|
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
|
|
36,681,333
|
(Class)
|
|
Outstanding at May 4, 2018
|
|
|
|
|
|
|
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.
|
||
|
|
|
|
|
|
|
|
|
|
|
March 31,
|
|
December 31,
|
||||
|
|
2018
|
|
2017
|
||||
ASSETS
|
|
|
|
|
|
|
||
Current assets:
|
|
|
|
|
|
|
||
Cash
|
|
$
|
29,777
|
|
|
$
|
26,862
|
|
Accounts receivable (net of allowance for doubtful accounts of $315 and $249, respectively)
|
|
13,162
|
|
|
18,270
|
|
||
Inventory
|
|
3,905
|
|
|
3,793
|
|
||
Other current assets
|
|
1,358
|
|
|
1,581
|
|
||
Total current assets
|
|
48,202
|
|
|
50,506
|
|
||
Property and equipment, net
|
|
4,207
|
|
|
4,071
|
|
||
Total assets
|
|
$
|
52,409
|
|
|
$
|
54,577
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
|
||
Accounts payable
|
|
$
|
5,768
|
|
|
$
|
5,552
|
|
Accrued expenses
|
|
4,007
|
|
|
5,573
|
|
||
Short term deferred rent
|
|
426
|
|
|
420
|
|
||
Current portion of term loan credit agreement (net of deferred costs of $69 and $67, respectively)
|
|
1,597
|
|
|
350
|
|
||
Warrant liabilities
|
|
1,921
|
|
|
1,014
|
|
||
Other
|
|
159
|
|
|
181
|
|
||
Total current liabilities
|
|
13,878
|
|
|
13,090
|
|
||
Revolving and term loan credit agreement (net of deferred costs of $185 and $196, respectively)
|
|
15,649
|
|
|
16,888
|
|
||
Long term deferred rent
|
|
1,947
|
|
|
2,059
|
|
||
Total liabilities
|
|
31,474
|
|
|
32,037
|
|
||
COMMITMENTS AND CONTINGENCIES (Note 12)
|
|
|
|
|
|
|
||
Shareholders’ equity:
|
|
|
|
|
|
|
||
Common stock, no par value; shares authorized — 75,000; shares issued and outstanding — 36,502 and 35,861, respectively
|
|
389,074
|
|
|
383,020
|
|
||
Warrants
|
|
397
|
|
|
397
|
|
||
Accumulated deficit
|
|
(368,536
|
)
|
|
(360,877
|
)
|
||
Total shareholders’ equity
|
|
20,935
|
|
|
22,540
|
|
||
Total liabilities and shareholders’ equity
|
|
$
|
52,409
|
|
|
$
|
54,577
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2018
|
|
2017
|
||||
Product sales, net
|
|
$
|
18,027
|
|
|
$
|
9,361
|
|
Cost of product sales
|
|
7,666
|
|
|
7,109
|
|
||
Gross profit
|
|
10,361
|
|
|
2,252
|
|
||
Research and development
|
|
3,729
|
|
|
3,467
|
|
||
Selling, general and administrative
|
|
10,954
|
|
|
8,408
|
|
||
Total operating expenses
|
|
14,683
|
|
|
11,875
|
|
||
Loss from operations
|
|
(4,322
|
)
|
|
(9,623
|
)
|
||
Other income (expense):
|
|
|
|
|
|
|
||
(Increase) decrease in fair value of warrants
|
|
(2,907
|
)
|
|
107
|
|
||
Foreign currency translation (loss)
|
|
(44
|
)
|
|
(1
|
)
|
||
Interest income
|
|
—
|
|
|
1
|
|
||
Interest expense
|
|
(432
|
)
|
|
(262
|
)
|
||
Other income
|
|
46
|
|
|
—
|
|
||
Total other income (expense)
|
|
(3,337
|
)
|
|
(155
|
)
|
||
Net loss
|
|
$
|
(7,659
|
)
|
|
$
|
(9,778
|
)
|
|
|
|
|
|
||||
Net loss per share attributable to common shareholders (Basic and Diluted)
|
|
$
|
(0.21
|
)
|
|
$
|
(0.31
|
)
|
Weighted average number of common shares outstanding (Basic and Diluted)
|
|
36,140
|
|
|
31,896
|
|
|
|
Three Months Ended March 31,
|
||||||
|
|
2018
|
|
2017
|
||||
Operating activities:
|
|
|
|
|
|
|
||
Net loss
|
|
$
|
(7,659
|
)
|
|
(9,778
|
)
|
|
Adjustments to reconcile net loss to net cash used for operating activities:
|
|
|
|
|
|
|
||
Depreciation and amortization
|
|
427
|
|
|
409
|
|
||
Stock compensation expense
|
|
1,342
|
|
|
502
|
|
||
Change in fair value of warrants
|
|
2,907
|
|
|
(107
|
)
|
||
Inventory provision
|
|
(94
|
)
|
|
93
|
|
||
Loss on sales of fixed assets
|
|
22
|
|
|
—
|
|
||
Foreign currency translation loss
|
|
44
|
|
|
1
|
|
||
Deferred rent
|
|
(106
|
)
|
|
102
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
||
Inventory
|
|
(18
|
)
|
|
(563
|
)
|
||
Accounts receivable
|
|
5,108
|
|
|
4,966
|
|
||
Other current assets
|
|
223
|
|
|
146
|
|
||
Accounts payable
|
|
(229
|
)
|
|
(300
|
)
|
||
Accrued expenses
|
|
(1,566
|
)
|
|
1,507
|
|
||
Other assets and liabilities, net
|
|
4
|
|
|
(100
|
)
|
||
Net cash provided by (used for) operating activities
|
|
405
|
|
|
(3,122
|
)
|
||
Investing activities:
|
|
|
|
|
|
|
||
Expenditures for property, plant and equipment
|
|
(184
|
)
|
|
(70
|
)
|
||
Net cash used in investing activities
|
|
(184
|
)
|
|
(70
|
)
|
||
Financing activities:
|
|
|
|
|
|
|
||
Net proceeds from issuance of common stock
|
|
985
|
|
|
71
|
|
||
Deferred financing costs
|
|
(8
|
)
|
|
—
|
|
||
Proceeds from exercise of warrants
|
|
1,727
|
|
|
—
|
|
||
Repayments of short-term debt
|
|
(10
|
)
|
|
—
|
|
||
Other
|
|
—
|
|
|
(10
|
)
|
||
Net cash provided by financing activities
|
|
2,694
|
|
|
61
|
|
||
Net increase (decrease) in cash
|
|
2,915
|
|
|
(3,131
|
)
|
||
Cash at beginning of period
|
|
26,862
|
|
|
22,978
|
|
||
Cash at end of period
|
|
$
|
29,777
|
|
|
$
|
19,847
|
|
|
|
|
|
|
1.
|
Organization
|
2.
|
Basis of Presentation
|
|
|
Three Months Ended March 31,
|
|||||||
(In thousands)
|
|
2018
|
|
2017
|
|||||
Supplementary Cash Flows information:
|
|
|
|
|
|||||
Warrants exchanged for common stock
|
|
$
|
2,000
|
|
|
$
|
—
|
|
|
Interest paid (net of interest capitalized)
|
|
357
|
|
226
|
|
221
|
|
||
Additions to equipment in process included in accounts payable
|
|
401
|
|
|
102
|
|
3.
|
Recent Accounting Pronouncements
|
|
|
Three Months Ended March 31,
|
||||||
Revenue by product (in thousands)
|
|
2018
|
|
2017
|
||||
MACI and Carticel implants and kits
|
|
|
|
|
||||
Implants - based on contracted rate
|
|
$
|
10,749
|
|
|
$
|
297
|
|
Implants - subject to third party reimbursement
|
|
1,008
|
|
|
6,385
|
|
||
Biopsy kits - direct bill
|
|
436
|
|
|
439
|
|
||
Change in estimates related to prior periods
|
|
(138
|
)
|
|
(2,114
|
)
|
||
Epicel
|
|
|
|
|
||||
Direct bill (hospital)
|
|
5,972
|
|
|
4,354
|
|
||
Total revenue
|
|
$
|
18,027
|
|
|
$
|
9,361
|
|
|
Revenue Concentration
|
|
Accounts Receivable Concentration
|
||||||||
|
Three months ended March 31,
|
|
March 31,
|
|
December 31,
|
||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||
MACI and Carticel
1
|
43
|
%
|
|
—
|
%
|
|
41
|
%
|
|
46
|
%
|
Epicel
|
14
|
%
|
|
16
|
%
|
|
—
|
%
|
|
—
|
%
|
5.
|
Selected Balance Sheet Components
|
(In thousands)
|
March 31, 2018
|
|
December 31, 2017
|
||||
Raw materials
|
$
|
3,537
|
|
|
$
|
3,532
|
|
Work-in-process
|
342
|
|
|
226
|
|
||
Finished goods
|
26
|
|
|
35
|
|
||
Inventory
|
$
|
3,905
|
|
|
$
|
3,793
|
|
(In thousands)
|
March 31, 2018
|
|
December 31, 2017
|
||||
Machinery and equipment
|
$
|
1,249
|
|
|
$
|
1,249
|
|
Furniture, fixtures and office equipment
|
872
|
|
|
872
|
|
||
Computer equipment and software
|
3,584
|
|
|
3,536
|
|
||
Leasehold improvements
|
4,255
|
|
|
4,213
|
|
||
Construction in process
|
1,295
|
|
|
822
|
|
||
Total property and equipment, gross
|
11,255
|
|
|
10,692
|
|
||
Less: Accumulated depreciation
|
(7,048
|
)
|
|
(6,621
|
)
|
||
|
$
|
4,207
|
|
|
$
|
4,071
|
|
(In thousands)
|
March 31, 2018
|
|
December 31, 2017
|
||||
Bonus related compensation
|
$
|
752
|
|
|
$
|
2,693
|
|
Employee related accruals
|
2,577
|
|
|
2,389
|
|
||
Clinical trial related accruals
|
678
|
|
|
491
|
|
||
|
$
|
4,007
|
|
|
$
|
5,573
|
|
6.
|
Stock Purchase Warrants
|
|
|
August 2013 Warrants
|
|
September 2016 Warrants
|
|
December 2017 Warrants
|
Exercise price
|
|
$4.80
|
|
$2.25
|
|
$4.27
|
Expiration date
|
|
August 16, 2018
|
|
September 9, 2022
|
|
December 6, 2023
|
Total shares issuable on exercise
|
|
365,150
|
|
117,074
|
|
53,902
|
August 2013 Warrants
|
|
March 31, 2018
|
|
December 31, 2017
|
||||
Closing stock price
|
|
$
|
9.95
|
|
|
$
|
5.45
|
|
Expected dividend rate
|
|
—
|
%
|
|
—
|
%
|
||
Expected stock price volatility
|
|
75.4
|
%
|
|
63.7
|
%
|
||
Risk-free interest rate
|
|
1.95
|
%
|
|
1.65
|
%
|
||
Expected life (years)
|
|
0.38
|
|
|
0.62
|
|
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
|
|
December 2017 Warrants
|
|
December 6, 2017
|
|
Closing stock price
|
|
5.10
|
|
Expected dividend rate
|
|
—
|
%
|
Expected stock price volatility
|
|
86.4
|
%
|
Risk-free interest rate
|
|
2.2
|
%
|
Expected life (years)
|
|
6.00
|
|
7.
|
Debt
|
(In thousands)
|
|
||
Years Ending December 31,
|
Amount
|
|
|
2018
|
$
|
417
|
|
2019
|
5,000
|
|
|
2020
|
5,000
|
|
|
2021
|
7,083
|
|
|
2022
|
—
|
|
|
Thereafter
|
—
|
|
|
|
$
|
17,500
|
|
8.
|
Stock-based Compensation
|
|
|
Three Months Ended March 31,
|
||||||
(In thousands)
|
|
2018
|
|
2017
|
||||
Cost of goods sold
|
|
$
|
142
|
|
|
$
|
91
|
|
Research and development
|
|
475
|
|
|
58
|
|
||
Selling, general and administrative
|
|
725
|
|
|
353
|
|
||
Total non-cash stock-based compensation expense
|
|
$
|
1,342
|
|
|
$
|
502
|
|
|
|
Three Months Ended March 31,
|
||||
Service-Based Stock Options
|
|
2018
|
|
2017
|
||
Expected dividend rate
|
|
—
|
%
|
|
—
|
%
|
Expected stock price volatility
|
|
82.3 – 84.4%
|
|
|
81.3 – 88.2%
|
|
Risk-free interest rate
|
|
2.4 – 2.8%
|
|
|
2 – 2.3%
|
|
Expected life (years)
|
|
6.1 – 6.3
|
|
|
6.1 – 6.3
|
|
|
|
|
|
|
|
|
|
|
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).
|
|
|
March 31, 2018
|
|
December 31, 2017
|
||||||||||||||||||||||||||||
|
|
|
|
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
|
|
$
|
1,921
|
|
|
$
|
—
|
|
|
$
|
1,921
|
|
|
$
|
—
|
|
|
$
|
1,014
|
|
|
$
|
—
|
|
|
$
|
1,014
|
|
|
$
|
—
|
|
10.
|
Shareholders' Equity
|
11.
|
Net Loss Per Common Share
|
|
Three months ended March 31,
|
||||||
(Amounts in thousands except per share amounts)
|
2018
|
|
2017
|
||||
Numerator:
|
|
|
|
|
|
||
Net loss
|
$
|
(7,659
|
)
|
|
$
|
(9,778
|
)
|
Denominator for basic and diluted EPS:
|
|
|
|
|
|
||
Weighted-average common shares outstanding
|
36,140
|
|
|
31,896
|
|
||
Net loss per share attributable to common shareholders (basic and diluted)
|
$
|
(0.21
|
)
|
|
$
|
(0.31
|
)
|
(In thousands)
|
|
Total
|
|
2018
|
|
2019
|
|
2020
|
|
2021
|
|
2022
|
|
More than 5 years
|
||||||||||||||
Operating leases
|
|
$
|
18,444
|
|
|
$
|
3,679
|
|
|
$
|
4,710
|
|
|
$
|
4,699
|
|
|
$
|
4,595
|
|
|
$
|
761
|
|
|
—
|
|
|
Purchase commitments
|
|
3,244
|
|
|
462
|
|
|
718
|
|
|
688
|
|
|
688
|
|
|
688
|
|
|
—
|
|
|||||||
Capital leases
|
|
101
|
|
|
63
|
|
|
14
|
|
|
10
|
|
|
10
|
|
|
4
|
|
|
—
|
|
|||||||
Debt and Interest Related Payments
|
|
18,413
|
|
|
1,431
|
|
|
6,068
|
|
|
5,620
|
|
|
5,294
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|||||
Total
|
|
$
|
40,202
|
|
|
$
|
5,635
|
|
|
$
|
11,510
|
|
|
$
|
11,017
|
|
|
$
|
10,587
|
|
|
$
|
1,453
|
|
|
$
|
—
|
|
|
|
Three Months Ended March 31,
|
||||||
(In thousands)
|
|
2018
|
|
2017
|
||||
Total revenues
|
|
$
|
18,027
|
|
|
$
|
9,361
|
|
Cost of product sales
|
|
7,666
|
|
|
7,109
|
|
||
Gross profit
|
|
10,361
|
|
|
2,252
|
|
||
Total operating expenses
|
|
14,683
|
|
|
11,875
|
|
||
Loss from operations
|
|
(4,322
|
)
|
|
(9,623
|
)
|
||
Other income (expense)
|
|
(3,337
|
)
|
|
(155
|
)
|
||
Net loss
|
|
$
|
(7,659
|
)
|
|
$
|
(9,778
|
)
|
|
|
Three Months Ended March 31,
|
||||||
Revenue by product (in thousands)
|
|
2018
|
|
2017
|
||||
Carticel and MACI
|
|
$
|
12,055
|
|
|
$
|
5,007
|
|
Epicel
|
|
5,972
|
|
|
4,354
|
|
||
Total Revenue
|
|
$
|
18,027
|
|
|
$
|
9,361
|
|
|
|
Three Months Ended March 31,
|
||||||
(In thousands)
|
|
2018
|
|
2017
|
||||
Gross profit
|
|
$
|
10,361
|
|
|
$
|
2,252
|
|
Gross profit %
|
|
57
|
%
|
|
24
|
%
|
|
|
Three Months Ended March 31,
|
||||||
(In thousands)
|
|
2018
|
|
2017
|
||||
Research and development costs
|
|
$
|
3,729
|
|
|
$
|
3,467
|
|
|
|
Three Months Ended March 31,
|
||||||
(In thousands)
|
|
2018
|
|
2017
|
||||
Dilated Cardiomyopathy
|
|
$
|
556
|
|
|
$
|
1,948
|
|
MACI
|
|
2,421
|
|
|
861
|
|
||
Carticel
|
|
35
|
|
|
110
|
|
||
Epicel
|
|
717
|
|
|
548
|
|
||
Total research and development costs
|
|
$
|
3,729
|
|
|
$
|
3,467
|
|
|
|
Three Months Ended March 31,
|
||||||
(In thousands)
|
|
2018
|
|
2017
|
||||
Selling, general and administrative costs
|
|
$
|
10,954
|
|
|
$
|
8,408
|
|
|
|
Three Months Ended March 31,
|
||||||
(In thousands)
|
|
2018
|
|
2017
|
||||
Decrease (increase) in fair value of warrants
|
|
$
|
(2,907
|
)
|
|
$
|
107
|
|
Foreign currency translation loss
|
|
(44
|
)
|
|
(1
|
)
|
||
Other income
|
|
46
|
|
|
—
|
|
||
Net interest expense
|
|
(432
|
)
|
|
(261
|
)
|
||
Total other expense
|
|
$
|
(3,337
|
)
|
|
$
|
(155
|
)
|
|
|
Three Months Ended March 31,
|
||||||
(In thousands)
|
|
2018
|
|
2017
|
||||
Cost of goods sold
|
|
$
|
142
|
|
|
$
|
91
|
|
Research and development
|
|
475
|
|
|
58
|
|
||
Selling, general and administrative
|
|
725
|
|
|
353
|
|
||
Total non-cash stock-based compensation expense
|
|
$
|
1,342
|
|
|
$
|
502
|
|
Exhibit No.
|
|
Description
|
|
|
|
10.1†**
|
|
|
|
|
|
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)
|
2.1
|
Specifications
|
2.2
|
Change in Specifications
|
2.3
|
Shrinkage
|
2.4
|
[***].
|
(a)
|
[***].
|
(b)
|
[***].
|
(c)
|
[***].
|
3.1
|
Matricel shall make the ACI-Maix-Membrane Products for the exclusive use and benefit of Vericel. Matricel shall supply to Vericel the ACI-Maix-Membrane Products on an exclusive basis and in such quantities as may be ordered by Vericel by way of binding purchase orders as set forth in Section 3.3.
|
3.2
|
Title to, and risk of damage or loss of, the ACI-Maix-Membrane Products shall pass to Vericel upon delivery to Vericel. Matricel shall be responsible for freight, transportation, transport insurance, shipping, storage, handling, customs duty, demurrage, taxes and other similar charges using carriers, warehouses and handlers as expressly directed by Vericel, subject to reimbursement by Vericel upon being invoiced by Matricel.
|
3.3
|
Upon execution of the Agreement Vericel will submit an initial non-binding forecast substantially in the form of
Annex 4 (“Initial Forecast”)
. Every [***] starting with [***], Vericel shall provide Matricel with an updated non-binding realistic forecast of its supply
|
3.4
|
All full ACI-Maix-Membrane Product lots delivered to Vericel shall have a minimum of [***] of shelf life remaining prior to expiration. Smaller ACI-Maix-Membrane Product deliveries to Vericel [***] due to reasons described in Section 3.3 shall have a minimum of [***] of shelf life remaining prior to expiration. The Parties will cooperate with each other to use diligent efforts to extend the shelf life of the ACI-Maix-Membrane Product.
|
3.5
|
Matricel shall ship the ordered full ACI-Maix-Membrane Product lot to the following address: 64 Sidney Street, Cambridge, MA 02139, USA within [***] days of receipt of each binding purchase order. If more than one full ACI-Maix-Membrane Product lot is ordered in the binding purchase order, then each additional lot will be delivered [***] days after shipment of the previous ACI-Maix-Membrane Product lot to the address listed above. Matricel shall package the ACI-Maix-Membrane Product in a manner suitable for shipment and sufficient to withstand the effects of shipping, and consistent with Vericel’s shipping requirements and instructions, including handling during loading and unloading. Matricel shall include the following with each shipment: (i) the Vericel purchase order number, and (ii) Matricel‘s lot and batch numbers.
|
3.6
|
All sales of the ACI-Maix-Membrane Product shall be at a net price per ACI-Maix-Membrane Product (the “
Unit Price
”) plus Value Added Tax (if applicable) according to the staggered table below:
|
3.7
|
Vericel shall pay the ordered ACI-Maix-Membrane Products within [***] days from the date of respective shipment to a bank account designated by Matricel. No cash discounts are allowed and the bank transfer costs shall be paid by Vericel.
|
3.8
|
The Parties agree that Matricel shall provide to Vericel demonstration membranes, which are not subject to the Product Specifications and may only be used by Vericel for demonstration purposes and be labeled as “Not For Human Use” in accordance with the following:
|
Demo Membrane
|
Size
|
Membranes per package
|
Price (Euros)
|
ACI-D4050-1
|
4 x 5 cm
|
1
|
[***]
|
ACI-D2530-10
|
2,5 x 3 cm
|
10
|
[***]
|
3.9
|
In order to fulfill the FDA requirements for ACI-Maix-Membrane Product batch release relating to [***], Vericel agrees to perform the [***] and will cover the costs for this testing. In exchange, Matricel:
|
(1)
|
agrees to perform the [***] testing and will cover the costs for this testing; and
|
(2)
|
[***].
|
4.1
|
All costs (internal & external) for maintaining regulatory approval of the medical device ACI-Maix-Membrane Product in Europe (CE mark) shall be paid for by Vericel, as a pass through cost, without markup. All costs (internal & external) for achieving or maintaining regulatory approval of Matricel´s quality system for the supply of the ACI-Maix-Membrane Product to countries designated by Vericel [***] shall be paid by Vericel (internal costs: [***]). Vericel will also reimburse Matricel for additional insurance costs for the supply of the ACI-Maix-Membrane Product to countries that are not covered by Matricel´s current insurance policy. If additional service providers are needed (e.g. regulatory consultants, publishers for FDA) or if additional internal or external studies are required for the registration or approval of the Product outside the EU, for instance to demonstrate compliance with national regulations, the Parties will agree on the performance of such studies and the costs for the studies will be covered by Vericel. [***] For any costs exceeding [***], an estimate of the costs shall be first provided to Vericel by Matricel prior to the initiation of work or payment of fees.
|
4.2
|
Matricel shall support the filing and approval of Vericel´s BLA for the Final Product with the United States Food and Drug Administration (“
FDA
”). Vericel may request that Matricel disclose certain Confidential Information directly to the FDA that Vericel believes will be required or that is required by FDA to be provided in the Device Master File (“
MAF
) or by direct correspondence with the FDA. Vericel confirms that Matricel will not be obligated to make available directly to Vericel any manufacturing process information for the ACI-Maix-Membrane Product that is considered Confidential Information by Matricel. In order to support the BLA filing and approval, the Parties have agreed [***].
|
4.3
|
Regulatory and compliance support by Matricel personnel, shall be provided [***] in case that it is related to either the ACI-Maix-Membrane Product in Europe or the submissions to the FDA as it relates to the ACI-Maix-Membrane Product information in the BLA and/or open and closed sections of the MAF. [***] If additional regulatory and compliance support is requested for other countries designated by Vericel or for other purposes [***] then Matricel shall [***] for consulting services. No consulting services will be performed by Matricel without a prior written request from Vericel detailing the nature and scope of the services to be provided and approval by Vericel of the approximate costs of the consulting services.
|
4.4
|
Matricel shall keep current with FDA medical device guidelines and standards, [***].
|
4.5
|
Matricel will keep complete and accurate records related to the ACI-Maix-Membrane Product (“
Records
“). All original Records on the development and manufacture of ACI-Maix-Membrane Product will be retained and archived by Matricel in accordance with 21 CFR 820 medical device regulations and applicable law, but in no case for less than a period of [***] (the “
Retention Period
“). Following the Retention Period, Matricel will not destroy the Records without first giving Vericel written notice and the opportunity to further store the Records at Vericel’s expense. Matricel agrees to quality audits by Vericel [***] (as described in the Quality Service Agreement) in order to ascertain the quality of ACI-Maix-Membrane Products and compliance with all applicable rules, regulations and Specifications (and related Records) during the term of this Agreement. [***].
|
4.6
|
[***].
|
4.7
|
Matricel shall provide Vericel with a current (as and when executed by the product’s manufacturer) Certificate of Analysis, Certificate of Compliance and Letter of Origin relating to the ACI-Maix-Membrane Product within [***] after Vericel’s request. Such Certificate of Compliance shall be a certified statement that [***]. Matricel shall notify Vericel in writing of any changes to the Certificate of Analysis, Certificate of Compliance and Letter of Origin relating to the ACI-Maix-Membrane Product [***] upon becoming aware of any such changes from the manufacturer and shall provide an updated copy of the Certificate of Analysis, Certificate of Compliance and Letter of Origin relating to the ACI-Maix-Membrane Product [***]. Matricel shall provide Vericel with a Certificate of Analysis [***].
|
4.8
|
In the performance of its obligations under this Agreement, Matricel and its employees and agents (i) shall not offer to make, make, promise, authorize or accept any payment or giving anything of value, including, without limitation, bribes, either directly or indirectly to any public official, regulatory authority or anyone else for the purpose of influencing, inducing or rewarding any act, omission or decision in order to secure an improper advantage, or obtain or retain business and (ii) shall comply with all applicable anti-corruption and anti-bribery laws and regulations. Matricel and its employees and agents shall not make any payment or provide any gift to a third party in connection with Matricel’s performance of this Agreement
|
(a)
|
it has obtained and shall, for the term of this Agreement, maintain a CE Marking for the ACI-Maix-Membrane Product in the European Union;
|
(b)
|
any submission to Vericel or to any regulatory body in connection with the ACI-Maix-Membrane Product was made or will be made in good faith and to the best of Matricel´s knowledge contained or will contain accurate and complete data and information as required by applicable laws, rules and regulations at the registered offices of the Parties;
|
(c)
|
Matricel shall transfer good title to all ACI-Maix-Membrane Product sold to Vericel, and that the ACI-Maix-Membrane Product supplied to Vericel shall (i) have been manufactured in accordance with all applicable laws, rules and regulations, including, without limitation, 21 CFR 820 medical device regulations as well as the Quality Service Agreement, and the Specifications, (ii) be of satisfactory quality and free from defects in material and workmanship, (iii) not be adulterated or misbranded under the United States Federal Food, Drug, and Cosmetic Act or other law; and
|
(d)
|
as of the date hereof, Matricel has not been debarred or is subject to debarment and will not use in any capacity in connection with the manufacture of ACI-Maix-Membrane Product, any person who has been debarred pursuant to Section 306 of the United States Federal Food, Drug, and Cosmetic Act, or who is the subject of a conviction described in such section. Matricel agrees to inform Vericel in writing immediately if it or any person who is performing services hereunder is debarred or is the subject of a conviction described in Section 306, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of Matricel’s knowledge, is threatened, relating to the debarment or conviction of Matricel or any person used in any capacity by Matricel in connection with the manufacture of the ACI-Maix-Membrane Product.
|
(a)
|
Vericel may reject any ACI-Maix-Membrane Product that is not in compliance with cGMP or fails to conform to the Specifications (“
Rejected Products
”) (i) for “apparent defects,” meaning those non-conformities that are capable of detection upon a reasonable visual inspection, within [***] days after receipt of the ACI-Maix-Membrane Products; or (ii) for “latent defects,” meaning those that are not capable of detection upon a reasonable visual inspection, within [***] days from the date of discovery of such non-conformity. Vericel shall inform Matricel of such rejection by providing notice in writing (including via email)
|
(b)
|
Section 377 of the German Commercial Code (Handelsgesetzbuch) is expressly excluded and replaced by the provisions of this Agreement and the Quality Service Agreement.
|
6.1
|
In the event Vericel receives information indicative of a risk relating to the use of one of its products which incorporates the ACI-Maix-Membrane Product, or of any injury or impairment of health or death of a patient, coincidental with or relating to the use of one of its products which incorporates the ACI-Maix-Membrane Product, and to the extent such risk, injury, impairment or death may be attributable to the ACI-Maix-Membrane Product, Vericel shall report within [***] days of receipt of that information by Vericel first by telephone and followed by facsimile to Matricel, any such report of risk, injury, impairment, or death. Matricel shall have a reciprocal obligation to inform Vericel upon its receipt of any information indicative of risk, injury, impairment of health or death associated with use of the ACI-Maix-Membrane Product or similar products of Matricel.
|
6.2
|
The Parties agree to [***] notify each other in the event either Party is the subject of any governmental or regulatory action, investigation, or sanction, or in the event any litigation is threatened or instituted against either Party [***].
|
7.
|
Indemnification and Insurance
|
7.1
|
Vericel shall indemnify and hold Matricel harmless against all claims
injuries, disabilities, losses, fines, penalties, costs, expenses (including reasonable attorneys' fees), damages or liabilities (“
Claims
”) arising out of (i) any breach by Vericel or any of its representatives of any obligation, representation, or warranty of Vericel under this Agreement, or (ii) any negligence, error, or omission by Vericel or any of its representatives with respect to its or their obligations under or by reason of this Agreement.
|
7.2
|
Matricel shall indemnify and hold Vericel harmless against any and all Claims arising out of (i) any breach by Matricel or any of its representatives of any obligation, representation, or warranty of Matricel under this Agreement, (ii) any negligence, error, or omission by Matricel or any of its representatives with respect to its or their obligations under or by reason of this Agreement.
|
7.3
|
Vericel and Matricel shall each procure and maintain in full force and effect during the term of this Agreement valid and collectible insurance policies in connection with their respective obligations in the supply of the ACI-Maix-Membrane Product under this Agreement. Such insurances shall each have a coverage of at least [***] in case of damage to property and
|
7.4
|
The Parties shall, within [***] days from the date of receipt of notice of any claims, furnish to the other Party a copy of such notice and inform the other Party of all known facts relating to such claims. The indemnifying Party shall, at its cost and expense, to defend, negotiate, and otherwise resolve any claim [***]. Each Party shall provide all information in its possession and all reasonable assistance to the other Party as necessary to enable the other Party to defend any claims.
|
8.
|
Confidentiality, Non-Disclosure
|
(a)
|
[sic] is already known or available to the Receiving Party or any of its affiliates, other than under an obligation of confidentiality or non-use, at the time of disclosure to the Receiving Party;
|
(b)
|
is generally available or known to a third party reasonably skilled in the field to which such information pertains, or is otherwise part of the public domain, at the time of its disclosure to the Receiving Party;
|
(c)
|
becomes generally available or known to a third party reasonably skilled in the field to which such information pertains, or otherwise becomes part of the public domain, after its disclosure to the Receiving Party through no fault of or breach of its obligations under this Section 8 by the Receiving Party;
|
(d)
|
is disclosed to the Receiving Party, other than under an obligation of confidentiality or non-use, by a third party who has no obligation not to disclose such information to others; or
|
(e)
|
is independently discovered or developed by the Receiving Party, its affiliates or permitted sublicensees, as evidenced by their written records, without the use of, Confidential Information.
|
(a)
|
made in response to a valid order of a court of competent jurisdiction or other governmental or regulatory body of competent jurisdiction;
provided
,
however
, that such Party will first have given notice to such other Party and given such other Party a reasonable opportunity to quash such order and to obtain a protective order requiring that the Confidential Information that is the subject of such order be held in confidence by such court or governmental or regulatory body or, if disclosed, be used only for the purposes for which the order was issued; and
provided
,
further, however
, that if a disclosure order is not quashed or a protective order is not obtained, the Confidential Information disclosed in response to such court or governmental order will be limited to that information which is legally required to be disclosed in response to such court or governmental order;
|
(b)
|
otherwise required by applicable law;
provided
,
however
, that the Disclosing Party will provide such other Party with written notice of such disclosure in advance thereof to the extent practicable;
|
(c)
|
made by such Party, in connection with the performance of this Agreement, to affiliates, permitted sublicensees, employees or consultants, each of whom prior to disclosure must be bound by obligations of confidentiality and non-use at least equivalent in scope to those set forth in this Section 8.
|
9.
|
Term and Termination
|
9.1
|
The Agreement shall have effect as of the Effective Date and, unless terminated earlier pursuant to any provisions of this Agreement, will end on December 31, 2022.So long as Matricel has not delivered written notice of its decision not to renew this Agreement to Vericel by June 30, 2021, Vericel has the option to extend the term of the Agreement by five (5) additional calendar years under the same terms defined in this Agreement by sending a written confirmation of the extension to Matricel before June 30, 2022. Following such initial term and term extension by Vericel, this Agreement shall automatically renew for one
|
9.2
|
At any time on or after the fifth anniversary of the Effective Date, Vericel shall have the right to terminate this Agreement, for any reason, upon nine months’ prior written notice to Matricel. At any time on or after July 1, 2021, Matricel shall have the right to terminate this Agreement for any reason upon eighteen (18) months’ prior written notice to Vericel.
|
9.3
|
Either Party may, at its option, terminate this Agreement in the event the other Party breaches any material obligation under this Agreement and fails to remedy or otherwise cure such breach within [***] days from the date of receipt of notice of such breach given by the non-breaching Party;
provided, however,
that if the other Party cures such breach within such [***] day period, then there shall be no termination of this Agreement for such breach pursuant to this Section 9.3.
|
9.4
|
Either Party shall have the right to terminate this Agreement immediately by written notice to the other Party in the event the other Party presents, or has presented, a petition for its voluntary winding up or dissolution, makes an assignment for the benefit of creditors, becomes subject to an attachment of, execution upon, or other judicial seizure of all or substantially all of its assets, or becomes subject to involuntary proceedings under any bankruptcy or insolvency law which proceedings are not dismissed within sixty (60) days.
|
9.5
|
Upon expiration or termination of this Agreement pursuant to Section 9.1 or 9.2, Vericel shall have the option [***].
|
9.6
|
Upon termination of this Agreement Vericel shall have the right to use any inventory of the ACI-Maix-Membrane Product which it then has, in accordance with its normal course of business.
|
9.7
|
Notwithstanding the termination of this Agreement for any reason, each Party shall be entitled to recover any and all damages that such Party shall have sustained by reason of the breach by the other Party hereto of any of the terms of this Agreement.
|
9.8
|
Any rights and obligations of the Parties that by their terms survive termination or expiration of this Agreement or of any purchase order will survive termination or expiration, including, without limitation, Sections 2.4 (including Annex 3, if applicable), 3.2, 3.4, 4.5, 5, 6, 7, 8, 9.5, 9.6, 9.7, 9.8, and 10.
|
(a)
|
This Agreement and all issues arising under or relating to this Agreement, including, without limitation, its construction, interpretation, breach, and damages for breach, shall be governed by and construed in accordance with the laws of Germany, excluding any conflicts or choice of law rule or principles and further excluding the UN Convention for the International Sale of Goods.
The Parties agree to attempt to resolve amicably any dispute, claim or controversy arising out of or relating to this Agreement or the breach, termination, enforcement, interpretation or validity thereof.
|
(b)
|
Unless specifically reserved for the competent courts of Cologne, Germany under German law, all disputes, controversies or claims arising out of or relating to the operation or interpretation of this Agreement, the Parties shall seek arbitration under the Rules of Arbitration of the International Chamber of Commerce by three (3) arbitrators. Each Party appoints one arbitrator and the Chamber appoints a third arbitrator who is to be the chairman of the arbitration tribunal. If a Party fails to appoint an arbitrator within thirty (30) days of having filed or received a request for arbitration, the Chamber shall appoint such arbitrator. The award rendered shall be final and binding upon both Parties. Such arbitration shall be held in Geneva, Switzerland, and be conducted in the English language. This arbitration agreement set forth herein shall be without prejudice to the right of a Party to seek any interim or conservatory measure as it deems appropriate to enforce Section 8. Each Party shall pay for the arbitrator it selects with the cost of the third arbitrator being split equally between the Parties. All other costs shall also be split equally between the Parties.
|
10.11
|
Language
|
1.0
|
Quality Service Agreement Signatures
|
Vericel Corporation (“Vericel”)
64 Sidney Street
Cambridge, MA 02139
USA
|
|
|
|
Name:
Cynthia Entstrasser
|
Date:
05/02/18
|
|
|
/s/ Cynthia Entstrasser
|
|
|
|
Title: Senior Director
|
|
|
|
Matricel GmbH (“Matricel”)
Kaiserstrasse 100
D-52134 Herzogenrath, Germany
|
|
|
|
|
Name:
Leon Olde Damink
|
Date:
18 Apr 18
|
|
Name:
Ingo Heschel
|
Date:
18 Apr 18
|
/s/ Leon Olde Damink
|
|
|
/s/Ingo Heschel
|
|
Title: Head of Regulatory Affairs and Quality Management
|
|
Title: Managing Director
|
|
|
|
|
|
|
|
|
|
|
|
|
2.0
|
Date of Issue
|
2.1
|
This Quality Service Agreement (“Quality Agreement”) is Annex 1 to the ACI-Maix Supply Agreement between Vericel and Matricel, dated October 20, 2015, as amended and restated on March 12, 2018 (“ACI-Maix Supply Agreement”), and is valid as long as this ACI-Maix Supply Agreement is in place.
|
Date of issue: May 2, 2018
|
|
||
Version:
02
|
|
Name:
/s/ Ingo Heschel
|
Date
: 18 Apr 18
|
3.0
|
Scope
|
3.1
|
This Quality Agreement constitutes the technical agreement required under European Good Manufacturing Practice (GMP) legislation 2003/94/EC Article 12, and FDA Good Manufacturing Practices 21CFR210, 211 to cover the final packaged ACI-Maix-Membrane Product manufactured by Matricel.
|
3.2
|
This Quality Agreement fulfills the requirements of 21 CFR 820.50 Purchasing Controls.
|
3.3
|
This Quality Agreement defines the individual responsibilities of Vericel and Matricel.
|
4.0
|
Procedures for Revision
|
4.1
|
Updates and changes will be addressed in collaboration with Vericel and Matricel.
|
5.0
|
Document Revision History
|
Original Version
(Issue 1)
|
|
6.0
|
Definitions
|
6.1
|
ACI-Maix-Membrane Product
|
|
[***]
|
|
6.2
|
Final Product
|
|
Vericel´s autologous chondrocyte implant incorporating the ACI-Maix-Membrane Product
|
|
6.3
|
For Cause Audit
|
|
An audit that is initiated for a particular reason [***]
|
|
6.4
|
ISO 11137, Parts 1,2,3 [in the current version(s)]
|
|
Sterilization of Health Care Products - Requirements for Validation and Routine Control -
Radiation Sterilization for Medical Devices
|
|
6.5
|
ISO 13485 [in the current version(s)]
|
|
Medical Devices -Quality Management Systems - Requirements for Regulatory Purposes
|
|
6.6
|
ISO 14644 Parts 1-5 [in the current version(s)]
|
|
Cleanrooms and associated controlled environments
|
|
6.7
|
Product Recall
|
|
[***]
|
|
6.8
|
Product Withdrawal
|
|
[***]
|
|
|
|
|
|
|
7.1
|
The obligations set out in this Quality Agreement shall apply to Matricel with respect to the ACI-Maix-Membrane Products manufactured by Matricel or any of its affiliates.
|
1.0
|
Quality System Requirements
|
Ref
|
Description of Activity
|
M
|
V
|
1.1
|
[***]
|
|
|
1.2
|
[***]
|
|
|
1.3
|
[***]
|
|
|
1.4
|
[***]
|
|
|
2.0
|
Regulatory Affairs (Actions, and Inspections)
|
Ref
|
Description of Activity
|
M
|
V
|
2.1
|
[***]
|
|
|
2.2
|
[***]
|
|
|
2.3
|
[***]
|
|
|
2.4
|
[***]
|
|
|
3.0
|
Production and Validation
|
4.0
|
Design/Change Control
|
Ref
|
Description of Activity
|
M
|
V
|
4.1
|
[***]
|
|
|
4.2
|
[***]
|
|
|
5.0
|
Deviations and Out of Specification Management
|
Ref
|
Description of Activity
|
M
|
V
|
5.1
|
[***]
|
|
|
5.2
|
[***]
|
|
|
5.3
|
[***]
|
|
|
5.4
|
[***]
|
|
|
5.5
|
[***]
|
|
|
6.0
|
Materials
|
Ref
|
Description of Activity
|
M
|
V
|
6.1
|
[***]
|
|
|
6.2
|
[***]
|
|
|
6.3
|
[***]
|
|
|
6.4
|
[***]
|
|
|
6.5
|
[***]
|
|
|
7.0
|
Lot Number Assignment & Expiration Dating Assignment
|
Ref
|
Description of Activity
|
M
|
V
|
7.1
|
[***]
|
|
|
7.2
|
[***]
|
|
|
7.3
|
[***]
|
|
|
Ref
|
Description of Activity
|
M
|
V
|
8.1
|
[***]
|
|
|
8.2
|
[***]
|
|
|
8.3
|
[***]
|
|
|
8.4
|
[***]
|
|
|
8.5
|
[***]
|
|
|
8.6
|
[***]
|
|
|
Ref
|
Description of Activity
|
M
|
V
|
9.1
|
[***]
|
|
|
9.2
|
[***]
|
|
|
9.3
|
[***]
|
|
|
9.4
|
[***]
|
|
|
9.5
|
[***]
|
|
|
9.6
|
[***]
|
|
|
Ref
|
Description of Activity
|
M
|
V
|
10.1
|
[***]
|
|
|
10.2
|
[***]
|
|
]
|
11.0
|
Product Complaints and Adverse Events
|
Ref
|
Description of Activity
|
M
|
V
|
11.1
|
[***]
|
|
|
11.2
|
[***]
|
|
|
11.3
|
[***]
|
|
|
11.4
|
[***]
|
|
|
11.5
|
[***]
|
|
|
Ref
|
Description of Activity
|
M
|
V
|
12.1
|
[***]
|
|
|
12.2
|
[***]
|
|
|
12.3
|
[***]
|
|
|
Ref
|
Description of Activity
|
M
|
V
|
13.1
|
[***]
|
|
|
13.2
|
[***]
|
|
|
13.3
|
[***]
|
|
|
14.0
|
Contract Manufacturing/Testing
|
Ref
|
Description of Activity
|
M
|
V
|
14.1
|
[***]
|
|
|
14.2
|
[***]
|
|
|
14.3
|
[***]
|
|
|
14.4
|
[***]
|
|
|
Test
|
Specification
|
Result
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
Test
|
Specification
|
Result
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
[***]
|
|
[***]
|
|
|
[***]
|
[***]
|
|
Vericel
|
||||
|
Name
|
Telephone Number
|
e-mail
|
Title
|
1
|
|
|
|
[***]
|
2
|
|
|
|
[***]
|
Matricel
|
||||
|
Name
|
Telephone Number
|
e-mail
|
Title
|
1
|
|
|
|
[***]
|
2
|
|
|
|
[***]
|
3
|
|
|
|
[***]
|
(a)
|
Dry ACI-Maix-Membrane Products are [***]. To be acceptable for use in the Final Product
("Usable ACI-Maix-Membrane Product"),
the minimum acceptable surface area of ACI-Maix-Membrane Products after hydration and before cell seeding is [***]
("Minimum Acceptable Surface Area After Hydration"). [***]
cannot be utilized in Final Product and will need to be discarded
("Unusable ACI-Maix-Membrane Product").
|
(b)
|
At the time of execution of this Agreement, an appropriate shrinkage specification for inclusion in the Quality Service Agreement has not been determined by the Parties.
|
(c)
|
Vericel and Matricel will jointly develop a work plan [***]. At the successful completion of this work, the Specifications and Quality Service Agreement shall be amended to include the jointly defined shrinkage release criterion.
|
(d)
|
For the time period between the execution of this Agreement and the execution of the amendment to the Specifications and Quality Service Agreement [***] the following provisions shall apply:
|
(i)
|
[***].
|
(ii)
|
[***].
|
(iii)
|
[***]
|
a.
|
[***].
|
b.
|
[***].
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|
/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)
|