, subcontractors and materialmen

 

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who performed such work. In addition to Tenant's obligations under Article 9 of this Lease, upon completion of any Alterations, Tenant agrees to cause a Notice of Completion to be recorded in the office of the Recorder of the County of San Mateo in accordance with Section 3093 of the Civil Code of the State of California or any successor statute, and Tenant shall deliver to the Project construction manager a reproducible copy of the " as built " drawings of the Alterations as well as all permits, approvals and other documents issued by any governmental agency in connection with the Alterations.

 

8.3 Payment for Improvements . In connection with any Alterations that affect the Building systems (other than minor changes such as adding or relocating electrical outlets and thermostats), or which have a cost in excess of $100,000, Tenant shall reimburse Landlord for Landlord's reasonable, actual, out-of-pocket costs and expenses actually incurred in connection with Landlord's review of such work.

 

8.4 Construction Insurance . In addition to the requirements of Article 10 of this Lease, in the event that Tenant makes any Alterations, prior to the commencement of such Alterations, Tenant shall provide Landlord with evidence that Tenant or Tenant's contractor carries " Builder's All Risk " insurance (to the extent that the cost of such work shall exceed $100,000) in an amount approved by Landlord covering the construction of such Alterations, and such other insurance as Landlord may reasonably require, it being understood and agreed that all of such Alterations shall be insured by Landlord pursuant to Article 10 of this Lease immediately upon completion thereof. In addition, Tenant's contractors and subcontractors shall be required to carry Commercial General Liability Insurance in an amount approved by Landlord and otherwise in accordance with the requirements of Article 10 of this Lease. In connection with Alterations with a cost in excess of $250,000, Landlord may, in its reasonable discretion, require Tenant to obtain a lien and completion bond or some alternate form of security satisfactory to Landlord in an amount sufficient to ensure the lien-free completion of such Alterations and naming Landlord as a co-obligee.

 

8.5 Landlord's Property . All Alterations, improvements, fixtures, equipment and/or appurtenances which may be installed or placed in or about the Premises, from time to time, shall be at the sole cost of Tenant and all Alterations and improvements, shall be and become the property of Landlord and remain in place at the Premises following the expiration or earlier termination of this Lease. Notwithstanding the foregoing, Landlord may, by written notice to Tenant given at the time it consents to an Alteration, require Tenant, at Tenant's expense, to remove any Alterations within the Premises and to repair any damage to the Premises and Building caused by such removal. If Tenant fails to complete such removal and/or to repair any damage caused by the removal of any Alterations, Landlord may do so and may charge the cost thereof to Tenant. Tenant hereby protects, defends, indemnifies and holds Landlord harmless from any liability, cost, obligation, expense or claim of lien in any manner relating to the installation, placement, removal or financing of any such Alterations, improvements, fixtures and/or equipment in, on or about the Premises, which obligations of Tenant shall survive the expiration or earlier termination of this Lease. Notwithstanding the foregoing, except to the extent the same are paid for by the Tenant Improvement Allowance, the items set forth in Exhibit F attached hereto (the " Tenant's Property ") shall at all times be and remain Tenant's property. Exhibit F may be updated from time to time by agreement of the parties. Tenant may remove the Tenant's Property from the Premises at any time, provided that Tenant repairs all damage caused by such removal. Landlord shall have no lien or other interest in the Tenant's Property.

 

9. COVENANT AGAINST LIENS. Tenant shall keep the Project and Premises free from any liens or encumbrances arising out of the work performed, materials furnished or obligations incurred by or on behalf of Tenant, and shall protect, defend, indemnify and hold Landlord harmless from and against any claims, liabilities, judgments or costs (including, without limitation, reasonable attorneys' fees and costs) arising out of same or in connection therewith. Except as to Alterations as to which no notice is required under the second sentence of Section 8.1 , Tenant shall give Landlord notice at least ten (10) business days prior to the commencement of any such work on the Premises (or such additional time as may be necessary under applicable laws) to afford Landlord the opportunity of posting and recording appropriate notices of non-responsibility (to the extent applicable pursuant to then applicable laws). Tenant shall remove any such lien or encumbrance by bond or otherwise within ten (10) business days after notice by Landlord, and if Tenant shall fail to do so, Landlord may pay the amount necessary to remove such lien or encumbrance, without being responsible for investigating the validity thereof.

 

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10. INSURANCE.

 

10.1 Indemnification and Waiver . Except as provided in Section 10.5 or to the extent due to the negligence, willful misconduct or violation of this Lease by Landlord or the Landlord Parties, Tenant hereby assumes all risk of damage to property in, upon or about the Premises from any cause whatsoever (including, but not limited to, any personal injuries resulting from a slip and fall in, upon or about the Premises) and agrees that Landlord, its partners, subpartners and their respective officers, agents, servants, employees, and independent contractors (collectively, " Landlord Parties ") shall not be liable for, and are hereby released from any responsibility for, any damage either to person or property or resulting from the loss of use thereof, which damage is sustained by Tenant or by other persons claiming through Tenant. Tenant shall indemnify, defend, protect, and hold harmless the Landlord Parties from any and all loss, cost, damage, expense and liability (including without limitation court costs and reasonable attorneys' fees) incurred in connection with or arising from any cause in, on or about the Premises (including, but not limited to, a slip and fall), any acts, omissions or negligence of Tenant or of any person claiming by, through or under Tenant, or of the contractors, agents, servants, employees, invitees, guests or licensees of Tenant or any such person, in, on or about the Project or any breach of the terms of this Lease, either prior to, during, or after the expiration of the Lease Term, provided that the terms of the foregoing indemnity and release shall not apply to the negligence or willful misconduct of Landlord or its agents, employees, contractors, licensees or invitees, or Landlord's violation of this Lease. Should Landlord be named as a defendant in any suit brought against Tenant in connection with or arising out of Tenant's occupancy of the Premises, Tenant shall pay to Landlord its costs and expenses incurred in such suit, including without limitation, its actual professional fees such as reasonable appraisers', accountants' and attorneys' fees. Notwithstanding anything to the contrary in this Lease, Landlord shall not be released or indemnified from, and shall indemnify, defend, protect and hold harmless Tenant from, all losses, damages, liabilities, claims, attorneys’ fees, costs and expenses arising from the gross negligence or willful misconduct of Landlord or its agents, contractors, licensees or invitees, or a violation of Landlord’s obligations or representations under this Lease. The provisions of this Section 10.1 shall survive the expiration or sooner termination of this Lease with respect to any claims or liability arising in connection with any event occurring prior to such expiration or termination.

 

10.2 Tenant's Compliance With Landlord's Property Insurance . Landlord shall insure the Building, Tenant Improvements and any Alterations during the Lease Term against loss or damage under an "all risk" property insurance policy. Such coverage shall be in such amounts, from such companies, and on such other terms and conditions, as Landlord may from time to time reasonably determine. Additionally, at the option of Landlord, such insurance coverage may include the risks of earthquakes and/or flood damage and additional hazards, a rental loss endorsement and one or more loss payee endorsements in favor of the holders of any mortgages or deeds of trust encumbering the interest of Landlord in the Building or the ground or underlying lessors of the Building, or any portion thereof. The costs of such insurance shall be included in Operating Expenses, subject to the terms of Section 4.2.4 . Tenant shall, at Tenant's expense, comply with all insurance company requirements pertaining to the use of the Premises. If Tenant's conduct or use of the Premises causes any increase in the premium for such insurance policies then Tenant shall reimburse Landlord for any such increase. Tenant, at Tenant's expense, shall comply with all rules, orders, regulations or requirements of the American Insurance Association (formerly the National Board of Fire Underwriters) and with any similar body. Notwithstanding anything to the contrary in this Lease, Tenant shall not be required to comply with or cause the Premises to comply with any laws, rules, regulations or insurance requirements requiring the construction of alterations unless such compliance is necessitated solely due to Tenant's particular use of the Premises.

 

10.3 Tenant's Insurance . Tenant shall maintain the following coverages in the following amounts during the Lease Term (except Tenant shall carry the insurance described in Section 10.3.1 during any period in which it enters the Premises).

 

10.3.1 Commercial General Liability Insurance on an occurrence form covering the insured against claims of bodily injury and property damage (including loss of use thereof) arising out of Tenant's operations, and contractual liabilities including a contractual coverage for limits of liability (which limits may be met together with umbrella liability insurance) of not less than:

 

Bodily Injury and Property Damage Liability

$4,000,000 each occurrence

$4,000,000 annual aggregate

Personal Injury Liability

$4,000,000 annual aggregate

 

 

 

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10.3.2 Property Insurance covering all office furniture, business and trade fixtures, office and lab equipment, free-standing cabinet work, movable partitions, merchandise and all other items of Tenant's property on the Premises installed by, for, or at the expense of Tenant. Such insurance shall be written on a special form causes of loss form, for the full replacement cost value (subject to reasonable deductible amounts) new without deduction for depreciation of the covered items and in amounts that meet any co-insurance clauses of the policies of insurance and shall include coverage for damage or other loss caused by fire or other peril including, but not limited to, vandalism and malicious mischief, theft, water damage (excluding flood), including sprinkler leakage, bursting or stoppage of pipes, and explosion, and providing business interruption coverage for a period of ninety (90) days.

 

10.3.3 Business Income Interruption in an amount not less than $500,000.00.

 

10.3.4 Worker's Compensation and Employer's Liability or other similar insurance pursuant to all applicable state and local statutes and regulations. The policy shall include a waiver of subrogation in favor of Landlord, its employees, Lenders and any property manager or partners.

 

10.4 Form of Policies . The minimum limits of policies of insurance required of Tenant under this Lease shall in no event limit the liability of Tenant under this Lease. Such insurance shall (i) name Landlord, its subsidiaries and affiliates, its property manager (if any) and any other party the Landlord so specifies, as an additional insured on the liability insurance, including Landlord's managing agent, if any; (ii) be issued by an insurance company having a rating of not less than A-:VII in Best's Insurance Guide or which is otherwise acceptable to Landlord and authorized to do business in the State of California; and (iv) be primary insurance as to all claims thereunder and provide that any insurance carried by Landlord is excess and is non-contributing with any insurance required of Tenant. Tenant shall not cause said insurance to be canceled unless thirty (30) days' prior written notice shall have been given to Landlord and any mortgagee of Landlord (unless such cancellation is the result of non-payment of premiums, in which case note less than five (5) days' notice shall be provided). Tenant shall deliver said policy or policies or certificates thereof to Landlord on or before the Lease Commencement Date before the expiration dates thereof. In the event Tenant shall fail to procure such insurance, or to deliver such policies or certificate, Landlord may, at its option, procure such policies for the account of Tenant, and the cost thereof shall be paid to Landlord within five (5) days after delivery to Tenant of bills therefor.

 

10.5 Subrogation . Landlord and Tenant hereby agree to look solely to, and seek recovery only from, their respective insurance carriers in the event of a property or business interruption loss to the extent that such coverage is agreed to be provided hereunder, notwithstanding the negligence of either party. Notwithstanding anything to the contrary in this Lease, the parties each hereby waive all rights and claims against each other for such losses, and waive all rights of subrogation of their respective insurers. The parties agree that their respective insurance policies do now, or shall, contain the waiver of subrogation.

 

10.6 Additional Insurance Obligations . Tenant shall carry and maintain during the entire Lease Term, at Tenant's sole cost and expense, increased amounts of the insurance required to be carried by Tenant pursuant to this Article 10 and such other reasonable types of insurance coverage and in such reasonable amounts covering the Premises and Tenant's operations therein, as may be reasonably requested by Landlord or Landlord's lender, but in no event in excess of the amounts and types of insurance then being required by landlords of buildings comparable to and in the vicinity of the Building.

 

10.7 Construction Period. The term " Construction Period " shall mean the period from the date of this Lease to the date that Landlord completes construction of the Landlord's Work (including any " Additional Base Building Items ", as defined in Section 3(f) of the Tenant Work Letter), and Common Areas, regardless of the occurrence of any Tenant Delay and without regard to the effect of any provision of this Lease pursuant to which the Premises are deemed to be Ready for Occupancy in advance of its actual occurrence. Notwithstanding any provision of this Lease to the contrary (including Exhibit B ), during the Construction Period only, the following provisions shall be applicable:

 

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10.7.1 with respect to any indemnity obligation of Tenant arising at any time during the Construction Period only, (A) the term " Landlord Parties " shall mean and shall be limited to HCP LS Brisbane LLC, a Delaware limited liability company (or any entity that that succeeds to HCP LS Brisbane LLC's interest as Landlord under the Lease) and shall not include any other person or entity; provided, however, that Landlord may include in any claim owed by Tenant to it any amount which Landlord shall pay or be obligated to indemnify any other person or entity, and (B) any indemnity obligation shall be limited to losses caused by, or arising as a result of any act or failure to act of, Tenant or Tenant's employees, agents or contractors; and

 

10.7.2 during the Construction Period only, Tenant's liability under this Lease for Tenant's actions or failures to act under the Lease during the Construction Period, including, without limitation, (A) Tenant's indemnity obligations, plus (B) Base Rent and Additional Rent (as a consequence of Tenant Delay), plus (C) any and all other costs payable to Landlord or otherwise payable by Tenant under this Lease, which amount shall calculated to include

(i) the accreted value of any payments previously made by Tenant plus (ii) the present value of the maximum amount that Tenant could be required to pay as of that point in time (whether or not construction is completed) discounted at Tenant's incremental borrowing rate used to classify the Lease under ASC 840 (FAS 13), shall be limited to 89.9% of Landlord's Project Costs determined as of the date of Landlord's claim for such amount owed by Tenant. As used herein, " Landlord's Project Costs " shall mean the amount capitalized in the Project by Landlord in accordance with GAAP, plus other costs related to the Project (including related site improvements and other Project costs) paid by Landlord to third parties other than lenders or owners of Landlord (excluding land acquisition costs and "Force Majeure Costs," as that term is defined below, but including land carrying costs, such as interest or ground rent incurred during the Construction Period, and including all other costs incurred by Landlord in connection with the development and construction of the Project);

 

10.7.3 " Force Majeure Costs " means the sum of (a) all costs and expenses that are incurred because the Building is damaged by a fire or other casualty event (including capitalized interest on such costs and expenses), less the amount of all insurance proceeds applied to restore the Building, and (b) any loss in fair market value of the Premises to the extent the same are not restored following a fire or other casualty event; and

 

10.7.4 the provisions of Section 21.1(H) of the Lease shall not apply during the Construction

Period.

 

 

10.8

For the avoidance of doubt, Landlord and Tenant agree that:

 

10.8.1 no claim by Landlord for Tenant's repudiation of this Lease at any time shall be limited under this section; and

 

10.8.2 for any claim other than under Section 10.8.1 above, if during the Construction Period Landlord makes any claim for any anticipatory breach by Tenant of any obligation under this Lease owed to Landlord for any period after the Construction Period and the amount payable by Tenant for such claim is limited by the provisions of Section 10.7.2 above, the entire amount (to the extent not theretofore paid) shall be payable promptly after the Construction Period; and

 

10.8.3 following the end of the Construction Period, the terms of Section 10.7 shall be of no further force or effect.

 

11. DAMAGE AND DESTRUCTION.

 

11.1 Repair of Damage to Premises by Landlord . Tenant shall promptly notify Landlord of any damage to the Premises resulting from fire or any other casualty. If the Premises or any Common Areas serving or providing access to the Premises shall be damaged by fire or other casualty, Landlord shall promptly and diligently, subject to reasonable delays for insurance adjustment or other matters beyond Landlord's reasonable control, and subject to all other terms of this Article 11 , restore the Premises and such Common Areas. Such restoration shall be to substantially the same condition of the Premises and the Common Areas prior to the casualty, except for modifications required by zoning and building codes and other laws or any other modifications to the Common Areas deemed desirable by

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Landlord, which are consistent with the character of the Project, provided that access to the Premises shall not be materially impaired. Landlord shall not be liable for any inconvenience or annoyance to Tenant or its visitors, or injury to Tenant's business resulting in any way from such damage or the repair thereof; provided however, that if such fire or other casualty shall have damaged the Premises or Common Areas necessary to Tenant's occupancy, and the damaged portions of the Premises are not occupied by Tenant as a result thereof, then during the time and to the extent the Premises are unfit for occupancy, the Rent shall be abated in proportion to the ratio that the amount of rentable square feet of the Premises which is unfit for occupancy for the purposes permitted under this Lease bears to the total rentable square feet of the Premises.

 

11.2 Landlord's Option to Repair . Notwithstanding the terms of Section 11.1 of this Lease, Landlord may elect not to rebuild and/or restore the Premises, Building and/or Project, and instead terminate this Lease, by notifying Tenant in writing of such termination within sixty (60) days after the date of discovery of the damage, such notice to include a termination date giving Tenant sixty (60) days to vacate the Premises, but Landlord may so elect only if the Building shall be damaged by fire or other casualty or cause, and one or more of the following conditions is present: (i) in Landlord's reasonable judgment, repairs cannot reasonably be completed within one (1) year after the date of discovery of the damage (when such repairs are made without the payment of overtime or other premiums);

(ii) the damage is due to a risk that Landlord is not required to insure under this Lease, and the cost of restoration exceed five percent (5%) of the replacement cost of the Building (unless Tenant agrees to pay any uninsured amount in excess of such five percent (5%)); or (iii) the damage occurs during the last twelve (12) months of the Lease Term and will take more than sixty (60) days to restore; provided, however, that if Landlord does not elect to terminate this Lease pursuant to Landlord's termination right as provided above, and the repairs cannot, in the reasonable opinion of Landlord, be completed within six (6) months days after the date of discovery of the damage (or are not in fact completed within seven (7) months after the date of discovery of the damage), Tenant may elect, no earlier than sixty

(60) days after the date of the damage and not later than ninety (90) days after the date of such damage, or within thirty (30) days after such repairs are not timely completed, to terminate this Lease by written notice to Landlord effective as of the date specified in the notice, which date shall not be less than thirty (30) days nor more than   sixty

(60) days after the date such notice is given by Tenant.

 

11.3 Waiver of Statutory Provisions . The provisions of this Lease, including this Article 11 , constitute an express agreement between Landlord and Tenant with respect to any and all damage to, or destruction of, all or any part of the Premises, the Building or the Project, and any statute or regulation of the State of California, including, without limitation, Sections 1932(2) and 1933(4) of the California Civil Code, with respect to any rights or obligations concerning damage or destruction in the absence of an express agreement between the parties, and any other statute or regulation, now or hereafter in effect, shall have no application to this Lease or any damage or destruction to all or any part of the Premises, the Building or the Project.

 

12. NONWAIVER. No provision of this Lease shall be deemed waived by either party hereto unless expressly waived in a writing signed thereby. The waiver by either party hereto of any breach of any term, covenant or condition herein contained shall not be deemed to be a waiver of any subsequent breach of same or any other term, covenant or condition herein contained. The subsequent acceptance of Rent hereunder by Landlord shall not be deemed to be a waiver of any preceding breach by Tenant of any term, covenant or condition of this Lease, other than the failure of Tenant to pay the particular Rent so accepted, regardless of Landlord's knowledge of such preceding breach at the time of acceptance of such Rent. No acceptance of a lesser amount than the Rent herein stipulated shall be deemed a waiver of Landlord's right to receive the full amount due, nor shall any endorsement or statement on any check or payment or any letter accompanying such check or payment be deemed an accord and satisfaction, and Landlord may accept such check or payment without prejudice to Landlord's right to recover the full amount due. No receipt of monies by Landlord from Tenant after the termination of this Lease shall in any way alter the length of the Lease Term or of Tenant's right of possession hereunder, or after the giving of any notice shall reinstate, continue or extend the Lease Term or affect any notice given Tenant prior to the receipt of such monies, it being agreed that after the service of notice or the commencement of a suit, or after final judgment for possession of the Premises, Landlord may receive and collect any Rent due, and the payment of said Rent shall not waive or affect said notice, suit or judgment.

 

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13. CONDEMNATION. If the whole or any part of the Premises shall be taken by power of eminent domain or condemned by any competent authority for any public or quasi-public use or purpose, or if any adjacent property or street shall be so taken or condemned, or reconfigured or vacated by such authority in such manner as to require the use or reconstruction of any part of the Premises, or if Landlord shall grant a deed or other instrument in lieu   of such taking by eminent domain or condemnation, Landlord shall have the option to terminate this Lease effective as of the date possession is required to be surrendered to the authority. Tenant shall not because of such taking assert any claim against Landlord or the authority for any compensation because of such taking and Landlord shall be entitled to the entire award or payment in connection therewith, except that Tenant shall have the right to file any separate claim available to Tenant for any taking of Tenant's personal property and fixtures belonging to Tenant and removable by Tenant upon expiration of the Lease Term pursuant to the terms of this Lease, for moving expenses, for the unamortized value of any improvements paid for by Tenant and for the Lease “bonus value”, so long as such claims are payable separately to Tenant. All Rent shall be apportioned as of the date of such termination. If any part of the Premises shall be taken, and this Lease shall not be so terminated, the Rent shall be proportionately abated. Tenant hereby waives any and all rights it might otherwise have pursuant to Section 1265.130 of The California Code of Civil Procedure. Notwithstanding anything to the contrary contained in this Article 13, in the event of a temporary taking of all or any portion of the Premises for a period of one hundred and eighty (180) days or less, then this Lease shall not terminate but the Base Rent and the Additional Rent shall be abated for the period of such taking in proportion to the ratio that the amount of rentable square feet of the Premises taken bears to the total rentable square feet of the Premises. Landlord shall be entitled to receive the entire award made in connection with any such temporary taking.

 

14. ASSIGNMENT AND SUBLETTING.

 

14.1 Transfers . Tenant shall not, without the prior written consent of Landlord, assign, mortgage, pledge, hypothecate, encumber, or permit any lien to attach to, or otherwise transfer, this Lease or any interest hereunder, permit any assignment, or other transfer of this Lease or any interest hereunder by operation of law, sublet the Premises or any part thereof, or enter into any license or concession agreements or otherwise permit the occupancy or use of the Premises or any part thereof by any persons other than Tenant and its employees and contractors (all of the foregoing are hereinafter sometimes referred to collectively as " Transfers " and any person to whom any Transfer is made or sought to be made is hereinafter sometimes referred to as a " Transferee "). If Tenant desires Landlord's consent to any Transfer, Tenant shall notify Landlord in writing, which notice (the " Transfer Notice ") shall include

(i) the proposed effective date of the Transfer, which shall not be less than thirty (30) days nor more than one hundred eighty (180) days after the date of delivery of the Transfer Notice, (ii) a description of the portion of the Premises to be transferred (the " Subject Space "), (iii) all of the terms of the proposed Transfer and the consideration therefor, including calculation of the " Transfer Premium ", as that term is defined in Section 14.3 below, in connection with such Transfer, the name and address of the proposed Transferee, and a copy of all existing executed and/or proposed documentation pertaining to the proposed Transfer, and (iv) current financial statements of the proposed Transferee certified by an officer, partner or owner thereof, and any other information reasonably required by Landlord which will enable Landlord to determine the financial responsibility, character, and reputation of the proposed Transferee, nature of such Transferee's business and proposed use of the Subject Space. Any Transfer made without Landlord's prior written consent shall, at Landlord's option, be null, void and of no effect, and shall, at Landlord's option, constitute a default by Tenant under this Lease. Whether or not Landlord consents to any proposed Transfer, Tenant shall pay Landlord's reasonable review and processing fees, as well as any reasonable professional fees (including, without limitation, attorneys', accountants', architects', engineers' and consultants' fees) incurred by Landlord (not to exceed $3,500 in the aggregate for any particular Transfer), within thirty (30) days after written request by Landlord.

 

14.2 Landlord's Consent . Landlord shall not unreasonably withhold or delay its consent to any proposed Transfer of the Subject Space to the Transferee on the terms specified in the Transfer Notice. Without limitation as to other reasonable grounds for withholding consent, the parties hereby agree that it shall be reasonable under this Lease and under any applicable law for Landlord to withhold consent to any proposed Transfer where one or more of the following apply:

 

14.2.1 The Transferee is of a character or reputation or engaged in a business which is not consistent with the quality of the Building or the Project;

 

14.2.2 The Transferee is either a governmental agency or instrumentality thereof;

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14.2.3 The Transferee is not a party of reasonable financial worth and/or financial stability in light of the responsibilities to be undertaken in connection with the Transfer on the date consent is requested; or

14.2.4 The proposed Transfer would cause a violation of another lease for space in the Project, or would give an occupant of the Project a right to cancel its lease.

 

If Landlord consents to any Transfer pursuant to the terms of this Section 14.2 (and does not exercise any recapture rights Landlord may have under Section 14.4 of this Lease), Tenant may within six (6) months after Landlord's consent, but not later than the expiration of said six-month period, enter into such Transfer of the Premises or portion thereof, upon substantially the same terms and conditions as are set forth in the Transfer Notice furnished by Tenant to Landlord pursuant to Section 14.1 of this Lease, provided that if there are any changes in the terms and conditions from those specified in the Transfer Notice such that Landlord would initially have been entitled to refuse its consent to such Transfer under this Section 14.2 , Tenant shall again submit the Transfer to Landlord for its approval and other action under this Article 14 (including Landlord's right of recapture, if any, under Section 14.4 of this Lease). Notwithstanding anything to the contrary in this Lease, if Tenant or any proposed Transferee claims that Landlord has unreasonably withheld or delayed its consent under Section 14.2 or otherwise has breached or acted unreasonably under this Article 14 , their sole remedies shall be a suit for contract damages (other than damages for injury to, or interference with, Tenant's business including, without limitation, loss of profits, however occurring) or declaratory judgment and an injunction for the relief sought, and Tenant hereby waives all other remedies, including, without limitation, any right at law or equity to terminate this Lease, on its own behalf and, to the extent permitted under all applicable laws, on behalf of the proposed Transferee.

 

14.3 Transfer Premium . If Landlord consents to a Transfer, as a condition thereto which the parties hereby agree is reasonable, Tenant shall pay to Landlord fifty percent (50%) of any " Transfer Premium ," as that term is defined in this Section 14.3 , received by Tenant from such Transferee. " Transfer Premium " shall mean all rent, additional rent or other consideration payable by such Transferee in connection with the Transfer in excess of the Rent and Additional Rent payable by Tenant under this Lease (including any Additional Tenant Improvement Allowance Payment) during the term of the Transfer on a per rentable square foot basis if less than all of the Premises is transferred, and after deduction of (i) any costs of improvements made to the Subject Space in connection with such Transfer (which may include the unamortized cost of the Tenant Improvements to the extent paid for by Tenant directly rather than through the Additional TI Allowance), (ii) brokerage commissions paid in connection with such Transfer, and (iii) reasonable legal fees incurred in connection with such Transfer. " Transfer Premium " shall also include, but not be limited to, key money, bonus money or other cash consideration paid by Transferee to Tenant in connection with such Transfer, and any payment in excess of fair market value for services rendered by Tenant to Transferee or for assets, fixtures, inventory, equipment, or furniture transferred by Tenant to Transferee in connection with such Transfer. Notwithstanding the foregoing, the reduction in Base Rent in the first eight (8) months of the Lease Term under Section 4 of the Summary shall be disregarded when calculating the Transfer Premium during such period. The determination of the amount of Landlord's applicable share of the Transfer Premium shall be made on a monthly basis as rent or other consideration is received by Tenant under the Transfer.

 

14.4 Landlord's Option as to Subject Space . Notwithstanding anything to the contrary contained in this Article 14 , in the event Tenant contemplates a Transfer other than to a Permitted Transferee which, together with all prior Transfers then remaining in effect, would cause fifty percent (50%) or more of the Premises to be Transferred for more than fifty percent (50%) of the then remaining Lease Term (taking into account any extension of the Lease Term which has irrevocably exercised by Tenant), Tenant shall give Landlord notice (the " Intention to Transfer Notice ") of such contemplated Transfer (whether or not the contemplated Transferee or the terms of such contemplated Transfer have been determined). The Intention to Transfer Notice shall specify the portion of and amount of rentable square feet of the Premises which Tenant intends to Transfer in the subject Transfer (the " Contemplated Transfer Space "), the contemplated date of commencement of the Contemplated Transfer (the " Contemplated Effective Date "), and the contemplated length of the term of such contemplated Transfer. Thereafter, Landlord shall have the option, by giving written notice to Tenant within thirty (30) days after receipt of any Intention to Transfer Notice, to recapture the Contemplated Transfer Space. Such recapture shall cancel and terminate this Lease with respect to such Contemplated Transfer Space as of the Contemplated Effective Date. In the event of a recapture by Landlord, if this Lease shall be canceled with respect to less than the entire Premises, the Rent reserved herein shall be prorated on the basis of the number of rentable square feet retained by Tenant in proportion to the number of rentable square feet

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contained in the Premises, and this Lease as so amended shall continue thereafter in full force and effect, and upon request of either party, the parties shall execute written confirmation of the same. If Landlord declines, or fails to elect in a timely manner, to recapture such Contemplated Transfer Space under this Section 14.4 , then, subject to the other terms of this Article 14 , for a period of nine (9) months (the " Nine Month Period ") commencing on the last day of such thirty (30) day period, Landlord shall not have any right to recapture the Contemplated Transfer Space with respect to any Transfer made during the Nine Month Period, provided that any such Transfer is substantially on the terms set forth in the Intention to Transfer Notice, and provided further that any such Transfer shall be subject to the remaining terms of this Article 14 . If such a Transfer is not so consummated within the Nine Month Period (or if a Transfer is so consummated, then upon the expiration of the term of any Transfer of such Contemplated Transfer Space consummated within such Nine Month Period), Tenant shall again be required to submit a new Intention to Transfer Notice to Landlord with respect any contemplated Transfer, as provided above in this Section 14.4 . Tenant shall not be required to provide a separate Intention to Transfer Notice and Tenant’s request for Landlord’s consent to a Transfer shall satisfy Tenant’s obligations in this Section 14.4 .

 

14.5 Effect of Transfer . If Landlord consents to a Transfer, (i) the terms and conditions of this Lease shall in no way be deemed to have been waived or modified, (ii) such consent shall not be deemed consent to any further Transfer by either Tenant or a Transferee, (iii) Tenant shall deliver to Landlord, promptly after execution, an original executed copy of all documentation pertaining to the Transfer in form reasonably acceptable to Landlord, (iv) Tenant shall furnish upon Landlord's request a complete statement, certified by an independent certified public accountant, or Tenant's chief financial officer, setting forth in detail the computation of any Transfer Premium Tenant has derived and shall derive from such Transfer, and (v) no Transfer relating to this Lease or agreement entered into with respect thereto, whether with or without Landlord's consent, shall relieve Tenant or any guarantor of the Lease from any liability under this Lease, including, without limitation, in connection with the Subject Space. Landlord or its authorized representatives shall have the right at all reasonable times to audit the books, records and papers of Tenant relating to any Transfer, and shall have the right to make copies thereof. If the Transfer Premium respecting any Transfer shall be found understated, Tenant shall, within thirty (30) days after demand, pay the deficiency, and if understated by more than two percent (2%), Tenant shall pay Landlord's costs of such audit.

 

14.6 Additional Transfers . For purposes of this Lease, the term " Transfer " shall also include if Tenant is a partnership, the withdrawal or change, voluntary, involuntary or by operation of law, of fifty percent (50%) or more of the partners, or transfer of fifty percent (50%) or more of partnership interests, within a twelve (12)-month period, or the dissolution of the partnership without immediate reconstitution thereof.

 

14.7 Occurrence of Default . Any Transfer hereunder shall be subordinate and subject to the provisions of this Lease, and if this Lease shall be terminated during the term of any Transfer, Landlord shall have the right to:

(i) treat such Transfer as cancelled and repossess the Subject Space by any lawful means, or (ii) require that such Transferee attorn to and recognize Landlord as its landlord under any such Transfer. If Tenant shall be in default under this Lease, Landlord is hereby irrevocably authorized, as Tenant's agent and attorney-in-fact, to direct any Transferee to make all payments under or in connection with the Transfer directly to Landlord (which Landlord shall apply towards Tenant's obligations under this Lease) until such default is cured. Such Transferee shall rely on any representation by Landlord that Tenant is in default hereunder, without any need for confirmation thereof by Tenant. Upon any assignment, the assignee shall assume in writing all obligations and covenants of Tenant thereafter to be performed or observed under this Lease. No collection or acceptance of rent by Landlord from any Transferee shall be deemed a waiver of any provision of this Article 14 or the approval of any Transferee or a release of Tenant from any obligation under this Lease, whether theretofore or thereafter accruing. In no event shall Landlord's enforcement of any provision of this Lease against any Transferee be deemed a waiver of Landlord's right to enforce any term of this Lease against Tenant or any other person. If Tenant's obligations hereunder have been guaranteed, Landlord's consent to any Transfer shall not be effective unless the guarantor also consents to such Transfer.

 

14.8 Non-Transfers . Notwithstanding anything to the contrary contained in this Article 14 , (i) an assignment or subletting of all or a portion of the Premises to an affiliate of Tenant (an entity which is controlled by, controls, or is under common control with, Tenant), (ii) an assignment of the Premises to an entity which acquires all or substantially all of the assets or interests (partnership, stock or other) of Tenant, (iii) an assignment of the Premises to an entity which is the resulting entity of a merger or consolidation of Tenant with another entity, or (iv) a sale of corporate shares of capital stock in Tenant in connection with an initial public offering of Tenant's stock on a

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nationally-recognized stock exchange (collectively, a " Permitted Transferee "), shall not be deemed a Transfer under this Article 14 , provided that (A) Tenant notifies Landlord of any such assignment or sublease and promptly supplies Landlord with any documents or information requested by Landlord regarding such assignment or sublease or   such affiliate, (B) such assignment or sublease is not a subterfuge by Tenant to avoid its obligations under this Lease, (C) such Permitted  Transferee  shall be of a character  and  reputation consistent  with the quality of the Building,    and (D) such Permitted Transferee described in subpart (ii) or (iii) above shall have a tangible net worth (not including goodwill as an asset) computed in accordance with generally accepted accounting principles (" Net Worth ") at least equal to the Net Worth of Tenant on the day immediately preceding the effective date of such assignment or sublease. An assignee of Tenant's entire interest that is also a Permitted Transferee may also be known as a " Permitted Assignee ". " Control ," as used in this Section 14.8 , shall mean the ownership, directly or indirectly, of at least fifty- one percent (51%) of the voting securities of, or possession of the right to vote, in the ordinary direction of its affairs, of at least fifty-one percent (51%) of the voting interest in, any person or entity. No such permitted assignment or subletting shall serve to release Tenant from any of its obligations under this Lease.

 

15. SURRENDER OF PREMISES; OWNERSHIP AND REMOVAL OF TRADE FIXTURES.

 

15.1 Surrender of Premises . No act or thing done by Landlord or any agent or employee of Landlord during the Lease Term shall be deemed to constitute an acceptance by Landlord of a surrender of the Premises unless such intent is specifically acknowledged in writing by Landlord. The delivery of keys to the Premises to Landlord or any agent or employee of Landlord shall not constitute a surrender of the Premises or effect a termination of this Lease, whether or not the keys are thereafter retained by Landlord, and notwithstanding such delivery Tenant shall be entitled to the return of such keys at any reasonable time upon request until this Lease shall have been properly terminated. The voluntary or other surrender of this Lease by Tenant, whether accepted by Landlord or not, or a mutual termination hereof, shall not work a merger, and at the option of Landlord shall operate as an assignment to Landlord of all subleases or subtenancies affecting the Premises or terminate any or all such sublessees or subtenancies.

 

15.2 Removal of Tenant Property by Tenant . Upon the expiration of the Lease Term, or upon any earlier termination of this Lease, Tenant shall, subject to the provisions of this Article 15 , quit and surrender possession of the Premises to Landlord in as good order and condition as when Tenant took possession and as thereafter improved by Landlord and/or Tenant, reasonable wear and tear, damage caused by casualty, repairs required as a result of condemnation, and repairs which are specifically made the responsibility of Landlord hereunder excepted. Upon such expiration or termination, Tenant shall, without expense to Landlord, remove or cause to be removed from the Premises all debris and rubbish, and such items of furniture, equipment, free-standing cabinet work, movable partitions (but not demountable walls) and other articles of personal property owned by Tenant or installed or placed by Tenant at its expense in the Premises, and such similar articles of any other persons claiming under Tenant, as Landlord may, in its sole discretion, require to be removed, and Tenant shall repair at its own expense all damage to the Premises and Building resulting from such removal.

 

15.3 Environmental Assessment . In connection with its surrender of the Premises, Tenant shall submit to Landlord, at least fifteen (15) days prior to the expiration date of this Lease (or in the event of an earlier termination of this Lease, as soon as reasonably possible following such termination), an environmental Assessment of the Premises by a competent and experienced environmental engineer or engineering firm reasonably satisfactory to Landlord (pursuant to a contract approved by Landlord and providing that Landlord can rely on the Environmental Assessment). If such Environmental Assessment reveals that remediation or Clean-up is required under any Environmental Laws that Tenant is responsible for under this Lease, Tenant shall submit a remediation plan prepared by a recognized environmental consultant and shall be responsible for all costs of remediation and Clean-up, as more particularly provided in Section 5.3 , above.

 

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15.4 Condition of the Building and Premises Upon Surrender . In addition to the above requirements of this Article 15 , upon the expiration of the Lease Term, or upon any earlier termination of this Lease, Tenant shall, surrender the Premises and Building with Tenant having complied with all of Tenant’s obligations under this Lease, including those relating to improvement, repair, maintenance, compliance with law, testing and other related obligations of Tenant set forth in Article 7 of this Lease. In the event that the Building and Premises shall be surrendered in a condition which does not comply with the terms of this Section 15.4 , because Tenant failed to comply with its obligations set forth in Lease, then following thirty (30) days' notice to Tenant, during which thirty (30) day period Tenant shall have the right to cure such noncompliance, Landlord shall be entitled to expend all reasonable costs in order to cause the same to comply with the required condition upon surrender and Tenant shall immediately reimburse Landlord for all such costs upon notice and, commencing on the later of the termination of this Lease and three (3) business days after Landlord's delivery of notice of such failure and that it elects to treat such failure as a holdover, Tenant shall be deemed during the period that Tenant or Landlord, as the case may be, perform obligations relating to the Surrender Improvements to be in holdover under Article 16 of this Lease.

 

16. HOLDING OVER. If Tenant holds over after the expiration of the Lease Term or earlier termination thereof, with the express or implied consent of Landlord, such tenancy shall be from month-to-month only, and shall not constitute a renewal hereof or an extension for any further term. If Tenant holds over after the expiration of the Lease Term of earlier termination thereof, without the express or implied consent of Landlord, such tenancy shall be deemed to be a tenancy by sufferance only, and shall not constitute a renewal hereof or an extension for any further term. In either case, Base Rent shall be payable at a monthly rate equal to one hundred fifty percent (150%) of the Base Rent applicable during the last rental period of the Lease Term under this Lease. Such month-to-month tenancy or tenancy by sufferance, as the case may be, shall be subject to every other applicable term, covenant and agreement contained herein. Nothing contained in this Article 16 shall be construed as consent by Landlord to any holding over by Tenant, and Landlord expressly reserves the right to require Tenant to surrender possession of the Premises to Landlord as provided in this Lease upon the expiration or other termination of this Lease. The provisions of this Article 16 shall not be deemed to limit or constitute a waiver of any other rights or remedies of Landlord provided herein or at law. If Tenant fails to surrender the Premises upon the termination or expiration of this Lease, in addition to any other liabilities to Landlord accruing therefrom, Tenant shall protect, defend, indemnify and hold Landlord harmless from all loss, costs (including reasonable attorneys' fees) and liability resulting from such failure, including, without limiting the generality of the foregoing, any claims made by any succeeding tenant founded upon such failure to surrender and any lost profits to Landlord resulting therefrom.

 

17. ESTOPPEL CERTIFICATES. Within ten (10) business days following a request in writing by Landlord, Tenant shall execute, acknowledge and deliver to Landlord an estoppel certificate, which, as submitted by Landlord, shall be substantially in the form of Exhibit D , attached hereto (or such other form as may be reasonably required by any prospective mortgagee or purchaser of the Project, or any portion thereof), indicating therein any exceptions thereto that may exist at that time, and shall also contain any other information reasonably requested by Landlord or Landlord's mortgagee or prospective mortgagee. Any such certificate may be relied upon by any prospective mortgagee or purchaser of all or any portion of the Project. Tenant shall execute and deliver whatever other instruments may be reasonably required for such purposes. At any time during the Lease Term, in connection with a sale or financing of the Building by Landlord, Landlord may require Tenant to provide Landlord with its most recent annual financial statement and annual financial statements of the preceding two (2) years. Such statements shall be prepared in accordance with generally accepted accounting principles and, if such is the normal practice of Tenant, shall be audited by an independent certified public accountant. Landlord shall hold such statements confidential. Failure of Tenant to timely execute, acknowledge and deliver such estoppel certificate or other instruments shall constitute an acceptance of the Premises and an acknowledgment by Tenant that statements included in the estoppel certificate are true and correct, without exception.

 

18. SUBORDINATION. Landlord hereby represents and warrants to Tenant that the Project is not currently subject to any ground lease, or to the lien of any mortgage or deed of trust. This Lease shall be subject and subordinate to all future ground or underlying leases of the Building or Project and to the lien of any mortgage, trust deed or other encumbrances now or hereafter in force against the Building or Project or any part thereof, if any, and to all renewals, extensions, modifications, consolidations and replacements thereof, and to all advances made or hereafter to be made upon the security of such mortgages or trust deeds, unless the holders of such mortgages, trust deeds or other encumbrances, or the lessors under such ground lease or underlying leases, require in writing that this Lease be

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superior thereto. The subordination of this Lease to any such future ground or underlying leases of the Building or Project or to the lien of any mortgage, trust deed or other encumbrances, shall be subject to Tenant's receipt of a commercially reasonable subordination, non-disturbance, and attornment agreement in favor of Tenant. Tenant covenants and agrees in the event any proceedings are brought for the foreclosure of any such mortgage or deed in lieu thereof (or if any ground lease is terminated), to attorn, without any deductions or set-offs whatsoever, to the lienholder or purchaser or any successors thereto upon any such foreclosure sale or deed in lieu thereof (or to the ground lessor), if so requested to do so by such purchaser or lienholder or ground lessor, and to recognize such purchaser or lienholder or ground lessor as the lessor under this Lease, provided such lienholder or purchaser or ground lessor shall agree to accept this Lease and not disturb Tenant's occupancy, so long as Tenant timely pays the rent and observes and performs the terms, covenants and conditions of this Lease to be observed and performed by Tenant. Landlord's interest herein may be assigned as security at any time to any lienholder. Tenant shall, within ten (10) days of request by Landlord, execute such further instruments or assurances as Landlord may reasonably deem necessary to evidence or confirm the subordination or superiority of this Lease to any such mortgages, trust deeds, ground leases or underlying leases. Tenant waives the provisions of any current or future statute, rule or law which may give or purport to give Tenant any right or election to terminate or otherwise adversely affect this Lease and the obligations of the Tenant hereunder in the event of any foreclosure proceeding or sale.

 

19. DEFAULTS; REMEDIES.

 

19.1 Events of Default . The occurrence of any of the following shall constitute a default of this Lease by Tenant:

 

19.1.1 Any failure by Tenant to pay any Rent or any other charge required to be paid under this Lease, or any part thereof, when due unless such failure is cured within five (5) business days after notice; or

 

19.1.2 Except where a specific time period is otherwise set forth for Tenant's performance in this Lease, in which event the failure to perform by Tenant within such time period shall be a default by Tenant under this Section 19.1.2 , any failure by Tenant to observe or perform any other provision, covenant or condition of this Lease to be observed or performed by Tenant where such failure continues for thirty (30) days after written notice thereof from Landlord to Tenant; provided that if the nature of such default is such that the same cannot reasonably be cured within a thirty (30) day period, Tenant shall not be deemed to be in default if it diligently commences such cure within such period and thereafter diligently proceeds to rectify and cure such default; or

 

19.1.3 Abandonment or vacation of all or a substantial portion of the Premises by Tenant while Tenant is in default under the Lease; or

 

19.1.4 The failure by Tenant to observe or perform according to the provisions of Articles 5 , 14 , 17 or 18 of this Lease where such failure continues for more than five (5) business days after notice from Landlord.

 

19.2 Remedies Upon Default . Upon the occurrence of any event of default by Tenant, Landlord shall have, in addition to any other remedies available to Landlord at law or in equity (all of which remedies shall be distinct, separate and cumulative), the option to pursue any one or more of the following remedies, each and all of which shall be cumulative and nonexclusive, without any notice or demand whatsoever.

 

19.2.1 Terminate this Lease, in which event Tenant shall immediately surrender the Premises to Landlord, and if Tenant fails to do so, Landlord may, without prejudice to any other remedy which it may have for possession or arrearages in rent, enter upon and take possession of the Premises and expel or remove Tenant and any other person who may be occupying the Premises or any part thereof, without being liable for prosecution or any claim or damages therefor; and Landlord may recover from Tenant the following:

 

(i) The worth at the time of award of the unpaid rent which has been earned at the time of such termination; plus

 

(ii) The worth at the time of award of the amount by which the unpaid rent which would have been earned after termination until the time of award exceeds the amount of such rental loss that Tenant proves could have been reasonably avoided; plus

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(iii) The worth at the time of award of the amount by which the unpaid rent for the balance of the Lease Term after the time of award exceeds the amount of such rental loss that Tenant proves could have been reasonably avoided; plus

 

(iv) Any other amount necessary to compensate Landlord for all the detriment proximately caused by Tenant's failure to perform its obligations under this Lease or which in the ordinary course of things would be likely to result therefrom, specifically including but not limited to, in each case to the extent allocable to the remaining Lease Term, brokerage commissions and advertising expenses incurred to obtain a new tenant, expenses of remodeling the Premises or any portion thereof for a new tenant, whether for the same or a different use, and any special concessions made to obtain a new tenant; and

 

(v) At Landlord's election, such other amounts in addition to or in lieu of the foregoing as may be permitted from time to time by applicable law.

 

The term " rent " as used in this Section 19.2 shall be deemed to be and to mean all sums of every nature required to be paid by Tenant pursuant to the terms of this Lease, whether to Landlord or to others. As used in Sections 19.2.1(i) and (ii) , above, the "worth at the time of award" shall be computed by allowing interest at the rate set forth in Article 25 of this Lease, but in no case greater than the maximum amount of such interest permitted by law. As used in Section 19.2.1(iii) above, the " worth at the time of award " shall be computed by discounting such amount at the discount rate of the Federal Reserve Bank of San Francisco at the time of award plus one percent (1%).

 

19.2.2 Landlord shall have the remedy described in California Civil Code Section 1951.4 (lessor may continue lease in effect after lessee's breach and abandonment and recover rent as it becomes due, if lessee has the right to sublet or assign, subject only to reasonable limitations). Accordingly, if Landlord does not elect to terminate this Lease on account of any default by Tenant, Landlord may, from time to time, without terminating this Lease, enforce all of its rights and remedies under this Lease, including the right to recover all rent as it becomes due.

 

19.2.3 Landlord shall at all times have the rights and remedies (which shall be cumulative with each other and cumulative and in addition to those rights and remedies available under Sections 19.2.1 and 19.2.2 , above, or any law or other provision of this Lease), without prior demand or notice except as required by applicable law, to seek any declaratory, injunctive or other equitable relief, and specifically enforce this Lease, or restrain or enjoin a violation or breach of any provision hereof.

 

19.3 Subleases of Tenant . If Landlord elects to terminate this Lease on account of any default by Tenant, as set forth in this Article 19 , Landlord shall have the right to terminate any and all subleases, licenses, concessions or other consensual arrangements for possession entered into by Tenant and affecting the Premises or may, in Landlord's sole discretion, succeed to Tenant's interest in such subleases, licenses, concessions or arrangements. In the event of Landlord's election to succeed to Tenant's interest in any such subleases, licenses, concessions or arrangements, Tenant shall, as of the date of notice by Landlord of such election, have no further right to or interest in the rent or other consideration receivable thereunder.

 

19.4 Efforts to Relet . No re-entry, repairs, maintenance, changes, alterations and additions, appointment of a receiver to protect Landlord's interests hereunder, or any other action or omission by Landlord shall be construed as an election by Landlord to terminate this Lease or Tenant's right to possession, or to accept a surrender of the Premises, nor shall same operate to release Tenant in whole or in part from any of Tenant's obligations hereunder, unless express written notice of such intention is sent by Landlord to Tenant.

 

20. COVENANT OF QUIET ENJOYMENT. Landlord covenants that Tenant, on paying the Rent, charges for services and other payments herein reserved and on keeping, observing and performing all the other terms, covenants, conditions, provisions and agreements herein contained on the part of Tenant to be kept, observed and performed, shall, during the Lease Term, peaceably and quietly have, hold and enjoy the Premises subject to the terms, covenants, conditions, provisions and agreements hereof without interference by any persons lawfully claiming by or through Landlord. The foregoing covenant is in lieu of any other covenant express or implied.

 

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21. LETTER OF CREDIT.

 

21.1 Delivery of Letter of Credit . Tenant shall deliver to Landlord, within five (5) business days after Tenant's execution of this Lease, an unconditional, clean, irrevocable letter of credit (the " L-C ") in the amount set forth in Section 8 of the Lease Summary (the " L-C Amount "), which L-C shall be issued by a money-center, solvent and nationally recognized bank (a bank which accepts deposits, maintains accounts, has a local San Francisco Bay Area office which will negotiate a letter of credit, and whose deposits are insured by the FDIC) reasonably acceptable to Landlord (such approved, issuing bank being referred to herein as the " Bank "), which Bank must have a rating from Standard and Poors Corporation of A- or better (or any equivalent rating thereto from any successor or substitute rating service selected by Lessor) and a letter of credit issuer rating from Moody’s Investor Service of A3 or better (or any equivalent rating thereto from any successor rating agency thereto)) (collectively, the " Bank’s Credit Rating Threshold "), and which L-C shall be in the form of Exhibit H , attached hereto. Notwithstanding the foregoing, Landlord hereby approves Silicon Valley Bank as the Bank with respect to the issuance of the initial L-C hereunder. Tenant shall pay all expenses, points and/or fees incurred by Tenant in obtaining the L-C. The L-C shall (i) be "callable" at sight, irrevocable and unconditional, (ii) be maintained in effect, whether through renewal or extension, for the period commencing on the date of this Lease and continuing until the date (the " L-C Expiration Date ") that is no less than sixty (60) days after the expiration of the Lease Term as the same may be extended, and Tenant shall deliver a new L-C or certificate of renewal or extension to Landlord at least thirty (30) days prior to the expiration of the L-C then held by Landlord, without any action whatsoever on the part of Landlord, (iii) be fully assignable by Landlord, its successors and assigns, (iv) permit partial draws and multiple presentations and drawings, and (v) be otherwise subject to the Uniform Customs and Practices for Documentary Credits (1993-Rev), International Chamber of Commerce Publication #500, or the International Standby Practices-ISP 98, International Chamber of Commerce Publication #590. Landlord, or its then managing agent, shall have the right to draw down an amount up to the face amount of the L-C if any of the following shall have occurred or be applicable: (A) such amount is due to Landlord under the terms and conditions of this Lease, and has not been paid within applicable notice and cure periods (or, if Landlord  is prevented  by law from providing notice,  within  the  period  for payment  set forth  in  the  Lease),   or (B) Tenant has filed a voluntary petition under the U. S. Bankruptcy Code or any state bankruptcy code (collectively, " Bankruptcy Code "), or (C) an involuntary petition has been filed against Tenant under the Bankruptcy Code that is not dismissed within thirty (30) days, or (D) the Lease has been rejected, or is deemed rejected, under Section 365 of the U.S. Bankruptcy Code, following the filing of a voluntary petition by Tenant under the Bankruptcy Code, or the filing of an involuntary petition against Tenant under the Bankruptcy Code, or (E) the Bank has notified Landlord that the L-C will not be renewed or extended through the L-C Expiration Date, and Tenant has not provided a replacement L-C that satisfies the requirements of this Lease at least thirty (30) days prior to such expiration, or (F) Tenant is placed into receivership or conservatorship, or becomes subject to similar proceedings under Federal or State law, or (G) Tenant executes an assignment for the benefit of creditors, or (H) if (1) any of the Bank's (other than Silicon Valley Bank) Fitch Ratings (or other comparable ratings to the extent the Fitch Ratings are no longer available) have been reduced below the Bank's Credit Rating Threshold, or (2) there is otherwise a material adverse change in the financial condition of the Bank, and Tenant has failed to provide Landlord with a replacement letter of credit, conforming in all respects to the requirements of this Article 21 (including, but not limited to, the requirements placed on the issuing Bank more particularly set forth in this Section 21.1 above), in the amount of the applicable L-C Amount, within ten (10) days following Landlord’s written demand therefor (with no other notice or cure or grace period being applicable thereto, notwithstanding anything in this Lease to the contrary) (each of the foregoing being an " L-C Draw Event "). The L-C shall be honored by the Bank regardless of whether Tenant disputes Landlord's right to draw upon the L-C. In addition, in the event the Bank is placed into receivership or conservatorship by the Federal Deposit Insurance Corporation or any successor or similar entity, then, effective as of the date such receivership or conservatorship occurs, said L-C shall be deemed to fail to meet the requirements of this Article 21 , and, within ten (10) days following Landlord's notice to Tenant of such receivership or conservatorship (the " L-C FDIC Replacement Notice "), Tenant shall replace such L-C with a substitute letter of credit from a different issuer (which issuer shall meet or exceed the Bank's Credit Rating Threshold and shall otherwise be acceptable to Landlord in its reasonable discretion) and that complies in all respects with the requirements of this Article 21 . If Tenant fails to replace such L-C with such conforming, substitute letter of credit pursuant to the terms and conditions of this Section 21.1 , then, notwithstanding anything in this Lease to the contrary, Landlord shall have the right to declare Tenant in default of this Lease for which there shall be no notice or grace or cure periods being applicable thereto (other than the aforesaid ten (10) day period). Tenant shall be responsible for the payment of any and all Tenant’s and Bank’s costs incurred with the review of any replacement L-C, which replacement is required pursuant to this Section or is otherwise requested by Tenant. In the

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event of an assignment by Tenant of its interest in the Lease (and irrespective of whether Landlord's consent is required for such assignment), the acceptance of any replacement or substitute letter of credit by Landlord from the assignee shall be subject to Landlord's prior written approval, in Landlord's reasonable discretion, and the actual and reasonable attorney's fees incurred by Landlord in connection with such determination shall be payable by Tenant to Landlord within ten (10) days of billing.

 

21.2 Application of L - C . Tenant hereby acknowledges and agrees that Landlord is entering into this Lease in material reliance upon the ability of Landlord to draw upon the L-C upon the occurrence of any L-C Draw Event. In the event of any L-C Draw Event, Landlord may, but without obligation to do so, and without notice to Tenant (except in connection with an L-C Draw Event under Section 21.1(H) above), draw upon the L-C, in part or in whole, in the amount necessary to cure any such L-C Draw Event and/or to compensate Landlord for any and all damages of any kind or nature sustained or which Landlord reasonably estimates that it will sustain resulting from Tenant's breach or default of the Lease or other L-C Draw Event and/or to compensate Landlord for any and all damages arising out of, or incurred in connection with, the termination of this Lease, including, without limitation, those specifically identified in Section 1951.2 of the California Civil Code. The use, application or retention of the L-C, or any portion thereof, by Landlord shall not prevent Landlord from exercising any other right or remedy provided by this Lease or by any applicable law, it being intended that Landlord shall not first be required to proceed against the L-C, and such L-C shall not operate as a limitation on any recovery to which Landlord may otherwise be entitled. Tenant agrees and acknowledges that (i) the L-C constitutes a separate and independent contract between Landlord and the Bank, (ii) Tenant is not a third party beneficiary of such contract, (iii) Tenant has no property interest whatsoever in the L-C or the proceeds thereof, and (iv) in the event Tenant becomes a debtor under any chapter of the Bankruptcy Code, Tenant is placed into receivership or conservatorship, and/or there is an event of a receivership, conservatorship or a bankruptcy filing by, or on behalf of, Tenant, neither Tenant, any trustee, nor Tenant's bankruptcy estate shall have any right to restrict or limit Landlord's claim and/or rights to the L-C and/or the proceeds thereof by application of Section 502(b)(6) of the U. S. Bankruptcy Code or otherwise.

 

21.3 Maintenance of L-C by Tenant . If, as a result of any drawing by Landlord of all or any portion of the L-C, the amount of the L-C shall be less than the L-C Amount, Tenant shall, within five (5) days thereafter, provide Landlord with additional letter(s) of credit in an amount equal to the deficiency, and any such additional letter(s) of credit shall comply with all of the provisions of this Article 21 . Tenant further covenants and warrants that it will neither assign nor encumber the L-C or any part thereof and that neither Landlord nor its successors or assigns will be bound by any such assignment, encumbrance, attempted assignment or attempted encumbrance. Without limiting the generality of the foregoing, if the L-C expires earlier than the L-C Expiration Date, Landlord will accept a renewal thereof (such renewal letter of credit to be in effect and delivered to Landlord, as applicable, not later than thirty (30) days prior to the expiration of the L-C), which shall be irrevocable and automatically renewable as above provided through the L-C Expiration Date upon the same terms as the expiring L-C or such other terms as may be acceptable to Landlord in its sole discretion. If Tenant exercises its option to extend the Lease Term pursuant to Section 2.2 of this Lease then, not later than thirty (30) days prior to the commencement of the Option Term, Tenant shall deliver to Landlord a new L C or certificate of renewal or extension evidencing the L-C Expiration Date as thirty (30) days after the expiration of the Option Term. However, if the L-C is not timely renewed, or if Tenant fails to maintain the L-C in the amount and in accordance with the terms set forth in this Article 21 , Landlord shall have the right to present the L-C to the Bank in accordance with the terms of this Article 21 , and the proceeds of the L-C may be applied by Landlord against any Rent payable by Tenant under this Lease that is not paid when due and/or to pay for all losses and damages that Landlord has suffered or that Landlord reasonably estimates that it will suffer as a result of any breach or default by Tenant under this Lease.     In the event Landlord elects to exercise its rights as provided above,

(I) any unused proceeds shall constitute the property of Landlord (and not Tenant’s property or, in the event of a receivership, conservatorship, or a bankruptcy filing by, or on behalf of, Tenant, property of such receivership, conservatorship  or Tenant’s  bankruptcy estate)  and  need  not  be segregated  from Landlord’s other  assets,     and

(II) Landlord agrees to pay to Tenant within thirty (30) days after the L-C Expiration Date the amount of any proceeds of the L-C received by Landlord and not applied against any Rent payable by Tenant under this Lease that was not paid when due or used to pay for any losses and/or damages suffered by Landlord (or reasonably estimated by Landlord that it will suffer) as a result of any breach or default by Tenant under this Lease; provided, however, that if prior to the L-C Expiration Date a voluntary petition is filed by Tenant, or an involuntary petition is filed against Tenant by any of Tenant’s creditors, under the Bankruptcy Code, then Landlord shall not be obligated to make such payment in the amount of the unused L-C proceeds until either all preference issues relating to payments under this

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Lease have been resolved in such bankruptcy or reorganization case or such bankruptcy or reorganization case has been dismissed. If Landlord draws on the L-C due to Tenant’s failure to timely renew or provide a replacement L-C, such failure shall not be considered a default under this Lease and Landlord shall return such cash proceeds upon Tenant’s presentation of a replacement L-C that satisfies the requirements of this Lease, subject to reasonable satisfaction of any preference risk to Landlord.

 

21.4 Transfer and Encumbrance . The L-C shall also provide that Landlord may, at any time and without notice to Tenant and without first obtaining Tenant's consent thereto, transfer (one or more times) all or any portion of its interest in and to the L-C to another party, person or entity, regardless of whether or not such transfer is from or as a part of the assignment by Landlord of its rights and interests in and to this Lease. In the event of a transfer of Landlord's interest in under this Lease, Landlord shall transfer the L-C, in whole or in part, to the transferee and thereupon Landlord shall, without any further agreement between the parties, be released by Tenant from all liability therefor, and it is agreed that the provisions hereof shall apply to every transfer or assignment of the whole of said L- C to a new landlord. In connection with any such transfer of the L-C by Landlord, Tenant shall, at Tenant's sole cost and expense, execute and submit to the Bank such applications, documents and instruments as may be necessary to effectuate such transfer and, Tenant shall be responsible for paying the Bank's transfer and processing fees in connection therewith; provided that, Landlord shall have the right (in its sole discretion), but not the obligation, to pay such fees on behalf of Tenant, in which case Tenant shall reimburse Landlord within ten (10) days after Tenant's receipt of an invoice from Landlord therefor.

 

21.5 L-C Not a Security Deposit . Landlord and Tenant (1) acknowledge and agree that in no event or circumstance shall the L-C or any renewal thereof or substitute therefor or any proceeds thereof be deemed to be or treated as a “security deposit” under any law applicable to security deposits in the commercial context, including, but not limited to, Section 1950.7 of the California Civil Code, as such Section now exists or as it may be hereafter amended or succeeded (the " Security Deposit Laws "), (2) acknowledge and agree that the L-C (including any renewal thereof or substitute therefor or any proceeds thereof) is not intended to serve as a security deposit, and the Security Deposit Laws shall have no applicability or relevancy thereto, and (3) waive any and all rights, duties and obligations that any such party may now, or in the future will, have relating to or arising from the Security Deposit Laws. Tenant hereby irrevocably waives and relinquishes the provisions of Section 1950.7 of the California Civil Code and any successor statute, and all other provisions of law, now or hereafter in effect, which (x) establish the time frame by which a landlord must refund a security deposit under a lease, and/or (y) provide that a landlord may claim from a security deposit only those sums reasonably necessary to remedy defaults in the payment of rent, to repair damage caused by a tenant or to clean the premises, it being agreed that Landlord may, in addition, claim those sums specified in this Article 21 and/or those sums reasonably necessary to (a) compensate Landlord for any loss or damage caused by Tenant's breach of this Lease, including any damages Landlord suffers following termination of this Lease, and/or

(b) compensate Landlord for any and all damages arising out of, or incurred in connection with, the termination of this Lease, including, without limitation, those specifically identified in Section 1951.2 of the California Civil Code. Tenant agrees not to interfere in any way with any payment to Landlord of the proceeds of the L-C, either prior to or following a "draw" by Landlord of all or any portion of the L-C, regardless of whether any dispute exists between Tenant and Landlord as to Landlord's right to draw down all or any portion of the L-C. No condition or term of this Lease shall be deemed to render the L-C conditional and thereby afford the Bank a justification for failing to honor a drawing upon such L-C in a timely manner. Tenant shall not request or instruct the Bank of any L-C to refrain from paying sight draft(s) drawn under such L-C.

 

21.6 Remedy for Improper Drafts . Tenant's sole remedy in connection with the improper presentment or payment of sight drafts drawn under any L-C shall be the right to obtain from Landlord a refund of the amount of any sight draft(s) that were improperly presented or the proceeds of which were misapplied, and reasonable actual out-of-pocket attorneys' fees, provided that at the time of such refund, Tenant increases the amount of such L-C to the amount (if any) then required under the applicable provisions of this Lease. Tenant acknowledges that the presentment of sight drafts drawn under any L-C, or the Bank's payment of sight drafts drawn under such L-C, could not under any circumstances cause Tenant injury that could not be remedied by an award of money damages, and that the recovery of money damages would be an adequate remedy therefor. In the event Tenant shall be entitled to a refund as aforesaid and Landlord shall fail to make such payment within ten (10) business days after demand, Tenant shall have the right to deduct the amount thereof from the next installment(s) of Base Rent.

 

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22. COMMUNICATIONS AND COMPUTER LINE. Tenant may install, maintain, replace, remove or use any communications or computer wires and cables serving the Premises (collectively, the " Lines "), provided that Tenant shall obtain Landlord's prior written consent, use an experienced and qualified contractor approved in writing by Landlord, and comply with all of the other provisions of Articles 7 and 8 of this Lease. Tenant shall pay all costs in connection therewith. Landlord reserves the right, upon notice to Tenant prior to the expiration or earlier termination of this Lease, to require that Tenant, at Tenant's sole cost and expense, remove any Lines located in or serving the Premises prior to the expiration or earlier termination of this Lease.

23. SIGNS.

 

23.1 Exterior Signage . Subject to Landlord's prior written approval, which shall not be unreasonably withheld, conditioned or delayed, and provided all signs are in keeping with the quality, design and style of the Building and Project, Tenant, at its sole cost and expense, may install (i) identification signage on the monument sign outside the front entrance to the Building (which Landlord shall install at its sole cost prior to the Lease Commencement Date), (ii) internal directional and lobby identification signage, and (iii) signage in two (2) locations on the exterior of the Building in accordance with the Project master signage program (collectively, " Tenant Signage "); provided, however, (a) in no event shall Tenant's Signage include an "Objectionable Name," as that term is defined in Section 23.3 , of this Lease, and (b) Landlord shall consult with Tenant prior to finalizing the master signage program and consider in good faith Tenant's reasonable comments with respect thereto. All such signage shall be subject to Tenant's obtaining all required governmental approvals. All permitted signs shall be maintained by Tenant at its expense in a first-class and safe condition and appearance. Upon the expiration or earlier termination of this Lease, Tenant shall remove all of its signs at Tenant's sole cost and expense. The graphics, materials, color, design, lettering, lighting, size, illumination, specifications and exact location of Tenant's Signage (collectively, the " Sign Specifications ") shall be subject to the prior written approval of Landlord, which approval shall not be unreasonably withheld, conditioned or delayed, and shall be consistent and compatible with the quality and nature of the Project. Tenant hereby acknowledges that, notwithstanding Landlord's approval of Tenant's Signage, Landlord has made no representation or warranty to Tenant with respect to the probability of obtaining all necessary governmental approvals and permits for Tenant's Signage. In the event Tenant does not receive the necessary governmental approvals and permits for Tenant's Signage, Tenant's and Landlord's rights and obligations under the remaining terms of this Lease shall be unaffected. Except as required by applicable law, Landlord shall not install any other signage on the Building. If Landlord elects to install a multi-tenant identification sign at the entrance to the Project, Tenant shall be entitled to install its name on such sign (subject to availability on a pro-rata basis based on the relative square footages leased by the tenants of the Project), at Tenant's sole cost and expense.

 

23.2 Objectionable Name . Tenant's Signage shall not include a name or logo which relates to an entity which is of a character or reputation, or is associated with a political faction or orientation, which is inconsistent with the quality of the Project, or which would otherwise reasonably offend a landlord of the Comparable Buildings (an " Objectionable Name ").  Landlord agrees that "MyoKardia, Inc." is not an Objectionable Name.

 

23.3 Prohibited Signage and Other Items . Any signs, notices, logos, pictures, names or advertisements which are installed and that have not been separately approved by Landlord may be removed without notice by Landlord at the sole expense of Tenant. Any signs, window coverings, or blinds (even if the same are located behind the Landlord-approved window coverings for the Building), or other items visible from the exterior of the Premises or Building, shall be subject to the prior approval of Landlord, in its sole discretion.

 

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24. COMPLIANCE WITH LAW. Tenant shall not do anything or suffer anything to be done in or about the Premises or the Project which will in any way conflict with any law, statute, ordinance or other governmental rule, regulation or requirement now in force or which may hereafter be enacted or promulgated. At its sole cost and expense, Tenant shall promptly comply with all such governmental measures. Should any standard or regulation now or hereafter be imposed on Landlord or Tenant by a state, federal or local governmental body charged with the establishment, regulation and enforcement of occupational, health or safety standards for employers, employees, landlords or tenants, then Tenant agrees, at its sole cost and expense, to comply promptly with such standards or regulations. Tenant shall be responsible, at its sole cost and expense, to make all alterations to the Building and Premises as are required to comply with the governmental rules, regulations, requirements or standards described in this Article 24 . The judgment of any court of competent jurisdiction or the admission of Tenant in any judicial action, regardless of whether Landlord is a party thereto, that Tenant has violated any of said governmental measures, shall be conclusive of that fact as between Landlord and Tenant. Tenant's obligations under this Article 24 are subject to the limitation in Section 10.2 , above.

 

25. LATE CHARGES. If any installment of Rent or any other sum due from Tenant shall not be received by Landlord or Landlord's designee within five (5) business days after Tenant's receipt of written notice from Landlord that said amount is delinquent, then Tenant shall pay to Landlord a late charge equal to five percent (5%) of the overdue amount plus any reasonable attorneys' fees incurred by Landlord by reason of Tenant's failure to pay Rent and/or other charges when due hereunder. The late charge shall be deemed Additional Rent and the right to require it shall be in addition to all of Landlord's other rights and remedies hereunder or at law and shall not be construed as liquidated damages or as limiting Landlord's remedies in any manner. In addition to the late charge described above, any Rent or other amounts owing hereunder which are not paid within ten (10) days after Tenant's receipt of written notice that said amount is delinquent shall bear interest from the date when due until paid at a rate per annum equal to the lesser of (i) the annual "Bank Prime Loan" rate cited in the Federal Reserve Statistical Release Publication G.13(415), published on the first Tuesday of each calendar month (or such other comparable index as Landlord and Tenant shall reasonably agree upon if such rate ceases to be published) plus four (4) percentage points, and (ii) the highest rate permitted by applicable law.

 

26. LANDLORD'S RIGHT TO CURE DEFAULT; PAYMENTS BY TENANT.

 

26.1 Landlord's Cure . All covenants and agreements to be kept or performed by Tenant under this Lease shall be performed by Tenant at Tenant's sole cost and expense and without any reduction of Rent, except to the extent, if any, otherwise expressly provided herein. If Tenant shall fail to perform any obligation under this Lease, and such failure shall continue in excess of the time allowed under Section 19.1.2 , above, unless a specific time period is otherwise stated in this Lease, Landlord may, but shall not be obligated to, make any such payment or perform any such act on Tenant's part without waiving its rights based upon any default of Tenant and without releasing Tenant from any obligations hereunder.

 

26.2 Tenant's Reimbursement . Except as may be specifically provided to the contrary in this Lease, Tenant shall pay to Landlord, upon delivery by Landlord to Tenant of statements therefor: (i) sums equal to expenditures reasonably made and obligations incurred by Landlord in connection with the remedying by Landlord of Tenant's defaults pursuant to the provisions of Section 26.1 ; (ii) sums equal to all losses, costs, liabilities, damages and expenses referred to in Article 10 of this Lease; and (iii) subject to Section 29.21 , sums equal to all expenditures made and obligations incurred by Landlord in collecting or attempting to collect the Rent or in enforcing or attempting to enforce any rights of Landlord under this Lease or pursuant to law, including, without limitation, all reasonable legal fees and other amounts so expended. Tenant's obligations under this Section 26.2 shall survive the expiration or sooner termination of the Lease Term.

 

27. ENTRY BY LANDLORD. Landlord reserves the right at all reasonable times and upon reasonable notice to Tenant (except in the case of an Emergency) to enter the Premises to (i) inspect them; (ii) show the Premises to prospective purchasers, or to current or prospective mortgagees, ground or underlying lessors or insurers or, during the last nine (9) months of the Lease Term, to prospective tenants; (iii) post notices of nonresponsibility (to the extent applicable pursuant to then applicable law); or (iv) repair the Premises or the Building, or for structural repairs to the Building or the Building's systems and equipment as provided under the Lease. Landlord may make any such entries without the abatement of Rent, except as otherwise provided in this Lease, and may take such reasonable steps as required to accomplish the stated purposes. In an Emergency, Landlord shall have the right to use any means that

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Landlord may deem proper to open the doors in and to the Premises. Any entry into the Premises by Landlord in the manner hereinbefore described shall not be deemed to be a forcible or unlawful entry into, or a detainer of, the Premises, or an actual or constructive eviction of Tenant from any portion of the Premises. Landlord shall use commercially reasonable efforts to minimize any interference with Tenant's use of or access to the Premises in connection with any such entry, and shall comply with Tenant's reasonable security measures. Landlord shall hold confidential any information regarding Tenant’s business that it may learn as a result of such entry.

 

28. TENANT PARKING. Tenant shall have the right, without the payment of any parking charge or fee (other than as a reimbursement of operating expenses to the extent allowed pursuant to the terms or Article 4 of this Lease, above), commencing on the Lease Commencement Date, to use the amount of parking set forth in Section 9 of the Summary, in the on-site parking lot and garage which serves the Building. Tenant shall abide by all reasonable rules and regulations which are prescribed from time to time for the orderly operation and use of the parking facility where the parking passes are located (including any sticker or other identification system established by Landlord and the prohibition of vehicle repair and maintenance activities in the parking facilities), and shall cooperate in seeing that Tenant's employees and visitors also comply with such rules and regulations. Tenant's use of the Project parking facility shall be at Tenant's sole risk and Tenant acknowledges and agrees that Landlord shall have no liability whatsoever for damage to the vehicles of Tenant, its employees and/or visitors, or for other personal injury or property damage or theft relating to or connected with the parking rights granted herein or any of Tenant's, its employees' and/or visitors' use of the parking facilities.

 

29. MISCELLANEOUS PROVISIONS.

 

29.1 Terms; Captions . The words " Landlord " and " Tenant " as used herein shall include the plural as well as the singular. The necessary grammatical changes required to make the provisions hereof apply either to corporations or partnerships or individuals, men or women, as the case may require, shall in all cases be assumed as though in each case fully expressed. The captions of Articles and Sections are for convenience only and shall not be deemed to limit, construe, affect or alter the meaning of such Articles and Sections.

 

29.2 Binding Effect . Subject to all other provisions of this Lease, each of the covenants, conditions and provisions of this Lease shall extend to and shall, as the case may require, bind or inure to the benefit not only of Landlord and of Tenant, but also of their respective heirs, personal representatives, successors or assigns, provided this clause shall not permit any assignment by Tenant contrary to the provisions of Article 14 of this Lease.

 

29.3 No Air Rights . No rights to any view or to light or air over any property, whether belonging to Landlord or any other person, are granted to Tenant by this Lease. If at any time any windows of the Premises are temporarily darkened or the light or view therefrom is obstructed by reason of any repairs, improvements, maintenance or cleaning in or about the Project, the same shall be without liability to Landlord and without any reduction or diminution of Tenant's obligations under this Lease.

 

29.4 Modification of Lease . Should any current or prospective mortgagee or ground lessor for the Building or Project require a modification of this Lease, which modification will not cause an increased cost or expense to Tenant or in any other way materially and adversely change the rights and obligations of Tenant hereunder or interfere with Tenant's use of the Premises, then and in such event, Tenant agrees that this Lease may be so modified and agrees to execute whatever documents are reasonably required therefor and to deliver the same to Landlord within ten (10) business days following a request therefor. At the request of Landlord or any mortgagee or ground lessor, Tenant agrees to execute a short form of Lease and deliver the same to Landlord within ten (10) business days following the request therefor.

 

29.5 Transfer of Landlord's Interest . Tenant acknowledges that Landlord has the right to transfer all or any portion of its interest in the Project or Building and in this Lease, and Tenant agrees that in the event of any such transfer, Landlord shall automatically be released from all liability under this Lease and Tenant agrees to look solely to such transferee for the performance of Landlord's obligations hereunder accruing after the date of transfer provided such transferee shall have fully assumed and agreed in writing to be liable for all obligations of this Lease to be performed by Landlord, including the return of any security deposit or L-C, and Tenant shall attorn to such transferee.

 

29.6 Prohibition Against Recording . Except as provided in Section 29.4 of this Lease, neither this Lease, nor any memorandum, affidavit or other writing with respect thereto, shall be recorded by Tenant or by anyone acting through, under or on behalf of Tenant.

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29.7 Landlord's Title . Landlord's title is and always shall be paramount to the title of Tenant. Nothing herein contained shall empower Tenant to do any act which can, shall or may encumber the title of Landlord.

 

29.8 Relationship of Parties . Nothing contained in this Lease shall be deemed or construed by the parties hereto or by any third party to create the relationship of principal and agent, partnership, joint venturer or any association between Landlord and Tenant.

 

29.9 Payment under Protest . If Tenant in good faith disputes any amounts billed by Landlord, other than (i) Base Rent, (ii) Tenant's Share of Direct Expenses (as to which Tenant may exercise its rights under Section 4.6, above), Tenant may make payment of such amounts under protest, and reserve all of its rights with respect to such amounts (the " Disputed Amounts "). Landlord and Tenant shall meet and confer to discuss the Disputed Amounts and attempt, in good faith, to resolve the particular dispute.  If, despite such good faith efforts, Landlord and Tenant are unable to reach agreement regarding the Disputed Amounts, either party may submit the matter to binding arbitration under the JAMS Streamlined Arbitration Rules & Procedures. The non-prevailing party, as determined by JAMS, will be responsible to pay all fees and costs incurred in connection with the JAMS procedure, as well as all other costs and expenses, including reasonable attorneys' fees, incurred by the prevailing party. This Section 29.9 shall not apply to claims relating to Landlord's exercise of any unlawful detainer rights pursuant to California law or rights or remedies used by Landlord to gain possession of the Premises or terminate Lessee's right of possession to the Premises.

 

29.10 Time of Essence . Time is of the essence with respect to the performance of every provision of this Lease in which time of performance is a factor.

 

29.11 Partial Invalidity . If any term, provision or condition contained in this Lease shall, to any extent, be invalid or unenforceable, the remainder of this Lease, or the application of such term, provision or condition to persons or circumstances other than those with respect to which it is invalid or unenforceable, shall not be affected thereby, and each and every other term, provision and condition of this Lease shall be valid and enforceable to the fullest extent possible permitted by law.

 

29.12 No Warranty . In executing and delivering this Lease, Tenant has not relied on any representations, including, but not limited to, any representation as to the amount of any item comprising Additional Rent or the amount of the Additional Rent in the aggregate or that Landlord is furnishing the same services to other tenants, at all, on the same level or on the same basis, or any warranty or any statement of Landlord which is not set forth herein or in one or more of the exhibits attached hereto.

 

29.13 Landlord Exculpation . The liability of Landlord or the Landlord Parties to Tenant for any default by Landlord under this Lease or arising in connection herewith or with Landlord's operation, management, leasing, repair, renovation, alteration or any other matter relating to the Project or the Premises shall be limited solely and exclusively to an amount which is equal to the lesser of (a) the interest of Landlord in the Project or (b) the equity interest Landlord would have in the Project if the Project were encumbered by third-party debt in an amount equal to eighty percent (80%) of the value of the Project (as such value is determined by Landlord), including any rental, condemnation, sales and insurance proceeds received by Landlord or the Landlord Parties in connection with the Project, Building or Premises. No Landlord Parties (other than Landlord) shall have any personal liability therefor, and Tenant hereby expressly waives and releases such liability on behalf of itself and all persons claiming by, through or under Tenant. The limitations of liability contained in this Section 29.13 shall inure to the benefit of Landlord's and the Landlord Parties' present and future partners, beneficiaries, officers, directors, trustees, shareholders, agents and employees, and their respective partners, heirs, successors and assigns. Under no circumstances shall any present or future partner of Landlord (if Landlord is a partnership), or trustee or beneficiary (if Landlord or any partner of Landlord is a trust), have any liability for the performance of Landlord's obligations under this Lease. Notwithstanding any contrary provision herein, neither Landlord nor the Landlord Parties shall be liable under any circumstances for injury or damage to, or interference with, Tenant's business, including but not limited to, loss of profits, loss of rents or other revenues, loss of business opportunity, loss of goodwill or loss of use, in each case, however occurring, or loss to inventory, scientific research, scientific experiments, laboratory animals, products, specimens, samples, and/or scientific, business, accounting and other records of every kind and description kept at the premises and any and all income derived or derivable therefrom.

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29.14 Entire Agreement . It is understood and acknowledged that there are no oral agreements between the parties hereto affecting this Lease and this Lease constitutes the parties' entire agreement with respect to the leasing of the Premises and supersedes and cancels any and all previous negotiations, arrangements, brochures, agreements and understandings, if any, between the parties hereto or displayed by Landlord to Tenant with respect to the subject matter thereof, and none thereof shall be used to interpret or construe this Lease. None of the terms, covenants, conditions or provisions of this Lease can be modified, deleted or added to except in writing signed by the parties hereto.

 

29.15 Right to Lease . Landlord reserves the absolute right to effect such other tenancies in the Project as Landlord in the exercise of its sole business judgment shall determine to best promote the interests of the Building or Project. Tenant does not rely on the fact, nor does Landlord represent, that any specific tenant or type or number of tenants shall, during the Lease Term, occupy any space in the Building or Project.

 

29.16 Force Majeure . Any prevention, delay or stoppage due to strikes, lockouts, labor disputes, acts of God, acts of war, terrorist acts, inability to obtain services, labor, or materials or reasonable substitutes therefor, governmental actions, civil commotions, fire or other casualty, and other causes beyond the reasonable control of the party obligated to perform, except with respect to the obligations imposed with regard to Rent and other charges to be paid by Tenant pursuant to this Lease (collectively, a " Force Majeure "), notwithstanding anything to the contrary contained in this Lease, shall excuse the performance of such party for a period equal to any such prevention, delay or stoppage and, therefore, if this Lease specifies a time period for performance of an obligation of either party, that time period shall be extended by the period of any delay in such party's performance caused by a Force Majeure, provided, however, the foregoing delays shall not apply to Tenant's termination rights hereunder.

 

29.17 Intentionally Omitted .

 

29.18 Notices . All notices, demands, statements, designations, approvals or other communications (collectively, " Notices ") given or required to be given by either party to the other hereunder or by law shall be in writing, shall be (A) sent by United States certified or registered mail, postage prepaid, return receipt requested (" Mail "), (B) delivered by a nationally recognized overnight courier, or (C) delivered personally. Any Notice shall be sent, transmitted, or delivered, as the case may be, to Tenant at the appropriate address set forth in Section 10 of the Summary, or to such other place as Tenant may from time to time designate in a Notice to Landlord, or to Landlord at the addresses set forth below, or to such other places as Landlord may from time to time designate in a Notice to Tenant. Any Notice will be deemed given (i) three (3) business days after the date it is posted if sent by Mail, (ii) the date the overnight courier delivery is made, or (iii) the date personal delivery is made. As of the date of this Lease, any Notices to Landlord must be sent, transmitted, or delivered, as the case may be, to the following addresses:

 

HCP, Inc.

1920 Main Street, Suite 1200

Irvine, CA 92614

Attention: Legal Department with a copy to:

HCP Life Science Estates 950 Tower Lane, Suite 1650 Foster City, CA 94404 Attention:  Scott Bohn

 

and

 

Allen Matkins Leck Gamble Mallory & Natsis LLP 1901 Avenue of the Stars, Suite 1800

Los Angeles, California 90067 Attention:  Anton N. Natsis, Esq.

 

29.19 Joint and Several . If there is more than one tenant, the obligations imposed upon Tenant under this Lease shall be joint and several.

 

42


 

29.20 Authority . If Tenant is a corporation, trust or partnership, Tenant hereby represents and warrants that Tenant is a duly formed and existing entity qualified to do business in the State of California and that Tenant has full right and authority to execute and deliver this Lease and that each person signing on behalf of Tenant is authorized to do so.

 

29.21 Attorneys' Fees . In the event that either Landlord or Tenant should bring suit for the possession of the Premises, for the recovery of any sum due under this Lease, or because of the breach of any provision of this Lease or for any other relief against the other, then all costs and expenses, including reasonable attorneys' fees, incurred by the prevailing party therein shall be paid by the other party, which obligation on the part of the other party shall be deemed to have accrued on the date of the commencement of such action and shall be enforceable whether or not the action is prosecuted to judgment.

 

29.22 Governing Law; WAIVER OF TRIAL BY JURY . This Lease shall be construed and enforced in accordance with the laws of the State of California. IN ANY ACTION OR PROCEEDING ARISING HEREFROM, LANDLORD AND TENANT HEREBY CONSENT TO (I) THE JURISDICTION OF ANY COMPETENT COURT WITHIN THE STATE OF CALIFORNIA, (II) SERVICE OF PROCESS BY ANY MEANS AUTHORIZED BY CALIFORNIA LAW, AND (III) IN THE INTEREST OF SAVING TIME AND EXPENSE, TRIAL WITHOUT A JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM BROUGHT BY EITHER OF THE PARTIES HERETO AGAINST THE OTHER OR THEIR SUCCESSORS IN RESPECT OF ANY MATTER ARISING OUT OF OR IN CONNECTION WITH THIS LEASE, THE RELATIONSHIP OF LANDLORD AND TENANT, TENANT'S USE OR OCCUPANCY OF THE PREMISES, AND/OR ANY CLAIM FOR INJURY OR DAMAGE, OR ANY EMERGENCY OR STATUTORY REMEDY. IN THE EVENT LANDLORD COMMENCES ANY SUMMARY PROCEEDINGS OR ACTION FOR NONPAYMENT OF BASE RENT OR ADDITIONAL RENT, TENANT SHALL NOT INTERPOSE ANY COUNTERCLAIM OF ANY NATURE OR DESCRIPTION (UNLESS SUCH COUNTERCLAIM SHALL BE MANDATORY) IN ANY SUCH PROCEEDING OR ACTION, BUT SHALL BE RELEGATED TO AN INDEPENDENT ACTION AT LAW.

 

29.23 Submission of Lease . Submission of this instrument for examination or signature by Tenant does not constitute a reservation of, option for or option to lease, and it is not effective as a lease or otherwise until execution and delivery by both Landlord and Tenant.

 

29.24 Brokers . Landlord and Tenant hereby warrant to each other that they have had no dealings with any real estate broker or agent in connection with the negotiation of this Lease, excepting only the real estate brokers or agents specified in Section 12 of the Summary (the " Brokers "), and that they know of no other real estate broker or agent who is entitled to a commission in connection with this Lease. Each party agrees to indemnify and defend the other party against and hold the other party harmless from any and all claims, demands, losses, liabilities, lawsuits, judgments, costs and expenses (including without limitation reasonable attorneys' fees) with respect to any leasing commission or equivalent compensation alleged to be owing on account of any dealings with any real estate broker or agent, other than the Brokers, occurring by, through, or under the indemnifying party. The terms of this Section 29.24 shall survive the expiration or earlier termination of the Lease Term.

 

29.25 Independent Covenants . This Lease shall be construed as though the covenants herein between Landlord and Tenant are independent and not dependent and Tenant hereby expressly waives the benefit of any statute to the contrary and agrees that if Landlord fails to perform its obligations set forth herein, Tenant shall not be entitled to make any repairs or perform any acts hereunder at Landlord's expense or to any setoff of the Rent or other amounts owing hereunder against Landlord.

 

29.26 Project or Building Name, Address and Signage . Landlord shall have the right at any time to change the name and/or address of the Project or Building (and Landlord shall reimburse Tenant its actual, reasonable costs incurred as a result of such change, if any) and, subject to Section 23.1 , to install, affix and maintain any and all signs on the exterior and on the interior of the Project or Building as Landlord may, in Landlord's sole discretion, desire. Tenant shall not use the name of the Project or Building or use pictures or illustrations of the Project or Building in advertising or other publicity or for any purpose other than as the address of the business to be conducted by Tenant in the Premises, without the prior written consent of Landlord.

 

43


 

29.27 Counterparts . This Lease may be executed in counterparts with the same effect as if both parties hereto had executed the same document. Both counterparts shall be construed together and shall constitute a single lease.

 

29.28 Good Faith . Except (i) for matters for which there is a standard of consent or discretion specifically set forth in this Lease; (ii) matters which could have an adverse effect on the Building Structure or the Building Systems,  or  which  could  affect  the  exterior  appearance  of  the  Building,  or  (iii) matters  covered  by  Article 4(Additional Rent), or Article 19 (Defaults; Remedies) of this Lease (collectively, the " Excepted Matters "), any time the consent of Landlord or Tenant is required, such consent shall not be unreasonably withheld or delayed, and, except with regard to the Excepted Matters, whenever this Lease grants Landlord or Tenant the right to take action, exercise discretion, establish rules and regulations or make an allocation or other determination, Landlord and Tenant shall act reasonably and in good faith.

 

29.29 Development of the Project .

 

29.29.1 Subdivision . Landlord reserves the right to subdivide all or a portion of the buildings and Common Areas, so long as the same does not interfere with Tenant's use of or access to the Premises or Tenant's parking rights. Tenant agrees to execute and deliver, upon demand by Landlord and in the form requested by Landlord, any additional documents needed to conform this Lease to the circumstances resulting from a subdivision and any all maps in connection therewith, so long as the same does not increase Tenant's obligations or decrease Tenant's rights under this Lease. Notwithstanding anything to the contrary set forth in this Lease, the separate ownership of any buildings and/or Common Areas by an entity other than Landlord shall not affect the calculation of Direct Expenses or Tenant's payment of Tenant's Share of Direct Expenses.

 

29.29.2 Construction of Property and Other Improvements . Tenant acknowledges that portions of the Project may be under construction following Tenant's occupancy of the Premises, and that such construction may result in levels of noise, dust, obstruction of access, etc. which are in excess of that present in a fully constructed project. Tenant hereby waives any and all rent offsets or claims of constructive eviction which may arise in connection with such construction, so long as the same does not interfere with Tenant's use of or access to the Premises or Tenant's parking rights.

 

29.30 No Violation . Tenant hereby warrants and represents that neither its execution of nor performance under this Lease shall cause Tenant to be in violation of any agreement, instrument, contract, law, rule or regulation by which Tenant is bound, and Tenant shall protect, defend, indemnify and hold Landlord harmless against any claims, demands, losses, damages, liabilities, costs and expenses, including, without limitation, reasonable attorneys' fees and costs, arising from Tenant's breach of this warranty and representation.

 

29.31 Transportation Management . Tenant shall fully comply with all present or future governmentally mandated programs intended to manage parking, transportation or traffic in and around the Project and/or the Building, and in connection therewith, Tenant shall take responsible action for the transportation planning and management of all employees located at the Premises as required by law by working directly with Landlord, any governmental transportation management organization or any other transportation-related committees or entities. Such programs may include, without limitation: (i) restrictions on the number of peak-hour vehicle trips generated by Tenant; (ii) increased vehicle occupancy; (iii) implementation of an in-house ridesharing program and an employee transportation coordinator; (iv) working with employees and any Project, Building or area-wide ridesharing program manager; (v) instituting employer-sponsored incentives (financial or in-kind) to encourage employees to rideshare; and (vi) utilizing flexible work shifts for employees.

 

[ Signatures on next page. ]

 

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IN WITNESS WHEREOF, Landlord and Tenant Have caused this Lease to be executed the day and date first above written.

 

LANDLORD :

 

TENANT :

HCP LS BRISBANE, LLC,

A Delaware limited liability company

 

MYOKARDIA, INC.,

A Delaware corporation

 

 

 

 

 

 

 

By:

Scott Bohn

 

By:

Tassos Gianakakos

 

Name:

Scott Bohn

 

 

Name:

Tassos Gianakakos

 

Its:

Vice President

 

 

Its:

President and Chief Executive Officer

 

 

 

 

 

 

 

 

 

 

 

By:

 

 

 

 

 

 

 

Name:

 

 

 

 

 

 

Its:

 

 

 

 

 

 

-45 -


 

 

EXHIBIT A

 

OUTLINE OF PREMISES; PROJECT SITE PLAN

 

 

EXHIBIT A

-1 -


 

 

 

 

 

 

 

 

 

EXHIBIT A

-2 -


 

 

 

EXHIBIT A

-3 -


 

EXHIBIT B

 

TENANT WORK LETTER

 

1. Defined Terms . As used in this Tenant Work Letter, the following capitalized terms have the following meanings:

 

(a) Approved TI Plans : Plans and specifications prepared by the applicable Architect for the Tenant Improvements and approved by Landlord and Tenant in accordance with Paragraph 2 of this Tenant Work Letter, subject to further modification from time to time to the extent provided in and in accordance with such Paragraph 2.

 

(b) Architect : Landlord shall engage DGA with respect to any Tenant Improvements which Landlord is to cause to be constructed pursuant to this Tenant Work Letter.

 

(c) Tenant Change Request : See definition in Paragraph 2(c)(ii) hereof.

 

(d) Final TI Working Drawings : See definition in Paragraph 2(a) hereof.

 

(e) General Contractor : The general contractor selected by Landlord and reasonably approved by Tenant with respect to Landlord's TI Work. Tenant shall have no right to direct or control such General Contractor.

 

(f) Landlord's TI Work : Any Tenant Improvements which Landlord is to construct or install pursuant to this Tenant Work Letter or by mutual agreement of Landlord and Tenant from time to time.

 

(g) Project Manager . Project Management Advisors, Inc., or any other project manager designated by Landlord in its reasonable discretion from time to time to act in a supervisory, oversight, project management or other similar capacity on behalf of Landlord in connection with the design and/or construction of the Tenant Improvements.

 

(h) Punch List Work : Minor corrections of construction or decoration details, and minor mechanical adjustments, that are required in order to cause any applicable portion of the Tenant Improvements or Landlord's Work as constructed to conform to the Approved TI Plans or this Tenant Work Letter in all material respects and that do not materially interfere with Tenant's use or occupancy of the Building and the Premises.

 

(i) Substantial Completion Certificate : See definition in Paragraph 3(a) hereof.

 

(j) Tenant Delay : Any of the following types of delay in the completion of construction of Landlord's TI Work (but in each instance, only to the extent that any of the following has actually and proximately caused substantial completion of Landlord's TI Work to be delayed):

 

(i) Any delay resulting from Tenant's failure to furnish, in a timely manner, information reasonably requested by Landlord or by Landlord's Project Manager in connection with the design or construction of Landlord's TI Work, or from Tenant's failure to approve in a timely manner any matters requiring approval by Tenant;

 

(ii) Any delay resulting from Tenant Change Requests initiated by Tenant, including any delay resulting from the need to revise any drawings or obtain further governmental approvals as a result of any such Tenant Change Request; or

 

(iii) Any delay caused by Tenant (or Tenant's contractors, agents or employees) materially interfering with the performance of Landlord's TI Work, provided that Landlord shall have given Tenant prompt notice of such material interference and, before the first time a Tenant Delay is deemed to have occurred as a result of such delay, such interference has continued for more than twenty-four(24) hours after Tenant’s receipt of such notice.

 

 

EXHIBIT B

-1 -


 

(k) Tenant Improvements : The improvements to or within the Building shown on the Approved TI Plans from time to time and to be constructed by Landlord pursuant to the Lease and this Tenant Work Letter. The term "Tenant Improvements" does not include the improvements existing in the Building and Premises on the Effective Date.

 

(l) Unavoidable Delays : Delays due to acts of God, acts of public agencies, labor disputes, strikes, fires, freight embargoes, inability (despite the exercise of due diligence) to obtain supplies, materials, fuels or permits, or other causes or contingencies (excluding financial inability) beyond the reasonable control of Landlord or Tenant, as applicable. Landlord shall use commercially reasonable efforts to provide Tenant with prompt notice of any Unavoidable Delays.

 

(m) Capitalized terms not otherwise defined in this Tenant Work Letter shall have the definitions set forth in the Lease.

 

2. Plans and Construction . Landlord and Tenant shall comply with the procedures set forth in this Paragraph 2 in preparing, delivering and approving matters relating to the Tenant Improvements.

 

(a) Approved Plans and Working Drawings for Tenant Improvements . Tenant shall promptly and diligently work with the Architect to cause to be prepared and delivered to Landlord for approval (which approval shall not be unreasonably withheld, conditioned or delayed by Landlord) proposed schematic plans and outline specifications for the Tenant Improvements. Landlord shall reimburse the Architect directly for the cost of the initial test-fit plans and outline specifications and one revision thereof, and such costs shall not be charged to the Tenant Improvement Allowance. Following mutual approval of such proposed schematic plans and outline specifications by Landlord and by Tenant (as so approved, the “ Approved Schematic Plans ”), Tenant shall then work with the Architect to cause to be prepared, promptly and diligently (assuming timely delivery by Landlord of any information and decisions required to be furnished or made by Landlord in order to permit preparation of final working drawings, all of which information and decisions Landlord will deliver promptly and with reasonable diligence), and delivered to Landlord for approval (which approval shall not be unreasonably withheld, conditioned or delayed by Landlord) final detailed working drawings and specifications for the Tenant Improvements, including (without limitation) any applicable life safety, mechanical, electrical and plumbing working drawings and final architectural drawings (collectively, “ Final TI Working Drawings ”), which Final TI Working Drawings shall substantially conform to the Approved Schematic Plans. Upon receipt from Tenant of proposed schematic plans and outline specifications, proposed Final TI Working Drawings, any other plans and specifications, or any revisions or resubmittals of any of the foregoing, as applicable, Landlord shall promptly and diligently (and in all events within 10 business days after receipt in the case of an initial submittal of schematic plans and outline specifications or proposed Final TI Working Drawings, and within 5 business days after receipt in the case of any other plans and specifications or any revisions or resubmittals of any of the foregoing) either approve such proposed schematic plans and outline specifications or proposed Final TI Working Drawings, as applicable, or set forth in writing with particularity any changes necessary to bring the aspects of such proposed schematic plans and outline specifications or proposed Final TI Working Drawings into a form which will be reasonably acceptable to Landlord. Upon approval of the Final TI Working Drawings by Landlord and Tenant, the Final TI Working Drawings shall constitute the “Approved TI Plans,” superseding (to the extent of any inconsistencies) any inconsistent features of the previously existing Approved Schematic Plans. Tenant shall respond to any request for information or approval of plans or drawings from Landlord or Architect within five (5) business days. Tenant acknowledges that the Tenant Improvements will include the items set forth on Schedule 2 to this Exhibit B, in order to allow the Premises to achieve a LEED "Silver" certification level.

 

(b) Cost of Improvements . “ Cost of Improvement ” shall mean, with respect to any item or component for which a cost must be determined in order to allocate such cost, or an increase in such cost, to Tenant pursuant to this Tenant Work Letter, the sum of the following (unless otherwise agreed in writing by Landlord and Tenant with respect to any specific item or component or any category of items or components): (i) all sums paid to contractors or subcontractors for labor and materials furnished in connection with construction of such item or component; (ii) all costs, expenses, payments, fees and charges (other than penalties) paid to or at the direction of any city, county or other governmental or quasi-governmental authority or agency which are required to be paid in order

 

 

EXHIBIT B

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to obtain all necessary governmental permits, licenses, inspections and approvals relating to construction of such item or component; (iii) engineering and architectural fees for services rendered in connection with the design and construction of such item or component (including, but not limited to, the Architect for such item or component and an electrical engineer, mechanical engineer, structural engineer and civil engineer, if applicable); (iv) sales and use taxes; (v) testing and inspection costs; (vi) the cost of power, water and other utility facilities and the cost of collection and removal of debris required in connection with construction of such item or component; (vii) costs for builder’s risk insurance; and (viii) all other “hard” and “soft” costs incurred in the construction of such item or component in accordance with the Approved TI Plans (if applicable) and this Tenant Work Letter; provided that the Cost of Improvements shall not include any internal or third-party costs incurred by Landlord  except  as  provided  in Section 2(e) .

 

(c) Construction of Landlord's TI Work . Following completion of the Approved TI Plans, Landlord shall apply for and use reasonable efforts to obtain the necessary permits and approvals to allow construction of all Tenant Improvements. Upon receipt of such permits and approvals, Landlord shall, at Tenant's expense (subject to Landlord's payment of the Tenant Improvement Allowance and, to the extent requested by Tenant, the Additional TI Allowance), construct and complete the Tenant Improvements substantially in accordance with the Approved TI Plans, subject to Unavoidable Delays and Tenant Delays (if any). Landlord shall use commercially reasonable efforts to complete the Tenant Improvements on or before December 31, 2019, subject to Unavoidable Delays and Tenant Delays (if any). Such construction of the Tenant Improvements and Landlord’s Work shall be performed in a neat, good and workmanlike manner, free of defects, using new materials and equipment of good quality, and shall materially conform to all applicable laws, rules, regulations, codes, ordinances, requirements, covenants, conditions and restrictions applicable thereto in force at the time such work is completed. Landlord shall cause Hathaway Dinwiddie (so long as obtaining such bid does not delay the completion of Landlord’s TI Work), Landmark Builders and any other potential general contractors requested by Tenant and reasonably approved by Landlord to bid on general conditions and fee for construction of the Tenant Improvements. All bids will be opened together with Tenant selecting the general contractor to construct the Tenant Improvements, subject to the reasonable approval of Landlord. Tenant shall have the right to value engineer the proposed Tenant Improvements before the final bid is selected. Tenant shall also have the right to approve all subcontractors engaged by the General Contractor, which subcontractors shall be competitively bid and which approval shall not be unreasonably withheld, conditioned or delayed. Landlord shall enter into a stipulated sum or guaranteed maximum price construction contract with the General Contractor as selected by Tenant and approved by Landlord in the amount of the construction costs approved by Landlord and   Tenant.

 

(d) Changes .

 

(i) If Landlord determines at any time that changes in the Final TI Working Drawings or in any other aspect of the Approved TI Plans relating to any item of Landlord's TI Work are required as a result of applicable law or governmental requirements, or are required as a result of unanticipated conditions encountered in the course of construction, then Landlord shall promptly (A) advise Tenant of such circumstances and (B) at Tenant's sole cost and expense, subject to Landlord's payment of the Tenant Improvement Allowance and, to the extent requested by Tenant, the Additional TI Allowance, cause revised Final TI Working Drawings to be prepared by the Architect and submitted to Tenant, for Tenant's approval, which shall not be unreasonably withheld. Failure of Tenant to deliver to Landlord written notice of disapproval and specification of such required changes on or before any deadline reasonably specified by Landlord (which shall not be less than three (3) business days after delivery thereof to Tenant) shall constitute and be deemed to be a Tenant Delay to the extent Landlord is delayed in completing Landlord’s TI Work.

 

(ii) If Tenant at any time desires any changes, alterations or additions to the Final TI Working Drawings, Tenant shall submit a detailed written request to Landlord specifying such changes, alterations or additions (a " Tenant Change Request "). Upon receipt of any such request, Landlord, within five (5) business days, shall promptly notify Tenant of (A) whether the matters proposed in the Tenant Change Request are approved by Landlord (which approval shall not be unreasonably withheld, conditioned or delayed by Landlord), (B) Landlord's estimate of the number of days of delay, if any, which shall be caused in the construction of the Tenant Improvements by such Tenant Change Request if implemented (including, without limitation, delays due to the need to obtain any revised plans or drawings and any governmental approvals), and (C) Landlord's estimate of the increase, if any, which shall occur in the cost of design,

 

 

EXHIBIT B

-3 -


 

permitting, project management and construction of the Tenant Improvements affected by such Tenant Change Request if such Tenant Change Request is implemented (including, but not limited to, any costs of compliance with laws or governmental regulations that become applicable because of the implementation of the Tenant Change Request). If Landlord approves the Tenant Change Request and Tenant notifies Landlord in writing, within three (3) business days after receipt of such notice from Landlord, of Tenant's approval of the Tenant Change Request (including the estimated delays and cost increases, if any, described in Landlord's notice), then Landlord shall cause such Tenant Change Request to be implemented and Tenant shall be responsible for all actual costs or cost increases resulting from or attributable to the implementation of the Tenant Change Request, and any delays resulting therefrom shall be deemed to be a Tenant Delay (subject to Landlord's payment of the Tenant Improvement Allowance and, to the extent requested by Tenant, the Additional TI Allowance). If Tenant fails to notify Landlord in writing of Tenant's approval of such Tenant Change Request within said three (3) business day period, then such Tenant Change Request shall be deemed to be withdrawn and shall be of no further effect.

 

(e) Project Management . Unless and until revoked by Landlord by written notice delivered to Tenant, Landlord hereby (i) delegates to Project Manager the authority to exercise all approval rights, supervisory rights and other rights or powers of Landlord under this Tenant Work Letter with respect to the design and construction of the Tenant Improvements, and (ii) requests that Tenant work with Project Manager with respect to any logistical or other coordination matters arising in the course of construction of the Tenant Improvements, including monitoring Tenant's compliance with its obligations under this Tenant Work Letter and under the Lease with respect to the design and construction of the Tenant Improvements. Tenant acknowledges the foregoing delegation and request, and agrees to cooperate reasonably with Project Manager as Landlord's representative pursuant to such delegation and request. Fees and charges of Project Manager for such services shall be at Tenant's sole expense, subject to Landlord's payment of the Tenant Improvement Allowance and, to the extent requested by Tenant, the Additional TI Allowance. Such fees shall be equal to 2.65% of all funds the Tenant Improvement Allowance or Additional Tenant Improvement Allowance used in connection with the construction of the Tenant Improvements, and 2% of any additional funds provided by Tenant for such construction.

 

3. Completion .

 

(a) When Landlord receives written certification from Architect that construction of the Tenant Improvements and Landlord's Work has been completed in accordance with the Approved TI Plans and Section 3(e) below (except for Punch List Work), Landlord shall prepare and deliver to Tenant a certificate (or separate certificates for the Tenant Improvements and Landlord's Work) signed by Landlord, Architect and General Contractor (the " Substantial Completion Certificate ") (i) certifying that the construction of the Tenant Improvements and Landlord's Work has been substantially completed in a good and workmanlike manner in accordance with the Approved TI Plans and Section 3(e) below in all material respects, subject only to completion of Punch List Work, and specifying the date of that completion, and (ii) certifying that the Tenant Improvements and Landlord's Work comply in all material respects with all laws, rules, regulations, codes, ordinances, requirements, covenants, conditions and restrictions applicable thereto at the time of such delivery, including the ADA and all building codes. Upon receipt by Tenant of the Substantial Completion Certificate and tender of possession of the Premises by Landlord to Tenant, and receipt of any certificate of occupancy or its legal equivalent, or other required sign-offs from any applicable governmental authority, allowing the legal occupancy of the Premises, the Tenant Improvements will be deemed delivered to Tenant and "Ready for Occupancy" for all purposes of the Lease (subject to Landlord's continuing obligations with respect to any Punch List Work, and to any other express obligations of Landlord under the Lease or this Tenant Work Letter with respect to such Tenant Improvements).

 

(b) Immediately prior to delivery of the Substantial Completion Certificate for the Tenant Improvements, Project Manager or other representatives of Landlord shall conduct one or more "walkthroughs" of the Building with Tenant and Tenant's representatives, to identify any items of Punch List Work that may require correction and to prepare a joint punch list reflecting any such items, following which Landlord shall diligently complete the Punch List Work reflected in such joint punch list. The Punch List Work shall be attached to the Substantial Completion Certificate, and shall not include damage caused by Tenant or any of Tenant's agents in connection with any work performed by Tenant in the Premises, or required as a result of Tenant's move-in to the Premises. At any time within thirty (30) days after delivery of such Substantial Completion Certificate, Tenant shall be entitled to submit one or more lists to Landlord supplementing such joint punch list by specifying any additional

 

 

EXHIBIT B

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items of Punch List Work to be performed on the applicable Tenant Improvements and Landlord's Work, and upon receipt of such list(s), Landlord shall diligently complete such additional Punch List Work. Promptly after Landlord provides Tenant with the Substantial Completion Certificate and completes all applicable Punch List Work for the Building, Landlord shall cause the recordation of a Notice of Completion (as defined in the California Civil Code) with respect to the Tenant Improvements.

 

(c) All construction, product and equipment warranties and guaranties obtained by Landlord with respect to the Tenant Improvements and Landlord's Work shall, to the extent reasonably obtainable, include a provision that such warranties and guaranties shall also run to the benefit of Tenant, and Landlord shall cooperate with Tenant in a commercially reasonable manner to assist in enforcing all such warranties and guaranties for the benefit of Tenant.

 

(d) Notwithstanding any other provisions of this Tenant Work Letter or of the Lease, if Landlord is delayed in substantially completing any of the Tenant Improvements as a result of any Tenant Delay, and if the Lease Commencement Date is being determined under clause (i) of Section 3.2 of the Lease Summary, then notwithstanding any other provision of the Lease to the contrary, then the Premises shall be deemed to have been Ready for Occupancy on the date the Premises would have been Ready for Occupancy absent such Tenant Delay.

 

(e) Notwithstanding any other provisions of this Tenant Work Letter or of the Lease, Landlord shall be responsible, at Landlord's sole cost and expense, and without deduction from the Tenant Improvement Allowance, to construct and deliver the Base Building and "Warm Shell" components of the Premises (" Landlord's Work "), which shall consist of the items set forth on Schedule 1 to this Exhibit B (the " Warm Shell Schedule ").

 

(f) Construction of Additional Base Building Items . To the extent that the Final TI Working Drawings contain any structural items, or items which would not reasonably be categorized as "normal tenant improvements" under applicable GAAP standards (the " Additional Base Building Items "), then such Additional Base Building Items shall not be constructed as a part of the Landlord's TI Work or the Tenant Improvements, but instead will be constructed by Landlord as a part of the Landlord's Work. The cost of construction of the Additional Base Building Items (the " Additional Base Building Costs ") shall be borne by Landlord. Before commencing construction thereof, Landlord shall obtain a reasonable, good faith bid for the Additional Base Building Items from the General Contractor, which bid shall take into account all reasonable factors, including, without limitation, reasonable contingencies in connection therewith, Landlord shall notify Tenant of the amount of such bid (the “ Estimated Base Building Costs ”), and the amount of the Tenant Improvement Allowance shall be reduced by the amount of the Estimated Base Building Costs. Landlord shall have the right to disapprove any aspect of the Final TI Working Drawing that would result in Additional Base Building Costs in excess of the then remaining Tenant Improvement Allowance, so that, while the Tenant Improvement Allowance may be reduced, under no circumstances would Tenant be required to pay for any Additional Base Building Items with its own funds.

 

4. Payment of Costs .

 

(a) Tenant Improvement Allowance . Subject to any restrictions, conditions or limitations expressly set forth in this Tenant Work Letter or in the Lease or as otherwise expressly provided by mutual written agreement of Landlord and Tenant, the cost of construction of the Tenant Improvements shall be paid or reimbursed by Landlord up to a maximum amount as set forth in Section 5 of the Summary to the Lease (the " Tenant Improvement Allowance "), which amount is being made available by Landlord to be applied towards the Cost of Improvements for the construction of the Tenant Improvements in the Premises. Tenant shall be responsible, at its sole cost and expense, for payment of the entire Cost of Improvements of the Tenant Improvements in excess of the Tenant Improvement Allowance, including (but not limited to) any costs or cost increases incurred as a result of delays (unless caused by Landlord), governmental requirements or unanticipated conditions (unless caused by Landlord), and for payment of any and all costs and expenses relating to any alterations, additions, improvements, furniture, furnishings, equipment, fixtures and personal property items which are not eligible for application of Tenant Improvement Allowance funds under the restrictions expressly set forth below in this paragraph, but Tenant shall be entitled to use or apply the entire Tenant Improvement Allowance toward the Cost of Improvements of the Tenant Improvements (subject to any applicable restrictions, conditions, limitations, reductions or charges set forth in the Lease or in this Tenant Work Letter) prior to being required to expend any of Tenant’s own funds for the Tenant Improvements.       The funding of the Tenant Improvement Allowance shall be made on a monthly basis or at other

 

 

EXHIBIT B

-5 -


 

convenient intervals mutually approved by Landlord and Tenant and in all other respects shall be based on such commercially reasonable disbursement conditions and procedures as Landlord, Project Manager and Landlord’s lender (if any) may reasonably prescribe. Notwithstanding the foregoing provisions, under no circumstances shall the Tenant Improvement Allowance or any portion thereof be used or useable by Tenant for any moving or relocation expenses of Tenant, or for any Cost of Improvement (or any other cost or expense) associated with any moveable furniture or trade fixtures, personal property or any other item or element which, under the applicable provisions of the Lease, will not become Landlord’s property and remain with the Building upon expiration or termination of the Lease. Notwithstanding anything to the contrary herein, the Tenant Improvements shall not include (and Landlord shall be solely responsible for and the Tenant Improvement Allowance shall not be used for) the following: (a) costs incurred due to the presence of any Hazardous Materials in the Premises, if any; (b) costs to bring the Project into compliance with Applicable Laws to the extent required in order to allow Tenant to obtain a certificate of occupancy or its legal equivalent, for the Premises for the Permitted Use assuming a normal and customary office occupancy density; (c) construction costs in excess of the contract amount stated in the contract with the General Contractor, as approved by Tenant (not to be unreasonably withheld), except for increases set forth in change orders approved by Tenant; (d) wages, labor and overhead for overtime and premium time unless approved by Tenant (which approval shall not be unreasonably withheld, conditioned or delayed); (e) attorneys' fees incurred in connection with negotiation of construction contracts, and attorneys' fees, experts' fees and other costs in connection with disputes with third parties; (f) interest and other costs of financing construction costs; (g) costs incurred as a consequence construction defects or default by a contractor; (h) costs as a consequence of casualties; (i) penalties and late charges attributable to Landlord’s failure to pay construction costs; and (j) costs due to compliance with the soil management plan for the Project or its appendices.

 

(b) Additional TI Allowance . In addition to the Tenant Improvement Allowance, Tenant shall have the right, by written notice to Landlord given on or before the Lease Commencement Date, to use up to

$40.00 per RSF of the Premises (i.e., up to $5,193,840.00) (the " Additional TI Allowance ") towards the payment of the costs of the Tenant Improvement Allowance Items. In the event Tenant exercises its right to use all or any portion of the Additional TI Allowance, Tenant shall be required to pay Landlord, commencing on the date the Tenant Improvements are completed (the " Additional Payment Commencement Date "), the "Additional TI Allowance Payment," as that term is defined below, in consideration of Landlord provision of the Additional TI Allowance. The " Additional TI Allowance Payment " shall be determined as the missing component of an annuity, which annuity shall have (i) the amount of the Additional TI Allowance utilized by Tenant as the present value amount, (ii) a number equal to the number of full calendar months then remaining in the Lease Term as the number of payments, (iii) a monthly interest factor equal to seventy-five one-hundredths percent (0.75%), which is equal to nine percent (9%) divided by twelve (12) months per year, and (iv) the Additional TI Allowance Payment as the missing component of the annuity, and shall not be subject to annual escalations. Following the calculation of the Additional TI Allowance Payment, Landlord and Tenant will enter into a lease amendment in the form of Exhibit G attached to the Lease, to confirm the amount thereof.

 

(c) Tenant Funds . Any additional funds required to complete the cost of the work, that are  in excess of or elected by the Tenant to be used in place of the Tenant Improvement Allowance and the Additional TI Allowance, shall be considered " Tenant Funds ." The total cost to construct the Tenant Improvements as managed by Landlord and the Project Manager under this Work Letter shall be the " Project Budget ." Landlord understands that at the time of the agreed upon Guaranteed Maximum Price (GMP), the Tenant Funds amount is an estimate and exact costs will not be known until project closeout. Tenant is required, at the time of agreement of the GMP, to provide a purchase order to the Landlord for the full estimated amount of the Tenant Funds. In the event the Tenant Funds at project closeout are less than the amount agreed upon within the Project Budget, Landlord will only bill Tenant for the Tenant Funds that have been utilized. In the event the Tenant Funds exceed the amount agreed upon within the Project Budget, through added scope changes, the Tenant shall provide additional purchases orders to the Landlord, which will be included in the Tenant Change Request process that the Landlord’s representative administers.

 

5. No Agency . Nothing contained in this Tenant Work Letter shall make or constitute Tenant as the agent of Landlord.

 

6. Tenant Access . Provided that Tenant and its agents do not interfere with Contactor’s work in the Building and the Premises (including by the use of non-union vendors without prior coordination with Landlord), Contractor and Landlord shall allow Tenant access to the Premises at least thirty (30) days prior to the Substantial

 

 

EXHIBIT B

-6 -


 

Completion of the Landlord’s TI Work without payment of Rent for the purpose of Tenant installing equipment or fixtures (including Tenant’s data and telephone equipment) in the Premises and preparing the Premises for occupancy. Prior to Tenant’s entry into the Premises as permitted by the terms of this Section 6 , Tenant shall submit a schedule to Landlord and Contractor, for their approval, which schedule shall detail the timing and purpose of Tenant’s entry. Tenant shall hold Landlord harmless from and indemnify, protect and defend Landlord against any loss or damage to the Building or Premises and against injury to any persons caused by Tenant’s actions pursuant to this Section 6 .

 

7. Miscellaneous . All references in this Tenant Work Letter to a number of days shall be construed to refer to calendar days, unless otherwise specified herein. In all instances where Landlord's or Tenant's approval is required, if no written notice of disapproval is given within the applicable time period, at the end of that period Landlord or Tenant shall be deemed to have given approval (unless the provision requiring Landlord's or Tenant's approval expressly states that non-response is deemed to be a disapproval or withdrawal of the pending action or request, in which event such express statement shall be controlling over the general statement set forth in this sentence) and the next succeeding time period shall commence. If any item requiring approval is disapproved by Landlord or Tenant (as applicable) in a timely manner, the procedure for preparation of that item and approval shall be repeated. Provided that the initial Tenant Improvements constructed in the Premises pursuant to the terms of this Tenant Work Letter are in material compliance with the Approved Schematic Plans, Tenant shall not be required to remove or restore such initial Tenant Improvements at the termination of the Lease.

 

8. Time Deadlines . Tenant shall use commercially reasonable, good faith, efforts and all due diligence to cooperate with the Architect, General Contractor and Landlord to complete all phases of the construction drawings set forth in this Tenant Work Letter and the permitting process and to receive the permits as soon as possible after the execution of the. The applicable dates for approval of items, plans and drawings as described in this Tenant Work Letter are set forth and further elaborated upon in Schedule 3 to this Exhibit B attached hereto (the " Time Deadlines "), attached hereto.  Tenant agrees to utilize commercially reasonable efforts to comply with the Time Deadlines.

 

9. Rooftop Space . Tenant hereby acknowledges that to the extent either (i) any portion of the Tenant Improvements, or (ii) any of Tenant's equipment installed in the Premises, requires a portion of the roof to be utilized by Tenant, that Tenant shall only be permitted to utilize that certain portion of the roof as designated on Schedule 4 to this Exhibit B (the " Rooftop Space ").

 

10. Standard Tenant Improvement Package Specifications . Tenant hereby acknowledges that the Tenant Improvements are subject to the specifications set forth on Schedule 5 to this Exhibit B .

 

 

EXHIBIT B

-7 -


 

SCHEDULE 1 TO EXHIBIT B

 

BASE BUILDING "WARM SHELL" DELIVERY CONDITION

 

 

The Shore at Sierra Point

Building D

1000 Sierra Point Parkway

Brisbane, CA 94005

Warm Shell Landlord Delivery Condition

 

DESCRIPTION

SITEWORK

1.

Exterior hardscape and landscape ,including site lighting, Perimeter sidewalks, street curbs, miscellaneous site furnishings, and bio-retention basins

2.

Surface parking lot

3.

Bike storage for pro rata allocation amongst Tenants

4.

Campus electrical vehicle charging stations for pro rata allocation amongst Tenants

5.

Exterior amenties space including all hardscape and landscape, lighting, and recreational infrastructure

6.

Service Yard foundation, structure, covered enclosure , and waterproofing for trash containers and storage area for allocation amongst tenants, subject to Landlord review and approval

7.

Foundation and enclosure for Landlord provided diesel Powered emergency generator

8.

Loading dock with at-grade shipping/receiving area with One (1) hydraulic scissor lift

STRUCTURE

1.

Pile supported structural slab-on-grade foundation system consisting of steel H-piles, pile caps, and horizontal grade beams

2.

Steel superstructure consisting of steel columns, girders, Beams, and concrete slab on composite metal deck ,with Live load capacity of 100 psf

3.

Type IB construction, code required primary structural fireproofing

4.

Slab edge fire safing

5.

Lateral seismic system utilizing buckling-restrained braced frames. Importance factor is 1.0

6.

Roof deck framing with live load capacity of 20 psf

7.

Mechanical platform with live load capacity allowance of 75 psf for equipment and grating Roof penthouse live Load capacity of 100 psf

8.

Roof screen

 

 

The shore Sierra point - Warm shell Landlord Delivery Condition: Building D – July 2,2018

 

 

 

 

 

EXHIBIT B

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9.

Floor to floor height of 17’, all floors

10.

Framed openings for Base Building utility risers. Shafts include floor slab openings and surrounding shaft walls

11.

Stairs and stair enclosures per code requirements, including enclosure doors, handrails, and guardrails. Roof penthouse access for one (1) set of stairs

12.

Window washing davit bases and arms

13.

Miscellaneous metals items and/or concrete pads for base Building equipment

ROOFING

1.

60 MIL single-ply thermoplastic polyolefin (TPO) roof membrane

2.

Rigid insulation, flashing, and sealants

3.

Roofing penetrations for Base Building equipment/systems

4.

Walkway pads along roof perimeter, outside of screened area

EXTERIOR

1.

Non load-bearing glazed aluminum curtain wall and glass fiber reinforced concrete (GFRC) panel building enclosure system

2.

Building entrances and openings

3.

Exterior signage connection points

4.

Walkway pads along roof perimeter, outside of screened area

COMMON AREAS

1.

Build-out of Main Lobby

2.

Stair enclosures painted at all building levels

3.

One (1) B-Occupancy Storage Room for pro rata allocation amongst Tenants

4.

Main Electrical Room

5.

Emergency Electrical Room

6.

Domestic Pump Room

7.

Fire Booster Pump Room

8.

Elevator Control Room

9.

Telecommunications Minimum point of Entry (MPOE) Room

10.

Service Yard/Loading Dock Area, including trash enclosure storage and generator enclosure

11.

Amenities Spaces including food service, fitness center, and recreational area located on campus

ELEVATORS

1.

Two (2) passenger elevators; 3,500 lbs., 350 fpm

2.

One (1) freight elevator; 5,000 lbs., 200 fpm

3.

Recessed elevator pits for three (3) elevators

4.

Seismic restraints inside freight elevator

5.

EPS (Express Priority Service) at freight elevator

 

 

The shore Sierra point - Warm shell Landlord Delivery Condition: Building D – July 2,2018

 

 

 

 

 

EXHIBIT B

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TENANT AREAS

1.

Restroom Cores: one (1) set per floor including Men’s and Women’s Restrooms with tile floors and wet walls, solid surface countertops, floor mounted metal partitions, hard lid ceiling, down lights and ADA low-flow plumbing fixtures. Slab depressions provided in elevated floors for future restroom core showers. ADA Men’s and Women’s showers, lockers, and benches provided as part of Fitness Center Amenities within Building D

2.

Janitor Closet – one (1) per floor

3.

Stud wall framing at restroom core to underside of slab

4.

Partial fire-rated assembly at restroom core to 6”above ceiling

5.

Electrical Room – one (1) per floor consisting of concrete floor, unfinished drywall and taped walls, no ceiling

6.

Intermediate Distribution Frame (IDF0 closets – one (1) per floor consisting of concrete floor, unfinished drywall and taped walls, no ceiling. Shafts include floor slab openings and surrounding shaft walls

7.

Freight elevator lobby on elevated floors

FIRE PROTECTION

1.

Wet fire protection system: risers, distribution piping, and sprinkler heads for core areas

2.

Primary distribution and sprinkler heads adequate for “Ordinary Hazard, Group 2”for core and shell coverage

3.

Fire extinguisher cabinets at core areas

4.

Fire safing at Base Building vertical penetrations, including penetrations for mechanical, electrical, and plumbing systems

5.

Fire service and double-check valve assembly

6.

Fire pump, jockey pump, controller, and test header

 

PLUMBING

1.

Building storm and overflow drainage system, including site underground storm sewer system and connection to storm sewer mains

2.

Domestic water service with backflow prevention and Base Building risers to Tenant spaces

3.

Domestic water booster pump

4.

Building lab waste consisting of under slab piping ground floor stub-outs, risers, and stubs in Tenant space

5.

Lab waste sewer connection to sanitary sewer, lab waste sampling port at connection

6.

Domestic sanitary waste piping and sewer connection to on-site sanitary sewer line

7.

Main water meter and irrigation meter

 

 

The shore Sierra point - Warm shell Landlord Delivery Condition: Building D – July 2,2018

 

 

 

 

 

EXHIBIT B

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NATURAL GAS

1.

Medium pressure natural gas service to Building

2.

Natural gas riser to the roof and service to Base Building boilers

HEATING, VENTILATION, AIR CONDITIONING

1.

Two (2) 72,000 cfm 100% outside air roof mounted air handlers serving Tenant lab spaces. Allocation to Tenant space: standard 36,000 cfm per floor (connected to standby power)

2.

Two (2) 40,000 cfm supply/return roof mounted air handlers serving Tenant office spaces. Allocation to Tenant space: standard 20,000 cfm per floor

3.

Three (3) 4,000 MBH input gas fired hot water boilers

4.

Two (2) 370-ton centrifugal chillers

5.

Chilled Water Pipe Risers, stubbed into Tenant space for future TI build out, if needed. Chilled water stub outs not meant for 24/7 systems

6.

Two (2) 6,135 MBH cooling towers

7.

Secondary mechanical equipment, including pumps, roof ducting, piping, valves, manifolds, etc. to support Base Building mechanical systems

8.

Heating hot water risers stubbed into Tenant space

9.

Vertical supply and return air duct risers

10.

Horizontal supply air distribution: ducting, VAV terminals, equipment connections, insultation, air terminals, dampers, hangers, etc. within building lobby

11.

Two (2) roof mounted dilution lab exhaust fan systems, with 72,000 cfm capacity per system, allocated to Tenant space (connected to standby power). Each system is designed for N+1

12.

Restroom exhaust for base Building restrooms

13.

Ventilation system for Base Building Electrical Room

14.

Exhaust fan, grille supply, and fire smoke dampers for ventilation of base Building Electrical Rooms on each floor

15.

Building Management System (BMS) for core area and Landlord infrastructure

ELECTRICAL

1.

Site campus 12kV medium voltage distribution system with connection to PG&E grid via pad mounted utility transformer adjacent to building

2.

4000A 480/277V Base Building Service Switchgear with underground primary feeder to PG&E campus main switchgear

3.

Normal power 1,200A bus duct riser providing average of 300 amps @480/277V per floor

4.

One (1) 1500kW diesel standby power generator

 

 

The shore Sierra point - Warm shell Landlord Delivery Condition: Building D – July 2,2018

 

 

 

 

 

EXHIBIT B

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5.

Standby power 660A bus duct risers providing average of 150 amps @480/277V per floor

6.

Automatic transfer switch for Tenant load

7.

Ground bar per floor connecting back to the Main Electric Room

8.

Lighting and power distribution provided for core areas separated from Tenant distribution

9.

Base Building common areas life safety emergency lighting and exit signage provided throughout

10.

Emergency Responder Radio Coverage System (ERRCS) consisting of head-end system, roof-mounted antenna, and 2” conduit risers in MPOE and IDF closet. Coverage within Tenant premises to be included in TI scope.

11.

Two (2) 4” sleeves in IDF closes for future cell network infrastructure

FIRE ALARM

1.

Base Building fire alarm system with devices in core areas connected to standby power)

2.

Fire Alarm Termination Cabinet (FATC) within each Electrical Room

TELEPHONE/DATA

1.

Underground local fiber optic & telephone conduit only to Minimum Point of Entry (MPOE) Room

2.

Two (2) 4”conduit risers from MPOE to Intermediate Distribution Frame (IDF) closet on each floor

3.

Two (2) 4”sleeves for future satellite antenna and ERRS antenna from IDF closets to the roof; landlord approval required for usage

4.

Underground conduit to be shared with base building uses consisting of four (4) 4”conduits for campus intertie, three (3) 4”conduits for AT&T

SECURITY

1.

Card access at Building entries, passenger elevators, MPOE, and certain electrical rooms

2.

2. Video surveillance and intercom system at entrance and receiving doors of the Building. Video surveillance only for general views adjacent to building exterior

3.

Main lobby desk for future security operations. Security guard scope TBD

4.

Door position switches for monitoring exterior and generator doors

5.

Access control, surveillance, and intercom server infrastructure for the Landlord’s campus wide security system

 

 

The shore Sierra point - Warm shell Landlord Delivery Condition: Building D – July 2,2018

 

 

 

 

 

EXHIBIT B

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METHANE MITIGATION

1.

Methane mitigation system including sub-slad piping, risers, one (1) wind turbine, and one (1) rain cap

2.

First floor Methane sensors connected to building management system (BMS) control panel and fire alarm system

3.

Sub-slab air sampling system, including PVC pipes and underground vault outside of the building footprint

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The shore Sierra point - Warm shell Landlord Delivery Condition: Building D – July 2,2018

 

 

 

 

 

EXHIBIT B

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SCHEDULE 2 TO EXHIBIT B

 

LEED REQUIREMENTS

 

 

The following is a list of LEED prerequisites and credits that all tenants are required to meet compliance for their associated tenant-occupied spaces beyond the current Core & Shell project scope. By signing this lease, tenants are agreeing to comply with all of the outlined requirements.

 

-Water Efficiency Prerequisite 1 and Credit 3, Water Use Reduction

 

All toilets in the core or those that are tenant-installed shall be dual-flush toilets or “high-efficiency,” using 1.28 gallons per flush (gpf) or less.

 

All urinals shall be waterless or ultra low-flow e.g., 0.125gpf or less.

 

Bathroom faucets are required to have flow restrictors limiting flow to .5 gallons per minute (gpm). Kitchen and breakroom faucets to allow 2.0 gpm.

 

 

- Energy and Atmosphere Prerequisite 2, Minimum Energy Performance, and Credit 1, Optimize Energy Performance

 

Envelope must meet the following requirements:

 

o

Walls: U = 0.082

 

o

Roof: U = 0.039

 

o

Curtain Glazing: U = 0.27, SHGC = 0.29 (Viracon)

 

Mechanical (Based on B3) systems must comply with the following:

 

o

Chiller Efficiency: 0.549 kw/ton

 

o

Boiler Efficiency: 93%

 

Plumbing (Based on B3) must comply with the following:

 

o

Water heater efficiency: 96%

 

Lighting requirements are as follows:

 

o

Office Spaces > 250 ft 2 : 0.75 w/sf

 

o

Office Spaces <= 250 ft 2 : 1.0 w/sf

 

o

Lab Spaces: 1.4 w/sf

-Energy and Atmosphere Credit 4, Enhanced Refrigerant Management

 

Tenants should specify HVAC systems that minimize refrigerant impact by avoiding refrigerants entirely or using systems that reduce their harmful impacts.

 

 

Tenants should not install or retain fire suppression systems with CFCs, HCFCs, or halons.

 

-Energy and Atmosphere Credit 5, Measurement & Verification

 

Tenants will be required to submeter

 

-Indoor Environmental Quality Prerequisite 1, Minimum Indoor Air Quality (IAQ) Performance

Tenant-installed mechanical ventilation systems must meet the requirements of ASHRAE 62.1-2007 sections 4-7.

 

-Indoor Environmental Quality Credit 1, Outdoor Air Delivery Monitoring

For mechanical ventilation systems that predominantly serve densely occupied spaces (those with a design occupant density greater than or equal to 25 people per 1000 sq. ft), tenants shall install a CO2 sensor within each densely occupied space.

For all other mechanical ventilation systems, provide an outdoor airflow measurement device capable of measuring the minimum outdoor airflow rate at all expected system operating conditions within 15 percent of the design minimum outdoor air rate.

 

 

 

EXHIBIT B

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-Indoor Environmental Quality Credit 5, Indoor Chemical and Pollutant Source Control

 

Walk off mats are installed at all building main entrances as part of the core and shell scope.

 

All rooms that contain chemicals or pollutants (such as copy rooms, photo labs, laundry, and janitorial rooms) must be built with deck-to-deck full-height walls and self-closing doors, separate ventilation systems with minimum .50 cfm/sqft exhaust fans, and containment drains for appropriate disposal of hazardous liquids

 

 

Tenants must also install MERV – 13 filters for all return and outside air intakes in regularly occupied mechanically ventilated spaces

 

 

-Indoor Environmental Quality Credit 6, Controllability of Systems - Thermal Comfort

 

Tenants shall provide thermal and ventilation controls for:

 

o

At least 50 percent of the occupants that enable adjustment to suit individual needs and preferences & all shared multi-occupant spaces where transient groups must share controls.

 

 

-Indoor Environmental Quality Credit 7, Thermal Comfort - Design

 

HVAC design must meet requirements of ASHRAE 55-2004, specifically in reference to air temperature, radiant temperature, humidity, and air speed

 

 

 

 

EXHIBIT B

-15 -


 

SCHEDULE 3 TO EXHIBIT B

 

TIME DEADLINES

 

MyoKardia TI – Building D

1000 Sierra Point Parkway

Brisbane, CA

Updated: 8/9/2018

Tenant Improvement Milestone Schedule

 

10822/2018

TI Design Commencement

11/16/2018

Tenant Approval of Test-fit

12/07/2018

Tenant Selection of General Contractor

12/14/2018

Tenant Submission of Final Equipment List and HMIS (Hazardous Material Inventory Statement)

12/25/2019

Tenant Approval of 100% Schematic Plans

01/25/2019

Tenant Approval of Preliminary Project Budget

02/01/2019

Tenant Approval of Design Development Drawings

03/11/2019

Anticipated Submittal of Issue for Permit Documents to City

03/18/2009

Tenant Approval of Issue for Permit  Drawings

04/25/2019

Tenant Approval of Final Project Budget*

05/31/2019

Anticipated Construction Commencement

12/31/2019

Anticipated Substantial Completion/Rent Commencement

 

*Final Project Budget s based on Pricing of Issue for Package. Changes to Budget & Schedule Thereafter Shall be approved via TCR Process.

 

 

EXHIBIT B

-1 -


 

 

SCHEDULE 4 TO EXHIBIT B

 

DESIGNATED ROOF ZONES

 

 

 

 

 

 

 

EXHIBIT B

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SCHEDULE 5 TO EXHIBIT B

 

TENANT IMPROVEMENT SPECIFICATIONS

 

 

EXHIBIT B

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TENANT IMPROVEMENT CONSTRUCTION MANUAL

TI CONSTRUCTION RULES, REQUIREMENTS, AND STANDARDS

 

 

 

 

 

 

THE SHORE AT SIERRA POINT

Building D

 

 

1000 SIERRA POINT PARKWAY

BRISBANE, CALIFORNIA

 

V1.1  August 9, 2018

 

 

 

 


 

TABLE OF CONTENTS

 

 

Tenant Improvement Construction Manual Overview

 

 

Tenant Improvement Construction Logistics & Coordination

 

 

 

 

 

Design References

 

 

Interior Finishes

 

 

Window Treatments

 

 

Lighting Temperature

 

 

Paint Color

 

 

Emergency Evacuation Signage

 

 

 

 

 

MEP Systems & Design

 

 

Base Building Systems & Conditions

 

 

Base Building Alterations

 

 

Base Building Systems Access

 

 

Tenant Sub-Metering

 

 

Building Management System (BMS)

 

 

Emergency Systems

 

 

Laboratory Waste

 

 

Security Systems

 

 

IDF & Utilities

 

 

Elevator

 

 

Methane Mitigation System

 

 

 

 

 

Leadership in Energy and Environmental Design (LEED)

 

 

Identification Signage

 

 

 

 

 

 

 

 

APPENDIX

 

 

The Shore Master Campus Site Plan

 

Appendix A

The Shore Construction Site Logistics Plan

 

Appendix B

Generator & Automatic Transfer Switch Description

 

Appendix C

Project Directory

 

Appendix D

 

 

 

 


 

TENANT IMPROVEMENT CONSTRUCTION MANUAL OVERVIEW

 

The Tenant Improvement (TI) Construction Manual is intended to provide direction to Tenants and Tenants’ Agents during TI construction at The Shore. It serves as an instructive guide on common building systems, procedures, finishes, and campus design and construction requirements. Landlord delivery conditions will be outlined in the Warm Shell Delivery Condition matrix, as provided by Landlord.

 

While every reasonable care has been taken in preparing the information contained in this guide, neither HCP, Inc., nor its appointed consultants, are responsible for any inaccuracy or change, or any loss or damage (whether direct or consequential) arising therefrom. Information in the manual is subject to change.

 

If there are conflicts between the Lease (including all Lease Exhibits) and the TI Manual, the Lease supersedes the TI Manual in all cases.

 

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TENANT IMPROVEMENT CONSTRUCTION LOGISTICS & COORDINATION

 

1.   LABOR REQUIREMENTS

 

All labor working on TI projects at The Shore must be unionized. Contracts with non-union labor forces will not be permitted during any active Landlord construction of any portion of the campus.

 

2.   CONSTRUCTION SITE SAFETY

 

Base Building General Contractor will maintain safe campus access for all parties as well as provide site specific rules to TI construction personnel. Site safety orientation & training will be the responsibility of the TI contractors.

 

3.     CONSTRUCTION LOGISTICS

 

If any portion of TI construction coincides with any portion of the Base Building construction, the TI Contractor shall coordinate with the Base Building Contractor regarding construction logistics, including but not limited to: site safety, deliveries, on-site parking (if allowed), removal of debris, use of man lift and operator during concurrent building construction, use of elevator, and Tenant Change Requests.

 

Refer to Appendix B for Construction Site Logistics Plan which identifies specific areas for TI contractor (i.e. laydown, parking). TI contractor staging and parking are subject to change based on construction activity on site.

 

4.     TI REPORTING AND DOCUMENTATION

 

The Tenant and TI Contractor shall be responsible for providing documentation at Landlord’s request, including, but not limited to: closeout checklist, and sustainability checklist. The Landlord may provide a template or instructions for such reporting during TI design and construction.

 

For TI approval requirements, please refer to lease language.

5.   MANLIFT

Base Building General Contractor can provide extended hours or duration for manlift operation and an interior elevator operator during construction as required by TI construction. Costs for manlift or interior elevator operators during TI construction will be the responsibility of the Tenant and will be reconciled by means of a Tenant Change Request (TCR).

 

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DESIGN REFERENCES

 

1.   AS-BUILT DRAWINGS AND 3D BIM MODEL

 

Resources:

Construction documents, 3D BIM model of the Base Building and as-builts (as available) will be provided by the Landlord. In situations where there is a conflict between 2D Drawings and the 3D model, please contact Landlord for direction.

 

List of Shell Reference Documents (as available):

 

General Information

 

Civil Drawings

 

Architectural Drawings

 

Structural Drawings

 

Mechanical Drawings

 

Electrical Drawings

 

Plumbing Drawings

 

Building Maintenance Drawings (BM)

 

Cathodic Protection Drawings (CP)

 

Landscape Drawings

 

Security Drawings (SE)

 

Gas Mitigation System (EV)

 

Project Manual

 

Basis of Design (BOD) for Shell Mechanical, Electrical, Plumbing, and Fire Protection

 

Master Signage Program

 

Base Building Fire Alarm System Deferred Submittal

 

Base Building Fire Sprinkler & Standpipe System Deferred Submittal

 

Base Building Buckling Restrained Braced Frames Deferred Submittal

 

Base Building Exterior Skin (Curtainwall, Metal Panel & GFRC) Deferred Submittal

 

Base Building Exterior Building Maintenance Deferred Submittal

 

Base Building ERRCS Drawings

 

 

 

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2.   ROOF ZONE DESIGNATIONS

 

Refer to the Roof Zone Designation Diagram, as provided by the Landlord, for locating potential TI equipment. Tenant zones are not drawn to scale and represent general space areas only; Landlord makes no warranty or guarantee of the space area, dimensions, or suitability for installation of Tenant equipment. Required clearances of Base Building equipment and path of travel shall be maintained.

 

3.   SERVICE YARD STORAGE

 

Any alterations to Storage Room shall be subject to Landlord review and approval and are at the sole cost and responsibility of the Tenant. If specific Nitrogen or other utility storage is needed beyond what is provided by Service Yard and Interior Tenant Spaces, Tenant will coordinate with Landlord on a potential additional location on site. Design and location is subject to Landlord review and approval. All costs related to the design and construction of additional storage areas are the sole responsibility of the Tenant.

 

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INTERIOR FINISHES

 

1.   WINDOW TREATMENTS

 

All perimeter TI installed window shades and film specifications are subject to review and approval by Landlord and will conform to Base Building standards provided by Landlord. Window film is required where any casework, fixed furniture, new walls, or other solid objects will be located against an exterior Base Building window. TI Contractor to coordinate any attachments to the window system with building envelope subcontractor.

 

2.   LIGHTING TEMPERATURE

Lighting color temperature shall be either 3500K or 4000K for all interior Tenant spaces, unless alternate direction is given and/or approved by the Landlord.

 

3.   PAINT COLOR

All fixed Tenant improvements, including but not limited to braced frames, columns, partitions, etc., within 2 feet of exterior windows shall be painted to match Base Building standard, as provided by Landlord.

 

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MEP SYSTEMS & DESIGN

 

1   MEP - GENERAL

 

1.A MEP DESIGN REVIEW

 

Any MEP modifications to the Base Building are a Tenant cost and responsibility. Tenant to provide all relevant signed and sealed drawings, submittals, and calculations to Landlord, subject to Landlord’s third-party MEP review, at the Tenant’s cost.

 

1.B COORDINATION WITH BUILDING SYSTEMS Tenant shall abide by the following:

Match Building Standard equipment manufacturers to maintain uniformity and simplicity with operations and maintenance. Maintain uniformity of manufacturers for equipment used in similar applications and sizes.

 

Submit ¼” scale drawings of Base Building lab equipment, electrical and mechanical equipment rooms when adding Tenant equipment to these areas. Show existing equipment in accurate locations along with the proposed added Tenant equipment.

 

All Tenant piping, ductwork, wiring, and conduit is to be installed a minimum of 10’ above finished floor, or above ceilings. Explicitly annotate on the design drawings any piping, wiring, conduit, etc. that will be visible, but not shown on the plans.

 

Prior to submitting drawings for review, the Tenant design team shall visit the lease space, become familiar with all existing conditions affecting the Tenant improvement work, and address any and all existing conditions as necessary that affect the Tenant work.

 

Preserve the continuity of all existing systems and equipment serving the base-building and other Tenants during TI construction, including, but not limited to the following: electrical circuits and equipment; Fire Alarm system; HVAC supply and exhaust; chilled and heating hot water; domestic cold and hot water; waste and vent piping; and the Fire Protection systems. All shutdown work shall be scheduled with the Landlord a minimum of ten business days in advance of the shutdown.

 

No piping or conduit shall penetrate the exterior of the building. If this is unavoidable, this shall be reviewed with Landlord and their team for approval and coordination.

 

New piping shall be coordinated with existing conditions and not pass through electrical or telecom equipment rooms.

 

Ductwork, piping, and conduit that penetrates another Tenant’s space shall be coordinated with the other Tenant and landlord for both invert elevations and scheduling of construction.

 

Sprinkler heads shall match existing building sprinkler specification.

 

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2   MECHANICAL

 

 

2.A LOAD CALCULATIONS

 

Tenant shall provide a tabulation of the TI loads compared to the available base-building loads for the tenancy, similar to the below. See mechanical drawings for air handler and exhaust fan capacities. Provide a separate table for each floor of the TI.

 

 

Base Building Available

Capacity for Tenancy

TI Requirement

Lab Exhaust Air (cfm)

1 st Floor: 36,000 cfm

2 nd Floor: 36,000 cfm

3 rd Floor: 36,000 cfm

4 th Floor: 36,000 cfm

 

Lab Supply Air (cfm)

1 st Floor: 36,000 cfm

2 nd Floor: 36,000 cfm

3 rd Floor: 36,000 cfm

4 th Floor: 36,000 cfm

 

Office Supply Air (cfm)

1 st Floor: 20,000 cfm

2 nd Floor: 20,000 cfm

3 rd Floor: 20,000 cfm

4 th Floor: 20,000 cfm

 

Office Return Air (cfm)

1 st Floor RA: 13950 cfm

1 st Floor OSA: 6050 cfm

2 nd Floor RA: 13950 cfm

2 nd Floor OSA: 6050 cfm

3 rd Floor: RA 13950 cfm

3 rd   Floor OSA: 6050 cfm

 

 

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4 th Floor RA: 13950 cfm

4 th Floor OSA: 6050 cfm

 

Heating Hot Water (gpm)

1 st Floor: 88 gpm

2 nd Floor: 88 gpm

3 rd Floor: 88 gpm

4 th Floor: 88 gpm

 

Chilled Water (gpm)

1 st Floor: 24 gpm

2 nd Floor: 24 gpm

3 rd Floor: 24 gpm

4 th   Floor: 24 gpm

 

 

 

2.B

DUCTWORK

 

Mechanical ductwork shall be subject to Landlord’s approval of TI MEP plans and specifications. Mechanical ductwork shall comply with all current codes and standards including but not limited to CBC/CMC, SMACNA, UL, and ASHRAE. Rigid metal duct shall be used throughout the TI MEP design, except at connections to air inlets and outlets, where a maximum of 5 feet of insulated flexible duct (manufactured by Acosta sheet Metal) may be used: Wireflex Pipe UL listed, UMC Class 1 duct; 7ft. long with collars on both ends; Maximum positive 10” w.g; Maximum negative 1” w.g; Maximum velocity 4000 fpm; Flame spread < 25; Smoke spread < 50; Vapor barrier 2.5 mil polyethylene gauge; R-4.2 insulation; Meets UL 181 class 1 and NFPA 90A, NFPA 90B . The following are not permitted: corrugated or flexible metal duct (such as ‘Alumaflex’); pleated elbows; and non-metallic ductwork (e.g. ‘KoolDuct’).

 

Fume exhaust ducts with acidic or alkaline exhaust shall be 316 stainless steel to the point of connection to the base-building exhaust air on each floor.

 

Ductwork serving glass wash/ autoclaves to be 316 stainless steel 18 GA. (with gasket tape joint). No duct lining in exhaust duct systems.

Design Velocity requirements:

 

 

<= 1500 fpm supply air ductwork

 

<= 1800 fpm exhaust air ductwork

 

 

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2.C

ZONING AND PRESSURIZATION DIAGRAMS

 

The Supply and return or exhaust for a given space are to connect to the same riser shaft: it is not permissible, for example, to provide supply air to a given room from Shaft 1, and exhaust the same room from Shaft 2.

 

Provide a set of zoning diagrams, demarcating each zone with a polygon, and indicating the tag of the VAV box or air valve serving the zone. Indicate the relative pressurization between adjacent spaces as “=”, “ –“, “- -“, “+” or “++”. Zoning plans will be provided by TI contractor .

 

 

2.D

LABORATORY EXHAUST FAN LIFE-SAFETY OPERATION

 

In order to provide for relative pressurization, the laboratory exhaust fans have been provided with a provision to connect with the Tenant systems. This hard-wired connection from the fire alarm system to the exhaust fan variable frequency drives to allow for on/off control. The TI design is to coordinate with the base-building provisions.

 

 

2.E

WATER METERING

 

2.E.1  BTU METER: ONICON Model F-1200

 

Every floor and/or Tenant is required to install a BTU meter with connection to the building management system and readable/trended through the front end graphics for tracking usage of the heating water system.

 

3   ELECTRICAL

 

 

3.A LOAD CALCULATIONS

 

Tenant shall provide a tabulation of the TI loads compared to the available base-building loads for the tenancy, similar to the below.  Provide a separate table for each floor of the TI.

 

 

Base      Building       Available

Capacity for Tenancy

TI Requirement

Standby Power (kVA)

600A bus duct risers providing

average of 150 amps

@480/277V per floor

 

Normal Power (kVA)

1,200A bus duct riser providing

average of 300 amps

@ 480/277V per floor

 

 

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3.B WIRING AND CONDUIT

 

All electrical wiring shall be copper only. Aluminum is not allowed, except for feeders 100 amps or greater. All panelboard equipment bussing and transformers shall be copper. All busway plug-in units shall be copper.

 

To prevent vibrating equipment from introducing vibration into the structure or other equipment, provide of two feet of metal flexible conduit or liquid-tight flexible conduit for the final connection to all hard-wired motors or other equipment with motors, i.e. compressors, fans or pumps.

3.C VIBRATION ISOLATOR REQUIREMENTS FOR ELECTRICAL EQUIPMENT

Floor-mounted Transformers:

 

a.

Floor mounted bridge bearing neoprene mounts with all directional seismic capability.

 

b.

Two separated and opposing molded bridge bearing neoprene elements contained in a ductile iron casting.

 

 

c.

Mason Industries type BR.

 

Suspended Transformers:

 

a.

Hanger rod neoprene isolators.

 

b.

45º slack seismic restraint cables.

 

c.

Neoprene element with a projecting bushing to prevent steel to steel contact.

 

d.

Steel retainer box encasing the neoprene element.

 

e.

Rod shall be able to swing 15º before contacting resilient bushing.

 

f.

Mason Industries type HD neoprene hanger and type SCB seismic cable brace.

 

3.D OTHER ELECTRICAL REQUIREMENTS

 

Conceal raceways in walls and ceilings wherever possible, except at surface mounted cabinets and freestanding equipment. Install minimum of 6 inches from flues or other heated lines. Provide flashing and counter-flashing for waterproofing of raceways which penetrate the roof. Route exposed raceways and raceways above suspended ceilings parallel or perpendicular to building lines with right angle turns and symmetrical bends. Provide sleeves in concrete walls, floor slabs and partitions. Waterproof sleeved raceways where required.

 

All electrical distribution equipment including switchboards, distribution boards, panelboards, transformers, busway plug-in units and motor disconnect switches shall be the same equipment manufacturer as the Base Building:  Square D by Schneider.

 

Base Building panels are provided for Base Building loads only. Tenant shall provide separate panels and distribution for the Tenant loads. Emergency egress lighting and exit signs within the Tenant space may be connected to the Base Building egress lighting panels. Only the code required egress lighting may be connected to the emergency egress panels. Egress lighting and exit signs shall be 277 volts.

 

Identify all new electrical equipment including distribution boards, transformers, panelboards, and busway plug-in devices. All new circuit breakers within existing switchboards and distribution boards shall also  be labeled. Permanently  attach black phenolic equipment nameplates with ½”  high    white engraved lettering. Nameplates connected to the emergency systems equipment shall be red with white lettering.

 

 

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Label all Tenant receptacles with circuiting by providing adhesive labels to the receptacle faceplates either on the inside of the face of the coverplate or on the face of the coverplate.

 

Carefully coordinate all wiring devices located within the floor slabs. All poke-through electrical and telecom outlets shall be coordinated with the ceiling space below. Avoid all conflicts with existing structural conditions and existing equipment. All junction boxes shall be accessible. Any core drilling shall be approved by the landlord and scheduled in advance of performing work.

 

The Tenant’s lighting control system should tie into the Base Building lighting control system. The Base Building lighting control system is the Wattstopper DLM System.

 

The building includes a diesel driven standby emergency generator to support emergency power, legally required standby and Tenant optional standby loads. The emergency/standby distribution system is segregated into the three branches (emergency, legally required standby and optional standby) as   required by the California Electric Code. Tenant connections to the emergency branch are limited to 277 volt egress lighting and 120 volt code required fire alarm equipment. Tenant equipment shall be connected to the optional standby system via the Tenant optional standby busway located in the electrical riser closet. Tenant added specialty exhaust fans may be connected to the legally required standby power distribution system located at the roof with landlord approval.

 

The Fire Management System manufacturer is Edwards System Technology. The Tenant fire alarm devices shall match building standard and shall be connected to the building fire alarm system by the Base Building fire alarm contractor at the Tenant’s cost. The fire alarm notification devices consist of horns only. Refer to Appendix D for contact information.

 

3.E UNDERGROUND ELECTRICAL

 

Due to the methane mitigation system, the ground floor slab will be installed completely during shell construction. No floor boxes or in-slab electrical can be installed as part of TI construction. TI Contractor will not be allowed to cut into or modify the ground floor slab without express written approval from Landlord.

 

4   PLUMBING

 

4.A DOMESTIC WATER

 

All water piping shall be copper type L. Cold water shall be sized for a maximum of 6 feet per second, hot water shall be sized for a maximum of 5 feet per second and hot water return for a maximum of 4 feet per second. All Tenant hot water shall be Tenant generated. Shock arrestors shall be provided for quick-closing fixtures and/or valves.

 

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4.B SANITARY

 

Above ground sanitary piping shall be no-hub cast iron. Above ground lavatory waste shall be polypropylene (PP) piping with fire retardant additive with fusion-joint fittings.

4.C UNDERGROUND PIPING

 

Due to the methane mitigation system, the ground floor slab will be installed complete during shell construction. Connection points through the structural slab have been provided throughout the ground floor for connection to the sanitary sewer and lab waste systems. Refer to Architectural and Plumbing drawings for additional detail. TI Contractor will not be allowed to cut into or modify the ground floor slab.

4.D ALLOWABLE FIXTURES

 

The Base Building plumbing has been designed to accommodate 86 lab sinks at 1.5 DFUs each (this is driven by 4” lab waste main sloped at 1%, capacity is 172 DFUs) for lab waste. For sanitary sewer, the Base Building can accommodate 14 DFUs per floor (driven by 2 water closets at 5 DFUs each, 2 lavatories at 1 DFU and one kitchen sink at 1.5 DFU).

Each floor is given a 2”cap for future connection inside the janitors closet with a capacity of 27 WFUs each (2 water closets, 2 lavatories, 10 lab sinks, 2 showers, 1 kitchen sink).

These fixtures shall be allocated equally per floor or as agreed within lease. Note that for greater flexibility of ground floor TI design, more tie-in connections have been provided than can be utilized for equal distribution of fixtures.

 

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BASE BUILDING SYSTEMS & CONDITIONS

 

1.   BASE BUILDING ALTERATIONS

 

1.A LANDLORD APPROVAL

Any Base Building alterations resulting from TI design and construction require written Landlord approval and are at Tenant’s cost and responsibility.

 

1.B STRUCTURAL MODIFICATIONS

Any structural modifications to the Base Building are a Tenant cost and responsibility. Tenant to provide all relevant signed and sealed drawings and calculations to Landlord, subject to Landlord’s third-party Structural review, at the Tenant’s cost.

 

1.C ROOFING MODIFICATIONS

 

Any and all roofing alterations must be completed by the Base Building Roofing Subcontractor—refer to Appendix D for contact information.

 

All roof penetrations, equipment, and modifications outside of Tenant’s designated roof zone are subject to Landlord review and approval.

 

Base Building Roof Zone Diagrams, to be provided by Landlord. The depicted zones are designated areas for any Tenant-installed equipment serving the respective Tenant spaces. Spaces designated for Landlord use or a potential vivarium can be utilized as overflow for Tenant space allocations pending Landlord approval.

 

1.D TEMPORARY OPENING OF BUILDING ENVELOPE

 

The building envelope can be opened to allow for access and material delivery as described below:

 

Individual glass lites can be removed from the exterior for replacement glass in the event of breakage or to create a small opening for building access. Individual curtain wall units and perimeter caulking can be removed and re-installed if a larger opening is needed for hoist-bay access to deliver materials into the building, at the Tenant’s cost, pending the Landlord’s written approval. Any enclosure openings require Landlord approval and coordination with ongoing construction and campus operations. All building enclosure work must be performed by the Base Building envelope subcontractor; refer to Appendix D for contact information.

 

1.E PERIMETER WORK PRIOR TO EDGE OF SLAB FIRE SAFING COMPLETION

In any instance that TI construction begins prior to Base Building edge of slab fire safing installation is complete, TI contractor shall be required to perform TI work at minimum 12’ away from perimeter walls.

 

Both Landlord and TI contractors shall coordinate regarding schedule, logistics, and timing completion of fire safing scope.

 

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1.F COORDINATION WITH EXTERIOR SKIN COMPLETION

 

TI construction to coordinate with shell completion of exterior skin as required, notably at manlift area. In addition, due to the methane mitigation system, Base Building glazing areas will be left out until the gas mitigation detection system is complete.

 

2.   BASE BUILDING SYSTEMS ACCESS

 

TI design and construction shall provide access to Base Building systems (ex. fire smoke damper) with Landlord approval for access point locations.

 

3.   TENANT SUB-METERING

 

Tenants shall provide sub-metering for utilities as described below:

 

 

BTU Meter: ONICON Model F-1200

 

Every floor and/or Tenant is required to install a BTU meter for tracking usage of the heating and chilled water system.

 

 

Natural Gas Meters:

Water Heater: ¾” AC-250 AM GM (MD-AC-250-34)

Boilers: 3” Elster (MI-RAB9)

 

Gas system has a ¾” low pressure gas (7-14” w.c.) CFF on the Penthouse level with a capacity of 200 CFH and a ¾”CFF (2 psi) on level 1 with a capacity of 500 CFH. There will be one main meter for the building, one sub-meter prior to the water heater and one sub-meter prior to the boilers. Every Tenant requiring specific natural gas must install a meter to track their usage.

 

 

Water Meter(s): Model to be determined

Hot Water: Badger ¾” MAG Meter (MWD-BM2000-34-G) and Badger 1½” MAG Meter (MWD-BM2000-112-G) will be used to monitor the hot water consumption.

 

Every Tenant requiring water (domestic or industrial) must install a meter, per floor, to track their usage.

 

 

Electrical Meter (Standard & Standby Power): Power Logic PM5000 series meter

 

Every Tenant who requires electrical power must install a meter on each floor where they derive power at or near each buss tap (two (2) per floor for standard and standby power). Each meter will require an enclosure, CTs per phase, 120V power, and a network connection back to the head end system. Square D, who is furnishing the front end panel, will visit the site to program the system and add the Tenant onto the system. The TI Controls Contractor will be required to coordinate with the Square D representative to pull their points in and include them in the graphics. Refer to Appendix D for contact information for the supplier and for Square D.

 

Tenant sub-metering must tie into the Base Building BMS system. BMS graphics should show temperature and flow.

 

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4.   BUILDING MANAGEMENT SYSTEM (BMS)

 

Each warm-shell delivered building is equipped with an open protocol, BACnet Controls Building Management System (BMS). Tenants may have their own systems, but must also connect to the Base Building system. The BMS system is Alerton Controls. The TI Contractor must use Alerton Controls on any build outs or upgrades to maintain proper connection to the system, ensure consistent programming, and simplify maintenance of the BMS control system. The communication protocol for the BMS is native BACnet.

 

Alerton utilizes Niagara AX to allow integration with all protocols BACnet, LON, MODBUS, and SNMP. The Alerton Building Controller - ACM provides a quad-core processor combined with 1G of

SDRAM. The Alerton Compass software is web based and provides graphical interface, trending, alarms, alarm notification, and advanced reporting. Omnigraphics included to graphically display room zone or building-wide operating conditions at a glance with color coded-shapes.

 

Hardware Standards:

 

 

1.

Supervisor Controller: ACM (Niagara AX)

 

2.

VAV (Variable Air Volume): VLC Controller

 

3.

CV (Constant Volume): VLC VAV Controller

 

4.

EV (Exhaust Valve): VLC VAV Controller

 

5.

Reheat and Central plant Valves: Belimo

 

6.

Thermostats

 

a.

Thermostat with display with programmable LED Status Indicators: Alerton MS4

 

b.

Thermostat with CO 2 sensor (for high occupancy rooms)with programmable LED Status Indicators: Alerton MS4CO2

 

 

c.

Thermostat with motion sensor: Alerton MS4

7. Temperature Sensors: Alerton or equal

Graphics to be Coordinated by TI

Contractor:

1. Graphics Pages: All new equipment to have its own graphics page; miscellaneous meters to have their own graphics pages; trending and alarming to have their own graphics pages.

 

Zoning Plan: Each floor to have a color-coded zoning plan showing thermostat locations, space temperature/set point, zone number, and CO2 read outs.

 

5.   EMERGENCY SYSTEMS

 

5.A FIRE ALARM SYSTEM

 

*See MEP Systems and Design section 3.D, “OTHER ELECTRICAL REQUIREMENTS.” Also refer to Appendix D for the Base Building emergency system Subcontractor’s contact information.

 

The Base Building fire alarm system is for code-required life safety use only. Tenant use of system for non-life safety purposes is not permitted.

 

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5.B SPRINKLER SYSTEM

 

The Base Building includes an interior sprinkler system for shell coverage. The Base Building sprinkler system shall be signed off by Brisbane Fire Department prior to TI tie-in.

 

The sprinkler systems shall be monitored by the fire alarm system by both waterflow switches and tamper switches on the control valves. Prior to connecting to the Base Building sprinkler system, the Tenant’s Contractor must notify the fire alarm company that the system will be out of service and back in service by the end of day. The Tenant’s Contractor must notify the fire alarm company prior to performing any filling of pipes, whether during the day, night, or weekend. Sprinkler system appurtenances shall match existing building models and manufacturers.

 

5.C STANDBY GENERATOR & POWER

 

Refer to Appendix C for Generator & Automatic Transfer Switch Description.

 

5.D EMERGENCY RESPONDER RADIO COVERAGE SYSTEM (ERRCS)

 

The Emergency Responder Radio Coverage System (ERRCS) is a building wide system, consisting of dedicated conduit and multiple antennae and repeaters per floor that serve to provide amplified wireless service for communication amongst emergency first responders.

 

Please note that this system will NOT be used to amplify personal cellular services within the building.

 

The Base Building is equipped with an ERRCS as required by the City of Brisbane for the warm shell only. The Base Building installation consists of the head-end system, roof mounted antenna, and conduit risers in stair shafts. The Tenant must design and install the ERRCS within Tenant spaces to accommodate the TI layout, at Tenant cost. This scope includes but is not limited to: antenna repeaters, rated conduit, tie-in to Base Building system, programming, and jurisdictional required system testing. All ERRCS work must be coordinated using the shell subcontractor.

 

The Base Building ERRCS is for code-required life safety use only. Tenant use or tie-in are not permitted; refer to Appendix D for contact information.

 

6.   LABORATORY WASTE

 

Labs are required to connect to the lab waste system, separate from the domestic waste system, to prevent contamination. A sampling manhole is provided on the lab waste line located in outside the building near gridlines 1/C.6, prior to the connection of the lab waste line to the sanitary sewer line directed to the municipal sewer system. Refer to the plumbing drawings for location. Lab waste and vent piping shall be fire-rated polypropylene (FRPP) with fusion joint fittings.

7.   SECURITY SYSTEMS

 

The Base Building security program includes the following:

 

1.

Card access control system with card reader locations at all building entry/exit points and all passenger and freight elevator carriages. See Base Building security drawings for reference.

 

 

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2.

Video surveillance at the entrance and receiving doors of the buildings. See Base Building security drawings for reference.

 

 

3.

Intercom at the entrance and receiving doors of the buildings. See Base Building security drawings for reference.

 

 

The Tenant should consider the following security options to incorporate the Base Building systems into a Tenant security program:

7.A ACCESS CONTROL SYSTEM

Base Building Security Information:

 

Base Building access card system reads both older proximity cards in 125kHz format and newer high frequency cards in the HID iClass format.

 

-

Base Building access card reader model: HID RP40 or HID RP15

 

Base Building access card format: HID Corporate 1000 Format

 

-

Part Number: 1386LGGMN MC-1000 Format# H2004333 (*Base Building cards are ordered by property management)

 

 

Base Building system is manufactured by Lenel and uses the OnGuard software application. The Tenant may choose to install a suite-specific card access control system at the Tenant’s own responsibility and cost.

 

 

If the Tenant installs an internal security system for their floor(s), their contracted security consultant should provide security access cards that are compatible with the Base Building readers, outlined above, to the Tenant, and, subsequently, to property management for programming onto the Base Building system. If the Tenant does NOT install an internal security system, the Tenant will need to coordinate with Property Management on procurement of Base Building security access cards.

 

 

Elevator (both passenger and freight) access can be programmed according to Tenant preferences during business hours. The Tenant may request programming of elevators to be open-access to the Tenant floors, allowing deliveries and other non-Tenant personnel to access the Tenant space, or closed-access to the Tenant floors, which would require a security card to access the Tenant space and would require a Tenant representative to escort deliveries up from the first floor in the elevator. After-hours operation will require a Tenant representative to escort non-Tenant personnel up from building perimeter areas to Tenant areas.

 

To assist in coordination between Base Building system and any TI security system, Tenant shall be responsible for:

 

Providing the Property Manager with the current Tenant access card format and facility code along with three (3) numbered sequential test cards in order to verify compatibility with the Base Building system.

 

 

Providing the Property Manager with the name and contact information of the Administrator for the Tenant Access Control system.

 

 

19


 

 

Coordinating with the Property Manager the protocol for adding and deleting users from the Base Building system cardholder database.

 

 

If the Tenant chooses not to provide their existing access card information to the Landlord, the Tenant must use a Base Building-issued card for parking and perimeter building access, and use the Tenant’s card for Tenant area access.

 

 

7.B VIDEO SURVEILLANCE SYSTEM

 

The Tenant may choose to install in-suite video surveillance systems at the Tenant’s own responsibility and cost. The Base Building video surveillance system is provided at critical common entry areas on the first floor. Forensic incident information in those areas may be obtained when requested through Property Management. See Base Building security drawings for reference. Additional Tenant-installed exterior surveillance is subject to Landlord written approval.

 

7.C INSTRUSION ALARM SYSTEM

 

The Tenant may choose to install in-suite intrusion alarm system at the Tenant’s own responsibility and cost. The Tenant shall provide the name and contact information of the monitoring firm to the Property Manager in case of alarm activation. In addition, all licensing and permits are the responsibility of the Tenant. For integration of a Base Building stairwell access card reader with the Tenant space intrusion alarm system, the Tenant shall provide a double pole double throw (DPDT) contact, replacing the existing single pole single throw (SPST) contact in the door allowing compatibility with the Base Building system and the Tenant intrusion panel.

 

7.D INTERCOM SYSTEM

 

The Tenant may choose to have the building intercom systems connected to their suite at the Tenant’s own responsibility and cost. Intercoms can be programmed to call mobile phone of TI personnel, if necessary.

The Tenant has two options for intercom system connectivity as outlined below.

Intercom System Operation:

 

Visitors contact the Tenant’s suite master intercom directly from the perimeter intercom

locations.

 

Direct voice communication and video authentication of the visitor through the intercom application.

 

 

Remote activation to the unlock feature allows the visitor to enter the building via the Base Building access control system at the Tenant’s discretion. Please note that a pre-determined schedule with Property Management will limit the hours that the remote unlock feature will be functional.

 

 

20


 

Option A – Hardwired Intercom System:

If selected, the Tenant shall consider the following information as it relates to construction and operation of the Tenant space:

 

Intercom devices will be hardwire connected to the Base Building network

 

Number of devices required per Tenant’s desires and device locations in-suite

 

See product data sheets for compatible models of hardwired video intercom stations, listed below:

 

- Stentofon IP Master station

 

Option B – Wireless Intercom Device:

The Tenant may choose to have a wireless intercom device via a suite specific Wireless Access Point (WAP). This will require the installation of a Base Building network connected (WAP) in the Tenant suite at the cost of the Tenant. The master intercom station software application shall run on Apple-iPad devices provided by Property Management at an additional cost to the Tenant. The wireless intercom device is functional within the constraints of the wireless communication signal area provided through the WAP. Please note, that due to the WAP being on the Base Building security network, the iPad device connection parameters will be configured directly by the Property Management over the secure WAP. The intercom application will be the only application allowed to run on the iPad device.

If selected, the Tenant shall consider the following information as it relates to construction and operation of the Tenant space:

 

Devices will be connected to the Base Building network

 

Quantity of iPad devices required

 

Anticipated locations in suite where intercoms will be used (Required for WAP installation locations as part of the TI build-out)

 

 

8.   IDF AND UTILITIES

 

8.A IDF CLOSETS

 

IDF closets are vertically stacked above the ground floor main point of utility entry MPOE Room.

Conduit risers are provided within IDF closets on each floor for Tenants to tie into the MPOE (two (2) 4” conduits per floor) and are allotted per the lease agreement. Sleeves are provided between floors and require Landlord approval prior to Tenant use. Any roof penetrations for conduit is the responsibility of the TI Contractor. The Tenant is responsible for providing the required ventilation in IDF closets.

 

8.B CAMPUS INTERCONNECTING CONDUIT

 

A campus interconnecting conduit loop connecting all Shore buildings is available for Tenant use subject to Landlord approval. Refer to the site utility drawings for routing layout.

 

21


 

 

8.C COMMUNICATION UTILITIES PROVIDED

 

 

1.

Telephone/Data/Fiber – AT&T:

Infrastructure provided via two (2) 4” conduits with pull string. Tenant must coordinate pulling cable with phone/data service provider in order to receive service. The provided conduits are designed to AT&T requirements. Providers in area for fiber cable include, AT&T, Level 3 and XO Communications.

 

2.

Internet & Cable – AT&T:

Infrastructure provided via one (1) 4” conduit. Any third-party provider can be used, but Tenant must coordinate pulling cable with internet and cable service provider in order to receive service.

 

8.D MPOE ROOM USAGE

 

 

1.

Unless otherwise stipulated within the lease agreement, the IDF closet on the Tenant floors should act as the landing point for all Tenant related utilities. The MPOE room is dedicated for Landlord usage and will act only as a pass through for the utilities to their respective Tenant floors.

 

2.

AT&T fiber and copper distribution panels for internet and phone services, respectively, to multiple Tenants may be located in the MPOE room. Tenant wiring from the distribution panels to Tenant IDF closets is the only Tenant equipment permitted in the MPOE room; all other Tenant equipment including racks, routers, etc. must be located in Tenant IDF rooms.

 

8.E ROOF-MOUNTED EQUIPMENT

 

Any roof-mounted equipment, including WiLine, satellites, etc., furnished and installed by the Tenant requires written Landlord approval. Specifications and plans showing proposed location must be submitted to the Landlord’s representative for review by the Base Building architect and property management.

 

9.   ELEVATOR

 

Two (2) Passenger and one (1) Freight Elevator are provided as part of the Base Building shell. The Freight Elevator is provided with an Express Priority Service (EPS) system and seismic restraints for bottle/cylinders.

 

10.   METHANE MITIGATION SYSTEM

 

The Base Building includes a methane mitigation system as per the requirement of the Title 27 Landfill Post Closure Development. The system consists of gas extraction system, gas barrier, and gas monitoring and alarm system. No modifications shall be performed prior to Landlord review, and special precautions shall be taken by the Tenant to avoid damage to the components of the methane mitigation system. Tenant shall be responsible for engaging Reliable Monitoring Services for review of TI drawings and any impacts on the building interior monitoring system, as well as implementing changes to system as required.

 

22


 

LEADERSHIP IN ENERGY AND ENVIRONMENTAL DESIGN (LEED)

 

1.   BASE BUILDING LEED CERTIFICATION

 

The following is a list of LEED pre-requisites and credits that all Tenants are required to meet for their associated Tenant-occupied spaces beyond the current Core and Shell project scope, to maintain the Core and Shell LEED Silver Certification. By signing the Lease, Tenants are agreeing to comply with all of the outlined requirements.

 

 

Location & Transportation Credit, Reduced Parking Footprint

 

-

Projects must achieve a minimum of 40% reduction from the base ratios.

 

Location & Transportation Credit, Bicycle Facilities

 

-

Long term bicycle storage facilities shall cater to at least 5% of regular building occupants, but no fewer than 2 storage spaces. Short term bicycle storage will include a minimum of 2 bicycle parking spaces for every 5000 sq.ft.

 

 

Water Efficiency Credit, Indoor Water Use Reduction

 

-

All toilets in the core or those that are Tenant-installed shall be dual-flush toilets or “high-

efficiency,” using 1.28 gallons per flush (gpf) or less.

 

-

All urinals shall be waterless or ultra low-flow e.g., 0.125 gpf or less.

 

-

Bathroom faucets are required to have flow restrictors limiting flow to .5 gallons per minute (gpm).

 

 

-

Kitchen and breakroom faucets to allow 1.8 gpm.

 

-

All newly installed toilets, urinals, private lavatory faucets, and showerheads that are eligible for labeling must be WaterSense labeled

 

 

Energy and Atmosphere Prerequisite, Minimum Energy Performance, and Credit, Optimize Energy Performance

 

 

-

Envelope must meet the following requirements:

 

Walls: U = 0.082

 

Roof: U = 0.039

 

Curtain Glazing: U = 0.27, SHGC = 0.29 (Viracon)

 

-

Mechanical (Based on BD) systems must comply with the following:

 

Chiller Efficiency: 0.5246 kw/ton

 

Boiler Efficiency: 93%

 

-

Plumbing (Based on BD) must comply with the following:

 

Water heater efficiency: 96%

 

-

Lighting requirements are as follows:

 

Office Spaces > 250 ft2: 0.75 w/sf

 

Office Spaces ≤ 250 ft2: 1.0 w/sf

 

Lab Spaces: 1.4 w/sf

 

 

23


 

Energy and Atmosphere Credit, Enhanced Refrigerant Management

 

-

Tenants should specify HVAC systems that minimize refrigerant impact by avoiding refrigerants entirely or using systems that have an ozone depletion potential (ODP) of zero and a global warming potential (GWP) of less than 50

 

 

Energy and Atmosphere Credit, Advanced Energy Metering

 

-

Install new or use existing Tenant-level energy meters to provide Tenant-level data representing total Tenant energy consumption (electricity, natural gas, chilled water, steam, fuel oil, propane, biomass, etc.). Utility-owned meters are acceptable.

 

 

-

Commit to sharing with USGBC the resulting energy consumption data and electrical demand data (if metered) for a five-year period beginning on the date the project accepts LEED certification. At a minimum, energy consumption must be tracked at one-month intervals.

 

 

Indoor Environmental Quality Prerequisite, Minimum Indoor Air Quality (IAQ) Performance

 

-

Tenant-installed mechanical ventilation systems must meet the requirements of ASHRAE 62.1- 2010 Section 4-7.

 

 

Indoor Environmental Quality Credit, Enhanced Indoor Air Quality Strategies

 

-

All rooms that contain chemicals or pollutants (such as copy rooms, photo labs, laundry, and janitorial rooms) must be built with deck-to-deck full-height walls and self-closing doors, separate ventilation systems with minimum .50 cfm/sqft exhaust fans, and containment drains for appropriate disposal of hazardous liquids

 

 

-

Walk off mats are installed at all building main entrances as part of the core and shell scope. However, Tenants must install 10’ long (in direction of travel) roll out mat at any other doors utilized as a building entrance.

 

 

-

744331.07/WLA

 

 

-

375072-00001/12-9-15/gjn/gjn

 

 

-

Tenants must also install MERV – 13 filters for all return and outside air intakes in regularly occupied mechanically ventilated spaces

 

 

-

For mechanical ventilation systems that predominantly serve densely occupied spaces (those with a design occupant density greater than or equal to 25 people per 1000 sq. ft), Tenants shall install a CO2 sensor within each densely occupied space.

 

 

-

For all other mechanical ventilation systems, provide an outdoor airflow measurement device capable of measuring the minimum outdoor airflow rate at all expected system operating conditions within 15 percent of the design minimum outdoor air rate.

 

 

Indoor Environmental Quality Credit, Thermal Comfort

 

-

HVAC design must meet requirements of ASHRAE 55-2010, specifically in reference to air temperature, radiant temperature, humidity, and air speed

 

 

2.   TENANT IMPROVEMENT LEED CERTIFICATION

 

All TIs are required to achieve and obtain ID+C LEED certification.

 

24


 

IDENTIFICATION SIGNAGE

 

Master Sign Program to be provided by Landlord.

 

If the Tenant has explicit rights to building façade signage per the Lease, the following sections apply:

 

 

Signage:

Tenant must abide by the Master Sign Program, provided by Landlord, for location, size, and design of signage.

 

 

Exterior façade signage installation details to be provided by Landlord. Building envelop penetrations must be completed by the Base Building envelope subcontractor, and any exposed raceways and/or sub-frames for the signage shall be painted to match the background color of the spandrel glazing; refer to Appendix D for contact information.

 

 

 

Façade Signage Illumination:

If illuminated, exterior façade signage must be halo-illuminated or internally illuminated per the Master Signage Program. There are provisions within the curtain wall allowing power to reach exterior façade signage, however the Tenant will be responsible for all costs and responsibilities associated with implementing exterior signage and any power requirements.

 

 

Signage Approval:

Signage design and vendor must be approved in writing by Landlord prior to installation.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

25


 

APPENDIX A

The Shore Master Campus Site Plan

 

 

 

 

 

 

 


 

APPENDIX B

The Shore Construction Logistics Site Plan

 

 

 

 

 

 


 

APPENDIX C

Generator & Automatic Transfer Switch Description

 

Generator – stand-by diesel-engine generator with base-mounted diesel fuel tank sized for 10 hours of continuous operation. Generator supplies power for life-safety emergency and legally-required mechanical equipment support situations, as well as optional stand-by situations. The diesel generators are exercised and tested on a monthly basis to ensure reliability of power generation when required.

The generator is secure in industry-proven out-door weather-proof enclosure that also serves as noise- containing vessels to minimize sound disturbances to building Tenants, customers, and surrounding businesses.

 

Transfer switches – the automatic transfer switch will automatically transfer the electrical panel it serves off the dead utility source (utility power outage) and onto the generator source. Transfer switch is in place to energize the building life-safety emergency service within 10 seconds from power outage.

Loads connected to legally-required mechanical equipment service and optional stand-by service will also be re-energized shortly following power restoration to the emergency service. Upon restoration of utility source, a delay of no less than 5 minutes will be set before loads are transferred back to the utility source from the diesel generator. Transfer switches will be regularly tested on a monthly basis – in the case of test failures, the Tenant optional stand-by transfer switch have the ability to be manually locked into the generator power source while the switch is serviced and fixed so no loss of power will be experienced for Tenant electronic equipment (requiring no less than 3-cycle break) on the optional stand-by power panel.

 

 


 

APPENDIX D

Project Directory

 

 

 

Landlord

HCP, Inc.

HCP LS Brisbane, LLC

950 Tower Lane, Suite 1650
Foster City, CA 94404

Contact: Scott Bohn
(650) 875-1007

 

Project Management

Project Management Advisors, Inc.

1 Tower Place, Suite 200

South San Francisco, CA 94080

Contact: Devin Bertsch
Devinb@pmainc.com

(650) 491-8833

 

Base Building General Contractor

Hathaway Dinwiddie Construction

275 Battery Street, Suite 300
South San Francisco, CA 94111

Contact: Sara Carmody
CarmodyS@HDCCO.com
(415) 986-2718

 

Base Building Architect

DES Architects + Engineers, Inc.

399 Bradford Street
Redwood City, CA
94063

Contact: Kevin Norman
knorman@des-ae.com
(415) 510-2021

 

Base Building Structural Engineer

DES Architects + Engineers, Inc.

399 Bradford Street
Redwood City, CA
94063

Contact: Kevin Norman
knorman@des-ae.com
(415) 510-2021

 

Building Envelope – Curtainwall & Metal Panel

Royal Glass Company, Inc.

3200 De La Cruz Blvd.
Santa Clara, CA 95054

Contact: Steve Gonzales steveg@royalglassco.com
(408) 969-0444

 

Building Envelope – GFRC

Willis Construction Co. Inc.

2261 San Juan Highway
San Juan Bautista, CA 95045

Contact: Bruce Grattan

bgrattan@willisconstruction.com
(831) 623-2900

 

Roof Installer

Alcal Specialty Contracting, Inc.

42950 Osgood Road
Fremont, CA 94539

Contact: Mark McActee Mark.McAtee@alcal.com
(510) 477-9380

 

 

 


 

 

Electric Meter Supplier

Square D by Schneider Electric

5735 W. Las Positas Rd. Suite 400
Pleasanton, CA
94588

Contact: Adam Jacobs Adam.Jacobs@schneider-electric.com

(925) 463-7100

 

Base Building Fire Alarm

AECO System Inc.

3512 Breakwater Ct.
Hayward, CA 94545

Contact: Brent Hensley

brent_hensley@aeco-systems.com

(510) 342-0008

 

Base Building Emergency DAS

Red Cloud Wireless Voice & Data

2850 Camino Diablo.
Walnut Creek, CA 94597

Contact: Bob Luhrs

bluhrs@redcloudinc.com

(888) 855-5353

 

GENSET/ATS Equipment

PowerGen Sales Engineer

Cummins Sales and Service

14775 Wicks Blvd
San Leandro, CA 94577

Contact: Guy W. Schullerts guy.w.schullerts@cummins.com

(510) 347-6664

 

Methane Monitoring

Reliable Monitoring

Services 21354 Nordhoff Street, Suite 105
Chatsworth, CA 91311

Contact: Ed Crofts

ecrofts@rmslifesafety.com

(310) 560-3078

 

 


 

EXHIBIT C

 

NOTICE OF LEASE TERM DATES

 

To:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Re:

Lease dated                   , 20       between                                , a                               

(" Landlord "), and                                 ,   a                                (" Tenant ")

concerning Suite                          on floor(s)                          of the building located at

                                                       , California.

 

 

Gentlemen:

 

In accordance with the Lease (the " Lease "), we wish to advise you and/or confirm as follows:

 

 

1.

The Lease Term shall commence on or has commenced on                                      for a term of

                               ending on                                .

 

 

2.

Rent commenced to accrue on                        , in the amount of                         .

 

 

3.

If the Lease Commencement Date is other than the first day of the month, the first billing will contain a pro rata adjustment. Each billing thereafter, with the exception of the final billing, shall be for the full amount of the monthly installment as provided for in the Lease.

 

 

4.

Your rent checks should be made payable to                         at                           .

 

 

5.

The number of rentable/usable square feet within the Premises is approximately                        square feet.

 

 

6.

Tenant's Share as adjusted based upon the exact number of usable square feet within the Premises is         %, subject to Section 6 of the Summary of Basic Lease Information.

 

 

"Landlord":                                           

 

                                                                  ,

a                                                                

By: Its:                                                      

 

 

 

EXHIBIT C

-1 -


 

Agreed to and Accepted as
of
, 20_ .

 

"Tenant":                                               

 

                                                                 

a                                                                

By: Its:                                                      

 

 

EXHIBIT C

-2 -


 

EXHIBIT D

 

FORM OF TENANT'S ESTOPPEL CERTIFICATE

 

The undersigned as Tenant under that certain Lease (the " Lease ") made and entered into as of                     , 20      by and between                       as Landlord, and the undersigned as Tenant, for Premises consisting of a portion of the building located at                                                           , California, certifies as follows:

 

1. Attached hereto as Exhibit A is a true and correct copy of the Lease and all amendments and modifications thereto. The documents contained in Exhibit A represent the entire agreement between the parties as to the Premises.

 

2. The undersigned currently occupies the Premises described in the Lease, the Lease Term commenced on                          , and the Lease Term expires on                       , and the undersigned has no      option to terminate or cancel the Lease or to purchase all or any part of the Premises, the Building and/or the Project, except as expressly set forth in the Lease.

 

 

3.

Base Rent became payable on                             .

 

4. The Lease is in full force and effect and has not been modified, supplemented or amended in any way except as provided in Exhibit A .

 

5. Tenant has not transferred, assigned, or sublet any portion of the Premises nor entered into any license or concession agreements with respect thereto except as follows:

 

6. Tenant shall not modify the documents contained in Exhibit A without the prior written consent of Landlord's mortgagee.

 

7. All monthly installments of Base Rent, all Additional Rent and all monthly installments of estimated Additional Rent have been paid when due through                         .  The current monthly installment of Base Rent is $                                      .

 

8. To Tenant's actual knowledge, without inquiry, all conditions of the Lease to be performed by Landlord necessary to the enforceability of the Lease have been satisfied and Landlord is not in default thereunder. In addition, the undersigned has not delivered any notice to Landlord regarding a default by Landlord thereunder. The Lease does not require Landlord to provide any rental concessions or to pay any leasing brokerage commissions except as expressly set forth therein.

 

9. No rental has been paid more than thirty (30) days in advance and no security has been deposited with Landlord except as provided in the Lease. Neither Landlord, nor its successors or assigns, shall in any event be liable or responsible for, or with respect to, the retention, application and/or return to Tenant of any security deposit paid to any prior landlord of the Premises, whether or not still held by any such prior landlord, unless and until the party from whom the security deposit is being sought, whether it be a lender, or any of its successors or assigns, has actually received for its own account, as landlord, the full amount of such security deposit.

 

10. To Tenant's actual knowledge, without inquiry, as of the date hereof, there are no existing defenses or offsets, or, to the undersigned's knowledge, claims or any basis for a claim, that the undersigned has against Landlord.

 

11. If Tenant is a corporation or partnership, Tenant hereby represents and warrants that Tenant is a duly formed and existing entity qualified to do business in California and that Tenant has full right and authority to execute and deliver this Estoppel Certificate and that each person signing on behalf of Tenant is authorized to do so.

 

12. There are no actions pending against the undersigned under the bankruptcy or similar laws of the United States or any state.

 

EXHIBIT D

-1-


 

13. Tenant is in full compliance with all federal, state and local laws, ordinances, rules and regulations affecting its use of the Premises, including, but not limited to, those laws, ordinances, rules or regulations relating to hazardous or toxic materials. Tenant has never permitted its agents, employees or contractors to engage in the generation, manufacture, treatment, use, storage, disposal or discharge of any hazardous, toxic or dangerous waste, substance or material in, on, under or about the Project or the Premises or any adjacent premises or property in violation of any federal, state or local law, ordinance, rule or regulation.

 

14. To the undersigned's knowledge, all tenant improvement work to be performed by Landlord under the Lease has been completed in accordance with the Lease and has been accepted by the undersigned and all reimbursements and allowances due to the undersigned under the Lease in connection with any tenant improvement work have been paid in full. All work (if any) in the common areas required by the Lease to be completed by Landlord has been completed and all parking spaces required by the Lease have been furnished and/or all parking ratios required by the Lease have been met.

 

The undersigned acknowledges that this Estoppel Certificate may be delivered to Landlord or to a prospective mortgagee or prospective purchaser, and acknowledges that said prospective mortgagee or prospective purchaser will be relying upon the statements contained herein in making the loan or acquiring the property of which the Premises are a part and that receipt by it of this certificate is a condition of making such loan or acquiring such property.

 

Executed at                        on the           day of                     , 20   .

 

"Tenant":                                               

 

                                                                  ,

a                                                                

By: Its:                                                      

By: Its:                                                      

 

 

 

 

EXHIBIT D

-2-


 

EXHIBIT E

 

ENVIRONMENTAL QUESTIONNAIRE

 

ENVIRONMENTAL QUESTIONNAIRE

FOR COMMERCIAL AND INDUSTRIAL PROPERTIES

 

Property Name:

 

 

 

Property Address:

 

 

Instructions : The following questionnaire is to be completed by the Lessee representative with knowledge of the planned operations for the specified building/location. Please print clearly and attach additional sheets as necessary.

 

 

1.0

PROCESS INFORMATION

 

Describe planned use, and include brief description of manufacturing processes employed.

 

 

 

 

 

2.0

HAZARDOUS MATERIALS

 

Are hazardous materials used or stored?  If so, continue with the next question.  If not, go to Section 3.0.

 

 

2.1

Are any of the following materials handled on the Property?                                                    Yes        No 

 

(A material is handled if it is used, generated, processed, produced, packaged, treated, stored, emitted, discharged, or disposed.) If so, complete this section. If this question is not applicable, skip this section and go on to Section 5.0.

 

Explosives

Fuels

Oils

Solvents

Oxidizers

Organics/Inorganics

Acids

Bases

Pesticides

Gases

PCBs

Radioactive Materials

Other (please specify)

 

 

 

 

 

 

2-2.

If any of the groups of materials checked in Section 2.1, please list the specific material(s), use(s), and quantity of each chemical used or stored on the site in the Table below. If convenient, you may substitute a chemical inventory and list the uses of each of the chemicals in each category separately.

 

 

Material

Physical State (Solid, Liquid, or Gas)

Usage

Container Size

Number of Containers

Total Quantity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2-3.

Describe the planned storage area location(s) for these materials.  Please include site maps and drawings as appropriate.

 

 

 

 

 

 

EXHIBIT E

-1 -


 

 

3.0

HAZARDOUS WASTES

 

Are hazardous wastes generated? YesNo

 

If yes, continue with the next question.  If not, skip this section and go to section 4.0.

 

 

3.1

Are any of the following wastes generated, handled, or disposed of (where applicable) on the Property?

 

Hazardous wastes

Industrial Wastewater

Waste oils

PCBs

Air emissions

Sludges

Regulated Wastes

Other (please specify)

 

 

3-2.

List and quantify the materials identified in Question 3-1 of this section.

 

WASTE GENERATED

RCRA listed Waste?

SOURCE

APPROXIMATE MONTHLY QUANTITY

WASTE CHARACTERIZATION

DISPOSITION

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3-3.

Please include name, location, and permit number (e.g. EPA ID No.) for transporter and disposal facility, if applicable).  Attach separate pages as necessary.

 

Transporter/Disposal Facility Name

Facility Location

Transporter (I) or Disposal (D) Facility

Permit Number

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

636079522034500 672655522034500 3-4.

Are pollution controls or monitoring employed in the process to prevent or minimize the release of wastes into the environment?YesNo

 

 

 

3-5.

If so, please describe.

 

 

 

 

 

4.0

USTS/ASTS

 

 

4.1

Are underground storage tanks (USTs), aboveground storage tanks (ASTs), or associated pipelines used for the storage of petroleum products, chemicals, or liquid wastes present on site (lease renewals) or required for planned operations (new tenants)?             Yes             No            

 

If not, continue with section 5.0. If yes, please describe capacity, contents, age, type of the USTs or ASTs, as well any associated leak detection/spill prevention measures. Please attach additional pages if necessary.

 

Capacity

Contents

Year Installed

Type (Steel,

Fiberglass, etc)

Associated Leak Detection / Spill

Prevention Measures *

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

* Note:

The following are examples of leak detection / spill prevention measures:

 

Integrity testing

Inventory reconciliation

Leak detection system

Overfill spill protection

Secondary containment

Cathodic protection

 

EXHIBIT E

-2 -


 

 

 

4-2.

Please provide copies of written tank integrity test results and/or monitoring documentation, if available.

 

 

4-3.

Is the UST/AST registered and permitted with the appropriate regulatory agencies?         Yes       No 

If so, please attach a copy of the required permits.

 

 

4-4.

If this Questionnaire is being completed for a lease renewal, and if any of the USTs/ASTs have leaked, please state the substance released, the media(s) impacted (e.g., soil, water, asphalt, etc.), the actions taken, and all remedial responses to the incident.

 

 

 

 

 

 

 

 

4-5.

If this Questionnaire is being completed for a lease renewal, have USTs/ASTs been removed from the Property?          Yes       No 

 

 

If yes, please provide any official closure letters or reports and supporting documentation (e.g., analytical test results, remediation report results, etc.).

 

 

4-6.

For Lease renewals, are there any above or below ground pipelines on site used to transfer chemicals or wastes?          Yes       No 

 

For new tenants, are installations of this type required for the planned operations?

 

         Yes       No 

 

If yes to either question, please describe.

 

 

 

 

 

5.0

ASBESTOS CONTAINING BUILDING MATERIALS

 

Please be advised that an asbestos survey may have been performed at the Property. If provided, please review the information that identifies the locations of known asbestos containing material or presumed asbestos containing material. All personnel and appropriate subcontractors should be notified of the presence of these materials, and informed not to disturb these materials. Any activity that involves the disturbance or removal of these materials must be done by an appropriately trained individual/contractor.

 

 

6.0

REGULATORY

 

 

6-1.

Does the operation have or require a National Pollutant Discharge Elimination System (NPDES) or equivalent permit?          Yes       No 

If so, please attach a copy of this permit.

 

6-2.

Has a Hazardous Materials Business Plan been developed for the site?          Yes       No 

If so, please attach a copy.

 

 

 

EXHIBIT E

-3 -


 

CERTIFICATION

 

I am familiar with the real property described in this questionnaire. By signing below, I represent and warrant that the answers to the above questions are complete and accurate to the best of my knowledge.      I also understand that Lessor will rely on the completeness and accuracy of my answers in assessing any environmental liability risks associated with the property.

 

Signature:

 

Name:

 

Title:

 

Date:

 

Telephone:

 

 

 

 

EXHIBIT E

-4 -


 

EXHIBIT F

 

TENANT'S PROPERTY

 

The following items, to the extent not purchased with the Tenant Improvement Allowance or Additional Improvement Allowance, shall be deemed "Tenant's Property":

 

 

1.

All moveable furniture and equipment that is not "built-in".

 

 

2.

Moveable lab casework (other than "built-in" lab casework), including moveable lab benches.

 

 

3.

Servers, server racks and back-up batteries.

 

 

4.

Furniture.

 

 

5.

Portable fume hoods.

 

 

6.

Biosafety cabinets.

 

 

EXHIBIT F

-1-


 

EXHIBIT G

 

FORM OF AGREEMENT FOR ADDITIONAL MONTHLY BASE RENT

FIRST AMENDMENT TO LEASE

This FIRST AMENDMENT TO LEASE (" Amendment ") is made and entered into as of , 2015, by and between HCP LS BRISBANE, LLC, a Delaware limited partner (" Landlord "), and MYOKARDIA, INC., a Delaware corporation (" Tenant ").

 

 

R E C I T A L S :

 

A. Landlord and Tenant are parties to that certain Lease dated                  , 2018, (the " Lease "), pursuant to which Tenant leases premises on the first through fourth floors (the " Premises ") containing approximately                          rentable square feet of space in the building located at 1000 Sierra Point Boulevard, Brisbane, California  (the " Building ").

 

B. Landlord and Tenant desire to amend the Lease on the terms and conditions set forth in this Amendment.

 

 

A G R E E M E N T :

 

NOW, THEREFORE, in consideration of the foregoing recitals and the mutual covenants contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto hereby agree as follows:

 

1. Terms . All capitalized terms when used herein shall have the same respective meanings as are given such terms in the Lease unless expressly provided otherwise in this Amendment.

 

2. Additional TI Allowance . Pursuant to the terms of Section 4 of the Tenant Work Letter attached to the Lease as Exhibit B , Tenant was entitled to an Additional TI Allowance of up to $                         (the "Additional TI Allowance"). Notwithstanding any provision to the contrary contained in the Lease, Landlord and Tenant hereby acknowledge  and  agree  that  Tenant has utilized                    and      /100 Dollars ($                .       ) of  the Additional TI Allowance (the "Utilized Additional TI Allowance").

 

4. Additional Monthly Base Rent . As a result of Tenant's use of the Utilized Additional TI Allowance, Tenant is required to pay Additional Monthly Base Rent calculated as provided in Section 4 of the Tenant Work Letter, which Additional Monthly Base Rent shall be equal to $                 per month, payable on or before the first (1 st ) day of each month commencing as of                    , and continuing through the expiration of the initial Lease Term.

 

5. No Further Modification . Except as specifically set forth in this Amendment, all of the terms and provisions of the Lease shall remain unmodified and in full force and effect.

 

 

EXHIBIT G

-1 -


 

IN WITNESS WHEREOF, this Amendment has been executed as of the day and year first above written.

 

LANDLORD:

TENANT:

 

 

HCP LS BRISBANE, LLC,

a Delaware limited liability company

MYOKARDIA, INC.,

a Delaware corporation

By:

 

 

By:

 

 

Name:

 

 

Name:

 

 

Its:

 

 

 

 

 

 

 

 

By:

 

 

 

 

 

Name:

 

 

 

 

 

Its:

 

 

 

 

 

EXHIBIT G

-2 -


 

EXHIBIT H

 

FORM OF LETTER OF CREDIT

 

(Letterhead of a money center bank acceptable to the Landlord)

 

FAX NO. [(           )            -            ]

SWIFT:  [Insert No., if any]

[Insert Bank Name And Address]

 

 

 

DATE OF ISSUE:                                         

 

 

BENEFICIARY:

[Insert Beneficiary Name And Address]

APPLICANT:

[Insert Applicant Name And Address]

 

 

 

LETTER OF CREDIT NO.                            

 

 

EXPIRATION DATE:

AMOUNT AVAILABLE:

                                AT OUR COUNTERS

USD[Insert Dollar Amount]

 

(U.S. DOLLARS [Insert Dollar Amount])

 

LADIES AND GENTLEMEN:

 

WE HEREBY ESTABLISH OUR IRREVOCABLE STANDBY LETTER OF CREDIT NO. IN YOUR

FAVOR FOR THE ACCOUNT OF [Insert Tenant's Name], A [Insert Entity Type], UP TO THE AGGREGATE AMOUNT OF USD[Insert Dollar Amount] ([Insert Dollar Amount] U.S. DOLLARS) EFFECTIVE IMMEDIATELY AND EXPIRING ON (Expiration Date) AVAILABLE BY PAYMENT UPON PRESENTATION OF YOUR DRAFT AT SIGHT DRAWN ON [Insert Bank Name] WHEN ACCOMPANIED BY THE FOLLOWING DOCUMENT(S):

 

1. THE ORIGINAL OF THIS IRREVOCABLE STANDBY LETTER OF CREDIT AND AMENDMENT(S), IF ANY.

 

2. BENEFICIARY'S SIGNED STATEMENT PURPORTEDLY SIGNED BY AN AUTHORIZED REPRESENTATIVE OF [Insert Landlord's Name], A [Insert Entity Type] ("LANDLORD") STATING THE FOLLOWING:

 

"THE UNDERSIGNED HEREBY CERTIFIES THAT THE LANDLORD, EITHER (A) UNDER THE LEASE (DEFINED BELOW), OR (B) AS A RESULT OF THE TERMINATION OF SUCH LEASE,  HAS THE RIGHT TO DRAW DOWN THE AMOUNT OF USD                              IN ACCORDANCE WITH THE TERMS OF THAT CERTAIN OFFICE LEASE DATED [Insert Lease Date], AS AMENDED (COLLECTIVELY, THE "LEASE"), OR SUCH AMOUNT CONSTITUTES DAMAGES OWING BY THE TENANT TO BENEFICIARY RESULTING FROM THE BREACH OF SUCH LEASE BY THE TENANT THEREUNDER, OR THE TERMINATION OF SUCH LEASE, AND SUCH AMOUNT REMAINS UNPAID AT THE TIME OF THIS DRAWING."

 

OR

 

"THE UNDERSIGNED HEREBY CERTIFIES THAT WE HAVE RECEIVED A WRITTEN NOTICE OF [Insert Bank Name]'S ELECTION NOT TO EXTEND ITS STANDBY LETTER OF CREDIT NO.                          AND HAVE  NOT  RECEIVED A REPLACEMENT  LETTER OF CREDIT WITHIN AT LEAST THIRTY (30) DAYS PRIOR TO THE PRESENT EXPIRATION DATE."

 

 

 

EXHIBIT H

-1 -


 

 

OR

 

"THE UNDERSIGNED HEREBY CERTIFIES THAT BENEFICIARY IS ENTITLED TO DRAW DOWN THE FULL AMOUNT OF LETTER OF CREDIT NO.                    AS THE RESULT OF THE FILING OF A VOLUNTARY PETITION UNDER THE U.S. BANKRUPTCY CODE OR A STATE BANKRUPTCY CODE BY THE TENANT UNDER THAT CERTAIN OFFICE LEASE DATED [Insert Lease Date], AS AMENDED (COLLECTIVELY, THE "LEASE"), WHICH FILING HAS NOT BEEN DISMISSED AT THE TIME OF THIS DRAWING."

 

OR

 

"THE UNDERSIGNED HEREBY CERTIFIES THAT BENEFICIARY IS ENTITLED TO DRAW DOWN THE FULL AMOUNT OF LETTER OF CREDIT NO.                    AS THE RESULT OF AN INVOLUNTARY PETITION HAVING BEEN FILED UNDER THE U.S. BANKRUPTCY CODE OR A STATE BANKRUPTCY CODE AGAINST THE TENANT UNDER THAT CERTAIN OFFICE LEASE DATED [Insert Lease Date], AS AMENDED (COLLECTIVELY, THE "LEASE"), WHICH FILING HAS NOT BEEN DISMISSED AT THE TIME OF THIS DRAWING."

 

OR

 

"THE UNDERSIGNED HEREBY CERTIFIES THAT BENEFICIARY IS ENTITLED TO DRAW DOWN THE FULL AMOUNT  OF LETTER OF     CREDIT NO.                    AS THE RESULT OF THE REJECTION, OR DEEMED REJECTION, OF THAT CERTAIN OFFICE LEASE DATED [Insert Lease Date], AS AMENDED, UNDER SECTION 365 OF THE U.S. BANKRUPTCY CODE."

 

SPECIAL CONDITIONS:

 

PARTIAL DRAWINGS AND MULTIPLE PRESENTATIONS MAY BE MADE UNDER THIS STANDBY LETTER OF CREDIT, PROVIDED, HOWEVER, THAT EACH SUCH DEMAND THAT IS PAID BY US SHALL REDUCE THE AMOUNT AVAILABLE UNDER THIS STANDBY LETTER OF CREDIT.

 

ALL INFORMATION  REQUIRED  WHETHER INDICATED  BY  BLANKS,  BRACKETS  OR  OTHERWISE,

MUST BE COMPLETED AT THE TIME OF DRAWING. [Please Provide The Required Forms For Review, And Attach As Schedules To The Letter Of Credit.]

 

ALL SIGNATURES MUST BE MANUALLY EXECUTED IN ORIGINALS. ALL BANKING CHARGES ARE FOR THE APPLICANT'S ACCOUNT.

IT IS A CONDITION OF THIS STANDBY LETTER OF CREDIT THAT IT SHALL BE DEEMED AUTOMATICALLY EXTENDED WITHOUT AMENDMENT FOR A PERIOD OF ONE YEAR FROM THE PRESENT OR ANY FUTURE EXPIRATION DATE, UNLESS AT LEAST SIXTY (60) DAYS PRIOR TO THE EXPIRATION DATE WE SEND YOU NOTICE BY NATIONALLY RECOGNIZED OVERNIGHT COURIER SERVICE THAT WE ELECT NOT TO EXTEND THIS LETTER OF CREDIT FOR ANY SUCH ADDITIONAL PERIOD. SAID NOTICE WILL BE SENT TO THE ADDRESS INDICATED ABOVE, UNLESS A CHANGE OF ADDRESS IS OTHERWISE NOTIFIED BY YOU TO US IN WRITING BY RECEIPTED MAIL OR COURIER. ANY NOTICE TO US WILL BE DEEMED EFFECTIVE ONLY UPON ACTUAL RECEIPT BY US AT OUR DESIGNATED OFFICE. IN NO EVENT, AND WITHOUT FURTHER NOTICE FROM OURSELVES, SHALL THE EXPIRATION DATE BE EXTENDED BEYOND A FINAL EXPIRATION DATE OF       (120 days from the

Lease Expiration Date).

 

EXHIBIT H

-2 -


 

THIS LETTER OF CREDIT MAY BE TRANSFERRED SUCCESSIVELY IN WHOLE OR IN PART ONLY UP TO THE THEN AVAILABLE AMOUNT IN FAVOR OF A NOMINATED TRANSFEREE ("TRANSFEREE"), ASSUMING SUCH TRANSFER TO SUCH TRANSFEREE IS IN COMPLIANCE WITH ALL APPLICABLE U.S. LAWS AND REGULATIONS. AT THE TIME OF TRANSFER, THE ORIGINAL LETTER OF CREDIT AND ORIGINAL AMENDMENT(S) IF ANY, MUST BE SURRENDERED TO US TOGETHER WITH OUR TRANSFER FORM (AVAILABLE UPON REQUEST) AND PAYMENT OF OUR CUSTOMARY TRANSFER FEES, WHICH FEES SHALL BE PAYABLE BY APPLICANT (PROVIDED THAT BENEFICIARY MAY, BUT SHALL NOT BE OBLIGATED TO, PAY SUCH FEES TO US ON BEHALF OF APPLICANT, AND SEEK REIMBURSEMENT THEREOF FROM APPLICANT). IN CASE OF ANY TRANSFER UNDER THIS LETTER OF CREDIT, THE DRAFT AND ANY REQUIRED STATEMENT MUST BE EXECUTED BY THE TRANSFEREE AND WHERE THE BENEFICIARY'S NAME APPEARS WITHIN THIS STANDBY LETTER OF CREDIT, THE TRANSFEREE'S NAME IS AUTOMATICALLY SUBSTITUTED THEREFOR.

 

ALL DRAFTS REQUIRED UNDER THIS STANDBY LETTER OF CREDIT MUST BE MARKED: ''DRAWN UNDER [Insert Bank Name] STANDBY LETTER OF CREDIT NO.                    ."

 

WE HEREBY AGREE WITH YOU THAT IF DRAFTS ARE PRESENTED TO [Insert Bank Name] UNDER THIS LETTER OF CREDIT AT OR PRIOR TO [Insert Time – ( e.g. , 11:00 AM)], ON A BUSINESS DAY, AND PROVIDED THAT SUCH DRAFTS PRESENTED CONFORM TO THE TERMS AND CONDITIONS OF THIS LETTER OF CREDIT, PAYMENT SHALL BE INITIATED BY US IN IMMEDIATELY AVAILABLE FUNDS BY OUR CLOSE OF BUSINESS ON THE SUCCEEDING BUSINESS DAY. IF DRAFTS ARE PRESENTED TO [Insert Bank Name] UNDER THIS LETTER OF CREDIT AFTER [Insert Time – ( e.g. , 11:00 AM)], ON A BUSINESS DAY, AND PROVIDED THAT SUCH DRAFTS CONFORM WITH THE TERMS AND CONDITIONS OF THIS LETTER OF CREDIT, PAYMENT SHALL BE INITIATED BY US IN IMMEDIATELY AVAILABLE FUNDS BY OUR CLOSE OF BUSINESS ON THE SECOND SUCCEEDING BUSINESS DAY. AS USED IN THIS LETTER OF CREDIT, "BUSINESS DAY" SHALL MEAN ANY DAY OTHER THAN A SATURDAY, SUNDAY OR A DAY ON WHICH BANKING INSTITUTIONS IN THE STATE OF CALIFORNIA ARE AUTHORIZED OR REQUIRED BY LAW TO CLOSE. IF THE EXPIRATION DATE FOR THIS LETTER OF CREDIT SHALL EVER FALL ON A DAY WHICH IS NOT A BUSINESS DAY THEN SUCH EXPIRATION DATE SHALL AUTOMATICALLY BE EXTENDED TO THE DATE WHICH IS THE NEXT BUSINESS DAY.

 

PRESENTATION OF A DRAWING UNDER THIS LETTER OF CREDIT MAY BE MADE ON OR PRIOR TO THE THEN CURRENT EXPIRATION DATE HEREOF BY HAND DELIVERY, COURIER SERVICE, OVERNIGHT MAIL, OR FACSIMILE. PRESENTATION BY FACSIMILE TRANSMISSION SHALL BE BY TRANSMISSION OF THE ABOVE REQUIRED SIGHT DRAFT DRAWN ON US TOGETHER WITH THIS LETTER OF CREDIT TO OUR FACSIMILE NUMBER, [Insert Fax Number – (      )       -            ], ATTENTION:

[Insert Appropriate Recipient], WITH TELEPHONIC CONFIRMATION OF OUR RECEIPT OF SUCH FACSIMILE TRANSMISSION AT OUR TELEPHONE NUMBER [Insert Telephone Number – (     )     -      ]    OR TO SUCH OTHER FACSIMILE OR TELEPHONE NUMBERS, AS TO WHICH YOU HAVE RECEIVED WRITTEN NOTICE FROM US AS BEING THE APPLICABLE SUCH NUMBER. WE AGREE TO NOTIFY YOU IN WRITING, BY NATIONALLY RECOGNIZED OVERNIGHT COURIER SERVICE, OF ANY CHANGE IN SUCH DIRECTION. ANY FACSIMILE PRESENTATION PURSUANT TO THIS PARAGRAPH SHALL ALSO STATE THEREON THAT THE ORIGINAL OF SUCH SIGHT DRAFT AND LETTER OF CREDIT ARE BEING REMITTED, FOR DELIVERY ON THE NEXT BUSINESS DAY, TO [Insert Bank Name] AT THE APPLICABLE ADDRESS FOR PRESENTMENT PURSUANT TO THE PARAGRAPH FOLLOWING THIS ONE.

 

WE HEREBY ENGAGE WITH YOU THAT ALL DOCUMENT(S) DRAWN UNDER AND IN COMPLIANCE WITH THE TERMS OF THIS STANDBY LETTER OF CREDIT WILL BE DULY HONORED IF DRAWN AND

PRESENTED FOR PAYMENT AT OUR OFFICE LOCATED AT [Insert Bank Name], [Insert Bank Address], ATTN:  [Insert  Appropriate  Recipient],  ON  OR  BEFORE  THE  EXPIRATION  DATE  OF  THIS      CREDIT,

         (Expiration Date)         .

 

 

 

EXHIBIT H

-3 -


 

IN THE EVENT THAT THE ORIGINAL OF THIS STANDBY LETTER OF CREDIT IS LOST, STOLEN, MUTILATED, OR OTHERWISE DESTROYED, WE HEREBY AGREE TO ISSUE A DUPLICATE ORIGINAL HEREOF  UPON  RECEIPT  OF  A WRITTEN  REQUEST  FROM  YOU  AND  A  CERTIFICATION  BY YOU (PURPORTEDLY SIGNED BY YOUR AUTHORIZED REPRESENTATIVE) OF THE LOSS, THEFT, MUTILATION, OR OTHER DESTRUCTION OF THE ORIGINAL HEREOF.

 

EXCEPT SO FAR AS OTHERWISE EXPRESSLY STATED HEREIN, THIS STANDBY LETTER OF CREDIT IS SUBJECT TO THE "INTERNATIONAL STANDBY PRACTICES" (ISP 98) INTERNATIONAL CHAMBER OF COMMERCE (PUBLICATION NO. 590).

 

 

 

Very truly yours,

(Name of Issuing Bank)

By:

 

 

 

EXHIBIT H

-4 -


 

 

 

 

 

 

 

 

LEASE

 

 

 

THE SHORE AT SIERRA POINT

 

 

 

 

 

 

 

 

 

HCP LS BRISBANE, LLC,

 

a Delaware limited liability company as Landlord,

and MYOKARDIA, INC.,

a Delaware corporation, as Tenant.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


 

TABLE OF CONTENTS

 

Page

 

1.

PREMISES, BUILDING, PROJECT, AND COMMON AREAS

4

2.

LEASE TERM; OPTION TERM

7

3.

BASE RENT

9

4.

ADDITIONAL RENT

9

5.

USE OF PREMISES

15

6.

SERVICES AND UTILITIES

19

7.

REPAIRS

21

8.

ADDITIONS AND ALTERATIONS

22

9.

COVENANT AGAINST LIENS

23

10.

INSURANCE

24

11.

DAMAGE AND DESTRUCTION

26

12.

NONWAIVER

27

13.

CONDEMNATION

28

14.

ASSIGNMENT AND SUBLETTING

28

15.

SURRENDER OF PREMISES; OWNERSHIP AND REMOVAL OF TRADE FIXTURES

31

16.

HOLDING OVER

32

17.

ESTOPPEL CERTIFICATES

32

18.

SUBORDINATION

32

19.

DEFAULTS; REMEDIES

33

20.

COVENANT OF QUIET ENJOYMENT

34

21.

LETTER OF CREDIT

35

22.

COMMUNICATIONS AND COMPUTER LINE

38

23.

SIGNS

38

24.

COMPLIANCE WITH LAW

39

25.

LATE CHARGES

39

26.

LANDLORD'S RIGHT TO CURE DEFAULT; PAYMENTS BY TENANT

39

27.

ENTRY BY LANDLORD

39

28.

TENANT PARKING

40

29.

MISCELLANEOUS PROVISIONS

40

 

 

EXHIBITS

 

 

A

OUTLINE OF PREMISES

B

TENANT WORK LETTER

C

FORM OF NOTICE OF LEASE TERM DATES

D

FORM OF TENANT'S ESTOPPEL CERTIFICATE

E

ENVIRONMENTAL QUESTIONNAIRE

F

TENANT'S PROPERTY

G

FORM OF AMENDMENT RE: ADDITIONAL MONTHLY BASE RENT

H

FORM OF LETTER OF CREDIT

 

 

 

 

 

(i )


 

INDEX

 

 

 

Page(s)

Accountant

14

Additional Base Building Items

25

Additional Rent

9

Advocate Arbitrators

8

Alterations

22

as built

23

Bank

34

Bank’s Credit Rating Threshold

35

Bankruptcy Code

35

Base Building

21

Base Rent

9

BOMA Standard

5

Brokers

43

Builder's All Risk

23

Building

4

Building Systems

21

Chemical Storage Room

20

Clean-up

18

Closure Letter

18

Common Areas

5

Comparable Buildings

8

Comparable Transactions

8

Concessions

8

Construction Period

25

Contemplated Effective Date

29

Contemplated Transfer Space

29

Control

31

Direct Expenses

9,10

Disputed Amounts

40

Emergency

22

Energy Disclosure Information

20

Energy Disclosure Requirements

20

Environmental Assessment

17

Environmental Laws

16

Environmental Questionnaire

15

Environmental Report

18

Estimate

14

Estimate Statement

14

Estimated Direct Expenses

13,14

Excepted Matters

44

Expense Year

10

Fair Rental Value

7

First Class Life Sciences Projects

3

First Offer Notice

5

First Offer Space

5

First Offer Space Expiration Date

6

First Offer Space Lease

6

Force Majeure

42

Force Majeure Costs

26

Fundamental Terms

5

Generator

20

(ii )


 

 

Page(s)

Hazardous Materials

15

Hazardous Materials Claims

16

Intention to Transfer Notice

29

Intervening Leases

5

Landlord

1, 40, 1

Landlord Parties

24, 26

Landlord Repair Obligations

21

Landlord's Project Costs

26

L-C

34

L-C Amount

34

L-C Draw Event

35

L-C Expiration Date

35

L -C FDIC Replacement Notice

35

Lease

1

Lease Commencement Date

7

Lease Expiration Date

7

Lease Term

7

Lease Year

7

Lines

37

Mail

42

Negotiation Period

6

Net Worth

31

Neutral Arbitrator

8

New Building Notice

6

New Buildings

6

Nine Month Period

30

Notices

42

Objectionable Name

38

Operating Expenses

10

Option Conditions

7

Option Rent

7

Option Term

7

Original Tenant

6

Outside Agreement Date

8

PCBs

15

Permitted Assignee

31

Permitted Transferee

30

Premises

4

Project,

4

Release

16

Released

16

Releases

16

rent

34

Rent

9

RSF

1

Security Deposit Laws

37

Sign Specifications

38

Statement

13

Subject Space

28

Summary

1

Superior Right Holders

5

Tax Expenses

10, 12

Tenant

1, 40, 1

(iii)


 

 

Page(s)

Tenant Damage

4

Tenant Energy Use Disclosure

20

Tenant Signage

38

Tenant Work Letter

4

Tenant's Accountant

14

Tenant's Agents

15

Tenant's Property

23

Tenant's Repair Obligations

21

Tenant's Share

9, 13

Transfer

30

Transfer Notice

28

Transfer Premium

28, 29

Transferee

28

Transfers

28

Triple Net

10

Underlying Documents

11

Warranty Period

4

worth at the time of award

34

 

 

(iv )

Exhibit 31.1

CERTIFICATION OF THE PRINCIPAL EXECUTIVE OFFICER

PURSUANT TO

SECURITIES EXCHANGE ACT RULES 13A-14(A) AND 15D-14(A)

I, Tassos Gianakakos, certify that:

1.

I have reviewed this Quarterly Report on Form 10-Q of MyoKardia, Inc.;

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c)

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d)

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 8, 2018

 

/s/ Tassos Gianakakos

Tassos Gianakakos

Chief Executive Officer

(Principal Executive Officer)

 

Exhibit 31.2

CERTIFICATION OF THE PRINCIPAL FINANCIAL OFFICER

PURSUANT TO

SECURITIES EXCHANGE ACT RULES 13A-14(A) AND 15D-14(A)

I, Taylor Harris, certify that:

1.

I have reviewed this Quarterly Report on Form 10-Q of MyoKardia, Inc.;

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4.

The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a)

Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b)

Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c)

Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d)

Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5.

The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

(a)

All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b)

Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 8, 2018

 

/s/ Taylor Harris

Taylor Harris

Chief Financial Officer

(Principal Financial and Accounting 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 of MyoKardia, Inc. (the “Company”) on Form 10-Q for the fiscal quarter ended September 30, 2018, as filed with the Securities and Exchange Commission (the “Report”), Tassos Gianakakos, Chief Executive Officer of the Company, and Taylor Harris, Chief Financial Officer (Principal Financial and Accounting Officer) of the Company, respectively, do each hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of his knowledge:

 

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

 

The information in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: November 8, 2018

 

/s/ Tassos Gianakakos

Tassos Gianakakos

Chief Executive Officer

(Principal Executive Officer)

 

/s/ Taylor Harris

Taylor Harris

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

A signed original of this written statement required by Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended, and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. Section 1350), has been provided to MyoKardia, Inc. and will be retained by MyoKardia, Inc. and furnished to the Securities and Exchange Commission or its staff upon request. This certification accompanies the Form 10-Q to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of MyoKardia, Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of the Form 10-Q), irrespective of any general incorporation language contained in such filing.