☒ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
California
|
94-3127919
|
|
(State or other jurisdiction of incorporation or organization)
|
(IRS Employer Identification No.)
|
Large accelerated filer
|
☐
|
Accelerated filer
|
☒
|
|
Non-accelerated filer
|
☐
|
(Do not check if a smaller reporting company)
|
Smaller reporting company
|
☐
|
Item 1. | Financial Statements |
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2015
|
2014
|
2015
|
2014
|
|||||||||||||
REVENUES:
|
||||||||||||||||
Subscription and advertisement revenues
|
$
|
343
|
$
|
285
|
$
|
1,020
|
$
|
880
|
||||||||
Royalties from product sales
|
357
|
148
|
631
|
322
|
||||||||||||
Grant income
|
1,466
|
648
|
3,596
|
1,863
|
||||||||||||
Sale of research products and services
|
140
|
110
|
328
|
300
|
||||||||||||
Total revenues
|
2,306
|
1,191
|
5,575
|
3,365
|
||||||||||||
Cost of sales
|
(432
|
)
|
(231
|
)
|
(957
|
)
|
(614
|
)
|
||||||||
Gross profit
|
1,874
|
960
|
4,618
|
2,751
|
||||||||||||
OPERATING EXPENSES:
|
||||||||||||||||
Research and development
|
(11,433
|
)
|
(8,836
|
)
|
(29,816
|
)
|
(26,268
|
)
|
||||||||
General and administrative
|
(7,545
|
)
|
(4,262
|
)
|
(18,911
|
)
|
(12,764
|
)
|
||||||||
Total operating expenses
|
(18,978
|
)
|
(13,098
|
)
|
(48,727
|
)
|
(39,032
|
)
|
||||||||
Loss from operations
|
(17,104
|
)
|
(12,138
|
)
|
(44,109
|
)
|
(36,281
|
)
|
||||||||
OTHER INCOME/(EXPENSE):
|
||||||||||||||||
Interest expense, net
|
(12
|
)
|
(7
|
)
|
(207
|
)
|
(30
|
)
|
||||||||
Other income/(expense), net
|
(573
|
)
|
(119
|
)
|
(408
|
)
|
157
|
|||||||||
Total other income/(expense), net
|
(585
|
)
|
(126
|
)
|
(615
|
)
|
127
|
|||||||||
LOSS BEFORE INCOME TAX BENEFIT
|
(17,689
|
)
|
(12,264
|
)
|
(44,724
|
)
|
(36,154
|
)
|
||||||||
Deferred income tax benefit
|
948
|
2,313
|
3,395
|
5,175
|
||||||||||||
NET LOSS
|
(16,741
|
)
|
(9,951
|
)
|
(41,329
|
)
|
(30,979
|
)
|
||||||||
Net loss attributable to non-controlling interest
|
3,115
|
1,683
|
7,762
|
5,151
|
||||||||||||
NET LOSS ATTRIBUTABLE TO BIOTIME, INC.
|
(13,626
|
)
|
(8,268
|
)
|
(33,567
|
)
|
(25,828
|
)
|
||||||||
Dividends on preferred shares
|
(363
|
)
|
(34
|
)
|
(415
|
)
|
(34
|
)
|
||||||||
NET LOSS ATTRIBUTABLE TO BIOTIME, INC. COMMON SHAREHOLDERS
|
$
|
(13,989
|
)
|
$
|
(8,302
|
)
|
$
|
(33,982
|
)
|
$
|
(25,862
|
)
|
||||
BASIC AND DILUTED NET LOSS PER COMMON SHARE
|
$
|
(0.18
|
)
|
$
|
(0.12
|
)
|
$
|
(0.43
|
)
|
$
|
(0.41
|
)
|
||||
WEIGHTED AVERAGE NUMBER OF COMMON STOCK OUTSTANDING: BASIC AND DILUTED
|
79,224
|
67,921
|
78,619
|
62,594
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
|||||||||||||||
2015
|
2014
|
2015
|
2014
|
|||||||||||||
NET LOSS
|
$
|
(16,741
|
)
|
$
|
(9,951
|
)
|
$
|
(41,329
|
)
|
$
|
(30,979
|
)
|
||||
Other comprehensive loss, net of tax:
|
||||||||||||||||
Change in foreign currency translation and other comprehensive income/(loss) from equity investments:
|
||||||||||||||||
Foreign currency translation gain/(loss)
|
44
|
(67
|
)
|
(273
|
)
|
(216
|
)
|
|||||||||
Unrealized loss on available-for-sale securities, net of taxes
|
-
|
(1
|
)
|
-
|
(3
|
)
|
||||||||||
COMPREHENSIVE LOSS
|
(16,697
|
)
|
(10,019
|
)
|
(41,602
|
)
|
(31,198
|
)
|
||||||||
Less: Comprehensive loss attributable to non-controlling interest
|
(3,115
|
)
|
(1,683
|
)
|
(7,762
|
)
|
(5,151
|
)
|
||||||||
COMPREHENSIVE LOSS ATTRIBUTABLE TO BIOTIME, INC. BEFORE PREFERRED STOCK DIVIDEND
|
(13,582
|
)
|
|
(8,336
|
)
|
(33,840
|
)
|
(26,047
|
)
|
|||||||
Preferred stock dividend
|
(363
|
)
|
(34
|
)
|
(415
|
)
|
(34
|
)
|
||||||||
COMPREHENSIVE LOSS ATTRIBUTABLE TO BIOTIME, INC. COMMON SHAREHOLDERS
|
$
|
(13,945
|
)
|
$
|
(8,370
|
)
|
$
|
(34,255
|
)
|
$
|
(26,081
|
)
|
Nine Months Ended
September 30
|
||||||||
2015
|
2014
|
|||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Net loss attributable to BioTime, Inc.
|
$
|
(33,567
|
)
|
$
|
(25,828
|
)
|
||
Net loss allocable to non-controlling interest
|
(7,762
|
)
|
(5,151
|
)
|
||||
Adjustments to reconcile net loss attributable to BioTime, Inc. to net cash used in operating activities:
|
||||||||
Depreciation expense
|
776
|
794
|
||||||
Amortization of intangible assets
|
3,942
|
4,104
|
||||||
Amortization of deferred consulting fees
|
-
|
19
|
||||||
Amortization of deferred license fees
|
85
|
82
|
||||||
Amortization of prepaid rent in common stock
|
63
|
42
|
||||||
Stock-based compensation
|
7,189
|
3,321
|
||||||
Amortization of discount on related party convertible debt
|
182
|
4
|
||||||
Loss on sale or write-off of equipment
|
-
|
9
|
||||||
Write-off for uncollectible receivables
|
-
|
(16
|
)
|
|||||
Deferred income tax benefit
|
(3,395
|
)
|
(5,175
|
)
|
||||
Contingently issuable subsidiary warrants in lieu of investor relations expenses
|
65
|
-
|
||||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable, net
|
(114
|
)
|
(86
|
)
|
||||
Grant receivable
|
212
|
66
|
||||||
Inventory
|
6
|
(75
|
)
|
|||||
Prepaid expenses and other current assets
|
(621
|
)
|
(114
|
)
|
||||
Other long-term assets
|
(100
|
)
|
-
|
|||||
Accounts payable and accrued liabilities
|
512
|
(1,545
|
)
|
|||||
Accrued interest on related party convertible debt
|
14
|
1
|
||||||
Other long-term liabilities
|
(9
|
)
|
(124
|
)
|
||||
Deferred grant income
|
1,869
|
-
|
||||||
Deferred rent liabilities
|
(2
|
)
|
(14
|
)
|
||||
Lease liability, noncurrent
|
(12
|
)
|
-
|
|||||
Deferred revenues
|
70
|
(58
|
)
|
|||||
Net cash used in operating activities
|
(30,597
|
)
|
(29,744
|
)
|
||||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Purchase of equipment
|
(514
|
)
|
(497
|
)
|
||||
Payments on construction in progress
|
(3,830
|
)
|
-
|
|||||
Loan receivable
|
(500 | ) | - | |||||
Proceeds from the sale of equipment
|
-
|
4
|
||||||
Security deposit paid, net
|
(9
|
)
|
(306
|
)
|
||||
Cash used in investing activities
|
(4,853
|
)
|
(799
|
)
|
||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Proceeds from exercises of stock options
|
621
|
220
|
||||||
Proceeds from sale of preferred stock
|
-
|
3,500
|
||||||
Proceeds from issuance of common shares
|
8,578
|
14,724
|
||||||
Fees paid on sale of common shares
|
-
|
(298
|
)
|
|||||
Proceeds from exercise of warrants
|
19
|
-
|
||||||
Proceeds from exercise of subsidiary stock options
|
27
|
-
|
||||||
Proceeds from sale of treasury shares
|
576
|
-
|
||||||
Proceeds from exercise of subsidiary warrants
|
11,700
|
-
|
||||||
Proceeds from sale of treasury shares and issuance of subsidiary warrants
|
-
|
13,582
|
||||||
Proceeds from sale of subsidiary common shares
|
11,586
|
468
|
||||||
Fees paid on sale of subsidiary common shares
|
(597
|
)
|
-
|
|||||
Reimbursement from landlord on construction in progress
|
2,564
|
-
|
||||||
Proceeds from issuance of related party convertible debt
|
188
|
467
|
||||||
Repayment of capital lease obligation
|
(31
|
)
|
(13
|
)
|
||||
Net cash provided by financing activities
|
35,231
|
32,650
|
||||||
Effect of exchange rate changes on cash and cash equivalents
|
110
|
(186
|
)
|
|||||
NET INCREASE/(DECREASE) IN CASH AND CASH EQUIVALENTS
|
(109
|
)
|
1,921
|
|||||
CASH AND CASH EQUIVALENTS:
|
||||||||
At beginning of the period
|
29,487
|
5,495
|
||||||
At end of the period
|
$
|
29,378
|
$
|
7,416
|
1.
|
Organization, Basis of Presentation, and Liquidity
|
(1) | Includes shares owned by BioTime, Asterias, and ESI. |
(2) | LifeMap Sciences, Ltd. and LifeMap Solutions, Inc. are wholly-owned subsidiaries of LifeMap Sciences, Inc. |
(3) | Includes shares owned by BioTime and Asterias. |
(4) | See Note 12 regarding OncoCyte’s O ctober 7, 2015, filing of a registration statement on Form 10 with the SEC in connection with BioTime’s planned distribution of shares of OncoCyte common stock to holders of BioTime common shares, on a pro rata basis . |
2.
|
Summary of Significant Accounting Policies
|
3.
|
Inventory, net
|
4.
|
Equipment, net and construction in progress
|
September 30,
2015
(Unaudited)
|
December 31,
2014
|
||||||||
Equipment, furniture and fixtures
|
$
|
5,383
|
$
|
4,871
|
|||||
Construction in progress
|
4,604
|
406
|
|||||||
Accumulated depreciation
|
(3,206
|
)
|
(2,419
|
)
|
|||||
Equipment, net and construction in progress
|
$
|
6,781
|
$
|
2,858
|
5.
|
Intangible assets, net
|
September 30,
2015
(Unaudited)
|
December 31,
2014
|
||||||||
Intangible assets
|
$
|
52,562
|
$
|
52,562
|
|||||
Accumulated amortization
|
(17,656
|
)
|
(13,714
|
)
|
|||||
Intangible assets, net
|
$
|
34,906
|
$
|
38,848
|
6.
|
Deferred License Fees
|
Year Ended
December 31,
|
Deferred
License Fees
|
||||
2015
|
$
|
34
|
|||
2016
|
125
|
||||
2017
|
120
|
||||
2018
|
83
|
||||
2019
|
34
|
||||
Thereafter
|
75
|
||||
Total
|
$
|
471
|
7.
|
Accounts Payable and Accrued Liabilities
|
September 30,
2015
(Unaudited)
|
December 31,
2014
|
||||||||
Accounts payable
|
$
|
1,934
|
$
|
2,297
|
|||||
Accrued expenses
|
4,729
|
3,125
|
|||||||
Accrued bonuses
|
804
|
964
|
|||||||
Other current liabilities
|
326
|
417
|
|||||||
Total
|
$
|
7,793
|
$
|
6,803
|
8.
|
Commitments and Related Party Transactions
|
9.
|
Shareholders’ Equity
|
10.
|
Sales of BioTime Common Shares by Subsidiaries
|
11.
|
Segment Information
|
12.
|
Subsequent Events
|
Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations |
Three Months Ended
September 30,
|
$ Increase
|
% Increase
|
|||||||||||||||
2015
|
2014
|
||||||||||||||||
License fees
|
$
|
343
|
$
|
285
|
$
|
+58
|
+20
|
%
|
|||||||||
Royalty from product sales
|
357
|
148
|
+209
|
+141
|
%
|
||||||||||||
Grant income
|
1,466
|
648
|
+818
|
+126
|
%
|
||||||||||||
Sales of research products and services
|
140
|
110
|
+30
|
+27
|
%
|
||||||||||||
Total revenues
|
2,306
|
1,191
|
+1,115
|
+94
|
%
|
||||||||||||
Cost of sales
|
(432
|
)
|
(231
|
)
|
+201
|
+87
|
%
|
||||||||||
Total revenues, net
|
1,874
|
960
|
+914
|
+95
|
%
|
Nine Months Ended
September 30,
|
$ Increase
|
% Increase
|
|||||||||||||||
2015
|
2014
|
||||||||||||||||
License fees
|
$
|
1,020
|
$
|
880
|
$
|
+140
|
+16
|
%
|
|||||||||
Royalty from product sales
|
631
|
322
|
+309
|
+96
|
%
|
||||||||||||
Grant income
|
3,596
|
1,863
|
+1,733
|
+93
|
%
|
||||||||||||
Sales of research products and services
|
328
|
300
|
+28
|
+9
|
%
|
||||||||||||
Total revenues
|
5,575
|
3,365
|
+2,210
|
+66
|
%
|
||||||||||||
Cost of sales
|
(957
|
)
|
(614
|
)
|
+343
|
+56
|
%
|
||||||||||
Total revenues, net
|
4,618
|
2,751
|
+1,867
|
+68
|
%
|
Three Months Ended
September 30,
|
Nine Months Ended
September 30,
|
||||||||||||||||
2015
|
|
2014 |
2015
|
2014
|
|||||||||||||
Asterias
|
353
|
85
|
528
|
167
|
|||||||||||||
BioTime
|
4
|
63
|
103
|
155
|
|||||||||||||
Total royalty revenues
|
357
|
148
|
631
|
322
|
Three Months Ended
September 30,
|
$ Increase
|
% Increase
|
|||||||||||||||
2015
|
2014
|
||||||||||||||||
Research and development expenses
|
$
|
(11,433
|
)
|
$
|
(8,836
|
)
|
$
|
+2,597
|
+29
|
%
|
|||||||
General and administrative expenses
|
(7,545
|
)
|
(4,262
|
)
|
+3,283
|
+77
|
%
|
Nine Months Ended
September 30,
|
$ Increase
|
% Increase
|
|||||||||||||||
2015
|
2014
|
||||||||||||||||
Research and development expenses
|
$
|
(29,816
|
)
|
$
|
(26,268
|
)
|
$
|
+3,548
|
+14
|
%
|
|||||||
General and administrative expenses
|
(18,911
|
)
|
(12,764
|
)
|
+6,147
|
+48
|
%
|
Amount
(1)
|
Percent
|
||||||||||||||||||
Company
|
Program
|
2015
|
2014
|
2015
|
2014
|
||||||||||||||
Asterias
|
hESC-based cell therapy and immunotherapy programs
|
$
|
11,839
|
$
|
7,910
|
39.7
|
%
|
30.1
|
%
|
||||||||||
BioTime
|
Hextend
®
|
$
|
41
|
$
|
49
|
0.1
|
%
|
0.2
|
%
|
||||||||||
BioTime
|
3D Culture
|
$
|
-
|
$
|
128
|
0.0
|
%
|
0.5
|
%
|
||||||||||
BioTime
|
Renevia™
and
HyStem
®
hydrogel products
|
$
|
2,774
|
$
|
4,487
|
9.3
|
%
|
17.1
|
%
|
||||||||||
BioTime and ESI
|
PureStem
®
hEPCs, cGMP hES cell lines, and related research products
|
$
|
3,587
|
$
|
2,397
|
12.0
|
%
|
9.1
|
%
|
||||||||||
Cell Cure Neurosciences
|
OpRegen
®
,
OpRegen
®
-Plus
, and neurological disease therapies
|
$
|
2,729
|
$
|
4,182
|
9.2
|
%
|
15.9
|
%
|
||||||||||
LifeMap Sciences
|
Database and mobile health software applications
|
$
|
3,792
|
$
|
2,754
|
12.7
|
%
|
10.5
|
%
|
||||||||||
OncoCyte
|
Cancer diagnostics
|
$
|
3,675
|
$
|
2,744
|
12.3
|
%
|
10.4
|
%
|
||||||||||
OrthoCyte
|
Orthopedic therapy
|
$
|
468
|
$
|
552
|
1.6
|
%
|
2.1
|
%
|
||||||||||
ReCyte Therapeutics
|
Cardiovascular therapy
|
$
|
911
|
$
|
1,065
|
3.1
|
%
|
4.1
|
%
|
||||||||||
Total
|
$
|
29,816
|
$
|
26,268
|
100.0
|
%
|
100.0
|
%
|
(1) | Amount also includes research and development expenses incurred directly by the applicable subsidiary and certain general research and development expenses, such as laboratory supplies, laboratory expenses, rent allocated, and insurance allocated to research and development expenses, incurred directly by BioTime on behalf of the subsidiary and allocated to the subsidiary. |
Amount
(1)
|
Percent
|
||||||||||||||||
Company
|
2015
|
2014
|
2015
|
2014
|
|||||||||||||
BioTime
|
$
|
6,104
|
$
|
4,789
|
32.3
|
%
|
37.5
|
%
|
|||||||||
Asterias
|
$
|
4,769
|
$
|
4,108
|
25.2
|
%
|
32.2
|
%
|
|||||||||
BioTime Asia
|
$
|
8
|
$
|
12
|
0.1
|
%
|
0.1
|
%
|
|||||||||
Cell Cure Neurosciences
|
$
|
444
|
$
|
534
|
2.3
|
%
|
4.2
|
%
|
|||||||||
ESI
|
$
|
161
|
$
|
153
|
0.9
|
%
|
1.2
|
%
|
|||||||||
LifeMap Sciences
|
$
|
4,048
|
$
|
1,986
|
21.4
|
%
|
15.6
|
%
|
|||||||||
OncoCyte
|
$
|
2,709
|
$
|
568
|
14.3
|
%
|
4.4
|
%
|
|||||||||
OrthoCyte
|
$
|
347
|
$
|
304
|
1.8
|
%
|
2.4
|
%
|
|||||||||
ReCyte Therapeutics
|
$
|
321
|
$
|
310
|
1.7
|
%
|
2.4
|
%
|
|||||||||
Total
|
$
|
18,911
|
$
|
12,764
|
100.0
|
%
|
100.0
|
%
|
(1) | Amount includes general and administrative expenses incurred directly by the subsidiary and allocations from BioTime for certain general overhead expenses. |
Principal Payments Due by Period
|
||||||||||||||||||||||
Contractual Obligations
(1)
|
Total
|
Less Than
1 Year
|
1-3 Years
|
4-5 Years
|
After
5 Years
|
|||||||||||||||||
Operating leases
(2)
|
$
|
10,068
|
364
|
2,910
|
2,760
|
4,034
|
||||||||||||||||
Capital lease
(3)
|
$
|
53
|
16
|
37
|
-
|
-
|
(1) | This table does not include payments to key employees that could arise if they were involuntary terminated or if their employment terminated following a change in control. |
(2) | Includes the lease of our principal office and laboratory facilities in Alameda, California, and leases of the offices and laboratory facilities of our subsidiaries Asterias, LifeMap Sciences, and Cell Cure Neurosciences. Also includes three operating leases for lab equipment. |
(3) | Includes one capital lease for lab equipment. |
Item 3. | Quantitative and Qualitative Disclosures about Market Risk |
Item 4. | Controls and Procedures |
Item 1. | Legal Proceedings. |
Item 1A. | Risk Factors |
· | We are attempting to develop new medical products and technologies. |
· | Many of our experimental products and technologies have not been applied in human medicine and have only been used in laboratory studies in vitro or in animals. These new products and technologies might not prove to be safe and efficacious in the human medical applications for which they were developed. |
· | The development of experimental products and technologies we are doing is costly, time consuming, and uncertain as to its results. We incurred research and development expenses amounting to $29.8 million, during the nine months ended September 30, 2015, and $37.5 million, $26.6 million, and $18.1 million during the fiscal years ended December 31, 2014, 2013, and 2012, respectively, excluding $17.4 million charged as in process research and development expenses during 2013 in accordance with ASC 805-50 on account of Asterias’ acquisition of certain assets from Geron. |
· | If we are successful in developing a new technology or product, refinement of the new technology or product and definition of the practical applications and limitations of the technology or product may take years and require the expenditure of large sums of money. Future clinical trials of new therapeutic products, particularly those products that are regulated as drugs or biological, will be very expensive and will take years to complete. We may not have the financial resources to fund clinical trials on our own and we may have to enter into licensing or collaborative arrangements with larger, well-capitalized pharmaceutical companies in order to bear the cost. Any such arrangements may be dilutive to our ownership or economic interest in the products we develop, and we might have to accept a royalty payment on the sale of the product rather than receiving the gross revenues from product sales. |
· | At September 30, 2015, we had $29.4 million of cash and cash equivalents on hand, of which $24.8 million was held by Asterias and other subsidiaries. Although Asterias has raised approximately $20.0 million and OncoCyte has raised $3.3 million of equity capital since January 1, 2015, there can be no assurance that we or our subsidiaries will be able to raise additional funds on favorable terms or at all, or that any funds raised will be sufficient to permit us or our subsidiaries to develop and market our products and technology. Unless we and our subsidiaries are able to generate sufficient revenue or raise additional funds when needed, it is likely that we will be unable to continue our planned activities, even if we make progress in our research and development projects. |
· | We may have to postpone or limit the pace of our research and development work and planned clinical trials of our product candidates unless our cash resources increase through a growth in revenues or additional equity investment or borrowing. |
· | OncoCyte may be required to obtain pre-market clearance or approval before selling its diagnostic tests; |
· | As a result of required FDA pre-market review, OncoCyte’s tests may not be cleared or approved on a timely basis, if at all; |
· | FDA labeling requirements may limit OncoCyte’s claims about its diagnostic tests, which may have a negative effect on orders from physicians; |
· | The regulatory approval process may involve, among other things, successfully completing additional clinical trials and making a 510(k) submission, or filing a pre-market approval application with the FDA; and, |
· | If regulatory actions affect any of the reagents OncoCyte obtain from suppliers and use in conducting its tests, its business could be adversely affected in the form of increased costs of testing or delays, limits or prohibitions on the purchase of reagents necessary to perform its testing. |
· | If data shows that the list price was greater than 130% of the payment using established methodology (a weighted median), CMS will recoup the difference from the laboratory through a payment claw back. |
· | Payment will be updated annually based on the weighted median of commercial payer reimbursement. |
Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds |
Item 3. | Default Upon Senior Securities |
Item 4. | Mine Safety Disclosures |
Item 5. | Other Information |
Item 6. | Exhibits |
Exhibit
Numbers
|
Description
|
3.1
|
Articles of Incorporation with all amendments (1)
|
3.2
|
By-Laws, as Amended (2)
|
4.1
|
Specimen of Series A Convertible Preferred Stock Certificate (3)
|
4.2
|
Certificate of Determination of Series A Convertible Preferred Stock (3)
|
10.1
|
Stock Purchase Agreements, dated September 14, 2015, between BioTime, Inc. and certain investors*
|
10.2
|
Letter Agreement, dated September 24, 2015, between BioTime, Inc. and Union Underwriting & Finances Ltd. (4)
|
10.3
|
Stock Purchase Agreements between BioTime, Inc. and certain investors*
|
10.4
|
Research & Development Agreement, dated September 29, 2015, between OrthoCyte Corporation and
Heraeus Medical GmbH (Portions of this exhibit have been omitted pursuant to a request for confidential treatment)*
|
10.5
|
License Agreement, dated
September 29, 2015, between OrthoCyte Corporation and
Heraeus Medical GmbH (Portions of this exhibit have been omitted pursuant to a request for confidential treatment)*
|
(1) | Incorporated by reference to BioTime’s Annual Report on Form 10-K/A-1 for the year ended December 31, 2013 filed with the Securities and Exchange Commission on April 29, 2014. |
(2) | Incorporated by reference to Registration Statement on Form S-1, File Number 33-48717 and Post-Effective Amendment No. 1 thereto filed with the Securities and Exchange Commission on June 22, 1992, and August 27, 1992, respectively. |
(3) | Incorporated by reference to BioTime’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 5, 2014. |
(4) | Incorporated by reference to Current Report on Form 8-K filed with the Securities and Exchange Commission on September 25, 2015. |
* | Filed herewith |
BIOTIME, INC.
|
||
Date: November 9, 2015
|
/s/ Michael D. West
|
|
Michael D. West
|
||
Co-Chief Executive Officer
|
Date: November 9, 2015
|
/s/ Aditya Mohanty
|
|
Aditya Mohanty
|
||
Co-Chief Executive Officer
|
Date: November 9, 2015
|
/s/ Robert W. Peabody
|
|
Robert W. Peabody
|
||
Chief Financial Officer
|
(1) | Incorporated by reference to BioTime’s Annual Report on Form 10-K/A-1 for the year ended December 31, 2013 filed with the Securities and Exchange Commission on April 29, 2014. |
(2) | Incorporated by reference to Registration Statement on Form S-1, File Number 33-48717 and Post-Effective Amendment No. 1 thereto filed with the Securities and Exchange Commission on June 22, 1992, and August 27, 1992, respectively. |
(3) | Incorporated by reference to BioTime’s Current Report on Form 8-K filed with the Securities and Exchange Commission on March 5, 2014. |
(4) | Incorporated by reference to Current Report on Form 8-K filed with the Securities and Exchange Commission on September 25, 2015. |
* | Filed herewith |
To Purchaser:
|
|
At the address or FAX number or email address of
|
|
Purchaser shown on the signature page of this Agreement
|
|||
To the Company:
|
BioTime Inc.
|
||
1301 Harbor Bay Parkway
|
|||
Alameda, California 94502
|
|||
Attention: Chief Financial Officer
|
|||
FAX: (510) 521- 3389
|
|||
Email: rpeabody@biotimemail.com
|
BioTime, Inc.
|
||
By:
|
/s/Michael D. West
|
|
Title:
|
Chief Executive Officer
|
|
PURCHASER
:
|
||
Broadwood Partners, L.P.
|
By:
|
/s/Neal C. Bradsher
|
Title:
|
President of the General Partner (Broadwood Capital, Inc.)
|
Number of Shares Purchased:
|
2,431,611
|
Address:
|
724 Fifth Avenue, 9
th
Floor
|
|
New York, NY 10019
|
FAX Number: |
(212) 508 5756
|
Email: |
|
To Purchaser: | At the address or FAX number or email address of Purchaser shown on the signature page of this Agreement |
To the Company: | BioTime Inc. |
By:
|
/s/Michael D. West
|
|
Title:
|
Chief Executive Officer
|
By:
|
/s/Phyllis M. Esposito
|
|
Title:
|
Number of Shares Purchased:
|
100,000
|
Address:
|
c/o Scarsdale Equities LLC
|
|
10 Rockefeller Plaza Suite 720
|
||
New York, NY 10020
|
FAX Number:
|
(212) 969-9013
|
Email:
|
lana@scarsdale-equities.com
|
To Purchaser: | At the address or FAX number or email address of Purchaser shown on the signature page of this Agreement |
To the Company: | BioTime Inc. |
By:
|
/s/Michael D. West
|
|
Title:
|
Chief Executive Officer
|
By:
|
/s/John Hotsopoulos
|
|
Title:
|
Number of Shares Purchased:
|
15,000
|
Address:
|
c/o Scarsdale Equities LLC
|
|
10 Rockefeller Plaza Suite 720
|
||
New York, NY 10020
|
FAX Number: |
(212) 969-9013
|
Email:
|
lana@scarsdale-equities.com
|
To Purchaser: | At the address or FAX number or email address of Purchaser shown on the signature page of this Agreement |
To the Company: | BioTime Inc. |
By:
|
/s/Michael D. West
|
|
Title:
|
Chief Executive Officer
|
By:
|
/s/Patrick Lin
|
|
Title:
|
|
Number of Shares Purchased:
|
60,790
|
Address:
|
45 Coachwood Terrace
|
|
Orinda, CA 64563
|
FAX Number:
|
Email:
|
bzliteyear@gmail.com
|
To any Purchaser: | At the address or FAX number or email address of Purchaser shown on the signature page of this Agreement |
To the Company: |
BioTime Inc.
1301 Harbor Bay Parkway
Alameda, California 94502
Attention: Chief Financial Officer
FAX: (510) 521- 3389
Email: rpeabody@biotimemail.com
|
COMPANY:
|
||
BioTime, Inc.
|
||
By:
|
/s/R W Peabody
|
|
Title:
|
SR VP
|
PURCHASER
:
|
||
Harel Financial Products Ltd.
|
||
By:
|
/s/Uri Shur
|
|
Uri Shur
|
||
Title:
|
CEO
|
|
By:
|
/s/David Yedid
|
|
David Yedid
|
||
Title: |
V.P.
|
Address: | 7 Jabotinsky St. |
Ranat-Gan | |
Israel | |
FAX Number: 03-754-6311 | |
Email: uris@hf.co.il |
WHEREAS | the Company and Purchaser have entered into a Purchase Agreement pursuant to which the Company shall sell Purchaser common shares of the Company, no par value (the " Shares "), in exchange for the Purchase Price (as defined in the Purchase Agreement) |
WHEREAS | the Company and Purchaser have agreed and desirous and willing that the closing of the Purchase Agreement will take place in accordance with the terms and provisions of this Agreement; |
WHEREAS | The Parties wish to appoint Union Bank Trust Co. Ltd to hold the Purchase Price for the purpose of ensuring the delivery of the Shares against receipt of the Purchase Price, in accordance with the terms of this Agreement and the share price as defined below; |
1. | The Company and the Purchaser hereby appoint the Union Bank Trust Co. Ltd Company as the "Escrow Agent" under this Agreement to hold the Purchase Price, and Union Bank Trust Co. Ltd accepts such designation and appointment and agrees to act in accordance with the terms of this Agreement and Purchase Agreement. It is hereby expressly provided that in the event a conflict should arise as between the terms of this Agreement and the Purchase Agreement, the terms of this Agreement shall control. The Escrow Agent agrees that upon receipt of the Purchase Price in accordance with Section 2 below, the Escrow Agent shall hold such funds in accordance with this Agreement. |
2. | Term of Escrow; Deposit and/or release of the shares and the Purchase Price . |
2.1. | At the end of the last Tel Aviv Stock Exchange Ltd. ("TASE") trading day preceding the Index Calculation Date (as defined in the Purchase Agreement, herein: "The Pricing Date"), the Purchaser shall deliver the Purchase Price to the Escrow Agent by wire transfer by depositing the Purchase Price to the bank account designated by Escrow Agent to the Company and Purchaser and by sending a proper documentation of such wire transfer to amos-f@ubi.co.il + shai@ubi.co.il ("E-Mail Delivery"). The Purchase Price shall be paid in Israeli New Shekels (NIS) and in immediately available funds. Union Underwriting & Finances Ltd. ("Union Underwriters") will notify the Escrow Agent of the Price Per Share determined according to the Purchase Agreement (the "PPS") that will be the last price of the Company's share at TASE in the Pricing Date and will calculate the Purchase Price for the purpose of the escrow. The above PPS and calculations by Union Underwriters are limited to the purposes of the Escrow Agreement and will not deteriorate from the parties' rights according to the Purchase Agreement. The parties hereby waive and release Union Underwriters from any claim regarding the PPS and the calculations. |
2.2. | The Escrow Agent shall immediately notify the Company and the Purchaser in writing of receipt of the Purchase Price (the "Written Notification"). |
2.3. | On or before the date on which the Purchase Prices is deposited with the Escrow Agent, Purchaser shall notify the Company and the Escrow Agent of the name, telephone number, and email address of an authorized person at the financial institution that will receive the Shares for Purchaser’s account, who the Company and the Escrow Agent may contact to confirm receipt of the Shares. |
2.4. | Upon receiving Written Notification, the Company shall take all necessary actions for the issuance of the Shares in the manner provided in the Purchase Agreement. Purchaser acknowledges and agrees to provide the Company with the proper Depository Trust Company Deposit/Withdrawal at Custodian system (“DWAC”) number for the account into which Purchaser’s Shares are to be issued. Purchaser shall provide American Stock Transfer & Trust Company, LLC, the transfer agent and registrar of the Shares (the “Transfer Agent”), with all information and documentation that the Transfer Agent requires to issue the Shares. |
2.5. | The Transfer Agent shall promptly provide written notification of the issuance of the Shares by DWAC to the account designated by Purchaser. |
2.6. | Immediately following receipt of the Shares in Purchaser’s account, but not before October 6th, 2015, Purchaser shall provide a written confirmation of receipt, including the number of shares by email to the Escrow Agent and the Company, and the Escrow Agent shall release and deliver the Purchase Price, calculated by the number of shares multiplied by the PPS and deduced by 1% (fee to Union Underwriters to be transferred by the Escrow Agent to Union Underwriters' account within the Union Bank) by wire transfer to a bank account of the Company designated in writing by the Company. Escrow Agent shall also deliver a confirmation of such transfer to the Company including the identification number of the wire. In case of excess funds deposited by the Purchaser within the Escrow Agent (comparing to the number of shares actually received by the Purchaser multiplied by the PPS), the Escrow Agent will return such excess funds to the Purchaser 14 days after being deposited. In case of excess of shares, allocated by the Company to the Purchaser above the scale required from the Purchaser's Purchase Price, the Escrow Agent's role will be limited to transferring the Purchase Price to the Company. |
2.7. | All incidental costs, fees and expenses related to the transfer of the Purchase Price to the Company will be incurred by the Company, so that the Company will receive the net value after such costs, if any, were deduced. In case that the Company decides or is required to receive the Purchase Price in USD, the Escrow Agent will act in good faith to convert the Purchase Price from NIS to USD at market values used in Union Bank, at the expense of the Company regarding the cost of such conversion. |
2.8. | Notwithstanding anything to the contrary hereunder, the Escrow Agent shall not be required to release the Purchase Price unless, prior thereto, it shall have received from the appropriate recipient: |
2.8.1. | Full bank account details (the account must be solely owned and controlled by BioTime): name of bank, branch number, account number, name of account, SWIFT, IBAN/ABA; |
2.8.2. | Any applied tax forms, if applicable; and |
2.8.3. | Bank account ownership approval which would be an official letter from the bank, approved for authenticity by either Pearl Cohen Zedek Latzer Baratz (PCTLB) directly or by PCTLB's approval of such certification done by a US-based law firm that regularly represents BioTime. |
2.8.4. | BioTime declares and commits that no tax deduction is required by the Escrow Agent prior to releasing the investment proceeds to BioTime. BioTime undertakes to indemnify and hold the Escrow Agent harmless against any and all losses, claims, damages, liabilities and expenses related to that matter. |
3. | Escrow Fees. Omitted. |
4. | Liability of the Escrow Agent . The Escrow Agent undertakes to perform only the duties as are expressly set forth herein and no other duties and obligations (fiduciary or otherwise) shall be implied. Escrow Agent shall have no duty to enforce any obligation of any other person to make any payment or delivery, or to direct or cause any payment or delivery to be made, or to enforce any obligation of any other person to perform any other act. The Escrow Agent shall have no liability under and no duty to inquire as to the provisions of any agreement (even though such agreement may be referenced in this Agreement) other than this Agreement. The Escrow Agent is not a party to the Purchase Agreement, is not bound by any of its terms, and has not undertaken in any way to effectuate, implement or comply with the Purchase Agreement. The Escrow Agent shall not be liable to any other party hereto or to anyone else for any action taken or omitted by it in good faith except to the extent that a court of competent jurisdiction determines that Escrow Agent’s gross negligence, willful misconduct or bad faith was the cause of any loss suffered by such party. The Escrow Agent’s sole responsibility shall be for the safekeeping and releasing of the Purchase Price in accordance with the terms of this Agreement. In no event shall the Escrow Agent be liable for incidental, indirect, special, consequential or punitive damages of any kind whatsoever (including lost profits), even if the Escrow Agent has been advised of the likelihood of such loss or damage and regardless of the form of action. |
5. | Indemnification of the Escrow Agent . Subject to the other provisions of this Agreement, the Company and the Purchaser agree to indemnify, in equal parts (50%-50%) and hold the Escrow Agent harmless against any and all losses, claims, damages, liabilities and expenses, including reasonable costs of investigation, counsel fees, including allocated costs of in-house counsel and disbursements that may be imposed on the Escrow Agent or incurred by the Escrow Agent in connection with the performance of its duties under this Agreement, including but not limited to any litigation arising from this Agreement or involving its subject matter. Notwithstanding the foregoing, there shall be no indemnification obligation under this Section in an event of the Escrow Agent’s breach of this Agreement, violation of applicable laws, gross negligence, bad faith or willful misconduct. The Escrow Agent shall notify the Company and the Purchaser in writing of any written assertion of a claim against the Escrow Agent, promptly after the Escrow Agent shall have received any such information as to the nature and basis of the claim or learns of circumstances that may bring about such claim. The Escrow Agent agrees not to settle any litigation in connection with any claim or liability with respect to which the Escrow Agent may seek indemnification from the Company and the Purchaser without the prior written consent of the Company and the Purchaser. |
6. | Notices . All notices required or permitted hereunder shall be in writing, must be by E-Mail Delivery as defined above (fax delivery may be added but will not suffice) and shall be deemed effectively given: (a) upon personal delivery to the Party to be notified; (b) when sent by facsimile or email with confirmation of transmission. All communications shall be sent to the Company, the Purchaser and the Escrow Agent at their respective facsimile numbers or email addresses set forth below. |
7. | Priority . In the event of any conflict between the provisions of this Agreement, this Agreement shall be construed in a manner prescribed by the Escrow Agent acting in good faith. |
8. | Miscellaneous |
PURCHASER
:
|
||||
Harel Financial Products Ltd
|
||||
By:
|
|
|||
Title:
|
||||
Address:
|
7 Jabotinsky St. | |||
Ranat-Gan | ||||
Israel | ||||
FAX Number: 03-756-6311 | ||||
Email: uris@hf.co.il |
ESCROW AGENT
:
|
|||
By:
|
|||
Amos Fargon
|
|||
Title:
|
Chief Operating Officer |
Address:
|
Union Bank Trust Co. Ltd
|
|
28 Ahad Ha'am St., Tel Aviv | ||
FAX Number: +972-3-5191208 | ||
Email: amos-f@ubi.co.il |
To any Purchaser: | At the address or FAX number or email address of Purchaser shown on the signature page of this Agreement |
To the Company: |
BioTime Inc.
1301 Harbor Bay Parkway
Alameda, California 94502
Attention: Chief Financial Officer
FAX: (510) 521- 3389
Email: rpeabody@biotimemail.com
|
COMPANY:
|
||
BioTime, Inc.
|
||
By:
|
/s/ R W Peabody
|
|
Title:
|
SR VP
|
WHEREAS | the Company and Purchaser have entered into a Purchase Agreement pursuant to which the Company shall sell Purchaser common shares of the Company, no par value (the " Shares "), in exchange for the Purchase Price (as defined in the Purchase Agreement) |
WHEREAS | the Company and Purchaser have agreed and desirous and willing that the closing of the Purchase Agreement will take place in accordance with the terms and provisions of this Agreement; |
WHEREAS | The Parties wish to appoint Union Bank Trust Co. Ltd to hold the Purchase Price for the purpose of ensuring the delivery of the Shares against receipt of the Purchase Price, in accordance with the terms of this Agreement and the share price as defined below; |
1. | The Company and the Purchaser hereby appoint the Union Bank Trust Co. Ltd Company as the "Escrow Agent" under this Agreement to hold the Purchase Price, and Union Bank Trust Co. Ltd accepts such designation and appointment and agrees to act in accordance with the terms of this Agreement and Purchase Agreement. It is hereby expressly provided that in the event a conflict should arise as between the terms of this Agreement and the Purchase Agreement, the terms of this Agreement shall control. The Escrow Agent agrees that upon receipt of the Purchase Price in accordance with Section 2 below, the Escrow Agent shall hold such funds in accordance with this Agreement. |
2. | Term of Escrow; Deposit and/or release of the shares and the Purchase Price . |
2.1. | At the end of the last Tel Aviv Stock Exchange Ltd. ("TASE") trading day preceding the Index Calculation Date (as defined in the Purchase Agreement, herein: "The Pricing Date"), the Purchaser shall deliver the Purchase Price to the Escrow Agent by wire transfer by depositing the Purchase Price to the bank account designated by Escrow Agent to the Company and Purchaser and by sending a proper documentation of such wire transfer to amos-f@ubi.co.il + shai@ubi.co.il ("E-Mail Delivery"). The Purchase Price shall be paid in Israeli New Shekels (NIS) and in immediately available funds. Union Underwriting & Finances Ltd. ("Union Underwriters") will notify the Escrow Agent of the Price Per Share determined according to the Purchase Agreement (the "PPS") that will be the last price of the Company's share at TASE in the Pricing Date and will calculate the Purchase Price for the purpose of the escrow. The above PPS and calculations by Union Underwriters are limited to the purposes of the Escrow Agreement and will not deteriorate from the parties' rights according to the Purchase Agreement. The parties hereby waive and release Union Underwriters from any claim regarding the PPS and the calculations. |
2.2. | The Escrow Agent shall immediately notify the Company and the Purchaser in writing of receipt of the Purchase Price (the "Written Notification"). |
2.3. | On or before the date on which the Purchase Prices is deposited with the Escrow Agent, Purchaser shall notify the Company and the Escrow Agent of the name, telephone number, and email address of an authorized person at the financial institution that will receive the Shares for Purchaser’s account, who the Company and the Escrow Agent may contact to confirm receipt of the Shares. |
2.4. | Upon receiving Written Notification, the Company shall take all necessary actions for the issuance of the Shares in the manner provided in the Purchase Agreement. Purchaser acknowledges and agrees to provide the Company with the proper Depository Trust Company Deposit/Withdrawal at Custodian system (“DWAC”) number for the account into which Purchaser’s Shares are to be issued. Purchaser shall provide American Stock Transfer & Trust Company, LLC, the transfer agent and registrar of the Shares (the “Transfer Agent”), with all information and documentation that the Transfer Agent requires to issue the Shares. |
2.5. | The Transfer Agent shall promptly provide written notification of the issuance of the Shares by DWAC to the account designated by Purchaser. |
2.6. | Immediately following receipt of the Shares in Purchaser’s account, but not before October 6th, 2015, Purchaser shall provide a written confirmation of receipt, including the number of shares by email to the Escrow Agent and the Company, and the Escrow Agent shall release and deliver the Purchase Price, calculated by the number of shares multiplied by the PPS and deduced by 1% (fee to Union Underwriters to be transferred by the Escrow Agent to Union Underwriters' account within the Union Bank) by wire transfer to a bank account of the Company designated in writing by the Company. Escrow Agent shall also deliver a confirmation of such transfer to the Company including the identification number of the wire. In case of excess funds deposited by the Purchaser within the Escrow Agent (comparing to the number of shares actually received by the Purchaser multiplied by the PPS), the Escrow Agent will return such excess funds to the Purchaser 14 days after being deposited. In case of excess of shares, allocated by the Company to the Purchaser above the scale required from the Purchaser's Purchase Price, the Escrow Agent's role will be limited to transferring the Purchase Price to the Company. |
2.7. | All incidental costs, fees and expenses related to the transfer of the Purchase Price to the Company will be incurred by the Company, so that the Company will receive the net value after such costs, if any, were deduced. In case that the Company decides or is required to receive the Purchase Price in USD, the Escrow Agent will act in good faith to convert the Purchase Price from NIS to USD at market values used in Union Bank, at the expense of the Company regarding the cost of such conversion. |
2.8. | Notwithstanding anything to the contrary hereunder, the Escrow Agent shall not be required to release the Purchase Price unless, prior thereto, it shall have received from the appropriate recipient: |
2.8.1. | Full bank account details (the account must be solely owned and controlled by BioTime): name of bank, branch number, account number, name of account, SWIFT, IBAN/ABA; |
2.8.2. | Any applied tax forms, if applicable; and |
2.8.3. | Bank account ownership approval which would be an official letter from the bank, approved for authenticity by either Pearl Cohen Zedek Latzer Baratz (PCTLB) directly or by PCTLB's approval of such certification done by a US-based law firm that regularly represents BioTime. |
2.8.4. | BioTime declares and commits that no tax deduction is required by the Escrow Agent prior to releasing the investment proceeds to BioTime. BioTime undertakes to indemnify and hold the Escrow Agent harmless against any and all losses, claims, damages, liabilities and expenses related to that matter. |
3. | Escrow Fees. Omitted. |
4. | Liability of the Escrow Agent . The Escrow Agent undertakes to perform only the duties as are expressly set forth herein and no other duties and obligations (fiduciary or otherwise) shall be implied. Escrow Agent shall have no duty to enforce any obligation of any other person to make any payment or delivery, or to direct or cause any payment or delivery to be made, or to enforce any obligation of any other person to perform any other act. The Escrow Agent shall have no liability under and no duty to inquire as to the provisions of any agreement (even though such agreement may be referenced in this Agreement) other than this Agreement. The Escrow Agent is not a party to the Purchase Agreement, is not bound by any of its terms, and has not undertaken in any way to effectuate, implement or comply with the Purchase Agreement. The Escrow Agent shall not be liable to any other party hereto or to anyone else for any action taken or omitted by it in good faith except to the extent that a court of competent jurisdiction determines that Escrow Agent’s gross negligence, willful misconduct or bad faith was the cause of any loss suffered by such party. The Escrow Agent’s sole responsibility shall be for the safekeeping and releasing of the Purchase Price in accordance with the terms of this Agreement. In no event shall the Escrow Agent be liable for incidental, indirect, special, consequential or punitive damages of any kind whatsoever (including lost profits), even if the Escrow Agent has been advised of the likelihood of such loss or damage and regardless of the form of action. |
5. | Indemnification of the Escrow Agent . Subject to the other provisions of this Agreement, the Company and the Purchaser agree to indemnify, in equal parts (50%-50%) and hold the Escrow Agent harmless against any and all losses, claims, damages, liabilities and expenses, including reasonable costs of investigation, counsel fees, including allocated costs of in-house counsel and disbursements that may be imposed on the Escrow Agent or incurred by the Escrow Agent in connection with the performance of its duties under this Agreement, including but not limited to any litigation arising from this Agreement or involving its subject matter. Notwithstanding the foregoing, there shall be no indemnification obligation under this Section in an event of the Escrow Agent’s breach of this Agreement, violation of applicable laws, gross negligence, bad faith or willful misconduct. The Escrow Agent shall notify the Company and the Purchaser in writing of any written assertion of a claim against the Escrow Agent, promptly after the Escrow Agent shall have received any such information as to the nature and basis of the claim or learns of circumstances that may bring about such claim. The Escrow Agent agrees not to settle any litigation in connection with any claim or liability with respect to which the Escrow Agent may seek indemnification from the Company and the Purchaser without the prior written consent of the Company and the Purchaser. |
6. | Notices . All notices required or permitted hereunder shall be in writing, must be by E-Mail Delivery as defined above (fax delivery may be added but will not suffice) and shall be deemed effectively given: (a) upon personal delivery to the Party to be notified; (b) when sent by facsimile or email with confirmation of transmission. All communications shall be sent to the Company, the Purchaser and the Escrow Agent at their respective facsimile numbers or email addresses set forth below. |
7. | Priority . In the event of any conflict between the provisions of this Agreement, this Agreement shall be construed in a manner prescribed by the Escrow Agent acting in good faith. |
8. | Miscellaneous |
PURCHASER
:
|
||||
KSM SAL INDICIES CERTIFICATES LTD.
|
||||
By:
|
||||
Title:
|
||||
Address:
|
25 Efaal St.
|
|||
Petah-Tikva 4951125
|
||||
Israel
|
||||
FAX Number: +972-3-753-2030
|
||||
Email: TZLILL.KEREN-BLUM@XNES.CO.IL
|
ESCROW AGENT
:
|
|||
By: | |||
Amos Fargon
|
|||
Title: | Chief Operating Officer |
Address:
|
Union Bank Trust Co. Ltd
|
|
28 Ahad Ha'am St., Tel Aviv
|
||
FAX Number: +972-3-5191208
|
||
Email:
amos-f@ubi.co.il
|
To any Purchaser: | At the address or FAX number or email address of Purchaser shown on the signature page of this Agreement |
To the Company: |
BioTime Inc.
1301 Harbor Bay Parkway
Alameda, California 94502
Attention: Chief Financial Officer
FAX: (510) 521- 3389
Email:
rpeabody@biotimemail.com
|
COMPANY:
|
||
BioTime, Inc.
|
||
By:
|
/s/R W Peabody
|
|
Title:
|
SR VP
|
PURCHASER
:
|
||
Psagot Exchange Traded Notes Indexes Ltd.
|
||
By:
|
/s/Gil Shapria and Itay Blumstein
|
|
Gil Shapira
|
||
Title:
|
CEO and VP Trading |
Address:
|
14 Ehad Ha’am St., Tel Aviv, Israel
|
FAX Number: 972-3-7968628
|
|
Email:
GilS@psagot.co.il
|
WHEREAS | the Company and Purchaser have entered into a Purchase Agreement pursuant to which the Company shall sell Purchaser common shares of the Company, no par value (the " Shares "), in exchange for the Purchase Price (as defined in the Purchase Agreement) |
WHEREAS | the Company and Purchaser have agreed and desirous and willing that the closing of the Purchase Agreement will take place in accordance with the terms and provisions of this Agreement; |
WHEREAS | The Parties wish to appoint Union Bank Trust Co. Ltd to hold the Purchase Price for the purpose of ensuring the delivery of the Shares against receipt of the Purchase Price, in accordance with the terms of this Agreement and the share price as defined below; |
1. | The Company and the Purchaser hereby appoint the Union Bank Trust Co. Ltd Company as the "Escrow Agent" under this Agreement to hold the Purchase Price, and Union Bank Trust Co. Ltd accepts such designation and appointment and agrees to act in accordance with the terms of this Agreement and Purchase Agreement. It is hereby expressly provided that in the event a conflict should arise as between the terms of this Agreement and the Purchase Agreement, the terms of this Agreement shall control. The Escrow Agent agrees that upon receipt of the Purchase Price in accordance with Section 2 below, the Escrow Agent shall hold such funds in accordance with this Agreement. |
2. | Term of Escrow; Deposit and/or release of the shares and the Purchase Price . |
2.1. | At the end of the last Tel Aviv Stock Exchange Ltd. ("TASE") trading day preceding the Index Calculation Date (as defined in the Purchase Agreement, herein: "The Pricing Date"), the Purchaser shall deliver the Purchase Price to the Escrow Agent by wire transfer by depositing the Purchase Price to the bank account designated by Escrow Agent to the Company and Purchaser and by sending a proper documentation of such wire transfer to amos-f@ubi.co.il + shai@ubi.co.il ("E-Mail Delivery"). The Purchase Price shall be paid in Israeli New Shekels (NIS) and in immediately available funds. Union Underwriting & Finances Ltd. ("Union Underwriters") will notify the Escrow Agent of the Price Per Share determined according to the Purchase Agreement (the "PPS") that will be the last price of the Company's share at TASE in the Pricing Date and will calculate the Purchase Price for the purpose of the escrow. The above PPS and calculations by Union Underwriters are limited to the purposes of the Escrow Agreement and will not deteriorate from the parties' rights according to the Purchase Agreement. The parties hereby waive and release Union Underwriters from any claim regarding the PPS and the calculations. |
2.2. | The Escrow Agent shall immediately notify the Company and the Purchaser in writing of receipt of the Purchase Price (the "Written Notification"). |
2.3. | On or before the date on which the Purchase Prices is deposited with the Escrow Agent, Purchaser shall notify the Company and the Escrow Agent of the name, telephone number, and email address of an authorized person at the financial institution that will receive the Shares for Purchaser’s account, who the Company and the Escrow Agent may contact to confirm receipt of the Shares. |
2.4. | Upon receiving Written Notification, the Company shall take all necessary actions for the issuance of the Shares in the manner provided in the Purchase Agreement. Purchaser acknowledges and agrees to provide the Company with the proper Depository Trust Company Deposit/Withdrawal at Custodian system (“DWAC”) number for the account into which Purchaser’s Shares are to be issued. Purchaser shall provide American Stock Transfer & Trust Company, LLC, the transfer agent and registrar of the Shares (the “Transfer Agent”), with all information and documentation that the Transfer Agent requires to issue the Shares. |
2.5. | The Transfer Agent shall promptly provide written notification of the issuance of the Shares by DWAC to the account designated by Purchaser. |
2.6. | Immediately following receipt of the Shares in Purchaser’s account, but not before October 6th, 2015, Purchaser shall provide a written confirmation of receipt, including the number of shares by email to the Escrow Agent and the Company, and the Escrow Agent shall release and deliver the Purchase Price, calculated by the number of shares multiplied by the PPS and deduced by 1% (fee to Union Underwriters to be transferred by the Escrow Agent to Union Underwriters' account within the Union Bank) by wire transfer to a bank account of the Company designated in writing by the Company. Escrow Agent shall also deliver a confirmation of such transfer to the Company including the identification number of the wire. In case of excess funds deposited by the Purchaser within the Escrow Agent (comparing to the number of shares actually received by the Purchaser multiplied by the PPS), the Escrow Agent will return such excess funds to the Purchaser 14 days after being deposited. In case of excess of shares, allocated by the Company to the Purchaser above the scale required from the Purchaser's Purchase Price, the Escrow Agent's role will be limited to transferring the Purchase Price to the Company. |
2.7. | All incidental costs, fees and expenses related to the transfer of the Purchase Price to the Company will be incurred by the Company, so that the Company will receive the net value after such costs, if any, were deduced. In case that the Company decides or is required to receive the Purchase Price in USD, the Escrow Agent will act in good faith to convert the Purchase Price from NIS to USD at market values used in Union Bank, at the expense of the Company regarding the cost of such conversion. |
2.8. | Notwithstanding anything to the contrary hereunder, the Escrow Agent shall not be required to release the Purchase Price unless, prior thereto, it shall have received from the appropriate recipient: |
2.8.1. | Full bank account details (the account must be solely owned and controlled by BioTime): name of bank, branch number, account number, name of account, SWIFT, IBAN/ABA; |
2.8.2. | Any applied tax forms, if applicable; and |
2.8.3. | Bank account ownership approval which would be an official letter from the bank, approved for authenticity by either Pearl Cohen Zedek Latzer Baratz (PCTLB) directly or by PCTLB's approval of such certification done by a US-based law firm that regularly represents BioTime. |
2.8.4. | BioTime declares and commits that no tax deduction is required by the Escrow Agent prior to releasing the investment proceeds to BioTime. BioTime undertakes to indemnify and hold the Escrow Agent harmless against any and all losses, claims, damages, liabilities and expenses related to that matter. |
3. | Escrow Fees. Omitted. |
4. | Liability of the Escrow Agent . The Escrow Agent undertakes to perform only the duties as are expressly set forth herein and no other duties and obligations (fiduciary or otherwise) shall be implied. Escrow Agent shall have no duty to enforce any obligation of any other person to make any payment or delivery, or to direct or cause any payment or delivery to be made, or to enforce any obligation of any other person to perform any other act. The Escrow Agent shall have no liability under and no duty to inquire as to the provisions of any agreement (even though such agreement may be referenced in this Agreement) other than this Agreement. The Escrow Agent is not a party to the Purchase Agreement, is not bound by any of its terms, and has not undertaken in any way to effectuate, implement or comply with the Purchase Agreement. The Escrow Agent shall not be liable to any other party hereto or to anyone else for any action taken or omitted by it in good faith except to the extent that a court of competent jurisdiction determines that Escrow Agent’s gross negligence, willful misconduct or bad faith was the cause of any loss suffered by such party. The Escrow Agent’s sole responsibility shall be for the safekeeping and releasing of the Purchase Price in accordance with the terms of this Agreement. In no event shall the Escrow Agent be liable for incidental, indirect, special, consequential or punitive damages of any kind whatsoever (including lost profits), even if the Escrow Agent has been advised of the likelihood of such loss or damage and regardless of the form of action. |
5. | Indemnification of the Escrow Agent . Subject to the other provisions of this Agreement, the Company and the Purchaser agree to indemnify, in equal parts (50%-50%) and hold the Escrow Agent harmless against any and all losses, claims, damages, liabilities and expenses, including reasonable costs of investigation, counsel fees, including allocated costs of in-house counsel and disbursements that may be imposed on the Escrow Agent or incurred by the Escrow Agent in connection with the performance of its duties under this Agreement, including but not limited to any litigation arising from this Agreement or involving its subject matter. Notwithstanding the foregoing, there shall be no indemnification obligation under this Section in an event of the Escrow Agent’s breach of this Agreement, violation of applicable laws, gross negligence, bad faith or willful misconduct. The Escrow Agent shall notify the Company and the Purchaser in writing of any written assertion of a claim against the Escrow Agent, promptly after the Escrow Agent shall have received any such information as to the nature and basis of the claim or learns of circumstances that may bring about such claim. The Escrow Agent agrees not to settle any litigation in connection with any claim or liability with respect to which the Escrow Agent may seek indemnification from the Company and the Purchaser without the prior written consent of the Company and the Purchaser. |
6. | Notices . All notices required or permitted hereunder shall be in writing, must be by E-Mail Delivery as defined above (fax delivery may be added but will not suffice) and shall be deemed effectively given: (a) upon personal delivery to the Party to be notified; (b) when sent by facsimile or email with confirmation of transmission. All communications shall be sent to the Company, the Purchaser and the Escrow Agent at their respective facsimile numbers or email addresses set forth below. |
7. | Priority . In the event of any conflict between the provisions of this Agreement, this Agreement shall be construed in a manner prescribed by the Escrow Agent acting in good faith. |
8. | Miscellaneous |
COMPANY:
|
||||
BioTime, Inc.
|
||||
By:
|
||||
Title:
|
Chief Financial Officer | |||
Address:
|
1301 Harbor Bay Parkway
|
|||
Alameda, California 94502
|
||||
Attention: Robert W. Peabody, Chief Financial Officer
|
||||
FAX Number: (415) 521-3389
|
||||
Email: rpeabody@biotimemail.com
|
PURCHASER
:
|
||||
Psagot Exchange Traded Notes Indexes Ltd
|
||||
By:
|
||||
Title:
|
||||
Address:
|
14 Ehad Ha’am St. | |||
Tel Aviv, Israel | ||||
FAX Number: 972-3-7968628
|
||||
Email: GilS@psagot.co.il
|
ESCROW AGENT
:
|
|||
By:
|
|
||
Amos Fargon
|
|||
Title: Chief Operating Officer
|
Address:
|
Union Bank Trust Co. Ltd
|
|
28 Ahad Ha'am St., Tel Aviv
|
||
FAX Number: +972-3-5191208
|
||
Email: amos-f@ubi.co.il
|
To any Purchaser: | At the address or FAX number or email address of Purchaser shown on the signature page of this Agreement |
To the Company: |
BioTime Inc.
1301 Harbor Bay Parkway
Alameda, California 94502
Attention: Chief Financial Officer
FAX: (510) 521- 3389
Email: rpeabody@biotimemail.com
|
COMPANY:
|
||
BioTime, Inc.
|
||
By:
|
/s/ R W Peabody
|
|
Title:
|
SR VP
|
PURCHASER
:
|
|||
Midgal Mutual Funds Ltd.
|
|||
By:
|
/s/ Sagi Stein
|
||
Title:
|
CEO
|
||
Address:
|
Saadia Gaon 2G Tel Aviv | ||
|
|||
|
|||
FAX Number:
|
|||
Email:
|
sigalfigmsh.co.il
|
WHEREAS | the Company and Purchaser have entered into a Purchase Agreement pursuant to which the Company shall sell Purchaser common shares of the Company, no par value (the " Shares "), in exchange for the Purchase Price (as defined in the Purchase Agreement) |
WHEREAS | the Company and Purchaser have agreed and desirous and willing that the closing of the Purchase Agreement will take place in accordance with the terms and provisions of this Agreement; |
WHEREAS | The Parties wish to appoint Union Bank Trust Co. Ltd to hold the Purchase Price for the purpose of ensuring the delivery of the Shares against receipt of the Purchase Price, in accordance with the terms of this Agreement and the share price as defined below; |
1. | The Company and the Purchaser hereby appoint the Union Bank Trust Co. Ltd Company as the "Escrow Agent" under this Agreement to hold the Purchase Price, and Union Bank Trust Co. Ltd accepts such designation and appointment and agrees to act in accordance with the terms of this Agreement and Purchase Agreement. It is hereby expressly provided that in the event a conflict should arise as between the terms of this Agreement and the Purchase Agreement, the terms of this Agreement shall control. The Escrow Agent agrees that upon receipt of the Purchase Price in accordance with Section 2 below, the Escrow Agent shall hold such funds in accordance with this Agreement. |
2. | Term of Escrow; Deposit and/or release of the shares and the Purchase Price . |
2.1. | At the end of the last Tel Aviv Stock Exchange Ltd. ("TASE") trading day preceding the Index Calculation Date (as defined in the Purchase Agreement, herein: "The Pricing Date"), the Purchaser shall deliver the Purchase Price to the Escrow Agent by wire transfer by depositing the Purchase Price to the bank account designated by Escrow Agent to the Company and Purchaser and by sending a proper documentation of such wire transfer to amos-f@ubi.co.il + shai@ubi.co.il ("E-Mail Delivery"). The Purchase Price shall be paid in Israeli New Shekels (NIS) and in immediately available funds. Union Underwriting & Finances Ltd. ("Union Underwriters") will notify the Escrow Agent of the Price Per Share determined according to the Purchase Agreement (the "PPS") that will be the last price of the Company's share at TASE in the Pricing Date and will calculate the Purchase Price for the purpose of the escrow. The above PPS and calculations by Union Underwriters are limited to the purposes of the Escrow Agreement and will not deteriorate from the parties' rights according to the Purchase Agreement. The parties hereby waive and release Union Underwriters from any claim regarding the PPS and the calculations. |
2.2. | The Escrow Agent shall immediately notify the Company and the Purchaser in writing of receipt of the Purchase Price (the "Written Notification"). |
2.3. | On or before the date on which the Purchase Prices is deposited with the Escrow Agent, Purchaser shall notify the Company and the Escrow Agent of the name, telephone number, and email address of an authorized person at the financial institution that will receive the Shares for Purchaser’s account, who the Company and the Escrow Agent may contact to confirm receipt of the Shares. |
2.4. | Upon receiving Written Notification, the Company shall take all necessary actions for the issuance of the Shares in the manner provided in the Purchase Agreement. Purchaser acknowledges and agrees to provide the Company with the proper Depository Trust Company Deposit/Withdrawal at Custodian system (“DWAC”) number for the account into which Purchaser’s Shares are to be issued. Purchaser shall provide American Stock Transfer & Trust Company, LLC, the transfer agent and registrar of the Shares (the “Transfer Agent”), with all information and documentation that the Transfer Agent requires to issue the Shares. |
2.5. | The Transfer Agent shall promptly provide written notification of the issuance of the Shares by DWAC to the account designated by Purchaser. |
2.6. | Immediately following receipt of the Shares in Purchaser’s account, but not before October 6th, 2015, Purchaser shall provide a written confirmation of receipt, including the number of shares by email to the Escrow Agent and the Company, and the Escrow Agent shall release and deliver the Purchase Price, calculated by the number of shares multiplied by the PPS and deduced by 1% (fee to Union Underwriters to be transferred by the Escrow Agent to Union Underwriters' account within the Union Bank) by wire transfer to a bank account of the Company designated in writing by the Company. Escrow Agent shall also deliver a confirmation of such transfer to the Company including the identification number of the wire. In case of excess funds deposited by the Purchaser within the Escrow Agent (comparing to the number of shares actually received by the Purchaser multiplied by the PPS), the Escrow Agent will return such excess funds to the Purchaser 14 days after being deposited. In case of excess of shares, allocated by the Company to the Purchaser above the scale required from the Purchaser's Purchase Price, the Escrow Agent's role will be limited to transferring the Purchase Price to the Company. |
2.7. | All incidental costs, fees and expenses related to the transfer of the Purchase Price to the Company will be incurred by the Company, so that the Company will receive the net value after such costs, if any, were deduced. In case that the Company decides or is required to receive the Purchase Price in USD, the Escrow Agent will act in good faith to convert the Purchase Price from NIS to USD at market values used in Union Bank, at the expense of the Company regarding the cost of such conversion. |
2.8. | Notwithstanding anything to the contrary hereunder, the Escrow Agent shall not be required to release the Purchase Price unless, prior thereto, it shall have received from the appropriate recipient: |
2.8.1. | Full bank account details (the account must be solely owned and controlled by BioTime): name of bank, branch number, account number, name of account, SWIFT, IBAN/ABA; |
2.8.2. | Any applied tax forms, if applicable; and |
2.8.3. | Bank account ownership approval which would be an official letter from the bank, approved for authenticity by either Pearl Cohen Zedek Latzer Baratz (PCTLB) directly or by PCTLB's approval of such certification done by a US-based law firm that regularly represents BioTime. |
2.8.4. | BioTime declares and commits that no tax deduction is required by the Escrow Agent prior to releasing the investment proceeds to BioTime. BioTime undertakes to indemnify and hold the Escrow Agent harmless against any and all losses, claims, damages, liabilities and expenses related to that matter. |
3. | Escrow Fees. Omitted. |
4. | Liability of the Escrow Agent . The Escrow Agent undertakes to perform only the duties as are expressly set forth herein and no other duties and obligations (fiduciary or otherwise) shall be implied. Escrow Agent shall have no duty to enforce any obligation of any other person to make any payment or delivery, or to direct or cause any payment or delivery to be made, or to enforce any obligation of any other person to perform any other act. The Escrow Agent shall have no liability under and no duty to inquire as to the provisions of any agreement (even though such agreement may be referenced in this Agreement) other than this Agreement. The Escrow Agent is not a party to the Purchase Agreement, is not bound by any of its terms, and has not undertaken in any way to effectuate, implement or comply with the Purchase Agreement. The Escrow Agent shall not be liable to any other party hereto or to anyone else for any action taken or omitted by it in good faith except to the extent that a court of competent jurisdiction determines that Escrow Agent’s gross negligence, willful misconduct or bad faith was the cause of any loss suffered by such party. The Escrow Agent’s sole responsibility shall be for the safekeeping and releasing of the Purchase Price in accordance with the terms of this Agreement. In no event shall the Escrow Agent be liable for incidental, indirect, special, consequential or punitive damages of any kind whatsoever (including lost profits), even if the Escrow Agent has been advised of the likelihood of such loss or damage and regardless of the form of action. |
5. | Indemnification of the Escrow Agent . Subject to the other provisions of this Agreement, the Company agrees to indemnify and hold the Escrow Agent harmless against any and all losses, claims, damages, liabilities and expenses, including reasonable costs of investigation, counsel fees, including allocated costs of in-house counsel and disbursements that may be imposed on the Escrow Agent or incurred by the Escrow Agent in connection with the performance of its duties under this Agreement, including but not limited to any litigation arising from this Agreement or involving its subject matter. Notwithstanding the foregoing, there shall be no indemnification obligation under this Section in an event of the Escrow Agent’s breach of this Agreement, violation of applicable laws, gross negligence, bad faith or willful misconduct. The Escrow Agent shall notify the Company and the Purchaser in writing of any written assertion of a claim against the Escrow Agent, promptly after the Escrow Agent shall have received any such information as to the nature and basis of the claim or learns of circumstances that may bring about such claim. The Escrow Agent agrees not to settle any litigation in connection with any claim or liability with respect to which the Escrow Agent may seek indemnification from the Company and the Purchaser without the prior written consent of the Company and the Purchaser. |
6. | Notices . All notices required or permitted hereunder shall be in writing, must be by E-Mail Delivery as defined above (fax delivery may be added but will not suffice) and shall be deemed effectively given: (a) upon personal delivery to the Party to be notified; (b) when sent by facsimile or email with confirmation of transmission. All communications shall be sent to the Company, the Purchaser and the Escrow Agent at their respective facsimile numbers or email addresses set forth below. |
7. | Priority . In the event of any conflict between the provisions of this Agreement, this Agreement shall be construed in a manner prescribed by the Escrow Agent acting in good faith. |
8. | Miscellaneous |
COMPANY:
|
||||
BioTime, Inc.
|
||||
By:
|
|
|||
Title:
|
Chief Financial Officer | |||
Address:
|
1301 Harbor Bay Parkway | |||
Alameda, California 94502 | ||||
Attention: Robert W. Peabody, Chief Financial Officer | ||||
FAX Number: (415) 521-3389
|
||||
Email: rpeabody@biotimemail.com
|
PURCHASER
:
|
||||
Migdal Mutual Funds Ltd.
|
||||
By:
|
||||
Title:
|
||||
Address:
|
Saadia Gaon 2G
|
|||
Tel Aviv | ||||
Israel | ||||
FAX Number:
|
||||
Email: sigalfi.cmsh.co.il
|
ESCROW AGENT
:
|
|||
By:
|
|
||
Amos Fargon | |||
Title: | Chief Operating Officer |
Address:
|
Union Bank Trust Co. Ltd
|
|
28 Ahad Ha'am St., Tel Aviv
|
||
FAX Number: +972-3-5191208
|
||
Email: amos-f@ubi.co.il
|
To any Purchaser: | At the address or FAX number or email address of Purchaser shown on the signature page of this Agreement |
To the Company: |
BioTime Inc.
1301 Harbor Bay Parkway
Alameda, California 94502
Attention: Chief Financial Officer
FAX: (510) 521- 3389
Email:
rpeabody@biotimemail.com
|
COMPANY:
|
||
BioTime, Inc.
|
||
By:
|
/s/ R W Peabody
|
|
Title:
|
SR VP
|
PURCHASER
:
|
|||
Tachlit Mutual Funds
|
|||
By:
|
/s/ Eyal Segal / Vereo Cohen Rubin
|
||
Title:
|
CEO / CRO | ||
Address:
|
130 Sheshet Hayamim | ||
Bnai-Barak | |||
|
|
||
FAX Number:
|
97237904401 | ||
Email:
|
shay@lmtds.co.il
|
WHEREAS | the Company and Purchaser have entered into a Purchase Agreement pursuant to which the Company shall sell Purchaser common shares of the Company, no par value (the " Shares "), in exchange for the Purchase Price (as defined in the Purchase Agreement) |
WHEREAS | the Company and Purchaser have agreed and desirous and willing that the closing of the Purchase Agreement will take place in accordance with the terms and provisions of this Agreement; |
WHEREAS | The Parties wish to appoint Union Bank Trust Co. Ltd to hold the Purchase Price for the purpose of ensuring the delivery of the Shares against receipt of the Purchase Price, in accordance with the terms of this Agreement and the share price as defined below; |
1. | The Company and the Purchaser hereby appoint the Union Bank Trust Co. Ltd Company as the "Escrow Agent" under this Agreement to hold the Purchase Price, and Union Bank Trust Co. Ltd accepts such designation and appointment and agrees to act in accordance with the terms of this Agreement and Purchase Agreement. It is hereby expressly provided that in the event a conflict should arise as between the terms of this Agreement and the Purchase Agreement, the terms of this Agreement shall control. The Escrow Agent agrees that upon receipt of the Purchase Price in accordance with Section 2 below, the Escrow Agent shall hold such funds in accordance with this Agreement. |
2. | Term of Escrow; Deposit and/or release of the shares and the Purchase Price . |
2.1. | On October 1, 2015, the Purchaser shall deliver the Purchase Price to the Escrow Agent by wire transfer by depositing the Purchase Price to the bank account designated by Escrow Agent to the Company and Purchaser and by sending a proper documentation of such wire transfer to amos-f@ubi.co.il + shai@ubi.co.il ("E-Mail Delivery"). The Purchase Price shall be paid in Israeli New Shekels (NIS) and in immediately available funds. Union Underwriting & Finances Ltd. ("Union Underwriters") will notify the Escrow Agent of the Price Per Share determined according to the Purchase Agreement (the "PPS") that will be the last price of the Company's share at TASE in the Pricing Date and will calculate the Purchase Price for the purpose of the escrow. The above PPS and calculations by Union Underwriters are limited to the purposes of the Escrow Agreement and will not deteriorate from the parties' rights according to the Purchase Agreement. The parties hereby waive and release Union Underwriters from any claim regarding the PPS and the calculations. |
2.2. | The Escrow Agent shall immediately notify the Company and the Purchaser in writing of receipt of the Purchase Price (the "Written Notification"). |
2.3. | On or before the date on which the Purchase Prices is deposited with the Escrow Agent, Purchaser shall notify the Company and the Escrow Agent of the name, telephone number, and email address of an authorized person at the financial institution that will receive the Shares for Purchaser’s account, who the Company and the Escrow Agent may contact to confirm receipt of the Shares. |
2.4. | Upon receiving Written Notification, the Company shall take all necessary actions for the issuance of the Shares in the manner provided in the Purchase Agreement. Purchaser acknowledges and agrees to provide the Company with the proper Depository Trust Company Deposit/Withdrawal at Custodian system (“DWAC”) number for the account into which Purchaser’s Shares are to be issued. Purchaser shall provide American Stock Transfer & Trust Company, LLC, the transfer agent and registrar of the Shares (the “Transfer Agent”), with all information and documentation that the Transfer Agent requires to issue the Shares. |
2.5. | The Transfer Agent shall promptly provide written notification of the issuance of the Shares by DWAC to the account designated by Purchaser. |
2.6. | Immediately following receipt of the Shares in Purchaser’s account, but not before October 6th, 2015, Purchaser shall provide a written confirmation of receipt, including the number of shares by email to the Escrow Agent and the Company, and the Escrow Agent shall release and deliver the Purchase Price, calculated by the number of shares multiplied by the PPS and deduced by 1% (fee to Union Underwriters to be transferred by the Escrow Agent to Union Underwriters' account within the Union Bank) by wire transfer to a bank account of the Company designated in writing by the Company. Escrow Agent shall also deliver a confirmation of such transfer to the Company including the identification number of the wire. In case of excess funds deposited by the Purchaser within the Escrow Agent (comparing to the number of shares actually received by the Purchaser multiplied by the PPS), the Escrow Agent will return such excess funds to the Purchaser 14 days after being deposited. In case of excess of shares, allocated by the Company to the Purchaser above the scale required from the Purchaser's Purchase Price, the Escrow Agent's role will be limited to transferring the Purchase Price to the Company. |
2.7. | All incidental costs, fees and expenses related to the transfer of the Purchase Price to the Company will be incurred by the Company, so that the Company will receive the net value after such costs, if any, were deduced. In case that the Company decides or is required to receive the Purchase Price in USD, the Escrow Agent will act in good faith to convert the Purchase Price from NIS to USD at market values used in Union Bank, at the expense of the Company regarding the cost of such conversion. |
2.8. | Notwithstanding anything to the contrary hereunder, the Escrow Agent shall not be required to release the Purchase Price unless, prior thereto, it shall have received from the appropriate recipient: |
2.8.1. | Full bank account details (the account must be solely owned and controlled by BioTime): name of bank, branch number, account number, name of account, SWIFT, IBAN/ABA; |
2.8.2. | Any applied tax forms, if applicable; and |
2.8.3. | Bank account ownership approval which would be an official letter from the bank, approved for authenticity by either Pearl Cohen Zedek Latzer Baratz (PCTLB) directly or by PCTLB's approval of such certification done by a US-based law firm that regularly represents BioTime. |
2.8.4. | BioTime declares and commits that no tax deduction is required by the Escrow Agent prior to releasing the investment proceeds to BioTime. BioTime undertakes to indemnify and hold the Escrow Agent harmless against any and all losses, claims, damages, liabilities and expenses related to that matter. |
3. | Escrow Fees. Omitted. |
4. | Liability of the Escrow Agent . The Escrow Agent undertakes to perform only the duties as are expressly set forth herein and no other duties and obligations (fiduciary or otherwise) shall be implied. Escrow Agent shall have no duty to enforce any obligation of any other person to make any payment or delivery, or to direct or cause any payment or delivery to be made, or to enforce any obligation of any other person to perform any other act. The Escrow Agent shall have no liability under and no duty to inquire as to the provisions of any agreement (even though such agreement may be referenced in this Agreement) other than this Agreement. The Escrow Agent is not a party to the Purchase Agreement, is not bound by any of its terms, and has not undertaken in any way to effectuate, implement or comply with the Purchase Agreement. The Escrow Agent shall not be liable to any other party hereto or to anyone else for any action taken or omitted by it in good faith except to the extent that a court of competent jurisdiction determines that Escrow Agent’s gross negligence, willful misconduct or bad faith was the cause of any loss suffered by such party. The Escrow Agent’s sole responsibility shall be for the safekeeping and releasing of the Purchase Price in accordance with the terms of this Agreement. In no event shall the Escrow Agent be liable for incidental, indirect, special, consequential or punitive damages of any kind whatsoever (including lost profits), even if the Escrow Agent has been advised of the likelihood of such loss or damage and regardless of the form of action. |
5. | Indemnification of the Escrow Agent . Subject to the other provisions of this Agreement, the Company agrees to indemnify and hold the Escrow Agent harmless against any and all losses, claims, damages, liabilities and expenses, including reasonable costs of investigation, counsel fees, including allocated costs of in-house counsel and disbursements that may be imposed on the Escrow Agent or incurred by the Escrow Agent in connection with the performance of its duties under this Agreement, including but not limited to any litigation arising from this Agreement or involving its subject matter. Notwithstanding the foregoing, there shall be no indemnification obligation under this Section in an event of the Escrow Agent’s breach of this Agreement, violation of applicable laws, gross negligence, bad faith or willful misconduct. The Escrow Agent shall notify the Company and the Purchaser in writing of any written assertion of a claim against the Escrow Agent, promptly after the Escrow Agent shall have received any such information as to the nature and basis of the claim or learns of circumstances that may bring about such claim. The Escrow Agent agrees not to settle any litigation in connection with any claim or liability with respect to which the Escrow Agent may seek indemnification from the Company and the Purchaser without the prior written consent of the Company and the Purchaser. |
6. | Notices . All notices required or permitted hereunder shall be in writing, must be by E-Mail Delivery as defined above (fax delivery may be added but will not suffice) and shall be deemed effectively given: (a) upon personal delivery to the Party to be notified; (b) when sent by facsimile or email with confirmation of transmission. All communications shall be sent to the Company, the Purchaser and the Escrow Agent at their respective facsimile numbers or email addresses set forth below. |
7. | Priority . In the event of any conflict between the provisions of this Agreement, this Agreement shall be construed in a manner prescribed by the Escrow Agent acting in good faith. |
8. | Miscellaneous |
COMPANY:
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BioTime, Inc.
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By:
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Title:
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Chief Financial Officer | |||
Address:
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1301 Harbor Bay Parkway
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Alameda, California 94502
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Attention: Robert W. Peabody, Chief Financial Officer
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FAX Number: (415) 521-3389
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Email: rpeabody@biotimemail.com
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PURCHASER
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Tachlit Mutual Funds
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By:
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Title:
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Address:
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130 Sheshet Hayamim
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Bnai Barak
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FAX Number: 972-237904401
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Email: Shay@lmtds.co.il
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ESCROW AGENT
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By:
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Amos Fargon
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Title:
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Chief Operating Officer |
Address:
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Union Bank Trust Co. Ltd
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28 Ahad Ha'am St., Tel Aviv
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FAX Number: +972-3-5191208
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Email:
amos-f@ubi.co.il
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WHEREAS | OrthoCyte owns, or has licensed rights to, and possesses two therapeutic development platforms. The first one being a comprehensive portfolio of embryonic stem cells and clonal progenitor stem cells of primate origin, as well as related know-how and technological expertise to propagate and differentiate these cells. More specifically, the first platform comprises osteochondro progenitor cell lines named PureStem® and related know-how and technological expertise to ensure the isolation and selection of clonal cells with high purity and optimised potency, including methods to ensure scalability of culturing and identification by comprehensive microarrays. The second platform technology is a scaffold technology for cell delivery, named HyStem®. Both technologies are patent protected and OrthoCyte owns or has licensed rights to the corresponding rights to these technologies, in particular Intellectual Property Rights and related trade secret technical information; these rights comprise in particular the selection of cell lines, manufacturing (culturing and differentiation of these cell lines), their combination with an appropriate scaffold and the use of this technology (application in medical indication). |
WHEREAS | Heraeus has experience in the field of bone cement and biomaterials, as medical implants for elective orthopaedic and trauma surgery, and possesses detailed market knowledge and data with regard to musculoskeletal indications and owns and/or licenses from a Third Party rights to certain scaffold technologies; |
WHEREAS | the Parties wish to carry out a research and development project “R&D of a Bioactive Bone Grafting Product” (as further described in the Project Plan attached hereto as Exhibit A (the “Project”); |
WHEREAS | OrthoCyte shall manufacture the Product (as defined below) for Heraeus, but is willing to grant Heraeus a license to establish a second manufacturing source and to manufacture and/or have manufactured and market or have marketed the Product the Product (the “Second Source”). For this purpose the Parties intend to sign a separate License Agreement as set out in Exhibit B . A manufacturing and supply agreement pursuant to which OrthoCyte will manufacture and supply Heraeus with Product shall be negotiated and concluded before Launch of the Product; the manufacturing and supply agreement will include terms and conditions for the establishment and availability of the Second Source. |
1. | Definitions. |
1.1 | "Affiliates ” shall mean, with respect to a Party, any corporation, company, partnership or other entity, which controls, is controlled by, or is under common control with a Party. For such purpose the term “control” shall mean the ownership, direct or indirect control of at least fifty percent (50 %) of the voting stock of the other entity. |
1.2 |
“Background Rights”
shall mean any and all Intellectual Property Rights and all substances and/or biological material and any rights therein or thereto (e.g. licenses) belonging to a Party and/or its Affiliates (irrespectively whether or not protectable under state, federal or foreign intellectual property laws), which is developed or acquired by such Party and/or its Affiliates prior to the Effective Date, or developed or acquired by such Party and/or its Affiliates independently from performance of this Agreement regardless whether developed or acquired either before or after the Effective Date and that are necessary or useful for the development of the Product. OrthoCyte Background Rights include OrthoCyte Materials and OrthoCyte Technology. Heraeus Backgrounds Rights include the Heraeus Materials and the Heraeus Technology.
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1.3 | “OrthoCyte Materials” shall be osteochondro progenitor PureStem® Cell Lines (or Stem Cell Derivatives) as well as the HyStem® Delivery System. |
1.4 | “OrthoCyte Technology” shall be the technology, including the HyStem® Delivery System, to select, expand, manufacture, combine and use the OrthoCyte Materials, as covered by the Intellectual Property Rights owned by OrthoCyte or BioTime or licensed in from a Third Party, including the University of Utah Research Foundation. The OrthoCyte Technology includes the patent applications and patents identified and listed in Exhibit C . |
1.5 | “Confidential Information” shall mean any and all data, material and/or information related to: (i) the terms of this Agreement including all Annexes etc., (ii) information made available by one Party ("Disclosing Party") to the other Party (“Receiving Party”) in tangible such as writing or other form including electronic, visual, oral or graphic form or as samples (including but not limited to a Party’s Background Rights and Intellectual Property Rights, any technical information, research-, products-, personnel-, marketing-, strategic information or other information), (iii) any data, material and information developed during the term of this Agreement, and (iv) any compound(s) and/or material(s) provided by one Party to the other pursuant to this Agreement, whether prior to or after the Effective Date and whether it is labelled "confidential" or not, in the course of the Parties' evaluation, negotiation of or performance under or in connection with this Agreement. There is no requirement to mark data, material and/or information as “Confidential” when exchanged between Parties, but this is a recommended best practice. |
1.6 | "Effective Date" shall mean the date of the last signature of the Parties to this Agreement. |
1.7 | " Field of Use" shall be bone grafting for the indications osteoskeleton diseases and injuries, thereby excluding dental and maxillofacial indications. |
1.8 | "Final Report" shall have the meaning as set out in Exhibit E. |
1.9 | “Heraeus Materials” shall be the Heraeus Scaffold and all market related research and data related to the Field of Use owned by Heraeus. |
1.10 | “Heraeus Scaffold” means the scaffold that is provided by Heraeus to OrthoCyte for use in the performance of the Project, and owned by Heraeus and/or licensed from a Third Party. |
1.11 | “Heraeus Technology” shall be the technology relating to the Heraeus Scaffold, as covered by the Intellectual Property Rights owned by Heraeus or licensed in from a Third Party. |
1.12 | “HyStem Delivery System” means the proprietary scaffold technology for delivery of bioactives, including, without limitation, small molecules, proteins, cells fractions or derivatives thereof, as covered by the Intellectual Property Rights owned by OrthoCyte or BioTime, or licensed in from a Third Party, including the University of Utah Research Foundation. |
1.13 | “Intellectual Property Rights ” shall mean the rights and interests in and to any and all issued patents and pending patent applications, know-how, trade secrets, utility certificates, utility models, registered design, trademarks, copyrights (including inventor’s certificates), in any country or jurisdiction, including but not limited to, any and all provisionals, non-provisionals, substitutions, continuations, continuations-in-part, divisionals and other continuing applications, supplementary protection certificates, renewals, and all letters patent on any of the foregoing, and any and all reissues, re-examinations, extensions, confirmations, registrations and patents of addition of any of the foregoing. |
1.14 | “Launch” shall mean the first commercial sale of the Product to Third Parties. |
1.15 | “ Product ” shall mean a cell therapy bone grafting product consisting of a select osteochondroprogenitor PureStem Cell Line (or Stem Cell Derivative) contained in a scaffold; such scaffold being Heraeus Material or OrthoCyte Material, and developed according to the Project Plan . |
1.16 | “PureStem Cell Line” means OrthoCyte’s (including its affiliate BioTime) comprehensive portfolio of embryonic stem cells and clonal progenitor stem cells of primate origin, as well as related know-how and technological expertise to propagate and differentiate such cells. |
1.17 | “ Stem Cell Derivative ” shall mean any of the following derived from a PureStem Cell Line: a select non-viable osteochondroprogenitor PureStem Cell Line, or fraction thereof such as, fractionate, extract, secretion products; lyophilized, concentrated, reconstituted or diluted in appropriate solvent if necessary. |
1.18 | "Results" shall mean all data, information, findings, know-how, substances and biological material, inventions, improvements and/or discoveries (irrespectively whether or not protectable under state, federal or foreign intellectual property laws), resulting from and made by or for OrthoCyte and/or OrthoCyte’s Affiliates by carrying out the Project. |
1.19 | “ Third Party ” shall mean any party other than OrthoCyte and Heraeus or their respective Affiliates. |
1.20 | “ University of Utah Patent Rights ” means the patent applications and patents identified and listed in Exhibit F attached to this Agreement. |
2. | Conduct of the Project. |
2.1 | OrthoCyte agrees to conduct the Project at least with the degree of care customary within the biotech industry with regard to similar research and development projects, by qualified personnel, in accordance with the state of the art known to OrthoCyte and in accordance with the timeframe and the workscope as described in detail in the Project Plan ( Exhibit A ). Heraeus shall dedicate such personnel to the performance of the Project as Heraeus and OrthoCyte reasonably mutually agree is necessary. |
2.2 | To the extent required to conduct the Project, the Parties grant each other and their Affiliates a non-exclusive, non-transferable, non-assignable, free of charge and non-sublicensable right to use each other’s Background Rights in the Field of Use for the sole purpose of conducting the Project for the term of this Agreement, only. |
2.3 | The Parties acknowledge and agree that the Project is experimental in nature and that the Product may have unforeseeable properties. Therefore, neither Party warrants or represents, express or implied, that a particular result will be obtained by conducting the Project, or for the merchantability or the fitness of the Product for a particular purpose or capability or safety or harmlessness to health, or that the use of the Background Rights, the Results or the Product will not infringe any Third Party’s patent or other proprietary rights. Unless otherwise expressly stated otherwise in this Agreement, neither Party makes any warranty of any kind with respect to the Background Rights, the Results and the Product and disclaims any liability thereto. Payment of the fee (see section 3) is conditioned upon reaching the Milestones as set out in the Project Plan ( Exhibit A ). |
2.4 | Any change in the Project requires prior agreement in writing by both Parties. If one Party wishes to modify and/or change the Project, the respective Party will notify the other in writing. The Parties shall then mutually negotiate in good faith and in a reasonable manner to reach agreement as to any such modification and/or change, but shall not be obligated to reach any such agreement. |
2.5 | It is the understanding of the Parties, however, that the timeframe of the Project and the timeframes for the Milestones, which is set forth in the Project Plan, should be regarded as guidelines. In the event that OrthoCyte becomes aware of circumstances, which might cause a delay in conducting the Project within the timeframe described in the Project Plan and/or that any of the Milestones might not be met within the respective timeframes described in the Project Plan, OrthoCyte shall inform Heraeus promptly in writing and the Parties agree to mutually discuss the further development undertaking and adjust the timeframes of the Milestones respectively. In no event shall OrthoCyte be responsible for any damages arising out of or in connection with a delay in conducting the Project and/or meeting a Milestone or shall be obliged to refund any received fee under this Agreement, unless caused by OrthoCyte’s gross negligence or willful misconduct. |
2.6 | Except to the extent prohibited by law and unless expressly stated otherwise in this Agreement, OrthoCyte assumes responsibility for its conducting of the Project and liability for damages which may arise from its and/or its employees’ conducting of the Project, cf. however, with respect to indemnification and payment of damages, section 9 below . |
2.7 | Any work under the Project will be managed by a Joint Development Committee (“JDC”), comprising of two (2) representatives each from OrthoCyte and Heraeus. The JDC will meet (by telephone, video conference or in person) regularly, and at least quarterly during the performance of the Project, to discuss progress against the Project Plan. All major decisions regarding direction of the Project shall be decided by the JDC. In the event that the representatives of OrthoCyte and Heraeus are unable to come to agreement on such a decision, the representatives of Heraeus shall have final decision-making power. The Parties will correspond and/or meet on a regular basis in order to coordinate and discuss the progress of the Project. |
2.8 | The cooperation between the Parties regarding the Project shall be exclusive regarding the Field of Use. |
2.9 | OrthoCyte shall be allowed to use subcontractors for the conduct of this Project only with prior written consent of Heraeus which shall not unreasonably be withheld. OrthoCyte shall be liable for its subcontractors. |
2.10 | Heraeus relies on OrthoCyte’s knowledge of the OrthoCyte Materials and OrthoCyte Technology and cannot assess whether the list of patents provided in Exhibit A is exhaustive or whether other Intellectual Property Rights exist that are relevant for the conduct of this Project or the later use, manufacturing or marketing of the Product. |
3. | Financial Contribution for R&D and delivery. |
3.1 | For covering the costs for the R&D performance (i.e., execution of the Project) and delivery of the Product until the Product Launch, Heraeus agrees to pay to OrthoCyte in total fees payable as follows: |
3.1.1 | an “Upfront Payment” in the amount of [**] US$ upon the Effective Date and |
3.1.2 | a per milestone “Remuneration” for the R & D works performed in accordance with Project Plan and the delivery of Products as follows: |
· | [**] US$ payable upon finalising the 1 st Milestone (“POC small animal data”) as described in the respective Project Plan attached hereto as Exhibit A . |
· | [**] US$ is payable upon finalising the 2 nd Milestone (“Setting up Definitive Development Plan”) as described in the respective Project Plan attached hereto as Exhibit A. |
· | [**] US$ payable upon finalising the 3 rd Milestone (“Filing the IND application”) as described in the respective Project Plan attached hereto as Exhibit A . |
· | Should the Parties decide that OrthoCyte shall be responsible for the clinical trials, an additional fourth instalment will be paid for their conduct, the amount of which will be agreed upon IND approval. |
· | In addition, OrthoCyte shall support Heraeus in the regulatory approval process, which shall be remunerated at their standard hourly FTE rates. |
3.1.3 | In addition to the Upfront Payment and Milestone Remunerations set forth in 3.1.1 and 3.1.2, Heraeus shall pay to OrthoCyte OrthoCyte’s costs and expenses incurred by OrthoCyte in performance of the Project (the “Development Costs”). OrthoCyte shall submit quarterly, verifiable invoices to Heraeus, which specify the Development Costs incurred by OrthoCyte and Heraeus shall pay to OrthoCyte the invoiced Development Costs within [**] days of receipt of each invoice. OrthoCyte agrees to provide Heraeus with a detailed cost break down for Heraeus’ approval prior to each Work Package/Milestone set out in the Project Plan, Annex A . The parties currently estimate that the first work-package’s Development Costs (for preparation and commitment) will amount to [**] US$. |
3.2 | All payments are exclusive of any indirect taxes, duties or bank charges, which shall be borne by Heraeus. If applicable, indirect taxes will be charged in addition. If OrthoCyte does not charge indirect taxes and it is subsequently found that indirect taxes are chargeable on such provision, Heraeus agrees to pay such indirect taxes (exclusive of interests and penalties) on receipt of a valid invoice for indirect tax purposes and a copy of the ruling from the relevant tax authority or a reasonable legal opinion indicating the amount and the rationale for such indirect tax burden. |
3.3 | Unless stated otherwise, any payment is due within [**] days upon the receipt of the respective invoice made by OrthoCyte. |
3.4 | Paid fees are only refundable in case of a termination for cause by Heraeus. In such case, OrthoCyte shall be entitled to a pro-rata remuneration, taking account of the percentage of works already performed for the respective Milestone. |
4. | Background Rights. |
4.1
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Unless otherwise agreed by the Parties as set forth in the License Agreement (
Exhibit B
), all Background Rights of a Party shall remain the sole property of this Party, no right or license to any such Background Rights shall be created, by virtue of the Project or of this Agreement, to the other Party. Background Rights of a Party shall not be used by the other Party or its Affiliates for any other purposes than carrying out the Project, or be transferred by the other Party to a Third Party without the express prior written consent of the supplying Party.
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4.2 | OrthoCyte will promptly provide Heraeus with the search results in its possession at the Effective Date and at any subsequent date at which it becomes aware of further or additional Third Party’s rights of potential relevance concerning OrthoCyte’s Technology, always provided that Heraeus’ taking notice of any of the foregoing shall not release OrthoCyte from any liability for infringement of such Third Party rights in accordance with the Agreement. |
5. | Ownership of Results |
5.1 | OrthoCyte agrees to keep Heraeus informed of the progress of the Project and the Product and the Results obtained on a monthly basis. |
5.2 | All right, title and interest in the Results made by OrthoCyte, both within and outside the Field of Use, shall remain with OrthoCyte, subject to the following: |
5.2.1 | Results, including with respect to the Product, that directly relate to the OrthoCyte Materials and/or the OrthoCyte Technology, or that incorporate into or embody OrthoCyte Materials and/or the OrthoCyte Technology in the Product, shall be owned by OrthoCyte, both within and outside the Field of Use; provided, however, that OrthoCyte’s ownership rights of such Results are and shall be subject to (i) Section 6.1 of this Agreement, (ii) the exclusive rights of Heraeus to use the OrthoCyte Materials and the OrthoCyte Technology (including the OrthoCyte Patent Rights) and the OrthoCyte Background Rights as provided in the License Agreement, and (iii) ownership by Heraeus of any Results (including any new Intellectual Property Rights related thereto but excluding any Third Party Intellectual Property Rights relating thereto) that are incorporated into the Product, or that relate to the interactions of the scaffold, including to the PureStem Cell Lines, to the PureStem Cell Lines, to the Product characteristics or functions, or to the manufacturing of the Product. |
5.2.2 | Results, including with respect to the Product, that directly relate to the Heraeus Materials and/or the Heraeus Technology, or that incorporate into or embody Heraeus Materials and/or the Heraeus Technology in the Product, shall be owned by Heraeus, both within and outside the Field of Use; provided, however, that Heraeus’ ownership of such Results are and shall be subject to the rights of OrthoCyte to use the Heraeus Materials and the Heraeus Technology outside the Field of Use as provided in the License Agreement |
5.3 | OrthoCyte herewith assigns to Heraeus all Results, which are created under this Project and which, according to Sections 5.2.1 (iii) and 5.2.2, shall be owned by Heraeus. To enable Heraeus to obtain legal protection of these Results, OrthoCyte shall reasonably assist Heraeus and shall provide Heraeus with all required information and make the required declarations in due form and time. |
6. | Exploitation of the Product, Required License and Manufacturing. |
6.1 | The Parties agree that Heraeus shall be entitled to commercially use and exploit the Product in the Field of Use, thereby using the Results and Background Rights owned by OrthoCyte. Further details, including OrthoCyte retained rights and OrthoCyte’s right to exploit the Results outside the Field of Use are set forth in the License Agreement set out in Exhibit B . The License Agreement shall be signed together with this Agreement. The Parties understand and agree that, depending on the nature of and specifications for the Product to be Launched, a sublicense of the University of Utah Patent Rights from OrthoCyte to Heraeus may be required for the later commercialisation of the Product, but not for the current research and development phase, as defined in the Project Plan. |
6.2 | Manufacturing of the Product will be done by OrthoCyte. The Parties will negotiate and conclude a supplier agreement/toll manufacturing agreement before the marketing authorisations are obtained. |
6.3 | In addition, OrthoCyte agrees to assist Heraeus, if so requested by Heraeus, to establish a Second Source and to assist, in the technology transfer regarding the manufacturing process and know-how to a Third Party, if Heraeus decides to have the Product manufactured and delivered by said Third Party. This assistance comprises, inter alia, suitable support and training of that Third Party by qualified personnel of OrthoCyte, to the extent necessary, to ensure the know-how transfer, such training to be remunerated at hourly rates agreed by the Parties. The Parties will negotiate in good faith to enter into a manufacturing and supply agreement pursuant to which OrthoCyte will manufacture and supply Heraeus with Product and cooperate with Heraeus for the establishment and availability of the Second Source. |
6.4 | During the development phase set out in the Project Plan (i.e. until finalising the market authorisation process), OrthoCyte will provide to Heraeus the Product [**] . |
7. | Confidentiality. |
7.1 | In respect of the Confidential Information received from the Disclosing Party or its Affiliates under this Agreement, the Receiving Party agrees to undertake and bind itself: |
7.1.1 | To keep the Confidential Information received from the Disclosing Party or its Affiliates strictly confidential and secret and not in any way or at any time to make any use thereof except for conducting the Project. |
7.1.2 | Not to disclose any Confidential Information received from the Disclosing Party or its Affiliates to any Third Party without the prior written consent from the Disclosing Party. |
7.1.3 | To take all reasonable measures to ensure that the Confidential Information received from the Disclosing Party or its Affiliates is not inadvertently disclosed in violation of this Agreement. |
7.1.4 | At no time without the express written consent of the Disclosing Party to derive directly or indirectly from the possession of the Confidential Information received from the Disclosing Party or its Affiliates any rights, grant of licence, title or interest therein contrary to the terms and conditions of this agreement, nor contrary to the terms and conditions of this agreement to claim any rights to disclose or use for its own benefit such Confidential Information. |
7.1.5 | Not without prior written consent of the Disclosing Party to copy, reproduce, distribute or disclose the Confidential Information received from the Disclosing Party or its Affiliates to any person other than those Employees who are directly and necessarily involved in the conduct of the Project, and in such instance, only on a “need to know” basis. In addition, such Employees need to be made aware of the confidential nature of the information and need to be contractually obligated to observe non-use and secrecy obligations which are at least as strict as the once set forth hereunder. Irrespective of this, The Receiving Party shall be liable for its Employees. |
7.1.6 | Without prejudice to its obligations pursuant to this Agreement, at the request of the Disclosing Party, immediately return or destroy all Confidential Information received from the Disclosing Party or its Affiliates. Each Party shall ensure that it has retained no copy of any Confidential Information other than one archival copy to be retained in its confidential files solely for the purpose of monitoring compliance with this Agreement. |
7.2 | The Parties’ obligations from the above stipulated under section 7.1. do not apply to the following: |
7.2.1 | Confidential Information received from the Disclosing Party or its Affiliates, which at the time of the disclosure is in the public domain as evidenced by the Receiving Party in writing. |
7.2.2 | Confidential Information received from the Disclosing Party or its Affiliates, which after disclosure is published or otherwise becomes part of the public domain through no fault or breach of this Agreement by the Receiving Party as evidenced by the Receiving Party in writing. |
7.2.3 | Confidential Information received from the Disclosing Party or its Affiliates, which the Receiving Party can establish by competent proof in writing was in his possession at the time of disclosure by the Disclosing Party and was not acquired directly or indirectly from the Disclosing Party. |
7.2.4 | Confidential Information received from the Disclosing Party or its Affiliates which is received after the time of disclosure from a Third Party who did not acquire such Confidential Information directly or indirectly from the Disclosing Party under obligations of confidentiality and who is in lawful possession of such Confidential Information as evidenced by the Receiving Party in writing. |
7.2.5 | Confidential Information received from the Disclosing Party or its Affiliates, which by documentary proof has been independently developed by employees, agents, consultants or other representatives of the Receiving Party without the use of Confidential Information received from the Disclosing Party. |
7.2.6 | Confidential Information received from the Disclosing Party or its Affiliates which is required to be disclosed by law or any regulatory or government authority, however, if a Party thus becomes legally required to disclose Confidential Information, received from the Disclosing Party or its Affiliates, the Receiving Party shall provide the Disclosing Party with prompt advance notice and in order to afford the Disclosing Party to seek confidential treatment thereof or other appropriate remedy. |
7.3 | The Parties agree and acknowledge that the Project, including the exchange of Confidential Information, does not imply any transfer of title and/or ownership to Confidential Information or the creation of any intellectual property rights, and thus title and ownership to Confidential Information shall remain vested at all times in the Disclosing Party. |
7.4 | The Confidential Information is made available without any warranties with respect to the accuracy and usefulness of the Confidential Information and the Disclosing Party shall never be liable for any damage or loss, which the other Party’s use of the Confidential Information might incur. |
7.5 | The confidentiality obligations set forth in this section 7 set forth above shall survive the termination or expiry of this Agreement for a period of [**] years . |
7.6 | No disclosure of proprietary, non-public technical information concerning the Project (such as details of technology and research and development plans),and technical details of the Product and the Results is permitted without prior written consent of the other Party, unless (i) in order to obtain patent or other proprietary protection for the Results or the Product (ii) in order to obtain regulatory approval or to conduct clinical studies for the commercialization of any Results or the Product, or (iii) as Heraeus may reasonably deem necessary for marketing the Results or Product. The Parties shall agree on a form of initial press release that may be used by either Party on an ongoing basis to describe this Agreement, the Project and the intended Product. Each Party shall provide the other Party with reasonable advance written notice of any other press release or other public disclosure of this Agreement or the Results; provided, that the Parties acknowledge that OrthoCyte or its parent BioTime, Inc. may be required to make immediate or prompt disclosure of the occurrence of material events concerning the Project, the Results or the Product, such as (by way of example only) an action, order, or determination by the FDA or other regulatory agency or authority. OrthoCyte and its parent BioTime, Inc. may summarize this Agreement, excluding confidential portions, and describe the Project, Products and Results (other than proprietary, non-public technical information and details of research and development plans) in any registration statement, prospectus, or report filed with the Securities and Exchange Commission (“SEC”) or any other securities regulatory agency or authority. If OrthoCyte or its parent BioTime, Inc. determines that it is required to file a copy of this Agreement or any portion of this Agreement with the SEC or any other securities regulatory agency or authority, the Parties shall confer and determine which portions, if any, of this Agreement should be subject to an application requesting confidential treatment, and OrthoCyte or BioTime shall file this Agreement or any relevant portion subject to such application in accordance with the applicable rules and regulations of the SEC or such other agency or authority; provided, that any portion of this Agreement that is initially redacted from such filing under such application may be filed in its entirety and otherwise disclosed in a registration statement, prospectus, or report if so required by the SEC or other agency or authority. This Agreement may be disclosed by a Party under a confidentiality agreement, without the prior consent of the other Party, to any actual or prospective investor, lender, underwriter, or acquirer of the Party or any parent or subsidiary of the Party, or any actual or potential acquirer of the portion of the business to which this Agreement relates. Additionally, the text of any press release, shareholders’ report or other communication to be published or disclosed in any way by or on behalf of OrthoCyte or its parent BioTime, Inc. by or in the media concerning Heraeus, the subject matter of this Agreement or concerning this Agreement itself, other than as required by law or by any regulatory or government authority or the rules of the SEC or any other regulatory agency or authority, or any securities exchange, shall be submitted to Heraeus at least five (5) business days in advance of publication or disclosure for approval. Such approval not to be unreasonably withheld; provided, that disclosure that repeats or restates prior public disclosure permitted by this Agreement need not be submitted to Heraeus for approval. |
7.7 | Notwithstanding anything to the contrary in this Agreement, including without limitation in this Section 7, the Parties agree not to disclose the economic terms of this Agreement to any Third Party without the prior written consent of the other Party except (a) as required by applicable securities laws or the requirements of any applicable stock exchange, including, without limitation, requirements to file a copy of this Agreement (redacted to the extent reasonably permitted by applicable law); (b) in confidence, to legal counsel; (c) in confidence, to accountants, banks, and financing sources and their advisors; and (d) to the extent necessary to enforce this Agreement or any rights or obligations hereunder. |
8. | Term and Duration. |
8.1 | This R&D Agreement shall commence on the Effective Date and shall be effective until completion and payment of the last Milestone of the Project Plan, Exhibit A . |
8.2 | A Party may only terminate this R&D Agreement with immediate effect by giving written notice to the other Party, if the other Party fails to remedy its material breach of this Agreement within [**] days upon receipt of a written notice requiring the other Party to remedy the breach. |
8.3 | In addition, Heraeus may terminate this R&D Agreement to the end of a Milestone by giving written notice to OrthoCyte up to [**] days upon finalization of each Milestone and payment of the respective Milestone instalment (c.f. section 3.1.2). Fees paid already to OrthoCyte or due to OrthoCyte according to the payment schedule agreed until the date of effectiveness of such termination shall not be refunded by OrthoCyte to Heraeus. |
8.4 | The obligations set forth in section 5 and 7 shall survive termination or expiration of this R&D Agreement. |
8.5 | Expiration or termination of this R&D Agreement shall not affect the License Agreement, unless this R&D Agreement is terminated prior to completion of the Project and Product Launch, in which case the License Agreement shall terminate with the termination of this R&D Agreement. |
8.6 | In the event Heraeus elects to terminate this Agreement at any time prior to Product Launch, OrthoCyte shall have the right to proceed with the Project, including development of the Product and commercialization of the Product in the Field of Use. Heraeus will cooperate with OrthoCyte to grant OrthoCyte a license at marketable terms or transfer to OrthoCyte rights and materials, including all Intellectual Property Rights, useful or necessary for OrthoCyte to proceed with completion of the Project and commercialization of the Product. OrthoCyte shall be provided with a [**] day right of first refusal to enter into one or more definitive agreements with Heraeus to effect the above mentioned license or transfer and assignment. Heraeus agrees to engage in good faith negotiations to come to agreement with OrthoCyte on commercially reasonable terms. |
9. | Liability |
10. | Miscellaneous. |
10.1 | Force Majeure. Neither Party shall be liable for failures or delays in conducting the Project, and neither Party shall be deemed in breach of its obligations, if such failure or delay is due to natural disasters or any causes beyond the reasonable control of the Parties, including any act of God, any civil commotion or strike ("Force Majeure"). In the event of such Force Majeure, the Party affected hereby shall (i) promptly notify the other Party in writing and (ii) use reasonable efforts to cure or overcome the same and resume performance of its obligations hereunder. |
10.2 | Notices. Any notice to be given under this Agreement must be in writing. Such notice shall be made by registered letter, return receipt requested or courier (e.g. FedEx, UPS, Optima etc.), or by email (such email shall be deemed received with confirmed transmission or when delivery confirmed otherwise) to the addresses set out below: |
10.3 | Independent Parties. The Parties’ relationship to each other shall be that of independent contractors and neither Party nor its employees are employees of the other Party. Furthermore, this Agreement shall not make either Party the agent or the legal representative of the other Party. Neither Party is granted any right or authority to assume or to create any obligation or responsibility, express or implied, on behalf of or in the name of the other Party, with regard to any manner or thing whatsoever, unless otherwise specifically agreed upon in writing. |
10.4 | Assignment and Successors. This Agreement and rights hereunder shall not be assigned or transferred, directly or indirectly, in whole or in part by the Parties without the prior written consent of the other Party. However, should OrthoCyte intend to assign this Agreement to another entity, which acquires all or substantially all of the business or assets of OrthoCyte to which this Agreement pertains, whether by merger, reorganization, acquisition, sale or otherwise, provided that such successor or assignee shall agree in writing to be bound by the terms and conditions of this Agreement prior to assignment, Heraeus agrees to not unduly withhold its consent. In |
10.5 | case of such assignment to a Third Party, OrthoCyte shall continue to be bound by the confidentiality obligations stipulated in Section 7. |
10.6 | Integration, Severability. Invalid provisions of this Agreement shall not in any way affect the validity and enforceability of the remaining provisions. The Parties agree to undertake to replace the invalid and enforceable provisions by new provisions, which will approximate as closely as possible the result intended by the Parties. The same shall apply in the case of an omission. |
10.7 | Amendment; Waiver. This Agreement may be amended, modified, superseded or cancelled, and any of the terms may be waived, only by mutual written agreement by the Parties. The written form requirement may not be amended. The delay or failure of any Party at any time or times to require the performance of any provisions shall in no manner affect the rights at a later time to enforce same. |
10.8 | Governing law and jurisdiction. The exclusive jurisdiction for any dispute, claim or proceeding between the Parties arising out or in connection with this Agreement shall be the United States District Court for the Southern District of New York or, only if there is no federal subject matter jurisdiction, in any state court of New York sitting in the City and County of New York, and each party hereby submits to the exclusive personal jurisdiction of the foregoing courts. |
10.9 | Exhibits |
Exhibit A:
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Project Plan and Milestones
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Exhibit B:
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License Agreement
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Exhibit C:
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Patent Rights of OrthoCyte (and Biotime)
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Exhibit D:
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Heraeus Patent Rights
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Exhibit E:
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Final Report
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Exhibit F:
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Patent Rights of University of Utah
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OrthoCyte Corporation
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/s/ Michael D. West
September 29, 2015
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Signature & Date
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Heraeus Medical GmbH
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Heraeus Medical GmbH
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ppa Nicole Petermann
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Hergen Haas
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Head of Commercial Services
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General Counsel Heraeus Group
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/s/ Nicole Petermann
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/s/ Hergen Haas
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Signature & Date
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Signature & Date
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Phase
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Cost
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Process
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Deliverables/
Milestones
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Timeline
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by and between
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OrthoCyte Corporation
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a California corporation and an Affiliate
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of BioTime, Inc. (“BioTime”),
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1301 Harbor Bay Parkway,
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Alameda, CA 94502 USA
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(in the following referred to as “
OrthoCyte
”)
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and
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Heraeus Medical GmbH
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Philip-Reis-Str. 8/13
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61273 Wehrheim, Germany
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(in the following referred to as “
Heraeus
”)
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WHEREAS | OrthoCyte owns, or has licensed rights to, and possesses two therapeutic development platforms. The first one being a comprehensive portfolio of embryonic stem cells and clonal progenitor stem cells of primate origin, as well as related know-how and technological expertise to propagate and differentiate these cells. More specifically, the first platform comprises osteochondro progenitor cell lines named PureStem® and related know-how and technological expertise to ensure the isolation and selection of clonal cells with high purity and optimised potency, including methods to ensure scalability of culturing and identification by comprehensive microarrays. The second platform technology is a scaffold technology for cell delivery, named HyStem®. Both technologies are patent protected and OrthoCyte owns, or has licensed rights to, the corresponding rights to these technologies, in particular Intellectual Property Rights and related secret technical information; these rights comprise in particular the selection of cell lines, manufacturing (culturing and differentiation of these cell lines), their combination with an appropriate scaffold and the use of this technology (application in medical indication). |
WHEREAS | Heraeus has experience in the field of bone cement and biomaterials, as medical implants for elective orthopaedic and trauma surgery, and possesses detailed market knowledge and data with regard to musculoskeletal indications and owns and/or licenses from a Third Party rights to certain scaffold technologies; |
WHEREAS | Heraeus has experience in the field of bone cement and biomaterials, as medical implants, for elective orthopaedic and trauma surgery; |
WHEREAS | The Parties have already entered into a Research & Development Agreement, to which this Agreement is attached as Exhibit B (the R&D Agreement”) |
WHEREAS | The Parties enter into this License Agreement, pursuant to which Heraeus shall receive a license under the respective Intellectual Property Rights owned, licensed to and/or otherwise controlled by OrthoCyte to use the OrthoCyte Technology and the BioTime Materials in the Field of Use in the Territory, and OrthoCyte shall receive a license under the respective Intellectual Property Rights owned, licensed to and/or otherwise controlled by Heraeus to use the Heraeus Technology and the Heraeus Materials outside the Field of Use in the Territory, as further specified in this Agreement. |
1. | Definitions. |
1.1 | "Affiliates ” shall mean, with respect to a Party, any corporation, company, partnership or other entity, which controls, is controlled by, or is under common control with a Party. For such purpose the term “control” shall mean the ownership, direct or indirect control of at least fifty percent (50 %) of the voting stock of the other entity. |
1.2 | “ Background Rights” shall mean any and all Intellectual Property Rights and all substances and/or biological material and any rights therein or thereto (e.g. licenses) belonging to a Party and/or its Affiliates (irrespectively whether or not protectable under state, federal or foreign intellectual property laws), which is developed or acquired by such Party and/or its Affiliates prior to the Effective Date, or developed or acquired by such Party and/or its Affiliates independently from performance of this Agreement regardless whether developed or acquired either before or after the Effective Date and that are necessary or useful for a Party to exercise its rights under Section 2.1 or 2.2 of this Agreement, as applicable. OrthoCyte’s Background Rights include the OrthoCyte Technology and the OrthoCyte Materials. Heraeus’ Background Rights include the Heraeus Technology and the Heraeus Materials. |
1.3 | “OrthoCyte Materials” shall be PureStem® Cell Lines (or Stem Cell Derivatives) as well as the HyStem® Delivery System. |
1.4 | “OrthoCyte Property Rights” means OrthoCyte’s personal proprietary rights in the PureStem Cell Lines, including ownership rights and rights in the know-how embodied in the Cell Lines. |
1.5 | “OrthoCyte Technology” shall be the technology, including the HyStem Delivery System, to select, expand, manufacture, combine and use the OrthoCyte Materials, as covered by the Intellectual Property Rights owned by OrthoCyte or BioTime or licensed in from a Third Party. The OrthoCyte Technology includes the patent applications and patents identified and listed in Exhibit C (the “OrthoCyte Patent Rights”). |
1.6 | “Confidential Information” shall mean any and all data, material and/or information related to: (i) the terms of this Agreement including all Annexes etc., (ii) information made available by one Party ("Disclosing Party") to the other Party (“Receiving Party”) in tangible such as writing or other form including electronic, visual, oral or graphic form or as samples (including but not limited to Party’s Background Rights and Intellectual Property Rights, any technical information, research-, products-, personnel-, marketing-, strategic information or other information), (iii) any data, material and information developed during the term of this Agreement, and (iv) any compound(s) and/or material(s) provided by one Party to the other pursuant to this Agreement, whether prior to or after the Effective Date and whether it is labelled "confidential" or not, in the course of the Parties' evaluation, negotiation of or performance under or in connection with this Agreement. There is no requirement to mark data, material and/or information as “Confidential” when exchanged between Parties, but this is a recommended best practice. |
1.7 | "Effective Date" shall mean the date of the last signature of the Parties to this Agreement. |
1.8 | "Field of Use" shall mean bone grafting for the indications osteoskeleton diseases and injuries, thereby excluding dental and maxillofacial indications. |
1.9 | “Heraeus Materials” shall be the Heraeus Scaffold and all market related research and data related to the Field of Use owned by Heraeus or licensed in from a third party. |
1.10 | “Heraeus Scaffold” means the scaffold that is owned by Heraeus or licensed in from a Third Party. |
1.11 | “Heraeus Technology” means the technology relating to the Heraeus Scaffold, as covered by the Intellectual Property Rights owned by Heraeus or licensed in from a Third Party. The Heraeus Technology includes the patent applications and patents identified and listed in Exhibit D . |
1.12 | “HyStem Delivery System” means the proprietary scaffold technology for delivery of bioactives, including, without limitation, small molecules, proteins, cells fractions or derivatives thereof, as covered by the Intellectual Property Rights owned by OrthoCyte or BioTime, or licensed in from a Third Party, including the University of Utah Research Foundation. |
1.13 | “Intellectual Property Rights” shall mean the rights and interests in and to any and all issued patents and pending patent applications, know-how, trade secrets, utility certificates, utility models, registered design, trademarks, copyrights (including inventor’s certificates), in any country or jurisdiction, including but not limited to, any and all provisionals, non-provisionals, substitutions, continuations, continuations-in-part, divisionals and other continuing applications, supplementary protection certificates, renewals, and all letters patent on any of the foregoing, and any and all reissues, re-examinations, extensions, confirmations, registrations and patents of addition of any of the foregoing. |
1.14 | “Launch” shall mean the first commercial sale of the Product to Third Parties. |
1.15 | “Net Sales” shall mean the actual gross amount of invoiced prices for the sale of Products by Heraeus and its Affiliates, or the sale by OrthoCyte and its Affiliates of Products, as applicable, less the following deductions actually taken with respect to such sales: (i) any rebates, quantity, trade and/or cash discounts and other usual and customary discounts to customers actually granted, if any, (ii) compulsory payments and rebates, actually paid or deducted; retroactive price reductions, credits or allowances actually granted upon rejections or returns of Product, including for recalls or damaged goods, (iii) value-added taxes, (iv) costs of packaging, insurance and transportation from the place of manufacture to the customer’s premises including import, export, excise, turnover, custom duties, and (v) sales taxes paid by Heraeus or its Affiliates. |
1.16 | “Product” shall mean the cell therapy bone grafting product consisting of a select osteochondroprogenitor PureStem Cell Line (or Stem Cell Derivative) contained in a scaffold and developed by the Parties under the Research and Development Agreement to which this License Agreement is attached. |
1.17 | “PureStem Cell Line” means OrthoCyte’s (including its Affiliate BioTime) comprehensive portfolio of embryonic stem cells and clonal progenitor stem cells of primate origin, as well as related know-how and technological expertise to propagate and differentiate such cells. |
1.18 | “ Stem Cell Derivative ” shall mean any of the following derived from a PureStem Cell Line: a select non-viable osteochondroprogenitor PureStem Cell Line, or fraction thereof such as, fractionate, extract, secretion products; lyophilized, concentrated, reconstituted or diluted in appropriate solvent if necessary. |
1.19 | "Results" shall mean all data, information, findings, know-how, substances and biological material, inventions, improvements and/or discoveries (irrespectively whether or not protectable under state, federal or foreign intellectual property laws), resulting from and made by or for OrthoCyte and/or OrthoCyte’s Affiliates by carrying out the Project (as defined in the R&D Agreement). Results owned by OrthoCyte are referred to as “OrthoCyte Results” and Results owned by Heraeus are referred to as “Heraeus Results.” |
1.20 | “Third Party” shall mean any party other than OrthoCyte and Heraeus or their respective Affiliates. |
1.21 | “Territory” shall mean worldwide. |
2 | Grant of licenses |
2.1 | OrthoCyte herewith grants Heraeus a royalty-bearing, exclusive license to use OrthoCyte Background Rights, including, but not limited to the OrthoCyte Materials , the OrthoCyte Property Rights, the OrthoCyte Technology, including without limitation the OrthoCyte Patent Rights, as well as the OrthoCyte Results to research, register or obtain and maintain marketing approval, develop, make, have made, use, market, distribute, import, export, offer to sell, sell and have sold, the Product in the Field of Use in the Territory, with the right to sublicense. The license granted in this section 2.1 also grants to Heraeus the right to use all related documents and data, e.g. the Final Report (as defined in the R&D Agreement), which are established by OrthoCyte or its Affiliates or subcontractors, in as far as such documents and data are useful or necessary for Heraeus to exploit the license rights granted to Heraeus in this Agreement. |
2.2 | Heraeus herewith grants OrthoCyte a royalty-bearing, exclusive license to use the Heraeus Materials, the Heraeus Technology, including without limitation the Heraeus Patent Rights, and the Heraeus Results, to the extent needed to register or obtain and maintain marketing approval, make, have made, use, market, distribute, import, export, offer to sell, sell and have sold the Product outside the Field of Use in the Territory, with the right to sublicense. |
2.3 | OrthoCyte reserves all rights to use the following outside the Field of Use: PureStem Cell Lines (and Stem Cell Derivatives), the OrthoCyte Property Rights, the OrthoCyte Technology, including without limitation the OrthoCyte Patent Rights, and the OrthoCyte Results. |
2.4 | Each Party’s right to grant commercial sublicenses (i.e. excluding licenses for toll-manufacturing and licenses to its affiliates) of its rights under Section 2.1 or 2.2, as applicable, is subject to the following conditions: |
3 | Royalties |
3.1 | Heraeus shall pay to OrthoCyte a royalty on Net Sales of Product by Heraeus (including sales of Heraeus’ Affiliates to Third Parties as follows: |
3.1.1
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[**] shall be due for Net Sales up to
[**] US$
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3.1.2
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[**]
shall be due for Net Sales between
[**] US$
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3.1.3
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[**]
shall be due on Net Sales above
[**] US$
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3.2 | OrthoCyte shall pay to Heraeus a royalty of [**] on Net Sales of Product by OrthoCyte (including sales by OrthoCyte Affiliates to Third Parties) into other fields than the Field of Use. |
3.3 | In case that Heraeus or OrthoCyte grants commercial sub-licenses to Third Parties (other than for the sole purpose of having such Third Party manufacturing the Product on behalf of a Party or its Affiliates and for further sale by such Party), OrthoCyte and Heraeus agree to each other a total of [**] of all Sublicense Income. "Sublicense Income" means consideration that Heraeus or OrthoCyte, as applicable, receives for the grant of rights to a Third Party sublicensee. |
3.4 | OrthoCyte shall manufacture the Product for Heraeus. Hereaus shall reimburse OrthoCyte the manufacturing costs occurred in fact (COGS) by OrthoCyte to manufacture the Product, which shall be disclosed to Heraeus in confidence by OrthoCyte. For this purpose the Parties intend to sign a separate manufacturing and supply agreement which shall be negotiated and concluded before Launch of the Product. |
3.5 | Within [**] days of the end of each calendar year (”Payment Period”), Heraeus shall provide to OrthoCyte a written report describing the Net Sales of Product sold by or on behalf of Heraeus and its Affiliates as well as a report on the proceeds received from its sub-licensees during said calendar year specifying the Net Sales and proceeds. All aforementioned payments shall be made in Euro. |
3.6 | Heraeus will make all payments due under this Agreement within [**] days of receipt of a corresponding invoice from OrthoCyte. Payments shall be effected to the following account of OrthoCyte: |
3.7 | Possible turnover taxes and indirect taxes on any fees, milestone payments or royalties shall, if they accrue, be added to the respective payments. Any direct taxes, by law at the charge of OrthoCyte, shall be borne by OrthoCyte but may be, if so required by law, withheld and paid by Heraeus on behalf of OrthoCyte. Heraeus shall forward official receipts to OrthoCyte for such withholding taxes paid. Heraeus and OrthoCyte shall use their best efforts to take advantage of any tax treaties which may be applicable and to minimize any deduction for withholding tax. |
3.8 | Both Parties shall keep and maintain records of sales of the Product made by or on behalf of them, its Affiliates and sub-licensees, so that the royalties payable and the royalty statements may be verified, including the proceeds shared and the proceeds statement. Such records shall be open to inspection during business hours for a [**] year period after the end of the Payment Period to which such records relate, but in any event not more than once per calendar year, by a nationally recognized independent certified public accountant selected by a Party to whom the other Party has no reasonable objections. Said accountant shall sign a confidentiality agreement prepared by the Party requesting the involvement of the accountant and reasonably acceptable to the other Party and shall then have the right to examine the records kept pursuant to this Agreement and report to both Parties the findings (but not the underlying data) of said examination of records as are necessary to evidence that the records were or were not maintained and used in accordance with this Agreement. A copy of any report shall be provided to both Parties. |
4 | Confidentiality |
4.1 | Subject to the terms and conditions of this Agreement, all Information, including concerning the BioTime Technology, the results, the Product, the Licensed Product, a Party’s marketing, technical, product and business affairs and proprietary and trade secrets information and all know-how communicated by a Party or its Affiliates to another Party or its Affiliates, including the existence and terms of this Agreement, shall be deemed Confidential Information as defined in section 1.5. The Receiving Party of Confidential Information may not reveal any such Confidential Information to any Third Party other than its Affiliates or sub-licensees, except with the prior written approval of the Disclosing Party. The Parties undertake to protect the other Party’s Confidential Information against unauthorized access by Third Parties. Affiliates and sub-licensees, which shall be bound by a non-disclosure agreement at least as restrictive than the stipulations in this Agreement. |
4.2 | In respect of the Confidential Information received from the other Party ( Disclosing Party ) or its Affiliates under this Agreement, the Receiving Party agrees to undertake and bind itself: |
(a) | to keep the Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees strictly confidential and not to disclose it or to make it otherwise available to any Third Party and not in any way or at any time to make any use thereof except according to the performance of this Agreement; |
(b) | to take all reasonable measures to ensure that the Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees is not inadvertently disclosed in violation of this Agreement; |
(c) | not without prior written consent of the Disclosing Party to copy, reproduce, distribute or disclose the Confidential Information received from the Disclosing Party, its |
(d) | without prejudice to its obligations pursuant to this Agreement, after termination for whatever reason and at the request of the Disclosing Party, immediately return or destroy all Confidential Information received from the Disclosing Party or its Affiliates. The destruction of the Confidential Information shall be confirmed promptly in writing. Each Party shall ensure that it has retained no copy of any Confidential Information other than one archival copy to be retained in its confidential files solely for the purpose of monitoring compliance with this Agreement. |
4.3 | The Parties’ obligations from the above stipulated under Article 4.2. do not apply to the following: |
(a) | Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees, which at the time of the disclosure is in the public domain as evidenced by the Receiving Party in writing ; |
(b) | Confidential Information received from the Disclosing Part, its Affiliates or sub-licensees, which at the time of the disclosure is in the public domain as evidenced by the Receiving Party by competent proof ; |
(c) | Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees, which after disclosure is published or otherwise becomes part of the public domain through no fault or breach of this Agreement by the Receiving Party as evidenced by the Receiving Party by competent proof ; |
(d) | Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees, which the Receiving Party can establish by competent proof in writing was in his possession at the time of Disclosure by the Disclosing Party and was not acquired directly or indirectly from the Disclosing Party ; |
(e) | Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees which is received after the time of disclosure from a Third Party who did not acquire such Confidential Information directly or indirectly from the Disclosing Party under obligations of confidentiality and who is in lawful possession of such Confidential Information as evidenced by the Receiving Party in writing ; |
(f) | Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees, which, as can be demonstrated by documentary proof, has been independently developed by employees, agents, consultants or other representatives of the Receiving Party without the use of Confidential Information received from the Disclosing Party. |
4.4 | Notwithstanding any other provisions of this Article 4 and Article 1.5: |
4.4.1 | all of the Disclosing Party’s Confidential Information may be disclosed by the Receiving Party: (i) to any regulatory authority to secure regulatory approvals; or (ii) if the Receiving Party is required by applicable laws to disclose such Confidential Information, and is not otherwise subject to a protective order. In the case of (ii), the Receiving Party agrees to notify the other Party immediately and to use its reasonable efforts to prevent the dissemination of the Confidential Information other than as strictly required by applicable laws. The Receiving Party shall use its reasonable efforts, at the request of the Disclosing Party, to obtain confidential treatment of such Confidential Information by the governmental authority or Third Party to whom the Confidential Information is disclosed at the Receiving Party’s costs; and |
4.4.2 | a Party may disclose the existence and terms of this Agreement to the extent required to be disclosed, as reasonably determined by the disclosing Party, by applicable law, or by order or other ruling of a competent court; and |
4.4.3 | upon prior written notice and acceptance by the other Party, which shall not be unreasonably or untimely withheld, a Party hereto may disclose the existence and terms of this Agreement to possible investors, acquirers and merging partners of such Party under respective confidentiality obligations. Prior to any disclosure of the other Party’s Confidential Information, a draft of the proposed disclosure (including marked redactions of such Confidential Information) shall be provided to the other Party for consent. This said, without its attachments, in particular the Project Plan, and further excluding or blackening any Confidential Information of the other Party, this Agreement, may be disclosed under respective confidentiality agreements without the prior consent of the other Party. |
4.5 | This Article 4 shall survive the expiry or termination of this Agreement. |
5 | Representations and warranties |
5.1 | OrthoCyte warrants, that OrthoCyte is the owner or licensee of the Intellectual Property Rights listed in Attachment 1 and that they exist and are active as of the Effective Date. OrthoCyte is entitled to grant the license under the Intellectual Property Rights as granted in this Agreement. |
5.2 | OrthoCyte has no knowledge that the development, manufacture or sell of Product in the Field of Use does infringe intellectual property rights of Third Parties. Should OrthoCyte gain knowledge of any facts, it will inform Heraeus immediately. |
5.3 | No Party makes any representations or warranties, either express or implied, with respect to the Product, in particular, does not make any representations concerning the usability or the merchantability of the Product. Both Parties expressly exclude all express and implied warranties with respect to utility, applicability, safety, harmlessness to health or the fitness of the Product for any purpose. |
5.4 | No Party makes any representations or warranties that the use of the Product will not infringe any patent or other proprietary rights of any Third Party and both Parties expressly disclaim any liability thereto. |
5.5 | Except in the event of gross negligence, breach, fraud or willful misconduct, neither Party shall be held liable for any, indirect, special consequential or incidental damages, such as, but not limited to, damage or loss of property or equipment, loss of profits or revenue, cost of capital or lost opportunities. |
5.6 | Heraeus shall at all times during the term of this Agreement and thereafter indemnify, defend and hold harmless and its Affiliates , members of the executive board, officers, agents and employees from any claims and expenses, including legal expenses and attorneys’ fees, arising out of the death of or injury to any person or persons or out of any damage to property and against any other claim, proceeding, demand, expense, liability, loss, or damage of any kind whatsoever arising out of the development, manufacture, use, handling, storing or sale of the Product in the Field of Use. |
6. | Rights to Background Rights |
6.1 | The Parties acknowledge that any Background Right of a Party used for the performance of this Agreement remains the property of the said Party introducing the same, except the Parties have agreed otherwise in writing. Nothing in this Agreement shall be interpreted as an obligation on a Party or an Affiliate thereof to give access to or grant a licence under its Background Rights, except as agreed herein otherwise in writing. |
7. | Term and Termination |
7.1 | This Agreement shall come into force on the Effective Date and shall, unless terminated prior in accordance with this Article below, remain in force until the last patent in a particular country, for which Heraeus has claimed a license under this Agreement, expires. After such expiration Heraeus shall have the right to further benefit from the license granted under this Agreement without paying any further royalties or other compensations towards OrthoCyte. Upon termination, not expiry, of this Agreement all sub-license agreements shall expire immediately. |
7.2 | Early termination before the expiry date of the last patent covered shall only be possible under the following conditions: |
7.2.1 | Early termination shall be available to Heraeus, at Heraeus’s sole discretion, upon [**] months prior written notice. |
7.2.2 | Early termination shall be available to either Party for cause. Notably, but not exclusively, a Party shall be entitled to terminate this Agreement for cause by giving written notice of such termination if: |
(i) | the other Party shall be in default of any of its material obligations under this Agreement and shall fail to remedy such default within [**] days after receipt of written notice thereof, or |
(ii) | the other Party challenges the validity of the Intellectual Property of the other Party regarding the licensed Intellectual Property Rights or supports Third Parties in such challenge. |
(iii) | an event of insolvency or bankruptcy occurs in relation to the other Party. |
7.3 | This Agreement shall terminate if the R&D Agreement is terminated prior to Product Launch. |
7.4 | Any royalties or payments paid or due prior to the date of effective termination shall not be refundable. |
7.5 | The termination of this Agreement does not affect any rights or obligations of either Party which have arisen or accrued up to and including the date of termination. |
8. | Miscellaneous |
8.1 | Force Majeure |
8.2 | Notices |
8.3 | Assignment and successors |
8.4
|
Severability
|
8.5
|
Amendment
|
9.6
|
Governing law and Jurisdiction; Interpretation
|
Signatures:
|
||
For OrthoCyte
|
||
|
||
Signature
|
||
Date:
|
||
For Heraeus Medical GmbH
|
||
|
|
|
Signature:
|
Signature:
|
|
Name:
|
Name:
|
|
Title:
|
Title:
|
|
Date:
|
Date:
|
TITLE
|
COUNTRY
|
APPLICATION
NUMBER
|
FILING DATE
|
PATENT
NUMBER
|
ISSUE
DATE
|
STATUS
|
|
BIOT-013
|
Methods to Accelerate the Isolation of Novel Cell Strains from Pluripotent Stem Cells and Cells Obtained Thereby
|
US
|
12/504,630
|
Jul 16, 2009
|
Pending
|
||
BIOT-024
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
US
|
13/384,289
|
Mar 16, 2012
|
8,685,386
|
Apr 1, 2014
|
Issued
|
BIOT-024AU
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
AU
|
2010273930
|
Jul 16, 2010
|
Pending
|
||
BIOT-024CA
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
CA
|
2,768,376
|
Jul 16, 2010
|
Pending
|
||
BIOT-024CN
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
CN
|
201080041322
|
Jul 16, 2010
|
Pending
|
||
BIOT-024 CON1
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
US
|
14/172,765
|
Feb 4, 2014
|
Pending
|
||
BIOT-024EP
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
EP
|
10800651.1
|
Jul 16, 2010
|
Pending
|
||
BIOT-024IL
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
IL
|
217552
|
Jul 16, 2010
|
Pending
|
BIOT-024IN
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
IN
|
1098/CHENP/2012
|
Jul 16, 2010
|
Pending
|
||
BIOT-024JP
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
JP
|
2012-520830
|
Jul 16, 2010
|
Pending
|
||
BIOT-024JP D
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
JP
|
2015-158197
|
Jul 16, 2010
|
Pending
|
||
BIOT-024KR
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
KR
|
10-2012-7003880
|
Jul 16, 2010
|
Pending
|
||
BIOT-024SG
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
SG
|
201200351-3
|
Jul 16, 2010
|
177694
|
Sept 16, 2014
|
Issued
|
BIOT-026
|
Improved Methods of Screening Embryonic Progenitor Cell Lines
|
US
|
13/683,241
|
Nov 21, 2012
|
Pending
|
||
BIOT-026AU
|
Improved Methods of Screening Embryonic Progenitor Cell Lines
|
AU
|
2011258249
|
May 25, 2011
|
2011258249
|
Sept 25, 2014
|
Issued
|
BIOT-026CA
|
Improved Methods of Screening Embryonic Progenitor Cell Lines
|
CA
|
2,800,616
|
May 25, 2011
|
Pending
|
||
BIOT-029SG2
|
Progenitor Cells and Methods and Uses Related Thereto
|
SG
|
200306634.7
|
Aug 9, 2001
|
100479
|
May 31, 2005
|
Issued
|
BIOT-030
|
Methods of Modifying Transcriptional Regulatory Networks in Stem Cells
|
US
|
13/279,123
|
Oct 21, 2011
|
Pending
|
||
BIOT-030AU
|
Methods of Modifying Transcriptional Regulatory Networks in Stem Cells
|
AU
|
2011316830
|
Oct 21, 2011
|
Pending
|
||
BIOT-030CA
|
Methods of Modifying Transcriptional Regulatory Networks in Stem Cells
|
CA
|
2,814,860
|
Oct 21, 2011
|
Pending
|
||
BIOT-030EP
|
Methods of Modifying Transcriptional Regulatory Networks in Stem Cells
|
EP
|
11835259.0
|
Oct 21, 2011
|
Pending
|
||
BIOT-030IN
|
Methods of Modifying Transcriptional Regulatory Networks in Stem Cells
|
IN
|
2198/CHENP/2013
|
Oct 21, 2011
|
Pending
|
||
BIOT-033
|
Novel Methods and Formulations for Orthopedic Cell Therapy
|
US
|
14/131,429
|
Jan 7, 2014
|
Pending
|
||
BIOT-034
|
Compositions and Methods Relating to Clonal Progenitor Cell Lines
|
US
|
14/238,160
|
Apr 29, 2014
|
Pending
|
TITLE
|
COUNTRY
|
APPLICATION NUMBER
|
FILING DATE
|
PATENT NUMBER
|
ISSUE DATE
|
STATUS
|
||
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
US
|
12/234,445
|
Sep 19, 2008
|
8,859,523
|
Oct 14, 2014
|
Issued
|
|
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
US
|
12/244,135
|
Oct 2, 2008
|
7,928,069
|
Apr 19, 2011
|
Issued
|
|
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
CA
|
2,489,712
|
May 15, 2003
|
Pending
|
|||
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
CH
|
03799796.2
|
May 15, 2003
|
1539799
|
Nov 14, 2013
|
Issued
|
|
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
DE
|
03799796.2
|
May 15, 2003
|
1539799
|
Nov 14, 2013
|
Issued
|
|
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
FR
|
03799796.2
|
May 15, 2003
|
1539799
|
Nov 14, 2013
|
Issued
|
|
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
GB
|
03799796.2
|
May 15, 2003
|
1539799
|
Nov 14, 2013
|
Issued
|
|
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
IE
|
03799796.2
|
May 15, 2003
|
1539799
|
Nov 14, 2013
|
Issued
|
|
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
IT
|
03799796.2
|
May 15, 2003
|
1539799
|
Nov 14, 2013
|
Issued
|
|
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
LX
|
03799796.2
|
May 15, 2003
|
1539799
|
Nov 14, 2013
|
Issued
|
|
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
MN
|
03799796.2
|
May 15, 2003
|
1539799
|
Nov 14, 2013
|
Issued
|
|
U-3656
|
Modified Macromolecules and Associated Methods of Synthesis and Use
|
US
|
10/581,571
|
Jul 13, 2007
|
7,981,871
|
Jul 19, 2011
|
Issued
|
|
U-3656
|
Modified Macromolecules and Associated Methods of Synthesis and Use
|
US
|
13/184,401
|
Jul 15, 2011
|
8,691,793
|
Apr 08, 2014
|
Issued
|
|
U-3656
|
Modified Macromolecules and Associated Methods of Synthesis and Use
|
CA
|
2,549,295
|
Dec 06, 2004
|
Pending
|
|||
U-3656
|
Modified Macromolecules and Associated Methods of Synthesis and Use
|
EP
|
04813101.5
|
Dec 06, 2004
|
Pending
|
|||
U-3362
|
Anti-adhesion Compositions and Methods of Use Thereof
|
US
|
10/556,693
|
Dec 03, 2008
|
8,324,184
|
Dec 04, 2012
|
Issued
|
|
U-3362
|
Anti-adhesion Compositions and Methods of Use Thereof
|
EP
|
04775992.3
|
May 13, 2004
|
Pending
|
by and between
|
OrthoCyte Corporation
|
|
a California corporation and an Affiliate
|
||
of BioTime, Inc. (“BioTime”),
|
||
1301 Harbor Bay Parkway,
|
||
Alameda, CA 94502 USA
|
||
(in the following referred to as “
OrthoCyte
”)
|
||
and
|
Heraeus Medical GmbH
|
|
Philip-Reis-Str. 8/13
|
||
61273 Wehrheim, Germany
|
||
(in the following referred to as “
Heraeus
”)
|
WHEREAS | OrthoCyte owns, or has licensed rights to, and possesses two therapeutic development platforms. The first one being a comprehensive portfolio of embryonic stem cells and clonal progenitor stem cells of primate origin, as well as related know-how and technological expertise to propagate and differentiate these cells. More specifically, the first platform comprises osteochondro progenitor cell lines named PureStem® and related know-how and technological expertise to ensure the isolation and selection of clonal cells with high purity and optimised potency, including methods to ensure scalability of culturing and identification by comprehensive microarrays. The second platform technology is a scaffold technology for cell delivery, named HyStem®. Both technologies are patent protected and OrthoCyte owns, or has licensed rights to, the corresponding rights to these technologies, in particular Intellectual Property Rights and related secret technical information; these rights comprise in particular the selection of cell lines, manufacturing (culturing and differentiation of these cell lines), their combination with an appropriate scaffold and the use of this technology (application in medical indication). |
WHEREAS | Heraeus has experience in the field of bone cement and biomaterials, as medical implants for elective orthopaedic and trauma surgery, and possesses detailed market knowledge and data with regard to musculoskeletal indications and owns and/or licenses from a Third Party rights to certain scaffold technologies; |
WHEREAS | Heraeus has experience in the field of bone cement and biomaterials, as medical implants, for elective orthopaedic and trauma surgery; |
WHEREAS | The Parties have already entered into a Research & Development Agreement, to which this Agreement is attached as Exhibit B (the R&D Agreement”) |
WHEREAS | The Parties enter into this License Agreement, pursuant to which Heraeus shall receive a license under the respective Intellectual Property Rights owned, licensed to and/or otherwise controlled by OrthoCyte to use the OrthoCyte Technology and the BioTime Materials in the Field of Use in the Territory, and OrthoCyte shall receive a license under the respective Intellectual Property Rights owned, licensed to and/or otherwise controlled by Heraeus to use the Heraeus Technology and the Heraeus Materials outside the Field of Use in the Territory, as further specified in this Agreement. |
1. | Definitions. |
1.1 | "Affiliates ” shall mean, with respect to a Party, any corporation, company, partnership or other entity, which controls, is controlled by, or is under common control with a Party. For such purpose the term “control” shall mean the ownership, direct or indirect control of at least fifty percent (50 %) of the voting stock of the other entity. |
1.2 | “ Background Rights” shall mean any and all Intellectual Property Rights and all substances and/or biological material and any rights therein or thereto (e.g. licenses) belonging to a Party and/or its Affiliates (irrespectively whether or not protectable under state, federal or foreign intellectual property laws), which is developed or acquired by such Party and/or its Affiliates prior to the Effective Date, or developed or acquired by such Party and/or its Affiliates independently from performance of this Agreement regardless whether developed or acquired either before or after the Effective Date and that are necessary or useful for a Party to exercise its rights under Section 2.1 or 2.2 of this Agreement, as applicable. OrthoCyte’s Background Rights include the OrthoCyte Technology and the OrthoCyte Materials. Heraeus’ Background Rights include the Heraeus Technology and the Heraeus Materials. |
1.3 | “OrthoCyte Materials” shall be PureStem® Cell Lines (or Stem Cell Derivatives) as well as the HyStem® Delivery System. |
1.4 | “OrthoCyte Property Rights” means OrthoCyte’s personal proprietary rights in the PureStem Cell Lines, including ownership rights and rights in the know-how embodied in the Cell Lines. |
1.5 | “OrthoCyte Technology” shall be the technology, including the HyStem Delivery System, to select, expand, manufacture, combine and use the OrthoCyte Materials, as covered by the Intellectual Property Rights owned by OrthoCyte or BioTime or licensed in from a Third Party. The OrthoCyte Technology includes the patent applications and patents identified and listed in Exhibit C (the “OrthoCyte Patent Rights”). |
1.6 | “Confidential Information” shall mean any and all data, material and/or information related to: (i) the terms of this Agreement including all Annexes etc., (ii) information made available by one Party ("Disclosing Party") to the other Party (“Receiving Party”) in tangible such as writing or other form including electronic, visual, oral or graphic form or as samples (including but not limited to Party’s Background Rights and Intellectual Property Rights, any technical information, research-, products-, personnel-, marketing-, strategic information or other information), (iii) any data, material and information developed during the term of this Agreement, and (iv) any compound(s) and/or material(s) provided by one Party to the other pursuant to this Agreement, whether prior to or after the Effective Date and whether it is labelled "confidential" or not, in the course of the Parties' evaluation, negotiation of or performance under or in connection with this Agreement. There is no requirement to mark data, material and/or information as “Confidential” when exchanged between Parties, but this is a recommended best practice. |
1.7 | "Effective Date" shall mean the date of the last signature of the Parties to this Agreement. |
1.8 | "Field of Use" shall mean bone grafting for the indications osteoskeleton diseases and injuries, thereby excluding dental and maxillofacial indications. |
1.9 | “Heraeus Materials” shall be the Heraeus Scaffold and all market related research and data related to the Field of Use owned by Heraeus or licensed in from a third party. |
1.10 | “Heraeus Scaffold” means the scaffold that is owned by Heraeus or licensed in from a Third Party. |
1.11 | “Heraeus Technology” means the technology relating to the Heraeus Scaffold, as covered by the Intellectual Property Rights owned by Heraeus or licensed in from a Third Party. The Heraeus Technology includes the patent applications and patents identified and listed in Exhibit D . |
1.12 | “HyStem Delivery System” means the proprietary scaffold technology for delivery of bioactives, including, without limitation, small molecules, proteins, cells fractions or derivatives thereof, as covered by the Intellectual Property Rights owned by OrthoCyte or BioTime, or licensed in from a Third Party, including the University of Utah Research Foundation. |
1.13 | “Intellectual Property Rights” shall mean the rights and interests in and to any and all issued patents and pending patent applications, know-how, trade secrets, utility certificates, utility models, registered design, trademarks, copyrights (including inventor’s certificates), in any country or jurisdiction, including but not limited to, any and all provisionals, non-provisionals, substitutions, continuations, continuations-in-part, divisionals and other continuing applications, supplementary protection certificates, renewals, and all letters patent on any of the foregoing, and any and all reissues, re-examinations, extensions, confirmations, registrations and patents of addition of any of the foregoing. |
1.14 | “Launch” shall mean the first commercial sale of the Product to Third Parties. |
1.15 | “Net Sales” shall mean the actual gross amount of invoiced prices for the sale of Products by Heraeus and its Affiliates, or the sale by OrthoCyte and its Affiliates of Products, as applicable, less the following deductions actually taken with respect to such sales: (i) any rebates, quantity, trade and/or cash discounts and other usual and customary discounts to customers actually granted, if any, (ii) compulsory payments and rebates, actually paid or deducted; retroactive price reductions, credits or allowances actually granted upon rejections or returns of Product, including for recalls or damaged goods, (iii) value-added taxes, (iv) costs of packaging, insurance and transportation from the place of manufacture to the customer’s premises including import, export, excise, turnover, custom duties, and (v) sales taxes paid by Heraeus or its Affiliates. |
1.16 | “Product” shall mean the cell therapy bone grafting product consisting of a select osteochondroprogenitor PureStem Cell Line (or Stem Cell Derivative) contained in a scaffold and developed by the Parties under the Research and Development Agreement to which this License Agreement is attached. |
1.17 | “PureStem Cell Line” means OrthoCyte’s (including its Affiliate BioTime) comprehensive portfolio of embryonic stem cells and clonal progenitor stem cells of primate origin, as well as related know-how and technological expertise to propagate and differentiate such cells. |
1.18 | “ Stem Cell Derivative ” shall mean any of the following derived from a PureStem Cell Line: a select non-viable osteochondroprogenitor PureStem Cell Line, or fraction thereof such as, fractionate, extract, secretion products; lyophilized, concentrated, reconstituted or diluted in appropriate solvent if necessary. |
1.19 | "Results" shall mean all data, information, findings, know-how, substances and biological material, inventions, improvements and/or discoveries (irrespectively whether or not protectable under state, federal or foreign intellectual property laws), resulting from and made by or for OrthoCyte and/or OrthoCyte’s Affiliates by carrying out the Project (as defined in the R&D Agreement). Results owned by OrthoCyte are referred to as “OrthoCyte Results” and Results owned by Heraeus are referred to as “Heraeus Results.” |
1.20 | “Third Party” shall mean any party other than OrthoCyte and Heraeus or their respective Affiliates. |
1.21 | “Territory” shall mean worldwide. |
2 | Grant of licenses |
2.1 | OrthoCyte herewith grants Heraeus a royalty-bearing, exclusive license to use OrthoCyte Background Rights, including, but not limited to the OrthoCyte Materials , the OrthoCyte Property Rights, the OrthoCyte Technology, including without limitation the OrthoCyte Patent Rights, as well as the OrthoCyte Results to research, register or obtain and maintain marketing approval, develop, make, have made, use, market, distribute, import, export, offer to sell, sell and have sold, the Product in the Field of Use in the Territory, with the right to sublicense. The license granted in this section 2.1 also grants to Heraeus the right to use all related documents and data, e.g. the Final Report (as defined in the R&D Agreement), which are established by OrthoCyte or its Affiliates or subcontractors, in as far as such documents and data are useful or necessary for Heraeus to exploit the license rights granted to Heraeus in this Agreement. |
2.2 | Heraeus herewith grants OrthoCyte a royalty-bearing, exclusive license to use the Heraeus Materials, the Heraeus Technology, including without limitation the Heraeus Patent Rights, and the Heraeus Results, to the extent needed to register or obtain and maintain marketing approval, make, have made, use, market, distribute, import, export, offer to sell, sell and have sold the Product outside the Field of Use in the Territory, with the right to sublicense. |
2.3 | OrthoCyte reserves all rights to use the following outside the Field of Use: PureStem Cell Lines (and Stem Cell Derivatives), the OrthoCyte Property Rights, the OrthoCyte Technology, including without limitation the OrthoCyte Patent Rights, and the OrthoCyte Results. |
2.4 | Each Party’s right to grant commercial sublicenses (i.e. excluding licenses for toll-manufacturing and licenses to its affiliates) of its rights under Section 2.1 or 2.2, as applicable, is subject to the following conditions: |
3 | Royalties |
3.1 | Heraeus shall pay to OrthoCyte a royalty on Net Sales of Product by Heraeus (including sales of Heraeus’ Affiliates to Third Parties as follows: |
3.2 | OrthoCyte shall pay to Heraeus a royalty of [**] on Net Sales of Product by OrthoCyte (including sales by OrthoCyte Affiliates to Third Parties) into other fields than the Field of Use. |
3.3 | In case that Heraeus or OrthoCyte grants commercial sub-licenses to Third Parties (other than for the sole purpose of having such Third Party manufacturing the Product on behalf of a Party or its Affiliates and for further sale by such Party), OrthoCyte and Heraeus agree to each other a total of [**] of all Sublicense Income. "Sublicense Income" means consideration that Heraeus or OrthoCyte, as applicable, receives for the grant of rights to a Third Party sublicensee. |
3.4 | OrthoCyte shall manufacture the Product for Heraeus. Hereaus shall reimburse OrthoCyte the manufacturing costs occurred in fact (COGS) by OrthoCyte to manufacture the Product, which shall be disclosed to Heraeus in confidence by OrthoCyte. For this purpose the Parties intend to sign a separate manufacturing and supply agreement which shall be negotiated and concluded before Launch of the Product. |
3.5 | Within [**] days of the end of each calendar year (”Payment Period”), Heraeus shall provide to OrthoCyte a written report describing the Net Sales of Product sold by or on behalf of Heraeus and its Affiliates as well as a report on the proceeds received from its sub-licensees during said calendar year specifying the Net Sales and proceeds. All aforementioned payments shall be made in Euro. |
3.6 | Heraeus will make all payments due under this Agreement within [**] days of receipt of a corresponding invoice from OrthoCyte. Payments shall be effected to the following account of OrthoCyte: |
3.7 | Possible turnover taxes and indirect taxes on any fees, milestone payments or royalties shall, if they accrue, be added to the respective payments. Any direct taxes, by law at the charge of OrthoCyte, shall be borne by OrthoCyte but may be, if so required by law, withheld and paid by Heraeus on behalf of OrthoCyte. Heraeus shall forward official receipts to OrthoCyte for such withholding taxes paid. Heraeus and OrthoCyte shall use their best efforts to take advantage of any tax treaties which may be applicable and to minimize any deduction for withholding tax. |
3.8 | Both Parties shall keep and maintain records of sales of the Product made by or on behalf of them, its Affiliates and sub-licensees, so that the royalties payable and the royalty statements may be verified, including the proceeds shared and the proceeds statement. Such records shall be open to inspection during business hours for a [**] year period after the end of the Payment Period to which such records relate, but in any event not more than once per calendar year, by a nationally recognized independent certified public accountant selected by a Party to whom the other Party has no reasonable objections. Said accountant shall sign a confidentiality agreement prepared by the Party requesting the involvement of the accountant and reasonably acceptable to the other Party and shall then have the right to examine the records kept pursuant to this Agreement and report to both Parties the findings (but not the underlying data) of said examination of records as are necessary to evidence that the records were or were not maintained and used in accordance with this Agreement. A copy of any report shall be provided to both Parties. |
4 | Confidentiality |
4.1 | Subject to the terms and conditions of this Agreement, all Information, including concerning the BioTime Technology, the results, the Product, the Licensed Product, a Party’s marketing, technical, product and business affairs and proprietary and trade secrets information and all know-how communicated by a Party or its Affiliates to another Party or its Affiliates, including the existence and terms of this Agreement, shall be deemed Confidential Information as defined in section 1.5. The Receiving Party of Confidential Information may not reveal any such Confidential Information to any Third Party other than its Affiliates or sub-licensees, except with the prior written approval of the Disclosing Party. The Parties undertake to protect the other Party’s Confidential Information against unauthorized access by Third Parties. Affiliates and sub-licensees, which shall be bound by a non-disclosure agreement at least as restrictive than the stipulations in this Agreement. |
4.2 | In respect of the Confidential Information received from the other Party ( Disclosing Party ) or its Affiliates under this Agreement, the Receiving Party agrees to undertake and bind itself: |
(a) | to keep the Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees strictly confidential and not to disclose it or to make it otherwise available to any Third Party and not in any way or at any time to make any use thereof except according to the performance of this Agreement; |
(b) | to take all reasonable measures to ensure that the Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees is not inadvertently disclosed in violation of this Agreement; |
(c) | not without prior written consent of the Disclosing Party to copy, reproduce, distribute or disclose the Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees to any person other than those employees and directors or employees or directors of its Affiliates who are directly and necessarily involved in the performance of this Agreement and who are contractually or otherwise obligated to keep it confidential, and in such instance, only on a “need to know” basis; |
(d) | without prejudice to its obligations pursuant to this Agreement, after termination for whatever reason and at the request of the Disclosing Party, immediately return or destroy all Confidential Information received from the Disclosing Party or its Affiliates. The destruction of the Confidential Information shall be confirmed promptly in writing. Each Party shall ensure that it has retained no copy of any Confidential Information other than one archival copy to be retained in its confidential files solely for the purpose of monitoring compliance with this Agreement. |
4.3 | The Parties’ obligations from the above stipulated under Article 4.2. do not apply to the following: |
(a) | Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees, which at the time of the disclosure is in the public domain as evidenced by the Receiving Party in writing ; |
(b) | Confidential Information received from the Disclosing Part, its Affiliates or sub-licensees, which at the time of the disclosure is in the public domain as evidenced by the Receiving Party by competent proof ; |
(c) | Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees, which after disclosure is published or otherwise becomes part of the public domain through no fault or breach of this Agreement by the Receiving Party as evidenced by the Receiving Party by competent proof ; |
(d) | Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees, which the Receiving Party can establish by competent proof in writing was in his possession at the time of Disclosure by the Disclosing Party and was not acquired directly or indirectly from the Disclosing Party ; |
(e) | Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees which is received after the time of disclosure from a Third Party who did not acquire such Confidential Information directly or indirectly from the Disclosing Party under obligations of confidentiality and who is in lawful possession of such Confidential Information as evidenced by the Receiving Party in writing ; |
(f) | Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees, which, as can be demonstrated by documentary proof, has been independently developed by employees, agents, consultants or other representatives of the Receiving Party without the use of Confidential Information received from the Disclosing Party. |
4.4 | Notwithstanding any other provisions of this Article 4 and Article 1.5: |
4.4.1 | all of the Disclosing Party’s Confidential Information may be disclosed by the Receiving Party: (i) to any regulatory authority to secure regulatory approvals; or (ii) if the Receiving Party is required by applicable laws to disclose such Confidential Information, and is not otherwise subject to a protective order. In the case of (ii), the Receiving Party agrees to notify the other Party immediately and to use its reasonable efforts to prevent the dissemination of the Confidential Information other than as strictly required by applicable laws. The Receiving Party shall use its reasonable efforts, at the request of the Disclosing Party, to obtain confidential treatment of such Confidential Information by the governmental authority or Third Party to whom the Confidential Information is disclosed at the Receiving Party’s costs; and |
4.4.2 | a Party may disclose the existence and terms of this Agreement to the extent required to be disclosed, as reasonably determined by the disclosing Party, by applicable law, or by order or other ruling of a competent court; and |
4.4.3 | upon prior written notice and acceptance by the other Party, which shall not be unreasonably or untimely withheld, a Party hereto may disclose the existence and terms of this Agreement to possible investors, acquirers and merging partners of such Party under respective confidentiality obligations. Prior to any disclosure of the other Party’s Confidential Information, a draft of the proposed disclosure (including marked redactions of such Confidential Information) shall be provided to the other Party for consent. This said, without its attachments, in particular the Project Plan, and further excluding or blackening any Confidential Information of the other Party, this Agreement, may be disclosed under respective confidentiality agreements without the prior consent of the other Party. |
4.5 | This Article 4 shall survive the expiry or termination of this Agreement. |
5 | Representations and warranties |
5.1 | OrthoCyte warrants, that OrthoCyte is the owner or licensee of the Intellectual Property Rights listed in Attachment 1 and that they exist and are active as of the Effective Date. OrthoCyte is entitled to grant the license under the Intellectual Property Rights as granted in this Agreement. |
5.2 | OrthoCyte has no knowledge that the development, manufacture or sell of Product in the Field of Use does infringe intellectual property rights of Third Parties. Should OrthoCyte gain knowledge of any facts, it will inform Heraeus immediately. |
5.3 | No Party makes any representations or warranties, either express or implied, with respect to the Product , in particular, does not make any representations concerning the usability or the merchantability of the Product . Both Parties expressly exclude all express and implied warranties with respect to utility, applicability, safety, harmlessness to health or the fitness of the Product for any purpose. |
5.4 | No Party makes any representations or warranties that the use of the Product will not infringe any patent or other proprietary rights of any Third Party and both Parties expressly disclaim any liability thereto. |
5.5 | Except in the event of gross negligence, breach, fraud or willful misconduct, neither Party shall be held liable for any, indirect, special consequential or incidental damages, such as, but not limited to, damage or loss of property or equipment, loss of profits or revenue, cost of capital or lost opportunities. |
5.6 | Heraeus shall at all times during the term of this Agreement and thereafter indemnify, defend and hold harmless and its Affiliates , members of the executive board, officers, agents and employees from any claims and expenses, including legal expenses and attorneys’ fees, arising out of the death of or injury to any person or persons or out of any damage to property and against any other claim, proceeding, demand, expense, liability, loss, or damage of any kind whatsoever arising out of the development, manufacture, use, handling, storing or sale of the Product in the Field of Use. |
6. | Rights to Background Rights |
6.1 | The Parties acknowledge that any Background Right of a Party used for the performance of this Agreement remains the property of the said Party introducing the same, except the Parties have agreed otherwise in writing. Nothing in this Agreement shall be interpreted as an obligation on a Party or an Affiliate thereof to give access to or grant a licence under its Background Rights, except as agreed herein otherwise in writing. |
7. | Term and Termination |
7.1 | This Agreement shall come into force on the Effective Date and shall, unless terminated prior in accordance with this Article below, remain in force until the last patent in a particular country, for which Heraeus has claimed a license under this Agreement, expires. After such expiration Heraeus shall have the right to further benefit from the license granted under this Agreement without paying any further royalties or other compensations towards OrthoCyte. Upon termination, not expiry, of this Agreement all sub-license agreements shall expire immediately. |
7.2 | Early termination before the expiry date of the last patent covered shall only be possible under the following conditions: |
7.2.1 | Early termination shall be available to Heraeus, at Heraeus’s sole discretion, upon [**] months prior written notice. |
7.2.2 | Early termination shall be available to either Party for cause. Notably, but not exclusively, a Party shall be entitled to terminate this Agreement for cause by giving written notice of such termination if: |
(i) | the other Party shall be in default of any of its material obligations under this Agreement and shall fail to remedy such default within [**] days after receipt of written notice thereof, or |
(ii) | the other Party challenges the validity of the Intellectual Property of the other Party regarding the licensed Intellectual Property Rights or supports Third Parties in such challenge. |
(iii) | an event of insolvency or bankruptcy occurs in relation to the other Party. |
7.3 | This Agreement shall terminate if the R&D Agreement is terminated prior to Product Launch. |
7.4 | Any royalties or payments paid or due prior to the date of effective termination shall not be refundable. |
7.5 | The termination of this Agreement does not affect any rights or obligations of either Party which have arisen or accrued up to and including the date of termination. |
8. | Miscellaneous |
8.1 | Force Majeure |
8.2 | Notices |
8.3 | Assignment and successors |
8.4
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Severability
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8.5
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Amendment
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9.6
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Governing law and
Jurisdiction; Interpretation
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For OrthoCyte
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/s/ Michael D. West
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Signature
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Date:
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September 29, 2015 | ||||
For Heraeus Medical GmbH
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/s/ Nicole Petermann
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/s/ Hergen Haas
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Signature:
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Signature:
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||||
Name:
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Nicole Petermann
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Name:
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Hergen Haas
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||
Title:
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Head of Commercial Services
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Title:
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General Counsel Heraeus Group
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Date:
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Date:
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WHEREAS | OrthoCyte owns, or has licensed rights to, and possesses two therapeutic development platforms. The first one being a comprehensive portfolio of embryonic stem cells and clonal progenitor stem cells of primate origin, as well as related know-how and technological expertise to propagate and differentiate these cells. More specifically, the first platform comprises osteochondro progenitor cell lines named PureStem® and related know-how and technological expertise to ensure the isolation and selection of clonal cells with high purity and optimised potency, including methods to ensure scalability of culturing and identification by comprehensive microarrays. The second platform technology is a scaffold technology for cell delivery, named HyStem®. Both technologies are patent protected and OrthoCyte owns or has licensed rights to the corresponding rights to these technologies, in particular Intellectual Property Rights and related trade secret technical information; these rights comprise in particular the selection of cell lines, manufacturing (culturing and differentiation of these cell lines), their combination with an appropriate scaffold and the use of this technology (application in medical indication). |
WHEREAS | Heraeus has experience in the field of bone cement and biomaterials, as medical implants for elective orthopaedic and trauma surgery, and possesses detailed market knowledge and data with regard to musculoskeletal indications and owns and/or licenses from a Third Party rights to certain scaffold technologies; |
WHEREAS | the Parties wish to carry out a research and development project “R&D of a Bioactive Bone Grafting Product” (as further described in the Project Plan attached hereto as Exhibit A (the “Project”); |
WHEREAS | OrthoCyte shall manufacture the Product (as defined below) for Heraeus, but is willing to grant Heraeus a license to establish a second manufacturing source and to manufacture and/or have manufactured and market or have marketed the Product the Product (the “Second Source”). For this purpose the Parties intend to sign a separate License Agreement as set out in Exhibit B . A manufacturing and supply agreement pursuant to which OrthoCyte will manufacture and supply Heraeus with Product shall be negotiated and concluded before Launch of the Product; the manufacturing and supply agreement will include terms and conditions for the establishment and availability of the Second Source. |
1. | Definitions. |
1.1 | "Affiliates ” shall mean, with respect to a Party, any corporation, company, partnership or other entity, which controls, is controlled by, or is under common control with a Party. For such purpose the term “control” shall mean the ownership, direct or indirect control of at least fifty percent (50 %) of the voting stock of the other entity. |
1.2 |
“Background Rights”
shall mean any and all Intellectual Property Rights and all substances and/or biological material and any rights therein or thereto (e.g. licenses) belonging to a Party and/or its Affiliates (irrespectively whether or not protectable under state, federal or foreign intellectual property laws), which is developed or acquired by such Party and/or its Affiliates prior to the Effective Date, or developed or acquired by such Party and/or its Affiliates independently from performance of this Agreement regardless whether developed or acquired either before or after the Effective Date and that are necessary or useful for the development of the Product. OrthoCyte Background Rights include OrthoCyte Materials and OrthoCyte Technology. Heraeus Backgrounds Rights include the Heraeus Materials and the Heraeus Technology.
|
1.3 | “OrthoCyte Materials” shall be osteochondro progenitor PureStem® Cell Lines (or Stem Cell Derivatives) as well as the HyStem® Delivery System. |
1.4 | “OrthoCyte Technology” shall be the technology, including the HyStem® Delivery System, to select, expand, manufacture, combine and use the OrthoCyte Materials, as covered by the Intellectual Property Rights owned by OrthoCyte or BioTime or licensed in from a Third Party, including the University of Utah Research Foundation. The OrthoCyte Technology includes the patent applications and patents identified and listed in Exhibit C . |
1.5 | “Confidential Information” shall mean any and all data, material and/or information related to: (i) the terms of this Agreement including all Annexes etc., (ii) information made available by one Party ("Disclosing Party") to the other Party (“Receiving Party”) in tangible such as writing or other form including electronic, visual, oral or graphic form or as samples (including but not limited to a Party’s Background Rights and Intellectual Property Rights, any technical information, research-, products-, personnel-, marketing-, strategic information or other information), (iii) any data, material and information developed during the term of this Agreement, and (iv) any compound(s) and/or material(s) provided by one Party to the other pursuant to this Agreement, whether prior to or after the Effective Date and whether it is labelled "confidential" or not, in the course of the Parties' evaluation, negotiation of or performance under or in connection with this Agreement. There is no requirement to mark data, material and/or information as “Confidential” when exchanged between Parties, but this is a recommended best practice. |
1.6 | "Effective Date" shall mean the date of the last signature of the Parties to this Agreement. |
1.7 | " Field of Use" shall be bone grafting for the indications osteoskeleton diseases and injuries, thereby excluding dental and maxillofacial indications. |
1.8 | "Final Report" shall have the meaning as set out in Exhibit E. |
1.9 | “Heraeus Materials” shall be the Heraeus Scaffold and all market related research and data related to the Field of Use owned by Heraeus. |
1.10 | “Heraeus Scaffold” means the scaffold that is provided by Heraeus to OrthoCyte for use in the performance of the Project, and owned by Heraeus and/or licensed from a Third Party. |
1.11 | “Heraeus Technology” shall be the technology relating to the Heraeus Scaffold, as covered by the Intellectual Property Rights owned by Heraeus or licensed in from a Third Party. |
1.12 | “HyStem Delivery System” means the proprietary scaffold technology for delivery of bioactives, including, without limitation, small molecules, proteins, cells fractions or derivatives thereof, as covered by the Intellectual Property Rights owned by OrthoCyte or BioTime, or licensed in from a Third Party, including the University of Utah Research Foundation. |
1.13 | “Intellectual Property Rights ” shall mean the rights and interests in and to any and all issued patents and pending patent applications, know-how, trade secrets, utility certificates, utility models, registered design, trademarks, copyrights (including inventor’s certificates), in any country or jurisdiction, including but not limited to, any and all provisionals, non-provisionals, substitutions, continuations, continuations-in-part, divisionals and other continuing applications, supplementary protection certificates, renewals, and all letters patent on any of the foregoing, and any and all reissues, re-examinations, extensions, confirmations, registrations and patents of addition of any of the foregoing. |
1.14 | “Launch” shall mean the first commercial sale of the Product to Third Parties. |
1.15 | “ Product ” shall mean a cell therapy bone grafting product consisting of a select osteochondroprogenitor PureStem Cell Line (or Stem Cell Derivative) contained in a scaffold; such scaffold being Heraeus Material or OrthoCyte Material, and developed according to the Project Plan . |
1.16 | “PureStem Cell Line” means OrthoCyte’s (including its affiliate BioTime) comprehensive portfolio of embryonic stem cells and clonal progenitor stem cells of primate origin, as well as related know-how and technological expertise to propagate and differentiate such cells. |
1.17 | “ Stem Cell Derivative ” shall mean any of the following derived from a PureStem Cell Line: a select non-viable osteochondroprogenitor PureStem Cell Line, or fraction thereof such as, fractionate, extract, secretion products; lyophilized, concentrated, reconstituted or diluted in appropriate solvent if necessary. |
1.18 | "Results" shall mean all data, information, findings, know-how, substances and biological material, inventions, improvements and/or discoveries (irrespectively whether or not protectable under state, federal or foreign intellectual property laws), resulting from and made by or for OrthoCyte and/or OrthoCyte’s Affiliates by carrying out the Project. |
1.19 | “ Third Party ” shall mean any party other than OrthoCyte and Heraeus or their respective Affiliates. |
1.20 | “ University of Utah Patent Rights ” means the patent applications and patents identified and listed in Exhibit F attached to this Agreement. |
2. | Conduct of the Project. |
2.1 | OrthoCyte agrees to conduct the Project at least with the degree of care customary within the biotech industry with regard to similar research and development projects, by qualified personnel, in accordance with the state of the art known to OrthoCyte and in accordance with the timeframe and the workscope as described in detail in the Project Plan ( Exhibit A ). Heraeus shall dedicate such personnel to the performance of the Project as Heraeus and OrthoCyte reasonably mutually agree is necessary. |
2.2 | To the extent required to conduct the Project, the Parties grant each other and their Affiliates a non-exclusive, non-transferable, non-assignable, free of charge and non-sublicensable right to use each other’s Background Rights in the Field of Use for the sole purpose of conducting the Project for the term of this Agreement, only. |
2.3 | The Parties acknowledge and agree that the Project is experimental in nature and that the Product may have unforeseeable properties. Therefore, neither Party warrants or represents, express or implied, that a particular result will be obtained by conducting the Project, or for the merchantability or the fitness of the Product for a particular purpose or capability or safety or harmlessness to health, or that the use of the Background Rights, the Results or the Product will not infringe any Third Party’s patent or other proprietary rights. Unless otherwise expressly stated otherwise in this Agreement, neither Party makes any warranty of any kind with respect to the Background Rights, the Results and the Product and disclaims any liability thereto. Payment of the fee (see section 3) is conditioned upon reaching the Milestones as set out in the Project Plan ( Exhibit A ). |
2.4 | Any change in the Project requires prior agreement in writing by both Parties. If one Party wishes to modify and/or change the Project, the respective Party will notify the other in writing. The Parties shall then mutually negotiate in good faith and in a reasonable manner to reach agreement as to any such modification and/or change, but shall not be obligated to reach any such agreement. |
2.5 | It is the understanding of the Parties, however, that the timeframe of the Project and the timeframes for the Milestones, which is set forth in the Project Plan, should be regarded as guidelines. In the event that OrthoCyte becomes aware of circumstances, which might cause a delay in conducting the Project within the timeframe described in the Project Plan and/or that any of the Milestones might not be met within the respective timeframes described in the Project Plan, OrthoCyte shall inform Heraeus promptly in writing and the Parties agree to mutually discuss the further development undertaking and adjust the timeframes of the Milestones respectively. In no event shall OrthoCyte be responsible for any damages arising out of or in connection with a delay in conducting the Project and/or meeting a Milestone or shall be obliged to refund any received fee under this Agreement, unless caused by OrthoCyte’s gross negligence or willful misconduct. |
2.6 | Except to the extent prohibited by law and unless expressly stated otherwise in this Agreement, OrthoCyte assumes responsibility for its conducting of the Project and liability for damages which may arise from its and/or its employees’ conducting of the Project, cf. however, with respect to indemnification and payment of damages, section 9 below . |
2.7 | Any work under the Project will be managed by a Joint Development Committee (“JDC”), comprising of two (2) representatives each from OrthoCyte and Heraeus. The JDC will meet (by telephone, video conference or in person) regularly, and at least quarterly during the performance of the Project, to discuss progress against the Project Plan. All major decisions regarding direction of the Project shall be decided by the JDC. In the event that the representatives of OrthoCyte and Heraeus are unable to come to agreement on such a decision, the representatives of Heraeus shall have final decision-making power. The Parties will correspond and/or meet on a regular basis in order to coordinate and discuss the progress of the Project. |
2.8 | The cooperation between the Parties regarding the Project shall be exclusive regarding the Field of Use. |
2.9 | OrthoCyte shall be allowed to use subcontractors for the conduct of this Project only with prior written consent of Heraeus which shall not unreasonably be withheld. OrthoCyte shall be liable for its subcontractors. |
2.10 | Heraeus relies on OrthoCyte’s knowledge of the OrthoCyte Materials and OrthoCyte Technology and cannot assess whether the list of patents provided in Exhibit A is exhaustive or whether other Intellectual Property Rights exist that are relevant for the conduct of this Project or the later use, manufacturing or marketing of the Product. |
3. | Financial Contribution for R&D and delivery. |
3.1 | For covering the costs for the R&D performance (i.e., execution of the Project) and delivery of the Product until the Product Launch, Heraeus agrees to pay to OrthoCyte in total fees payable as follows: |
3.1.1 | an “Upfront Payment” in the amount of [**] US$ upon the Effective Date and |
3.1.2 | a per milestone “Remuneration” for the R & D works performed in accordance with Project Plan and the delivery of Products as follows: |
· | [**] US$ payable upon finalising the 1 st Milestone (“POC small animal data”) as described in the respective Project Plan attached hereto as Exhibit A . |
· | [**] US$ is payable upon finalising the 2 nd Milestone (“Setting up Definitive Development Plan”) as described in the respective Project Plan attached hereto as Exhibit A. |
· | [**] US$ payable upon finalising the 3 rd Milestone (“Filing the IND application”) as described in the respective Project Plan attached hereto as Exhibit A . |
· | Should the Parties decide that OrthoCyte shall be responsible for the clinical trials, an additional fourth instalment will be paid for their conduct, the amount of which will be agreed upon IND approval. |
· | In addition, OrthoCyte shall support Heraeus in the regulatory approval process, which shall be remunerated at their standard hourly FTE rates. |
3.1.3 | In addition to the Upfront Payment and Milestone Remunerations set forth in 3.1.1 and 3.1.2, Heraeus shall pay to OrthoCyte OrthoCyte’s costs and expenses incurred by OrthoCyte in performance of the Project (the “Development Costs”). OrthoCyte shall submit quarterly, verifiable invoices to Heraeus, which specify the Development Costs incurred by OrthoCyte and Heraeus shall pay to OrthoCyte the invoiced Development Costs within [**] days of receipt of each invoice. OrthoCyte agrees to provide Heraeus with a detailed cost break down for Heraeus’ approval prior to each Work Package/Milestone set out in the Project Plan, Annex A . The parties currently estimate that the first work-package’s Development Costs (for preparation and commitment) will amount to [**] US$. |
3.2 | All payments are exclusive of any indirect taxes, duties or bank charges, which shall be borne by Heraeus. If applicable, indirect taxes will be charged in addition. If OrthoCyte does not charge indirect taxes and it is subsequently found that indirect taxes are chargeable on such provision, Heraeus agrees to pay such indirect taxes (exclusive of interests and penalties) on receipt of a valid invoice for indirect tax purposes and a copy of the ruling from the relevant tax authority or a reasonable legal opinion indicating the amount and the rationale for such indirect tax burden. |
3.3 | Unless stated otherwise, any payment is due within [**] days upon the receipt of the respective invoice made by OrthoCyte. |
3.4 | Paid fees are only refundable in case of a termination for cause by Heraeus. In such case, OrthoCyte shall be entitled to a pro-rata remuneration, taking account of the percentage of works already performed for the respective Milestone. |
4. | Background Rights. |
4.1
|
Unless otherwise agreed by the Parties as set forth in the License Agreement (
Exhibit B
), all Background Rights of a Party shall remain the sole property of this Party, no right or license to any such Background Rights shall be created, by virtue of the Project or of this Agreement, to the other Party. Background Rights of a Party shall not be used by the other Party or its Affiliates for any other purposes than carrying out the Project, or be transferred by the other Party to a Third Party without the express prior written consent of the supplying Party.
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4.2 | OrthoCyte will promptly provide Heraeus with the search results in its possession at the Effective Date and at any subsequent date at which it becomes aware of further or additional Third Party’s rights of potential relevance concerning OrthoCyte’s Technology, always provided that Heraeus’ taking notice of any of the foregoing shall not release OrthoCyte from any liability for infringement of such Third Party rights in accordance with the Agreement. |
5. | Ownership of Results |
5.1 | OrthoCyte agrees to keep Heraeus informed of the progress of the Project and the Product and the Results obtained on a monthly basis. |
5.2 | All right, title and interest in the Results made by OrthoCyte, both within and outside the Field of Use, shall remain with OrthoCyte, subject to the following: |
5.2.1 | Results, including with respect to the Product, that directly relate to the OrthoCyte Materials and/or the OrthoCyte Technology, or that incorporate into or embody OrthoCyte Materials and/or the OrthoCyte Technology in the Product, shall be owned by OrthoCyte, both within and outside the Field of Use; provided, however, that OrthoCyte’s ownership rights of such Results are and shall be subject to (i) Section 6.1 of this Agreement, (ii) the exclusive rights of Heraeus to use the OrthoCyte Materials and the OrthoCyte Technology (including the OrthoCyte Patent Rights) and the OrthoCyte Background Rights as provided in the License Agreement, and (iii) ownership by Heraeus of any Results (including any new Intellectual Property Rights related thereto but excluding any Third Party Intellectual Property Rights relating thereto) that are incorporated into the Product, or that relate to the interactions of the scaffold, including to the PureStem Cell Lines, to the PureStem Cell Lines, to the Product characteristics or functions, or to the manufacturing of the Product. |
5.2.2 | Results, including with respect to the Product, that directly relate to the Heraeus Materials and/or the Heraeus Technology, or that incorporate into or embody Heraeus Materials and/or the Heraeus Technology in the Product, shall be owned by Heraeus, both within and outside the Field of Use; provided, however, that Heraeus’ ownership of such Results are and shall be subject to the rights of OrthoCyte to use the Heraeus Materials and the Heraeus Technology outside the Field of Use as provided in the License Agreement |
5.3 | OrthoCyte herewith assigns to Heraeus all Results, which are created under this Project and which, according to Sections 5.2.1 (iii) and 5.2.2, shall be owned by Heraeus. To enable Heraeus to obtain legal protection of these Results, OrthoCyte shall reasonably assist Heraeus and shall provide Heraeus with all required information and make the required declarations in due form and time. |
6. | Exploitation of the Product, Required License and Manufacturing. |
6.1 | The Parties agree that Heraeus shall be entitled to commercially use and exploit the Product in the Field of Use, thereby using the Results and Background Rights owned by OrthoCyte. Further details, including OrthoCyte retained rights and OrthoCyte’s right to exploit the Results outside the Field of Use are set forth in the License Agreement set out in Exhibit B . The License Agreement shall be signed together with this Agreement. The Parties understand and agree that, depending on the nature of and specifications for the Product to be Launched, a sublicense of the University of Utah Patent Rights from OrthoCyte to Heraeus may be required for the later commercialisation of the Product, but not for the current research and development phase, as defined in the Project Plan. |
6.2 | Manufacturing of the Product will be done by OrthoCyte. The Parties will negotiate and conclude a supplier agreement/toll manufacturing agreement before the marketing authorisations are obtained. |
6.3 | In addition, OrthoCyte agrees to assist Heraeus, if so requested by Heraeus, to establish a Second Source and to assist, in the technology transfer regarding the manufacturing process and know-how to a Third Party, if Heraeus decides to have the Product manufactured and delivered by said Third Party. This assistance comprises, inter alia, suitable support and training of that Third Party by qualified personnel of OrthoCyte, to the extent necessary, to ensure the know-how transfer, such training to be remunerated at hourly rates agreed by the Parties. The Parties will negotiate in good faith to enter into a manufacturing and supply agreement pursuant to which OrthoCyte will manufacture and supply Heraeus with Product and cooperate with Heraeus for the establishment and availability of the Second Source. |
6.4 | During the development phase set out in the Project Plan (i.e. until finalising the market authorisation process), OrthoCyte will provide to Heraeus the Product [**] . |
7. | Confidentiality. |
7.1 | In respect of the Confidential Information received from the Disclosing Party or its Affiliates under this Agreement, the Receiving Party agrees to undertake and bind itself: |
7.1.1 | To keep the Confidential Information received from the Disclosing Party or its Affiliates strictly confidential and secret and not in any way or at any time to make any use thereof except for conducting the Project. |
7.1.2 | Not to disclose any Confidential Information received from the Disclosing Party or its Affiliates to any Third Party without the prior written consent from the Disclosing Party. |
7.1.3 | To take all reasonable measures to ensure that the Confidential Information received from the Disclosing Party or its Affiliates is not inadvertently disclosed in violation of this Agreement. |
7.1.4 | At no time without the express written consent of the Disclosing Party to derive directly or indirectly from the possession of the Confidential Information received from the Disclosing Party or its Affiliates any rights, grant of licence, title or interest therein contrary to the terms and conditions of this agreement, nor contrary to the terms and conditions of this agreement to claim any rights to disclose or use for its own benefit such Confidential Information. |
7.1.5 | Not without prior written consent of the Disclosing Party to copy, reproduce, distribute or disclose the Confidential Information received from the Disclosing Party or its Affiliates to any person other than those Employees who are directly and necessarily involved in the conduct of the Project, and in such instance, only on a “need to know” basis. In addition, such Employees need to be made aware of the confidential nature of the information and need to be contractually obligated to observe non-use and secrecy obligations which are at least as strict as the once set forth hereunder. Irrespective of this, The Receiving Party shall be liable for its Employees. |
7.1.6 | Without prejudice to its obligations pursuant to this Agreement, at the request of the Disclosing Party, immediately return or destroy all Confidential Information received from the Disclosing Party or its Affiliates. Each Party shall ensure that it has retained no copy of any Confidential Information other than one archival copy to be retained in its confidential files solely for the purpose of monitoring compliance with this Agreement. |
7.2 | The Parties’ obligations from the above stipulated under section 7.1. do not apply to the following: |
7.2.1 | Confidential Information received from the Disclosing Party or its Affiliates, which at the time of the disclosure is in the public domain as evidenced by the Receiving Party in writing. |
7.2.2 | Confidential Information received from the Disclosing Party or its Affiliates, which after disclosure is published or otherwise becomes part of the public domain through no fault or breach of this Agreement by the Receiving Party as evidenced by the Receiving Party in writing. |
7.2.3 | Confidential Information received from the Disclosing Party or its Affiliates, which the Receiving Party can establish by competent proof in writing was in his possession at the time of disclosure by the Disclosing Party and was not acquired directly or indirectly from the Disclosing Party. |
7.2.4 | Confidential Information received from the Disclosing Party or its Affiliates which is received after the time of disclosure from a Third Party who did not acquire such Confidential Information directly or indirectly from the Disclosing Party under obligations of confidentiality and who is in lawful possession of such Confidential Information as evidenced by the Receiving Party in writing. |
7.2.5 | Confidential Information received from the Disclosing Party or its Affiliates, which by documentary proof has been independently developed by employees, agents, consultants or other representatives of the Receiving Party without the use of Confidential Information received from the Disclosing Party. |
7.2.6 | Confidential Information received from the Disclosing Party or its Affiliates which is required to be disclosed by law or any regulatory or government authority, however, if a Party thus becomes legally required to disclose Confidential Information, received from the Disclosing Party or its Affiliates, the Receiving Party shall provide the Disclosing Party with prompt advance notice and in order to afford the Disclosing Party to seek confidential treatment thereof or other appropriate remedy. |
7.3 | The Parties agree and acknowledge that the Project, including the exchange of Confidential Information, does not imply any transfer of title and/or ownership to Confidential Information or the creation of any intellectual property rights, and thus title and ownership to Confidential Information shall remain vested at all times in the Disclosing Party. |
7.4 | The Confidential Information is made available without any warranties with respect to the accuracy and usefulness of the Confidential Information and the Disclosing Party shall never be liable for any damage or loss, which the other Party’s use of the Confidential Information might incur. |
7.5 | The confidentiality obligations set forth in this section 7 set forth above shall survive the termination or expiry of this Agreement for a period of [**] years . |
7.6 | No disclosure of proprietary, non-public technical information concerning the Project (such as details of technology and research and development plans),and technical details of the Product and the Results is permitted without prior written consent of the other Party, unless (i) in order to obtain patent or other proprietary protection for the Results or the Product (ii) in order to obtain regulatory approval or to conduct clinical studies for the commercialization of any Results or the Product, or (iii) as Heraeus may reasonably deem necessary for marketing the Results or Product. The Parties shall agree on a form of initial press release that may be used by either Party on an ongoing basis to describe this Agreement, the Project and the intended Product. Each Party shall provide the other Party with reasonable advance written notice of any other press release or other public disclosure of this Agreement or the Results; provided, that the Parties acknowledge that OrthoCyte or its parent BioTime, Inc. may be required to make immediate or prompt disclosure of the occurrence of material events concerning the Project, the Results or the Product, such as (by way of example only) an action, order, or determination by the FDA or other regulatory agency or authority. OrthoCyte and its parent BioTime, Inc. may summarize this Agreement, excluding confidential portions, and describe the Project, Products and Results (other than proprietary, non-public technical information and details of research and development plans) in any registration statement, prospectus, or report filed with the Securities and Exchange Commission (“SEC”) or any other securities regulatory agency or authority. If OrthoCyte or its parent BioTime, Inc. determines that it is required to file a copy of this Agreement or any portion of this Agreement with the SEC or any other securities regulatory agency or authority, the Parties shall confer and determine which portions, if any, of this Agreement should be subject to an application requesting confidential treatment, and OrthoCyte or BioTime shall file this Agreement or any relevant portion subject to such application in accordance with the applicable rules and regulations of the SEC or such other agency or authority; provided, that any portion of this Agreement that is initially redacted from such filing under such application may be filed in its entirety and otherwise disclosed in a registration statement, prospectus, or report if so required by the SEC or other agency or authority. This Agreement may be disclosed by a Party under a confidentiality agreement, without the prior consent of the other Party, to any actual or prospective investor, lender, underwriter, or acquirer of the Party or any parent or subsidiary of the Party, or any actual or potential acquirer of the portion of the business to which this Agreement relates. Additionally, the text of any press release, shareholders’ report or other communication to be published or disclosed in any way by or on behalf of OrthoCyte or its parent BioTime, Inc. by or in the media concerning Heraeus, the subject matter of this Agreement or concerning this Agreement itself, other than as required by law or by any regulatory or government authority or the rules of the SEC or any other regulatory agency or authority, or any securities exchange, shall be submitted to Heraeus at least five (5) business days in advance of publication or disclosure for approval. Such approval not to be unreasonably withheld; provided, that disclosure that repeats or restates prior public disclosure permitted by this Agreement need not be submitted to Heraeus for approval. |
7.7 | Notwithstanding anything to the contrary in this Agreement, including without limitation in this Section 7, the Parties agree not to disclose the economic terms of this Agreement to any Third Party without the prior written consent of the other Party except (a) as required by applicable securities laws or the requirements of any applicable stock exchange, including, without limitation, requirements to file a copy of this Agreement (redacted to the extent reasonably permitted by applicable law); (b) in confidence, to legal counsel; (c) in confidence, to accountants, banks, and financing sources and their advisors; and (d) to the extent necessary to enforce this Agreement or any rights or obligations hereunder. |
8. | Term and Duration. |
8.1 | This R&D Agreement shall commence on the Effective Date and shall be effective until completion and payment of the last Milestone of the Project Plan, Exhibit A . |
8.2 | A Party may only terminate this R&D Agreement with immediate effect by giving written notice to the other Party, if the other Party fails to remedy its material breach of this Agreement within [**] days upon receipt of a written notice requiring the other Party to remedy the breach. |
8.3 | In addition, Heraeus may terminate this R&D Agreement to the end of a Milestone by giving written notice to OrthoCyte up to [**] days upon finalization of each Milestone and payment of the respective Milestone instalment (c.f. section 3.1.2). Fees paid already to OrthoCyte or due to OrthoCyte according to the payment schedule agreed until the date of effectiveness of such termination shall not be refunded by OrthoCyte to Heraeus. |
8.4 | The obligations set forth in section 5 and 7 shall survive termination or expiration of this R&D Agreement. |
8.5 | Expiration or termination of this R&D Agreement shall not affect the License Agreement, unless this R&D Agreement is terminated prior to completion of the Project and Product Launch, in which case the License Agreement shall terminate with the termination of this R&D Agreement. |
8.6 | In the event Heraeus elects to terminate this Agreement at any time prior to Product Launch, OrthoCyte shall have the right to proceed with the Project, including development of the Product and commercialization of the Product in the Field of Use. Heraeus will cooperate with OrthoCyte to grant OrthoCyte a license at marketable terms or transfer to OrthoCyte rights and materials, including all Intellectual Property Rights, useful or necessary for OrthoCyte to proceed with completion of the Project and commercialization of the Product. OrthoCyte shall be provided with a [**] day right of first refusal to enter into one or more definitive agreements with Heraeus to effect the above mentioned license or transfer and assignment. Heraeus agrees to engage in good faith negotiations to come to agreement with OrthoCyte on commercially reasonable terms. |
9. | Liability |
10. | Miscellaneous. |
10.1 | Force Majeure. Neither Party shall be liable for failures or delays in conducting the Project, and neither Party shall be deemed in breach of its obligations, if such failure or delay is due to natural disasters or any causes beyond the reasonable control of the Parties, including any act of God, any civil commotion or strike ("Force Majeure"). In the event of such Force Majeure, the Party affected hereby shall (i) promptly notify the other Party in writing and (ii) use reasonable efforts to cure or overcome the same and resume performance of its obligations hereunder. |
10.2 | Notices. Any notice to be given under this Agreement must be in writing. Such notice shall be made by registered letter, return receipt requested or courier (e.g. FedEx, UPS, Optima etc.), or by email (such email shall be deemed received with confirmed transmission or when delivery confirmed otherwise) to the addresses set out below: |
10.3 | Independent Parties. The Parties’ relationship to each other shall be that of independent contractors and neither Party nor its employees are employees of the other Party. Furthermore, this Agreement shall not make either Party the agent or the legal representative of the other Party. Neither Party is granted any right or authority to assume or to create any obligation or responsibility, express or implied, on behalf of or in the name of the other Party, with regard to any manner or thing whatsoever, unless otherwise specifically agreed upon in writing. |
10.4 | Assignment and Successors. This Agreement and rights hereunder shall not be assigned or transferred, directly or indirectly, in whole or in part by the Parties without the prior written consent of the other Party. However, should OrthoCyte intend to assign this Agreement to another entity, which acquires all or substantially all of the business or assets of OrthoCyte to which this Agreement pertains, whether by merger, reorganization, acquisition, sale or otherwise, provided that such successor or assignee shall agree in writing to be bound by the terms and conditions of this Agreement prior to assignment, Heraeus agrees to not unduly withhold its consent. In |
10.5 | case of such assignment to a Third Party, OrthoCyte shall continue to be bound by the confidentiality obligations stipulated in Section 7. |
10.6 | Integration, Severability. Invalid provisions of this Agreement shall not in any way affect the validity and enforceability of the remaining provisions. The Parties agree to undertake to replace the invalid and enforceable provisions by new provisions, which will approximate as closely as possible the result intended by the Parties. The same shall apply in the case of an omission. |
10.7 | Amendment; Waiver. This Agreement may be amended, modified, superseded or cancelled, and any of the terms may be waived, only by mutual written agreement by the Parties. The written form requirement may not be amended. The delay or failure of any Party at any time or times to require the performance of any provisions shall in no manner affect the rights at a later time to enforce same. |
10.8 | Governing law and jurisdiction. The exclusive jurisdiction for any dispute, claim or proceeding between the Parties arising out or in connection with this Agreement shall be the United States District Court for the Southern District of New York or, only if there is no federal subject matter jurisdiction, in any state court of New York sitting in the City and County of New York, and each party hereby submits to the exclusive personal jurisdiction of the foregoing courts. |
10.9 | Exhibits |
Exhibit A:
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Project Plan and Milestones
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Exhibit B:
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License Agreement
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Exhibit C:
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Patent Rights of OrthoCyte (and Biotime)
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Exhibit D:
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Heraeus Patent Rights
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Exhibit E:
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Final Report
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Exhibit F:
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Patent Rights of University of Utah
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OrthoCyte Corporation
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/s/ Michael D. West
September 29, 2015
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Signature & Date
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Heraeus Medical GmbH
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Heraeus Medical GmbH
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ppa Nicole Petermann
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Hergen Haas
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Head of Commercial Services
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General Counsel Heraeus Group
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/s/ Nicole Petermann
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/s/ Hergen Haas
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Signature & Date
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Signature & Date
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Phase
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Cost
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Process
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Deliverables/
Milestones
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Timeline
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by and between
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OrthoCyte Corporation
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a California corporation and an Affiliate
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of BioTime, Inc. (“BioTime”),
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1301 Harbor Bay Parkway,
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Alameda, CA 94502 USA
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(in the following referred to as “
OrthoCyte
”)
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and
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Heraeus Medical GmbH
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Philip-Reis-Str. 8/13
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61273 Wehrheim, Germany
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(in the following referred to as “
Heraeus
”)
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WHEREAS | OrthoCyte owns, or has licensed rights to, and possesses two therapeutic development platforms. The first one being a comprehensive portfolio of embryonic stem cells and clonal progenitor stem cells of primate origin, as well as related know-how and technological expertise to propagate and differentiate these cells. More specifically, the first platform comprises osteochondro progenitor cell lines named PureStem® and related know-how and technological expertise to ensure the isolation and selection of clonal cells with high purity and optimised potency, including methods to ensure scalability of culturing and identification by comprehensive microarrays. The second platform technology is a scaffold technology for cell delivery, named HyStem®. Both technologies are patent protected and OrthoCyte owns, or has licensed rights to, the corresponding rights to these technologies, in particular Intellectual Property Rights and related secret technical information; these rights comprise in particular the selection of cell lines, manufacturing (culturing and differentiation of these cell lines), their combination with an appropriate scaffold and the use of this technology (application in medical indication). |
WHEREAS | Heraeus has experience in the field of bone cement and biomaterials, as medical implants for elective orthopaedic and trauma surgery, and possesses detailed market knowledge and data with regard to musculoskeletal indications and owns and/or licenses from a Third Party rights to certain scaffold technologies; |
WHEREAS | Heraeus has experience in the field of bone cement and biomaterials, as medical implants, for elective orthopaedic and trauma surgery; |
WHEREAS | The Parties have already entered into a Research & Development Agreement, to which this Agreement is attached as Exhibit B (the R&D Agreement”) |
WHEREAS | The Parties enter into this License Agreement, pursuant to which Heraeus shall receive a license under the respective Intellectual Property Rights owned, licensed to and/or otherwise controlled by OrthoCyte to use the OrthoCyte Technology and the BioTime Materials in the Field of Use in the Territory, and OrthoCyte shall receive a license under the respective Intellectual Property Rights owned, licensed to and/or otherwise controlled by Heraeus to use the Heraeus Technology and the Heraeus Materials outside the Field of Use in the Territory, as further specified in this Agreement. |
1. | Definitions. |
1.1 | "Affiliates ” shall mean, with respect to a Party, any corporation, company, partnership or other entity, which controls, is controlled by, or is under common control with a Party. For such purpose the term “control” shall mean the ownership, direct or indirect control of at least fifty percent (50 %) of the voting stock of the other entity. |
1.2 | “ Background Rights” shall mean any and all Intellectual Property Rights and all substances and/or biological material and any rights therein or thereto (e.g. licenses) belonging to a Party and/or its Affiliates (irrespectively whether or not protectable under state, federal or foreign intellectual property laws), which is developed or acquired by such Party and/or its Affiliates prior to the Effective Date, or developed or acquired by such Party and/or its Affiliates independently from performance of this Agreement regardless whether developed or acquired either before or after the Effective Date and that are necessary or useful for a Party to exercise its rights under Section 2.1 or 2.2 of this Agreement, as applicable. OrthoCyte’s Background Rights include the OrthoCyte Technology and the OrthoCyte Materials. Heraeus’ Background Rights include the Heraeus Technology and the Heraeus Materials. |
1.3 | “OrthoCyte Materials” shall be PureStem® Cell Lines (or Stem Cell Derivatives) as well as the HyStem® Delivery System. |
1.4 | “OrthoCyte Property Rights” means OrthoCyte’s personal proprietary rights in the PureStem Cell Lines, including ownership rights and rights in the know-how embodied in the Cell Lines. |
1.5 | “OrthoCyte Technology” shall be the technology, including the HyStem Delivery System, to select, expand, manufacture, combine and use the OrthoCyte Materials, as covered by the Intellectual Property Rights owned by OrthoCyte or BioTime or licensed in from a Third Party. The OrthoCyte Technology includes the patent applications and patents identified and listed in Exhibit C (the “OrthoCyte Patent Rights”). |
1.6 | “Confidential Information” shall mean any and all data, material and/or information related to: (i) the terms of this Agreement including all Annexes etc., (ii) information made available by one Party ("Disclosing Party") to the other Party (“Receiving Party”) in tangible such as writing or other form including electronic, visual, oral or graphic form or as samples (including but not limited to Party’s Background Rights and Intellectual Property Rights, any technical information, research-, products-, personnel-, marketing-, strategic information or other information), (iii) any data, material and information developed during the term of this Agreement, and (iv) any compound(s) and/or material(s) provided by one Party to the other pursuant to this Agreement, whether prior to or after the Effective Date and whether it is labelled "confidential" or not, in the course of the Parties' evaluation, negotiation of or performance under or in connection with this Agreement. There is no requirement to mark data, material and/or information as “Confidential” when exchanged between Parties, but this is a recommended best practice. |
1.7 | "Effective Date" shall mean the date of the last signature of the Parties to this Agreement. |
1.8 | "Field of Use" shall mean bone grafting for the indications osteoskeleton diseases and injuries, thereby excluding dental and maxillofacial indications. |
1.9 | “Heraeus Materials” shall be the Heraeus Scaffold and all market related research and data related to the Field of Use owned by Heraeus or licensed in from a third party. |
1.10 | “Heraeus Scaffold” means the scaffold that is owned by Heraeus or licensed in from a Third Party. |
1.11 | “Heraeus Technology” means the technology relating to the Heraeus Scaffold, as covered by the Intellectual Property Rights owned by Heraeus or licensed in from a Third Party. The Heraeus Technology includes the patent applications and patents identified and listed in Exhibit D . |
1.12 | “HyStem Delivery System” means the proprietary scaffold technology for delivery of bioactives, including, without limitation, small molecules, proteins, cells fractions or derivatives thereof, as covered by the Intellectual Property Rights owned by OrthoCyte or BioTime, or licensed in from a Third Party, including the University of Utah Research Foundation. |
1.13 | “Intellectual Property Rights” shall mean the rights and interests in and to any and all issued patents and pending patent applications, know-how, trade secrets, utility certificates, utility models, registered design, trademarks, copyrights (including inventor’s certificates), in any country or jurisdiction, including but not limited to, any and all provisionals, non-provisionals, substitutions, continuations, continuations-in-part, divisionals and other continuing applications, supplementary protection certificates, renewals, and all letters patent on any of the foregoing, and any and all reissues, re-examinations, extensions, confirmations, registrations and patents of addition of any of the foregoing. |
1.14 | “Launch” shall mean the first commercial sale of the Product to Third Parties. |
1.15 | “Net Sales” shall mean the actual gross amount of invoiced prices for the sale of Products by Heraeus and its Affiliates, or the sale by OrthoCyte and its Affiliates of Products, as applicable, less the following deductions actually taken with respect to such sales: (i) any rebates, quantity, trade and/or cash discounts and other usual and customary discounts to customers actually granted, if any, (ii) compulsory payments and rebates, actually paid or deducted; retroactive price reductions, credits or allowances actually granted upon rejections or returns of Product, including for recalls or damaged goods, (iii) value-added taxes, (iv) costs of packaging, insurance and transportation from the place of manufacture to the customer’s premises including import, export, excise, turnover, custom duties, and (v) sales taxes paid by Heraeus or its Affiliates. |
1.16 | “Product” shall mean the cell therapy bone grafting product consisting of a select osteochondroprogenitor PureStem Cell Line (or Stem Cell Derivative) contained in a scaffold and developed by the Parties under the Research and Development Agreement to which this License Agreement is attached. |
1.17 | “PureStem Cell Line” means OrthoCyte’s (including its Affiliate BioTime) comprehensive portfolio of embryonic stem cells and clonal progenitor stem cells of primate origin, as well as related know-how and technological expertise to propagate and differentiate such cells. |
1.18 | “ Stem Cell Derivative ” shall mean any of the following derived from a PureStem Cell Line: a select non-viable osteochondroprogenitor PureStem Cell Line, or fraction thereof such as, fractionate, extract, secretion products; lyophilized, concentrated, reconstituted or diluted in appropriate solvent if necessary. |
1.19 | "Results" shall mean all data, information, findings, know-how, substances and biological material, inventions, improvements and/or discoveries (irrespectively whether or not protectable under state, federal or foreign intellectual property laws), resulting from and made by or for OrthoCyte and/or OrthoCyte’s Affiliates by carrying out the Project (as defined in the R&D Agreement). Results owned by OrthoCyte are referred to as “OrthoCyte Results” and Results owned by Heraeus are referred to as “Heraeus Results.” |
1.20 | “Third Party” shall mean any party other than OrthoCyte and Heraeus or their respective Affiliates. |
1.21 | “Territory” shall mean worldwide. |
2 | Grant of licenses |
2.1 | OrthoCyte herewith grants Heraeus a royalty-bearing, exclusive license to use OrthoCyte Background Rights, including, but not limited to the OrthoCyte Materials , the OrthoCyte Property Rights, the OrthoCyte Technology, including without limitation the OrthoCyte Patent Rights, as well as the OrthoCyte Results to research, register or obtain and maintain marketing approval, develop, make, have made, use, market, distribute, import, export, offer to sell, sell and have sold, the Product in the Field of Use in the Territory, with the right to sublicense. The license granted in this section 2.1 also grants to Heraeus the right to use all related documents and data, e.g. the Final Report (as defined in the R&D Agreement), which are established by OrthoCyte or its Affiliates or subcontractors, in as far as such documents and data are useful or necessary for Heraeus to exploit the license rights granted to Heraeus in this Agreement. |
2.2 | Heraeus herewith grants OrthoCyte a royalty-bearing, exclusive license to use the Heraeus Materials, the Heraeus Technology, including without limitation the Heraeus Patent Rights, and the Heraeus Results, to the extent needed to register or obtain and maintain marketing approval, make, have made, use, market, distribute, import, export, offer to sell, sell and have sold the Product outside the Field of Use in the Territory, with the right to sublicense. |
2.3 | OrthoCyte reserves all rights to use the following outside the Field of Use: PureStem Cell Lines (and Stem Cell Derivatives), the OrthoCyte Property Rights, the OrthoCyte Technology, including without limitation the OrthoCyte Patent Rights, and the OrthoCyte Results. |
2.4 | Each Party’s right to grant commercial sublicenses (i.e. excluding licenses for toll-manufacturing and licenses to its affiliates) of its rights under Section 2.1 or 2.2, as applicable, is subject to the following conditions: |
3 | Royalties |
3.1 | Heraeus shall pay to OrthoCyte a royalty on Net Sales of Product by Heraeus (including sales of Heraeus’ Affiliates to Third Parties as follows: |
3.1.1
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[**] shall be due for Net Sales up to
[**] US$
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3.1.2
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[**]
shall be due for Net Sales between
[**] US$
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3.1.3
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[**]
shall be due on Net Sales above
[**] US$
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3.2 | OrthoCyte shall pay to Heraeus a royalty of [**] on Net Sales of Product by OrthoCyte (including sales by OrthoCyte Affiliates to Third Parties) into other fields than the Field of Use. |
3.3 | In case that Heraeus or OrthoCyte grants commercial sub-licenses to Third Parties (other than for the sole purpose of having such Third Party manufacturing the Product on behalf of a Party or its Affiliates and for further sale by such Party), OrthoCyte and Heraeus agree to each other a total of [**] of all Sublicense Income. "Sublicense Income" means consideration that Heraeus or OrthoCyte, as applicable, receives for the grant of rights to a Third Party sublicensee. |
3.4 | OrthoCyte shall manufacture the Product for Heraeus. Hereaus shall reimburse OrthoCyte the manufacturing costs occurred in fact (COGS) by OrthoCyte to manufacture the Product, which shall be disclosed to Heraeus in confidence by OrthoCyte. For this purpose the Parties intend to sign a separate manufacturing and supply agreement which shall be negotiated and concluded before Launch of the Product. |
3.5 | Within [**] days of the end of each calendar year (”Payment Period”), Heraeus shall provide to OrthoCyte a written report describing the Net Sales of Product sold by or on behalf of Heraeus and its Affiliates as well as a report on the proceeds received from its sub-licensees during said calendar year specifying the Net Sales and proceeds. All aforementioned payments shall be made in Euro. |
3.6 | Heraeus will make all payments due under this Agreement within [**] days of receipt of a corresponding invoice from OrthoCyte. Payments shall be effected to the following account of OrthoCyte: |
3.7 | Possible turnover taxes and indirect taxes on any fees, milestone payments or royalties shall, if they accrue, be added to the respective payments. Any direct taxes, by law at the charge of OrthoCyte, shall be borne by OrthoCyte but may be, if so required by law, withheld and paid by Heraeus on behalf of OrthoCyte. Heraeus shall forward official receipts to OrthoCyte for such withholding taxes paid. Heraeus and OrthoCyte shall use their best efforts to take advantage of any tax treaties which may be applicable and to minimize any deduction for withholding tax. |
3.8 | Both Parties shall keep and maintain records of sales of the Product made by or on behalf of them, its Affiliates and sub-licensees, so that the royalties payable and the royalty statements may be verified, including the proceeds shared and the proceeds statement. Such records shall be open to inspection during business hours for a [**] year period after the end of the Payment Period to which such records relate, but in any event not more than once per calendar year, by a nationally recognized independent certified public accountant selected by a Party to whom the other Party has no reasonable objections. Said accountant shall sign a confidentiality agreement prepared by the Party requesting the involvement of the accountant and reasonably acceptable to the other Party and shall then have the right to examine the records kept pursuant to this Agreement and report to both Parties the findings (but not the underlying data) of said examination of records as are necessary to evidence that the records were or were not maintained and used in accordance with this Agreement. A copy of any report shall be provided to both Parties. |
4 | Confidentiality |
4.1 | Subject to the terms and conditions of this Agreement, all Information, including concerning the BioTime Technology, the results, the Product, the Licensed Product, a Party’s marketing, technical, product and business affairs and proprietary and trade secrets information and all know-how communicated by a Party or its Affiliates to another Party or its Affiliates, including the existence and terms of this Agreement, shall be deemed Confidential Information as defined in section 1.5. The Receiving Party of Confidential Information may not reveal any such Confidential Information to any Third Party other than its Affiliates or sub-licensees, except with the prior written approval of the Disclosing Party. The Parties undertake to protect the other Party’s Confidential Information against unauthorized access by Third Parties. Affiliates and sub-licensees, which shall be bound by a non-disclosure agreement at least as restrictive than the stipulations in this Agreement. |
4.2 | In respect of the Confidential Information received from the other Party ( Disclosing Party ) or its Affiliates under this Agreement, the Receiving Party agrees to undertake and bind itself: |
(a) | to keep the Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees strictly confidential and not to disclose it or to make it otherwise available to any Third Party and not in any way or at any time to make any use thereof except according to the performance of this Agreement; |
(b) | to take all reasonable measures to ensure that the Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees is not inadvertently disclosed in violation of this Agreement; |
(c) | not without prior written consent of the Disclosing Party to copy, reproduce, distribute or disclose the Confidential Information received from the Disclosing Party, its |
(d) | without prejudice to its obligations pursuant to this Agreement, after termination for whatever reason and at the request of the Disclosing Party, immediately return or destroy all Confidential Information received from the Disclosing Party or its Affiliates. The destruction of the Confidential Information shall be confirmed promptly in writing. Each Party shall ensure that it has retained no copy of any Confidential Information other than one archival copy to be retained in its confidential files solely for the purpose of monitoring compliance with this Agreement. |
4.3 | The Parties’ obligations from the above stipulated under Article 4.2. do not apply to the following: |
(a) | Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees, which at the time of the disclosure is in the public domain as evidenced by the Receiving Party in writing ; |
(b) | Confidential Information received from the Disclosing Part, its Affiliates or sub-licensees, which at the time of the disclosure is in the public domain as evidenced by the Receiving Party by competent proof ; |
(c) | Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees, which after disclosure is published or otherwise becomes part of the public domain through no fault or breach of this Agreement by the Receiving Party as evidenced by the Receiving Party by competent proof ; |
(d) | Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees, which the Receiving Party can establish by competent proof in writing was in his possession at the time of Disclosure by the Disclosing Party and was not acquired directly or indirectly from the Disclosing Party ; |
(e) | Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees which is received after the time of disclosure from a Third Party who did not acquire such Confidential Information directly or indirectly from the Disclosing Party under obligations of confidentiality and who is in lawful possession of such Confidential Information as evidenced by the Receiving Party in writing ; |
(f) | Confidential Information received from the Disclosing Party, its Affiliates or sub-licensees, which, as can be demonstrated by documentary proof, has been independently developed by employees, agents, consultants or other representatives of the Receiving Party without the use of Confidential Information received from the Disclosing Party. |
4.4 | Notwithstanding any other provisions of this Article 4 and Article 1.5: |
4.4.1 | all of the Disclosing Party’s Confidential Information may be disclosed by the Receiving Party: (i) to any regulatory authority to secure regulatory approvals; or (ii) if the Receiving Party is required by applicable laws to disclose such Confidential Information, and is not otherwise subject to a protective order. In the case of (ii), the Receiving Party agrees to notify the other Party immediately and to use its reasonable efforts to prevent the dissemination of the Confidential Information other than as strictly required by applicable laws. The Receiving Party shall use its reasonable efforts, at the request of the Disclosing Party, to obtain confidential treatment of such Confidential Information by the governmental authority or Third Party to whom the Confidential Information is disclosed at the Receiving Party’s costs; and |
4.4.2 | a Party may disclose the existence and terms of this Agreement to the extent required to be disclosed, as reasonably determined by the disclosing Party, by applicable law, or by order or other ruling of a competent court; and |
4.4.3 | upon prior written notice and acceptance by the other Party, which shall not be unreasonably or untimely withheld, a Party hereto may disclose the existence and terms of this Agreement to possible investors, acquirers and merging partners of such Party under respective confidentiality obligations. Prior to any disclosure of the other Party’s Confidential Information, a draft of the proposed disclosure (including marked redactions of such Confidential Information) shall be provided to the other Party for consent. This said, without its attachments, in particular the Project Plan, and further excluding or blackening any Confidential Information of the other Party, this Agreement, may be disclosed under respective confidentiality agreements without the prior consent of the other Party. |
4.5 | This Article 4 shall survive the expiry or termination of this Agreement. |
5 | Representations and warranties |
5.1 | OrthoCyte warrants, that OrthoCyte is the owner or licensee of the Intellectual Property Rights listed in Attachment 1 and that they exist and are active as of the Effective Date. OrthoCyte is entitled to grant the license under the Intellectual Property Rights as granted in this Agreement. |
5.2 | OrthoCyte has no knowledge that the development, manufacture or sell of Product in the Field of Use does infringe intellectual property rights of Third Parties. Should OrthoCyte gain knowledge of any facts, it will inform Heraeus immediately. |
5.3 | No Party makes any representations or warranties, either express or implied, with respect to the Product, in particular, does not make any representations concerning the usability or the merchantability of the Product. Both Parties expressly exclude all express and implied warranties with respect to utility, applicability, safety, harmlessness to health or the fitness of the Product for any purpose. |
5.4 | No Party makes any representations or warranties that the use of the Product will not infringe any patent or other proprietary rights of any Third Party and both Parties expressly disclaim any liability thereto. |
5.5 | Except in the event of gross negligence, breach, fraud or willful misconduct, neither Party shall be held liable for any, indirect, special consequential or incidental damages, such as, but not limited to, damage or loss of property or equipment, loss of profits or revenue, cost of capital or lost opportunities. |
5.6 | Heraeus shall at all times during the term of this Agreement and thereafter indemnify, defend and hold harmless and its Affiliates , members of the executive board, officers, agents and employees from any claims and expenses, including legal expenses and attorneys’ fees, arising out of the death of or injury to any person or persons or out of any damage to property and against any other claim, proceeding, demand, expense, liability, loss, or damage of any kind whatsoever arising out of the development, manufacture, use, handling, storing or sale of the Product in the Field of Use. |
6. | Rights to Background Rights |
6.1 | The Parties acknowledge that any Background Right of a Party used for the performance of this Agreement remains the property of the said Party introducing the same, except the Parties have agreed otherwise in writing. Nothing in this Agreement shall be interpreted as an obligation on a Party or an Affiliate thereof to give access to or grant a licence under its Background Rights, except as agreed herein otherwise in writing. |
7. | Term and Termination |
7.1 | This Agreement shall come into force on the Effective Date and shall, unless terminated prior in accordance with this Article below, remain in force until the last patent in a particular country, for which Heraeus has claimed a license under this Agreement, expires. After such expiration Heraeus shall have the right to further benefit from the license granted under this Agreement without paying any further royalties or other compensations towards OrthoCyte. Upon termination, not expiry, of this Agreement all sub-license agreements shall expire immediately. |
7.2 | Early termination before the expiry date of the last patent covered shall only be possible under the following conditions: |
7.2.1 | Early termination shall be available to Heraeus, at Heraeus’s sole discretion, upon [**] months prior written notice. |
7.2.2 | Early termination shall be available to either Party for cause. Notably, but not exclusively, a Party shall be entitled to terminate this Agreement for cause by giving written notice of such termination if: |
(i) | the other Party shall be in default of any of its material obligations under this Agreement and shall fail to remedy such default within [**] days after receipt of written notice thereof, or |
(ii) | the other Party challenges the validity of the Intellectual Property of the other Party regarding the licensed Intellectual Property Rights or supports Third Parties in such challenge. |
(iii) | an event of insolvency or bankruptcy occurs in relation to the other Party. |
7.3 | This Agreement shall terminate if the R&D Agreement is terminated prior to Product Launch. |
7.4 | Any royalties or payments paid or due prior to the date of effective termination shall not be refundable. |
7.5 | The termination of this Agreement does not affect any rights or obligations of either Party which have arisen or accrued up to and including the date of termination. |
8. | Miscellaneous |
8.1 | Force Majeure |
8.2 | Notices |
8.3 | Assignment and successors |
8.4
|
Severability
|
8.5
|
Amendment
|
9.6
|
Governing law and Jurisdiction; Interpretation
|
Signatures:
|
||
For OrthoCyte
|
||
|
||
Signature
|
||
Date:
|
||
For Heraeus Medical GmbH
|
||
|
|
|
Signature:
|
Signature:
|
|
Name:
|
Name:
|
|
Title:
|
Title:
|
|
Date:
|
Date:
|
TITLE
|
COUNTRY
|
APPLICATION
NUMBER
|
FILING DATE
|
PATENT
NUMBER
|
ISSUE
DATE
|
STATUS
|
|
BIOT-013
|
Methods to Accelerate the Isolation of Novel Cell Strains from Pluripotent Stem Cells and Cells Obtained Thereby
|
US
|
12/504,630
|
Jul 16, 2009
|
Pending
|
||
BIOT-024
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
US
|
13/384,289
|
Mar 16, 2012
|
8,685,386
|
Apr 1, 2014
|
Issued
|
BIOT-024AU
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
AU
|
2010273930
|
Jul 16, 2010
|
Pending
|
||
BIOT-024CA
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
CA
|
2,768,376
|
Jul 16, 2010
|
Pending
|
||
BIOT-024CN
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
CN
|
201080041322
|
Jul 16, 2010
|
Pending
|
||
BIOT-024 CON1
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
US
|
14/172,765
|
Feb 4, 2014
|
Pending
|
||
BIOT-024EP
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
EP
|
10800651.1
|
Jul 16, 2010
|
Pending
|
||
BIOT-024IL
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
IL
|
217552
|
Jul 16, 2010
|
Pending
|
BIOT-024IN
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
IN
|
1098/CHENP/2012
|
Jul 16, 2010
|
Pending
|
||
BIOT-024JP
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
JP
|
2012-520830
|
Jul 16, 2010
|
Pending
|
||
BIOT-024JP D
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
JP
|
2015-158197
|
Jul 16, 2010
|
Pending
|
||
BIOT-024KR
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
KR
|
10-2012-7003880
|
Jul 16, 2010
|
Pending
|
||
BIOT-024SG
|
Methods and Compositions For In Vitro and In Vivo Chondrogenesis
|
SG
|
201200351-3
|
Jul 16, 2010
|
177694
|
Sept 16, 2014
|
Issued
|
BIOT-026
|
Improved Methods of Screening Embryonic Progenitor Cell Lines
|
US
|
13/683,241
|
Nov 21, 2012
|
Pending
|
||
BIOT-026AU
|
Improved Methods of Screening Embryonic Progenitor Cell Lines
|
AU
|
2011258249
|
May 25, 2011
|
2011258249
|
Sept 25, 2014
|
Issued
|
BIOT-026CA
|
Improved Methods of Screening Embryonic Progenitor Cell Lines
|
CA
|
2,800,616
|
May 25, 2011
|
Pending
|
||
BIOT-029SG2
|
Progenitor Cells and Methods and Uses Related Thereto
|
SG
|
200306634.7
|
Aug 9, 2001
|
100479
|
May 31, 2005
|
Issued
|
BIOT-030
|
Methods of Modifying Transcriptional Regulatory Networks in Stem Cells
|
US
|
13/279,123
|
Oct 21, 2011
|
Pending
|
||
BIOT-030AU
|
Methods of Modifying Transcriptional Regulatory Networks in Stem Cells
|
AU
|
2011316830
|
Oct 21, 2011
|
Pending
|
||
BIOT-030CA
|
Methods of Modifying Transcriptional Regulatory Networks in Stem Cells
|
CA
|
2,814,860
|
Oct 21, 2011
|
Pending
|
||
BIOT-030EP
|
Methods of Modifying Transcriptional Regulatory Networks in Stem Cells
|
EP
|
11835259.0
|
Oct 21, 2011
|
Pending
|
||
BIOT-030IN
|
Methods of Modifying Transcriptional Regulatory Networks in Stem Cells
|
IN
|
2198/CHENP/2013
|
Oct 21, 2011
|
Pending
|
||
BIOT-033
|
Novel Methods and Formulations for Orthopedic Cell Therapy
|
US
|
14/131,429
|
Jan 7, 2014
|
Pending
|
||
BIOT-034
|
Compositions and Methods Relating to Clonal Progenitor Cell Lines
|
US
|
14/238,160
|
Apr 29, 2014
|
Pending
|
TITLE
|
COUNTRY
|
APPLICATION NUMBER
|
FILING DATE
|
PATENT NUMBER
|
ISSUE DATE
|
STATUS
|
||
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
US
|
12/234,445
|
Sep 19, 2008
|
8,859,523
|
Oct 14, 2014
|
Issued
|
|
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
US
|
12/244,135
|
Oct 2, 2008
|
7,928,069
|
Apr 19, 2011
|
Issued
|
|
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
CA
|
2,489,712
|
May 15, 2003
|
Pending
|
|||
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
CH
|
03799796.2
|
May 15, 2003
|
1539799
|
Nov 14, 2013
|
Issued
|
|
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
DE
|
03799796.2
|
May 15, 2003
|
1539799
|
Nov 14, 2013
|
Issued
|
|
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
FR
|
03799796.2
|
May 15, 2003
|
1539799
|
Nov 14, 2013
|
Issued
|
|
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
GB
|
03799796.2
|
May 15, 2003
|
1539799
|
Nov 14, 2013
|
Issued
|
|
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
IE
|
03799796.2
|
May 15, 2003
|
1539799
|
Nov 14, 2013
|
Issued
|
|
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
IT
|
03799796.2
|
May 15, 2003
|
1539799
|
Nov 14, 2013
|
Issued
|
|
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
LX
|
03799796.2
|
May 15, 2003
|
1539799
|
Nov 14, 2013
|
Issued
|
|
U-3405
|
Crosslinked Compounds and Methods of Making and Using Thereof
|
MN
|
03799796.2
|
May 15, 2003
|
1539799
|
Nov 14, 2013
|
Issued
|
|
U-3656
|
Modified Macromolecules and Associated Methods of Synthesis and Use
|
US
|
10/581,571
|
Jul 13, 2007
|
7,981,871
|
Jul 19, 2011
|
Issued
|
|
U-3656
|
Modified Macromolecules and Associated Methods of Synthesis and Use
|
US
|
13/184,401
|
Jul 15, 2011
|
8,691,793
|
Apr 08, 2014
|
Issued
|
|
U-3656
|
Modified Macromolecules and Associated Methods of Synthesis and Use
|
CA
|
2,549,295
|
Dec 06, 2004
|
Pending
|
|||
U-3656
|
Modified Macromolecules and Associated Methods of Synthesis and Use
|
EP
|
04813101.5
|
Dec 06, 2004
|
Pending
|
|||
U-3362
|
Anti-adhesion Compositions and Methods of Use Thereof
|
US
|
10/556,693
|
Dec 03, 2008
|
8,324,184
|
Dec 04, 2012
|
Issued
|
|
U-3362
|
Anti-adhesion Compositions and Methods of Use Thereof
|
EP
|
04775992.3
|
May 13, 2004
|
Pending
|
Subscriber
|
Pro Rata Percentage
|
Shares in Allocation
|
||
BioTime, Inc.
|
73.56%
|
5,421,714
|
__________ | (a) | Subscriber is a natural person whose net worth, or joint net worth with spouse, at the date of purchase exceeds $1,000,000 (not including the value of Subscriber’s principal residence and excluding mortgage debt secured by Subscriber’s principal residence up to the estimated fair market value of the home, except that any mortgage debt incurred by Subscriber within 60 days prior to the date of this Agreement shall not be excluded from the determination of Subscriber’s net worth unless such mortgage debt was incurred to acquire the residence). |
__________ | (b) | Subscriber is a natural person whose individual gross income (excluding that of spouse) exceeded $200,000 in each of the past two calendar years, and who reasonably expects individual gross income exceeding $200,000 in the current calendar year. |
__________ | (c) | Subscriber is a natural person whose joint gross income with spouse exceeded $300,000 in each of the past two calendar years, and who reasonably expects joint gross income with spouse exceeding $300,000 in the current calendar year. |
_____X____ | (d) | Subscriber is a tax-exempt organization described in Section 501(c) (3) of the Internal Revenue Code, or a corporation, Massachusetts or similar business trust, or partnership, not formed for the specific purpose of acquiring Shares, with total assets in excess of $5,000,000. |
__________ | (e) | Subscriber is a trust with total assets in excess of $5,000,000, not formed for the specific purpose of acquiring Shares, whose purchase is directed by a person who has such knowledge and experience in financial and business matters that he is capable of evaluating the merits and risks of an investment in the Shares. |
(a)
|
Address:
|
1301 Harbor Bay Parkway
|
Alameda, California 94502
|
||
(b)
|
email:
|
rpeabody@biotimemail.com
|
(c)
|
Telephone:
|
(510) 921-5300
|
(d)
|
Social Security Number:
|
|
or Taxpayer Identification Number:
|
||
(e)
|
State of Residence or Principal Place of Business:
|
California
|
Number of Shares
|
Total Subscription Price of Subscription
|
||
5,421,714
|
x $1.54 =
|
$
8,349,439.56
|
|
|
BioTime, Inc.
|
||
By:
|
/s/R.W. Peabody
|
||
Title:
|
SR VP
|
Dated:
|
September 29
|
, 2015
|
ONCOCYTE CORPORATION
|
||
By:
|
/s/William Annett
|
||||
Title
:
|
CEO
|
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which the periodic reports are being prepared; |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting. |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: November 9, 2015
|
|
/s/ Michael D. West
|
|
Michael D. West
|
|
Co-Chief Executive Officer
|
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which the periodic reports are being prepared; |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting. |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: November 9, 2015
|
|
/s/ Aditya Mohanty
|
|
Aditya Mohanty
|
|
Co-Chief Executive Officer
|
(a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which the periodic reports are being prepared; |
(b) | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
(c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
(d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting. |
(a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
(b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: November 9, 2015
|
|
/s/ Robert W. Peabody
|
|
Robert W. Peabody
|
|
Chief Financial Officer
|
1. | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and |
2. | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: November 9, 2015
|
|
/s/ Michael D. West
|
|
Michael D. West
|
|
Co-Chief Executive Officer
|
/s/ Aditya Mohanty
|
|
Aditya Mohanty
|
|
Co-Chief Executive Officer
|
/s/ Robert W. Peabody
|
|
Robert W. Peabody
|
|
Chief Financial Officer
|