|
Michigan
|
|
94-3096597
|
(State or other jurisdiction of
|
|
(I.R.S. employer
|
incorporation or organization)
|
|
identification no.)
|
|
|
|
64 Sidney Street
|
||
Cambridge, MA 02139
|
||
(Address of principal executive offices, including zip code)
|
Large accelerated filer -
o
|
|
Accelerated filer -
x
|
|
|
|
Non-accelerated filer -
o
|
|
Smaller reporting company -
o
|
(Do not check if a smaller reporting company)
|
|
Emerging growth company -
o
|
COMMON STOCK, NO PAR VALUE
|
|
34,907,789
|
(Class)
|
|
Outstanding at November 3, 2017
|
|
|
|
|
|
|
PART I — FINANCIAL INFORMATION
|
|
|
|
|
|
Item 1.
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
|
||
|
|
|
Item 2.
|
||
|
|
|
Item 3.
|
||
|
|
|
Item 4.
|
||
|
|
|
PART II — OTHER INFORMATION
|
|
|
|
|
|
Item 1.
|
||
|
|
|
Item 1A.
|
||
|
|
|
Item 1B.
|
||
|
|
|
Item 2.
|
||
|
|
|
Item 6.
|
||
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2017
|
|
2016
|
||||
ASSETS
|
|
|
|
|
|
|
||
Current assets:
|
|
|
|
|
|
|
||
Cash
|
|
$
|
15,466
|
|
|
$
|
22,978
|
|
Accounts receivable (net of allowance for doubtful accounts of $226 and $225, respectively)
|
|
15,430
|
|
|
17,093
|
|
||
Inventory
|
|
4,049
|
|
|
3,488
|
|
||
Other current assets
|
|
1,366
|
|
|
1,164
|
|
||
Total current assets
|
|
36,311
|
|
|
44,723
|
|
||
Property and equipment, net
|
|
3,967
|
|
|
3,875
|
|
||
Total assets
|
|
$
|
40,278
|
|
|
$
|
48,598
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
|
||
Accounts payable
|
|
$
|
5,972
|
|
|
$
|
6,535
|
|
Accrued expenses
|
|
4,514
|
|
|
4,523
|
|
||
Current portion of term loan credit agreement (net of deferred costs of $110)
|
|
2,557
|
|
|
779
|
|
||
Warrant liabilities
|
|
1,269
|
|
|
757
|
|
||
Other
|
|
216
|
|
|
259
|
|
||
Total current liabilities
|
|
14,528
|
|
|
12,853
|
|
||
Revolving and term loan credit agreement (net of deferred costs of $211 and $293, respectively)
|
|
7,400
|
|
|
9,318
|
|
||
Long term deferred rent
|
|
1,613
|
|
|
1,687
|
|
||
Other long term debt
|
|
—
|
|
|
32
|
|
||
Total liabilities
|
|
23,541
|
|
|
23,890
|
|
||
COMMITMENTS AND CONTINGENCIES (Note 13)
|
|
|
|
|
|
|
||
Shareholders’ equity:
|
|
|
|
|
|
|
||
Series B-2 voting convertible preferred stock, no par value: shares authorized and reserved — 39, shares issued and outstanding — 0 and 12, respectively
|
|
—
|
|
|
38,389
|
|
||
Common stock, no par value; shares authorized — 75,000; shares issued and outstanding — 34,852 and 31,595, respectively
|
|
377,711
|
|
|
329,720
|
|
||
Warrants
|
|
190
|
|
|
190
|
|
||
Accumulated deficit
|
|
(361,164
|
)
|
|
(343,591
|
)
|
||
Total shareholders’ equity
|
|
16,737
|
|
|
24,708
|
|
||
Total liabilities and shareholders’ equity
|
|
$
|
40,278
|
|
|
$
|
48,598
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Product sales, net
|
|
$
|
14,260
|
|
|
$
|
10,929
|
|
|
$
|
40,574
|
|
|
$
|
37,860
|
|
Cost of product sales
|
|
7,186
|
|
|
6,856
|
|
|
21,965
|
|
|
20,716
|
|
||||
Gross profit
|
|
7,074
|
|
|
4,073
|
|
|
18,609
|
|
|
17,144
|
|
||||
Research and development
|
|
2,919
|
|
|
3,443
|
|
|
9,357
|
|
|
11,037
|
|
||||
Selling, general and administrative
|
|
8,186
|
|
|
7,010
|
|
|
25,427
|
|
|
19,463
|
|
||||
Total operating expenses
|
|
11,105
|
|
|
10,453
|
|
|
34,784
|
|
|
30,500
|
|
||||
Loss from operations
|
|
(4,031
|
)
|
|
(6,380
|
)
|
|
(16,175
|
)
|
|
(13,356
|
)
|
||||
Other income (expense):
|
|
|
|
|
|
|
|
0
|
|
|
|
|
||||
(Increase) decrease in fair value of warrants
|
|
(1,060
|
)
|
|
(203
|
)
|
|
(512
|
)
|
|
99
|
|
||||
Foreign currency translation loss
|
|
(6
|
)
|
|
(6
|
)
|
|
(20
|
)
|
|
(17
|
)
|
||||
Interest income
|
|
2
|
|
|
—
|
|
|
6
|
|
|
7
|
|
||||
Interest expense
|
|
(317
|
)
|
|
(86
|
)
|
|
(878
|
)
|
|
(92
|
)
|
||||
Other income (expense)
|
|
5
|
|
|
—
|
|
|
6
|
|
|
(10
|
)
|
||||
Total other income (expense)
|
|
(1,376
|
)
|
|
(295
|
)
|
|
(1,398
|
)
|
|
(13
|
)
|
||||
Net loss
|
|
$
|
(5,407
|
)
|
|
$
|
(6,675
|
)
|
|
$
|
(17,573
|
)
|
|
$
|
(13,369
|
)
|
|
|
|
|
|
|
|
|
|
||||||||
Net loss per share attributable to common shareholders (Basic and Diluted) (see note 12)
|
|
$
|
(0.16
|
)
|
|
$
|
(0.38
|
)
|
|
$
|
(0.54
|
)
|
|
$
|
(0.84
|
)
|
Weighted average number of common shares outstanding (Basic and Diluted)
|
|
33,667
|
|
|
22,744
|
|
|
32,783
|
|
|
22,678
|
|
|
|
Nine Months Ended September 30,
|
||||||
|
|
2017
|
|
2016
|
||||
Operating activities:
|
|
|
|
|
|
|
||
Net loss
|
|
$
|
(17,573
|
)
|
|
(13,369
|
)
|
|
Adjustments to reconcile net loss to net cash used for operating activities:
|
|
|
|
|
|
|
||
Depreciation and amortization
|
|
1,186
|
|
|
1,393
|
|
||
Stock compensation expense
|
|
2,053
|
|
|
1,973
|
|
||
Change in fair value of warrants
|
|
512
|
|
|
(99
|
)
|
||
Inventory provision
|
|
232
|
|
|
98
|
|
||
Foreign currency translation loss
|
|
20
|
|
|
17
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
||
Inventory
|
|
(793
|
)
|
|
(2,325
|
)
|
||
Accounts receivable
|
|
1,663
|
|
|
3,048
|
|
||
Other current assets
|
|
(202
|
)
|
|
(278
|
)
|
||
Accounts payable
|
|
(1,068
|
)
|
|
(2,173
|
)
|
||
Accrued expenses
|
|
(9
|
)
|
|
(205
|
)
|
||
Tenant improvement reimbursement
|
|
89
|
|
|
898
|
|
||
Deferred rent expense
|
|
2
|
|
|
438
|
|
||
Other assets and liabilities, net
|
|
(129
|
)
|
|
—
|
|
||
Net cash used for operating activities
|
|
(14,017
|
)
|
|
(10,584
|
)
|
||
Investing activities:
|
|
|
|
|
|
|
||
Expenditures for property, plant and equipment
|
|
(792
|
)
|
|
(1,314
|
)
|
||
Net cash used in investing activities
|
|
(792
|
)
|
|
(1,314
|
)
|
||
Financing activities:
|
|
|
|
|
|
|
||
Net proceeds from issuance of common stock
|
|
7,549
|
|
|
469
|
|
||
Deferred financing costs
|
|
—
|
|
|
(244
|
)
|
||
Borrowings under revolving credit agreement and term loan
|
|
—
|
|
|
8,400
|
|
||
Repayments of short-term debt
|
|
—
|
|
|
(2,400
|
)
|
||
Payments on long-term debt
|
|
(252
|
)
|
|
(28
|
)
|
||
Net cash provided by financing activities
|
|
7,297
|
|
|
6,197
|
|
||
Net decrease in cash
|
|
(7,512
|
)
|
|
(5,701
|
)
|
||
Cash at beginning of period
|
|
22,978
|
|
|
14,581
|
|
||
Cash at end of period
|
|
$
|
15,466
|
|
|
$
|
8,880
|
|
|
|
|
|
|
||||
Supplemental cash flow information (non-cash):
|
|
|
|
|
|
|
||
Additions to equipment in process included in accounts payable
|
|
$
|
486
|
|
|
$
|
36
|
|
Conversion of preferred stock into common stock
|
|
$
|
38,389
|
|
|
—
|
|
|
Warrants issued in connection with debt arrangement
|
|
$
|
—
|
|
|
$
|
190
|
|
Supplementary cash flows information:
|
|
|
|
|
||||
Interest paid, net of interest capitalized
|
|
$
|
691
|
|
|
$
|
73
|
|
1.
|
Organization
|
2.
|
Basis of Presentation
|
3.
|
Recent Accounting Pronouncements
|
5.
|
Selected Balance Sheet Components
|
(In thousands)
|
September 30, 2017
|
|
December 31, 2016
|
||||
Raw materials
|
$
|
3,727
|
|
|
$
|
3,214
|
|
Work-in-process
|
279
|
|
|
257
|
|
||
Finished goods
|
43
|
|
|
17
|
|
||
Inventory
|
$
|
4,049
|
|
|
$
|
3,488
|
|
(In thousands)
|
September 30, 2017
|
|
December 31, 2016
|
||||
Machinery and equipment
|
$
|
3,264
|
|
|
$
|
3,150
|
|
Furniture, fixtures and office equipment
|
981
|
|
|
931
|
|
||
Computer equipment and software
|
3,485
|
|
|
3,147
|
|
||
Leasehold improvements
|
3,908
|
|
|
3,332
|
|
||
Construction in process
|
608
|
|
|
408
|
|
||
Total property and equipment, gross
|
12,246
|
|
|
10,968
|
|
||
Less: Accumulated depreciation
|
(8,279
|
)
|
|
(7,093
|
)
|
||
|
$
|
3,967
|
|
|
$
|
3,875
|
|
(In thousands)
|
September 30, 2017
|
|
December 31, 2016
|
||||
Bonus related compensation
|
$
|
1,608
|
|
|
$
|
2,433
|
|
Employee related accruals
|
2,021
|
|
|
1,668
|
|
||
Clinical trial related accruals
|
379
|
|
|
422
|
|
||
Other
|
506
|
|
|
—
|
|
||
|
$
|
4,514
|
|
|
$
|
4,523
|
|
6.
|
Stock Purchase Warrants
|
|
|
August 2013
Warrants |
|
September 2016 Warrants
|
Exercise price
|
|
$4.80
|
|
$2.48
|
Expiration date
|
|
August 16, 2018
|
|
September 9, 2022
|
Total shares issuable on exercise
|
|
724,950
|
|
117,074
|
August 2013 Warrants
|
|
September 30, 2017
|
|
December 31, 2016
|
||||
Closing stock price
|
|
$
|
6.00
|
|
|
$
|
3.00
|
|
Expected dividend rate
|
|
—
|
%
|
|
—
|
%
|
||
Expected stock price volatility
|
|
50.6
|
%
|
|
97.9
|
%
|
||
Risk-free interest rate
|
|
1.3
|
%
|
|
1.0
|
%
|
||
Expected life (years)
|
|
0.88
|
|
|
1.62
|
|
September 2016 Warrants
|
|
September 9, 2016
|
||
Closing stock price
|
|
$
|
2.20
|
|
Expected dividend rate
|
|
—
|
%
|
|
Expected stock price volatility
|
|
89.8
|
%
|
|
Risk-free interest rate
|
|
1.4
|
%
|
|
Expected life (years)
|
|
6.00
|
|
7.
|
Debt
|
8.
|
Stock-based Compensation
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
(In thousands)
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Cost of goods sold
|
|
$
|
119
|
|
|
$
|
117
|
|
|
$
|
316
|
|
|
$
|
330
|
|
Research and development
|
|
177
|
|
|
133
|
|
|
$
|
391
|
|
|
$
|
392
|
|
||
Selling, general and administrative
|
|
459
|
|
|
404
|
|
|
1,346
|
|
|
1,251
|
|
||||
Total non-cash stock-based compensation expense
|
|
$
|
755
|
|
|
$
|
654
|
|
|
$
|
2,053
|
|
|
$
|
1,973
|
|
|
|
Nine Months Ended September 30,
|
||||
Service-Based Stock Options
|
|
2017
|
|
2016
|
||
Expected dividend rate
|
|
—
|
%
|
|
—
|
%
|
Expected stock price volatility
|
|
80.1 – 88.2%
|
|
|
78.7 – 92.2%
|
|
Risk-free interest rate
|
|
1.8 – 2.3%
|
|
|
1.1 – 1.8%
|
|
Expected life (years)
|
|
5.5 – 6.3
|
|
|
5.5 – 6.3
|
|
Service-Based Stock Options
|
|
Options
|
|
Weighted
Average
Exercise Price
|
|
Weighted Average
Remaining
Contractual Term
(Years)
|
|
Aggregate
Intrinsic Value
|
|||||
Outstanding at December 31, 2016
|
|
3,355,692
|
|
|
$
|
4.66
|
|
|
8.2
|
|
$
|
610
|
|
Granted
|
|
1,677,760
|
|
|
$
|
2.82
|
|
|
|
|
|
|
|
Exercised
|
|
(165,678
|
)
|
|
$
|
3.12
|
|
|
|
|
$
|
362
|
|
Expired
|
|
(100,131
|
)
|
|
$
|
16.31
|
|
|
|
|
|
|
|
Forfeited
|
|
(190,766
|
)
|
|
$
|
3.35
|
|
|
|
|
|
|
|
Outstanding at September 30, 2017
|
|
4,576,877
|
|
|
$
|
3.84
|
|
|
8.2
|
|
$
|
13,336
|
|
Exercisable at September 30, 2017
|
|
1,870,011
|
|
|
$
|
5.18
|
|
|
7.5
|
|
$
|
4,988
|
|
9.
|
Fair Value Measurements
|
•
|
Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;
|
•
|
Level 2: Quoted prices in markets that are not active, or inputs which are observable, either directly or indirectly, for substantially the full term of the asset or liability; and
|
•
|
Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable (i.e., supported by little or no market activity).
|
|
|
September 30, 2017
|
|
December 31, 2016
|
||||||||||||||||||||||||||||
|
|
|
|
Fair value measurement category
|
|
|
|
Fair value measurement category
|
||||||||||||||||||||||||
(In thousands)
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
||||||||||||||||
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Warrant liabilities
|
|
$
|
1,269
|
|
|
$
|
—
|
|
|
$
|
1,269
|
|
|
$
|
—
|
|
|
$
|
757
|
|
|
$
|
—
|
|
|
$
|
757
|
|
|
$
|
—
|
|
10.
|
Shareholders' Equity
|
11.
|
Preferred Stock
|
12.
|
Net Loss Per Common Share
|
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
||||||||||||
(Amounts in thousands except per share amounts)
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss
|
|
$
|
(5,407
|
)
|
|
$
|
(6,675
|
)
|
|
$
|
(17,573
|
)
|
|
$
|
(13,369
|
)
|
Dividends accumulated on convertible preferred stock
|
|
—
|
|
|
(1,931
|
)
|
|
—
|
|
|
(5,591
|
)
|
||||
Net loss attributable to common shareholders
|
|
$
|
(5,407
|
)
|
|
$
|
(8,606
|
)
|
|
$
|
(17,573
|
)
|
|
$
|
(18,960
|
)
|
Denominator:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Denominator for basic and diluted EPS:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Weighted-average common shares outstanding
|
|
33,667
|
|
|
22,744
|
|
|
32,783
|
|
|
22,678
|
|
||||
Net loss per share attributable to common shareholders (basic and diluted)
|
|
$
|
(0.16
|
)
|
|
$
|
(0.38
|
)
|
|
$
|
(0.54
|
)
|
|
$
|
(0.84
|
)
|
(In thousands)
|
|
Total
|
|
2017
|
|
2018
|
|
2019
|
|
2020
|
|
2021
|
|
More than 5 Years
|
||||||||||||||
Operating leases
|
|
$
|
20,378
|
|
|
$
|
1,317
|
|
|
$
|
4,806
|
|
|
$
|
4,473
|
|
|
$
|
4,475
|
|
|
$
|
4,546
|
|
|
$
|
761
|
|
Purchase commitments
|
|
2,940
|
|
|
45
|
|
|
681
|
|
|
576
|
|
|
546
|
|
|
546
|
|
|
546
|
|
|||||||
Capital leases
|
|
43
|
|
|
11
|
|
|
32
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
Total
|
|
$
|
23,361
|
|
|
$
|
1,373
|
|
|
$
|
5,519
|
|
|
$
|
5,049
|
|
|
$
|
5,021
|
|
|
$
|
5,092
|
|
|
$
|
1,307
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
(In thousands)
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Total revenues
|
|
$
|
14,260
|
|
|
$
|
10,929
|
|
|
$
|
40,574
|
|
|
$
|
37,860
|
|
Cost of product sales
|
|
7,186
|
|
|
6,856
|
|
|
21,965
|
|
|
20,716
|
|
||||
Gross profit
|
|
7,074
|
|
|
4,073
|
|
|
18,609
|
|
|
17,144
|
|
||||
Total operating expenses
|
|
11,105
|
|
|
10,453
|
|
|
34,784
|
|
|
30,500
|
|
||||
Loss from operations
|
|
(4,031
|
)
|
|
(6,380
|
)
|
|
(16,175
|
)
|
|
(13,356
|
)
|
||||
Other income (expense)
|
|
(1,376
|
)
|
|
(295
|
)
|
|
(1,398
|
)
|
|
(13
|
)
|
||||
Net loss
|
|
$
|
(5,407
|
)
|
|
$
|
(6,675
|
)
|
|
$
|
(17,573
|
)
|
|
$
|
(13,369
|
)
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
Revenue by product (in thousands)
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Carticel and MACI
|
|
$
|
9,909
|
|
|
$
|
8,319
|
|
|
$
|
27,821
|
|
|
$
|
26,117
|
|
Epicel
|
|
4,351
|
|
|
2,610
|
|
|
12,753
|
|
|
11,743
|
|
||||
|
|
$
|
14,260
|
|
|
$
|
10,929
|
|
|
$
|
40,574
|
|
|
$
|
37,860
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
(In thousands)
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Gross profit
|
|
$
|
7,074
|
|
|
$
|
4,073
|
|
|
$
|
18,609
|
|
|
$
|
17,144
|
|
Gross profit %
|
|
50
|
%
|
|
37
|
%
|
|
46
|
%
|
|
45
|
%
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||
(In thousands)
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||
Research and development costs
|
|
$
|
2,919
|
|
|
$
|
3,443
|
|
|
9,357
|
|
|
11,037
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
(In thousands)
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Dilated Cardiomyopathy
|
|
$
|
909
|
|
|
$
|
1,875
|
|
|
$
|
4,050
|
|
|
$
|
5,732
|
|
MACI
|
|
1,385
|
|
|
636
|
|
|
3,309
|
|
|
1,916
|
|
||||
Carticel
|
|
45
|
|
|
462
|
|
|
369
|
|
|
1,828
|
|
||||
Epicel
|
|
580
|
|
|
470
|
|
|
1,629
|
|
|
1,561
|
|
||||
Total research and development costs
|
|
$
|
2,919
|
|
|
$
|
3,443
|
|
|
$
|
9,357
|
|
|
$
|
11,037
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
(In thousands)
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Selling, general and administrative costs
|
|
$
|
8,186
|
|
|
$
|
7,010
|
|
|
$
|
25,427
|
|
|
$
|
19,463
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
(In thousands)
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Decrease in fair value of warrants
|
|
$
|
(1,060
|
)
|
|
$
|
(203
|
)
|
|
$
|
(512
|
)
|
|
$
|
99
|
|
Foreign currency translation (loss)
|
|
(6
|
)
|
|
(6
|
)
|
|
(20
|
)
|
|
(17
|
)
|
||||
Other income (expense)
|
|
5
|
|
|
—
|
|
|
6
|
|
|
(10
|
)
|
||||
Net interest (expense) income
|
|
(315
|
)
|
|
(86
|
)
|
|
(872
|
)
|
|
(85
|
)
|
||||
Total other income (expense)
|
|
$
|
(1,376
|
)
|
|
$
|
(295
|
)
|
|
$
|
(1,398
|
)
|
|
$
|
(13
|
)
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
(In thousands)
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
||||||||
Cost of goods sold
|
|
$
|
119
|
|
|
$
|
117
|
|
|
$
|
316
|
|
|
$
|
330
|
|
Research and development
|
|
177
|
|
|
133
|
|
|
$
|
391
|
|
|
$
|
392
|
|
||
Selling, general and administrative
|
|
459
|
|
|
404
|
|
|
1,346
|
|
|
1,251
|
|
||||
Total non-cash stock-based compensation expense
|
|
$
|
755
|
|
|
$
|
654
|
|
|
$
|
2,053
|
|
|
$
|
1,973
|
|
Exhibit No.
|
|
Description
|
|
|
|
10.1
|
|
First Amendment to Executive Employment Agreement by and between Dominick C. Colangelo and the Company, dated September 14, 2017, filed as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on September 19, 2017, incorporated herein by reference.
|
|
|
|
10.2
|
|
Amended and Restated Employment Agreement by and between Daniel Orlando and the Company, dated September 14, 2017, filed as Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on September 19, 2017, incorporated herein by reference.
|
|
|
|
10.3
|
|
Amended and Restated Employment Agreement by and between Gerard Michel and the Company, dated September 15, 2017, filed as Exhibit 10.3 to the Company’s Current Report on Form 8-K filed on September 19, 2017, incorporated herein by reference.
|
|
|
|
10.4**
|
|
|
|
|
|
10.5**
|
|
|
|
|
|
10.6**
|
|
|
|
|
|
10.7**
|
|
|
|
|
|
10.8†**
|
|
|
|
|
|
31.1**
|
|
|
|
|
|
31.2**
|
|
|
|
|
|
32.1**
|
|
|
|
|
|
32.2**
|
|
|
|
|
|
101.INS**
|
|
|
|
|
|
101.SCH**
|
|
|
|
|
|
101.CAL**
|
|
|
|
|
|
101.LAB**
|
|
|
|
|
|
101.PRE**
|
|
|
|
|
|
101 DEF**
|
|
|
VERICEL CORPORATION
|
|
|
|
|
|
/s/ DOMINICK C. COLANGELO
|
|
Dominick C. Colangelo
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
|
|
|
|
|
/s/ GERARD MICHEL
|
|
Gerard Michel
|
|
Chief Financial Officer and Vice President, Corporate Development
|
|
(Principal Financial Officer)
|
1.
|
AMENDMENTS
|
2.
|
MISCELLANEOUS
|
Innovative Cellular Therapeutics Co., Ltd.
|
Vericel Corporation
|
BY:____/s/Lei Xiao____________________
NAME: __Lei Xiao____________________
TITLE: __Chairman___________________
|
BY:___/s/Dominick Colangelo___________
NAME: _Dominick Colangelo___________
TITLE: _Chief Executive Officer_________
|
1.
|
AMENDMENTS
|
2.
|
MISCELLANEOUS
|
Innovative Cellular Therapeutics Co., Ltd.
|
Vericel Corporation
|
BY:____/s/Lei Xiao____________________
NAME: __Lei Xiao____________________
TITLE: __Chairman___________________
|
BY:___/s/Dominick Colangelo___________
NAME: _Dominick Colangelo___________
TITLE: _Chief Executive Officer_________
|
1.
|
AMENDMENTS
|
Innovative Cellular Therapeutics Co., Ltd.
|
Vericel Corporation
|
BY:___/s/Lei Xiao_____________________
NAME: __Lei Xiao____________________
TITLE: __Chairman___________________
|
BY:____/s/Dominick Colangelo__________
NAME: __Dominick Colangelo__________
TITLE: __Chief Executive Officer________
|
1.
|
AMENDMENTS
|
Innovative Cellular Therapeutics Co., Ltd.
|
Vericel Corporation
|
BY:___/s/Lei Xiao_____________________
NAME: __Lei Xiao____________________
TITLE: __Chairman___________________
|
BY:____/s/Dominick Colangelo__________
NAME: __Dominick Colangelo__________
TITLE: __Chief Executive Officer________
|
1.
|
Exhibit A
. In order to remove Carticel and add an additional NDC for MACI (corresponding to an order of two cases per pack, with each case containing one implant), the Parties agree to delete and replace in its entirety the table “Products and Prices” with the following:
|
Product
|
NDC Number
|
List Price*
|
MACI
|
69866-1030-01
|
[***]
|
MACI
|
69866-1030-02
|
[***]
|
2.
|
No Other Changes
. Except as provided in this Amendment, the terms and conditions of the Distribution Agreement will continue in full force.
|
Vericel Corporation
By: /s/ Daniel Orlando
Name: Daniel Orlando
Title: Chief Operating Officer
Date: 11 August 2017
|
Orsini Pharmaceutical Services, Inc.
By: /s/ Michael Fieri
Name: Michael Fieri
Title: President and CEO
Date: 08.10.2017
|
|
/s/ DOMINICK C. COLANGELO
|
|
Dominick C. Colangelo
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
|
/s/ GERARD MICHEL
|
|
Gerard Michel
|
|
Chief Financial Officer and Vice President, Corporate Development
|
|
(
Principal Financial Officer)
|
|
/s/ DOMINICK C. COLANGELO
|
|
Dominick C. Colangelo
|
|
President and Chief Executive Officer
|
|
(Principal Executive Officer)
|
|
/s/ GERARD MICHEL
|
|
Gerard Michel
|
|
Chief Financial Officer and Vice President, Corporate Development
|
|
(Principal Financial Officer)
|