Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

(Mark One)

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

For the quarterly period ended June 30, 2019

or

 

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

For the transition period from                      to                     

Commission file number: 001-36199

 

 

PULMATRIX, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   46-1821392

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

99 Hayden Avenue, Suite 390

Lexington, MA

  02421
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code (781) 357-2333

 

 

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

Indicate by check mark whether the registrant has submitted electronically 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 during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  ☒    No  ☐

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

 

Large accelerated filer      Accelerated filer  
Non-accelerated filer      Smaller reporting company  
     Emerging growth company  

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

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

Securities registered pursuant to Section 12(b) of the Exchange Act:

 

Title of each Class

 

Trading

Symbol(s)

 

Name of each exchange

on which registered

Common Stock, par value $0.0001 per share   PULM   The NASDAQ Stock Market LLC

As of August 1, 2019, the registrant had 19,624,560 shares of common stock outstanding.

 

 

 


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PULMATRIX, INC.

FORM 10-Q

FOR THE QUARTERLY PERIOD ENDED June 30, 2019

TABLE OF CONTENTS

 

PART I — FINANCIAL INFORMATION

  

Item 1. Financial Statements

     3  

Condensed Consolidated Balance Sheets as of June  30, 2019 (unaudited) and December 31, 2018

     3  

Condensed Consolidated Statements of Operations for the Three Months and Six Months Ended June 30, 2019 and 2018 (unaudited)

     4  

Condensed Consolidated Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2019 and 2018 (unaudited)

     5  

Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2019 and 2018 (unaudited)

     6  

Notes to Condensed Consolidated Financial Statements (unaudited)

     7  

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

     17  

Item 3. Quantitative and Qualitative Disclosures About Market Risk

     24  

Item 4. Controls and Procedures

     24  

PART II — OTHER INFORMATION

  

Item 1. Legal Proceedings

     25  

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

     26  

Item 3. Defaults Upon Senior Securities

     26  

Item 4. Mine Safety Disclosures

     26  

Item 5. Other Information

     26  

Item 6. Exhibits

     26  

SIGNATURES

     28  

 

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PART I — FINANCIAL INFORMATION

Item 1. Financial Statements.

PULMATRIX, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

 

     At June 30,
2019
    At December 31,
2018
 
     (unaudited)        

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 31,817     $ 2,563  

Prepaid expenses and other current assets

     1,114       717  
  

 

 

   

 

 

 

Total current assets

     32,931       3,280  

Property and equipment, net

     335       394  

Long-term restricted cash

     204       204  

Goodwill

     3,577       10,845  
  

 

 

   

 

 

 

Total assets

   $ 37,047     $ 14,723  
  

 

 

   

 

 

 

Liabilities and stockholders’ equity

    

Current liabilities:

    

Accounts payable

     543       1,183  

Accrued expenses

     1,231       1,696  

Deferred revenue

     10,979       —    
  

 

 

   

 

 

 

Total current liabilities

     12,753       2,879  

Deferred revenue, net of current portion

     6,202       ——    
  

 

 

   

 

 

 

Total liabilities

     18,955       2,879  
  

 

 

   

 

 

 

Commitments (Note 13)

    

Stockholders’ equity:

    

Preferred stock, $0.0001 par value—500,000 authorized and 0 issued and outstanding at June 30, 2019 and December 31, 2018

     —       —  

Common stock, $0.0001 par value—200,000,000 shares authorized; 19,624,560, and 4,932,723 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively.

     2       —    

Additional paid-in capital

     225,655       206,409  

Accumulated deficit

     (207,565     (194,565
  

 

 

   

 

 

 

Total stockholders’ equity

     18,092       11,844  
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 37,047     $ 14,723  
  

 

 

   

 

 

 

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

 

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PULMATRIX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(unaudited)

(in thousands, except share and per share data)

 

     For the Three Months Ended
June 30,
    For the Six Months Ended
June 30,
 
     2019     2018     2019     2018  

Revenues

   $ 4,819   $ —     $ 4,819   $ 153
  

 

 

   

 

 

   

 

 

   

 

 

 

Operating expenses

        

Research and development

     3,164       4,013       5,340       7,234  

General and administrative

     3,128       2,115       5,115       4,161  

Impairment of goodwill

     6,474       —         7,268       —    
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     12,766       6,128       17,723       11,395  
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (7,947     (6,128     (12,904     (11,242

Interest expense

     —         (80     —         (186

Other income/(expense), net

     103       20       (96     19  
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (7,844   $ (6,188   $ (13,000   $ (11,409
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per share, basic and diluted

   $ (0.41   $ (1.34   $ (0.99   $ (3.35
  

 

 

   

 

 

   

 

 

   

 

 

 

Weighted average shares of common stock used to compute basic and diluted net loss per share

     19,216,172       4,610,205       13,114,242       3,405,644  
  

 

 

   

 

 

   

 

 

   

 

 

 

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

 

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PULMATRIX, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY

For the three and six months ended June 30, 2019 and 2018

(in thousands, except share data)

 

     Common
Stock
     Additional
Paid-In
Capital
     Accumulated
Deficit
    Total  
     Shares      Amount  

Balance — January 1, 2019

     4,932,723      $ —      $ 206,409      $ (194,565   $ 11,844  

Adjustment for reverse stock split

     2,717        —        —        —       —  

Issuance of common stock, net of issuance costs

     2,394,955        1        2,978        —       2,979  

Exercise of pre-funded warrants

     697,500        —        70        —       70  

Stock-based compensation

     —        —        459        —       459  

Net loss

     —        —        —        (5,156     (5,156
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

 

Balance — March 31, 2019

     8,027,895        1      $ 209,916        (199,721     10,196  

Issuance of common stock, net of issuance costs

     3,319,553        —          14,566        —       14,566  

Exercise of pre-funded warrants

     8,277,112        1        82        —       83  

Stock-based compensation

     —        —        1,091        —       1,091  

Net loss

     —        —        —        (7,844     (7,844
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

 

Balance — June 30, 2019

     19,624,560      $ 2      $ 225,655      $ (207,565   $ 18,092  
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

 

 

     Common
Stock
     Additional
Paid-In
Capital
     Accumulated
Deficit
    Total  
     Shares      Amount  

Balance — January 1, 2018

     2,104,750      $ —      $ 184,139      $ (174,002   $ 10,137  

Issuance of common stock, net of issuance costs

     123,266        —        1,847        —       1,847  

Stock-based compensation

     —        —        765        —       765  

Net loss

     —        —        —        (5,221     (5,221
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

 

Balance — March 31, 2018

     2,228,016        —        186,751        (179,223     7,528  

Issuance of common stock, net of issuance costs

     1,681,000        —          14,449        —       14,449  

Exercise of pre-funded warrants

     783,707        —        76        —       76  

Stock-based compensation

     —        —        933        —       933  

Net loss

     —        —        —        (6,188     (6,188
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

 

Balance — June 30, 2018

     4,692,723      $ —        $ 202,209      $ (185,411   $ 16,798  
  

 

 

    

 

 

    

 

 

    

 

 

   

 

 

 

 

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PULMATRIX, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

(in thousands)

 

     For the 
Six Months Ended
June 30,
 
     2019     2018  

Cash flows from operating activities:

    

Net loss

   $ (13,000   $ (11,409

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

    

Depreciation and amortization

     95       118  

Stock-based compensation

     1,550       1,698  

Impairment of goodwill

     7,268       —    

Deferred rent

     (11     —  

Non-cash interest expense

     —         55  

Non-cash debt issuance expense

     —         3  

Fair value adjustment on derivative liability

     —         (1

(Gain)/Loss on disposal of property and equipment

     (1     —    

Changes in operating assets and liabilities:

    

Prepaid expenses and other current assets

     (397     77  

Accounts payable

     (640     1,050  

Accrued expenses

     (454     334  

Deferred revenue

     17,181       —  
  

 

 

   

 

 

 

Net cash provided by (used in) operating activities

     11,591       (8,075
  

 

 

   

 

 

 

Cash flows from investing activities:

    

Purchases of property and equipment

     (35     (2
  

 

 

   

 

 

 

Net cash used in investing activities

     (35     (2
  

 

 

   

 

 

 

Cash flows from financing activities:

    

Proceeds from issuance of common stock, net of issuance costs

     17,545       16,372  

Proceeds from the exercise of pre-funded warrants

     153       —  

Term loan principal payments

     —         (3,259

End of term payments

     —         (245
  

 

 

   

 

 

 

Net cash provided by financing activities

     17,698       12,868  
  

 

 

   

 

 

 

Net increase in cash and cash equivalents

     29,254       4,791  

Cash, cash equivalents and restricted cash — beginning of period

     2,767       3,754  
  

 

 

   

 

 

 

Cash, cash equivalents and restricted cash — end of period

   $ 32,021     $ 8,545  
  

 

 

   

 

 

 

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

 

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PULMATRIX, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

June 30, 2019

(unaudited)

(in thousands, except share and per share data)

1. Organization

Pulmatrix, Inc. (the “Company”) was incorporated in 2013 as a Nevada corporation and converted to a Delaware corporation in September 2013. On June 15, 2015, the Company completed a merger with Pulmatrix Operating Company, Inc. changed its name from Ruthigen, Inc. to “Pulmatrix, Inc.” and relocated its corporate headquarters to Lexington, Massachusetts. The Company is a clinical stage biotechnology company focused on the discovery and development of a novel class of inhaled therapeutic products. The Company’s proprietary dry powder delivery platform, iSPERSE™ (inhaled Small Particles Easily Respirable and Emitted), is engineered to deliver small, dense particles with highly efficient dispersibility and delivery to the airways, which can be used with an array of dry powder inhaler technologies and can be formulated with a variety of drug substances. The Company is developing a pipeline of iSPERSE-based therapeutic candidates targeted at prevention and treatment of a range of respiratory diseases and infections with significant unmet medical needs.

On February 5, 2019, the Company effectuated a 1-for-10 reverse stock split of its issued and outstanding shares of common stock (the “Reverse Stock Split”) pursuant to which every 10 shares of the Company’s issued and outstanding common stock were automatically converted into one share of common stock. Accordingly, all common share and per share data are retrospectively restated to give effect of the Reverse Stock Split for all periods presented herein.

Liquidity

At June 30, 2019, the Company had unrestricted cash and cash equivalents of $31,817 and working capital of $20,178. The Company had incurred recurring losses and as of June 30, 2019 had an accumulated deficit of $207,565. During the six months ended June 30, 2019, the Company had used approximately $11,591 in its operating activities.

During the six months ended June 30, 2019, the Company raised an aggregate of $17,698 in net proceeds through the sale of its common stock and the exercise of pre-funded warrants (note 7). On April 15, 2019, the Company entered into a material definitive agreement with Cipla Technologies, LLP (“Cipla”) and $22,000 was received pursuant to the terms of the agreement (note 6).

2. Summary of Significant Accounting Policies and Recent Accounting Standards

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements of the Company have been prepared on a going concern basis in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim financial information have been included. When preparing financial statements in conformity with GAAP, the Company must make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and related disclosures at the date of the financial statements. Actual results could differ from those estimates. Additionally, operating results for the six months ended June 30, 2019, are not necessarily indicative of the results that may be expected for any other interim period or for the fiscal year ending December 31, 2019. For further information, refer to the financial statements and footnotes included in the Company’s annual financial statements for the fiscal year ended December 31, 2018, which are included in the Company’s annual report on Form 10-K filed with the SEC on February 19, 2019.

Use of Estimates

In preparing consolidated financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting period. Due to inherent uncertainty involved in making estimates, actual results may differ from these estimates. On an ongoing basis, the Company evaluates its estimates and assumptions. These estimates and assumptions include valuing equity securities in share-based payments, estimating the useful lives of depreciable and amortizable assets, valuation allowance against deferred tax assets, recognition of research and development and license revenues, goodwill impairment, and estimating the fair value of long-lived assets to assess whether impairment charges may apply.

 

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Cash, Cash Equivalents and Restricted Cash

Cash and cash equivalents consist of cash, checking accounts and money market accounts. Restricted cash consists of cash deposited with a financial institution for $204.

The following table provides a reconciliation of cash, cash equivalents and restricted cash as reported in the condensed consolidated balance sheets that sum to the total of the same amounts in the statement of cash flows.

 

     Six Months Ended
June 30,
 
     2019      2018  

Cash and cash equivalents

   $ 31,817      $ 8,341  

Restricted Cash

     204        204  
  

 

 

    

 

 

 

Total cash, cash equivalents and restricted cash in the statement of cash flows

   $ 32,021      $ 8,545  
  

 

 

    

 

 

 

Significant Accounting Policies

In the six months ended June 30, 2019, there were no changes to the Company’s significant accounting policies identified in the Company’s most recent annual financial statements for the fiscal year ended December 31, 2018, which are included in the Company’s current report on Form 10-K.

Recent Accounting Pronouncements

In November 2018, the FASB issued ASU No. 2018-18, Clarifying the Interaction between Topic 808 (Collaborative Arrangements) and Topic 606 (Revenue from Contracts with Customers). The amendments are effective for public business entities for fiscal years beginning after December 15, 2019. Early adoption is permitted. The Company has early adopted ASU 2018-18 and adoption of this ASU has no significant impact on its condensed consolidated financial statements.

In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement . ASU 2018-13 modifies the disclosure requirements for fair value measurements by removing, modifying, or adding certain disclosures. The amendments in ASU 2018-13 will be effective for fiscal years beginning after December 15, 2019. Early adoption is permitted. An entity is permitted to early adopt any removed or modified disclosures upon issuance of ASU No. 2018-13 and delay adoption of the additional disclosures until their effective date. The Company has not yet evaluated the impact of adoption of this ASU on its condensed consolidated financial statements disclosures.

In June 2018, the FASB issued ASU No. 2018-07, Compensation — Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting . Subtopic 505-50, Equity — Equity-Based Payments to Non-Employees, addresses aspects of the accounting for nonemployee share based compensation. The amendments are effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. The Company has adopted ASU 2018-07 and adoption of this ASU has no significant impact on its condensed consolidated financial statements.

In February 2018, the FASB issued ASU No. 2018-02, “Income Statement — Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income” (“ASU 2018-02”), which allows a reclassification from accumulated other comprehensive income to retained earnings for stranded tax effects resulting from the Tax Act and requires certain disclosures about stranded tax effects. ASU 2018-02 is effective for us beginning January 1, 2019 (with early adoption permitted) and shall be applied either in the period of adoption or retrospectively to each period (or periods) in which the effect of the change in the corporate income tax rate in the Tax Act is recognized. The Company has adopted ASU 2018-02 and adoption of this ASU has no significant impact on its condensed consolidated financial statements.

In July 2017, FASB issued ASU No. 2017-11, Earnings per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815). ASU 2017-11 consists of two parts. The amendments in Part I of this Update change the classification analysis of certain equity-linked financial instruments (or embedded features) with down round features. When determining whether certain financial instruments should be classified as liabilities or equity instruments, a down round feature no longer precludes equity classification when assessing whether the instrument is indexed to an entity’s own stock. The amendments also clarify existing disclosure requirements for equity-classified instruments. As a result, a freestanding equity-linked financial instrument (or embedded conversion option) no longer would be accounted for as a derivative liability at fair value as a result of the

 

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existence of a down round feature. For freestanding equity classified financial instruments, the amendments require entities that present earnings per share (EPS) in accordance with Topic 260 to recognize the effect of the down round feature when it is triggered. That effect is treated as a dividend and as a reduction of income available to common shareholders in basic EPS. Convertible instruments with embedded conversion options that have down round features are now subject to the specialized guidance for contingent beneficial conversion features (in Subtopic 470-20, Debt—Debt with Conversion and Other Options), including related EPS guidance (in Topic 260). The amendments in Part II of this Update re-characterize the indefinite deferral of certain provisions of Topic 480 that now are presented as pending content in the Codification, to a scope exception. Those amendments do not have an accounting effect. For public business entities, the amendments in Part I of this Update are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2018. The amendments in Part II of this Update do not require any transition guidance because those amendments do not have an accounting effect. The Company has adopted ASU 2017-11 and adoption of this ASU has no significant impact on its condensed consolidated financial statements.

In February 2016, the FASB issued authoritative guidance under ASU 2016-02, Leases (Topic 842). ASU 2016-02 provides new comprehensive lease accounting guidance that supersedes existing lease guidance. Upon adoption of ASU 2016-02, the Company will be required to recognize most leases on its balance sheet at the beginning of the earliest comparative period presented with a corresponding adjustment to stockholders’ equity. ASU 2016-02 requires the Company to capitalize most current operating lease obligations as right-of-use assets with a corresponding liability based on the present value of future operating lease obligations. Criteria for distinguishing leases between finance and operating are substantially similar to criteria for distinguishing between capital leases and operating leases in previous lease guidance. Lease agreements that are 12 months or less are permitted to be excluded from the balance sheet. Topic 842 includes a number of optional practical expedients that the Company may elect to apply. Expanded disclosures with additional qualitative and quantitative information will also be required. The adoption will include updates as provided under ASU 2018-01, Leases (Topic 842): Land Easement Practical Expedient for Transition to Topic 842 and ASU 2018-10, Codification Improvements to Topic 842, Leases. Since the Company is an emerging growth company and elected to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act, this ASU 2016-02 and related ASUs will be effective for the Company beginning in fiscal 2020. The Company is currently evaluating the potential impact of adoption of this standard on its condensed consolidated financial statements and the additional transition method under ASU 2018-11, which allows the Company to recognize Topic 842’s cumulative effect within retained earnings in the period of adoption.

In May 2014, the FASB issued ASU No. 2014-09 (Topic 606) “Revenue from Contracts with Customers.” Topic 606 supersedes the revenue recognition requirements in Topic 605 “Revenue Recognition” (Topic 605). The new standard’s core principal is that an entity will recognize revenue at an amount that reflects the consideration to which the entity expects to be entitled in exchange for transferring good or services to a customer. The principles in the standard are applied in five steps: 1) Identify the contract(s) with a customer; 2) Identify the performance obligations in the contract; 3) Determine the transaction price; 4) Allocate the transaction price to the performance obligations in the contract; and 5) Recognize revenue when (or as) the entity satisfies a performance obligation. The Company adopted Topic 606 as of January 1, 2019 using the modified retrospective transition method. The adoption of Topic 606 did not have any material impact on the Company’s condensed consolidated financial statements.

Goodwill

Goodwill represents the difference between the consideration transferred and the fair value of the net assets acquired, and liabilities assumed under the acquisition method of accounting for push-down accounting. Goodwill is not amortized but is evaluated for impairment within the Company’s single reporting unit on an annual basis during the fourth quarter, or more frequently if an event occurs or circumstances change that would more likely than not reduce the fair value of the Company’s reporting unit below its carrying amount. When performing the impairment assessment, the accounting standard for testing goodwill for impairment permits a company to first assess the qualitative factors to determine whether the existence of events and circumstances indicates that it is more likely than not that the goodwill is impaired. If the Company believes, as a result of the qualitative assessment, that it is more likely than not that the fair value of goodwill is impaired, the Company then must perform a quantitative analysis to determine if the carrying value of the reporting entity exceeds its fair value.

As of June 30, 2019, the Company’s common stock value declined, accordingly, the Company determined that its carrying value is in excess of its fair value and as such, recorded an impairment charge of $6,474 and revalued goodwill to $3,577.

 

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3. Prepaid Expenses and Other Current Assets

Prepaid expenses consisted of the following:

 

     At June 30, 2019      At December 31, 2018  

Prepaid Insurance

   $ 377      $ 243  

Prepaid Clinical Trials

     513      419  

Prepaid Other

     211        27  

Deferred Operating Costs

     13        28  
  

 

 

    

 

 

 

Total prepaid expenses and other current assets

   $ 1,114      $ 717  
  

 

 

    

 

 

 

4. Property and Equipment, net

Property and equipment consisted of the following:

 

     At June 30, 2019      At December 31, 2018  

Laboratory equipment

   $ 1,538      $ 1,529  

Computer equipment

     191        185  

Office furniture and equipment

     217        217  

Leasehold improvements

     579        579  

Construction in progress

     14        ——    
  

 

 

    

 

 

 

Total property and equipment

     2,539        2,510  

Less accumulated depreciation and amortization

     (2,204      (2,116
  

 

 

    

 

 

 

Property and equipment, net

   $ 335      $ 394  
  

 

 

    

 

 

 

Depreciation and amortization expense for the three months and six months ended June 30, 2019, was $45 and $95, respectively. Depreciation and amortization expense for the three months and six months ended June 30, 2018, was $58 and $118, respectively.

5. Accrued Expenses

Accrued expenses consisted of the following:

 

     At June 30, 2019      At December 31, 2018  

Accrued vacation

   $ 82      $ 59  

Accrued wages and incentive

     369        915  

Accrued clinical & consulting

     216        517  

Accrued legal & patent

     171        67  

Deferred rent

     56        67  

Accrued other expenses

     337        71  
  

 

 

    

 

 

 

Total accrued expenses

   $ 1,231      $ 1,696  
  

 

 

    

 

 

 

6. Collaborations

On April 15, 2019 (“Effective Date”), the Company entered into a Development and Commercialization Agreement (the “Cipla Agreement”) with Cipla Technologies, LLC. for the worldwide development and commercialization of Pulmazole (the “Product”), an inhaled formulation of the anti-fungal drug itraconazole (developed using iSPERSE technology designed to treat allergic bronchopulmonary aspergillosis (“ABPA”) in patients with asthma.

Pursuant to the Cipla Agreement, the Company is responsible for the development of the Product in accordance with the development plan, which includes completion of the Phase 2 ABPA study, as well as any additional Phase 2/2b and/or Phase 3 clinical studies that may be required for regulatory approval. In addition, the Company will be responsible for submission of investigational new drug (“IND”) applications, annual reports and other regulatory filings to the extent required to conduct the development activities, including any clinical studies. Subsequent to regulatory approval of the Product for marketing in the U.S. or in any other country, Cipla will be responsible for the implementation of the commercialization plan, including all activities, arrangements and other matters related to commercialization.

 

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The Company received a non-refundable upfront payment of $22 million under the Cipla Agreement (the “Upfront Payment”). Upon receipt of the Upfront Payment, the Company irrevocably assigned to Cipla the following assets, solely to the extent that each covers the Product in connection with any treatment, prevention, and/or diagnosis of diseases of the pulmonary system (“Pulmonary Indications”): all existing and future technologies, current and future drug master files, dossiers, third-party contracts, regulatory filings, regulatory materials and regulatory approvals, patents, and intellectual property rights, as well as any other associated rights and assets directly related to the Product, specifically in relation to Pulmonary Indications (collectively, the “Assigned Assets”), excluding most specifically the Company’s iSPERSE technology. A portion of the Upfront Payment was deposited by the Company into a bank account, along with an equal amount from the Company, and will be dedicated to the development of the Product (the “Initial Development Funding”). After the Initial Development Funding is depleted, the Company and Cipla will each be responsible for 50% of the development costs actually incurred (the “Co-Development Phase”).

The Company and Cipla have established a joint steering committee (the “JSC”). The JSC will, among other powers and responsibilities, direct the further development and commercialization activities, including all budgetary activities in relation to the Product. The JSC will oversee the performance of the Company and Cipla under the Cipla Agreement and will provide a forum for sharing advice, progress and results relating to such activities. The JSC is also responsible for reviewing and approving the development plan developed by the Company, and the commercialization plan developed by Cipla.

The Cipla Agreement will remain in effect in perpetuity, unless otherwise earlier terminated in accordance with its terms. In the event of circumstances affecting the continuity of development of the Product in line with the Cipla Agreement, the JSC will evaluate the cause and effect and make a recommendation as to the most optimal option available to Cipla and the Company. In any event, either the Company or Cipla may elect to terminate (a “Terminating Party”) its obligation to fund additional costs and expenses for the development and/or commercialization of the Product. If the non-Terminating Party wishes to continue the development of the Product, it will have the right to purchase the rights of the Terminating Party in the Product at fair market value. If both the Company and Cipla abandon the development program, the Company and Cipla shall make commercially reasonable efforts to monetize the Product and development program in connection with the Pulmonary Indications. The Company and Cipla will equally share the proceeds.

The Cipla Agreement also contains customary representations, warranties and covenants by both parties, as well as customary provisions relating to indemnification, confidentiality and other matters.

Accounting Treatment

The Company concluded that because both it and Cipla are active participants in the arrangement and are exposed to the significant risks and rewards of the collaboration, the Company’s collaboration with Cipla is within the scope of ASC 808 Collaborative Arrangements (“ASC 808”) for accounting purposes. Contemplating the guidance of ASU 2018-18, the Company concluded that because Cipla contracted with the Company to obtain research and development services and an irrevocable license to the Assigned Assets, each of which is an output of the Company’s ordinary activities in exchange for consideration, Cipla is a customer. Therefore, in order to determine the appropriate treatment for the research and development services and the license grant, the Company has applied the guidance in ASC 606 Revenue from Contracts with Customers (“ASC 606”) to account for and present consideration received from Cipla. Accordingly, the Company identified the following material promises under the arrangement: (1) the research and development services for the Product and (2) an irrevocable license to the Assigned Assets. The Company determined that the research and development services and license to the Assigned Assets are considered highly interdependent and highly interrelated and combined into a single performance obligation because it is impossible for Cipla to benefit from the license to the Assigned Assets without the performance by Pulmatrix of the research and development services. Such research and development services are highly specialized and proprietary to Pulmatrix and therefore not available to Cipla from any other third party.

The Company determined the total transaction price to be $22 million. Any consideration related to the Co-Development Phase has not been included in the transaction price as such amounts are subject to the variable consideration constraint. Additionally, upon Commercialization, Cipla and the Company will share equally, both positive and negative total free cash-flows earned by Cipla in respect of the Product. However, the Company has not included such free cash-flows in the transaction price as these milestones are constrained until after the commercialization of the Product.

Revenue associated with the combined research and development services for the Product and the irrevocable license to the Assigned Assets is recognized as revenue as the research and development services are provided using an input method, according to the ratio of costs incurred to the total costs expected to be incurred in the future to satisfy the performance obligation. In management’s judgment, this input method is the best measure of the transfer of control of the performance obligation. The amounts received that have not yet been recognized as revenue are recorded in deferred revenue on the Company’s condensed consolidated balance sheet.

None of the performance obligations have been fully satisfied as of June 30, 2019. During the three and six months ended June 30, 2019, the Company recognized $4.8 million in revenue in the Company’s condensed consolidated statements of operations under the Cipla Agreement. The Company received the $22.0 million Upfront Payment, and $4.8 million of revenue was recognized during the three and six months ended June 30, 2019. The aggregate amount of the transaction price related to the Company’s unsatisfied performance obligations and recorded $17.2 million in deferred revenue, of which $11.0 million is current. The Company expects to recognize the deferred revenue according to costs incurred, over the remaining research term, which is expected to be up to three years as of June 2019.

 

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7. Common Stock

2019

Public Offering

On April 8, 2019, the Company closed its underwritten public offering in which, pursuant to the underwriting agreement entered into between the Company and H.C. Wainwright & Co., LLC, as representative of the underwriters, dated April 3, 2019, the Company issued and sold an aggregate of (i) 1,719,554 common units, with each common unit being comprised of one share of the Company’s common stock, par value $0.0001 per share and one warrant to purchase one share of common stock and (ii) 8,947,112 pre-funded units with each pre-funded unit being comprised of one pre-funded warrant to purchase one share of common stock and one common warrant to purchase one share of common stock. The public offering price was $1.35 per common unit and $1.34 per pre-funded unit. The common warrants have an exercise price of $1.35 per share.

In addition, on April 8, 2019, the Company closed on the sale of an additional 1,599,999 common units purchased pursuant to the exercise in full of the underwriter’s option to purchase additional securities. Each common unit contains one share of common stock and one common warrant to purchase a share of common stock.

During the three months ended June 30, 2019, pre-funded warrants issued in this offering were exercised and 8,277,112 shares of common stock were issued with net proceeds of $83.

Warrants were also issued to the underwriters to purchase 797,334 shares of common stock at an exercise price of $1.6875 per share. Both the common and underwriter warrants have an exercise term of five years and are exercisable immediately following their issuance.

After giving effect to the exercise of the Underwriters’ overallotment option and the exercise of 8,277,112 pre-funded warrants, the gross aggregate proceeds from the offering on April 8 was $16,553, prior to deducting underwriting discounts and commissions and other estimated offering expenses. The Company agreed to pay H.C. Wainwright & Co, LLC a commission of 7% of the gross proceeds. The Company also agreed to pay or reimburse certain expenses on behalf of H.C. Wainwright. A total of $1,904 of commissions and other issuance costs were associated with the public offering.

For the three months ending June 30, 2019, after giving effect to fees, commissions and other expenses of approximately $1,904, the Company recorded net proceeds of $14,649 in aggregate for the sale of the public offering and the pre-funded warrant exercises.

Confidential Marketed Public Offering (“CMPO”)

On January 31, 2019 and February 4, 2019, the Company closed two CMPOs, pursuant to which the Company sold 156,118 and 532,353 shares of common stock, respectively, at $1.70 per share and issued warrants to exercise 10,151 and 34,605 shares of common stock, respectively, to underwriters at an exercise price of $2.125 per share with expiration dates of January 26, 2024 and January 30, 2024, respectively. Prior to deducting fees and commissions for both offerings, the Company recorded aggregate gross proceeds of approximately $1,170.

Registered Direct Offering

On February 12, 2019, the Company sold 1,706,484 shares at $1.465 per share for gross proceeds of approximately $2,500. In this registered direct offering, the Company issued warrants to purchase 1,706,484 shares of its common stock to investors with an exercise price of $1.34 per share and an expiration date of August 12, 2024. In addition, the Company issued warrants to purchase 110,922 shares of its common stock to underwriters with an exercise price of $1.8313 per share and an expiration date of February 7, 2024.

Exercise of Warrants

During the three months ended March 31, 2019, 697,500 pre-funded warrants, which were issued as part of the November 2018 securities purchase agreement with an institutional investor, were exercised and the Company recorded $70 in net proceeds.

 

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For the three months ending March 31, 2019, after giving effect to fees, commissions and other expenses of approximately $691, the Company recorded net proceeds of $3,049 in aggregate for the sale of the CMPOs, the registered direct offering and the pre-funded warrant exercises.

For the six months ending June 30, 2019, after giving effect to fees, commissions and other expenses of approximately $2,595, the Company recorded net proceeds of $17,698 in aggregate for the sale of the public offering, CMPOs, the registered direct offering and the pre-funded warrant exercises. The Company intends to use the net proceeds for research and development of its therapeutic candidates, particularly the development of Pulmazole, as well as for working capital and general corporate purposes.

2018

Public Offering

On April 3, 2018, the Company closed its previously announced an underwritten public offering in which, pursuant to the underwriting agreement entered into between the Company and Oppenheimer & Co. Inc., as representative of the underwriters, dated March 28, 2018, the Company issued and sold (i) 1,566,000 common units, with each common unit being comprised of one share of the Company’s common stock, par value $0.0001 per share, one Series A warrant to purchase one share of common stock and one Series B warrant to purchase one share of common stock, and (ii) 784,000 pre-funded units, with each pre-funded unit being comprised of one pre-funded warrant to purchase one share of common stock, one Series A Warrant and one Series B Warrant. The public offering price was $6.50 per common unit and $6.40 per pre-funded unit, and the gross proceeds received by the Company on April 3, 2018 pursuant to such sales were $15,197, prior to deducting underwriting discounts and commissions and other estimated offering expenses.

In addition, on April 4, 2018, the Company closed on the sale of 115,000 additional common units pursuant to the underwriters’ option, under the underwriting agreement, to purchase up to an additional 115,000 common and pre-funded units, which were exercised in full. After giving effect to the exercise of the Underwriters’ overallotment option, the gross aggregate proceeds from the offering on April 3 and 4 were $15,944, prior to deducting underwriting discounts and commissions and other estimated offering expenses.

All of the pre-funded warrants issued in the offering were exercised in April 2018 and, as 15,000 were exercised on a cashless basis, resulted in the issuance of an additional 783,707 shares of common stock with gross proceeds of $78.

The Series A Warrants included in the common units and the pre-funded units were immediately exercisable at a price of $6.50 per share of common stock, subject to adjustment in certain circumstances, and will expire six months from the date of issuance. The Series B Warrants included in the common units and the pre-funded units were immediately exercisable at a price of $7.50 per share of common stock, subject to adjustment in certain circumstances, and will expire five years from the date of issuance. The shares of common stock, or pre-funded warrants in the case of the pre-funded units, and the Series A Warrants and Series B Warrants were offered together, but the securities contained in the common units and the pre-funded units were issued separately.

The Company agreed to pay Oppenheimer & Co., Inc. a commission of (a) 7% of the gross proceeds raised up to $5,000 and (b) 6.5% of the gross proceeds raised in excess of $5,000. The Company also agreed to pay or reimburse certain expenses on behalf of Oppenheimer. A total of $1,497 of commissions and other issuance costs were associated with the public offering.

The net proceeds to the Company from the Offering of the common units and pre-funded units were approximately $14,525, after deducting the underwriting discounts and commissions and estimated offering expenses payable by the Company. The Company intends to use the net proceeds from the Offering for research and development of its therapeutic candidates, particularly the development of Pulmazole, as well as for working capital and general corporate purposes.

At-the-Market Offering

On March 17, 2017, the Company entered into an At-The-Market Sales Agreement (the “Sales Agreement”) with BTIG, LLC (“BTIG”) to act as the Company’s sales agent with respect to the issuance and sale of up to $11,000 of the Company’s shares of common stock, from time to time in an at-the-market public offering. Sales of common stock under the Sales Agreement are made pursuant to an effective shelf registration statement on Form S-3, which was filed with the Securities and Exchange Commission on July 15, 2016, and subsequently declared effective on August 3, 2016 (File No. 333-212546), and a related prospectus. BTIG acts as the Company’s sales agent on a commercially reasonable efforts basis, consistent with its normal trading and sales practices and applicable state and federal laws, rules and regulations and the rules of The NASDAQ Global Market. If expressly authorized by the Company, BTIG may also sell the Company’s common stock in privately negotiated transactions. There is no specific date on which the offering will end, there are no minimum sale requirements and there are no arrangements to place any of the proceeds of this offering in an escrow, trust or similar account.

 

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BTIG is entitled to compensation at a fixed commission rate of 3.0% of the gross proceeds from the sale of the Company’s common stock pursuant to the Sales Agreement.

During the six-month period ended June 30, 2018, the Company sold 123,266 shares of its common stock under the Sales Agreement at an average selling price of approximately $15.40 per share which resulted in gross proceeds of approximately $1,904 and net proceeds of approximately $1,847 after payment of 3% commission to BTIG and other issuance costs.

8. Warrants

A rollforward of the common stock warrants outstanding at June 30, 2019 is as follows.

 

     Number of
Warrants
     Weighted
Average
Exercise Price
     Weighted
Average
Remaining
Contractual
Term (Years)
     Aggregate
Intrinsic
Value
 

Outstanding January 1, 2019

     4,428,444      $ 10.78         $ —  

Adjustment for Reverse Stock Split

     16      $          

Warrants issued

     14,926,161      $ 1.37        

Pre-funded warrants issued

     8,947,112      $ 0.01        

Pre-funded warrants exercised

     (8,974,612    $ 0.01        

Expirations

     (3,926    $ 226.60        
  

 

 

          

Outstanding June 30, 2019

     19,323,195      $ 3.48        4.52      $ —  
  

 

 

          

The following represents a summary of the warrants outstanding at each of the dates identified:

 

     Classification      Exercise
Price
     Expiration
Date
     Number of Shares
Underlying Warrants
 
     For the Period Ended
June 30,
 

Issue Date

   2019      2018  

April 8, 2019

     Equity      $ 0.01        -----        670,000        —    

April 8, 2019

     Equity      $ 1.35        April 8, 2024        12,266,665        —    

April 8, 2019

     Equity      $ 1.6875        April 3, 2024        797,334        —    

February 12, 2019

     Equity      $ 1.8313        February 7, 2024        110,922        —    

February 12, 2019

     Equity      $ 1.34        August 12, 2024        1,706,484        —    

February 04, 2019

     Equity      $ 2.125        January 30, 2024        34,605        —    

January 31, 2019

     Equity      $ 2.125        January 26, 2024        10,151        —    

December 3, 2018

     Equity      $ 3.90        June 3, 2024        937,500        —    

April 3, 2018

     Equity      $ 7.50        April 3, 2023        2,350,011        4,815,000  

April 4, 2018

     Equity      $ 7.50        April 4, 2023        115,000        230,000  

August 31, 2015

     Equity      $ 118.00        August 31, 2020        3,000        3,000  

June 15, 2015

     Equity      $ 75.50        May 6, 2024        319,008        319,008  

June 15, 2015

     Equity      $ 83.50        June 16, 2020        2,515        2,515  

June 15, 2015

     Equity      $ 83.50        Mar 21, 2019        —          3,926  

Adjustment for Reverse Stock Split

              —          (5
           

 

 

    

 

 

 

Total Outstanding

              19,323,195        5,258,444  
           

 

 

    

 

 

 

9. Stock-Based Compensation

The Company sponsors the Pulmatrix, Inc. 2013 Employee, Director and Consultant Equity Incentive Plan (the “2013 Plan). As of June 30, 2019, the 2013 Plan provides for the grant of up to 12,500,000 shares of common stock, of which 59,043 shares remained available for future grant.

 

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In addition, the Company has two legacy plans: The Pulmatrix Operating’s 2013 Employee, Director and Consultant Equity Incentive Plan (the “Original 2013 Plan”) and Pulmatrix Operating’s 2003 Employee, Director, and Consultant Stock Plan (the “2003 Plan”). As of June 30, 2019, a total of 43,768 shares of common stock may be delivered under options outstanding under the Original 2013 Plan and the 2003 Plan, however no additional awards may be granted under the Original 2013 Plan or the 2003 Plan.

Options

During the three and six months ended June 30, 2019, the Company granted 561,600 options to employees and 90,000 options to directors. At the date of grant, the fair value of the options was $393 and $63 respectively. No options were granted to consultants during the period. The stock options granted vest over either 36 or 48 months (the “Time Based Options”). Subject to the grantees’ continuous service with the Company and as defined in the grant agreement, Time Based Options vest in one of the following ways: (i) 25% on the first anniversary of the option grant date and the remainder in 36 equal monthly installments beginning in the month after the vesting start date, (ii) 25% on the option grant date and the remainder in 36 equal monthly installments beginning in the month after the vesting start date or (iii) in 48 equal monthly installments beginning on the monthly anniversary of the vesting start date. Stock options generally expire ten years after the date of grant.

The following table summarizes stock option activity for the six months ended June 30, 2019:

 

     Number of
Options
     Weighted-
Average
Exercise
Price
     Weighted-
Average
Remaining
Contractual
Term
( Years)
     Aggregate
Intrinsic
Value
 

Outstanding — January 1, 2019

     972,569      $ 23.85         $ —  

Granted

     651,600      $ 1.06        

Exercised

     —      $ —        

Forfeited or expired

     (197,124    $ 23.18        
  

 

 

          

Outstanding — June 30, 2019

     1,427,045      $ 13.54        8.81      $ —  
  

 

 

          

Exercisable — June 30, 2019

     607,879      $ 28.24        7.72      $ —  
  

 

 

          

Vested and expected to vest — June 30, 2019

     1,420,302      $ 13.58        8.81      $ —  
  

 

 

          

The estimated fair values of employee stock options granted during the three and six months ended June 30, 2019 and 2018, were determined on the date of grant using the Black-Scholes option-pricing model with the following assumptions:

 

     Three and Six
Months Ended June 30,
 
     2019     2018  

Expected option life (years)

     6.02       5.58  

Risk-free interest rate

     2.22     2.77

Expected volatility

     74.14     79.68

Expected dividend yield

     0     0

The risk-free interest rate was obtained from U.S. Treasury rates for the applicable periods. The Company’s expected volatility was based upon the historical volatility for industry peers and used an average of those volatilities. The expected life of the Company’s options was determined using the simplified method as a result of limited historical data regarding the Company’s activity. The dividend yield considers that the Company has not historically paid dividends and does not expect to pay dividends in the foreseeable future. As of June 30, 2019, there was $1,563 of unrecognized stock-based compensation expense related to unvested stock options granted under the Company’s stock award plans. This expense is expected to be recognized over a weighted-average period of approximately 2.1 years.

 

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The following table presents total stock-based compensation expense for the three and six months ended June 30, 2019 and 2018:

 

     Three Months Ended
June 30,
     Six Months Ended
June 30,
 
     2019      2018      2019      2018  

Research and development

   $ 18      $ 306      $ 67      $ 516  

General and administrative

     1,073        627      $ 1,483      $ 1,182  
  

 

 

    

 

 

    

 

 

    

 

 

 

Total stock based compensation expense

   $ 1,091      $ 933      $ 1,550      $ 1,698  
  

 

 

    

 

 

    

 

 

    

 

 

 

10. Other Income/(Expense), net

For the three months ended June 30, 2019, other income/(expense), net is primarily comprised of $103 of interest income.

For the six months ended June 30, 2019, other income/(expense), net is primarily comprised of a settlement charge of $200 partially offset by $106 of interest income.

For both the three and six months ended June 30, 2018, other income/(expense), net is primarily comprised of interest income.

11. Income Taxes

The Company has total deferred tax assets of $44,770 and a full valuation allowance recorded against the assets. In general, if the Company experiences a greater than 50 percent aggregate change in ownership of certain significant stockholders over a three-year period, or a Section 382 ownership change, utilization of the Company’s pre-change net operating loss (“NOL”) carryforwards are subject to an annual limitation under Section 382 of the Internal Revenue Code of 1986, as amended, and similar state laws. Such limitations may result in expiration of a portion of the NOL carryforwards before utilization and may be substantial. The Company has not, as of yet, completed a study to determine if any such changes have occurred that could limit its ability to use the net operating losses and tax credit carryforwards.

12. Net Loss Per Share

The Company computes basic and diluted net loss per share using a methodology that gives effect to the impact of outstanding participating securities (the “two-class method”). As the three months and six months ended June 30, 2019 and 2018 resulted in net losses attributable to common shareholders, there is no income allocation required under the two-class method or dilution attributed to weighted average shares outstanding in the calculation of diluted net loss per share.

The following potentially dilutive securities outstanding prior to the use of the treasury stock method have been excluded from the computation of diluted weighted-average shares outstanding, as they would be anti-dilutive.

 

     As of June 30,  
     2019      2018  

Options to purchase common stock

     1,427,045        1,039,617  

Warrants to purchase common stock

     18,653,195        5,258,444  

13. Commitments

Future minimum lease payments under the non-cancelable operating lease for office and lab space is as follows:

 

     Amount  

2019

   $ 338  

2020

     698  
  

 

 

 

Total

   $ 1,036  
  

 

 

 

 

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Item 2.

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

The information set forth below should be read in conjunction with the condensed consolidated financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q as well as the audited financial statements and the notes thereto contained in our current report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2019. Unless stated otherwise, references in this Quarterly Report on Form 10-Q to “us,” “we,” “our,” or our “Company” and similar terms refer to Pulmatrix, Inc., a Delaware corporation, and its subsidiaries.

Forward-Looking Statements

This Quarterly Report contains forward-looking statements as that term is defined in the federal securities laws. The events described in forward-looking statements contained in this Quarterly Report may not occur. Generally, these statements relate to business plans or strategies, projected or anticipated benefits or other consequences of our plans or strategies, projected or anticipated benefits from acquisitions to be made by us, or projections involving anticipated revenues, earnings or other aspects of our operating results. The words “anticipates,” “assumes,” “believes,” “can,” “could,” “estimates,” “expects,” “forecasts,” “guides,” “intends,” “is confident that”, “may,” “plans,” “seeks,” “projects,” “targets,” and “would,” and their opposites and similar expressions are intended to identify forward-looking statements. We caution you that these statements are not guarantees of future performance or events and are subject to a number of uncertainties, risks and other influences, many of which are beyond our control that could cause our actual results, performance and achievements to differ materially from those expressed or implied in these forward-looking statements. Factors which may affect our results include, but are not limited to:

 

   

our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives;

 

   

our inability to carry out research, development and commercialization plans;

 

   

our inability to manufacture our product candidates on a commercial scale on our own, or in collaborations with third parties;

 

   

our inability to complete preclinical testing and clinical trials as anticipated;

 

   

our ability to adequately protect and enforce rights to intellectual property;

 

   

difficulties in obtaining financing on commercially reasonable terms;

 

   

intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do;

 

   

entry of new competitors and products and potential technological obsolescence of our products;

 

   

adverse market and economic conditions;

 

   

loss of one or more key executives or scientists; and

 

   

difficulties in securing regulatory approval to market our product candidates.

For a more detailed discussion of these and other factors that may affect our business and that could cause the actual results to differ materially from those projected in these forward-looking statements, see the risk factors and uncertainties set forth in Part II, Item 1A of this Quarterly Report. Any one or more of these uncertainties, risks and other influences could materially affect our results of operations and whether forward-looking statements made by us ultimately prove to be accurate. We undertake no obligation to publicly update or revise any forward-looking statements, whether from new information, future events or otherwise.

Overview

Business

The Company is a clinical stage biotechnology company focused on the discovery and development of a novel class of inhaled therapeutic products. The Company’s proprietary dry powder delivery platform, iSPERSE™ (inhaled Small Particles Easily Respirable and Emitted), is engineered to deliver small, dense particles with highly efficient dispersibility and delivery to the airways, which can be used with an array of dry powder inhaler technologies and can be formulated with a variety of drug substances. The Company is developing a pipeline of iSPERSE-based therapeutic candidates targeted at prevention and treatment of a range of respiratory diseases and infections with significant unmet medical needs. Since our inception in 2003, we have devoted substantially all of our efforts to product research and development. We do not have any products approved for sale and have not generated any revenue from product sales. We have funded our operations to date through proceeds from issuances of common and convertible preferred stock, issuances of convertible debt, collaborations with third parties and non-dilutive grants received from government agencies.

 

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Recent Developments

On April 15, 2019, we entered into a Development and Commercialization Agreement (the “Cipla Agreement”) with Cipla Technologies LLC (“Cipla”) for the co-development and commercialization, on a worldwide exclusive basis, of Pulmazole, our inhaled iSPERSE drug delivery system enabled formulation of the antifungal drug, itraconazole, for the treatment of all pulmonary indications, including allergic bronchopulmonary aspergillosis (“ABPA”) in patients with asthma.

Pursuant to the Cipla Agreement, Cipla made an initial upfront payment of $22 million to us in exchange for an irrevocable assignment of all existing and future technologies, current and future drug master files, dossiers, third-party contracts, regulatory filings, regulatory materials and regulatory approvals, patents, and intellectual property rights, as well as any other associated rights and assets with respect to Pulmazole, specifically in relation to pulmonary indications (the “Assigned Assets”) which Cipla will then irrevocably licensed back to us only for non-pulmonary application. As a condition precedent to signing agreement, we demonstrated to Cipla that we had at least $15 million of unencumbered cash available for the development of Pulmazole. Pursuant to the terms of the agreement, we dedicated $24 million of cash to the development of Pulmazole. The $24 million is expected to fund the development of Pulmazole beyond the completion of the initiated Phase 2 study. After such $24 million is exhausted, each of us and Cipla will bear 50% of any costs incurred with respect to the development, regulatory and commercialization costs of Pulmazole. The parties will share equally the total free cash flow in relation to commercialization of Pulmazole. Pulmatrix will remain primarily responsible for the execution of the clinical development of Pulmazole, and Cipla will be responsible for the global commercialization of the product.

Revenue associated with the combined research and development services for the Product and the irrevocable license to the Assigned Assets is recognized as revenue as the research and development services are provided using an input method, according to the ratio of costs incurred to the total costs expected to be incurred in the future to satisfy the performance obligation. In management’s judgment, this input method is the best measure of the transfer of control of the performance obligation. The amounts received that have not yet been recognized as revenue are recorded in deferred revenue on the Company’s condensed consolidated balance sheet.

We expect to continue to incur significant expenses and increasing operating losses for at least the next several years based on our drug development plans. We expect our expenses and capital requirements will increase substantially in connection with our ongoing activities, as we:

 

   

initiate and expand clinical trials for Pulmazole for ABPA, and other indications for immunocompromised at-risk patients;

 

   

seek regulatory approval for our product candidates;

 

   

hire personnel to support our product development, commercialization and administrative efforts; and

 

   

advance the research and development related activities for inhaled therapeutic products in our pipeline.

We will not generate product sales unless, and until, we successfully complete clinical developments and obtain regulatory approvals for our product candidates. Additionally, we currently utilize third-party contract research organizations, or CROs, to carry out our clinical development activities, and we do not yet have a commercial organization. If we obtain regulatory approval for any of our product candidates, we expect to incur significant expenses related to developing our internal commercialization capability to support product sales, marketing and distribution. Accordingly, we anticipate that we will seek to fund our operations through public or private equity or debt financings or other sources, potentially including collaborative commercial arrangements. Likewise, we intend to seek to limit our commercialization costs by partnering with other companies with complementary capabilities or larger infrastructure including sales and marketing.

 

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Because of the numerous risks and uncertainties associated with product development, we are unable to predict the timing or amount of increased expenses or when or if we will be able to achieve or maintain profitability. Even if we are able to generate product sales, we may not become profitable. If we fail to become profitable or are unable to sustain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce or terminate our operations.

Financial Overview

Revenues

To date, we have not generated any product sales. Our 2019 revenue resulted from the portion of the upfront payment received and recognized as part of the Cipla Agreement. Our 2018 revenue resulted from an award from Cystic Fibrosis Foundation Therapeutics (“CFFT”), the nonprofit drug discovery and development affiliate of the Cystic Fibrosis Foundation, to support the development of Pulmazole for the treatment of ABPA in patients with asthma and cystic fibrosis.

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for the research and development of our preclinical and clinical candidates, and include:

 

   

employee-related expenses, including salaries, benefits and stock-based compensation expense;

 

   

expenses incurred under agreements with CROs, contract manufacturing organizations, or CMOs, and consultants that conduct our clinical trials and preclinical activities;

 

   

the cost of acquiring, developing and manufacturing clinical trial materials and lab supplies;

 

   

facility, depreciation and other expenses, which include direct and allocated expenses for rent, maintenance of our facility, insurance and other supplies; and

 

   

costs associated with preclinical activities and regulatory operations.

We expense research and development costs to operations as incurred. We recognize costs for certain development activities, such as clinical trials, based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations or information provided to us by our vendors.

Research and development activities are central to our business model. We utilize a combination of internal and external efforts to advance product development from early stage work to clinical trial manufacturing and clinical trial support. External efforts include work with consultants and substantial work at CROs and CMOs. We support an internal research and development team and facility for our pipeline programs. To move these programs forward along our development timelines, a large portion, approximately 67% of staff, are research and development employees. In addition, we maintain a 12,000 square foot research and development facility which includes capital equipment for the manufacture and characterization of our iSPERSE™ powders for our pipeline programs. As we identify opportunities for iSPERSE™ in respiratory indications, we anticipate additional head count, capital, and development costs will be incurred to support these programs.

Because of the numerous risks and uncertainties associated with product development, however, we cannot determine with certainty the duration and completion costs of these or other current or future preclinical studies and clinical trials. The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors, including the uncertainties of future clinical and preclinical studies, uncertainties in clinical trial enrollment rates and significant and changing government regulation. In addition, the probability of success for each product candidate will depend on numerous factors, including competition, manufacturing capability and commercial viability.

General and Administrative Expenses

General and administrative expenses consist principally of salaries and related costs such as stock-based compensation for personnel and consultants in executive, finance, business development, corporate communications and human resource functions, facility costs not otherwise included in research and development expenses, patent filing fees and professional legal fees. Other general and administrative expenses include travel expenses and professional fees for consulting, auditing and tax services.

We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued research and development and potential commercialization of our product candidates. We also anticipate increased expenses related to audit, legal, regulatory, and tax-related services associated with maintaining compliance with exchange listing and Securities and Exchange Commission requirements, director and officer liability insurance, investor relations costs and other costs associated

 

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with being a public company. Additionally, if and when we believe a regulatory approval of a product candidate appears likely, we anticipate an increase in staffing and related expenses as a result of our preparation for commercial operations, especially as it relates to the sales and marketing of our product candidates.

Interest Expense

We incurred interest expense associated with a term loan executed in June 2015. The term loan was paid in its entirety as of June 30, 2018.

Other Income/(Expense), net

The 2019 other income/(expense), net is comprised of a settlement charge which is net of interest income on cash deposits and gains and/or losses resulting from disposal of fixed assets.

Critical Accounting Policies

This management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses and the disclosure of contingent assets and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to accrued expenses and stock-based compensation. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

While our significant accounting policies are described in more detail in the notes to our condensed consolidated financial statements appearing elsewhere in this Form 10-Q and in our audited financial statements included in our annual report on Form 10-K filed with the SEC on February 19, 2019, we believe the following accounting policies to be most critical to the judgments and estimates used in the preparation of our financial statements.

Use of Estimates

In preparing consolidated financial statements in conformity with GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported amounts of expenses during the reporting period. Due to inherent uncertainty involved in making estimates, actual results may differ from these estimates. On an ongoing basis, the Company evaluates its estimates and assumptions. These estimates and assumptions include valuing equity securities in share-based payments, estimating the useful lives of depreciable and amortizable assets, valuation allowance against deferred tax assets, recognition of research and development and license revenues, goodwill impairment, and estimating the fair value of long-lived assets to assess whether impairment charges may apply.

Revenue Recognition

In May 2014, the FASB issued ASU No. 2014-09 (Topic 606) “Revenue from Contracts with Customers.” Topic 606 supersedes the revenue recognition requirements in Topic 605 “Revenue Recognition” (Topic 605). The new standard’s core principal is that an entity will recognize revenue at an amount that reflects the consideration to which the entity expects to be entitled in exchange for transferring good or services to a customer. The principles in the standard are applied in five steps: 1) Identify the contract(s) with a customer; 2) Identify the performance obligations in the contract; 3) Determine the transaction price; 4) Allocate the transaction price to the performance obligations in the contract; and 5) Recognize revenue when (or as) the entity satisfies a performance obligation. The Company adopted Topic 606 as of January 1, 2019 using the modified retrospective transition method. The adoption of Topic 606 did not have any material impact on the Company’s condensed consolidated financial statements.

During the six months ended June 30, 2019, our principal source of revenue was income from the amortization of the $22 million upfront payment received as part of the Cipla Agreement.

During the six months ended June 30, 2018, our principle source of revenue was income for reimbursement of clinical study costs as part of a grant received from CFFT.

 

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Goodwill

Goodwill represents the difference between the consideration transferred and the fair value of the net assets acquired under the acquisition method of accounting for push-down accounting. Goodwill is not amortized but is evaluated for impairment on an annual basis, during the fourth quarter, or more frequently if an event occurs or circumstances change that would more likely than not reduce the fair value of the related reporting unit below its carrying amount. When performing the impairment assessment, the accounting standard for testing goodwill for impairment permits a company to first assess the qualitative factors to determine whether the existence of events and circumstances indicates that it is more likely than not that the goodwill is impaired. If we believe, as a result of the qualitative assessment, that it is more likely than not that the fair value of goodwill is impaired, we must perform the goodwill impairment test. As of June 30, 2019, the Company’s common stock value declined, accordingly, the Company determined that its carrying value is in excess of its fair value and as such, recorded an impairment charge of $6,474 and revalued goodwill to $3,577.

Results of Operations

Three Months Ended June 30, 2019 Compared with Three Months Ended June 30, 2018

The following table sets forth our results of operations for each of the periods set forth below (in thousands):

 

     Three months ended
June 30,
     Change  
     2019      2018  

Revenue

   $ 4,819    $ —      $ 4,819

Operating expenses

        

Research and development

     3,164        4,013        (849

General and administrative

     3,128        2,115        1,013  

Impairment of goodwill

     6,474        —          6,474  
  

 

 

    

 

 

    

 

 

 

Total operating expenses

     12,766        6,128        6,638  
  

 

 

    

 

 

    

 

 

 

Loss from operations

     (7,947      (6,128      (1,819

Interest expense

     —          (80      80  

Other income/(expense), net

     103        20        83  
  

 

 

    

 

 

    

 

 

 

Net loss

   $ (7,844    $ (6,188    $ (1,656
  

 

 

    

 

 

    

 

 

 

Revenue  — For the three months ended June 30, 2019, revenue was $4.8 million compared to no revenue for the three months ended June 30, 2018. The increase in revenue was the result of recognition of income pursuant to the Cipla Agreement.

Research and development expenses  — For the three months ended June 30, 2019, research and development expense was $3.2 million compared to $4.0 million for the three months ended June 30, 2018, a decrease of $0.8 million. The decrease was primarily due to decreased spend of $0.8 million on the PUR1800 project, $0.5 million for employment costs, and $0.3 million of stock compensation charges, partially offset by increased spend of $0.8 million on the Pulmazole project.

General and administrative expenses  — For the three months ended June 30, 2019, general and administrative expense was $3.1 million compared to $2.1 million for the three months ended June 30, 2018. The increase of $1.0 million was primarily due to $0.5 million of increased stock compensation charges pursuant to accelerated vesting of options of our former chief executive officer, $0.3 million of a royalty payment as required by the terms of the 2017 agreement with CFFT and increased legal expense of $0.2 million relating to the Cipla Agreement.

Impairment of goodwill  — For the three months ended June 30, 2019, due to the decline in the company’s common stock value, we recorded a charge of approximately $6.5 million for impairment of goodwill.

Interest expense  — For the three months ended June 30, 2019 interest expense was $0 compared to $0.1 million for the three months ended June 30, 2018. Interest expense incurred related to the term loan agreement that we entered in June 2015 which was paid in its entirety by June 30, 2018.

Other income/(expense), net — For the three months ended June 30, 2019 and 2018, other income/(expense) net, was primarily comprised of interest income.

 

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Six Months Ended June 30, 2019 Compared with Six Months Ended June 30, 2018

The following table sets forth our results of operations for each of the periods set forth below (in thousands):

 

     Six months ended
June 30,
     Change  
     2019      2018  

Revenue

   $ 4,819      $ 153    $ 4,666  

Operating expenses

     

Research and development

     5,340        7,234        (1,894

General and administrative

     5,115        4,161        954  

Impairment of goodwill

     7,268        —          7,268  
  

 

 

    

 

 

    

 

 

 

Total operating expenses

     17,723        11,395        6,328  
  

 

 

    

 

 

    

 

 

 

Loss from operations

     (12,904      (11,242      (1,662

Interest expense

     —          (186      186  

Other income/(expense), net

     (96      19        (115
  

 

 

    

 

 

    

 

 

 

Net loss

   $ (13,000    $ (11,409      (1,591
  

 

 

    

 

 

    

 

 

 

Revenue  — For the six months ended June 30, 2019, revenue was $4.8 million compared to $0.2 million for the six months ended June 30, 2018. The increase in revenue was the result of recognition of income pursuant to the Cipla Agreement.

Research and development expenses  — For the six months ended June 30, 2019, research and development expense was $5.3 million compared to $7.2 million for the six months ended June 30, 2018, a decrease of $1.9 million. The decrease was primarily due to decreased spend of $1.2 million on the PUR1800 project, $0.8 million in employment costs, $0.4 million in stock compensation expense, and $0.2 million in consulting costs, partially offset by $0.7 million of increased spend on the Pulmazole program.

General and administrative expenses  — For the six months ended June 30, 2019, general and administrative expense was $5.1 million compared to $4.1 million for the six months ended June 30, 2018, an increase of $1.0 million. The increase was primarily due to $0.3 million of increased stock compensation charges pursuant to accelerated vesting of options of our former chief executive officer, $0.3 million of a royalty payment as required by the terms of the 2017 agreement with CFFT, increased legal expense of $0.3 million relating to the Cipla Agreement and increased employment expenses of $0.1 million.

Impairment of goodwill  — For the six months ended June 30, 2019, due to the decline in the company’s common stock value, we recorded charges that totaled approximately $7.3 million for impairment of goodwill.

Interest expense  — For the six months ended June 30, 2019, we recorded no interest expense as compared to $0.2 million for the six months ended June 30, 2018. During both periods, interest expense incurred related to the term loan agreement that we entered in June 2015 which was paid in its entirety as of June 30, 2018.

Other income/(expense), net — For the six months ended June 30, 2019, other income/(expense), net was $0.1 million compared with $0 for the six months ended June 30, 2018. The 2019 amount was comprised of a settlement charge of $0.2 million which was partially offset by interest income of $0.1 million. The 2018 amount was primarily comprised of interest income.

Liquidity and Capital Resources

Through June 30, 2019, we have incurred an accumulated deficit of $207.6 million, primarily as a result of expenses incurred through a combination of research and development activities related to our various product candidates and general and administrative expenses supporting research and development and business activities. We have financed our operations since inception primarily through the sale of preferred and common stock and the issuance of convertible promissory notes and term loans. Our total cash and cash equivalents balance as of June 30, 2019 was $31.8 million. In April 2019, the Company received gross proceeds of approximately $16.6 million in connection with the sale of the Units in the Offering. 8,277,112 pre-funded warrants issued in the Offering were exercised and resulted in the issuance shares of common stock and gross proceeds of approximately $0.1 million. In May 2019, $22.0 million was received pursuant to the terms of the Cipla Agreement, which was entered into between the Company and Cipla during April 2019.

We anticipate that we will continue to incur losses, and that such losses will increase over the next several years due to development costs associated with our iSPERSE™ pipeline programs. We expect that our research and development and general and administrative expenses will continue to increase and, as a result, we will need additional capital to fund our operations, which we may raise through a combination of equity offerings, debt financings, other third-party funding and other collaborations and strategic alliances. The Pulmazole Phase 2 study is fully funded. Development costs for that program beyond the Phase 2 study will be shared with our partner, Cipla.

 

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

 

     Six months ended
June 30,
 
     2019      2018  

Net cash provided by/(used) in operating activities

   $ 11,591      $ (8,075

Net cash used in investing activities

     (35      (2

Net cash provided by financing activities

     17,698        12,868  
  

 

 

    

 

 

 

Net increase in cash and cash equivalents

   $ 29,254      $ 4,791  
  

 

 

    

 

 

 

Cash Flows from Operating Activities

Net cash provided by operating activities for the six months ended June 30, 2019 was $11.6 million, which was primarily the result of a net loss of $13.0 million, offset by $8.9 million of net non-cash adjustments and $15.7 million in cash inflows associated with changes in operating assets and liabilities. Our non-cash adjustments were primarily comprised of $7.3 million of goodwill impairment, $1.5 million of stock-based compensation expense and $0.1 million of depreciation and expense. The net cash inflows associated with changes in operating assets and liabilities were primarily due to an increase of $17.2 million of deferred revenue offset by decreases in accounts payable of $0.6 million, in accrued expenses of $0.5 million, and in prepaid expenses and other current assets of $0.4 million.

Net cash used in operating activities for the six months ended June 30, 2018 was $8.1 million, which was primarily the result of a net loss of $11.4 million, partially offset by $1.9 million of net non-cash adjustments and $1.4 million in cash inflows associated with changes in operating assets and liabilities. Our non-cash adjustments were primarily comprised of $1.7 million of stock-based compensation expense, $0.1 million of depreciation and amortization, and $0.1 million of debt issuance expense. The net cash inflows associated with changes in operating assets and liabilities was primarily due to increases in accounts payable of $1.0 million, increases in accrued expenses of $0.3 million, and increases in prepaid expenses and other current assets of $0.1 million.

Cash Flows from Investing Activities

Net cash used in investing activities for the six months ended June 30, 2019 and June 30, 2018 were entirely due to purchases of property and equipment.

Cash Flows from Financing Activities

Net cash provided by financing activities for the six months ended June 30, 2019 was $17.7 million, as compared to $12.9 for the six months ended June 30, 2018. Net cash provided by financing activities for the six months ended June 30, 2019 resulted from the issuance of common stock net of issuance costs, of $17.5 million, and pre-funded warrant exercises of $0.2 million. Net cash provided by financing activities for the six months ended June 30, 2018 resulted from the issuance of common stock, net of issuance costs of $16.4 million, partially offset by $3.5 million of principal and end of term loan payments.

Financings

2019

On April 8, 2019, we closed our firm commitment underwritten public offering in which, pursuant to the underwriting agreement (the “Underwriting Agreement”) entered into between the Company and H.C. Wainwright & Co., LLC, as representative of the underwriters (the “Underwriters”), dated April 3, 2019, we issued and sold an aggregate of (i) 1,719,554 Common Units (“Common Units”), with each Common Unit being comprised of one share of the Company’s common stock, par value $0.0001 per share and one warrant to purchase one share of common stock and (ii) 8,947,112 pre-funded units (the “Pre-Funded Units”) with each Pre-Funded Unit being comprised of one pre-funded warrant to purchase one share of common stock and one common warrant to purchase a share of common stock. The public offering price was $1.35 per Common Unit and $1.34 per Pre-Funded Unit. The common warrants have an exercise price of $1.35 per share.

In addition, on April 8, 2019, we closed on the sale of an additional 1,599,999 Common Units purchased pursuant to the exercise in full of the underwriter’s option to purchase additional securities. Each Common Unit contains one share of common stock and one common warrant to purchase a share of common stock. 8,277,112 of the 8,947,112 pre-funded warrants issued in the offering were exercised during the period which resulted in the issuance of an additional 8,277,112 shares of common stock with net proceeds of $83.

We recorded gross proceeds of $16.6 million and after commissions and fees of $1.9 million, the financing resulted in $14.6 million of net proceeds.

 

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2018

On March 17, 2017, the Company entered into an At-The-Market Sales Agreement with respect to the issuance and sale of up to $11 million of the Company’s common stock from time to time in an at-the-market public offering. During the six months ended June 30, 2018, the Company sold 123,266 shares of its common stock pursuant to the At-The-Market Sales Agreement for aggregate net proceeds of $1.8 million.

On March 28, 2018, we entered into an underwriting agreement with Oppenheimer and Co., Inc. relating to the Offering, pursuant to which the Company sold, 1,681,000 common units and 784,000 pre-funded units. All of the pre-funded warrants issued in the Offering were exercised in April 2018 and, as 15,000 were exercised on a cashless basis, resulted in the issuance of an additional 783,707 shares of common stock. Each common unit was comprised of one share of common stock, one Series A Warrant to purchase one share of common stock and one Series B Warrant to purchase one share of common stock. Each Pre-Funded Unit was comprised of one pre-funded warrant to purchase one share of common stock, one Series A Warrant and one Series B Warrant. Gross proceeds from the Offering and of the exercise of the pre-funded warrants issued in the Offering, before commissions and fees, were approximately $16.0 million.

Based on our planned use for our existing cash resources, we believe that our available funds will be sufficient to enable us to support clinical development of our Pulmazole program through the issuance of the final report on the Phase 2 trial, preparation costs relating to our planned Phase 2b/3 trial and completion of a toxicology study in support of PUR1800, all of which are expected to conclude during the third quarter, 2020. The funding will not be sufficient to complete additional clinical work for any of the pipeline programs. We have based our projections of operating capital requirements on assumptions that may prove to be incorrect and we may use all of our available capital resources sooner than we expect. Because of the numerous risks and uncertainties associated with research, development and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements. Our future funding requirements will depend on many factors, including, but not limited to:

 

   

the initiation, progress, timing, costs and results of clinical studies for existing and new pipeline programs based on iSPERSE™;

 

   

the outcome, timing and cost of regulatory approvals by the FDA and European regulatory authorities, including the potential for these agencies to require that we perform studies in addition to those that we currently have planned;

 

   

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

 

   

our need to expand our research and development activities;

 

   

our need and ability to hire additional personnel;

 

   

our need to implement additional infrastructure and internal systems;

 

   

the cost of establishing and maintaining a commercial-scale manufacturing line; and

 

   

the cost of establishing sales, marketing and distribution capabilities for any products for which we may receive regulatory approval.

If we cannot expand our operations or otherwise capitalize on our business opportunities because we lack sufficient capital, our business, financial condition and results of operations could be materially adversely affected.

Off-Balance Sheet Arrangements

We have no off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that is material to investors.

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk.

Not applicable.

 

Item 4.

Controls and Procedures.

(a) Evaluation of Disclosure Controls and Procedures . Our principal executive officer and principal financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e)) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of the end of the period covered by this Form 10-Q, have concluded that, based on such evaluation, our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported,

 

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within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.

In designing and evaluating our disclosure controls and procedures, our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

(b)  Changes in Internal Controls. There were no changes in our internal control over financial reporting, identified in connection with the evaluation of such internal control that occurred during the quarter ended June 30, 2019 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

PART II — OTHER INFORMATION

 

Item 1.

Legal Proceedings.

From time to time, we may be involved in litigation that arises through the normal course of business. As of the date of this filing, we are not aware of any material legal proceedings to which we or any of our subsidiaries is a party or to which any of our property is subject, nor are we aware of any such threatened or pending litigation or any such proceedings known to be contemplated by governmental authorities.

We are not aware of any material proceedings in which any of our directors, officers or affiliates or any registered or beneficial stockholder of more than 5% of our common stock, or any associate of any of the foregoing, is a party adverse to or has a material interest adverse to, us or any of our subsidiaries.

 

Item 1A.

Risk Factors.

There have been no material changes to the risk factors disclosed under “Item 1A. Risk Factors” of our most recent Annual Report on Form 10-K. For more information concerning our risk factors, please refer to “Item 1A. Risk Factors” of our most recent Annual Report on Form 10-K.

 

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Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds.

(a) Unregistered Sales of Equity Securities

None.

(b) Issuer Purchases of Equity Securities

We did not repurchase any of our equity securities during the quarter ended June 30, 2019.

 

Item 3.

Defaults Upon Senior Securities.

None.

 

Item 4.

Mine Safety Disclosures.

Not applicable.

 

Item 5.

Other Information.

None.

 

Item 6.

Exhibits.

See Index to Exhibits.

 

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EXHIBIT INDEX

 

Exhibit
   No.   
  

Description

  1.1    Form of Underwriting Agreement (incorporated by reference to Exhibit 1.1 to the Company’s Amendment No. 1 to Form S-1 filed with the Securities and Exchange Commission on April 1, 2019).
  3.1    Amended and Restated Certificate of Incorporation of Pulmatrix, Inc., as amended through June 15, 2015 (incorporated by reference to Exhibit 3.1 to Quarterly Report on Form 10-Q filed with the Securities and Exchange commission on August 14, 2015).
  3.2    Certificate of Amendment to Amended and Restated Certificate of Incorporation of Pulmatrix, Inc., dated as of June 5, 2018 (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on June 7, 2018).
  3.3    Restated Bylaws of Pulmatrix, Inc., as amended through June 15, 2015 (incorporated by reference to Exhibit 3.2 to Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 14, 2015).
  4.1    Form of Common Stock Warrant (incorporated by reference to Exhibit 4.13 to the Company’s Amendment No. 1 to Form S-1 filed with the Securities and Exchange Commission on April 1, 2019).
  4.2    Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.11 to the Company’s Amendment No. 1 to Form S-1 filed with the Securities and Exchange Commission on April 1, 2019).
  4.3    Form of Underwriter Warrant (incorporated by reference to Exhibit 4.12 to the Company’s Amendment No. 1 to Form S-1 filed with the Securities and Exchange Commission on April 1, 2019).
10.1**    Amended and Restated Employment Agreement, dated June 28, 2019, by and between the Company and Teofilo Raad (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K/A filed with the Securities and Exchange Commission on June 28, 2019).
10.2**    General Release and Severance Agreement, dated May 16, 2019, by and between the Company and Robert Clarke, Ph.D. (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on May 16, 2019).
10.3    Term Sheet, between Cipla Technologies, LLC and Pulmatrix, Inc., dated as of April 1, 2019 (incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on April 1, 2019).
10.4*    Development and Commercialization Agreement, dated as of April 15, 2019, by and between Cipla Technologies, LLC and Pulmatrix, Inc.
10.5**    Second Amendment to the Pulmatrix, Inc. Amended and Restated 2013 Employee, Director and Consultant Equity Incentive Plan, dated March 11, 2019 (incorporated by reference to Exhibit 99.3 to the Company’s registration statement on Form S-8, filed with the SEC on June 4, 2019).
31.1*    Certification of the Principal Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*    Certification of the Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*    Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101*    The following materials from the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets as of June 30, 2018 (unaudited) and December 31, 2017, (ii) Condensed Consolidated Statements of Operations for the six months ended June 30, 2018 and 2017 (unaudited), (iii) Condensed Consolidated Statements of Cash Flows for the six months ended June 30, 2018 and 2017 (unaudited), and (iv) Notes to Condensed Consolidated Financial Statements (unaudited).

 

*

Filed herewith.

**

These exhibits are management contracts.

 

27


Table of Contents

SIGNATURES

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

 

    PULMATRIX, INC.
Date: August 5, 2019     By:  

/s/ Teofilo Raad

      Teofilo Raad
      President and Chief Executive Officer
      (Principal Executive Officer)
Date: August 5, 2019     By:  

/s/ William Duke, Jr.

      William Duke, Jr.
      Chief Financial Officer
      (Principal Financial Officer)

 

28

Exhibit 10.4

DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

This DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (together with the schedules and exhibits attached hereto, the “ Agreement ”) is entered into as of April 15, 2019 (the “ Effective Date ”) by and between PULMATRIX, INC., a Delaware corporation with its principal place of business in 99 Hayden Avenue, Suite 390, Lexington, Massachusetts 02421, United States of America (the “ Company ”), and CIPLA TECHNOLOGIES, LLC, a Delaware limited liability company with its principal place of business in 12220, El Camino Real, Ste 310, San Diego, 92130 California, United States of America (“ Cipla ”). Company and Cipla may each be referred to as a “ Party ” or, collectively, as the “ Parties .”

RECITALS

WHEREAS Company is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases using its patented drug delivery platform, namely iSPERSE technology;

WHEREAS Company’s lead candidate is Pulmazole (PUR1900), an inhaled formulation of the anti-fungal drug itraconazole , developed using iSPERSE technology, ready for Phase II Clinical Studies (the “ Product ”) designed to treat allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma (the “ Initial Indication ”);

WHEREAS Cipla is a global pharmaceutical company with well-known strengths in the respiratory field that seeks to focus its U.S. operations on targeting niche/orphan indications, particularly those with unmet needs that may be served by modifying existing therapeutics through technological innovation; and

WHEREAS Company and Cipla desire to enter into an agreement for the worldwide (“ Territory ”) Development and Commercialization (each defined below) of the Product for the Initial Indication and other Pulmonary Indications (defined below) for which the Product may be Developed and/or Commercialized in the future, if any.

NOW, THEREFORE, in consideration of the foregoing premises and the mutual promises, covenants and conditions contained in this Agreement, the receipt of which is hereby acknowledged, the Parties agree as follows:

ARTICLE 1

DEFINITIONS

As used in this Agreement, the following terms, and any derivative forms of such terms, have the respective meanings set forth below.

Adverse Drug Experience ” means any adverse event associated with the use of the Product in humans, whether or not considered Product-related, including the following: an adverse event occurring in the course of the use of the Product in professional practice; an adverse event occurring from drug overdose whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of expected pharmacological action.

 

1


Affiliate ” means, with respect to a Party, any Person, corporation or other entity which, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with such Party, as the case may be. As used in this definition, “control” means (i) direct or indirect beneficial ownership of more than fifty percent (50%) of the voting stock or other ownership interest (whether directly or pursuant to any option, warrant, or other similar arrangement) in a corporation or other entity; or (ii) possession, direct or indirect, of the power to affirmatively direct the management and policies of a person, corporation, or other entity, whether through ownership of voting stock or other ownership interest or by contract relating to voting rights or corporate governance.

Agreement ” has the meaning set forth in the Preamble.

Alliance Manager ” has the meaning set forth in Section  2.2 .

Allowable Expenses ” means the Commercialization Costs that are incurred in accordance with the Commercialization Plan approved by the JSC, without duplication of any expenses included in Cost of Goods Sold or Capital Expenditures.

Applicable Law ” means all applicable laws, statutes, rules, regulations, including any applicable rules, regulations, guidelines, or other requirements set forth by the Governmental Authorities with jurisdiction over the activities performed under this Agreement that may be in effect from time to time.

Assigned Assets ” has the meaning set forth in Section  6.1 .

Assigned Patent s” has the meaning set forth in Section  8.2(a) .

Breaching Party ” has the meaning set forth in Section  12.2 .

Business Day ” means any day other than a Saturday, Sunday, or day on which commercial banks located in Boston, Massachusetts or San Diego, California are authorized or required by Applicable Law to remain closed.

Calendar Quarter ” means each of the three-month periods ending on March 31, June 30, September 30, and December 31 of any Calendar Year.

Calendar Year ” means the twelve-month period ending on March 31; provided, however, that (a) the first Calendar Year of the Term will begin on the Effective Date and end on March 31, 2020 and (b) the last Calendar Year of the Term will end upon the expiration or termination of this Agreement.

Capital Expenditure ” means funds used by a Party to acquire or upgrade any physical or intangible assets which are necessary for the Commercialization or Development of the Product after the Effective Date, which has a useful life of more than one year, without duplication of any costs or expenses included in Costs of Goods Sold or Allowable Expenses.

Change in Control ” means the occurrence after the date hereof of any (a) acquisition by an individual or legal entity or “group” (within the meaning of Section 13 of the Securities Exchange Act of 1934, as amended) of effective control (whether through legal or beneficial ownership of capital stock of the Company, by contract or otherwise) of 50% or more of the voting securities of the Company, (b) the Company merges into or consolidates with any other Third Party, or any Third Party merges into or consolidates with the Company and, after giving effect to such transaction, the stockholders of the Company immediately prior to such transaction own less than 50% of the aggregate voting power of the Company or the successor entity of such transaction, or (c) the Company disposes of all or substantially all of its assets to a Third Party.

 

2


Cipla Damages ” has the meaning set forth in Section  10.1 .

Cipla Disposition ” has the meaning set forth in Section  6.5 .

Cipla Indemnitees ” has the meaning set forth in Section  10.1 .

Cipla Notice Period ” has the meaning set forth in Section  6.6 .

Claim ” has the meaning set forth in Section  10.1 .

Clinical Studies ” means any clinical study in humans that is designed to generate data in support or maintenance of an IND or NDA (or other equivalent Regulatory Filings or Regulatory Approvals) and any post-approval clinical study in humans.

Co-Development Phase ” has the meaning set forth in Section  3.5 .

Commercially Reasonable Efforts ” means reasonable and good faith efforts by a Party to accomplish such objective as that Party would normally use to accomplish a similar objective under similar circumstances, it being understood and agreed that, with respect to the conduct of the Development or Commercialization of the Product, such efforts must be substantially equivalent to that level of efforts and resources commonly employed by similarly situated pharmaceutical companies to perform any activity for a compound or product at a similar stage of research, development, or commercialization, taking into account measures of patent coverage, relative safety and efficacy, product profile, the competitiveness of the marketplace, the proprietary position of such product, the regulatory structure involved, the market potential of such compound or product, industrial standard in manufacturing and supplying pharmaceutical products, and other relevant factors, including comparative technical, legal, scientific, and/or medical factors.

Commercialize ” or “ Commercialization ” means, with respect to the Product, the conduct of any and all processes and activities to establish and maintain sales for such Product (including with respect to reimbursement and patient access). Such activities may include offering for sale, selling, Promoting, storing, transporting, manufacturing, distributing, and importing such Product, in each case with respect to the applicable Pulmonary Indication. “Commercialization” does not include Development activities but does include any actions taken in preparation for Commercialization, as well as the phase IV Clinical Studies to be conducted and implemented by the Company, if so required by the Regulatory Authorities in the respective countries in the Territory.

Commercialization Cost ” means those costs associated with the Commercialization of the Product under this Agreement set forth in the Commercialization Plan prepared by Cipla and approved by the JSC and shall include reasonable travel expenses of the Parties in connection with meetings of the JSC or for other travel necessary for the Commercialization.

 

3


Commercialization Plan ” means a detailed written plan, detailed budget and/or Commercialization Costs approved by the JSC for the Commercialization of the Product, including pre-approval commercialization activities, in connection with each approved Pulmonary Indication in the respective market, setting forth a reasonably detailed description of anticipated Commercialization efforts, objectives, and timelines, encompassing, among other things: launch date(s), demographics and market dynamics, Promotion, projected milestones, resource allocation requirements, sales and expense forecast, manufacturing plans, compliance program(s), reimbursement, and patient access and, in any case, consistent with the framework attached hereto as Exhibit I and as otherwise supplemented by the JSC. For the sake of clarity, Commercialization Plan shall also include post marketing surveillance study and/or phase IV clinical study, if so required by the Regulatory Authorities in any country(ies) in the Territory which shall be conducted and implemented by the Company and the cost of such phase IV study shall be included in the Commercialization Costs and shared equally by the Parties.

Company Damages ” has the meaning set forth in Section  10.2 .

Company Disposition ” has the meaning set forth in Section  6.6 .

Company Indemnitees ” has the meaning set forth in Section  10.2 .

Company Notice Period ” has the meaning set forth in Section  6.5 .

“Confidential Information” means any and all information of a confidential or proprietary nature disclosed by one Party to the other Party under this Agreement, in any form, including printed, written, oral, visual, graphic, electronic, physical objects, or software, disclosed by either of the Parties including written or unwritten materials relating to plans, strategies, opportunities, marketing programs, technologies, inventions, trade secrets, know-how, ideas or expressions thereof, methodologies, practices, procedures, products, samples, product or service specifications, business plans and methods, pricing service fees and charges, costs, vendor information, customer information, supplier information, inventories, employees, facilities, financial data, strategic partner and hiring information, and other business information, including any work prepared by the receiving Party that includes information disclosed by the disclosing Party. Even if information disclosed to the other Party is not expressly designated as proprietary or Confidential Information, it will not change the receiving Party’s obligation with respect to such information so long as the information exchanged falls within the definition contained herein or is the type of information a Party would treat as Confidential Information of its own. Confidential Information will not be deemed to be in the public domain merely because any part of the information is embodied in general disclosures or because individual features, components, or combinations thereof are now or may later become known to the public. Furthermore, even if any portion of information provided by the disclosing party falls within any one of the above exceptions, the remainder will continue to be Confidential Information subject to the restrictions of this Agreement.

Cost of Goods Sold ” means the direct costs attributable to the production of the Product, this includes the cost of the materials used for manufacturing, direct labor costs, and directly attributable manufacturing overheads. If the Product is manufactured by Affiliates of Cipla, costs will be included at an arm’s length basis. If the Product is manufactured by third party CMO, cost of goods sold will be at the purchase cost plus royalty (if any) payable. Cost of goods sold will also include any other costs directly attributable to the manufacturing of the Product. In any case, Cost of Goods Sold is without duplication of any costs in included in Allowable Expenses or Capital Expenditures.

 

4


Develop ” or “ Development ” means all activities related to test method development and stability testing, toxicology and/or toxicity studies, formulation, process development, manufacturing scale-up, qualification and validation, quality assurance/quality control, Clinical Studies, statistical analysis and report writing, preparation and submission of Regulatory Filings, regulatory affairs with respect to the foregoing and all other activities required by a Regulatory Authority as a condition or in support of obtaining, maintaining, or modifying a Regulatory Approval.

Development Costs ” means those costs associated with the Development of the Product under this Agreement set forth in the Development Plan prepared by Company and approved by the JSC, which shall include: (1) the Out-of-Pocket and internal costs incurred by the Company and/or its Affiliates to the extent attributable to, or reasonably allocable to, the Development of the Product for any applicable Pulmonary Indication, including costs incurred for: (i) the preparation for and conduct of Clinical Studies (but does not include any costs incurred towards Pre-Clinical Studies and phase I Clinical Studies already conducted by Company in respect of the Product); (ii) data collection, analysis, and report writing; (iii) clinical laboratory work; (iv) regulatory activities with direct relation to such studies, such as IND and NDA submissions, annual reports, Adverse Drug Experience recording and reporting, and pre-submission meetings or other regulatory correspondence, among others; (v) Capital Expenditure incurred during Development and (vi) reasonable travel expenses of the Parties in connection with meetings of the JSC or for other travel necessary for the Development; and (2) the costs incurred by Cipla in connection with the Development of the Product.

Development Plan ” means a detailed written development plan, detailed budget and Development Costs approved by the JSC that describes all activities to be conducted by the Company and its Affiliates or other designees in relation to Development of the Product for Pulmonary Indications, including associated timelines, priorities, and the applicable budget. “Development Plan” includes the initial Development Plan, which is attached hereto as Exhibit II .

Dispute ” has the meaning set forth in Section  14.9 .

DRAA ” has the meaning set forth in Section  14.9 .

Effective Date ” has the meaning set forth in the Preamble.

Excluded Assets ” has the meaning set forth in Section  6.1 .

Fair Market Value ” means the value in arm’s-length transactions, consistent with the price that an asset would bring as the result of bona fide bargaining between well-informed buyers and sellers who are not otherwise in a position to generate business for the other party, or the compensation that would be included in a service agreement as the result of bona fide bargaining between well-informed parties to the agreement who are not otherwise in a position to generate business for the other party, on the date of acquisition of the asset or at the time of the service agreement.

FD&C Act ” means the federal Food, Drug, & Cosmetic Act, as amended.

FDA ” means the U.S. Food and Drug Administration.

 

5


Free Cash Flow ” means, with respect to each Calendar Quarter, an amount equal to Net Sales less Cost of Goods Sold less Allowable Expenses plus the amount of any decrease in Working Capital compared to the previous Calendar Quarter or, as applicable, less the amount of any increase in Working Capital compared to the previous Calendar Quarter and less Capital Expenditures, in each case, with respect to such Calendar Quarter.

Fundamental Breaches ” has the meaning set forth in Section  12.2 .

Good Clinical Practice ” or “ GCP ” means all applicable Good Clinical Practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of Clinical Studies, including, as applicable: (i) U.S. Code of Federal Regulations (C.F.R.) Title 21, Parts 50 (Protection of Human Subjects), 56 (Institutional Review Boards) and 312 (Investigational New Drug Application), as may be amended from time to time, and (ii) the equivalent Applicable Law in any relevant country, each as may be amended and applicable from time to time and in each case, that provide for, among other things, assurance that the clinical data and reported results are credible and accurate and protect the rights, integrity, and confidentiality of trial subjects.

Good Laboratory Practice ” or “ GLP ” means the then-current standards for laboratory activities for pharmaceuticals, as set forth in the FD&C Act and applicable regulations promulgated thereunder, as amended from time to time, and such standards of good laboratory practice as are required by the European Union and other organizations and Regulatory Authorities in countries in which the Product is intended to be sold.

Good Manufacturing Practice ” or “ GMP ” means all applicable Good Manufacturing Practices, including, as applicable, (i) the principles detailed in the U.S. Current Good Manufacturing Practices (21 C.F.R. Parts 210 and 211) and (ii) equivalent Applicable Law in any relevant country or region having jurisdiction over the Product or Manufacturing, each as may be amended and applicable from time to time.

Governmental Authority ” means any federal, national, supranational, state, provincial, or local government, or agency thereof. Governmental Authorities include all Regulatory Authorities.

Grant-Back License ” has the meaning set forth in Section  6.2 .

IND ” means an investigational new drug application, Pre-Clinical Studies application, Pre-Clinical Studies data, Clinical Studies application, Clinical Studies exemption, or similar application or submission for Regulatory Approval to conduct human clinical investigations filed with, or submitted to, a Regulatory Authority in accordance with the applicable regulatory requirements.

Indemnified Party ” has the meaning set forth in Section  10.3 .

Indemnifying Party ” has the meaning set forth in Section  10.3 .

Indication ” means the use of a given drug product for the diagnosis, treatment, prevention, cure, or management of a specific human disease, disorder, illness, condition, or symptom related thereto.

Initial Development Funding ” has the meaning set forth in Section  3.4.

 

6


Initial Indication ” has the meaning set forth in the Preamble.

Intellectual Property Rights ” means certain rights in relation to the Assigned Assets, including, but not limited to, Patents, Inventions, Confidential Information, trade secrets, brand names, and copyrights.

Intrinsic Defect ” means an intrinsic problem or defect in the efficacy or safety of the Product.

Invention ” shall mean and include any and all inventions and discoveries which are, or may be, patentable or otherwise protectable under the patent or other intellectual property laws of any country, which relate to the Product, and which are conceived, discovered or reduced to practice during the continuance of this Agreement.

“iSPERSE means the proprietary engineered dry powder delivery platform of the Company, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.

iSPERSE Inventions ” has the meaning set forth in Section  8.1 .

Joint Steering Committee ” or “ JSC ” has the meaning set forth in Section  3.1(a) .

NDA ” or “ New Drug Application ” shall mean a new drug application filed with the FDA pursuant to 21 C.F.R. §314, seeking permission to market the Product for a Pulmonary Indication in interstate commerce in the United States.

Net Sales ” means with respect to the Product means, the gross amounts invoiced for the sale of Product by Cipla for any Pulmonary Indication, or its Affiliates, or licensees or sublicensees to independent, unrelated Third Parties, including wholesalers, in bonafide arm’s-length transactions, in each case after subtracting all applicable deductions to the extent specifically and solely allocated to the Product and actually taken, paid, accrued, allowed, included or allocated based on good faith estimates in calculating the Net Sales with respect to the Product (and consistently applied as set forth below).

By way of example only, such deductions include, where applicable, but are not limited to:

(i)    all discounts of any type or nature (such as retroactive price reductions, cash discounts, volume discounts, promotional discounts, chargebacks, allowances, rebates, returns and credits);

(ii)    all rejections, returns, credits, and returned goods allowances and retroactive corrections;

(iii)    the costs of recalls, seizures or destruction of goods, whether voluntarily or pursuant to a governmental request;

(iv)    redistribution center fees, information service agreement fees, and like fees that are passed from wholesalers, retailers, distributors, and other customers back to Cipla;

(v)    any failure-to-supply penalties that Cipla may incur from any Third Party customer;

(vi)    credits or allowances actually granted upon prompt payment or claims, bad debts and losses actually incurred as a result of actual write-offs of uncollectible customer accounts;

 

7


(vii)    commissions of sales agents or brokers;

(viii)    compulsory payments and cash rebates related to the sales of the Product paid to a government authority (or agent thereof) pursuant to governmental regulations by reason of any national or local health insurance program, compensation program, or similar program (such as Medicaid and Supplemental State Program rebates, Medicare Part D “Donut Hole” Coverage Gap rebates and “Industry Fees” for brand drugs as required by the Patient Protection and Affordable Care Act as amended by the Health Care Education Affordability Reconciliation Act), to the extent allowed and taken;

(ix)    freight, shipping and insurance costs;

(x)    excise taxes. use taxes, sales taxes, value added taxes, goods and services taxes, custom duties, and/or government charges imposed on the sales of the Product;

(xi)    obsolescence, short-dated Product cost and associated destruction cost;

(xii)    any costs incurred in connection with, or arising out of, compliance with the Generic Drug User Fee Act and/or the Prescription Drug User Fee Act and/or any similar law in effect from time to time in any country;

(xiii)    the costs associated with any required risk evaluation and mitigation strategies for the Product, if applicable; and

(xiv)    other specifically identifiable amounts that have been credited against or deducted from Product’s gross sales and are substantially similar to those credits and deductions listed above.

Net Sales shall exclude any samples of the Product transferred or disposed of at no cost for promotional or educational purposes.

In the case of any sale or other disposal of a Product between or among Cipla and its Affiliates for resale, Net Sales shall be calculated as above only on the value charged or invoiced on the first arm’s-length sale thereafter to an unrelated Third Party. In the case of any sale or other disposal for value, such as barter or counter-trade, of any Product, or part thereof, other than in an arm’s-length transaction exclusively for money, in addition to the inclusion of any such cash consideration in the calculation of Net Sales, Net Sales shall be calculated on the value of the non-cash consideration received or the fair market price (if higher) of the Products in the country of the sale or disposal. To the extent that any item deducted from gross amounts invoiced for the sale of the Product to determine Net Sales is not permitted to be deducted under the accounting requirements of any jurisdiction, then such amount (without duplication) may be reflected in Allowable Expenses and vice versa .

At the end of every Calendar Quarter, the Parties shall carry out a true-up reconciliation of all accrued payables during such Calendar Quarter versus actuals for such Calendar Quarter and shall make any applicable adjustment to Net Sales for such Calendar Quarter based on such true-up reconciliation.

Non-Pulmonary Indications ” means any Indication other than the Pulmonary Indications.

Notice ” has the meaning set forth in Section  14.1 .

 

8


NPI Transaction ” has the meaning set forth in Section  6.4 .

Party ” or “ Parties ” has the meaning set forth in the Preamble.

Out-of-Pocket Costs ” means amounts paid to Third-Party vendors, consultants, suppliers, or contractors for services and/or materials provided directly in connection with the performance of activities under the Development Plan and/or the Commercialization Plan, to the extent such services or materials apply directly to a Product.

Patents ” means those patents listed in Exhibit V and shall also mean and include any new patents or patent applications, additions, extensions or supplementary protection certificates which arise from Development under this Agreement or otherwise covers the Product in connection with any Pulmonary Indications.

Person ” means an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust, unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government.

Phase 2 ABPA Study ” has the meaning set forth in Section  3.2(a) .

Practical Limitation ” has the meaning set forth in Section  4.1(c) .

Pre-Clinical Studies ” means in vitro and in vivo studies not in humans, including those studies conducted in whole animals and other test systems, designed to determine the toxicity, bioavailability, and pharmacokinetics of the Product and whether the Product has a desired effect.

Product ” has the meaning set forth in the Recitals .

Promotion ” means with respect to the Product, any activities undertaken to encourage sales or use of the Product, including, but not limited to, Product detailing, product samples, drop-offs, coupons, discount cards, journal advertising, direct mail programs, direct-to-consumer advertising, convention exhibits and all other forms of marketing, advertising, public relations or promotion or use of Promotional Materials.

Promotional Materials ” means all sales representative training materials and all written, printed, graphic, electronic, audio or video matter, including, without limitation, journal advertisements, sales visual aids, formulary binders, reprints, direct mail, direct-to-consumer advertising, internet postings and sites and broadcast advertisements intended for use or used by either Party or its Affiliates or sublicensees in connection with any Promotion of the Product.

Pulmonary Indication(s) ” means, in relation to the Product, any past, present or future Indication for the treatment, prevention, and/or diagnosis of diseases of the pulmonary system, including, without limitation, the following conditions: Asthma, Cystic Fibrosis (CF), ABPA in patients with asthma and/or CF, idiopathic pulmonary fibrosis (IPF), acute respiratory distress syndrome (ARDS), chronic obstructive pulmonary disease (COPD), non CF bronchiectasis, severe asthma with fungal sensitization (SAFS), aspergillus induced asthma, hypersensitivity pneumonitis due to fungal infection, aspergilloma, invasive pulmonary aspergillosis, any condition caused or exacerbated by fungal infection/ presence in the lung and any other pulmonary condition treatable by inhaled Itraconazole . For the sake of clarity, Pulmonary Indication does not include conditions solely limited to the upper respiratory tract (nose and nasal passages, paranasal sinuses, the pharynx, and the portion of the larynx above the vocal folds (cords)).

 

9


Recall ” has the meaning set forth in Section  4.4 .

Regulatory Approval ” means the applicable approval(s) necessary to Develop or Commercialize, as applicable, the Product in a given country or jurisdiction.

Regulatory Authority ” means the FDA, the Centers for Medicare and Medicaid Services (CMS), the Office for Civil Rights (OCR), and any Governmental Authority in the U.S. or another country or jurisdiction that serves a regulatory role analogous to that of the FDA’s, CMS’s, or OCR’s in the U.S.

Regulatory Filing ” means any IND, NDA, or any other application, notification, or submission made to or with the FDA or other Regulatory Authority, including all data arising from Pre-Clinical Studies and Development, for Regulatory Approval of a human pharmaceutical product, together with all amendments and supplements to any of the foregoing.

Regulatory Materials ” means any regulatory notification, communication, correspondence, Regulatory Filings, Regulatory Approvals and other filings made to, received from, or otherwise conducted with a Regulatory Authority related to Developing, manufacturing, obtaining marketing authorization, marketing, selling, or otherwise Commercializing a pharmaceutical product in a particular country or jurisdiction.

ROFR ” has the meaning set forth in Section  6.5 .

Rules ” has the meaning set forth in Section  14.9 .

Senior Executives ” has the meaning set forth in Section  2.1(g) .

Subcontractors ” has the meaning set forth in Section  5.3 .

Term ” has the meaning set forth in Section  12.1 .

Terminating Party ” has the meaning set forth in Section  3.6(a) .

Territory ” has the meaning set forth in the Recitals.

Third Party ” means any Person other than the Company, Cipla, or the respective Affiliates of either Party.

Trademark ” means any word, name, symbol, color, designation or device, or any combination thereof, whether registered or unregistered, including without limitation any trademark, trade dress, service mark, service name, brand mark, trade name, brand name, logo, or business symbol

Upfront Payment ” has the meaning set forth in Section  7.1 .

Working Capital ” means working capital in respect of the Product in day-to-day trading operations, calculated as the difference between the Product’s current assets (such as accounts receivable, inventories of raw materials and finished goods) and its current liabilities (such as accounts payable).

 

10


ARTICLE 2

GOVERNANCE

 

2.1

Joint Steering Committee

 

  (a)

Establishment . Immediately following the execution of this Agreement, the Parties shall establish a joint steering committee (“ Joint Steering Committee ” or “ JSC ”) to direct the further Development and Commercialization activities, including all budgetary activities in relation to the Product. The JSC will oversee the performance of the Parties’ activities under this Agreement and provide a forum for sharing advice, progress, and results relating to such activities.

 

  (b)

Composition . The JSC will be comprised of four (4) persons representing Cipla and four (4) persons representing the Company. The initial members of the JSC shall be comprised of the individuals listed on Exhibit III.

 

  (c)

Meetings . The JSC will meet, in person, by teleconference, or by video-conference, on a quarterly basis, or more or less often as unanimously agreed by all eight JSC members, provided that the JSC meets in-person at least once per Calendar Year. Either Party may call a JSC meeting when reasonably necessary upon no less than five (5) Business Days’ Notice to all JSC members. In-person meetings will be held at the Parties’ principal places of business on an alternating basis, beginning with the Company’s principal place of business, or at such other locations as unanimously agreed upon by the JSC. The first in-person meeting will be not later than thirty (30) days after the Effective Date or such other later date as mutually agreed by the Parties. Upon both Parties’ prior joint consent, guests who are subject to written confidentiality obligations commensurate in scope to the provisions in Article 11 may attend JSC meetings as observers, without any voting rights. Each Party may replace its JSC members with other of its employees from time to time upon written Notice to the other Party, provided that such Notice is given at least five (5) Business Days prior to the next JSC meeting. For the sake of clarity, Parties agree to ensure that the JSC members for Development phase and Commercialization phase shall have relevant expertise in the respective areas to effectively and qualitatively perform their obligations under the Agreement.

 

  (d)

Chairperson; Secretary; Agenda; Minutes .

 

  (i)

A chairperson of the JSC shall be appointed each six (6) months, with the Company appointing the initial chairperson. The Parties shall rotate the chairperson for the JSC alternatively amongst the Parties every six (6) months commencing from the Effective Date, unless that JSC unanimously determines that it would be advisable for the then sitting chairperson to continue his or her term as chairperson. The chairperson shall be responsible for (i) calling meetings, (ii) appointing a secretary to prepare and issue minutes of each such meeting within fifteen (15) days thereafter, and (iii) preparing and circulating an agenda for the upcoming meeting along with the Notice of the Meeting; provided that the chairperson shall include any additional agenda items proposed by either Party no less than three (3) days prior to the next scheduled JSC meeting. The chairperson shall not have any duties other than those specifically enumerated herein. In addition, the chairperson shall have no special authority, powers or voting rights beyond those held by other JSC members.

 

11


  (ii)

The Secretary will be responsible for preparing and circulating minutes within fifteen (15) days after each meeting of the JSC setting forth, among other things, a description, in reasonable detail, of the discussions at the meeting and a list of any actions, decisions, or determinations approved by the JSC. The minutes of each JSC meeting will be finalized no later than thirty (30) days after the date of the meeting to which the minutes pertain.

 

  (e)

Duties . In addition to other duties assigned to the JSC elsewhere in this Agreement, the JSC will:

 

  (i)

Review and approve budget for Development and the Development Costs required to be reimbursed to the Company pursuant to Section  3.4, not later than thirty (30) days after its receipt thereof.

 

  (ii)

Review and approve the Development Plan developed by the Company submitted to the JSC pursuant to Section  3.1 not later than thirty (30) days after its receipt thereof.

 

  (iii)

Review and approve the Commercialization Plan developed by Cipla for each jurisdiction in which the Product has Regulatory Approval for a Pulmonary Indication not later than thirty (30) days after its receipt thereof.

 

  (iv)

Work collaboratively to make adjustments to the Development Plan, budget and/or Development Costs and costs incurred by Cipla for Development of the Product, as well as to the Commercialization Plan as required on an annual basis and six (6) months in advance of each Calendar Year. JSC approved increase or decrease in the Development Costs and/or Commercialization Costs shall also be equally borne by the Parties on actuals.

 

  (v)

Review the overall progress of the Parties’ collaborative efforts under this Agreement and monitor progress under, and compliance with, each Development Plan and the Commercialization Plan.

 

  (vi)

Such other responsibilities as may be assigned to the JSC pursuant to this Agreement or as may be mutually agreed upon by the Parties from time to time, provided, however that the JSC shall not have the power to amend or modify this Agreement.

 

  (f)

Decision-Making; Limitations . Except as expressly stated otherwise herein, decisions of the JSC will be made by unanimous vote or written consent, with each Party having one collective vote in all decisions. The presence, whether in-person or via teleconference or videoconference, of at least one (1) JSC member representing each Party will constitute a quorum for decisions to be made at a given meeting. The JSC will have only such powers as are specifically delegated to it in this Agreement, and such powers will be subject to the terms and conditions set forth herein. Amendments or changes to this Agreement will be valid and binding only upon mutual written agreement of the Parties in accordance with Section  14.17 and the JSC will have no authority to amend, change, or modify the terms and conditions of this Agreement. The JSC will use Commercially Reasonable Efforts to resolve the matters within its roles and functions or otherwise referred to it.

 

12


  (g)

Deadlock . In case of a deadlock, the Parties will refer the dispute to Company’s Chief Executive Officer and Cipla’s Specialty Head (“ Senior Executives ”), for attempted resolution in good faith within thirty (30) days following Notice of the dispute. If a dispute cannot be resolved by the Senior Executives, the JSC will defer to either an agreed-upon binding arbitration process or panel of expert review for final decision.

 

  (h)

Discontinuation . The JSC will disband upon the termination of this Agreement, unless otherwise stipulated in another agreement as of this Agreement’s termination date.

 

2.2

Alliance Managers. Promptly after the Effective Date, each Party will appoint an individual to act as the alliance manager for such Party (each, an “ Alliance Manager ”) (who may be a member of the JSC). Each Alliance Manager will thereafter be permitted to attend meetings of the JSC as a nonvoting observer (if not a member), subject to the confidentiality provisions of Article 11 . The Alliance Managers will be the primary point of contact for the Parties regarding the activities contemplated by this Agreement and will facilitate communication regarding all activities hereunder. The Alliance Managers will lead the communications between the Parties and will be responsible for following-up on decisions made by the JSC. The name and contact information for each Party’s Alliance Manager, as well as any replacement(s) chosen by the Parties in their sole discretion, from time to time, will be promptly provided to the other Party in accordance with Section  14.1 .

ARTICLE 3

DEVELOPMENT

 

3.1

Development Plan. All Development with respect to the Product for a Pulmonary Indication will be conducted pursuant to a Development Plan prepared by the Company and approved by the JSC in relation to the Product’s clinical Development and Regulatory Approval. Such Development Plans shall be prepared separately for each country in the Territory and will generally set forth, with reasonable specificity and detail, the anticipated budget, Development Costs as well as the development and operational plan, including without limitation, research objectives, priorities, milestones, and personnel requirements, for the Product’s Development and Regulatory Approval in relation to the applicable Pulmonary Indication and corresponding country in the Territory. The Company shall submit its Development Plan, which shall include a report of the Development Costs incurred prior to the Effective Date, to the JSC within five (5) days from the Effective Date, and the JSC shall review and approve such Development Plan within five (5) days after receipt thereof. Development Plans established under this Agreement (including the initial Development Plan) may be amended or modified from time to time by the Company in writing, subject to the review and approval of the JSC. Following JSC review and approval of the Development Plan, the JSC shall review the implementation and execution of the

 

13


  Development Plan on at least a quarterly basis; provided, that if the JSC identifies any unexpected circumstance or material deviations from the Development Plan, GCP and/or GLP, then the JSC shall promptly convene a special meeting to review the causes for such variation and establish a plan for remediation. By the June 30 th following the date of the initial Development Plan and each June 30 th thereafter, the Company will prepare and present to the JSC updated Development Plans on a country by country basis for the immediately following Calendar Year (e.g., the Company will prepare and present to the JSC the Calendar Year 2021 Development Plan by June 30, 2020). The JSC shall make a determination from time to time regarding the particular jurisdictions in which the Product will be Developed and then the Company shall prepare and present Development Plans (including annually updated Development Plans) for such jurisdiction within thirty (30) days of such determination.

 

3.2

Development Activities. The Company shall be primarily responsible for implementing the Development of the Product in accordance with the Development Plan, budget and Development Costs. The Parties acknowledge that the Development Plan and the Development Costs in Exhibit I have been previously provided to Cipla by the Company and mutually agreed by the Parties. The Company shall conduct and shall be primarily responsible for implementing all activities related to the Product’s Development for all Pulmonary Indications in accordance with the Development Plan, budget, Development Costs and the terms of this Agreement. Subject to the right of the JSC to review and approve the Company’s Development Plan, the Company will have discretion over the Product’s Development and all activities, arrangements, and other matters related to such Development, provided, that the Company must adhere to the Development Plan approved by the JSC and conduct all Development activities in compliance with GCP and GLP. Any material deviation from the Development Plan shall be subject to scrutiny and requires approval of the JSC. Any increase or material deviation from the mutually agreed Development Plan and/or budget and/or Development Costs shall be subject to pre-approval by JSC.

 

  (a)

Current Development Status . Prior to the Effective Date, the Company received Notice from the FDA that it completed its review of the Company’s IND application and that the Company could, accordingly, initiate the contemplated Phase 2 Clinical Trial entitled, “A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Phase 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) in Adult Asthmatic Patients With Allergic Bronchopulmonary Aspergillosis” (the “ Phase 2 ABPA Study ”).

 

  (b)

Continued Development . The Company shall conduct the Development activities for which it is responsible in accordance with the applicable Development Plan. The Company acknowledges that its technical and scientific personnel dedicated to the Development program are critical to the continuity of the Development of the Product. Accordingly, the Company shall ensure availability of such technical and scientific capability and personnel throughout the Development program, who are well versed with and able to perform Development activities in compliance with GCP, GLP and GMP requirements.

 

14


  (i)

The Company shall use Commercially Reasonable Efforts to complete the Phase 2 ABPA Study, as well as any additional Phase 2/2b, and/or Phase 3 Clinical Studies that may be required for Regulatory Approval in accordance with the Development Plan.

 

  (ii)

The Company shall provide to the JSC and Cipla reasonable progress and spending updates on the status of Development activities under the Development Plan on a quarterly basis, including summaries of data, actual and anticipated areas of spending and expenses, the likely timeline for completion of such activities and advancement of the Product to the next phase of Development, and such other information as Cipla may reasonably request.

 

  (iii)

The Company will be responsible for submission of INDs, annual reports, and other Regulatory Filings to the extent required to conduct the Development activities, including any Clinical Studies in connection with the Product’s Development for Pulmonary Indications, as described further in Section  4.1(a) .

 

  (iv)

The Company has obtained, or will, obtain all applicable Regulatory Approvals required to carry out the Development Plan, including any Clinical Studies contemplated thereby.

 

3.3

Subcontracts. The Company may perform any of its Development activities under this Agreement by delegating to an Affiliate or through one or more Third-Party subcontractors or consultants with the prior approval of the JSC, provided that with respect to each arrangement entered into on or after the Effective Date: (i) The Company remains responsible for the work allocated to such Affiliates, subcontractors, and/or consultants to the same extent as if it had done such work itself; and (ii) the Affiliate or subcontractor (as the case may be) undertakes, in writing, the obligations of confidentiality and non-use regarding the Confidential Information that are substantially the same as those undertaken by the Parties pursuant to Article 11 . Without limiting the foregoing, each Company-permitted subcontractor will be subject to the applicable terms and conditions of this Agreement, and no agreement with any such subcontractor will release the Company from any of its activities under this Agreement. The Parties agree that PPD Development, L.P. is an approved subcontractor for the Phase 2 ABPA Study in the United States, United Kingdom, Poland, India and Australia and does not require any approval from the JSC, provided however that the details of the Development Plan, including the study budget or Development Costs, with respect to conduct of Clinical Studies by PPD Development, L.P. shall be reviewed and pre-approved by JSC.

 

3.4

Development Costs. The Company has, prior to the Effective Date, represented to Cipla that it has Fifteen Million United States Dollars ($15,000,000.00) unencumbered cash available in its bank account dedicated for the Development of the Product in accordance with this Agreement and shall not be subject to any earlier debt repayment condition. The Company represents that it shall not create or permit its funding agencies or investors to create in respect of the Development, Commercialization, Products, or Assigned Assets, any lien, or charge, or encumbrance, or mortgage, existing or future, on the said dedicated bank account. Within thirty (30) days after the Effective Date, the

 

15


  Company shall deposit Twenty Four Million United States Dollars ($24,000,000.00) into the bank account dedicated to the Development of the Product in accordance with this Agreement and which shall be used exclusively for payment of Development Costs incurred under the Development Plan that has been pre-approved by the JSC (the “ Initial Development Funding ”). The Development Costs for the Development program forms an integral part of the Development Plan as set out in Exhibit I. All JSC approved Development Costs actually incurred in connection with the Company’s Development activities under this Agreement, including all costs incurred by Cipla for the Development (as set out separately in the Development Plan as Cipla’s costs in the Development Plan), will be first paid from the Initial Development Funding, until all such funding has been exhausted. The Company may reimburse itself for one-half of the Development Costs incurred prior to the execution of this Agreement included in Development Plan, subject to review and approval by the JSC, with the initial Development Funding.

 

3.5

Co-Development Contributions.

 

  (a)

Cost Sharing . After the Initial Developing Funding is depleted (the “ Co-Development Phase ”), the Company and Cipla will each be responsible for 50% of Development Costs actually incurred. Expenses incurred by either Party To ensure continuity of the Development program, the Company shall designate two of its bank accounts, one to be used exclusively for Cipla’s Development contributions and the other to be used exclusively for the Company’s Development contributions. These accounts must be separately maintained with no commingling of the contributed funds.

 

  (b)

Funding of Accounts . The Parties shall set aside and contribute equally the funds needed for Development under this Agreement. The contributions of the Parties shall be dedicated solely for Development under this Agreement and all funds drawn down in accordance with the Development Costs set forth in the Development Plan. All payments and expenses for the Development shall be undertaken and monitored only through the specific bank accounts for Development, in compliance with the Development Costs and Development Plan pre-approved by the JSC. No payment of dividend or any other expenses for the Development under this Agreement shall be permitted from the funds in these dedicated bank accounts. Each Party will fund the respective account established pursuant to Section  3.5(c) on a quarterly basis. Ten (10) days prior to the first day of each calendar quarter, the Company shall deliver a notice to Cipla indicating the Development Costs to be incurred by the Company during such quarter in accordance with the Development Plan approved by the JSC. Within fifteen (15) days of after delivery of such notice, each Party shall fund its respective account established pursuant to Section  3.5(c) with an amount equal to one-half of such Development Costs set forth in the notice.

 

  (c)

Insufficient Funds . To the extent that the funds in each account maintained pursuant to Section  3.5(a) are, at any time, insufficient for any current Development Costs, the Company may, at its option, pay for such Development Costs from its other funds and, in such instance, Cipla will promptly reimburse the Company for its share of such expenditure by the Company (provided, for clarity,

 

16


  that such Development Costs are set forth in the Development Plan and pre-approved by the JSC). Any amounts for which Cipla is required to reimburse the Company shall be a secured claim against Cipla. Parties agree that JSC will decide the appropriate and optimal use of any excess funds arising from better management of the Development Costs by the Parties vis-à-vis the budgeted expenses.

 

  (d)

Cipla’s Lien; Rights of First Creditor . After the initial Development Fund is completely depleted, Cipla shall contribute its share of Development Costs to a separate dedicated bank account as stated in Section 3.5(a). In connection with the said account designated for Cipla’s contributions to the Product’s Development during the Co-Development Phase, Cipla will have a lien and the rights of first creditor in case of default by the Company, and the Company shall use Commercially Reasonable Efforts to ensure that Cipla’s lien and right as first creditor is protected at all times. Cipla’s lien and right of first creditor over funds is expressly limited to the bank account dedicated for its funds and will, in no event, extend to or include the dedicated bank account opened by the Company for the any other funds of the Company. Promptly following the last business day of each calendar month, the Company shall provide Cipla with written documentation demonstrating that the Development Costs have been funded equally from both accounts and that both the funds withdrawn from each dedicated bank account were used solely for the applicable Development activities.

 

3.6

Circumstances Affecting Continuity of Development. If (i) the applicable Regulatory Authority deems the data from one or more applicable Clinical Studies do not meet anticipated safety or efficacy endpoints and/or there is failure in Clinical Studies; (ii) a Regulatory Authority suggests additional Clinical Studies that will have a significant financial impact on the total Development Costs; (iii) there is change in market scenario or change in global research and development scenario or an unforeseen competitive event or change in Applicable Law, which causes commercial or technical unviability and has a material adverse impact on the Development activities contemplated under the Development Plan, as amended from time to time; or (iv) any change in Applicable Law results in a materially adverse market environment for the Commercialization of the Product which is not likely to abate within a period of twelve (12) calendar months:

 

  (a)

The JSC will evaluate the cause and effect of each scenario in (i), (ii), (iii) and (iv) above and make a recommendation as to the most optimal option available to the Parties, which may include, without limitation, repeating Clinical Studies, abandoning the Development program, or discussing new ways to monetize the Assigned Assets. Either Party may, without any binding obligation, elect to follow, or decide against, the recommendation of the JSC. In any event, either Party may elect to terminate (a “ Terminating Party ”) its obligation to fund additional costs and expenses for the Development and/or Commercialization of the Product.

 

  (b)

If the non-Terminating Party wishes to continue the Development of the Product, it will have the right to purchase the rights of the Terminating Party in the Product at Fair Market Value as may be determined by a qualified independent Third Party expert acceptable to both Parties or based on external bid received on the Product by a Third Party and continue with the Development program either by itself or by partnering with any third party.

 

17


  (c)

If both Parties decide to follow the recommendation of the JSC and, thereby, abandon the Development program, the Parties shall make Commercially Reasonable Efforts to monetize the Product and the Development program in connection with the Pulmonary Indications. The Parties will equally share the proceeds. The events described above will not be considered an event of default or breach under this Agreement.

ARTICLE 4

REGULATORY MATTERS

 

4.1

Regulatory Filings.

 

  (a)

Company Responsibility . With respect to the Product in relation to the Pulmonary Indications, the Company is responsible for all Regulatory Filings in the Territory. For the avoidance of doubt, the Company’s responsibility for Regulatory Filings, with respect to each country in which the Parties intend to market the Product for Pulmonary Indications, is limited to Regulatory Filings required between the commencement of Development activities and the date on which the Product is approved by the applicable Regulatory Authority by way of grant of Regulatory Approvals. Some of the specific Regulatory Filings for which the Company is responsible include: INDs (which, as used here includes applicable foreign equivalents), annual reports in connection with INDs, NDAs (which, as used here includes applicable foreign equivalents), and any other Regulatory Filings required under Applicable Law between the date on which the IND became effective and the date on which the NDA was approved by the applicable Regulatory Authority. To the extent that the Company is not required by Applicable Law to submit an IND or NDA (or applicable foreign equivalents) under Company’s name, or on Company’s behalf, Company will submit all Regulatory Filings in the name, or on Cipla’s behalf. Cipla shall cooperate with the Company and facilitate the Company’s efforts to the extent reasonably requested by the Company. Parties acknowledge and agree that, to the extent permitted by Applicable Law, the ownership of all Regulatory Approvals for the Product with respect to Pulmonary Indications in each country in the Territory shall be transferred to Cipla within thirty (30) days of grant of Regulatory Approval. Company shall, as required by Applicable Law, file necessary documents and applications for variation of title of the Regulatory Approvals in the name of Cipla in each country in the Territory.

 

  (b)

Cipla Responsibility . With respect to the Product in relation to the Pulmonary Indications, Cipla is responsible for all Regulatory Filings that relate to Commercialization activities, subject to sharing of expenses equally by the Parties. For the avoidance of doubt, Cipla’s responsibility for Regulatory Filings, with respect to each country in which the Parties intend to market the Product for Pulmonary Indications, begins immediately after the Product is approved by the applicable Regulatory Authority. Some of the specific Regulatory Filings for which Cipla is responsible include:

 

18


  (i)

Advertising and Promotional Materials . Subject to the right of the JSC to review and approve Cipla’s Commercialization Plan, Cipla will have discretion over the Product’s Commercialization activities relating to developing, filing, and making decisions about all Promotional Materials and associated Regulatory Filings for the Product, after it is approved for marketing by the applicable Regulatory Authority in each applicable country provided, that the Company must adhere to the Commercialization Plan approved by the JSC. Specifically, Cipla must submit a Form 2253 (or such other form as required by FDA) to the FDA for all Promotional Materials that it seeks to disseminate in the U.S. (typically at least thirty (30) days before dissemination or such other time period permitted by Applicable Law). Additionally, in connection with each such Regulatory Filing, Cipla shall provide the Company with complete copies of all correspondence with the FDA regarding the applicable Promotional Materials not later than ten (10) Business Days after receipt, for the sole purpose of obtaining regulatory status of advertising and Promotional Materials, subject to the Company complying with confidentiality obligations under Section 11 of the Agreement. To the extent that the Product is approved for Pulmonary Indications in other countries (i.e., other than the U.S.), Cipla will be responsible for any Regulatory Filings that other Regulatory Authorities may impose in relation to marketing, Promotions, and advertising;

 

  (ii)

Adverse Drug Experiences . Once the Product is approved by the applicable Regulatory Authority, Cipla will have the responsibility for investigating, recording, and reporting to each such Regulatory Authority all Adverse Drug Experiences in relation to the Product in accordance with Applicable Law; and

 

  (iii)

Regulatory Requests . In addition to the Regulatory Filings referenced in (i) and (ii) above, Cipla will also be responsible for any Regulatory Filings that may be required to comply with Applicable Law or requested by the applicable Regulatory Authority in relation to Promotional Materials and Adverse Drug Experiences after the Product is approved for a Pulmonary Indication in the applicable country in the Territory.

 

  (c)

Ownership . With respect to the Product in relation to the Pulmonary Indications, all Regulatory Filings, Regulatory Materials and Regulatory Approvals, advertising and Promotional Materials, including IND and NDA shall be Assigned Assets, shall be fully and exclusively owned by Cipla. All Regulatory Filings made by the Company shall reflect Cipla’s

 

19


  ownership of the Assigned Assets. In the event the ownership of INDs (and applicable foreign equivalents), in the opinion of a Party’s regulatory consultants, would result in material delay or otherwise frustrate the execution of the Development Plan (a “ Practical Limitation ”) the Company will maintain such INDs (and applicable foreign equivalents) in trust for and on behalf of Cipla, until the time that such Practical Limitation is no longer applicable. Subject to the other terms of this Section 4.1(c), the Company shall file all required applications and documents for recording the ownership of Cipla in respect of such IND with the applicable Regulatory Authorities, as required. Nothing contained herein shall limit or restrict the ownership rights of Cipla in respect of any other Assigned Assets Cipla will own and maintain NDAs (and any applicable foreign equivalent or U.S. equivalent under a different approval pathway) in connection with each Regulatory Approval granted to the Product for Pulmonary Indications.]

 

4.2

Notice of Threatened Action . If any Governmental Authority threatens or initiates any action in relation to the Product that: (i) raises a concern regarding the safety or efficacy of Product; (ii) is reasonably likely to lead to a recall, market withdrawal, or market notification of, or about, the Product; or (iii) relates to an Adverse Drug Experience in connection with use of the Product or any other occurrence that may have a material adverse effect on the Development and/or Commercialization of the Product, the Party with knowledge that such Governmental Authority has threatened or initiated the applicable action in relation to the Product shall notify the other Party in writing immediately, but in no event later than five (5) Business Days following such Party’s receipt of Notice of the Governmental Authority’s threat or initiation of action.

 

4.3

Clinical Trial Holds . Each Party will promptly (but in any event within five (5) Business Days) inform the other Party in the event that any Clinical Study for the Product in connection with the Pulmonary Indications is suspended, put on hold, or terminated in its prior to completion as a result of any action by a Regulatory Authority or such Party voluntarily.

 

4.4

Recalls; Market Withdrawal. If a Regulatory Authority threatens or initiates any issues or requests a recall, stop sale, field correction, or market withdrawal or takes similar action (collectively, “ Recalls ”) in connection with the Product in the country over which such Regulatory Authority has jurisdiction over the Product, the Party receiving notice thereof shall notify the other Party of such communication immediately, but in no event later than five (5) business days, after receipt of such information. Each of Cipla and the Company will have the right to propose that a Product Recall should be initiated; the JSC shall promptly meet and discuss in good faith the reasons for any such proposed Recall and determine whether such Recall should be initiated.

 

4.5

Regulatory Delays Outside a Party’s Control. In addition to the provisions under Section  14.18 , neither Party will be responsible for its respective failure to comply with a given deadline or requirement in connection with the Party’s Development or Commercialization obligations under this Agreement to the extent such failure is caused by factors beyond its reasonable control (e.g., regulatory delays, changes in regulatory timelines by Regulatory Authorities or arising from change in regulations, other similar unforeseeable circumstances) and occurs despite the Party’s Commercially Reasonable Efforts to accomplish the applicable objective in a timely manner.

 

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ARTICLE 5

COMMERCIALIZATION

 

5.1

Commercialization Plan. Cipla will be responsible for preparing and presenting to the JSC a Commercialization Plan twelve (12) months prior to the anticipated Regulatory Approval of the Product for marketing in the U.S. or in any other country in the Territory in connection with the Pulmonary Indication. Following JSC review and approval of such Commercialization Plan, the JSC shall review the implementation and execution of the Commercialization Plan on at least a quarterly basis; provided, that if any unexpected circumstance occurs that would result in a variation from the Commercialization budget set forth in such Commercialization Plan of fifteen percentage (15%) or greater, then the JSC shall promptly convene a special meeting to review the causes for such variation and establish a plan for remediation. For clarity, in no event, will either Party be required to incur Commercialization Costs in excess of one hundred and fifteen percentage (115%) of the amount set forth in the budget and/or Commercialization Costs contained in the Commercialization Plan unless such costs are pre-approved by JSC. By the June 30 th following the date of the initial Commercialization Plan and each June 30 th thereafter, Cipla, will prepare and present to the JSC an updated Commercialization Plan for the immediately following Calendar Year (e.g., Cipla will prepare and present to the JSC the Calendar Year 2021 Commercialization Plan by September 3, 2020). In the event that the Product receives Regulatory Approval for a Pulmonary Indication in any country other than the U.S., the JSC shall make a determination if the Product will be Commercialized in such jurisdiction within thirty (30) days of such Regulatory Approval and, if the JSC so determines to Commercialize the Product in such jurisdiction, then Cipla shall prepare and present Commercialization Plans (including annually updated Commercialization Plans) for such jurisdiction following the same procedure set forth above for the U.S.

 

5.2

Commercialization Activities. Cipla shall use its Commercially Reasonable Efforts to implement the Commercialization Plan. During the Term, Cipla will, in general, be primarily responsible for implementing Commercialization of the Product in connection with the Pulmonary Indications in accordance with the Commercialization Plans approved by the JSC and in compliance with GMP requirements for manufacturing and Commercialization of the Product Subject to the right of the JSC to review and approve Cipla’s Commercialization Plan, Cipla will have discretion over the Product’s Commercialization and all activities, arrangements, and other matters related to such Commercialization, provided, that Cipla must adhere to the Commercialization Plan approved by the JSC. Any material deviation from the mutually agreed Commercialization Plan and/or increase in Commercialization Costs requires approval by JSC. For the sake of clarity, notwithstanding anything contained in Section 5.1, Parties agree and acknowledge that Cipla shall have no binding obligation to Commercialize the Product in any specific country in the Territory and, in such instance Cipla does not Commercialize in any specific country, Cipla shall make Commercially Reasonable Efforts to out-license the Commercialization rights for the Product to any Third Party in any such country, subject to JSC approval.

 

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5.3

Affiliates and Subcontractors. Cipla may perform any of its Commercialization activities under this Agreement by delegating to an Affiliate or through one or more Third-Party subcontractors or consultants or licensees or sub-licensees (“Subcontractors”). Any subcontracting of Commercialization through such Subcontractors shall be subject to the prior approval of the JSC. Each of such Commercialization arrangement of the Product by Cipla’s Affiliate or the Subcontractor entered into on or after the date of Regulatory Approval in the corresponding country in the Territory shall be subject to the condition that: (i) Cipla remains responsible for the work allocated to such Affiliates and/or Subcontractors (as the case may be) to the same extent as if it had done such work itself; and (ii) the Affiliate or Subcontractor (as the case may be) undertakes, in writing, the obligations of confidentiality and non-use regarding the Confidential Information that are substantially the same as those undertaken by the Parties pursuant to Article 11 . Without limiting the foregoing, each Cipla-permitted Subcontractor will be subject to the applicable terms and conditions of this Agreement, and no agreement with any such Subcontractor will release Cipla from any of its activities under this Agreement.

 

5.4

Commercialization Cost Sharing.

 

  (a)

The Company and Cipla will each be responsible for 50% of Commercialization Costs set forth in the Commercialization Plans approved by the JSC and actually incurred by Cipla. Such Commercialization Costs shall include, without limitation, pre-Commercialization activities undertaken before and after Regulatory Approval of the Product that relate to marketing, promoting, distributing and selling the Product in each of the countries in the Territory. For the sale of clarity, Commercialization Costs shall also cover expenses towards Phase IV studies that may be required by applicable Regulatory Authority in the Territory.

 

  (b)

In furtherance of the foregoing, Cipla shall establish a segregated bank account which shall be used to fund such Commercialization Costs. Each Party will fund such account on a quarterly basis as follows: ten (10) days prior to the first day of each Calendar Quarter, Cipla shall deliver a notice to the Company indicating estimated negative Free Cash Flow for such Calendar Quarter in accordance with the Commercialization Plan approved by the JSC. Within fifteen (15) days after delivery of such notice, each Party shall fund such account established pursuant to this Section  5.4(b) with an amount equal to one-half of such estimated negative Free Cash Flow. To extent that actual negative Free Cash Flow for such Calendar Quarter materially varies from the estimate set forth in such notice, any positive or negative variance will be accounted for in the amount each Party is required to fund for the next Calendar Quarter.

 

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  (c)

All funds that the Company contributes to the segregated account shall be held in trust by Cipla for the Company for the purposes set forth in this Agreement and shall remain the property of the Company until expended in accordance with the Commercialization Plan.

 

  (d)

Insufficient Funds . To the extent that the funds in the account maintained pursuant to Section  5.4(a) are, at any time, insufficient for any current Commercialization Costs, Cipla may, at its option, pay for such Commercialization Costs from its other funds and, in such instance, Company will, not later than five (5) days reimburse Cipla for its share of such expenditure by Cipla (provided, for clarity, that such Commercialization Costs are set forth in the Commercialization Plan approved by the JSC). Any amounts for which the Company is required to reimburse Cipla shall be a secured claim against the Company. If the Company fails to reimburse Cipla its share of such Commercialization Costs within the aforesaid period, then Cipla shall, at its option, either suspend and withhold any payment of Free Cash-Flow until the time the Company fully reimburses such amount or set off such expenditure against any positive Free Cash-Flow payable to the Company.

 

  (e)

Within thirty (30) days following the last business day of each calendar month, Cipla shall provide the Company with written documentation of the Commercialization Costs incurred during such calendar month.

 

  (f)

The JSC may agree on any reasonable alternate funding procedures for Commercialization Costs if the Parties determine alternate procedures to be desirable.

ARTICLE 6

ASSIGNMENT OF RIGHTS

 

6.1

Assignment to Cipla. Subject to the terms and conditions of this Agreement, including the Grant-Back License and simultaneously upon the Company’s receipt of the full amount of the Upfront Payment, Company hereby irrevocably assigns to Cipla the following assets, solely to the extent that each covers the Product in connection with any Pulmonary Indications: all existing and future technologies, current and future drug master files, dossiers, third-party contracts, Regulatory Filings, Regulatory Materials and Regulatory Approvals, Patents, and Intellectual Property Rights, as well as any other associated rights and assets directly related to the Product, specifically in relation to Pulmonary Indications (collectively, the “ Assigned Assets ”), provided that the Company’s iSPERSE ® technology, along with any rights associated therewith, including Intellectual Property Rights and any other rights and assets related to the foregoing, is excluded from the Assigned Assets. For the avoidance of doubt, this Assignment does not extend to (i) any current or future right affiliated with the Product with respect to Non- Pulmonary Indications, (ii) any rights associated with the Company’s iSPERSE ® technology solely directed to the Product for Pulmonary

 

23


  Indications or (iii) to any patent or patent application that would otherwise be an Assigned Asset but which is subject to a terminal disclaimer over any of the foregoing (“ Excluded Assets ”). The Company represents and warrants that as on the Effective Date, it has all legal rights, title and interests in the Assigned Assets and Excluded Assets in order to validly assign and transfer full and unencumbered ownership rights in the Assigned Assets and grant license rights in the iSPERSE technology to Cipla in accordance with the terms of the Agreement. All rights not expressly assigned to Cipla are entirely reserved by the Company. For clarity, following assignment of the Assigned Assets pursuant to this Section  6.1 , Cipla shall be owner of the Assigned Assets in all respects and the Company shall execute all documents and file necessary applications with the relevant Regulatory Authorities to perfect the ownership of Cipla in the Assigned Assets in the official records. Notwithstanding any other provision of this Agreement, the Company will have the right to reference and use any Regulatory Filing that is part of the Assigned Assets, or any portion thereof, in connection with or useful for the Company’s Regulatory Filings under this Agreement, provided that Company’s use is not directed specifically to the Product or for Pulmonary Indications and has general utility in connection with the Company’s iSPERSE ® technology. Notwithstanding the foregoing, such right of reference of the Company may be terminated by Cipla to the extent that the Company materially breached this Agreement or claims ownership of any of the Assigned Assets in contravention of this Agreement.

 

6.2

Grant-Back License to Company. To the extent any of the Assigned Assets are related to or cover Non-Pulmonary Indications, Cipla hereby grants Company an exclusive, perpetual, irrevocable, royalty-free, and transferrable license (the “ Grant-Back License ”) with the right to sublicense to any Third Party, all Intellectual Property Rights related to the Product that are directed to Non-Pulmonary Indications, to make, use, develop, and commercialize formulations and final products, either individually or in combination with any other active or inactive component. Notwithstanding the foregoing, such license maybe terminated by Cipla to the extent that Company materially breached this Section 6.2 or the exclusivity and non-compete obligations in Section 14.19 or claims ownership of any of the Assigned Assets in contravention of this Agreement.

 

6.3

Cipla Rights to Excluded Assets; Sublicenses. Subject to the terms and conditions of this Agreement, to enable Cipla to exercise its rights and perform its obligations under this Agreement, the Company hereby grants to Cipla a non-exclusive, perpetual, irrevocable, royalty-free, transferrable and sub-licensable license of the Intellectual Property Rights to the Excluded Assets solely for use with respect to the Product for the Pulmonary Indications; provided, however, with respect to any Patent that covers the Product for Pulmonary Indications that is an Excluded Asset as a result of a terminal disclaimer, such license shall be exclusive with respect to the Product in Pulmonary Indications. Cipla may authorize and grant direct sublicenses (without further right to sublicense) under the limited right granted to Cipla to the Excluded Assets under this Section  6.3 , provided that , (a) Cipla shall require each sublicensee to comply with the terms and conditions of this Agreement that are applicable to such sublicensee, (b) Cipla shall provide, and shall cause any sublicensee with respect to its further sublicensing to provide, a copy of any and all executed sublicense agreements within

 

24


  thirty (30) days of such agreement’s execution, provided that Cipla or such sublicensee may redact from any such copy those terms not reasonably necessary to determine Cipla’s or such sublicensee’s compliance with its obligations under this Agreement, and (c) Cipla will be liable for any and all acts and omissions of any such sublicensee in connection with such sublicenses. Notwithstanding the foregoing, such license maybe terminated by the Company to the extent that Cipla materially breaches this Agreement or claims ownership of any of the Excluded Assets in contravention of this Agreement.

 

6.4

Cipla Right of First Refusal with Respect to Non-Pulmonary Indications . Cipla will have a right of first refusal (“ ROFR ”) with respect to any license, sale, assignment, transfer or other disposition or co-Development arrangement with a Third Party for Non-Pulmonary Indications of the Product (an “ NPI Transaction ”). Accordingly, before entering into an NPI Transaction with any Third Party, Pulmatrix shall notify Cipla in writing that it may pursue such a potential NPI Transaction with a Third Party, which notice shall include the proposed terms of the NPI Transaction with such Third Party. Cipla shall have thirty (30) days from the receipt of such notice to provide Pulmatrix written notice that it desires to enter into such NPI Transaction with the Company. If Cipla does not provide written notice that it is exercising the ROFR within such thirty (30) day period, then the Company shall have no further obligation with respect to the ROFR and shall be free to enter into the NPI Transaction with such Third Party on the terms set forth in the notice. If Cipla properly exercises, by delivering a binding written offer to enter into the NPI Transaction, , then the Parties shall consummate such NPI Transaction on the terms set forth in the written notice within sixty (60) days after the Company’s delivery of such notice. If the Company and Cipla do not enter the NPI Transaction with the Company on such terms within such sixty (60) day period, the Company may enter such NPI transaction with such Third Party. The ROFR shall reset if the Company does not enter into an NPI Transaction with the Third Party within ninety (90) days of Cipla’s declination to exercise the ROFR or Cipla’s failure to enter into the NPI Transaction after exercising the ROFR. .

 

6.5

Company Right of First Offer . In the event that Cipla proposes to sell, transfer or in any manner alienate the Product or the Assigned Assets or the Intellectual Property Rights in respect of the Product or Assigned Assets (a “ Cipla Disposition ”), Cipla shall advise the Company in writing of its intent and the Company shall for a period of sixty (60) days following written notice (the “ Company Notice Period ”), have the right to confirm its decision to purchase the Product or Assigned Assets or the Intellectual Property Rights. The sale price shall be the Fair Market Value of Cipla’s interest in the Product, Assigned Assets or Intellectual Property Rights being alienated, as may be determined by an independent Third Party expert or external bid received on the Product, Assigned Assets or Intellectual Property Rights by a Third Party; provided however, that if the Company does not exercise its right of first offer set forth in this Section 6.5, the Company shall ensure that, to the extent Cipla possesses a license to such Intellectual Property Rights, any such sale or alienation of the Product by Cipla must not adversely impact Cipla’s ability to license such Intellectual Property Rights to any Third Party solely to the extent necessary to utilize the Product for the Pulmonary Indications. All rights and obligations of the respective Parties under this Agreement

 

25


  will survive any such sale of rights to a Third Party and shall inure to the third party. If the Company does not deliver the notice described in the preceding sentence within the Company Notice Period, Cipla will be free for a period of sixty (60) days thereafter to notify its intention to consummate the Cipla Disposition on substantially the same terms described in its written notice to the Company. If Cipla does not consummate the Cipla Disposition within such period, the Company’s rights under this Section shall reset. In any case, in the event of a Cipla Disposition to a Third Party, such Third Party must assume all of Cipla’s obligations hereunder, such Third Party must demonstrate the wherewithal to perform all of Cipla’s obligations under this Agreement and Cipla shall ensure such Third Party’s performance of Cipla’s obligations hereunder so assumed by such Third Party. Notwithstanding the foregoing, a sale of all or substantially all of the assets of Cipla, including the Assigned Assets, or a merger or consolidation of the Company is not a Cipla Disposition. Upon consummation of the Cipla Disposition, Cipla shall be relieved of its obligations hereunder. Notwithstanding anything contained in this Section 6 or elsewhere in this Agreement, the Company shall not have ROFR in respect of a Cipla Disposition to Cipla’s Affiliates.

 

6.6

Cipla Right of First Offer . Company shall advise Cipla in writing in the event it proposes to sell or in any manner alienate its rights in the Product (including its right to receive 50% of Free Cash-Flow) (a “ Company Disposition ”) and Cipla shall, for a period of sixty (60) days following written notice (“ Cipla Notice Period ”), have the right to elect to purchase such rights. The sale price shall be the fair market value of the Company’s rights in the Product being sold or alienated, as may be determined by an independent third party expert or, if available, based on the external bid received on the Product by a third party; provided, however, that if Cipla does not timely exercise its right of first offer under this Section 6.6, the Company may proceed with the sale or alienation. The Company shall ensure that any such sale or alienation must not adversely impact Cipla’s license to Intellectual Property Rights hereunder or Cipla’s ability to sublicense such Intellectual Property Rights in accordance with this Agreement. All rights and obligations of the Parties under this Agreement will survive any such sale of rights to a Third Party and shall inure to the Third Party. If Cipla does not deliver the notice described in the preceding sentence within Cipla Notice Period, the Company will be free for a period of ninety (90) days thereafter to consummate the Company Disposition on substantially the same terms described in its written notice to Cipla. If the Company does not consummate the Company Disposition within such period, Cipla’s rights under this Section shall reset. In any case, in the event of a Company Disposition to a Third Party, such Third Party must assume all of the Company’s obligations hereunder and such Third Party must demonstrate the wherewithal to perform all of the Company’s obligations under this Agreement. The Company shall ensure that any Company Disposition to such Third Party shall not, in any manner, adversely affect any of Cipla’s rights under the Agreement. All rights and obligations of Cipla under the Agreement shall be protected and will survive any such sale of Company Disposition to a Third Party and shall inure to the Third Party. Upon consummation of the Company Disposition, the Company shall be relieved of its obligations under this Agreement. Notwithstanding the foregoing, Change in Control of the Company is not a Company Disposition.

 

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6.7

Right of First Offer for Other Inhaled Anti-Fungal Products for SAFS and the Initial Indication . If either Party intends to Develop and/or Commercialize (a “ Developing Party ”), whether independently or jointly with Third Parties, any inhaled anti-fungal product for the Initial Indication and SAFS (a “ New Product ”), such Developing Party shall advise the other Party in writing of its intention to do so (a “ Development Notice ”). For a period of thirty (30) days following the other Party’s receipt of the Development Notice (the “ Development Notice Period ”), such other Party shall have the exclusive option, exercisable upon delivery of a written notice to Developing Party, to enter into a co-Development and Co-Commercialization agreement for such New Product with the Developing Party on “substantially the same terms as set forth in this Agreement”. The Parties shall enter into such binding agreement for the New Product within ninety (90) days (or such longer period as the Parties mutually agree) of the other Parties exercise of its rights hereunder. If such other Party does not deliver the notice described in the preceding sentence within Development Notice Period, then the Developing Party will be free to Develop and/or Commercialize such Product (either individually or together with Third Parties). For purposes of this Section “on substantially the same terms as set forth in this Agreement” means, generally, an arrangement between the Company and Cipla whereby each Party equally shares the costs of Development and Commercialization of the New Product and equally shares the free cash flow for such New Product.

 

6.8

Right of First Offer for Other Inhaled Anti-Fungal Products other than SAFS and the Initial Indication . If either Party Develops and/or Commercializes (a “ AF Developing Party ”), whether independently or jointly with Third Parties, any inhaled anti-fungal product for Pulmonary Indications (other than the Initial Indication and SAFS) (a “ AF Product ”), such Developing Party shall advise the other Party in writing of its intention to do so (a “ AF Development Notice ”) and the proposed terms on which it would enter into a co-Development/co-Commercialization agreement the other Party (the “ AF Terms ”). For a period of thirty (30) days following the other Party’s receipt of the AF Development Notice (the “ AF Development Notice Period ”), such other Party shall have the option, exercisable upon written notice to AF Developing Party, to enter such agreement on the AF Terms or such other terms as the Parties may mutually determine. If (i) the other Party does not deliver the notice described in the preceding sentence within AF Development Notice Period or (ii) the Parties do enter into a binding term sheet or other binding agreement with respect to the Development and/or Commercialization of the New Product within ninety (90) days from the date of such other Party’s notice, then the AF Developing Party will be free to Develop and/or Commercialize such AF Product (either individually or together with Third Parties).

ARTICLE 7

COMPENSATION

 

7.1

Upfront Payment. Except as set forth in Section  12.2 (Immediate Termination for material breach), not later than thirty (30) days after the Effective Date, Cipla shall make an upfront payment to the Company in the amount of Twenty Two million United States Dollars ($22,000,000) (the “ Upfront Payment ”) towards a worldwide, irrevocable assignment and transfer of all ownership in the Assigned Assets to Cipla.

 

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7.2

Free Cash-Flow Sharing. As further consideration of the Assigned Assets, Cipla and the Company will share equally, both positive and negative total Free Cash-Flow earned by Cipla in respect of the Product. Cipla shall, within forty five (45) days from the end of each Calendar Quarter during which sales of the Product have generated Free Cash-Flow, either positive or negative, deliver to the Company a report setting out Free Cash-Flow including the following:

 

  (a)

gross sales and Net Sales for the Product on a country-by-country basis;

 

  (b)

break up of Allowable Expenses;

 

  (c)

all relevant exchange rate conversions;

 

  (d)

change in Working Capital; and

 

  (e)

Capital Expenditure.

Cipla shall make Commercially Reasonable Efforts to deliver to the Company any additional information relating to Free Cash-Flow that may be requested by Company, which shall be reasonable in nature and standard industry practice.

Within fifteen (15) days after the date of receipt of a positive Free Cash-Flow report, Cipla shall deliver to the Company an amount in cash equal to 50% of the positive Free Cash-Flow for such Calendar Quarter. For clarity, negative Free Cash Flow is funded in accordance with Section 5.4. For the sake of clarity, the royalties or other receivables, including any upfront or milestone payments, arising from license or sublicense to Third Party shall be shared equally by the Parties and treated so in the Free Cash-Flow.

 

7.3

Manner of Payment; Late Payment . All payments due to a Party hereunder will be made in U.S. Dollars by wire transfer of immediately available funds into an account designated by such Party from time to time. If a Party does not receive payment of any sum due to it on or before the due date, simple interest will thereafter accrue on the sum due until the date of payment at the per annum rate of the then-current prime lending rate quoted by Citibank in New York City or the maximum rate allowable by Applicable Law, whichever is lower.

 

7.4

Audit Rights . As of the Effective Date, each Party has the right, during normal business hours, and no more than twice per Calendar Year, other than following a finding of material deficiency, with more frequent audits upon agreement of the Parties, to inspect and audit:

 

  (a)

those portions of the facilities of the other Party, its Affiliate, subcontractor, and investigator site used in the performance of the Development Plan or the manufacturing of the Product to be supplied for use, to ascertain compliance with Applicable Law and Regulatory Approvals, and conformance with the applicable specifications and quality assurance standards, provided that the inspecting Party is accompanied by a representative of the other Party on such occasions; and

 

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  (b)

any of the other Party’s documentation or its Affiliates’, subcontractors’ or investigators’ documentation relating to such Development Plan or manufacturing of the Product to be supplied for use, including, to the extent permitted by Applicable Law, Governmental Authority, Regulatory Authority, and any applicable privacy policies, the medical records of any patient participating in any of the Clinical Studies under the Development Plan. A Party’s audit rights are limited by bona fide Third-Party agreements or confidentiality obligations in effect as of the Effective Date; provided, however, that each Party shall use Commercially Reasonable Efforts to (i) obtain audit rights for the other Party under such pre-existing agreements and (ii) ensure that such other Party is granted audit rights to the same extent which a Party has audit rights in any future agreements.

 

  (c)

any of the other Party’s records as may be reasonably necessary to verify the accuracy of any financial reports and calculations made under this Agreement, including the calculation of Free Cash Flow.

 

  (d)

Any audit and inspection of a Party’s records hereunder with respect to Free Cash Flow, Developments Costs or Commercialization Costs for a particular Calendar Year or Calendar Quarter shall be commenced within one year from the last day of such Calendar Year or Calendar Quarter, and shall be completed within four (4) months of commencement (provided the Party being audited reasonably responds to the requests for books and records by the auditing Party), and the cost of such audits shall be borne by the auditing Party.

 

7.5

Record Keeping . Each Party will maintain complete and accurate books, records and accounts used for the determination of Development Costs, Commercialization Costs, Allowable Expenses and Free Cash-Flow, in sufficient detail to confirm the accuracy of any payments required under this Agreement in accordance with Section  7.4 , which books, records and accounts will be retained by such Party for the number of years after the end of the period to which such books, records and accounts pertain, as is required by law.

ARTICLE 8

INTELLECTUAL PROPERTY

 

8.1

Inventorship.

 

  (a)

Cipla shall promptly disclose to the Company in writing any Inventions that are not specific to the Product, but created by it during the Term in connection with the Company’s iSPERSE ® technology (“ iSPERSE Inventions ”), and Cipla shall promptly assign any such iSPERSE Inventions created by Cipla to the Company and such iSPERSE Inventions are part of the Excluded Assets. Notwithstanding the foregoing, the

 

29


  Company shall own all rights, title, and interest in and to Inventions that are not specific to the Product and have general utility in connection with the Company’s iSPERSE ® technology (“ iSPERSE Inventions ”), and Cipla shall promptly assign any such iSPERSE Inventions created by or on behalf of Cipla to the Company.

 

  (b)

Cipla shall own all rights, title, and interest in and to Inventions created by either Party, past, present or future, related to the Product for the Pulmonary Indications and/or in respect of the Assigned Assets and the Company shall promptly disclose in writing and assign any such Inventions created by the Company to Cipla.

 

8.2

Patent Prosecution, Maintenance, and Enforcement.

 

  (a)

Subject to the right of the JSC to review, Cipla will make all decisions regarding the prosecution, maintenance, and enforcement, including any action against Third Parties for infringement, of the Patents included within the Assigned Assets (“ Assigned Patents ”) and any Patents included within the Excluded Assets that are licensed to Cipla hereunder on an exclusive basis, provided that such decision to (or not to) so prosecute, maintain or enforce is in compliance with the Commercialization Plan approved by the JSC.

 

  (b)

Cipla will submit a report regarding Assigned Patents by September 30 of every Calendar Year regarding costs and expenses incurred and damages and other amounts collected relating to any prosecution, maintenance, and enforcement of the Patents included within the Assigned Assets pursuant to this Section  8.2 and Section  8.4 . The JSC shall determine whether the costs and expenses towards Patent prosecution, maintenance and enforcement are in accordance with the approved Development Plan and/or Commercialization Plan. Any damages arising from such Assigned Patents shall be included as Commercialization Costs and/or Development Cost, as applicable, as determined by the JSC.

 

  (c)

With respect to Excluded Assets that are licensed to Cipla on a non-exclusive basis under this Agreement, subject to the right of the JSC to review, the Company will make all decisions regarding the prosecution, maintenance, and enforcement, including any action against Third Parties for infringement, of the Excluded Assets. The JSC shall determine whether the costs and expenses towards any such prosecution, maintenance and enforcement are in accordance with the approved Development Plan and/or Commercialization Plan. The Company will provide Cipla with reasonable advance notice of any decision not to prosecute, enforce or maintain any Excluded Asset in which Cipla has a license hereunder as not prejudice any rights of Cipla in such Excluded Asset.

 

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  (d)

The Company will submit a report regarding Excluded Assets in which Cipla has a license by September 30 of every Calendar Year regarding costs and expenses incurred and damages and other amounts collected relating to any prosecution, maintenance, and enforcement of the Excluded Assets in which Cipla has a license pursuant to this Section  8.2 and Section  8.4 to the extent related to the Product for Pulmonary Indications . The JSC shall determine whether the costs and expenses towards prosecution, maintenance and enforcement are in accordance with the approved Commercialization Plan. Any damages arising from such Excluded Assets to the extent related to the Product for Pulmonary Indications shall be included as Commercialization Costs and/or Development Costs, as applicable, as determined by the JSC.

 

8.3

Notification . The Parties shall promptly notify each other of any allegation that any: (i) information that a Third Party is violating any Intellectual Property Rights related to the Product; or (ii) allegation that any activity undertaken pursuant to this Agreement infringes, or may infringe, the Intellectual Property Rights of any Third Party. Each Party shall assist and cooperate with the other Party in the prosecution or defense of any Proceeding relating to the Intellectual Property Rights or the Product, as applicable (including consenting to being named as a party thereto if required for standing to enforce any of the Patents).

 

8.4

Infringement of Third-Party Rights . If a Third Party asserts that a Patent or other Intellectual Property Right owned or controlled by such Third Party is infringed by the Development and Commercialization activities hereunder, the Party first-obtaining knowledge of such a claim shall immediately provide the other Party Notice of such claim, along with the related facts in reasonable detail. Cipla, as the Commercializing Party, will, subject to JSC oversight, control the defense of any such claim or counterclaim. If Cipla does not accept control of the defense of such claim within ninety (90) days of learning of the claim, or earlier notifies Company in writing of its intent not to so assume control of such defense, then Company will have the right, but not the obligation, to defend against such claim; provided, however, that Cipla will, in such an event, have the right, at its own expense, to be represented in any such action by counsel of its own choice. Neither Party will settle any such suit admitting liability on the part of the other Party without the prior written consent of the Party not controlling such litigation, to the extent such settlement would result in material damage or prejudice to the non-controlling party. Any disagreement among the Parties with respect to the settlement of any such suit will be referred to the JSC for resolution.

 

8.5

Trademark. Cipla shall have the sole right to determine and own the trademark under which the Product is sold in the Territory, including Pulmazole . Cipla shall own all right, title, and interest to the trademarks used in relation to the Product, and shall be responsible for the registration, prosecution, and maintenance thereof. Following receipt of the Upfront Payment, the Company will file all necessary assignments with the U.S. Patent and Trademark Office (and all equivalent foreign offices) for the assignment of the Pulmazole trademark to Cipla. A list of all trademark registrations and applications is attached hereto as Exhibit IV.

 

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ARTICLE 9

REPRESENTATIONS; WARRANTIES; COVENANTS

 

9.1

No Representation of Success. Without limiting the Company’s obligations to perform its duties under this Agreement, Cipla understands that the Product is subject to ongoing Clinical Studies and Development and that the Company, accordingly, cannot make assurances whether it will be granted Regulatory Approval by the FDA or any other Regulatory Authority. Accordingly, the Company will not be liable for any unsuccessful Clinical Studies or denial or delay of Regulatory Approval. ALL CONFIDENTIAL INFORMATION DISCLOSED BY COMPANY TO CIPLA IS ACCURATE AND COMPLETE AND NO INFORMATION IS WITHHELD. COMPANY MAKES NO WARRANTIES, EXPRESS, IMPLIED OR OTHERWISE, REGARDING ASSURANCE OF SUCCESS OF THE DEVELOPMENT PROGRAM. Without limiting Cipla’s obligations to perform its duties under this Agreement, the Company understands that Cipla is not guaranteeing the successful Commercialization of the Product or that sales of the Products will result in any specific amount of Free Cash Flow.

 

9.2

Mutual Representations and Warranties. Each Party hereby represents and warrants to the other Party as follows, as of the Effective Date:

 

  (a)

Corporate Existence . The Party is a company or corporation, duly organized, validly existing, and in good standing under the Applicable Law of the jurisdiction in which it was incorporated or formed.

 

  (b)

Authority. The Party has taken all necessary action on its part and has the requisite power and authority to enter into this Agreement and to perform its respective obligations under this Agreement

 

  (c)

Binding Effect. Agreement has been duly executed and delivered on behalf of each Part, and constitutes a legal, valid, and binding obligation of such Party that is enforceable against it in accordance with its terms.

 

  (d)

No Conflict. The execution and delivery of this Agreement, the performance of such Party’s obligations hereunder and the assignments, licenses and Sublicenses to be granted pursuant to this Agreement (i) do not conflict with or violate any requirement of Applicable Law; (ii) do not conflict with or violate the certificate of incorporation, bylaws or other organizational documents of such Party; and (iii) do not conflict with, violate, breach or constitute a default under any contractual obligations of such Party or any of its Affiliates. To the Company’s knowledge, none of the Intellectual Property Rights or Trademarks, in each case in relation to the Product for Pulmonary Indications, infringe on the rights of any Third Parties.

 

  (e)

Other Rights. Neither the Party nor any of its Affiliates is a party to or otherwise bound by any oral or written contract or agreement that will result in any other Person obtaining any interest in, or that would give to any other Person any right to assert any claim in or with respect to, any of the other Party’s rights under this Agreement.

 

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  (f)

Consents. To the extent required, all necessary consents, approvals, and authorizations of all Governmental Authorities and other Persons that each Party was required to obtain in connection with this Agreement have been obtained.

 

  (g)

No Violation. Neither such Party nor any of its Affiliates is under any obligation to any Person, contractual or otherwise, that is in violation of the terms of this Agreement or that would impede the fulfillment of such Party’s obligations hereunder. The Company acknowledges and agrees that upon execution of the Agreement, no payments or liabilities or other obligations, in respect of the Product shall be owed or incurred by Cipla to any Third Party as a result of any obligation created by the Company.

 

  (h)

No Debarment. Each Party also represents that it is not debarred and that it does not knowingly use, in any capacity, in connection with the services to be performed under this Agreement, any Person who has been debarred or convicted of a crime pursuant to Section 306 of the FD&C Act, anti-bribery and anti-corruption laws, anti-terrorism and money laundering laws, data protection and privacy laws and/or under the provisions of any other Applicable Law.

 

  (i)

No Exclusion or Debarment under Federal Healthcare Laws or other equivalent laws in the Territory . Each Party represents and warrants that it is not, and each of its Affiliates performing activities hereunder are not, excluded from any federal healthcare program, or debarred from federal contracting under Federal Healthcare Laws or other equivalent laws in the Territory , and such Party will not, during the Term, employ or use the services of any person who is so excluded or debarred, or who has been convicted of or pled nolo contendere to (i) any felony; (ii) any federal or state legal violation (including misdemeanors) relating to prescription drug or device products or fraud; or (iii) any other crime that could cause an entity or person to be excluded or debarred.

 

  (j)

Liens. The Company represents and warrants that the Assigned Assets are not subject to any liens, security interests, mortgages or other adverse claims on title.

 

9.3

Mutual Covenants.

 

  (a)

Knowledge of Debarment or Exclusion . In the event that either Party becomes aware of the debarment, exclusion, or threatened debarment or exclusion, of any Person conducting activities on behalf of such Party under this Agreement, such Party shall promptly notify the other Party in writing.

 

  (b)

Healthcare Investigation . Each Party shall immediately notify the other Party of any healthcare investigation, reprimand, sanction, inspection, survey, demand for arbitration, lawsuit, charge, or conviction regardless of the Person against whom such action is brought or imposed that the other Party could, in its sole discretion, reasonably expect would cause a material adverse effect upon the operations of the Party receiving any healthcare investigation, reprimand, sanction, inspection, survey, demand for arbitration, lawsuit, charge, or conviction.

 

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  (c)

Compliance with Applicable Law . Each Party covenants that it will perform its obligations and exercise its rights pursuant to this Agreement in compliance with Applicable Law.

ARTICLE 10

INDEMNIFICATION

 

10.1

Indemnification by Company. Company shall defend, indemnify, and hold Cipla, its Affiliates, and their respective officers, directors, employees, and agents (the “ Cipla Indemnitees ”) harmless from and against any and all damages or losses or other amounts suffered by Cipla, or payable to a Third Party claimant, as well as any reasonable attorneys’ fees and costs of litigation incurred by such Cipla Indemnitees (collectively, “ Cipla Damages ”), all to the extent resulting from claims for damages or losses made by Cipla or, as the case may be, the claims, suits, proceedings or causes of action brought by such Third Party (“ Claims ”) against such Cipla Indemnitee that arise from or are based on: (a) a breach of any of Company’s representations, warranties, and obligations under this Agreement; (b) the willful misconduct or grossly negligent or intentional acts or omissions of Company, its Affiliates, or the officers, directors, employees, or agents of Company or its Affiliates in the performance of activities under this Agreement; (c) the research or Development of the Product by Company before the Effective Date; or (d) the Development, testing, manufacture, storage, handling, use, sale, offer for sale, distribution and importation of Products by Company or its Affiliates or licensees (excluding, for clarity, Cipla); or (e) owing to or arising from the iSPERSE technology; (f) third party claims of infringement of Intellectual Property Rights arising from use of the Assigned Assets by Cipla (for clarity, excluding Trademark infringement claims arising after the Effective Date) or in relation to the Company’s use of iSPERSE technology and other Excluded Assets, during the Term of this Agreement. The foregoing indemnity obligation does not apply if the Cipla Indemnitees materially fail to comply with the indemnification procedures set forth in Section  10.3 , or to the extent that such Claim is based on: (i) a breach of any of Cipla’s representations, warranties, and obligations under this Agreement; (ii) a Claim for which Cipla would be required to indemnify the Company pursuant to Section  10.2 or (iii) the willful misconduct or grossly negligent or intentional acts or omissions of Cipla or its Affiliates, or the officers, directors, employees, or agents of Cipla or its Affiliates, in the performance of activities under this Agreement.

 

10.2

Indemnification by Cipla. Cipla shall defend, indemnify, and hold Company, its Affiliates, and each of their respective officers, directors, employees, and agents, (the “ Company Indemnitees ”) harmless from and against any and all damages or losses or other amounts payable to the Company or a Third-Party claimant, as well as any reasonable attorneys’ fees and costs of litigation incurred by such Company Indemnitees (collectively, “ Company Damages ”), all to the extent resulting from any Claims made by the Company or any Claims against such Company Indemnitee that arise from or are based on: (a) the Commercialization, testing, manufacture, storage,

 

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  handling, use, sale, offer for sale, distribution and importation of Products by Cipla or its Affiliates, Sublicensees, or distributors, provided these are not attributable to any Intrinsic Defects in the Product (which are addressed in Section 10.4) or defects in or owing to iSPERSE technology; (b) a breach of any of Cipla’s representations, warranties, and obligations under the Agreement; (c) the willful misconduct or grossly negligent or intentional acts or omissions of Cipla or its Affiliates, or the officers, directors, employees, or agents of Cipla or its Affiliates in the performance of activities under this Agreement; or (d) Trademark infringement claims arising after the Effective Date. The foregoing indemnity obligation does not apply if the Company Indemnitees materially fail to comply with the indemnification procedures set forth in Section  10.3 , or to the extent that such Claim is based on: (i) a breach of any of Company’s representations, warranties, and obligations under this Agreement, (ii) a Claim for which the Company would be required to indemnify Cipla pursuant to Section  10.2 ; or (iii) the willful misconduct or grossly negligent or intentional acts or omissions of Company or its Affiliates, or the officers, directors, employees, or agents of Company or its Affiliates in the performance of activities under this Agreement.

 

10.3

Indemnification Procedures . The Party seeking indemnity under this Article 10 (the “ Indemnified Party ”) shall give written Notice to the Party from whom indemnity is being sought (the “ Indemnifying Party ”) promptly after learning of such Claim. The Indemnifying Party has the right to assume and conduct the defense of the Claim with counsel of its choice, and the Indemnified Party may participate in and monitor such defense with counsel of its own choosing at its sole expense. The Indemnified Party shall provide the Indemnifying Party with reasonable assistance, at the Indemnifying Party’s expense, in connection with the defense of the Claim for which indemnity is being sought. Each Party shall not settle or compromise any Claim without the prior written consent of the other Party, which consent will not be unreasonably withheld, delayed or conditioned, provided that a Party may settle if there is no admission of any liability by the other Party and if such settlement involves only monetary damages that such Party will pay. If the Parties cannot agree as to the application of the foregoing Sections 10.1 and 10.2 , each may conduct separate defenses of the Claim, and each Party reserves the right to seek indemnity from the other in accordance with this Article 10 upon the resolution of the underlying Claim.

 

10.4

Intrinsic Defect . Notwithstanding anything contained herein to the contrary, to the extent a Third Party Claim arises from any Intrinsic Defect, all Liabilities that are incurred by the Parties as a result of such Third Party Claim shall be equally shared between the Parties and shall be deemed part of the Allowable Expenses, if applicable.

 

10.5

Limitation of Liability . Except in the event of and to the extent of (a) damages awarded to a Third Party (i) in connection with the indemnification provisions set forth in this Section 10 or (ii) in connection with a suit concerning Intellectual Property Rights, (b) a breach of Applicable Law, Confidentiality (Section 11) or the Intellectual Property Rights of the other Party or the other Party’s Affiliates, and (c) damages arising from the gross negligence or willful misconduct or intentional act or omission or fraudulent acts or misrepresentation of a Party or its Affiliates, no Party or its Affiliates shall be liable to the other Party or its Affiliates for special, indirect, incidental or consequential damages (including, without limitation, lost profits to the extent constituting consequential damages), whether in contract, warranty, negligence, tort, strict liability or otherwise, arising out of this Agreement or the activities contemplated hereunder.

 

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ARTICLE 11

CONFIDENTIALITY

 

11.1

Confidentiality. During the Term and for a period of five (5) years after the Agreement’s Termination, each Party shall maintain all Confidential Information of the other Party in trust and confidence and shall not, without the written consent of the other Party, disclose any Confidential Information of the other Party to any Third Party or use any Confidential Information of the other Party for any purpose other than as necessary in connection with the exercise of rights or discharge of obligations under this Agreement. The confidentiality obligations of this Section  11.1 do not apply to Confidential Information to the extent that the receiving Party can establish by competent evidence that such Confidential Information: (a) is publicly known prior or subsequent to disclosure without breach of confidentiality obligations by such Party or its employees, consultants or agents; (b) was in such Party’s possession at the time of disclosure without any restrictions on further disclosure; (c) is received by such receiving Party, without any restrictions on further disclosure, from a Third Party who has the lawful right to disclose it; or (d) is independently developed by employees or agents of the receiving Party who had no access to the disclosing Party’s Confidential Information.

 

11.2

Authorized Disclosure. Nothing in this Agreement precludes a Party from disclosing the Confidential Information of the other Party to the extent:

 

  (a)

such disclosure is reasonably necessary (i) for the filing or prosecuting of Patents or other Intellectual Property Rights as contemplated by this Agreement; (ii) to comply with the requirement of Regulatory Authorities with respect to obtaining and maintaining Regulatory Approval (or any pricing and reimbursement approvals) of any Product; or (iii) for prosecuting or defending litigations as contemplated by this Agreement;

 

  (b)

such disclosure is reasonably necessary to its employees, agents, consultants, or subcontractors on a need-to-know basis for the sole purpose of performing its obligations or exercising its rights under this Agreement; provided that, in each case, the disclosees are bound by written obligations of confidentiality and non-use consistent with those contained in this Agreement;

 

  (c)

such disclosure is reasonably necessary to any bona fide potential or actual investor, acquirer, merger partner, or other financial or commercial partner for the sole purpose of evaluating an actual or potential investment, acquisition, or other business relationship, or any legal counsel for advice regarding this Agreement; provided that, in each case where the obligation does not already exist, the disclosees are bound by written obligations of confidentiality and non-use consistent with those contained in this Agreement;

 

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  (d)

such disclosure is reasonably necessary to comply with Applicable Law, including regulations promulgated by applicable security exchanges, a valid order of a court of competent jurisdiction, administrative subpoena or order. Each Party acknowledges that the other Party will be required to disclose the full text of this Agreement in its public filings with applicable securities exchanges.

Notwithstanding the foregoing, in the event a Party is required to make a disclosure of the other Party’s Confidential Information pursuant to this Section  11.2 , such Party shall promptly notify the other Party of such required disclosure and shall use reasonable efforts to obtain, or to assist the other Party in obtaining, a protective order preventing or limiting the required disclosure.

 

11.3

Return of Confidential Information. Promptly after the termination or expiration of this Agreement for any reason, each Party shall return to the other Party all tangible manifestations of such other Party’s Confidential Information at that time in the possession of the receiving Party, or with the disclosing Party’s authorization, the receiving Party shall destroy such Confidential Information and an officer of that Party will certify such destruction to the disclosing Party, provided that in all cases each Party may retain any electronic materials containing such Confidential Information in its archival backups provided they will be destroyed in due course at the same time as that Party’s other contemporaneous archival backups.

 

11.4

Publicity; Terms of the Agreement; Confidential Treatment.

 

  (a)

The Parties agree that the terms of this Agreement shall be considered Confidential Information of each Party, subject to the special authorized disclosure provisions set forth in Section  11.2 and this Section  11.4 .

 

  (b)

If either Party desires to make a public announcement concerning the material terms of this Agreement, such Party shall give reasonable prior Notice of the proposed text of such announcement to the other Party for its prior review and approval (except as otherwise provided herein), such approval not to be unreasonably withheld, conditioned or delayed. A Party commenting on such a proposed press release shall provide its comments, if any, within five (5) Business Days after receiving the press release for review. In addition, to the extent required by Applicable Law, including regulations promulgated by applicable security exchanges, each Party shall have the right to issue a press release announcing the achievement of each milestone under this Agreement as it is achieved, and the achievements of Regulatory Approvals as they occur, subject to the other Party’s consent as to form and substance of such announcement, which will not be unreasonably withheld, conditioned or delayed. In relation to the other Party’s review and approval of such an announcement, such other Party may make specific, reasonable comments on such proposed press release within the prescribed time for commentary but shall not withhold its consent to

 

37


  disclosure of the information that the relevant milestone has been achieved and triggered a payment hereunder. Neither Party is required to seek the permission of the other Party to repeat any information regarding the terms of this Agreement that has already been publicly disclosed by such Party, or by the other Party, in accordance with this Section  11.4 , provided such information remains accurate as of such time and contains no modification or additional information.

 

  (c)

In addition, the Parties acknowledge that either or both Parties may be obligated to file under applicable law and regulation a copy of this Agreement with the U.S. Securities and Exchange Commission or similar stock exchange authorities or other governmental authorities. Each Party is entitled to make such a required filing; provided , however , that it requests confidential treatment of the commercial terms and sensitive technical terms hereof and thereof to the extent such confidential treatment is reasonably available to such Party. In the event of any such filing, each Party shall provide the other Party with a copy of this Agreement marked to show provisions for which such Party intends to seek confidential treatment and shall reasonably consider and incorporate the other Party’s comments thereon to the extent consistent with the legal requirements, with respect to the filing Party, governing disclosure of material agreements and material information that must be publicly filed.

ARTICLE 12

TERM; TERMINATION

 

12.1

Term. This Agreement is effective as of the Effective Date and will continue in perpetuity (the “ Term ”).

 

12.2

Termination for Material Breach. At any time during the Term of this Agreement, should either Party (a “ Breaching Party ”) (i) materially breach this Agreement (and such material breach is not cured within thirty (30) days of written Notice of its occurrence from the non-breaching Party), (ii) engage in willful misconduct or gross negligence (as understood under the laws of the State of New York) in its performance of this Agreement or (iii) engaged in fraud in connection with the negotiation, execution or performance of this Agreement (collectively, (i) – (iii), “ Fundamental Breaches ”), the non-Breaching Party, may, at its option, terminate the Agreement by delivering a written Notice to the Breaching Party within ninety (90) days after the later of the occurrence of the Fundamental Breach or the expiration of any applicable cure period and (x) to the extent that the Company is the Breaching Party, Cipla shall acquire the Company’s interest in the Product for an amount equal to 25% of the Fair Market Value of the Product as such Fair Market Value may be determined by an independent Third-Party appraiser and (y) to the extent that Cipla is the breaching party, the Company shall acquire sole ownership/rights with respect to Cipla’s interest in the Product for an amount equal to 25% of the Fair Market Value of the Product as may be determined by an independent Third-Party appraiser.

 

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12.3

Insolvency or Bankruptcy. This Agreement shall automatically terminate if, at any time, a Party files a petition in bankruptcy, or enters an arrangement with its creditors, or applies for or consents to the appointment of a receiver or trustee, or makes an assignment for the benefit of creditors, or suffers or permits the entry of an order adjudicating it to be bankrupt or insolvent.

 

12.4

Intentionally Omitted.

 

12.5

Force Majeure Event Termination. If a force majeure event as described in Section 14.18 continues for a consecutive period of at least one hundred twenty (120) days, the Party affected may, upon notice to the other Party, terminate this Agreement, such termination to be effective thirty (30) days from the date of such notice.

 

12.6

Country by Country Termination. Upon written notice to the other Party, a Party shall be entitled to terminate this Agreement with respect to a specific country, on a country by country basis with a written notice of thirty (30) days under the following circumstances:

 

  12.6.1

If the Regulatory Authority in such country revokes or suspends the Regulatory Approval for such county or takes such other action that in the reasonable judgment of the JSC may adversely affect the Regulatory Approval in such country and/or Development and/or Commercialization in such country;

 

  12.6.2

The Product suffers any safety and/or quality issues, which is attributable to Intrinsic Defects in the Product or arising from Development of the Product, which involves additional Development Costs with respect to such country which is not commercially viable for the Party;

 

  12.6.3

Failure in Development of the Product in such country

 

  12.6.4

Failure to obtain Regulatory Approval in such country; or

 

  12.6.5

If there is any claim of infringement of Intellectual Property Rights against the Party filed by any Third Party in such country.

For clarity, if this Agreement is terminated with respect to a specific country under this Section 12.6, this Agreement shall continue in full force and effect with respect to each other country in the Territory.

 

12.7

Consequences of Termination . Expiration or termination of this Agreement for whatever reason shall not affect the liabilities or obligations of the Parties hereunder in respect of matters accrued at the time of such expiration or termination, and shall be without prejudice to any other right or remedies available at law or in equity. Upon the effective date of expiration of the Term or upon termination of this Agreement, the following consequences shall apply:

 

  12.7.1

Except as provided in Section 12.2, Cipla shall continue to own absolute and exclusive ownership of the Product, Assigned Assets and Intellectual Property Rights therein in Territory in perpetuity and shall be fully free to exploit them and/or Commercialize the Product in the Territory;

 

  12.7.2

Except as set forth in Section 12.2, Parties shall be entitled to all receivables of Free Cash-Flow pursuant to Commercialization of the Product until the date of termination of the Agreement;

 

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  12.7.3

All licenses and sub-licenses shall cease on the effective date of termination of the Agreement;

 

  12.7.4

Except as expressly permitted and agreed by the Parties herein, neither Party shall make any use whatsoever of the Confidential Information owned by the other Party and forthwith return and deliver to the other Party, any and all Confidential Information, documents, work in progress, complete and incomplete deliverables, disclosed or arising from this Agreement together with all original or copied documents relating to or in any way appertaining to the Confidential Information and/or Intellectual Property Rights relating to such Confidential Information;

 

12.8

Survival. Article 6 (Assignment of Rights), Article 7 (Compensation), Article 8 (Intellectual Property Rights), Article 9 (Representations and Warranties), Article 10 (Indemnification), Article 11 (Confidentiality), Article 12 (Termination), Article 13 (Dispute Resolution) and Article 14 (Miscellaneous), shall survive any expiry or earlier termination of the Agreement as per the terms therein or for a five year period or for such maximum period of time as allowed under the Applicable Law.

ARTICLE 13

DISPUTE RESOLUTION; FAIR MARKET VALUE

 

13.1

Disputes . The Parties recognize that disputes as to certain matters may from time to time arise that relate to either Party’s rights and/or obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in this Article 13 to resolve any controversy or claim arising out of, relating to or in connection with any provision of this Agreement, if and when a dispute arises under this Agreement.

 

13.2

Internal Resolution.   With respect to all disputes arising between the Parties under this Agreement, including any alleged breach of this Agreement or any issue relating to the interpretation or application of this Agreement, if the Parties are unable to resolve such dispute in the JSC within thirty (30) days after such dispute is first identified by either Party in writing to the other, or there is a deadlock in the JSC within the said period, the Parties shall refer such dispute to the Senior Executives for attempted resolution by good faith negotiations within thirty (30) days after such Notice is received, including at least one in-person meeting of the Senior Executives within twenty (20) days after such Notice is received. If the Senior Executives are not able to resolve such dispute referred to them within such thirty (30) day period, then Section  14.9 shall control.

 

13.3

Equitable Relief.  Nothing in this Article 13 will prevent either Party from seeking equitable or other relief in a court of competent jurisdiction, subject to the requirements of Section  14.9 .

 

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13.4

Fair Market Value . For all purposes of this Agreement, the JSC shall appoint the appraiser that determines Fair Market Value.

 

13.5

Waiver of Jury Trial. EACH PARTY ACKNOWLEDGES AND AGREES THAT ANY CONTROVERSY THAT MAY ARISE UNDER THIS AGREEMENT IS LIKELY TO INVOLVE COMPLICATED AND DIFFICULT ISSUES AND, THEREFORE, EACH SUCH PARTY IRREVOCABLY AND UNCONDITIONALLY WAIVES ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT OF ANY LEGAL ACTION ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY. EACH PARTY TO THIS AGREEMENT CERTIFIES AND ACKNOWLEDGES THAT (A) NO REPRESENTATIVE OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT SEEK TO ENFORCE THE FOREGOING WAIVER IN THE EVENT OF A LEGAL ACTION; (B) SUCH PARTY HAS CONSIDERED THE IMPLICATIONS OF THIS WAIVER; (C) SUCH PARTY MAKES THIS WAIVER VOLUNTARILY; AND (D) SUCH PARTY HAS NOT BEEN INDUCED TO ENTER INTO THIS AGREEMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 13.5 .

ARTICLE 14

MISCELLANEOUS

 

14.1

Notices. All notices, requests, consents, claims, demands, waivers, and other communications hereunder (each, a “ Notice ”) must be in writing and will be deemed to have been given: (i) when delivered by hand (with written confirmation of receipt); (ii) when received by the addressee if sent by a nationally recognized overnight courier (return receipt requested); (iii) on the date sent by facsimile or email (with confirmation of transmission) if sent during normal business hours of the recipient, and on the next Business Day if sent after normal business hours of the recipient; or (iv) on the third day after the date mailed, by certified or registered mail (in each case, return receipt requested, postage pre-paid). Notices must be sent to the respective Parties at the following addresses (or at such other address for a Party as may be specified in a Notice given in accordance with this Section  14.1 .

 

  If to Company:

Pulmatrix, Inc.

99 Hayden Ave.

Suite 390

Lexington, MA 02421

Facsimile: [Include facsimile number]

traad@pulmatrix.com

Attention: Ted Raad, Chief Business Officer

 

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With a copy to (which will not constitute Notice):

Haynes and Boone, LLP

30 Rockefeller Plaza

26th Floor

New York, NY 10112

Facsimile: (212) 884-9568

greg . kramer@haynesboone.com

Attention: Rick A. Werner and Greg Kramer

 

  If to Cipla:

Cipla Technologies, LLC

1156 Sorrento Valley Rd.

San Diego, CA 92121

Facsimile: [Include facsimile number]

ajay.luharuka@Cipla.com

Attention: Ajay Luharuka, Chief Financial Officer

With a copy to (which will not constitute Notice):

Mr. AS Kumar, Esq.

Global General Counsel

Cipla House, Peninsula Business Park,

Ganpatrao Kadam Marg, Lower Parel,

Mumbai 400013, India

Facsimile: [Include facsimile number]

as.kumar@cipla.com

 

14.2

No Strict Construction; Headings; Interpretation. This Agreement has been prepared jointly by the Parties and will not be strictly construed against either Party. Ambiguities, if any, in this Agreement will not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision. The headings of each Article and Section in this Agreement have been inserted for convenience of reference only and are not intended to limit or expand on the meaning of the language contained in the particular Article or Section. For purposes of this Agreement, (i) the words “include,” “includes,” and “including” will be deemed followed by the phrase “without limitation,” regardless of whether it is actually included and drawing no implication from the actual inclusion of such phrase in some instances but not others;” (ii) the word “or” is not exclusive; and (iii) the words “herein,” “hereof,” “hereby,” “hereto,” and “hereunder” refer to this Agreement as a whole; (iv) references to sections, schedules, and exhibits mean the sections of, and schedules and exhibits attached to, this Agreement; (v) references to another agreement, instrument, or other document means such agreement, instrument, or other document as amended, supplemented, and modified from time to time to the extent permitted by the provisions thereof; and (vi) references to a statute means such statute as amended from time to time and includes any successor legislation thereto and any regulations promulgated thereunder.

 

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14.3

Assignment; Successors and Assigns. Neither Party shall assign or otherwise transfer this Agreement, or any right or obligation hereunder to any Third Party, without the prior written consent of the other Party. However, the Parties shall be free to assign or otherwise transfer all its rights and obligations under this Agreement to its Affiliates without the prior written consent of the other Party. This Agreement shall enure to the benefit of assigns and successors of the respective Parties.

 

14.4

Performance by Affiliates. Each Party may discharge any obligations and exercise any right under this Agreement through any of its Affiliates. Each Party guarantees the performance by its Affiliates of such Party’s obligations under this Agreement and shall cause its Affiliates to comply with the provisions of this Agreement in connection with such performance. Any breach by a Party’s Affiliate of any of such Party’s obligations under this Agreement will be deemed a breach by such Party, and the other Party may proceed directly against such Party without any obligation to first-proceed against such Party’s Affiliate.

 

14.5

Further Actions and Assurances. Each Party agrees to execute, acknowledge, and deliver such further instruments, and to do all such other acts, as may be necessary or appropriate to carry out the purposes and intent of this Agreement.

 

14.6

Severability. If any competent court finds any provision of this Agreement to be invalid, illegal, or unenforceable, then such provision will be construed, to the extent feasible, so as to render the provision valid, legal, and enforceable, and if no feasible interpretation would save such provision, it will be severed from the remainder of this Agreement. The remainder of this Agreement will remain in full force and effect, unless the severed provision is essential and material to the rights or benefits received by either Party. In such event, the Parties shall negotiate, in good faith, and substitute a valid and enforceable provision or agreement that most nearly implements the Parties’ intent in entering into this Agreement.

 

14.7

No Waiver. No provision of this Agreement can be waived except by the express written consent of the Party waiving compliance. No waiver by any Party shall operate or be construed as a waiver in respect of any failure, breach, or default not expressly identified by such written waiver, whether of a similar or different character, and whether occurring before or after that waiver. No failure to exercise, or delay in exercising, any right, remedy, power, or privilege arising from this Agreement will operate or be construed as a waiver thereof; nor will any single or partial exercise of any right, remedy, power, or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, remedy, power, or privilege.

 

14.8

Independent Contractors. For all purposes under this Agreement, Company and Cipla, and their respective Affiliates, are independent contractors with respect to each other, and will not be deemed to be employee, agent, partner, or legal representative of the other Party. This Agreement does not grant any Party or its employees, consultants, or agents any authority (express or implied) to do any of the following without the prior express written consent of the other Party: create or assume any obligation; enter into any agreement; make any representation or warranty; serve or accept legal process on behalf of the other Party; settle any claim by or against the other Party; or bind or otherwise render the other liable in any way. For the avoidance of doubt, nothing in this Agreement will be construed to create a joint venture or partnership between the Parties.

 

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14.9

Governing Law. This Agreement will be governed by and construed in accordance with the laws of Delaware without regard to conflicts of laws principles. The Parties irrevocably agree that any dispute arising out of or in connection with this Agreement (a “ Dispute ”) that is not resolved by the Senior Executives within thirty (30) days will be referred to, and finally and exclusively settled by, arbitration under the Delaware Rapid Arbitration Act (the “ DRAA ,” 10 Del. C. § 5801 et seq.) and the Delaware Rapid Arbitration Rules promulgated thereunder by the Supreme Court of the State of Delaware (“ Rules ”) in effect at the time of the date of delivery of the notice of arbitration, which are incorporated into, and made a part of, this Agreement. The Parties accordingly agree to submit to the DRAA and the Rules. The seat of arbitration will be Wilmington, Delaware and conducted by a sole arbitrator in English language appointed in accordance with the DRAA and the Rules.

 

14.10

Counterparts. This Agreement may be executed in two or more counterparts, each of which is an original but all of which, together, constitutes the same legal instrument. Any party’s executed copy and delivery of this Agreement by facsimile or PDF will constitute a legal, valid, and binding execution and delivery of this Agreement by such Party. The Parties agree that a copy of the original signature (including an electronic copy) may be used for any and all purposes for which the original signature may have been used. The Parties agree they will have no rights to challenge the use or authenticity of this document based solely on the absence of an original signature.

 

14.11

Expenses. All costs and expenses incurred in connection with entering this Agreement and the transactions contemplated hereby will be paid by the Party incurring such costs and expenses unless otherwise set forth in this Agreement.

 

14.12

Attorneys’ Fees. In the event that any Party institutes any legal suit, action, or proceeding, including arbitration, against the other Party to enforce the covenants contained in this Agreement (or obtain any other remedy in respect of any alleged breach of this Agreement)/arising out of or relating to this Agreement, the prevailing Party in the suit, action, or proceeding will be entitled to receive, in addition to all other damages to which it may be entitled, the costs incurred by such Party in conducting the suit, action, or proceeding, including reasonable attorneys’ fees and expenses and court costs.

 

14.13

Public Announcements. Unless otherwise required by Applicable Law, including stock exchange requirements (based upon the reasonable advice of counsel), no Party to this Agreement shall make any public announcements in respect of this Agreement or the transactions contemplated hereby or otherwise communicate with any news media without the prior written consent of the other Party (which consent may not be unreasonably withheld, conditioned, or delayed), and the Parties shall cooperate as to the timing and contents of any such announcement. Cipla acknowledges that the Company will be required to disclose the full text of this Agreement in its public filings with the U.S. Securities and Exchange Commission.

 

14.14

Cumulative Remedies. The rights and remedies under this Agreement are cumulative and are in addition to and not in substitution for any other rights and remedies available at law or in equity or otherwise.

 

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14.15

Equitable Remedies. Each Party acknowledges that a breach or threatened breach by such Party of any of its obligations under this Agreement, including those of Article 11 , would give rise to irreparable harm to the other Party for which monetary damages would not be an adequate remedy and agrees that in the event of a breach or a threatened breach by such Party of any such obligations, the other Party will, in addition to any and all other rights and remedies that may be available to it in respect of such breach, be entitled to equitable relief, including a temporary restraining order, injunction, specific performance, and any other relief that may be available from a court of competent jurisdiction (without any requirement to post bond).

 

14.16

No Third-Party Beneficiaries. This Agreement is for the sole benefit of the Parties and their respective successors and permitted assigns and nothing in this Agreement, express or implied, is intended to or will confer upon any other Person or entity any legal or equitable right, benefit, or remedy of any nature whatsoever.

 

14.17

Entire Agreement; Supersession; Amendment. This Agreement sets forth the complete, final, and exclusive Agreement between the Parties. As of the Effective Date, this Agreement supersedes all prior agreements and understandings between the Parties, whether written or oral, with respect to the subject matter hereof. In the event of any inconsistency between any plan hereunder (including the Development Plan or Commercialization Plan) and this Agreement, the terms of this Agreement will govern and control. There are no covenants, promises, agreements, warranties, representations, conditions, or understandings, either oral or written, between the Parties other than as are set forth herein. No subsequent alteration, amendment, change, or addition to this Agreement will be binding upon the Parties unless reduced to writing and signed by an authorized representative of each Party.

 

14.18

Force Majeure. A Party will be excused from the performance of its obligations (other than the payment of any amount owed under this Agreement) under this Agreement to the extent that such performance is prevented by force majeure events or circumstances, provided that the nonperforming Party promptly provides Notice of the force majeure events or circumstances to the other Party referencing this Section  14.18 . Such excuse will continue so long as the condition constituting the force majeure continues and the nonperforming Party takes reasonable efforts to remove the condition. For purposes of this Agreement, force majeure includes conditions beyond the reasonable control of the affected Party, including without limitation, an act of God, war, civil commotion, terrorist act, general labor strike or lock-out, epidemic, failure or default of public utilities or common carriers, destruction of production facilities or materials by fire, earthquake, storm or like catastrophe, and failure of plant or machinery (provided that such failure could not have been prevented by the exercise of skill, diligence, and prudence that would be reasonably and ordinarily expected from a skilled and experienced person engaged in the same type of undertaking under the same or similar circumstances).

 

14.19

Exclusivity . Other than the Product, neither Party nor its respective Affiliates will, individually or jointly with any Third Parties, directly or indirectly, Develop or Commercialize any inhaled anti-fungal product containing Itracanazole for the treatment of Pulmonary Indications For clarity, except as provided in the preceding sentence, either Party shall be entitled to independently continue its own Development program for any inhaled anti-fungal product for Pulmonary Indications.

 

45


14.20

Change in Control. In the event of Change in Control of a Party, such Party shall promptly inform the other Party of such change in Control in a written Notice, in any event not later than thirty (30) days prior to the consummation of such Change of Control.

 

14.21

Tax. All amounts mentioned in this Agreement are exclusive of VAT and other applicable taxes. Cipla shall make all payments from a bank account in the United States to the Company under this Agreement without deduction or withholding for taxes, except to the extent that any such deduction or withholding is required by Applicable Law in effect at the time of payment. As of the Effective Date, Cipla does not intend to withhold. Any tax required to be withheld on amounts payable under this Agreement shall promptly be paid by Cipla on behalf of the Company to the appropriate governmental authority, and Cipla shall furnish the Company with proof of payment of such tax. Any such tax required to be withheld will be borne by the Company. Each Party will cooperate with respect to all documentation required by any taxing authority or reasonably requested by Cipla in relation to this Agreement.

[Signature Page Follows]

 

46


The Parties have executed this Agreement as of the Effective Date.

 

PULMATRIX, INC.     CIPLA TECHNOLOGIES, LLC
By:  

/s/ Robert Clarke

    By:  

/s/ Vikram Sudarsan

Name:  

Robert Clarke

    Name:  

Vikram Sudarsan

Title:  

Chief Executive Officer

    Title:  

CEO

 

 

47

Exhibit 31.1

CERTIFICATIONS UNDER SECTION 302

I, Teofilo Raad, certify that:

 

1.

I have reviewed this Quarterly Report on Form 10-Q of Pulmatrix, Inc.;

 

2.

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

 

3.

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

 

4.

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

 

  a)

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

 

  b)

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

 

  c)

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

 

  d)

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

 

5.

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

 

  a)

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

 

  b)

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

 

Date: August 5, 2019
/s/ Teofilo Raad
Teofilo Raad
President and Chief Executive Officer
(Principal Executive Officer)

Exhibit 31.2

CERTIFICATIONS UNDER SECTION 302

I, William Duke, Jr., certify that:

 

1.

I have reviewed this Quarterly Report on Form 10-Q of Pulmatrix, Inc.;

 

2.

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

 

3.

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

 

4.

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

 

  a)

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

 

  b)

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

 

  c)

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

 

  d)

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

 

5.

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

 

  a)

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

 

  b)

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

 

Date: August 5, 2019
/s/ William Duke, Jr.
William Duke, Jr.

Chief Financial Officer

(Principal Financial Officer)

Exhibit 32.1

CERTIFICATIONS UNDER SECTION 906

Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), each of the undersigned officers of Pulmatrix, Inc., a Delaware corporation (the “Company”), does hereby certify, to such officer’s knowledge and in the capacity of an officer, that:

The Quarterly Report for the quarter ended June 30, 2019 (the “Form 10-Q”) of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, and the information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results of operations of the Company as of, and for, the periods presented in the Form 10-Q.

 

Date: August 5, 2019    

/s/ Teofilo Raad

    Teofilo Raad
    President and Chief Executive Officer
    (Principal Executive Officer)
Date: August 5, 2019    

/s/ William Duke, Jr.

    William Duke, Jr.
    Chief Financial Officer
    (Principal Financial Officer)