Table of Contents

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended September 30, 2016

 

OR

 

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

 

For the transition period from       to      

 

Commission File Number 0-30739

 

INSMED INCORPORATED

(Exact name of registrant as specified in its charter)

 

Virginia

 

54-1972729

(State or other jurisdiction of incorporation or organization)

 

(I.R.S. employer identification no.)

 

 

 

10 Finderne Avenue, Building 10

 

 

Bridgewater, New Jersey

 

08807

(Address of principal executive offices)

 

(Zip Code)

 

(908) 977-9900

(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  x   No  o

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).  Yes  x  No  o

 

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

 

Large accelerated filer  x

 

Accelerated filer  o

 

 

 

Non-accelerated filer  o

 

Small Reporting Company  o

 

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

 

As of October 31, 2016, there were 61,877,905 shares of the registrant’s common stock, $0.01 par value, outstanding.

 

 

 



Table of Contents

 

INSMED INCORPORATED

FORM 10-Q

FOR THE QUARTER ENDED SEPTEMBER 30, 2016

 

INDEX

 

PART I.  FINANCIAL INFORMATION

 

 

 

 

ITEM 1

Consolidated Financial Statements

 

 

 

 

 

Consolidated Balance Sheets as of September 30, 2016 (unaudited) and December 31, 2015

3

 

 

 

 

Consolidated Statements of Comprehensive Loss (unaudited) for the three and nine months ended September 30, 2016 and 2015

4

 

 

 

 

Consolidated Statements of Cash Flows (unaudited) for the nine months ended September 30, 2016 and 2015

5

 

 

 

 

Notes to Consolidated Financial Statements (unaudited)

6

 

 

 

ITEM 2

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

13

ITEM 3

Quantitative and Qualitative Disclosures about Market Risk

26

ITEM 4

Controls and Procedures

26

 

 

 

PART II.  OTHER INFORMATION

 

 

 

 

ITEM 1

Legal Proceedings

27

ITEM 1A

Risk Factors

27

ITEM 2

Unregistered Sales of Equity Securities and Use of Proceeds

30

ITEM 3

Defaults Upon Senior Securities

30

ITEM 4

Mine Safety Disclosures (Not Applicable)

30

ITEM 5

Other Information

30

ITEM 6

Exhibits

30

 

 

 

SIGNATURE

 

31

EXHIBIT INDEX

32

 

In this Form 10-Q, we use the words “Insmed Incorporated” to refer to Insmed Incorporated, a Virginia corporation, and we use the words “Company,” “Insmed,” “Insmed Incorporated,” “we,” “us” and “our” to refer to Insmed Incorporated and its consolidated subsidiaries. IPLEX is a registered trademark and ARIKAYCE, INSMED and CONVERT are trademarks of Insmed Incorporated. This Form 10-Q also contains trademarks of third parties. Each trademark of another company appearing in this Form 10-Q is the property of its owner.

 

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Table of Contents

 

PART I.  FINANCIAL INFORMATION

 

ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS

 

INSMED INCORPORATED

Consolidated Balance Sheets

(in thousands, except par value and share data)

 

 

 

As of

 

As of

 

 

 

September 30, 2016

 

December 31, 2015

 

 

 

(unaudited)

 

 

 

Assets

 

 

 

 

 

Current assets:

 

 

 

 

 

Cash and cash equivalents

 

$

200,518

 

$

282,876

 

Prepaid expenses and other current assets

 

5,778

 

5,242

 

Total current assets

 

206,296

 

288,118

 

 

 

 

 

 

 

In-process research and development

 

58,200

 

58,200

 

Fixed assets, net

 

10,274

 

8,092

 

Other assets

 

1,874

 

2,146

 

Total assets

 

$

276,644

 

$

356,556

 

 

 

 

 

 

 

Liabilities and shareholders’ equity

 

 

 

 

 

Current liabilities:

 

 

 

 

 

Accounts payable

 

$

8,283

 

$

7,468

 

Accrued expenses

 

14,528

 

10,995

 

Other current liabilities

 

647

 

683

 

Current portion of long-term debt

 

 

3,113

 

Total current liabilities

 

23,458

 

22,259

 

 

 

 

 

 

 

Debt, long-term

 

34,681

 

22,027

 

Other long-term liabilities

 

676

 

572

 

Total liabilities

 

58,815

 

44,858

 

 

 

 

 

 

 

Shareholders’ equity:

 

 

 

 

 

Common stock, $0.01 par value; 500,000,000 authorized shares, 61,877,905 and 61,813,995 issued and outstanding shares at September 30, 2016 and December 31, 2015, respectively

 

619

 

618

 

Additional paid-in capital

 

914,049

 

900,043

 

Accumulated deficit

 

(696,834

)

(588,963

)

Accumulated other comprehensive (loss)

 

(5

)

 

Total shareholders’ equity

 

217,829

 

311,698

 

Total liabilities and shareholders’ equity

 

$

276,644

 

$

356,556

 

 

See accompanying notes to consolidated financial statements

 

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Table of Contents

 

INSMED INCORPORATED

Consolidated Statements of Comprehensive Loss (unaudited)

(in thousands, except per share data)

 

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

 

 

2016

 

2015

 

2016

 

2015

 

 

 

 

 

 

 

 

 

 

 

Revenues

 

$

 

$

 

$

 

$

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

23,433

 

19,221

 

67,851

 

54,631

 

General and administrative

 

13,716

 

11,024

 

38,498

 

30,272

 

Total operating expenses

 

37,149

 

30,245

 

106,349

 

84,903

 

 

 

 

 

 

 

 

 

 

 

Operating loss

 

(37,149

)

(30,245

)

(106,349

)

(84,903

)

 

 

 

 

 

 

 

 

 

 

Investment income

 

138

 

75

 

472

 

166

 

Interest expense

 

(769

)

(725

)

(2,015

)

(2,165

)

Other income (expense), net

 

45

 

(67

)

92

 

(36

)

Loss before income taxes

 

(37,735

)

(30,962

)

(107,800

)

(86,938

)

 

 

 

 

 

 

 

 

 

 

Provision for income taxes

 

25

 

 

71

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(37,760

)

$

(30,962

)

$

(107,871

)

$

(86,938

)

 

 

 

 

 

 

 

 

 

 

Basic and diluted net loss per share

 

$

(0.61

)

$

(0.50

)

$

(1.74

)

$

(1.51

)

 

 

 

 

 

 

 

 

 

 

Weighted average basic and diluted common shares outstanding

 

61,878

 

61,774

 

61,871

 

57,565

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(37,760

)

$

(30,962

)

$

(107,871

)

$

(86,938

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

Foreign currency translation loss

 

(17

)

 

(5

)

 

Total comprehensive loss

 

$

(37,777

)

$

(30,962

)

$

(107,876

)

$

(86,938

)

 

See accompanying notes to consolidated financial statements

 

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Table of Contents

 

INSMED INCORPORATED

Consolidated Statements of Cash Flows (unaudited)

(in thousands)

 

 

 

Nine months ended September 30,

 

 

 

2016

 

2015

 

Operating activities

 

 

 

 

 

Net loss

 

$

(107,871

)

$

(86,938

)

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

 

 

 

 

 

Depreciation

 

1,756

 

1,342

 

Stock based compensation expense

 

13,879

 

11,757

 

Amortization of debt discount and debt issuance costs

 

250

 

343

 

Accrual of the end of term charge on the debt

 

 

57

 

Changes in operating assets and liabilities:

 

 

 

 

 

Prepaid expenses and other assets

 

(230

)

(2,616

)

Accounts payable

 

361

 

1,340

 

Accrued expenses and other

 

3,109

 

1,562

 

Net cash used in operating activities

 

(88,746

)

(73,153

)

 

 

 

 

 

 

Investing activities

 

 

 

 

 

Purchase of fixed assets

 

(3,428

)

(3,047

)

Net cash used in investing activities

 

(3,428

)

(3,047

)

 

 

 

 

 

 

Financing activities

 

 

 

 

 

Proceeds from exercise of stock options

 

128

 

5,001

 

Proceeds from issuance of debt

 

10,000

 

 

Payment of debt issuance costs

 

(308

)

 

Proceeds from issuance of common stock, net

 

 

222,942

 

Net cash provided by financing activities

 

9,820

 

227,943

 

 

 

 

 

 

 

Effect of exchange rates on cash and cash equivalents

 

(4

)

 

Net (decrease) / increase in cash and cash equivalents

 

(82,358

)

151,743

 

Cash and cash equivalents at beginning of period

 

282,876

 

159,226

 

 

 

 

 

 

 

Cash and cash equivalents at end of period

 

$

200,518

 

$

310,969

 

 

 

 

 

 

 

Supplemental disclosures of cash flow information:

 

 

 

 

 

Cash paid for interest

 

$

2,471

 

$

2,230

 

Cash paid / (received) for income taxes

 

$

49

 

$

(994

)

 

See accompanying notes to consolidated financial statements

 

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Table of Contents

 

INSMED INCORPORATED

NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

 

1.             The Company and Basis of Presentation

 

Insmed is a global biopharmaceutical company focused on the unmet needs of patients with rare diseases. The Company’s lead product candidate is ARIKAYCE, or liposomal amikacin for inhalation (LAI), which is in late-stage development for patients with nontuberculous mycobacteria (NTM) lung disease, a rare and often chronic infection that is capable of causing irreversible lung damage and which can be fatal. The Company’s earlier clinical-stage pipeline includes INS1007, a novel oral reversible inhibitor of dipeptidyl peptidase 1, and INS1009, an inhaled prodrug formulation of treprostinil.

 

The Company was incorporated in the Commonwealth of Virginia on November 29, 1999 and its principal executive offices are located in Bridgewater, New Jersey. The Company has operations in the United States (US), Ireland, Germany, France, the United Kingdom (UK) and the Netherlands. The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany transactions and balances have been eliminated in consolidation.

 

The accompanying unaudited interim consolidated financial statements have been prepared pursuant to the rules and regulations for reporting on Form 10-Q. Accordingly, certain information and disclosures required by accounting principles generally accepted in the US for complete consolidated financial statements are not included herein. The interim statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015.

 

The results of operations of any interim period are not necessarily indicative of the results of operations for the full year. The unaudited interim consolidated financial information presented herein reflects all normal adjustments that are, in the opinion of management, necessary for a fair statement of the financial position, results of operations and cash flows for the periods presented.

 

2.              Summary of Significant Accounting Policies

 

The following are interim updates to certain of the policies described in “Note 2” to the Company’s audited consolidated financial statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015:

 

Fair Value Measurements - The Company categorizes its financial assets and liabilities measured and reported at fair value in the financial statements on a recurring basis based upon the level of judgments associated with the inputs used to measure their fair value. Hierarchical levels, which are directly related to the amount of subjectivity associated with the inputs used to determine the fair value of financial assets and liabilities, are 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 prices included in Level 1) are either directly or indirectly observable for the assets 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.

 

Each major category of financial assets and liabilities measured at fair value on a recurring basis are categorized based upon the lowest level of significant input to the valuations. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Financial instruments in Level 1 generally include US treasuries and mutual funds listed in active markets.

 

The Company’s only assets and liabilities which were measured at fair value as of September 30, 2016 and December 31, 2015 were Level 1 and such assets were comprised of cash and cash equivalents of $200.5 million and $282.9 million, respectively.

 

The Company’s cash and cash equivalents permit daily redemption and the fair values of these investments are based upon the quoted prices in active markets provided by the holding financial institutions. Cash equivalents consist of liquid investments with a maturity of three months or less from the date of purchase.

 

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The Company recognizes transfers between levels within the fair value hierarchy, if any, at the end of each quarter. There were no transfers in or out of Level 1, Level 2 or Level 3 during the three and nine months ended September 30, 2016 and 2015, respectively.

 

As of September 30, 2016 and December 31, 2015, the Company held no securities that were in an unrealized gain or loss position. The Company reviews the status of each security quarterly to determine whether an other-than-temporary impairment has occurred. In making its determination, the Company considers a number of factors, including: (1) the significance of the decline; (2) whether the securities were rated below investment grade; (3) how long the securities have been in an unrealized loss position; and (4) the Company’s ability and intent to retain the investment for a sufficient period of time for it to recover.

 

Net Loss Per Common Share - Basic net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per common share is computed by dividing net loss by the weighted average number of common shares and other dilutive securities outstanding during the period. Potentially dilutive securities from stock options, restricted stock units and warrants to purchase common stock would be antidilutive as the Company incurred a net loss. Potentially dilutive common shares resulting from the assumed exercise of outstanding stock options and warrants are determined based on the treasury stock method.

 

The following table sets forth the reconciliation of the weighted average number of shares used to compute basic and diluted net loss per share for the three and nine months ended September 30, 2016 and 2015:

 

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

 

 

2016

 

2015

 

2016

 

2015

 

 

 

(in thousands, except per share amounts)

 

Numerator:

 

 

 

 

 

 

 

 

 

Net loss

 

$

(37,760

)

$

(30,962

)

$

(107,871

)

$

(86,938

)

Denominator:

 

 

 

 

 

 

 

 

 

Weighted average common shares used in calculation of basic net loss per share:

 

61,878

 

61,774

 

61,871

 

57,565

 

Effect of dilutive securities:

 

 

 

 

 

 

 

 

 

Common stock options

 

 

 

 

 

Restricted stock and restricted stock units

 

 

 

 

 

Weighted average common shares outstanding used in calculation of diluted net loss per share

 

61,878

 

61,774

 

61,871

 

57,565

 

Net loss per share:

 

 

 

 

 

 

 

 

 

Basic and diluted

 

$

(0.61

)

$

(0.50

)

$

(1.74

)

$

(1.51

)

 

The following potentially dilutive securities have been excluded from the computations of diluted weighted average common shares outstanding as of September 30, 2016 and 2015 as their effect would have been anti-dilutive (in thousands):

 

 

 

2016

 

2015

 

Stock options to purchase common stock

 

7,306

 

5,241

 

Unvested restricted stock units

 

89

 

44

 

 

New Accounting Pronouncements —In April 2015, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2016-02, Leases (Topic 842). This update requires an entity to recognize assets and liabilities for leases with lease terms of more than 12 months on the balance sheet. The Company plans to adopt this standard on January 1, 2019, and is still evaluating the impact that this standard will have on its consolidated financial statements.

 

In March 2016, the FASB issued ASU 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. This update simplifies the accounting for employee share-based payment transactions, including the accounting for income taxes, forfeitures, and statutory tax withholding requirements, as well as classification in the statement of cash flows. The Company plans to adopt this standard on January 1, 2017, and is evaluating the impact that this standard will have on its consolidated financial statements.

 

3.              Identifiable Intangible Asset

 

The Company believes there are no indicators of impairment relating to its in-process research and development intangible asset as of September 30, 2016.

 

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4.              Accrued Expenses

 

Accrued expenses consist of the following:

 

 

 

As of September 30,

 

As of December 31,

 

 

 

2016

 

2015

 

 

 

(in thousands)

 

 

 

 

 

 

 

Accrued clinical trial expenses

 

$

5,623

 

$

4,331

 

Accrued compensation

 

6,063

 

4,302

 

Accrued professional fees

 

1,898

 

1,202

 

Accrued technical operation expenses

 

446

 

702

 

Accrued interest payable

 

195

 

199

 

Other accrued expenses

 

303

 

259

 

 

 

$

14,528

 

$

10,995

 

 

5.             Debt

 

On September 30, 2016, the Company and its domestic subsidiaries, as co-borrowers, entered into an Amended and Restated Loan and Security Agreement (the A&R Loan Agreement) with Hercules Capital, Inc. (Hercules). The A&R Loan Agreement includes a total commitment from Hercules of up to $55.0 million, of which $25.0 million was previously outstanding. The amount of borrowings was initially increased by $10.0 million to an aggregate total of $35.0 million on September 30, 2016. An additional $20.0 million was available at the Company’s option through June 30, 2017 subject to certain conditions, including the payment of a facility fee of 0.375%. The Company exercised this option in early October 2016 and borrowed an additional $20.0 million in connection with its upfront payment obligation under the License Agreement with AstraZeneca (see Note 10 — Subsequent Event ). The interest rate for the term is floating and is defined as the greater of (i) 9.25% or (ii) 9.25% plus the sum of the US prime rate minus 4.50%, along with a backend fee of 4.15% of the aggregate principal amount outstanding and an aggregate facility fee of $337,500. The interest-only period extends through May 1, 2018, but can be extended up to 12 months under certain conditions. The maturity date of the loan facility was also extended to October 1, 2020. Pursuant to the A&R Loan Agreement, the Company is required to have consolidated minimum cash liquidity in an amount no less than $25.0 million. Such requirement terminates upon the earlier of the date by which the Company completes an equity financing with at least $75.0 million in proceeds or the date the Company generates and announces data from the CONVERT Phase III study in a manner that could support an NDA filing. In addition, pursuant to the A&R Loan Agreement, Hercules has the right to participate, in an aggregate amount of up to $2.0 million, in a subsequent private financing of equity securities.

 

In connection with the A&R Loan Agreement, the Company granted Hercules a first position lien on all of the Company’s assets, excluding intellectual property. Prepayment of the loans made pursuant to the A&R Loan Agreement is subject to penalty. The backend fee of 4.15% on the aggregate outstanding principal balance will be charged to interest expense (and accreted to the debt) using the effective interest method over the original life of the A&R Loan Agreement. Debt issuance fees paid to Hercules were recorded as a discount on the debt and are being amortized to interest expense using the effective interest method over the life of the A&R Loan Agreement.

 

The following table presents the components of the Company’s debt balance as of September 30, 2016 (in thousands):

 

Debt:

 

 

 

Notes payable

 

$

35,000

 

Debt issuance costs

 

(319

)

Current portion of long-term debt

 

 

Debt, long-term

 

$

34,681

 

 

As of September 30, 2016, future principal repayments of the debt for each of the years ending December 31, were as follows (in thousands):

 

Year Ending in December 31:

 

 

 

2016

 

$

 

2017

 

 

2018

 

8,527

 

2019

 

13,837

 

2020

 

12,636

 

 

 

$

35,000

 

 

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The estimated fair value of the debt (categorized as a Level 2 liability for fair value measurement purposes) is determined using current market factors and the ability of the Company to obtain debt at comparable terms to those that are currently in place.  The Company believes the estimated fair value at September 30, 2016 approximates the carrying amount.

 

6.              Shareholders’ Equity

 

Common Stock — As of September 30, 2016, the Company had 500,000,000 shares of common stock authorized with a par value of $0.01 and 61,877,905 shares of common stock issued and outstanding. In addition, as of September 30, 2016, the Company had reserved 7,306,178 shares of common stock for issuance upon the exercise of outstanding common stock options.

 

On April 6, 2015, the Company completed an underwritten public offering of 11,500,000 shares of the Company’s common stock, which included the underwriter’s exercise in full of its over-allotment option of 1,500,000 shares, at a price to the public of $20.65 per share. The Company’s net proceeds from the sale of the shares, after deducting the underwriter’s discount and offering expenses of $14.5 million, were $222.9 million.

 

Preferred Stock — As of September 30, 2016 and December 31, 2015, the Company had 200,000,000 shares of preferred stock authorized with a par value of $0.01 and no shares of preferred stock were issued and outstanding.

 

7.              Stock-Based Compensation

 

The Company’s current equity compensation plan, the 2015 Incentive Plan, was approved by shareholders at the Company’s Annual Meeting of Shareholders on May 21, 2015. The 2015 Incentive Plan is administered by the Compensation Committee and the Board of Directors of the Company. Under the terms of the 2015 Incentive Plan, the Company is authorized to grant a variety of incentive awards based on its common stock, including stock options (both incentive stock options and non-qualified stock options), performance options/shares and other stock awards, as well as the payment of incentive bonuses to all employees and non-employee directors. On May 21, 2015, 5,000,000 shares of the Company’s common stock were authorized and as of September 30, 2016, there were 2,130,917 shares available for future grants (or issuances) of stock options, stock appreciation rights, restricted stock, restricted stock units and incentive bonuses under the 2015 Incentive Plan. The 2015 Incentive Plan will terminate on April 9, 2025 unless it is extended or terminated earlier pursuant to its terms. In addition, from time to time, the Company makes inducement grants of stock options. These awards are made pursuant to the Nasdaq inducement grant exception as a component of new hires’ employment compensation in connection with the Company’s equity grant program.

 

Stock Options - The Company calculates the fair value of stock options granted using the Black-Scholes valuation model. The following table summarizes the Company’s grant date fair value and assumptions used in determining the fair value of all stock options granted:

 

 

 

Three Months Ended September 30,

 

Nine Months Ended September 30,

 

 

 

2016

 

2015

 

2016

 

2015

 

 

 

 

 

 

 

 

 

 

 

Volatility

 

75%-76%

 

78%-79%

 

75%-77%

 

78%-82%

 

Risk-free interest rate

 

1.00%-1.18%

 

1.49%-1.72%

 

1.00%-1.73%

 

1.31%-1.72%

 

Dividend yield

 

0.0%

 

0.0%

 

0.0%

 

0.0%

 

Expected option term (in years)

 

6.25

 

6.25

 

6.25

 

6.25

 

Weighted-average fair value of stock options granted

 

$7.79

 

$17.32

 

$8.74

 

$14.38

 

 

For all periods presented, the volatility factor was based on the Company’s historical volatility since the closing of the Company’s merger with Transave in December 2010. The expected life was determined using the simplified method as described in ASC Topic 718, Accounting for Stock Compensation, which is the midpoint between the vesting date and the end of the contractual term. The risk-free interest rate is based on the US Treasury yield in effect at the date of grant. Forfeitures are based on the actual percentage of option forfeitures since the closing of the Company’s merger with Transave in December 2010, and this is the basis for future forfeiture expectations.

 

From time to time, the Company grants performance-condition options to certain of the Company’s employees. Vesting of these options is subject to the Company achieving certain performance criteria established at the date of grant and the individuals fulfilling a service condition (continued employment). As of September 30, 2016, the Company had performance options totaling 158,334 shares outstanding which have not met the recognition criteria to date. For the nine months ended September 30, 2015, $1.5 million of non-cash compensation expense was recorded related to certain performance based options as the recognition criteria was

 

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met upon the marketing authorization application for ARIKAYCE being accepted for filing by the European Medicines Agency in February 2015.

 

The following table summarizes the Company’s aggregate stock option activity for the nine months ended September 30, 2016:

 

 

 

Number of
Shares

 

Weighted
Average
Exercise
Price

 

Weighted
Average
Remaining
Contractual
Life in Years

 

Aggregate
Intrinsic
Value (in
thousands)

 

Options outstanding at December 31, 2015

 

5,273,722

 

$

13.64

 

 

 

 

 

Granted

 

2,406,165

 

$

12.89

 

 

 

 

 

Exercised

 

(20,356

)

$

6.32

 

 

 

 

 

Forfeited or expired

 

(353,353

)

$

16.29

 

 

 

 

 

Options outstanding at September 30, 2016

 

7,306,178

 

$

13.29

 

7.85

 

$

22,537

 

Vested and expected to vest at September 30, 2016

 

6,998,262

 

$

13.23

 

7.80

 

$

21,995

 

Exercisable at September 30, 2016

 

3,062,677

 

$

10.81

 

6.58

 

$

15,758

 

 

The total intrinsic value of stock options exercised during the three months ended September 30, 2015 was $0.7 million and during the nine months ended September 30, 2016 and 2015 was $0.1 million and $4.6 million, respectively. There were no stock options exercised during the three months ended September 30, 2016.

 

As of September 30, 2016, there was $29.2 million of unrecognized compensation expense related to unvested stock options which is expected to be recognized over a weighted average period of 2.8 years. Included in unrecognized compensation expense was $1.2 million related to outstanding performance-based options. The following table summarizes the range of exercise prices and the number of stock options outstanding and exercisable:

 

Outstanding as of September 30, 2016

 

Exercisable as of September 30, 2016

 

 

 

 

 

Weighted

 

 

 

 

 

 

 

 

 

 

 

Average

 

 

 

 

 

 

 

 

 

 

 

Remaining

 

Weighted

 

 

 

 

 

Range of Exercise

 

Number of

 

Contractual

 

Average

 

Number of

 

Weighted Average

 

Prices ($)

 

Options

 

Term (in years)

 

Exercise Price ($)

 

Options

 

Exercise Price ($)

 

3.03

 

3.40

 

850,137

 

5.83

 

3.34

 

850,137

 

3.34

 

3.60

 

6.96

 

673,847

 

6.20

 

6.14

 

563,814

 

6.00

 

8.77

 

10.85

 

1,186,595

 

9.56

 

10.84

 

3,000

 

8.77

 

11.14

 

12.44

 

791,505

 

7.37

 

12.00

 

388,892

 

12.05

 

12.45

 

14.24

 

822,857

 

7.59

 

13.28

 

402,074

 

13.35

 

14.32

 

16.09

 

509,512

 

7.86

 

15.90

 

207,570

 

15.85

 

16.16

 

16.16

 

766,650

 

9.07

 

16.16

 

10,250

 

16.16

 

16.19

 

20.92

 

754,750

 

7.51

 

19.38

 

366,013

 

19.58

 

21.20

 

22.14

 

51,800

 

4.94

 

21.62

 

30,075

 

21.77

 

22.76

 

27.38

 

898,525

 

8.38

 

22.92

 

240,852

 

22.93

 

 

Restricted Stock and Restricted Stock Units — The Company may grant Restricted Stock (RS) and Restricted Stock Units (RSUs) to eligible employees, including its executives, and non-employee directors. Each RS and RSU represents a right to receive one share of the Company’s common stock upon the completion of a specific period of continued service or achievement of a certain milestone. RS and RSU awards granted are valued at the market price of the Company’s common stock on the date of grant. The Company recognizes noncash compensation expense for the fair values of these RS and RSUs on a straight-line basis over the requisite service period of these awards. The following table summarizes the Company’s RSU award activity during the nine months ended September 30, 2016:

 

 

 

 

 

Weighted

 

 

 

Number of

 

Average

 

 

 

RSUs

 

Grant Price ($)

 

Outstanding at December 31, 2015

 

43,554

 

16.07

 

Granted

 

89,194

 

10.85

 

Released

 

(43,554

)

16.07

 

Outstanding at September 30, 2016

 

89,194

 

10.85

 

 

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The following table summarizes the aggregate stock-based compensation recorded in the Consolidated Statements of Comprehensive Loss related to stock options and RSUs during the three and nine months ended September 30, 2016 and 2015:

 

 

 

Three months ended September 30,

 

Nine months ended September 30,

 

 

 

2016

 

2015

 

2016

 

2015

 

 

 

(in millions)

 

(in millions)

 

 

 

 

 

 

 

 

 

 

 

Research and development expenses

 

$

1.7

 

$

0.8

 

$

4.6

 

$

3.1

 

General and administrative expenses

 

3.4

 

3.0

 

9.3

 

8.7

 

 

 

 

 

 

 

 

 

 

 

Total

 

$

5.1

 

$

3.8

 

$

13.9

 

$

11.8

 

 

8.              Income Taxes

 

The Company’s provision for income taxes was $25,000 and $71,000 for the three and nine months ended September 30, 2016, respectively. The current year provision was a result of certain of the Company’s subsidiaries in Europe, which had taxable income during the three and nine months ended September 30, 2016. In jurisdictions where the Company has net losses, there was a full valuation allowance recorded against the Company’s deferred tax assets and therefore no tax benefit was recorded. The Company is subject to US federal, US state and foreign income taxes. The statute of limitations for tax audit is open for the US federal tax returns for the years ended 2013 and later and is generally open for certain states for the years 2012 and later. The Company’s US federal tax return for the year ended December 31, 2013 is currently under audit by the Internal Revenue Service. The Company has incurred net operating losses since inception, with the exception of 2009. Such loss carryforwards are subject to audit in any tax year in which those losses are utilized, notwithstanding the year of origin. As of September 30, 2016 and December 31, 2015, the Company has recorded no reserves for unrecognized income tax benefits, nor has it recorded any accrued interest or penalties related to uncertain tax positions. The Company does not anticipate any material changes in the amount of unrecognized tax positions over the next twelve months.

 

9.              Commitments and Contingencies

 

Commitments

 

The Company has an operating lease for office and laboratory space located in Bridgewater, NJ, its corporate headquarters, for which the initial lease term expires in November 2019. Future minimum rental payments under this lease are $3.2 million. In July 2016, the Company signed an operating lease for additional laboratory space located in Bridgewater, NJ for which the initial lease term expires in September 2021. Future minimum rental payments under this lease are $2.1 million.

 

Rent expense charged to operations was $0.4 million and $0.2 million for the three months ended September 30, 2016 and 2015, respectively, and $0.9 million and $0.6 million for the nine months ended September 30, 2016 and 2015, respectively. Future minimum rental payments required under the Company’s operating leases for the period from October 1, 2016 to December 31, 2016 and for each of the next five years are as follows (in thousands):

 

Year Ending December 31:

 

 

 

2016 (remaining)

 

$

340

 

2017

 

1,395

 

2018

 

1,433

 

2019

 

1,390

 

2020

 

444

 

2021

 

423

 

 

 

$

5,425

 

 

Legal Proceedings

 

On July 15, 2016, a purported class action lawsuit was filed in the U.S. District Court for the District of New Jersey against the Company and certain of its executive officers: Hoey v. Insmed Incorporated, et al, No. 3:16-cv-04323-FLW-TJB (D.N.J. July 15, 2016). The complaint alleges that from March 18, 2013 through June 8, 2016, the Company and certain of our executive officers made material misstatements or omissions concerning the likelihood of the EMA approving the Company’s European MAA for use of ARIKAYCE in the treatment of NTM lung disease and the likelihood of commercialization of ARIKAYCE in Europe. The complaint alleges violations of Section 10(b) and 20(a) of the Securities Exchange Act of 1934, and Rule 10b-5 promulgated thereunder. The complaint seeks unspecified damages. On October 25, 2016, the Court issued an order appointing Bucks County Employees Retirement Funds as lead plaintiff for the putative class. A consolidated amended complaint has not yet been filed. The Company believes that the allegations in the complaint are without merit and intends to defend the lawsuit vigorously; however, there can be no assurance regarding the ultimate outcome of the lawsuit.

 

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10.           Subsequent Event

 

License Agreement

 

AstraZeneca — On October 4, 2016, the Company entered into a license agreement (the License Agreement) with AstraZeneca AB, a Swedish corporation (AstraZeneca). Pursuant to the terms of the License Agreement, AstraZeneca granted the Company global exclusive rights for the purpose of developing and commercializing AZD7986 (renamed INS1007 by the Company). INS1007 is a novel oral inhibitor of dipeptidyl peptidase 1 (DPP1). DPP1 is an enzyme that catalyzes the activation of neutrophil serine proteases, which play a key role in pulmonary diseases such as non-cystic fibrosis bronchiectasis.

 

In consideration of the licenses and other rights granted by AstraZeneca, the Company paid an upfront payment of $30.0 million in early November 2016, which will be included as research and development expense in the fourth quarter of 2016. In connection with the upfront payment obligation in the License Agreement, the Company borrowed an additional $20.0 million under the A&R Loan Agreement in early October 2016, as further described in Note 5 - Debt . The Company will make a series of contingent milestone payments totaling up to an additional $85.0 million upon the achievement of clinical development and regulatory filing milestones. If the Company elects to develop INS1007 for a second indication, the Company will make an additional series of contingent milestone payments equal to half of the contingent milestone payments in the preceding sentence. No additional milestone payments are due for any indications beyond the first and second indications. In addition, the Company will pay AstraZeneca tiered royalties ranging from a high single-digit to mid-teen on net sales of any approved product based on INS1007 and one additional payment of $35.0 million upon the first achievement of $1 billion in annual net sales. The License Agreement provides AstraZeneca with the option to negotiate a future agreement with the Company for commercialization of INS1007 in chronic obstructive pulmonary disease or asthma.

 

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ITEM 2.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

Cautionary Note Regarding Forward Looking Statements

 

This Quarterly Report on Form 10-Q contains forward looking statements.  “Forward-looking statements,” as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties.  Words herein such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “intends,” “potential,” “continues,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) identify forward-looking statements.

 

Forward-looking statements are based upon our current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause our actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timing discussed, projected, anticipated or indicated in any forward-looking statements. Such factors include, among others, the factors discussed in Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2015 filed with the Securities and Exchange Commission (SEC) on February 25, 2016, our subsequent quarterly reports on Form 10-Q filed in 2016, and the following: the ability to complete development of, receive regulatory approval for, and successfully commercialize ARIKAYCE, or liposomal amikacin for inhalation, INS1007, an oral reversible inhibitor of dipeptidyl peptidase, and INS1009, an inhaled treprostinil prodrug; the number of patients enrolled and the timing of patient enrollment in the Company’s global phase 3 clinical study of ARIKAYCE; estimates of expenses and future revenues and profitability; plans to develop and market new products and the timing of these development programs; status, timing, and the results of preclinical studies and clinical trials and preclinical and clinical data described herein; the sufficiency of preclinical and clinical data in obtaining regulatory approval for the Company’s product candidates; the timing of responses to information and data requests from the US Food and Drug Administration, the European Medicines Agency, and other regulatory authorities; clinical development of product candidates; the ability to obtain and maintain regulatory approval for product candidates; expectation as to the timing of regulatory review and approval; estimates regarding capital requirements, including milestone payments due to AstraZeneca, and the needs for additional financing; the ability to repay our existing indebtedness; estimates of the size of the potential markets for product candidates; selection and licensing of product candidates; ability to attract third parties with acceptable development, regulatory and commercialization expertise; the benefits to be derived from corporate license agreements and other third party efforts, including those relating to the development and commercialization of product candidates; the degree of protection afforded to the Company by its intellectual property portfolio; the safety and efficacy of product candidates; sources of revenues and anticipated revenues, including contributions from license agreements and other third party efforts for the development and commercialization of products; the ability to create an effective direct sales and marketing infrastructure for products the Company elects to market and sell directly; the rate and degree of market acceptance of product candidates; the impact of any litigation the Company is a party to, including, without limitation, the class action lawsuit filed against the Company; the timing, scope and rate of reimbursement for product candidates; the success of other competing therapies that may become available; and the availability of adequate supply and manufacturing capacity and quality for product candidates.

 

We caution readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. We disclaim any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

 

The following discussion should be read in conjunction with our consolidated financial statements and related notes thereto included elsewhere in this Quarterly Report on Form 10-Q and the consolidated financial statements and related notes thereto in our Annual Report on Form 10-K for the year ended December 31, 2015.

 

OVERVIEW

 

We are a global biopharmaceutical company focused on the unmet needs of patients with rare diseases. Our lead product candidate is ARIKAYCE, or liposomal amikacin for inhalation (LAI), which is in late-stage development for patients with nontuberculous mycobacteria (NTM) lung disease, a rare and often chronic infection that is capable of causing irreversible lung damage and can be fatal. Our earlier clinical-stage pipeline includes INS1007 and INS1009. INS1007 is a novel oral reversible inhibitor of dipeptidyl peptidase 1 (DPP1), an enzyme responsible for activating neutrophil serine proteases, which are implicated in the pathology of chronic inflammatory lung diseases, such as non-cystic fibrosis (non-CF) bronchiectasis. INS1009 is our inhaled treprostinil prodrug that may offer a differentiated product profile for rare pulmonary disorders, including pulmonary arterial hypertension (PAH).

 

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We are conducting a global phase 3 clinical study of ARIKAYCE (the 212 or CONVERT study) in adult patients with treatment refractory NTM lung disease caused by Mycobacterium avium complex (MAC), which is the predominant infective species in NTM lung disease in the United States (US), Europe, and Japan.

 

In October 2016, we acquired the global exclusive rights to INS1007 (formerly known as AZD7986) from AstraZeneca and we are finalizing our plans for a phase 2 study in our lead indication, non-CF bronchiectasis. In a phase 1 study of healthy volunteers, AZD7986 was well tolerated and demonstrated inhibition of the activity of the neutrophil serine protease neutrophil elastase in a dose and concentration dependent manner. In preclinical studies, AZD7986 was shown to effectively and reversibly inhibit DPP1 and the activation of neutrophil serine proteases within maturing neutrophils.

 

We have completed a phase 1 study of INS1009 in healthy subjects and the results were presented at the European Respiratory Society international congress in September 2016. This first-in-human study of INS1009 determined the maximum-tolerated dose of a single dose of INS1009 and characterized a pharmacokinetic profile that supports once- or twice-daily dosing. The longer half-life of treprostinil associated with INS1009 was likely due to a sustained pulmonary release.

 

Our earlier-stage pipeline includes preclinical compounds that we are evaluating in multiple rare diseases of unmet medical need, including methicillin-resistant staph aureus (MRSA), NTM, and sarcoidosis. To complement our internal research and development, we actively evaluate in-licensing and acquisition opportunities for a broad range of rare diseases.

 

The following table summarizes the current status of and anticipated milestones for ARIKAYCE, INS1007, and INS1009:

 

Product Candidate/Target

 

 

 

 

Indications

 

Status

 

Next Expected Milestones

ARIKAYCE for adult patients with treatment refractory NTM lung infections caused by MAC

 

·        We are advancing the CONVERT study, a randomized, open-label global phase 3 clinical study of ARIKAYCE in adult patients with treatment refractory NTM lung disease caused by MAC.

·        The US Food and Drug Administration (FDA) has designated ARIKAYCE as an orphan drug, a breakthrough therapy, and a qualified infectious disease product (QIDP). Breakthrough therapy features intensive guidance on efficient drug development and offers the potential for a rolling review. A QIDP-designated product qualifies for the same benefits as fast track designation and is typically eligible for priority review.

·        The European Commission granted an orphan designation for ARIKAYCE for the treatment of NTM lung disease.

 

·        We have achieved our enrollment objective for the CONVERT study. We expect to report top-line results for the Month 6 primary endpoint in 2017.

·        If the CONVERT study meets its primary endpoint, we intend to seek accelerated marketing approval for ARIKAYCE in the US. We intend to seek marketing approvals for ARIKAYCE in certain countries outside the US, when sufficient data are available. If approved, we expect ARIKAYCE would be the first inhaled antibiotic specifically indicated for the treatment of NTM lung infections in North America, Europe, and Japan.

·        If approved, we plan to commercialize ARIKAYCE in the US, certain countries in Europe, Japan and certain other countries.

 

 

 

 

 

INS1007 (oral reversible inhibitor of dipeptidyl peptidase 1)

 

·        In October 2016, we entered into a licensing agreement with AstraZeneca for the global exclusive rights to AZD7986. We renamed the compound INS1007 and plan to pursue an initial indication of non-CF bronchiectasis.

 

·        We plan to submit an Investigational New Drug (IND) application with FDA and subsequently commence a phase 2 clinical study of INS1007 in non-CF bronchiectasis. The study is expected to begin in 2017.

 

 

 

 

 

INS1009 (inhaled treprostinil prodrug) for
rare pulmonary disorders

 

·        The results of our phase 1 study of INS1009 were presented at the European Respiratory Society international congress in September 2016.

·        The phase 1 study was a randomized, double-blind, placebo-controlled single ascending dose study of INS1009 for inhalation to determine its safety, tolerability, and pharmacokinetics in healthy volunteers.

 

·        We have additional preclinical studies reading out later this year, which will help inform our clinical development strategy for INS1009.

 

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Product Pipeline

 

ARIKAYCE for patients with NTM lung disease

 

Our lead product candidate is ARIKAYCE, or LAI, a novel, once-daily formulation of amikacin that is in late-stage clinical development for patients with NTM lung disease, a rare and often chronic infection that is capable of causing irreversible lung damage and death. Amikacin solution for parenteral administration is an established drug that has activity against a variety of NTM; however, its use is limited by the need to administer it intravenously and by toxicity to hearing, balance, and kidney function (Peloquin et al., 2004). Our advanced liposome technology uses charge-neutral liposomes to deliver amikacin directly to the lung where it is taken up by the lung macrophages where the NTM infection resides. This prolongs the release of amikacin in the lungs while minimizing systemic exposure thereby offering the potential for decreased systemic toxicities. ARIKAYCE’s ability to deliver high levels of amikacin directly to the lung distinguishes it from intravenous amikacin. ARIKAYCE is administered once-daily using an optimized, investigational eFlow® Nebulizer System manufactured by PARI Pharma GmbH, a novel, highly efficient and portable aerosol delivery system.

 

The CONVERT study

 

ARIKAYCE is currently being evaluated in a global phase 3 randomized, open-label clinical study designed to confirm the culture conversion results seen in our phase 2 clinical trial. This phase 3 study, which is known as the CONVERT (or 212) study, is comprised of non-CF patients 18 years and older with an NTM lung infection caused by MAC that is refractory to a stable multi-drug regimen for at least six months with the regimen either ongoing or completed within 12 months of screening. In our completed phase 2 study, the highest response to ARIKAYCE treatment was observed in the subgroup of non-CF patients with NTM lung infection caused by MAC. The CONVERT study also excludes subjects whose susceptibility scores indicate that their MAC NTM infection is resistant to amikacin. We believe the CONVERT study will confirm the culture conversion results seen in the phase 2 study and provide the basis for submitting a New Drug Application (NDA) to the FDA, as well as regulatory submissions in Europe, Japan and other countries.

 

After a screening period of approximately 10 weeks, eligible subjects are randomized 2:1 to once-daily ARIKAYCE plus a multi-drug regimen or the same multi-drug regimen without ARIKAYCE.  The primary efficacy endpoint is the proportion of subjects who achieve culture conversion by Month 6 in the ARIKAYCE plus multi-drug regimen arm compared to the arm in which subjects receive the same multi-drug regimen without ARIKAYCE. A converter is defined as a subject with three consecutive monthly negative sputum cultures by Month 6. The study’s key secondary endpoints include the change from baseline in the six-minute walk test and off-treatment assessments to evaluate durability of effect. The study also includes a comprehensive pharmacokinetic sub-study in Japanese subjects in lieu of a separate local pharmacokinetic study in Japan.

 

At Month 8, after all sputum culture results are known up to and including Month 6, subjects will be assessed as converters or non-converters for the primary efficacy endpoint. All converters will continue on their randomized treatment regimen for 12 months beginning from the first negative culture that defined culture conversion. All converters will return for off-treatment follow-up visits. A 12-month off-treatment study visit will be the last visit for the CONVERT study. All non-converters, as determined at the Month 8 visit, may be eligible to enter a separate 12-month open-label study (the 312 study). The primary objective of the 312 study is to evaluate the long-term safety and tolerability of ARIKAYCE in combination with a standard multi-drug regimen. The secondary endpoints of the 312 study include evaluating the proportion of subjects achieving culture conversion (three consecutive monthly negative sputum cultures) by Month 6 and the proportion of subjects achieving culture conversion by Month 12 (end of treatment).

 

The protocol for the CONVERT study incorporates feedback from the FDA and the European Medicines Agency (EMA) via its scientific advice working party process, as well as local health authorities in other countries, including Japan’s Pharmaceuticals and Medical Devices Agency. If the CONVERT study meets the primary endpoint of culture conversion by Month 6, we believe we would be eligible to submit an NDA pursuant to 21 CFR 314 Subpart H (Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses), which permits FDA to approve a drug based on a surrogate endpoint provided the sponsor commits to study the drug further to verify and describe the drug’s clinical benefit. We believe that efficacy data from the CONVERT study after Month 6, if successful, will suffice to meet this commitment. The CONVERT study is taking place in North America, Europe, Australia, New Zealand and Asia. The CONVERT study is designed to enroll enough subjects to ensure at least 261 patients are evaluable for the primary endpoint.

 

Phase 2 Study (112 Study)

 

Our completed phase 2 study, which is also known as the 112 study, was a randomized, double-blind, placebo-controlled study that evaluated the efficacy and safety of ARIKAYCE in adults with NTM lung disease due to MAC or Mycobacterium

 

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abscessus ( M. abscessus ) that was refractory to guideline-based therapy. The study included an 84-day double-blind phase in which subjects were randomized 1:1 either to ARIKAYCE once-daily plus a multi-drug regimen or to placebo once-daily plus the same multi-drug regimen. After completing the 84-day double-blind phase, subjects had the option of continuing in an 84-day open-label phase during which all subjects received ARIKAYCE plus the same multi-drug regimen. The study also included 28-day and 12-month off-ARIKAYCE follow-up assessments.

 

Eighty-nine (89) subjects were randomized and dosed in the study. Of the 80 subjects who completed the 84-day double-blind phase, 78 subjects entered the open-label phase and received ARIKAYCE plus the same multi-drug regimen for an additional 84 days. Seventy-six (76) percent (59/78) of subjects who entered the open-label phase of the study completed the open-label study.

 

The primary efficacy endpoint of the study was the change from baseline (day 1) to the end of the double-blind phase of the trial (day 84) in a semi-quantitative measurement of mycobacterial density on a seven-point scale. ARIKAYCE did not meet the pre-specified level for statistical significance although there was a positive trend (p=0.072) in favor of ARIKAYCE. The p-value for the key secondary endpoint of culture conversion to negative at Day 84 was 0.003, in favor of ARIKAYCE. A shorter time to first negative sputum culture was also observed with ARIKAYCE relative to placebo during the double-blind phase (p=0.013).

 

The microbiologic outcomes from the 112 study were also explored post hoc using a more stringent definition of culture conversion, which is defined as at least three consecutive monthly sputum samples that test negative for NTM. This definition of culture conversion is in the guidelines and used in clinical practice.

 

Twenty-three (23) subjects achieved at least three consecutive negative monthly sputum samples by the 28-day follow-up assessment, of which four started to convert at baseline prior to administration of study drug. For the 19 patients who achieved culture conversion, 17 achieved culture conversion after receiving ARIKAYCE, 10 who were randomized to ARIKAYCE in the double-blind phase and seven after entering the open-label phase. Two patients achieved culture conversion while receiving placebo in the double-blind phase.

 

The majority of subjects who achieved culture conversion (three consecutive negative monthly sputum samples) during the double-blind phase continued to have negative cultures through the open-label and follow-up phases.

 

At the end of the double-blind phase, the ARIKAYCE group improved from baseline in mean distance walked in the six-minute walk test. At the end of the open-label phase, patients in the ARIKAYCE group continued to improve in the mean distance walked in the six-minute walk test while the patients who previously received placebo in the double-blind phase and subsequently received ARIKAYCE in the open-label phase demonstrated a reduced rate of decline from baseline.

 

The majority (90 percent) of patients in both treatment groups experienced at least one treatment-emergent adverse event with most events either mild or moderate in severity. During the double-blind phase a greater percentage of patients treated with ARIKAYCE experienced dysphonia, bronchiectasis exacerbation, cough, oropharyngeal pain, fatigue, chest discomfort, wheezing, and infective pulmonary exacerbation of cystic fibrosis. No clinically relevant changes were detected in laboratory values and vital signs.

 

In October 2016, the phase 2 study was published online in the American Journal of Respiratory and Critical Care Medicine (Olivier et al. 2016).

 

ARIKAYCE for NTM in the EU

 

We previously filed a marketing authorization application (MAA) with the EMA for ARIKAYCE as a treatment for NTM lung disease. The filing was based on data from our phase 2 study. In May 2016, we participated in an oral explanation meeting with the EMA’s Committee for Medicinal Products for Human Use (CHMP). After the oral explanation meeting, the CHMP concluded that the data submitted did not provide enough evidence to support an approval. In June 2016, we withdrew our MAA. We intend to resubmit our MAA when sufficient clinical data from our ongoing global CONVERT study are available.

 

NTM Market Opportunity

 

NTM is a rare and serious disorder associated with increased morbidity and mortality. There is an increasing rate of lung disease caused by NTM and this is an emerging public health concern worldwide. Patients with NTM lung disease may experience a multitude of symptoms such as fever, weight loss, cough, lack of appetite, night sweats, blood in the sputum, and fatigue. Patients with NTM lung disease frequently require lengthy, and repeat, hospital stays to manage their condition. There are no inhaled antibiotic treatments specifically indicated for the treatment of NTM lung disease in North America, Europe or Japan. Current guideline-based approaches involve multi-drug regimens that may cause severe side effects and treatment can be as long as two years or more.

 

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The prevalence of human disease attributable to NTM has increased over the past two decades. In a decade-long study (1997-2007), researchers found that the prevalence of NTM in the US is increasing at approximately 8% per year and that NTM patients on Medicare over the age of 65 are 40% more likely to die over the period of the study than those who did not have the disease (Adjemian et al., 2012). A 2015 publication from co-authors from several US government departments stated that prior year statistics led to a projected 181,037 national annual cases in 2014 costing the US healthcare system approximately $1.7 billion (Strollo et al., 2015).

 

Our market research indicates that there are approximately 100,000 patients in the US, the EU5 (France, Germany, Italy, Spain and the United Kingdom), and Japan who have a confirmed diagnosis of NTM lung disease, of which an estimated 10 to 30 percent are refractory to current treatments. In 2012, in collaboration with the NIH, we funded a study performed by Clarity Pharma Research that showed there were an estimated 50,000 cases of pulmonary disease attributable to NTM in the US in 2011 and that such cases were estimated to be growing at a rate of 10% per year. In 2013, we engaged Clarity Pharma Research to perform a similar chart audit study of NTM in Europe and Japan. Based on results of this study, researchers estimated that there are approximately 20,000 cases of pulmonary disease attributable to NTM within the EU5 and approximately 30,000 in the 28 countries comprising the EU. In addition, there are nearly 32,000 cases in Japan. Although population-based data on the epidemiology of NTM lung disease are limited, and determining the true prevalence and incidence of rare diseases can be challenging, studies worldwide have described an increasing prevalence.

 

NTM currently includes over 165 species. MAC is the predominant pathogenic species in NTM pulmonary disease in the US, Japan and Europe, followed by M. abscessus . Thus far, we have studied ARIKAYCE in both MAC and M. abscessus .

 

We are studying the economic and societal implications of NTM lung infections. We have conducted a burden of illness study in the US with a major medical benefits provider. This study showed that patients with NTM lung infections are costly to healthcare plans and ATS/IDSA guideline-based treatment results in healthcare savings as opposed to suboptimal treatment.

 

In partnership with one of the nation’s largest Medicare insurance providers, we presented the results of three claims-based studies.

 

·                   At the Interscience Conference of Antimicrobial Agents and Chemotherapy in September 2015, researchers reported a 36.1% increase in the incidence of NTM lung infections between 2008 and 2013 in US Medicare population of a national managed care health plan, with the greatest incidence increase (56.3%) observed in members 65 to 74 years of age. Following diagnosis with NTM lung infections, over 50% of members were still in the plan after six years (Abraham et al., 2015).

 

·                   At the Infectious Disease Week in October 2015, researchers reported that patients with NTM lung infections were using greater healthcare resources than their age and gender-matched controls in the period preceding their initial diagnosis. Ordering mycobacterial testing of sputum earlier may help in preventing a misdiagnosis or delaying a diagnosis (Holt et al., 2015).

 

·                   At the Academy of Managed Care Pharmacy conference in October 2015, researchers reported higher resource utilization and costs for patients with NTM lung infections than their age and gender-matched controls both pre- and post-diagnosis. Patients who received treatment regimens conforming to the 2007 ATS/IDSA guidelines showed lower healthcare resource utilization and total medical costs than patients who received suboptimal treatment. These data suggest that healthcare plans should consider mechanisms to identify and appropriately treat patients with NTM lung disease (Abraham et al., 2015).

 

We plan to repeat this type of research globally in support of our overall disease awareness and education efforts. Results from an EU burden of illness study were recently presented at the International Society of Pharmacoeconomic and Outcomes Research annual European congress.

 

The FDA has designated ARIKAYCE as an orphan drug, a breakthrough therapy, and a QIDP for NTM lung disease. Orphan designation features seven years of post-approval market exclusivity, and QIDP features an additional five years of post-approval exclusivity. A QIDP-designated product is eligible for fast track and priority review designations. A priority review designation for a drug means the FDA’s goal is to take action on the NDA within six months of the 60-day filing date, as compared to 10 months of the 60-day filing date under a standard review.

 

INS1007

 

INS1007 is a small molecule, oral reversible inhibitor of DPP1, an enzyme responsible for activating neutrophil serine proteases in neutrophils when they are formed in the bone marrow. Neutrophils are the most common type of white blood cell and play an essential role in pathogen destruction and inflammatory mediation. Neutrophils contain three neutrophil serine proteases, neutrophil elastase, proteinase 3, and cathepsin G, that have been implicated in a variety of inflammatory diseases. In chronic

 

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inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive active neutrophil serine proteases that cause lung destruction and inflammation. INS1007 may decrease the damaging effects of inflammatory diseases, such as non-CF bronchiectasis, by inhibiting DPP1 and its activation of neutrophil serine proteases.

 

Non-CF bronchiectasis

 

Non-CF bronchiectasis is a rare, progressive pulmonary disorder in which the bronchi become permanently dilated due to chronic inflammation and infection. Neutrophils play a key role in the pathologic inflammatory process. Symptoms include chronic cough, excessive sputum production, shortness of breath, and repeated respiratory infections, which can worsen the underlying condition. There is currently no cure for non-CF bronchiectasis.

 

Bronchiectasis increases susceptibility to NTM lung disease, and up to 50 percent of patients with bronchiectasis may also have an active NTM infection. We have completed a phase 2 study of ARIKAYCE for the treatment of chronic Pseudomonas aeruginosa infection in patients with non-CF bronchiectasis.

 

INS1009

 

INS1009 is an investigational sustained-release inhaled treprostinil prodrug that has the potential to address certain of the current limitations of existing inhaled prostanoid therapies. We believe that INS1009 prolongs duration of effect and may provide PAH patients with greater consistency in pulmonary arterial pressure reduction over time. Current inhaled prostanoid therapies must be dosed four to nine times per day for the treatment of PAH. Reducing dose frequency has the potential to ease patient burden and improve compliance. Additionally, we believe that INS1009 may be associated with fewer side effects, including elevated heart rate, low blood pressure, and severity and/or frequency of cough, associated with high initial drug levels and local upper airway exposure when using current inhaled prostanoid therapies. We believe INS1009 may offer a differentiated product profile for rare pulmonary disorders, including PAH.

 

In late 2014, we had a pre-investigational new drug (pre-IND) meeting with the FDA for INS1009 and clarified that, subject to final review of the preclinical data, INS1009 could be eligible for an approval pathway under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (FDCA) (505(b)(2) approval). Like a traditional NDA that is submitted under Section 505(b)(1) of the FDCA, a 505(b)(2) NDA must establish that the drug is safe and effective, but unlike a traditional NDA the applicant may rely at least in part on studies not conducted by or for the applicant and for which the applicant does not have a right of reference. The ability to rely on existing third-party data to support safety and/or effectiveness can reduce the time and cost associated with traditional NDAs. We have completed a phase 1 study of INS1009. The phase 1 study was a randomized, double-blind, placebo-controlled single ascending dose study of INS1009 for inhalation to determine its safety, tolerability, and pharmacokinetics in healthy volunteers. The pharmacokinetic characteristics supported once- or twice-daily whereas existing inhaled therapies are dosed four to nine times per day. The adverse event profile was consistent with other inhaled prostanoids.

 

Twenty-four (24) subjects were enrolled and received INS1009 with cohorts of eight subjects receiving doses of 85 mcg, 170 mcg, 340 mcg or placebo. Participants in the first cohort (8 patients) received a single dose of open label treprostinil (Tyvaso) at 54 mcg 24 hours prior to receiving INS1009 at 85 mcg. The 85 mcg dose of INS1009 provides an equivalent amount of treprostinil on a molar basis as the 54 mcg dose of Tyvaso. The peak serum concentration was approximately 90% lower for treprostinil after INS1009 administration compared with Tyvaso, which could indicate a reduced future adverse event (AE) profile. The pharmacokinetic characteristics also supported once- or twice-daily dosing. The longer half-life of treprostinil for INS1009 was likely due to a sustained pulmonary release. The AE profile was consistent with other inhaled prostanoids. These data were presented at the European Respiratory Society international congress in September 2016.

 

Our Strategy

 

Our strategy focuses on the needs of patients with rare diseases. We are currently focused on the development and commercialization of ARIKAYCE. There are currently no inhaled products specifically indicated to treat NTM lung disease in North America, Europe or Japan. While we believe that ARIKAYCE has the potential to treat many different diseases, we are prioritizing securing US regulatory approval of ARIKAYCE in NTM lung disease caused by MAC. We are also advancing earlier-stage programs in other rare pulmonary disorders.

 

Our current priorities are as follows:

 

·                   Advancing the global CONVERT study;

·                   Preparing our US NDA submission, which will be based on the primary endpoint of the CONVERT study;

 

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·                   Ensuring our product supply chain will support the clinical development and, if approved, commercialization of ARIKAYCE;

·                   Preparing for potential commercialization of ARIKAYCE in the US, Europe, Japan, and certain other countries;

·                   Supporting further research and lifecycle management strategies for ARIKAYCE, including investigator-initiated studies;

·                   Developing the core value dossier to support the global reimbursement of ARIKAYCE;

·                   Filing an IND with FDA and starting a phase 2 study of INS1007 in non-CF bronchiectasis;

·                   Generating preclinical findings from our earlier-stage program(s); and

·                   Expanding our rare disease pipeline through corporate development.

 

Corporate Development

 

We plan to develop, acquire, in license or co-promote complementary products that address rare diseases. We are focused broadly on rare disease therapeutics and prioritizing those areas that best align with our core competencies and current therapeutic focus in the area of rare pulmonary diseases.

 

Manufacturing

 

ARIKAYCE is manufactured by Therapure Biopharma Inc. (Therapure) in Canada at a 200 liter scale and by Ajinimoto Althea, Inc. (Althea) in the US at a 50 liter scale. In September 2015, we entered into a commercial fill/finish services agreement with Althea to produce ARIKAYCE. Althea has the right to terminate this agreement upon written notice for our uncured material breach, if we are the subject of specified bankruptcy or liquidation events, or without cause with 24 months’ prior written notice. In February 2014, we entered into a contract manufacturing agreement with Therapure for the manufacture of ARIKAYCE. We have also identified certain second source suppliers for our supply chain, and plan to implement supply and quality agreements in preparation for commercialization of ARIKAYCE. In July 2014, we entered into a commercialization agreement with PARI, the manufacturer of our drug delivery nebulizer, to address our commercial supply needs. We expect to enter into a commercial supply agreement with AstraZeneca related to certain short-term production needs for INS1007. In addition, we expect our future requirements for INS1007 will be manufactured by a contract manufacturing organization. We currently produce INS1009, our investigational inhaled treprostinil prodrug, and plan to utilize third parties to manufacture INS1009 at a larger scale and the drug delivery device.

 

KEY COMPONENTS OF OUR STATEMENT OF OPERATIONS

 

Revenues

 

In 2015, the French National Agency for Medicines and Health Products Safety granted LAI several nominative Temporary Authorization for Use (Autorisation Temporaire d’Utilisation or ATU). Pursuant to this program, we shipped ARIKAYCE to pharmacies after receiving requests from physicians for patients in France. In 2016, the revenue recorded from the ATU program was immaterial to disclose and is included as a component of “other income (expense), net” Other than the ATU revenue in France, we currently do not recognize any revenue from product sales or other sources.

 

Research and Development Expenses

 

Research and development expenses consist primarily of salaries, benefits and other related costs, including stock based compensation, for personnel serving in our research and development functions. Expenses also include other internal operating expenses, the cost of manufacturing our drug candidate for clinical study, the cost of conducting clinical studies, and the cost of conducting preclinical and research activities. Our expenses related to manufacturing our drug candidate for clinical study are primarily related to activities at contract manufacturing organizations that manufacture ARIKAYCE for our use. Our expenses related to clinical trials are primarily related to activities at contract research organizations that conduct and manage clinical trials on our behalf. These contracts set forth the scope of work to be completed at a fixed fee or amount per patient enrolled. Payments under these contracts primarily depend on performance criteria such as the successful enrollment of patients or the completion of clinical trial milestones as well as time-based fees. Expenses are accrued based on contracted amounts applied to the level of patient enrollment and to activity according to the clinical trial protocol. Nonrefundable advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts are then recognized as an expense as the related goods are delivered or the services are performed, or when the goods or services are no longer expected to be provided.

 

Since 2011, we have focused our development activities principally on our proprietary, advanced liposomal technology designed specifically for inhalation lung delivery. In 2015, we commenced the CONVERT study for ARIKAYCE for patients with NTM lung disease. In 2015, we also completed an open-label extension study in which CF patients that completed our phase 3 trial

 

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received ARIKAYCE for a period of two years. The majority of our research and development expenses have been for our ARIKAYCE development programs. Our development efforts in 2015 and 2016 principally relate to the development of ARIKAYCE in the NTM indication.

 

General and Administrative Expenses

 

General and administrative expenses consist primarily of salaries, benefits and other related costs, including stock-based compensation, for personnel serving in our executive, finance and accounting, legal, pre-commercial, corporate development, information technology, program management and human resource functions. General and administrative expenses also include professional fees for legal, including patent-related expenses, consulting, insurance, board of director fees, tax and accounting services. We expect that our general and administrative expenses will increase in order to support increased levels of development activities and preparation for commercialization activities for our product candidates.

 

Debt Issuance Costs

 

Debt issuance costs are amortized to interest expense using the effective interest rate method over the term of the debt. Our balance sheet reflects debt net of debt issuance costs paid to the lender. Unamortized debt issuance costs associated with extinguished debt are expensed in the period of the extinguishment.

 

Investment Income and Interest Expense

 

Investment income consists of interest and dividend income earned on our cash and cash equivalents. Interest expense consists primarily of interest costs related to our debt.

 

RESULTS OF OPERATIONS

 

Comparison of the Three Months Ended September 30, 2016 and 2015

 

Net Loss

 

Net loss for the quarter ended September 30, 2016 was $37.8 million, or ($0.61) per common share—basic and diluted, compared with a net loss of $31.0 million, or ($0.50) per common share—basic and diluted, for the quarter ended September 30, 2015. The $6.8 million increase in our net loss for the quarter ended September 30, 2016 as compared to the same period in 2015 was primarily due to:

 

·                   Increased research and development expenses of $4.2 million resulting from higher compensation and related expenses due to an increase in headcount compared to the prior year period and in increase in clinical trial expenses primarily related to the CONVERT study. These increases were partially offset by a decrease in manufacturing expenses primarily due to the completion of the build-out of our production area at Therapure’s facility in 2015; and

 

·                   Increased general and administrative expenses of $2.7 million primarily resulting from an increase in pre-commercial activities and higher compensation and related expenses due to an increase in headcount as compared to the prior year period.

 

Research and Development Expenses

 

Research and development expenses for the quarters ended September 30, 2016 and 2015 were comprised of the following (in thousands):

 

 

 

Quarters Ended
September 30,

 

Increase (decrease)

 

 

 

2016

 

2015

 

$

 

%

 

External Expenses

 

 

 

 

 

 

 

 

 

Clinical development & research

 

$

9,628

 

$

6,515

 

$

3,113

 

47.8

%

Manufacturing

 

2,967

 

5,713

 

(2,746

)

-48.1

%

Regulatory and quality assurance

 

401

 

956

 

(555

)

-58.1

%

Subtotal—external expenses

 

$

12,996

 

$

13,184

 

$

(188

)

-1.4

%

Internal Expenses

 

 

 

 

 

 

 

 

 

Compensation and related expenses

 

$

8,086

 

$

4,464

 

$

3,622

 

81.1

%

Other internal operating expenses

 

2,351

 

1,573

 

778

 

49.5

%

Subtotal—internal expenses

 

$

10,437

 

$

6,037

 

$

4,400

 

72.9

%

Total

 

$

23,433

 

$

19,221

 

$

4,212

 

21.9

%

 

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Research and development expenses increased to $23.4 million during the quarter ended September 30, 2016 from $19.2 million in the same period in 2015. The $4.2 million increase was due to a $3.1 million increase in external clinical development expenses primarily related to the CONVERT study and a $3.6 million increase in compensation and related expenses, including stock-based compensation, due to an increase in headcount. These increases were partially offset by a $2.7 million decrease in manufacturing expenses primarily due to the completion of the build-out of our production area at Therapure’s facility in 2015. We expect research and development expenses to increase in 2016 as compared to 2015 due primarily to the clinical trial activity related to the CONVERT study.

 

General and Administrative Expenses

 

General and administrative expenses for the quarters ended September 30, 2016 and 2015 were comprised of the following (in thousands):

 

 

 

Quarters Ended
September 30,

 

Increase (decrease)

 

 

 

2016

 

2015

 

$

 

%

 

General & administrative

 

$

9,097

 

$

7,508

 

$

1,589

 

21.2

%

Pre-commercial expenses

 

4,619

 

3,516

 

1,103

 

31.4

%

Total general & administrative expenses

 

$

13,716

 

$

11,024

 

$

2,692

 

24.4

%

 

Total general and administrative expenses increased to $13.7 million during the quarter ended September 30, 2016 from $11.0 million in the same period in 2015. The $2.7 million increase was primarily due to an increase of $1.4 million in consulting expenses related to pre-commercial marketing activities and legal expenses and an increase of $1.4 million due to higher compensation, including stock-based compensation, related to an increase in headcount.

 

Interest Expense

 

Interest expense was $0.8 million during the quarter ended September 30, 2016 as compared to $0.7 million in the same period in 2015. The $0.1 million increase in interest expense in 2016 was due to expenses for debt issuance costs related to our previous loan agreement with Hercules.

 

Comparison of the Nine Months Ended September 30, 2016 and 2015

 

Net Loss

 

Net loss for the nine months ended September 30, 2016 was $107.9 million, or ($1.74) per common share—basic and diluted, compared with a net loss of $86.9 million, or ($1.51) per common share—basic and diluted, for the nine months ended September 30, 2015. The $20.9 million increase in our net loss for the nine months ended September 30, 2016 as compared to the same period in 2015 was primarily due to:

 

·                   Increased research and development expenses of $13.2 million resulting from an increase in clinical trial expenses primarily related to the CONVERT study and higher compensation and related expenses due to an increase in headcount compared to the prior year period. These increases were partially offset by a decrease in manufacturing expenses primarily due to the completion of the build-out of our production area at Therapure’s facility in 2015; and

 

·                   Increased general and administrative expenses of $8.2 million primarily resulting from an increase in pre-commercial activities and higher compensation and related expenses due to an increase in headcount as compared to the prior year period.

 

Research and Development Expenses

 

Research and development expenses for the nine months ended September 30, 2016 and 2015 were comprised of the following (in thousands):

 

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Nine Months Ended
September 30,

 

Increase (decrease)

 

 

 

2016

 

2015

 

$

 

%

 

External Expenses

 

 

 

 

 

 

 

 

 

Clinical development & research

 

$

26,266

 

$

18,393

 

$

7,873

 

42.8

%

Manufacturing

 

12,243

 

16,141

 

(3,898

)

-24.1

%

Regulatory and quality assurance

 

1,366

 

1,897

 

(531

)

-28.0

%

Subtotal—external expenses

 

$

39,875

 

$

36,431

 

$

3,444

 

9.5

%

Internal Expenses

 

 

 

 

 

 

 

 

 

Compensation and related expenses

 

$

21,463

 

$

13,795

 

$

7,668

 

55.6

%

Other internal operating expenses

 

6,513

 

4,405

 

2,108

 

47.9

%

Subtotal—internal expenses

 

$

27,976

 

$

18,200

 

$

9,776

 

53.7

%

Total

 

$

67,851

 

$

54,631

 

$

13,220

 

24.2

%

 

Research and development expenses increased to $67.9 million during the nine months ended September 30, 2016 from $54.6 million in the same period in 2015. The $13.2 million increase was due to a $7.9 million increase in external clinical development expenses primarily related to the CONVERT study and a $7.7 million increase in compensation and related expenses, including stock-based compensation, due to an increase in headcount. These increases were partially offset by a $3.9 million decrease in manufacturing expenses primarily due to the completion of the build-out of our production area at Therapure’s facility in 2015. We expect research and development expenses to increase in 2016 as compared to 2015 due primarily to the clinical trial activity related to the CONVERT study.

 

General and Administrative Expenses

 

General and administrative expenses for the nine months ended September 30, 2016 and 2015 were comprised of the following (in thousands):

 

 

 

Nine Months Ended
September 30,

 

Increase (decrease)

 

 

 

2016

 

2015

 

$

 

%

 

General & administrative

 

$

26,789

 

$

22,840

 

$

3,949

 

17.3

%

Pre-commercial expenses

 

11,709

 

7,432

 

4,277

 

57.5

%

Total general & administrative expenses

 

$

38,498

 

$

30,272

 

$

8,226

 

27.2

%

 

General and administrative expenses increased to $38.5 million during the nine months ended September 30, 2016 from $30.3 million in the same period in 2015. The $8.2 million increase was primarily due to an increase of $4.6 million in consulting fees relating to pre-commercial marketing activities and legal and consulting expenses and an increase of $3.6 million due to higher compensation costs, including stock-based compensation, related to an increase in headcount.

 

Interest Expense

 

Interest expense was $2.0 million during the nine months ended September 30, 2016 as compared to $2.2 million in the same period in 2015. The $0.2 million decrease in interest expense relates to a decrease in the amortization of our debt issuance costs in 2016.

 

LIQUIDITY AND CAPITAL RESOURCES

 

Overview

 

There is considerable time and cost associated with developing a potential drug or pharmaceutical product to the point of regulatory approval and commercialization. In recent years, we have funded our operations through public and private placements of equity securities and through debt financing. We expect to continue to incur losses both in our US and certain international entities, as we plan to fund research and development activities and commercial launch activities.

 

We believe we currently have sufficient funds to meet our financial needs for at least the next twelve months. We will opportunistically raise additional capital and may do so through equity or debt financing(s), strategic transactions or otherwise. Such additional funding may be necessary to continue to develop our potential product candidates, to pursue the license or purchase of other technologies, to commercialize our product candidates or to purchase other products. We cannot assure you that adequate capital will be available on favorable terms, or at all, when needed. If we are unable to obtain sufficient additional funds when required, we may

 

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be forced to delay, restrict or eliminate all or a portion of our research or development programs, dispose of assets or technology or cease operations. During the remainder of 2016 and 2017, we plan to continue to fund further clinical development of ARIKAYCE and INS1007, support efforts to obtain regulatory approvals, and prepare for commercialization of ARIKAYCE. Our cash requirements in 2016 and 2017 will be impacted by a number of factors, the most significant of which, being expenses related to the CONVERT study, and to a lesser extent, research and clinical expenses related to INS1007.

 

Cash Flows

 

As of September 30, 2016, we had total cash and cash equivalents of $200.5 million, as compared with $282.9 million as of December 31, 2015. The $82.4 million decrease was due primarily to the use of cash in operating activities. Our working capital was $182.8 million as of September 30, 2016 as compared with $265.9 million as of December 31, 2015.

 

Net cash used in operating activities was $88.7 million and $73.2 million for the nine months ended September 30, 2016 and 2015, respectively. The net cash used in operating activities during 2016 and 2015 was primarily for the clinical, manufacturing and pre-commercial activities related to ARIKAYCE, as well as general and administrative expenses.

 

Net cash used in investing activities was $3.4 million and $3.0 million for the nine months ended September 30, 2016 and 2015, respectively. The net cash used in investing activities during 2016 was primarily related to payments for the expansion of our headquarters and lab facility in Bridgewater, New Jersey. The net cash used in investing activities during 2015 was primarily related to payments for the build out of our headquarters and lab facility in Bridgewater, New Jersey, as well as investments in an enterprise resource planning system.

 

Net cash provided by financing activities was $9.8 million and $227.9 million for the nine months ended September 30, 2016 and 2015, respectively. Net cash provided by financing activities in 2016 was cash proceeds of $9.7 million from the issuance of debt (net of $0.3 million of debt issuance costs) and cash proceeds received from stock option exercises. Net cash provided by financing activities in 2015 included net proceeds of $222.9 million received from the issuance of 11.5 million common shares in April 2015 and cash proceeds of $5.0 million received from stock option exercises.

 

Contractual Obligations

 

On September 30, 2016, we and our domestic subsidiaries, as co-borrowers, entered into an Amended and Restated Loan and Security Agreement (the A&R Loan Agreement) with Hercules. The A&R Loan Agreement includes a total commitment from Hercules of up to $55.0 million, of which $25.0 million was previously outstanding. The amount of borrowings was initially increased by $10.0 million to an aggregate total of $35.0 million on September 30, 2016. An additional $20.0 million was available at our option through June 30, 2017 subject to certain conditions, including the payment of a facility fee of 0.375%. We exercised this option in early October 2016 and borrowed an additional $20.0 million in connection with our upfront payment obligation under the License Agreement with AstraZeneca. The interest rate for the term is floating and is defined as the greater of (i) 9.25% or (ii) 9.25% plus the sum of the US prime rate minus 4.50%, along with a backend fee of 4.15% of the aggregate principal amount outstanding and an aggregate facility fee of $337,500. The interest-only period extends through May 1, 2018, but can be extended up to 12 months under certain conditions. The maturity date of the loan facility was also extended to October 1, 2020. Pursuant to the A&R Loan Agreement, we are required to have a consolidated minimum cash liquidity in an amount no less than $25.0 million. Such requirement terminates upon the earlier of the date by which we complete an equity financing with at least $75.0 million in proceeds or the date we generate and announce data from the CONVERT Phase III study in a manner that could support an NDA filing. In addition, pursuant to the A&R Loan Agreement, Hercules has the right to participate, in an aggregate amount of up to $2.0 million, in a subsequent private financing of equity securities.

 

In connection with the A&R Loan Agreement, we granted the lender a first position lien on all of our assets, excluding intellectual property. Prepayment of the loans made pursuant to the A&R Loan Agreement is subject to penalty. The backend fee of 4.15% on the aggregate outstanding principal balance will be charged to interest expense (and accreted to the debt) using the effective interest method over the original life of the A&R Loan Agreement. Debt issuance fees paid to the lender were recorded as a discount on the debt and are being amortized to interest expense using the effective interest method over the life of the A&R Loan Agreement.

 

We have an operating lease for office and laboratory space located in Bridgewater, NJ, our corporate headquarters, for which the initial lease term expires in November 2019. Future minimum rental payments under this lease total approximately $3.2 million. In July 2016, we signed an operating lease for additional laboratory space located in Bridgewater, NJ for which the initial lease term expires in September 2021. Future minimum rental payments under this lease are $2.1 million.

 

As of September 30, 2016, future payments under our long-term debt agreement, capital leases, minimum future payments under non-cancellable operating leases and minimum future payment obligations are as follows:

 

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As of September 30, 2016
Payments Due By Period

 

 

 

Total

 

Less than
1 year

 

1 - 3 Years

 

4 - 5 Years

 

After
5 Years

 

 

 

(in thousands)

 

Debt obligations

 

 

 

 

 

 

 

 

 

 

 

Debt maturities

 

$

35,000

 

$

 

$

18,782

 

$

16,218

 

$

 

Contractual interest

 

10,981

 

3,208

 

5,415

 

2,358

 

 

Operating leases

 

5,425

 

1,383

 

2,888

 

1,075

 

79

 

Purchase obligations

 

3,375

 

2,700

 

675

 

 

 

Total contractual obligations

 

$

54,781

 

$

7,291

 

$

27,760

 

$

19,651

 

$

79

 

 

This table does not include: (a) any milestone payments which may become payable to third parties under our license and collaboration agreements as the timing and likelihood of such payments are not known; (b) any royalty payments to third parties as the amounts of such payments, timing and/or the likelihood of such payments are not known; (c) contracts that are entered into in the ordinary course of business which are not material in the aggregate in any period presented above; or (d) any payments related to the agreements mentioned below.

 

We currently have a licensing agreement with PARI for the use of the optimized eFlow Nebulizer System for delivery of ARIKAYCE in treating patients with NTM infections, CF and bronchiectasis. We have rights to several US and foreign issued patents, and patent applications involving improvements to the optimized eFlow Nebulizer System. Under the licensing agreement, PARI is entitled to receive payments either in cash, qualified stock or a combination of both, at PARI’s discretion, based on achievement of certain milestone events including phase 3 trial initiation (which occurred in 2012), first acceptance of MAA submission (or equivalent) in the US for ARIKAYCE and the device, first receipt of marketing approval in the US for ARIKAYCE and the device, and first receipt of marketing approval in a major EU country for ARIKAYCE and the device. In addition, PARI is entitled to receive royalty payments in the mid-single digits on commercial net sales of ARIKAYCE pursuant to the licensing agreement, subject to certain specified annual minimum royalties. In July 2014, we entered into a Commercialization Agreement (the PARI Agreement) with PARI for the manufacture and supply of eFlow nebulizer systems and related accessories (the Device) as optimized for use with our proprietary liposomal amikacin for inhalation. The PARI Agreement has an initial term of fifteen years from the first commercial sale of ARIKAYCE pursuant to the licensing agreement (the Initial Term). The term of the PARI Agreement may be extended by us for an additional five years by providing written notice to PARI at least one year prior to the expiration of the Initial Term.

 

In 2004 and 2009, we entered into a research funding agreements with Cystic Fibrosis Foundation Therapeutics, Inc. (CFFT) whereby we received $1.7 million and $2.2 million for each respective agreement in research funding for the development of ARIKAYCE. If ARIKAYCE becomes an approved product for patients with CF in the US, we will owe a payment to CFFT of up to $13.4 million that is payable over a three-year period after approval as a commercialized drug in the US. Furthermore, if certain global sales milestones are met within five years of the drug commercialization, we would owe an additional $3.9 million in additional payments. Since there is significant development risk associated with ARIKAYCE, we have not accrued these obligations.

 

In February 2014, we entered into a contract manufacturing agreement with Therapure for the manufacture of ARIKAYCE at the larger scales necessary to support commercialization. Pursuant to the agreement, we collaborated with Therapure to construct a production area for the manufacture of ARIKAYCE in Therapure’s existing manufacturing facility in Canada. We paid Therapure approximately $12 million for the build out of the construction area and related manufacturing costs. Therapure manufactures ARIKAYCE for us on a non-exclusive basis. The agreement has an initial term of five years from the first date on which Therapure delivers ARIKAYCE to us after we obtain permits related to the manufacture of ARIKAYCE. Under the agreement, we are obligated to pay certain minimum amounts for the batches of ARIKAYCE produced each calendar year.

 

In December 2014, we entered into a services agreement with SynteractHCR, Inc. (Synteract) pursuant to which we retained Synteract to perform implementation and management services in connection with the 212 study. We anticipate that aggregate costs relating to all work orders for the 212 study will be approximately $40 million over the period of the study. In April 2015, we entered into a work order with Synteract to perform implementation and management services for the 312 study. We anticipate that aggregate costs relating to all work orders for the 312 study will be approximately $20 million over the period of the study.

 

On October 4, 2016, we entered into a license agreement (License Agreement) with AstraZeneca AB, a Swedish corporation (AstraZeneca). Pursuant to the terms of the License Agreement, AstraZeneca granted to us global exclusive rights for the purpose of developing and commercializing AZD7986 (renamed INS 1007). INS1007 is a novel oral inhibitor of dipeptidyl peptidase 1 (DPP1). DPP1 is an enzyme that catalyzes the activation of neutrophil serine proteases, which play a key role in pulmonary diseases such as non-CF bronchiectasis. In consideration of the licenses and other rights granted by AstraZeneca, we paid an upfront payment of $30.0 million in early November 2016, which will be included as research and development expense in the fourth quarter of 2016. In connection with the upfront payment obligation in the License Agreement, we borrowed an additional $20.0 million under the A&R

 

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Loan Agreement in early October 2016. We are also obligated to make a series of contingent milestone payments totaling up to an additional $85.0 million upon the achievement of clinical development and regulatory filing milestones. If we elect to develop INS1007 for a second indication, we will be obligated to make an additional series of contingent milestone payments equal to half of the contingent milestone payments in the preceding sentence. No additional milestone payments are due for any indications beyond the first and second indications. In addition, we will pay AstraZeneca tiered royalties ranging from a high single-digit to mid-teen on net sales of any approved product based on INS1007 and one additional payment of $35.0 million upon the first achievement of $1 billion in annual net sales. The License Agreement provides AstraZeneca with the option to negotiate a future agreement with us for commercialization of INS1007 in chronic obstructive pulmonary disease or asthma.

 

Future Funding Requirements

 

We will need to raise additional capital to fund our operations, to develop and commercialize ARIKAYCE, to develop INS1007 and INS1009, and to develop, acquire, in-license or co-promote other products that address orphan or rare diseases. Our future capital requirements may be substantial and will depend on many factors, including:

 

·                   the timing and cost of our anticipated clinical trials of ARIKAYCE for the treatment of patients with NTM lung infections;

·                   the decisions of the FDA and EMA with respect to our applications for marketing approval of ARIKAYCE in the US and Europe; the costs of activities related to the regulatory approval process; and the timing of approvals, if received;

·                   the cost of putting in place the sales and marketing capabilities necessary to be prepared for a potential commercial launch of ARIKAYCE, if approved;

·                   the cost of filing, prosecuting, defending and enforcing patent claims;

·                   the timing and cost of our anticipated clinical trials, including INS1007 and the related milestone payments due to AstraZeneca;

·                   the costs of our manufacturing-related activities;

·                   the costs associated with commercializing ARIKAYCE if we receive marketing approval; and

·                   subject to receipt of marketing approval, the levels, timing and collection of revenue received from sales of approved products, if any, in the future.

 

In April 2015, we generated net proceeds of $222.9 million from the issuance of 11.5 million shares of common stock. On September 30, 2016, we received a commitment of $55.0 million pursuant to the A&R Loan Agreement with Hercules, of which $25.0 million was previously outstanding. We believe we currently have sufficient funds to meet our financial needs for the next twelve months. However, our business strategy will require us to, or we may otherwise determine to, raise additional capital at any time through equity or debt financing(s), strategic transactions or otherwise. Such additional funding will be necessary to continue to develop our potential product candidates, to pursue the license or purchase of complementary technologies, to commercialize our product candidates or to purchase other products. If we are unable to obtain additional financing, we may be required to reduce the scope of our planned product development and commercialization or our plans to establish a sales and marketing force, any of which could harm our business, financial condition and results of operations. The source, timing and availability of any future financing will depend principally upon equity and debt market conditions, interest rates and, more specifically, our continued progress in our regulatory, development and commercial activities. We cannot assure you that such capital funding will be available on favorable terms or at all. If we are unable to obtain sufficient additional funds when required, we may be forced to delay, restrict or eliminate all or a portion of our research or development programs, dispose of assets or technology or cease operations.

 

To date, we have not generated material revenue from ARIKAYCE and we do not know when, or if, we will generate material revenue. We do not expect to generate significant revenue unless or until we obtain marketing approval of, and secure reimbursement of and commercialize, ARIKAYCE.

 

Off-Balance Sheet Arrangements

 

We do not have any off-balance sheet arrangements, other than operating leases, that have or are reasonably likely to have a current or future material effect on our financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources. We do not have any interest in special purpose entities, structured finance entities or other variable interest entities.

 

CRITICAL ACCOUNTING POLICIES

 

Preparation of financial statements in accordance with generally accepted accounting principles in the US requires us to make estimates and assumptions affecting the reported amounts of assets, liabilities, revenues and expenses and the disclosures of contingent assets and liabilities. We use our historical experience and other relevant factors when developing our estimates and assumptions. We continually evaluate these estimates and assumptions. The amounts of assets and liabilities reported in our consolidated balance sheets and the amounts of revenue reported in our consolidated statements of comprehensive loss are effected by

 

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estimates and assumptions, which are used for, but not limited to, the accounting for research and development, stock-based compensation, identifiable intangible assets, and accrued expenses. The accounting policies discussed below are considered critical to an understanding of our consolidated financial statements because their application places the most significant demands on our judgment. Actual results could differ from our estimates. There have been no material changes to our critical accounting policies as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2015. For the required interim updates of our accounting policies see Note 2 to our Consolidated Financial Statements — “Summary of Significant Accounting Policies” in this Quarterly Report on Form 10-Q.

 

ITEM 3.                                                 QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

As of September 30, 2016, our cash and cash equivalents were in cash accounts or were invested in money market funds. Such accounts or investments are not insured by the federal government.

 

As of September 30, 2016, we had $35.0 million of fixed rate borrowings that bear interest at 9.25% outstanding under the A&R Loan Agreement with Hercules. If a 10% change in interest rates was to have occurred on September 30, 2016, this change would not have had a material effect on the fair value of our debt as of that date, nor would it have had a material effect on our future earnings or cash flows.

 

The majority of our business is conducted in US dollars. However, we do conduct certain transactions in other currencies, including Euros, British Pounds, and Japanese Yen. Historically, fluctuations in foreign currency exchange rates have not materially affected our results of operations and during the three and nine months ended September 30, 2016 and 2015, our results of operations were not materially affected by fluctuations in foreign currency exchange rates.

 

ITEM 4.                                                 CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

 

Our management, under the supervision and with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, 2016.  The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), means controls and other procedures that are designed to provide reasonable assurance that information required to be disclosed by us in the periodic reports that we file or submit with the SEC is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms, and to ensure that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure.  Based on that evaluation as of September 30, 2016, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures are effective at the reasonable assurance level.

 

Changes in Internal Control Over Financial Reporting

 

There were no changes in our internal control over financial reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the Exchange Act) during the three months ended September 30, 2016 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II. OTHER INFORMATION

 

ITEM 1.                                                 LEGAL PROCEEDINGS

 

On July 15, 2016, a purported class action lawsuit was filed in the U.S. District Court for the District of New Jersey against us and certain of our executive officers: Hoey v. Insmed Incorporated, et al, No. 3:16-cv-04323-FLW-TJB (D.N.J. July 15, 2016). The complaint alleges that from March 18, 2013 through June 8, 2016, we and certain of our executive officers made material misstatements or omissions concerning the likelihood of the EMA approving our European MAA for use of ARIKAYCE in the treatment of NTM lung disease and the likelihood of commercialization of ARIKAYCE in Europe. The complaint alleges violations of Section 10(b) and 20(a) of the Securities Exchange Act of 1934, and Rule 10b-5 promulgated thereunder. The complaint seeks unspecified damages. On October 25, 2016, the Court issued an order appointing Bucks County Employees Retirement Funds as lead plaintiff for the putative class. A consolidated amended complaint has not yet been filed. We believe that the allegations in the complaint are without merit and intend to defend the lawsuit vigorously; however, there can be no assurance regarding the ultimate outcome of the lawsuit.

 

ITEM 1A.                                        RISK FACTORS

 

Except for the historical information in this report on Form 10-Q, the matters contained in this report include forward-looking statements that involve risks and uncertainties. Our operating results and financial condition have varied in the past and may in the future vary significantly depending on a number of factors. These factors, among others, could cause actual results to differ materially from those contained in forward-looking statements made in this report and presented elsewhere by management from time to time. Such factors may have a material adverse effect upon our business, results of operations and financial condition.

 

You should consider carefully the risk factors, together with all of the other information included in our Annual Report on Form 10-K for the year ended December 31, 2015. Each of these risk factors could adversely affect our business, results of operations and financial condition, as well as adversely affect the value of an investment in our common stock. There have been no material changes to our risk factors as previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2015 and our Quarterly Report on Form 10-Q for the three months ended June 30, 2016, except for the following updates:

 

Risks Related to Development and Commercialization of our Product Candidates

 

We may not have, or may be unable to obtain, sufficient quantities of our product candidates to meet our required supply for clinical studies or commercialization requirements.

 

We do not have any in-house manufacturing capability other than for development and characterization and depend completely on a small number of third-party manufacturers and suppliers for the manufacture of our product candidates on a clinical or commercial scale. In September 2015, we entered into a Commercial Fill/Finish Services Agreement with Althea to produce ARIKAYCE on a non-exclusive basis. Althea currently manufactures ARIKAYCE at a relatively small scale. In order to meet potential commercial demand, we have constructed a manufacturing operation at Therapure in Canada as an alternate site of manufacture that operates at a larger scale. In February 2014, we entered into a contract manufacturing agreement with Therapure for the manufacture of ARIKAYCE. Our supply of the active pharmaceutical ingredient for INS1009 is dependent on a single supplier. We expect to enter into a commercial supply agreement with AstraZeneca related to certain short-term production needs for INS1007. In addition, we expect our future requirements for INS1007 will be manufactured by a contract manufacturing organization. The inability of a supplier to fulfill our supply requirements could materially adversely affect our ability to obtain and maintain regulatory approvals and future operating results. A change in the relationship with any supplier, or an adverse change in their business, could materially adversely affect our future operating results.

 

We are dependent upon Althea and Therapure being able to provide an adequate supply of ARIKAYCE both for our clinical trials and for commercial sale in the event ARIKAYCE receives marketing approval. We intend to work closely with Althea and Therapure to coordinate efforts regarding regulatory requirements and our supply needs.

 

We are dependent upon PARI being able to provide an adequate supply of nebulizers both for our clinical trials and for commercial sale in the event ARIKAYCE receives marketing approval. PARI is the sole manufacturer of the eFlow nebulizer system. These nebulizers must be in good working order and meet specific performance characteristics. We intend to work closely with PARI to coordinate efforts regarding regulatory requirements.

 

We do not have long-term commercial agreements with all of our suppliers and if any of our suppliers are unable or unwilling to perform for any reason, we may not be able to locate suppliers or enter into favorable agreements with them. Any

 

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inability to acquire sufficient quantities of our components in a timely manner from these third parties could delay clinical trials or commercialization and prevent us from developing and distributing our products in a cost-effective manner or on a timely basis.

 

In addition, manufacturers of our components are subject to cGMP and similar standards and we do not have control over compliance with these regulations by our manufacturers. If one of our contract manufacturers fails to maintain compliance, the production of our products could be interrupted, resulting in delays and additional costs. In addition, if the facilities of such manufacturers do not pass a pre-approval or post-approval plant inspection, the FDA, as well as other regulatory authorities in jurisdictions outside the US, will not grant approval and may institute restrictions on the marketing or sale of our products. We are reliant on third-party manufacturers and suppliers to meet our clinical supply demands and any future commercial products. Delays in receipt of materials, scheduling, release, custom’s control and regulatory compliance issues may adversely impact our ability to initiate, maintain or complete clinical trials that we are sponsoring or may adversely impact commercialization. Issues arising from scale-up, facility construction, environmental controls, equipment requirements, local and federal permits and allowances or other factors may have an adverse impact on our ability to manufacture our product candidates.

 

We may not be able to enroll enough patients to complete our clinical trials.

 

The completion rate of our global phase 3 clinical study of ARIKAYCE for NTM and other future clinical studies of our products is dependent on, among other factors, the patient enrollment rate. Patient enrollment is a function of many factors, including:

 

·                   Investigator identification and recruitment;

·                   Regulatory approvals to initiate study sites;

·                   Patient population size;

·                   The nature of the protocol to be used in the trial;

·                   Patient proximity to clinical sites;

·                   Eligibility criteria for the study;

·                   The patients’ willingness to participate in the study;

·                   Competition from other companies’ potential clinical studies for the same patient population; and

·                   Ability to obtain any necessary comparator drug or medical device.

 

Delays in patient enrollment for future clinical trials could increase costs and delay ultimate commercialization and sales, if any, of our products.

 

If any of our products meet the criteria for approval pursuant to Subpart H (accelerated approval), such approval will be subject to our carrying out, with due diligence, adequate and well-controlled post market studies to verify and describe their clinical benefit. If we fail to complete such studies with due diligence, or if the results of such studies fail to demonstrate clinical benefit, FDA may, following a hearing, withdraw product approval.

 

Risks Related to Regulatory Matters

 

We may not be able to obtain regulatory approvals for ARIKAYCE or any other products we develop in the US, Europe or other countries. If we fail to obtain such approvals, we will not be able to commercialize our products.

 

We are required to obtain various regulatory approvals prior to studying our products in humans and then again before we market and distribute our products. The regulatory review and approval processes in both the US and Europe require evaluation of preclinical studies and clinical studies, as well as the evaluation of our manufacturing process. These processes are complex, lengthy, expensive, resource intensive and uncertain. Securing regulatory approval to market our products requires the submission of much more extensive preclinical and clinical data, manufacturing information regarding the process and facility, scientific data characterizing our product and other supporting data to the regulatory authorities in order to establish its safety and effectiveness. This process also is complex, lengthy, expensive, resource intensive and uncertain. We have limited experience in submitting and pursuing applications necessary to gain these regulatory approvals.

 

Data submitted to the regulators is subject to varying interpretations that could delay, limit or prevent regulatory agency approval. We may also encounter delays or rejections based on changes in regulatory agency policies during the period in which we develop a product and the period required for review of any application for regulatory agency approval of a particular product. For example, FDA has designated ARIKAYCE for Fast Track, Breakthrough Therapy and QIDP status, all programs intended to expedite or streamline the development and regulatory review of the drug. If we were to lose the current designation under one or more of those programs, we could face delays in the FDA review and approval process. Even with these designations, there is no guarantee we will receive approval for ARIKAYCE on a timely basis, or at all.

 

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The Generating Antibiotic Incentives Now (GAIN) Act established incentives for the development of new therapies for serious and life-threatening infections by making streamlined priority review and fast track processes available for drugs which the FDA designates as QIDPs. To qualify for designation as a QIDP according to the criteria established in the GAIN Act, a product must be an antibacterial or anti-fungal drug for human use intended to treat serious or life-threatening infections, including: those caused by an anti-fungal resistant pathogen, including novel or emerging infectious pathogens; or caused by qualifying pathogens listed by the FDA in accordance with the GAIN Act. Under the fast track program generally, the sponsor of an IND may request FDA to designate the drug candidate as a fast track drug if it is intended to treat a serious condition and fulfill an unmet medical need. FDA must determine if the drug candidate qualifies for fast track designation within 60 days of receipt of the sponsor’s request. Once FDA designates a drug as a fast track candidate, it is required to facilitate the development and expedite the review of that drug by providing more frequent communication with and guidance to the sponsor.

 

Delays in obtaining regulatory agency approvals could adversely affect the development and marketing of any drugs that we or any third parties develop. Resolving such delays could force us or third parties to incur significant costs, could limit our allowed activities or the allowed activities of third parties, could diminish any competitive advantages that we or our third parties may attain or could adversely affect our ability to receive royalties, any of which could materially adversely affect our business, financial condition, results of operations or prospects.

 

To market our products outside of the US and Europe we, and any potential third parties, must comply with numerous and varying regulatory requirements of other countries. The approval procedures vary among countries and can involve additional product testing and administrative review periods. The time required to obtain approval in these other territories might differ from that required to obtain FDA or EMA approval. The regulatory approval process in these other territories includes at least all of the risks associated with obtaining FDA and EMA approval detailed above.

 

Specifically related to INS1009, we believe that this product could be eligible for approval under Section 505(b)(2) of the FDCA. Like a traditional NDA that is submitted under Section 505(b)(1) of the FDCA, a 505(b)(2) NDA must establish that the drug is safe and effective, but unlike a traditional NDA the applicant may rely at least in part on studies not conducted by or for the applicant and for which the applicant does not have a right of reference. The ability to rely on existing data to support safety and/or effectiveness can reduce the time and cost associated with traditional NDAs. We cannot be sure that we will obtain approval for INS1009 under the 505(b)(2) pathway.

 

We plan to submit an IND application with the FDA and subsequently commence a phase 2 study of INS1007 in non-CF bronchiectasis. We anticipate an initial NDA submission under Section 505(b)(1) of the FDCA for the treatment of non-CF bronchiectasis. We are defining our regulatory strategies to potentially expedite the development and regulatory review of INS1007 through programs such as US fast track designation, breakthrough therapy, and US and EU orphan drug designations. We cannot be sure that we will obtain approval for INS1007 under the 505(b)(1) pathway and there is no guarantee INS1007 will be eligible to receive such regulatory designations.

 

Approval by the FDA or the EMA does not ensure approval by the regulatory authorities of other countries. Marketing approval in one country does not ensure marketing approval in another, but a failure or delay in obtaining marketing approval in one country may have a negative effect on the regulatory process in others. In addition, we may be subject to fines, suspension or withdrawal of marketing approvals, product recalls, seizure of products, operating restrictions and criminal prosecution if we fail to comply with applicable US and foreign regulatory requirements. If we fail to comply with regulatory requirements or to obtain and maintain required approvals, our target market may be reduced and our ability to realize the full market potential of our product candidates may be harmed. The failure to obtain such approvals may materially adversely affect our business, financial condition, results of operations and our prospects.

 

Risks Related to Our Intellectual Property

 

We may infringe the intellectual property rights of others, which may prevent or delay our product development efforts, prevent us from commercializing our products or increase the costs of commercializing our products.

 

Third parties may claim that we have infringed upon or misappropriated their proprietary rights. Third parties may attempt to obtain patent protection relating to the production and use of our product candidates. We cannot assure you that any existing third-party patents, or patents that may later issue to third parties, would not negatively affect our commercialization of ARIKAYCE, INS1007, INS1009 or any other product. We cannot assure you that such patents can be avoided or invalidated or would be licensed to us at commercially reasonable rates or at all. We cannot assure you that we will be successful in any intellectual property litigation that may arise or that such litigation would not have an adverse effect on our business, financial condition, results of operation or prospects. In the event of a successful claim against us for infringement or misappropriation of a third party’s proprietary rights, we may be required to take actions including, but not limited to, the following:

 

·                   Pay damages, including up to treble damages, and the other party’s attorneys’ fees, which may be substantial;

·                   Cease the development, manufacture, marketing and sale of products or use of processes that infringe the proprietary rights of others;

 

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·                   Expend significant resources to redesign our products or our processes so that they do not infringe the proprietary rights of others, which may not be possible;

·                   Redesign our products or processes to avoid third-party proprietary rights, which means we may suffer significant regulatory delays associated with conducting additional clinical trials or other steps to obtain regulatory approval; and/or

·                   Obtain one or more licenses arising out of a settlement of litigation or otherwise from third parties which license(s) may not be available to us on acceptable terms or at all.

 

Furthermore, litigation with any third party, even if the allegations are without merit, would likely be expensive and time-consuming and divert management’s attention.

 

In particular, PAH is a competitive indication with established products, including other formulations of treprostinil. Our supply of the active pharmaceutical ingredient for INS1009 is dependent upon a single supplier. The supplier owns patents on its manufacturing process and we have filed patent applications for INS1009. A competitor in the PAH indication may claim that we or our supplier have infringed upon or misappropriated their proprietary rights. We cannot be sure that we or our supplier will be successful in any intellectual property litigation that may arise or that such litigation would not have an adverse effect on our business, financial condition, results of operation or prospects.

 

If we fail to comply with our obligations in the agreements under which we license rights to technology from third parties, or if the license agreements are terminated for other reasons, we could lose license rights that are important to our business.

 

On October 4, 2016, we entered into a License Agreement with AstraZeneca. Pursuant to the terms of the License Agreement, AstraZeneca granted us global exclusive rights for the purpose of developing and commercializing INS1007. If we fail to comply with our obligations under our agreements with AstraZeneca (including, among other things, if we fail to use commercially reasonable efforts to develop and commercialize a product based on INS1007, or we are subject to a bankruptcy or insolvency), AstraZeneca may have the right to terminate the license. Termination of the License Agreement or reduction or elimination of our licensed rights may result in our having to negotiate new or reinstated licenses with less favorable terms and may materially harm our business .

 

ITEM 2.                                                 UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

There were no unregistered sales of the Company’s equity securities during the quarter ended September 30, 2016.

 

ITEM 3.                                                 DEFAULTS UPON SENIOR SECURITIES

 

None.

 

ITEM 4.                                                 MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5.                                                 OTHER INFORMATION

 

None.

 

ITEM 6.                                                 EXHIBITS

 

A list of exhibits filed herewith is included on the Exhibit Index, which immediately precedes such exhibits and is incorporated herein by reference.

 

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SIGNATURE

 

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.

 

 

 

INSMED INCORPORATED

 

 

 

 

 

 

Date: November 3, 2016

By

/s/ Andrew T. Drechsler

 

 

Andrew T. Drechsler

 

 

Chief Financial Officer

 

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EXHIBIT INDEX

 

10.1

 

Amended and Restated Loan and Security Agreement, dated as of September 30, 2016, by and between Insmed Incorporated and its domestic subsidiaries and Hercules Capital, Inc.

 

 

 

10.2

 

Employment Agreement, effective as of September 27, 2016, between Insmed Incorporated and Roger Adsett.

 

 

 

31.1

 

Certification of William H. Lewis, Chief Executive Officer of Insmed Incorporated, pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002.

 

 

 

31.2

 

Certification of Andrew T. Drechsler, Chief Financial Officer of Insmed Incorporated, pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes Oxley Act of 2002.

 

 

 

32.1

 

Certification of William H. Lewis, Chief Executive Officer of Insmed Incorporated, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002.

 

 

 

32.2

 

Certification of Andrew T. Drechsler, Chief Financial Officer of Insmed Incorporated, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes Oxley Act of 2002.

 

 

 

101

 

The following materials from Insmed Incorporated’s quarterly report on Form 10-Q for the quarter ended September 30, 2016 formatted in XBRL (eXtensible Business Reporting Language): (i) Consolidated Balance Sheets as of September 30, 2016 and December 31, 2015, (ii) Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2016 and 2015, (iii) Consolidated Statements of Cash Flows for the nine months ended September 30, 2016 and 2015, and (iv) Notes to the Unaudited Consolidated Financial Statements.

 

32


Exhibit 10.1

 

Execution Version

 

AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT

 

THIS AMENDED AND RESTATED LOAN AND SECURITY AGREEMENT is made and dated as of September 30, 2016 and is entered into by and among INSMED INCORPORATED, a Virginia corporation (“Parent”), CELTRIX PHARMACEUTICALS, a Delaware corporation (“Celtrix”), and each of the subsidiaries joined hereto (the “Joined Subsidiaries”, together with Parent and Celtrix are hereinafter collectively referred to as the “Borrowers” and each individually as a “Borrower”), the several banks and other financial institutions or entities from time to time parties to this Agreement as lenders hereunder (collectively referred to as “Lender”) and HERCULES CAPITAL, INC., a Maryland corporation (formerly known as Hercules Technology Growth Capital, Inc.) in its capacity as administrative agent and collateral agent for itself and Lender (in such capacity, the “Agent”).

 

RECITALS

 

A.                                     WHEREAS , the Borrowers, Lender and Agent are party to that certain Loan and Security Agreement dated as of June 29, 2012 (the “Original Closing Date”), as amended by that certain Amendment No. 1 to Loan and Security Agreement dated as of July 24, 2012, as amended by that certain Amendment No. 2 to Loan and Security Agreement dated as of November 25, 2013, as amended by that certain Amendment No. 3 to the Loan and Security Agreement dated as of December 15, 2014, as further amended by that certain Consent and Amendment No. 4 to the Loan and Security Agreement dated as of June 9, 2015 and as further amended by that certain Amendment No. 5 to the Loan and Security Agreement dated as of December 22, 2015 (as the same may have been amended, modified, supplemented or restated and in effect from time to time, the “Existing Loan and Security Agreement”);

 

B.                                     WHEREAS , immediately prior to the effectiveness of this Amended and Restated Loan and Security Agreement, there are Term Loans outstanding under the Existing Loan and Security Agreement in the aggregate principal amount of $25,000,000 (the “Existing Term Loans”);

 

C.                                     WHEREAS , the Borrowers desire to obtain financing to increase the aggregate amount of Term Loans up to an aggregate amount of $55,000,000 (inclusive of the Existing Term Loans) for general corporate purposes permitted pursuant to the terms of this Amended and Restated Loan and Security Agreement;

 

D.                                     WHEREAS , the parties hereto desire to amend and restate the Existing Loan and Security Agreement upon the terms and subject to the conditions set forth herein.

 

NOW, THEREFORE , in consideration of the mutual conditions and agreements set forth in this Amended and Restated Loan and Security Agreement, and for good and valuable consideration, the receipt of which is hereby acknowledged, the parties hereto hereby agree that

 



 

the Existing Loan and Security Agreement shall be amended and restated in its entirety to read as follows (it being agreed that this Amended and Restated Loan and Security Agreement shall not be deemed to evidence or result in a novation or repayment and reborrowing of the Existing Term Loans under the Existing Loan and Security Agreement):

 

SECTION 1.  DEFINITIONS AND RULES OF CONSTRUCTION

 

1.1                              Unless otherwise defined herein, the following capitalized terms shall have the following meanings:

 

“Account Control Agreement(s)” means any agreement entered into by and among the Agent, any Borrower and a third party Bank or other institution (including a Securities Intermediary) with which such Borrower maintains a Deposit Account or an account holding Investment Property in which such Borrower has granted to the Agent a perfected first priority security interest in the subject account or accounts.

 

“ACH Authorization” means the ACH Debit Authorization Agreement in substantially the form of Exhibit I.

 

“Additional Advance Conditions” means, in addition to the conditions set forth in Sections 4.2 and 4.3 hereof, (i) Borrowers’ receipt of the consent of Lender, in its sole discretion, to the making of the Additional Advance, (ii) receipt by Agent of an Advance Request in respect of the Additional Advance, and (iii) payment on the Advance Date of the Additional Advance of a fee equal to three hundred seventy-five one hundredths of one percent (0.375%) of the original principal amount of the Additional Advance (which fee shall be in addition to the Facility Charge and shall be fully earned and non-refundable on the Advance Date of the Additional Advance).

 

“Additional Advance” has the meaning given to it in Section 2.2(a).

 

“Administrative Borrower” has the meaning given to it in Section 11.20.

 

“Advance(s)” means a Term Loan Advance.

 

“Advance Date” means the funding date of any Advance.

 

“Advance Request” means a request for an Advance submitted by the Administrative Borrower to the Agent in substantially the form of Exhibit A.

 

“Affiliate” means (a) any Person that directly or indirectly controls, is controlled by, or is under common control with the Person in question or (b) any Person related by blood or marriage to any Person described in subsection (a) of this paragraph.  As used in the definition of “Affiliate,” the term “control” means the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of a Person, whether through ownership of voting securities, by contract or otherwise.

 

“Agent” has the meaning given to it in the preamble to this Agreement.

 

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“Agreement” means this Amended and Restated Loan and Security Agreement, as amended, restated, supplemented or otherwise modified from time to time.

 

“Amortization Date” means May 1, 2018; provided that (i) such date shall be extended by six (6) months if Borrowers complete patient enrollment in a CONVERT Phase III study (INS-212) and (ii) such date also shall be extended by six (6) months if a Financing Event occurs.  For clarity, the total extension of the Amortization Date could be for twelve (12) months if both conditions (i) and (ii) above are satisfied.

 

“Assignee” has the meaning given to it in Section 11.13.

 

“Borrower Products” means all products (including all drugs and biologics), software, service offerings, technical data or technology currently being designed, manufactured or sold by any Borrower or which any Borrower intends to sell, license, or distribute in the future including any products or service offerings under development, collectively, together with all products, software, service offerings, technical data or technology that have been sold, licensed or distributed by any Borrower since its incorporation.

 

“Business Day” means any day other than Saturday, Sunday and any other day on which banking institutions in the State of California are closed for business.

 

“Cash” means all cash, cash equivalents and liquid funds.

 

“Change in Control” means any reorganization, recapitalization, consolidation or merger (or similar transaction or series of related transactions) of any Borrower or any Subsidiary, sale or exchange of outstanding shares (or similar transaction or series of related transactions) of any Borrower or any Subsidiary in which the holders of such Borrower or such Subsidiary’s outstanding shares immediately before consummation of such transaction or series of related transactions do not, immediately after consummation of such transaction or series of related transactions, retain shares representing more than fifty percent (50%) of the voting power of the surviving entity of such transaction or series of related transactions (or the parent of such surviving entity if such surviving entity is wholly owned by such parent), in each case without regard to whether such Borrower or such Subsidiary is the surviving entity.

 

“Claims” has the meaning given to it in Section 11.10.

 

“Closing Date” means the date of this Agreement.

 

“Closing Date Term Loan Advance” has the meaning given in Section 2.2(a).

 

“Collateral” means the property described in Section 3.

 

“Confidential Information” has the meaning given to it in Section 11.12.

 

“Contingent Obligation” means, as applied to any Person, any direct or indirect liability, contingent or otherwise, of that Person with respect to (i) any Indebtedness, lease, dividend, letter of credit or other obligation of another, including any such obligation directly or indirectly guaranteed, endorsed, co-made or discounted or sold with recourse by that Person, or in

 

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respect of which that Person is otherwise directly or indirectly liable; (ii) any obligations with respect to undrawn letters of credit, corporate credit cards or merchant services issued for the account of that Person; and (iii) all obligations arising under any interest rate, currency or commodity swap agreement, interest rate cap agreement, interest rate collar agreement, or other agreement or arrangement designated to protect a Person against fluctuation in interest rates, currency exchange rates or commodity prices; provided, however, that the term “Contingent Obligation” shall not include endorsements for collection or deposit in the ordinary course of business.  The amount of any Contingent Obligation shall be deemed to be an amount equal to the stated or determined amount of the primary obligation in respect of which such Contingent Obligation is made or, if not stated or determinable, the maximum reasonably anticipated liability in respect thereof as determined by such Person in good faith; provided, however, that such amount shall not in any event exceed the maximum amount of the obligations under the guarantee or other support arrangement.

 

“Copyright License” means any written agreement granting any right to use any Copyright or Copyright registration, now owned or hereafter acquired by any Borrower or in which any Borrower now holds or hereafter acquires any interest.

 

“Copyrights” means all copyrights, whether registered or unregistered, held pursuant to the laws of the United States of America, any State thereof, or of any other country.

 

“Deposit Accounts” means any “deposit accounts,” as such term is defined in the UCC, and includes any checking account, savings account, or certificate of deposit.

 

“ERISA” means the Employee Retirement Income Security Act of 1974, as amended, and the regulations promulgated thereunder.

 

“Event of Default” has the meaning given to it in Section 9.

 

“Existing Loan and Security Agreement” as defined in Recital A.

 

“Existing Term Loans” as defined in Recital B.

 

“Facility Charge” means Two Hundred Sixty Two Thousand Five Hundred Dollars ($262,500).

 

“Financial Statements” has the meaning given to it in Section 7.1.

 

“Financing Event” means evidence delivered by the Borrower to Agent that the Borrowers have received, after the Closing Date, unrestricted and unencumbered net cash proceeds in an amount of at least One Hundred Million Dollars ($100,000,000.00) from (a) the issuance and sale of new equity or convertible debt securities, and/or (b) net upfront payments paid to the Borrowers in conjunction with a development and/or commercial partnership(s) and/or other corporate transaction.

 

“GAAP” means generally accepted accounting principles in the United States of America, as in effect from time to time.

 

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“Indebtedness” means indebtedness of any kind, including (a) all indebtedness for borrowed money or the deferred purchase price of property or services, including reimbursement and other obligations with respect to surety bonds and letters of credit, (b) all obligations evidenced by notes, bonds, debentures or similar instruments, (c) all capital lease obligations, and (d) all Contingent Obligations.

 

“Insolvency Proceeding” is any proceeding by or against any Person under the United States Bankruptcy Code, or any other bankruptcy or insolvency law, including assignments for the benefit of creditors, compositions, extensions generally with its creditors, or proceedings seeking reorganization, arrangement, or other relief.

 

“Intellectual Property” means all of any Borrower’s Copyrights; Trademarks; Patents; Licenses; trade secrets and inventions; mask works; any Borrower’s applications for any of the foregoing and reissues, extensions, or renewals thereof; and any Borrower’s goodwill associated with any of the foregoing, together with any Borrower’s rights to sue for past, present and future infringement of Intellectual Property and the goodwill associated therewith.

 

“Investment” means any beneficial ownership (including stock, partnership or limited liability company interests) of or in any Person, or any loan, advance or capital contribution to any Person or the acquisition of all, or substantially all, of the assets of another Person.

 

“Joined Subsidiaries” has the meaning given to it in the preamble to this Agreement.

 

“Joinder Agreements” means for each Subsidiary, a completed and executed Joinder Agreement in substantially the form attached hereto as Exhibit G.

 

“Lender” has the meaning given to it in the preamble to this Agreement.

 

“License” means any Copyright License, Patent License, Trademark License or other license of rights or interests.

 

“Lien” means any mortgage, deed of trust, pledge, hypothecation, assignment for security, security interest, encumbrance, levy, lien or charge of any kind, whether voluntarily incurred or arising by operation of law or otherwise, against any property, any conditional sale or other title retention agreement, and any lease in the nature of a security interest.

 

“Loan” means the Advances made under this Agreement.

 

“Loan Documents” means this Agreement, the Notes (if any), the ACH Authorization, the Account Control Agreements, the Joinder Agreements, all UCC Financing Statements, the Warrant and any other documents executed in connection with the Secured Obligations or the transactions contemplated hereby, as the same may from time to time be amended, modified, supplemented or restated.

 

“Material Adverse Effect” means a material adverse effect upon: (i) the business, operations, properties, assets, prospects or condition (financial or otherwise) of the Borrowers

 

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(taken as a whole); or (ii) the ability of the Borrowers to perform or pay the Secured Obligations in accordance with the terms of the Loan Documents, or the ability of the Agent or Lender to enforce any of its rights or remedies with respect to the Secured Obligations; or (iii) the Collateral or the Agent’s Liens on the Collateral or the priority of such Liens.

 

“Maximum Term Loan Amount” means Fifty-Five Million and No/100 Dollars ($55,000,000).

 

“Maximum Rate” shall have the meaning assigned to such term in Section 2.3.

 

“Note(s)” means a Term Note.

 

“Original Closing Date” as defined in Recital A.

 

“Patent License” means any written agreement granting any right with respect to any invention on which a Patent is in existence or a Patent application is pending, now owned or hereafter acquired by any Borrower or in which any Borrower now holds or hereafter acquires any interest.

 

“Patents” means all letters patent, or rights corresponding thereto, in the United States of America or in any other country, all registrations and recordings thereof, and all applications for letters patent of, or rights corresponding thereto, in the United States of America or any other country.

 

“Permitted Indebtedness” means: (i) Indebtedness of any Borrower in favor of the Agent or Lender arising under this Agreement or any other Loan Document; (ii) Indebtedness existing on the Closing Date which is disclosed in Schedule 1A; (iii) Indebtedness of up to $500,000 outstanding at any time secured by a Lien described in clause (vii) of the defined term “Permitted Liens,” provided such Indebtedness does not exceed the lesser of the cost or fair market value of the Equipment financed with such Indebtedness; (iv) Indebtedness to trade creditors incurred in the ordinary course of business, including Indebtedness incurred in the ordinary course of business with corporate credit cards; (v) Indebtedness that also constitutes a Permitted Investment; (vi) Subordinated Indebtedness; (vii) reimbursement obligations in connection with letters of credit that are secured by Cash and issued on behalf of any Borrower or a Subsidiary thereof in an amount not to exceed $250,000 at any time outstanding, (viii) other Indebtedness in an amount not to exceed $500,000 at any time outstanding, (ix) guarantees of the obligations of any Borrower, (x) Indebtedness of any Borrower to another Borrower; and (xi) extensions, refinancings and renewals of any items of Permitted Indebtedness, provided that the principal amount is not increased or the terms modified to impose materially more burdensome terms upon any Borrower or any Subsidiary, as the case may be.

 

“Permitted Investment” means: (i) Investments existing on the Closing Date which are disclosed in Schedule 1B; (ii) (a) marketable direct obligations issued or unconditionally guaranteed by the United States of America or any agency or any State thereof maturing within one year from the date of acquisition thereof, (b) commercial paper maturing no more than one year from the date of creation thereof and currently having a rating of at least A-2 or P-2 from either Standard & Poor’s Corporation or Moody’s Investors Service, (c) certificates of deposit issued by any bank with assets of at least $500,000,000 maturing no more than one year from the

 

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date of investment therein, and (d) money market accounts; (iii) repurchases of stock from former employees, directors, or consultants of any Borrower under the terms of applicable repurchase agreements at the fair market value of such securities in an aggregate amount not to exceed $250,000 in any fiscal year, provided that no Event of Default has occurred, is continuing or would exist after giving effect to the subject repurchase; (iv) Investments accepted in connection with Permitted Transfers; (v) Investments (including debt obligations) received in connection with the bankruptcy or reorganization of customers or suppliers and in settlement of delinquent obligations of, and other disputes with, customers or suppliers arising in the ordinary course of the Borrowers’ business; (vi) Investments consisting of notes receivable of, or prepaid royalties and other credit extensions, to customers and suppliers who are not Affiliates, in the ordinary course of business, provided that this subparagraph (vi) shall not apply to Investments of any Borrower in any Subsidiary; (vii) Investments consisting of loans not involving the net transfer on a substantially contemporaneous basis of cash proceeds to employees, officers or directors relating to the purchase of capital stock of any Borrower pursuant to employee stock purchase plans or other similar agreements approved by such Borrower’s Board of Directors; (viii) Investments consisting of travel advances or other customary business expenses, in each case, in the ordinary course of business; (ix) Investments in newly-formed Subsidiaries organized in the United States, provided that each such Subsidiary enters into a Joinder Agreement promptly after their formation by any Borrower and execute such other documents as shall be reasonably requested by the Agent; (x) Investments in other Borrowers; (xi)  Investments in Subsidiaries organized outside of the United States for current, ordinary, and necessary operating expenses, not to exceed Fifteen Million Dollars ($15,000,000.00) in the aggregate in any calendar year, provided that no Event of Default has occurred and is continuing or would exist after giving effect to such Investment; (xii) joint ventures or strategic alliances in the ordinary course of the Borrowers’ business consisting of the nonexclusive licensing of technology, the development of technology or the providing of technical support, provided that any cash Investments by any Borrower do not exceed $300,000 in the aggregate in any fiscal year; and (xiii) additional Investments that do not exceed $250,000 in the aggregate.

 

“Permitted Liens” means any and all of the following: (i) Liens in favor of the Agent or Lender; (ii) Liens existing on the Closing Date which are disclosed in Schedule 1C; (iii) Liens for taxes, fees, assessments or other governmental charges or levies, either not delinquent or being contested in good faith by appropriate proceedings; provided, that the Borrowers maintain adequate reserves therefor in accordance with GAAP; (iv) Liens securing claims or demands of materialmen, artisans, mechanics, carriers, warehousemen, landlords and other like Persons arising in the ordinary course of the Borrowers’ business; provided, that the payment thereof is not yet required; (v) Liens arising from judgments, decrees or attachments in circumstances which do not constitute an Event of Default hereunder; (vi) the following deposits, to the extent made in the ordinary course of business:  deposits under worker’s compensation, unemployment insurance, social security and other similar laws, or to secure the performance of bids, tenders or contracts (other than for the repayment of borrowed money) or to secure indemnity, performance or other similar bonds for the performance of bids, tenders or contracts (other than for the repayment of borrowed money) or to secure statutory obligations (other than Liens arising under ERISA or environmental Liens) or surety or appeal bonds, or to secure indemnity, performance or other similar bonds; (vii) Liens on Equipment or software or other intellectual property constituting purchase money Liens and Liens in connection with capital leases securing Indebtedness permitted in clause (iii) of “Permitted Indebtedness”;  (viii) Liens

 

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incurred in connection with Subordinated Indebtedness; (ix) leasehold interests in leases or subleases and licenses granted in the ordinary course of business and not interfering in any material respect with the business of the licensor; (x) Liens in favor of customs and revenue authorities arising as a matter of law to secure payment of custom duties that are promptly paid on or before the date they become due; (xi) Liens on insurance proceeds securing the payment of financed insurance premiums that are promptly paid on or before the date they become due (provided that such Liens extend only to such insurance proceeds and not to any other property or assets); (xii) statutory and common law rights of set-off and other similar rights as to deposits of cash and securities in favor of banks, other depository institutions and brokerage firms; (xiii) easements, zoning restrictions, rights-of-way and similar encumbrances on real property imposed by law or arising in the ordinary course of business so long as they do not materially impair Borrowers’ use of the related property; (xiv) Liens on Cash securing obligations permitted under clause (vii) of the definition of Permitted Indebtedness; and (xv) Liens incurred in connection with the extension, renewal or refinancing of the Indebtedness secured by Liens of the type described in clauses (i) through (xi) above; provided, that any extension, renewal or replacement Lien shall be limited to the property encumbered by the existing Lien and the principal amount of the Indebtedness being extended, renewed or refinanced (as may have been reduced by any payment thereon) does not increase.

 

“Permitted Transfers” means (i) sales of Inventory in the normal course of business, (ii) non-exclusive and exclusive licenses and similar arrangements for the use of Intellectual Property in the ordinary course of business (including, without limitation, licenses of the Arikayce product) and licenses that could not result in a legal transfer of title of the licensed property, or (iii) dispositions of (x) worn-out, obsolete or surplus Equipment or (y) Intellectual Property or Licenses that are not material, in each case, at fair market value in the ordinary course of business, and (iv) other Transfers of assets having a fair market value of not more than $250,000 in the aggregate in any fiscal year.

 

“Person” means any individual, sole proprietorship, partnership, joint venture, trust, unincorporated organization, association, corporation, limited liability company, other entity or government.

 

“Preferred Stock” means at any given time any equity security issued by any Borrower that has any rights, preferences or privileges senior to such Borrower’s common stock.

 

“Prepayment Charge” shall have the meaning assigned to such term in Section 2.5.

 

“Prime Rate” means for any day, the prime rate as reported in The Wall Street Journal for such day or if such rate is not published, as reasonably determined by the Agent by reference to a similar publication.

 

“Receivables” means (i) all of the Borrowers’ Accounts, Instruments, Documents, Chattel Paper, Supporting Obligations, letters of credit, proceeds of any letter of credit, and Letter of Credit Rights, and (ii) all customer lists, software, and business records related thereto.

 

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“Required Lenders” means at any time, the holders of more than 50% of the aggregate unpaid principal amount of the Term Loans then outstanding.

 

“Secured Obligations” means the Borrowers’ obligations under this Agreement (other than Section 8.1) and any Loan Document (other than the Warrant), including any obligation to pay any amount now owing or later arising.

 

“Subordinated Indebtedness” means Indebtedness subordinated to the Secured Obligations in amounts and on terms and conditions satisfactory to the Lender in its sole discretion.

 

“Subsequent Financing” means the sale by any Borrower, following the Closing Date, pursuant to a broadly marketed offering to multiple investors, of shares of its capital stock or of securities or instruments convertible into or exercisable for shares of its capital stock (including, without limitation, an offering and sale of units consisting of more than one type of Borrower security) to one or more investor purchasers for cash in a single transaction or series of related transactions, which offering and sale are not registered under the Securities Act of 1933, as amended (such as a transaction in the nature of a so-called “private investment in public equity,” or PIPE, transaction), the primary purpose of which is a bona fide equity financing of the Borrower.

 

“Subsidiary” means an entity, whether corporate, partnership, limited liability company, joint venture or otherwise, in which a Borrower owns or controls more than 50% of the outstanding voting securities, including each entity listed on Schedule 1 hereto.

 

“Term Commitment” means as to any Lender, the obligation of such Lender, if any, to make a Term Loan Advance to the Borrower in a principal amount not to exceed the amount set forth under the heading “Term Commitment” opposite such Lender’s name on Schedule 1.1.

 

“Term Loan Advance” means any Term Loan funds advanced under this Agreement.

 

“Term Loan Interest Rate” means for any day, greater of (a) nine and one-quarter percentage points (9.25%) plus the sum of (x) the Prime Rate minus (y) four and one-half percentage points (4.50%) or (b) nine and one-quarter percentage points (9.25%).

 

“Term Loan Maturity Date” means October 1, 2020.

 

“Term Note” means a Promissory Note in substantially the form of Exhibit B.

 

“Trademark License” means any written agreement granting any right to use any Trademark or Trademark registration, now owned or hereafter acquired by any Borrower or in which any Borrower now holds or hereafter acquires any interest.

 

“Trademarks” means all trademarks (registered, common law or otherwise) and any applications in connection therewith, including registrations, recordings and applications in

 

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the United States Patent and Trademark Office or in any similar office or agency of the United States of America, any State thereof or any other country or any political subdivision thereof.

 

“UCC” means the Uniform Commercial Code as the same is, from time to time, in effect in the State of California; provided, that in the event that, by reason of mandatory provisions of law, any or all of the attachment, perfection or priority of, or remedies with respect to, the Agent’s Lien on any Collateral is governed by the Uniform Commercial Code as the same is, from time to time, in effect in a jurisdiction other than the State of California, then the term “UCC” shall mean the Uniform Commercial Code as in effect, from time to time, in such other jurisdiction solely for purposes of the provisions thereof relating to such attachment, perfection, priority or remedies and for purposes of definitions related to such provisions.

 

“Warrant” means the warrant dated the Original Closing Date by and between Parent and Hercules Capital, Inc.

 

Unless otherwise specified, all references in this Agreement or any Annex or Schedule hereto to a “Section,” “subsection,” “Exhibit,” “Annex,” or “Schedule” shall refer to the corresponding Section, subsection, Exhibit, Annex, or Schedule in or to this Agreement.  Unless otherwise specifically provided herein, any accounting term used in this Agreement or the other Loan Documents shall have the meaning customarily given such term in accordance with GAAP, and all financial computations hereunder shall be computed in accordance with GAAP, consistently applied. Unless otherwise defined herein or in the other Loan Documents, terms that are used herein or in the other Loan Documents and defined in the UCC shall have the meanings given to them in the UCC.  Any obligations of a person under an operating lease (whether existing on the date hereof or entered into thereafter) that is not required (or would not be required) to be classified and accounted for as a capital lease on a balance sheet of such Person under GAAP as in effect on date hereof shall not be treated as a capital lease solely as a result of the changes in GAAP after the date hereof.

 

SECTION 2.  THE LOANS

 

2.1                              [Reserved.].

 

2.2                              Term Loans.

 

(a)                                  Advances.  Subject to the terms and conditions of this Agreement, (i) the Lender made and the Borrower drew the Existing Term Loans on the Original Closing Date (which Existing Term Loans remain outstanding on the Closing Date), (ii) the Lender will make, and the Borrowers agree to draw, a Term Loan Advance (exclusive of the Existing Term Loans Advance) of $10,000,000 on the Closing Date (the “Closing Date Term Loan Advance”) and (iii) beginning on the Closing Date and continuing through June 30, 2017, and subject to the Additional Advance Conditions, the Administrative Borrower may request one (1) additional Term Loan Advance (the “Additional Advance”) in the amount of $20,000,000.  The aggregate outstanding Term Loan Advances shall in no event exceed the Maximum Term Loan Amount.

 

(b)                                  Advance Request.  To obtain a Term Loan Advance, the Administrative Borrower shall complete, sign and deliver an Advance Request (at least two Business

 

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Days before the Advance Date in the case of the Closing Date Term Loan Advance) to the Agent.  Lender shall fund a Term Loan Advance in the manner requested by the Advance Request provided that each of the conditions precedent to such Term Loan Advance is satisfied as of the requested Advance Date.

 

(c)                                   Interest.  The principal balance of each Term Loan Advance shall bear interest thereon from such Advance Date at the Term Loan Interest Rate based on a year consisting of 360 days, with interest computed daily based on the actual number of days elapsed.  The Term Loan Interest Rate will float and change on the day the Prime Rate changes from time to time.

 

(d)                                  Payment.  The Borrowers will pay interest in arrears on each Term Loan Advance on the first day of each month, beginning the month after the Advance Date.  The Borrowers shall repay the aggregate Term Loan principal balance that is outstanding on the Amortization Date in thirty (30) equal monthly installments of principal and interest commencing on the applicable Amortization Date and continuing on the first business day of each month thereafter with any yet to accrue amortization payments due on the Term Loan Maturity Date.  The entire Term Loan principal balance and all accrued but unpaid interest hereunder, shall be due and payable on the Term Loan Maturity Date.  The Borrowers shall make all payments under this Agreement without setoff, recoupment or deduction and regardless of any counterclaim or defense. Lender will initiate debit entries to the Administrative Borrower’s account as authorized on the ACH Authorization (i) on each payment date of all periodic obligations payable to Lender under each Term Loan Advance and (ii) reasonable invoiced out-of-pocket legal fees and costs incurred by the Agent or Lender in connection with Section 11.11 of this Agreement.

 

2.3                                          Maximum Interest.  Notwithstanding any provision in this Agreement or any other Loan Document, it is the parties’ intent not to contract for, charge or receive interest at a rate that is greater than the maximum rate permissible by law that a court of competent jurisdiction shall deem applicable hereto (which under the laws of the State of California shall be deemed to be the laws relating to permissible rates of interest on commercial loans) (the “Maximum Rate”).  If a court of competent jurisdiction shall finally determine that the Borrowers have actually paid to the Lender an amount of interest in excess of the amount that would have been payable if all of the Secured Obligations had at all times borne interest at the Maximum Rate, then such excess interest actually paid by the Borrowers shall be applied as follows:  first, to the payment of principal outstanding on the Secured Obligations; second, after all principal is repaid, to the payment of Lender’s and the Agent’s accrued interest, costs, expenses, professional fees and any other Secured Obligations; and third, after all Secured Obligations are repaid, the excess (if any) shall be refunded to the Borrowers.

 

2.4                                          Default Interest.  In the event any payment is not paid on the scheduled payment date, an amount equal to five percentage points (5%) of the past due amount shall be payable on demand. In addition, upon the occurrence and during the continuation of an Event of Default hereunder, all Secured Obligations, including principal, interest, compounded interest, and professional fees, shall bear interest at a rate per annum equal to the rate set forth in Section 2.2(c) plus five percentage points (5%) per annum.  In the event

 

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any interest is not paid when due hereunder, delinquent interest shall be added to principal and shall bear interest on interest, compounded at the rate set forth in Section 2.2(c) or Section 2.4, as applicable.

 

2.5                                          Prepayment.  At the Borrowers’ option upon at least 7 Business Days’ prior notice to the Agent from the Administrative Borrower, the Borrowers may prepay all, but not less than all, of the outstanding Advances by paying entire principal balance, all accrued and unpaid interest, together with a prepayment charge equal to the following percentage of the Advance amount being prepaid: if such Advance amounts are prepaid in any of the first twelve (12) months following the Closing Date, 2%; after twelve (12) months but prior to twenty four (24) months, 1%; and thereafter, 0.50% (each, a “Prepayment Charge”).  The Borrowers agree that the Prepayment Charge is a reasonable calculation of the Lender’s lost profits in view of the difficulties and impracticality of determining actual damages resulting from an early repayment of the Advances.  The Borrowers shall prepay the outstanding amount of all principal and accrued interest and unpaid interest upon a Change in Control.

 

2.6                                          End of Term Charges.  On the earliest to occur of (i) the Term Loan Maturity Date, (ii) the date that the Borrowers prepay the outstanding Secured Obligations, or (iii) the date that the Secured Obligations become due and payable, the Borrowers shall pay Lender a charge equal to 4.15% of the aggregate initial principal amount of all Advances funded hereunder. Notwithstanding the required payment date of such charges, such charges shall be deemed earned by Lender as of the Closing Date.

 

2.7                                          Notes .  If so requested by Lender by written notice to Borrowers, then Borrowers shall execute and deliver to Lender (and/or, if applicable and if so specified in such notice, to any Person who is an assignee of Lender pursuant to Section 11.13) (promptly after Borrowers’ receipt of such notice) a Note or Notes to evidence Lender’s Loans.

 

2.8                                          Commitment Fee; Facility Charge . The parties acknowledge and agree that (i) Borrower paid to Lender a commitment fee of $15,000 on or before the Closing Date, and that such commitment fee was fully earned on the Closing Date and non-refundable regardless of the early termination of this Agreement and (ii) the Facility Charge is fully earned and owed on the Closing Date and non-refundable regardless of the early termination of this Agreement.

 

2.9                                          Pro Rata Treatment .  Each payment (including prepayment) on account of any fee and any reduction of the Term Loans shall be made pro rata according to the Term Commitments of the relevant Lender.

 

SECTION 3.  SECURITY INTEREST

 

3.1                                          As security for the prompt, complete and indefeasible payment when due (whether on the payment dates or otherwise) of all the Secured Obligations, the Borrowers grant to the Agent a security interest in all of the Borrowers’ right, title, and interest in and to the following: all of each Borrower’s personal property whether now owned or hereafter acquired (collectively, the “Collateral”), including the following:  (a) Receivables; (b)

 

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Equipment; (c) Fixtures; (d) General Intangibles (other than Intellectual Property); (e) Inventory; (f) Investment Property (but excluding thirty-five percent (35%) of the capital stock of any foreign Subsidiary if to include such capital stock as Collateral would cause Parent adverse tax consequences under Internal Revenue Section 956 (or any successor statute); (g) Deposit Accounts; (h) Cash; (i) Goods; and other tangible and intangible personal property of the Borrowers whether now or hereafter owned or existing, leased, consigned by, or acquired by, any Borrower and wherever located; and, to the extent not otherwise included, all Proceeds of each of the foregoing and all accessions to, substitutions and replacements for, and rents, profits and products of each of the foregoin g ; provided , however , that the Collateral shall include all Accounts and General Intangibles (other than Intellectual Property Licenses which prohibit such assignment (unless such provision would be rendered ineffective with respect to the creation of the security interest hereunder pursuant to Sections 9-406 or 9-408 of the UCC (or any successor provision or provisions) of any relevant jurisdiction or any other applicable law (including the Bankruptcy Code) or principles of equity)) that consist of rights to payment and proceeds from the sale, licensing or disposition of all or any part, or rights in, the Intellectual Property (the “Rights to Payment”).  Notwithstanding the foregoing, if a judicial authority (including a U.S. Bankruptcy Court) holds that a security interest in the underlying Intellectual Property is necessary to have a security interest in the Rights to Payment, then the Collateral shall automatically, and effective as of the date of this Agreement, include the Intellectual Property to the extent necessary to permit perfection of the Agent’s security interest in the Rights to Payment.

 

SECTION 4.  CONDITIONS PRECEDENT TO LOANS

 

The obligations of Lender to make Term Loan Advances hereunder are subject to the satisfaction by the Borrowers of the following conditions:

 

4.1                                          Closing Date Advance.  On or prior to the Closing Date, the Borrowers shall have delivered to the Agent the following:

 

(a)                                  executed originals of the Loan Documents, Account Control Agreements, a legal opinion of the Borrowers’ counsel, and all other documents and instruments reasonably required by the Lender to effectuate the transactions contemplated hereby or to create and perfect the Liens of the Agent with respect to all Collateral, in all cases in form and substance reasonably acceptable to the Agent;

 

(b)                                  certified copy of resolutions of each Borrower’s board of directors evidencing approval of the Loan and other transactions evidenced by the Loan Documents;

 

(c)                                   certified copies of the Certificate of Incorporation and the Bylaws, as amended through the Closing Date, of each Borrower;

 

(d)                                  a certificate of good standing for each Borrower from its state of incorporation and similar certificates from all other jurisdictions in which such Borrower does business and where the failure to be qualified would have a Material Adverse Effect;

 

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(e)                                   payment of the Facility Charge and reimbursement of the Agent’s and Lender’s current expenses reimbursable pursuant to this Agreement, which amounts may be deducted from the Closing Date Term Loan Advance; and

 

(f)                                    such other documents as the Agent may reasonably request.

 

4.2                                          All Advances.  On each Advance Date:

 

(a)                                  The Agent shall have received (i) an Advance Request for the relevant Advance duly executed by the Administrative Borrower’s Chief Executive Officer or Chief Financial Officer, and (ii) any other documents the Agent may reasonably request.

 

(b)                                  The representations and warranties of the Borrowers set forth in this Agreement and in the Warrant shall be true and correct in all material respects on and as of the Advance Date with the same effect as though made on and as of such date, except to the extent such representations and warranties expressly relate to an earlier date.

 

(c)                                   The Borrowers shall be in compliance in all material respects with all the terms and provisions set forth herein and in each other Loan Document on its part to be observed or performed, and at the time of and immediately after such Advance no Event of Default shall have occurred and be continuing.

 

(d)                                  Each Advance Request shall be deemed to constitute a representation and warranty by the Borrowers on the relevant Advance Date as to the matters specified in paragraphs (b) and (c) of this Section 4.2 and as to the matters set forth in the Advance Request.

 

4.3                                          No Default.  As of the Closing Date and each Advance Date, (i) no fact or condition exists that would (or would, with the passage of time, the giving of notice, or both) constitute an Event of Default and (ii) no event that has had or could reasonably be expected to have a Material Adverse Effect has occurred and is continuing.

 

4.4                                          Additional Advance.  In addition to the conditions set forth in Sections 4.2 and 4.3, the Additional Advance shall be subject to the Additional Advance Conditions.

 

SECTION 5.  REPRESENTATIONS AND WARRANTIES OF THE BORROWERS

 

Each Borrower represents and warrants that:

 

5.1                                            Corporate Status.  Each Borrower is a corporation duly organized, legally existing and in good standing under the laws of its State of incorporation, and is duly qualified as a foreign corporation in all jurisdictions in which the nature of its business or location of its properties require such qualifications and where the failure to be qualified could reasonably be expected to have a Material Adverse Effect.  Each Borrower’s present name, former names (if any), locations, place of formation, tax identification number, organizational identification number and other information are correctly set forth in Exhibit

 

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C, as may be updated by the Administrative Borrower in a written notice (including any Compliance Certificate) provided to the Agent after the Closing Date.

 

5.2                                          Collateral.  Each Borrower owns the Collateral and the Intellectual Property, free of all Liens, except for Permitted Liens.  Each Borrower has the power and authority to grant to the Agent a Lien in the Collateral as security for the Secured Obligations.

 

5.3                                          Consents.  Each Borrower’s execution, delivery and performance of the Notes, this Agreement and all other Loan Documents, and the Parent’s execution of the Warrant, (i) have been duly authorized by all necessary corporate action of such Borrower, (ii) will not result in the creation or imposition of any Lien upon the Collateral, other than Permitted Liens and the Liens created by this Agreement and the other Loan Documents, (iii) do not violate any provisions of such Borrower’s Certificate or Articles of Incorporation (as applicable), bylaws, or any, law, regulation, order, injunction, judgment, decree or writ to which such Borrower is subject and (iv) except as described on Schedule 5.3, do not violate any contract or agreement to which such Borrower is a party or require the consent or approval of any other Person.  The individual or individuals executing the Loan Documents on behalf of the Borrowers are duly authorized to do so.

 

5.4                                          Material Adverse Effect.  No event that has had or could reasonably be expected to have a Material Adverse Effect has occurred and is continuing. No Borrower is aware of any event likely to occur that is reasonably expected to result in a Material Adverse Effect.

 

5.5                                          Actions Before Governmental Authorities.  Except as described on Schedule 5.5, there are no actions, suits or proceedings at law or in equity or by or before any governmental authority now pending or, to the knowledge of any Borrower, threatened against or affecting any Borrower or its property.

 

5.6                                          Laws.  No Borrower is in violation of any law, rule or regulation, or in default with respect to any judgment, writ, injunction or decree of any governmental authority, where such violation or default is reasonably expected to result in a Material Adverse Effect.  No Borrower is in default in any manner under any provision of any agreement or instrument evidencing Indebtedness, or any other material agreement to which it is a party or by which it is bound.  Each Borrower, its Affiliates and, to the knowledge of such Borrower and its Affiliates, any agent or other party acting on behalf of such Borrower or its Affiliates are in compliance with all applicable anti-money laundering, economic sanctions and anti-bribery laws and regulations, and none of the funds to be provided under this Agreement will be used, directly or indirectly, for any activities in violation of such laws and regulations.

 

5.7                                          Information Correct and Current.  No information, report, Advance Request, financial statement, exhibit or schedule furnished, by or on behalf of any Borrower to the Agent or Lender in connection with any Loan Document or included therein or delivered pursuant thereto contained, contains or will contain any material misstatement of fact or omitted, omits or will omit to state any material fact necessary to make the statements therein, in the light of the circumstances under which they were, are or will be made, not

 

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misleading at the time such statement was made or deemed made. Additionally, any and all financial or business projections provided by any Borrower to the Agent or Lender shall be (i) provided in good faith and based on the most current data and information available to such Borrower, and (ii) the most current of such projections provided to such Borrower’s Board of Directors.

 

5.8                                          Tax Matters.  Except as described on Schedule 5.8, (a) each Borrower has filed all federal, state and local tax returns that it is required to file, (b) each Borrower has duly paid or fully reserved for all taxes or installments thereof (including any interest or penalties) as and when due, which have or may become due pursuant to such returns, and (c) each Borrower has paid or fully reserved for any tax assessment received by such Borrower for the three (3) years preceding the Closing Date, if any (including any taxes being contested in good faith and by appropriate proceedings).

 

5.9                                          Intellectual Property Claims.  Each Borrower is the sole owner of, or otherwise has the right to use, its Intellectual Property.  Except as described on Schedule 5.9, (i) each of the material Copyrights, Trademarks and Patents is valid and enforceable, (ii) no material part of the Intellectual Property has been judged invalid or unenforceable, in whole or in part, and (iii) no claim has been made to any Borrower that any material part of the Intellectual Property violates the rights of any third party. Exhibit D is a true, correct and complete list of each Borrower’s Patents, registered Trademarks, registered Copyrights, and material agreements under which each Borrower licenses Intellectual Property from third parties (other than shrink-wrap software licenses), together with application or registration numbers, as applicable, owned by each Borrower or any Subsidiary, in each case as of the Closing Date. No Borrower is in material breach of, nor has any Borrower failed to perform any material obligations under, any of the foregoing contracts, licenses or agreements and, to any Borrower’s knowledge, no third party to any such contract, license or agreement is in material breach thereof or has failed to perform any material obligations thereunder.

 

5.10                                   Intellectual Property.  Except as described on Schedule 5.10, each Borrower has, or in the case of any proposed business, will have, all material rights with respect to Intellectual Property necessary in the operation or conduct of such Borrower’s business as currently conducted and proposed to be conducted by such Borrower.  Without limiting the generality of the foregoing, and in the case of Licenses, except for restrictions that are unenforceable under Division 9 of the UCC, each Borrower has the right, to the extent required to operate such Borrower’s business, to freely transfer, license or assign Intellectual Property without condition, restriction or payment of any kind (other than license payments in the ordinary course of business) to any third party, and each Borrower owns or has the right to use, pursuant to valid licenses, all software development tools, library functions, compilers and all other third-party software and other items that are used in the design, development, promotion, sale, license, manufacture, import, export, use or distribution of Borrower Products.

 

5.11                                   Borrower Products.  Except as described on Schedule 5.11, no Intellectual Property owned by any Borrower or any Borrower Product has been or is subject to any actual or, to the knowledge of any Borrower, threatened litigation, proceeding (including

 

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any proceeding in the United States Patent and Trademark Office or any corresponding foreign office or agency) or outstanding decree, order, judgment, settlement agreement or stipulation that restricts in any manner such Borrower’s use, transfer or licensing thereof or that may affect the validity, use or enforceability thereof. There is no decree, order, judgment, agreement, stipulation, arbitral award or other provision entered into in connection with any litigation or proceeding that obligates any Borrower to grant licenses or ownership interest in any future Intellectual Property related to the operation or conduct of the business of any Borrower or any Borrower Products.  No Borrower has received any written notice or claim, or, to the knowledge of any Borrower, oral notice or claim, challenging or questioning any Borrower’s ownership in any Intellectual Property (or written notice of any claim challenging or questioning the ownership in any licensed Intellectual Property of the owner thereof) or suggesting that any third party has any claim of legal or beneficial ownership with respect thereto nor, to any Borrower’s knowledge, is there a reasonable basis for any such claim.  No Borrower’s use of its Intellectual Property nor the production and sale of any Borrower Products infringes the Intellectual Property or other rights of others.

 

5.12                                   Financial Accounts.  Exhibit E, as it may be updated by the Administrative Borrower in a written notice provided to the Agent after the Closing Date, is a true, correct and complete list of (a) all banks and other financial institutions at which any Borrower or any Subsidiary maintains Deposit Accounts and (b) all institutions at which any Borrower or any Subsidiary maintains an account holding Investment Property, and such exhibit correctly identifies the name, address and telephone number of each bank or other institution, the name in which the account is held, a description of the purpose of the account, and the complete account number therefor.

 

5.13                                   Employee Loans.  Except for Permitted Investments, no Borrower has any outstanding loans to any employee, officer or director of any Borrower, nor has any Borrower guaranteed the payment of any loan made to an employee, officer or director of any Borrower by a third party.

 

5.14                                   Capitalization and Subsidiaries.  Each Borrower’s capitalization as of the Closing Date is set forth on Schedule 5.14 annexed hereto.  No Borrower owns any stock, partnership interest or other securities of any Person, except for Permitted Investments.  Attached as Schedule 5.14, as such schedule may be updated by the Administrative Borrower in a written notice provided after the Closing Date, is a true, correct and complete list of each Subsidiary.

 

SECTION 6.  INSURANCE; INDEMNIFICATION

 

6.1                                          Coverage.  Each Borrower shall cause to be carried and maintained commercial general liability insurance, on an occurrence form (except for products liability coverage, which may be on a claims made basis), against risks customarily insured against in such Borrower’s line of business.  Such risks shall include the risks of bodily injury, including death, property damage, personal injury, advertising injury, and contractual liability.  Borrower’s must maintain a minimum of $1,000,000 of commercial general liability insurance for each occurrence and a minimum of $2,000,000 in the aggregate.

 

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Parent has and agrees to maintain a minimum of $2,000,000 of directors and officers’ insurance for each occurrence and $5,000,000 in the aggregate.  So long as there are any Secured Obligations outstanding, each Borrower shall also cause to be carried and maintained insurance upon the Collateral, insuring against all risks of physical loss or damage howsoever caused, in an amount not less than the full replacement cost of the Collateral, provided that such insurance may be subject to standard exceptions and deductibles.  Each Borrower shall also carry and maintain a fidelity insurance policy in an amount not less than $100,000.

 

6.2                                          Certificates.  Each Borrower shall deliver to the Agent certificates of insurance that evidence such Borrower’s compliance with its insurance obligations in Section 6.1 and the obligations contained in this Section 6.2.  Each Borrower’s insurance certificate shall state the Agent (shown as “Hercules Capital, Inc.”, as Agent”) is an additional insured for commercial general liability, an additional insured and a loss payee for all risk property damage insurance and subject to the insurer’s approval, a loss payee for fidelity insurance.  Attached to the certificates of insurance will be additional insured endorsements for liability and lender’s loss payable endorsements for all risk property damage insurance and fidelity.  All certificates of insurance will provide for a minimum of thirty (30) days advance written notice to the Agent of cancellation (other than cancellation for non-payment of premiums, for which ten (10) days’ advance written notice shall be sufficient) or any other change adverse to the Agent’s interests.  Any failure of the Agent to scrutinize such insurance certificates for compliance is not a waiver of any of the Agent’s rights, all of which are reserved.

 

6.3                                          Indemnity.  Each Borrower agrees to indemnify and hold the Agent, Lender and their officers, directors, employees, agents, in-house attorneys, representatives and shareholders (each, an “Indemnified Person”) harmless from and against any and all claims, costs, expenses, damages and liabilities (including such claims, costs, expenses, damages and liabilities based on liability in tort, including strict liability in tort), including reasonable attorneys’ fees and disbursements and other costs of investigation or defense (including those incurred upon any appeal) (collectively, “Liabilities”), that may be instituted or asserted against or incurred by such Indemnified Person as the result of credit having been extended, suspended or terminated under this Agreement and the other Loan Documents or the administration of such credit, or in connection with or arising out of the transactions contemplated hereunder and thereunder, or any actions or failures to act in connection therewith, or arising out of the disposition or utilization of the Collateral, excluding in all cases Liabilities to the extent resulting solely from any Indemnified Person’s gross negligence or willful misconduct. Each Borrower agrees to pay, and to save the Agent and Lender harmless from, any and all liabilities with respect to, or resulting from any delay in paying, any and all excise, sales or other similar taxes (excluding taxes imposed on or measured by the net income of the Agent or Lender) that may be payable or determined to be payable with respect to any of the Collateral or this Agreement.  In no event shall any Indemnified Person be liable on any theory of liability for any special, indirect, consequential or punitive damages (including any loss of profits, business or anticipated savings). This Section 6.3 shall survive the repayment of indebtedness under, and otherwise shall survive the expiration or other termination of, the Loan Agreement.

 

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SECTION 7.  COVENANTS OF BORROWER

 

Each Borrower agrees as follows:

 

7.1                                          Financial Reports.  The Administrative Borrower shall furnish to the Agent the Compliance Certificate in the form of Exhibit F monthly within thirty (30) days after the end of each month and the financial statements listed hereinafter (the “Financial Statements”):

 

(a)                                  as soon as practicable (and in any event within thirty (30) days) after the end of each month, unaudited interim and year-to-date financial statements as of the end of such month (prepared on a consolidated and consolidating basis, if applicable), including balance sheet and related statements of income and cash flows accompanied by a report detailing any material contingencies (including the commencement of any material litigation by or against any Borrower) or any other occurrence that would reasonably be expected to have a Material Adverse Effect, all certified by the Administrative Borrower’s Chief Executive Officer or Chief Financial Officer or Vice President of Finance to the effect that they have been prepared in accordance with GAAP, except (i) for the absence of footnotes, (ii) that they are subject to normal year-end adjustments, and (iii) they do not contain certain non-cash items that are customarily included in quarterly and annual financial statements;

 

(b)                                  as soon as practicable (and in any event within forty (40) days) after the end of each calendar quarter, unaudited interim and year-to-date financial statements as of the end of such calendar quarter (prepared on a consolidated and consolidating basis, if applicable), including balance sheet and related statements of income and cash flows accompanied by a report detailing any material contingencies (including the commencement of any material litigation by or against any Borrower) or any other occurrence that would reasonably be expected to have a Material Adverse Effect,  certified by the Administrative Borrower’s Chief Executive Officer or Chief Financial Officer or Vice President of Finance to the effect that they have been prepared in accordance with GAAP, except (i) for the absence of footnotes, and (ii) that they are subject to normal year-end adjustments; as well as the most recent capitalization table for each Borrower, including the weighted average exercise price of employee stock options;

 

(c)                                   as soon as practicable (and in any event within one hundred fifty (150) days) after the end of each fiscal year, unqualified audited financial statements as of the end of such year (prepared on a consolidated and consolidating basis, if applicable), including balance sheet and related statements of income and cash flows, and setting forth in comparative form the corresponding figures for the preceding fiscal year, certified by a firm of independent certified public accountants selected by the Borrowers and reasonably acceptable to the Agent, accompanied by any management report from such accountants; provided, that consolidating financial statements may be prepared by the Borrowers;

 

(d)                                  [Reserved.]

 

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(e)                                   promptly after the sending or filing thereof, as the case may be, copies of any proxy statements, financial statements or reports that any Borrower has made available to holders of its Preferred Stock and copies of any regular, periodic and special reports or registration statements that any Borrower files with the Securities and Exchange Commission or any governmental authority that may be substituted therefor, or any national securities exchange; provided that delivery hereunder shall be deemed made when Parent notifies the Lender that the subject document is available on Parent’s website or a public database;

 

(f)                                    upon written request of the Agent, copies of all notices, minutes, consents and other materials that any Borrower provides to its directors in connection with meetings of the Board of Directors and minutes of such meeting; provided, that each Borrower may, in good faith, withhold any information from the Agent and/or redact any and all minutes, to the extent that (i) access to such information or minutes would adversely affect the attorney-client privilege between such Borrower and its counsel, (ii) access to such information or minutes could reasonably be expected to result in disclosure of trade secrets or a conflict of interest, (iii) the Agent or Lender is the subject matter of such information or the topic of discussion in such portion of such minutes, (iv) such information is related to executive sessions or officer performance and/or (v) such information is subject to a confidentiality agreement; and

 

(g)                                   financial and business projections promptly following their approval by each Borrower’s Board of Directors, as well as budgets, operating plans and other financial information reasonably requested by the Agent.

 

The executed Compliance Certificate may be sent via email to the Agent at legal@herculestech.com.  All Financial Statements required to be delivered pursuant to clauses (a), (b) and (c) shall be sent via e-mail to financialstatements@herculestech.com with a copy to legal@herculestech.com provided, that if e-mail is not available or sending such Financial Statements via e-mail is not possible, they shall be sent to the Agent at: legal@herculestech.com, attention Chief Credit Officer.

 

7.2                                          Management Rights.  Each Borrower shall permit any representative that the Agent or Lender authorizes, including its attorneys and accountants, to inspect the Collateral and examine and make copies and abstracts of the books of account and records of such Borrower at reasonable times and upon reasonable notice during normal business hours.  In addition, any such representative shall have the right to meet with management and officers of each Borrower to discuss such books of account and records.  In addition, the Agent and Lender shall be entitled at reasonable times and intervals to consult with and advise the management and officers of each Borrower concerning significant business issues affecting the Borrowers.  Such consultations shall not unreasonably interfere with the Borrowers’ business operations.  The parties intend that the rights granted the Agent and Lender shall constitute “management rights” within the meaning of 29 C.F.R Section 2510.3-101(d)(3)(ii), but that any advice, recommendations or participation by the Agent or Lender with respect to any business issues shall not be deemed to give the Agent or Lender, nor be deemed an exercise by the Agent or Lender of, control over any Borrower’s management or policies.

 

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7.3                                          Further Assurances.  Each Borrower shall from time to time execute, deliver and file, alone or with the Agent, any financing statements, security agreements, collateral assignments, notices, control agreements, or other documents to perfect or give the highest priority to the Agent’s Lien on the Collateral.  Each Borrower shall from time to time procure any instruments or documents as may be requested by the Agent, and take all further action that may be necessary or desirable, or that the Agent may reasonably request, to perfect and protect the Liens granted hereby and thereby.  In addition, and for such purposes only, each Borrower hereby authorizes the Agent to execute and deliver on behalf of such Borrower and to file such financing statements (including an indication that the financing statement covers “all assets” or “all personal property” of each Borrower in accordance with Section 9-504 of the UCC), collateral assignments, notices, control agreements, security agreements and other documents without the signature of such Borrower either in the Agent’s name or in the name of the Agent as agent and attorney-in-fact for such Borrower if Borrower unreasonably withholds or delays the delivery of such signatures.  Each Borrower shall protect and defend such Borrower’s title to the Collateral and the Agent’s Lien thereon against all Persons claiming any interest adverse to such Borrower or the Agent other than Permitted Liens.

 

7.4                                          Minimum Cash Liquidity.  Borrowers and any guarantors under this Agreement or the other Loan Documents shall maintain, at all times, unrestricted cash and cash equivalents on a consolidated basis in an amount of not less than $25,000,000, which cash and cash equivalents shall (x) be subject to a first priority perfected lien in favor of Agent for the benefit of Lenders and (y) held in a Deposit Account that is subject to a Deposit Account Control Agreement.  This provision shall commence on the date of the funding of the Additional Advance and shall terminate upon the earlier of the date by which a Borrower completes an equity financing with at least $75,000,000 in proceeds or the date a Borrower generates and announces data from the CONVERT Phase III study in a manner that could support an NDA filing.

 

7.5                                          Indebtedness.  No Borrower shall create, incur, assume, guarantee or be or remain liable with respect to any Indebtedness, or permit any Subsidiary so to do, other than Permitted Indebtedness, or prepay any Indebtedness or take any actions which impose on any Borrower an obligation to prepay any Indebtedness, except for the conversion of Indebtedness into equity securities and the payment of cash in lieu of fractional shares in connection with such conversion.

 

7.6                                          Collateral.  Each Borrower shall at all times keep the Collateral, the Intellectual Property and all other property and assets used in such Borrower’s business or in which such Borrower now or hereafter holds any interest free and clear from any legal process or Liens whatsoever (except for Permitted Liens), and shall give the Agent prompt written notice of any legal process affecting the Collateral, the Intellectual Property, such other property and assets, or any Liens (except for Permitted Liens) thereon.  Each Borrower shall cause its Subsidiaries to protect and defend such Subsidiary’s title to its assets from and against all Persons claiming any interest adverse to such Subsidiary, and each Borrower shall cause its Subsidiaries at all times to keep such Subsidiary’s property and assets free and clear from any legal process or Liens whatsoever (except for Permitted Liens), and shall give the Agent prompt written notice of any legal process affecting such Subsidiary’s assets.

 

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No Borrower shall agree with any Person other than the Agent not to encumber its property (except for negative pledges in favor of holders of Permitted Liens described in clause (vii) of such definition).

 

7.7                                          Investments.  No Borrower shall directly or indirectly acquire or own, or make any Investment in or to any Person, or permit any of its Subsidiaries so to do, other than Permitted Investments.

 

7.8                                          Distributions.  No Borrower shall, or allow any Subsidiary to, (a) repurchase or redeem any class of stock or other equity interest other than pursuant to employee, director or consultant repurchase plans or other similar agreements, provided, however, in each case, the repurchase or redemption price does not exceed the fair market value of such stock or equity interest, or (b) declare or pay any cash dividend or make a cash distribution on any class of stock or other equity interest, except that a Subsidiary may pay dividends or make distributions to its equity owners, or (c) lend money to any employees, officers or directors or guarantee the payment of any such loans granted by a third party in excess of $100,000 in the aggregate, or (d) waive, release or forgive any indebtedness owed by any employees, officers or directors in excess of $100,000 in the aggregate.

 

7.9                                          Transfers.  Except for Permitted Transfers, no Borrower shall, or allow any Subsidiary to, voluntarily or involuntarily transfer, sell, lease, license, lend or in any other manner convey any equitable, beneficial or legal interest in any material portion of its assets.

 

7.10                                   Mergers or Acquisitions.  No Borrower shall merge or consolidate (except with another Borrower), or permit any of its Subsidiaries to merge or consolidate, with or into any other business organization (other than mergers or consolidations of a Subsidiary into another Subsidiary or into a Borrower), or acquire, or permit any of its Subsidiaries to acquire, all or substantially all of the capital stock or property of another Person.

 

7.11                                   Taxes.  Each Borrower and its Subsidiaries shall pay when due all taxes, fees or other charges of any nature whatsoever (together with any related interest or penalties) now or hereafter imposed or assessed against such Borrower, the Lender or the Collateral or upon such Borrower’s ownership, possession, use, operation or disposition thereof or upon such Borrower’s rents, receipts or earnings arising therefrom.  Each Borrower shall file on or before the due date therefor all personal property tax returns in respect of the Collateral.  Notwithstanding the foregoing, a Borrower may contest, in good faith and by appropriate proceedings, taxes for which such Borrower maintains adequate reserves therefor in accordance with GAAP.

 

7.12                                   Corporate Changes.  No Borrower nor any Subsidiary shall change its corporate name, legal form or jurisdiction of formation without twenty (20) days’ prior written notice to the Agent.  No Borrower nor any Subsidiary shall suffer a Change in Control. No Borrower nor any Subsidiary shall relocate its chief executive office or its principal place of business unless: (i) it has provided prior written notice to the Agent; and (ii) such relocation shall be within the continental United States.  No Borrower nor any Subsidiary shall relocate any item of Collateral (other than (x) sales of Inventory in the

 

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ordinary course of business, (y) relocations of Equipment having an aggregate value of up to $150,000 in any fiscal year (other than relocations of Equipment in the ordinary course of business to establish additional sources to manufacture Borrower’s Products), and (z) relocations of Collateral from a location described on Exhibit C to another location described on Exhibit C) unless (i) it has provided prompt written notice to the Agent, (ii) such relocation is within the continental United States and, (iii) if such relocation is to a third party bailee, it has delivered a bailee agreement in form and substance reasonably acceptable to the Agent.

 

7.13                                   Deposit Accounts.  No Borrower nor any Subsidiary shall maintain any Deposit Accounts, or accounts holding Investment Property, except with respect to which the Agent has an Account Control Agreement.

 

7.14                                   Joinder.  Each Borrower shall notify the Agent of each Subsidiary formed subsequent to the Closing Date and, within 15 days of formation, shall cause any such Subsidiary organized under the laws of any State within the United States to execute and deliver to the Agent a Joinder Agreement.

 

7.15                                   Notification of Event of Default.  The Borrowers shall notify the Agent immediately of the occurrence of any Event of Default.

 

SECTION 8.   RIGHT TO INVEST

 

8.1                                          So long as any Term Loans remain outstanding after closing of a Subsequent Financing, each bank or other financial institution or entity holding such Term Loans and constituting “Lender” hereunder, or its assignee or nominee, shall have the right, in its discretion, to participate in a Subsequent Financing on a pro rata basis (based upon the relative principal amount of outstanding Term Loans then held by such bank or other financial institution or entity) in an aggregate amount of up to $2,000,000 on the same terms, conditions and pricing afforded to others participating in any such Subsequent Financing.  The foregoing notwithstanding, such participation right shall terminate at such time as Lender has participated for $2,000,000 in a Subsequent Financing.

 

SECTION 9.  EVENTS OF DEFAULT

 

The occurrence of any one or more of the following events shall be an Event of Default:

 

9.1                                          Payments.  The Borrowers fail to pay (a) any principal or interest when due under this Agreement or (ii) fails to pay any other amounts due under any of the other Loan Documents within five (5) days of when due; provided, that, in each case, it will not be a violation of this Section 9.1 if the Borrower has sufficient funds in the account subject to the ACH Authorization, but the Agent fails to timely make any ACH transfer or any technical malfunction (not the result of any action or inaction of the Borrower) occurs so long as the Borrower makes such payment within three (3) Business Days after it has received written notice of such technical malfunction; or

 

9.2                                          Covenants.  Any Borrower breaches or defaults in the performance of any covenant or Secured Obligation under this Agreement, the Notes, or any of the other Loan

 

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Documents, and (a) with respect to a default under any covenant under this Agreement (other than under Sections 6, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 7.10 or 7.15) such default continues for more than twenty (20) days after the earlier of the date on which (i) the Agent has given notice of such default to such Borrower and (ii) such Borrower has actual knowledge of such default or (b) with respect to a default under any of Sections 6, 7.4, 7.5, 7.6, 7.7, 7.8, 7.9, 7.10 or 7.15 the occurrence of such default; or

 

9.3                                          Material Adverse Effect.  A circumstance has occurred that would reasonably be expected to have a Material Adverse Effect; or

 

9.4                                          Other Loan Documents.  The occurrence of any default under any Loan Document or any other agreement between any Borrower and the Lender or the Agent and such default continues for more than twenty (20) days after the earlier of (a) the Agent has given notice of such default to such Borrower, or (b) such Borrower has actual knowledge of such default; or

 

9.5                                          Representations.  Any representation or warranty made by any Borrower in any Loan Document or in the Warrant shall have been false or misleading in any material respect; or

 

9.6                                          Insolvency.  Any Borrower (A) (i) shall make an assignment for the benefit of creditors; or (ii) shall be unable to pay its debts as they become due or shall become insolvent; or (iii) shall file a voluntary petition in bankruptcy; or (iv) shall file any petition, answer, or document seeking for itself any reorganization, arrangement, composition, readjustment, liquidation, dissolution or similar relief under any present or future statute, law or regulation pertinent to such circumstances; or (v) shall seek or consent to or acquiesce in the appointment of any trustee, receiver, or liquidator of such Borrower or of all or any substantial part (i.e., 33-1/3% or more) of the assets or property of such Borrower; or (vi) shall cease operations of its business as its business has normally been conducted, or terminate substantially all of its employees; or (vii) any Borrower or its directors or majority shareholders shall take any action initiating any of the foregoing actions described in clauses (i) through (vi); or (B) either (i) sixty (60) days shall have expired after the commencement of an involuntary action against such Borrower seeking reorganization, arrangement, composition, readjustment, liquidation, dissolution or similar relief under any present or future statute, law or regulation, without such action being dismissed or all orders or proceedings thereunder affecting the operations or the business of such Borrower being stayed; or (ii) a stay of any such order or proceedings shall thereafter be set aside and the action setting it aside shall not be timely appealed; or (iii) any Borrower shall file any answer admitting or not contesting the material allegations of a petition filed against such Borrower in any such proceedings; or (iv) the court in which such proceedings are pending shall enter a decree or order granting the relief sought in any such proceedings; or (v) sixty (60) days shall have expired after the appointment, without the consent or acquiescence of such Borrower, of any trustee, receiver or liquidator of such Borrower or of all or any substantial part of the properties of such Borrower without such appointment being vacated; or

 

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9.7                                          Attachments; Judgments.  Any portion of any Borrower’s assets is attached or seized, or a levy is filed against any such assets (having a fair market value in excess of $100,000), or a judgment or judgments is/are entered for the payment of money, individually or in the aggregate, of at least $300,000 for which such Borrower has not been reimbursed by or which is not within the coverage of its insurer (and as to which the insurer has not disclaimed coverage), or any Borrower is enjoined or in any way prevented by court order from conducting any material part of its business; or

 

9.8                                          Other Obligations.  The occurrence of any default under any agreement or obligation of any Borrower involving any Indebtedness in excess of $300,000, or the occurrence of any default under any agreement or obligation of any Borrower that could reasonably be expected to have a Material Adverse Effect.

 

SECTION 10.  REMEDIES

 

10.1                                   General.  Upon and during the continuance of any one or more Events of Default, (i) the Agent may, and at the direction of the Required Lenders shall, accelerate and demand payment of all or any part of the Secured Obligations together with a Prepayment Charge and declare them to be immediately due and payable (provided, that upon the occurrence of an Event of Default of the type described in Section 9.6, all of the Secured Obligations shall automatically be accelerated and made due and payable, in each case without any further notice or act), (ii) the Agent may, at its option, sign and file in any Borrower’s name any and all collateral assignments, notices, control agreements, security agreements and other documents it deems necessary or appropriate to perfect or protect the repayment of the Secured Obligations, and in furtherance thereof, each Borrower hereby grants the Agent an irrevocable power of attorney coupled with an interest, and (iii) the Agent may notify any of the Borrowers’ account debtors to make payment directly to the Agent, compromise the amount of any such account on the Borrowers’ behalf and endorse the Agent’s name without recourse on any such payment for deposit directly to the Agent’s account.  The Agent may, and at the direction of the Required Lenders shall, exercise all rights and remedies with respect to the Collateral under the Loan Documents or otherwise available to it under the UCC and other applicable law, including the right to release, hold, sell, lease, liquidate, collect, realize upon, or otherwise dispose of all or any part of the Collateral and the right to occupy, utilize, process and commingle the Collateral.  All of the Agent’s rights and remedies shall be cumulative and not exclusive.

 

10.2                                   Collection; Foreclosure.  Upon the occurrence and during the continuance of any Event of Default, the Agent may, and at the direction of the Required Lenders shall, at any time or from time to time, apply, collect, liquidate, sell in one or more sales, lease or otherwise dispose of, any or all of the Collateral, in its then condition or following any commercially reasonable preparation or processing, in such order as the Agent may elect.  Any such sale may be made either at public or private sale at its place of business or elsewhere.  Each Borrower agrees that any such public or private sale may occur upon ten (10) calendar days’ prior written notice to Parent.  The Agent may require each Borrower to assemble the Collateral and make it available to the Agent at a place designated by the Agent that is reasonably convenient to the Agent and such Borrower.  The proceeds of any

 

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sale, disposition or other realization upon all or any part of the Collateral shall be applied by the Agent in the following order of priorities:

 

First, to the Agent and Lender in an amount sufficient to pay in full the Agent’s and Lender’s costs and professionals’ and advisors’ fees and expenses as described in Section 11.11;

 

Second, to Lender in an amount equal to the then unpaid amount of the Secured Obligations (including principal, interest, and the Default Rate interest), in such order and priority as the Agent may choose in its sole discretion; and

 

Finally, after the full, final and indefeasible payment in Cash of all of the Secured Obligations (other than inchoate obligations), to any creditor holding a junior Lien on the Collateral, or to the Administrative Borrower or its representatives or as a court of competent jurisdiction may direct.

 

The Agent shall be deemed to have acted reasonably in the custody, preservation and disposition of any of the Collateral if it complies with the obligations of a secured party under the UCC.

 

10.3                                   No Waiver.  The Agent shall be under no obligation to marshal any of the Collateral for the benefit of any Borrower or any other Person, and each Borrower expressly waives all rights, if any, to require the Agent to marshal any Collateral.

 

10.4                                   Cumulative Remedies.  The rights, powers and remedies of Agent hereunder shall be in addition to all rights, powers and remedies given by statute or rule of law and are cumulative.  The exercise of any one or more of the rights, powers and remedies provided herein shall not be construed as a waiver of or election of remedies with respect to any other rights, powers and remedies of Agent.

 

SECTION 11.  MISCELLANEOUS

 

11.1                                   Severability.  Whenever possible, each provision of this Agreement shall be interpreted in such manner as to be effective and valid under applicable law, but if any provision of this Agreement shall be prohibited by or invalid under such law, such provision shall be ineffective only to the extent and duration of such prohibition or invalidity, without invalidating the remainder of such provision or the remaining provisions of this Agreement.

 

11.2                                   Notice.  Except as otherwise provided herein, any notice, demand, request, consent, approval, declaration, service of process or other communication (including the delivery of Financial Statements) that is required, contemplated, or permitted under the Loan Documents or with respect to the subject matter hereof shall be in writing, and shall be deemed to have been validly served, given, delivered, and received upon the earlier of: (i) the day of transmission by electronic mail or hand delivery or delivery by an overnight express service or overnight mail delivery service; or (ii) the third calendar day after deposit in the United States of America mails, with proper first class postage prepaid, in each case addressed to the party to be notified as follows:

 

(a)                                  If to Agent:

 

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HERCULES CAPITAL, INC.
Legal Department
Attention:  Chief Legal Officer and R. Bryan Jadot
400 Hamilton Avenue, Suite 310
Palo Alto, CA 94301

email: legal@herculestech.com
Telephone:  650-289-3060

 

(b)                                  If to Lender:

 

HERCULES CAPITAL, INC.
Legal Department
Attention: Chief Legal Officer and R. Bryan Jadot
400 Hamilton Avenue, Suite 310
Palo Alto, CA  94301

email: legal@herculestech.com
Telephone:  650-289-3060

 

(c)                                   If to Borrower:

 

INSMED INCORPORATED

Attention:  Chief Financial Officer

10 Finderne Avenue, Building 10

Bridgewater, NJ 08807

Facsimile:  908-526-4026
Telephone:  908-977-9900

 

or to such other address as each party may designate for itself by like notice.

 

11.3                                   Entire Agreement; Amendments.

 

(a)                                  This Agreement and the other Loan Documents constitute the entire agreement and understanding of the parties hereto in respect of the subject matter hereof and thereof, and supersede and replace in their entirety any prior proposals, term sheets, letters, negotiations or other documents or agreements, whether written or oral, with respect to the subject matter hereof or thereof (including the Lender’s revised proposal letter dated June 10, 2016).  None of the terms of this Agreement, the Notes or any of the other Loan Documents may be amended except by an instrument executed by each of the parties hereto.

 

(b)                                  Neither this Agreement, any other Loan Document, nor any terms hereof or thereof may be amended, supplemented or modified except in accordance with the provisions of this Section 11.3(b).  The Required Lenders and Borrowers party to the relevant Loan Document may, or, with the written consent of the Required Lenders, the Agent and the Borrowers party to the relevant Loan Document may, from time to time, (i) enter into written amendments, supplements or modifications hereto and to the other Loan Documents for the purpose of adding any provisions to this Agreement or the other

 

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Loan Documents or changing in any manner the rights of the Lenders or of the Borrowers hereunder or thereunder or (ii) waive, on such terms and conditions as the Required Lenders or the Agent, as the case may be, may specify in such instrument, any of the requirements of this Agreement or the other Loan Documents or any default or Event of Default and its consequences; provided, however, that no such waiver and no such amendment, supplement or modification shall (A) forgive the principal amount or extend the final scheduled date of maturity of any Loan, extend the scheduled date of any amortization payment in respect of any Term Loan, reduce the stated rate of any interest or fee payable hereunder) or extend the scheduled date of any payment thereof, in each case without the written consent of each Lender directly affected thereby; (B) eliminate or reduce the voting rights of any Lender under this Section 11.3(b) without the written consent of such Lender; (C) reduce any percentage specified in the definition of Required Lenders, consent to the assignment or transfer by any Borrower of any of its rights and obligations under this Agreement and the other Loan Documents, release all or substantially all of the Collateral or release a Borrower from its obligations under the Loan Documents, in each case without the written consent of all Lenders; or (D) amend, modify or waive any provision of Section 11.17 without the written consent of the Agent.  Any such waiver and any such amendment, supplement or modification shall apply equally to each Lender and shall be binding upon Borrowers, Lender, the Agent and all future holders of the Loans.

 

11.4                                   No Strict Construction.  The parties hereto have participated jointly in the negotiation and drafting of this Agreement.  In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the parties hereto and no presumption or burden of proof shall arise favoring or disfavoring any party by virtue of the authorship of any provisions of this Agreement.

 

11.5                                   No Waiver.  The powers conferred upon the Agent and Lender by this Agreement are solely to protect its rights hereunder and under the other Loan Documents and its interest in the Collateral and shall not impose any duty upon the Agent or Lender to exercise any such powers.  No omission or delay by the Agent or Lender at any time to enforce any right or remedy reserved to it, or to require performance of any of the terms, covenants or provisions hereof by any Borrower at any time designated, shall be a waiver of any such right or remedy to which the Agent or Lender is entitled, nor shall it in any way affect the right of the Agent or Lender to enforce such provisions thereafter.

 

11.6                                   Survival.  All agreements, representations and warranties contained in this Agreement and the other Loan Documents or in any document delivered pursuant hereto or thereto shall be for the benefit of the Agent and Lender and shall survive the execution and delivery of this Agreement. Sections 6.3 and 11.17 shall survive payment in full of the Secured Obligations and the termination of this Agreement.

 

11.7                                   Successors and Assigns.  The provisions of this Agreement and the other Loan Documents shall inure to the benefit of and be binding on each Borrower and its permitted assigns (if any). No Borrower shall assign its obligations under this Agreement or any of the other Loan Documents without the Agent’s express prior written consent, and any such attempted assignment shall be void and of no effect.  The Agent and Lender may

 

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assign, transfer, or endorse its rights hereunder and under the other Loan Documents without prior notice to any of the Borrowers, and all of such rights shall inure to the benefit of the Agent’s and Lender’s successors and assigns; provided that, so long as no Event of Default exists, the Agent and Lender shall not assign, transfer or endorse any of its rights hereunder and under the other Loan Documents to any direct competitor of any Borrower (as reasonably determined by the Agent) without the consent of Borrower, it being understood that in all cases, any transfer to an Affiliate of any Lender or the Agent shall be permitted.

 

11.8                                   Governing Law.  This Agreement and the other Loan Documents have been negotiated and delivered to the Agent and Lender in the State of California, and shall have been accepted by the Agent and Lender in the State of California.  Payment to the Agent and Lender by the Borrowers of the Secured Obligations is due in the State of California.  This Agreement and the other Loan Documents shall be governed by, and construed and enforced in accordance with, the laws of the State of California, excluding conflict of laws principles that would cause the application of laws of any other jurisdiction.

 

11.9                                   Consent to Jurisdiction and Venue.  All judicial proceedings (to the extent that the reference requirement of Section 11.10 is not applicable) arising in or under or related to this Agreement or any of the other Loan Documents may be brought in any state or federal court located in the State of California.  By execution and delivery of this Agreement, each party hereto generally and unconditionally: (a) consents to nonexclusive personal jurisdiction in Santa Clara County, State of California; (b) waives any objection as to jurisdiction or venue in Santa Clara County, State of California; (c) agrees not to assert any defense based on lack of jurisdiction or venue in the aforesaid courts; and (d) irrevocably agrees to be bound by any judgment rendered thereby in connection with this Agreement or the other Loan Documents.  Service of process on any party hereto in any action arising out of or relating to this Agreement shall be effective if given in accordance with the requirements for notice set forth in Section 11.2, and shall be deemed effective and received as set forth in Section 11.2.  Nothing herein shall affect the right to serve process in any other manner permitted by law or shall limit the right of either party to bring proceedings in the courts of any other jurisdiction.

 

11.10                            Mutual Waiver of Jury Trial / Judicial Reference.

 

(a)                                  Because disputes arising in connection with complex financial transactions are most quickly and economically resolved by an experienced and expert Person and the parties wish applicable state and federal laws to apply (rather than arbitration rules), the parties desire that their disputes be resolved by a judge applying such applicable laws.  EACH BORROWER, THE AGENT AND LENDER EACH SPECIFICALLY WAIVES ANY RIGHT IT MAY HAVE TO TRIAL BY JURY OF ANY CAUSE OF ACTION, CLAIM, CROSS-CLAIM, COUNTERCLAIM, THIRD PARTY CLAIM OR ANY OTHER CLAIM (COLLECTIVELY, “CLAIMS”) ASSERTED BY ANY BORROWER AGAINST THE AGENT, LENDER OR THEIR RESPECTIVE ASSIGNEE OR BY THE AGENT, LENDER OR THEIR RESPECTIVE ASSIGNEE AGAINST ANY BORROWER.  This waiver extends to all such Claims, including Claims that involve Persons other than the Agent, the Borrowers and Lender; Claims that arise out of or are in

 

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any way connected to the relationship among the Borrowers, the Agent and Lender; and any Claims for damages, breach of contract, tort, specific performance, or any equitable or legal relief of any kind, arising out of this Agreement, any other Loan Document.

 

(b)                                  If the waiver of jury trial set forth in Section 11.10(a) is ineffective or unenforceable, the parties agree that all Claims shall be resolved by reference to a private judge sitting without a jury, pursuant to Code of Civil Procedure Section 638, before a mutually acceptable referee or, if the parties cannot agree, a referee selected by the Presiding Judge of the Santa Clara County, California.  Such proceeding shall be conducted in Santa Clara County, California, with California rules of evidence and discovery applicable to such proceeding.

 

(c)                                   In the event Claims are to be resolved by judicial reference, either party may seek from a court identified in Section 11.9, any prejudgment order, writ or other relief and have such prejudgment order, writ or other relief enforced to the fullest extent permitted by law notwithstanding that all Claims are otherwise subject to resolution by judicial reference.

 

11.11                              Professional Fees.  The Borrowers promise to pay all of the Agent’s and Lender’s fees and expenses necessary to finalize the loan documentation, including but not limited to reasonable invoiced attorneys fees, UCC searches, filing costs, and other miscellaneous expenses. In addition, the Borrowers promise to pay any and all reasonable attorneys’ and other professionals’ fees and expenses (including fees and expenses of in-house counsel) incurred by the Agent and Lender after the Closing Date in connection with or related to:  (a) the Loan; (b) the administration (exclusive of normal overhead), collection, or enforcement of the Loan; (c) the amendment or modification of the Loan Documents; (d) any waiver, consent, release, or termination under the Loan Documents; (e) the protection, preservation, sale, lease, liquidation, or disposition of Collateral or the exercise of remedies with respect to the Collateral; (f) any legal, litigation, administrative, arbitration, or out of court proceeding in connection with or related to any Borrower or the Collateral, and any appeal or review thereof; and (g) any bankruptcy, restructuring, reorganization, assignment for the benefit of creditors, workout, foreclosure, or other action related to any Borrower, the Collateral, the Loan Documents, including representing the Agent or Lender in any adversary proceeding or contested matter commenced or continued by or on behalf of Borrower’s estate, and any appeal or review thereof.

 

11.12                              Confidentiality.  The Agent and Lender acknowledge that certain items of Collateral and information provided to the Agent and Lender by the Borrowers are confidential and proprietary information of the Borrowers, if and to the extent such information either (x) is marked as confidential by the Borrowers at the time of disclosure, or (y) should reasonably be understood to be confidential (the “Confidential Information”).  Accordingly, the Agent and Lender agree that any Confidential Information it may obtain in the course of originating, administering or enforcing the Term Loans or acquiring, administering, or perfecting the Agent’s security interest in the Collateral shall not be disclosed to any other Person or entity in any manner whatsoever, in whole or in part, without the prior written consent of any Borrower, except that the Agent and Lender may disclose any such information:  (a) to its own directors, officers, employees, accountants,

 

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counsel and other professional advisors and to its Affiliates if the Agent or Lender in their sole discretion determines that any such party should have access to such information in connection with such party’s responsibilities in connection with the Loan or this Agreement and, provided that such recipient of such Confidential Information either (i) agrees to be bound by the confidentiality provisions of this paragraph or (ii) is otherwise subject to confidentiality restrictions that reasonably protect against the disclosure of Confidential Information; (b) if such information is generally available to the public; (c) if required or appropriate in any report, statement or testimony submitted to any governmental authority having or claiming to have jurisdiction over the Agent or Lender; (d) if required or appropriate in response to any summons or subpoena or in connection with any litigation, to the extent permitted or deemed advisable by the Agent’s or Lender’s counsel; (e) to comply with any legal requirement or law applicable to the Agent or Lender; (f) to the extent reasonably necessary in connection with the exercise of any right or remedy under any Loan Document, including the Agent’s sale, lease, or other disposition of Collateral after default; (g) to any participant or assignee of the Agent or Lender or any prospective participant or assignee; provided, that such participant or assignee or prospective participant or assignee agrees in writing to be bound by this Section prior to disclosure; or (h) otherwise with the prior consent of Parent; provided, that any disclosure made in violation of this Agreement shall not affect the obligations of any Borrower or any of its Affiliates or any guarantor under this Agreement or the other Loan Documents.

 

11.13                              Assignment of Rights.  Each Borrower acknowledges and understands that the Agent or Lender may sell and assign all or part of its interest hereunder and under the Loan Documents to any Person or entity (an “Assignee”).  After such assignment the term “Agent” or “Lender” as used in the Loan Documents shall mean and include such Assignee, and such Assignee shall be vested with all rights, powers and remedies of the Agent and Lender hereunder with respect to the interest so assigned; but with respect to any such interest not so transferred, the Agent and Lender shall retain all rights, powers and remedies hereby given.  No such assignment by the Agent or Lender shall relieve any Borrower of any of its obligations hereunder.  Lender agrees that in the event of any transfer by it of the Note(s)(if any), it will endorse thereon a notation as to the portion of the principal of the Note(s), which shall have been paid at the time of such transfer and as to the date to which interest shall have been last paid thereon.

 

11.14                              Revival of Secured Obligations.  This Agreement and the Loan Documents shall remain in full force and effect and continue to be effective if any petition is filed by or against any Borrower for liquidation or reorganization, if any Borrower becomes insolvent or makes an assignment for the benefit of creditors, if a receiver or trustee is appointed for all or any significant part of any Borrower’s assets, or if any payment or transfer of Collateral is recovered from the Agent or Lender.  The Loan Documents and the Secured Obligations and Collateral security shall continue to be effective, or shall be revived or reinstated, as the case may be, if at any time payment and performance of the Secured Obligations or any transfer of Collateral to the Agent, or any part thereof is rescinded, avoided or avoidable, reduced in amount, or must otherwise be restored or returned by, or is recovered from, the Agent, Lender or by any obligee of the Secured Obligations, whether as a “voidable preference,” “fraudulent conveyance,” or otherwise, all as though such payment, performance, or transfer of Collateral had not been made.  In the event that any

 

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payment, or any part thereof, is rescinded, reduced, avoided, avoidable, restored, returned, or recovered, the Loan Documents and the Secured Obligations shall be deemed, without any further action or documentation, to have been revived and reinstated except to the extent of the full, final, and indefeasible payment to the Agent or Lender in Cash.

 

11.15                              Counterparts.  This Agreement and any amendments, waivers, consents or supplements hereto may be executed in any number of counterparts, and by different parties hereto in separate counterparts, each of which when so delivered shall be deemed an original, but all of which counterparts shall constitute but one and the same instrument.

 

11.16                              No Third Party Beneficiaries.  No provisions of the Loan Documents are intended, nor will be interpreted, to provide or create any third-party beneficiary rights or any other rights of any kind in any Person other than the Agent, Lender and the Borrowers unless specifically provided otherwise herein, and, except as otherwise so provided, all provisions of the Loan Documents will be personal and solely among the Agent, Lender and the Borrowers.

 

11.17                              Agency.

 

(a)                                  Lender hereby irrevocably appoints Hercules Capital, Inc. to act on its behalf as the Agent hereunder and under the other Loan Documents and authorizes the Agent to take such actions on its behalf and to exercise such powers as are delegated to the Agent by the terms hereof or thereof, together with such actions and powers as are reasonably incidental thereto.

 

(b)                                  Lender agrees to indemnify the Agent in its capacity as such (to the extent not reimbursed by the Borrowers and without limiting the obligation of the Borrowers to do so), according to its respective Term Commitment percentage (based upon the total outstanding Term Loan Commitments) in effect on the date on which indemnification is sought under this Section 11.17, from and against any and all liabilities, obligations, losses, damages, penalties, actions, judgments, suits, costs, expenses or disbursements of any kind whatsoever that may at any time be imposed on, incurred by or asserted against the Agent in any way relating to or arising out of, this Agreement, any of the other Loan Documents or any documents contemplated by or referred to herein or therein or the transactions contemplated hereby or thereby or any action taken or omitted by the Agent under or in connection with any of the foregoing; The agreements in this Section shall survive the payment in full of the Secured Obligations.

 

(c)                                   Agent in Its Individual Capacity.  The Person serving as the Agent hereunder shall have the same rights and powers in its capacity as a Lender as any other Lender and may exercise the same as though it were not the Agent and the term “Lender” shall, unless otherwise expressly indicated or unless the context otherwise requires, include each such Person serving as Agent hereunder in its individual capacity.

 

(d)                                  Exculpatory Provisions.  The Agent shall have no duties or obligations except those expressly set forth herein and in the other Loan Documents.  Without limiting the generality of the foregoing, the Agent shall not:

 

32



 

(i)              be subject to any fiduciary or other implied duties, regardless of whether any default or any Event of Default has occurred and is continuing;

 

(ii)           have any duty to take any discretionary action or exercise any discretionary powers, except discretionary rights and powers expressly contemplated hereby or by the other Loan Documents that the Agent is required to exercise as directed in writing by the Lender, provided that the Agent shall not be required to take any action that, in its opinion or the opinion of its counsel, may expose the Agent to liability or that is contrary to any Loan Document or applicable law; and

 

(iii)        except as expressly set forth herein and in the other Loan Documents, have any duty to disclose, and the Agent shall not be liable for the failure to disclose, any information relating to the Borrowers or any of their Affiliates that is communicated to or obtained by any Person serving as the Agent or any of its Affiliates in any capacity.

 

(e)                                   The Agent shall not be liable for any action taken or not taken by it (i) with the consent or at the request of Lender or as the Agent shall believe in good faith shall be necessary, under the circumstances or (ii) in the absence of its own gross negligence or willful misconduct.

 

(f)                                    The Agent shall not be responsible for or have any duty to ascertain or inquire into (i) any statement, warranty or representation made in or in connection with this Agreement or any other Loan Document, (ii) the contents of any certificate, report or other document delivered hereunder or thereunder or in connection herewith or therewith, (iii) the performance or observance of any of the covenants, agreements or other terms or conditions set forth herein or therein or the occurrence of any default or Event of Default, (iv) the validity, enforceability, effectiveness or genuineness of this Agreement, any other Loan Document or any other agreement, instrument or document or (v) the satisfaction of any condition set forth in Section 4 or elsewhere herein, other than to confirm receipt of items expressly required to be delivered to the Agent.

 

(g)                                   Reliance by Agent.  The Agent may rely, and shall be fully protected in acting, or refraining to act, upon, any resolution, statement, certificate, instrument, opinion, report, notice, request, consent, order, bond or other paper or document that it has no reason to believe to be other than genuine and to have been signed or presented by the proper party or parties or, in the case of cables, telecopies and telexes, to have been sent by the proper party or parties.  In the absence of its gross negligence or willful misconduct, the Agent may conclusively rely, as to the truth of the statements and the correctness of the opinions expressed therein, upon any certificates or opinions furnished to the Agent and conforming to the requirements of the Loan Agreement or any of the other Loan Documents.  The Agent may consult with counsel, and any opinion or legal advice of such counsel shall be full and complete authorization and protection in respect of any action taken, not taken or suffered by the Agent hereunder or under any Loan Documents in accordance therewith.  The Agent shall have the right at any time to seek

 

33



 

instructions concerning the administration of the Collateral from any court of competent jurisdiction.  The Agent shall not be under any obligation to exercise any of the rights or powers granted to the Agent by this Agreement, the Loan Agreement and the other Loan Documents at the request or direction of Lender unless the Agent shall have been provided by Lender with adequate security and indemnity against the costs, expenses and liabilities that may be incurred by it in compliance with such request or direction.

 

11.18                              Publicity.  The Agent and Lender may use each Borrower’s name and logo, and include a brief description (without disclosure of any material non-public information) of the relationship between such Borrower and the Agent and Lender, in the Agent’s and Lender’s marketing materials.

 

11.19                              Joint and Several Liability.  Each Borrower is accepting joint and several liability hereunder and under the other Loan Documents (other than the Warrant) in consideration of the financial accommodations to be provided by the Lender under this Agreement, for the mutual benefit, directly and indirectly, of each Borrower and in consideration of their undertakings to accept joint and several liability for the Secured Obligations.  Each Borrower, jointly and severally, hereby irrevocably, absolutely and unconditionally accepts, not merely as a surety but also as a co-debtor, joint and several liability with respect to the payment and performance of all of the Secured Obligations (including, without limitation, any Secured Obligations arising under this Section 11.19), it being the intention of each Borrower that all the Secured Obligations shall be the joint and several obligations of each Borrower without preferences or distinction among them.  If and to the extent that any Borrower fails to make any payment with respect to any of the Secured Obligations as and when due or to perform any of the Secured Obligations in accordance with the terms thereof, then in each such event, the other Persons comprising the Borrowers will make such payment with respect to, or perform, such Secured Obligation.  Each Borrower hereby agrees that it will not enforce any of its rights of contribution or subrogation against any other Persons comprising the Borrowers with respect to any liability incurred by it hereunder or under any of the other Loan Documents, any payments made by it to the Lender with respect to any of the Secured Obligations or any collateral security therefor until such time as all of the Secured Obligations have been paid in full in Cash.  Any claim which any of the Borrowers may have against any other Persons comprising the Borrowers with respect to any payments to the Lender hereunder or under any other Loan Documents are hereby expressly made subordinate and junior in right of payment, without limitation as to any increases in the Secured Obligations arising hereunder or thereunder, to the prior payment in full in Cash of the Secured Obligations and, in the event of any insolvency, bankruptcy, receivership, liquidation, reorganization or other similar proceeding under the laws of any jurisdiction relating to any of the Borrowers, their respective debt or assets, whether voluntary or involuntary, all such Secured Obligations shall be paid in full in Cash before any payment or distribution of any character, whether in Cash, securities or other property, shall be made to any other Persons comprising the Borrowers therefor.

 

11.20                              Administrative Borrower.  Each Borrower irrevocably appoints the Parent as the borrowing agent and attorney-in-fact (“Administrative Borrower”) for all Persons comprising the Borrowers, which appointment shall remain in full force and effect unless

 

34



 

and until the Agent shall have received prior written notice signed by each of the other Borrowers that such appointment has been revoked and that another Borrower has been appointed as the Administrative Borrower.

 

11.21                              Lien Release.  At such time as the Secured Obligations have been repaid in full and the Borrowers have no further rights to request any Advances hereunder, the Liens granted to the Agent hereunder shall be deemed terminated and released without requirement of any further action on the part of any Person, and the Agent shall, at the request and expense of the Borrowers, execute, deliver and file (or permit the Borrowers to file) any and all termination statements and other documents as may be necessary or appropriate in order to give effect to such release or Liens hereunder.

 

11.22                              Existing Loan and Security Agreement Amended and Restated .  Upon satisfaction of the conditions precedent to the effectiveness of this Agreement, (a) this Agreement shall amend and restate the Existing Loan and Security Agreement in its entirety (except to the extent that definitions from the Existing Loan and Security Agreement are incorporated herein by reference) and (b) the rights and obligations of the parties under the Existing Loan and Security Agreement shall be subsumed within, and be governed by, this Agreement; provided, however, that the Borrowers hereby agree that all outstanding Secured Obligations of the Borrowers under, and as defined in, the Existing Loan and Security Agreement and the other Loan Documents shall remain outstanding, shall constitute continuing Secured Obligations secured by the Collateral, and this Agreement shall not be deemed to evidence or result in a novation or repayment and re-borrowing of such obligations and other liabilities.  The Borrowers hereby acknowledge and reaffirm each and every Loan Document entered into in connection with the Existing Loan and Security Agreement and acknowledges that each such Loan Document remains in full force and effect and enforceable against the Borrowers in accordance with its respective terms after giving effect to the execution and delivery of this Agreement without further action by Lender, the Borrowers or any other Person. All reference to the “Loan and Security Agreement” in each such Loan Document shall be deemed to be a reference to this Agreement.

 

(SIGNATURES TO FOLLOW)

 

35



 

IN WITNESS WHEREOF, the Borrowers and the Agent and Lender have duly executed and delivered this Amended and Restated Loan and Security Agreement as of the day and year first above written.

 

 

ADMINISTRATIVE BORROWER:

 

 

 

INSMED INCORPORATED

 

 

 

By:

/s/Andrew T. Drechsler

 

Name:

Andrew T. Drechsler

 

Its:

Chief Financial Officer

 

 

 

BORROWERS:

 

 

 

INSMED INCORPORATED

 

 

 

By:

/s/Andrew T. Drechsler

 

Name:

Andrew T. Drechsler

 

Its:

Chief Financial Officer

 

 

 

CELTRIX PHARMACEUTICALS, INC.

 

 

 

By:

/s/Andrew T. Drechsler

 

Name:

Andrew T. Drechsler

 

Its:

Chief Financial Officer

 

 

 

 

 

Accepted in Palo Alto, California:

 

 

 

 

AGENT:

 

 

 

HERCULES CAPITAL, INC. formerly known as Hercules Technology Growth Capital, Inc.)

 

 

 

 

By:

/s/Jennifer Choe

 

Name:

Jennifer Choe

 

Its:

Assistant General Counsel

 

 

 

LENDER:

 

 

 

HERCULES CAPITAL, INC. (formerly known as Hercules Technology Growth Capital, Inc.)

 

36



 

 

By:

 /s/Jennifer Choe

 

Name:

Jennifer Choe

 

Its:

Assistant General Counsel

 

 

HERCULES CAPITAL FUNDING TRUST 2014-1

 

 

 

 

 

By: Hercules Capital, Inc., Servicer

 

 

 

By:

/s/Jennifer Choe

 

Name:

Jennifer Choe

 

Its:

Assistant General Counsel

 

37



 

Table of Addenda, Exhibits and Schedules

 

Exhibit A:

 

Advance Request

 

 

Attachment to Advance Request

 

 

 

Exhibit B:

 

Term Note

 

 

 

Exhibit C:

 

Name, Locations, and Other Information for Borrowers

 

 

 

Exhibit D:

 

Borrowers’ Patents, Trademarks, Copyrights and Licenses

 

 

 

Exhibit E:

 

Borrowers’ Deposit Accounts and Investment Accounts

 

 

 

Exhibit F:

 

Compliance Certificate

 

 

 

Exhibit G:

 

Joinder Agreement

 

 

 

Exhibit H:

 

ACH Debit Authorization Agreement

 

 

 

Schedule 1

 

Subsidiaries

Schedule 1A

 

Existing Permitted Indebtedness

Schedule 1B

 

Existing Permitted Investments

Schedule 1C

 

Existing Permitted Liens

Schedule 5.3

 

Consents, Etc.

Schedule 5.5

 

Actions Before Governmental Authorities

Schedule 5.8

 

Tax Matters

Schedule 5.9

 

Intellectual Property Claims

Schedule 5.10

 

Intellectual Property

Schedule 5.11

 

Borrower Products

Schedule 5.14

 

Capitalization

 

38



 

EXHIBIT A

 

ADVANCE REQUEST

 

To:

The Agent:

Date:             [ ], 20[ ]

 

 

 

 

Hercules Capital, Inc.

 

 

400 Hamilton Avenue, Suite 310

 

 

Palo Alto, CA 94301

 

 

Facsimile: 650-473-9194

 

 

Attn: Bryan Jadot

 

 

Insmed Incorporated (the “Administrative Borrower”) hereby requests from Hercules Capital, Inc. (“Lender”) an Advance in the amount of [                      Dollars ($                ) on              ,      ] (the “Advance Date”) pursuant to the Amended and Restated Loan and Security Agreement between the Administrative Borrower, the other borrowers from time to time party thereto, and the Lender (the “Agreement”). Capitalized words and other terms used but not otherwise defined herein are used with the same meanings as defined in the Agreement.

 

Please:

Wire Funds to the Administrative Borrower’s account

 

 

 

Bank:

 

 

Address:

 

 

 

 

 

ABA Number:

 

 

Account Number:

 

 

Account Name:

 

 

The Administrative Borrower represents that the conditions precedent to the Advance set forth in the Agreement are satisfied and shall be satisfied upon the making of such Advance, including but not limited to:  (i) that no event that has had or could reasonably be expected to have a Material Adverse Effect has occurred and is continuing; (ii) that the representations and warranties set forth in the Agreement and in the Warrant are and shall be true and correct in all material respects on and as of the Advance Date with the same effect as though made on and as of such date, except to the extent such representations and warranties expressly relate to an earlier date; (iii) that each Borrower is in compliance, in all material respects, with all the terms and provisions set forth in each Loan Document on its part to be observed or performed; and (iv) that as of the Advance Date, no fact or condition exists that would (or would, with the passage of time, the giving of notice, or both) constitute an Event of Default under the Loan Documents.  The Administrative Borrower understands and acknowledges that the Agent and Lender has the right to review the financial information supporting this representation and, based upon such review, the Lender may decline to fund the requested Advance.

 

The Administrative Borrower hereby represents that the Borrowers’ corporate status and locations have not changed since the date of the Agreement or, if the Attachment to this Advance Request is completed, are as set forth in the Attachment to this Advance Request.

 

39



 

The Administrative Borrower agrees to notify the Agent promptly before the funding of the Loan if any of the matters which have been represented above shall not be true and correct on the Advance Date and if the Agent has received no such notice before the Advance Date then the statements set forth above shall be deemed to have been made and shall be deemed to be true and correct as of the Advance Date.

 

Executed as of [         ], 20[         ].

 

 

 

 

ADMINISTRATIVE BORROWER:

 

 

 

INSMED INCORPORATED

 

 

 

 

SIGNATURE:

 

 

TITLE:

 

 

PRINT NAME:

 

 

40



 

ATTACHMENT TO ADVANCE REQUEST

 

 

Dated:

 

 

 

The Administrative Borrower hereby represents and warrants to the Agent that each Borrower’s current name and organizational status is as follows:

 

Names:

[                                          ]

 

 

Type of organizations:

Corporation

 

 

States of organization:

[                                          ]

 

 

Organization file numbers:

 

 

The Administrative Borrower hereby represents and warrants to the Agent that the street addresses, cities, states and postal codes of each Borrower’s current locations are as follows:

 

41



 

EXHIBIT B

 

SECURED TERM PROMISSORY NOTE

 

$[  ],000,000

Advance Date:       , 20[  ]

 

 

 

Maturity Date: September 1, 2020

 

FOR VALUE RECEIVED, INSMED INCORPORATED, a Virginia corporation (“Parent”), for itself and each of its Subsidiaries joined to the below-defined Loan Agreement (the “Borrowers”) hereby promise to pay to the order of Hercules Capital, Inc., a Maryland corporation,  or the holder of this Note (the “Lender”) at 400 Hamilton Avenue, Suite 310, Palo Alto, CA 94301 or such other place of payment as the holder of this Secured Term Promissory Note (this “Promissory Note”) may specify from time to time in writing, in lawful money of the United States of America, the principal amount of [  ] Million Dollars ($[  ],000,000) or such other principal amount as Lender has advanced to the Borrowers, together with interest at a floating rate equal to the Term Loan Interest Rate (as defined in the Loan Agreement (as defined below)), with interest computed daily based on the actual number of days in each month.

 

This Promissory Note is the Note referred to in, and is executed and delivered in connection with, that certain Amended and Restated Loan and Security Agreement dated September 30, 2016 by and among the Borrowers, Hercules Capital, Inc., a Maryland corporation (the “Agent”) and the several banks and other financial institutions or entities from time to time party thereto as lender (as the same may from time to time be amended, modified or supplemented in accordance with its terms, the “Loan Agreement”), and is entitled to the benefit and security of the Loan Agreement and the other Loan Documents (as defined in the Loan Agreement), to which reference is made for a statement of all of the terms and conditions thereof.  All payments shall be made in accordance with the Loan Agreement.  All terms defined in the Loan Agreement shall have the same definitions when used herein, unless otherwise defined herein.  An Event of Default under the Loan Agreement shall constitute a default under this Promissory Note.

 

Each Borrower waives presentment and demand for payment, notice of dishonor, protest and notice of protest under the UCC or any applicable law.   The Borrowers agree to make all payments under this Promissory Note without setoff, recoupment or deduction and regardless of any counterclaim or defense.  This Promissory Note has been negotiated and delivered to Lender and is payable in the State of California.  This Promissory Note shall be governed by and construed and enforced in accordance with, the laws of the State of California, excluding any conflicts of law rules or principles that would cause the application of the laws of any other jurisdiction.

 

[ signature page follows ]

 



 

 

INSMED INCORPORATED

 

 

 

By:

 

 

Name:

 

 

Its:

 

 

 

 

 

CELTRIX PHARMACEUTICALS, INC.

 

 

 

 

By:

 

 

Name:

 

 

Its:

 

 



 

EXHIBIT C

 

NAME, LOCATIONS, AND OTHER INFORMATION FOR BORROWERS

 

1.                                       Each Borrower represents and warrants to the Agent and Lender that such Borrower’s current name and organizational status as of each applicable Advance Date is as follows:

 

Names:

Parent: Insmed Incorporated

 

 

 

Sub (1): Celtrix Pharmaceuticals, Inc.

 

 

Type of organizations:

Parent: Corporation

 

 

 

Sub (1): Corporation

 

 

States of organization:

Parent: Virginia

 

 

 

Sub (1): Delaware

 

 

Organization file numbers:

Parent: 05305412

 

 

 

Sub (1): 2248091

 

2.                                       Each Borrower represents and warrants to the Agent and Lender that for five (5) years prior to the Closing Date, such Borrower did not do business under any other name or organization or form except the following:

 

Name:            Transave, Inc. (Prior to Transave, LLC)
Used during dates of: Prior to December 1, 2010
Type of Organization: Corporation
State of organization: Delaware
Organization file Number: 2754858
Borrowers’ fiscal year ends on December 31
Borrowers’ federal employer tax identification numbers are

 

:                                                                                                                                                                                             Parent: Insmed Incorporated Tax ID# 54-1972729

 

Sub (1): Celtrix Pharmaceuticals, Inc. Tax ID# 94-3121462

 

3.                                       Each Borrower represents and warrants to the Agent and Lender that its chief executive office is located at 10 Finderne Avenue, Building 10, Bridgewater, NJ 08807.

 



 

EXHIBIT D

 

BORROWERS’ PATENTS, TRADEMARKS, COPYRIGHTS AND LICENSES

 

Patents

 

Insmed Allowed Applications / Issued Patents

 

Cooley Docket
No.

 

Client-Matter

 

Country

 

Application No.

 

Application
Date

 

Patent No.

 

Issue Date

 

INMD-004/02AU

 

315953-2036

 

Australia

 

2009303542

 

10/13/2009

 

2009303542

 

8/28/2014

 

INMD-004/03AU

 

315953-3181

 

Australia

 

2014201765

 

10/13/2009

 

2014201765

 

3/23/2016

 

INMD-005/02AU

 

315953-2070

 

Australia

 

2008316841

 

10/23/2008

 

2008316841

 

7/31/2014

 

INMD-012/01AU

 

315953-2088

 

Australia

 

2003304204

 

10/29/2003

 

2003304204

 

4/8/2010

 

INMD-012/03AU

 

315953-2007

 

Australia

 

2006270008

 

7/19/2006

 

2006270008

 

1/3/2013

 

INMD-018/01AU

 

315953-2024

 

Australia

 

2006322076

 

12/5/2006

 

2006322076

 

10/31/2013

 

INMD-012/01AT

 

315953-3151

 

Austria

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03AT

 

315953-3113

 

Austria

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05AT

 

315953-3259

 

Austria

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-015/01AT

 

315953-3292

 

Austria

 

E459637

 

12/20/2005

 

E459637

 

3/3/2010

 

INMD-048/01AT

 

315953-2683

 

Austria

 

04755315.1

 

6/14/2004

 

1646650

 

4/22/2009

 

INMD-052/00AT

 

315953-2898

 

Austria

 

99955220.1

 

5/28/1999

 

1082133

 

7/14/2004

 

INMD-012/01BE

 

315953-3152

 

Belgium

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03BE

 

315953-3112

 

Belgium

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05BE

 

315953-3260

 

Belgium

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-015/01BE

 

315953-3293

 

Belgium

 

05854704.3

 

12/20/2005

 

1828225

 

3/3/2010

 

INMD-048/01BE

 

315953-2684

 

Belgium

 

04755315.1

 

6/14/2004

 

1646650

 

4/22/2009

 

INMD-052/00BE

 

315953-2900

 

Belgium

 

99955220.1

 

5/28/1999

 

1082133

 

7/14/2004

 

INMD-012/01BG

 

315953-3153

 

Bulgaria

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03BG

 

315953-3114

 

Bulgaria

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05BG

 

315953-3261

 

Bulgaria

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-005/02CA

 

315953-2071

 

Canada

 

2703179

 

10/23/2008

 

2703179

 

6/7/2016

 

INMD-012/01CA

 

315953-2019

 

Canada

 

2504317

 

10/29/2003

 

2504317

 

5/22/2012

 

INMD-012/03CA

 

315953-2102

 

Canada

 

2614764

 

7/19/2006

 

2614764

 

3/18/2014

 

INMD-012/04CA

 

315953-2022

 

Canada

 

2646255

 

4/3/2007

 

2646255

 

8/26/2014

 

INMD-012/05CA

 

315953-3144

 

Canada

 

2838108

 

7/19/2006

 

2838108

 

5/17/2016

 

INMD-012/06CA

 

315953-3184

 

Canada

 

2853611

 

4/3/2007

 

 

 

 

 

INMD-015/01CA

 

315953-2243

 

Canada

 

2592014

 

12/20/2005

 

2592014

 

11/24/2015

 

INMD-018/01CA

 

315953-2031

 

Canada

 

2631872

 

12/5/2006

 

2631872

 

4/1/2014

 

INMD-018/02CA

 

315953-3145

 

Canada

 

2838111

 

12/5/2006

 

2838111

 

1/19/2016

 

INMD-048/01CA

 

315953-2368

 

Canada

 

2529282

 

6/14/2004

 

2529282

 

5/28/2013

 

INMD-052/00CA

 

315953-2136

 

Canada

 

2330925

 

5/28/1999

 

2330925

 

2/9/2010

 

INMD-012/01CN

 

315953-2090

 

China

 

200380106534.2

 

10/29/2003

 

ZL 200380106534.2

 

11/24/2010

 

INMD-012/03CN

 

315953-2029

 

China

 

200680034397.X

 

7/19/2006

 

ZL200680034397.X

 

8/7/2013

 

INMD-012/03CR

 

315953-2104

 

Costa Rica

 

9736

 

7/19/2006

 

2979

 

12/12/2013

 

INMD-012/01CY

 

315953-3155

 

Cyprus

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03CY

 

315953-3116

 

Cyprus

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

 



 

Insmed Allowed Applications / Issued Patents

 

Cooley Docket
No.

 

Client-Matter

 

Country

 

Application No.

 

Application
Date

 

Patent No.

 

Issue Date

 

INMD-012/05CY

 

315953-3263

 

Cyprus

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-012/01CZ

 

315953-3156

 

Czech Republic

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03CZ

 

315953-3117

 

Czech Republic

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05CZ

 

315953-3264

 

Czech Republic

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-012/01DK

 

315953-3158

 

Denmark

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03DK

 

315953-3119

 

Denmark

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05DK

 

315953-3266

 

Denmark

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-012/01EE

 

315953-3159

 

Estonia

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03EE

 

315953-3120

 

Estonia

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05EE

 

315953-3267

 

Estonia

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-012/01EP

 

315953-2091

 

European Patent Office

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03EP

 

315953-2047

 

European Patent Office

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/04EP

 

315953-2172

 

European Patent Office

 

07754853.5

 

4/3/2007

 

 

 

 

 

INMD-012/05EP

 

315953-2023

 

European Patent Office

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-015/01EP

 

315953-3296

 

European Patent Office

 

05854704.3

 

12/20/2005

 

1828225

 

3/3/2010

 

INMD-018/01EP

 

315953-2130

 

European Patent Office

 

06847502.9

 

12/5/2006

 

1962805

 

7/6/2016

 

INMD-048/01EP

 

315953-2369

 

European Patent Office

 

04755315.1

 

6/14/2004

 

1646650

 

4/22/2009

 

INMD-052/00EP

 

315953-2696

 

European Patent Office

 

99955220.1

 

5/28/1999

 

1082133

 

7/14/2004

 

INMD-057/01EP

 

315953-2051

 

European Patent Office

 

99926092.0

 

5/28/1999

 

1082427

 

8/10/2005

 

INMD-012/01FI

 

315953-3161

 

Finland

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03FI

 

315953-3122

 

Finland

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05FI

 

315953-3276

 

Finland

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-052/00FI

 

315953-2906

 

Finland

 

99955220.1

 

5/28/1999

 

1082133

 

7/14/2004

 

INMD-012/01FR

 

315953-3188

 

France

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03FR

 

315953-3123

 

France

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05FR

 

315953-3277

 

France

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-015/01FR

 

315953-3298

 

France

 

05854704.3

 

12/20/2005

 

1828225

 

3/3/2010

 

INMD-048/01FR

 

315953-2688

 

France

 

04755315.1

 

6/14/2004

 

1646650

 

4/22/2009

 

INMD-052/00FR

 

315953-2907

 

France

 

99955220.1

 

5/28/1999

 

1082133

 

7/14/2004

 

INMD-012/01DE

 

315953-3157

 

Germany

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03DE

 

315953-3118

 

Germany

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05DE

 

315953-3265

 

Germany

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-015/01DE

 

315953-3295

 

Germany

 

602005019784-2

 

12/20/2005

 

602005019784-2

 

3/3/2010

 

INMD-048/01DE

 

315953-2686

 

Germany

 

602004020771.3

 

6/14/2004

 

1646650

 

4/22/2009

 

INMD-052/00DE

 

315953-2904

 

Germany

 

99955220.1

 

5/28/1999

 

1082133

 

7/14/2004

 

INMD-012/01GR

 

315953-3163

 

Greece

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03GR

 

315953-3125

 

Greece

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05GR

 

315953-3279

 

Greece

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-015/01GR

 

315953-3300

 

Greece

 

05854704.3

 

12/20/2005

 

1828225

 

3/3/2010

 

INMD-012/03HN

 

315953-2108

 

Honduras

 

2008-84

 

7/19/2006

 

4987

 

1/24/2011

 

 



 

Insmed Allowed Applications / Issued Patents

 

Cooley Docket
No.

 

Client-Matter

 

Country

 

Application No.

 

Application
Date

 

Patent No.

 

Issue Date

 

INMD-012/03HK

 

315953-2107

 

Hong Kong

 

09102316.4

 

7/19/2006

 

1124770

 

1/30/2014

 

INMD-012/05HK

 

315953-2139

 

Hong Kong

 

12102361.3

 

10/29/2003

 

1162303

 

4/1/2016

 

INMD-012/01HU

 

315953-3164

 

Hungary

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03HU

 

315953-3126

 

Hungary

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05HU

 

315953-3280

 

Hungary

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-015/01HU

 

315953-3301

 

Hungary

 

05854704.3

 

12/20/2005

 

1828225

 

3/3/2010

 

INMD-048/01HU

 

315953-2690

 

Hungary

 

04755315.1

 

6/14/2004

 

E006533

 

4/22/2009

 

INMD-012/03IS

 

315953-3128

 

Iceland

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/01IN

 

315953-2087

 

India

 

2219/DELNP/2005

 

10/29/2003

 

243438

 

10/18/2010

 

INMD-012/01IE

 

315953-3165

 

Ireland

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03IE

 

315953-3127

 

Ireland

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05IE

 

315953-3281

 

Ireland

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-015/01IE

 

315953-3302

 

Ireland

 

05854704.3

 

12/20/2005

 

1828225

 

3/3/2010

 

INMD-048/01IE

 

315953-2691

 

Ireland

 

04755315.1

 

6/14/2004

 

1646650

 

4/22/2009

 

INMD-012/01IL

 

315953-2086

 

Israel

 

168279

 

10/29/2003

 

168279

 

10/1/2015

 

INMD-012/01IT

 

315953-3166

 

Italy

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03IT

 

315953-3129

 

Italy

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05IT

 

315953-3282

 

Italy

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-015/01IT

 

315953-3303

 

Italy

 

05854704.3

 

12/20/2005

 

1828225

 

3/3/2010

 

INMD-048/01IT

 

315953-2692

 

Italy

 

04755315.1

 

6/14/2004

 

1646650

 

4/22/2009

 

INMD-052/00IT

 

315953-2912

 

Italy

 

99955220.1

 

5/28/1999

 

1082133

 

7/14/2004

 

ELSN-002/02JP

 

321893-2002

 

Japan

 

2007-540183

 

11/8/2005

 

5735724

 

4/24/2015

 

INMD-004/02JP

 

315953-2012

 

Japan

 

2011-532180

 

10/13/2009

 

5677695

 

1/9/2015

 

INMD-005/02JP

 

315953-2073

 

Japan

 

2010-531241

 

10/23/2008

 

5855829

 

12/18/2015

 

INMD-012/01JP

 

315953-2092

 

Japan

 

2005-500829

 

10/29/2003

 

5118302

 

10/26/2012

 

INMD-012/02JP

 

315953-2097

 

Japan

 

2011-1318

 

10/29/2003

 

5411878

 

11/15/2013

 

INMD-012/03JP

 

315953-2110

 

Japan

 

2008-522895

 

7/19/2006

 

5415759

 

11/22/2013

 

INMD-012/04JP

 

315953-2173

 

Japan

 

2009-504281

 

4/3/2007

 

5918922

 

4/15/2016

 

INMD-012/05JP

 

315953-3098

 

Japan

 

2013-146934

 

7/19/2006

 

5800865

 

9/4/2015

 

INMD-012/06JP

 

315953-3102

 

Japan

 

2013-167610

 

10/29/2003

 

5684343

 

1/23/2015

 

INMD-012/08JP

 

315953-3215

 

Japan

 

2014-196130

 

7/19/2006

 

5902782

 

3/18/2016

 

INMD-018/01JP

 

315953-2202

 

Japan

 

2008-544430

 

12/5/2006

 

5324223

 

7/26/2013

 

INMD-047/01JP

 

315953-2365

 

Japan

 

2009-504301

 

4/4/2007

 

5600432

 

8/22/2014

 

INMD-012/03LV

 

315953-3132

 

Latvia

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05LI

 

315953-3283

 

Liechtenstein

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-012/03LT

 

315953-3130

 

Lithuania

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-015/01LT

 

315953-3304

 

Lithuania

 

5854704.3

 

12/20/2005

 

1828225

 

3/3/2010

 

INMD-012/01LU

 

315953-3167

 

Luxembourg

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03LU

 

315953-3131

 

Luxembourg

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-015/01LU

 

315953-3305

 

Luxembourg

 

05854704.3

 

12/20/2005

 

1828225

 

3/3/2010

 

INMD-005/02MX

 

315953-2074

 

Mexico

 

MX/a/2010/004389

 

10/23/2008

 

334870

 

11/17/2015

 

INMD-012/01MX

 

315953-2028

 

Mexico

 

PA/a/2005/004580

 

10/29/2003

 

276999

 

7/1/2010

 

INMD-012/02MX

 

315953-2098

 

Mexico

 

MX/a/2010/000195

 

10/29/2003

 

318205

 

2/26/2014

 

 



 

Insmed Allowed Applications / Issued Patents

 

Cooley Docket
No.

 

Client-Matter

 

Country

 

Application No.

 

Application
Date

 

Patent No.

 

Issue Date

 

INMD-012/03MX

 

315953-2114

 

Mexico

 

MX/a/2008/000425

 

7/19/2006

 

280091

 

10/18/2010

 

INMD-012/04MX

 

315953-2122

 

Mexico

 

MX/a/2008/012684

 

4/3/2007

 

293096

 

12/5/2011

 

INMD-012/01MC

 

315953-3168

 

Monaco

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03MC

 

315953-3133

 

Monaco

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05MC

 

315953-3284

 

Monaco

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-004/02ME

 

315953-2042

 

Montenegro

 

P-2011/64

 

10/13/2009

 

01166

 

3/20/2014

 

INMD-012/03ME

 

315953-2113

 

Montenegro

 

P-68/2009

 

7/19/2006

 

00597

 

8/16/2011

 

INMD-012/01NL

 

315953-3169

 

Netherlands

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03NL

 

315953-3134

 

Netherlands

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05NL

 

315953-3285

 

Netherlands

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-015/01NL

 

315953-3306

 

Netherlands

 

05854704.3

 

12/20/2005

 

1828225

 

3/3/2010

 

INMD-052/00NL

 

315953-2916

 

Netherlands

 

99955220.1

 

5/28/1999

 

1082133

 

7/14/2004

 

INMD-004/02NZ

 

315953-2014

 

New Zealand

 

592217

 

10/13/2009

 

592217

 

7/2/2013

 

INMD-004/03NZ

 

315953-3080

 

New Zealand

 

606383

 

10/13/2009

 

606383

 

1/6/2015

 

INMD-012/01NZ

 

315953-2093

 

New Zealand

 

540087

 

10/29/2003

 

540087

 

1/8/2009

 

INMD-012/03NZ

 

315953-2116

 

New Zealand

 

565300

 

7/19/2006

 

565300

 

11/7/2011

 

INMD-012/03PL

 

315953-3135

 

Poland

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-015/01PL

 

315953-3307

 

Poland

 

05854704.3

 

12/20/2005

 

1828225

 

3/3/2010

 

INMD-048/01PL

 

315953-2693

 

Poland

 

04755315.1

 

6/14/2004

 

1646650

 

4/22/2009

 

INMD-012/01PT

 

315953-3170

 

Portugal

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03PT

 

315953-3136

 

Portugal

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05PT

 

315953-3286

 

Portugal

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-012/01KR

 

315953-2020

 

Republic of Korea

 

10-2005-7007679

 

10/29/2003

 

10-1301653

 

8/23/2013

 

INMD-012/02KR

 

315953-3088

 

Republic of Korea

 

10-2013-7010499

 

10/29/2003

 

10-1424980

 

7/24/2014

 

INMD-012/03KR

 

315953-2111

 

Republic of Korea

 

10-2008-7002031

 

7/19/2006

 

10-1358660

 

1/28/2014

 

INMD-012/04KR

 

315953-3106

 

Republic of Korea

 

10-2013-7031379

 

7/19/2006

 

10-1437338

 

8/28/2014

 

INMD-012/05KR

 

315953-3180

 

Republic of Korea

 

10-2014-7005780

 

10/29/2003

 

10-1504616

 

3/16/2015

 

INMD-012/01RO

 

315953-3171

 

Romania

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03RO

 

315953-3137

 

Romania

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05RO

 

315953-3287

 

Romania

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-015/01RO

 

315953-2532

 

Romania

 

05854704.3

 

12/20/2005

 

1828225

 

3/3/2010

 

INMD-004/02RU

 

315953-2044

 

Russian Federation

 

2011119018

 

10/13/2009

 

2537238

 

10/31/2014

 

INMD-012/03RU

 

315953-2048

 

Russian Federation

 

2008102651

 

7/19/2006

 

2438655

 

1/10/2012

 

INMD-012/03SG

 

315953-2118

 

Singapore

 

200800137-2

 

7/19/2006

 

138968

 

8/31/2010

 

INMD-012/01SK

 

315953-3174

 

Slovakia

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03SK

 

315953-3140

 

Slovakia

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05SK

 

315953-3290

 

Slovakia

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-012/01SI

 

315953-3173

 

Slovenia

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03SL

 

315953-3139

 

Slovenia

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05SI

 

315953-3289

 

Slovenia

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-004/02ZA

 

315953-2004

 

South Africa

 

2011/02745

 

10/13/2009

 

2011/02745

 

12/28/2011

 

 



 

Insmed Allowed Applications / Issued Patents

 

Cooley Docket
No.

 

Client-Matter

 

Country

 

Application No.

 

Application
Date

 

Patent No.

 

Issue Date

 

INMD-012/01ZA

 

315953-2096

 

South Africa

 

2005/04281

 

10/29/2003

 

2005/04281

 

9/27/2006

 

INMD-012/03ZA

 

315953-2030

 

South Africa

 

2008/00367

 

7/19/2006

 

2008/00367

 

12/31/2008

 

INMD-012/01ES

 

315953-3160

 

Spain

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03ES

 

315953-3121

 

Spain

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05ES

 

315953-3268

 

Spain

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-015/01ES

 

315953-3297

 

Spain

 

05854704.3

 

12/20/2005

 

1828225

 

3/3/2010

 

INMD-048/01ES

 

315953-2687

 

Spain

 

04755315.1

 

6/14/2004

 

1646650

 

4/22/2009

 

INMD-052/00ES

 

315953-2905

 

Spain

 

99955220.1

 

5/28/1999

 

1082133

 

7/14/2004

 

INMD-012/01SE

 

315953-3172

 

Sweden

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03SE

 

315953-3138

 

Sweden

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05SE

 

315953-3288

 

Sweden

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-015/01SE

 

315953-3308

 

Sweden

 

5854704.3

 

12/20/2005

 

05854704-3

 

3/3/2010

 

INMD-048/01SE

 

315953-2694

 

Sweden

 

04755315.1

 

6/14/2004

 

1646650

 

4/22/2009

 

INMD-052/00SE

 

315953-2919

 

Sweden

 

99955220.1

 

5/28/1999

 

1082133

 

7/14/2004

 

INMD-012/01CH

 

315953-3154

 

Switzerland

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03CH

 

315953-3115

 

Switzerland

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05CH

 

315953-3262

 

Switzerland

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-015/01CH

 

315953-3294

 

Switzerland

 

05854704.3

 

12/20/2005

 

1828225

 

3/3/2010

 

INMD-048/01CH

 

315953-2685

 

Switzerland

 

04755315.1

 

6/14/2004

 

1646650

 

4/22/2009

 

INMD-052/00CH

 

315953-2902

 

Switzerland

 

99955220.1

 

5/28/1999

 

1082133

 

7/14/2004

 

INMD-012/01TR

 

315953-3175

 

Turkey

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03TR

 

315953-3141

 

Turkey

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05TR

 

315953-3291

 

Turkey

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-004/02UA

 

315953-2045

 

Ukraine

 

201105955

 

10/13/2009

 

105644

 

6/10/2014

 

INMD-012/01GB

 

315953-3162

 

United Kingdom

 

03816990.0

 

10/29/2003

 

1581236

 

10/16/2013

 

INMD-012/03GB

 

315953-3124

 

United Kingdom

 

06787716.7

 

7/19/2006

 

1909759

 

9/4/2013

 

INMD-012/05GB

 

315953-3278

 

United Kingdom

 

11159754.8

 

10/29/2003

 

2363114

 

5/20/2015

 

INMD-015/01GB

 

315953-3299

 

United Kingdom

 

05854704.3

 

12/20/2005

 

1828225

 

3/3/2010

 

INMD-048/01GB

 

315953-2689

 

United Kingdom

 

04755315.1

 

6/14/2004

 

1646650

 

4/22/2009

 

INMD-052/00GB

 

315953-2908

 

United Kingdom

 

99955220.1

 

5/28/1999

 

1082133

 

7/14/2004

 

ELSN-001/02US

 

321893-2001

 

United States

 

12/027,752

 

2/7/2008

 

9,186,322

 

11/17/2015

 

ELSN-003/02US

 

321893-2003

 

United States

 

12/122,191

 

5/16/2008

 

9,107,824

 

8/18/2015

 

ELSN-004/03US

 

321893-2051

 

United States

 

10/224,532

 

8/20/2002

 

6,793,912

 

9/21/2004

 

INMD-004/01US

 

315953-2017

 

United States

 

12/250,412

 

10/13/2008

 

9,114,081

 

8/25/2015

 

INMD-004/03US

 

315953-2540

 

United States

 

13/480,246

 

5/24/2012

 

9,119,783

 

9/1/2015

 

INMD-004/04US

 

315953-2775

 

United States

 

13/566,707

 

8/3/2012

 

9,333,214

 

5/10/2016

 

INMD-012/01US

 

315953-2094

 

United States

 

10/696,389

 

10/29/2003

 

7,544,369

 

6/9/2009

 

INMD-012/03US

 

315953-2119

 

United States

 

11/185,448

 

7/19/2005

 

7,718,189

 

5/18/2010

 

INMD-012/04US

 

315953-2174

 

United States

 

11/398,859

 

4/6/2006

 

7,879,351

 

2/1/2011

 

INMD-012/06US

 

315953-2049

 

United States

 

12/748,756

 

3/29/2010

 

8,802,137

 

8/12/2014

 

INMD-015/01US

 

315953-2196

 

United States

 

11/311,633

 

12/20/2005

 

7,968,679

 

6/28/2011

 

 



 

Insmed Allowed Applications / Issued Patents

 

Cooley Docket
No.

 

Client-Matter

 

Country

 

Application No.

 

Application
Date

 

Patent No.

 

Issue Date

 

INMD-018/01US

 

315953-2131

 

United States

 

11/634,343

 

12/5/2006

 

8,226,975

 

7/24/2012

 

INMD-018/02US

 

315953-2541

 

United States

 

13/527,213

 

6/19/2012

 

8,632,804

 

1/21/2014

 

INMD-018/03US

 

315953-2774

 

United States

 

13/664,181

 

10/30/2012

 

8,679,532

 

3/25/2014

 

INMD-018/04US

 

315953-2778

 

United States

 

13/666,420

 

11/1/2012

 

8,642,075

 

2/4/2014

 

INMD-018/05US

 

315953-2779

 

United States

 

13/675,559

 

11/13/2012

 

8,673,348

 

3/18/2014

 

INMD-018/06US

 

315953-2780

 

United States

 

13/675,587

 

11/13/2012

 

8,673,349

 

3/18/2014

 

INMD-018/08US

 

315953-3256

 

United States

 

14/987,508

 

1/4/2016

 

9,402,845

 

8/2/2016

 

INMD-019/02US

 

315953-2133

 

United States

 

10/130,951

 

11/17/2000

 

7,060,291

 

6/13/2006

 

INMD-026/02US

 

315953-2228

 

United States

 

08/950,618

 

10/15/1997

 

6,087,325

 

7/11/2000

 

INMD-026/05US

 

315953-2230

 

United States

 

09/343,650

 

6/29/1999

 

6,339,069

 

1/15/2002

 

INMD-048/01US

 

315953-3094

 

United States

 

10/866,086

 

6/14/2004

 

7,354,994

 

4/8/2008

 

INMD-050/02US

 

315953-2058

 

United States

 

10/778,636

 

2/13/2004

 

7,371,813

 

5/13/2008

 

INMD-052/00US

 

315953-2059

 

United States

 

09/089,062

 

6/1/1998

 

6,436,897

 

8/20/2002

 

INMD-055/00US

 

315953-2936

 

United States

 

09/326,189

 

6/4/1999

 

6,040,292

 

3/21/2000

 

INMD-057/01US

 

315953-2949

 

United States

 

09/322,484

 

5/27/1999

 

6,417,330

 

7/9/2002

 

INMD-092/03US

 

315953-2874

 

United States

 

09/418,861

 

6/1/1998

 

6,518,238

 

2/11/2003

 

INMD-092/04US

 

315953-3045

 

United States

 

09/123,217

 

7/27/1998

 

6,514,937

 

2/4/2003

 

INMD-093/01US

 

315953-2884

 

United States

 

09/123,050

 

7/27/1998

 

6,087,090

 

7/11/2000

 

INMD-120/05US

 

315953-3217

 

United States

 

14/523,538

 

10/24/2014

 

 

 

 

 

INMD-120/07US

 

315953-3230

 

United States

 

14/641,104

 

3/6/2015

 

9,255,064

 

2/9/2016

 

 

Insmed Pending Patent Applications

 

Cooley Docket
No.

 

Client-Matter

 

Country

 

Application No.

 

Application
Date

 

Publication No.

 

Publication
Date

 

INMD-005/03AU

 

315953-3186

 

Australia

 

2014202745

 

10/23/2008

 

 

 

 

 

INMD-056/01AU

 

315953-3202

 

Australia

 

2013266400

 

5/21/2013

 

 

 

 

 

INMD-096/01AU

 

315953-3233

 

Australia

 

2013352259

 

11/27/2013

 

 

 

 

 

INMD-117/01AU

 

315953-3242

 

Australia

 

2013351934

 

12/2/2013

 

 

 

 

 

INMD-119/02AU

 

315953-3319

 

Australia

 

2014290536

 

7/17/2014

 

 

 

 

 

INMD-120/05AU

 

315953-3340

 

Australia

 

2014339866

 

10/24/2014

 

 

 

 

 

INMD-004/02BR

 

315953-2008

 

Brazil

 

PI0920334-6

 

10/13/2009

 

1223097

 

3/1/2016

 

INMD-012/03BR

 

315953-2101

 

Brazil

 

PI0613865-9

 

7/19/2006

 

PI0613865-9

 

 

 

INMD-056/01BR

 

315953-3203

 

Brazil

 

1120140290105

 

5/21/2013

 

 

 

 

 

INMD-096/01BR

 

315953-3234

 

Brazil

 

1120150123511

 

11/27/2013

 

 

 

 

 

INMD-117/01BR

 

315953-3243

 

Brazil

 

1120150125476

 

12/2/2013

 

 

 

 

 

INMD-120/05BR

 

315953-3346

 

Brazil

 

1120160092074

 

10/24/2014

 

 

 

 

 

ELSN-001/02CA

 

321893-2020

 

Canada

 

2724230

 

2/6/2009

 

 

 

 

 

INMD-004/02CA

 

315953-2037

 

Canada

 

2739954

 

10/13/2009

 

 

 

 

 

INMD-015/02CA

 

315953-3274

 

Canada

 

2899824

 

12/20/2005

 

 

 

 

 

INMD-018/03CA

 

315953-3271

 

Canada

 

2896083

 

12/5/2006

 

 

 

 

 

INMD-056/01CA

 

315953-3204

 

Canada

 

2870860

 

5/21/2013

 

 

 

 

 

 



 

Insmed Pending Patent Applications

 

Cooley Docket
No.

 

Client-Matter

 

Country

 

Application No.

 

Application
Date

 

Publication No.

 

Publication
Date

 

INMD-096/01CA

 

315953-3235

 

Canada

 

2891487

 

11/27/2013

 

 

 

 

 

INMD-117/01CA

 

315953-3244

 

Canada

 

2890219

 

12/2/2013

 

 

 

 

 

INMD-119/02CA

 

315953-3320

 

Canada

 

2917605

 

7/17/2014

 

 

 

 

 

INMD-120/05CA

 

315953-3341

 

Canada

 

2927788

 

10/24/2014

 

 

 

 

 

INMD-004/02CL

 

315953-2009

 

Chile

 

814-2011

 

10/13/2009

 

814-2011

 

 

 

INMD-004/03CN

 

315953-3219

 

China

 

201410564453.7

 

10/13/2009

 

104523594A

 

4/22/2015

 

INMD-005/03CN

 

315953-3150

 

China

 

201410050891.1

 

10/23/2008

 

103860469A

 

6/18/2014

 

INMD-012/04CN

 

315953-3087

 

China

 

201310149581.0

 

7/19/2006

 

103263387

 

8/28/2013

 

INMD-056/01CN

 

315953-3205

 

China

 

201380030763.4

 

5/21/2013

 

104349783A

 

2/11/2015

 

INMD-096/01CN

 

315953-3254

 

China

 

201380068974.7

 

11/27/2013

 

104884047A

 

9/2/2015

 

INMD-117/01CN

 

315953-3245

 

China

 

201380062668.2

 

12/2/2013

 

104822372A

 

8/5/2015

 

INMD-120/05CN

 

315953-3347

 

China

 

201480070936.X

 

10/24/2014

 

105848479A

 

8/10/2016

 

INMD-012/03CO

 

315953-2103

 

Colombia

 

08016117

 

7/19/2006

 

 

 

 

 

INMD-056/01CO

 

315953-3206

 

Colombia

 

14-244438

 

5/21/2013

 

 

 

 

 

INMD-012/03EG

 

315953-2106

 

Egypt

 

PCT84/2008

 

7/19/2006

 

 

 

 

 

INMD-120/05EA

 

315953-3348

 

Eurasian Patent Organization

 

201690623

 

10/24/2014

 

 

 

 

 

ELSN-001/02EP

 

321893-2021

 

European Patent Office

 

09708680.5

 

2/6/2009

 

2252304

 

 

 

INMD-004/02EP

 

315953-2011

 

European Patent Office

 

09821103.0

 

10/13/2009

 

2349282

 

8/3/2011

 

INMD-005/02EP

 

315953-2027

 

European Patent Office

 

08840993.3

 

10/23/2008

 

2214645

 

 

 

INMD-012/06EP

 

315953-3101

 

European Patent Office

 

13175824.5

 

7/19/2006

 

2649988

 

10/16/2013

 

INMD-012/08EP

 

315953-3199

 

European Patent Office

 

14183066.1

 

10/29/2003

 

2823820

 

1/14/2015

 

INMD-018/02EP

 

315953-3332

 

European Patent Office

 

16156100.6

 

12/5/2006

 

3067047

 

9/14/2016

 

INMD-018/03EP

 

315953-3333

 

European Patent Office

 

16156099.0

 

12/5/2006

 

3067046

 

9/14/2016

 

INMD-047/01EP

 

315953-2363

 

European Patent Office

 

07754936.8

 

4/4/2007

 

2012750

 

 

 

INMD-056/01EP

 

315953-3207

 

European Patent Office

 

13793204.2

 

5/21/2013

 

2852391

 

4/1/2015

 

INMD-096/01EP

 

315953-3236

 

European Patent Office

 

13858844.7

 

11/27/2013

 

2925298

 

10/7/2015

 

INMD-117/01EP

 

315953-3246

 

European Patent Office

 

13859435.3

 

12/2/2013

 

2925303

 

10/7/2015

 

INMD-119/02EP

 

315953-3321

 

European Patent Office

 

14827034.1

 

7/17/2014

 

3021920

 

5/25/2016

 

INMD-120/05EP

 

315953-3342

 

European Patent Office

 

14855785.3

 

10/24/2014

 

3060041

 

8/31/2016

 

ELSN-001/02HK

 

321893-2010

 

Hong Kong

 

11105186.0

 

2/6/2009

 

1150979

 

1/20/2012

 

INMD-004/02HK

 

315953-2015

 

Hong Kong

 

12101079.8

 

10/13/2009

 

 

 

 

 

INMD-012/04HK

 

315953-3108

 

Hong Kong

 

13112330.9

 

7/19/2006

 

1184711A

 

1/30/2014

 

INMD-012/06HK

 

315953-3183

 

Hong Kong

 

14103632.2

 

7/19/2006

 

1190338A

 

7/4/2014

 

INMD-012/08HK

 

315953-3224

 

Hong Kong

 

15102375.4

 

10/29/2003

 

1201749A

 

9/11/2015

 

INMD-056/01HK

 

315953-3227

 

Hong Kong

 

15103492.0

 

5/21/2013

 

1202812A

 

10/9/2015

 

INMD-096/01HK

 

315953-3339

 

Hong Kong

 

16103947.0

 

11/27/2013

 

 

 

 

 

INMD-117/01HK

 

315953-3345

 

Hong Kong

 

16103948.9

 

12/2/2013

 

 

 

 

 

INMD-005/02IN

 

315953-2072

 

India

 

3616/DELNP/2010

 

10/23/2008

 

 

 

 

 

 



 

Insmed Pending Patent Applications

 

Cooley Docket
No.

 

Client-Matter

 

Country

 

Application No.

 

Application
Date

 

Publication No.

 

Publication
Date

 

INMD-012/03IN

 

315953-2109

 

India

 

353/DELNP/2008

 

7/19/2006

 

 

 

8/8/2008

 

INMD-012/04IN

 

315953-3196

 

India

 

6406/DELNP/2014

 

7/19/2006

 

 

 

 

 

INMD-056/01IN

 

315953-3209

 

India

 

9003/DELNP/2014

 

5/21/2013

 

 

 

 

 

INMD-004/02ID

 

315953-2038

 

Indonesia

 

W00201101412

 

10/13/2009

 

 

 

 

 

INMD-004/03ID

 

315953-3191

 

Indonesia

 

P00201406127

 

10/13/2009

 

 

 

 

 

INMD-004/02IL

 

315953-2039

 

Israel

 

212268

 

10/13/2009

 

 

 

 

 

INMD-012/04IL

 

315953-2016

 

Israel

 

216401

 

7/19/2006

 

 

 

 

 

INMD-012/05IL

 

315953-3221

 

Israel

 

236190

 

10/29/2003

 

 

 

 

 

INMD-012/06IL

 

315953-3370

 

Israel

 

246026

 

7/19/2006

 

 

 

 

 

INMD-056/01IL

 

315953-3208

 

Israel

 

234898

 

5/21/2013

 

 

 

 

 

INMD-117/01IL

 

315953-3247

 

Israel

 

238984

 

12/2/2013

 

 

 

 

 

INMD-120/05IL

 

315953-3349

 

Israel

 

245184

 

10/24/2014

 

 

 

 

 

INMD-004/03JP

 

315953-3182

 

Japan

 

2014-75240

 

10/13/2009

 

2014-122249

 

7/3/2014

 

INMD-005/04JP

 

315953-3354

 

Japan

 

2016-82745

 

10/23/2008

 

2016-130262

 

7/21/2016

 

INMD-012/09JP

 

315953-3220

 

Japan

 

2014-222230

 

10/29/2003

 

2015-25016

 

2/5/2015

 

INMD-012/10JP

 

315953-3326

 

Japan

 

2016-003289

 

7/19/2006

 

2016-56194

 

4/21/2016

 

INMD-012/11JP

 

315953-3336

 

Japan

 

2016-29641

 

10/29/2003

 

2016-104807

 

6/9/2016

 

INMD-012/12JP

 

315953-3359

 

Japan

 

2016-105882

 

4/3/2007

 

 

 

 

 

INMD-047/03JP

 

315953-3197

 

Japan

 

2014-165736

 

4/4/2007

 

2014-210819

 

11/13/2014

 

INMD-056/01JP

 

315953-3210

 

Japan

 

2015-514136

 

5/21/2013

 

2015-517576

 

 

 

INMD-096/01JP

 

315953-3237

 

Japan

 

2015-545418

 

11/27/2013

 

2016-505545

 

2/25/2016

 

INMD-117/01JP

 

315953-3248

 

Japan

 

2015-545499

 

12/2/2013

 

 

 

4/17/2015

 

INMD-119/02JP

 

315953-3322

 

Japan

 

2016-527100

 

7/17/2014

 

 

 

 

 

INMD-120/05JP

 

315953-3350

 

Japan

 

2016-525531

 

10/24/2014

 

 

 

 

 

INMD-012/03KS

 

315953-2112

 

Kosovo

 

861

 

7/19/2006

 

 

 

 

 

INMD-004/02MX

 

315953-2013

 

Mexico

 

MX/a/2011/003760

 

10/13/2009

 

 

 

 

 

INMD-005/03MX

 

315953-3270

 

Mexico

 

MX/a/2015/008005

 

10/23/2008

 

 

 

 

 

INMD-005/04MX

 

315953-3311

 

Mexico

 

MX/a/2015/015702

 

10/23/2008

 

 

 

 

 

INMD-012/05MX

 

315953-3143

 

Mexico

 

2013-013982

 

10/29/2003

 

 

 

 

 

INMD-056/01MX

 

315953-3212

 

Mexico

 

MX/a/2014/014219

 

5/21/2013

 

 

 

 

 

INMD-096/01MX

 

315953-3238

 

Mexico

 

MX/a/2015/006681

 

11/27/2013

 

 

 

 

 

INMD-120/05MX

 

315953-3352

 

Mexico

 

MX/a/2016/005293

 

10/24/2014

 

 

 

 

 

INMD-056/01NZ

 

315953-3213

 

New Zealand

 

700983

 

5/21/2013

 

 

 

 

 

INMD-056/02NZ

 

315953-3356

 

New Zealand

 

719739

 

5/21/2013

 

 

 

 

 

INMD-096/01NZ

 

315953-3239

 

New Zealand

 

708082

 

11/27/2013

 

 

 

 

 

INMD-117/01NZ

 

315953-3250

 

New Zealand

 

707551

 

12/2/2013

 

 

 

 

 

INMD-120/05NZ

 

315953-3343

 

New Zealand

 

719297

 

10/24/2014

 

 

 

 

 

INMD-012/03NI

 

315953-2115

 

Nicaragua

 

2008-000019

 

7/19/2006

 

 

 

 

 

INMD-122/04WO

 

315953-3255

 

Patent Cooperation Treaty

 

PCT/US2015/031079

 

5/15/2015

 

WO 2015/175939

 

11/19/2015

 

INMD-123/02WO

 

315953-3358

 

Patent Cooperation Treaty

 

PCT/US2016/044542

 

7/28/2016

 

 

 

 

 

 



 

Insmed Pending Patent Applications

 

Cooley Docket
No.

 

Client-Matter

 

Country

 

Application No.

 

Application
Date

 

Publication No.

 

Publication
Date

 

INMD-124/01WO

 

315953-3367

 

Patent Cooperation Treaty

 

PCT/US2016/043940

 

7/25/2016

 

 

 

 

 

INMD-125/01WO

 

315953-3361

 

Patent Cooperation Treaty

 

PCT/US2016/041776

 

7/11/2016

 

 

 

 

 

INMD-127/01WO

 

315953-3315

 

Patent Cooperation Treaty

 

PCT/US2015/061427

 

11/18/2015

 

WO 2016/081658

 

5/26/2016

 

INMD-128/01WO

 

315953-3317

 

Patent Cooperation Treaty

 

PCT/US2016/030049

 

4/29/2016

 

 

 

 

 

INMD-004/02PH

 

315953-2043

 

Philippines

 

1-2011-500726

 

10/13/2009

 

 

 

 

 

INMD-004/02KR

 

315953-2041

 

Republic of Korea

 

10-2011-7008430

 

10/13/2009

 

 

 

 

 

INMD-056/01KR

 

315953-3211

 

Republic of Korea

 

10-2014-7035838

 

5/21/2013

 

10-2015-0020224

 

2/25/2015

 

INMD-117/01KR

 

315953-3249

 

Republic of Korea

 

10-2015-7017536

 

12/2/2013

 

10-2015-0089087

 

8/4/2015

 

INMD-120/05KR

 

315953-3351

 

Republic of Korea

 

10-2016-7013749

 

10/24/2014

 

 

 

6/28/2016

 

INMD-056/01RU

 

315953-3214

 

Russian Federation

 

2014151554

 

5/21/2013

 

 

 

 

 

INMD-096/01RU

 

315953-3240

 

Russian Federation

 

2015125293

 

11/27/2013

 

 

 

 

 

INMD-012/03RS

 

315953-2117

 

Serbia

 

P-19/2008

 

7/19/2006

 

 

 

7/15/2009

 

INMD-004/02SG

 

315953-2006

 

Singapore

 

201102419-7

 

10/13/2009

 

 

 

 

 

INMD-004/03UA

 

315953-3176

 

Ukraine

 

a201401583

 

10/13/2009

 

 

 

 

 

ELSN-003/03US

 

321893-2063

 

United States

 

14/796,920

 

7/10/2015

 

 

 

 

 

INMD-003/02US

 

315953-3149

 

United States

 

14/198,724

 

3/6/2014

 

2014-0248335

 

9/4/2014

 

INMD-004/05US

 

315953-3272

 

United States

 

14/809,127

 

7/24/2015

 

 

 

5/26/2016

 

INMD-004/06US

 

315953-3273

 

United States

 

14/809,128

 

7/24/2015

 

 

 

6/2/2016

 

INMD-005/02US

 

315953-2018

 

United States

 

12/256,692

 

10/23/2008

 

2009-0104257

 

4/23/2009

 

INMD-012/05US

 

315953-2005

 

United States

 

12/424,177

 

4/15/2009

 

2010-0068257

 

3/18/2010

 

INMD-012/07US

 

315953-2176

 

United States

 

12/983,659

 

1/3/2011

 

2011-0159079

 

6/30/2011

 

INMD-012/08US

 

315953-3192

 

United States

 

14/319,018

 

6/30/2014

 

2014-0314835

 

10/23/2014

 

INMD-012/09US

 

315953-3337

 

United States

 

15/093,180

 

4/7/2016

 

 

 

 

 

INMD-018/07US

 

315953-3109

 

United States

 

14/080,922

 

11/15/2013

 

2014-0072620

 

3/13/2014

 

INMD-018/09US

 

315953-3334

 

United States

 

15/066,346

 

3/10/2016

 

2016-0184301

 

6/30/2016

 

INMD-018/10US

 

315953-3335

 

United States

 

15/066,360

 

3/10/2016

 

2016-0184302

 

6/30/2016

 

INMD-018/11US

 

315953-3362

 

United States

 

15/205,918

 

7/8/2016

 

 

 

 

 

INMD-018/12US

 

315953-3363

 

United States

 

15/205,925

 

7/8/2016

 

 

 

 

 

INMD-018/13US

 

315953-3369

 

United States

 

15/241,439

 

8/19/2016

 

 

 

 

 

INMD-047/01US

 

315953-2025

 

United States

 

11/696,343

 

4/4/2007

 

2008-0089927

 

4/17/2008

 

INMD-056/01US

 

315953-3084

 

United States

 

13/899,457

 

5/21/2013

 

2013-0330400

 

12/12/2013

 

INMD-096/01US

 

315953-3241

 

United States

 

14/648,203

 

11/27/2013

 

2015-0314002

 

11/5/2015

 

INMD-117/01US

 

315953-3251

 

United States

 

14/648,632

 

12/2/2013

 

2015-0328232

 

11/19/2015

 

INMD-119/02US

 

315953-3193

 

United States

 

14/334,121

 

7/17/2014

 

2015-0020802

 

1/22/2015

 

INMD-119/03US

 

315953-3323

 

United States

 

14/905,274

 

7/17/2014

 

2016-0175553

 

6/23/2016

 

INMD-120/06US

 

315953-3344

 

United States

 

15/031,604

 

10/24/2014

 

 

 

 

 

INMD-120/09US

 

315953-3313

 

United States

 

15/154,631

 

5/13/2016

 

 

 

 

 

INMD-122/04US

 

315953-3257

 

United States

 

14/713,926

 

5/15/2015

 

2015-0328244

 

11/19/2015

 

 



 

Insmed Pending Patent Applications

 

Cooley Docket
No.

 

Client-Matter

 

Country

 

Application No.

 

Application
Date

 

Publication No.

 

Publication
Date

 

INMD-123/01US

 

315953-3329

 

United States

 

62/293,121

 

2/9/2016

 

 

 

 

 

INMD-124/01US

 

315953-3366

 

United States

 

15/219,219

 

7/25/2016

 

 

 

 

 

INMD-126/00US

 

315953-3318

 

United States

 

62/256,851

 

11/18/2015

 

 

 

 

 

INMD-128/01US

 

315953-3316

 

United States

 

15/142,569

 

4/29/2016

 

 

 

 

 

INMD-130/00US

 

315953-3360

 

United States

 

62/354,234

 

6/24/2016

 

 

 

 

 

INMD-131/00US

 

315953-3368

 

United States

 

62/368,400

 

7/29/2016

 

 

 

 

 

ELSN-001/03US

 

321893-2064

 

United States of America

 

14/881,011

 

10/12/2015

 

 

 

 

 

 

Trademarks

 

MARK
Owner

 

COUNTRY

 

APPLICATION/
REGISTRATION
NO.

 

HISTORY & CURRENT STATUS

ARIKACE

Insmed Incorporated

 

United States

 

Registration No.

3938202

 

Filed 1/31/07

Registered 3/29/11

First Use: 2/09

ARIKAYCE

Insmed, Inc.

 

United States

 

Application No.

85972453

 

Filed 6/28/13 (on the basis of intended use)

Notice of Allowance issued 12/3/13

ARYKAYCE

Insmed, Inc.

 

United States

 

Application No.

85972458

 

Filed 6/28/13 (on the basis of intended use)

Notice of Allowance issued 12/3/13

INSMED

Insmed, Inc.

 

United States

 

Application No.

86/103,118

 

Filed 10/28/13 (on the basis of intended use)

Notice of Allowance issued 5/20/14

INSMED

Insmed, Inc.

 

United States

 

Application No.

85930667

 

Filed 5/13/13 (on the basis of intended use)

Notice of Allowance issued 12/3/13

IPLEX

Insmed, Inc.

 

United States

 

Registration No.

4045902

 

Filed 8/18/09

Registered 10/25/11

First Use: 5/06

 



 

MARK
Owner

 

COUNTRY

 

APPLICATION/
REGISTRATION
NO.

 

HISTORY & CURRENT STATUS

 

Lungs design

Insmed Incorporated

 

United States

 

Application No.

86444498

 

Filed 11/4/14 (intent-to-use)

Notice of Allowance issued 6/2/15

 

Lungs design

Insmed Incorporated

 

Argentina

 

Application No.

3406997

 

Filed 5/4/15 (based on US App. No. 86444498)

Published 1/13/16 for 30 day opposition period and not opposed

INSMED

Insmed, Inc.

 

Argentina

 

Registration No.

2702779

 

Filed 1/8/14

Registered 12/30/14

LONSPIRA

Insmed Incorporated

 

Argentina

 

Registration No.

2590819

 

Filed 4/23/12

Registered 9/6/13

VONCERA

Insmed Incorporated

 

Argentina

 

Registration No.

590820

 

Filed 4/23/12

Registered 9/6/13

ARIKAYCE

Insmed, Inc.

 

Argentina

 

Registration No.

2.709.607

 

Filed 12/27/13 (claiming of 6/28/13 priority date)

Registered 2/9/15

ARYKAYCE

Insmed, Inc.

 

Argentina

 

Registration No.

2.714.357

 

Filed 12/27/13 (claiming of 6/28/13 priority date)

Registered 3/18/15

RIKACIA

Insmed, Inc.

 

Argentina

 

Registration No.

2.714.358

 

Filed 12/27/13 (claiming of 6/28/13 priority date)

Registered 3/18/15

 



 

MARK
Owner

 

COUNTRY

 

APPLICATION/
REGISTRATION
NO.

 

HISTORY & CURRENT STATUS

 

Lungs design

Insmed Incorporated

 

Brazil

 

Application No.

909328366

 

Filed 5/4/15 (based on US App. No. 86444498)

Published 6/5/15

INSMED

Insmed, Inc.

 

Brazil

 

Application No.

840758324

 

Filed 1/7/14

Published 4/29/14

ARIKAYCE

Insmed, Inc.

 

Brazil

 

Application No.

840753381

 

Filed 12/27/13 (claiming of 6/28/13 priority date)

Published 4/29/14

ARYKAYCE

Insmed, Inc.

 

Brazil

 

Application No.

840753365

 

Filed 12/27/13 (claiming of 6/28/13 priority date)

Published 4/29/14

ARIKACE

Insmed Incorporated

 

Brazil

 

Application No.

840123612

 

Filed 5/11/12

Registration fee paid

VONCERA

Insmed Incorporated

 

Brazil

 

Registration No.

840131356

 

Filed 5/18/12

Registered 6/23/15

INSMED

Insmed, Inc.

 

Australia

 

IR Reg. No.

1184673

 

Registered 11/13/13

Statement of Grant of Protection issued 3/20/14

INSMED

Insmed, Inc.

 

Australia

 

IR Reg. No.

1205306

 

Registered 4/28/14 (based on U.S. Appl. No. 86103118

Statement of Grant of Protection issued 10/22/14

 



 

MARK
Owner

 

COUNTRY

 

APPLICATION/
REGISTRATION
NO.

 

HISTORY & CURRENT STATUS

ARIKAYCE

Insmed, Inc.

 

Australia

 

IR Reg. No.

1193205

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 6/9/14

ARYKAYCE

Insmed, Inc.

 

Australia

 

IR Reg. No.

1193361

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 6/9/14

RIKACIA

Insmed, Inc.

 

Australia

 

IR Reg. No.

1192975

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 5/29/14

ARIKACE

Insmed Incorporated

 

Australia

 

IR Reg. No.

919298

 

Registered 3/9/07

Statement of Grant of Protection issued 12/20/07

LONSPIRA

Insmed Incorporated

 

Australia

 

IR Reg. No.

1121695

 

Registered 4/24/12

Statement of Grant of Protection issued 11/28/12

Lungs design

Insmed, Inc.

 

Australia

 

IR Reg. No.

1252822

 

Registered 5/1/15 (based on US App. No. 86444498)

Statement of Grant of Protection issued 12/9/15

VONCERA

Insmed Incorporated

 

Australia

 

IR Reg. No.

1121781

 

Registered 4/24/12

Statement of Grant of Protection issued 12/10/12

Lungs design

Insmed Incorporated

 

Canada

 

Application No.

1726512

 

Filed 5/1/15 (based on US App. No. 86444498)

Office action response filed 3/18/16 and accepted

 



 

MARK
Owner

 

COUNTRY

 

APPLICATION/
REGISTRATION
NO.

 

HISTORY & CURRENT STATUS

ARIKAYCE

Insmed, Inc.

 

Canada

 

Application No.

1657970

 

Filed 12/27/13 (claiming of 6/28/13 priority date)

Notice of Allowance issued 1/23/15

ARYKAYCE

Insmed, Inc.

 

Canada

 

Application No.

1657971

 

Filed 12/27/13 (claiming of 6/28/13 priority date)

Notice of Allowance issued 1/23/15

ARIKACE

Insmed Incorporated

 

Canada

 

Application No. 

1543553

 

Filed 9/7/11 (on the basis of intended use);

Notice of Allowance issued 9/21/12

INSMED

Insmed, Inc.

 

Canada

 

Application No.

1674571

 

Filed 4/28/14 (on the basis of intended use and the

priority of US App. No. 86/103,118)

Notice of Allowance issued 1/9/15

INSMED

Insmed, Inc.

 

Canada

 

Application No.

1651732

 

Filed 11/12/13

Notice of Allowance 5/22/15

INSMED

Insmed, Inc.

 

China

 

IR Reg. No.

1184673

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 8/20/14

INSMED

Insmed, Inc.

 

China

 

IR Reg. No.

1205306

 

Registered 4/28/14 (based on U.S. Appl. No. 86103118

Statement of Grant of Protection issued 1/21/15

ARIKACE

Insmed Incorporated

 

China

 

IR Reg. No.

 919298

 

Registered 3/9/07

Statement of Grant of Protection issued 7/1/15

ARIKAYCE

Insmed, Inc.

 

China

 

IR Reg. No.

1193205

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 2/27/14

 



 

MARK
Owner

 

COUNTRY

 

APPLICATION/
REGISTRATION
NO.

 

HISTORY & CURRENT STATUS

ARYKAYCE

Insmed, Inc.

 

China

 

IR Reg. No.

1193361

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 11/13/14

RIKACIA

Insmed, Inc.

 

China

 

IR Reg. No.

1192975

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 11/26/14

LONSPIRA

Insmed Incorporated

 

China

 

IR Reg. No.

1121695

 

Registered 4/24/12

Statement of Grant of Protection issued 4/24/13

VONCERA

Insmed Incorporated

 

China

 

IR Reg. No.

1121781

 

Registered 4/24/12

Statement of Grant of Protection issued 4/24/13

Lungs design

Insmed, Inc.

 

European Union

 

IR Reg. No.

1252822

 

Registered 5/1/15 (based on US App. No. 86444498)

Advertised — deadline to oppose 3/26/16

INSMED

Insmed, Inc.

 

European Union

 

IR Reg. No.

1184673

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 10/30/14

INSMED

Insmed, Inc.

 

European Union

 

IR Reg. No.

1205306

 

Registered 4/28/14 (based on U.S. Appl. No. 86103118

Statement of Grant of Protection issued 4/14/15

ARIKAYCE

Insmed, Inc.

 

European Union

 

IR Reg. No.

1193205

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 1/7/15

 



 

MARK
Owner

 

COUNTRY

 

APPLICATION/
REGISTRATION
NO.

 

HISTORY & CURRENT STATUS

ARYKAYCE

Insmed, Inc.

 

European Union

 

IR Reg. No.

1193361

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 1/7/15

NTM

Insmed Incorporated

 

European Union

 

Application No.

15538267

 

Filed 6/15/16

RIKACIA

Insmed, Inc.

 

European Union

 

IR Reg. No. 1192975

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 12/30/14

ARIKACE

Insmed Incorporated

 

European Union

 

IR Reg. No.

919298

 

Registered 3/9/07

Statement of Grant of Protection issued 4/24/08

LONSPIRA

Insmed Incorporated

 

European Union

 

IR Reg. No.

1121695

 

Registered 4/24/12

Statement of Grant of Protection issued 6/7/13

VONCERA

Insmed Incorporated

 

European Union

 

IR Reg. No.

1121781

 

Registered 4/24/12

Statement of Grant of Protection issued 6/7/13

NTM IM DIALOG

Insmed Incorporated

 

Germany

 

Application No.

30 2016 017 991.7

 

Filed 6/21/16

INSMED

Insmed, Inc.

 

India

 

IR Reg. No. 1184673

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

INSMED

Insmed, Inc.

 

India

 

IR Reg. No.

1205306

 

Filed 4/28/14 (based on U.S. Appl. No. 86103118

Late refusal issued - Argument for Registered status

filed 10/15/15

ARIKAYCE

Insmed, Inc.

 

India

 

IR Reg. No.

1193205

 

Filed 12/27/13 (claiming of 6/28/13 priority date)

Response to refusal filed 10/16/15

 



 

MARK
Owner

 

COUNTRY

 

APPLICATION/
REGISTRATION
NO.

 

HISTORY & CURRENT STATUS

ARYKAYCE

Insmed, Inc.

 

India

 

IR Reg. No.

1193361

 

Filed 12/27/13 (claiming of 6/28/13 priority date)

Response to refusal filed 10/16/15

LONSPIRA

Insmed Incorporated

 

India

 

Registration No. 2320390

 

Filed 4/23/12

Registered 9/22/14

VONCERA Insmed Incorporated

 

India

 

Registration No.

2320391

 

Filed 4/23/12

Registered 9/22/14

Lungs design

Insmed, Inc.

 

International Register

 

Registration No.

1252822

 

Registered 5/1/15 (based on US App. No. 86444498)

ARIKACE

Insmed Incorporated

 

International Register

 

Registration No.

919298

 

Registered 3/9/07 (based on US App. No. 77095378)

ARIKAYCE

Insmed, Inc.

 

International Register

 

Registration No.

1193205

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

ARYKAYCE

Insmed, Inc.

 

International Register

 

Registration No.

1193361

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

RIKACIA

Insmed, Inc.

 

International Register

 

Registration No.

1192975

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

INSMED

Insmed, Inc.

 

International Register

 

Registration No.

1184673

 

Registered 11/13/13 (claiming of 6/28/13 priority date)

INSMED

Insmed, Inc.

 

International Register

 

Registration No.

1205306

 

Filed 4/28/14 (based on U.S. Appl. No. 86103118

 



 

MARK
Owner

 

COUNTRY

 

APPLICATION/
REGISTRATION
NO.

 

HISTORY & CURRENT STATUS

LONSPIRA

Insmed Incorporated

 

International Register

 

Registration No.

1121695

 

Registered 4/24/12

VONCERA

Insmed Incorporated

 

International Register

 

Registration No.

1121781

 

Registered 4/24/12

Lungs design

Insmed, Inc.

 

Japan

 

IR Reg. No.

1252822

 

Registered 5/1/15 (based on US App. No. 86444498)

Statement of Grant of Protection issued 11/26/15

INSMED

Insmed, Inc.

 

Japan

 

IR Reg. No.

1184673

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 7/15/14

INSMED

Insmed, Inc.

 

Japan

 

IR Reg. No.

1205306

 

Registered 4/28/14 (based on U.S. Appl. No. 86103118

Statement of Grant of Protection issued 11/20/14

ARIKAYCE

Insmed, Inc.

 

Japan

 

IR Reg. No.

1193205

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 11/20/14

ARYKAYCE

Insmed, Inc.

 

Japan

 

IR Reg. No.

1193361

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 9/4/14

RIKACIA

Insmed, Inc.

 

Japan

 

IR Reg. No.

1192975

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 9/8/14

 



 

MARK
Owner

 

COUNTRY

 

APPLICATION/
REGISTRATION
NO.

 

HISTORY & CURRENT STATUS

ARIKACE

Insmed Incorporated

 

Japan

 

IR Reg. No.

919298

 

Registered 3/9/07

Statement of Grant of Protection issued 3/6/08

LONSPIRA

Insmed Incorporated

 

Japan

 

IR Reg. No.

1121695

 

Registered 4/24/12

Statement of Grant of Protection issued 2/5/13

VONCERA

Insmed Incorporated

 

Japan

 

IR Reg. No. 

1121781

 

Registered 4/24/12

Statement of Grant of Protection issued 2/5/13

ARIKACE
Insmed Incorporated

 

Macedonia

 

IR Reg. No. 

919298

 

Registered 3/9/07

Statement of Grant of Protection issued 6/7/12

LONSPIRA

Insmed Incorporated

 

Macedonia

 

IR Reg. No.

1121695

 

Registered 4/24/12

Statement of Grant of Protection issued 8/2/12

VONCERA
Insmed Incorporated

 

Macedonia

 

IR Reg. No.

1121781

 

Registered 4/24/12

Statement of Grant of Protection issued 8/2/12

ARIKAYCE
Insmed, Inc.

 

Mexico

 

IR Reg. No.

1193205

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 2/17/15

ARYKAYCE

Insmed, Inc.

 

Mexico

 

IR Reg. No.

1193361

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 2/17/15

RIKACIA

Insmed, Inc.

 

Mexico

 

IR Reg. No.

1192975

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 2/11/15

ARIKACE

Insmed Incorporated

 

Mexico

 

Registration No. 1325228

 

Filed 6/18/12

Registered 10/30/12

LONSPIRA Insmed Incorporated

 

Mexico

 

Registration No.

1325229

 

Filed 6/18/12

Registered 10/30/12

 



 

MARK
Owner

 

COUNTRY

 

APPLICATION/
REGISTRATION
NO.

 

HISTORY & CURRENT STATUS

Lungs design

Insmed, Inc.

 

Norway

 

IR Reg. No.

1252822

 

Registered 5/1/15 (based on US App. No. 86444498)

Statement of Grant of Protection issued 1/22/16

INSMED

Insmed, Inc.

 

Norway

 

IR Reg. No.

1184673

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 7/23/14

INSMED

Insmed, Inc.

 

Norway

 

IR Reg. No.

1205306

 

Registered 4/28/14 (based on U.S. Appl. No. 86103118

Statement of Grant of Protection issued 1/28/15

ARIKAYCE
Insmed, Inc.

 

Norway

 

IR Reg. No.

1193205

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 9/26/14

ARYKAYCE

Insmed, Inc.

 

Norway

 

IR Reg. No.

1193361

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 1/20/15

RIKACIA

Insmed, Inc.

 

Norway

 

IR Reg. No.

1192975

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 9/26/14

ARIKACE

Insmed Incorporated

 

Norway

 

IR Reg. No.

919298

 

Registered 3/9/07

Statement of Grant of Protection issued 2/1/13

LONSPIRA

Insmed Incorporated

 

Norway

 

IR Reg. No.

1121695

 

Registered 4/24/12

Statement of Grant of Protection issued 3/13/13

 



 

MARK
Owner

 

COUNTRY

 

APPLICATION/
REGISTRATION
NO.

 

HISTORY & CURRENT STATUS

INSMED

Insmed, Inc.

 

Russian Federation

 

IR Reg. No. 

1184673

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 11/20/14

INSMED

Insmed, Inc.

 

Russian Federation

 

IR Reg. No.

1205306

 

Registered 4/28/14 (based on U.S. Appl. No. 86103118

Statement of Grant of Protection issued 6/18/15

ARIKAYCE

Insmed, Inc.

 

Russian Federation

 

IR Reg. No.

1193205

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 1/26/15

ARYKAYCE

Insmed, Inc.

 

Russian Federation

 

IR Reg. No.

1193361

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 1/29/15

RIKACIA

Insmed, Inc.

 

Russian Federation

 

IR Reg. No.

1192975

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 1/8/15

ARIKACE

Insmed Incorporated

 

Russian Federation

 

IR Reg. No.

919298

 

Registered 3/9/07

Statement of Grant of Protection issued 3/20/13

LONSPIRA

Insmed Incorporated

 

Russian Federation

 

IR Reg. No. 

1121695

 

Registered 4/24/12

Statement of Grant of Protection issued 6/6/13

VONCERA

Insmed Incorporated

 

Russian Federation

 

IR Reg. No. 

1121781

 

Registered 4/24/12

Statement of Grant of Protection issued 6/6/13

ARIKACE

Insmed Incorporated

 

Serbia

 

IR Reg. No. 

919298

 

Registered 3/9/07

Statement of Grant of Protection issued 6/7/12

 



 

MARK
Owner

 

COUNTRY

 

APPLICATION/
REGISTRATION
NO.

 

HISTORY & CURRENT STATUS

LONSPIRA

Insmed Incorporated

 

Serbia

 

IR Reg. No. 

1121695

 

Registered 4/24/12

Statement of Grant of Protection issued 6/13/13

VONCERA

Insmed Incorporated

 

Serbia

 

IR Reg. No. 

1121781

 

Registered 4/24/12

Statement of Grant of Protection issued 6/13/13

 

Lungs design

Insmed Incorporated

 

South Africa

 

Application No.

2015/11432

 

Filed 5/4/15 (based on US App. No. 86444498)

ARIKAYCE

Insmed, Inc.

 

South Africa

 

Application No.

2014/00184

 

Filed 1/6/14 (claiming of 6/28/13 priority date)

Approved for publication

ARYKAYCE

Insmed, Inc.

 

South Africa

 

Registration No.

2014/00185

 

Filed 1/6/14(claiming of 6/28/13 priority date)

Registered 11/27/15

RIKACIA

Insmed, Inc.

 

South Africa

 

Registration No.

2014/00183

 

Filed 1/6/14 (claiming of 6/28/13 priority date)

Registered 8/27/15

ARIKACE

Insmed Incorporated

 

South Africa

 

Registration No. 

2012/10959

 

Filed 4/26/12 Registered 1/6/14

INSMED

Insmed, Inc.

 

South Africa

 

Application No.

2014/10808

 

Filed 4/29/14 (on the basis of intended use and the priority of US App. No. 86/103,118) Office action response filed 8/12/15

INSMED

Insmed, Inc.

 

South Africa

 

Registration No.

2013/31724

 

Filed 11/13/13 Registered 6/24/15

 



 

MARK
Owner

 

COUNTRY

 

APPLICATION/
REGISTRATION
NO.

 

HISTORY & CURRENT STATUS

LONSPIRA

Insmed Incorporated

 

South Africa

 

Registration No.

2012/10961

 

Filed 4/26/12

Registered 1/6/14

VONCERA

Insmed Incorporated

 

South Africa

 

Registration No.

2012/10963

 

Filed 4/26/12

Registered 1/6/14

  Lungs design

Insmed, Inc.

 

South Korea

 

IR Reg. No.

1252822

 

Registered 5/1/15 (based on US App. No. 86444498)

Statement of Grant of Protection issued 1/18/16

INSMED

Insmed, Inc.

 

South Korea

 

IR Reg. No.

1184673

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 6/13/13

INSMED

Insmed, Inc.

 

South Korea

 

IR Reg. No.

1205306

 

Registered 4/28/14 (based on U.S. Appl. No. 86103118

Statement of Grant of Protection issued 3/2/15

ARIKAYCE

Insmed, Inc.

 

South Korea

 

IR Reg. No.

1193205

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 4/27/15

ARYKAYCE

Insmed, Inc.

 

South Korea

 

IR Reg. No.

1193361

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 4/9/15

RIKACIA

Insmed, Inc.

 

South Korea

 

IR Reg. No.

1192975

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 10/27/14

 



 

MARK
Owner

 

COUNTRY

 

APPLICATION/
REGISTRATION
NO.

 

HISTORY & CURRENT STATUS

ARIKACE

Insmed Incorporated

 

South Korea

 

IR Reg. No.

919298

 

Registered 3/9/07

Statement of Grant of Protection issued 5/6/08

LONSPIRA

Insmed Incorporated

 

South Korea

 

IR Reg. No. 

1121695

 

Registered 4/24/12

Statement of Grant of Protection issued 6/20/13

VONCERA

Insmed Incorporated

 

South Korea

 

IR Reg. No. 

1121781

 

Registered 4/24/12

Statement of Grant of Protection issued 6/20/13

ARIKAYCE

Insmed, Inc.

 

Switzerland

 

IR Reg. No.

1193205

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

INSMED

Insmed, Inc.

 

Switzerland

 

IR Reg. No. 

1184673

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Provisional refusal issued 1/6/15; Response filed 7/10/15; Appeal filed 1/12/16

INSMED

Insmed, Inc.

 

Switzerland

 

IR Reg. No. 

1205306

 

Filed 4/28/14 (based on U.S. Appl. No. 86103118

Provisional refusal issued 6/2/15; Response filed

9/12/15

ARYKAYCE

Insmed, Inc.

 

Switzerland

 

IR Reg. No.

1193361

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 3/26/15

RIKACIA

Insmed, Inc.

 

Switzerland

 

IR Reg. No.

1192975

 

Registered 12/27/13 (claiming of 6/28/13 priority date)

Statement of Grant of Protection issued 3/26/15

ARIKACE

Insmed Incorporated

 

Switzerland

 

IR Reg. No.

919298

 

Registered 3/9/07

Statement of Grant of Protection issued 6/18/13

LONSPIRA

Insmed Incorporated

 

Switzerland

 

IR Reg. No.

1121695

 

Registered 4/24/12

Statement of Grant of Protection issued 8/9/13

 



 

MARK
Owner

 

COUNTRY

 

APPLICATION/
REGISTRATION
NO.

 

HISTORY & CURRENT STATUS

VONCERA

Insmed Incorporated

 

Switzerland

 

IR Reg. No.

1121781

 

Registered 4/24/12

Statement of Grant of Protection issued 8/9/13

LONSPIRA

Insmed Incorporated

 

Canada

 

Application No. 

1576212

 

Filed 4/23/12 (on the basis of intended use and the priority of US App. No. 85604091)

Notice of Allowance 2/28/14

VONCERA

Insmed Incorporated

 

Canada

 

Application No. 

1576211

 

Filed 4/23/12 (on the basis of intended use and the priority of US App. No. 85604083)

RIKACIA

Insmed, Inc.

 

Canada

 

Application No.

1657972

 

Filed 12/27/13 (claiming of 6/28/13 priority date)

Notice of Allowance issued 7/24/15

VONCERA

Insmed Incorporated

 

Mexico

 

Application No. 

1283698

 

Filed 6/18/12

 

Copyrights - None

 



 

EXHIBIT E

 

BORROWERS’ DEPOSIT ACCOUNTS AND INVESTMENT ACCOUNTS

 

 

 

 

 

Depository
AC #

 

Financial
Institution

 

Account Type
(Depository /
Securities)

 

Last Month
Ending Account
Balance

 

Purpose of
Account

BORROWER Name/Address:

 

 

 

 

 

 

 

 

 

 

 

 

INSMED INCORPORATED

 

1

 

3810-3271-7310

 

Bank of America

 

Checking

 

$0

 

Clearing

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2

 

3810-3271-7307

 

Bank of America

 

Operating

 

$14,143,680.47

 

Operating

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3

 

5S8-01A38-1-6 MSS

 

Bank of America/ML

 

Securities

 

$193,723,325.89

 

Investment

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4

 

80-2633-6668

 

PNC

 

 

 

$0

 

New Equity (replacing JPM)

 

 

5

 

TBD

 

PNC

 

Securities

 

$0

 

In Process of Opening

 

 

6

 

753748672 and 753748953

 

JP Morgan

 

Operating and Checking

 

Closed

 

Closed

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7

 

423104

 

Bank of America/ML

 

CERTIFICATE OF DEPOSIT

 

$456,630.64

 

LOAN COLLATERAL 2

 

 

 

 

 

 

 

 

 

 

 

 

 

BORROWER SUSIDIARY / AFFILIATE COMPANY Name/Address

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1

 

56284014

 

Bank of America

 

COMMERCIAL

 

€28,537.74

 

INSMED HOLDINGS LIMITED / Ireland

 

 

2

 

56284022

 

Bank of America

 

COMMERCIAL

 

$892.42

 

INSMED HOLDINGS LIMITED / Ireland

 

 

3

 

56285012

 

Bank of America

 

COMMERCIAL

 

€785.38

 

INSMED IRELAND LIMITED

 

 

4

 

56285020

 

Bank of America

 

COMMERCIAL

 

$718,272.13

 

INSMED IRELAND LIMITED

 

 

5

 

32660018

 

Bank of America

 

COMMERCIAL

 

€420,201.06

 

INSMED FRANCE SAS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6

 

20449011

 

Bank of America

 

COMMERCIAL

 

€563,476.99

 

INSMED GMBH / Germany

 



 

 

 

 

 

Depository
AC #

 

Financial
Institution

 

Account Type
(Depository /
Securities)

 

Last Month
Ending Account
Balance

 

Purpose of
Account

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7

 

19638010

 

Bank of America

 

COMMERCIAL

 

€565,114.72

 

INSMED NETHERLANDS B.V.

 

 

8

 

70733011

 

Bank of America

 

COMMERCIAL

 

£223,542.89

 

INSMED LIMITED / UK

 



 

EXHIBIT F

 

COMPLIANCE CERTIFICATE

 

Hercules Capital, Inc. (as “Agent”)
400 Hamilton Avenue, Suite 310

Palo Alto, CA 94301

 

Reference is made to that certain Amended and Restated Loan and Security Agreement dated September 30, 2016, and all ancillary documents entered into in connection with such Amended and Restated Loan and Security Agreement all as may be amended from time to time, (hereinafter referred to collectively as the “Loan Agreement”) by and among Hercules Capital, Inc., as agent for the Lender (the “Agent”), the several banks and other financial institutions or entities from time to time party thereto (collectively, “Lender”), Insmed Incorporated, as the Administrative Borrower (the “Company”), and the other borrowers from time to time party thereto (the “Borrowers). All capitalized terms not defined herein shall have the same meaning as defined in the Loan Agreement.

 

The undersigned is an Officer of the Company, knowledgeable of all financial matters relating to the Borrowers, and is authorized to provide certification of information regarding the Borrowers; hereby certifies that in accordance with the terms and conditions of the Loan Agreement, the Borrowers are in compliance in all material respects for the period ending             with all covenants, conditions and terms and hereby reaffirms that all representations and warranties contained therein are true and correct on and as of the date of this Compliance Certificate with the same effect as though made on and as of such date, except to the extent such representations and warranties expressly relate to an earlier date, after giving effect in all cases to any standard(s) of materiality contained in the Loan Agreement as to such representations and warranties.  Attached are the required documents supporting the above certification.  The undersigned further certifies that these are prepared in accordance with GAAP (except to the extent otherwise permitted under the Loan Agreement) and are consistent from one period to the next except as explained below.

 

REPORTING REQUIREMENT

 

REQUIRED

 

CHECK IF
ATTACHED

 

 

 

 

 

Interim Financial Statements

 

Monthly within 30 days

 

 

 

 

 

 

 

Interim Financial Statements

 

Quarterly within 40 days

 

 

 

 

 

 

 

Audited Financial Statements

 

FYE within 150 days

 

 

 

The undersigned hereby also confirms the accounts disclosed in the Loan Agreement represent all depository accounts and securities accounts presently open in the name of each Borrower or Borrower Subsidiary/Affiliate, as applicable.

 



 

 

Very Truly Yours,

 

 

 

INSMED INCORPORATED,

 

as Administrative Borrower

 

 

 

By:

 

 

 

 

 

Name:

 

 

 

 

 

Its:

 

 



 

EXHIBIT G

 

FORM OF JOINDER AGREEMENT

 

This Joinder Agreement (the “Joinder Agreement”) is made and dated as of [            ], 20[  ], and is entered into by and between                  ., a             corporation (“Subsidiary”), and HERCULES CAPITAL, INC., a Maryland corporation (as “Agent”).

 

RECITALS

 

A.  Subsidiary’s Affiliate, Insmed Incorporated (“Company”) [has entered/desires to enter] into that certain Amended and Restated Loan and Security Agreement dated September 30, 2016, with the several banks and other financial institutions or entities from time to time party thereto as lender (collectively, “Lender”) and the Agent, as such agreement may be amended (the “Loan Agreement”), together with the other agreements executed and delivered in connection therewith;

 

B.  Subsidiary acknowledges and agrees that it will benefit both directly and indirectly from Company’s execution of the Loan Agreement and the other agreements executed and delivered in connection therewith;

 

AGREEMENT

 

NOW THEREFORE, Subsidiary and Agent agree as follows:

 

1.               The recitals set forth above are incorporated into and made part of this Joinder Agreement.  Capitalized terms not defined herein shall have the meaning provided in the Loan Agreement.

 

2.               By signing this Joinder Agreement, Subsidiary shall be bound by the terms and conditions of the Loan Agreement the same as if it were a Borrower (as defined in the Loan Agreement) under the Loan Agreement, mutatis mutandis, provided however, that (a) with respect to (i) Section 5.1 of the Loan Agreement, Subsidiary represents that it is an entity duly organized, legally existing and in good standing under the laws of [        ], (b) neither the Agent nor Lender shall have any duties, responsibilities or obligations to Subsidiary arising under or related to the Loan Agreement or the other Loan Documents, (c) that if Subsidiary is covered by Company’s insurance, Subsidiary shall not be required to maintain separate insurance or comply with the provisions of Sections 6.1 and 6.2 of the Loan Agreement, and (d) that as long as Company satisfies the requirements of Section 7.1 of the Loan Agreement, Subsidiary shall not have to provide Agent separate Financial Statements.  To the extent that the Agent or Lender has any duties, responsibilities or obligations arising under or related to the Loan Agreement or the other Loan Documents, those duties, responsibilities or obligations shall flow only to Company and not to Subsidiary or any other Person or entity.  By way of example (and not an exclusive list): (i) the Agent’s providing notice to Company in accordance with the Loan Agreement or as otherwise agreed among Company, the Agent and Lender shall be deemed provided to Subsidiary; (ii) Lender’s providing an Advance to Company shall be deemed an Advance to Subsidiary; and (iii) Subsidiary shall have no right to request an Advance or make any other demand on Lender except as expressly provided in the Loan Agreement.

 

3.               Subsidiary agrees not to certificate its equity securities without delivery of such equity securities to the Agent in order to perfect the Agent’s security interest in such equity securities.

 

4.               Subsidiary acknowledges that it benefits, both directly and indirectly, from the Loan Agreement, and hereby waives, for itself and on behalf on any and all successors in interest (including without limitation any assignee for the benefit of creditors, receiver, bankruptcy trustee or itself as debtor-in-possession under any bankruptcy proceeding) to the fullest extent provided by law, any and all claims,

 



 

rights or defenses to the enforcement of this Joinder Agreement on the basis that (a) it failed to receive adequate consideration for the execution and delivery of this Joinder Agreement or (b) its obligations under this Joinder Agreement are avoidable as a fraudulent conveyance.

 

[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]

 



 

[SIGNATURE PAGE TO JOINDER AGREEMENT]

 

SUBSIDIARY:

 

 

 

[                                 ]

 

 

 

 

By:

 

 

Name:

 

 

Title:

 

 

 

 

Address:

 

 

 

 

 

Telephone:

 

 

 

Facsimile:

 

 

 

 

 

HERCULES CAPITAL, INC.,

 

a Maryland corporation

 

 

 

 

By:

 

 

 

Name:

 

 

 

Its:

 

 

 

Address:
400 Hamilton Ave., Suite 310
Palo Alto, CA 94301
Facsimile:  650-473-9194
Telephone:  650-289-3060

 



 

EXHIBIT H

 

ACH DEBIT AUTHORIZATION AGREEMENT

 

Hercules Capital, Inc.
400 Hamilton Avenue, Suite 310
Palo Alto, CA  94301

 

Re:  Amended and Restated Loan and Security Agreement dated September 30, 2016 (the “Agreement”), by and among Insmed Incorporated (the “Administrative Borrower”) and the other Borrowers from time to time party thereto, and Hercules Capital, Inc., as agent and the lenders party thereto (collectively, “Lender”)

 

In connection with the above referenced Agreement, the Administrative Borrower hereby authorizes the Agent to initiate debit entries for (i) the periodic payments due under the Agreement and (ii) reasonable, invoiced out-of-pocket legal fees and costs incurred by the Agent or Lender pursuant to Section 11.11 of the Agreement to the Administrative Borrower’s account indicated below.  The Administrative Borrower authorizes the depository institution named below to debit to such account.

 

DEPOSITORY NAME

BRANCH

 

 

CITY

STATE AND ZIP CODE

 

 

TRANSIT/ABA NUMBER

ACCOUNT NUMBER

 

This authority will remain in full force and effect so long as any amounts are due under the Agreement.

 

 

 

(Borrower)(Please Print)

 

 

By:

 

 

 

 

 

Date:

 

 

 



 

SCHEDULE 1.1

 

COMMITMENTS

 

EXISTING TERM LOANS

 

Lender

 

Existing Term
Loans(1)

 

 

 

 

 

Hercules Capital, Inc.

 

$

            

 

Hercules Capital Funding Trust 2012-1

 

$

            

 

Total

 

$

25,000,000

 

 

CLOSING DATE TERM LOANS

 

Hercules Capital, Inc.

 

$

            

 

Hercules Capital Funding Trust 2012-1

 

$

            

 

Total

 

$

10,000,000

 

 


(1)  Fully funded on the Original Closing Date

 



 

Schedule 1 Subsidiaries

 

Name

 

Jurisdiction of Formation

Celtrix Pharmaceuticals, Inc.

 

Delaware

Insmed Limited

 

England and Wales

Insmed Netherlands B.V.

 

The Netherlands

Insmed France SAS

 

France

Insmed Germany GmbH

 

Germany

Insmed Ireland Limited

 

Ireland

Insmed Holdings Limited

 

Ireland

 



 

Schedule 1A Existing Permitted Indebtedness

 

Equipment Leases (in each case, Insmed Incorporated is the lessee)

 

·                   Lessor: US Bancorp

·                   Description: Lab Equipment

·                   Value: $38,510

·                   Date of contract: 11/17/2008

·                   Final payment 10/17/13

·                   Balance @ 6/17/12 $9,017.06

 

·                   Lessor: General Electric Capital Corporation

·                   Description: Lab Equipment

·                   Value: $177,650

·                   Date of contract: 07/22/2008

·                   Final payment 08/01/13

·                   Balance @ 6/01/12 $49,465.49

 

·                   Lessor: Ricoh Equipment Financing

·                   Description: Printer

·                   Value: $4,263

·                   Date of contract: 02/05/2008

·                   Final payment 02/01/13

·                   Balance @ 6/20/12 $3,920

 



 

Schedule 1B Existing Permitted Investments

 

Bank of America/Merrill Lynch Investments as of 07/31/2016

 

COB Date

 

Security #

 

Symbol

 

CUSIP #

 

Security Description

 

Account
Nickname

 

Account
Registration

 

Account #

 

Quantity

 

Price ($)

 

Value ($)

 

6/19/2012

 

9HTT2

 

 

998911UC3

 

BBIF MONEY FUND

 

INSMED

 

WCMA

 

5VL-02045

 

402,596

 

1

 

402,596.00

 

6/19/2012

 

95RA9

 

 

998916FP0

 

PREFERRED DEPOSIT (BUS)

 

INSMED

 

WCMA

 

5VL-02045

 

8,348,481

 

1

 

8,348,481.00

 

 

 

 

 

 

 

 

 

Cash

 

 

 

 

 

 

 

 

 

 

 

0.43

 

 

 

 

 

 

 

 

 

Subtotal cash & Money accounts

 

 

 

 

 

 

 

 

 

 

 

8,751,077.43

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6/19/2012

 

9H1D9

 

NSTMX

 

19765H362

 

COLUMBIA SHORT TERM BOND

 

INSMED

 

WCMA

 

5VL-02045

 

496,504.88

 

9.92

 

4,925,328.38

 

6/19/2012

 

9KT56

 

DTINX

 

245912506

 

DELAWARE LIMITED TERM

 

INSMED

 

WCMA

 

5VL-02045

 

552,104.53

 

8.94

 

4,935,814.48

 

6/19/2012

 

9EGO2

 

DIMIX

 

261918502

 

DREYFUS SHORT INTERMED

 

INSMED

 

WCMA

 

5VL-02045

 

320,199.48

 

13.3

 

4,258,653.03

 

6/19/2012

 

9KWW1

 

FMUSX

 

31417P858

 

FEDERATED MUNICIPAL

 

INSMED

 

WCMA

 

5VL-02045

 

490,576.46

 

10.05

 

4,930,293.43

 

6/19/2012

 

97K22

 

FSXIX

 

315807859

 

FIDELITY ADV SH FIXED

 

INSMED

 

WCMA

 

5VL-02045

 

530,709.74

 

9.29

 

4,930,293.43

 

6/19/2012

 

3.10E+51

 

SHY

 

464287457

 

ISHARES BARCLYS 1-3 YEAR

 

INSMED

 

WCMA

 

5VL-02045

 

5,000

 

84.39

 

421,950.00

 

6/19/2012

 

9HUY1

 

HLLVX

 

4812C1330

 

JP MORGAN SHORT DURATION

 

INSMED

 

WCMA

 

5VL-02045

 

449,024.90

 

10.98

 

4,930,293.43

 

6/19/2012

 

9KWP2

 

FLTIX

 

670678648

 

NUVEEN SHORT TERM BOND

 

INSMED

 

WCMA

 

5VL-02045

 

496,504.88

 

9.94

 

4,935,258.48

 

6/19/2012

 

9PK01

 

PTSPX

 

72201M594

 

PIMCO SHORT-TERM FUND

 

INSMED

 

WCMA

 

5VL-02045

 

503,091.17

 

9.81

 

4,935,324.34

 

6/19/2012

 

9MQE2

 

TSYYX

 

89155T664

 

TOUCHSTONE ULTRA SHORT

 

INSMED

 

WCMA

 

5VL-02045

 

516,261.09

 

9.55

 

4,930,293.43

 

6/19/2012

 

31L60

 

BSV

 

921937827

 

VANGUARD SHORT TERM BOND

 

INSMED

 

WCMA

 

5VL-02045

 

5,000

 

81.07

 

405,350.00

 

 

 

 

 

 

 

 

 

Subtotal investments

 

 

 

 

 

 

 

 

 

 

 

44,538,852.43

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total

 

53,289,929.86

 

 

Bank of America Certificate of Deposits as of 07/31/2016 (and related Letters of Credit)

 

Total Balance $456,630.64, detailed as follows:

 

$200,000.00 Matures 02/01/17 — Rate 0.75%

 

$256,630.64 Matures 06/16/17 — Rate 0.85%

 

Investments in Stock resulting from out licensing of non core assets

 

·                   NAPO agreement dated January 5, 2007

·                   Product: Masoprocal (INS 18) Diabetes, Cardiac and metabolic diseases

·                   Consideration received to date: 270,611 shares of NAPO Common stock

·                   Other stock grants based on NAPO achieving certain developmental milestones

·                   TriAct agreement dated December 20, 2010

·                   Product: Masoprocal (INS 18) for all other areas excluding NAPO field of use

·                   Consideration received to date: 500,000 shares of TriAct Common stock

·                   Other stock grants based on TriAct achieving certain developmental milestones

 



 

Schedule 1C Existing Permitted Liens

 

None, except in respect of the equipment which is the subject of the leases disclosed in Schedule 1A.

 



 

Schedule 5.3 Consents, Etc.

 

None

 



 

Schedule 5.5 Actions Before Government Authorities

 

Name of Claimant

 

Hoey v. Insmed Incorporated, et al.

 

Amount and Description

 

On July 15, 2016, a purported class action lawsuit was filed in the U.S. District Court for the District of New Jersey against us and certain executive officers: Hoey v. Insmed Incorporated, et al. The complaint includes allegations that, during the class period between March 18, 2013 and June 8, 2016, we and certain executive officers violated Section 10(b) of the Securities Exchange Act of 1934 (the “Exchange Act”), Rule 10b-5 promulgated thereunder, and Section 20(a) of the Exchange Act in making various statements related to the European MAA of ARIKAYCE with the EMA. The complaint seeks unspecified damages.

 



 

Schedule 5.8 Tax Matters

 

None

 



 

Schedule 5.9 Intellectual Property Claims

 

None

 



 

Schedule 5.10 Intellectual Property

 

None

 



 

Schedule 5.11 Borrower Products

 

IPLEX

 

SETTLEMENT, LICENSE AND DEVELOPMENT AGREEMENT , dated March 5, 2007 by and between Tercica, Inc., Genentech Inc. and Insmed Inc.  Pursuant to this Agreement, Tercica and Genentech agreed to withdraw a pending litigation against the Parent in consideration of the Parent’s agreement to withdraw its Iplex product from the market for a short period of time, and to develop such product only in certain named indications with opt-ins for Tercica and Genentech.  The Parent is no longer developing the Iplex product, and has no present intention of resuming such development.

 



 

Schedule 5.14 Capitalization

 

1.               Insmed Incorporated

 

Capitalization Table as at June 20, 2012

 

Authorized Common Stock

 

500,000,000

 

 

 

 

 

Authorized Preferred Stock

 

200,000,000

 

 

 

 

 

Common Stock issued & outstanding

 

24,874,852

 

 

 

 

 

Common Stock issuable persuant to options, purchases, awards & plans

 

2,069,549

 

 

 

 

 

Common Stock available for issue

 

473,055,599

 

 

 

 

 

Preferred Stock available for issue

 

200,000,000

 

 

2.               Celtrix Pharmaceuticals, Inc.

 

5,000 common shares authorized; 5,000 shares issued and outstanding, all owned by Insmed Incorporated.

 


Exhibit 10.2

 

EMPLOYMENT AGREEMENT

 

This Employment Agreement (“Agreement”) is effective on the Commencement Date (as defined below), by and between Insmed Incorporated, a Virginia corporation (the “Company”), and Roger Adsett (hereinafter, the “Executive”).  When referring to the Executive, the term “he” or “she” throughout this Agreement is intended to be gender neutral.

 

WITNESSETH:

 

WHEREAS, the Company desires to employ the Executive and the Executive desires to be employed by the Company on the terms herein described.

 

NOW, THEREFORE, in consideration of the premises and mutual covenants set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are mutually acknowledged, the Company and the Executive hereby agree as follows:

 

1.                                       Definitions . When used in this Agreement, the following terms shall have the following meanings:

 

a)                                      Accrued Obligations ” means:

 

(i)                                      all accrued but unpaid Base Salary through the end of the Term of Employment;

 

(ii)                                   any unpaid or unreimbursed expenses incurred in accordance with Company policy, including amounts due under Section 5(a) hereof, to the extent incurred during the Term of Employment;

 

(iii)                                any accrued but unpaid benefits provided under the Company’s employee benefit plans, subject to and in accordance with the terms of those plans;

 

(iv)                               rights to indemnification by virtue of the Executive’s position as an officer or director of the Company or its subsidiaries and the benefits under any directors’ and officers’ liability insurance policy maintained by the Company, in accordance with its terms thereof; and

 

(v)                                  any accrued but unused vacation pay.

 

b)                                      Base Salary” means the salary provided for in Section 4(a) hereof or any increased salary granted to Executive pursuant to Section 4(a) hereof.

 

c)                                       Beneficial Ownership ” shall have the meaning ascribed to such term in Rule 13d-3 promulgated under the Securities Exchange Act of 1934, as amended.

 

d)                                      Board ” means the Board of Directors of the Company.

 

e)                                       Bonus ” means any bonus payable to the Executive pursuant to Section 4(b) hereof.

 

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f)                                        Cause ” means:

 

(i)                                      a conviction of the Executive, or a plea of nolo contendere, to a felony involving moral turpitude; or

 

(ii)                                   willful misconduct or gross negligence by the Executive resulting, in either case, in material economic harm to the Company or any Related Entities; or

 

(iii)                                a willful failure by the Executive to carry out the reasonable and lawful directions of the Board and failure by the Executive to remedy the failure within thirty (30) days after receipt of written notice of same from the Board; or

 

(iv)                               fraud, embezzlement, theft or dishonesty of a material nature by the Executive against the Company or any Related Entity, or a willful material violation by the Executive of a policy or procedure of the Company or any Related Entity, resulting, in any case, in material economic harm to the Company or any Related Entity; or

 

(v)                                  a willful material breach by the Executive of this Agreement and failure by the Executive to remedy the material breach within 30 days after receipt of written notice of same from the Board.

 

g)                                       Change in Control ” means:

 

(i)                                      The acquisition by any Person of Beneficial Ownership of at least 40% of either (A) the value of the then outstanding shares of common stock of the Company (the “Outstanding Company Common Stock”) or (B) the combined voting power of the then outstanding voting securities of the Company entitled to vote generally in the election of directors (the “Outstanding Company Voting Securities”) (the foregoing Beneficial Ownership hereinafter being referred to as a “Controlling Interest”); provided, however, that for purposes of this definition, the following acquisitions shall not constitute or result in a Change of Control: (v) any acquisition directly from the Company; (w) any acquisition by the Company; (x) any acquisition by any person that as of the Commencement Date owns Beneficial Ownership of a Controlling Interest; (y) any acquisition by any employee benefit plan (or related trust) sponsored or maintained by the Company or any subsidiary of the Company; or (z) any acquisition by any corporation pursuant to a transaction which complies with clauses (A), (B) and (C) of subsection (iii) below; or

 

(ii)                                   During any period of two consecutive years (not including any period prior to the Commencement Date) individuals who constitute the Board on the Commencement Date (the “Incumbent Board”) cease for any reason to constitute at least a majority of the Board; provided, however, that any individual becoming a director subsequent to the Commencement Date whose election, or nomination for election by the Company’s shareholders, was approved by a vote of at least a majority of the directors then comprising the Incumbent Board shall be considered as though such individual were a member of the Incumbent Board, but excluding, for this purpose, any such individual whose initial assumption of office occurs as a result of an actual or threatened election contest with respect to the election or removal of directors or other actual or threatened solicitation of proxies or consents by or on behalf of a Person other than the Board; or

 

2



 

(iii)                                Consummation of a reorganization, merger, statutory share exchange or consolidation or similar corporate transaction involving the Company or any of its subsidiaries, a sale or other disposition of all or substantially all of the assets of the Company, or the acquisition of assets or stock of another entity by the Company or any of its subsidiaries (each a “Business Combination”), in each case, unless, following such Business Combination, (A) all or substantially all of the Persons who were the Beneficial Owners, respectively, of the Outstanding Company Common Stock and Outstanding Company Voting Securities immediately prior to such Business Combination beneficially own, directly or indirectly, more than 60% of the then outstanding shares of common stock and the combined voting power of the then outstanding voting securities entitled to vote generally in the election of directors, as the case may be, of the corporation resulting from such Business Combination (including, without limitation, a corporation which as a result of such transaction owns the Company or all or substantially all of the Company’s assets either directly or through one or more subsidiaries) (such resulting or acquiring corporation is referred to herein as the “ Acquiring Corporation ”) in substantially the same proportions as their ownership, immediately prior to such Business Combination of the Outstanding Company Common Stock and Outstanding Company Voting Securities, as the case may be, (B) no Person (excluding the Acquiring Corporation or any employee benefit plan (or related trust) of the Company or such Acquiring Corporation) beneficially owns, directly or indirectly, more than 40% of the then outstanding shares of common stock of the corporation resulting from such Business Combination or the combined voting power of the then outstanding voting securities of such corporation except to the extent that such ownership existed prior to the Business Combination, and (C) at least a majority of the members of the Board of Directors of the corporation resulting from such Business Combination were members of the Incumbent Board at the time of the execution of the initial agreement, or of the action of the Board, providing for such Business Combination; or

 

(iv)                               approval by the shareholders of the Company of a complete liquidation or dissolution of the Company.

 

Notwithstanding the foregoing, no event or transaction will constitute a Change in Control hereunder unless it also constitutes a “change in control event” under Section 409A of the Code.

 

h)                                      COBRA ” means the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended from time to time.

 

i)                                          Code ” means the Internal Revenue Code of 1986, as amended.

 

j)                                         Commencement Date ” shall be the date on which Executive commences employment with the Company which will be on September 27, 2016.

 

k)                                      Competitive Activity ” means (i) the discovery, design, development, distribution, marketing or sale of inhalation therapies for rare lung diseases and/or disorders, or (ii) any other activity in competition with the material activities of the Company or any of its Related Entities, in either case in any of the States within the United States, or countries within the world, in which the Company or any of its Related Entities conducts business.  For this purpose, the activities of the Company and its Related Entities, and where the Company and its

 

3



 

Relates Entities do business, will be determined as of the earlier of the date of the application of this definition or the Termination Date.

 

l)                                          Confidential Information ” means all trade secrets and information disclosed to the Executive or known by the Executive as a consequence of or through the unique position of his employment with the Company or any Related Entity (including information conceived, originated, discovered or developed by the Executive and information acquired by the Company or any Related Entity from others) prior to or after the date hereof, and not generally or publicly known (other than as a result of unauthorized disclosure by the Executive), about the Company or any Related Entity or its business. Confidential Information includes, but is not limited to, inventions, ideas, designs, computer programs, circuits, schematics, formulas, algorithms, trade secrets, works of authorship, mask works, developmental or experimental work, processes, techniques, improvements, methods of manufacturing, know-how, data, financial information and forecasts, product plans, marketing plans and strategies, price lists, customer lists and contractual obligations and terms thereof, data, documentation and other information, in whatever form disclosed, relating to the Company or any Related Entity, including, but not limited to, financial statements, financial projections, business plans, listings and contractual obligations and terms thereof, components of intellectual property, unique designs, methods of manufacturing or other technology of the Company or any Related Entity.

 

m)                                  Disability ” means the Executive’s inability, or failure, to perform the essential functions of his position, with or without reasonable accommodation, for any period of six months or more in any 12 month period, by reason of any medically determinable physical or mental impairment.

 

n)                                      “Equity Awards ” means any stock options, restricted stock, restricted stock units, stock appreciation rights, phantom stock or other equity based awards granted by the Company to the Executive.

 

o)                                      Excise Tax ” means any excise tax imposed by Section 4999 of the Code, together with any interest and penalties imposed with respect thereto, or any interest or penalties that are incurred by the Executive with respect to any such excise tax.

 

p)                                      Good Reason ” means the occurrence of any of the following: (i) a material diminution in the Executive’s base compensation (consisting of his base salary and pro-rata bonus opportunity as set forth in Section 4 below); (ii) a material diminution in the Executive’s title, authority, duties, or responsibilities; (iii) a material diminution in the title, authority, duties, or responsibilities of the supervisor to whom the Executive is required to report; (iv) the Company’s or Related Entity’s requiring the Executive to be based at any office or location outside of 50 miles from the location of employment or service as of the effective date of this Agreement, except for travel reasonably required in the performance of the Executive’s responsibilities; or (v) any other action or inaction that constitutes a material breach by the Company of this Agreement.  For purposes of this Agreement, Good Reason shall not be deemed to exist unless the Executive’s termination of employment for Good Reason occurs within six months following the initial existence of one of the conditions specified in clauses (i) through (v) above, the Executive provides the Company with written notice of the existence of

 

4



 

such condition within 90 days after the initial existence of the condition, and the Company fails to remedy the condition within 30 days after its receipt of such notice.

 

q)                                      Group ” shall have the meaning ascribed to such term in Section 13(d) of the Securities Exchange Act of 1934.

 

r)                                         Person ” shall have the meaning ascribed to such term in Section 3(a)(9) of the Securities Exchange Act of 1934 and used in Sections 13(d) and 14(d) thereof.

 

s)                                        “Pro-Rata Bonus” means the Bonus that (but for the cessation of the Executive’s employment) would otherwise have been payable to the Executive for the fiscal year in which the Termination Date occurs (based on actual performance outcomes for that year), multiplied by the following fraction: (i) the number of days that the Executive was employed by the Company during that fiscal year, divided by (ii) 365.  For this purpose, the Bonus that would otherwise have been payable to the Executive shall be determined in good faith and in the same manner applicable to active named executive officers of the Company.

 

t)                                         Related Entity ” means any Person controlling, controlled by or under common control with the Company or any of its subsidiaries.  For this purpose, the terms controlling,” “controlled by” and “under common control with” mean the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of a Person, whether through the ownership of voting securities, as trustee or executor, by contract or otherwise, including (without limitation) the ownership, directly or indirectly, of securities having the power to elect a majority of the board of directors or similar body governing the affairs of such Person.

 

u)                                      Restricted Period ” shall be the Term of Employment and the one year period immediately following termination of the Term of Employment.

 

v)                                      Severance Amount ” shall mean an amount equal to the Executive’s annual Base Salary, as in effect immediately prior to the Termination Date.

 

w)                                    Severance Term ” means the twelve month period following the date on which the Term of Employment ends.

 

x)                                      Target Bonus ” has the meaning described in Section 4(b).

 

y)                                      Term of Employment ” means the period during which the Executive shall be employed by the Company pursuant to the terms of this Agreement, which period shall begin on the Commencement Date and continue until terminated in accordance with Section 6 hereof.

 

z)                                       Termination Date ” means the date on which the Term of Employment ends.

 

2.                                       Employment . The Company hereby agrees to employ the Executive and the Executive hereby agrees to serve the Company during the Term of Employment on the terms and conditions set forth herein.

 

5



 

3.                                       Duties of Executive . During the Term of Employment, the Executive shall be employed and serve as the Chief Commercial Officer, and shall have such duties typically associated with such title, including, without limitation, leading global commercial operations and playing a key management and leadership role for Insmed. The Executive shall faithfully and diligently perform all services consistent with his position as may be assigned to him by Executive Management or the Board in their reasonable and lawful discretion.  The Executive shall devote his full business time, attention and efforts to the performance of his duties under this Agreement, render such services to the best of his ability, and use his reasonable best efforts to promote the interests of the Company.  The Executive shall not engage in any other business or occupation during the Term of Employment, including, without limitation, any activity that (i) conflicts with the interests of the Company or its subsidiaries, (ii) interferes with the proper and efficient performance of his duties for the Company, or (iii) interferes with the exercise of his judgment in the Company’s best interests.  Notwithstanding the foregoing or any other provision of this Agreement, it shall not be a breach or violation of this Agreement for the Executive to (w) serve on up to two outside corporate or scientific advisory boards with prior notice to, and approval by, the Board, (x) serve on civic or charitable boards or committees, (y) deliver lectures, fulfill speaking engagements or teach at educational institutions, or (z) manage personal investments, so long as such activities do not constitute a Competitive Activity or significantly interfere with or significantly detract from the performance of the Executive’s responsibilities to the Company in accordance with this Agreement.

 

4.                                       Compensation .

 

a)                                      Base Salary . The Executive shall receive a Base Salary at the annual rate of $430,000 during the Term of Employment, with such Base Salary payable in installments consistent with the Company’s normal payroll schedule, subject to applicable withholding and other taxes.  The Base Salary shall be reviewed, at least annually, for merit increases and may, by action and in the discretion of the Board, be increased at any time or from time to time, but may not be decreased from the then current Base Salary.

 

b)                                      Bonuses .  Commencing in 2016, the Executive shall participate in the Company’s annual incentive compensation plan, program and/or arrangements applicable to senior-level executives, as established and modified from time to time by the Compensation Committee of the Board in its sole discretion.  During the Term of Employment, the Executive shall have a target bonus opportunity under such plan or program equal to 40% of his current Base Salary, (the “Target Bonus”), based on satisfaction of performance criteria to be established by the Compensation Committee of the Board within the first three months of each fiscal year that begins during the Term of Employment. Payment of annual incentive compensation awards shall be made in the same manner and at the same time that other senior-level executives receive their annual incentive compensation awards and, except as otherwise provided herein, will be subject to the Executive’s continued employment through the applicable payment date.  For the 2016 calendar year, Executive’s bonus will be prorated based on four months of employment in the year (in other words, Executive will be eligible to receive 1/3 of the bonus he would have been entitled to if he had worked the entire calendar year).   In addition, upon the completion of 30 days employment the executive will be eligible to receive a $25,000 sign-on bonus.  All sign-on bonuses are subject to the appropriate payroll taxes.  Should the Executive resign without

 

6



 

Good Reason within twelve (12) of the Commencement date, and the entire $25,000 has been paid in full, the Executive shall be responsible to reimburse the Company for the full sign-on.

 

5.                                       Expense Reimbursement and Other Benefits .

 

a)                                      Reimbursement of Expenses . Upon the submission of proper substantiation by the Executive, and subject to such rules and guidelines as the Company may from time to time adopt with respect to the reimbursement of expenses of executive personnel, the Company shall reimburse the Executive for all reasonable expenses actually paid or incurred by the Executive during the Term of Employment in the course of and pursuant to the business of the Company.  The Executive shall account to the Company in writing for all expenses for which reimbursement is sought and shall supply to the Company copies of all relevant invoices, receipts or other evidence reasonably requested by the Company. In addition, the Company shall reimburse the Executive for (or directly pay) reasonable attorneys’ fees incurred by the Executive in the negotiation and drafting of this Agreement, up to a maximum of $5,000.

 

b)                                      Compensation/Benefit Programs . During the Term of Employment, the Executive shall be entitled to participate in all medical, dental, hospitalization, accidental death and dismemberment, disability, travel and life insurance plans, and any and all other plans as are from time to time offered by the Company to its executive personnel, including savings, pension, profit-sharing and deferred compensation plans, subject to the general eligibility and participation provisions set forth in such plans.

 

c)                                       Working Facilities . During the Term of Employment, the Company shall furnish the Executive with an office, administrative help and such other facilities similar to those provided to similarly situated executives of the Company.  The Executive’s principal place of employment (subject to reasonable travel) shall be Bridgewater, NJ.  During the Term of Employment, the Executive will continue residing in the greater Philadelphia metropolitan area, and will commute to and from the Company’s Bridgewater, NJ office.

 

d)                                      Stock Options . As a material inducement to entering into this Agreement, you will receive an option to purchase a number of common shares equivalent to the value of $850,000. The exact number of options will be determined using a Black-Scholes calculation based upon the closing price at the end of the day on the first day of the month following your date of hire.  The exercise price per share will be equal to the fair market value per share also as determined based upon the closing price at the end of the day on the first day of the month following your date of hire. The options will vest at the rate of twenty-five percent (25%) on the first anniversary of the date of the grant and an additional twelve and half (12.5%) percent on each sixth month anniversary thereafter so that the entire grant will be fully vested on the fourth anniversary of the date of grant. The terms and conditions of the options will be consistent with the Company’s standard stock option agreement and stock incentive plan to be provided to you.

 

e)                                       Vacation . The Executive shall be entitled to take vacation time as per our Professional Judgment Vacation Policy.  This policy provides the Executive the ability, with advanced approval from his manager, to take vacation days as and when appropriate throughout the calendar year.

 

7



 

6.                                       Termination .

 

a)                                      General . The Term of Employment shall terminate upon the earliest to occur of (i) the Executive’s death, (ii) a termination by the Company by reason of the Executive’s Disability, (iii) a termination by the Company with or without Cause, or (iv) a termination by Executive with or without Good Reason.  Upon any termination of Executive’s employment for any reason, except as may otherwise be requested by the Company in writing and agreed upon in writing by Executive, the Executive shall resign from any and all directorships, committee memberships or any other positions Executive holds with the Company or any of its Related Entities.

 

b)                                      Termination By Company for Cause. The Company shall at all times have the right, upon written notice to the Executive, to terminate the Term of Employment, for Cause.  In no event shall a termination of the Executive’s employment for Cause occur unless the Company gives written notice to the Executive in accordance with this Agreement stating with reasonable specificity the events or actions that constitute Cause and providing the Executive with an opportunity to cure (if curable) within a reasonable period of time, but not less than a period of 10 days.  Cause shall in no event be deemed to exist except upon a decision made by the Board, at a meeting, duly called and noticed, to which the Executive (and the Executive’s counsel) shall be invited upon proper notice and shall be permitted to present evidence.    In the event that the Term of Employment is terminated by the Company for Cause, Executive shall be entitled only to the Accrued Obligations, payable as and when those amounts would have been payable had the Term of Employment not ended. Nothing in this paragraph shall be construed as a release of any claims against the Company and the Board’s determination of cause shall not be considered a waiver of any claims the Executive may have.

 

c)                                       Disability . The Company shall have the option, in accordance with applicable law, to terminate the Term of Employment upon written notice to the Executive, at any time during which the Executive is suffering from a Disability.  In the event that the Term of Employment is terminated due to the Executive’s Disability, the Executive shall be entitled to (i) the Accrued Obligations, payable as and when those amounts would have been paid had the Term of Employment not ended, (ii) the Pro-Rata Bonus, payable within 2 ½ months following the end of the fiscal year in which the Termination Date occurs, (iii) any earned but unpaid Bonus in respect to any completed fiscal year that has ended on or prior to the Termination Date, payable within 2 ½ months following the last day of the month in which the Termination Date occurs, and (iv) any insurance benefits to which he and his beneficiaries are entitled as a result of his Disability.

 

d)                                      Death . In the event that the Term of Employment is terminated due to the Executive’s death, the Executive’s estate shall be entitled to (i) the Accrued Obligations, payable as and when those amounts would have been paid had the Term of Employment not ended, (ii) the Pro-Rata Bonus, payable within 2 ½ months following the end of the fiscal year in which the Termination Date occurs, (iii) any earned but unpaid Bonus in respect to any completed fiscal year that has ended on or prior to the Termination Date, payable within 2 ½ months following the last day of the month in which the Termination Date occurs, and (iv) any insurance benefits to which he and his beneficiaries are entitled as a result of his death.

 

8



 

e)                                       Termination Without Cause or Resignation With Good Reason . The Company may terminate the Term of Employment without Cause, and the Executive may terminate the Term of Employment for Good Reason, at any time upon written notice.  If the Term of Employment is terminated by the Company without Cause (other than due to the Executive’s death or Disability) or by the Executive for Good Reason, in either case prior to the date of a Change in Control or more than one year after a Change in Control, the Executive shall be entitled to the following:

 

(i)                                      The Accrued Obligations, payable as and when those amounts would have been paid had the Term of Employment not ended;

 

(ii)                                   Any unpaid Bonus in respect to any completed fiscal year that has ended on or prior to the Termination Date, payable within 2 ½ months following the last day of the month in which the Termination Date occurs;

 

(iii)                                The Pro-Rata Bonus, payable within 2 ½ months following the end of the fiscal year in which the Termination Date occurs;

 

(iv)                               The Severance Amount, payable in equal installments consistent with the Company’s normal payroll schedule over the 12 month period beginning with the first regularly scheduled payroll date that occurs more than 30 days following the Termination Date;

 

(v)                                  Provided that the Executive timely elects continued coverage under COBRA, the Company will reimburse the Executive for the monthly COBRA cost of continued health and dental coverage of the Executive and his qualified beneficiaries paid by the Executive under the health and dental plans of the Company, less the amount that the Executive would be required to contribute for health and dental coverage if the Executive were an active employee of the Company, for 12  months (or, if less, for the duration that such COBRA coverage is available to Executive); and

 

(vi)                               Accelerated vesting, as of the Termination Date, of any stock options that would have otherwise vested within six months following the Termination Date.

 

f)                                        Termination by Executive Without Good Reason . The Executive may terminate his employment without Good Reason by providing the Company 30 days’ written notice of such termination.  In the event of a termination of employment by the Executive under this Section 6(f), the Executive shall be entitled only to the Accrued Obligations payable as and when those amounts would have been payable had the Term of Employment not ended.  In the event of termination of the Executive’s employment under this Section 6(f), the Company may, in its sole and absolute discretion, by written notice, accelerate such date of termination and still have it treated as a termination without Good Reason.

 

g)                                       Change in Control of the Company . If the Executive’s employment is terminated by the Company (or any entity to which the obligations and benefits under this Agreement have been assigned, pursuant to Section (11) without Cause or by the Executive for Good Reason during the one year period immediately following the Change in Control, then the Executive shall be entitled to the same payments, rights and benefits described in Section 6(e), subject to the following enhancements:

 

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(i)                                      The Severance Amount will be paid in a lump-sum on the first regularly scheduled payroll date that occurs more than 30 days following the Termination Date (rather than in installments over 12 months);

 

(ii)                                   Provided that the Executive timely elects continued coverage under COBRA, the Company will reimburse the Executive for the monthly COBRA cost of continued health and dental coverage of the Executive and his qualified beneficiaries paid by the Executive under the health and dental plans of the Company, less the amount that the Executive would be required to contribute for health and dental coverage if the Executive were an active employee of the Company, for 12  months (or, if less, for the duration that such COBRA coverage is available to Executive); and

 

(iii)                                All time-vested Equity Awards will vest in full.

 

h)                                      Release .  All rights, payments and benefits due to the Executive under this Article 6 (other than the Accrued Obligations) shall be conditioned on the Executive’s execution of a general release of claims against the Company and its affiliates substantially in the form attached hereto as Exhibit A (the “Release”) and on that Release becoming effective and irrevocable within 30 days following the Termination Date.

 

i)                                          Section 280G Certain Reductions of Payments by the Company .

 

(i)                                      Anything in this Agreement to the contrary notwithstanding, in the event it shall be determined that any payment or distribution by the Company to or for the benefit of the Executive, whether paid or payable or distributed or distributable pursuant to the terms of this Agreement or otherwise (a “Payment”), would be nondeductible by the Company for Federal income tax purposes because of Section 280G of the Code, then the aggregate present value of amounts payable or distributable to or for the benefit of the Executive pursuant to this Agreement (such payments or distributions pursuant to this Agreement are hereinafter referred to as “Agreement Payments”) shall be reduced to the Reduced Amount.  The “Reduced Amount” shall be an amount expressed in present value that avoids any Payment being nondeductible by the Company because of Section 280G of the Code.  To the extent necessary to avoid imposition of the Excise Tax, the amounts payable or benefits to be provided to the Executive shall be reduced such that the reduction of compensation to be provided to the Executive is minimized.  In applying this principle, the reduction shall be made in a manner consistent with the requirements of Section 409A of the Code, and where two economically equivalent amounts are subject to reduction but payable at different times, such amounts shall be reduced on a pro rata basis (but not below zero).  Anything to the contrary notwithstanding, if the Reduced Amount is zero and it is determined further that any Payment which is not an Agreement Payment would nevertheless be nondeductible by the Company for Federal income tax purposes because of Section 280G of the Code, then the aggregate present value of Payments which are not Agreement Payments shall also be reduced (but not below zero) to an amount expressed in present value which maximizes the aggregate present value of Payments without causing any Payment to be nondeductible by the Company because of Section 280G of the Code.  If a reduction of any Payment is required pursuant to this Section 6(i), such reduction shall occur to the amounts in the order that results in the greatest economic present value of all payments and

 

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benefits actually made or provided to the Executive. For purposes of this Section 6(i), present value shall be determined in accordance with Section 280G(d)(4) of the Code.

 

(ii)                                   All determinations required to be made under this Section 6(i) shall be made by a tax or compensation consulting firm of national reputation selected by the Company (the “Consulting Firm”), which shall provide detailed supporting calculations both to the Company and the Executive within 20 business days of the date of termination or such earlier time as is requested by the Company and an opinion to the Executive that he has substantial authority not to report any excise tax on his Federal income tax return with respect to any Payments.  Any such determination by the Consulting Firm shall be binding upon the Company and the Executive.  Within five business days thereafter, the Company shall pay to or distribute to or for the benefit of the Executive such amounts as are then due to the Executive under this Agreement.  All fees and expenses of the Consulting Firm incurred in connection with the determinations contemplated by this Section 6(i) shall be borne by the Company.

 

(iii)                                As a result of the uncertainty in the application of Section 280G of the Code at the time of the initial determination by the Consulting Firm hereunder, it is possible that Payments will have been made by the Company which should not have been made (“Overpayment”) or that additional Payments which will not have been made by the Company could have been made (“Underpayment”), in each case, consistent with the calculations required to be made hereunder. In the event that the Consulting Firm, based upon the assertion of a deficiency by the Internal Revenue Service against the Executive which the Consulting Firm believes has a high probability of success, determines that an Overpayment has been made, any such Overpayment paid or distributed by the Company to or for the benefit of the Executive shall be promptly repaid to the Company by the Executive.  In the event that the Consulting Firm, based upon controlling precedent or other substantial authority, determines that an Underpayment has occurred, any such Underpayment shall be promptly paid by the Company to or for the benefit of the Executive together with interest at the applicable federal rate provided for in Section 7872(f)(2) of the Code.

 

j)                                         Cooperation . Following the Term of Employment, the Executive shall give his assistance and cooperation willingly, upon reasonable advance notice with due consideration for his other business or personal commitments, with respect to any investigation or the Company’s defense or prosecution of any existing or future claims or litigations or other proceedings relating to matters in which he was involved or potentially had knowledge by virtue of his employment with the Company, including his attendance and truthful testimony where deemed appropriate by the Company. In no event shall his cooperation materially interfere with his services for a subsequent employer or other similar service recipient. To the extent permitted by law, the Company agrees that (i) it shall promptly reimburse the Executive for his reasonable and documented expenses in connection with his rendering assistance and/or cooperation under this Section 6(j) upon his presentation of documentation for such expenses and (ii) the Executive shall be reasonably compensated for any continued material services as required under this Section 6(j).

 

k)                                      Return of Company Property . Following the Termination Date, the Executive or his personal representative shall return all Company property in his possession, including but not limited to all computer equipment (hardware and software), telephones,

 

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facsimile machines, palm pilots and other communication devices, credit cards, office keys, security access cards, badges, identification cards and all copies (including drafts) of any documentation or information (however stored) relating to the business of the Company, its customers and clients or its prospective customers and clients (provided that the Executive may retain a copy of the addresses contained in his rolodex, smart phone or similar device).

 

l)                                          Compliance with Section 409A .

 

(i)                                      General .  It is the intention of both the Company and the Executive that the benefits and rights to which the Executive could be entitled pursuant to this Agreement comply with Section 409A of the Code and the Treasury Regulations and other guidance promulgated or issued thereunder (“Section 409A”), to the extent that the requirements of Section 409A are applicable thereto, and the provisions of this Agreement shall be construed in a manner consistent with that intention.

 

(ii)                                   Distributions on Account of Separation from Service . If and to the extent required to comply with Section 409A, no payment or benefit required to be paid under this Agreement on account of termination of the Executive’s employment shall be made unless and until the Executive incurs a “separation from service” within the meaning of Section 409A.

 

(iii)                                Six Month Delay for Specified Employees .  If the Executive is a “specified employee” (within the meaning of Section 409A(a)(2)(B)(i) of the Code), then no payment or benefit that is considered deferred compensation subject to Section 409A of the Code (and not exempt from Section 409A of the Code as a short term deferral or otherwise) that is payable on account of the Executive’s “separation from service”, as that term is defined for purposes of Section 409A, shall be made before the date that is six months after the Executive’s “separation from service” (or, if earlier, the date of the Executive’s death) if and to the extent that such payment or benefit constitutes deferred compensation (or may be nonqualified deferred compensation) under Section 409A and such deferral is required to comply with the requirements of Section 409A.  Any payment or benefit delayed by reason of the prior sentence shall be paid out or provided in a single lump sum at the end of such required delay period in order to catch up to the original payment schedule.

 

(iv)                               Treatment of Each Installment as a Separate Payment . For purposes of applying the provisions of Section 409A to this Agreement, each separately identified amount to which the Executive is entitled under this Agreement shall be treated as a separate payment.  In addition, any series of installment payments under this Agreement shall be treated as a right to a series of separate payments.

 

(v)                                  Taxable Reimbursements and In-Kind Benefits .

 

(A)                                Any reimbursements by the Company to the Executive of any eligible expenses under this Agreement that are not excludable from the Executive’s income for Federal income tax purposes (the “Taxable Reimbursements”) shall be made by no later than the last day of the taxable year of the Executive following the year in which the expense was incurred.

 

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(B)                                The amount of any Taxable Reimbursements, and the value of any in-kind benefits to be provided to the Executive, during any taxable year of the Executive shall not affect the expenses eligible for reimbursement, or in-kind benefits to be provided, in any other taxable year of the Executive.

 

(C)                                The right to Taxable Reimbursement, or in-kind benefits, shall not be subject to liquidation or exchange for another benefit.

 

(vi)                               No Guaranty of 409A Compliance . Notwithstanding the foregoing, the Company does not make any representation to the Executive that the payments or benefits provided under this Agreement are exempt from, or satisfy, the requirements of Section 409A, and the Company shall have no liability or other obligation to indemnify or hold harmless the Executive or any beneficiary of the Executive for any tax, additional tax, interest or penalties that the Executive or any beneficiary of the Executive may incur in the event that any provision of this Agreement, or any amendment or modification thereof, or any other action taken with respect thereto, is deemed to violate any of the requirements of Section 409A.

 

7.                                       Restrictive Covenants .

 

a)                                      Non-competition . At all times during the Restricted Period, the Executive shall not, directly or indirectly (whether as a principal, agent, partner, employee, officer, investor, owner, consultant, board member, security holder, creditor or otherwise), engage in any Competitive Activity, or have any direct or indirect interest in any sole proprietorship, corporation, company, partnership, association, venture or business or any other person or entity that directly or indirectly (whether as a principal, agent, partner, employee, officer, investor, owner, consultant, board member, security holder, creditor, or otherwise) engages in a Competitive Activity; provided that the foregoing shall not apply to the Executive’s ownership of securities of the Company or the acquisition by the Executive, solely as an investment, of securities of any issuer that is registered under Section 12(b) or 12(g) of the Securities Exchange Act of 1934, and that are listed or admitted for trading on any United States national securities exchange or that are quoted on the Nasdaq Stock Market, or any similar system or automated dissemination of quotations of securities prices in common use, so long as the Executive does not control, acquire a controlling interest in or become a member of a group which exercises direct or indirect control of, more than five percent of any class of capital stock of such corporation.

 

b)                                      Non-solicitation of Employees and Certain Other Third Parties . At all times during the Restricted Period, the Executive shall not, directly or indirectly, for himself or for any other person, firm, corporation, partnership, association or other entity (i) employ or attempt to employ or enter into any contractual arrangement with any employee, consultant or individual contractor performing services for the Company, or any Related Entity, unless such employee, consultant or independent contractor, has not been employed or engaged by the Company for a period in excess of six months and/or (ii) call on, solicit, or engage in business with, any of the actual or targeted prospective customers or clients of the Company or any Related Entity on behalf of any person or entity in connection with any Competitive Activity, nor shall the Executive make known the names and addresses of such actual or targeted prospective customers or clients, or any information relating in any manner to the trade or business relationships of the Company or any Related Entities with such customers or clients, other than

 

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in connection with the performance of the Executive’s duties under this Agreement, and/or (iii) persuade or encourage or attempt to persuade or encourage any persons or entities with whom the Company or any Related Entity does business or has some business relationship to cease doing business or to terminate its business relationship with the Company or any Related Entity or to engage in any Competitive Activity on its own or with any competitor of the Company or any Related Entity.

 

c)                                       Confidential Information. The Executive shall not at any time divulge, communicate, use to the detriment of the Company or any Related Entity or for the benefit of any other person or persons, or misuse in any way, any Confidential Information pertaining to the business of the Company. Any Confidential Information or data now or hereafter acquired by the Executive with respect to the business of the Company or any Related Entity (which shall include, but not be limited to, information concerning the Company’s or any Related Entity’s financial condition, prospects, technology, customers, suppliers, sources of leads and methods of doing business) shall be deemed a valuable, special and unique asset of the Company and its Related Entities that is received by the Executive in confidence and as a fiduciary, and the Executive shall remain a fiduciary to the Company and its Related Entities with respect to all of such information. Notwithstanding the foregoing, nothing in this Agreement shall be deemed to restrict or prohibit Executive from initiating communications directly with, responding to any inquiries from, providing testimony before, providing confidential information to, reporting possible violations of law or regulation to, or from filing a claim or assisting with an investigation directly with a self-regulatory authority or a government agency or entity, including the U.S. Equal Employment Opportunity Commission (“EEOC”), the Department of Labor (“DOL”), the National Labor Relations Board (“NLRB”“), the Department of Justice (“DOJ”), the Securities and Exchange Commission (“SEC”), the Congress, and any agency Inspector General (collectively, the “Regulators”), or from making other disclosures that are protected under the whistleblower provisions of state or federal law or regulation. Federal law provides criminal and civil immunity to federal and state claims for trade secret misappropriation to individuals who disclose a trade secret to their attorney, a court, or a government official in certain, confidential circumstances that are set forth at 18 U.S.C. §§ 1833(b)(1) and 1833(b)(2), related to the reporting or investigation of a suspected violation of the law, or in connection with a lawsuit for retaliation for reporting a suspected violation of the law.

 

d)                                      Ownership of Developments . All processes, concepts, techniques, inventions and works of authorship, including new contributions, improvements, formats, packages, programs, systems, machines, compositions of matter manufactured, developments, applications and discoveries, and all copyrights, patents, trade secrets, or other intellectual property rights associated therewith conceived, invented, made, developed or created by the Executive during the Term of Employment either during the course of performing work for the Company or its Related Entities, or their clients, or which are related in any manner to the business (commercial or experimental) of the Company or its Related Entities or their clients (collectively, the “Work Product”) shall belong exclusively to the Company and its Related Entities and shall, to the extent possible, be considered a work made by the Executive for hire for the Company and its Related Entities within the meaning of Title 17 of the United States Code. To the extent the Work Product may not be considered work made by the Executive for hire for the Company and its Related Entities, the Executive agrees to assign, and automatically assign at the time of creation of the Work Product, without any requirement of further consideration, any

 

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right, title, or interest the Executive may have in such Work Product. Upon the request of the Company, the Executive shall take such further actions, including execution and delivery of instruments of conveyance, as may be appropriate to give full and proper effect to such assignment. The Executive shall further: (i) promptly disclose the Work Product to the Company; (ii) assign to the Company or its assignee, without additional compensation, all patent or other rights to such Work Product for the United States and foreign countries; (iii) sign all papers necessary to carry out the foregoing; and (iv) give testimony in support of his inventions, all at the sole cost and expense of the Company.

 

e)                                       Books and Records . All books, records, and accounts relating in any manner to the customers or clients of the Company or its Related Entities, whether prepared by the Executive or otherwise coming into the Executive’s possession, shall be the exclusive property of the Company and its Related Entities and shall be returned immediately to the Company on termination of the Executive’s employment hereunder or on the Company’s request at any time.

 

f)                                        Acknowledgment by Executive . The Executive acknowledges and confirms that the restrictive covenants contained in this Section 7 (including without limitation the length of the term of the provisions of this Section 7) are reasonably necessary to protect the legitimate business interests of the Company and its Related Entities, and are not overbroad, overlong, or unfair and are not the result of overreaching, duress or coercion of any kind. The Executive further acknowledges and confirms that the compensation payable to the Executive under this Agreement is in consideration for the duties and obligations of the Executive hereunder, including the restrictive covenants contained in this Section 7, and that such compensation is sufficient, fair and reasonable. The Executive further acknowledges and confirms that his full, uninhibited and faithful observance of each of the covenants contained in this Section 7 will not cause him any undue hardship, financial or otherwise, and that enforcement of each of the covenants contained herein will not impair his ability to obtain employment commensurate with his abilities and on terms fully acceptable to him or otherwise to obtain income required for the comfortable support of him and his family and the satisfaction of the needs of his creditors. The Executive acknowledges and confirms that his special knowledge of the business of the Company and its Related Entities is such as may cause the Company and its Related Entities serious injury or loss if he were to use such ability and knowledge to the benefit of a competitor or were to compete with the Company or its Related Entities in violation of the terms of this Section 7. The Executive further acknowledges that the restrictions contained in this Section 7 are intended to be, and shall be, for the benefit of and shall be enforceable by, the Company’s successors and assigns. The Executive expressly agrees that upon any breach or violation of the provisions of this Section 7, the Company shall be entitled to seek in addition to any other rights or remedies it may have, to (i) temporary and/or permanent injunctive relief in any court of competent jurisdiction as described in Section 7(i) hereof, and (ii) such damages as are provided at law or in equity.  The existence of any claim or cause of action against the Company or its Related Entities, whether predicated upon this Agreement or otherwise, shall not constitute a defense to the enforcement of the restrictions contained in this Section 7.

 

g)                                       Reformation by Court . In the event that a court of competent jurisdiction shall determine that any provision of this Article 7 is invalid or more restrictive than permitted

 

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under the governing law of such jurisdiction, then only as to enforcement of this Article 7 within the jurisdiction of such court, such provision shall be interpreted or reformed and enforced as if it provided for the maximum restriction permitted under such governing law.

 

h)                                      Extension of Time . If the Executive shall be in violation of any provision of this Section 7, then each time limitation set forth in this Section 7 shall be extended for a period of time equal to the period of time during which such violation or violations occur.

 

i)                                          Injunction . It is recognized and hereby acknowledged by the parties hereto that a breach by the Executive of any of the covenants contained in Section 7 of this Agreement may cause irreparable harm and damage to the Company, and its Related Entities, the monetary amount of which may be virtually impossible to ascertain.  As a result, the Executive recognizes and hereby acknowledges that the Company and its Related Entities shall be entitled to seek an injunction from any court of competent jurisdiction enjoining and restraining any violation of any or all of the covenants contained in Section 7 of this Agreement by the Executive or any of his affiliates, associates, partners or agents, either directly or indirectly, and that such right to injunction shall be cumulative and in addition to whatever other remedies the Company may possess.

 

8.                                       Representations and Warranties of Executive . The Executive represents and warrants to the Company that:

 

a)                                      The Executive’s employment will not conflict with or result in his breach of any agreement to which he is a party or otherwise may be bound;

 

b)                                      The Executive has not violated, and in connection with his employment with the Company will not violate, any non-solicitation, non-competition or other similar covenant or agreement of a prior employer by which he is or may be bound; and

 

c)                                       In connection with Executive’s employment with the Company, he will not use any confidential or proprietary information that he may have obtained in connection with employment with any prior employer; and

 

d)                                      The Executive has not (i) been convicted of any felony; or (ii) committed any criminal act with respect to Executive’s current or any prior employment; and

 

e)                                       The Executive is not dependent on alcohol or the illegal use of drugs. The Executive recognizes that Company shall have the right to conduct random drug testing of its employees and that Executive may be called upon in such a manner.

 

9.                                       Agreement to Abide by Company Policies : By executing this Agreement, the Executive acknowledges and agrees to comply with any Company policies, standard operating procedures (“SOPs”), and additional agreements between the Executive and the Company which may be in effect from time to time, including, but not limited to (i) the Company’s Code of Conduct; (ii) Company policies against harassment and discrimination; and (iii) the Company’s Code of Ethics.

 

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10.                                Taxes .  All payments or transfers of property made by the Company to the Executive or his estate or beneficiaries shall be subject to the withholding of such amounts relating to taxes as the Company may reasonably determine it should withhold pursuant to any applicable law or regulation.

 

11.                                Assignment . The Company shall have the right to assign this Agreement and its rights and obligations hereunder in whole, but not in part, to any corporation or other entity with or into which the Company may hereafter merge or consolidate or to which the Company may transfer all or substantially all of its assets, if in any such case said corporation or other entity shall by operation of law or expressly in writing assume all obligations of the Company hereunder as fully as if it had been originally made a party hereto, but may not otherwise assign this Agreement or its rights and obligations hereunder.  The Executive may not assign or transfer this Agreement or any rights or obligations hereunder, but Executive’s rights hereunder shall inure to the benefit of his estate, executors, administrators and heirs.

 

12.                                Governing Law . This Agreement shall be governed by and construed and enforced in accordance with the laws of the State of New Jersey, without regard to principles of conflict of laws.

 

13.                                Jurisdiction and Venue . The parties acknowledge that a substantial portion of the negotiations, anticipated performance and execution of this Agreement occurred or shall occur in Somerset, New Jersey, and that, therefore, without limiting the jurisdiction or venue of any other federal or state courts, each of the parties irrevocably and unconditionally (i) agrees that any suit, action or legal proceeding arising out of or relating to this Agreement which is expressly permitted by the terms of this Agreement to be brought in a court of law, may be brought in the courts of record of the Superior Court of the State of New Jersey, Somerset County, or the court of the United States, District of New Jersey; (ii) consents to the jurisdiction of each such court in any such suit, action or proceeding; (iii) waives any objection which it or he may have to the laying of venue of any such suit, action or proceeding in any of such courts; and (iv) agrees that service of any court papers may be effected on such party by mail, as provided in this Agreement and as permitted by New Jersey or Federal law, or in such other manner as may be provided under applicable laws or court rules in such courts.

 

14.                                Entire Agreement . This Agreement, together with the exhibit attached hereto, constitutes the entire agreement between the parties hereto with respect to the subject matter hereof and, upon its effectiveness, shall supersede all prior agreements, understandings and arrangements, both oral and written, between the Executive and the Company (or any of its Related Entities) with respect to such subject matter.  This Agreement may not be modified in any way unless by a written instrument signed by both the Company and the Executive.

 

15.                                Notices . All notices required or permitted to be given hereunder shall be in writing and shall be personally delivered by courier, sent by registered or certified mail, return receipt requested or sent by confirmed facsimile transmission addressed as set forth herein. Notices personally delivered, sent by facsimile or sent by overnight courier shall be deemed given on the date of delivery and notices mailed in accordance with the foregoing shall be deemed given upon receipt by the addressee, as evidenced by the return receipt thereof.  Notice shall be sent (i) if to the Company, addressed to, 10 Finderne Ave, Building 10, Bridgewater, NJ

 

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08807-2265, Attention: General Counsel, and (ii) if to the Executive, to his address as reflected on the payroll records of the Company, or to such other address as either party shall request by notice to the other in accordance with this provision.

 

16.                                Benefits; Binding Effect. This Agreement shall be for the benefit of and binding upon the parties hereto and their respective heirs, personal representatives, legal representatives, successors and, where permitted and applicable, assigns, including, without limitation, any successor to the Company, whether by merger, consolidation, sale of stock, sale of assets or otherwise.

 

17.                                Right to Consult with Counsel; No Drafting Party . The Executive acknowledges having read and considered all of the provisions of this Agreement carefully, and having had the opportunity to consult with counsel of his own choosing, and, given this, the Executive agrees that the obligations created hereby are not unreasonable.  The Executive acknowledges that he has had an opportunity to negotiate any and all of these provisions and no rule of construction shall be used that would interpret any provision in favor of or against a party on the basis of who drafted the Agreement.

 

18.                                Severability . The invalidity of any one or more of the words, phrases, sentences, clauses, provisions, sections or articles contained in this Agreement shall not affect the enforceability of the remaining portions of this Agreement or any part thereof, all of which are inserted conditionally on their being valid in law, and, in the event that any one or more of the words, phrases, sentences, clauses, provisions, sections or articles contained in this Agreement shall be declared invalid, this Agreement shall be construed as if such invalid word or words, phrase or phrases, sentence or sentences, clause or clauses, provisions or provisions, section or sections or article or articles had not been inserted.  If such invalidity is caused by length of time or size of area, or both, the otherwise invalid provision will be considered to be reduced to a period or area which would cure such invalidity.

 

19.                                Waivers .  The waiver by either party hereto of a breach or violation of any term or provision of this Agreement shall not operate nor be construed as a waiver of any subsequent breach or violation.

 

20.                                Damages; Attorneys’ Fees .  Nothing contained herein shall be construed to prevent the Company or the Executive from seeking and recovering from the other damages sustained by either or both of them as a result of its or his breach of any term or provision of this Agreement.  Each party shall bear its own costs and attorneys’ fees.

 

21.                                Waiver of Jury Trial . The Executive hereby knowingly, voluntarily and intentionally waives any right that the Executive may have to a trial by jury in respect of any litigation arising out of, under or in connection with the express terms of this Agreement and any agreement, document or instrument contemplated to be executed in connection herewith.

 

22.                                No Set-off or Mitigation . The Company’s obligation to make the payments provided for in this Agreement and otherwise to perform its obligations hereunder shall not be affected by any set­ off, counterclaim, recoupment, defense or other claim, right or action which

 

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the Company may have against the Executive or others.  In the event of any termination of the Executive’s employment under this Agreement, he shall be under no obligation to seek other employment or otherwise in any way to mitigate the amount of any payment provided for hereunder.

 

23.                                Section Headings . The article, section and paragraph headings contained in this Agreement are for reference purposes only and shall not affect in any way the meaning or interpretation of this Agreement.

 

24.                                No Third Party Beneficiary .  The Related Entities are intended third party beneficiaries of this Agreement.  Otherwise, nothing expressed or implied in this Agreement is intended, or shall be construed, to confer upon or give any person other than the Company, the parties hereto and their respective heirs, personal representatives, legal representatives, successors and permitted assigns, any rights or remedies under or by reason of this Agreement.

 

25.                                Counterparts . This Agreement may be executed in one or more counterparts, each of which shall be deemed to be an original but all of which together shall constitute one and the same instrument and agreement.

 

26.                                Indemnification .

 

a)                                      Subject to limitations imposed by law, the Company shall indemnify and hold harmless the Executive to the fullest extent permitted by law from and against any and all claims, damages, expenses (including attorneys’ fees), judgments, penalties, fines, settlements, and all other liabilities incurred or paid by him in connection with the investigation, defense, prosecution, settlement or appeal of any threatened, pending or completed action, suit or proceeding, whether civil, criminal, administrative or investigative and to which the Executive was or is a party or is threatened to be made a party by reason of the fact that the Executive is or was an officer, employee or agent of the Company, or by reason of anything done or not done by the Executive in any such capacity or capacities, provided that the Executive acted in good faith, in a manner that was not grossly negligent or constituted willful misconduct and in a manner he reasonably believed to be in or not opposed to the best interests of the Company, and, with respect to any criminal action or proceeding, had no reasonable cause to believe his conduct was unlawful. The Company also shall pay any and all expenses (including attorney’s fees) incurred by the Executive as a result of the Executive being called as a witness in his capacity as a current or former officer or director of the Company.

 

b)                                      The Company shall pay any expenses (including attorneys’ fees, judgments, penalties, fines, settlements, and other liabilities incurred by the Executive in investigating, defending, settling or appealing any action, suit or proceeding described in this Section 26) in advance of the final disposition of such action, suit or proceeding.  The Company shall promptly pay the amount of such expenses to the Executive, but in no event later than ten days following the Executive’s delivery to the Company of a written request for an advance pursuant to this Section 26, together with a reasonable accounting of such expenses.

 

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c)                                       The Executive hereby undertakes and agrees to repay to the Company any advances made pursuant to this Section 26 if and to the extent that it shall ultimately be found that the Executive is not entitled to be indemnified by the Company for such amounts.

 

d)                                      The Company shall make the advances contemplated by this Section 26 regardless of the Executive’s financial ability to make repayment, and regardless whether indemnification of the Executive by the Company will ultimately be required.  Any advances and undertakings to repay pursuant to this Section 26 shall be unsecured and interest-free.

 

e)                                       The provisions of this Section 26 shall survive the Term of Employment.

 

[Signatures on Following Page]

 

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IN WITNESS WHEREOF, the undersigned have executed this Agreement on the date first above written.

 

 

COMPANY:

 

 

 

Insmed Incorporated, a Virginia corporation

 

By:

/s/ William H. Lewis

 

Name:

William H. Lewis

 

Title:

President and CEO

 

 

 

EXECUTIVE:

 

/s/ Roger Adsett

 

 

 

Name: Roger Adsett

 

21



 

Exhibit A

 

General Release of Claims

 

1.                                       Roger Adsett (“Executive”), for himself and his family, heirs, executors, administrators, legal representatives and their respective successors and assigns, in exchange for the consideration received pursuant to Sections 6(e) [and 6(g)] of the Employment Agreement (the “Severance Benefits”) to which this release is attached as Exhibit A (the “Employment Agreement”), does hereby release and forever discharge Insmed Incorporated (the “Company”), its subsidiaries, affiliated companies, successors and assigns, and its current or former directors, officers, employees, shareholders or agents in such capacities (collectively with the Company, the “Released Parties”) from any and all actions, causes of action, suits, controversies, claims and demands whatsoever, for or by reason of any matter, cause or thing whatsoever, whether known or unknown including, but not limited to, all claims under any applicable laws arising under or in connection with Executive’s employment or termination thereof, whether for tort, breach of express or implied employment contract, wrongful discharge, intentional infliction of emotional distress, or defamation or injuries incurred on the job or incurred as a result of loss of employment.  Without limiting the generality of the release provided above, Executive expressly waives any and all claims under Age Discrimination in Employment Act (“ ADEA’ ’) that he may have as of the date hereof.  Executive further understands that, by signing this General Release of Claims, he is in fact waiving, releasing and forever giving up any claim under the ADEA as well as all other laws within the scope of this paragraph 1 that may have existed on or prior to the date hereof.  Notwithstanding anything in this paragraph 1 to the contrary, this General Release of Claims shall not apply to (i) any rights to receive any payments or benefits to which the Executive is entitled under COBRA, (ii) any rights or claims that may arise as a result of events occurring after the date this General Release of Claims is executed, (iii) any indemnification and advancement rights Executive may have as a former employee, officer or director of the Company or its subsidiaries or affiliated companies (including any rights under Section 26 of the Employment Agreement or under the Company’s charter or bylaws), (iv) any claims for benefits under any directors’ and officers’ liability policy maintained by the Company or its subsidiaries or affiliated companies in accordance with the terms of such policy, (v) rights to vested benefits under the Company’s 401(k) plan, and (vi) any rights as a holder of equity securities or debt securities/notes of the Company.

 

2.                                       Executive represents that he has not filed against the Released Parties any complaints, charges, or lawsuits arising out of his employment, or any other matter arising on or prior to the date of this General Release of Claims, and covenants and agrees that he will never individually or with any person file, or commence the filing of any lawsuits, complaints or proceedings with any governmental agency, or against the Released Parties with respect to any of the matters released by Executive pursuant to paragraph 1 hereof; provided, that nothing herein shall prevent his from filing a charge or complaint with the Equal Employment Opportunity Commission (“EEOC”) or similar federal or state agency or his ability to participate in any investigation or proceeding conducted by such agency.  Executive does agree, however, that he is waiving his right to recover any money in connection with such an investigation or charge filed by his or by any other individual, or a charge filed by the Equal Employment Opportunity Commission or any other federal, state or local agency.

 

1



 

3.                                       Executive acknowledges that, in the absence of his execution of this General Release of Claims, the Severance Benefits would not otherwise be due to his.

 

4.                                       Executive acknowledges and agrees that he received adequate consideration in exchange for agreeing to the covenants contained in Section 7 of the Employment Agreement, that such covenants remain reasonable and necessary to protect the legitimate business interests of the Company and its affiliates and that he will continue to comply with those covenants.

 

5.                                       Executive hereby acknowledges that the Company has informed his that he has up to 21 days to sign this General Release of Claims and he may knowingly and voluntarily waive that 21 day period by signing this General Release of Claims earlier.  Executive also understands that he shall have seven days following the date on which he signs this General Release of Claims within which to revoke it by providing a written notice of his revocation to the Company in the manner described in Section 15 of the Employment Agreement.

 

6.                                       Executive acknowledges and agrees that this General Release of Claims will be governed by and construed and enforced in accordance with the internal laws of the State of New Jersey applicable to contracts made and to be performed entirely within such State.

 

7.                                       Executive acknowledges that he has read this General Release of Claims, that he has been advised that he should consult with an attorney before he executes this General Release of Claims, and that he understands all of its terms and executes it voluntarily and with full knowledge of its significance and the consequences thereof.

 

8.                                       This General Release of Claims shall become irrevocable on the eighth day following Executive’s execution of this General Release of Claims, unless previously revoked in accordance with paragraph 5, above.

 

Intending to be legally bound hereby, Executive has executed this General Release of Claims on            , 20  .

 

 

2


EXHIBIT 31.1

 

Section 302 Certification

 

I, William H. Lewis, Chief Executive Officer of Insmed Incorporated, certify that:

 

(1) I have reviewed this Quarterly Report on Form 10-Q of Insmed Incorporated;

 

(2) Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

(3) Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

(4) The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

(5) The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date:  November 3, 2016

 

 

/s/ William H. Lewis

 

William H. Lewis

 

Chief Executive Officer

 

(Principal Executive Officer)

 


EXHIBIT 31.2

 

Section 302 Certification

 

I, Andrew T. Drechsler, Chief Financial Officer of Insmed Incorporated, certify that:

 

(1) I have reviewed this Quarterly Report on Form 10-Q of Insmed Incorporated;

 

(2) Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

(3) Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

(4) The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

(5) The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date:  November 3, 2016

 

 

/s/ Andrew T. Drechsler

 

Andrew T. Drechsler

 

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 2003

 

Solely for the purposes of complying with 18 U.S.C. § 1350, I, William Lewis, Chief Executive Officer of Insmed Incorporated (the “Company”), hereby certify, based on my knowledge, that:

 

(1)                              the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2016 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

 

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

 

/s/ William H. Lewis

 

William H. Lewis

 

Chief Executive Officer

 

(Principal Executive Officer)

 

 

November 3, 2016

 

This certification accompanies the Quarterly Report on 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 Insmed Incorporated 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.  A signed original of this statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

 


EXHIBIT 32.2

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2003

 

Solely for the purposes of complying with 18 U.S.C. § 1350, I, Andrew T. Drechsler, Chief Financial Officer of Insmed Incorporated (the “Company”), hereby certify, based on my knowledge, that:

 

(1)                              the Quarterly Report on Form 10-Q of the Company for the quarter ended September 30, 2016 (the “Report”) fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and

 

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

 

/s/ Andrew T. Drechsler

 

Andrew T. Drechsler

 

Chief Financial Officer

 

(Principal Financial and Accounting Officer)

 

 

November 3, 2016

 

This certification accompanies the Quarterly Report on 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 Insmed Incorporated 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.  A signed original of this statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.