|
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 -
x
|
|
|
Emerging growth company -
o
|
COMMON STOCK, NO PAR VALUE
|
|
43,347,348
|
(Class)
|
|
Outstanding at November 2, 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.
|
||
|
|
|
|
|
|
|
|
|
|
|
September 30,
|
|
December 31,
|
||||
|
|
2018
|
|
2017
|
||||
ASSETS
|
|
|
|
|
|
|
||
Current assets:
|
|
|
|
|
|
|
||
Cash and cash equivalents
|
|
$
|
53,289
|
|
|
$
|
26,862
|
|
Short term investments
|
|
44,462
|
|
|
—
|
|
||
Accounts receivable (net of allowance for doubtful accounts of $286 and $249, respectively)
|
|
15,528
|
|
|
18,270
|
|
||
Inventory
|
|
3,638
|
|
|
3,793
|
|
||
Other current assets
|
|
2,339
|
|
|
1,581
|
|
||
Total current assets
|
|
119,256
|
|
|
50,506
|
|
||
Property and equipment, net
|
|
5,207
|
|
|
4,071
|
|
||
Total assets
|
|
$
|
124,463
|
|
|
$
|
54,577
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY
|
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
|
||
Accounts payable
|
|
$
|
4,580
|
|
|
$
|
5,552
|
|
Accrued expenses
|
|
5,592
|
|
|
5,573
|
|
||
Deferred rent
|
|
534
|
|
|
420
|
|
||
Current portion of term loan credit agreement (net of deferred costs of $69 and $67, respectively)
|
|
4,097
|
|
|
350
|
|
||
Warrant liabilities
|
|
—
|
|
|
1,014
|
|
||
Other
|
|
189
|
|
|
181
|
|
||
Total current liabilities
|
|
14,992
|
|
|
13,090
|
|
||
Revolving and term loan credit agreement (net of deferred costs of $150 and $196, respectively)
|
|
13,183
|
|
|
16,888
|
|
||
Deferred rent
|
|
1,813
|
|
|
2,059
|
|
||
Total liabilities
|
|
29,988
|
|
|
32,037
|
|
||
COMMITMENTS AND CONTINGENCIES (Note 13)
|
|
|
|
|
|
|
||
Shareholders’ equity:
|
|
|
|
|
|
|
||
Common stock, no par value; shares authorized — 75,000; shares issued and outstanding — 43,170 and 35,861, respectively
|
|
468,447
|
|
|
383,020
|
|
||
Other comprehensive loss
|
|
(18
|
)
|
|
—
|
|
||
Warrants
|
|
302
|
|
|
397
|
|
||
Accumulated deficit
|
|
(374,256
|
)
|
|
(360,877
|
)
|
||
Total shareholders’ equity
|
|
94,475
|
|
|
22,540
|
|
||
Total liabilities and shareholders’ equity
|
|
$
|
124,463
|
|
|
$
|
54,577
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Product sales, net
|
|
$
|
22,484
|
|
|
$
|
14,260
|
|
|
$
|
59,522
|
|
|
$
|
40,574
|
|
Cost of product sales
|
|
8,138
|
|
|
7,186
|
|
|
23,531
|
|
|
21,965
|
|
||||
Gross profit
|
|
14,346
|
|
|
7,074
|
|
|
35,991
|
|
|
18,609
|
|
||||
Research and development
|
|
3,113
|
|
|
2,919
|
|
|
10,581
|
|
|
9,357
|
|
||||
Selling, general and administrative
|
|
12,569
|
|
|
8,186
|
|
|
35,314
|
|
|
25,427
|
|
||||
Total operating expenses
|
|
15,682
|
|
|
11,105
|
|
|
45,895
|
|
|
34,784
|
|
||||
Loss from operations
|
|
(1,336
|
)
|
|
(4,031
|
)
|
|
(9,904
|
)
|
|
(16,175
|
)
|
||||
Other income (expense):
|
|
|
|
|
|
|
|
0
|
|
|
|
|
||||
Decrease (increase) in fair value of warrants
|
|
420
|
|
|
(1,060
|
)
|
|
(2,524
|
)
|
|
(512
|
)
|
||||
Foreign currency translation loss
|
|
—
|
|
|
(6
|
)
|
|
(49
|
)
|
|
(20
|
)
|
||||
Interest income
|
|
307
|
|
|
2
|
|
|
390
|
|
|
6
|
|
||||
Interest expense
|
|
(460
|
)
|
|
(317
|
)
|
|
(1,340
|
)
|
|
(878
|
)
|
||||
Other income
|
|
—
|
|
|
5
|
|
|
48
|
|
|
6
|
|
||||
Total other income (expense)
|
|
267
|
|
|
(1,376
|
)
|
|
(3,475
|
)
|
|
(1,398
|
)
|
||||
Net loss
|
|
$
|
(1,069
|
)
|
|
$
|
(5,407
|
)
|
|
$
|
(13,379
|
)
|
|
$
|
(17,573
|
)
|
|
|
|
|
|
|
|
|
|
||||||||
Net loss per share attributable to common shareholders (Basic and Diluted)
|
|
$
|
(0.02
|
)
|
|
$
|
(0.16
|
)
|
|
$
|
(0.34
|
)
|
|
$
|
(0.54
|
)
|
Weighted average number of common shares outstanding (Basic and Diluted)
|
|
42,925
|
|
|
33,667
|
|
|
39,163
|
|
|
32,783
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Net loss
|
|
$
|
(1,069
|
)
|
|
$
|
(5,407
|
)
|
|
$
|
(13,379
|
)
|
|
$
|
(17,573
|
)
|
Other comprehensive loss:
|
|
|
|
|
|
|
|
|
||||||||
Net change in unrealized loss on investments
|
|
$
|
(18
|
)
|
|
—
|
|
|
$
|
(18
|
)
|
|
$
|
—
|
|
|
Comprehensive loss
|
|
$
|
(1,087
|
)
|
|
$
|
(5,407
|
)
|
|
$
|
(13,397
|
)
|
|
$
|
(17,573
|
)
|
|
|
Nine Months Ended September 30,
|
||||||
|
|
2018
|
|
2017
|
||||
Operating activities:
|
|
|
|
|
|
|
||
Net loss
|
|
$
|
(13,379
|
)
|
|
(17,573
|
)
|
|
Adjustments to reconcile net loss to net cash used for operating activities:
|
|
|
|
|
|
|
||
Depreciation and amortization expense
|
|
1,133
|
|
|
1,186
|
|
||
Stock compensation expense
|
|
5,739
|
|
|
2,053
|
|
||
Change in fair value of warrants
|
|
2,524
|
|
|
512
|
|
||
Inventory provision
|
|
303
|
|
|
232
|
|
||
Loss on sale of fixed assets
|
|
23
|
|
|
—
|
|
||
Foreign currency translation loss
|
|
49
|
|
|
20
|
|
||
Change in operating assets and liabilities:
|
|
|
|
|
|
|
||
Inventory
|
|
(148
|
)
|
|
(793
|
)
|
||
Deferred rent
|
|
(132
|
)
|
|
91
|
|
||
Accounts receivable
|
|
2,742
|
|
|
1,663
|
|
||
Prepaid and other current assets
|
|
(758
|
)
|
|
(202
|
)
|
||
Accounts payable
|
|
(1,212
|
)
|
|
(1,068
|
)
|
||
Accrued expenses
|
|
19
|
|
|
(9
|
)
|
||
Other assets and liabilities, net
|
|
74
|
|
|
(129
|
)
|
||
Net cash used for operating activities
|
|
(3,023
|
)
|
|
(14,017
|
)
|
||
Investing activities:
|
|
|
|
|
|
|
||
Purchases of short term investments
|
|
(44,480
|
)
|
|
—
|
|
||
Expenditures for property, plant and equipment
|
|
(2,101
|
)
|
|
(792
|
)
|
||
Net cash used in investing activities
|
|
(46,581
|
)
|
|
(792
|
)
|
||
Financing activities:
|
|
|
|
|
|
|
||
Net proceeds from equity offering
|
|
70,028
|
|
|
—
|
|
||
Net proceeds from common stock issuance due to stock option exercises
|
|
3,310
|
|
|
7,549
|
|
||
Proceeds from exercise of warrants
|
|
2,716
|
|
|
—
|
|
||
Other
|
|
(23
|
)
|
|
(252
|
)
|
||
Net cash provided by financing activities
|
|
76,031
|
|
|
7,297
|
|
||
Net increase (decrease) in cash and cash equivalents
|
|
26,427
|
|
|
(7,512
|
)
|
||
Cash and cash equivalents at beginning of period
|
|
26,862
|
|
|
22,978
|
|
||
Cash and cash equivalents at end of period
|
|
$
|
53,289
|
|
|
$
|
15,466
|
|
|
|
|
|
|
1.
|
Organization
|
2.
|
Basis of Presentation
|
|
|
Nine Months Ended September 30, 2018
|
||||||
(In thousands)
|
|
2018
|
|
2017
|
||||
Supplementary Cash Flows information:
|
|
|
|
|
||||
Warrants exercised for common stock
|
|
$
|
3,538
|
|
|
$
|
—
|
|
Interest paid (net of interest capitalized)
|
|
1,161
|
|
|
691
|
|
||
Shares converted to common from preferred stock
|
|
—
|
|
|
38,389
|
|
||
Additions to equipment in process included in accounts payable
|
|
191
|
|
|
486
|
|
3.
|
Recent Accounting Pronouncements
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
Revenue by product (in thousands)
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
MACI and Carticel implants and kits
|
|
|
|
|
|
|
|
|
||||||||
Implants - based on contracted rate
|
|
$
|
243
|
|
|
$
|
8,046
|
|
|
$
|
18,354
|
|
|
$
|
11,145
|
|
Implants - subject to third party reimbursement
|
|
15,593
|
|
|
1,079
|
|
|
23,156
|
|
|
15,172
|
|
||||
Biopsy kits - direct bill
|
|
488
|
|
|
412
|
|
|
1,392
|
|
|
1,274
|
|
||||
Change in estimates related to prior periods
|
|
125
|
|
|
372
|
|
|
(273
|
)
|
|
230
|
|
||||
Epicel
|
|
|
|
|
|
|
|
|
||||||||
Direct bill (hospital)
|
|
6,035
|
|
|
4,351
|
|
|
16,893
|
|
|
12,753
|
|
||||
Total revenue
|
|
$
|
22,484
|
|
|
$
|
14,260
|
|
|
$
|
59,522
|
|
|
$
|
40,574
|
|
|
Revenue Concentration
|
|
Accounts Receivable Concentration
|
||||||||||||
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
|
September 30,
|
|
December 31,
|
||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||
MACI and Carticel
1
|
<10%
|
|
55
|
%
|
|
24
|
%
|
|
25
|
%
|
|
<10%
|
|
46
|
%
|
Epicel
|
<10%
|
|
10
|
%
|
|
<10%
|
|
|
13
|
%
|
|
<10%
|
|
<10%
|
|
5.
|
Selected Balance Sheet Components
|
(In thousands)
|
September 30, 2018
|
|
December 31, 2017
|
||||
Raw materials
|
$
|
3,130
|
|
|
$
|
3,532
|
|
Work-in-process
|
456
|
|
|
226
|
|
||
Finished goods
|
52
|
|
|
35
|
|
||
Inventory
|
$
|
3,638
|
|
|
$
|
3,793
|
|
(In thousands)
|
September 30, 2018
|
|
December 31, 2017
|
||||
Machinery and equipment
|
$
|
1,424
|
|
|
$
|
1,249
|
|
Furniture, fixtures and office equipment
|
757
|
|
|
872
|
|
||
Computer equipment and software
|
3,695
|
|
|
3,536
|
|
||
Leasehold improvements
|
4,459
|
|
|
4,213
|
|
||
Construction in process
|
2,084
|
|
|
822
|
|
||
Total property and equipment, gross
|
12,419
|
|
|
10,692
|
|
||
Less: Accumulated depreciation
|
(7,212
|
)
|
|
(6,621
|
)
|
||
|
$
|
5,207
|
|
|
$
|
4,071
|
|
(In thousands)
|
September 30, 2018
|
|
December 31, 2017
|
||||
Bonus related compensation
|
$
|
2,180
|
|
|
$
|
2,693
|
|
Employee related accruals
|
2,955
|
|
|
2,389
|
|
||
Other accrued expenses
|
457
|
|
|
491
|
|
||
|
$
|
5,592
|
|
|
$
|
5,573
|
|
6.
|
Stock Purchase Warrants
|
|
|
September 2016 Warrants
|
|
December 2017 Warrants
|
Exercise price
|
|
$2.25
|
|
$4.27
|
Expiration date
|
|
September 9, 2022
|
|
December 6, 2023
|
Total shares issuable on exercise
|
|
58,537
|
|
53,902
|
|
|
|
|
|
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 September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
(In thousands)
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Cost of goods sold
|
|
$
|
284
|
|
|
$
|
119
|
|
|
$
|
820
|
|
|
$
|
316
|
|
Research and development
|
|
365
|
|
|
177
|
|
|
1,282
|
|
|
391
|
|
||||
Selling, general and administrative
|
|
1,283
|
|
|
459
|
|
|
3,637
|
|
|
1,346
|
|
||||
Total non-cash stock-based compensation expense
|
|
$
|
1,932
|
|
|
$
|
755
|
|
|
$
|
5,739
|
|
|
$
|
2,053
|
|
|
|
Nine Months Ended September 30,
|
||||
Service-Based Stock Options
|
|
2018
|
|
2017
|
||
Expected dividend rate
|
|
—
|
%
|
|
—
|
%
|
Expected stock price volatility
|
|
82.3 – 88.3%
|
|
|
80.1 – 88.2%
|
|
Risk-free interest rate
|
|
2.4 – 2.9%
|
|
|
1.8 – 2.3%
|
|
Expected life (years)
|
|
5.3 – 6.3
|
|
|
5.5 – 6.3
|
|
|
|
|
|
|
|
|
|
|
9.
|
Cash Equivalents and Investments
|
|
|
September 30, 2018
|
||||||||||||||
|
|
|
|
Gross Unrealized
|
|
|
||||||||||
(In thousands)
|
|
Amortized Cost
|
|
Gains
|
|
Losses
|
|
Fair Value
|
||||||||
Money market funds
|
|
$
|
18,684
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
18,684
|
|
Repurchase agreements
|
|
10,002
|
|
|
—
|
|
|
—
|
|
|
10,002
|
|
||||
Commercial paper
|
|
21,832
|
|
|
—
|
|
|
—
|
|
|
21,832
|
|
||||
Corporate notes
|
|
13,058
|
|
|
—
|
|
|
(11
|
)
|
|
13,047
|
|
||||
U.S. government securities
|
|
3,174
|
|
|
—
|
|
|
(1
|
)
|
|
3,173
|
|
||||
U.S. asset-backed securities
|
|
8,430
|
|
|
—
|
|
|
(6
|
)
|
|
8,424
|
|
||||
|
|
$
|
75,180
|
|
|
$
|
—
|
|
|
$
|
(18
|
)
|
|
$
|
75,162
|
|
Classified as:
|
|
|
|
|
|
|
|
|
||||||||
Cash equivalents
|
|
|
|
|
|
|
|
$
|
30,700
|
|
||||||
Short-term investments
|
|
|
|
|
|
|
|
44,462
|
|
|||||||
|
|
|
|
|
|
$
|
75,162
|
|
10.
|
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, 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
|
||||||||||||||||
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||
Money market funds
|
|
$
|
18,684
|
|
|
$
|
18,684
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||
Repurchase agreements
|
|
10,002
|
|
|
—
|
|
|
10,002
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Commercial paper
|
|
21,832
|
|
|
—
|
|
|
21,832
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
Corporate notes
|
|
13,047
|
|
|
—
|
|
|
13,047
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
U.S. government securities
|
|
3,173
|
|
|
—
|
|
|
3,173
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
U.S. asset-backed securities
|
|
8,424
|
|
|
—
|
|
|
8,424
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
||||||||
|
|
$
|
75,162
|
|
|
$
|
18,684
|
|
|
$
|
56,478
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Warrant liabilities
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,014
|
|
|
$
|
—
|
|
|
$
|
1,014
|
|
|
$
|
—
|
|
Warrant Liabilities (In thousands)
|
|
||
Balance at December 31, 2017
|
$
|
1,014
|
|
Increase in fair value (net of expired warrants)
|
2,524
|
|
|
Warrant exercise
|
(3,538
|
)
|
|
Balance at September 30, 2018
|
$
|
—
|
|
11.
|
Shareholders' Equity
|
12.
|
Net Loss Per Common Share
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
(Amounts in thousands except per share amounts)
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Numerator:
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss
|
|
$
|
(1,069
|
)
|
|
$
|
(5,407
|
)
|
|
$
|
(13,379
|
)
|
|
$
|
(17,573
|
)
|
Denominator for basic and diluted EPS:
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Weighted-average common shares outstanding
|
|
42,925
|
|
|
33,667
|
|
|
39,163
|
|
|
32,783
|
|
||||
Net loss per share attributable to common shareholders (basic and diluted)
|
|
$
|
(0.02
|
)
|
|
$
|
(0.16
|
)
|
|
$
|
(0.34
|
)
|
|
$
|
(0.54
|
)
|
(In thousands)
|
|
Total
|
|
2018
|
|
2019
|
|
2020
|
|
2021
|
|
2022
|
|
More than 5 years
|
||||||||||||||
Operating leases
|
|
$
|
16,915
|
|
|
$
|
1,273
|
|
|
$
|
4,908
|
|
|
$
|
4,902
|
|
|
$
|
4,811
|
|
|
$
|
957
|
|
|
$
|
64
|
|
Debt and interest related payments
|
|
20,860
|
|
|
814
|
|
|
6,290
|
|
|
5,817
|
|
|
7,939
|
|
|
—
|
|
|
—
|
|
|||||||
Purchase commitments
|
|
3,206
|
|
|
526
|
|
|
711
|
|
|
681
|
|
|
644
|
|
|
644
|
|
|
—
|
|
|||||||
Total
|
|
$
|
40,981
|
|
|
$
|
2,613
|
|
|
$
|
11,909
|
|
|
$
|
11,400
|
|
|
$
|
13,394
|
|
|
$
|
1,601
|
|
|
$
|
64
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
(In thousands)
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Total revenues
|
|
$
|
22,484
|
|
|
$
|
14,260
|
|
|
$
|
59,522
|
|
|
$
|
40,574
|
|
Cost of product sales
|
|
8,138
|
|
|
7,186
|
|
|
23,531
|
|
|
21,965
|
|
||||
Gross profit
|
|
14,346
|
|
|
7,074
|
|
|
35,991
|
|
|
18,609
|
|
||||
Total operating expenses
|
|
15,682
|
|
|
11,105
|
|
|
45,895
|
|
|
34,784
|
|
||||
Loss from operations
|
|
(1,336
|
)
|
|
(4,031
|
)
|
|
(9,904
|
)
|
|
(16,175
|
)
|
||||
Other income (expense)
|
|
267
|
|
|
(1,376
|
)
|
|
(3,475
|
)
|
|
(1,398
|
)
|
||||
Net loss
|
|
$
|
(1,069
|
)
|
|
$
|
(5,407
|
)
|
|
$
|
(13,379
|
)
|
|
$
|
(17,573
|
)
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
Revenue by product (in thousands)
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Carticel and MACI
|
|
$
|
16,449
|
|
|
$
|
9,909
|
|
|
$
|
42,629
|
|
|
$
|
27,821
|
|
Epicel
|
|
6,035
|
|
|
4,351
|
|
|
16,893
|
|
|
12,753
|
|
||||
Total Revenue
|
|
$
|
22,484
|
|
|
$
|
14,260
|
|
|
$
|
59,522
|
|
|
$
|
40,574
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
(In thousands)
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Gross profit
|
|
$
|
14,346
|
|
|
$
|
7,074
|
|
|
$
|
35,991
|
|
|
$
|
18,609
|
|
Gross profit %
|
|
64
|
%
|
|
50
|
%
|
|
60
|
%
|
|
46
|
%
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
(In thousands)
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Research and development costs
|
|
$
|
3,113
|
|
|
$
|
2,919
|
|
|
$
|
10,581
|
|
|
$
|
9,357
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
(In thousands)
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Dilated Cardiomyopathy
|
|
$
|
153
|
|
|
$
|
909
|
|
|
$
|
1,119
|
|
|
$
|
4,050
|
|
MACI
|
|
2,095
|
|
|
1,430
|
|
|
7,169
|
|
|
3,678
|
|
||||
Epicel
|
|
865
|
|
|
580
|
|
|
2,293
|
|
|
1,629
|
|
||||
Total research and development costs
|
|
$
|
3,113
|
|
|
$
|
2,919
|
|
|
$
|
10,581
|
|
|
$
|
9,357
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
(In thousands)
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Selling, general and administrative costs
|
|
$
|
12,569
|
|
|
$
|
8,186
|
|
|
$
|
35,314
|
|
|
$
|
25,427
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
(In thousands)
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Decrease (increase) in fair value of warrants
|
|
$
|
420
|
|
|
$
|
(1,060
|
)
|
|
$
|
(2,524
|
)
|
|
$
|
(512
|
)
|
Foreign currency translation loss
|
|
—
|
|
|
(6
|
)
|
|
(49
|
)
|
|
(20
|
)
|
||||
Other income
|
|
—
|
|
|
5
|
|
|
48
|
|
|
6
|
|
||||
Net interest expense
|
|
(153
|
)
|
|
(315
|
)
|
|
(950
|
)
|
|
(872
|
)
|
||||
Total other expense
|
|
$
|
267
|
|
|
$
|
(1,376
|
)
|
|
$
|
(3,475
|
)
|
|
$
|
(1,398
|
)
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
(In thousands)
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Cost of goods sold
|
|
$
|
284
|
|
|
$
|
119
|
|
|
$
|
820
|
|
|
$
|
316
|
|
Research and development
|
|
365
|
|
|
177
|
|
|
1,282
|
|
|
391
|
|
||||
Selling, general and administrative
|
|
1,283
|
|
|
459
|
|
|
3,637
|
|
|
1,346
|
|
||||
Total non-cash stock-based compensation expense
|
|
$
|
1,932
|
|
|
$
|
755
|
|
|
$
|
5,739
|
|
|
$
|
2,053
|
|
Exhibit No.
|
|
Description
|
|
|
|
10.1**†
|
|
|
|
|
|
10.2**†
|
|
|
|
|
|
10.3**†
|
|
|
|
|
|
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.
|
Section 1.1 Distribution
. Section 1.1 shall be modified to add the following at the end of the first paragraph: “A Payor is defined as a Healthcare Provider, Healthcare Facility, or insurer. The Parties agree that any cases [***] shall not be processed under the Agreement.” In addition, the second and third paragraphs of Section 1.1 shall be deleted, with the exception of the first sentence of the second paragraph which shall remain.
|
4.
|
Section 2 Obligations of Vericel
. This Section shall be deleted and be replaced with [Intentionally omitted].
|
5.
|
Section 7.1 Term
. The first two sentences of Section 7.1 shall remain, but the last sentence of the Section shall be deleted and replaced with the following:
|
6.
|
Exhibit A
. The Parties agree that Exhibit A to the Agreement – Payment Terms and Pricing shall be deleted and replaced with the attached revised and restated Exhibit A.
|
7.
|
No Other Changes
. To the extent terms in the Fourth Amendment conflict with the Agreement and/or any of the amendments to the Agreement, the terms of this Fourth Amendment shall prevail. Except as provided in this Fourth Amendment, the terms and conditions of the Agreement will continue in full force.
|
8.
|
Counterparts/Signatures
. This Fourth Amendment may be executed in multiple counterparts, each of which constitutes an original, and all of which, collectively, constitute only one agreement. The signatures of the parties need not appear on the same counterpart, and delivery of an executed counterpart signature page by facsimile or other form of electronic transmission shall be as effective as executing and delivering this Fourth Amendment in the presence of the other parties to this Fourth Amendment.
|
Vericel Corporation
By: /s/ Daniel Orlando
Name: Daniel Orlando
Title: Chief Operating Officer
Date: 25 July 2018
|
Orsini Pharmaceutical Services, Inc.
By: /s/ Michael Fieri
Name: Michael Fieri
Title: President and CEO
Date: 25 July 2018
|
1.
|
Product.
|
|
Product
|
NDC Number
|
|
MACI
|
69866-1030-01
|
|
MACI
|
69866-1030-02
|
2.
|
Orsini Counseling and Dispensing
.
|
A.
|
Orsini, when acting as the dispensing specialty pharmacy for Product, shall [***]. Vericel shall provide Orsini, through its vendors or its web-based data-sharing platform (“Vericel Central”), with daily data feeds regarding cases, [***].
|
B.
|
Vericel shall, [***], arrange for Product to be shipped to Orsini so that Orsini may label and dispense the Product [***] by the surgery date. Vericel shall also be responsible [***].
|
C.
|
By [***], Orsini, in coordination with Vericel, shall use commercially reasonable efforts to determine the feasibility of dispensing from a facility near Vericel’s Cambridge, Massachusetts manufacturing facility. [***]. Orsini shall have no liability under the Agreement if it determines use of another facility is not feasible.
|
D.
|
In order to perform its specialty pharmacy services, Orsini shall take title to the Product upon receipt of the Product at its facility. [***].
|
3.
|
Claim Submittal, Contracting and Payment Coordination between Parties.
|
A.
|
The Parties agree that Orsini shall dedicate at least one full-time experienced person to the Product (“Vericel Program Manager”). The Vericel Program Manager shall work exclusively on Product cases and serve as the point of contact for Vericel and Vericel’s contractor. In consideration of the Vericel Program Manager, Vericel shall pay Orsini a fee of [***] each month. Orsini shall screen and select a candidate for the Vericel Program Manager position and present such a candidate to Vericel for approval, which shall not be unreasonably withheld. Upon hiring of the Vericel Program Manager, the fee is due the first of each month and shall be applied to such [***] service.
|
B.
|
To the extent permitted by Orsini’s Payor agreements, the Parties agree that they will work together to manage reimbursement issues regarding the Product. Orsini, working with Vericel’s contractor, shall submit claims for Products [***] of Product implantation. [***]. Orsini shall appeal or resubmit for payment all denied and otherwise rejected claims for
|
C.
|
When reasonably determined by Vericel representatives and Orsini, Orsini will consult with Vericel and its designated representatives with [***].
|
D.
|
[***]. Orsini agrees to provide to Vericel representatives the payment history for the Product. If required for Vericel’s financial reporting purposes under generally accepted accounting principles, Orsini agrees to provide redacted portions of the relevant agreements or other payment arrangements between a Payor and Orsini to the extent allowed by the confidentiality provisions of such agreements.
|
4.
|
Payment Terms.
|
A.
|
The Payment Terms outlined in this Fourth Amendment shall apply to (i) any existing case listed on Exhibit C, and (ii) any case for which an order is accepted by Orsini in Vericel Central and for which a claim is submitted to a Payor after June 15, 2018. Other cases will be handled in accordance with the terms of the Agreement in place at the time of the claim submission.
|
B.
|
Vericel shall pay Orsini for each Product dispensed by Orsini, regardless of the Product NDC, [***] (“Dispensing Fee”). Orsini shall invoice Vericel for the Dispensing Fee weekly for claims submitted during the week, and such payment is due to Orsini [***] of Vericel’s receipt of the invoice. Vericel’s obligation to pay this fee shall survive the termination of the Agreement.
|
C.
|
The Parties agree that Vericel, in consideration of Orsini’s administrative services relating to the submission and collection of claims relating to the Product, shall pay Orsini an administrative fee [***] (“Administrative Fee”) for [***] that are Eligible Cases (as defined below). The Administrative Fee applies to [***] cases (i) listed on Exhibit C, or (ii) for which an order is accepted by Orsini in Vericel Central and for which a claim is submitted to a Payor after June 15, 2018 (collectively, “Eligible Cases”); provided, however, cases shall not be deemed Eligible Cases and will not count [***] if a Payor denies payment for an otherwise Eligible Case. Vericel shall notify Orsini at the end of each calendar quarter the number of Eligible Cases remaining [***] cases. Orsini shall be allowed to deduct from each Payor reimbursement for an Eligible Case the amount of the Administrative Fee.
|
D.
|
Within [***] of receipt of payment from a Payor related to the Product, Orsini shall remit to Vericel all reimbursements related to Products dispensed by Orsini except as provided above. The payments shall be deposited into a bank account maintained by and in the name and sole control of Vericel (the “Vericel Account”). In conjunction with each deposit, Orsini shall remit to Vericel a schedule detailing the cases for which a payment was deposited into the account including the case number and the amount deposited for each case.
|
E.
|
On a [***] basis, Orsini shall remit to Vericel a schedule which includes the gross reimbursements received [***] related to Products dispensed by Orsini, including whether
|
F.
|
In addition to the remitting of payment to Vericel as set forth above, Orsini shall update, [***], the payment status of submitted cases to Vericel and its contractors through Vericel Central or other mutually agreed upon method.
|
G.
|
Subject to the terms of the Agreement, as amended, Vericel acknowledges that it retains the risk of [***].
|
H.
|
Except as provided herein, all payments (including interest payments, if any) for the Product received by Orsini during the Term and after the expiration or termination of the Agreement shall be the sole property of Vericel and shall be remitted to Vericel in accordance with the Agreement. In the event of a termination or expiration of the Agreement, Orsini shall continue to collect on claims covered by the Agreement, consistent with the terms of the Agreement, for a period [***] following the expiration or termination of the Agreement.
|
I.
|
If Vericel terminates the Agreement for any reason other than the reasons contained in Section 7.2(b)(1) of the Agreement or a failure of Orsini to submit claims for payment and/or resubmit or appeal pursuant to Paragraph 3B of this Exhibit (except that this shall not apply to the failure of Orsini to submit claims within the timelines set forth in Paragraph 3B, unless such failure is repeated and results in the denial of claims by Payors) or Paragraph 4D of this Exhibit regarding the payment to Vericel of amounts received from Payors or Orsini has not been paid an Administrative Fee on [***] by June 30, 2019, Orsini shall continue to receive the Administrative Fees associated with the unpaid cases, and the Administrative Fee on both paid and unpaid Eligible Cases shall be increased [***]. Within the earlier of thirty (30) days of the effective date of the termination or June 30, 2019, Vericel shall pay Orsini [***].
|
J.
|
Orsini represents and warrants that each of Orsini’s Payor agreements set forth on Exhibit B are in full force and effect and apply to the Product.
|
K.
|
If a Payor recoups any payment on a case for which Orsini has made payment to Vericel, Orsini shall notify Vericel and shall be entitled to deduct from Vericel funds a sum equal to the amount of the recoupment. If there are insufficient Vericel Funds, Orsini shall invoice
|
L.
|
The Parties agree that fees paid hereunder are not designed nor constitute inducements for Orsini to utilize or recommend the utilization of Vericel Products under federal and/or similar state laws. Orsini shall properly disclose and otherwise comply with applicable law.
|
1.1
|
AllCare acknowledges and agrees that [***], Vericel’s [***], will use certain AllCare identifiers including, but not limited to, provider name, address, National Provider Identifier (NPI), taxonomy, and other information necessary to perform [***] related to the Product. AllCare acknowledges and agrees that [***] may use the following: AllCare Plus Pharmacy,
50 Bearfoot Rd, Northborough, MA 01532;
NPI 1902167596 and any other required identifiers.
|
1.2
|
AllCare authorizes Vericel’s contractor, [***], with which it will enter into a Business Associate Agreement, to act as an authorized representative of AllCare with respect to [***] services for the Product. If required by Healthcare Providers, Healthcare Facilities, or insurers (collectively “Payors”), AllCare agrees to provide [***] with a Designation of Authorized Representative letter which [***] may provide to Payors.
|
1.3
|
Vericel’s contractor shall conduct [***], which shall also include [***] required by Payors, including [***] and/or other relevant materials (collectively “Case Materials”). AllCare agrees that Vericel’s contractor may utilize any [***] to make submissions of Case Materials to Payors.
|
1.4
|
AllCare agrees and authorizes Vericel and its contractor to [***] as a medical benefit. Vericel shall not modify existing agreements between AllCare and Payors concerning pharmacy benefits.
|
1.5
|
AllCare agrees that Vericel’s contractor shall [***] which arise regarding the Product, including the [***].
|
1.6
|
Vericel’s contractor shall advise [***] upon the implantation of the Product. After the Product is implanted into a patient, AllCare shall be responsible for the [***]. The Parties shall coordinate the manner of communications to the patient regarding the [***].
|
1.7
|
AllCare shall cooperate with and work with Vericel and [***] regarding claim submission and any claim appeal procedures. Such cooperation shall include AllCare notifying Vericel within [***] day of receiving notices of denials or claims otherwise rejected. If any Payor notifies AllCare that it plans to recoup any payment previously made for a Product, AllCare shall notify Vericel within [***] day.
|
1.8
|
AllCare, consistent with Exhibit A, shall collect and pass-on to Vericel, [***]. In order for the Parties to segregate payments made to AllCare for the Product, AllCare agrees to utilize a billing system for the Product that is either separate or walled-off from other funds it receives. The Parties shall agree on the specifics of such a system and Vericel shall have access to such a system for the purpose of determining compliance with this Agreement.
|
1.10.
|
Vericel shall be responsible for any acts or omissions by its contractor.
|
2.
|
Dispensing and Shipment of Product
. AllCare will coordinate with Vericel to ensure the dispensing of Product by AllCare on the [***] day Product is received by AllCare. From Monday to Saturday, AllCare, in coordination with Vericel, shall pick-up Product at Vericel’s manufacturing facility at 64 Sidney Street, Cambridge, MA 02139 and transport the Product to AllCare’s pharmacy location in Northborough, MA. During such transport, [***] shall bear the risk of loss. On Sundays, [***] shall be responsible for transporting Product to AllCare’s pharmacy and shall bear the risk of loss during such transport. Upon dispensing the Product, which shall be the [***] day as the Product is received by AllCare, AllCare shall coordinate for the Product’s pick-up by Vericel or its agent at AllCare’s pharmacy. [***] shall be responsible for shipping the dispensed Product to the customer identified in the order and shall bear the risk of loss during transport from AllCare’s pharmacy to the customer. For purpose of dispensing the Product, the title to the Product shall transfer to AllCare upon AllCare’s possession of the Product.
|
3.
|
Standard of Care
. AllCare shall maintain all applicable licenses or certifications, including DEA numbers, and will dispense the Product in accordance with applicable professional standards and applicable federal, state and local laws, rules, regulations and guidelines (collectively, "Standards and Legal Requirements"). AllCare shall maintain internal controls to facilitate compliance with its obligations under this Agreement. In the event AllCare receives a notice from any governmental authority regarding its obligations pertaining to Standards and Legal Requirements that have a material adverse effect on its ability to
|
4.
|
Obligation of the Parties
.
|
4.1.
|
Financial and Credit Position. Each Party will maintain a financial condition reasonably satisfactory to the other. If, during the Term, the financial condition of a Party is impaired or unsatisfactory, the other Party may require such Party to perform its obligations in advance or provide other reasonable adequate assurances of performance.
|
4.2.
|
Compliance with Laws. Each Party shall maintain all federal, state and local registrations necessary to comply with this Agreement and will immediately notify the other Party of any denial, revocation or suspension of any such registration. Each Party will comply with all Standards and Legal Requirements applicable to performance of its obligations under this Agreement, including without limitation, (i) Drug Quality and Security Act, (ii) federal and state Food, Drug and Cosmetics Acts; (iii) federal and state Anti-kickback laws; (iv) any federal, state or local statutes, regulations, rules, guidelines or manuals relating to dispensing pharmaceutical products; (v) guidelines of the Joint Commission on Accreditation of Healthcare Organizations; (vi) federal, state or local laws relating to billing or sales practices; (vii) Health Insurance Portability and Accountability Act of 1996 and applicable regulations. In the event there is any change in law, regulation or interpretation thereof that has the effect of prohibiting any right or obligation of a Party under the Agreement that is material to the Party's rights and obligations under this Agreement or materially and adversely affects such right or obligation, the Parties shall meet in good faith to mutually agree on an appropriate amendment to this Agreement to reflect the changed circumstances.
|
4.3
|
Debarment/Exclusion. Each Party represents and certifies that it and any person or entity employed or engaged by it including, without limitation, employees, contractors, or agents who will provide Services in connection with this Agreement (collectively, “Personnel”) are not currently:
|
(i)
|
excluded, debarred, suspended or otherwise ineligible to participate in federal health care programs as defined in 42 U.S.C. § 1320a-7b or in federal procurement or non procurement activities as defined in Executive Order 12689 (collectively, “ Ineligible”);
|
(ii)
|
debarred pursuant to the Generic Drug Enforcement Act of 1992, 21 U.S.C. § 335(a), as amended, or any similar state law or regulation (“Debarred”);
|
(iii)
|
excluded by the Office of Inspector General pursuant to 42 U.S.C. § 1320a-7, et seq. or any state agency from participation in any federal or state health care program as defined in 42 U.S.C. § 1320a-7 and 42 U.S.C. § 1320a-7b (“Excluded”); and/or
|
(iv)
|
otherwise disqualified or restricted by the FDA pursuant to 21 CFR § 312.70 or any other regulatory authority (“Disqualified”).
|
4.4
|
Proper Handling and Storage. Vericel and AllCare agree to handle and store Product in a manner which will assure that the quality of Product is maintained.
|
4.5
|
Adverse Event and Product Complaint Reporting. During the course of this Agreement, if AllCare becomes aware of an adverse event associated with use of a Vericel product (whether or not expected or labeled), Consultant shall report the adverse event to Vericel within 1 working day, by email at
PatientSafety@vcel.com
or by telephone at 1-800-453-6948 or in any of the following forms: (i) CIOMS I; (ii) Med Watch; or (iii) adverse event reporting form (electronic or hardcopy). Information reported shall include: patient identifiers, reporter (including reporter name and contact information), the suspect product information (drug, dose, route, date of administration), and details regarding the adverse event. If Vericel concludes that the AllCare should be trained on Vericel’s Adverse Event Reporting policy, AllCare agrees to cooperate to complete such training.
|
4.6
|
Product Informational Materials. If requested by AllCare, Vericel shall provide AllCare, at no cost, reasonable amounts of applicable supplies of materials describing the Product as prepared by Vericel in the ordinary course of Vericel's marketing of the Product, including for example, Product FAQs and fact sheets. AllCare shall not make any changes or provide supplemental information to any descriptive, educational, promotional or other Product-related materials supplied by Vericel without the prior written authorization of Vericel. Moreover, AllCare shall not distribute any descriptive, educational, promotional or other Product-related materials created or developed by AllCare or any third Party without the prior written authorization of Vericel.
|
4.7
|
Records Retention and Audit. The Parties shall maintain complete and accurate records of all transactions related to the conduct of business under this Agreement. During the Term of this Agreement and for a period of [***] thereafter both Parties shall retain records pertaining to transactions undertaken pursuant to this Agreement
|
4.8
|
Recalls. In the event that (i) any governmental agency or authority issues a request or directive or orders that the Product be recalled or retrieved, (ii) a court of competent jurisdiction orders that the Product be recalled or retrieved, or (iii) Vericel reasonably determines that the Product should be recalled, retrieved or a "dear doctor" letter is required relating to restrictions on use of Product, AllCare will provide Vericel with any reasonable assistance requested by Vericel, and the Parties will take all agreed to corrective actions. Vericel will be responsible for all of the expenses of such activities, except to the extent the event causing the recall results from a breach of any of AllCare's obligations under this Agreement or AllCare's negligence or willful misconduct. For purposes of this Agreement, the expenses may include, but are not limited to, the expenses of notification and return or destruction (if authorized by Vericel) of the Product, the cost of replacement of the Product, and any costs directly associated with the distribution of replacement Product. AllCare and Vericel will cooperate fully with one another in conducting any activity contemplated by this provision. AllCare will arrange for the destruction of Product lawfully recalled only upon Vericel's (or any regulatory authority's) written instruction to arrange for the destruction of such Product.
|
5.
|
Warranty/Indemnification
.
|
5.1
|
Warranty. Vericel warrants and represents to AllCare that: (i) Vericel will convey to AllCare good title to the Product, free and clear of all security interest, liens or other encumbrances; (ii) Vericel has manufactured, packaged and is selling the Product in compliance with all Standards and Legal Requirements; and (iii) as of the date of delivery, the Product will be free from material defects in materials and workmanship and will conform to Vericel's specifications. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT OR THE CONTINUING GUARANTY (AS DEFINED BELOW), THE WARRANTIES SET OUT IN THIS AGREEMENT ARE IN LIEU OF ALL OTHER REPRESENTATIONS OR WARRANTIES, WHETHER EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTIBILITY OR FITNESS FOR A PARTICULAR PURPOSE.
|
5.2
|
Indemnification by Vericel. Vericel agrees to indemnify and hold harmless AllCare, its Affiliates and the officers, directors and employees of each of them, from and against all damages, expenses, claims, judgments and liabilities including, reasonable attorneys' fees ("Claims"), incurred by AllCare arising from or in connection with (1) Vericel's manufacturing, processing, labeling, marketing, storage, handling or sale of Product; (2) third Party Claims that the Product [***] or any other standards and legal requirements; (3) label, promotional literature, or other information concerning the Product provided by Vericel; (4) Payor claims for recoupment of any payments to Vericel for Products; or (4) any negligent, grossly negligent, or willful act or omission by Vericel in the performance of its obligations under this Agreement, except to the extent subject to AllCare’s Indemnification obligations.
|
5.3
|
Indemnification by AllCare. AllCare agrees to indemnify and hold harmless Vericel, its Affiliates and the officers, directors and employees of any of them, from and against all Claims incurred by Vericel arising from or in connection with (1) any negligent, grossly negligent, or willful act or omission by AllCare in the performance of its obligations under this Agreement; (2) any third Party claim arising from AllCare’s negligent actions related to the Products; or (3) AllCare's breach of this Agreement.
|
5.5
|
Insurance. AllCare shall maintain primary, noncontributory medical professional insurance and Commercial General Liability insurance of not less than [***] per occurrence for claims relating to Services. If the required insurance is underwritten on a "claims made" basis, the insurance must include a provision for an extended reporting period ("ERP") of not less than twenty-four months; AllCare further agrees to purchase the ERP if continuous claims made insurance, with a retroactive date not later than the date of this Agreement, is not continually maintained or is otherwise unavailable. Self-insured retentions and/or deductibles shall be at AllCare's sole discretion and responsibility. AllCare warrants that it has sufficient assets to cover any self-insurance or retained risk. Upon request, AllCare will promptly provide satisfactory evidence of the required insurance.
|
6.
|
Taxes
. Each Party shall be responsible to pay or collect any federal, state or local taxes, including excise, sales, use or other taxes ("Taxes") arising from the Party’s performance under this Agreement.
|
7.
|
Term/Termination
.
|
7.1
|
Term. The term of this Agreement will commence on the Effective Date and continue for a period of two (2) years thereafter (the "Term"). The Parties may renew
|
7.2
|
Termination. This Agreement may be terminated by the Parties as follows:
|
a.
|
Either Party may terminate this Agreement for any reason upon ninety (90) days' written notice to the other Party.
|
b.
|
In addition to other available remedies, either Party may immediately terminate this Agreement for cause upon written notice to the other Party upon the other Party's:
|
1.
|
(i) filing an application for or consenting to appointment of a trustee, receiver or custodian of its assets; (ii) having an order for relief entered in Bankruptcy Code proceedings; (iii) making a general assignment for the benefit of creditors; (iv) having a trustee, receiver, or custodian of its assets appointed unless proceedings and the person appointed are dismissed within thirty (30) days; (v) insolvency within the meaning of Uniform Commercial Code Section 1-201 or failing generally to pay its debts as they become due within the meaning of Bankruptcy Code Section 303(h)(l), as amended; or, (vi) certification in writing of its inability to pay its debts as they become due (and either Party may periodically require the other to certify its ability to pay its debts as they become due) (collectively, "Bankruptcy"); or
|
2.
|
failure to perform any material obligation and such failure continues for sixty (60) days after it receives notice of such breach from the non-breaching Party; provided, however, if the other Party has commenced to cure such breach within such sixty (60) days, but such cure is not completed within such sixty (60) days, it will have a reasonable time to complete its cure if it diligently pursues the cure until completion.
|
7.3
|
Effect of Termination. Upon expiration or earlier termination of this Agreement:
|
a.
|
Each Party will immediately pay the other Party all amounts due under any invoice or credit memo;
|
b.
|
The Parties agree to cooperate with one another and use commercially reasonable efforts to ensure a smooth transition up to and through the termination date, including complying with the terms of this Agreement regarding the submission and collection of claims. The Parties also agree that the terms of this Agreement related to the collection of claims shall continue for a period of [***] following the expiration or termination of the Agreement.
|
8.
|
General Provisions
|
8.1
|
Neither Vericel nor AllCare will be liable to the other for failing or delaying the performance of any obligations under this Agreement where such failure or delay arises out of a cause beyond the reasonable control of the Party claiming relief, including, without limitation, storms, floods, other acts of nature, fires, explosions,
|
8.2
|
During the Term, each Party may find it necessary to disclose confidential and proprietary information to the other ("Information"). Information may include but is not limited to [***] for Product by AllCare or Vericel, delivery schedules, manufacturing schedules, [***] amounts and [***]. During the Term and for three years after, regardless of any termination earlier than the expiration of the Term, each Party will maintain Information in confidentiality and may not reveal the Information to third Parties without the written consent of the disclosing Party, except as required by law. Each Party will use Information only for the purposes of this Agreement. These restrictions do not apply to Information that:
|
(1)
|
is in the public domain at the time of disclosure or afterward, other than by breach of this Agreement by the Party receiving the Information;
|
(2)
|
the receiving Party can establish by documentary evidence was in its lawful possession at the time of disclosure by the other Party;
|
(3)
|
is in the possession of the receiving Party from third Parties not under an obligation to maintain its confidentiality;
|
(4)
|
is independently developed by employees of the receiving Party where such employees had no access to Information as shown by documentary evidence; or
|
8.3
|
If either party (with respect to the other party’s Confidential Information) is required or requested to disclose the same by law, court or Regulatory Authority order, subpoena, interrogatory, request for admission, demand or other similar process of Law, such disclosure shall be permitted; provided, however, that the receiving party shall promptly notify the disclosing party of the existence and terms of such legal process and provide the disclosing party a copy of the demand or request, and reasonably assist (at the disclosing party’s cost and expense) the disclosing party’s efforts to obtain a protective order or such other relief as may be available to prevent or limit such disclosure.
|
8.4
|
This Agreement is the entire and only understanding between the Parties as to its subject matter and supersedes all prior promises, agreements or understandings between the Parties. This Agreement may be executed in counterparts. All attachments to this Agreement are incorporated by this reference. This Agreement
|
8.5
|
This Agreement may not be assigned by either Party without the written consent of the other Party, whose consent shall not be unreasonably withheld.
|
8.6
|
All notices, claims, certificates, requests, demands and other communications under this Agreement must be in writing and delivered personally or sent by facsimile transmission, nationally-recognized express courier, or United States registered or certified mail, return receipt requested, addressed as follows. Items delivered personally will be deemed delivered on the date of actual delivery. Items sent by facsimile will be deemed delivered on the day sent if sent during normal business hours of the receiving Party (or, otherwise, on the first business day after the date of transmission). Items sent by certified or registered mail will be deemed delivered three (3) business days after mailing. Either Party may change its contact information by a written notice delivered pursuant to this Section.
|
8.7
|
Captions in this Agreement are intended for convenience of reference only. Words, regardless of the number and gender specifically used, will be construed to include any other number, singular or plural, and any gender, masculine, feminine, or neuter, as the context requires. "And" includes "or." "Or" is disjunctive but not necessarily exclusive. "Including" means "including but not limited to." This Agreement will be interpreted as if written jointly by the Parties. This Agreement will benefit, and be binding upon, the successors and assigns of the patties. The relationship between the Parties is that of independent contractors and not partners, joint ventures, principal and agent or employer and employee. Time is of the essence in the performance of all obligations under this Agreement.
|
8.8
|
Neither party shall issue or release any announcement, statement, press release or other publicity or marketing materials relating to this Agreement without the prior consent of the other party (which consent shall not unreasonably be withheld or delayed); provided, however that either Vericel or AllCare may identify the other as a provider or customer of services hereunder without obtaining the consent of the other party. If Vericel files a copy of this Agreement with any regulatory authority or any stock exchange, Vericel shall, to the extent permitted by law or the rules of any applicable stock exchange, redact or otherwise obtain confidential treatment of any of the pricing or other confidential terms set forth in this Agreement.
|
8.9
|
Neither Party's failure to insist on performance of any term, condition, or instruction nor failure to exercise any right or privilege or its waiver of any breach, shall thereafter be construed to constitute a waiver of such term, condition, instruction, right or privilege. No consent or waiver, expressed or implied, by a Party to the performance by the other Party or of any breach or default by the other Party of its obligations hereunder shall be deemed or construed to be a consent or waiver to or of any other breach or default in the performance by such other Party of the same or any other obligations of such other Party hereunder. The giving of consent by a Party in any one instance shall not limit or waive the necessity to obtain such Party's consent in any future instance. No waiver of any rights under this Agreement
shall
be binding unless it is in writing and signed by the Party waiving such rights.
|
8.10
|
This Agreement shall be governed by the laws of the Commonwealth of Massachusetts.
|
1.
|
Product.
|
|
Product
|
NDC Number
|
|
MACI
|
69866-1030-01
|
|
MACI
|
69866-1030-02
|
2.
|
Payment Terms.
|
A.
|
Vericel shall pay AllCare [***] for each Patient to whom Product is dispensed. If a customer receives more than one Product within the same order, AllCare shall receive [***].
|
B.
|
At the end of each [***], AllCare shall invoice Vericel for Product dispensed during the [***]. Vericel shall pay the undisputed amounts of the invoice within [***] days of its receipt.
|
C.
|
On a [***] basis, AllCare shall remit to Vericel all reimbursement [***] related to the Product received by AllCare. Such payments shall include the case number and other identifiers agreed to by the Parties.
|
D.
|
All [***] payments for the Product (“Vericel Funds”) shall be deposited into a bank account maintained by and in the name and sole control of Vericel (the “Vericel Account”). In conjunction with each deposit, AllCare shall remit to Vericel a schedule detailing the cases for which a payment was deposited into the account including the case number and the amount deposited for each case..
|
E.
|
In addition to the remitting of payment into the Vericel Account, AllCare shall update, on a [***] basis, the payment status of submitted Cases to Vericel and its contractors through the web-based data sharing platform or other mutually agreed upon method.
|
F.
|
All payments (including interest payments, if any) for the Product received by AllCare after the expiration or termination of this Agreement shall be the sole property of Vericel and shall be remitted to Vericel in accordance with this Agreement.
|
G.
|
AllCare represents and warrants that the billing and collection procedures set forth in this Agreement comply with all applicable laws and with each of AllCare’s Payor agreements.
|
H.
|
The Parties agree that such fees are not designed nor constitute inducements for AllCare to utilize or recommend the utilization of Vericel Products under federal and/or similar state laws. AllCare shall properly disclose and otherwise comply with applicable law.
|
I.
|
In the event that any Payor recoups any amounts paid to AllCare for Products, whether by requiring payment from AllCare or by offsetting the recoupment amount from amounts owed by a Payor to AllCare for pharmacy benefits, Vericel shall reimburse AllCare for the amount of such recoupment.
|
1.
|
Exhibit A
. The Parties agree that Section 4(A) of Exhibit A to the Agreement – Payment Terms and Pricing shall be modified to state the following:
|
2.
|
Exhibit B.
The Parties agree that Exhibit B to the Agreement – Exclusive Payors shall be deleted and replaced with the attached revised Exhibit B.
|
3.
|
Exhibit C.
The Parties agree that Exhibit C to the Agreement – Existing Eligible Cases shall be deleted.
|
4.
|
No Other Changes
. To the extent terms in the Fifth Amendment conflict with the Agreement and/or any of the amendments to the Agreement, the terms of this Fifth Amendment shall prevail. Except as provided in this Fifth Amendment, the terms and conditions of the Agreement will continue in full force.
|
5.
|
Counterparts/Signatures
. This Fifth Amendment may be executed in multiple counterparts, each of which constitutes an original, and all of which, collectively, constitute only one agreement. The signatures of the parties need not appear on the same counterpart, and delivery of an executed counterpart signature page by facsimile or other form of electronic transmission shall
|
Vericel Corporation
By: /s/Daniel Orlando
Name: Daniel Orlando
Title: Chief Operating Officer
Date:
10 August 2018
|
Orsini Pharmaceutical Services, Inc.
By: /s/Carla Sawa
Name: Carla Sawa
Title: Chief Financial Officer
Date:
10 August 2018
|
|
/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)
|