Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM 10-Q

 

 

 

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

For the quarterly period ended March 31, 2015

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 1-10352

 

 

JUNIPER PHARMACEUTICALS, INC.

(Exact name of Registrant as specified in its charter)

 

 

 

Delaware   59-2758596

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

4 Liberty Square

Boston, Massachusetts

  02109
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (617) 639-1500

 

 

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

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

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

 

Large accelerated filer   ¨    Accelerated filer   ¨
Non-accelerated filer   x   (Do not check if a smaller reporting company)    Smaller reporting company   ¨

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

The number of shares outstanding of the registrant’s common stock as of April 30, 2015: 10,775,101.

 

 

 


Table of Contents

Juniper Pharmaceuticals, Inc.

Table of Contents

 

         Page  
Part I—Financial Information   
Item 1.  

Financial Statements (unaudited)

  
 

Consolidated Balance Sheets as of March 31, 2015 and December 31, 2014

     3   
 

Consolidated Statements of Operations for the three month periods ended March 31, 2015 and 2014

     4   
 

Consolidated Statements of Comprehensive (Loss) Income for the three month periods ended March  31, 2015 and 2014

     5   
 

Consolidated Statements of Cash Flows for the three month periods ended March 31, 2015 and 2014

     6   
 

Notes to Consolidated Financial Statements (unaudited)

     7   
Item 2.  

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

     18   
Item 3.  

Quantitative and Qualitative Disclosures About Market Risk

     26   
Item 4.  

Controls and Procedures

     26   
Part II—Other Information   
Item 1.  

Legal Proceedings

     27   
Item 1A.  

Risk Factors

     27   
Item 6.  

Exhibits

     28   

Signatures

     29   

 

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Juniper Pharmaceuticals, Inc.

Consolidated Balance Sheets

(in thousands, except per share data)

 

     March 31,
2015
    December 31,
2014
 
     (unaudited)        

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 16,301      $ 16,762   

Accounts receivable, net

     4,803        5,289   

Inventories

     3,333        3,201   

Prepaid expenses and other current assets

     1,684        1,134   
  

 

 

   

 

 

 

Total current assets

  26,121      26,386   

Property and equipment, net

  12,269      13,041   

Intangible assets, net

  1,958      2,182   

Goodwill

  10,031      10,503   

Other assets

  91      96   
  

 

 

   

 

 

 

Total assets

$ 50,470    $ 52,208   
  

 

 

   

 

 

 

Liabilities and Shareholders’ Equity

Current liabilities:

Accounts payable

$ 2,520    $ 2,873   

Accrued expenses

  2,203      1,918   

Deferred revenue

  862      914   

Notes payable

  233      243   
  

 

 

   

 

 

 

Total current liabilities

  5,818      5,948   

Deferred revenue, net of current portion

  1,305      1,553   

Notes payable, net of current portion

  3,083      3,289   
  

 

 

   

 

 

 

Total liabilities

  10,206      10,790   
  

 

 

   

 

 

 

Commitments and contingencies

Contingently redeemable series C preferred stock, 0.55 shares issued and outstanding (liquidation preference of $550)

  550      550   
  

 

 

   

 

 

 

Shareholders’ equity:

Preferred stock, $0.01 par value; 1,000 shares authorized Series B convertible preferred stock, 0.13 shares issued and outstanding (liquidation preference of $13)

  —       —    

Common stock $0.01 par value; 150,000 shares authorized; 12,186 issued and 10,775 outstanding at March 31, 2015 and 12,186 issued and 10,775 outstanding at December 31, 2014

  122      122   

Additional paid-in capital

  288,185      287,660   

Treasury stock (at cost), 1,411 shares at March 31, 2015

  (8,579   (8,579

Accumulated deficit

  (238,964   (238,272

Accumulated other comprehensive loss

  (1,050   (63
  

 

 

   

 

 

 

Total shareholders’ equity

  39,714      40,868   
  

 

 

   

 

 

 

Total liabilities and shareholders’ equity

$ 50,470    $ 52,208   
  

 

 

   

 

 

 

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

 

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Juniper Pharmaceuticals, Inc.

Consolidated Statements of Operations

(in thousands, except per share data)

(unaudited)

 

    

Three Months Ended

March 31,

 
     2015     2014  

Revenues

    

Product revenues

   $ 4,875      $ 3,294   

Product revenues from related party

     —          167  

Service revenues

     2,460        2,478   

Royalties

     991        363   

Royalties from related party

     —          714   
  

 

 

   

 

 

 

Total revenues

  8,326      7,016   

Cost of product revenues

  3,112      2,426   

Cost of service revenues

  1,766      1,846   
  

 

 

   

 

 

 

Total cost of revenues

  4,878      4,272   

Gross profit

  3,448      2,744   

Operating expenses

Sales and marketing

  321      401   

Research and development

  1,384      —     

General and administrative

  2,574      2,451   
  

 

 

   

 

 

 

Total operating expenses

  4,279      2,852   

Loss from operations

  (831   (108
  

 

 

   

 

 

 

Interest expense, net

  (27   (34

Change in fair value of common stock warrant liability

  —        309   

Other income (expense), net

  171      (3
  

 

 

   

 

 

 

Total non-operating income

  144      272   

(Loss) Income before income taxes

  (687   164   

Provision for income taxes

  5      12   
  

 

 

   

 

 

 

Net (loss) income

$ (692 $ 152   
  

 

 

   

 

 

 

Basic net (loss) income per common share

$ (0.06 $ 0.01   
  

 

 

   

 

 

 

Diluted net loss per common share

$ (0.06 $ (0.01
  

 

 

   

 

 

 

Basic weighted average common shares outstanding

  10,752      11,739   
  

 

 

   

 

 

 

Diluted weighted average common shares outstanding

  10,752      11,764   
  

 

 

   

 

 

 

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

 

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Juniper Pharmaceuticals, Inc.

Consolidated Statements of Comprehensive (Loss) Income

(in thousands)

(unaudited)

 

     Three Months Ended
March 31,
 
     2015     2014  

Net (loss) income

   $ (692   $ 152   

Other comprehensive (loss) income components:

    

Foreign currency translation

     (987     206   
  

 

 

   

 

 

 

Total other comprehensive (loss) income

  (987   206   
  

 

 

   

 

 

 

Comprehensive (loss) income

$ (1,679 $ 358   
  

 

 

   

 

 

 

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

 

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Juniper Pharmaceuticals, Inc.

Consolidated Statements of Cash Flows

(in thousands)

(unaudited)

 

     Three Months Ended
March 31,
 
     2015     2014  

Operating activities:

    

Net (loss) income

   $ (692   $ 152   

Reconciliation of net income to net cash (used in) provided by operating activities:

    

Depreciation and amortization

     523        448   

Change in fair value of common stock warrant liability

     —          (309

Stock-based compensation expense

     532        164   

Deferred income taxes

     —          7  

Changes in operating assets and liabilities:

    

Accounts receivable

     353        224   

Due from related party

     —          900   

Inventories

     (130     178   

Prepaid expenses and other current assets

     (564     (428

Other non-current assets

     5       (2

Accounts payable

     (343     373   

Accrued expenses

     331        (605

Deferred revenue

     (191     (218
  

 

 

   

 

 

 

Net cash (used in) provided by operating activities

  (176   884   

Investing activities:

Purchases of property and equipment

  (168   (799
  

 

 

   

 

 

 

Net cash used in investing activities

  (168   (799

Financing activities:

Proceeds from exercise of common stock options

  —        12   

Purchase of treasury stock

  —        (8,509

Principal payments on notes payable

  (59   (58

Dividends paid

  (7   (7
  

 

 

   

 

 

 

Net cash used in financing activities

  (66   (8,562

Effect of exchange rate changes on cash and cash equivalents

  (51   5   
  

 

 

   

 

 

 

Net decrease in cash and cash equivalents

  (461   (8,472

Cash and cash equivalents, beginning of period

  16,762      20,715   
  

 

 

   

 

 

 

Cash and cash equivalents, end of period

$ 16,301    $ 12,243   
  

 

 

   

 

 

 

Supplemental cash flow information

Cash paid for interest

$ 25    $ 34   
  

 

 

   

 

 

 

Cash paid for income taxes

$ 2    $ 3   
  

 

 

   

 

 

 

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

 

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Juniper Pharmaceuticals, Inc.

Notes to Consolidated Financial Statements

(Unaudited)

(1) Interim Consolidated Financial Statements

The accompanying unaudited interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) for interim information and pursuant to the rules and regulations of the Securities and Exchange Commission (the “SEC”) for reporting on Form 10-Q. Accordingly, certain information and footnote disclosures required for complete financial statements are not included herein. It is recommended that these financial statements be read in conjunction with the consolidated financial statements and related notes that appear in the Annual Report on Form 10-K of Juniper Pharmaceuticals, Inc. (formerly Columbia Laboratories, Inc.) (“Juniper” or the “Company”) for the year ended December 31, 2014 filed with the SEC on March 18, 2015, (the “2014 Annual Report”). In the opinion of management, all adjustments (consisting only of normal recurring adjustments) necessary for the fair presentation of the consolidated financial information for the interim periods reported have been made. Results of operations for the three months ended March 31, 2015 are not necessarily indicative of the results for the year ending December 31, 2015 or any period thereafter.

In April 2015, the Company changed its name from Columbia Laboratories, Inc. to Juniper Pharmaceuticals, Inc. In addition, the Company’s subsidiary formerly known as Molecular Profiles Ltd. changed its name to Juniper Pharma Services Ltd.

Revision of Prior Interim Period Financial Statements

During the fourth quarter of 2014, the Company identified errors relating to the recognition of revenue for certain services transactions and contractual arrangements during 2014. Specifically, the Company determined that certain service revenues were recorded in the incorrect periods within 2014 and that revenue for certain services transactions was recognized outside the conditions required for revenue recognition under the Company’s accounting policies. The Company determined that, under U.S. GAAP rules, $0.2 million of its first quarter revenues for 2014 should not have been recognized.

The Company assessed the effect of the revisions, individually and in the aggregate, on its prior interim periods financial statements in accordance with the SEC’s Staff Accounting Bulletins No. 99 – Materiality and 108 – Considering the Effects of Prior Period Misstatements when Quantifying Misstatements in Current Year Financial Statements. Based on an analysis of quantitative and qualitative factors, the Company determined that its prior interim period financial statements for 2014 needed to be revised and provided such revised financial information in its 2014 Form 10-K. See Note 2 of the 2014 Form 10-K.

The first quarter 2014 numbers have been adjusted to reflect these adjustments.

Management Estimates

The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures at the date of the financial statements during the reporting period. Significant estimates are used for, but are not limited to revenue recognition, allowance for doubtful accounts, inventory reserve, impairment analysis of goodwill and intangibles including their useful lives, deferred tax assets, liabilities and valuation allowances, common stock warrant valuations, and fair value of stock options. On an ongoing basis, management evaluates its estimates. Actual results could differ from those estimates.

(2) Inventories

Inventories are stated at the lower of cost (first-in, first-out) or market. Components of inventory cost include materials, labor and manufacturing overhead. Inventories consist of the following (in thousands):

 

     March 31,
2015
     December 31,
2014
 

Raw materials

   $ 628       $ 761   

Work in process

     1,641         1,095   

Finished goods

     1,064         1,345   
  

 

 

    

 

 

 

Total

$ 3,333    $ 3,201   
  

 

 

    

 

 

 

 

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(3) Goodwill and Intangible Assets

Changes to goodwill during the three months ended March 31, 2015 were as follows (in thousands):

 

     Total  

Balance—December 31, 2014

   $ 10,503   

Effects of foreign currency translation

     (472
  

 

 

 

Balance—March 31, 2015

$ 10,031   
  

 

 

 

 

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Intangible assets consist of the following at March 31, 2015 and December 31, 2014 (in thousands):

 

     Trademark      Developed
Technology
     Customer
Relationships
     Total  

Gross carrying amount—March 31, 2015

   $ 300       $ 1,370       $ 1,240       $ 2,910   

Translation adjustment

     (18      (81      (73      (172

Accumulated amortization

     (145      (378      (257      (780
  

 

 

    

 

 

    

 

 

    

 

 

 

Balance—March 31, 2015

$ 137    $ 911    $ 910    $ 1,958   
  

 

 

    

 

 

    

 

 

    

 

 

 

 

     Trademark      Developed
Technology
     Customer
Relationships
     Total  

Gross carrying amount—December 31, 2014

   $ 300       $ 1,370       $ 1,240       $ 2,910   

Translation adjustment

     (5      (20      (18      (43

Accumulated amortization

     (127      (333      (225      (685
  

 

 

    

 

 

    

 

 

    

 

 

 

Balance—December 31, 2014

$ 168    $ 1,017    $ 997    $ 2,182   
  

 

 

    

 

 

    

 

 

    

 

 

 

Amortization expense related to the developed technology is classified as a component of cost of service revenues in the accompanying consolidated statements of operations. Amortization expense related to trademark and customer relationships is classified as a component of general and administrative expenses in the accompanying consolidated statements of operations.

Amortization expense for the three months ended March 31, 2015 and 2014 was $0.1 million in both periods. As of March 31, 2015, amortization expense on existing intangible assets for the next five years and beyond is as follows (in thousands):

 

Year ending December 31,

   Total  

Remainder of 2015

   $ 356   

2016

     437   

2017

     347   

2018

     318   

2019

     288   

2020 and thereafter

     212   
  

 

 

 

Total

$ 1,958   
  

 

 

 

(4) Debt and other Contractual Obligations

In September 2013, Juniper assumed debt of $3.9 million in connection with its acquisition of Juniper Pharma Services (formerly Molecular Profiles Ltd.). Juniper Pharma Services had entered into a Business Loan Agreement (“Loan Agreement”) covering three loan facilities with Lloyds TSB Bank (“Lloyds”), as administrative agent. Juniper Pharma Services had drawn down $3.9 million under the Loan Agreement and as of March 31, 2015 owed $3.3 million. The three loan facilities are each repayable in monthly installments, one started repayment in February 2013 and the remaining two commenced in October 2013. All facilities are due for repayment over 15 years from the date of drawdown. Two of the facilities bear interest at the Bank of England’s base rate plus 1.95% and 2.55%, respectively. The interest rate at March 31, 2015 for these two facilities was 2.45% and 3.05%, respectively. The third facility is a fixed rate agreement bearing interest at 3.52% per annum. The weighted average interest rate for the three loan facilities for the three months ended March 31, 2015 was 3.00%. The Loan Agreement is secured by the mortgaged property and an unlimited lien on other assets of Juniper Pharma Services. The Loan Agreement contains financial covenants that limit the amount of indebtedness Juniper Pharma Services may incur, requires Juniper Pharma Services to maintain certain levels of net worth, and restricts Juniper Pharma Service’s ability to materially alter the character of its business. As of March 31, 2015, Juniper Pharma Services is in compliance with all of the covenants under the Loan Agreement.

 

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Juniper assumed a $2.5 million obligation under a grant arrangement with the Regional Growth Fund on behalf of the Secretary of State for Business, Innovation, and Skills in the United Kingdom. Juniper Pharma Services used this grant to fund the expansion of its facility. As part of the arrangement, Juniper Pharma Services is required to create and maintain certain full-time equivalent personnel levels through October 2017. As of March 31, 2015, the Company is in compliance with the covenants of the arrangement.

The Regional Growth Fund obligation is recognized in the other income (expense), net line item in the consolidated statement of operations and is recognized on a decelerated basis over the obligation period through October 2017. As of March 31, 2015, the obligation is valued at $1.9 million and is recorded as deferred revenue on the consolidated balance sheets. The amount of other income on the obligation that will be recognized provided the Company remains in compliance with the covenants will be the following (in thousands):

 

Year

   Total  

Remainder of 2015

   $ 415   

2016

     772   

2017

     712   
  

 

 

 

Total

$ 1,899   
  

 

 

 

(5) Intra-Vaginal Ring Technology Licensing

In March 2015, the Company licensed exclusive worldwide rights (“License Agreement”) to a proprietary intra-vaginal ring (“IVR”) technology. Due to a novel polymer composition and segmentation capability, the IVR has the ability to deliver drugs, including larger molecules such as peptides, at different dosages and release rates within a single segmented ring. This technology was developed by Dr. Robert Langer from the Massachusetts Institute of Technology and Dr. William Crowley from Massachusetts General Hospital and Harvard Medical School. Drs. Langer and Crowley have each agreed to serve a three-year term as strategic advisors to the Company in exchange for an upfront one-time payment plus quarterly fees and equity compensation.

Juniper has agreed to incur minimum annual expenditures to develop products using the vaginal ring technology, and will make milestone-based payments to MGH/MIT when various stages of product development and commercialization are achieved. The Company will also share a portion of any royalties or sublicense revenues received from products utilizing the IVR technology with MGH and MIT.

Juniper has the right to terminate the License Agreement by giving 90 days advance written notice to the Licensor. The Licensor has the right to terminate the License Agreement based on Juniper’s failure to make payments due under the License Agreement, subject to a 15 day cure period, or Juniper’s failure to maintain the insurance required by the license Agreement. The Licensor may also terminate the License Agreement based on Juniper’s non-financial default under the License Agreement, subject to a 60 day cure period.

(6) Segments and Geographic Information

The Company currently operates in two segments: product and service. The product segment oversees the supply chain management including the manufacturing of CRINONE, the Company’s sole commercialized product. The product segment also includes the royalty stream the Company receives from Actavis for CRINONE sales in the United States. The service segment includes pharmaceutical development, clinical trial manufacturing, and advanced analytical and consulting services for the Company’s customers as well as characterizing and developing pharmaceutical product candidates for the Company’s internal programs. The Company has consolidated and runs all of its operational functions in one location in Nottingham, United Kingdom. The Company owns certain plant and equipment physically located at third party contractor facilities in the United Kingdom and Switzerland. The Company conducts its advanced formulation, analytical and consulting services through its subsidiary, Juniper Pharma Services.

The Company’s largest customer, Merck Serono, utilizes a Switzerland-based subsidiary to acquire product from the Company, which it then sells throughout the world excluding the U.S. The Company’s primary domestic customer, Actavis, Inc. (“Actavis”) is responsible for the commercialization and sale of progesterone products in the United States. The following tables show selected information by geographic area (in thousands):

 

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Revenues:

 

     Three Months Ended
March 31,
 
     2015      2014  

United States

   $ 1,747       $ 2,501   

Switzerland

     4,938         3,531   

United Kingdom

     982         470   

Other countries

     659         514   
  

 

 

    

 

 

 

Total

$ 8,326    $ 7,016   
  

 

 

    

 

 

 

Total assets:

 

     March 31,
2015
     December 31,
2014
 

United States

   $ 18,046       $ 18,212   

Switzerland

     1,767         1,661   

United Kingdom

     30,541         32,140   

Other countries

     116         195   
  

 

 

    

 

 

 

Total

$ 50,470    $ 52,208   
  

 

 

    

 

 

 

 

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Long-lived assets:

 

     March 31,
2015
     December 31,
2014
 

United States

   $ 249       $ 245   

Switzerland

     534         529   

United Kingdom

     11,575         12,361   

Other countries

     2         2  
  

 

 

    

 

 

 

Total

$ 12,360    $ 13,137   
  

 

 

    

 

 

 

No other individual country represented greater than 10% of total revenues, total assets, or total long-lived assets for any period presented.

For the three months ended March 31, 2015 and 2014, Merck Serono and Actavis accounted for 59% and 12%, and 45% and 16% of total revenues, respectively. No additional customers accounted for 10% or more of total revenues for the three months ended March 31, 2015 and 2014.

At March 31, 2015 Merck Serono and Actavis each made up 50% of the product segment accounts receivable. At December 31, 2014 Merck Serono and Actavis account for 54% and 46% of the product segment accounts receivable, respectively. At March 31, 2015 no customers accounted for greater than 10% of the service segment accounts receivable. At December 31, 2014 two customers accounted for 18% and 11% of total service segment accounts receivable.

The following summarizes other information by segment for the quarter ended March 31, 2015 (in thousands):

 

     Product      Service      Total  

Revenues

        

Product revenues

   $ 4,875       $ —         $ 4,875   

Service revenues

     —           2,460         2,460   

Royalties

     991         —           991   
  

 

 

    

 

 

    

 

 

 

Total revenues

  5,866      2,460      8,326   
  

 

 

    

 

 

    

 

 

 

Cost of product revenues

  3,112      —        3,112   

Cost of service revenues

  —        1,766      1,766   
  

 

 

    

 

 

    

 

 

 

Total cost of revenues

  3,112      1,766      4,878   
  

 

 

    

 

 

    

 

 

 

Gross profit

  2,754      694      3,448   

Total operating expenses

  4,279   

Total non-operating income

  144   

Loss before income taxes

  (687

The following summarizes other information by segment for the quarter ended March 31, 2014 (in thousands):

 

     Product      Service      Total  

Revenues

        

Product revenues

   $ 3,461       $ —         $ 3,461   

Service revenues

     —           2,478         2,478   

Royalties

     1,077         —           1,077   

Other revenues

     —           —           —     
  

 

 

    

 

 

    

 

 

 

Total revenues

  4,538      2,478      7,016   
  

 

 

    

 

 

    

 

 

 

Cost of product revenues

  2,426      —        2,426   

Cost of service revenues

  —        1,846      1,846   
  

 

 

    

 

 

    

 

 

 

Total cost of revenues

  2,426      1,846      4,272   
  

 

 

    

 

 

    

 

 

 

Gross profit

  2,112      632      2,744   

Total operating expenses

  2,852   

Total non-operating income

  272   

Income before income taxes

  164   

 

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(7) Property and Equipment

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

 

     Estimated
Useful Life
(Years)
   March 31, 2015
Cost
     December 31, 2014
Cost
 

Machinery and equipment

   3-10    $ 6,116       $ 6,080   

Furniture and fixtures

   3-5      1,019         1,019   

Computer equipment and software

   3      200         188   

Buildings

   Up to 39      8,655         9,062   

Land

   Indefinite      564         590   

Construction in-process

        51         107   
     

 

 

    

 

 

 
  16,605      17,046   

Less: Accumulated depreciation

  (4,336   (4,005
     

 

 

    

 

 

 

Total

$ 12,269    $ 13,041   
     

 

 

    

 

 

 

Depreciation expense for the three months ended March 31, 2015 and 2014 was $0.4 million and $0.4 million, respectively.

(8) Net (Loss) Income Per Common Share

The calculation of basic and diluted (loss) per common and common equivalent share is as follows (in thousands except for per share data):

 

     Three Months Ended
March 31,
 
     2015      2014  

Basic income per common share

     

Net (loss) income

   $ (692    $ 152   

Less: Preferred stock dividends

     —           (7
  

 

 

    

 

 

 

Net (loss) income applicable to common stock

$ (692 $ 145   
  

 

 

    

 

 

 

Basic weighted average number of common shares outstanding

  10,752      11,739   
  

 

 

    

 

 

 

Basic net (loss) income per common share

$ (0.06 $ 0.01   
  

 

 

    

 

 

 

Diluted (loss) income per common share

Net income applicable to common stock

$ (692 $ 145   

Add: Preferred stock dividends

  —        7   

Less: Fair value of stock warrants for dilutive warrants

  —        (309
  

 

 

    

 

 

 

Net (loss) applicable to dilutive common stock

$ (692 $ (157
  

 

 

    

 

 

 

Basic weighted average number of common shares outstanding

  10,752      11,739   

Effect of dilutive securities

Dilutive stock awards

  —        25   
  

 

 

    

 

 

 
  —        25   

Diluted weighted average number of common shares outstanding

  10,752      11,764   
  

 

 

    

 

 

 

Diluted net (loss) per common share

$ (0.06 $ (0.01
  

 

 

    

 

 

 

 

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Basic (loss) income per common share is computed by dividing the net income, less preferred dividends by the weighted-average number of shares of common stock outstanding during a period. The diluted loss per common share calculation gives effect to dilutive options, warrants, convertible notes, convertible preferred stock, and other potential dilutive common stock including selected restricted shares of common stock outstanding during the period. Diluted loss per share is based on the treasury stock method and includes the effect from potential issuance of common stock, such as shares issuable pursuant to the exercise of stock options, assuming the exercise of all in-the-money stock options. Common share equivalents have been excluded where their inclusion would be anti-dilutive.

Shares to be issued upon the exercise of the outstanding options and warrants, convertible preferred stock and selected restricted shares of common stock excluded from the income per share calculation amounted to 2.2 million and 1.8 million in each of the three month periods ended March 31, 2015 and 2014, respectively, because the awards were anti-dilutive.

(9) Accumulated Other Comprehensive Loss

Changes to accumulated other comprehensive income during the three months ended March 31, 2015 were as follows (in thousands):

 

     Translation
Adjustment
     Accumulated Other
Comprehensive
Income
 

Balance—December 31, 2014

   $ (63    $ (63

Current period other comprehensive income

     (987      (987
  

 

 

    

 

 

 

Balance—March 31, 2015

$ (1,050 $ (1,050
  

 

 

    

 

 

 

(10) Stock-Based Compensation

Stock-based compensation expense for the three months ended March 31, 2015 and 2014 was $0.5 million and $0.2 million, respectively.

Total stock-based compensation expense was recorded to cost of revenues and operating expenses based upon the functional responsibilities of the individuals holding the respective options as follows (in thousands):

 

     Three Months Ended
March 31,
 
     2015      2014  

Cost of revenues

   $ 19       $ —     

Sales and marketing

     8         3  

Research and development

     375         —     

General and administrative

     130         161   
  

 

 

    

 

 

 

Total

$ 532    $ 164   
  

 

 

    

 

 

 

There were no option exercises in the three months ended March 31, 2015. Cash received from option exercises was $12,000 for the three months ended March 31, 2014.

Juniper granted 232,000 and 222,000 stock options to employees during the three months ended March 31, 2015 and 2014, respectively.

The Company records stock-based compensation expense for stock options granted to non-employees based on the fair value of the stock options which is re-measured over the graded vesting term resulting in periodic adjustments to stock-based compensation expense. During the three months ended March 31, 2015, 240,000 stock options were granted by the Company to non-employees. One-third of the options vested immediately and as such, the Company has recorded stock-based compensation expense of $0.4 million, which is recorded in the research and development line of the statement of operations. The remaining options will vest over a two year period from the date of grant.

 

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The Company uses the Black-Scholes option pricing model to determine the estimated grant date fair values for stock-based awards. The weighted-average grant date fair values of the options granted during the three months ended March 31, 2015 and 2014 were $3.35 and $4.51, respectively for employees and $4.44 and $0 for non-employees, using the following assumptions:

 

     Three Months Ended
March 31,
 
     2015   2014  

Risk free interest rate

   0.90% - 1.47%     1.64

Expected term

   4.56 - 7 years     4.75 years   

Dividend yield

       —    

Expected volatility

   76.76% - 82.88%     81.36

 

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Option-pricing models require the input of various subjective assumptions, including the option’s expected life and the price volatility of the underlying stock. Juniper’s estimated expected stock price volatility is based on its own historical volatility. Juniper’s expected term of options granted during the three months ended March 31, 2015 and 2014 was derived using the simplified method for employees and the contractual term of the option for non-employees. The risk-free rate for the expected term of the option is based on the U.S. Treasury yield curve in effect at the time of grant.

As of March 31, 2015, the total unrecognized compensation cost related to outstanding stock options and restricted stock awards expected to vest was $2.4 million, which the Company expects to recognize over a weighted-average period of 3.02 years.

(11) Legal Proceedings

Claims and lawsuits are filed against the Company from time to time. Although the results of pending claims are always uncertain, the Company believes that it has adequate reserves or adequate insurance coverage in respect of these claims, but no assurance can be given as to the sufficiency of such reserves or insurance coverage in the event of any unfavorable outcome resulting from these actions.

Between February 1, 2012 and February 6, 2012, two putative securities class action complaints were filed against Juniper and certain of its officers and directors in the United States District Court for the District of New Jersey. These actions were filed under the captions Wright v. Columbia Laboratories, Inc., et al ., and Shu v. Columbia Laboratories, Inc., et al. and asserted claims under sections 10(b) and 20(a) of the Securities Exchange Act of 1934 as amended (the “Exchange Act”) and Rule 10b-5 promulgated under the Exchange Act on behalf of an alleged class of purchasers of the common stock during the period from December 6, 2010 through January 20, 2012. Both actions were consolidated into a single proceeding entitled In re Columbia Laboratories, Inc., Securities Litigation , under which Actavis and three of its officers were added as defendants. The Consolidated Amended Complaint alleged that Juniper and two of its officers, one of whom is a director, omitted to state material facts that they were under a duty to disclose, and made materially false and misleading statements that related to the results of Juniper’s PREGNANT study and the likelihood of approval by the U.S. Food and Drug Administration (“FDA”) of a New Drug Application (“NDA”) to market progesterone vaginal gel 8% for the prevention of preterm birth in women with premature cervical shortening. According to the amended complaint, these alleged omissions and misleading statements had the effect of artificially inflating the market price of the common stock. The plaintiffs sought unspecified damages on behalf of the putative class and an award of costs and expenses, including attorney’s fees. On June 11, 2013, the Court dismissed the amended complaint for failure to state a claim upon which relief could be granted, holding that the plaintiffs did not adequately plead facts supporting an inference of an intent to deceive investors. The Court permitted the plaintiffs to file a second amended complaint, which they did on July 11, 2013. Juniper moved to dismiss the second amended complaint, which the court did on October 21, 2013. The Court ruled that changes the plaintiffs made to their first amended complaint “still do not create a strong inference that the Defendants acted with an intent to deceive, manipulate or defraud.” The Court ordered that if the plaintiffs sought to attempt to plead a cognizable action in a third amended complaint, they must do so within thirty days and specifically address why the attempt would not be futile. The plaintiffs chose not to file any further amendments and the case was dismissed with prejudice on December 2, 2013. On December 20, 2013, the plaintiffs appealed the dismissal to the United States Court of Appeals for the Third Circuit. The Court heard oral arguments on December 9, 2014. On March 10, 2015, the Court affirmed the dismissal in a written opinion. Juniper believes that the action is without merit, and intends to defend it vigorously. At this time, it is not possible to determine the likely outcome of, or to estimate the potential liability related to this action, and Juniper has not made any provision for losses in connection with it.

 

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(12) Fair Value of Financial Instruments

U.S. GAAP establishes a framework for measuring fair value under generally accepted accounting principles and enhances disclosures about fair value measurements. Fair value is defined as the amount that would be received for an asset or paid to transfer a liability (i.e., an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value maximize the use of observable inputs and minimize the use of unobservable inputs. The standard describes the following fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value:

Level 1: Quoted prices in active markets for identical assets and liabilities.

Level 2: Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

Level 3: Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

The fair value of cash and cash equivalents are classified as Level 1 at March 31, 2015 and December 31, 2014.

There was no fair value of the common stock warrant liability as of March 31, 2015. The value as of March 31, 2015 was determined by using the Black-Scholes option pricing model, which is based on the Company’s stock price at measurement date, exercise price of the common stock warrants, risk-free interest rate and historical volatility, and are classified as a Level 2 measurement. During the three months ended March 31, 2015 no income or expense was recorded to adjust the value of the common stock warrant liability to fair value. During the three months ended March 31, 2014, the Company recorded income of $0.3 million, to adjust the value of the common stock warrant liability to fair value.

The fair values of accounts receivable and accounts payable approximate their respective carrying amounts. The Company’s long-term debt is carried at amortized face value, which approximates fair value based on current market pricing of similar debt instruments and is categorized as a Level 2 measurement.

(13) Related Party Transactions

On March 7, 2014 the Company acquired all of its common stock beneficially owned by Actavis, which represented approximately 11.5% of the Company’s outstanding common stock at that time. Immediately following the closing of the stock repurchase and as of March 31, 2015, Actavis did not own any of the Company’s outstanding common stock. Juniper purchased the 1.4 million shares held by Actavis at a price of $6.08 per share, which represented a 10.75% discount to the market closing price on March 6, 2014. The total purchase price was approximately $8.5 million.

Pursuant to its Purchase and Collaboration Agreement with Actavis, Juniper receives royalties equal to a minimum of 10% of annual net sales of CRINONE by Actavis for annual net sales up to $150 million; 15% for sales above $150 million but less than $250 million; and 20% for annual net sales of $250 million and over. Actavis also purchased the remaining raw materials Juniper had on hand in the three months ended March 31, 2014.

The table below presents the transactions between the Company and Actavis during the three months ended March 31, 2015 and 2014 (prior to the time Actavis ceased to be a related party) (in thousands):

 

     Three Months Ended
March 31,
 
     2015      2014  

Revenues

     

Product revenues

   $ —         $ 167   

Royalties

     —           714   
  

 

 

    

 

 

 

Total revenues

$ —      $ 881   
  

 

 

    

 

 

 

As of March 31, 2015 any amounts due from Actavis are now classified as a component of accounts receivable, net on the consolidated balance sheet. There were no amounts due from Actavis at December 31, 2014. There were no amounts due to Actavis at March 31, 2015 and December 31, 2014.

 

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(14) Income Taxes

During the three months ended March 31, 2015 and 2014, Juniper recorded income tax expense of $5,000 and $12,000, respectively, representing an effective tax rate of 0.7% and 2.7%, respectively. The income tax provision for the three months ended March 31, 2015 is primarily attributable to state taxes owed. The income tax provision for the three months ended March 31, 2014 is primarily attributable to taxable income generated in foreign jurisdictions.

Juniper files income tax returns in the U.S. federal jurisdiction, and in various state and foreign jurisdictions. Juniper is no longer subject to U.S. federal income tax examinations by tax authorities for years prior to 2012. Additionally, with few exceptions, Juniper is no longer subject to U.S. state tax examinations for years prior to 2012.

(15) Recent Accounting Pronouncements

In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2014-09, “Revenue from Contracts with Customers” (“ASU 2014-09”), which provides guidance for revenue recognition. ASU 2014-09 affects any entity that either enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets and supersedes the revenue recognition requirements in Topic 605, “Revenue Recognition,” and most industry-specific guidance. This ASU also supersedes some cost guidance included in Subtopic 605-35, “Revenue Recognition-Construction-Type and Production-Type Contracts.” The standard’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which a company expects to be entitled in exchange for those goods or services. In doing so, companies will need to use more judgment and make more estimates than under today’s guidance. These may include identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance obligation. ASU 2014-09 is effective for the Company beginning January 1, 2018 and, at that time the Company may adopt the new standard under the full retrospective approach or the modified retrospective approach. Early adoption is not permitted. The Company is currently evaluating the method and impact that the adoption of ASU 2014-09 will have on the Company’s consolidated financial statements and related disclosures.

In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements—Going Concern. The provisions of ASU No. 2014-15 require management to assess an entity’s ability to continue as a going concern by incorporating and expanding upon certain principles that are currently in U.S. auditing standards. Specifically, the amendments (1) provide a definition of the term substantial doubt, (2) require an evaluation every reporting period including interim periods, (3) provide principles for considering the mitigating effect of management’s plans, (4) require certain disclosures when substantial doubt is alleviated as a result of consideration of management’s plans, (5) require an express statement and other disclosures when substantial doubt is not alleviated, and (6) require an assessment for a period of one year after the date that the financial statements are issued (or available to be issued). The amendments in this ASU are effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. The Company does not believe this ASU will have an impact on the Company’s financial statements.

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

Forward-Looking Information

This Quarterly Report on Form 10-Q contains information that may constitute forward-looking statements. Generally, forward-looking statements can be identified by words such as “may,” “will,” “plan,” “believe,” “expect,” “intend,” “anticipate,” “potential,” “should,” “estimate,” “predict,” “project,” “would,” and similar expressions, which are generally not historical in nature. However, the absence of these words or similar expressions does not mean that a statement is not forward-looking. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future—including statements relating to our future operating or financial performance or events, our strategy, goals, plans and projections regarding our financial position, our liquidity and capital resources, and our product development—are forward-looking statements. Management believes that these forward-looking statements are reasonable as and when made. However, caution should be taken not to place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. Our Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain known and unknown risks, uncertainties and factors that may cause actual results to differ materially from our Company’s historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in our Annual Report on Form 10-K for the year ended December 31, 2014, those described in this Quarterly Report on Form 10-Q, and those described from time to time in our future reports filed with the Securities and Exchange Commission (the “SEC”).

 

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Table of Contents

You should read this Quarterly Report and the documents that we have filed as exhibits to this Quarterly Report completely and with the understanding that our actual future results may be materially different from what we expect. While we may elect to update forward-looking statements at some point in the future, we do not undertake any obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.

Company Overview

In April 2015, we changed our name from Columbia Laboratories, Inc. to Juniper Pharmaceuticals, Inc. In addition, our subsidiary formerly known as Molecular Profiles Ltd. changed its name to Juniper Pharma Services Ltd.

We are in the business of developing, manufacturing, licensing and selling pharmaceutical products that utilize proprietary drug delivery technologies to treat unmet medical needs in women’s health. We expect to advance programs through Phase II clinical studies and then partner with larger pharmaceutical firms for Phase III studies and commercialization. We also provide a range of drug development and consulting services to pharmaceutical industry customers through our subsidiary Juniper Pharma Services.

To date, we have developed six prescription and “over-the-counter” pharmaceutical products: five Bioadhesive Delivery System (“BDS”) vaginal gel products that are indicated for conditions such as vaginal dryness, vaginal pH adjustment, progesterone supplementation as part of fertility treatments, amenorrhea, and a BDS testosterone buccal system for male hypogonadism. Currently, we receive revenues from only one of our pharmaceutical products, CRINONE 8% (progesterone gel). We manufacture and sell CRINONE to Merck Serono, internationally. We sold the rights to CRINONE to Actavis in the United States and receive royalty revenues from Actavis based on their U.S. sales.

Juniper Pharma Services provides an established capability in pharmaceutical development, clinical trial manufacturing and advanced analytical and consulting services for our customers as well as characterizing and developing pharmaceutical product candidates for our internal programs. We have expanded our enabling technologies that facilitate the development of difficult-to-progress molecules and are pursuing business development opportunities within the U.S. and European markets.

We are actively evaluating drug candidates to add to our proprietary pipeline. The next product in development is COL-1077, investigational 10% lidocaine bioadhesive vaginal gel, which is intended as an acute use anesthetic for pain associated with minimally invasive gynecological procedures.

Our strategic focus is on the following objectives:

 

    supplying CRINONE to our marketing partner, Merck Serono, for sale in over 60 countries around the world;

 

    growing our Pharmaceutical Services business;

 

    advancing COL-1077, investigational 10% lidocaine bioadhesive vaginal gel, into clinical development; and

 

    identifying product candidates and building a pipeline of pharmaceutical products focused on women’s health particularly utilizing our BDS and intra-vaginal ring (“IVR”) technologies.

We believe we will be able to generate sufficient cash from operations to execute on our objectives and maintain our strong balance sheet.

Supply of CRINONE:

Under the terms of the amended license and supply agreement with Merck Serono, we sell CRINONE to Merck Serono on a country-by-country basis at the greater of (i) cost plus 20% or (ii) a percentage of Merck Serono’s net selling price. Through 2020, the percentage of net selling price will be determined based on a tiered structure. As sales volumes increase our percentage of incremental sales decrease. These thresholds serve to incentivize Merck Serono to continue to develop existing markets and to enter new markets. Additionally, the parties are jointly cooperating to evaluate and implement manufacturing cost reduction measures, with both parties sharing any reductions realized from these initiatives. If, at the end of the supply term, the parties cannot agree upon mutually acceptable terms for renewal of the supply arrangement, Merck Serono may elect to retain a license to the product and will have an irrevocable fully paid-up license to the product.

We manufacture our products in Europe using third party contract manufacturers on behalf of our foreign subsidiaries who sell the products to our worldwide licensee, and to us, in the case of products supplied for resale in the United States prior to November 2013. Because our foreign subsidiaries recognize these sales and only their associated product manufacturing costs, we have historically shown a profit from our foreign operations.

 

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Table of Contents

Product Development

Development of COL-1077-Sustained Release Vaginal Lidocaine Gel Program:

COL-1077 is an investigational sustained-release 10% lidocaine vaginal gel, which is intended as an acute use anesthetic for the treatment of pain associated with minimally invasive gynecological procedures. In March 2015, we filed an Investigational New Drug (“IND”) application with the U.S. Food and Drug Administration (“FDA”) for COL-1077. We expect to commence a phase II randomized, double-blinded, placebo controlled study that will enroll 150 patients at fifteen U.S. sites in the second quarter of 2015. We are leveraging our internal capabilities at our Nottingham facility for the development and clinical trial manufacturing of this product. We will utilize external contract research organizations for clinical development and clinical trial management.

Intra-Vaginal Ring Technology Licensing:

In March 2015 we licensed exclusive worldwide rights to a proprietary IVR technology. Due to a novel polymer composition and segmentation capability, the IVR has the potential to deliver drugs, including larger molecules such as peptides, at different dosages and release rates within a single segmented ring. This technology was developed by Dr. Robert Langer from the Massachusetts Institute of Technology and Dr. William Crowley from Massachusetts General Hospital and Harvard Medical School, who serve on our newly created Scientific Advisory Board (“SAB”). This drug delivery system aligns with our strategy to develop proprietary products targeting areas of unmet medical needs in women’s health and we see numerous new product and life cycle management opportunities for it.

Scientific Advisory Board

In April 2015, we created a SAB comprised of internationally renowned physicians and scientists. The SAB will provide scientific and clinical advise on the identification and advancement of product candidates for our women’s health strategy. The SAB consists of the following doctors: William F. Crowley, Jr., Martyn Davies, Robert S. Langer, Ginger D. Constantine and Daniel A. Shames. The expertise of the SAB covers multiple areas of relevance to our proprietary product development strategy, including drug delivery and biomaterials, innovative engineering, women’s health, including reproductive endocrinology, and regulatory affairs.

Sources of Revenue:

We generate revenues primarily from the sale of our products and services and from a royalty stream and certain other revenues. During the three months ended March 31, 2015, we derived approximately 59% of our revenues from the sale of our products, 29% from the sale of our services and 12% from our royalty stream and certain other revenues. During the three months ended March 31, 2014, we derived approximately 49% of our revenues from the sale of our products, 35% from the sale of our services and 16% from our royalty stream and certain other revenues. Generally, we recognize revenue from the sale of our products upon shipment to our customers, revenues from services as the work is performed and revenues from royalties as sales are made by the licensees.

We expect that future recurring revenues will be derived from product sales to Merck Serono, a royalty stream from Actavis and from offering pharmaceutical development, clinical trial manufacturing, and analytical and consulting services. Quarterly sales results can vary widely and affect comparisons with prior periods because (i) products shipped to Merck Serono occur only in full batches, and may not correlate to Merck Serono’s in-market sales and (ii) service revenues are driven by obtaining and retaining our customer contracts, which may vary widely from quarter to quarter.

 

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Table of Contents

Results of Operations

The following tables contain selected consolidated statement of operations information, which serves as the basis of the discussion surrounding the results of our operations for the three months ended March 31, 2015 and 2014:

 

     Three Months Ended
March 31,
             
     2015     2014              
(in thousands, except for percentages)    Amount     As a % of
Total
Revenues
    Amount     As a % of
Total
Revenues
    $
Change
    %
Change
 

Product revenues

   $ 4,875        59   $ 3,461        49   $ 1,414        41

Service revenues

     2,460        29        2,478        35        (18     (1

Royalties

     991        12        1,077        16        (86     (8
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total revenues

  8,326      100      7,016      100      1,310      19   

Cost of product revenues

  3,112      37      2,426      35      686      28   

Cost of service revenues

  1,766      21      1,846      26      (80   (4
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total cost of revenues

  4,878      59      4,272      61      606      14   

Gross profit

  3,448      41      2,744      39      704      26   

Operating expenses:

Sales and marketing

  321      4      401      6      (80   (20

Research and development

  1,384      17      —        —        1,384      100   

General and administrative

  2,574      31      2,451      35      123      5   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

  4,279      51      2,852      41      1,427      50   
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

(Loss) income from operations

  (831   (10   (108   (2   (723   669   

Interest expense, net

  (27   —        (34   —        7      (21

Change in fair value of common stock warrant liability

  —        —        309      4      (309   (100

Other income (expense), net

  171      2      (3   —        174      (5,800
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

(Loss) income before income taxes

  (687   (8   164      2      (851   (519

Provision for income taxes

  5      —        12      —        (7   (58
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Net (loss) income

$ (692   (8 )%  $ 152      2 $ (844   (555 )% 
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Revenues

 

     Three Months Ended
March 31,
     $
Change
     %
Change
 
(in thousands, except for percentages)    2015      2014        

Product revenues

   $ 4,875       $ 3,461       $ 1,414         41

Service revenues

     2,460         2,478         (18      (1

Royalties

     991         1,077         (86      (8
  

 

 

    

 

 

    

 

 

    

 

 

 

Total revenues

$ 8,326    $ 7,016    $ 1,310      19
  

 

 

    

 

 

    

 

 

    

 

 

 

 

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Table of Contents

Revenues in the three months ended March 31, 2015 increased by $1.3 million, or 19%, from the three months ended March 31, 2014. The increase was primarily attributable to the following factors by segment:

Product

 

    Revenues from the sale of products increased by approximately $1.4 million, or 41%, from the 2014 period primarily due to the resumption of shipments of CRINONE in the three months ended March 31, 2015 to one of Merck Serono’s higher volume, higher margin markets.

 

    Royalty revenues decreased $0.1 million, or 8%, for the three months ended March 31, 2015 as compared to the three months ended March 31, 2014. The intellectual property rights and technology for Legatrin PM was monetized for $2.1 million in the third quarter of 2014 eliminating recurring royalties (approximately $0.1 million per quarter) for that product.

Service

 

    Service revenues from our pharmaceutical development, clinical trial manufacturing, consulting and analytic services business remained consistent with the 2014 period.

Cost of revenues

 

     Three Months Ended
March 31,
    $
Change
     %
Change
 
(in thousands, except for percentages)    2015     2014       

Cost of product revenues

   $ 3,112      $ 2,426      $ 686         28

Cost of service revenues

     1,766        1,846        (80      (4
  

 

 

   

 

 

   

 

 

    

 

 

 

Total cost of revenues

$ 4,878    $ 4,272    $ 606      14
  

 

 

   

 

 

   

 

 

    

 

 

 

Total cost of revenues (as a percentage of total revenues)

  59   61

Product gross margin

  47   47

Service gross margin

  28   26

Total cost of revenues were $4.9 million and $4.3 million for the three months ended March 31, 2015 and 2014, respectively. The increase in total cost of revenues in 2015 was largely driven by the resumption of shipments of CRINONE to one of Merck Serono’s larger markets as well as higher revenues in the period. Accordingly, cost of product revenues increased due to a 42% increase in units shipped in the 2015 period as compared to the 2014 period. Cost of service revenues consist mainly of personnel costs, external consultant fees, depreciation and materials used in connection with generating our service revenues. Product gross margin remained consistent in 2015 as compared to 2014. Service gross margin increased in 2015 as compared to 2014 due to a change in mix of revenue type within the service segment.

Sales and marketing expenses

 

     Three Months Ended
March 31,
    $
Change
     %
Change
 
(in thousands, except for percentages)    2015     2014       

Sales and marketing

   $ 321      $ 401      $ (80      (20 )% 

Sales and marketing (as a percentage of total revenues)

     4     6     

Sales and marketing expenses incurred during the three months ended March 31, 2015 and 2014 were attributable to our services business and consist of personnel costs for our sales force as well as marketing costs for certain tradeshows and conference fees. This decrease primarily relates to costs associated with certain organizational changes within Juniper Pharma Services Ltd.

Research and development

 

     Three Months Ended
March 31,
    $
Change
     %
Change
 
(in thousands, except for percentages)    2015     2014       

Research and development

   $ 1,384      $ —       $ 1,384         100

Research and development (as a percentage of total revenues)

     17     —       

 

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Research and development costs incurred during the three months ended March 31, 2015 were primarily associated with the development of COL-1077. These costs mainly consist of personnel-related expenses for employees directly involved in product development as well as professional service consultants. Drs. Robert Langer and William Crowley joined as strategic advisors to the Company in March 2015 and we incurred $0.4 million of stock compensation expense in connection with their agreements. There were no research and development expenses in the three months ended March 31, 2014. As we continue to advance COL-1077 and other potential proprietary product programs, we expect corresponding increases in research and development costs for the foreseeable future.

General and administrative expenses

 

     Three Months Ended
March 31,
    $
Change
     %
Change
 
(in thousands, except for percentages)    2015     2014       

General and administrative

   $ 2,574      $ 2,451      $ 123         5

General and administrative (as a percentage of total revenues)

     31     35     

Total general and administrative expenses increased by $0.1 million to $2.6 million for the three months ended March 31, 2015, compared with $2.5 million for the three months ended March 31, 2014. This increase primarily relates to costs associated with certain organizational changes in addition to administrative costs related to our facility in the United Kingdom, which we acquired in September 2013.

Non-operating income and expense

 

     Three Months Ended
March 31,
     $
Change
     %
Change
 
(in thousands, except for percentages)    2015      2014        

Interest expense, net

   $ (27    $ (34    $ 7         (21 )% 

Change in fair value of common stock warrant liability

   $ —         $ 309       $ (309      (100 )% 

Other income (expense), net

   $ 171       $ (3    $ 174         (5,800 )% 

Interest expense, net, remains consistent in the comparable periods and relates to interest paid on the debt we currently have on our Nottingham facility.

The change in fair value of common stock warrant liability for the three months ended March 31, 2015 was $0 as the warrants issued in October 2009 grew closer to expiration in April 2015. The income of $0.3 million associated with the change in fair value of common stock warrant liability for the three months ended March 31, 2014 is related to a stabilization of the volatility rate used in our Black-Scholes model as the warrants moved closer to their expiration date.

Other income (expense), net, for the three months ended March 31, 2015 increased primarily due to the income associated with the Regional Growth Fund, which is recognized on a decelerated basis over the obligation period as well as net foreign currency transaction gains related to the weakening of the Euro and the British Pound against the U.S dollar in the 2015 period. The other expense for the three months ended March 31, 2014 relates to income associated with the Regional Growth Fund offset with net foreign currency transaction losses related to the strengthening of the Euro and the British pound against the U.S. dollar.

 

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Provision for income taxes

 

     Three Months Ended
March 31,
    $
Change
     %
Change
 
(in thousands, except for percentages)    2015     2014       

Provision for income taxes

   $ 5      $ 12      $ (7      (58 )% 

Provision for income taxes (as a percentage of income before income taxes)

     0.7     7     

The 2015 effective tax rate represents state minimum taxes owed. The 2014 effective tax rate represents state minimum taxes owed and foreign tax expense calculated on the investment in a foreign subsidiary.

Liquidity and Capital Resources

We require cash to pay our operating expenses, including research and development activities, fund working capital needs, make capital expenditures and fund acquisitions.

At March 31, 2015, our cash and cash equivalents were $16.3 million. Our cash and cash equivalents are highly liquid investments with original maturities of 90 days or less at date of purchase and consist of cash in operating accounts.

In March 2014, we acquired all of our common stock beneficially owned by Actavis, which represented 11.5% of our outstanding common stock at the time. Immediately following the closing of the stock repurchase and as of March 31, 2015, Actavis did not own any of our outstanding common stock. We purchased the 1.4 million shares held by Actavis at a price of $6.08 per share, which represented a 10.75% discount to the market closing price on March 6, 2014. The total purchase price was approximately $8.5 million.

We assumed debt of $3.9 million in connection with our acquisition of Juniper Pharma Services. Juniper Pharma Services had entered into a Business Loan Agreement (“Loan Agreement”) covering three loan facilities with Lloyds TSB Bank (“Lloyds”), as administrative agent, to fund the construction and expansion of their facility, which includes analytical labs, office space, and a manufacturing facility in the United Kingdom. Prior to the acquisition, Juniper Pharma Services had drawn down $3.9 million under the loan facilities and as of March 31, 2015 owed $3.3 million under the Loan Agreement. The three loan facilities are each repayable in monthly installments that began in February 2013 for one of the facilities and in October 2013 for the other two facilities. Repayment of the three facilities is scheduled to occur over a 15-year period from the date of drawdown. Two of the facilities bear interest at the Bank of England’s base rate plus 1.95% and 2.55%, respectively. The interest rate at March 31, 2015 for these two facilities was 2.45% and 3.05%, respectively. The third facility is a fixed rate agreement bearing interest at 3.52% per annum. The weighted average interest rate for the three loan facilities for the three months ending March 31, 2015 was 3.00%. Borrowings under the Loan Agreement are secured by the mortgaged property and an unlimited lien on other assets of Juniper Pharma Services. The Loan Agreement contains financial covenants that limit the amount of indebtedness we may incur, requires us to maintain certain levels of net worth, and restricts our ability to materially alter the character of Juniper Pharma Services’ business. As of March 31, 2015, Juniper Pharma Services remained in compliance with all of the covenants under the Loan Agreement.

As part of the acquisition of Juniper Pharma Services, we assumed a $2.5 million obligation under a grant arrangement with the Regional Growth Fund on behalf of the Secretary of State for Business, Innovation, and Skills in the United Kingdom. Juniper Pharma Services used this grant to fund the building of their second facility, which includes analytical labs, office space, and a manufacturing facility. As a part of the arrangement, Juniper Pharma Services is required to create and maintain certain full-time equivalent personnel levels through October 2017. As of March 31, 2015, we remained in compliance with the covenants of the arrangement.

The income from the Regional Growth Fund will be recognized on a decelerated basis over the next three years. As of March 31, 2015, the obligation is valued at $1.9 million and is recorded as deferred revenue on the consolidated balance sheets. The amount of other income on the obligation that will be recognized provided we remain in compliance with the covenants will be the following:

(in thousands):

 

Year

   Total  

Remainder of 2015

   $ 415   

2016

     772   

2017

     712   
  

 

 

 

Total

$ 1,899   
  

 

 

 

 

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Our future capital requirements depend on a number of factors, including the rate of market acceptance of our current and future services and products and the resources we devote to developing and supporting the same. Our capital expenditures decreased for the three months ended March 31, 2015, as compared to the three months ended March 31, 2014. Our capital expenditures primarily relate to investments in capital equipment made at our Nottingham, U.K. site and for our contract manufacturer sites. We expect our capital expenditures to remain consistent in the year ending December 31, 2015, as compared to the year ended December 31, 2014, primarily due to continued investments made at the Nottingham site.

Research and development expenses include costs for product and clinical development, which were a combination of internal and third-party costs, and regulatory fees. In 2014, we resumed research and development activities for COL-1077, an investigational sustained-release vaginal lidocaine gel, for which the target indication is an acute use anesthetic for minimally invasive gynecological procedures. In 2015, we expect our research and development expenses to increase as a percentage of revenue as a result of our further research and development efforts including our SAB, COL-1077 development costs, our IVR technology, and other drug development opportunities as compared to the 2014 period.

As of March 31, 2015, we had 282,152 exercisable options, and 1,124,182 exercisable warrants outstanding which, if exercised, would result in approximately $15.6 million of additional capital and would cause the number of shares outstanding to increase; provided, however, that the cashless exercise feature of certain warrants will result in no cash to us. There can be no assurance that any such options or warrants will be exercised. The intrinsic value of exercisable options and warrants was $0.1 million for the three months ended March 31, 2015. There was no aggregate intrinsic value of exercisable options and warrants for the three months ended March 31, 2014. We believe that our current cash and cash equivalents, as well as cash generated from operations, will be sufficient to meet our anticipated cash needs for working capital and capital expenditures for the foreseeable future.

Cash Flows

Net cash used by operating activities for the three months ended March 31, 2015 was $0.2 million and resulted primarily from a $0.7 million net loss for the period and increased by approximately $1.1 million in depreciation and amortization and stock-based compensation expense. Net changes in working capital items decreased cash from operating activities by approximately $0.5 million driven by increases to inventory and prepaid expenses and other current assets as well as decreases to accounts payable offset by decreases to accounts receivable from increased collection efforts and increases to accrued expenses. Net cash used in investing activities was $0.2 million for the three months ended March 31, 2015, which resulted primarily from the purchase of property plant and equipment. Net cash used in financing activities was approximately $0.1 million for the three months ended March 31, 2015, primarily relating to the principal payments on the note.

Net cash provided by operating activities for the three months ended March 31, 2014 was $0.9 million and resulted primarily from $0.2 million of net income for the period, increased by approximately $0.6 million in depreciation and amortization and stock-based compensation expense and decreased by $0.3 million for the change in fair value of stock warrant liability. Net changes in working capital items increased cash from operating activities by approximately $0.4 million, primarily due to a decrease in accounts receivable of $1.1 million offset by decreases in accrued expenses and deferred revenue. Net cash used in investing activities was $0.8 million for the three months ended March 31, 2014, which resulted primarily from the purchase of property plant and equipment. Net cash used in financing activities was approximately $8.6 million for the three months ended March 31, 2014, primarily relating to the $8.5 million stock buyback from Actavis.

Critical Accounting Policies and Estimates

The discussion and analysis of our financial condition and results of operations set forth above are based on our financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses. On an ongoing basis, we evaluate our estimates and judgments, including those described in our Annual Report on Form 10-K for the year ended December 31, 2014. We base our estimates on historical experience and on various assumptions that we believe to be reasonable under the circumstances. These estimates and assumptions form the basis for making judgments about the carrying values of assets and liabilities, and the reported amounts of revenues and expenses, that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. There have been no material changes to our critical accounting policies as of March 31, 2015.

 

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Item 3. Quantitative and Qualitative Disclosures About Market Risk

Market Rate Risk

We do not believe that we have material exposure to market rate risk. We may, however, require additional financing to fund future obligations and no assurance can be given that the terms of future sources of financing will not expose us to material market risk.

There has been no material change to our market rate risk exposure since December 31, 2014.

Foreign Currency Exchange

A significant portion of our operations is conducted through operations in countries other than the United States. Revenues from our international operations that were recorded in U.S. dollars represented approximately 66% of our total international revenues for the three months ended March 31, 2015. The remaining 34% were sales in British pounds. Since we conduct our business in U.S. dollars, our main exposure, if any, results from changes in the exchange rate between the British pound and the U.S. dollar. Our policy is to reduce exposure to exchange rate fluctuations by designating most of our assets and liabilities, as well as most of our revenues and expenditures, in U.S. dollars, or having them be U.S. dollar-linked. We have not historically engaged in hedging activities relating to our non-U.S. dollar operations.

There has been no material change to our foreign currency exchange risk exposure since December 31, 2014.

Item 4. Controls and Procedures

Evaluation of Disclosure Controls and Procedures

We maintain “disclosure controls and procedures,” as such term is defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that are designed to ensure that information required to be disclosed by us in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

The Company’s management, under the supervision of and with the participation of the Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the design and operation of the Company’s disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this report. Based on this evaluation, the Chief Executive Officer and Chief Financial Officer concluded that, as of March 31, 2015, the Company’s disclosure controls and procedures were not effective due to a material weakness in internal control over financial reporting reported in the Company’s Form 10-K for the period ended December 31, 2014, as filed with the SEC on March 18, 2015. The material weakness identified by management relates to revenue recognition for services transactions and contractual agreements. This material weakness continued to exist as of March 31, 2015.

Management has commenced the following steps to remediate the material weakness identified above:

 

    Staffing: In addition to a realignment of our accounting staff structure and operations, we have added key personnel in our UK office to better ensure compliance with our revenue recognition policies. We have also designed various controls around the review and approval of transactions that impact our judgment on recognizing revenue.

 

    Policies and procedures: We will be engaging external accounting experts to assist us with enhancing our policies and procedures related to revenue recognition, contracting and other areas reflected in the material weakness.

 

    Systems: We are currently implementing a series of incremental software solutions to enhance our documentation in critical areas such as revenue recognition.

 

    Process improvements: We have redesigned specific processes and controls associated with services revenue recognition, including the targeted review and approval of relevant transactions and enhanced monthly closing and reconciliation processes.

 

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The Company is implementing procedures and controls to remediate the internal controls deficiencies that have been identified and will test these procedures and controls in order to verify the remediation of such deficiencies. The Company anticipates that the implementation and testing of these controls will be completed later in 2015.

Changes in Internal Control over Financial Reporting

While there were no changes in our internal control over financial reporting that occurred during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting, the Company is in the process of instituting measures to address the material weakness in our internal control over financial reporting which is described above.

A “material weakness,” as defined by Rule 12b-2 of the Exchange Act and PCAOB Auditing Standard No. 5, Paragraph A.7, is a deficiency, or combination of deficiencies, in internal control over financial reporting such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis.

As a result of the material weakness described above, we have concluded our internal control over financial reporting was not effective at March 31, 2015.

Part II—Other Information

Item 1. Legal Proceedings

Claims and lawsuits are filed against the Company from time to time. Although the results of pending claims are always uncertain, the Company believes that it has adequate reserves or adequate insurance coverage in respect of these claims, but no assurance can be given as to the sufficiency of such reserves or insurance coverage in the event of any unfavorable outcome resulting from these actions.

Between February 1, 2012 and February 6, 2012, two putative securities class action complaints were filed against Juniper and certain of its officers and directors in the United States District Court for the District of New Jersey. These actions were filed under the captions Wright v. Columbia Laboratories, Inc., et al ., and Shu v. Columbia Laboratories, Inc., et al. and asserted claims under sections 10(b) and 20(a) of the Exchange Act and Rule 10b-5 promulgated under the Exchange Act on behalf of an alleged class of purchasers of the common stock during the period from December 6, 2010 through January 20, 2012. Both actions were consolidated into a single proceeding entitled In re Columbia Laboratories, Inc., Securities Litigation , under which Actavis, Inc., and three of its officers were added as defendants. The Consolidated Amended Complaint alleged that Juniper and two of its officers, one of whom is a director, omitted to state material facts that they were under a duty to disclose, and made materially false and misleading statements that related to the results of Juniper’s PREGNANT study and the likelihood of approval by the FDA of a New Drug Application (“NDA”) to market progesterone vaginal gel 8% for the prevention of preterm birth in women with premature cervical shortening. According to the amended complaint, these alleged omissions and misleading statements had the effect of artificially inflating the market price of the common stock. The plaintiffs sought unspecified damages on behalf of the putative class and an award of costs and expenses, including attorney’s fees. On June 11, 2013, the Court dismissed the amended complaint for failure to state a claim upon which relief could be granted, holding that the plaintiffs did not adequately plead facts supporting an inference of an intent to deceive investors. The Court permitted the plaintiffs to file a second amended complaint, and they did so on July 11, 2013. Juniper moved to dismiss the second amended complaint, which the court did on October 21, 2013. The Court ruled that changes the plaintiffs made to their first amended complaint “still do not create a strong inference that the Defendants acted with an intent to deceive, manipulate or defraud.” The Court ordered that if the plaintiffs sought to attempt to plead a cognizable action in a third amended complaint, they must do so within thirty days and specifically address why the attempt would not be futile. The plaintiffs chose not to file any further amendments and the case was dismissed with prejudice on December 2, 2013. On December 20, 2013, the plaintiffs appealed the dismissal to the United States Court of Appeals for the Third Circuit. The Court heard oral arguments on December 9, 2014. On March 10, 2015, the Court affirmed the dismissal in a written opinion. Juniper believes that the action is without merit, and intends to defend it vigorously. At this time, it is not possible to determine the likely outcome of, or to estimate the potential liability related to this action, and Juniper has not made any provision for losses in connection with it.

Item 1a. Risk Factors

Investing in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described in our Annual Report on Form 10-K for the year ended December 31, 2014 in addition to the other information included in this Quarterly Report.

 

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Item 6. Exhibits

(a) Exhibits

 

    3.1 Certificate of Amendment of Restated Certificate of Incorporation of Juniper Pharmaceuticals, Inc. (f/k/a Columbia Laboratories, Inc.) (incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-103532), filed on April 3, 2015).
    3.2 Amended and Restated By-Laws of Company (incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K (File No. 001-10352), filed on January 12, 2015).
    3.3 Amendment No. 1 to the Amended and Restated By-Laws of Juniper Pharmaceuticals, Inc. (f/k/a Columbia Laboratories, Inc.) incorporated by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K (File No. 001-10352), filed on April 3, 2015).
    4.1 Amended and Restated Rights Agreement, dated as of January 28, 2015, by and between Juniper Pharmaceuticals, Inc. (f/k/a Columbia Laboratories, Inc.) and American Stock Transfer & Trust Company, LLC, as Rights Agent (incorporated by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No. 001-10352), filed on January 30, 2015).
  10.1†* Exclusive Patent License Agreement, dated as of March 27, 2015, by and between Juniper Pharmaceuticals, Inc. (f/k/a Columbia Laboratories, Inc.) and The General Hospital Corporation, d/b/a Massachusetts General Hospital.
  31.1* Rule 13a-14(a)/15d-14(a) Certification of Chief Executive Officer of the Company.
  31.2* Rule 13a-14(a)/15d-14(a) Certification of Chief Financial Officer of the Company.
  32.1** Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
  32.2** Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101* The following materials from the Juniper Pharmaceuticals, Inc. Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, formatted in XBRL (eXtensible Business Reporting Language): (i) Consolidated Statements of Operations for the three months ended March 31, 2015 and 2014, (ii) Consolidated Balance Sheets at March 31, 2015 and December 31, 2014, (iii) Consolidated Statements of Comprehensive (Loss) Income for the three months ended March 31, 2015 and 2014, (iv) Consolidated Statements of Cash Flows for the three months ended March 31, 2015 and 2014, and (v) Notes to Consolidated Financial Statements.

 

Confidential treatment requested as to portions of the exhibit. Confidential materials omitted and filed separately with the Securities and Exchange Commission.
* Filed herewith.
** Furnished herewith.

 

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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.

 

Juniper Pharmaceuticals, Inc.

/s/ George O. Elston

George O. Elston
Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer)
DATE: May 6, 2015

 

29

Exhibit 10.1

CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

T HE G ENERAL H OSPITAL C ORPORATION

EXCLUSIVE PATENT LICENSE AGREEMENT

MGH Agreement No: A223525

MGH Case No: 02289 and 23317

This License Agreement (“Agreement”) is made as of the 25th day of March, 2015 (“Effective Date”), by and between Columbia Laboratories Inc., a Delaware corporation, having a principal place of business at Four Liberty Square, Boston, MA 02109 (“Company”) and The General Hospital Corporation, d/b/a Massachusetts General Hospital, a not-for-profit Massachusetts corporation, with a principal place of business at 55 Fruit Street, Boston, Massachusetts 02114 (“Hospital”), each referred to herein individually as a “Party” and collectively as the “Parties”.

RECITALS

Hospital, as a center for patient care, research and education, is the co-owner of certain Patent Rights (defined below) and desires to grant a license of those Patent Rights to Company in order to benefit the public by disseminating the results of its research via the commercial development, manufacture, distribution and use of Products and Processes (defined below).

Company has the capability to commercially develop, manufacture, distribute and use Products and Processes for public use and benefit and desires to license such Patent Rights.

Hospital and the Massachusetts Institute of Technology (“MIT”) have entered into an Invention and License Administration Agreement (the “ILAA”) effective April 29, 2003 under which Hospital has been granted exclusive agency rights to grant licenses and options to the Patent Rights hereunder.

For good and valuable consideration, the sufficiency of which is hereby acknowledged, the Parties hereby agree as follows:

1. CERTAIN DEFINITIONS

As used in this Agreement, the following terms shall have the following meanings, unless the context requires otherwise.

1.1 “ Affiliate ” with respect to either Party shall mean any corporation or other legal entity other than that Party in whatever country organized, controlling, controlled by or under common control with that Party. The term “control” shall mean (i) in the case of Company, direct or


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

indirect ownership of fifty percent (50%) or more of the voting securities having the right to elect directors, and (ii) in the case of Hospital, the power, direct or indirect, to elect or appoint fifty percent (50%) or more of the directors or trustees, or to cause direction of management and policies, whether through the ownership of voting securities, by contract or otherwise.

1.2 “ Claim ” shall mean any pending or issued claim of any Patent Right that has not been permanently revoked, nor held unenforceable or invalid by a decision of a court or other governmental agency of competent jurisdiction that is unappealable or unappealed in the time allowed for appeal.

1.3 “ Commercially Reasonable Efforts ” shall mean with respect to the efforts to be expended by Company with respect to the objective that is the subject of such efforts, reasonable, good faith efforts and resources to accomplish such objective that a US-based pharmaceutical company of similar size and market capitalization would normally use to accomplish a similar objective under similar circumstances when developing a women’s health product, it being understood and agreed that with respect to the development or commercialization of a Product or Process, such efforts shall be similar to those efforts and resources consistent with the usual practice of such US-based pharmaceutical company in pursuing the development or commercialization of a potential women’s health medical product owned by it or to which it has exclusive rights, with similar product characteristics as the relevant Product or Process.

1.4 “ Distributor ” shall mean any third party entity to whom Company, a Company Affiliate or a Sublicensee has granted, express or implied, the right to distribute any Product or Process pursuant to Section 2.1(b)(ii).

1.5 “ First Commercial Sale ” shall mean the initial Sale in an arms-length transaction to a third party anywhere in the applicable License Territory after obtaining necessary marketing and pricing approval from regulatory authorities of a specific Product or Process, but excluding any Sale of a reasonable quantity of Products for clinical trial purposes or marketing samples.

1.6 “ License Field ” shall mean all human and animal pharmaceutical, therapeutic, preventative, diagnostic and palliative uses, including, without limitation vaginal delivery of pharmaceuticals and shall not include any other field not specifically set forth herein.

1.7 “ License Territory ” shall mean worldwide.

1.8 “ Net Sales ” shall be calculated as set forth in this Section 1.8, all in accordance with Generally Accepted Accounting Principles (“GAAP”).

 

  (a) Subject to the conditions set forth below, “Net Sales” shall mean:

 

2


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  (i)     

(x) the gross amount invoiced, or if no such invoice is issued, the amount received by Company and its Affiliates for or on account of Sales of Products and Processes, and

(y) with respect to royalties based on Net Sales due from Sublicensee as set forth in Section 4.4(a), the gross amount invoiced, or if no such invoice is issued, the amount received by Sublicensee for or on account of Sales of Products and Processes (“Sublicensee Net Sales”);

 

  (ii) less the following amounts to the extent separately stated on the invoice, actually paid or credited by Company and its Affiliates in effecting such Sale:

 

  1. amounts repaid or credited by reason of charge-backs, retroactive price reductions, billing errors, rejection or return of applicable Products or Processes, and cash, credit or free goods allowances;

 

  2. reasonable and customary trade, quantity or cash rebates (including without limitation, government mandated and managed care rebates) or discounts to the extent allowed and taken;

 

  3. amounts for outbound transportation, insurance, packaging, handling and shipping, but only to the extent separately invoiced in a manner that clearly specifies the charges applicable to the applicable Products; and

 

  4. import, export, excise and sales taxes, customs duties, value added taxes, and other governmental charges levied on or measured by Sales of Products or Processes, whether paid by or on behalf of Company, but not franchise or income taxes of any kind whatsoever.

 

  (b) [reserved]

 

  (c) Specifically excluded from the definition of “Net Sales” are amounts attributable to any Sale of any Product or Process between or among Company and any Company Affiliate and/or Sublicensee, unless the transferee is the end purchaser, user or consumer of such Product or Process.

 

3


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  (d) No deductions shall be made for any commissions paid to any individuals or for any costs or expenses of collections.

 

  (e) Net Sales shall be deemed to have occurred and the applicable Product or Process “Sold” on the earliest of the date of billing, invoicing, delivery or payment or the due date for payment.

 

  (f) If any Product or Process is Sold at a discounted price that is substantially lower than the customary non-discounted and discounted price charged, or for non-cash consideration (whether or not at a discount), Net Sales for such Product or Process shall be calculated based on the non-discounted cash amount charged to an independent third party for the Product or Process during the same Reporting Period or, in the absence of such transaction, on the fair market value of the Product or Process. Non-cash consideration that could affect any payment due to Hospital hereunder shall not be accepted without the prior written consent of Hospital.

 

  (g) In the event Company or an Affiliate or Sublicensee (as used in this Section 1.8(g) each a “Combination Product Seller”) uses a functionally active component (for clarity, functionally active components shall exclude routine components including without limitation common buffers and standard cell culture media) not licensed by Hospital to Company hereunder (“Other Components”) to form a product that is a combination of a Product and/or Process and Other Component(s) (a “Combination Product”), Net Sales for the purposes of calculating the royalty owed to Hospital on Sales of such Product and/or Process shall be calculated as described in the subsections below:

 

  (i)

If all Products and/or Processes and Other Components contained in the Combination Product(s) are Sold separately, Net Sales for Sales of Products and/or Processes for the purposes of calculating royalty payments shall be determined by multiplying the greatest of the gross amount invoiced, or if no such invoice is issued the amount received by the Combination Product Seller for or on account of Sales of Combination Products (for the purposes of this Section 1.8(g), the “Gross Sales Price”) by the fraction A/(A+B), in which “A” is the Gross Sales Price of the Product and/or Process portion of the Combination Product when Sold separately during the most recent Reporting Period in the country in which the Sale was made, and “B” is the Gross Sales Price of the Other Components of the Combination Product Sold separately during said Reporting Period in said country. For clarity, a Product or Process that

 

4


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  delivers a drug either sold separately by Company or acquired from a third party shall not be considered a Combination Product with respect to such drug being included in such Product or Process.

 

  (ii) If the Combination Product contains Products and/or Processes or Other Components not sold separately (and thus the Gross Sales Price is not available for such Products and/or Processes or Other Components), then Net Sales for purposes of determining royalty payments will be calculated as above, but the Gross Sales Price in the above equation shall be determined by mutual agreement reached in good faith by the Parties prior to the end of the accounting period in question based on an equitable method of determining same that takes into account, in the applicable country, variations in dosage units and the relative fair market value of each Other Component in the Combination Product. If the Parties are unable to reach such an agreement prior to the end of the applicable accounting period, then the Parties will refer such matter for dispute resolution pursuant to Section 12.15 .

1.9 “Patent Rights ” shall mean, inclusively, U.S. patent number 7,833,545, filed on April 29, 2004, and U.S. provisional patent application 62/121,893 filed February 27, 2015 , and (a) any patent applications resulting from the provisional applications listed on Appendix A , (b) any foreign counterparts thereof, (c) all divisionals, continuations, continuations in-part (but only to the extent the claims are directed to the subject matter specifically described in the aforementioned applications in this paragraph) thereof, and (d) all patents issued or issuing on any of the foregoing, and any foreign counterparts thereof, together with all registrations, reissues, re-examinations, renewals, supplemental protection certificates, or extensions of any of the foregoing, and any foreign counterparts thereof, as may be further described in Appendix A .

1.10 “ Process ” shall mean any process, method or service the use or performance of which, in whole or in part:

 

  (a) absent the license granted hereunder would infringe, or is covered by, one or more Claims of Patent Rights (“Patented Process”); or

 

  (b) does not meet the requirements of the foregoing clause “(a)” but incorporates or is based upon Technological Information (“Unpatented Process”).

1.11 “ Product ” shall mean any article, device or composition, the manufacture, use, or sale of which, in whole or in part:

 

5


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  (a) absent the license granted hereunder would infringe, or is covered by, one or more Claims of Patent Rights; (“Patented Product”) or

 

  (b) does not meet the requirements of the foregoing clause “(a)” but incorporates or is based upon Technological Information (“Unpatented Product”).

1.12 “ Reporting Period ” shall mean each three month period ending March 31, June 30, September 30 and December 31.

1.13 “ Sell ” (and “Sale” and “Sold” as the case may be) shall mean to sell or have sold, to lease or have leased, to import or have imported for valuable consideration (in the form of cash or otherwise), or otherwise to transfer or have transferred a Product or Process for valuable consideration (in the form of cash or otherwise), and further in the case of a Process to use or perform such Process for the benefit of a third party.

1.14 “ Sublicense Income ” shall mean consideration in any form received by Company and/or Company’s Affiliate(s) in connection with or otherwise attributable to a grant of a sublicense or any other right, license, privilege or immunity (regardless of whether such grantee is a “Sublicensee” as defined in this Agreement) to make, have made, use, have used, Sell or have Sold Products or Processes, but excluding royalties on or consideration included within Net Sales except to the extent provided under Section 4.4(a). Sublicense Income shall include without limitation any license signing fee, license maintenance fee, milestone payment (other than for a milestone event for which Hospital receives a milestone payment under Section 4.3 hereof), unearned portion of any minimum royalty payment, distribution or joint marketing fee whether or not including sublicense rights, research and development funding in excess of the cost of performing such research and development plus reasonable overhead charges, and any consideration received for an equity interest in, extension of credit to or other investment in Company or Company’s Affiliates to the extent such consideration exceeds the fair market value of the equity or other interest received as determined by agreement of the Parties or by an independent appraiser mutually agreeable to the Parties. Sublicense Income shall not include payments made to reimburse direct costs such as (i) payments or reimbursement for documented sponsored research and/or development activities, valued at the actual direct cost of such activities plus reasonable overhead charges; or (ii) payment or reimbursement of reasonable patent expenses actually incurred or paid by Company and not otherwise reimbursed, or payment of patent expenses required to be paid by Company hereunder. Sublicense Income shall also not include (iii) payments received with respect to a change of control of the Company; and (iv) payments for the purchase of equity in the Company at the fair market value of such equity. In the event a sublicense grants rights to both the Company’s or third party’s patented technology and the Patent Rights and/or Technological Information, the Sublicense Income will be reduced by an amount proportional to the relative value of the Company’s or third party’s patented

 

6


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

technology as determined by agreement of the Parties or by an independent appraiser mutually agreeable to the Parties.

1.15 “ Sublicensee ” shall mean any sublicensee of rights granted in accordance with Section 2.1(a)(ii). For purpose of this Agreement, a Distributor of a Product or Process shall not be included in the definition of Sublicensee unless such Distributor (i) is granted any right to make, have made, use or have used Products or Processes in accordance with Section 2.1(a)(ii), or (ii) has agreed to pay to Company or its Affiliate(s) royalties on such Distributor’s sales of Products or Processes, in which case such Distributor shall be a Sublicensee for all purposes of this Agreement. For clarity, a clinic that is granted the right to use or have used Products or Processes to treat patients shall not be considered a Sublicensee if the Company or its Affiliate(s) do not receive royalties or other payments (other than the price paid for the Product) related to such clinic’s use of Products or Processes

1.16 “ Technological Information ” shall mean any materials, reports, data summaries, and other information, methods, protocols, data, know-how, or other intellectual property for which no patent has been filed whether or not patentable, but excluding Patent Rights, pertaining to the vaginal ring technology platform that is the subject of the Patent Rights and owned or controlled by Hospital and/or MIT as applicable, as of the Effective Date, with the right to license (other than the Patent Rights). In particular, Technological Information shall include the know-how possessed by investigators Crowley, Langer, and Ron as of the Effective Date and that is not confidential information of or otherwise obligated to any third party and which any of Drs. Crowley, Langer, and Ron knows as of the Effective Date and reasonably believes is necessary in order for Company to utilize the licenses granted hereunder. Company agrees to treat all Technological Information in accordance with the provisions of Appendix D.

2. LICENSE

2.1 Grant of License .

 

  (a) Subject to the terms of this Agreement and Hospital’s and MIT’s rights in Patent Rights, Hospital hereby grants to Company in the License Field in the License Territory:

 

  (i) an exclusive, royalty-bearing license under its rights in Patent Rights to make, have made, use, have used, Sell, have Sold, import and have imported Products and Processes;

 

  (ii) a non-exclusive, royalty-bearing license to use the Technological Information to make, have made, use, have used, Sell, have Sold, import and have imported Products and Processes; and

 

7


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  (iii) the right to grant sublicenses under the rights granted in Sections 2.1(a)(i) and 2(a)(ii) to Sublicensees (including the right for Sublicensees to grant further sublicenses consistent with these terms), provided that in each case Company shall be responsible for the performance of any obligations of Sublicensees relevant to this Agreement as if such performance were carried out by Company itself, including, without limitation, the payment of any royalties or other payments provided for hereunder, regardless of whether the terms of any sublicense provide for such amounts to be paid by the Sublicensee directly to Hospital.

 

  (b) The license granted in Section 2.1(a) above includes:

 

  (i) the right to grant to the final purchaser, user or consumer of Products the right to use such purchased Products in a method coming within the scope of Patent Rights and Technological Information within the License Field and License Territory; and

 

  (ii) the right to grant a Distributor the right to Sell, have Sold, use, have used, import and have imported (but not to make and have made) such Products and/or Processes for or on behalf of Company, its Affiliates and Sublicensees in a manner consistent with this Agreement.

 

  (c) The foregoing license grant shall include the grant of such license to any Affiliate of Company, provided that such Affiliate shall assume the same obligations as those of Company and be subject to the same terms and conditions hereunder; and further provided that Company shall be responsible for the performance of all of such obligations and for compliance with all of such terms and conditions by Affiliate. Company shall provide to Hospital and MIT a fully signed, non-redacted copy of each agreement with each Affiliate that assumes the aforesaid obligations, including all exhibits, attachments and related documents and any amendments, within thirty (30) days of request by Hospital.

2.2 Sublicenses . Each sublicense granted hereunder shall be consistent with and comply with all relevant terms of this Agreement, shall incorporate terms and conditions sufficient to enable Company to comply with this Agreement, shall provide that Company shall be responsible for performance of all such obligations and for compliance with all such terms and conditions by Sublicensees Company shall provide to Hospital and MIT a fully signed redacted (to remove content unrelated to obligations due Hospital or MIT) copy of all sublicense agreements and amendments thereto, including all exhibits, attachments and related documents, within thirty (30)

 

8


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

days of executing the same. Upon termination of this Agreement or any license granted hereunder for any reason, any Sublicenses shall be addressed in accordance with Section 10.7.

2.3 Retained Rights; Requirements . Any and all licenses granted hereunder are subject to:

 

  (a) the right of Hospital, Hospital’s Affiliates, MIT and other academic, government and not-for-profit institutions to make, have made, and to use the subject matter described and/or claimed in the Patent Rights for research, teaching, and educational purposes (such research, teaching and educational purposes shall not include the production and manufacture of Products or Processes for sale); and

 

  (b) for Patent Rights supported by federal funding, the rights, conditions and limitations imposed by U.S. law ( see 35 U.S.C. § 202 et seq . and regulations pertaining thereto), including without limitation:

 

  (i) the royalty-free non-exclusive license granted to the U.S. government; and

 

  (ii) the requirement (to the extent required by law) that any Products used or sold in the United States shall be manufactured substantially in the United States.

2.4 No Additional Rights . It is understood that nothing in this Agreement shall be construed to grant Company or any of its Affiliates a license, express or implied, under any patent owned solely or jointly by Hospital and/or MIT other than the Patent Rights expressly licensed hereunder. Hospital shall have the right to license any Patent Rights to any other party for any purpose outside of the License Field or the License Territory.

2.5 Disclosure of Technological Information . At Company’s request prior to execution of this Agreement, Hospital (through Dr. Langer and Dr. Crowley) shall use reasonable efforts to disclose in confidence within three (3) months after execution of this Agreement the Technological Information licensed hereunder.

 

9


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

3. DUE DILIGENCE OBLIGATIONS

3.1 Diligence Requirements . Company shall use, and shall cause its Affiliates and Sublicensees, as applicable, to use, Commercially Reasonable Efforts to develop and make available to the public at least one Product and/or Processes in the License Territory in the License Field. Such efforts shall include achieving the following objectives within the time periods designated below, the achievement of which shall be deemed to fully satisfy Company’s, or its Affiliates’ or Sublicensee’s obligation to use Commercially Reasonable Efforts as set forth in this Section 3.1:

 

  (a) Pre-Sales Requirements .

 

  (i) Within [****] of the Effective Date, invest at least [****] in the development and/or commercialization of Products or Processes.

 

  (ii) Within [****] of the Effective Date, invest at least [****] in the development and/or commercialization of Products or Processes.

 

  (iii) Within [****] of the Effective Date, invest at least [****] in the development and/or commercialization of Products or Processes.

 

  (iv) Within [****] of the Effective Date, invest at least [****] in the development and/or commercialization of Products or Processes.

 

  (v) Within [****] of the Effective Date, file for an IND on a Product or Process or invest at least [****] in the development and/or commercialization of Products or Processes.

 

  (vi) Within [****] of satisfying 3.1(a)(iv) above, apply for an NDA or PMA on a Product or Process.

 

  (vii) Within [****] of satisfying 3.1(a)(v) above, make a First Commercial Sale or file a second IND on a Product or Process.

 

10


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  (b) Purchased Extensions of Time . The Company may elect to extend the time period for a particular diligence requirement set forth in 3.1(a) by [****] upon notice to Hospital and payment of a non refundable extension payment of [****]. The extension of time, once elected and paid for, shall have the effect of extending all subsequent diligence requirements set forth in 3.1(a). Company may exercise the extension of time under this section no more than two times over the life of the Agreement (not per diligence requirement).

3.2 Diligence Failures . In the event Company has failed to fulfill any of its obligations under Section 3.1(a), and subject to resolution under the dispute resolution provisions of Section 12.15 hereof, then Hospital may treat such failure as a default and may terminate this Agreement and/or any license granted to Company hereunder in accordance with Section 10.4.

3.3 Diligence Reports . Company shall provide all reports with respect to its obligations under Section 3.1 as set forth in Section 5.

4. PAYMENTS AND ROYALTIES

4.1 Patent Cost Reimbursement . Company shall reimburse Hospital for all costs associated with the preparation, filing, prosecution and maintenance of all Patent Rights (“Patent Costs”) incurred during the Term. Patent Costs shall not include the cost of time of staff members of Hospital’s Innovation office to attend to patent prosecution matters unless previously agreed to in writing by Company. As of the Effective Date, Hospital and MIT have incurred approximately [****] in Patent Costs, which amount Company shall pay to Hospital within forty-five (45) days of the Effective Date of this Agreement. Company shall pay to Hospital, or at Hospital’s request directly to patent counsel, all other Patent Costs within forty-five (45) days of Company’s receipt of an invoice for such Patent Costs either from Hospital or Hospital’s patent counsel. Hospital shall instruct patent counsel to provide copies to Hospital for Hospital’s administrative files of all invoices detailing Patent Costs which are sent directly to Company. If Company pays any Patent Costs directly, Company shall advise patent counsel that Hospital is and shall remain patent counsel’s client.

4.2 Annual License Fee; Annual Minimum Royalty .

 

  (a) Company shall pay to Hospital the following non-refundable amounts as an annual license fee within thirty (30) days after each of the following anniversaries of the Effective Date:

 

  (i) the first anniversary of the Effective Date: fifty thousand dollars ($50,000);

 

11


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  (ii) the second anniversary of the Effective Date: fifty thousand dollars ($50,000);

 

  (iii) the third anniversary of the Effective Date: fifty thousand dollars ($50,000);

 

  (iv) the fourth anniversary of the Effective Date: fifty thousand dollars ($50,000);

 

  (v) the fifth anniversary of the Effective Date: fifty thousand dollars ($50,000);

 

  (vii) the sixth anniversary and on each subsequent anniversary of the Effective Date thereafter: one hundred thousand dollars ($100,000).

 

  (b) The annual minimum royalty shall be credited against royalties subsequently due on Net Sales and Sublicense Income made during the same calendar year, if any, but shall not be credited against royalties due on Net Sales and Sublicense Income made in any other year.

4.3 Milestone Payments . In addition to the payments set forth in Sections 4.1 and 4.2 above, Company shall pay Hospital milestone payments of one million two-hundred thousand dollars ($1,200,000), as follows:

 

  (a) [****] within thirty (30) days of completion of the first successful Phase 2B trial or equivalent of a Product or Process,

 

  (b) [****] within thirty (30) days of completion of the first successful Phase 3 or equivalent trial of a Product or Process,

 

  (c) [****] within thirty (30) days of completion of the First Commercial Sale in the US of a Product or Process,

 

  (d) [****] within thirty (30) days of completion of the First Commercial Sale of a subsequent distinct Product or Process such as (i) a new Product or Process other than a product line extension, or (ii) a Product or Process containing a new active ingredient, and

 

  (e)

[****] within thirty (30) days of completion of the First Commercial Sale of a second subsequent distinct Product or Process such as (i) a new Product or Process other than

 

12


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  a product line extension, or (ii) a Product or Process containing a new active ingredient.

For the avoidance of doubt, each of the milestones (a) through (e) above shall be paid only once, regardless of the number of disease indications or Products or Processes developed under the Agreement.

4.4 Royalties and Sublicense Income .

 

  (a) Subject to Section 4.4(d), beginning with the First Commercial Sale in any country in the License Territory, Company shall pay Hospital based on Net Sales in each calendar year:

 

  (i) a royalty of [****] of the Net Sales of all Patented Products and Patented Processes on that portion of aggregate Net Sales of all Patented Products and Patented Processes equal to or less than three hundred fifty million dollars ($350,000,000) in such calendar year; and

 

  (ii) a royalty of [****] of the Net Sales of all Patented Products and Patented Processes on that portion of aggregate Net Sales of all Patented Products and Patented Processes greater than three hundred fifty million dollars ($350,000,000) in such calendar year; or

 

  (iii) in lieu of any royalty payable under (i) or (ii) above, a royalty of [****] of the Net Sales of all Unpatented Products and Unpatented Processes.

Provided that with respect to Sublicensee Net Sales, the royalty to be paid to the Hospital on such Sublicensee Net Sales will be the greater of: (i) [****] of Sublicensee Net Sales or (ii) the amount of Sublicense Income that Company would owe to Hospital if such royalties paid by sublicensee to Company were deemed to be included in Sublicense Income. Notwithstanding the foregoing, Hospital shall be entitled to a minimum royalty of [****] of Sublicensee Net Sales. Such minimum royalty is an absolute minimum royalty rate and cannot be further reduced by any means including but not limited to adjustments for royalty stacking or combination products, except to the extent Company is also subject to such combination product adjustments as applied to the royalties paid by sublicensee to Company, provided that such combination product adjustment will be consistent with the combination product language in Section 1.8(g).

 

13


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

Royalties due hereunder will terminate Product by Product and Process by Process on a country by country basis upon such Product or Process becoming subject to generic competition.

 

  (b) In the event that Company is legally required to make royalty payments to one or more third parties in order to develop or commercialize the Product or Process, Company may offset a total of [****] of such third-party payments against any royalty payments that are due under Section 4.4(a) to Hospital in the same Reporting Period, provided that in no event shall the royalty payments under Section 4.4(a), when aggregated with any other offsets and credits allowed under this Agreement, be reduced by more than [****] in any Reporting Period.

 

  (c) Company shall pay Hospital [****] of any and all Sublicense Income for Sublicenses executed before the second anniversary of the Effective Date and [****] of any and all Sublicense Income for Sublicenses executed after the second anniversary of the Effective Date.

 

  (d) To the extent any Net Sales or Sublicensee Net Sales arise from the Sale of Product by Company or its Affiliates or Sublicensees for or on account of Sales of Products and Processes to Hospital and Hospital’s Affiliates, then Company shall, in lieu of paying any royalties to Hospital hereunder, pay directly to MIT [****] of the royalties that would have been due to Hospital with respect to such Net Sales or Sublicensee Net Sales, as the case may be, in accordance with this Section 4.4(d). These Net Sales or Sublicensee Net Sales, as the case may be, will be reported separately and specifically indicated per the reporting requirements of Section 5.3(c). Hospital reserves the right to modify or eliminate this Section 4.4(d) at any time upon written notice to Company to reflect changes in Hospital’s policies that would allow the Hospital to receive full or partial royalty payments on the Sales of Products or Processes to Hospital and Hospital’s Affiliates.

 

  (e) All payments due to Hospital (or MIT pursuant to Section 4.4(d)) under this Section 4.4 shall be due and payable by Company within sixty (60) days after the end of each Reporting Period, and shall be accompanied by a report as set forth in Sections 5.3 and 5.4.

4.5 Form of Payment . All payments due under this Agreement shall be drawn on a United States bank and shall be payable in United States dollars. Each payment shall reference this Agreement and its Agreement Number and identify the obligation under this Agreement that the payment satisfies. Conversion of foreign currency to U.S. dollars shall be made at the conversion rate existing in the United States, as reported in The Wall Street Journal, on the last working day of the applicable Reporting Period, consistent with GAAP. Such payments shall be

 

14


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

without deduction of exchange, collection or other charges, and, specifically, without deduction of withholding or similar taxes or other government imposed fees or taxes, except as permitted in the definition of Net Sales.

Checks for all payments due to the Hospital under this Agreement shall be made payable to the Hospital and addressed as set forth below:

Massachusetts General Hospital

BOA-Lockbox Services

PCSR Lockbox #415007

MA5-527-02-07

2 Morrissey Blvd

Dorchester, MA 02125

Reference Agreement #: A223525

Payments via wire transfer should be made as follows:

ACH Credit: ABA # 011-000-138

Federal Reserve Wire: ABA#026-009-593

SWIFT Code: BOFAUS3N

Account #0050169434

Massachusetts General Hospital

Bank of America

100 Federal Street

Boston, MA 02110

Reference Agreement #: A223525

Checks for all payments to be made to MIT in pursuant to Section 4.4(d) shall be made payable to “Massachusetts Institute of Technology” and sent to the address below:

Massachusetts Institute of Technology

Technology Licensing Office, Room NE18-501

255 Main Street

Cambridge, MA 02142-1601

Attention: Director

4.6 Overdue Payments . The payments due under this Agreement shall, if overdue, bear interest beginning on the first day following the Reporting Period to which such payment was incurred and until payment thereof at a per annum rate equal to [****] above the prime rate in

 

15


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

effect on the due date as reported by The Wall Street Journal, such interest rate being compounded on the last day of each Reporting Period, not to exceed the maximum permitted by law. Any such overdue payments when made shall be accompanied by all interest so accrued. Said interest and the payment and acceptance thereof shall not preclude Hospital from exercising any other rights it may have as a consequence of the lateness of any payment.

5. REPORTS AND RECORDS

5.1 Diligence Reports . Within sixty (60) days after the end of each calendar year, Company shall report in writing to Hospital on progress made toward the objectives set forth in Section 3.1 during such preceding 12 month period, including, without limitation, progress on research and development, status of applications for regulatory approvals, manufacturing, sublicensing and the number of sublicenses entered into and marketing.

5.2 Milestone Achievement Notification . Company shall report to Hospital the dates on which it achieves the milestones set forth in Section 4.3 within sixty (60) days of each such occurrence.

5.3 Sales Reports . Company shall report to Hospital the date of the First Commercial Sale in each country of the License Territory within the later of sixty (60) days after the applicable Reporting Period of each such occurrence, or sixty (60) days after Company is notified by a Sublicensee of a First Commercial Sale made by such Sublicensee, but in no event later than one-hundred twenty (120) days after the date of such First Commercial Sale. Following the First Commercial Sale, Company shall deliver reports to Hospital within the later of sixty (60) days after the end of each Reporting Period, or sixty (60) days after Company receives a corresponding report from its Sublicensee, but in no event later than one-hundred twenty (120) days after the end of such Reporting Period. Each report under this Section 5.4 shall have substantially the format outlined in Appendix B , shall be certified as correct by an officer of Company and shall contain at least the following information as may be pertinent to a royalty accounting hereunder for the immediately preceding Reporting Period:

 

  (a) the number of Products and Processes Sold by Company, its Affiliates and Sublicensees in each country;

 

  (b) the amounts billed, invoiced and received by Company, its Affiliates and Sublicensees for each Product and Process, in each country, and total billings or payments due or made for all Products and Processes;

 

  (c) calculation of Net Sales for the applicable Reporting Period in each country, including an itemized listing of permitted offsets and deductions;

 

16


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  (d) total royalties payable on Net Sales in U.S. dollars, together with the exchange rates used for conversion; and

 

  (e) any other payments due to Hospital under this Agreement.

If no amounts are due to Hospital for any Reporting Period, the report shall so state.

5.4 Sublicense Income Reports . Company shall, along with delivering payment as set forth in Section 4.5, report to Hospital within sixty (60) days of receipt the amount of all Sublicense Income received by Company, and Company’s calculation of the amount due and paid to Hospital from such income, including an itemized listing of the source of income comprising such consideration, and the name and address of each entity making such payments in substantially the format outlined in Appendix C .

5.5 Audit Rights . Company shall maintain, and shall cause each of its Affiliates and Sublicensees to maintain, complete and accurate records relating to the rights and obligations under this Agreement and any amounts payable to Hospital in relation to this Agreement, which records shall contain sufficient information to permit Hospital to confirm the accuracy of any payments and reports delivered to Hospital and compliance in all other respects with this Agreement. Company shall retain and make available, and shall cause each of its Affiliates and Sublicensees to retain and make available as set forth below, such records for at least five (5) years following the end of the calendar year to which they pertain, to Hospital upon at least fifteen (15) days’ advance written notice, for examination during normal business hours, by independent certified public accountants hired by Hospital and reasonably acceptable to Company, its Affiliates and Sublicensees, as the case may be, to verify any reports and payments made and/or compliance in other respects under this Agreement. Company may require such accountants to enter into a reasonably acceptable confidentiality agreement, and in no event shall such accountants disclose to Hospital any information, other than such as relates to the accuracy of the corresponding reports pursuant to Section 5 . Such confidentiality agreement shall permit such accountants to perform all activities typically associated with an audit of a license agreement. The foregoing right of examination may be exercised only once in relation to each twelve (12)-month period during the Term. If any examination conducted by such independent certified public accountants pursuant to the provisions of this Section show an underreporting or underpayment of five percent (5%) or more in any payment due to Hospital hereunder, Company shall bear the full cost of such audit and shall remit any amounts due to Hospital (including interest due in accordance with Section 4.6) within thirty (30) days of receiving notice thereof from Hospital.

 

17


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

6. PATENT PROSECUTION AND MAINTENANCE

6.1 Prosecution . Hospital shall be responsible for the preparation, filing, prosecution and maintenance of all patent applications and patents included in Patent Rights by outside patent counsel selected by Hospital and reasonably acceptable to Company. Company shall reimburse Hospital for Patent Costs incurred by Hospital relating thereto in accordance with Section 4.1.

6.2 Copies of Documents . With respect to any Patent Right licensed hereunder, Hospital shall instruct the patent counsel prosecuting such Patent Right to (i) promptly copy Company on patent prosecution documents that are received from or filed with the United States Patent and Trademark Office and foreign equivalent, as applicable; (ii) promptly provide Company with copies of draft submissions to the USPTO prior to filing with reasonably sufficient time for Company and its patent counsel to review and provide comments for incorporation into such submission; and (iii) consult with Company, and take any of Company’s or its patent counsel’s comments and requests into good faith consideration, with respect to the preparation, prosecution and maintenance of the Patent Rights.

6.3 Company’s Election Not to Proceed . Company may elect to surrender any patent or patent application in Patent Rights in any country upon sixty (60) days advance written notice to Hospital (“Waived Patent Rights”). Such notice shall relieve Company from the obligation to pay for future Patent Costs but shall not relieve Company from responsibility to pay Patent Costs incurred prior to the expiration of the sixty (60) day notice period:

 

  (a) If the Waived Patent Rights are in [****], such patent application or patent in such country shall thereupon cease to be a Patent Right hereunder and Hospital shall be free to license its rights to that particular U.S. or foreign patent application or patent to any other party on any terms.

 

  (b) If the Waived Patent Rights are in any other country (i.e., other than a country set forth above in (a)), the licenses granted with respect to such patent application or patent in such other country under Section 2.1(a)(i) shall thereupon become non-exclusive, Company will be obligated to pay a royalty on Unpatented Products and Unpatented Processes in those countries at the rates set forth in Section 4.4, and Hospital shall be free to license its rights non-exclusively to that particular patent application or patent in such other country to any other party on any terms.

6.4 Confidentiality of Prosecution and Maintenance Information . Company agrees to treat all information related to prosecution and maintenance of Patent Rights as Confidential Information in accordance with the provisions of Appendix D .

 

18


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

7. THIRD PARTY INFRINGEMENT AND LEGAL ACTIONS

7.1 Company Right to Prosecute . Each Party agrees to immediately notify the other Party in writing upon becoming aware of any infringement of the Patent Rights in the License Field and provide to the other Party all reasonably-available evidence of such infringement. Company shall have the first right, but not the obligation, to protect Patent Rights from infringement and prosecute infringers in the License Field in the License Territory. Before commencing such action, Company and, as applicable, any Affiliate, shall consult with Hospital, concerning, among other things, Company’s standing to bring suit, the advisability of bringing suit, the selection of counsel and the jurisdiction for such action (provided Company must have Hospital’s and MIT’s prior written consent, not to be unreasonably withheld, conditioned or delayed, with respect to selection of jurisdiction for any action in which Hospital and/or MIT may be joined as a party-plaintiff) and shall use reasonable efforts to accommodate the views of Hospital regarding the proposed action, including without limitation with respect to potential effects on the public interest. Company shall be responsible for all costs, expenses and liabilities in connection with any such action and shall indemnify and hold Hospital and MIT harmless therefrom, regardless of whether Hospital and/or MIT is a party-plaintiff, except for the expense of any independent counsel retained by Hospital or MIT in accordance with Section 7.5 below. If Hospital shall have supplied Company with written evidence demonstrating to Company’s reasonable satisfaction prima facie infringement of a claim of a Patent Right in the License Field in the License Territory by a third party, Hospital may by notice request Company to take steps to protect such Patent Right. Company shall notify Hospital within three (3) months of the receipt of such notice whether Company intends to prosecute the alleged infringement. If Company notifies Hospital that it intends to so prosecute, Company shall, within three (3) months after its notice to Hospital either (i) cause such infringement to terminate, or (ii) initiate legal proceedings against the infringer.

7.2 Hospital Right to Prosecute . In the event Company notifies Hospital that Company does not intend to prosecute infringement identified under Section 7.1, or in the event that Company is unsuccessful in persuading the alleged infringer to desist, Hospital has the right, but not the obligation, upon notice to Company, to initiate legal proceedings against the infringer at Hospital’s expense with respect to a claim of a Patent Right in the License Field in the License Territory, and any recovery obtained shall first be applied to reimbursement of any legal fees and expenses incurred by either Party and the remainder shall belong to Hospital.

7.3 Hospital and MIT Joined as Party-Plaintiff . If Company elects to commence an action as described in Section 7.1 above, Hospital and MIT shall each have, in its sole discretion, the option to join such action as party-plaintiffs. If Hospital and MIT are required by law to join such action as party-plaintiffs, Hospital and MIT may either (i) in their joint discretion, permit themselves to be joined as party-plaintiffs at the sole expense of Company, or (ii) assign to Company all of Hospital’s and MIT’s right, title and interest in and to the Patent Right which is

 

19


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

the subject of such action (subject to all of Hospital’s and MIT’s obligations to the government under law and any other rights that others may have in such Patent Right). If Hospital and MIT make such an assignment, such action by Company shall thereafter be brought or continued without Hospital or MIT as a party; provided, however, that Hospital and MIT shall continue to have all rights of prosecution and maintenance with respect to Patent Rights and Company shall continue to meet all of its obligations under this Agreement as if the assigned Patent Right were still licensed to Company hereunder.

7.4 Notice of Actions; Settlement . The Party commencing an action as described under this Section 7 shall promptly inform the other of any action or suit relating to Patent Rights and shall not enter into any settlement, consent judgment or other voluntary final disposition of any action relating to Patent Rights, including but not limited to appeals, without the prior written consent of such other Party, such consent not to be unreasonably withheld, conditioned or delayed.

7.5 Cooperation . Each Party agrees to cooperate reasonably in any action under Section 7 which is controlled by the other Party, provided that the controlling party reimburses the cooperating party for any costs and expenses incurred by the cooperating party in connection with providing such assistance, except for the expense of any independent counsel retained by the cooperating party in accordance with this Section 7.5. Such controlling party shall keep the cooperating party informed of the progress of such proceedings and shall make its counsel available to the cooperating party. The cooperating party shall also be entitled to independent counsel in such proceedings but at its own expense, said expense to be offset against any damages received by the Party bringing suit in accordance with Section 7.6.

7.6 Recovery . Any award paid by third parties as the result of proceedings brought by Company under Section 7.1 (whether by way of settlement or otherwise) shall first be applied to reimbursement of any legal fees and expenses incurred by either Party (or MIT as applicable); and then Company shall receive an amount equal to its lost profits or a reasonable royalty on the infringing sales, or whichever measure of damages the settlement or court shall have applied (“Damages”), such Damages will be deemed to constitute Net Sales hereunder for which Hospital will receive the royalty amounts set forth in Section 4.4, and then the remainder shall be shared equally by the Parties.

8. INDEMNIFICATION AND INSURANCE

8.1 Indemnification .

 

  (a)

Company shall indemnify, defend and hold harmless MIT, Hospital and its Affiliates and their respective trustees, directors, officers, medical and professional staff, employees, faculty, students, and agents and their respective

 

20


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  successors, heirs and assigns (the “Indemnitees”), against any liability, damage, loss or expense (including reasonable attorney’s fees and expenses of litigation)(collectively, “Losses”) incurred by or imposed upon the Indemnitees or any one of them in connection with any claims, suits, actions, demands or judgments arising out of or related to the exercise of any rights granted to Company under this Agreement, any breach of this Agreement by Company, or any theory of product liability (including, but not limited to, actions in the form of contract, tort, warranty, or strict liability) concerning any product, process or service made, used, or sold or performed pursuant to any right or license granted under this Agreement (collectively, “Claims”), except to the extent such Losses arise from the gross negligence or willful misconduct of an Indemnitee.

 

  (b) An Indemnitee that intends to claim indemnification under this Section 8.1 shall promptly notify Company of any claim in respect of which the Indemnitee intends to claim such indemnification reasonably promptly after the Indemnitee is aware thereof before any formal deadline for responding to a such claim has passed, and Company shall assume the defense of such Claim with counsel mutually satisfactory to the Parties; provided, however , that an Indemnitee shall have the right to retain its own counsel and participate in the defense thereof at its own cost and expense, and further provided, that any Indemnitee shall have the right to retain its own counsel, at the expense of Company, if representation of such Indemnitee by counsel retained by Company would be inappropriate because of conflict of interests of such Indemnitee and any other party represented by such counsel.

 

  (c) The indemnity obligation in this Section 8.1 shall not apply to amounts paid in settlement of any Claim if such settlement is effected by or on behalf of an Indemnitee without the consent of Company. The Indemnitee under this Section 8.1 shall cooperate fully with Company and its legal representatives in the investigation and defense of any matter covered by this indemnification. Company agrees to keep Hospital and MIT informed of the progress in the defense and disposition of such claim and to consult with Hospital and MIT prior to any proposed settlement.

 

  (d) This section 8.1 shall survive expiration or termination of this Agreement.

8.2 Insurance .

 

  (a)

Company shall, at its sole cost and expense, procure and maintain commercial general liability and products-completed operations liability insurance policy(ies) in amounts not less than [****] per incident and [****] annual aggregate which

 

21


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  shall be issued by an insurer licensed to practice in the Commonwealth of Massachusetts and which shall name the Indemnitees as additional insureds. Such insurance shall provide (i) product liability coverage (ii) errors and omissions liability coverage and (iii) contractual liability coverage. The limits of such insurance shall not be less than [****] per occurrence with an annual aggregate of [****] for bodily injury including death; [****] per occurrence with an annual aggregate of [****] for property damage; and [****] per occurrence with an annual aggregate of [****] for errors and omissions. If Company desires to self-insure all or part of the limits described above (including deductibles or retentions which are in excess of [****] annual aggregate) such self-insurance program must be acceptable to the Hospital, MIT and the Risk Management Foundation. The minimum amounts of insurance coverage required under this Section 8.2 shall not be construed to create a limit of Company’s liability with respect to its indemnification under Section 8.1 of this Agreement.

 

  (b) Company shall provide Hospital with written evidence of such insurance upon request of Hospital. Company shall provide Hospital with written notice at least fifteen (15) days prior to the cancellation, non-renewal or material change in such insurance; if Company does not obtain replacement insurance providing comparable coverage prior to the expiration of such fifteen (15) day period, Hospital shall have the right to terminate this Agreement effective at the end of such fifteen (15) day period without notice or any additional waiting periods.

 

  (c) Company shall maintain such commercial general liability insurance beyond the expiration or termination of this Agreement during (i) the period that any such product, process, or service is being commercially distributed, sold, leased or otherwise transferred, or performed or used (other than for the purpose of obtaining regulatory approvals), by Company or by a licensee, affiliate or agent of Company and (ii) a reasonable period after the period referred to in (c) (i) above which in no event shall be less than fifteen (15) years.

 

  (d) This section 8.2 shall survive expiration or termination of this Agreement.

9. DISCLAIMER OF WARRANTIES; LIMITATION OF LIABILITY

9.1 Title to Patent Rights . To the best actual knowledge of Hospital’s Innovation Office as of the Effective Date without investigation, Hospital represents that (i) Hospital and/or MIT own all right, title and interest in the Patent Rights, and that Hospital has not received any notice of any current claims, liens or encumbrances with respect to such Patent Rights, except as otherwise stated in this agreement, (ii) Hospital and MIT are the owners by assignment from Dr. Robert Langer, Dr. William Crowley and Dr. Eyal Ron of the Patent Rights, (iii) Hospital has the

 

22


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

authority to enter into this Agreement, (iv) Hospital has received no current claims of a third party to rights in the Patent Rights, (v) the Patent Rights are subsisting, and Hospital has not received any claim or notice that the Patent Rights are invalid or unenforceable, and (vi) Hospital has not received any notice of any current claims, liens or encumbrances with respect to the rights and licenses to the Patent Rights granted to Company hereunder, except as otherwise stated in this agreement. For the purposes of this section, the definition of Patent Rights does not include provisional patent application number 62/121,893 filed on February 27, 2015. Hospital makes no representations with respect to such patent application.

9.2 No Warranties . EXCEPT WITH RESPECT TO HOSPITAL AS SET FORTH IN SECTION 9.1, HOSPITAL AND MIT MAKE NO REPRESENTATIONS OR WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, CONCERNING THE PATENT RIGHTS AND THE RIGHTS GRANTED HEREUNDER, INCLUDING, WITHOUT LIMITATION, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT, VALIDITY OF PATENT RIGHTS CLAIMS, WHETHER ISSUED OR PENDING, AND THE ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE, AND HEREBY DISCLAIMS THE SAME. SPECIFICALLY, AND NOT TO LIMIT THE FOREGOING, HOSPITAL AND MIT MAKE NO WARRANTY OR REPRESENTATION (i) REGARDING THE VALIDITY OR SCOPE OF ANY OF THE CLAIM(S), WHETHER ISSUED OR PENDING, OF ANY OF THE PATENT RIGHTS, AND (ii) THAT THE EXPLOITATION OF THE PATENT RIGHTS OR ANY PRODUCT WILL NOT INFRINGE ANY PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS OF HOSPITAL, MIT, OR OF ANY THIRD PARTY.

9.3 Limitation of Liability . IN NO EVENT SHALL COMPANY, HOSPITAL, OR MIT OR ANY OF THEIR AFFILIATES OR ANY OF THEIR RESPECTIVE TRUSTEES, DIRECTORS, OFFICERS, MEDICAL OR PROFESSIONAL STAFF, EMPLOYEES, STUDENTS AND AGENTS BE LIABLE HEREUNDER FOR INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND ARISING IN ANY WAY OUT OF THIS AGREEMENT OR THE LICENSE OR RIGHTS GRANTED HEREUNDER, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, INCLUDING WITHOUT LIMITATION ECONOMIC DAMAGES OR INJURY TO PROPERTY OR LOST PROFITS, REGARDLESS OF WHETHER SUCH PARTY SHALL BE ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE POSSIBILITY OF THE FOREGOING; PROVIDED HOWEVER THAT (A) SUCH LIMITATION SHALL NOT APPLY TO ANY BREACH BY COMPANY OF SECTION 12.7 HEREOF AND (B) NOTHING IN THIS SECTION 9.3 SHALL BE CONSTRUED TO LIMIT COMPANY’S INDEMNIFICATION OBLIGATIONS UNDER SECTION 8 OF THE AGREEMENT WITH RESPECT TO THIRD PARTY CLAIMS.

 

23


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

10. TERM AND TERMINATION

10.1 Term . The term of this Agreement shall commence on the Effective Date and shall remain in effect until the later of:

 

  (a) the date on which all issued patents and filed patent applications within the Patent Rights have expired or been abandoned, and

 

  (b) one (1) year after the last Sale for which a royalty is due under Section 4.4(a)(ii) or ten (10) years after such expiration or abandonment date set forth in Section 10.1(a) above, whichever is earlier;

unless this Agreement is terminated earlier in accordance with any of the other provisions of Section 10. Upon expiration per this Section 10.1, the licenses granted herein shall convert automatically to fully-paid irrevocable licenses. For clarity, the grant conversion of this Section 10.1 shall not apply if the Agreement is terminated pursuant to Sections 10.2, 10.3 or 10.4, or the obligations of Section 10.8 are not met.

10.2 Termination for Failure to Pay . If Company fails to make any payment due hereunder, Hospital shall have the right to terminate this Agreement upon fifteen (15) business days written notice, unless, subject to Company’s right to dispute such payment under the provisions of Section 12.15 , Company makes such payments plus any interest due, as set forth in Section 4.6, within said fifteen (15) day notice period. If undisputed payments are not made, Hospital may immediately terminate this Agreement at the end of said fifteen (15) day period. Company shall be entitled to two (2) such cure periods in a calendar year; for a third failure to make an undisputed payment on time in such calendar year, Hospital shall have the right to terminate this Agreement immediately upon written notice.

10.3 Termination for Insurance and Insolvency .

 

  (a) Insurance . Hospital shall have the right to terminate this Agreement in accordance with Section 8.2(b) if Company fails to maintain the insurance required by Section 8.2.

 

  (b) Insolvency and other Bankruptcy Related Events . Hospital shall have the right to terminate this Agreement immediately upon written notice to Company with no further notice obligation or opportunity to cure if Company: (i) shall become insolvent; (ii) shall make an assignment for the benefit of creditors; or (iii) or shall have a petition in bankruptcy filed for or against it.

 

24


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

10.4 Termination for Non-Financial Default . If Company, any of its Affiliates or any Sublicensee shall default in the performance of any of its other obligations under this Agreement not otherwise covered by the provisions of Section 10.2 and 10.3, and if such default has not been cured within sixty (60) days after notice by Hospital in writing of such default, Hospital may immediately terminate this Agreement and/or any license granted hereunder at the end of said sixty (60) day cure period. Hospital shall also have the right to terminate this Agreement and/or any such license immediately, upon written notice, in the event of repeated defaults even if cured within such sixty (60) day periods.

10.5 Challenging Validity . During the term of this Agreement, Company shall not challenge, and shall restrict Company Affiliates and Sublicensees from challenging, the validity, enforceability or patentability of the Patent Rights and in the event of any breach of this provision Hospital shall have the right to terminate this Agreement and any license (and sublicense in the case of a challenge from a Sublicensee) granted hereunder immediately. In addition, if the Patent Rights are upheld Company shall reimburse Hospital for its legal costs and expenses incurred in defending any such challenge.

10.6 Termination by Company . Company shall have the right to terminate this Agreement by giving ninety (90) days advance written notice to Hospital and upon such termination shall immediately cease all use and Sales of Products and Processes, subject to Section 10.9.

10.7 Effect of Termination on Sublicenses . Upon the termination of this Agreement, any and all sublicenses granted pursuant to Section 2.1 to a Sublicensee that has operations directed to the research and development of pharmaceutical drug products that are at least equal to Company’s operations in scope and quality shall remain in effect and be assigned on substantially the same terms with Hospital deemed for all purposes to be the licensor thereunder provided that (i) Sublicensee is in good standing under its sublicense agreement at the time of termination; (ii) the sublicense is consistent with the terms of this Agreement; (iii) Hospital shall have no obligations under such sublicenses other than to preserve the effectiveness, scope, and validity of the licenses granted therein under the Patent Rights and Technological Information; (iv) the relevant sublicense(s), when taken together, provide Hospital with similar or greater benefits than this Agreement, including without limitation, with respect to reimbursement of patent costs; (v) Hospital and MIT shall not assume any obligation of Company to such Sublicensee pursuant to any representation, warranty or indemnification provision; (vi) MIT shall have no obligations under such sublicenses; and (vii) further provided that such Sublicensee enters into an agreement directly with Hospital to effectuate such assignment. Hospital shall be entitled to all payments due Company and Hospital (but excluding any duplicate payments) from each Sublicensee under any such sublicense in accordance with the terms of such sublicense; and such sublicense shall be deemed assigned to Hospital if necessary to ensure continued payments.

 

25


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

10.8 Effects of Termination of Agreement . Upon termination of this Agreement or any of the licenses hereunder for any reason, final reports in accordance with Section 5 shall be submitted to Hospital and all royalties and other payments, including without limitation any unreimbursed Patent Costs, accrued or due to Hospital as of the termination date shall become immediately payable. Company shall cease, and shall cause its Affiliates and Sublicensees to cease under any sublicense granted by Company, all Sales and uses of Products and Processes upon such termination, subject to Sections 10.7 and 10.9. The termination or expiration of this Agreement or any license granted hereunder shall not relieve Company, its Affiliates or Sublicensees of obligations arising before such termination or expiration.

10.9 Inventory . Upon early termination of this Agreement other than for Company default, Company, Company Affiliates and Sublicensees, subject to Section 10.7, may complete and sell any work-in-progress and inventory of Products that exist as of the effective date of termination provided that (i) Company pays Hospital the applicable running royalty or other amounts due on such Net Sales in accordance with the terms and conditions of this Agreement, and (ii) Company, Company Affiliates and Sublicensees, subject to Section 10.7, shall complete and sell all work-in-progress and inventory of Products within six (6) months after the effective date of termination. Upon expiration of this Agreement, Company shall pay to Hospital the royalties set forth in Section 4.4(a) for Sales of any Product that was in inventory or was a work-in-progress on the date of expiration of the Agreement.

11. COMPLIANCE WITH LAW

11.1 Compliance . Company shall have the sole obligation for compliance with, and shall ensure that any Affiliates and Sublicensees comply with, all government statutes and regulations that relate to Products and Processes, including, but not limited to, those of the Food and Drug Administration and the Export Administration, as amended, and any applicable laws and regulations of any other country in the License Territory. Company agrees that it shall be solely responsible for obtaining any necessary licenses to export, re-export, or import Products or Processes covered by Patent Rights and/or Confidential Information. Company shall indemnify and hold harmless Hospital and MIT (in accordance with Section 8) for any breach of Company’s obligations under this Section 11.1.

11.2 Patent Numbers . Company shall cause all Products sold in the United States to be marked with all applicable U.S. Patent Numbers, to the full extent required by United States law. Company shall similarly cause all Products shipped to or sold in any other country to be marked in such a manner as to conform with the patent laws and practices of such country.

 

26


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

12. MISCELLANEOUS

12.1 Entire Agreement . This Agreement constitutes the entire understanding between the Parties with respect to the subject matter hereof.

12.2 Notices . Any notices, reports, waivers, correspondences or other communications required under or pertaining to this Agreement shall be in writing and shall be delivered by hand, or sent by a reputable overnight mail service (e.g., Federal Express), or by first class mail (certified or registered), or by facsimile confirmed by one of the foregoing methods, to the other party. Notices will be deemed effective (a) three (3) working days after deposit, postage prepaid, if mailed, (b) the next day if sent by overnight mail, or (c) the same day if sent by facsimile and confirmed as set forth above or delivered by hand. Unless changed in writing in accordance with this Section, the notice address for Hospital shall be as follows:

If to Hospital:

Executive Director, Innovation

Massachusetts General Hospital

101 Huntington Avenue, 4 th Floor

Boston, MA 02199

Fax: (617) 954-9361

If to MIT:

Massachusetts Institute of Technology

Technology Licensing Office, Room NE18-501

255 Main Street

Cambridge, MA 02142-1601

Attention: Director

Tel: 617-253-6966

Fax: 617-258-6790

If to Company:

Columbia Laboratories, Inc.

4 Liberty Square

Boston, MA 02109

Tel: 617-639-1516

Fax: 617-482-0618

Attn: Chief Financial Officer

12.3 Amendment; Waiver . This Agreement may be amended and any of its terms or conditions may be waived only by a written instrument executed by an authorized signatory of

 

27


CONFIDENTIAL TREATMENT REQUESTED

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INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

the Parties or, in the case of a waiver, by the Party waiving compliance. The failure of either Party at any time or times to require performance of any provision hereof shall in no manner affect its rights at a later time to enforce the same. No waiver by either Party of any condition or term shall be deemed as a further or continuing waiver of such condition or term or of any other condition or term.

12.4 Binding Effect . This Agreement shall be binding upon and inure to the benefit of and be enforceable by the Parties hereto and their respective permitted successors and assigns.

12.5 Assignment .

 

  (a) Company shall not assign this Agreement or any of its rights or obligations under this Agreement without the prior written consent of Hospital; provided, however, that if Company is not in breach of this Agreement and there are no disputes pending under Section 12.15, no such consent will be required to assign this Agreement to a successor of the Company’s business to which this Agreement pertains or to a purchaser of substantially all of the Company’s assets related to this Agreement, so long as such successor or purchaser shall agree in writing to be bound by all of the terms and conditions hereof prior to such assignment.

 

  (b) Further, no Sublicensee shall be permitted to assign a sublicense agreement with Company or any of its rights or obligations thereunder without the prior written consent of Hospital; provided, however, that if such Sublicensee is not in breach of this Agreement, no such consent will be required to assign this Agreement to a successor of the Sublicensee’s business to which this Agreement pertains or to a purchaser of substantially all of the Sublicensee’s assets related to this Agreement, so long as such successor or purchaser shall agree in writing to be bound by all of the terms and conditions thereof prior to such assignment.

 

  (c) Company shall notify Hospital in writing of any such assignment of this Agreement or a Sublicense and provide a copy of all assignment documents and related agreements to Hospital within thirty (30) days of such assignment. Failure of an assignee to agree to be bound by the terms hereof or failure of Company to notify Hospital and provide copies of assignment documentation shall be grounds for termination of this Agreement for default.

12.6 Force Majeure . Neither Party shall be responsible for delays resulting from causes beyond the reasonable control of such Party, including without limitation fire, explosion, flood, war, sabotage, terrorism, strike or riot, provided that the nonperforming Party uses commercially reasonable efforts to avoid or remove such causes of nonperformance and continues performance under this Agreement with reasonable dispatch whenever such causes are removed.

 

28


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

12.7 Use of Name . Company and its Affiliates and Sublicenses shall not use the name of Hospital, Massachusetts Institute of Technology,, Lincoln Laboratory or any trustee, director, officer, staff member, faculty, employee, student or agent of Hospital or MIT or any adaptation variation or abbreviation thereof, or any terms of this Agreement in any advertising, promotional or sales literature, publicity or in any document employed to obtain funds or financing without the prior written approval of Hospital and/or MIT, as applicable. For Hospital, such approval shall be obtained from Hospital’s VP of Public Affairs. For MIT, such approval shall be obtained from the Use of Name Officer at the MIT Technology Licensing Office. Notwithstanding anything contained in this Agreement to the contrary, this Agreement shall not prohibit the Company from disclosing the name of Hospital, MIT, or any trustee, director, officer, staff member, employee, student or agent of Hospital or MIT or any adaptation thereof to the extent required in order for Company to comply with applicable laws and regulations (including, without limitation, stock exchange rules or the rules of any regulatory authority), provided that Company provides prior written notice of such required disclosure to Hospital and/or MIT, as applicable, and takes reasonable and lawful actions to avoid and/or minimize the extent of such disclosure.

12.8 Governing Law . This Agreement shall be governed by and construed and interpreted in accordance with the laws of the Commonwealth of Massachusetts, excluding with respect to conflict of laws, except that questions affecting the construction and effect of any patent shall be determined by the law of the country in which the patent shall have been granted. Each Party agrees to submit to the exclusive jurisdiction of the Superior Court for Suffolk County, Massachusetts, and the United States District Court for the District of Massachusetts with respect to any claim, suit or action in law or equity arising in any way out of this Agreement or the subject matter hereof.

12.9 Hospital Policies . Company acknowledges that Hospital’s employees and medical and professional staff members and the employees and staff members of Hospital’s Affiliates are subject to the applicable policies of Hospital and such Affiliates, including, without limitation, policies regarding conflicts of interest, intellectual property and other matters. Company shall provide Hospital with any agreement it proposes to enter into with any employee or staff member of Hospital or any of Hospital’s Affiliates for Hospital’s prior review and shall not enter into any oral or written agreement with such employee or staff member which conflicts with any such policy. Hospital shall provide Company, at Company’s request, with copies of any such policies applicable to any such employee or staff member.

12.10 U.S. Manufacturing . Company agrees that any Products or Processes used or sold in the United States will be manufactured substantially in the United States to the extent required by law.

 

29


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

12.11 Severability . If any provision(s) of this Agreement are or become invalid, are ruled illegal by any court of competent jurisdiction or are deemed unenforceable under then current applicable law from time to time in effect during the term hereof, it is the intention of the parties that the remainder of this Agreement shall not be effected thereby. It is further the intention of the parties that in lieu of each such provision which is invalid, illegal or unenforceable, there be substituted or added as part of this Agreement a provision which shall be as similar as possible in economic and business objectives as intended by the parties to such invalid, illegal or enforceable provision, but shall be valid, legal and enforceable.

12.12 Survival . In addition to any specific survival references in this Agreement, Sections 1, 2.4, 4.1, 4.5, 4.6, 5.3, 5.4, 5.5, 6.4, 8.1, 8.2, 9.2, 9.3, 10.7, 10.8, 10.9, 12.1, 12.2, 12.3, 12.4, 12.7, 12.8, 12.9, 12.11, 12.12, 12.13, 12.14 and 12.15 shall survive termination or expiration of this Agreement. Any other rights, responsibilities, obligations, covenants and warranties which by their nature should survive this Agreement shall similarly survive and remain in effect.

12.13 Interpretation . The parties hereto are sophisticated, have had the opportunity to consult legal counsel with respect to this transaction and hereby waive any presumptions of any statutory or common law rule relating to the interpretation of contracts against the drafter.

12.14 Headings . All headings are for convenience only and shall not affect the meaning of any provision of this Agreement.

12.15 Dispute Resolution .

 

  (a) Any dispute or issue relating to or in connection with this Agreement (a “ Dispute ”) shall initially be referred to Hospital’s Director of Innovation and Company’s CEO to resolve the Dispute. However, notwithstanding any of the terms of this Section 12.15 and without limiting any other remedies that may be available, each Party shall have the right to seek immediate injunctive relief and other equitable relief from any court of competent jurisdiction to enjoin any breach or violation of this Agreement concerning confidential information or any other intellectual property licensed under this Agreement, without any obligation to undertake extra-judicial dispute resolution of any such Dispute or claim or otherwise to comply with this Section 12.15.

 

  (b)

If the Director of Innovation and Company’s CEO are unable to resolve the Dispute within thirty (30) days after such referral, then such Dispute shall be referred to a mediator who has been mutually selected by the Parties. If the Parties are unable to agree upon a mediator, then either Party may petition a court of competent jurisdiction in the Commonwealth of Massachusetts and such court

 

30


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

  shall appoint an independent mediator with relevant experience and sufficient qualifications to provide mediation services to the Parties.

 

  (c) If the Parties are unable to resolve the Dispute with the assistance of a mediator within sixty (60) business days of the selection or appointment thereof, each Party shall have the right to seek other equitable relief from any court of competent jurisdiction.

 

  (d) Each Party shall bear its own costs in obtaining the dispute resolution, as outlined above.

[Remainder of page intentionally left blank.]

 

31


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their duly authorized representatives as of the Effective Date first written above.

 

Columbia Laboratories Inc. The General Hospital Corporation
BY:

 

BY:

 

Name: Name:
TITLE:

 

TITLE:

 

DATE:

 

DATE:

 

 

32


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

Appendix A

DESCRIPTION OF PATENT RIGHTS

 

IP ID

  

Title

  

Serial Number

  

Original

Filing

Date

  

Filing

Type

  

Country Of
Publication

  

Status

  

Patent

Number

02289.01    Methods for Contraception and Treatment of Female Reproductive Conditions and Disorders (MIT Case No. 10669)    60/473,579    5/27/2003    PROV    US    Converted   
02289.02    Intra Vaginal Drug Delivery Device (MIT Case No. 10669)    60/466,318    4/29/2003    PROV    US    Converted   
02289.03    Methods and Devices for the Sustained Release of Multiple Drugs (MIT Case No. 10669)    PCT/US04/013172    4/29/2004    PCT    WO    Nationalized   
02289.04    Methods and Devices for the Sustained Release of Multiple Drugs (MIT Case No. 10669)    10/835,414    4/29/2004    UTIL    US    Issued    7,833,545
02289.05    Methods and Devices for the Sustained Release of Multiple Drugs (MIT Case No. 10669)    2004233997    4/29/2004    PCT    AU    Issued    2004233997
02289.06    Methods and Devices for the Sustained Release of Multiple Drugs (MIT Case No. 10669)    2006-513416    4/29/2004    PCT    JP    Issued    4898431
02289.07    Methods and Devices for the Sustained Release of Multiple Drugs (MIT Case No. 10669)    2,523,859    4/29/2004    PCT    CA    Issued    2,523,859
02289.08    Methods and Devices for the Sustained Release of Multiple Drugs (MIT Case No. 10669)    04760436.8    4/29/2004    PCT    EP    Issued    1620060
02289.11    Methods and Devices for the Sustained Release of Multiple Drugs (MIT Case No. 10669)    12/125,581    5/22/2008    DIV    US    Issued    7,883,718

 

33


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

02289.12 Methods and Devices for the Sustained Release of Multiple Drugs (MIT Case No. 10669) 12/125,571 5/22/2008 DIV US Issued 7,838,024
02289.13 Methods and Devices for the Sustained Release of Multiple drugs (MIT Case No. 10669) 12/125,593 5/22/2008 DIV US Issued 7,829,112
02289.14 Multi Component EVA Rings for the Intra Vaginal Delivery of Sex Steroids alone or in Combination (MIT Case No. 10669) 04760436.8 4/29/2004 PCT DE Issued 1620060
02289.15 Multi Component EVA Rings for the Intra Vaginal Delivery of Sex Steroids alone or in Combination (MIT Case No. 10669) 04760436.8 4/29/2004 PCT FR Issued 1620060
02289.16 Multi Component EVA Rings for the Intra Vaginal Delivery of Sex Steroids alone or in Combination (MIT Case No. 10669) 04760436.8 4/29/2004 PCT GB Issued 1620060
23317.01 Transvaginal Ring Delivery System and Methods of Using Same (MIT Case No. 17796) 62/121,893 2/27/2015 PROV US Filed

 

34


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

Appendix B

SALES REPORTS

 

AGREEMENT INCOME REPORT Royalty Income
[MGH][BWH] Agreement # -        

 

Licensee -

 

Sub-Licensee -

 

Separate reports must be filed for:

 

  1. Each Product sold.

 

  2. Each country of sale, if different deductions or royalty rates apply.

 

Product Name:

 

Report Time Period:
                From mm/dd/yyyy

 

                To mm/dd/yyyy

 

 

Country of Sale

 

 

 

Quantity Sold

 

 

 

Gross Sales (USD)

$

 

$

 

$

 

Exchange Rate

 

 

 

Deductions (Itemize)
Please list each deduction separately. Use same definition as appears in Agreement and include the contract paragraph as a reference (Std Section 1.8(a)(ii) line item deductions listed below).
                        A1.

 

 

 

                        A2.

 

 

 

                        A3.

 

 

 

                        A4.

 

 

 

                        B.

 

 

 

Total Deductions

(

 

) (

 

) (

 

)

Net Sales

 

 

 

Royalty Percentage

 

 

 

Credits (itemize)

(

 

) (

 

) (

 

)

Royalties Due

$

 

$

 

$

 

 

35


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

PLEASE ATTACH DETAIL SALES REPORTS AS REQUIRED

Appendix C

 

AGREEMENT INCOME REPORT Sublicense Income
[MGH][BWH] Agreement # - 

 

Licensee -

 

Sub-Licensee -

 

Separate reports must be filed for Payments associated with each Product:

 

Product Name:

 

 

Report Time Period:
                From mm/dd/yyyy

 

                To mm/dd/yyyy

 

Detailed Explanation of Payment

Required for “Other Payment”

 

Annual Fees/Minimum Royalties

$

 

 

Milestone Payments

$

 

 

Sublicense Fees and Royalties

$

 

 

Other Payment

$

 

 

Other Payment

$

 

 

 

36


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

Other Payment

$

 

 

TOTAL

$

 

PLEASE ATTACH DETAIL AS REQUIRED

 

37


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

Appendix D

CONFIDENTIALITY TERMS AND CONDITIONS

1. Definition of Confidential Information . “Confidential Information” shall mean any information, including but not limited to data, techniques, protocols or results, or business, financial, commercial or technical information, disclosed by one Party (each a “Discloser” as applicable) to the other Party (each a “Recipient” as applicable) in connection with the terms of that certain Exclusive License Agreement dated March 25, 2015 (the “License Agreement”) and identified as confidential at the time of disclosure (the “Purpose”). Hospital’s Confidential Information shall also include all information disclosed by Hospital to Company in connection with the Patent Rights. Capitalized terms used in this Appendix that are not otherwise defined herein have the meanings ascribed in the License Agreement to which this Appendix is attached and made a part thereof.

2. Exclusions . “Confidential Information” under this Agreement shall not include any information that (i) is or becomes publicly available through no wrongful act of Recipient; (ii) was known by Recipient prior to disclosure by Discloser, as evidenced by tangible records; (iii) becomes known to Recipient after disclosure from a third party having an apparent bona fide right to disclose it; (iv) is independently developed or discovered by Recipient without use of Discloser’s Confidential Information, as evidenced by tangible records; or (v) is disclosed to another party by Discloser without restriction on further disclosure.

3. Permitted Purpose . Recipient shall have the right to, and agrees that it will, use Discloser’s Confidential Information solely for the Purpose as described in the License Agreement, except as may be otherwise specified in a separate definitive written agreement negotiated and executed between the parties.

4. Restrictions . For the term of the License Agreement and a period of three (3) years thereafter (and indefinitely with respect to any individually identifiable health information disclosed by Hospital to Company, if any), each Recipient agrees that: (i) it will not use such Confidential Information for any purpose other than as specified herein, including without limitation for its own benefit or the benefit of any other person or entity; and (ii) it will use reasonable efforts (but no less than the efforts used to protect its own confidential and/or proprietary information of a similar nature) not to disclose such Confidential Information to any other person or entity except as expressly permitted hereunder. Recipient may, however, disclose Discloser’s Confidential Information only on a need-to-know basis to its and its Affiliates employees, staff members and agents (“Receiving Individuals”) who are directly participating in the Purpose and who are informed of the confidential nature of such information,

 

38


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

provided Recipient shall be responsible for compliance by Receiving Individuals with the terms of this Agreement and any breach thereof. Notwithstanding the foregoing, Company may disclose Confidential Information regarding the existence and content of the License Agreement to investors, potential institutional investors, Sublicensees, potential Sublicensees, partners, potential partners, bankers, financial institutions, and acquirers and potential acquirers of the Company. Each party further agrees not to use the name of the other party or any of its Affiliates or any of their respective trustees, directors, officers, staff members, employees, students or agents in any advertising, promotional or sales literature, publicity or in any document employed to obtain funds or financing without the prior written approval of the party or individual whose name is to be used, in the case of Hospital such approval to be given by the Public Affairs Department. This Section 4 shall survive termination or expiration of this Agreement. Notwithstanding anything contained in this Agreement to the contrary, this Agreement shall not prohibit the Recipient from disclosing Confidential Information to the extent required in order for the Recipient to comply with applicable laws and regulations (including, without limitation, stock exchange rules or the rules of any regulatory or self-regulatory authority), provided that the Recipient provides prior written notice of such required disclosure to the Discloser and takes reasonable and lawful actions to avoid and/or minimize the extent of such disclosure.

5. Right to Disclose . Discloser represents that to the best of its knowledge it has the right to disclose to each Recipient all of Discloser’s Confidential Information that will be disclosed hereunder.

6. Ownership . All Confidential Information disclosed pursuant to this Agreement, including without limitation all written and tangible forms thereof, shall be and remain the property of the Discloser. Upon termination of this Agreement, if requested by Discloser, Recipient shall return or destroy at Discloser’s discretion all of Discloser’s Confidential Information, provided that Recipient shall be entitled to keep one copy of such Confidential Information in a secure location solely for the purpose of determining Recipient’s legal obligations hereunder.

7. No License . Nothing in this Agreement shall be construed as granting or conferring, expressly or impliedly, any rights by license or otherwise, under any patent, copyright, or other intellectual property rights owned or controlled by Discloser relating to Confidential Information, except as specifically set forth in the License Agreement.

8. Remedies . Each party acknowledges that any breach of this Agreement by it may cause irreparable harm to the other party and that each party is entitled to seek injunctive relief and any other remedy available at law or in equity.

9. General . These Confidentiality Terms and Conditions, along with the License Agreement, contain the entire understanding of the parties with respect to the subject matter

 

39


CONFIDENTIAL TREATMENT REQUESTED

UNDER C.F.R. SECTION 240.24b-2. [****]

INDICATES OMITTED MATERIAL THAT IS

THE SUBJECT OF A CONFIDENTIAL

TREATMENT REQUEST

FILED SEPARATELY WITH THE

COMMISSION. THE OMITTED MATERIAL

HAS BEEN FILED SEPARATELY WITH THE

COMMISSION.

 

hereof, and supersede any prior oral or written understandings between the parties relating to confidential treatment of information. Sections 1, 2, 4, 6, 8 and 9 of these Confidentiality Terms and Conditions shall survive any expiration or termination of the License Agreement.

 

40

Exhibit 31(i).1

Certification Pursuant to Rule 13a-14(a)/15d-14(a)

of the Securities Exchange Act of 1934

I, Frank C. Condella, Jr. certify that:

1. I have reviewed this quarterly report on Form 10-Q of Juniper Pharmaceuticals, Inc.;

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

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

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

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

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

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

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

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

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.

 

/s/ Frank C. Condella Jr.

Frank C. Condella Jr.
President and Chief Executive Officer
DATE: May 6, 2015

Exhibit 31(i).2

Certification Pursuant to Rule 13a-14(a)/15d-14(a)

of the Securities Exchange Act of 1934

I, George O. Elston, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Juniper Pharmaceuticals, Inc.;

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

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

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

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

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

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

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

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

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.

 

/s/ George O. Elston

George O. Elston
Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer)
DATE: May 6, 2015

Exhibit 32.1

Certification Pursuant to

18 U.S.C. Section 1350

as Adopted Pursuant to

Section 906 of the Sarbanes-Oxley Act of 2002

In connection with the Quarterly Report of Juniper Pharmaceuticals, Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2015 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Frank C. Condella, Jr., President and Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:

 

(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

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

 

/s/ Frank C. Condella, Jr.

Frank C. Condella, Jr.
President and Chief Executive Officer
Date: May 6, 2015

Exhibit 32.2

Certification Pursuant to

18 U.S.C. Section 1350

as Adopted Pursuant to

Section 906 of the Sarbanes-Oxley Act of 2002

In connection with the Quarterly Report of Juniper Pharmaceuticals, Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2015 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, George O. Elston, Vice President, Chief Financial Officer and Treasurer of the Company, certify, pursuant to 18 U.S.C. section 1350, as adopted pursuant to section 906 of the Sarbanes-Oxley Act of 2002, that to the best of my knowledge:

 

(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

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

 

/s/ George O. Elston

George O. Elston
Chief Financial Officer and Treasurer
(Principal Financial and Accounting Officer)
DATE: May 6, 2015