ABMD ABIOMED Inc

Table of Contents

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q

 

 

(Mark One)

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

For the quarterly period ended September 30, 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 001-09585

 

 

ABIOMED, INC.

(Exact name of registrant as specified in its charter)

 

 

 

DELAWARE		04-2743260
(State or other jurisdiction of incorporation or organization)		(IRS Employer Identification No.)

22 CHERRY HILL DRIVE

DANVERS, MASSACHUSETTS 01923

(Address of principal executive offices, including zip code)

(978) 646-1400

(Registrant’s telephone number, including area code)

 

 

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

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate website, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 229.405 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 “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer		x		Accelerated filer		¨
Non-accelerated filer		¨  (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

As of October 30, 2015, 42,417,469 shares of the registrant’s common stock, $.01 par value, were outstanding.

 

 

 

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ABIOMED, INC. AND SUBSIDIARIES

TABLE OF CONTENTS

 

				Page
PART I - FINANCIAL INFORMATION:
Item 1.		Condensed Financial Statements (unaudited)			3
		Condensed Consolidated Balance Sheets as of September 30, 2015 and March 31, 2015			3
		Condensed Consolidated Statements of Operations for the three and six months ended September  30, 2015 and 2014			4
		Condensed Consolidated Statements of Comprehensive Income (Loss) for the three and six months ended September 30, 2015 and 2014			5
		Condensed Consolidated Statements of Cash Flows for the six months ended September 30, 2015 and 2014			6
		Notes to Condensed Consolidated Financial Statements (unaudited)			7
Item 2.		Management’s Discussion and Analysis of Financial Condition and Results of Operations			20
Item 3.		Quantitative and Qualitative Disclosures About Market Risk			28
Item 4.		Controls and Procedures			28
PART II - OTHER INFORMATION:
Item 1.		Legal Proceedings			29
Item 1A.		Risk Factors			29
Item 2.		Unregistered Sales of Equity Securities and Use of Proceeds			30
Item 3.		Defaults Upon Senior Securities			30
Item 4.		Mine Safety Disclosures			30
Item 5.		Other Information			30
Item 6.		Exhibits			31
SIGNATURES					32

NOTE REGARDING COMPANY REFERENCES

Throughout this report on Form 10-Q (the “Report”), “Abiomed, Inc.,” the “Company,” “we,” “us” and “our” refer to ABIOMED, Inc. and its consolidated subsidiaries.

NOTE REGARDING TRADEMARKS

ABIOMED, ABIOCOR, IMPELLA, IMPELLA CP, IMPELLA RP and Symphony are trademarks of ABIOMED, Inc., and are registered in the U.S. and certain foreign countries. BVS is a trademark of ABIOMED, Inc. and is registered in the U.S. AB5000 is a trademark of ABIOMED, Inc. RECOVER is a trademark of Abiomed Europe GmbH, a subsidiary of ABIOMED, Inc., and is registered in the U.S. and certain foreign countries.

 

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PART 1. FINANCIAL INFORMATION

 

ITEM 1:

FINANCIAL STATEMENTS

ABIOMED, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

(in thousands, except share and per share data)

 

		September 30, 2015				March 31, 2015
ASSETS
Current assets:
Cash and cash equivalents		$	54,421			$	22,401
Short-term marketable securities			121,087				109,557
Accounts receivable, net			37,119				31,828
Inventories			23,032				16,774
Prepaid expenses and other current assets			4,030				4,479
Deferred tax assets, net			25,715				35,100
Total current assets			265,404				220,139
Long-term marketable securities			—				13,996
Property and equipment, net			11,420				9,127
Goodwill			32,676				31,534
In-process research and development			15,243				14,711
Long-term deferred tax assets, net			44,240				45,206
Other assets			4,423				3,654
Total assets		$	373,406			$	338,367
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable		$	8,788			$	10,389
Accrued expenses			18,861				21,894
Deferred revenue			6,803				7,036
Total current liabilities			34,452				39,319
Other long-term liabilities			217				183
Contingent consideration			6,817				6,510
Long-term deferred tax liabilities			824				795
Total liabilities			42,310				46,807
Commitments and contingencies (Note 10)
Stockholders’ equity:
Class B Preferred Stock, $.01 par value			—				—
Authorized - 1,000,000 shares; Issued and outstanding - none
Common stock, $.01 par value			424				413
Authorized - 100,000,000 shares; Issued - 43,756,550 shares at September 30, 2015 and 42,618,717 shares at March 31, 2015;
Outstanding - 42,417,469 shares at September 30, 2015 and 41,335,773 shares at March 31, 2015
Additional paid in capital			489,463				465,046
Accumulated deficit			(120,628	)			(137,222	)
Treasury stock at cost - 1,339,081 shares at September 30, 2015 and 1,282,944 shares at March 31, 2015			(23,157	)			(19,347	)
Accumulated other comprehensive loss			(15,006	)			(17,330	)
Total stockholders’ equity			331,096				291,560
Total liabilities and stockholders’ equity		$	373,406			$	338,367

The accompanying notes are an integral part of the condensed consolidated financial statements (unaudited)

 

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ABIOMED, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(in thousands, except per share data)

 

		For the Three Months Ended September 30,								For the Six Months Ended September 30,
		2015				2014				2015				2014
Revenue:
Product revenue		$	76,354			$	51,774			$	149,780			$	100,434
Funded research and development			5				164				11				315
			76,359				51,938				149,791				100,749
Costs and expenses:
Cost of product revenue			12,144				9,612				23,012				19,301
Research and development			11,569				8,693				21,779				17,755
Selling, general and administrative			39,829				29,455				77,152				61,053
			63,542				47,760				121,943				98,109
Income from operations			12,817				4,178				27,848				2,640
Other income (loss):
Investment income, net			62				36				125				80
Other income (loss), net			87				(39	)			140				(28	)
			149				(3	)			265				52
Income before income taxes			12,966				4,175				28,113				2,692
Income tax provision			5,231				336				11,519				562
Net income		$	7,735			$	3,839			$	16,594			$	2,130
Basic net income per share		$	0.18			$	0.09			$	0.40			$	0.05
Basic weighted average shares outstanding			42,228				40,448				41,963				40,256
Diluted net income per share		$	0.17			$	0.09			$	0.37			$	0.05
Diluted weighted average shares outstanding			44,922				42,239				44,778				42,069

The accompanying notes are an integral part of the condensed consolidated financial statements (unaudited)

 

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ABIOMED, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(Unaudited)

(in thousands)

 

		For the Three Months Ended September 30,								For the Six Months Ended September 30,
		2015				2014				2015				2014
Net income		$	7,735			$	3,839			$	16,594			$	2,130
Other comprehensive income:
Foreign currency translation gains (losses)			710				(4,804	)			2,308				(5,240	)
Net unrealized gains (losses) on marketable securities			6				(22	)			16				5
Other comprehensive income (loss)			716				(4,826	)			2,324				(5,235	)
Comprehensive income (loss)		$	8,451			$	(987	)		$	18,918			$	(3,105	)

The accompanying notes are an integral part of the condensed consolidated financial statements (unaudited)

 

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ABIOMED, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(in thousands)

 

		For the Six Months Ended September 30,
		2015				2014
Operating activities:
Net income		$	16,594			$	2,130
Adjustments required to reconcile net income to net cash provided by operating activities:
Depreciation and amortization			1,352				1,196
Bad debt (recovery) expense			(18	)			27
Stock-based compensation			15,592				8,314
Write-down of inventory			952				559
Excess tax benefit from stock-based awards			(383	)			—
Deferred tax provision			10,803				450
Change in fair value of contingent consideration			307				219
Changes in assets and liabilities:
Accounts receivable			(5,214	)			1,108
Inventories			(6,855	)			(653	)
Prepaid expenses and other assets			456				(139	)
Accounts payable			(1,817	)			(581	)
Accrued expenses and other long-term liabilities			(2,674	)			(3,732	)
Deferred revenue			(239	)			1,004
Net cash provided by operating activities			28,856				9,902
Investing activities:
Purchases of marketable securities			(99,002	)			(44,920	)
Proceeds from the sale and maturity of marketable securities			101,453				47,890
Acquisition of ECP and AIS, net of cash assumed			—				(15,697	)
Purchase of other investment			(750	)			(750	)
Purchases of property and equipment			(3,419	)			(1,496	)
Net cash used for investing activities			(1,718	)			(14,973	)
Financing activities:
Proceeds from the exercise of stock options			7,971				2,560
Excess tax benefit from stock-based awards			383				—
Taxes paid related to net share settlement of vesting of stock awards			(3,810	)			(1,013	)
Proceeds from the issuance of stock under employee stock purchase plan			451				397
Net cash provided by financing activities			4,995				1,944
Effect of exchange rate changes on cash			(113	)			(306	)
Net increase (decrease) in cash and cash equivalents			32,020				(3,433	)
Cash and cash equivalents at beginning of period			22,401				20,916
Cash and cash equivalents at end of period		$	54,421			$	17,483
Supplemental disclosure of cash flow information:
Cash paid for income taxes		$	576			$	299
Supplemental disclosure of non-cash investing and financing activities:
Contingent consideration related to acquisition of ECP			—				6,000
Property and equipment in accounts payable and accrued expenses			396				577

The accompanying notes are an integral part of the condensed consolidated financial statements (unaudited)

 

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ABIOMED, INC. AND SUBSIDIARIES

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

(In thousands, except share data)

Note 1. Nature of Business and Basis of Preparation

Abiomed, Inc. (the “Company”) is a leading provider of mechanical circulatory support devices and offers a continuum of care to heart failure patients. The Company develops, manufactures and markets proprietary products that are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping function of the heart. The Company’s products are used in the cardiac catheterization lab, or cath lab, by interventional cardiologists and in the heart surgery suite by heart surgeons for patients who are in need of hemodynamic support prophylactically or emergently before, during or after angioplasty or heart surgery procedures.

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP, for interim financial reporting and in accordance with Article 10 of Regulation S-X. Accordingly, they do not include all of the information and note disclosures required by GAAP for complete financial statements. These statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2015 that has been filed with the Securities and Exchange Commission (the “SEC”).

In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, which are of a normal recurring nature and are necessary for a fair presentation of results for the interim periods presented. The results of operations for any interim period may not be indicative of results for the full fiscal year or any other subsequent period.

There have been no changes in the Company’s significant accounting policies for the three and six months ended September 30, 2015 as compared to the significant accounting policies described in the Company’s Annual Report on Form 10-K for the fiscal year ended March 31, 2015 that has been filed with the SEC.

Recent Accounting Pronouncements

In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-09, Revenue from Contracts with Customers to provide updated guidance on revenue recognition. ASU 2014-09 requires a company to recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. In doing so, companies may 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 in the first quarter of fiscal 2019 with early adoption permitted for fiscal years beginning on or after December 15, 2016. The Company is currently evaluating the impact of adopting ASU 2014-09 on its condensed consolidated financial statements.

In July 2015, the FASB issued ASU 2015-11, Inventory (Topic 330): Simplifying the Measurement of Inventory, which applies to inventory that is measured using first-in, first-out or average cost methods. Under the updated guidance, an entity should measure inventory that is within scope at the lower of cost and net realizable value, which is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. Subsequent measurement is unchanged for inventory that is measured using last-in, last-out. This ASU is effective for annual and interim periods beginning after December 15, 2016, and should be applied prospectively with early adoption permitted at the beginning of an interim or annual reporting period. The Company is currently evaluating the impact of adopting ASU 2015-11 on its condensed consolidated financial statements.

 

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Note 2. Net Income Per Share

Basic net income per share is computed by dividing net income by the weighted average number of common shares outstanding during the period. Diluted net income per share is computed by dividing net income by the weighted average number of dilutive common shares outstanding during the period. Diluted shares outstanding are calculated by adding to the weighted average shares outstanding any potential dilutive securities outstanding for the period. Potential dilutive securities include stock options, restricted stock units, performance-based stock awards and shares to be purchased under the Company’s employee stock purchase plan. In periods when a net loss is reported, all common stock equivalents are excluded from the calculation because they would have an anti-dilutive effect, meaning the loss per share would be reduced. Therefore, in periods when a loss is reported, basic and dilutive loss per share are the same. The Company’s basic and diluted net income per share for the three and six months ended September 30, 2015 and 2014 were as follows (in thousands, except per share data):

 

		For the Three Months Ended September 30,								For the Six Months Ended September 30,
		2015				2014				2015				2014
Basic Net Income Per Share
Net income		$	7,735			$	3,839			$	16,594			$	2,130
Weighted average shares used in computing basic net income per share			42,228				40,448				41,963				40,256
Net income per share - basic		$	0.18			$	0.09			$	0.40			$	0.05

 

		For the Three Months Ended September 30,								For the Six Months Ended September 30,
		2015				2014				2015				2014
Diluted Net Income Per Share
Net income		$	7,735			$	3,839			$	16,594			$	2,130
Weighted average shares used in computing basic net income per share			42,228				40,448				41,963				40,256
Effect of dilutive securities			2,694				1,791				2,815				1,813
Weighted average shares used in computing diluted net income per share			44,922				42,239				44,778				42,069
Net income per share - diluted		$	0.17			$	0.09			$	0.37			$	0.05

For the three and six months ended September 30, 2015, approximately 1,000 shares underlying out-of-the-money stock options were not included in the computation of diluted earnings per share because their effect would have been anti-dilutive. Also, approximately 227,000 and 226,000 restricted shares in the three and six months ended September 30, 2015, respectively, related to performance-based awards for which milestones have not been met, were not included in the computation of diluted earnings per share.

For the three and six months ended September 30, 2014, approximately 47,000 and 44,000 shares, respectively, underlying out-of-the-money stock options were not included in the computation of diluted earnings per share because their effect would have been anti-dilutive. Also, approximately 465,000 restricted shares in each of the three and six months ended September 30, 2014 related to performance-based awards for which milestones had not been met, were not included in the computation of diluted earnings per share.

Note 3. Acquisitions

Acquisition of ECP Entwicklungsgesellschaft mbH

On July 1, 2014, the Company entered into a share purchase agreement with its wholly owned German subsidiary, Abiomed Europe GmbH (“Abiomed Europe”) and Syscore GmbH (“Syscore”), a limited liability company located in Berlin, Germany, providing for the Company’s acquisition of all of the share capital of ECP Entwicklungsgesellschaft mbH (“ECP”), a limited liability company incorporated in Germany. ECP is engaged in research, development, prototyping and the production of a percutaneous expandable catheter pump which increases blood circulation from the heart with an external drive shaft. The Company’s acquisition of ECP closed on July 1, 2014.

 

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The Company acquired ECP for $13.0 million in cash, with additional potential payouts totaling $15.0 million payable to Syscore based on the achievement of certain technical, regulatory and commercial milestones. These milestone payments may be made, at the Company’s option, by a combination of cash or the Company’s common stock. With respect to such milestone payments, the share purchase agreement provides:

 

•

that, upon the earlier of (i) the Company’s receipt of European CE Marking approval relating to the sale of an expandable device based on certain patent rights acquired from ECP, or (ii) the Company’s bringing of a successful claim against a third party competitor (or reaching an economically equivalent settlement) for the infringement of certain patent rights acquired from ECP, it will pay Syscore an additional $7.0 million (provided that if such claim or settlement does not prohibit the third party competitor’s further marketing, production, sale, distribution, lease or use of any violating or infringing products, but only awards monetary damages to the Company or to Abiomed Europe, the amount payable to Syscore shall be limited to the lower of the amount of aggregate damages received and $7.0 million); and

 

•

that, upon the first to occur of (i) the Company’s successful commercialization of one or more rotatable and expandable devices based on certain patent rights acquired from ECP, where such devices achieve aggregate worldwide revenues of $125.0 million, including the revenues of third-party licensees, or (ii) the Company’s sale of (A) ECP, (B) all or substantially all of ECP’s assets, or (C) certain of ECP’s patent rights, the Company will pay to Syscore the lesser of (x) one-half of the profits earned from such sale described in the foregoing item (ii), after accounting for the costs of acquiring and operating ECP, or (y) $15.0 million (less any previous milestone payment).

ECP’s Acquisition of AIS GmbH Aachen Innovative Solutions

In connection with the Company’s acquisition of ECP, ECP acquired all of the share capital of AIS GmbH Aachen Innovative Solutions (“AIS”), a limited liability company incorporated in Germany, pursuant to a share purchase agreement dated as of June 30, 2014, by and among ECP and AIS’s four individual shareholders. AIS, based in Aachen, Germany, holds certain intellectual property useful to ECP’s business, and, prior to being acquired by ECP, had licensed such intellectual property to ECP.

The purchase price for the acquisition of AIS’s share capital was approximately $2.8 million in cash, which was provided by the Company, and the acquisition closed immediately prior to Abiomed Europe’s acquisition of ECP. The share purchase agreement contains representations, warranties and closing conditions customary for transactions of its size and nature.

Purchase Price Allocation

The acquisition of ECP and AIS was accounted for as a business combination. The purchase price for the acquisition has been allocated to the assets acquired and liabilities assumed based on their estimated fair values.

The acquisition-date fair value of the consideration transferred is as follows:

 

		Total Acquisition Date Fair Value (in thousands)
Cash consideration		$	15,750
Contingent consideration			6,000
Total consideration transferred		$	21,750

 

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The following table summarizes the estimated fair values of the assets acquired and liabilities assumed on July 1, 2014, the date of acquisition (in thousands):

 

Acquired assets:
Cash and cash equivalents		$	53
Accounts receivable			25
Property and equipment			619
In-process research and development			18,500
Goodwill			1,964
Long-term deferred tax assets			1,874
Other assets acquired			141
Total assets acquired			23,176
Liabilities assumed:
Accounts payable			295
Accrued liabilities			131
Long-term deferred tax liabilities			1,000
Total liabilities assumed			1,426
Net assets acquired		$	21,750

In-process research and development (“IPR&D”) is the estimated fair value of the ECP and AIS technology that had either not reached commercial technological feasibility nor had alternative future use at the time of the acquisition. Therefore the Company considered IPR&D, with assigned values to be allocated among the various IPR&D assets acquired.

Goodwill is calculated as the difference between the acquisition-date fair value of the consideration transferred and the fair values of the assets acquired and liabilities assumed. The goodwill resulting from these acquisitions arises largely from synergies expected from combining the operations of ECP and AIS with the Company’s existing operations. The goodwill is not deductible for income tax purposes.

Note 4. Marketable Securities and Fair Value Measurements

Marketable Securities

The Company’s marketable securities are classified as available-for-sale securities and, accordingly, are recorded at fair value. The difference between amortized cost and fair value is included in stockholders’ equity.

The Company’s marketable securities at September 30, 2015 and March 31, 2015 are invested in the following:

 

		Amortized Cost				Gross Unrealized Gains				Gross Unrealized Losses				Fair Market Value
		(in $000’s)
September 30, 2015:
US Treasury mutual fund securities		$	19,487			$	—			$	—			$	19,487
Short-term government-backed securities			101,588				14				(2	)			101,600
		$	121,075			$	14			$	(2	)		$	121,087

 

		Amortized Cost				Gross Unrealized Gains				Gross Unrealized Losses				Fair Market Value
		(in $000’s)
March 31, 2015:
US Treasury mutual fund securities		$	19,487			$	—			$	—			$	19,487
Short-term government-backed securities			90,070				9				(9	)			90,070
Long-term government-backed securities			13,999				2				(5	)			13,996
		$	123,556			$	11			$	(14	)		$	123,553

 

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Fair Value Hierarchy

Fair value is defined as the price that would be received upon the sale of an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three categories:

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

Level 2: Observable market-based inputs or unobservable inputs that are corroborated by market data.

Level 3: Unobservable inputs that are not corroborated by market data.

Level 1 primarily consists of financial instruments whose values are based on quoted market prices such as exchange-traded instruments and listed equities.

Level 2 includes financial instruments that are valued using models or other valuation methodologies. These models are primarily industry-standard models that consider various assumptions, including time value, yield curve, volatility factors, prepayment speeds, default rates, loss severity, current market and contractual prices for the underlying financial instruments, as well as other relevant economic measures. Substantially all of these assumptions are observable in the marketplace, can be derived from observable data or are supported by observable levels at which transactions are executed in the marketplace.

Level 3 is comprised of unobservable inputs that are supported by little or no market activity. Financial assets are considered Level 3 when their fair values are determined using pricing models, discounted cash flows, or similar techniques, and at least one significant model assumption or input is unobservable.

The following table presents the Company’s financial instruments recorded at fair value in the condensed consolidated balance sheets, classified according to the three categories described above:

 

		Level 1				Level 2				Level 3				Total
		(in $000’s)
September 30, 2015:
Assets
U.S. Treasury mutual fund securities		$	—			$	19,487			$	—			$	19,487
Short-term government-backed securities			—				101,600				—				101,600
Liabilities
Contingent consideration			—				—				6,817				6,817

 

		Level 1				Level 2				Level 3				Total
		(in $000’s)
March 31, 2015:
Assets
U.S. Treasury mutual fund securities		$	—			$	19,487			$	—			$	19,487
Short-term government-backed securities			—				90,070				—				90,070
Long-term government-backed securities			—				13,996				—				13,996
Liabilities
Contingent consideration			—				—				6,510				6,510

The Company’s investments in U.S. Treasury mutual fund securities, short-term government-backed securities and long-term government-backed securities are reported as Level 2 financial assets as they are not exchange-traded instruments.

The Company’s financial liabilities consisted of contingent consideration potentially payable to former ECP shareholders related to the acquisition of ECP in July 2014. This liability is reported as Level 3 as the estimated fair value of the contingent consideration related to the acquisition of the ECP requires significant management judgment or estimation and is calculated using the income approach, using various revenue and cost assumptions and applying a probability to each outcome.

 

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The following table summarizes the change in fair value, as determined by Level 3 inputs, of the contingent consideration for the six months ended September 30, 2015:

 

		For the Six Months Ended September 30,
		2015
		(in $000’s)
Level 3 liabilities, beginning balance		$	6,510
Additions			—
Payments			—
Change in fair value			307
Level 3 liabilities, ending balance		$	6,817

The change in fair value of the contingent consideration of $0.2 million and $0.3 million for the three and six months ended September 30, 2015, respectively, and $0.2 million for each of the three and six months ended September 30, 2014, was due to an increase in fair value caused by the effect of the passage of time on the fair value measurement of milestones related to the ECP acquisition. Adjustments associated with the change in fair value of contingent consideration are included in research and development expenses on the Company’s condensed consolidated statements of operations.

The following table presents quantitative information about the inputs and valuation methodologies used for the Company’s fair value measurements as of September 30, 2015 classified as Level 3:

 

		Fair Value at
		September 30, 2015						Significant		Weighted Average (range, if
		(in $000’s)				Valuation Methodology		Unobservable Input		applicable)
Contingent consideration		$	6,817			Probability weighted income approach		Milestone dates		2018 to 2021
								Discount rate		8% to 12%
								Probability of occurrence		Probability adjusted level of 40% for the base case scenario and 5% to 25% for various upside and downside scenarios

Other Investments

The Company periodically makes investments in private medical device companies that focus on heart failure and heart pump technologies. In July 2015, the Company invested $0.8 million for its participation in a preferred stock offering of a private medical technology company. The aggregate carrying amount of the Company’s other investments was $4.4 million and $3.6 million at each of September 30, 2015 and March 31, 2015, respectively, and is classified within other assets in the unaudited condensed consolidated balance sheets. These investments are accounted for using the cost method and are measured at fair value only if there are identified events or changes in circumstances that may have a significant adverse effect on the fair value of these investments.

Note 5. Inventories

The components of inventories are as follows:

 

		September 30, 2015				March 31, 2015
		(in $000’s)
Raw materials and supplies		$	8,479			$	7,417
Work-in-progress			9,358				6,466
Finished goods			5,195				2,891
		$	23,032			$	16,774

 

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The Company’s inventories relate to its circulatory care product lines, primarily its Impella^® heart pump product platforms. Finished goods and work-in-process inventories consist of direct material, labor and overhead. During the six months ended September 30, 2015 and 2014, the Company recorded $1.0 million and $0.6 million, respectively, in write-downs of inventory.

Note 6. Goodwill and In-Process Research and Development

Goodwill

The carrying amount of goodwill at September 30, 2015 and March 31, 2015 was $32.7 million and $31.5 million, respectively, and has been recorded in connection with the Company’s acquisition of Impella Cardiosystems AG, or Impella Cardiosystems in May 2005 and ECP and AIS in July 2014. The goodwill activity is as follows:

 

		(in $000’s)
Balance at March 31, 2015		$	31,534
Foreign currency translation impact			1,142
Balance at September 30, 2015		$	32,676

The Company evaluates goodwill at least annually at October 31, as well as whenever events or changes in circumstances suggest that the carrying amount may not be recoverable. The Company has no accumulated impairment losses on goodwill.

As described in Note 3 “Acquisitions,” in July 2014, the Company acquired ECP and AIS and recorded $18.5 million of IPR&D. The estimated fair value of IPR&D was determined using a probability-weighted income approach, which discounts expected future cash flows to present value. The projected cash flows from the expandable catheter pump technology were based on certain key assumptions, including estimates of future revenue and expenses, taking into account the stage of development of the technology at the acquisition date and the time and resources needed to complete development. The Company used a discount rate of 22.5% and cash flows that have been probability adjusted to reflect the risks of product commercialization, which the Company believes are appropriate and representative of market participant assumptions.

The carrying value of the Company’s IPR&D assets and the change in the balance for the six months ended September 30, 2015 are as follows:

 

		(in $000’s)
Balance at March 31, 2015		$	14,711
Foreign currency translation impact			532
Balance at September 30, 2015		$	15,243

Note 7. Accrued Expenses

Accrued expenses consist of the following:

 

		September 30, 2015				March 31, 2015
		(in $000’s)
Employee compensation		$	11,343			$	15,978
Research and development			2,957				1,744
Sales and income taxes			1,249				1,506
Professional, legal and accounting fees			1,112				710
Warranty			697				1,103
Other			1,503				853
		$	18,861			$	21,894

Employee compensation consists primarily of accrued bonuses, accrued commissions and accrued employee benefits at September 30, 2015 and March 31, 2015.

 

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Note 8. Stock-Based Compensation

The following table summarizes stock-based compensation expense by financial statement line item in the Company’s condensed consolidated statements of operations for the three and six months ended September 30, 2015 and 2014:

 

		For the Three Months Ended September 30,								For the Six Months Ended September 30,
		2015				2014				2015				2014
		(in $000’s)								(in $000’s)
Cost of product revenue		$	218			$	148			$	455			$	357
Research and development			989				773				1,920				1,626
Selling, general and administrative			9,586				3,103				13,217				6,331
		$	10,793			$	4,024			$	15,592			$	8,314

The components of stock-based compensation for the three and six months ended September 30, 2015 and 2014 were as follows:

 

		For the Three Months Ended September 30,								For the Six Months Ended September 30,
		2015				2014				2015				2014
		(in $000’s)								(in $000’s)
Restricted stock units		$	8,446			$	3,334			$	12,349			$	6,754
Stock options			2,227				624				3,046				1,423
Employee stock purchase plan			120				66				197				137
		$	10,793			$	4,024			$	15,592			$	8,314

The Company’s former Chief Financial Officer retired effective July 31, 2015 and currently serves as a consultant to the Company through July 31, 2017. In connection with the former Chief Financial Officer’s retirement agreement, his unvested options and restricted stock units were modified such that they will continue to vest and he will be permitted to exercise any vested options until July 31, 2017, including any options that vest after his retirement date, other than such options that expire on the tenth anniversary of the grant date. The Company recorded costs of $2.5 million in stock compensation expense, which is recorded in selling, general and administrative expenses for the three and six months ended September 30, 2015.

In June 2015, the Company’s Board of Directors adopted a non-employee director retirement policy that provides for the accelerated vesting of all stock options, restricted stock units and other equity awards held by a non-employee director if he or she permanently ceases his or her service on the Company’s Board of Directors by reason of death, disability, or the non-employee director’s retirement following at least five years of service and so long as his or her age plus service equals or exceeds 65. This retirement policy accelerated the recognition of stock-based compensation because the outstanding unvested restricted stock units held by retirement eligible non-employee directors are able to vest at their decision to retire. The Company recorded costs of $1.4 million in accelerated stock compensation expense, which is recorded in selling, general and administrative expenses for the six months ended September 30, 2015.

In August 2015, the Company approved the annual equity award grant to non-employee directors in the form of restricted stock units covering 3,900 shares of the Company’s common stock, which vest on the earlier of: (a) the one year anniversary of the grant date; or (b) the next annual meeting of stockholders. In conjunction with the Company’s non-employee director retirement policy, the stock compensation expense for awards to retirement eligible non-employee directors was fully recognized upon grant. The Company recorded costs of $2.0 million in stock compensation expense, which is recorded in selling, general and administrative expenses for the three and six months ended September 30, 2015.

 

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Stock Options

The following table summarizes the stock option activity for the six months ended September 30, 2015:

 

		Options (in thousands)				Weighted Average Exercise Price				Weighted Average Remaining Contractual Term (years)				Aggregate Intrinsic Value (in thousands)
Outstanding at beginning of period			2,892			$	14.72				5.18
Granted			145				69.50
Exercised			(703	)			11.33
Cancelled and expired			(1	)			14.00
Outstanding at end of period			2,333			$	19.16				5.56			$	172,712
Exercisable at end of period			1,696			$	13.76				4.50			$	134,674
Options vested and expected to vest at end of period			2,277			$	18.98				5.50			$	169,000

The aggregate intrinsic value of options exercised was $49.5 million for the six months ended September 30, 2015. The total fair value of options that vested during the six months ended September 30, 2015 was $2.4 million.

The remaining unrecognized stock-based compensation expense for unvested stock option awards at September 30, 2015 was approximately $6.4 million, net of forfeitures, and the weighted-average period over which this cost will be recognized is 2.3 years.

The Company estimates the fair value of each stock option granted at the grant date using the Black-Scholes option valuation model. The weighted average grant-date fair value for options granted during the six months ended September 30, 2015 and 2014 was $18.08 and $9.05 per share, respectively.

The fair value of options granted during the three and six months ended September 30, 2015 and 2014 were calculated using the following weighted average assumptions:

 

		For the Three Months Ended September 30,								For the Six Months Ended September 30,
		2015				2014				2015				2014
Risk-free interest rate			1.63	%			1.75	%			1.59	%			1.60	%
Expected option life (years)			4.13				4.19				4.14				4.19
Expected volatility			48.3	%			48.7	%			49.7	%			49.3	%

The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant for a term consistent with the expected life of the stock options. Volatility assumptions are calculated based on the historical volatility of the Company’s stock and adjustments for factors not reflected in historical volatility that may be more indicative of future volatility. The Company estimates the expected term of options based on historical exercise experience and estimates of future exercises of unexercised options. An expected dividend yield of zero is used in the option valuation model because the Company does not pay cash dividends and does not expect to pay any cash dividends in the foreseeable future. The Company estimates forfeitures based on an analysis of actual historical forfeitures, adjusted to the extent historic forfeitures may not be indicative of forfeitures in the future.

 

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Restricted Stock and Restricted Stock Units

The following table summarizes the activity of restricted stock and restricted stock units for the six months ended September 30, 2015:

 

		Number of Shares				Weighted Average Grant Date Fair Value
		(in thousands)				(per share)
Restricted stock and restricted stock units at beginning of period			1,160			$	21.90
Granted			655			$	80.70
Vested			(461	)		$	22.55
Forfeited			(42	)		$	13.09
Restricted stock and restricted stock units at end of period			1,312			$	51.31

As of September 30, 2015, there are no restricted stock awards outstanding.

The weighted average grant-date fair value for restricted stock units granted, including performance and market-based awards, during the six months ended September 30, 2015 and 2014 was $80.70 and $21.88 per share, respectively. This includes 322,980 market based awards which were valued at $107.10 per share in which a Monte Carlo simulation was used to account for the market condition in valuing the award. See details below in “Market Based Awards”.

The total fair value of restricted stock units that vested during the six months ended September 30, 2015 and 2014 was $10.2 million and $9.5 million, respectively. The remaining unrecognized compensation expense for outstanding restricted stock units, including performance and market-based awards, as of September 30, 2015 was $33.3 million and the weighted-average period over which this cost will be recognized is 2.8 years.

Performance and Market-Based Awards

Included in the restricted stock units activity are certain awards that vest subject to certain performance and market-based criteria. The remaining unrecognized compensation expense for outstanding performance and market-based restricted stock units as of September 30, 2015 was $22.7 million and the weighted-average period over which this cost will be recognized is 3.0 years.

Performance-Based Awards

In May 2015, performance-based awards of restricted stock units for the potential issuance of 183,940 shares of common stock were issued to certain executive officers and employees, all of which vest upon achievement of prescribed service milestones by the award recipients and performance milestones by the Company. As of September 30, 2015, the Company is recognizing compensation expense based on the probable outcome related to the prescribed performance targets on the outstanding awards.

In May 2014, performance-based awards of restricted stock units for the potential issuance of 379,752 shares of common stock were issued to certain executive officers and employees, all of which vest upon achievement of prescribed service milestones by the award recipients and performance milestones by the Company. The Company met the prescribed performance milestones in fiscal 2015. As of September 30, 2015, 222,563 shares of common stock underlying restricted stock units remain unvested and such restricted stock units will vest subject to service requirements for vesting for these employees.

In March 2014, the Company modified the performance condition on 50,000 restricted stock units originally granted in June 2011. During the three months ended June 30, 2015, the Company reversed $1.0 million that had been previously recorded as stock-based compensation expense based on the expectation that it is not probable that certain performance milestones related to this award will be achieved within the time period required by the award.

In May 2013, performance-based awards of restricted stock units for the potential issuance of 268,988 shares of common stock were issued to certain executive officers and employees, all of which vest upon achievement of prescribed service milestones by the award recipients and performance milestones by the Company. The Company met the prescribed performance milestones in fiscal 2014. As of September 30, 2015, 148,995 shares of common stock underlying restricted stock units remain unvested and such restricted stock units will vest subject to service requirements for vesting for these employees.

Market-Based Awards

In June 2015, the Company awarded certain executive officers a total of up to 322,980 market-based restricted share units. These restricted stock units will vest and result in the issuance of common stock based on continuing employment and the relative ranking of the total shareholder return (“TSR”) of the Company’s common stock in relation to the TSR of the component companies in the S&P Health Care Equipment Select Industry Index over a three-year performance period based on a comparison of average

 

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closing stock prices between June 2015 and June 2018. The actual number of market-based restricted stock units that may be earned can range from 0% to 300% of the target number of shares. One-half of the market-based restricted stock units earned will vest in June 2018 and the remaining restricted stock units will vest one year thereafter.

The Company used a Monte Carlo simulation model to estimate that the grant-date fair value of the restricted stock units. The fair value related to the restricted stock units will be recorded as stock compensation expense over the period from date of grant to June 2018 regardless of the actual TSR outcome achieved.

The table below sets forth the assumptions used to value the awards and the estimated grant-date fair value:

 

Risk-free interest rate			1.10	%
Dividend yield			0	%
Remaining performance period (years)			2.96
Expected volatility			47.2	%
Estimated grant date fair value (per share)		$	107.10
Target performance (number of shares)			107,660

Note 9. Income Taxes

The income tax provision represents the Company’s federal and state income tax obligations as well as foreign tax provisions. The Company’s income tax provision was $5.2 million and $11.5 million for the three and six months ended September 30, 2015, respectively. The Company’s income tax provision was $0.3 million and $0.6 million for the three and six months ended September 30, 2014, respectively. The estimated annual effective income tax rate is based upon estimated income before income taxes for the year, the geographical composition of the estimated income before taxes and estimated permanent differences. The estimated annual effective income tax rate can fluctuate and may differ from the actual tax rate recognized in fiscal 2016 for various reasons, including estimates of income before taxes, tax legislation, permanent differences, discrete items, and any adjustments between tax provision calculations and filed tax returns.

The significant differences between the statutory tax rate and effective tax rate for the three and six months ended September 30, 2015 and 2014 were as follows:

 

		For the Three Months Ended September 30,								For the Six Months Ended September 30,
		2015				2014				2015				2014
Statutory income tax rate			35.0	%			34.0	%			35.0	%			34.0	%
Increase (decrease) resulting from:
Losses not benefited			—				(26.0	)			—				(15.7	)
Credits			(1.2	)			—				(1.4	)			—
State taxes, net			3.3				—				3.3				—
Permanent differences			3.0				—				3.5				—
Other			0.2				—				0.6				2.6
Effective tax rate			40.3	%			8.0	%			41.0	%			20.9	%

The Company and its subsidiaries are subject to U.S. federal income tax, as well as income taxes in Germany and multiple state jurisdictions. All tax years remain subject to examination by the Internal Revenue Service and state tax authorities, because the Company has net operating loss and tax credit carryforwards which may be utilized in future years to offset taxable income, those years may also be subject to review by relevant taxing authorities if the carryforwards are utilized. Fiscal years 2012 through 2015 remain open to examination in Germany.

 

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Note 10. Commitments and Contingencies

Commitments

In April 2015, the Company entered into an amendment to lease an additional 24,560 square feet of space at its existing headquarters in Danvers, Massachusetts. The Company has certain rights to terminate the lease early, subject to the payment of a specified termination fee based on the timing of the termination, as further outlined in the lease amendment. The amendment also grants the Company a one-time right of first offer to lease new space in the facility and a one-time first right of refusal to buy the facility, subject to certain conditions set forth therein This facility encompasses most of the Company’s U.S. operations, including research and development, manufacturing, sales and marketing and general and administrative departments. The monthly lease payments over the term of the lease are as follows:

 

•

The base rent for May 2014 through December 2015 is $74,050 per month; and

 

•

The base rent for January 2016 through February 2016 will be $85,818 per month; and

 

•

The base rent for March 2016 through February 2018 will be $82,518 per month; and

 

•

The base rent for March 2018 through February 2021 will be $85,030 per month.

The Company’s European headquarters is located in Aachen, Germany and consists of approximately 33,000 square feet of space under an operating lease. In July 2013, the Company entered into a lease agreement to continue renting its existing space in Aachen, Germany through July 31, 2023. In October 2015, the Company entered into an amendment to this lease agreement to lease 9,000 square feet of additional space effective July 1, 2015. The Company also entered into another lease agreement in October 2015 to lease approximately 30,000 square feet of additional space adjacent to its Aachen facility from July 1, 2015 through June 30, 2016. This agreement also provided the Company with options to extend the lease through July 31, 2033. The lease payments under these agreements are approximately 64,500€ (euro) (approximately U.S. $72,500 at September 30, 2015 exchange rates) per month. The building houses most of the manufacturing operations for the Impella product lines as well as certain research and development functions and the sales, marketing and general and administrative functions for most of its product lines sold in Europe and the Middle East.

License Agreement

In April 2014, the Company entered into an exclusive license agreement with Opsens, Inc. for the rights to certain optical sensor technologies in the field of cardio-circulatory assist devices. The Company made a $1.5 million upfront payment upon execution of the agreement and agreed to make additional payments of up to $4.5 million upon the achievement of certain development milestones.

Litigation

From time to time, the Company is involved in legal and administrative proceedings and claims of various types. In some actions, the claimants seek damages, as well as other relief, which, if granted, would require significant expenditures. The Company records a liability in its condensed consolidated financial statements for these matters when a loss is known or considered probable and the amount can be reasonably estimated. The Company reviews these estimates each accounting period as additional information is known and adjusts the loss provision when appropriate. If a matter is both probable to result in liability and the amounts of loss can be reasonably estimated, the Company estimates and discloses the possible loss or range of loss. If the loss is not probable or cannot be reasonably estimated, a liability is not recorded in its condensed consolidated financial statements.

On October 26, 2012, the Company was informed that the Department of Justice, United States Attorney’s Office for the District of Columbia was conducting an investigation (“Marketing and Labeling Investigation”) focused on the Company’s marketing and labeling of the Impella 2.5. On October 31, 2012, the Company accepted service of a subpoena related to this investigation seeking documents and other materials related to the Impella^® 2.5 heart pump. The Company cooperated fully with the Marketing and Labeling Investigation, and on June 29, 2015, the Company received confirmation that the Department of Justice had closed the Marketing and Labeling Investigation without taking enforcement action.

On April 25, 2014, the Company received a subpoena from the Boston regional office of the United States Department of Health and Human Services, or HHS, Office of Inspector General requesting materials relevant to the Company’s reimbursement of expenses and remuneration to healthcare providers for a six month period from July 2012 through December 2012 in connection with a civil investigation under the False Claims Act (the “FCA Investigation”). The Company submitted the requested documents to HHS and believes that it substantially complied with the subpoena. On November 6, 2014, the Company received notice from the Department of Justice, United States Attorney’s Office for the District of Massachusetts in the form of a Civil Investigative Demand (“CID”) requesting additional materials relating to this matter for the time period of January 1, 2012 through December 31, 2013. The Company is currently in the process of responding to the additional requests for information contained in the CID, and other informal requests, and intends to continue to cooperate with the U.S. Attorney’s Office in connection with the FCA Investigation.

 

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In July and August 2015, Thoratec Corporation (“Thoratec”), acquired by St. Jude Medical, Inc. in October 2015, brought actions in connection with two Company patents relevant to Thoratec’s HeartMate PHP (“Percutaneous Heart Pump”) medical device (“PHP”). In those proceedings, which are in the United Kingdom and Germany, Thoratec asserts that the two patents are invalid. In September 2015, the Company filed counterclaims in the action in Germany asserting that the PHP product infringes the two patents and a third patent owned by the Company. Both the Germany and United Kingdom proceedings are ongoing.

The Company is unable to estimate a potential liability with respect to the legal matters noted above. There are numerous factors that make it difficult to meaningfully estimate possible loss or range of loss at this stage of the legal proceedings, including that the FCA Investigation and patent dispute with Thoratec remain in relatively early stages, there are significant factual and legal issues to be resolved and information obtained or rulings made during any potential lawsuits or investigations could affect the methodology for calculation. Therefore, the Company is unable at this time to estimate any possible losses and accordingly, no adjustment has been made to the financial statements to reflect the outcome of these uncertainties.

Note 11. Segment and Enterprise Wide Disclosures

The Company operates in one business segment—the research, development and sale of medical devices to assist or replace the pumping function of the failing heart. The Company’s chief operating decision maker (determined to be the Chief Executive Officer) does not manage any part of the Company separately, and the allocation of resources and assessment of performance are based on the Company’s consolidated operating results. Approximately 77% of the Company’s total consolidated assets were located within the U.S. as of September 30, 2015 and March 31, 2015. The remaining assets were located primarily in Germany and included goodwill and IPR&D of $47.9 million and $46.2 million at September 30, 2015 and March 31, 2015, respectively, associated with the Impella Cardiosystems acquisition in May 2005 and the ECP acquisition in July 2014. Total assets outside of the U.S. excluding goodwill and IPR&D amounted to 10% of total consolidated assets as of each of September 30, 2015 and March 31, 2015. International sales (primarily in Europe) accounted for 7% of total revenue for each of the three and six months ended September 30, 2015 and 11% of total revenue for each of the three and six months ended September 30, 2014.

 

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ITEM 2:

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Forward Looking Statements

This Report may contain “forward looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements may be accompanied by such words as “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “project,” “target,” “will” and other words and terms of similar meaning. These forward-looking statements address various matters including, among others, future actions related to ongoing investigations and expenditures related thereto; our expectations with respect to submissions to and approvals from regulatory bodies, such as the FDA, including our expectation that the Impella CP^®, Impella 5.0^® and Impella LD^® devices will retain their 510(k) clearances until completion of the FDA review process of our Pre-Market Approval (“PMA”) supplemental submissions for those devices and the expectation that the PMA supplements will receive regulatory approval by the FDA in the summer of 2016; the development and commercialization of new and existing products and anticipated costs, including research and development, sales and marketing and training costs associated with product development and commercialization; expected capital expenditures for the fiscal year ending March 31, 2016; commercial plans for our products into new markets such as Japan; demand and expected shipments of our products; anticipated shifts in the revenue mix associated with our products; and our ability to increase revenues from our Impella line of products and the sufficiency of revenues to fund future operations. Each forward-looking statement in this Report is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, our inability to predict the outcome of investigations and litigation and associated expenses; possible delays in our research and development programs; our ability to obtain regulatory approvals and market our products, and uncertainties related to regulatory processes; greater government scrutiny and regulation of the medical device industry and our ability to respond to changing laws and regulations affecting our industry, including any reforms to the regulatory approval process administered by the FDA, including the 510(k) process and 515 Program Initiative, and changing enforcement practices related thereto; the inability to manufacture products in commercial quantities at an acceptable cost; the acceptance by physicians and hospitals of our products; the impact of competitive products and pricing; uncertainties associated with future capital needs and the risks identified under Item 1A of Part I of our Annual Report on Form 10-K, for the year ended March 31, 2015, as well as the other information we file with the Securities and Exchange Commission. Readers are cautioned not to place considerable reliance on any forward-looking statements contained in this Report, which speak only as of the date of this Report. We undertake no obligation to update or revise these forward-looking statements whether as a result of new information, future events or otherwise, unless required by law. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Overview

We are a leading provider of temporary percutaneous mechanical circulatory support devices and we offer a continuum of care to heart failure patients. We develop, manufacture and market proprietary products that are designed to enable the heart to rest, heal and recover by improving blood flow to the coronary arteries and end-organs and/or temporarily performing the pumping function of the heart. Our products are used in the cardiac catheterization lab, or cath lab, by interventional cardiologists, the electrophysiology lab, the hybrid lab and in the heart surgery suite by heart surgeons. A physician may use our devices for patients who are in need of hemodynamic support prophylactically or emergently before, during or after angioplasty or heart surgery procedures. We believe heart recovery is the optimal clinical outcome for patients experiencing heart failure because it enables patients to go home with their own native heart and restores their quality of life. In addition, we believe that for the care of such patients, heart recovery is the most cost-effective solution for the healthcare system.

Our strategic focus and the driver of the majority of our revenue growth is the market penetration of our family of Impella products. Our Impella 2.5 product received 510(k) clearance in June 2008 from the U.S Food and Drug Administration, or FDA, for partial circulatory support for up to six hours. In March 2015, we received a PMA from the FDA for Impella 2.5 during elective and urgent high-risk percutaneous coronary intervention, or PCI, procedures. Impella 2.5 is the first hemodynamic support device to receive a PMA indication for use during high-risk PCI procedures, demonstrating its safety and effectiveness for this complex patient population. With this approval, the Impella 2.5 is a temporary (up to six hours) ventricular support device indicated for use during high-risk PCI performed in elective or urgent hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability that may occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events. The product labeling allows for the clinical decision to leave Impella 2.5 in place beyond the intended duration of up to six hours due to unforeseen circumstances. As required by our PMA approval, we will conduct a single-arm, post approval study on the Impella 2.5, collecting data on high-risk PCI patients. The study will be a prospective, multi-center study comprised of 369 patients from 70 sites supported with the Impella 2.5 system. The Impella 2.5 heart pump is supported by clinical guidelines and has been eligible to be reimbursed in the U.S. by the Centers for Medicare & Medicaid Services, or CMS under ICD-9-CM code 37.68 since 2008 for multiple indications, including high-risk PCI. On July 31, 2015, the CMS reconfirmed reimbursement levels for the Impella products and confirmed that the existing MS-DRG mapping for the Impella products remains unchanged in the transition from ICD-9 to ICD-10, which is effective October 1, 2015.

 

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We received 510(k) clearance in April 2009 for our Impella 5.0 and Impella LD devices for circulatory support for up to six hours. These devices are larger and provide more blood flow to patients than the Impella 2.5. In September 2012, our Impella CP product received 510(k) clearance from the FDA for partial circulatory support for up to six hours.

In August 2015, we submitted the PMA supplement submissions requesting to expand Impella 2.5 PMA approval to most of our other Impella devices (Impella CP, Impella 5.0 and Impella LD). The submissions are for a set of indications related to the use of the Impella devices in patients suffering cardiogenic shock following acute myocardial infarction or cardiac surgery and for a longer duration of support. We anticipate receiving regulatory approval on the PMA supplements from the FDA in the summer of 2016.

These submissions are proposed as a supplement to the Impella 2.5 PMA approval for high risk PCI received on March 23, 2015, and include analysis on 415 patients from the FDA study RECOVER 1 and the U.S. Impella product registry (the “U.S. Impella Registry”), and a relevant literature review that references 692 patients in 17 clinical studies. Additionally, over 24,000 patients supported by Impella devices were reviewed in a safety analysis provided using the FDA/Medical Device Reporting (MDR) database. Through its review of the supplemental submission, the FDA will ultimately render a decision concerning the safety and efficacy of the Impella CP, Impella 5.0 and Impella LD in the applied-for patient populations.

We expect the Impella CP, Impella 5.0 and Impella LD to retain their 510(k) clearances until completion of the FDA process.

We received FDA approval for Impella RP under a Humanitarian Device Exemption, or HDE, in January 2015. The Impella RP is the first percutaneous single access heart pump designed for right heart support to receive FDA approval. As part of the HDE approval, we are required to conduct two post approval studies (PAS) for Impella RP. One includes an adult patient population of 30 patients and the other, a pediatric patient population for a maximum of 15 patients. These studies will be conducted to monitor the post-market safety and probable benefit of the Impella RP device. Both studies will be single-arm multicenter studies that will follow the respective patients at 30 and 180 days post device explant.

The Impella product portfolio, which includes the Impella 2.5, Impella CP, Impella RP, Impella LD and Impella 5.0, has supported over 25,000 patients in the U.S. Our Impella 2.5, Impella 5.0, Impella LD, Impella CP and Impella RP products also have CE Mark approval and Health Canada approval which allows us to market these devices in the European Union and Canada.

In July 2014, we acquired all of the issued shares of ECP Entwicklungsgellschaft mbH, or ECP, a German limited liability company, for $13.0 million in cash, with additional potential payments up to a maximum of $15.0 million based on the achievement of certain technical, regulatory and commercial milestones. ECP, based in Berlin, Germany, is engaged in research, development, prototyping and the pre-serial production of a percutaneous expandable catheter pump which increases blood circulation from the heart with an external drive shaft. In connection with our acquisition of ECP, ECP acquired all of the issued shares of AIS GmbH Aachen Innovative Solutions, or AIS, a German limited liability company, for $2.8 million in cash which was provided by us. AIS, based in Aachen, Germany, holds certain intellectual property useful to ECP’s business, and, prior to being acquired by ECP, had licensed such intellectual property to ECP.

Our revenues are primarily generated from our Impella line of products. Revenues from our non-Impella products, largely focused on the heart surgery suite, have been lower over the past several years as we have strategically shifted our sales and marketing efforts towards our Impella products and the cath lab. We expect that most of our product and service revenues in the near future will be from our Impella products.

Our Products

Impella 2.5

The Impella 2.5 catheter is a percutaneous micro heart pump with an integrated motor and sensors. The device is designed primarily for use by interventional cardiologists to support patients in the cath lab who may require assistance to maintain their circulation. The Impella 2.5 catheter can be quickly inserted via the femoral artery to reach the left ventricle of the heart where it is directly deployed to draw blood out of the ventricle and deliver it to the circulatory system. This function is intended to reduce ventricular work and provide flow to vital organs. The Impella 2.5 is introduced with normal interventional cardiology procedures and can pump up to 2.5 liters of blood per minute.

The Impella 2.5 product received 510(k) clearance in June 2008 from the FDA for partial circulatory support for up to six hours. In March 2015, we received PMA from the FDA for Impella 2.5 during elective and urgent high-risk PCI procedures. Impella 2.5 is the first hemodynamic support device to receive a PMA indication for use during high-risk PCI procedures, demonstrating its safety and effectiveness for this complex patient population. With this approval, the Impella 2.5 is a temporary (up to six hours) ventricular support device indicated for use during high-risk PCI performed in elective or urgent hemodynamically stable patients with severe

 

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coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 in these patients may prevent hemodynamic instability that may occur during planned temporary coronary occlusions and may reduce periprocedural and post-procedural adverse events. The product labeling allows for the clinical decision to leave Impella 2.5 in place beyond the intended duration of up to six hours due to unforeseen circumstances. Per our PMA approval, we will conduct a single-arm, post-approval study on the Impella 2.5, collecting data on high-risk PCI patients. The study will be a prospective, multi-center study comprised of 369 patients from 70 sites supported with the Impella 2.5 system. The Impella 2.5 device has CE mark approval in Europe for up to five days of use and is approved for use in over 40 countries.

A November 2011 update to the American College of Cardiology Foundation, or ACCF, / American Heart Association, or AHA, Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions Guidelines for Percutaneous Coronary Intervention, for the first time, included Impella devices in both the emergent and prophylactic hemodynamic support settings. In addition, a December 2012 update to the AHA’s Recommendations for the Use of Mechanical Circulatory Support: Device Strategies and Patient Selection recommended Impella devices for use in mechanical circulatory support; a December 2012 update to the ACCF/AHA Guidelines for the Management of ST-Elevation Myocardial Infarction (STEMI) included Impella 2.5 for use in patients requiring urgent coronary artery bypass grafting with STEMI and in treatment of patients with cardiogenic shock complications after STEMI; and a January 2013 update to the International Society for Heart and Lung Transplantation Guidelines for Mechanical Circulatory Support included Impella devices for the first time for patients with multi-organ failure. In addition, Impella devices were included in a January 2013 update to the ACCF /AHA Task Force on Practice Guidelines for the Management of ST-Elevation Myocardial Infarction and a September 2014 AHA /the American College of Cardiology (ACC) Task Force on Practice Guidelines for the Management of Patients with Non-ST-Elevation Acute Coronary Syndromes.

In addition to the U.S. clinical trial data, the Impella 2.5 PMA submission included clinical and scientific supporting evidence from more than 215 publications, covering 1,638 Impella 2.5 patients and incorporated a medical device reporting (MDR) analysis from 13,981 Impella 2.5 patients. In addition to PROTECT I and PROTECT II, further data was provided in the submission from 637 high-risk patients enrolled in the U.S. Impella Registry. The U.S. Impella Registry is an ongoing multicenter, observational retrospective registry that includes 49 centers that collects data on the Impella 2.5, Impella 5.0 and Impella CP. The data collection from the registry includes Institutional Review Board, or IRB, approval, complete data monitoring and Clinical Events Committee adjudication. Additionally, the PMA analysis included hemodynamic science described in the literature and validated with a series of pre-clinical and clinical studies.

Impella CP

In September 2012, we announced that the Impella CP received 510(k) clearance from the FDA. The Impella CP provides blood flow of approximately one liter more per minute than the Impella 2.5 and is primarily used by either interventional cardiologists to support patients in the cath lab or by surgeons in the heart surgery suite. The Impella CP is indicated for up to six hours of partial circulatory support using an extracorporeal bypass control unit. It is also intended to be used to provide partial circulatory support, for up to six hours, during procedures not requiring cardiopulmonary bypass. The Impella CP received CE Mark approval to be marketed in the European Union in April 2012 and Health Canada approval to be marketed in Canada in June 2012.

In August 2015, we submitted the PMA supplement submissions requesting to expand Impella 2.5 PMA approval for most of our other Impella devices (Impella CP, Impella 5.0 and Impella LD). The submissions are for a set of indications related to the use of the Impella devices in patients suffering cardiogenic shock following acute myocardial infarction or cardiac surgery and for a longer duration of support. We anticipate receiving regulatory approval on the PMA supplements from the FDA in the summer of 2016.

We expect the Impella CP to retain its 510(k) clearance until completion of the FDA process.

Impella 5.0 and Impella LD

The Impella 5.0 and Impella LD are percutaneous micro heart pumps with integrated motors and sensors for use primarily in the heart surgery suite. These devices are designed to support patients who require higher levels of circulatory support as compared to the Impella 2.5. The Impella 5.0 and Impella LD devices received 510(k) clearance in April 2009, for circulatory support for up to six hours and have CE Mark approval in Europe for up to ten days’ duration and are approved for use in over 40 countries.

The Impella 5.0 can be inserted into the left ventricle via femoral cut down or through the axillary artery. The Impella 5.0 pump goes through the ascending aorta, across the valve and into the left ventricle. The Impella LD is similar to the Impella 5.0 but is implanted directly through an aortic graft. The Impella 5.0 and Impella LD can pump up to five liters of blood per minute, providing full circulatory support.

In August 2015, we submitted the PMA supplement submissions requesting to expand Impella 2.5 PMA approval for most of our other Impella devices (Impella CP, Impella 5.0 and Impella LD). The submissions are for a set of indications related to the use of

 

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the Impella devices in patients suffering cardiogenic shock following acute myocardial infarction or cardiac surgery and for a longer duration of support. We anticipate receiving regulatory approval on the PMA supplements from the FDA in the summer of 2016. We expect the Impella 5.0 and Impella LD to retain their 510(k) clearances until completion of the FDA process.

Impella RP

The Impella RP is a percutaneous catheter-based axial flow pump that is designed to allow greater than four liters of flow per minute and is intended to provide the flow and pressure needed to compensate for right side heart failure.

In November 2012, we announced that the Impella RP received U.S. investigational device exemption, or IDE, approval from the FDA for use in RECOVER RIGHT, a pivotal clinical study in the U.S. In March 2014, we completed enrollment of 30 patients at sites that present with signs of right side heart failure, require hemodynamic support, and are being treated in the catheterization lab or cardiac surgery suite. The study collected safety and effectiveness data on the percutaneous use of the Impella RP and was submitted to the FDA in connection with the HDE application towards the submission of an HDE. In January 2015, we received FDA approval for Impella RP under an HDE. As part of the HDE approval, we are required to conduct two post approval studies (PAS) for Impella RP. One includes an adult patient population of 30 patients and the other, a pediatric patient population for a maximum of 15 patients. These studies will be conducted to monitor the post-market safety and probable benefit of the Impella RP device. Both studies will be single-arm multicenter studies that will follow the respective patients at 30 and 180 days post device explant.

Impella RP is the first percutaneous single access heart pump designed for right heart support to receive FDA approval. An HDE is similar to a PMA application but is intended for patient populations of 4,000 or less per year in the U.S. and is subject to certain profit and use restrictions. The Impella RP is a percutaneous device approved to provide support of the right heart during times of acute failure for certain patients who have received a left ventricle assist device or have suffered heart failure due to acute myocardial infarction, or AMI, or a failed heart transplant. An HDE requires demonstration of the safety and probable benefit of the product, which is a lower standard than is applied to a PMA. In order to receive an HDE, there must be no comparable devices approved under PMA that are available to treat the targeted population. An approved HDE authorizes sales of the device to any hospital after Institutional Review Board review and approval by the hospital. In April 2014, the Impella RP received CE Marking approval which allows for commercial sales of Impella RP in the EU and other countries that require a CE Marking approval for sales.

AB5000

We manufacture and sell the AB5000 Circulatory Support System for the temporary support of acute heart failure patients in profound shock, including patients suffering from cardiogenic shock after a heart attack, post-cardiotomy cardiogenic shock, or myocarditis. We believe the AB5000 is the only commercially available cardiac assist device that is approved by the FDA for all indications where heart recovery is the desired outcome, including patients who have undergone successful cardiac surgery and subsequently develop low cardiac output, or patients who suffer from acute cardiac disorders leading to hemodynamic instability. We expect revenues from the AB5000 to be a smaller part of our business in the future as we focus our efforts on the Impella family of products.

Critical Accounting Policies and Estimates

There have been no significant changes in our critical accounting policies during the three and six months ended September 30, 2015, as compared to the critical accounting policies disclosed in Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the fiscal year ended March 31, 2015.

Recent Accounting Pronouncements

Information regarding recent accounting pronouncements is included in “Note 1. Nature of Business and Basis of Preparation” to our condensed consolidated financial statements and are incorporated herein by reference.

 

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Results of Operations

The following table sets forth certain condensed consolidated statements of operations data for the periods indicated as a percentage of total revenues:

 

		For the Three Months Ended September 30,								For the Six Months Ended September 30,
		2015				2014				2015				2014
Revenues:
Product			100.0	%			99.7	%			100.0	%			99.7	%
Funded research and development			—				0.3				—				0.3
Total revenues			100.0				100.0				100.0				100.0
Costs and expenses as a percentage of total revenues:
Cost of product revenue			15.9				18.5				15.4				19.2
Research and development			15.1				16.8				14.5				17.6
Selling, general and administrative			52.2				56.7				51.5				60.6
Total costs and expenses			83.2				92.0				81.4				97.4
Income from operations			16.8				8.0				18.6				2.6
Other income and income tax provision			6.7				0.6				7.5				0.5
Net income as a percentage of total revenues			10.1	%			7.4	%			11.1	%			2.1	%

Three and six months ended September 30, 2015 compared with the three and six months ended September 30, 2014

Revenue

Our revenues are comprised of the following:

 

		For the Three Months Ended September 30,								For the Six Months Ended September 30,
		2015				2014				2015				2014
		(in $000’s)								(in $000’s)
Impella product revenue		$	71,701			$	46,910			$	140,506			$	91,885
Service and other revenue			3,929				3,297				8,082				6,577
Other products			724				1,567				1,192				1,972
Total product revenues			76,354				51,774				149,780				100,434
Funded research and development			5				164				11				315
Total revenues		$	76,359			$	51,938			$	149,791			$	100,749

Impella product revenue encompasses Impella 2.5, Impella CP, Impella 5.0, Impella LD and Impella RP product sales. Other product revenue includes AB5000 and product accessory revenue. Service and other revenue represents revenue earned on service maintenance contracts and preventive maintenance calls.

Total revenues for the three months ended September 30, 2015 increased $24.5 million, or 47%, to $76.4 million from $51.9 million for the three months ended September 30, 2014. Total revenues for the six months ended September 30, 2015 increased by $49.1 million, or 49%, to $149.8 million from $100.7 million for the six months ended September 30, 2014. The increase in total revenue was primarily due to higher Impella product revenue from increased utilization in the U.S., which was attributable to increased use of Impella 2.5 as a result of PMA approval in March 2015 and higher utilization of Impella CP for those interventional cardiologists who prefer higher blood flow.

Impella product revenues for the three months ended September 30, 2015 increased by $24.8 million, or 53%, to $71.7 million from $46.9 million for the three months ended September 30, 2014. Impella product revenues for the six months ended September 30, 2015 increased by $48.6 million, or 53%, to $140.5 million from $91.9 million for the six months ended September 30, 2014. Most of the increase in Impella product revenue was from Impella CP and Impella 2.5 catheter sales in the U.S., as we focus on increasing utilization of our disposable catheter products through continued investment in our field organization and physician training programs. We expect Impella product revenues to continue to increase with our recent PMA approval in the U.S. as we increase utilization at existing customer sites, add new customer sites, continue our commercial launch of Impella CP, begin our controlled launch of Impella RP in the U.S. and expand our efforts in Europe.

 

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Service and other revenue for the three months ended September 30, 2015 increased by $0.6 million, or 18%, to $3.9 million from $3.3 million for the three months ended September 30, 2014. Service and other revenue for the six months ended September 30, 2015 increased by $1.5 million, or 23%, to $8.1 million from $6.6 million for the six months ended September 30, 2014. The increase in service revenue was primarily due to an increase in preventative maintenance service contracts, as we expand the use of our Impella AIC consoles to additional sites and place more consoles at existing higher using sites.

Other product revenues for the three months ended September 30, 2015 decreased by $0.9 million, or 56%, to $0.7 million from $1.6 million for the three months ended September 30, 2014. Other product revenues for the six months ended September 30, 2015 decreased by $0.8 million, or 40%, to $1.2 million from $2.0 million for the six months ended September 30, 2014. We expect that AB5000 revenue will continue to decline in fiscal 2016 as we focus our sales efforts in the surgical suite on Impella 5.0 and Impella LD.

Costs and Expenses

Cost of Product Revenue

Cost of product revenue for the three months ended September 30, 2015 increased by $2.5 million, or 26%, to $12.1 million from $9.6 million for the three months ended September 30, 2014. Gross margin was 84% for the three months ended September 30, 2015 and 82% for the three months ended September 30, 2014. Cost of product revenue for the six months ended September 30, 2015 increased by $3.7 million, or 19%, to $23.0 million from $19.3 million for the six months ended September 30, 2014. Gross margin was 85% for the six months ended September 30, 2015 and 81% for the six months ended September 30, 2014. The increase in cost of product revenues was related to increased demand for Impella products and higher production volume and costs to support growing demand for our Impella products. Gross margin has been impacted favorably in fiscal 2016 by higher manufacturing production volume, fewer shipments of Impella AIC consoles and improved efficiencies in manufacturing production.

Research and Development Expenses

Research and development expenses for the three months ended September 30, 2015 increased by $2.9 million, or 33%, to $11.6 million from $8.7 million for the three months ended September 30, 2014. Research and development expenses for the six months ended September 30, 2015 increased by $4.0 million, or 22%, to $21.8 million from $17.8 million for the six months ended September 30, 2014. The increase in research and development expenses was primarily due to product development initiatives on our existing products and new technologies, increased clinical spending primarily related to our U.S. Impella Registry and post approval studies and a renewed focus on quality initiatives for our Impella products.

We expect research and development to increase in fiscal 2016 as we continue to increase clinical spending related to our U.S. Impella Registry, apply for regulatory approval for our Impella products in Japan and support the PMA supplements for Impella CP, Impella 5.0 and Impella LD which were submitted in August 2015. In addition, we expect to incur additional costs as we continue to focus on engineering initiatives to improve our existing products and develop new technologies.

Selling, General and Administrative Expenses

Selling, general and administrative expenses for the three months ended September 30, 2015 increased by $10.3 million, or 35%, to $39.8 million from $29.5 million for the three months ended September 30, 2014. The increase in selling, general and administrative expenses was primarily due to the hiring of additional U.S. field sales and clinical personnel, increased spending on marketing initiatives as we continue to educate physicians on the benefits of hemodynamic support after receiving PMA approval for Impella 2.5, higher stock-based compensation expense, higher excise taxes associated with the medical device tax in the U.S. and higher professional fees to support the growth of our business. In the three months ended September 30, 2015, we recorded stock compensation expense amounts of $2.5 million related to the acceleration of vesting of equity awards upon retirement of our former Chief Financial Officer and $2.0 million related to equity awards granted in August 2015 to retirement eligible non-employee directors which was fully recognized upon grant.

Selling, general and administrative expenses for the six months ended September 30, 2015 increased by $16.1 million, or 26%, to $77.2 million from $61.1 million for the six months ended September 30, 2014. The increase in selling, general and administrative expenses was primarily due to the hiring of additional U.S. field sales and clinical personnel, increased spending on marketing initiatives as we continue to educate physicians on the benefits of hemodynamic support after receiving PMA approval for Impella 2.5, higher stock-based compensation expense, higher excise taxes associated with the medical device tax in the U.S. and higher professional fees to support the growth of our business. In the six months ended September 30, 2015, we recorded stock compensation expense amounts totaling $5.9 million which consist of $1.4 million recorded in the three months ended June 30, 2015 due to the non-employee director retirement policy that was adopted in June 2015, which upon occurrence of certain specified events, provides for the accelerated vesting of outstanding unvested restricted stock units held by retirement eligible non-employee directors and $4.5 million in expense recorded in the three months ended September 30, 2015 for items described above.

 

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Increases in selling, general and administrative expenses for the three and six months ended September 30, 2015 were partially offset by lower legal expenses related to the Marketing and Labeling Investigation which was closed in June 2015. We expect to continue to incur legal expenses for the foreseeable future related to the FCA Investigation discussed in “Note 10. Commitments and Contingencies—Litigation,” to our condensed consolidated financial statements. Additionally, we expect to continue to increase our expenditures on sales and marketing activities, with particular investments in field sales and clinical personnel with cath lab expertise to drive recovery awareness for acute heart failure patients. We also plan to increase our marketing, service and training investments after PMA approval in the U.S. for Impella 2.5.

Income Tax Provision

We recorded an income tax provision of $5.2 million and $11.5 million for the three and six months ended September 30, 2015, respectively, compared to $0.3 million and $0.6 million for the three and six months ended September 30, 2014, respectively. The increase in income tax provision for the three and six months ended September 30, 2015 was due to the fact that we had a full valuation allowance on most of our federal, state and certain foreign deferred tax assets prior to March 31, 2015, at which time most of the valuation allowance was reversed. The income tax provision for the three and six months ended September 30, 2015 was primarily due to the income generated in the U.S. and Germany in the period. The income tax provision for the three and six months ended September 30, 2014 was primarily due to income taxes related to our deferred tax liability associated with tax deductible goodwill that is not amortized for U.S. GAAP purposes.

Net Income

For the three months ended September 30, 2015, we recognized net income of $7.7 million, or $0.18 per basic share and $0.17 per diluted share, compared to $3.8 million, or $0.09 per basic and diluted share for the three months ended September 30, 2014. For the six months ended September 30, 2015, we recognized net income of $16.6 million, or $0.40 per basic share and $0.37 per diluted share, compared to a net income of $2.1 million, or $0.05 per basic and diluted share for the six months ended September 30, 2014. Our net income for the three and six months ended September 30, 2015 was driven primarily to higher Impella product revenue due to greater utilization of our Impella products in the U.S. and Europe.

Liquidity and Capital Resources

At September 30, 2015, our total cash, cash equivalents, and short and long-term marketable securities totaled $175.5 million, an increase of $29.5 million compared to $146.0 million at March 31, 2015. The increase in our cash, cash equivalents, and short and long-term marketable securities was due primarily to positive cash flows from operations in the six months ended September 30, 2015 and proceeds from stock option exercises.

Following is a summary of our cash flow activities:

 

		For the Six Months Ended September 30,
		2015				2014
Net cash provided by operating activities		$	28,856			$	9,902
Net cash used for investing activities			(1,718	)			(14,973	)
Net cash provided by financing activities			4,995				1,944
Effect of exchange rate changes on cash			(113	)			(306	)
Net increase (decrease) in cash and cash equivalents		$	32,020			$	(3,433	)

Cash Provided by Operating Activities

For the six months ended September 30, 2015, cash provided by operating activities consisted of net income of $16.6 million, adjustments for non-cash items of $28.6 million and cash used in working capital of $16.3 million. The increase in net income was primarily due to higher Impella product revenues from increased utilization of our Impella products. Adjustments for non-cash items consisted primarily of $15.6 million of stock-based compensation expense and a $10.8 million change in deferred tax provision. The decrease in cash from changes in working capital included a $5.2 million increase in accounts receivable associated with our higher revenues, a $6.9 million increase in inventory as we build up our inventory safety stock to support growing demand for our Impella products and $4.5 million decrease in accounts payable and accrued expenses.

For the six months ended September 30, 2014, cash provided by operating activities consisted of net income of $2.1 million, adjustments for non-cash items of $10.8 million and cash used in working capital of $3.0 million. Adjustments for non-cash items primarily consisted of $8.3 million of stock-based compensation expense and $1.2 million of depreciation and amortization of long-lived

 

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assets. The decrease in cash from changes in working capital included a $1.1 million increase in accounts receivable associated with our higher revenues and a $4.5 million for changes in accounts payable and accrued expenses. These amounts were partially offset by an increase in deferred revenue of $1.0 million.

Cash Used for Investing Activities

For the six months ended September 30, 2015, net cash provided by investing activities included $2.5 million in maturities (net of purchases) of marketable securities, partially offset by $3.4 million for the purchase of property and equipment mostly related to expansion of manufacturing capacity and office space in Danvers, Massachusetts and Aachen, Germany. We also made a $0.8 million investment in a private medical technology company during the six months ended September 30, 2015.

For the six months ended September 30, 2014, net cash used for investing activities included $3.0 million in net proceeds from the sale and maturity of marketable securities (net of purchases) and $1.5 million for the purchase of property and equipment mostly related to expansion of manufacturing capacity in Aachen, Germany. We used $15.7 million in net cash with our acquisition of ECP and AIS in July 2014. We also made a $0.8 million investment in a private medical technology company during the six months ended September 30, 2014.

Capital expenditures for fiscal 2016 are estimated to range from $10.0 to $30.0 million, and are expected to be for manufacturing capacity expansions in both our Danvers, Massachusetts and Aachen, Germany facilities, leasehold improvements associated with build-out of additional rental office space and software development projects.

Cash Provided by Financing Activities

For the six months ended September 30, 2015, net cash provided by financing activities included $8.0 million in proceeds from the exercise of stock options, $0.5 million in proceeds from the issuance of stock under the employee stock purchase plan and $0.4 million in excess tax benefits on stock-based awards. This amount was partially offset by $3.8 million in payments in lieu of issuance of common stock for payroll withholding taxes upon vesting of certain equity awards.

For the six months ended September 30, 2014, net cash provided by financing activities included $2.6 million in proceeds from the exercise of stock options and $0.4 million in proceeds from the issuance of stock under the employee stock purchase plan. This amount was offset by $1.0 million in payments in lieu of issuance of common stock for payroll withholding taxes upon vesting of certain equity awards.

Operating Capital and Liquidity Requirements

We believe that our revenue from product sales together with existing resources will be sufficient to fund our operations for at least the next twelve months, exclusive of activities involving any future acquisitions of products or companies that complement or augment our existing line of products.

Our primary liquidity requirements are to fund the expansion of our commercial infrastructure in the U.S., increase our manufacturing capacity, expand our office space in Danvers, Massachusetts and Aachen, Germany, increase our inventory levels in order to meet growing customer demand for our Impella products, fund new product development initiatives, prepare for commercial launches of Impella products in new markets in the future, such as Japan, increased clinical spending associated with our U.S. Impella Registry, as well as post approval study on Impella 2.5 related to our PMA approval and the Impella RP post approval study, costs of legal fees related to the FCA Investigation and patent activities and to provide for general working capital needs. To date, we have primarily funded our operations principally from product sales and through the sale of equity securities.

Our liquidity is influenced by our ability to sell our products in a competitive industry and our customers’ ability to pay for our products. Factors that may affect liquidity include our ability to penetrate the market for our products, maintain or reduce the length of the selling cycle for our products, capital expenditure requirements, investments in collaborative arrangements with other partners, and our ability to collect cash from customers after our products are sold. We also expect to continue to incur legal expenses for the foreseeable future related to the FCA Investigation and our response to requests for information. We continue to review our long-term cash needs on a regular basis. At September 30, 2015, we had no long-term debt outstanding.

Marketable securities at September 30, 2015 and March 31, 2015 consisted of $121.1 million and $123.6 million held in funds that invest in U.S. Treasury and government-backed securities, respectively. We are not a party to any interest rate swaps, currency hedges or derivative contracts of any type and have no exposure to commercial paper or auction rate securities markets.

Cash and cash equivalents held by our foreign subsidiaries totaled $7.5 million and $3.6 million at September 30, 2015 and March 31, 2015, respectively. Our operating income outside the U.S. is deemed to be permanently reinvested in foreign jurisdictions. We do not intend or currently foresee a need to repatriate cash and cash equivalents held by our foreign subsidiaries. If these funds are needed in the U.S., we believe that the potential U.S. tax impact to repatriate these funds would be immaterial.

 

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ITEM 3:

QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK

Primary Market Risk Exposures

Our cash, cash equivalents and marketable securities are subject to interest rate risk and will fall in value if market interest rates increase. If market interest rates were to increase immediately and uniformly by 10 percent from levels at September 30, 2015, we believe the decline in fair market value of our investment portfolio would be immaterial.

Currency Exchange Rates

We have foreign currency exposure to exchange rate fluctuations and particularly with respect to the euro, British pound sterling and Japanese yen. Therefore, our investment in our subsidiaries is sensitive to fluctuations in currency exchange rates. The effect of a change in currency exchange rates on our net investment in international subsidiaries is reflected in the accumulated other comprehensive income (loss) component of stockholders’ equity. If rates of exchange for the euro, British pound and Japanese yen were to have depreciated immediately and uniformly by 10% relative to the U.S. dollar from levels at September 30, 2015, the result would have been a reduction of stockholders’ equity of approximately $6.3 million.

Fair Value of Financial Instruments

At September 30, 2015, our financial instruments consist primarily of cash and cash equivalents, short-term marketable securities, accounts receivable, accounts payable and contingent consideration. The estimated fair values of the financial instruments have been determined by us using available market information and appropriate valuation techniques. Considerable judgment is required, however, to interpret market data to develop the estimates of fair value. The use of different market assumptions and/or estimation methodologies may have a material effect on the estimated fair value amounts.

 

ITEM 4.

CONTROLS AND PROCEDURES

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act), as of September 30, 2015. Based on this evaluation, our principal executive officer and principal financial officer concluded that, as of September 30, 2015, these disclosure controls and procedures are effective to provide reasonable assurance that material information required to be disclosed by us, including our consolidated subsidiaries, in reports that we file or submit under the Exchange Act, is recorded, processed, summarized and reported, within the time periods specified in the Securities and Exchange Commission rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure.

Evaluation of Changes in Internal Control over Financial Reporting

During the second quarter of our fiscal year ending March 31, 2016, there were no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II — OTHER INFORMATION

 

Item 1.

Legal Proceedings

We are from time to time involved in various legal actions, the outcomes of which are not within our complete control and may not be known for prolonged periods of time. In some actions, the claimants seek damages, as well as other relief, which, if granted, would require significant expenditures. We record a liability in our condensed consolidated financial statements for these actions when a loss is known or considered probable and the amount can be reasonably estimated. We review these estimates each accounting period as additional information is known and adjust the loss provision when appropriate. If the loss is not probable or cannot be reasonably estimated, a liability is not recorded in the condensed consolidated financial statements. Material legal proceedings are discussed in “Note 10. Commitments and Contingencies—Litigation” to our condensed consolidated financial statements and are incorporated herein by reference.

 

Item 1A.

Risk Factors

Investing in our common stock involves a high degree of risk. In addition to the other information set forth in this Report, you should carefully consider the factors discussed in Part I, “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended March 31, 2015, which could materially affect our business, financial condition or future results. As of the date of this Report there has been no material change in any of the risk factors described in our Annual Report on Form 10-K for the fiscal year ended March 31, 2015, except as noted below:

We own patents, trademarks, trade secrets, copyrights and other intellectual property and know-how that we believe gives us a competitive advantage. If we cannot protect our intellectual property and develop or otherwise acquire additional intellectual property, competition could force us to lower our prices, which could hurt our profitability.

Our intellectual property rights are and will continue to be a critical component of our success. We rely and expect to continue to rely on a combination of intellectual property, including patent, trademark, copyright, trade secret and domain name protection laws, as well as confidentiality agreements with our employees and others, to protect our intellectual property and proprietary rights. If we fail to obtain and maintain adequate intellectual property protection, we may not be able to prevent third parties from using our proprietary technologies or from marketing products that are very similar or identical to ours.

A substantial portion of our intellectual property rights relating to the Impella products and other products under development is in the form of trade secrets, rather than patents. Unlike patents, trade secrets are only recognized under applicable law if they are kept secret by restricting their disclosure to third parties. We protect our trade secrets and proprietary knowledge in part through confidentiality agreements with employees, consultants and other parties. However, certain consultants and third parties with whom we have business relationships, and to whom in some cases we have disclosed trade secrets and other proprietary knowledge, may also provide services to other parties in the medical device industry, including companies, universities and research organizations that are developing competing products. In addition, some of our former employees who were exposed to certain of our trade secrets and other proprietary knowledge in the course of their employment may seek employment with, and become employed by, our competitors. We cannot be assured that consultants, employees and other third parties with whom we have entered into confidentiality agreements will not breach the terms of such agreements by improperly using or disclosing our trade secrets or other proprietary knowledge, that we will have adequate remedies for any such breach, or that our trade secrets will not become known to or be independently developed by our competitors. The loss of trade secret protection for technologies or know-how relating to our product portfolio and products under development could adversely affect our business and our prospects.

Our business position also depends in part on our ability to maintain and defend our existing patents and obtain, maintain, and defend additional patents and other intellectual property rights. We intend to seek additional patents, but our pending and future patent applications may not result in issued patents or be granted on a timely basis. In addition, issued patents may not contain claims sufficiently broad to protect us against third parties with similar technologies or products or provide us with any competitive advantage, including exclusivity in a particular product area. The scope of our patent claims also may vary between countries, as individual countries have distinctive patent laws. We may be subject to challenges by third parties regarding our intellectual property, including, among others, claims regarding validity, enforceability, scope and effective term. Patent prosecution, related proceedings, and litigation in the U.S. and in other countries may be expensive, time consuming and ultimately unsuccessful. In addition, patents issued by foreign countries may afford less protection than is available under U.S. patent law and may not adequately protect our proprietary information. Our competitors may independently develop proprietary technologies and processes that are the same as or substantially equivalent to ours or design around our patents. Our competition may also hold or obtain intellectual property rights that would threaten our ability to develop or commercialize our product offerings. The expiration of patents on which we rely for protection of key products could diminish our competitive advantage and adversely affect our business and our prospects.

 

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Companies in the medical device industry typically obtain patents and frequently engage in substantial intellectual property litigation. Our products and technologies could infringe on the rights of others. If a third-party successfully asserts a claim for infringement against us, we may be liable for substantial damages, be unable to sell products using that technology, or have to seek a license or redesign the related product. These alternatives may be uneconomical or impossible. Intellectual property litigation could be costly, result in product development delays and divert the efforts and attention of management from our business.

In July and August 2015, Thoratec Corporation (“Thoratec”), acquired by St. Jude Medical, Inc. in October 2015, brought actions in connection with two Company patents relevant to Thoratec’s HeartMate PHP (“Percutaneous Heart Pump”) medical device (“PHP”). In those proceedings, which are in the United Kingdom and Germany, Thoratec asserts that the two patents are invalid. In September 2015, the Company filed counterclaims in the action in Germany asserting that the PHP product infringes the two patents and a third patent owned by the Company. Both the Germany and United Kingdom proceedings are ongoing.

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

(a) Not applicable.

(b) Not applicable.

(c) Not applicable.

 

Item 3.

Defaults Upon Senior Securities

None

 

Item 4.

Mine Safety Disclosures

Not applicable.

 

Item 5.

Other Information

None

 

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Item 6.

Exhibits

 

Exhibit No.

Description

Filed with This Form 10-Q

Incorporated by Reference

Form

Filing Date

Exhibit No.

3.1

Restated Certificate of Incorporation.

S-3

September 29, 1997

3.1

3.2

Restated By-Laws, as amended.

10-K

May 27, 2004 (File No. 001-09585)

3.2

3.3

Certificate of Designations of Series A Junior Participating Preferred Stock.

S-3

September 29, 1997

3.3

3.4

Amendment to the Company’s Restated Certificate of Incorporation to increase the authorized shares of common stock from 25,000,000 to 100,000,000.

8-K

March 21, 2007 (File No. 001-09585)

3.4

4.1

Specimen Certificate of common stock.

S-1

June 5, 1987

4.1

10.1

Lease agreement for additional commercial space dated October 19, 2015 for the facility located in Aachen, Germany.

X

10.2

Supplemental contract no. 1 dated October 19, 2015, to the lease agreement dated July 29, 2013 for the facility located in Aachen, Germany.

X

10.3

2015 Omnibus Incentive Plan.

Sch. 14A (File No. 001-09585)

July 2, 2015

Appendix A

31.1

Principal Executive Officer Certification pursuant to Securities Exchange Act Rules 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

X

31.2

Principal Financial Officer Certification pursuant to Securities Exchange Act Rule 13a-14(a) and 15d-14(a) as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

X

32.1

Principal Executive Officer and Principal Financial Officer Certifications pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

X

101

The following financial information from the ABIOMED, Inc. Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, formatted in Extensible Business Reporting Language (XBRL): (i) Condensed Consolidated Balance Sheets as of September 30, 2015 and March 31, 2015; (ii) Condensed Consolidated Statements of Operations for the three and six months ended September 30, 2015 and 2014; (iii) Condensed Consolidated Statements of Comprehensive Income (Loss) for the three and six months ended September 30, 2015 and 2014; (iv) Condensed Consolidated Statements of Cash Flows for the six months ended September 30, 2015 and 2014; and (v) Notes to Condensed Consolidated Financial Statements.

X

 

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ABIOMED, INC. AND SUBSIDIARIES

PART II. OTHER INFORMATION

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.

 

				ABIOMED, Inc.
Date: November 4, 2015				/s/    MICHAEL J. TOMSICEK
				Michael J. Tomsicek
				Vice President and Chief Financial Officer
				(Principal Accounting and Financial Officer)

 

32

Exhibit 10.1

 

 

Mietvertrag für gewerbliche Räume		Lease Agreement for Commercial Space
Zwischen		Of the one part:
der gewoge AG, Kleinmarschierstraße 54-58, 52062 Aachen, vertreten durch den Vorstand, Herren Thomas Hübner und Ulrich Warner, , ebenda,		gewoge AG, Kleinmarschierstrasse 54-58, 52062 Aachen, represented by the managing directors thereof, Messrs. Thomas Huebner and Ulrich Warner, ditto,
Umsatzsteuernummer Nr. Vermieter: DE121684276		VAT No. of Lessor: DE121684276,
Vermieter		Lessor;
und		and of the other:
der Firma Abiomed Europe GmbH, Neuenhofer Weg 3, 52074 Aachen, vertreten durch Herrn Dirk Michels und Herrn Dr. Thorsten Sieß		Abiomed Europe GmbH, Neuenhofer Weg 3, 52074 Aachen, represented by, Mr. Dirk Michels and Dr. Thorsten Siess
Mieter		Lessee
wird folgender Mietvertrag geschlossen:		hereby conclude the following Lease Agreement:
§ 1 Mietgegenstand		§ 1 Leased Object
1. Die auf dem Grundstück/im Hause		1. The rooms/spaces below located on the real property/in the building at
Neuenhofer Weg 3-5, 52074 Aachen		Neuenhofer Weg 3-5, 52074 Aachen,
gelegenen nachstehenden Räume/Flächen, die in den Anlagen I – V beigefügten Lageplänen rot gekennzeichnet sind:		which are marked in red in the site plans attached in Annexes I – V :
Neuenhofer Weg Nr. 3, 52074 Aachen, sämtliche im 3. Obergeschoss gelegenen Räumlichkeiten;		Neuenhofer Weg Nr. 3, 52074 Aachen, all rooms located on the 3rd floor;
Büro-/Nebenfläche 671 m²		Office/ancillary space 671 m²
Neuenhofer Weg Nr. 5, 52074 Aachen, sämtliche im Erdgeschoss, im 1. Obergeschoss, im 2. Obergeschoss und im 3. Obergeschoss gelegenenen Räumlichkeiten („Mietobjekt);		Neuenhofer Weg Nr. 5, 52074 Aachen, all rooms located on the ground floor, on the 1st, 2nd and 3rd floors (“leased property);

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Erdgeschoss Ground floor		Büro-/Nebenfläche Office/ancillary space		560 m²
1. Obergeschoss 1st floor		Büro-/Nebenfläche Office/ancillary space		559 m²
2. Obergeschoss 2nd floor		Büro-/Nebenfläche Office/ancillary space		558 m²
3. Obergeschoss 3rd floor		Büro-/Nebenfläche Office/ancillary space		477 m²
Untergeschoss Basement		Tiefgaragenstellplätze Underground parking garage spaces		43 Stck./spaces
Aussenbereich Outside area		Aussenstellplätze Outside parking spaces		9 Stck./spaces

 

werden zum ausschließlichen Betrieb der Abiomed Europe GmbH als Büro-, Labor-, Grau-, Rein- und Lagerräume vermietet.		shall be leased for the exclusive operation of Abiomed Europe GmbH as office, laboratory, gray, sterile and storage room space.
2. Mitvermietet werden folgende Zubehörgegenstände: keine		2. The following accessories shall also be leased: none
3. Die ausgehändigten Schlüssel sind bei Beendigung des Mietverhältnisses zurückzugeben; gleichzeitig hat der Mieter Schlüssel, die er zusätzlich auf seine Kosten hat anfertigen lassen, kostenlos an den Vermieter auszuliefern oder ihre Vernichtung nachzuweisen. Bevor der Mieter zusätzliche Schlüssel anfertigen lässt, muss der Mieter die schriftliche Genehmigung des Vermieters einholen.		3 The delivered keys are to be returned upon cessation of the lease relation; at the same time, the Lessee must deliver to the Lessor free of charge the keys which the Lessee additionally had made at its own cost or document the destruction thereof. Before the Lessee has additional keys made, the Lessee must obtain the written approval of the Lessor.
Der Vermieter ist aus Gründen der Sicherheit des Gesamtobjekts berechtigt, bei Verlust ausgehändigter oder durch den Mieter selbst beschaffter Schlüssel, auf Kosten des Mieters die erforderliche Zahl von Schlüsseln und neuen Schlössern anfertigen zu lassen; diese Regelung gilt entsprechend für die zentrale Schließanlage des Anwesens.		The Lessor shall be entitled for the security of the overall property to have the necessary number of new keys made at the Lessee’s cost in the event of the loss of the delivered keys or keys procured by the Lessee itself; this provision shall apply correspondingly to the central lock system for the property.
§ 2 Mietzeit – Vertrag von bestimmter Dauer		§ 2 Term – Contract for a fixed period
1. Das Mietverhältnis beginnt am 01.07.2015 und endet am 30.06.2016,		1. The lease relation shall commence on 1st July 2015 and cease on 30 June 2016,.
Dem Mieter wird ein Optionsrecht von einem weiteren Jahr, d.h. bis zum 30.06.2017, eingeräumt. Das Optionsrecht muss mindestens bis zum 31.12.2015schriftlich durch den Mieter geltend gemacht werden.		The Lessee shall be granted an option of one additional year, i.e. until 30 June 2017. The option must be exercised in writing by the Lessee prior to 31 December 2015 at the latest.
Danach wird dem Mieter ein weiteres Optionsrecht um 6 Jahre und 1 Monat bis zum 31.07.2023 eingeräumt. Dieses Optionsrecht muss spätestens bis		Thereafter, a further option of six years and 1 month until 31 July 2023 shall be granted to the Lessee. This option must be exercised in writing

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zum31.01.2017 schriftlich durch den Mieter geltend gemacht werden.		by the Lessee prior to 31 January 2017 at the latest.
Danach wird dem Mieter ein weiteres Optionsrecht von weiteren fünf Jahren, d. h. bis zum 31.07.2028, eingeräumt unter der zwingenden Voraussetzung der gleichlautenden Optionsausübung gemäß § 3 des Gewerberaummietvertrages zwischen den Parteien vom 19.07.2013 bzw. 29.07.2013 bezüglich der dort von der Vermieterin an die Mieterin vermieteten anderweitigen Flächen.		Thereafter the Lessee shall be granted an option for a further five years, i.e. until 31 July 2028. subject to the mandatory precondition that the equivalent option has also been exercised under §3 of the commercial lease contract between the parties dated 19th / 29th July 2013 in relation to the other premises let thereunder by the Lessor to the Lessee.
Das Optionsrecht muss mindestens bis zum 31.01.2023 schriftlich durch den Mieter geltend gemacht werden und besteht nicht, wenn nicht o.g. Voraussetzung erfüllt wird (gleichzeitige und gleichlautende Optionsausübung durch die Mieterin auch im Rahmen des Gewerberaummietvertrages zwischen den Parteien vom 19.07.2013 bzw. 29.07.2013).		This option must be exercised in writing by the Lessee prior to 31 January 2023 at the latest and shall not apply if the above condition is not fulfilled (simultaneous and identical exercise by the Lessee of the option under the commercial lease contract between the parties dated 19th / 29th July 2013).
Danach wird ein weiteres Optionsrecht um ganze Jahre, maximal jedoch um fünf Jahre, d. h. bis zum 31.7.2033 eingeräumt – ebenfalls unter der zwingenden Voraussetzung der gleichlautenden Optionsausübung gemäß § 3 des Gewerberaum-mietvertrages zwischen den Parteien vom 19.07.2013 bzw. 29.07.2013 bezüglich der dort von der Vermieterin an die Mieterin vermieteten anderweitigen Flächen. Dieses Optionsrecht muss spätestens bis zum 31.01.2028 schriftlich durch den Mieter geltend gemacht werden und besteht nicht, wenn nicht o.g. Voraussetzung erfüllt wird (gleichzeitige und gleichlautende Optionsausübung durch die Mieterin auch im Rahmen des Gewerberaummietvertrages zwischen den Parteien vom 19.07.2013 bzw. 29.07.2013).		Thereafter, a further option shall be granted for entire years, though up to a maximum of five years, i.e. until 31 July 2033 also subject to the mandatory precondition that the equivalent option has also been exercised under §3 of the commercial lease contract between the parties dated 19th / 29th July 2013 in relation to the other premises let thereunder by the Lessor to the Lessee. This option must be exercised in writing by the Lessee prior to 31 January 2028 at the latest and shall not apply if the above condition is not fulfilled (simultaneous and identical exercise by the Lessee of the option under the commercial lease contract between the parties dated 19th / 29th July 2013).
2. Nach Beendigung des Mietverhältnisses kommt eine stillschweigende Vertragsverlängerung gem. § 545 BGB nicht in Betracht.		2. After the cessation of the lease relation, no tacit contractual extension pursuant to § 545 of the Civil Code shall come into consideration.
§ 3 Außerordentliches Kündigungsrecht des Vermieters		§ 3 Extraordinary Right to Termination of the Lessor
1. Der Vermieter kann das Mietverhältnis ohne Einhaltung einer Kündigungsfrist mit sofortiger Wirkung kündigen,		1. The Lessor may terminate the lease relation without observing any notice period with immediate effect if the Lessee:
a) wenn der Mieter ungeachtet einer schriftlichen Abmahnung des Vermieters entweder für zwei aufeinanderfolgende Termine mit der Entrichtung des Mietzinses oder eines nicht unerheblichen Teils des		a) irrespective of a written warning by the Lessor is in default for two consecutive deadlines with the payment of the rent or a not inconsiderable portion of the rent;

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Mietzinses in Verzug ist;
oder in einem Zeitraum, der sich über mehr als zwei Termine erstreckt, mit der Entrichtung des Mietzinses in Höhe eines Betrages in Verzug gekommen ist, der den Mietzins für zwei Monate erreicht, wobei die schriftliche Abmahnung bereits nach Eintritt des Verzugs mit dem Mietzins für einen Termin bzw. in Höhe eines Betrags, der den Mietzins für einen Monat erreicht, versandt werden kann;		or in the period which extends beyond two deadlines is in default with the payment of rent in an amount reaching the rent for two months; nevertheless, a written warning notice may be sent after the Lessee has defaulted in respect of the rent for only one payment deadline or for a sum amounting to only one month’s rent;
b) wenn der Mieter, ungeachtet einer schriftlichen Abmahnung des Vermieters, einen vertragswidrigen Gebrauch der Mietsache fortsetzt, insbesondere ohne schriftliche Erlaubnis des Vermieters die Mietsache zu anderen als in § 1 Ziff. 1 genannten Zwecken benutzt, bei unbefugter Untervermietung oder sonstiger Gebrauchsüberlassung an Dritte und wenn er die Rechte des Vermieters in erheblichem Maße verletzt (vgl. § 11 Ziff. 4);		b) irrespective of a written warning by the Lessor, continues to use the leased premises in breach of contract, particularly uses the leased premises for purposes other than those mentioned in § 1(1) without the written permission of the Lessor, sublets the premises in an unauthorized fashion or provides them to third parties in another fashion for use and if the Lessee infringes on the rights of the Lessor to any significant degree (cf. § 11(4));
c) wenn der Mieter in solchem Maße seine Verpflichtungen verletzt, daß dem Vermieter die Fortsetzung des Mietverhältnisses nicht zugemutet werden kann, insbesondere trotz schriftlicher Abmahnung des Vermieters Mietzahlungen weiterhin verspätet (insgesamt oder nur in Teilbeträgen) leistet oder schuldhaft gegen in diesem Vertrag statuierte Pflichten verstößt;		c) breaches its obligations to a degree so significant that the Lessor can no longer be reasonably expected to continue the lease relation, particularly continues to render rent payments late (in whole or in part) despite a written warning from the Lessor, or negligently breaches duties stipulated in this Agreement;
2. Die Kündigung hat schriftlich zu erfolgen.		2. Termination must be made in writing.
3. Daneben gelten auch alle weiteren außerordentlichen jeweils gültigen gesetzlichen Kündigungstatbestände, sowie alle diejenigen, die in der Rechtsprechung des BGH anerkannt sind.		3. In addition, all further extraordinary and valid states of affairs justifying termination as stipulated by law and all those recognized by the legal rulings of the German Federal Supreme Court shall also apply.
§ 4 Miete und Nebenkosten		§ 4 Rent and Ancillary Costs
1. Die Miete beträgt bei Vertragsabschluss monatlich		1. From the closing date of this Agreement the monthly rent shall amount to
a) Grundmiete		Basic Rent

 

Raumart Type of Space		Lage Location		Fläche / Anzahl Space / Number		m²-Preis / je Stp. m² Price / per Unit		Summe / Gesamt Total
Büro-/Nebenfläche Office/ancillary space		Hs.Nr.3, 3. OG		671,00 m²		6,60 €		4.428,60 €

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		Building No.3, 3rd floor
Büro-/Nebenfläche Office/ancillary space		Hs.Nr.5, EG Building No.5, ground floor		560,00 m²		6,60 €		3.696,00 €
Büro-/Nebenfläche Office/ancillary space		Hs.Nr.5, 1. OG Building No.5, 1st floor		559,00 m²		6,60 €		3.689,40 €
Büro-/Nebenfläche Office/ancillary space		Hs.Nr.5, 2. OG Building No.5, 2nd floor		558,00 m²		6,60 €		3.682,80 €
Büro-/Nebenfläche Office/ancillary space		Hs.Nr.5, 3. OG Building No.5, 3rd floor		477,00m²		6,60 €		3.148,20 €
Tiefgaragenstellplatz Underground parking garage space		UG basement		43		35,00 €		1.505,00 €
Außenstellplatz Outside parking space		Aussen outside		9		20,00 €		180,00 €
Gesamt Total								20.330,00€

 

b) Betriebs-/Heizkostenvorauszahlungen		Advance payments for operating/heating costs

 

Vorauszahlung Betriebskosten Advance payment for operating costs			3.000,00 €
Vorauszahlung Heizkosten Advance payment for heating costs			1.500,00 €
Gesamt netto Net total			24.830,00€

 

c) Umsatzssteuer / Mehrwertsteuer		Turnover tax / value-added tax

 

19 % MWSt. 19% VAT			4.717,70 €
Gesamt brutto Gross total			29.547,70€

 

d. Hinweis zur Umsatzsteueroption:		d. Notes regarding the turnover tax option:

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Wie aus der Angabe der Umsatzsteuernummer des Vermieters im Rubrum des Vertrages, aber auch aus vorher gehenden Eintragung zur Grundmiete, monatlichen Betriebskostenvorauszahlungen und darauf insgesamt entfallener Umsatzsteuer zu sehen, optiert der Vermieter zur Umsatzsteuer im Rahmen dieses Gewerberaummietvertrages. Dem Mieter ist dies bekannt und von ihm ausdrücklich anerkannt. Insbesondere versichert der Mieter, dass er ein Unternehmen im Sinne des UStG ist und dass er im Objekt nur solche Umsätze tätigt, die den Vorsteuerabzug nicht ausschließen. Des Weiteren verpflichtet sich der Mieter, bei etwaiger genehmigter Untervermietung nur solche Untermieter zu akzeptieren, die ebenfalls ausschließlich umsatzsteuerpflichtige Gewerbe betreiben, sowie diesen Untermietern im eigenen Untermietvertrag die Verpflichtung weiterzugeben, ausschließlich umsatzsteuerpflichtiges Gewerbe im Objekt zu betreiben.		As is evident from the turnover tax number specified by the Lessor in the caption to this Agreement and also from the preceding entry for the basic rent, monthly advance payments for operating costs and the total turnover tax incurred thereon, the Lessor has opted to participate in the turnover tax system within the framework of this Commercial Space Lease Agreement. The Lessee is aware of and expressly recognizes this. In particular, the Lessee represents that the Lessee is an enterpriser in the terms of the Turnover Tax Act and that the Lessee will only earn turnover in the property which does not exclude the input tax deduction. The Lessee further agrees that, if sub-letting is permitted, it will accept only sub-tenants whose business in the property also generates only taxable turnover and that in its own sub-lease contract it will pass the obligation to carry out only taxable business in the property to its sub-tenants.
Missachtet der Mieter diese Grundsätze und Voraussetzungen, wird er dem Vermieter verschuldensunabhängig zum Ersatze all derjenigen Schäden verpflichtet sein, die aus der Missachtung dem Vermieter entstehen.		If the Lessee disregards these principles and prerequisites, the Lessee shall be obliged to compensate the Lessor for all damage incurred by the Lessor based on the Lessee’s defiance.
e.Die in zuvor geregelter Mietberechnung enthaltenen Flächenangaben dienen ausdrücklich nicht der Festlegung einer Sollbeschaffenheit des Mietobjektes. Sie dienen nur zur Festlegung eines angemessenen Mietzinses, wobei die Sollbeschaffenheit sich ausschließlich aus der örtlichen Flächenangabe des Mietobjektes ergibt.		e.The specified spaces in the above-regulated rent calculation expressly do not serve to determine any owed features of the Leased Object. They merely serve to determine adequate rent, whereby the owed features shall exclusively result from the in-situ specification of the space of the Leased Object.
2. Die Änderung der Grundmiete netto einschließlich Umsatzsteuer richtet sich nach § 5 des Mietvertrages.   3. Folgende Nebenkosten werden neben der Grundmiete umgelegt, wobei die Mieterin den betriebsbedingten Strom auf eigener Vertragsgrundlage und auf eigene Kosten vom zuständigen Versorger zu beziehen hat. Hilfsweise bzw. im Übrigen sind folgende Betriebskosten immer umlagefähig (mit X gekennzeichnet = einschlägig), sofern von der Vermieterin vorfinanziert:		2. The change in the net base rent including value added tax is governed by § 5 of the lease agreement.   3. The following ancillary costs shall be allocated in addition to the basic rent, whereby the Lessee must procure the power conditioned by its operations based on its own contracts and at its own cost from the competent utility provider. Alternatively or otherwise, the following operating costs shall always be subject to allocation (if marked with X = applicable), if pre-financed by the Lessor:
X		X
a) Die Betriebskosten im Sinne der Betriebskostenverordnung in der jeweils gültigen Fassung, zumindest nachstehende (angekreuzt):		a) The operating costs in the terms of the Operating Code Ordinance as amended, though at least the following (marked with “x”):
- x Kosten des Betriebs und der Unterhaltung der		- x costs of the operation and maintenance of

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Heizungs- und Warmwasseranlage		the heating and hot water system;
- x Kosten der Wasserversorgung		- x costs of the water supply;
- x Kosten der Entwässerung (einschließlich Regenwasser/Oberflächenwasser)		- x costs of the drainage (including rainwater/surface water);
- x Kosten des Betriebs und der Unterhaltung des Aufzuges		- x costs of the operation and maintenance of the elevator;
- x Grundsteuer		- x property tax;
- x Straßenreinigung/Winterdienst		- x street cleaning/winter service;
- x Schornsteinreinigung		- x chimney sweeping;
- x Reinigung des Gebäudes und der Nebenanlagen und Ungezieferbekämpfung		- x cleaning of the building and ancillary facilities and pest control;
- x Hauswart		- x building superintendent;
- x Gartenpflege		- x gardening;
- x Versicherungsbeiträge		- x insurance premiums;
- x Beleuchtungskosten/Allgemeinstrom		- x lighting costs/general power;
- x Kosten des Betriebs und der Unterhaltung der Lüftungsanlage und/oder Klimaanlage		- x costs of the operation and maintenance of the ventilation system and/or air conditioner;
- x Kosten des Betriebs und der Unterhaltung von vorhandenen Feuerlösch- und Brandschutzeinrichtungen (z.B. Rauchabzüge, Brandmelde- und Sprinkleranlagen etc.) Anmerkung: Die Kosten für individuell geforderte Brandschutzeinrichtungen, die für den Betrieb des Mieters notwendig und gefordert sind (z.B. Feuerlöscher etc.) werden durch den Mieter auf seine Kosten eingebracht und betrieben, unterhalten und gewartet.		- x costs of the operation and maintenance of the existing fire extinguishers and fire protection equipment (e.g. smoke extractors, fire alarm and sprinkler systems, etc.) Note: The costs for the required pieces of fire safety equipment necessary or required for the Lessee’s operations (e.g. fire extinguishers, etc.) shall be brought into the premises, operated, maintained and serviced by the Lessee;
- x Kosten des Betriebs und der Unterhaltung von vorhandenen Toranlagen (z.B. elektrische Rolltore), sofern diese nicht unmittelbar durch den Mieter auf seine Kosten eingebracht und betrieben, unterhalten und gewartet werden.		- x costs of the operation and maintenance of the existing gate systems (e.g. electric rolling gates), unless these are brought into the premises directly by the Lessee and operated, maintained and serviced at its cost;
- x Müllabfuhr / Mülltonnen, sofern vom Mieter benötigt und/oder ein Restmüllvolumen bei der zuständigen Behörde je nach Gewerbebetrieb abgenommen werden muss.		- x garbage disposal/garbage containers, if needed by the Lessee; and/or a residual garbage volume must be picked up by the competent authorities due to the business operations;
- x Heiz- und Warmwasserkosten		- x heating and hot water costs;
- x Sonstige Betriebskosten (z.B.: Objektbewachung, Sicherheitsdienst, Gemeinschaftsantennenanlage, Breitbandkabelanlage oder nach Abschluss des Vertrages neu eingeführte und das Mietobjekt betreffende Steuern, Gebühren,Beiträge und Prämien sowie die Kosten für Maßnahmen an den Gebäuden, die aufgrund nach Abschluss des Vertrages wirksam werdender gesetzlicher oder behördlicher Anordnungen erforderlich werden; ebenso Kosten für Betrieb und Wartung von Rauchgasanlagen, Rauchmeldern, Legionellenprüfung, Dichtigkeitsprüfungen von Leitungen)		- x miscellaneous operating costs (e.g.: property surveillance, security service, community antenna system, broadband cable system or taxes, fees, contributions, premiums and costs relating to the Leased Object that are introduced after the closing of this Agreement and the cost for measures to the buildings that are necessary based on legal or administrative orders which become valid after the closing of this Agreement; likewise, costs for the operation and maintenance of exhaust extractors, smoke alarms, legionella testing, testing of seals in lines).
x		x
b) Strom – Energiekosten, sofern diese nicht unmittelbar von Dritten bezogen werden können		b) Power and energy costs, insofar as these cannot be procured directly from third parties.
x		x

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x		x
) c) Eigenleistungen des Vermieters dürfen bei den Betriebs- und Verwaltungskosten in Höhe der ersparten Kosten für gleichwertige Leistungen Dritter angesetzt werden, jedoch ohne Ansatz der Umsatzsteuer.		) c) The Lessor’s own performances may be applied to the operating and administrative costs in the amount of the saved costs for equivalent performances of third parties, though without applying turnover tax.
4. Für die gemäß Ziffer 3 erhobenen Nebenkosten sind monatliche Vorauszahlungen entsprechend § 4 b zu leisten.		4. For the ancillary costs charged pursuant to No. 3, monthly advance payments are to be rendered in accordance with § 4b.
5. Verteilungsmaßstäbe		5. Distribution criteria
a) Die Verteilung der Heiz- und Warmwasserversorgungskosten erfolgt nach dem unter § 9 festgelegten Umlageschlüssel.		a) The heating and hot water supply costs shall be distributed in accordance with the allocation key determined under § 9.
b) Die Kosten der Warmwasserversorgung werden nach dem Verbrauch des Gebäudes/der Wirtschaftseinheit abgerechnet, soweit entsprechende Meßeinrichtungen vorhanden sind. Andernfalls werden sie nach folgendem Umlegungsschlüssel verteilt: nach qm-Nutzfläche		b) The costs of the hot water supply shall be settled in accordance with the consumption of the building/economic unit, insofar as corresponding metering equipment is available. Otherwise, they shall be distributed in accordance with the following allocation key: by m² of usable space
c) Die Kosten der Entwässerung werden entsprechend den Kosten der Wasserversorgung umgelegt.		c) The costs of the drainage shall be allocated in accordance with the costs of the water supply.
d) Die Aufzugskosten werden nach dem unter § 10 festgelegten Verteilungsschlüssel umgelegt.		d) The elevator costs shall be allocated in accordance with the distribution key determined under § 10.
e) Alle übrigen Betriebskosten und die Verwaltungskosten werden nach dem Verhältnis der Nutz-/Wohnflächen des Gebäudes/der Wirtschaftseinheit verteilt, soweit nicht folgender Umlegungsmaßstab vereinbart ist: nach qm-Nutzfläche		e) All other operating and administrative costs shall be distributed in the ratio of the usable/residential space of the building/economic unit, unless the following allocation key is agreed: by m² of usable space
f) Soweit infolge der Benutzungsart der Sache dem Vermieter besondere Kosten entstehen (z.B.: Zuschlag zur Feuerversicherung, zusätzliche Müllbehälter), werden diese Beträge in voller Höhe auf den Mieter umgelegt. Der Vermieter kann die Umlegungsmaßstäbe nach billigem Ermessen ändern, wenn Gründe einer ordnungsgemäßen Bewirtschaftung des Gebäudes/der Wirtschaftseinheit dies erfordern.		f) Insofar special costs are incurred by the Lessor as a consequence of the type of use of the thing (e.g.: premium for fire insurance, additional garbage containers), these amounts shall be allocated to the Lessee in full. The Lessor may alter the allocation criteria at its fair discretion, if reasons of proper management of the building/economic unit so require.
6. Über die Vorauszahlungen ist jährlich abzurechnen. Der Vermieter kann den Abrechnungszeitraum aus Zweckmäßigkeitsgründen ändern. Im Falle der Erhöhung oder der Verringerung		6. The advance payments are to be settled annually. The Lessor may alter the settlement period for reasons of expediency. In the event of an increase or decrease in the ancillary costs, the

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der Nebenkosten ist der Vermieter berechtigt, die Vorauszahlungen mit Wirkung des auf die Jahresabrechnung folgenden Monats neu festzusetzen. Für neu entstehende Neben-, insbesondere Betriebskosten kann der Vermieter ab dem Zeitpunkt der Kenntnisnahme angemessene Vorauszahlungen verlangen.		Lessor shall be entitled to redetermine the advance payments with effect from the month following the annual settlement. For newly arising ancillary (particularly operating) costs, the Lessor may request reasonable advance payments as of the date the Lessor becomes aware thereof.
7. Treten Erhöhungen von Betriebskosten ein, so ist der Vermieter berechtigt, die Erhöhungen durch schriftliche Erklärung anteilig auf den Mieter umzulegen; in der Erklärung ist der Grund für die Umlage zu bezeichnen und zu erläutern. Im Falle von rückwirkenden Erhöhungen der Betriebskosten wirkt die Erklärung des Vermieters auf den Zeitpunkt der Erhöhung zurück.		7. If increases in operating costs occur, the Lessor shall be entitled to allocate the increases by written declaration on a prorated basis to the Lessee; the ground for the allocation is to be designated and explained in the declaration. In the event of retroactive increases in the operating costs, the declaration of the Lessor shall have retroactive effect to the date of the increase.
Dies gilt auch, wenn nach Abschluß des Mietvertrages Betriebskosten im Sinne der Betriebskostenverordnung neu entstehen bzw. anfallen. Ermäßigen sich die Betriebskosten, so sind sie vom Zeitpunkt der Ermäßigung ab entsprechend herabzusetzen.		This shall also apply if operating costs in the terms of the Operating Cost Ordinance arise or are incurred after the closing of this Lease Agreement. If operating costs decrease, they are to be reduced from the date of the decrease.
§ 5 Änderung der Miete		§ 5 Change in Rent
Die Parteien sind sich einig darüber, dass im Falle der wirksamen Optionsausübungen durch die Mieterin gemäß § 2 des Mietvertrages sich die von der Mieterin zu zahlende Grundmiete netto (also dann jeweils zzgl. der Umsatzsteuer) nach folgender Staffel für alle Büro-/ und Nebenflächen in Hs.Nr.3, 3.OG sowie in Hs.Nr.5, EG, 1.OG, 2. OG, 3.OG laut tabellarischer Aufstellung in § 4 hiesigen Vertrages erhöht:		The parties agree that in the event of the effective exercise of the options by the Lessee in accordance with § 2 of the lease, the basic rent net amount (VAT to be added) to be paid by the Lessee for all Office / and secondary areas in Hs.Nr.3, 3rd floor, as well as in Hs.Nr.5, ground, 1st, 2nd floor, 3rd floor, corresponding to the table under § 4 of this agreement will increase according to the following graduated price scale:

 

ab dem/ start date		Für/for		QM/m²						auf sodann pro QM/new price/m²				neue Grundmiete ab dann/new basic rent
01.07.2017		Büro-/Nebenfläche Office/ancillary space		2825			m²				7,50	€			21.187,50	€
01.07.2018		Büro-/Nebenfläche Office/ancillary space		2825			m²				7,61	€			21.498,25	€
01.07.2019		Büro-/Nebenfläche Office/ancillary space		2825			m²				7,73	€			21.837,25	€
01.07.2020		Büro-/Nebenfläche Office/ancillary space		2825			m²				7,84	€			22.148,00	€
01.07.2021		Büro-/Nebenfläche Office/ancillary space		2825			m²				7,96	€			22.487,00	€
01.07.2022		Büro-/Nebenfläche Office/ancillary space		2825			m²				8,08	€			22.826,00	€

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01.07.2023		Büro-/Nebenfläche Office/ancillary space		2825			m²				8,20 €				23.165,00 €

 

Zu den jeweils neuen Grundmieten treten sodann jeweils die dann gültigen Betriebs- und Heizkostenvorauszahlungen, sowie die jeweils gültige Umsatzsteuer hinzu. Zudem bleiben Stellplatzmieten unverändert.		In addition to each new base rent the respective applicable advanced payments for operating and heating costs as well as for the applicable VAT will be added. The rates for parking spaces will remain unchanged.
§ 6 Sicherheitsleistung		§ 6 Provision of Security
1. Der Mieter verpflichtet sich unwiderruflich wegen sämtlicher Forderungen des Vermieters zu folgender Sicherheitsleistung:		1. The Lessee hereby agrees to provide the following security regarding all claims of the Lessor:
in der Höhe von 3 Monatsgrundmieten netto, mithin in Höhe eines Betrages von 60.990,00€		in the net amount of three months’ basic rent, thus in the amount of € 60.990,00
die sofort, hilfsweise nach gesetzlicher Maßgabe fällig ist.		which shall be due immediately or, alternatively, in accordance with the provisions of law.
Der Mieter verpflichtet sich, eine selbstschuldnerische Bürgschaft einer deutschen Bank zum Nennbetrag mit dem Zusatz „auf erste Anforderung” beibringen und für die Dauer des Mietverhältnisses bei dem Vermieter zu hinterlegen.		The Lessee hereby agrees to provide an absolute guarantee from a German bank in the nominal amount with the addition “payable upon first demand” and to deposit such guarantee with the Lessor for the term of the lease relation.
2. Der Vermieter ist zur Aufrechnung mit Ersatzforderungen wegen Veränderungen oder Verschlechterungen der Mietsache durch den Mieter gegen den Anspruch des Mieters auf Kautionsrückzahlung berechtigt. Die Möglichkeit der Verrechnung der Kaution auch mit verjährten Forderungen des Vermieters folgt im Einzelnen den Regularien des § 215 BGB, der wörtlich zitiert, wie folgt lautet:		2. The Lessor shall be entitled to set off compensation claims due to changes or deterioration in the leased premises by the Lessee against the Lessee’s claim to repayment of the security deposit. The detailed formalities for setting off statute-barred claims due to the Landlord shall be as provided for in Civil Code [BGB] §215, which reads word for word as follows:
§215 BGB Aufrechnung und Zurückbehaltung nach Eintritt der Verjährung		Civil Code §215: Set-off and right of retention after a claim is statute-barred
Die Verjährung schließt die Aufrechnung und die Geltendmachung eines Zurückbehaltungsrechts nicht aus, wenn der Anspruch in dem Zeitpunkt noch nicht verjährt war, in dem erstmals aufgerechnet oder die Leistung verweigert werden konnte.		Limitation of actions does not exclude set-off and the assertion of a right of retention if the claim was not yet statute-barred at the time when the set-off could first have been made or performance first refused.
Im Übrigen darf die Vermieterin ein Kautionsguthaben gegen Schadenersatzforderungen wegen Verschlechterung der Mietsache, gegen Betriebskostenrückstände aus Abrechnungen, gegen notwendige Rechtsverfolgungskosten in gesetzlicher		Otherwise, the Lessor may net out any credit balance of the security deposit with damage compensation claims due to the deterioration of the leased premises, with arrears in operating

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Höhe, die durch schuldhafte Pflichtverletzungen der Mieterin bedingt wurden, gegen Verzugsschäden- und Zinsen im Übrigen und gegen Mietschulden verrechnen – in dieser Reihenfolge. Der Vermieter wird dem Mieter eine Liste aller Kosten und Schäden zur Prüfung bereitstellen bevor er irgendwelche Kosten mit der Kaution verrechnet.		costs based on settlement statements, with the necessary costs of legal prosecution as stipulated by law which are conditioned by negligent breaches of duty on the part of the Lessee, with default damage and interest and with rent in arrears, in this order. The Lessor will provide the Lessee with a list of all costs and damages for his review before he sets off any cost against the deposit.
3. Der Mieter erkennt an, daß er zu einer Verrechnung der Mieten und Nebenkosten oder sonstigen Forderungen, soweit diese nicht unbestritten oder rechtskräftig festgestellt worden sind, mit der Kaution nicht berechtigt ist.		3. The Lessee acknowledges that the Lessee is not entitled to net out the rent and ancillary costs or other claims with the security deposit, unless this is undisputed or declared by non-appealable judgment.
§ 7 Zahlung der Miete und Nebenkosten		§ 7 Payment of the Rent and Ancillary Costs
1. Der Gesamtbetrag der monatlichen Miete einschließlich Nebenkosten (und Umsatzsteuer) ist jeweils im voraus, spätestens am 3. Werktag des Monats, an den Vermieter oder an die von ihm zur Entgegennahme ermächtigte Person oder Stelle bzw. auf das Konto der Aareal Bank Wiesbaden   IBAN:        DE 48 55010400 0000137935 BIC:           AARBDE5WDOM   kostenfrei zu zahlen.		1. The total amount of monthly rent, including ancillary costs (and turnover tax) shall be payable in advance free of charge on the third working day of the month at the latest to the Lessor or the person or agent authorized by the Lessor to receive such amounts and/or onto the following bank account at Aareal Bank Wiesbaden:   IBAN:        DE 48 55010400 0000137935 BIC:           AARBDE5WDOM
2. Für die Rechtzeitigkeit der Zahlung ist nicht die Absendung, sondern der Zugang bzw. die Gutschrift des Betrages maßgebend. Aus mehrfach nicht termingerechter Leistung kann der Mieter kein Recht auf verspätete Mietzahlung herleiten. Verspätete Zahlungen berechtigen den Vermieter, Mahngebühren und Verzugszinsen zu erheben und das Mietverhältnis gegebenenfalls fristlos zu kündigen (siehe § 3 Ziff. 1 c).		2. For the timeliness of the payment, the receipt and/or credit of the amount shall be decisive and not the dispatch thereof. The Lessee may not derive any right to late payment of the rent based on having paid the rent late several times. Late payments shall entitle the Lessor to charge payment reminder fees and default interest and to terminate the lease relation if relevant without notice (cf. § 3(1)c).
§ 8 Minderung, Aufrechnung, Zurückbehaltungsrecht		§ 8 Rent Reduction, Set-Off, Retention Right
Der Mieter kann gegen die Miete weder aufrechnen, noch ein Zurückbehaltungsrecht ausüben oder die Miete mindern, wobei dem Mieter ausdrücklich die Geltendmachung etwaiger Rückforderungsansprüche aus Minderungsrecht, Aufrechnungsbefugnissen oder		The Lessee cannot exercise any right of set-off or retention against the rent, and has no right to reduce the rent; however, any rights of the Lessee to reclaim payments by way of reduction or under a power of set-off or right of retention are

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Zurückbehaltungsrechten offen stehen bleibt. Zudem sind hiervon ausgenommen Forderungen des Mieters wegen Schadenersatz für Nichterfüllung oder Aufwendungsersatz infolge eines anfänglichen oder nachträglichen Mangels der Mietsache, den der Vermieter wegen Vorsatz oder grober Fahrlässigkeit zu vertreten hat, und andere Forderungen aus dem Mietverhältnis, soweit sie unbestritten oder rechtskräftig festgestellt sind. Die Aufrechnung oder die Ausübung des Zurückbehaltungsrechts ist nur zulässig, wenn der Mieter seine Absicht dem Vermieter mindestens einen Monat vor Fälligkeit schriftlich angezeigt hat.		expressly reserved. Nor does this apply to the Lessee’s rights in respect of damages for non-performance or expenditure incurred as a result of an initial or subsequent defect in the demised premises for which the Lessor is liable by reason of deliberate fault or gross negligence, or other rights under the lease if they are undisputed or have been the subject of binding determination. Set-off and the exercise of the right of retention is permitted only if the Lessee has notified the Lessor in writing of its intention at least one month before the due date.
§ 9 Beheizung und Warmwasserversorgung		§ 9 Heating and Hot Water Supply
1. Die durch Umlage (siehe auch § 4) zu deckenden Heizkosten umfassen:		1. The heating cost to be covered by the allocation (see also § 4) shall encompass:
Kosten der verbrauchten Brennstoffe und ihrer Lieferung, die Kosten des Betriebsstroms, die Kosten der Bedienung, Überwachung und Pflege der Anlage, der regelmäßigen Prüfung ihrer Betriebsbereitschaft und Betriebssicherheit einschließlich der Einstellung durch einen Fachmann, der Reinigung der Anlage einschließlich des Tanks und des Betriebsraums, die Kosten der Messungen nach dem Bundes-Immissionsschutzgesetz, die Kosten der Anmietung oder anderer Arten der Gebrauchsüberlassung einer Ausstattung zur Verbrauchserfassung sowie die Kosten der Verwendung einer Ausstattung zur Verbrauchserfassung einschließlich der Kosten der Berechnung und Aufteilung.		the costs of the consumed fuels and the delivery thereof, the costs of operating current, the costs of the operation, monitoring and upkeep of systems, the regular verification of the operability and operating safety thereof, including fine tuning by a specialist, the cleaning of the systems, including the tank and operating room, the costs of measurements in accordance with the Federal Emissions Control Act, the costs of leasing or other types of use of any equipment to ascertain consumption, including the costs of the calculation and distribution.
Außerdem trägt der Mieter anteilig die Kosten der im Zusammenhang mit vorstehenden Einzelpositionen durchgeführten Kleinreparaturen. Die vorstehenden Regelungen gelten für die Kosten einer Warmwasserversorgungsanlage des Gebäudes/der Wirtschaftseinheit entsprechend.		Moreover, the Lessee shall bear on a prorated basis the costs of the minor repairs carried out in connection with the above individual items. The above provisions shall apply accordingly to the costs of any hot water supply system in the building or economic unit.
2. Die Heiz- und Warmwasserkosten werden wie folgt umgelegt:		2. The heating and hot water costs shall be allocated as follows:
Zu 70 % nach dem Ergebnis der Wärmemesser oder Heizkostenverteiler bzw. Warmwasserzähler oder Warmwasserkostenverteiler.		70% in accordance with the result of the heat meter or heating cost distributor or hot water meter or hot water cost distributor.
Zu 30 % nach der Nutz- bzw. Wohnfläche/dem umbauten Raum des Gebäudes bzw. der Wirtschaftseinheit.		30% in accordance with the usable or livable space/the remodeled space of the building and/or the economic unit.
Zu der Änderung der Abrechnungsmaßstäbe ist der Vermieter nach billigem Ermessen im gesetzlich zulässigen Rahmen befugt, wenn berechtigte Interessen dies zur odnungsgemäßen Bewirtschaftung des Gebäudes/der Wirtschaftseinheit erfordern.		The Lessor shall be entitled to modify the settlement criteria at its fair discretion as permitted by law, if legitimate interests so require for the purposes of proper management of the building/economic unit.

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§ 10 Aufzug		§ 10 Elevator
Kosten eines Aufzuges werden im Verhältnis der gemieteten Nutzfläche/Gesamtfläche des Objektes, hier aufgeteilt nach Haus Nr. 3 und Haus Nr. 5 umgelegt.		The costs of an elevator shall be allocated in proportion to the least usable space/total space of the property, here divided by Building No. 3 and Building No. 5.
§ 11 Benutzung der Mietsache		§ 11 Use of Leased Premises
1. Der Mieter verpflichtet sich, die Mietsache und die gemeinschaftlichen Gebäudeteile, Anlagen und Einrichtungen schonend und pfleglich zu behandeln. Im Rahmen der vertragsgemäßen Benutzung der Mietsache hat der Mieter jede Rücksichtnahme zu üben.		1. The Lessee hereby agrees to treat the leased premises and the common building components, facilities and installations carefully. Within the framework of the agreed use of the leased premises, the Lessee must exercise consideration.
2. Die Voraussetzungen für den Betrieb des Gewerbes in der vertraglich vorgesehenen Nutzungsart, hat der Mieter selbst auf eigene Kosten zu schaffen und während der Mietzeit zu erhalten. Dies gilt insbesondere für persönliche und betriebliche Voraussetzungen für die Erteilung und das Fortbestehen von Konzessionen und sonstigen behördlichen Genehmigungen sowie die Erfüllung entsprechender Auflagen. Der Vermieter übernimmt für die Einhaltung dieser Voraussetzungen keine Haftung. Auf einen Wegfall der Geschäftsgrundlage kann sich der Mieter im Falle der Nichterfüllung der vorgenannten Voraussetzungen nicht berufen.		2. The prerequisites for the operation of the business in the contractually foreseen type of use, , must be procured by the Lessee itself at its own cost and maintained throughout the term of lease. This shall apply in particular to personnel and operating prerequisites for the issuance and continuance of concessions and other administrative permits and the fulfillment of the corresponding conditions. The Lessor shall assume no liability for compliance with these prerequisites. The Lessee may not invoke the frustration of the contract in the event the aforementioned prerequisites are not fulfilled.
3. Der Mieter darf die Mietsache zu anderen als den in § 1 Ziff. 1 vorgesehenen Zwecken nicht ohne eine vorherige Zustimmung des Vermieters bzw. nicht ohne besondere Vereinbarung der Parteien benutzen. Der Mieter darf nichts in Gebrauch nehmen, was ihm nicht durch diesen Vertrag oder besondere Vereinbarung vermietet worden ist.		3. The Lessee may not use the leased premises for purposes other than those foreseen in § 1(1) without the prior approval of the Lessor and/or not without a special agreement between the Parties. The Lessee may not use anything which has not been leased to the Lessee by way of this Agreement or a separate agreement.
4. Jede Änderung oder erhebliche Ausweitung der Art des Betriebes sowie Untervermietung und sonstige teilweise oder vollständige Gebrauchsüberlassung der Mieträume an Dritte sind ohne vorherige Zustimmung des Vermieters untersagt. Der Vermieter wird eine Zustimmung nur dann versagen, wenn ein wichtiger Grund für die Versagung vorliegt. Grundsätzlich kann eine Untervermietung an verbundene Unternehmen der Abiomed Europe GmbH im Sinne des § 15 AktG nur aus wichtigem Grund untersagt werden. Das Gleiche gilt für eine Untervermietung an Personen/Unternehmen, sofern gegen die Bonität der Person/des Unternehmens keine objektiv erkennbaren Bedenken bestehen oder die Person/das		4. Any change or significant expansion of the kind of business as well as any subletting and other full or partial provision of the use of the leased premises to third parties shall be prohibited without the prior approval of the Lessor. The Lessor shall refuse its consent only if it has an important reason to do so. Basically, sub-letting to companies associated with Abiomed Europe GmbH within the meaning of Stock Companies Act [AktG] §15 may be refused only for an important reason. The same applies to sub-letting to persons / businesses in respect of whose creditworthiness there are no objectively discernible doubts, or if that person / business operates in a business sector related to that of the

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Unternehmen dem Unternehmen des Mieters branchenverwandt ist. Für die Grundlagen und Fakten solcher Beurteilung ist die Mieterin darlegungs- und beweisbelastet. Die Nichterteilung der Zustimmung des Vermieters berechtigt den Mieter nicht, das Mietverhältnis zu kündigen. Eine Zustimmung zur Untervermietung oder Gebrauchsüberlassung gilt nur für den Einzelfall.		Lessee. The Lessee shall be responsible for demonstrating and providing the evidence necessary to judge whether the above grounds and factual conditions are met.. The non-issuance of the approval by the Lessor shall not entitle the Lessee to terminate the lease relation. An approval for subletting or any transfer of use applies only on an individual basis.
Auf Verlangen ist der Mieter zur Abtretung seiner ihm gegen den Untermieter zustehenden Forderungen verpflichtet, sofern Mietrückstände aus diesem Mietvertrag bestehen. Der Mieter haftet ungeachtet einer Zustimmung des Vermieters für das Verhalten des Untermieters bzw. des Dritten, dem er den Gebrauch der Mieträume überlassen hat.		Upon request, the lessee shall be obliged to assign the claims against the sublessee to which it is entitled, if rent is in arrears based on this Lease Agreement. The Lessee shall be liable without regard to any approval of the Lessor for the conduct of the sublessee and/or that third party to whom the Lessee has provided the use of the leased premises.
§ 12 Zustand der Mietsache, Instandhaltung, Schönheitsreparaturen		§ 12 Condition of Leased Premises, Maintenance, Interior Decorative Repairs
1. Der Mieter übernimmt die Mietsache in dem vorhandenen Zustand als vertragsgemäß und bezugsfertig, mit Ausnahme der im zwischen den Parteien gefertigten Protokoll – Anlage VI - aufgeführten Mängel, die seitens der Vermieterin noch beseitigt werden. Im Übrigen hat der Mieter bei der ausführlichen Besichtigung und Überprüfung der Mietsache vor seinem Einzug keinerlei Schäden festgestellt und erkennt den Zustand bei Vertragsbeginn ausdrücklich als vertragsgerecht an. Das zwischen den Parteien einvernehmlich gefertigte Protokoll über vermieterseits zu beseitigende Mängel wird diesem Vertrag als ANLAGE VI beigefügt		1. The Lessee shall assume the leased premises in the current conditions as being pursuant to this Agreement and agrees that they are ready for occupation, with the exception of the defects listed in the protocol drawn up between the parties – Annexe VI –, which the Lessor shall rectify. Otherwise, the Lessee has not identified any damage of whatever nature during the course of its comprehensive inspection and checks of the demised premises made before moving in, and expressly acknowledges that their condition at the commencement of the contract complies with it. The protocol of defects to be rectified by the Lessor drawn up by agreement between the parties is attached to this contract as ANNEXE VI.
2. Der Mieter ist zur Instandhaltung der Mietsache einschließlich mitvermieteter Anlagen und Einrichtungen im nachstehenden Umfange verpflichtet: Er hat die Mietsache ordnungsgemäß zu reinigen und in dem nach ihrer Ausstattung erforderlichen Umfange zu beheizen und zu belüften. Bei vorhandenen isolierverglasten Fenstern ist er insbesondere zur Vermeidung von Kondenswasserschäden zu gegebenenfalls verstärktem Belüften und Beheizen verpflichtet.		2. The Lessee shall be obliged to maintain the leased premises, including the leased facilities and installations in the scope set out below: The Lessee must duly clean the leased premises and heat and ventilate them to the degree required by their fit-out. In the case of insulated glass windows, the Lessee shall be obliged to avoid damage from condensate through increased ventilation and heating.
Der Mieter trägt außerdem die Kosten kleinerer Instandsetzungsarbeiten (Reparaturen) an denjenigen Gegenständen, die dem direkten und häufigen Zugriff unterliegen, wie den Installationsgegenständen für Elektrizität, Wasser und Gas, den Heiz- und Kocheinrichtungen, den Fenster- und Türverschlüssen		The Lessee shall moreover bear the costs of minor reconditioning work (repairs) to those objects subject to direct and frequent use, such as the installed objects for electricity, water and gas, heating and cooking appliances, window and door locks and the locks systems for window shutters

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sowie den Verschlußvorrichtungen von Fensterläden; ferner auch von Rolläden. Je Einzelfall darf der Betrag von zur Zeit € 300,00 nicht überschritten werden; pro Jahr sind die gesamten Kosten auf zur Zeit € 1.000,00 beschränkt.		and rolling grates. Each specific case may not exceed the current amount of € 300.00; the total costs per year shall be currently restricted to € 1,000.00.
3. Der Mieter ist außerdem verpflichtet, Schönheitsreparaturen laufend auf eigene Kosten fachgerecht durchzuführen bzw. durchführen zu lassen, sobald der Grad der Abnutzung dies nach der Art des Gewerbebetriebs bzw. der vertraglichen Nutzung erfordert und solche Erforderlichkeiten nicht durch ein Vermieterverhalten bedingt sind. Die Schönheitsreparaturen umfassen insbesondere sämtliche Innenanstriche, das Tapezieren, Kalken oder Anstreichen von Wänden und Decken, das Anstreichen bzw. Lackieren von Heizkörpern, Heizrohren, sonstigen Versorgungsleitungen, der Innentüren, Fenster und Außentüren von innen. Der Mieter ist weiter verpflichtet, die vorhandenen Fußbodenbeläge einschließlich Leisten bei Bedarf fachgerecht zu behandeln.		3. The Lessee shall moreover be obliged to carry out to or have carried out interior decorative repairs professionally on an ongoing basis at its own cost, as soon as required by the degree of wear and tear in accordance with the type of business operations and/or the contractual use and such requirements are not conditioned by the Lessor’s conduct. The interior decorative repairs shall encompass in particular all interior painting, wallpapering, whitewashing or painting of walls and ceilings, painting and/or varnishing of radiators, heating pipes, others supply lines, inside doors, windows and outside doors from the inside. The Lessee shall further be obliged to treat the existing flooring, including the base boards, in a professional fashion as needed.
4. Der Mieter ist zur unverzüglichen Anzeige aller Schäden an der Mietsache verpflichtet, sobald er sie bemerkt. Ebenso hat er sonstige, von ihm an anderen Grundstücks- und Gebäudeteilen bemerkte Schäden unverzüglich anzuzeigen. Kommt der Mieter dieser Verpflichtung nicht rechtzeitig nach, so ist er zum Ersatz des daraus entstehenden Schadens verpflichtet.		4. The Lessee shall be obliged to immediately notify any damage to the leased premises as soon as the Lessee notices such damage. Likewise, the Lessee must notify without delay other damage noticed by the Lessee to other property and building components. If the Lessee fails to observe this obligation in due time, the Lessee shall be obliged to compensate the resulting damage.
5. Der Mieter ist verpflichtet, die für seinen Betrieb erforderliche Anzahl an Feuerlöschern bereitzustellen und zu unterhalten.		5. The Lessee shall be obliged to provide and maintain the necessary number of fire extinguishers for its operations.
Nachträgliche öffentlich rechtliche Vorschriften und Vorgaben, z.B. der Feuerwehr zum vorbeugenden Brandschutz oder einer Behörde das Bestandsgebäude betreffend sind vom Mieter auch rückwirkend zu dulden und auf Kosten des Vermieters umzusetzen und die daraus ggf. resultierenden Auflagen auf Kosten des Vermieters zu erfüllen. Nachträgliche Auflagen, die aus dem mieterseitigen Betrieb resultieren, hat der Mieter auf eigene Kosten zu erfüllen und umzusetzen.		Subsequent public law provisions and regulations (e.g. of the fire department as preventative fire protection or from other authorities) pertaining to the existing building are to be tolerated by the Lessee, even retroactively, and are to be implemented at the cost of the Lessor, and the resulting conditions are to be fulfilled at the cost of the Lessor. The Lessee has to fulfill at his own expense and to implement any subsequent requirements resulting from the Lessee’s operation.
§ 13 Haftung des Vermieters		§ 13 Liability of the Lessor
Schadenersatzansprüche des Mieters wegen anfänglicher oder nachträglicher Mängel der Mietsache sind ausgeschlossen, es sei denn, daß der		Damage compensation claims of the Lessee due to initial or subsequent defects in the leased premises shall be excluded, unless the Lessor is

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Vermieter Vorsatz oder grobe Fahrlässigkeit zu vertreten hat. Auch im übrigen haftet der Vermieter nur für Vorsatz und grobe Fahrlässigkeit, einschließlich des Verhaltens seines Vertreters oder Erfüllungsgehilfen. Hiervon unberührt bleiben Erfüllungsansprüche des Mieters sowie sein gesetzliches Recht zur fristlosen Kündigung.		responsible intentionally or due to gross negligence. Otherwise, the Lessor shall also be liable only for intentional action or gross negligence, including the conduct of its representatives or vicarious agents. Performance claims of the Lessee and its legal right to termination without notice shall not be prejudiced hereby.
§ 14 Bauliche Änderungen und andere Maßnahmen		§ 14 Structural Alterations and Other Measures
1. Maßnahmen des Vermieters		1. Measures of the Lessor
a) Der Vermieter darf bauliche Änderungen, die zur Erhaltung der Mieträume, des Gebäudes bzw. der Wirtschaftseinheit oder zur Abwendung drohender Gefahren oder zur Beseitigung von Schäden notwendig sind, auch ohne Zustimmung des Mieters nach entsprechender vorheriger Ankündigung vornehmen.		a) The Lessor may undertake structural alterations which are necessary for the preservation of the leased premises, the building or the economic unit and to avert imminent danger or to remedy damage, even without the approval of the Lessee, after corresponding prior notice.
b) Das gleiche Recht hat der Vermieter für alle vorteilhaften oder zweckmäßigen oder von ihm nicht zu vertretenden Maßnahmen, insbesondere für alle Modernisierungsmaßnahmen, z.B. Wärme- und Schallschutzmaßnahmen, Verbesserung von Installationen. Diese Regelung gilt sinngemäß für Erschließungs- und Ausbaumaßnahmen an Verkehrsflächen, Versorgungs- und Entsorgungsanlagen einschließlich der Hausanschlüsse solcher Einrichtungen sowie Anschlüsse an das Breitbandkabelnetz der Deutschen Bundespost/Telekom.		b) The Lessor shall have the same right for all advantageous or expedient measures or measures for which it is not responsible, particularly for all upgrading measures, e.g. heat and noise insulation measures, improvements of installations. This provision shall apply analogously to improvements and finishing work in traffic areas, supply and waste systems, including the building connections of such installations and connections to the broadband cable network of Deutsche Bundespost/Telekom.
c) Maßnahmen nach den Buchstaben a) und b) hat der Mieter zu dulden. Er hat die in Betracht kommenden Räume nach vorheriger Terminabsprache zugänglich zu halten und darf die Ausführung der Arbeiten nicht behindern oder verzögern; anderenfalls hat er für die dadurch entstehenden Mehrkosten und Schäden aufzukommen. Der Vermieter ist verpflichtet, entsprechende Arbeiten möglichst schonend für den Geschäftsbetrieb des Mieters durchzuführen.		c) Measures in accordance with Literi a) and b) must be tolerated by the Lessee. The Lessee must keep the rooms in consideration accessible after prior scheduling and may not hinder or delay the execution of the work; otherwise, the Lessee must bear the additional costs in damage incurred as a result. The Lessor shall be obliged to carry out corresponding work as protectively as possible for the business operations of the Lessee.
d) Ersatzansprüche des Mieters sind wegen zu duldender Maßnahmen ausgeschlossen, es sei denn, der Vermieter hat Vorsatz oder grobe Fahrlässigkeit zu vertreten.		d) Compensation claims of the Lessee regarding the measures to be tolerated shall be excluded, unless the Lessor is responsible intentionally or due to gross negligence.
2. Maßnahmen des Mieters		2. Measures of the Lessee
Der Mieter ist zu baulichen und sonstigen		The Lessee shall be entitled to make structural or

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Veränderungen und zur Schaffung neuer Einrichtungen nur nach vorheriger Zustimmung des Vermieters berechtigt. Der Vermieter wird seine Zustimmung zu erwünschten baulichen Veränderungen, die der Mieter anhand qualifizierter Pläne oder sonstiger geeigneter Dokumente zuvor anzuzeigen hat, nur aus wichtigem Grund verweigern können. Es gilt der Grundsatz, dass für leichte Umbauarbeiten (Trockenbauarbeiten, Bodenbeläge, nicht tragende Wände, Bürotüren etc.) innerhalb der Mieträume, welche die Grundstruktur (Dach, tragende Gebäudeteile, Treppenhäuser, Außenfassade etc. ) des Bestandsgebäudes nicht beeinträchtigen eine Genehmigung grundsätzlich erteilt ist, gleichwohl eine Information und Abstimmung über Art und Umfang der Maßnahme im Vorfeld mit dem Vermieter zu erfolgen hat.		other alterations and to create new installations only after obtaining the prior approval of the Lessor. The Lessor may only deny consent to structural changes desired by the Lessee for good cause. It is understood that the Lessee will have previously submitted to the Lessor qualified plans or other appropriate documents. The general principle is that for minor renovation work (drywall works, floor coverings, non-load bearing walls, office doors, etc.) within the demised premises, which do not interfere with the underlying structure of the existing building (roof, load-bearing elements, stairwells, exterior façade etc.) consent is generally granted, nevertheless the Lessor must be first informed and consulted about the nature and extent of the works.
Ohne Zustimmung des Vermieters vorgenommene Maßnahmen sind auf Verlangen des Vermieters von dem Mieter auf dessen eigene Kosten unter Wiederherstellung des früheren Zustandes unverzüglich zu beseitigen. Nach vergeblicher Mahnung unter angemessener Fristsetzung ist der Vermieters insoweit zur Ersatzvornahme auf Kosten des Mieters berechtigt. Das Recht des Vermieters, die Wiederherstellung des früheren Zustandes bei Beendigung des Mietverhältnisses auf Kosten des Mieters zu verlangen, wird nicht dadurch ausgeschlossen, dass er einer baulichen Änderung des Mieters zugestimmt hat. Ein Aufwendungsersatz durch den Vermieter für notwendige Verwendungen des Mieters wird ausgeschlossen. Der Mieter haftet für alle im Zusammenhang mit den von ihm vorgenommenen Maßnahmen entstehenden Schäden. Die Parteien werden bei jeder Anfrage zu gewünschten baulichen Veränderungen im Rahmen der dann vermieterseits zu prüfenden Gestattung auch Einvernehmen darüber erzielen, was von den geplanten baulichen Veränderungen am Ende des Mietverhältnisses durch den Mieter auf seine Kosten zurückzubauen sein wird und was nicht. Dem Mieter wird bereits jetzt der Austausch der Schließanlage durch eine eigene Anlage gestattet, dies unter der Voraussetzung, dass dem Vermieter ein jederzeitiger Zugang zu Allgemeinflächen gewährt bleibt und dass der Mieter am Ende wieder die alte Anlage sach- und fachgerecht einbauen lässt. Für evtl. entstehende Schäden im Zusammenhang mit der Durchführung der vorgenannten Maßnahmen haftet der Mieter. Der Mieter trägt ebenfalls die Verkehrssicherungspflicht in den durch die Arbeiten betroffenen Innen- und Außenbereichen während aller von ihm durchgeführten baulichen Veränderungen. Der Mieter hält die Vermieterin von sämtlichen privatrechtlichen und öffentlich-rechtlichen Inanspruchnahmen, die sich		Measures conducted without the approval of the Lessor are to be remedied without delay at the request of the Lessor by the Lessee at the Lessee’s own cost while restoring the earlier conditions. After an unsuccessful warning and the establishment of a reasonable grace period, the Lessor shall be entitled to itself undertake the work at the costs of the Lessee. The right of the Lessor to demand the restoration of the former state at termination of the lease at the expense of the Lessee is not excluded by the fact that he has agreed to a structural change by the Lessee. Any expense reimbursement by the Lessor for the necessary applications of the Lessee shall be excluded. The Lessee shall be liable for all damage incurred in connection with the measures undertaken by it.In the event of any enquiry in relation to a desire to carry out structural alterations, as part of the Lessor’s deliberations as to whether to give its consent the parties shall try to agree which of the proposed structural alterations must be removed by the Lessee at its expense at the end of the lease and which need not. Consent is given now to the Lessee replacing the locking system with its own system, on condition that the Lessor continues to be allowed to access the common areas at any time and that at the end of the lease the Lessee has the old system properly and professionally reinstalled. The Lessee shall be liable for any damages arising in connection with carrying out the aforementioned work. The Lessee shall also be bear the occupier’s duty of care in the internal and external areas affected by the works during all structural alterations carried out by it. The Lessee shall indemnify the Lessor against all private and public law claims which arise as a result of the works or of a breach of the occupier’s duty of

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aus den Arbeiten ergeben bzw. wegen der Verletzung der Verkehrssicherungspflicht eintreten, frei.		care.
§ 15 Haftung des Mieters		§ 15 Liability of the Lessee
1. Der Mieter haftet gegenüber dem Vermieter wegen Beschädigungen der Mieträume und des Gebäudes/der Wirtschaftseinheit sowie der zu den Mieträumen oder zu dem Gebäude/der Wirtschaftseinheit gehörenden Einrichtungen und Anlagen, die durch ihn, zu seinem Haushalt gehörenden Personen, Arbeiter, Angestellte sowie von ihm beauftragte Handwerker und ähnliche Personen verursacht worden sind, soweit er dies zu vertreten hat.		1. The Lessee shall be liable to the Lessor for damage to the leased premises and the buildings/economic unit and the installations and facilities pertaining to the leased premises or the building/economic unit caused by the Lessee, persons pertaining to the Lessee’s household, collaborators, employees, and manual laborers and all persons contracted by the Lessee, insofar as the Lessee is responsible for such damage.
Beschädigte Glasscheiben einschließlich Schaufenster sowie Spiegel verursacht durch den Mieter hat dieser auf seine Kosten zu ersetzen. Der Vermieter hat die objektive Pflichtverletzung zu beweisen. Der Mieter hat die Beweislast dafür, daß ein schuldhaftes Verhalten nicht vorgelegen hat, soweit Räume, Anlagen und Einrichtungen seiner Obhut unterliegen. Der Mieter haftet nicht für Zufall oder höhere Gewalt.		Damaged glass panes, including display windows and mirrors, caused by the Lessee are to be replaced at the Lessee’s cost. The Lessor must document the objective breach of duty. The Lessee shall have the burden of proving that no negligent conduct existed, insofar as rooms, systems and installations are under its control. The Lessee shall not be liable for coincidental happenstance or force majeure.
2. Vor der Aufstellung von schweren Gegenständen, Maschinen, Einrichtungen und anderen Anlagen in den Mieträumen hat der Mieter sich zu vergewissern, daß die zulässige Belastung der Stockwerkdecken nicht überschritten wird. Eine hierzu im Einzelfall erforderliche statische Berechnung hat er auf eigene Kosten erstellen zu lassen und dem Vermieter auf Verlangen vorzulegen. Der Mieter haftet für Schäden, die dem Vermieter oder Dritten infolge Nichteinhaltung dieser Regelung enststehen. Erhebliche nachteilige Auswirkungen der Anlage für das Gebäude wie Erschütterungen und Risse, sowie Unzuträglichkeiten, wie unzumutbare Belästigungen anderer Personen, berechtigen den Vermieter zum Widerruf der erteilten Zustimmung und Untersagung.		2. Before setting up heavy objects, machinery, installations and other equipment in the lease premises, the Lessee must satisfy itself that the permissible floor capacity will not be exceeded. Any statistical calculation necessary in the specific case must be prepared by the Lessee at its own cost and presented to the Lessor upon request. The Lessee shall be liable for damage incurred to the Lessor or third parties as a consequence of the failure to observe this provision. Substantial detrimental effects of the equipment on the building, such as vibrations and cracks, and intolerable conduct, such as unreasonable nuisances for other persons, shall entitle the Lessor to revoke the issued approval and to prohibit the objects.
3. Der Mieter haftet dem Vermieter für Schäden an Gebäuden, Anlagen, Einrichtungen und an dem sonstigen Grundstück, die durch seine Fahrzeuge oder durch die bei ihm verkehrenden Fahrzeuge verursacht werden. Nur mit Zustimmung des Vermieters dürfen Fahrzeuge des Mieters auf den ihm nicht angewiesenen Plätzen, fremde Fahrzeuge nur während der zum Be- und Entladen erforderlichen Zeit auf dem Grundstück abgestellt werden.		3. The Lessee shall be liable to the Lessor for damage to buildings, facilities, installations and the other property which is caused by the Lessee’s vehicles or vehicles trafficking with the Lessee. Only with the approval of the Lessor may vehicles of the Lessee be parked in the spaces not allocated to the Lessee; third-party vehicles may only be parked on the property during the time necessary for loading and unloading.
4. Der Mieter ist verpflichtet, die Mieträume,		4. The Lessee shall be obliged to always

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mitvermietete Einrichtungen und Flächen, Kundenparkplätze, Garageneinfahrten, Zugänge und die vor den Mieträumen liegenden Verkehrsflächen stets verkehrssicher zu halten. Durch den Betrieb des Mieters auftretende Verschmutzungen hat er unverzüglich zu beseitigen. Im Rahmen seiner gesetzlichen und vertraglichen Verkehrssicherungspflicht stellt der Mieter den Vermieter von jeder Haftung frei, soweit den Vermieter nicht im Einzelfall vorsätzliches oder grob fahrlässiges Mitverschulden trifft.		safeguard the traffic in the leased premises, leased installations and spaces, customer parking spaces, garage entrances, accessories and the traffic spaces in front of the leased premises. Soilage appearing through the operations of the Lessee must be remedied without delay. Within the framework of its legal and contractual duty to safeguard traffic, the Lessee shall indemnify the Lessor against any liability, provided the Lessor is not responsible in the individual case for damage due to intentional action or gross negligence.
5. Der Mieter verpflichtet sich zum Abschluß ausreichender Inventar- und (Betriebs-) Haftpflichtversicherungen. Der Mieter ist ferner verpflichtet, sein Inventar/seine Betriebseinrichtung sowie die Mietsache (z.B. Fenster und Eingangstüren) ausreichend, auch gegen Einbruch und Vandalismus, zu versichern. Die vom Vermieter abgeschlossene Gebäudeversicherung für Feuer-, Leitungswasser- und Sturmschäden dient im Schadenfall lediglich zur Absicherung fest mit dem Gebäude verbundener Einrichtungen und Anlagen des Vermieters, nicht jedoch für Inventar und Betriebseinrichtung des Mieters.		5. The Lessee hereby agrees to take out sufficient inventory and (business) liability insurance. The Lessee shall further be obliged to secure its inventory/operating equipment and the leased premises (e.g. windows and entry doors) sufficiently, also against break-in and vandalism. The building insurance taken out by the Lessor for fire, water and storm damage merely serves in a claim event to secure installations and equipment of the Lessor firmly attached to the building and not the inventory or operating equipment of the Lessee.
§ 16 Werbemaßnahmen / Konkurrenzschutz/ Markenschutz/ Unterlassung		§ 16 Advertising Measures / Protection from Competition / Trademark Protection / Desistance
1. Der Mieter ist nur zur Anbringung von Firmenschildern in einer der Umgebung und dem Stile des Gebäudes bzw. Grundstücks entsprechenden Größe und Gestaltung an der von dem Vermieter vorher bezeichneten Fläche berechtigt.		1. The Lessee shall only be entitled to affix name signs in a size and design corresponding to the environment and style of the building and property on the surface previously designated by the Lessor
2. Die ordnungsgemäße Anbringung und Unterhaltung einschließlich gesetzlicher und behördlicher Bestimmungen obliegt dem Mieter. Die vorstehenden Regelungen gelten sinngemäß für sonstige Vorrichtungen zu Verkaufs- und Werbezwecken, die nur nach schriftlicher Vereinbarung mit dem Mieter zulässig sind. Von dem Vermieter gestellte Sammelschildanlagen kann der Mieter bei anteiliger Kostenübernahme mitzubenutzen. Der Mieter haftet für alle Schäden, die durch die betreffenden Gegenstände und deren Anbringung entstehen. Bei Herausgabe der Mietsache ist der Mieter zur Wiederherstellung des alten Zustandes auf seine Kosten verpflichtet.		2. The Lessee shall be responsible for the proper mounting and maintenance, including applicable legal and administrative regulations. The above provision shall apply analogously to other equipment for sales and advertising purposes, which shall only be permissible after written agreement with the Lessee. The Lessee may jointly use the collective sign installations set up by the Lessor, provided the Lessee assumes the prorated costs. The Lessee shall be liable for all damage incurred through the relevant objects and the mounting thereof. Upon surrender of the leased premises, the Lessee shall be obliged to restore the old conditions at its own cost.
3. Konkurrenzschutz wird dem Mieter außerhalb des hier betreffenden Gebäudes und bei etwaigen Mietern, die mit deren Gewerbe das Produkt- und		3. No protection from competition is granted to the Lessee except in the building in question and in respect of any tenants whose trade does not

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Leistungsportfolio des Mieters nicht tangieren nicht gewährt.		affect the Lessee’s range of products and services.
§ 17 Vermieterpfandrecht		§ 17 Lessor’s Lien
1. Der Mieter erklärt, dass die von ihm in das Mietobjekt eingebrachten Sachen in seinem Eigentum stehen und verpflichtet sich, den Vermieter von einer etwaigen Pfändung bei Einzug oder nachträglich eingebrachter Sachen unverzüglich zu unterrichten.		1. The Lessee hereby declares that the things brought into the Leased Object by the Lessee are its property and hereby agrees to notify without delay the Lessor of any attachment of things brought into the premises when moving in or at a later time.
2. Wissentlich unrichtige Erklärungen und unterlassene Unterrichtung über nachträgliche Beschränkungen berechtigen den Vermieter zur fristlosen Kündigung des Vertrages (siehe auch § 3 Ziff. 1 c).		2. Knowingly false declarations and the failure to notify subsequent restrictions shall entitle the Lessor to terminate this Agreement without notice (cf. also § 3(1) c).
3. Wenn der Mieter der Vermieterin jährlich zum 01.12. eines jeden Jahres aussagekräftige Bonitätsnachweise überlässt, die eine mindestens gute Bonität nachweisen, wird die Vermieterin für die Dauer der rechtzeitigen Erbringung dieser jährlich vorzulegenden Nachweise auf die Geltendmachung eines etwaigen Vermieterpfandrechts verzichten.		3. If each year the Lessee sends the Lessor persuasive evidence that its covenant strength as at 1st December is at least good, the Lessor shall waive its right to assert any Lessor’s lien for the period in respect of which this annual evidence is provided on time.
§ 18 Betreten der Mietsache durch den Vermieter		§ 18 Access to the Leased Premises by the Lessor
1. Der Vermieter und sein Beauftragter können während der Geschäftszeit nach vorheriger Anmeldung die Mieträume zur Überprüfung ihres Zustandes betreten. Will der Vermieter das Grundstück verkaufen oder ist das Mietverhältnis gekündigt oder aufgehoben, so darf der Vermieter oder sein Beauftragter die Mieträume zusammen mit den Kauf- bzw. Mietinteressenten zu den gleichen Stunden betreten. Wenn die Schlüssel dem Vermieter nicht zur Verfügung stehen, so ist er bei Gefahr im Verzug berechtigt, die Mieträume auf Kosten des Mieters öffnen zu lassen. Ein Zugang zu den Allgemeinflächen ist dem Vermieter immer und zu jedem Zeitpunkt zu gewähren.		1. The Lessor and its agent may access the leased premises to review the conditions thereof during business hours after prior notice. If the Lessor plans to sell the property or if the lease relation is terminated or rescinded, the Lessor or its agent may access the leased premises together with the potential buyer or tenant during the same time. If the keys are not provided to the Lessor, the Lessor shall be entitled in the event of imminent danger to have the leased premises opened at the cost of the Lessee. The Lessor must be granted access to the common areas always and at any time.
§ 19 Beendigung des Mietverhältnisses		§ 19 Cessation of the Lease Relation
1. Die Mietsache ist bei Beendigung der Mietzeit in vertragsgemäßem Zustand, geräumt und vollständig gereinigt mit sämtlichen Schlüsseln zurückzugeben.		1. The leased premises are to be returned upon the cessation of the term of lease in the conditions pursuant to this Agreement, vacated and fully cleaned, with all keys.
2. Der Vermieter kann die Entfernung der von dem		2. The Lessor can require the removal of the

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Mieter eingebrachten Einrichtungen, Anlagen und baulichen Veränderungen unter Wiederherstellung des früheren Zustandes auf dessen Kosten verlangen, wobei zwischen den Parteien Einigkeit besteht, dass etwaige Rückbaupflichten frühestmöglich im Rahmen der Gestattungsprüfung durch den Vermieter festgelegt und verhandelt werden sollen... Es gilt der Grundsatz, dass für leichte Umbauarbeiten (Trockenbauarbeiten, Bodenbeläge, nicht tragende Wände, Bürotüren etc.) innerhalb der Mieträume, welche die Grundstruktur (Dach, tragende Gebäudeteile, Treppenhäuser, Außenfassade etc. ) des Bestandsgebäudes nicht beeinträchtigen eine Genehmigung grundsätzlich erteilt ist und bei erfolgter vorheriger Information und Abstimmung über Art und Umfang der Maßnahme im Vorfeld mit dem Vermieter ein Rückbau nicht zu erfolgen hat – dies auch unter der zwingenden Voraussetzung, dass baubehördliche Einschränkungen und/oder Untersagungen nicht entgegen stehen und, dass sich die Mieterin um sämtliche hierfür erforderlichen Auflagen und Genehmigungen selbst und auf eigene Kosten kümmert, sowie die Vermieterin von allen damit zusammenhängenden Regularien, Ansprüchen und Auflagen freistellt, sofern diese Veränderungen überhaupt in Anbetracht der in § 14 Nummer Ziffer 2 geäußerten Vorgaben und zwingenden Voraussetzungen in Betracht kommen und die baulichen Veränderungen zur Ausführung gelangen können. Im Falle behördlicher Erfordernisse, mithin konkreter Ordnungsverfügungen zuständiger Baubehörden, die einen Rückbau solcher Umbauten einfordern, ist die Mieterin wieder zum Rückbau auf eigene Kosten verpflichtet – auch schon während des Mietverhältnisses.		installations, equipment and structural alterations brought into the premises by the Lessee and the reinstatement of the premises to their original condition at the Lessee’s expense, but the parties agree that any obligations to reinstate shall be determined and negotiated as early as possible as part of the Lessor’s deliberations as to whether to give its consent. Basically, consent is granted for minor alterations (drywall works, floor coverings, non-load-bearing walls, office doors etc.) within the demised premises which do not interfere with the underlying structure of the existing building (roof, load-bearing elements, stairwells, exterior façade etc.), and reinstatement is not required if the Lessor is first informed of the nature and extent of the works and they are agreed with it in advance – subject to the mandatory condition that restrictions and/or prohibitions imposed by the building authorities do not preclude them and that the Lessee itself deals at its own expense with all necessary stipulations and permissions and indemnifies the Lessor in respect of all associated formalities, claims and requirements, if these alterations can be considered at all in view of the rules and mandatory conditions set out at §14 point number 2 and the structural alterations are capable of implementation. If official requirements and specific orders by competent building authorities require that such alterations be removed, the Lessee shall be obliged to remove them at its own expense – including during the lease.
3. Verspätete Rückgabe der Mietsache verpflichtet den Mieter für die Dauer der Vorenthaltung zur Entschädigung nach Wahl des Vermieters in Höhe der vereinbarten oder der für vergleichbare Räume ortsüblich erzielbaren Miete.		3. The late return of the leased premises shall oblige the Lessee for the time the premises are withheld to pay compensation at the choice of the Lessor in the amount of the agreed rent or the standard local rent attainable for comparable spaces.
4. Im Falle einer von dem Mieter zu vertretenden vorzeitigen Beendigung des Mietverhältnisses haftet er für den Ausfall der Miete, Nebenkosten und sonstigen Leistungen sowie für alle weiteren Schäden, welche dem Vermieter durch ein Leerstehen der Mieträume während der vertragsgemäßen Mietzeit entstehen.		4. In the event of the early cessation of the lease relation due to reasons for which the Lessee is responsible, the Lessee shall be liable for the loss of rent, ancillary costs and other performances and for all further damage incurred by the Lessor through the vacancy of the leased premises during the agreed term of lease.
§ 20 Personenmehrheit		§ 20 Several Persons
1. Mehrere Mieter haften für alle Verpflichtungen aus		1. Several Lessees shall be liable for all

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dem Mietverhältnis als Gesamtschuldner.		obligations from the lease relation as joint and several debtors.
2. Für die Rechtswirksamkeit einer Willenserklärung des Vermieters genügt es, wenn sie gegenüber einem der Mieter abgegeben wird. Die Mieter bevollmächtigen sich gegenseitig zur Entgegennahme von Willenserklärungen des Vermieters. Willenserklärungen eines der Mieter gelten auch für und gegen die anderen Mieter. Vorstehende Bestimmungen gelten auch für Vertragsabänderungen und Entgegennahme von Kündigungen.		2. For a declaration of intent of the Lessor to be legally valid, it shall be sufficient if the declaration is issued to one of the Lessees. The Lessees hereby mutually authorize each other to receive declarations of intent from the Lessor. Declaration of intent of one of the Lessees shall apply for and against the other Lessees. The above provisions shall also apply to contractual changes and the receipt of terminations.
3. Eine vorzeitige Entlassung eines Mieters bedarf der schriftlichen vorherigen Zustimmung des Vermieters im Einzelfall.		3. Any early resignation of a Lessee shall require the prior written approval of the Lessor in the specific case.
§ 21 Änderungen und Ergänzungen/Schriftform		§ 21 Modifications and Additions/Written Form
1. Nachträgliche Änderungen und Ergänzungen dieses Mietvertrages bedürfen der schriftlichen Vertragsform. Dies gilt auch für einen teilweisen Verzicht auf das Schriftformerfordernis. In Anbetracht etwaiger Absprachen zwischen den Parteien zu Umbaugenehmigungen zugunsten des Mieters und dann schon zu regelnder Rückbaupflichten verpflichten sich beide Parteien zur Erstellung eines der Schriftform entsprechenden Nachtrages zum hiesigen Mietvertrag, der getroffene Absprachen dezidiert aufführt. Das Gleiche gilt für angefragte und genehmigte Untervermietung.		1. Subsequent modifications of or additions to this Agreement must be made in writing. This shall also apply to any partial waiver of this requirement for the written form. With regard to any agreements between the parties in relation to consent to alterations by the Lessee and the need for reinstatement works, both parties agree to draw up a supplement to the present lease contract, which complies with the requirement for writing, in which the agreed terms are set out conclusively. The same shall apply to requests for consent to sub-letting and consents granted.
2. Den Mietparteien sind die besonderen gesetzlichen Schriftformerfordernisse des § 578 BGB iVm. § 550 BGB und die sich hieruas ergebenden Rechtsfolgen bekannt. Sie verpflichten sich hiermit gegenseitig auf jederzeitiges Verlangen einer Partei alle Handlungen vorzunehmen und Erklärungen abzugeben, die erforderlich sind, um dem gesetzlichen Schriftformerfordernis Genüge zu tun und den Mietvertrag nicht unter Berufung auf die Nichteinhaltung der gesetzlichen Schriftrom vorzeitig zu kündigen, wobei diese Regularien nicht für einen etwaigen Erwerber des Objektes gelten.		2. The Parties are aware of the special requirements for the written form stipulated by law in § 578 as related to § 550 of the Civil Code and of the resulting legal consequences. The Parties hereby mutually agree upon the request at any to time of one Party to undertake all acts and issue all declarations that are necessary to satisfy the requirement for the written form prescribed by law and not to terminate this Lease Agreement early, invoking the non-observance of the statutory written form, whereby these provisions shall not apply to any buyer of the property.
3. Etwaige anderweitige/vorherige mitvertragliche Regelungen das Mietobjekt oder Teile des Mietobjektes zwischen den Parteien betreffend werden durch hiesigen Vertrag vollständig ersetzt.		3. Any other/previous leased agreement arrangements regarding the Leased Object or parts thereof between the Parties shall be completely replaced by this Agreement.

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§ 22 Hausordnung		§ 22 Building Rules
¨ Eine Hausordnung existiert und wird als Anlage Bestandteil dieses Vertrages.		¨ Building rules exist and shall form an integral component of this Agreement.
x Eine Hausordnung existiert nicht, d.h.ein friedliches Zusammenleben der Mieter / Hausbewohner ist nur möglich, wenn jeder sich von dem Gedanken der Gemeinschaft leiten läßt.		x No building rules exist, i.e. peaceful coexistence of the lessees/residents is only possible if everybody is guided by thoughts about the community.
§ 23 Sonstige Vereinbarungen		§ 23 Miscellaneous Covenants
1. Der Vermieter sichert zu, dass die Zufahrt/der Zugang zur Tiefgarage im Untergeschoss der Gebäude Neuenhofer Weg 3 – 5 ausschließlich den Mietern der hierin befindlichen Stellplätze sowie jederzeit dem Eigentümer ermöglicht wird.		1. The Lessor represents that entry by vehicle or foot to the underground parking garage in the basement of the building at Neuenhofer Weg 3 – 5 will exclusively be enabled for the lessees of the parking spaces there as well as the owner at any time.
Insbesondere wird keine bauliche Änderung vorgenommen, die eine Durchfahrt durch die Tiefgarage in benachbarte Tiefgaragen ermöglicht.		In particular, no structural alteration shall be undertaken enabling cars to pass through the underground parking garage into the neighboring underground parking garage.
2. Sollte der Vermieter beabsichtigen, das Objekt zu verkaufen, wird dem Mieter ein Vorkaufsrecht eingeräumt. Die Parteien des Mietvertrages kommen überein, dass auf die dingliche Absicherung dieses Vorkaufsrechts verzichtet wird.		2. Should the Lessor plan to sell the property, the Lessee shall be granted a preemptive purchase right. The Parties to this Lease Agreements agree to waive having this preemptive purchase right secured in rem.
3. Dem Mieter wird ein Optionsrecht auf frei werdende Flächen und Tiefgaragen- bzw. Außenstellplätzen im Objekt Neuenhofer Weg 3 – 5 eingeräumt, wobei potentiell frei werdende Mietflächen nur in folgenden, derzeit von der Finders GmbH angemieteten Räumen bestehen können.		3. The Lessee is granted an option in respect of premises and underground or external parking spaces which become available in the premises at Neuenhofer Weg 3-5, although there may only be potentially available rental space in the following premises currently let to Finders GmbH.
4. Der Vermieter wird dem Mieter die frei werdenden Flächen nach Kenntnis des Freiwerdens zu den unten aufgeführten Mietkonditionen anbieten. Der Mieter hat innerhalb eines Monats nach Zugang eines entsprechenden Angebots des Vermieters das Anmietrecht durch Rücksendung seiner schriftlichen Annahme auszuüben, wobei die Mietkonditionen als vereinbart gelten (s. nachfolgende tabellarische Auflistung).		4. The Lessor shall offer space which becomes available to the Lessee after the Lessor becomes aware of it, on the lease conditions set out below. The Lessee must exercise its right to rent them within one month after receipt of the Lessor’s offer by returning its written acceptance, at which point the lease conditions shall be deemed to have been agreed (see list in the table below).
a)      Grundmiete / Basic Rent

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Raumart/Room type

Lage/Location

Fläche /m² Anzahl/#

m²-Preis / je Stp.

Summe / Gesamt

Gastraum, Küche, Lager, Umkleide, Damen/Herren WC Restaurant, kitchen, storage, changing room, bathroom women/men

Hs.Nr.3, EG Groundfloor

130,00 m²

11,50 €

1.495,- €

Lagerfläche / Storage

UG / Basement

13,60 m²

7,72 €

105,- €

Außenstellplatz / Parking space outside

Außen / outside

1

20,00 €

20,- €

Gesamt / Total

1.620,- €

 

b)

Betriebs-/Heizkostenvorauszahlungen / Advance payments for operating/heating costs

 

Vorauszahlung Betriebskosten/ advance payment operating costs			150,00 €
Vorauszahlung Heizkosten/ advance payment heating costs			86,00 €
Gesamt netto / Net Total			1.856,00 €

 

c)

Umsatzsteuer / Mehrwertsteuer / Turnover tax / value-added tax

 

19 % MwSt. / VAT 19%			352,64 €
Gesamt brutto / Gross Total			2.208,64 €

 

§ 24 Wirksamkeit von Vertragsbestimmungen		§ 24 Validity of the Contractual Provisions
Durch die etwaige, auch im Wege der Vertragsauslegung durch Umdeutung oder Zurückführung auf einen wirksamen Kern nicht zu heilende Ungültigkeit einer Bestimmung, eines Teils einer Bestimmung oder mehrerer Bestimmungen dieses Mietvertrages wird die Gültigkeit der übrigen Bestimmungen nicht berührt.		Through any invalidity of a provision, part of a provision or several provisions of this Agreement which cannot be healed even by reinterpreting this Agreement or referring to a valid core, the validity of the other provisions shall not be affected thereby.
Dieser Vertrag ist doppelt und gleichlautend ausgefertigt, selbst gelesen, genehmigt und eigenhändig unterschrieben. Beide Vertragsparteien haben eine Ausfertigung erhalten. Die Parteien verpflichten sich, alle nachträglichen Vereinbarungen unter Beachtung der Schriftform zu fertigen und		This Agreement is hereby executed in two identical counterparts, each read, approved and signed in person. Both Parties have received one counterpart. The Parties hereby agree to make all subsequent agreements in observance of the written form and to bind them firmly to the

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jeweils fest mit dem Originalexemplar zu verbinden, sich jedenfalls bei Nichtbeachtung nicht auf Verstoß gegen die Schriftform zu berufen.		original counterpart, and at any rate not to invoke a breach of the requirement for the written form in the event of non-observance.
(Ort, Datum)		(Ort, Datum)
October 19, 2015		October 19, 2015
/s/ Dirk Michels		/s/ Thomas Huebner
Abiomed Europe GmbH		gewoge AG, Thomas Huebner
Dirk Michels
/s/ Rita Geffers		/s/ Ulrich Warner
Abiomed Europe GmbH		gewoge AG, Ulrich Warner
Rita Geffers
Anlagen		Annexes
Anlagen Nummern I- V – farblich markierte Pläne		Annex Nos. I- V– maps marked in color
Anlage VI Mängelprotokoll über vermieterseits zu beseitigende Mängel   Anlage VII – Mietvertrag zwischen den Parteien über anderweitige Flächen vom 19.07.2013 bzw. 29.07.2013 in Kopie nebst 1. Nachtrag in Kopie		Annex VI Notice of defects which need to be rectified by Lessor   Annex VII – Lease agreement between the parties for supplemental space dated 19 July 2013 / 29 July 2013 in copy together with the first amendment in copy

Exhibit 10.2

 

 

Nachtrag Nr. 1 zum Gewerberaummietvertrag vom 29.07.2013 bzw. 19.07.2013 (nebst Anlagen I – VI zu diesem Vertrag)		Supplemental contract no. 1 to the lease contract for commercial premises dated 29th / 19th July 2013 (together with Annexes I-VI thereto)
Zwischen		The following subsidiary provisions regarding additional premises and provisions supplementing / amending the commercial lease relating to the rooms and space in the buildings at Neuenhofer Weg 3-5, 52074 Aachen, are agreed between
der gewoge AG, Kleinmarschierstraße 54-58, 52062 Aachen, vertreten durch deren Vorstände Thomas Hübner und Ulrich Warner, ebenda,		gewoge AG, Kleinmarschierstrasse 54-58, 52062 Aachen, represented by its directors Thomas Hübner and Ulrich Warner, ibid,
Vermieter,		Landlord,
und		and
der Firma Abiomed Europe GmbH, Neuenhofer Weg 3, 52074 Aachen, vertreten durch die Geschäftsführer Herrn Dirk Michels und Herrn Dr. Thorsten Sieß, ebenda,		Abiomed Europe GmbH, Neuenhofer Weg 3, 52074 Aachen, represented by its directors Mr Dirk Michels und Dr. Thorsten Siess, ibid,
Mieter,		Tenant,
werden nachfolgende originäre Regelungen zu Zusatzflächen bzw. ergänzende/modifizierende Regelungen zum Gewerberaummietverhältnis die Räume und Flächen in den Gebäuden Neuenhofer Weg 3-5, 52074 Aachen, betreffend getroffen:
Präambel/Vertragshistorie		Preliminary / history of contract
Die Parteien schlossen unter dem 19.07.2013 (Unterschriftsleistung der Mieterin) bzw. 29.07.2013 (Unterschriftsleistung der Vermieterin) einen Gewerberaummietvertrag über Räume und Flächen, die überwiegend im Haus Neuenhofer Weg 3, 52074 Aachen gelegen sind und zu einem geringen Teil im Haus Neuenhofer Weg 5, 52074 Aachen nebst definierter Anzahl an ebenfalls dort liegender Tiefgaragen- und Außenstellplätzen. Die genaue Lage der bisher schon vermieteten Flächen/Räume/Stellplätze ergibt sich aus zum Gewerberaummietvertrag vom 19.07.2013/29.07.2013 gehörenden Anlagen I – III (genaue Grundrisspläne nebst farbigen Kennzeichnungen). Neben diesem Vertrag und seinen 3 Anlagen gibt es zwischen den Parteien keine weiteren mündlichen oder schriftlichen		On 19th July 2013 (signature by the Tenant) / 29th July 2013 (signature by the Landlord), the parties concluded a commercial lease contract in respect of rooms and space mainly situated in the building at Neuenhofer Weg 3, 52074 Aachen and a small part of which are in the building at Neuenhofer Weg 5, 52074 Aachen, together with a defined number of underground and external parking spaces also situated there. The precise location of the space/rooms/parking spaces already let is shown in Annexes I-III to the commercial lease dated 19th / 29th July 2013 (precise layout plans together with identification in colour). Apart from that contract and its 3 annexes there are no other oral or written agreements between the parties. All further terms existing in the view of either or both parties or either party in addition to the written terms of the

 

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vertraglichen Absprachen. Alles, was aus Sicht beider Parteien oder einer einzelnen Partei neben den schriftlichen Regelungen des Vertrages vom 19.07.2013/29.07.2013 an weiteren Regelungen existiert, etwaige Nachträge und Zusätze werden im Einvernehmen der Parteien hiermit aufgehoben. Die Parteien sind sich einig, dass bisher einzig der Vertrag vom 19.07.2013/29.07.2013 nebst den dort angefügten und genannten drei Anlagen die mietvertraglichen Modalitäten regelt. Diese Regelungen bleiben hinsichtlich der schon vermieteten Flächen/Stellplätze/Räume vollumfänglich verbindlich und gültig, sofern nicht ausdrücklich im hiesigen Nachtrag eine verändernde/ergänzende/ aufhebende Regelung getroffen wird und als solche gekennzeichnet ist.				contract dated 19th / 29th July 2013, and any supplemental contracts and additions, are hereby terminated by agreement between the parties. The parties are in agreement that until now the contractual conditions of the lease have been regulated only by the contract dated 19th / 29th July 2013 together with the three annexes attached thereto and referred to therein. These terms remain fully binding and valid in respect of the space /parking spaces / rooms already let, save insofar as an amending, supplemental or abrogating term is expressly agreed and designated as such in this supplemental contract.
Mietobjekt				Demised Premises
1.		Die bisher vermieteten Räume und Flächen sind im Gewerberaummietvertrag vom 19.07.2013 /29.07.2013 in § 1, sowie in den Anlagen I – III zum besagten Mietvertrag genau umschrieben.		1.		The rooms and space let until now are precisely described in §1 of the commercial lease contract dated 19th/29th July 2013 and in Annexes I-III to that lease contract.
2.		Zusätzlich zu den bisherigen Räumen/Flächen vermietet der Vermieter dem Mieter mit Wirkung ab dem 01.07.2015 nachstehende zusätzliche Flächen, auf deren Anmietung der Mieter gemäß § 20 des Mietvertrages vom 19.07.2013/29.07.2013 bereits ein exklusives Optionsrecht innehatte und dieses Anmietungsrecht geltend gemacht hat:		2.		In addition to the previous rooms / space, with effect from 1st July 2015 the Landlord lets the additional space referred to below, which the Tenant already had an exclusive option to rent pursuant to §20 of the lease contract dated 19th / 29th July 2013 and in respect of which it has exercised that right:

 

- Neuenhofer Weg Nr. 3, 52074 Aachen:
I. OG vollständig Entire 2nd floor (AE)		Büro/Nebenfläche Offices / ancillary space			759,00 m²
- Neuenhofer Weg Nr. 5, 52074 Aachen:
Untergeschoss Basement		Lagerfläche Storage			73,34 m²
Gesamtfläche zusätzlich: Total additional space:					832,34 m²

 

3.		Zusätzlich zu den bisher schon angemieteten Tiefgaragenstellplätzen und Außenstellplätzen		3.		In addition to the underground and external parking spaces already rented, the

 

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Raumart Type of room		Fläche/Anzahl Area/number				m²-Preis / je Stp. Rent per sqm /space				Summe / Gesamt Total / grand total
Büro-/Nebenfläche Offices / ancillary space			759,00 m²				11,50 €				8.728,50 €
Lagerfläche Storage			73,34 m²				6,00 €				440,04 €
Tiefgaragenstellplatz Underground parking spaces			7				45,00 €				315,00 €
Außenstellplatz External parking spaces			9				20,00 €				180,00 €
Gesamt Total											9.663,54 €
Vorauszahlung Betriebskosten Advance payment of service charges											1.400,00 €
Vorauszahlung Heizkosten Advance payment of heating costs											700,00 €
Gesamt netto Total net											11.763,54 €
19 % MWSt. 19% VAT											2.235,07 €
Gesamt brutto Total gross											13.998,61 €

 

 

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Aachen, den				Aachen, den
/s/ Thomas Hübner				/s/ Dirk Michels
Unterschrift, Thomas Hübner				Unterschrift, Dirk Michels
gewoge AG				Abiomed Europe GmbH
Aachen, den				Aachen, den
/s/ Ulrich Warner				/s/ Rita Geffers
Unterschrift, Ulrich Warner				Unterschrift, Rita Geffers
gewoge AG				Abiomed Europe GmbH

Anlagen/Annexes

Anlagen Nummern I bis VI des 1. Nachtrages vom                      zum Mietvertrag vom 19.07.2013/29.072013

Annexes number I to VI to the 1^st supplemental contract dated                      to the lease contract dated 19^th / 29^th July 2013

 

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Exhibit 31.1

CERTIFICATIONS

I, Michael R. Minogue certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of ABIOMED, Inc.

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

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

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

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

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

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

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

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

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

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

 

Date: November 4, 2015						/s/ MICHAEL R. MINOGUE
						Michael R. Minogue
						Chairman, President and Chief Executive Officer (Principal Executive Officer)

Exhibit 31.2

I, Michael J. Tomsicek certify that:

1. I have reviewed this Quarterly Report on Form 10-Q of ABIOMED, Inc.

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

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

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

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

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

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

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

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

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

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

 

Date: November 4, 2015						/s/ MICHAEL J. TOMSICEK
						Michael J. Tomsicek
						Vice President and Chief Financial Officer (Principal Accounting and Financial Officer)

Exhibit 32.1

CERTIFICATION PURSUANT TO

18 U.S.C. § 1350

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the Quarterly Report on Form 10-Q of ABIOMED, Inc., (the “Company”) for the quarter ended September 30, 2015, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), each of the undersigned President and Chief Executive Officer, and Chief Financial Officer, of the Company, certifies, to the best knowledge and belief of the signatory, pursuant to 18 U.S.C. § 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 that:

 

(1)

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

 

(2)

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

 

/s/ MICHAEL R. MINOGUE				/s/ MICHAEL J. TOMSICEK
Michael R. Minogue				Michael J. Tomsicek
Chairman, President and Chief Executive Officer				Vice President and Chief Financial Officer
Date: November 4, 2015				Date: November 4, 2015