| x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
| o | 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
|
o
|
|
Accelerated filer
|
T
|
|
Non-accelerated filer
|
o
|
(Do not check if a smaller reporting company)
|
o
|
|
|
June 30, 2014
(Unaudited)
|
December 31,
2013
|
||||||
|
|
||||||||
|
ASSETS
|
||||||||
|
CURRENT ASSETS
|
||||||||
|
Cash and cash equivalents
|
$
|
15,721,508
|
$
|
5,495,478
|
||||
|
Inventory
|
257,929
|
178,694
|
||||||
|
Trade accounts and grants receivable, net
|
1,190,723
|
998,393
|
||||||
|
Prepaid expenses and other current assets
|
1,476,104
|
1,277,405
|
||||||
|
Total current assets
|
18,646,264
|
7,949,970
|
||||||
|
|
||||||||
|
Equipment, net
|
2,982,973
|
2,997,733
|
||||||
|
Deferred license and consulting fees
|
391,584
|
444,833
|
||||||
|
Deposits
|
435,482
|
129,129
|
||||||
|
Other long-term assets
|
57,048
|
-
|
||||||
|
Intangible assets, net
|
43,472,089
|
46,208,085
|
||||||
|
TOTAL ASSETS
|
$
|
65,985,440
|
$
|
57,729,750
|
||||
|
|
||||||||
|
LIABILITIES AND EQUITY
|
||||||||
|
CURRENT LIABILITIES
|
||||||||
|
Accounts payable and accrued liabilities
|
$
|
4,741,617
|
$
|
6,722,624
|
||||
|
Capital lease liability, current portion
|
57,500
|
-
|
||||||
|
Deferred license and subscription revenue, current portion
|
270,348
|
235,276
|
||||||
|
Total current liabilities
|
5,069,465
|
6,957,900
|
||||||
|
|
||||||||
|
LONG-TERM LIABILITIES
|
||||||||
|
Deferred rent, net of current portion
|
20,112
|
35,997
|
||||||
|
Capital lease, net of current portion
|
57,500
|
-
|
||||||
|
Deferred tax liability, net
|
14,244,078
|
8,277,548
|
||||||
|
Other long-term liabilities
|
9,860
|
195,984
|
||||||
|
Total long-term liabilities
|
14,331,550
|
8,509,529
|
||||||
|
|
||||||||
|
Commitments and contingencies
|
||||||||
|
|
||||||||
|
STOCKHOLDERS' EQUITY
|
||||||||
|
Preferred shares, no par value, authorized 2,000,000 shares as of June 30, 2014 and December 31, 2013; 70,000 and nil issued and outstanding as of June 30, 2014 and December 31, 2013, respectively
|
3,500,000
|
-
|
||||||
|
Common shares, no par value, authorized 125,000,000 shares as of June 30, 2014 and December 31, 2013; 72,268,526 issued and 66,869,984 outstanding as of June 30, 2014 and 67,412,139 issued and 56,714,424 outstanding at December 31, 2013
|
199,944,402
|
203,456,401
|
||||||
|
Contributed capital
|
59,934
|
93,972
|
||||||
|
Accumulated other comprehensive (loss)/income
|
(85,134
|
) |
62,899
|
|||||
|
Accumulated deficit
|
(163,387,382
|
)
|
(145,778,547
|
)
|
||||
|
Treasury stock at cost: 5,398,542 and 10,697,715 shares at June 30, 2014 and at December 31, 2013, respectively
|
(22,119,467
|
)
|
(43,033,957
|
)
|
||||
|
BioTime stockholders' equity
|
17,912,353
|
14,800,768
|
||||||
|
Noncontrolling interest
|
28,672,072
|
27,461,553
|
||||||
|
Total stockholders' equity
|
46,584,425
|
42,262,321
|
||||||
|
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
|
$
|
65,985,440
|
$
|
57,729,750
|
||||
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
||||||||||||||
|
|
2014
|
2013
|
2014
|
2013
|
||||||||||||
|
|
||||||||||||||||
|
REVENUES:
|
||||||||||||||||
|
License fees
|
$
|
300,079
|
$
|
362,249
|
$
|
594,582
|
$
|
712,078
|
||||||||
|
Royalties from product sales
|
76,109
|
103,315
|
173,996
|
210,914
|
||||||||||||
|
Grant income
|
640,034
|
693,480
|
1,215,614
|
777,293
|
||||||||||||
|
Sale of research products
|
90,478
|
57,281
|
189,068
|
124,005
|
||||||||||||
|
Total revenues
|
1,106,700
|
1,216,325
|
2,173,260
|
1,824,290
|
||||||||||||
|
|
||||||||||||||||
|
Cost of sales
|
(251,265
|
)
|
(180,811
|
)
|
(383,179
|
)
|
(363,560
|
)
|
||||||||
|
|
||||||||||||||||
|
Gross Profit
|
855,435
|
1,035,514
|
1,790,081
|
1,460,730
|
||||||||||||
|
|
||||||||||||||||
|
EXPENSES:
|
||||||||||||||||
|
Research and development
|
(9,081,137
|
)
|
(5,530,395
|
)
|
(17,469,570
|
)
|
(10,975,825
|
)
|
||||||||
|
General and administrative
|
(4,835,972
|
)
|
(3,621,570
|
)
|
(8,503,259
|
)
|
(7,005,091
|
)
|
||||||||
|
Total operating expenses
|
(13,917,109
|
)
|
(9,151,965
|
)
|
(25,972,829
|
)
|
(17,980,916
|
)
|
||||||||
|
|
||||||||||||||||
|
Loss from operations
|
(13,061,674
|
)
|
(8,116,451
|
)
|
(24,182,748
|
)
|
(16,520,186
|
)
|
||||||||
|
OTHER INCOME/(EXPENSES):
|
||||||||||||||||
|
Interest (expense)/income, net
|
(10,024
|
)
|
579
|
(18,398
|
)
|
1,522
|
||||||||||
|
Gain/(loss) on sale or write off of fixed assets
|
-
|
800
|
(8,576
|
)
|
(710
|
)
|
||||||||||
|
Other income/(expense), net
|
164,732
|
|
(80,541
|
)
|
242,868
|
|
(109,520
|
)
|
||||||||
|
Total other expenses, net
|
154,708
|
|
(79,162
|
)
|
215,894
|
|
(108,708
|
)
|
||||||||
|
LOSS BEFORE INCOME TAX BENEFIT
|
(12,906,966
|
)
|
(8,195,613
|
)
|
(23,966,854
|
)
|
(16,628,894
|
)
|
||||||||
|
|
||||||||||||||||
|
Deferred income tax benefit
|
1,513,258
|
-
|
2,862,284
|
-
|
||||||||||||
|
|
||||||||||||||||
|
NET LOSS
|
(11,393,708
|
)
|
(8,195,613
|
)
|
(21,104,570
|
)
|
(16,628,894
|
)
|
||||||||
|
|
||||||||||||||||
|
Net loss attributable to noncontrolling interest
|
|
1,873,518
|
|
645,848
|
|
3,495,735
|
|
1,346,503
|
||||||||
|
|
||||||||||||||||
|
NET LOSS ATTRIBUTABLE TO BIOTIME, INC.
|
|
(9,520,190
|
)
|
|
(7,549,765
|
)
|
|
(17,608,835
|
)
|
|
(15,282,391
|
)
|
||||
| Dividends on preferred shares | (34,038 | ) | - | (34,038 | ) | - | ||||||||||
| Net loss attributable to common shareholders | (9,554,228 | ) | (7,549,765 | ) | (17,642,873 | ) | (15,282,391 | ) | ||||||||
|
Unrealized gain/(loss) on available-for-sale assets
|
1,120
|
-
|
(1,530
|
)
|
-
|
|||||||||||
|
Foreign currency translation (loss)/gain
|
(74,831
|
)
|
28,857
|
(182,071
|
)
|
177,294
|
||||||||||
|
|
||||||||||||||||
|
TOTAL COMPREHENSIVE NET LOSS
|
$
|
(9,593,901
|
)
|
$
|
(7,520,908
|
)
|
$
|
(17,792,436
|
)
|
$
|
(15,105,097
|
)
|
||||
|
|
||||||||||||||||
|
BASIC AND DILUTED NET LOSS PER COMMON SHARE
|
$
|
(0.16
|
)
|
$
|
(0.14
|
)
|
$
|
(0.29
|
)
|
$
|
(0.29
|
)
|
||||
|
|
||||||||||||||||
|
WEIGHTED AVERAGE NUMBER OF COMMON STOCK OUTSTANDING: BASIC AND DILUTED
|
61,498,164
|
53,791,434
|
59,886,748
|
52,490,767
|
||||||||||||
|
|
Six Months Ended June 30,
|
|||||||
|
|
2014
|
2013
|
||||||
|
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
|
Net loss attributable to BioTime, Inc.
|
$
|
(17,608,835
|
)
|
$
|
(15,282,391
|
)
|
||
|
Adjustments to reconcile net loss attributable to BioTime, Inc. to net cash used in operating activities:
|
||||||||
|
Depreciation expense
|
522,714
|
253,215
|
||||||
|
Amortization of intangible assets
|
2,735,996
|
1,285,145
|
||||||
|
Amortization of deferred consulting fees
|
18,993
|
32,559
|
||||||
|
Amortization of deferred license fees
|
54,750
|
54,750
|
||||||
|
Amortization of deferred rent
|
(10,080
|
)
|
(4,446
|
)
|
||||
|
Amortization of deferred license, royalty and subscription revenues
|
(280
|
)
|
(75,914
|
)
|
||||
|
Amortization of stock-based prepaid rent
|
42,293
|
-
|
||||||
|
Net loss allocable to noncontrolling interest
|
(3,495,735
|
)
|
(1,346,503
|
)
|
||||
|
Stock-based compensation
|
2,212,141
|
1,351,795
|
||||||
|
Deferred income tax benefit
|
(2,862,284
|
)
|
-
|
|||||
|
Loss on sale or write-off of equipment
|
21,031
|
710
|
||||||
|
Write-off for uncollectible receivables
|
(16,356
|
)
|
-
|
|||||
|
Changes in operating assets and liabilities:
|
||||||||
|
Accounts receivable, net
|
(36,998
|
)
|
(25,701
|
)
|
||||
|
Grant receivable
|
(132,876
|
)
|
(269,365
|
)
|
||||
|
Inventory
|
(79,236
|
)
|
(9,429
|
)
|
||||
|
Prepaid expenses and other current assets
|
(314,601
|
)
|
(414,449
|
)
|
||||
|
Other long-term assets
|
-
|
(5,000
|
)
|
|||||
|
Accounts payable and accrued liabilities
|
(2,034,852
|
)
|
(30,865
|
)
|
||||
|
Deferred revenues
|
35,352
|
62,381
|
||||||
|
Other long-term liabilities
|
(186,386
|
)
|
(41,731
|
)
|
||||
|
Net cash used in operating activities
|
(21,135,249 |
)
|
(14,465,239
|
)
|
||||
|
|
||||||||
|
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
|
Purchase of equipment
|
(404,649
|
)
|
(735,124
|
)
|
||||
|
Security deposit paid, net
|
(306,246
|
)
|
(54,423
|
)
|
||||
|
Proceeds from the sale of equipment
|
4,000
|
-
|
||||||
|
Cash used in investing activities
|
(706,895
|
)
|
(789,547
|
)
|
||||
|
|
||||||||
|
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
|
Employee options exercised
|
12,500
|
-
|
||||||
|
Director options exercised
|
207,000
|
-
|
||||||
|
Proceeds from issuance of common stock
|
14,724,107
|
23,810,421
|
||||||
|
Fees paid on sale of common stock
|
(302,123
|
)
|
(747,907
|
)
|
||||
|
Proceeds from sale of treasury stock and subsidiary warrants
|
13,582,209
|
1,819,500
|
||||||
|
Proceeds from sale of preferred stock
|
3,500,000
|
-
|
||||||
|
Proceeds from sale of common shares of subsidiary
|
468,000
|
255,502
|
||||||
|
Net cash provided by financing activities
|
32,191,693
|
25,137,516
|
||||||
|
|
||||||||
|
Effect of exchange rate changes on cash and cash equivalents
|
(123,519
|
)
|
73,599
|
|||||
|
|
||||||||
|
NET CHANGE IN CASH AND CASH EQUIVALENTS:
|
10,226,030
|
9,956,329
|
||||||
|
CASH AND CASH EQUIVALENTS:
|
||||||||
|
At beginning of the period
|
5,495,478
|
4,349,967
|
||||||
|
At end of the period
|
$
|
15,721,508
|
$
|
14,306,296
|
||||
|
|
||||||||
|
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
|
||||||||
|
Cash paid during the period for interest
|
$
|
18,655
|
$
|
-
|
||||
|
|
||||||||
|
SUPPLEMENTAL SCHEDULE OF NON CASH FINANCING AND INVESTING ACTIVITIES:
|
||||||||
| Capital expenditure funded by capital lease borrowing |
$
|
115,000
|
$
|
-
|
||||
|
Common shares issued for consulting services
|
$
|
-
|
$
|
148,920 | ||||
|
Common shares issued for rent
|
$
|
-
|
$
|
242,726
|
||||
|
Subsidiary
|
Field of Business
|
BioTime Ownership
|
Country
|
|
Asterias Biotherapeutics, Inc.
|
Research, development and commercialization of human therapeutic products from stem cells, focused initially in the fields of neurology and oncology
|
70.6%
|
USA
|
|
BioTime Asia, Limited
|
Stem cell products for research
|
81%
|
Hong Kong
|
|
Cell Cure Neurosciences Ltd.
|
Age-related macular degeneration
Multiple sclerosis
Parkinson’s disease
|
62.5%
|
Israel
|
|
ES Cell International Pte Ltd
|
Stem cell products for research, including clinical grade cell lines produced under cGMP
|
100%
|
Singapore
|
|
LifeMap Sciences, Inc.
|
Genetic, disease, and stem cell databases
|
74.52%
|
USA
|
|
LifeMap Sciences, Ltd.
|
Stem cell database
|
(1)
|
Israel
|
|
LifeMap Solutions, Inc.
|
Mobile health software
|
(1)
|
USA
|
|
OncoCyte Corporation
|
Cancer diagnostics
|
75.3%
|
USA
|
|
OrthoCyte Corporation
|
Orthopedic diseases, including chronic back pain and osteoarthritis
|
100%
|
USA
|
|
ReCyte Therapeutics, Inc.
|
Vascular disorders, including cardiovascular-related diseases, ischemic conditions, vascular injuries
Stem cell-derived endothelial and cardiovascular related progenitor cells for research, drug testing, and therapeutics
|
94.8%
|
USA
|
| (1) | LifeMap Sciences, Ltd. and LifeMap Solutions, Inc. are wholly-owned subsidiaries of LifeMap Sciences, Inc. |
|
|
June 30, 2014
(Unaudited)
|
December 31,
2013
|
||||||
|
Equipment, furniture and fixtures
|
$
|
4,942,835
|
$
|
4,431,586
|
||||
|
Accumulated depreciation
|
(1,959,862
|
)
|
(1,433,853
|
)
|
||||
|
Equipment, net
|
$
|
2,982,973
|
$
|
2,997,733
|
||||
|
|
June 30, 2014
(Unaudited)
|
December 31,
2013
|
||||||
|
Intangible assets
|
$
|
54,719,918
|
$
|
54,719,918
|
||||
|
Accumulated amortization
|
(11,247,829
|
)
|
(8,511,833
|
)
|
||||
|
Intangible assets, net
|
$
|
43,472,089
|
$
|
46,208,085
|
||||
|
|
June 30, 2014
(Unaudited)
|
December 31,
2013
|
||||||
|
Accounts payable
|
$
|
1,880,095
|
$
|
3,887,950
|
||||
|
Accrued bonuses
|
207,250
|
600,000
|
||||||
|
Other accrued liabilities
|
2,654,272
|
2,234,674
|
||||||
|
|
$
|
4,741,617
|
$
|
6,722,624
|
||||
|
Consideration transferred to BioTime:
|
||||
|
Asterias Series B shares
|
$
|
52,164,568
|
||
|
Warrants to purchase Asterias Series B shares
|
2,012,481
|
|||
|
Excess of contributed assets’ value over consideration
|
4,800,063
|
|||
|
Total consideration issued
|
$
|
58,977,112
|
||
|
|
||||
|
Assets transferred by BioTime:
|
||||
|
BioTime common shares, at fair value
|
$
|
34,985,163
|
||
|
BioTime Warrants, at fair value
|
18,276,406
|
|||
|
Cancellation of outstanding obligation to BioTime
|
5,000,000
|
|||
|
Investment in affiliates, at cost
|
415,543
|
|||
|
Geron asset acquisition related transaction costs paid by BioTime
|
300,000
|
|||
|
Total assets transferred
|
$
|
58,977,112
|
||
|
Consideration paid to Geron:
|
||||
|
Asterias Series A shares, net of share issuance costs of $541,800
|
$
|
15,121,222
|
||
|
Obligation to distribute BioTime Warrants
|
18,276,406
|
|||
|
Transaction and other costs
|
1,519,904
|
|||
|
Total consideration paid
|
$
|
34,917,532
|
||
|
Assets acquired from Geron (preliminary allocation):
|
||||
|
Patents and other intellectual property rights related to hES cells
|
$
|
29,017,009
|
||
|
Deferred tax liability arising from difference in book versus tax basis on Geron intangible assets acquired
|
(11,558,243
|
)
|
||
|
IPR&D expensed upon acquisition
|
17,458,766
|
|||
|
Total assets and in-process research and development acquired
|
$
|
34,917,532
|
||
|
|
Six Months Ended June 30,
|
|||||||
|
|
2014
|
2013
|
||||||
| Gross Profit |
$
|
1,790,081
|
$
|
473,070
|
||||
|
|
||||||||
|
Net loss available to common shareholders
|
$
|
(17,608,835
|
)
|
$
|
(25,568,831
|
)
|
||
|
|
||||||||
|
Net loss per common share – basic and diluted
|
$
|
(0.29
|
)
|
$
|
(0.42
|
)
|
||
| Item 2. | Management's Discussion and Analysis of Financial Condition and Results of Operations |
|
Subsidiary
|
Field of Business
|
BioTime
Ownership
|
Country
|
|
Asterias Biotherapeutics, Inc.
|
Research, development and commercialization of human therapeutic products from stem cells focused initially in the fields of neurology and oncology
|
70.6%
|
USA
|
|
BioTime Asia, Limited
|
Stem cell products for research
|
81%
|
Hong Kong
|
|
Cell Cure Neurosciences Ltd.
|
Age-related macular degeneration
Multiple sclerosis
Parkinson’s disease
|
62.5%
|
Israel
|
|
ES Cell International Pte Ltd
|
Stem cell products for research, including clinical grade cell lines
produced under cGMP
|
100%
|
Singapore
|
|
LifeMap Sciences, Inc.
|
Genetic, disease, and stem cell databases
|
74.52%
|
USA
|
|
LifeMap Sciences, Ltd.
|
Stem cell database
|
(1)
|
Israel
|
|
LifeMap Solutions, Inc.
|
Mobile health software
|
(1)
|
USA
|
|
OncoCyte Corporation
|
Cancer diagnostics
|
75.3%
|
USA
|
|
OrthoCyte Corporation
|
Orthopedic diseases, including chronic back pain and osteoarthritis
|
100%
|
USA
|
|
ReCyte Therapeutics, Inc.
|
Vascular disorders, including cardiovascular-related diseases, ischemic conditions, vascular injuries. Stem cell-derived endothelial and cardiovascular related progenitor cells for research, drug testing, and therapeutics
|
94.8%
|
USA
|
| (1) | LifeMap Sciences, Ltd. and LifeMap Solutions, Inc. are wholly-owned subsidiaries of LifeMap Sciences, Inc. |
|
|
|
Three Months Ended June 30,
|
Six Months Ended June 30,
|
||||||||
|
Company
|
Program
|
2014
|
2013
|
2014
|
2013
|
||||||
|
Asterias
|
hESC-based cell therapeutic programs
|
30.2%
|
10.6%
|
30.6%
|
7.1%
|
||||||
|
BioTime and ESI
|
PureStem® hEPCs, cGMP hES cell lines, and related research products
|
8.8%
|
13.5%
|
9.3%
|
13.2%
|
||||||
|
BioTime
|
PureStem® technology
|
–%
|
–%
|
–%
|
1.8%
|
||||||
|
BioTime
|
Hydrogel therapeutic products and HyStem® research
|
18.8%
|
20.6%
|
17.3%
|
21.1%
|
||||||
|
BioTime
|
Hextend®
|
0.2%
|
0.4%
|
0.2%
|
0.4%
|
||||||
|
BioTime
|
HyStem® 3D cell culture platform for cancer drug discovery
|
1.0%
|
–%
|
0.7%
|
–%
|
||||||
|
BioTime Asia
|
Stem cell products for research
|
–%
|
0.1%
|
–%
|
0.1%
|
||||||
|
Cell Cure Neurosciences
|
Age related macular degeneration (OpRegen® and OpRegen®-Plus), and neurological disease therapeutics
|
14.5%
|
18.4%
|
14.6%
|
20.8%
|
||||||
|
LifeMap Sciences
|
Database development and sales and mobile health software development
|
9.9%
|
11.7%
|
9.6%
|
11.4%
|
||||||
|
OncoCyte
|
Cancer diagnostics
|
10.5%
|
12.6%
|
10.8%
|
12.8%
|
||||||
|
OrthoCyte
|
Orthopedic therapeutics
|
2.0%
|
6.3%
|
2.3%
|
5.5%
|
||||||
|
ReCyte Therapeutics
|
Cardiovascular therapeutics
|
4.1%
|
5.8%
|
4.6%
|
5.8%
|
||||||
|
|
Three Months Ended June 30,
|
$ Increase/
|
% Increase/
|
|||||||||||||
|
|
2014
|
2013
|
Decrease
|
Decrease
|
||||||||||||
|
License fees
|
$
|
300,079
|
$
|
362,249
|
$
|
-62,170
|
-17.2%
|
|
||||||||
|
Royalty from product sales
|
76,109
|
103,315
|
-27,206
|
-26.3%
|
|
|||||||||||
|
Grant income
|
640,034
|
693,480
|
-53,446
|
-7.7%
|
|
|||||||||||
|
Sales of research products and services
|
90,478
|
57,281
|
+33,197
|
+58.0%
|
|
|||||||||||
|
Total revenues
|
1,106,700
|
1,216,325
|
-109,625
|
-9.0%
|
|
|||||||||||
|
Cost of sales
|
(251,265
|
)
|
(180,811
|
)
|
+70,454
|
+39.0%
|
|
|||||||||
|
Gross profit
|
855,435
|
1,035,514
|
-180,079
|
-17.4%
|
|
|||||||||||
|
|
Six Months Ended June 30,
|
$ Increase/
|
% Increase/
|
|||||||||||||
|
|
2014
|
2013
|
Decrease
|
Decrease
|
||||||||||||
|
License fees
|
$
|
594,582
|
$
|
712,078
|
$
|
-117,496
|
-16.5%
|
|
||||||||
|
Royalty from product sales
|
173,996
|
210,914
|
-36,918
|
-17.5%
|
|
|||||||||||
|
Grant income
|
1,215,614
|
777,293
|
+438,321
|
+56.4%
|
|
|||||||||||
|
Sales of research products and services
|
189,068
|
124,005
|
+65,063
|
+52.5%
|
|
|||||||||||
|
Total revenues
|
2,173,260
|
1,824,290
|
+348,970
|
+19.1%
|
|
|||||||||||
|
Cost of sales
|
(383,179
|
)
|
(363,560
|
)
|
+19,619
|
+5.4%
|
|
|||||||||
|
Gross profit
|
1,790,081
|
1,460,730
|
+329,351
|
+22.5%
|
|
|||||||||||
|
|
Three Months Ended June 30,
|
$ Increase/
|
% Increase/
|
|||||||||||||
|
|
2014
|
2013
|
Decrease
|
Decrease
|
||||||||||||
|
Research and development expenses
|
$
|
(9,081,137
|
)
|
$
|
(5,530,395
|
)
|
$
|
+3,550,742
|
+64.2%
|
|
||||||
|
General and administrative expenses
|
(4,835,972
|
)
|
(3,621,570
|
)
|
+1,214,402
|
+33.5%
|
|
|||||||||
|
Interest (expense)/income, net
|
(10,024
|
)
|
579
|
-10,603
|
-1,831.3%
|
|
||||||||||
|
Other income/(expense), net
|
164,732
|
|
(80,541
|
)
|
+245,273
|
+304.53%
|
|
|||||||||
|
|
Six Months Ended June 30,
|
$ Increase/
|
% Increase/
|
|||||||||||||
|
|
2014
|
2013
|
Decrease
|
Decrease
|
||||||||||||
|
Research and development expenses
|
$
|
(17,469,570
|
)
|
$
|
(10,975,825
|
)
|
$
|
+6,493,745
|
+59.2%
|
|
||||||
|
General and administrative expenses
|
(8,503,259
|
)
|
(7,005,091
|
)
|
+1,498,168
|
+21.4%
|
|
|||||||||
|
Interest (expense)/income, net
|
(18,398
|
)
|
1,522
|
-19,920
|
-1,308.8%
|
|
||||||||||
|
Other income/(expense), net
|
242,868
|
|
(109,520
|
)
|
+352,388
|
+321.75%
|
|
|||||||||
|
|
Six Months Ended June 30,
|
|||||||||
|
Company
|
Program
|
2014
|
2013
|
|||||||
|
Asterias
|
hESC-based cell therapeutic programs
|
$
|
5,341,884
|
$
|
781,989
|
|||||
|
BioTime and ESI
|
PureStem® hEPCs, cGMP hES cell lines, and related research products
|
1,629,966
|
1,445,600
|
|||||||
|
BioTime
|
PureStem® technology
|
-
|
199,447
|
|||||||
|
BioTime
|
Hydrogel therapeutic products and HyStem® research
|
3,019,683
|
2,312,730
|
|||||||
|
BioTime
|
Hextend®
|
31,862
|
44,163
|
|||||||
|
BioTime
|
HyStem® 3D cell culture platform for cancer drug discovery
|
117,432
|
-
|
|||||||
|
BioTime Asia
|
Stem cell products for research
|
-
|
16,055
|
|||||||
|
Cell Cure Neurosciences
|
OpRegen®, OpRegen®-Plus, and neurological disease therapeutics
|
2,555,712
|
2,281,952
|
|||||||
|
LifeMap Sciences
|
Database development and sales and mobile health software development
|
1,680,249
|
1,248,767
|
|||||||
|
OncoCyte
|
Cancer diagnostics
|
1,884,284
|
1,406,873
|
|||||||
|
OrthoCyte
|
Orthopedic therapeutics
|
405,852
|
603,438
|
|||||||
|
ReCyte Therapeutics
|
Cardiovascular therapeutics
|
802,646
|
634,811
|
|||||||
| Total research and development expenses | $ |
17,469,570
|
$ |
10,975,825
|
||||||
|
|
Six Months Ended June 30,
|
|||||||
|
Company
|
2014
|
2013
|
||||||
|
BioTime
|
$
|
3,147,273
|
$
|
3,632,920
|
||||
|
Asterias
|
$
|
2,639,134
|
$
|
1,364,296
|
||||
|
BioTime Asia
|
$
|
3,111
|
$
|
83,341
|
||||
|
Cell Cure Neurosciences
|
$
|
383,073
|
$
|
360,383
|
||||
|
ES Cell International Pte Ltd
|
$
|
118,470
|
$
|
133,902
|
||||
|
LifeMap
|
$
|
1,379,517
|
$
|
824,208
|
||||
|
OncoCyte
|
$
|
375,814
|
$
|
209,048
|
||||
|
OrthoCyte
|
$
|
227,255
|
$
|
198,231
|
||||
|
ReCyte Therapeutics
|
$
|
229,612
|
$
|
198,762
|
||||
|
Total general and administrative expenses
|
$
|
8,503,259
|
$
|
7,005,091
|
||||
|
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)
|
$
|
12,297,111
|
$
|
906,227
|
$
|
3,548,764
|
$
|
2,579,280
|
$
|
5,262,840
|
||||||||||
| Capital lease (3) | $ | 127,009 | $ | 26,460 | $ | 100,549 | $ | - | $ | - | ||||||||||
| 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, ESI, LifeMap Sciences, and Cell Cure Neurosciences. Also includes two 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 experimentation we are doing is costly, time consuming, and uncertain as to its results. We incurred research and development expenses amounting to $17,469,570, during the six months ended June 30, 2014, and $26,609,423, $18,116,688, and $13,699,691 during the fiscal years ended December 31, 2013, 2012, and 2011, respectively, excluding $17,458,766 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. See Note 8 to condensed consolidated interim financial statements. |
| · | 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 June 30, 2014, we had $15,721,508 of cash and cash equivalents on hand. There can be no assurance that we or our subsidiaries will be able to raise 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. |
| 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
|
Co-Development and Option Agreement, dated May 6, 2014, between LifeMap Solutions, Inc. and the Icahn School of Medicine at Mount Sinai (Portions of this exhibit have been omitted pursuant to a request for confidential treatment) *
|
|
|
|
|
10.2
|
Stock Purchase Agreement, dated May 6, 2014, between LifeMap Sciences, Inc. and BioTime, Inc. (Portions of this exhibit have been omitted pursuant to a request for confidential treatment) *
|
|
|
|
|
10.3
|
Stock Purchase Agreement, dated June 12, 2014, between Pedro Lichtinger and Asterias Biotherapeutics, Inc. *
|
|
|
|
|
10.4
|
Purchase Agreement, dated June 13, 2014, between Broadwood Partners, L.P. and Asterias Biotherapeutics, Inc. *
|
|
|
|
|
10.5
|
Purchase Agreement, dated June 13, 2014, between The George Karfunkel 2007 Grantor Trust #1 and Asterias Biotherapeutics, Inc. *
|
|
|
|
|
10.6
|
Registration Rights Agreement, dated June 16, 2014, between The George Karfunkel 2007 Grantor Trust #1, Broadwood Partners, L.P., and Asterias Biotherapeutics, Inc. *
|
|
|
|
|
10.7
|
Employment Agreement, dated as of June 9, 2014, between Pedro Lichtinger and Asterias Biotherapeutics, Inc. *
|
|
|
|
|
10.8
|
LifeMap Solutions, Inc. 2014 Stock Option Plan *
|
| 10.9 |
Form of LifeMap Solutions, Inc. Incentive Stock Option Agreement *
|
| 10.10 | |
|
31
|
Rule 13a-14(a)/15d-14(a) Certification.*
|
|
|
|
|
32
|
Section 1350 Certification.*
|
|
|
|
|
101
|
Interactive Data File
|
|
|
|
|
101.INS
|
XBRL Instance Document *
|
|
|
|
|
101.SCH
|
XBRL Taxonomy Extension Schema *
|
|
|
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase *
|
|
|
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase *
|
|
|
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase *
|
|
|
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Document *
|
| (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 30, 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 |
| * | Filed herewith |
|
|
BIOTIME, INC.
|
|
|
|
|
|
|
Date: August 11, 2014
|
/s/ Michael D. West
|
|
|
|
Michael D. West
|
|
|
|
Chief Executive Officer
|
|
|
Date: August 11, 2014
|
/s/ Robert W. Peabody
|
|
|
|
Robert W. Peabody
|
|
|
|
Chief Financial Officer
|
|
|
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)
|
|
|
|
|
Co-Development and Option Agreement, dated May 6, 2014, between LifeMap Solutions, Inc. and the Icahn School of Medicine at Mount Sinai (Portions of this exhibit have been omitted pursuant to a request for confidential treatment) *
|
|
|
|
|
|
Stock Purchase Agreement, dated May 6, 2014, between LifeMap Sciences, Inc. and BioTime, Inc. (Portions of this exhibit have been omitted pursuant to a request for confidential treatment) *
|
|
|
|
|
|
Stock Purchase Agreement, dated June 12, 2014, between Pedro Lichtinger and Asterias Biotherapeutics, Inc. *
|
|
|
|
|
|
Purchase Agreement, dated June 13, 2014, between Broadwood Partners, L.P. and Asterias Biotherapeutics, Inc. *
|
|
|
|
|
|
Purchase Agreement, dated June 13, 2014, between The George Karfunkel 2007 Grantor Trust #1 and Asterias Biotherapeutics, Inc. *
|
|
|
|
|
|
Registration Rights Agreement, dated June 16, 2014, between The George Karfunkel 2007 Grantor Trust #1, Broadwood Partners, L.P., and Asterias Biotherapeutics, Inc. *
|
|
|
|
|
|
Employment Agreement, dated as of June 9, 2014, between Pedro Lichtinger and Asterias Biotherapeutics, Inc. *
|
|
|
|
|
| 10.8 |
LifeMap Solutions, Inc. 2014 Stock Option Plan *
|
| 10.9 |
Form of LifeMap Solutions, Inc. Incentive Stock Option Agreement *
|
| 10.10 |
Form of LifeMap Solutions, Inc. Stock Option Agreement *
|
|
Rule 13a-14(a)/15d-14(a) Certification.*
|
|
| 32 |
Section 1350 Certification.*
|
|
101.INS
|
XBRL Instance Document *
|
|
|
|
|
101.SCH
|
XBRL Taxonomy Extension Schema *
|
|
|
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase *
|
|
|
|
|
101.LAB
|
XBRL Taxonomy Extension Label Linkbase *
|
|
|
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase *
|
|
|
|
|
101.DEF
|
XBRL Taxonomy Extension Definition Document *
|
| (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 30, 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 |
| * | Filed herewith |
|
1.
|
DEFINITIONS
|
|
2.
|
DEVELOPMENT ACTIVITIES
|
|
3.
|
TERM OF AGREEMENT
|
|
4.
|
REIMBURSEMENT OF COSTS; PAYMENT
|
|
5.
|
RECORDS AND REPORTS
|
|
6.
|
INTELLECTUAL PROPERTY
|
|
7.
|
OPTION
|
|
8.
|
CONFIDENTIAL INFORMATION
|
|
9.
|
HANDLING OF USER DATA BY MOUNT SINAI
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10.
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PUBLICATION, USE OF NAME
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11.
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TERMINATION
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12.
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DISCLAIMER OF WARRANTIES; INDEMNIFICATION
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13.
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ADDITIONAL PROVISIONS
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| Icahn School of Medicine at Mount Sinai |
LifeMap Solutions, Inc.
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By:
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s/Scott L. Friedman
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By: |
s/Corey Bridges
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Name:
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Scott L. Friedman
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Name: |
Corey Bridges
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Title:
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Dean of Therapeutic Discovery
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Title: |
CEO
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Date:
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May 6, 2014
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Date: |
May 6, 2014
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By:
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s/Eric Schadt
|
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Date:
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May 6, 2014 | |
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1.
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DEFINITIONS AND INTERPRETATION.
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2.
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Visiting Scientists
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3.
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LIFEMAP RESPONSIBILITIES.
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4.
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MOUNT SINAI RESPONSIBILITIES.
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5.
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INTELLECTUAL PROPERTY.
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6.
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CONFIDENTIALITY.
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7.
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REPRESENTATIONS.
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8.
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TERM AND TERMINATION.
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9.
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INDEMNIFICATION.
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10.
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COPY OF AGREEMENT.
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11.
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MISCELLANEOUS.
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Lifemap Solutions, Inc.
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Icahn School of Medicine at Mount Sinai
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By:
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By:
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Name:
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Name:
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Title:
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Title:
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Print Name:
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| Signature: |
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| Institution: |
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Date:
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Parties
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Icahn School of Medicine at Mount Sinai, a nonprofit education corporation organized and existing under the laws of the State of New York having an office at One Gustave L. Levy Place, New York, New York 10029 (“Mount Sinai”), and LifeMap Solutions, Inc., a corporation organized and existing under the laws of Delaware (“LifeMap”), having a place of business at 1301 Bay Harbor Parkway, Suite 100, Alameda, CA 94502. LifeMap shall include LifeMap and its Affiliates. Mount Sinai shall include Mount Sinai and its Affiliates. “Affiliate” means a legal entity that is controlling, controlled by or under common control with a Party. For purposes of the definitive license agreement, the word “control” means (x) the direct or indirect ownership of more than fifty percent (50%) of the outstanding voting securities of a legal entity, (y) the right to receive fifty percent (50%) or more of the profits or earnings of a legal entity, or (z) the right to determine the policy decisions of, or to direct or cause the direction of the management of, a legal entity. Each Party shall be fully liable for its Affiliate’s compliance with the terms and obligations of the definitive license agreement.
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Patent Rights
|
United States and foreign patents and/or patent applications claiming Mount Sinai Intellectual Property or Joint Intellectual Property, as well as any and all patents issuing therefrom and from all divisionals and continuations, reissues, reexaminations, renewals, substitutions, and extensions thereof, that claim priority to such patents and/or patent applications; for clarity this includes but is not limited to all claims of continuation-in-part applications (solely to the extent such continuation-in-part can claim the same priority date) and patents issuing thereon that claim priority to said United States patent applications. Such Patent Rights will be specifically listed/described in an exhibit to the definitive license agreement.
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Mount Sinai Intellectual Property and Joint Intellectual Property
|
As defined in Section 6.2 of the Agreement
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Technical Information
|
Technical Information is all Intellectual Property Rights not covered by a Valid Claim, including Results, the Mount Sinai Intellectual Property, the Code, and the LMN Engine, owned solely or jointly by, or licensed by, Mount Sinai. For clarity, Technical Information expressly excludes Logic and LMN Components. Such Technical Information will be specifically listed/described in an exhibit to the definitive license agreement.
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Logic
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Underlying know-how possessed by Mount Sinai prior to the effective date of the definitive license agreement that relates to development of software, algorithms, and databases capable of analyzing complex data sets and generating predictive models.
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Mount Sinai Background Intellectual Property
|
Background Intellectual Property owned by, or licensed by, Mount Sinai that are necessary to practice the Patent Rights and/or Technical Information and are available for licensing. Such Mount Sinai Background Intellectual Property will be specifically listed/described in an exhibit to the definitive license agreement, and shall include the Background Intellectual Property as defined in the Agreement to which this Attachment E is attached.
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Valid Claim
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(a) an unexpired claim of an issued patent within the Patent Rights that has not been ruled unpatentable, invalid or unenforceable by a final and unappealable decision of a court or other competent authority in the subject country; or
(b) a claim of a pending application within the Patent Rights.
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Deliverables
|
Copies of the Code and Documentation and other related materials reasonably requested by LifeMap from time to time (but Mount Sinai shall not be required to deliver such more frequently than [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] in the case of Code) shall be delivered by Mount Sinai to LifeMap (and shall be held strictly confidential by LifeMap in accordance with Article 8; provided, however, LifeMap may disclose such information, subject to reasonable confidentiality provisions, or as otherwise reasonably appropriate, with respect to the development and commercialization of the Licensed Products and Licensed Services); provided that, if reasonable, only the Improvements need be delivered. If LifeMap requires a full copy of any of the foregoing, Mount Sinai shall reasonably comply.
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Licensed Products
|
Products or part(s) thereof, that are made, made for, Used (including used), imported, sold or offered for sale by LifeMap, its Distributors (as defined below), or its Sublicensees: (i) where in the absence of the definitive license agreement, such activity would infringe at least one Valid Claim; or (ii) where such products arise or are derived from the use of, or otherwise incorporate, Technical Information, Logic, LMN Components, and/or Mount Sinai Background Intellectual Property, including, for the avoidance of doubt, Code and the LMN Engine (to the extent, with respect to all of the foregoing, not solely owned by LifeMap).
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Licensed Service
|
Any service, including without limitation database access, provided by LifeMap, its Distributors (as defined below), or its Sublicensees to a third party in exchange for consideration where such service makes use of Licensed Product(s) or otherwise exploits or monetizes Mount Sinai Technical Information, Logic, LMN Components, and/or Background Intellectual Property, including, for the avoidance of doubt, Code and the LMN Engine (to the extent, with respect to all of the foregoing, not solely owned by LifeMap).
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Use
|
Defined in Article 1 of the Agreement.
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Term
|
Subject to the terms of the Agreement, and as further specified in this Attachment, from the Effective Date of the definitive license agreement until the expiration of the Royalty Term.
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Territory
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Worldwide
|
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Consumer
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Defined in Article 1 of the Agreement.
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User Data
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Defined in Article 1 of the Agreement.
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Mobile User Application
|
Defined in Article 1 of the Agreement.
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Field of Use
|
Consumer applications (including, for clarity, Internet, Web-based, mobile user and Mobile User Applications, databases and software products), based on interpretation and/or presentation of Wide Scale Health Related Information which is defined as one or more components of genetic information, clinical data and other information of individuals relating to human disease, health and/or wellness, in which the genetic information component (if such component is available) involves [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
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Business Development Plan
|
Prior to execution of a definitive license, LifeMap shall provide Mount Sinai with a detailed business development plan. The Parties shall discuss in good faith any of Mount Sinai’s requests for additional details or clarifications to such business development plan.
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Due Diligence
|
LifeMap shall use reasonable commercial efforts to develop and commercialize Licensed Products. LifeMap shall be required to demonstrate suitable investment in the development of Licensed Products. The Parties shall negotiate in good faith defined diligence milestones and timelines to be included in the definitive license agreement to ensure such Licensed Products are being diligently developed.
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Diligence Milestone
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Due Date
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|
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Documentation of at least [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] in funding [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] committed by LifeMap to fund development of Licensed Products (the investment made into LifeMap prior to the due date will be counted toward the funding sum above)
|
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] months after execution of definitive license agreement
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Prototype complete
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[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] months after execution of definitive license agreement
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Beta launch
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[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] months after execution of definitive license agreement
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Public product launch
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[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] months after execution of definitive license agreement
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If LifeMap fails to meet such diligence milestones as defined in the definitive license agreement, Mount Sinai can convert said license to a non-exclusive license provided that any delays caused by Mount Sinai will extend the foregoing due dates on a day-for-day basis.
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Copies of the Code and Documentation
|
Copies of the Code and Documentation shall be delivered by Mount Sinai to LifeMap not less than every [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] days (and shall be held strictly confidential by LifeMap in accordance with Article 8; provided, however, LifeMap may disclose such information, subject to reasonable confidentiality provisions, or as otherwise reasonably appropriate, with respect to the development and commercialization of the Licensed Products and Licensed Services); provided that, if there are only Improvements and if reasonable, only the Improvements need be delivered. If LifeMap requires a full copy of any of the foregoing, Mount Sinai shall reasonably comply.
|
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Patent Maintenance and Reimbursement
|
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
|
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Patent Extension
|
LifeMap shall promptly notify Mount Sinai of any marketing authorization for any Licensed Product for which an application for patent term extension may be based, including any third-party product, or any other event in any country that would enable Mount Sinai or LifeMap as appropriate to apply for patent term extension. For clarity, LifeMap will notify Mount Sinai of an opportunity to apply for patent term extensions as soon as the event triggering the opportunity for application has occurred. LifeMap agrees to cooperate fully with Mount Sinai to provide any information or documentation necessary to support an application for patent term extension.
|
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Royalty Term
|
On a Licensed Product-by-Licensed Product or Licensed Service-by-Licensed Service and country-by-country basis, from first commercial sale or commercial license, whichever comes first, until the later of: (a) expiration of the last Patent Rights covering such Licensed Product or Licensed Service in such country; (b) expiration of any market exclusivity period granted by a regulatory agency with respect to such Licensed Product or Licensed Service in such country; or (c) LifeMap’s final discontinuation of sale or commercial licensing of a Licensed Product or Licensed Service in such country. For clarity, should LifeMap discontinue sale of a Licensed Product or Licensed Service in a country and later resume sale of such Licensed Product or Licensed Service in said country, LifeMap would still be subject to the royalty obligations hereunder and its license rights hereunder.
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Net Sales
|
The gross amount, prior to any discounts or other list price reductions, invoiced by LifeMap and its Affiliates and its Sublicensee(s) for sales of Licensed Products or Licensed Services for end use or consumption by third parties that are not Affiliates or Sublicensees of the selling party (unless such purchasing Affiliate or Sublicensee is the end user of the Licensed Product or Licensed Service, in which case the amount billed therefore shall be deemed to be the same amount that would be billed to a third-party end user in an arm’s-length transaction) less the total of the following deductions to the extent they are included in the gross invoiced sale price of the Licensed Products or Licensed Services or otherwise directly paid or incurred by LifeMap or its Affiliates or its Sublicensees with respect to the sale of the Licensed Product or Licensed Services to such third party:
(a) normal and customary quantity and/or cash discounts and sales returns and allowances, including, without limitation, those granted on account of price adjustments, billing errors, rejected goods, damaged goods, returns, rebates actually allowed and taken, administrative or other fees or reimbursements of similar payments to wholesalers or other distributors, buying groups, or other institutions;
(b) any rebates or similar payments made with respect to sales paid for by any governmental or regulatory authority such as, by way of illustration and not in limitation of the Parties’ rights hereunder, Federal or state Medicaid, Medicare or similar state program or equivalent foreign governmental program;
(c) customs or excise duties or other duties directly imposed and related to the sales making up the gross invoice amount;
(d) sales and other taxes and duties directly related to the sale, to the extent that such items are included in the gross invoice price (but not including taxes assessed against the income derived from such sale);
(e) freight, postage, shipping, and insurance expenses (if separately identified in such invoice).
|
|
Running Royalties
|
LifeMap will pay to Mount Sinai a quarterly royalty of [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] percent ([*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]%) of Net Sales of all Licensed Products and Licensed Services that are sold by LifeMap, its Affiliates, and/or Sublicensees.
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|
Reports and Records
|
· Royalty Reports: Within [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] days after the end of each calendar quarter following first commercial sale or commercial licensing of a Licensed Product or Licensed Service, LifeMap will deliver to Mount Sinai a detailed report, certified by the chief financial officer of LifeMap, detailing the calculation of all royalties and fees due to Mount Sinai for such quarter. The report will include, at a minimum: (a) the number of Licensed Products or Licensed Services involved in sales, listed by product and by country; (b) gross consideration invoiced, billed or received for sales in such quarter; (c) Net Sales, listed by product or service and by country including an itemized list of all deductions permitted in the definition of Net Sales; (e) sublicense fees and other consideration received by LifeMap from Sublicensees, listed by product and by country; and (f) royalties and fees owed to Mount Sinai, listed by category, by product or service, and by country.
· Development Reports: LifeMap will provide Mount Sinai annually with detailed written progress reports discussing the development, evaluation, testing, and commercialization of all Licensed Products or Licensed Services and development plans for the upcoming year. Within [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] days of receipt of such development report, Mount Sinai can request additional information and clarification and LifeMap shall provide to Mount Sinai a revised development report addressing Mount Sinai’s request for additional information and clarification within [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] days of Mount Sinai’s request.
· Records: LifeMap will maintain, and will cause its Affiliates and Sublicensees to maintain, complete and accurate books and records to verify Net Sales, and all of the royalties, fees, and other payments payable under the definitive license Agreement. The records for each calendar quarter will be maintained for at least [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] years after the calendar quarter to which they pertain.
· Audit Rights: Upon reasonable prior written notice to LifeMap, LifeMap and its Affiliates and Sublicensees will provide Mount Sinai and its accountants with access to all of the books and records required by the definitive license agreement to conduct a review or audit of all of the royalties, fees, and other payments payable under the definitive license agreement. Access will be made available: (a) during normal business hours; (b) in a manner reasonably designed to facilitate Mount Sinai’s review or audit without unreasonable disruption to LifeMap’s business; and (c) no more than once each calendar year during the term of the definitive license agreement and for a period of [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] years thereafter. LifeMap will promptly pay to Mount Sinai the amount of any underpayment determined by the review or audit plus accrued interest unless such amount is subject to a good faith dispute, which dispute shall be settled in accordance with the dispute resolution process. If the review or audit determines that LifeMap has underpaid any royalty payment by [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] percent ([*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]%) or more, then LifeMap will also promptly pay the costs and expenses of Mount Sinai and its accountants in connection with the review or audit. [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] an independent audit of all of the royalties, fees, and other payments payable under the definitive license agreement. Promptly after completion of the audit, LifeMap will provide to Mount Sinai a copy of the report of the independent auditors.
|
|
Sublicensee and Distributor
|
A “Sublicensee” shall be any third party (other than end users or Affiliates) granted the right by LifeMap to develop, use, make, sell, offer for sale, or import Licensed Products or Licensed Service or otherwise make use of, monetize, and/or exploit the Patent Rights, Mount Sinai Technical Information, Logic, LMN Components, and/or Mount Sinai Background Intellectual Property.
A “Distributor” shall be any third party (other than end users or Affiliates) granted the right by LifeMap to distribute, sell, import or offer for sale Licensed Products or Licensed Service. For clarity, a Distributor shall not be granted the right by LifeMap to develop, use, or make Licensed Products or Licensed Service or otherwise make use of, monetize, and/or exploit the Patent Rights, Mount Sinai Technical Information, Logic, LMN Components, and/or Mount Sinai Background Intellectual Property.
For clarity, the Parties acknowledge and agree that the term “sublicense” or “sublicense agreement,” as used in the definitive license agreement, shall mean any license by and between LifeMap and a Sublicensee or Distributor under which LifeMap grants to such Sublicensee or Distributor the rights outlined above and such “sublicense” will be subject to the “Sublicensing Obligations” and the “Sublicensing Revenue”, as applicable to whether such “sublicense” is to a Sublicensee or a Distributor in accordance with the terms of the definitive license agreement as outlined herein.
|
|
Sublicensing Revenue
|
LifeMap will pay Mount Sinai the following percentages of all consideration, based on timing of Sublicensing, other than running royalties or an advancement payment creditable against future Net Sales (“Royalty Advance”) received by LifeMap from Sublicensees, and/or Distributors, within [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] days of receipt of such consideration. Any non-cash consideration received by LifeMap from such Sublicensees and/or Distributor will be valued at its fair market value as of the date of receipt.
For sublicenses to Sublicensees:
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
For sublicenses Distributors:
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
For further clarity, royalties shall be payable in accordance with the terms of the definitive license agreement for all Net Sales by a Sublicensee and/or Distributor as if it were Company.
The Parties acknowledge and agree that any Royalty Advance received by Company from a Sublicensee and/or Distributor shall be subject to Company’s Running Royalty obligation
|
|
Compelled Sublicensing
|
In the event that at any time [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] or more years after the effective date of the definitive license agreement Mount Sinai is given a written offer by an entity to license the Patent Rights or Technical Information to develop and commercialize a Licensed Product or Licensed Service in the Field of Use that is not being developed or commercialized by LifeMap (an “Underdeveloped Indication”), then the rights to develop such Licensed Product or Licensed Service for such Undeveloped Indication shall automatically revert to Mount Sinai unless LifeMap, within [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] days of the date Mount Sinai provides LifeMap with a written notice identifying such entity and describing in reasonable detail such written offer, either (a) offers a sublicense to such entity for such Undeveloped Indication on reasonable commercial terms; or (b) presents to Mount Sinai a credible development plan reasonably acceptable to Mount Sinai acting in good faith to pursue development of such Licensed Product for such Undeveloped Indication and begins to execute that plan.
|
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No Warranty
|
Subject to the following, the Patent Rights, Technical Information, Logic, and Background Intellectual Property are provided on an “as is” basis, and each Party makes no representations or warranties, express or implied. EXCEPT AS EXPRESSLY SET FORTH HEREIN, EACH PARTY MAKES NO WARRANTIES, EXPRESS OR IMPLIED, AS TO ANY MATTER WHATSOEVER, INCLUDING, WITHOUT LIMITATION, WARRANTIES WITH RESPECT TO THE CONDUCT, COMPLETION, SUCCESS OR PARTICULAR RESULTS, OR THE SCIENTIFIC OR COMMERCIAL VALUE OF THE DEVELOPMENT ACTIVITIES, OR THE CONDITION, OWNERSHIP, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR THE OUTCOME OF DEVELOPMENT ACTIVITIES. WITHOUT LIMITING THE FOREGOING, EACH PARTY DOES NOT GUARANTEE THAT ANY PATENT OR OTHER INTELLECTUAL PROPERTY RIGHTS SHALL RESULT FROM THE DEVELOPMENT ACTIVITIES, THAT THE SCOPE OF ANY PATENT OR OTHER INTELLECTUAL PROPERTY RIGHTS THAT MAY RESULT THEREFROM WILL COVER THE OTHER PARTY’S INTERESTS, OR THAT ANY SUCH PATENT OR OTHER INTELLECTUAL PROPERTY RIGHTS SHALL BE FREE OF DOMINANCE BY OTHER PATENTS, INCLUDING PATENTS BASED UPON INVENTIONS MADE BY OTHER INVENTORS AT SUCH PARTY INDEPENDENTLY OF THE DEVELOPMENT ACTIVITIES. EXCEPT IN THE CASE OF A BREACH OF THE FOLLOWING SENTENCE, EACH PARTY SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, CONSEQUENTIAL, PUNITIVE OR OTHER DAMAGES SUFFERED BY THE OTHER PARTY OR ANY OTHER PERSON RESULTING FROM THE DEVELOPMENT ACTIVITIES OR THE USE OF THE OTHER PARTY’S INTELLECTUAL PROPERTY PRODUCT. NOTWITHSTANDING THE FOREGOING, (i) EACH PARTY HERETO REPRESENTS THAT IT HAS NO ACTUAL KNOWLEDGE THAT ANY OF THE INTELLECTUAL PROPERTY RIGHTS TO BE UTILIZED HEREUNDER INFRINGE THE ACTIVITIES OF ANY THIRD PARTIES AND AGREES THAT IN UNDERTAKING THE OBLIGATIONS CONTAINED HEREIN IT SHALL NOT KNOWINGLY INFRINGE ANY SUCH THIRD PARTY INTELLECTUAL PROPERTY RIGHTS; AND (ii) MOUNT SINAI AGREES THAT IN ITS PERFORMANCE HEREUNDER IT SHALL NOT MAKE ANY CONTRIBUTIONS TO THE DEVELOPMENT ACTIVITIES THAT REQUIRE ANY MOUNT SINAI BACKGROUND INTELLECTUAL PROPERTY OR OTHER MOUNT SINAI INTELLECTUAL PROPERTY RIGHTS THAT ARE NOT LICENSED HEREUNDER.
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Indemnification
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LifeMap will indemnify, defend and hold harmless Mount Sinai from and against any and all liability, loss, damage, action, claim or expense that results from or arises out of: (a) the development, use, manufacture, promotion, sale or other disposition of any Licensed Products or Licensed Services by LifeMap or Sublicensees or other third parties, including end users, except as a result of, or to the extent caused by, the action or inaction of Mount Sinai; and (b) any breach by LifeMap or its Sublicensees of the definitive license agreement.
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Insurance
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LifeMap will procure and maintain policies of insurance, including [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]. Each policy shall be written on an occurrence basis and shall name Mount Sinai as additional insured on a primary and non-contributory basis.
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Legal Jurisdiction and Venue
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The definitive license agreement shall be construed and enforced in accordance with the laws of the State of New York without regard to any choice or conflict of laws. Any suit to enforce the agreement will be brought in the federal or state courts located in the State of New York.
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Non-Use of Name
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Except as otherwise provided in Article 10 of the Agreement, neither Party, nor its employees and agents will use the other Party’s name, seal, logo, trademark, or service mark, or any adaptation thereof, or the name, mark, or logo of the other Party in any way, except as may be required by applicable law, without the prior written consent of the other Party whose name is to be used. If Mount Sinai uses the Developed Intellectual Property outside the Field of Use, it will give credit as appropriate regarding LifeMap’s involvement in the creation of such Developed Intellectual Property.
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Assignment
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LifeMap may assign the definitive license agreement or substantially all of the license agreement, either directly or by merger or operation of law, without the prior written consent of Mount Sinai, as long as: (a) at least [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] days before the proposed transaction, LifeMap gives Mount Sinai written notice and such background information as may be reasonably necessary to enable Mount Sinai to give an informed consent; (b) the assignee agrees in writing to be legally bound by this Agreement; and (c) the assignee agrees to deliver to Mount Sinai an updated business development plan within [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] days after the closing of the proposed transaction. Any permitted assignment will not relieve LifeMap of responsibility for performance of any obligation of LifeMap that has accrued at the time of the assignment. Any prohibited assignment will be null and void. Notwithstanding the foregoing, LifeMap shall be permitted to assign the definitive license agreement to LifeMap Sciences to the extent LifeMap and LifeMap Sciences will have fulfilled the obligations outlined under (a) and (b) above.
|
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Global Social Responsibility
|
LifeMap and Mount Sinai shall take into consideration the principle of “Global Social Responsibility” when executing the full license agreement. “Global Social Responsibility” means facilitating the availability of Licensed Products in Developing Countries (i.e., The World Bank’s listing of “Low Income Economies”) at locally affordable prices to improve access to such Licensed Products or Licensed Services in Developing Countries.
|
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Additional Terms
|
Additional terms to be negotiated in good faith include, without limitation, termination, payment/interest, infringement obligations, confidentiality obligations, and miscellaneous legal provisions (independent contractor language, legal compliance, waivers, notices, severability, dispute resolution, etc.).
|
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COMPANY:
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LifeMap Sciences, Inc.
|
||
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By:
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s/David Warshawsky
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David Warshawsky, President
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BIOTIME:
|
||
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BioTime, Inc.
|
||
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By:
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s/Michael D. West
|
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|
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Michael D. West, Chief Executive Officer
|
|
| 1. | DEFINITIONS |
|
2.
|
DEVELOPMENT ACTIVITIES
|
| 3. | TERM OF AGREEMENT |
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Icahn School of Medicine at Mount Sinai
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|
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LifeMap Solutions, Inc.
|
||
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By:
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s/Scott L. Friedman
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By:
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s/Corey Bridges
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|
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Name:
|
Scott L. Friedman
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Name:
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Corey Bridges
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Title:
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Dean of Therapeutic Discovery
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|
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Title:
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CEO
|
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Date:
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May 6, 2014
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Date:
|
May 6, 2014
|
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By:
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s/Eric Schadt
|
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Date:
|
May 6, 2014
|
|
| 2. |
Visiting Scientists
|
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Lifemap Solutions, Inc.
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Icahn School of Medicine at Mount Sinai
|
|||
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By:
|
By:
|
|||
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Name:
Title:
|
Name:
Title:
|
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Print Name:
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Signature:
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Institution:
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Date:
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Parties
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Icahn School of Medicine at Mount Sinai, a nonprofit education corporation organized and existing under the laws of the State of New York having an office at One Gustave L. Levy Place, New York, New York 10029 (“Mount Sinai”), and LifeMap Solutions, Inc., a corporation organized and existing under the laws of Delaware (“LifeMap”), having a place of business at 1301 Bay Harbor Parkway, Suite 100, Alameda, CA 94502. LifeMap shall include LifeMap and its Affiliates. Mount Sinai shall include Mount Sinai and its Affiliates. “Affiliate” means a legal entity that is controlling, controlled by or under common control with a Party. For purposes of the definitive license agreement, the word “control” means (x) the direct or indirect ownership of more than fifty percent (50%) of the outstanding voting securities of a legal entity, (y) the right to receive fifty percent (50%) or more of the profits or earnings of a legal entity, or (z) the right to determine the policy decisions of, or to direct or cause the direction of the management of, a legal entity. Each Party shall be fully liable for its Affiliate’s compliance with the terms and obligations of the definitive license agreement.
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Patent Rights
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United States and foreign patents and/or patent applications claiming Mount Sinai Intellectual Property or Joint Intellectual Property, as well as any and all patents issuing therefrom and from all divisionals and continuations, reissues, reexaminations, renewals, substitutions, and extensions thereof, that claim priority to such patents and/or patent applications; for clarity this includes but is not limited to all claims of continuation-in-part applications (solely to the extent such continuation-in-part can claim the same priority date) and patents issuing thereon that claim priority to said United States patent applications. Such Patent Rights will be specifically listed/described in an exhibit to the definitive license agreement.
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Mount Sinai Intellectual Property and Joint Intellectual Property
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As defined in Section 6.2 of the Agreement
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Technical Information
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Technical Information is all Intellectual Property Rights not covered by a Valid Claim, including Results, the Mount Sinai Intellectual Property, the Code, and the LMN Engine, owned solely or jointly by, or licensed by, Mount Sinai. For clarity, Technical Information expressly excludes Logic and LMN Components. Such Technical Information will be specifically listed/described in an exhibit to the definitive license agreement.
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Logic
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Underlying know-how possessed by Mount Sinai prior to the effective date of the definitive license agreement that relates to development of software, algorithms, and databases capable of analyzing complex data sets and generating predictive models.
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Mount Sinai Background Intellectual Property
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Background Intellectual Property owned by, or licensed by, Mount Sinai that are necessary to practice the Patent Rights and/or Technical Information and are available for licensing. Such Mount Sinai Background Intellectual Property will be specifically listed/described in an exhibit to the definitive license agreement, and shall include the Background Intellectual Property as defined in the Agreement to which this Attachment E is attached.
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Valid Claim
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(a) an unexpired claim of an issued patent within the Patent Rights that has not been ruled unpatentable, invalid or unenforceable by a final and unappealable decision of a court or other competent authority in the subject country; or
(b) a claim of a pending application within the Patent Rights.
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Deliverables
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Copies of the Code and Documentation and other related materials reasonably requested by LifeMap from time to time (but Mount Sinai shall not be required to deliver such more frequently than [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] in the case of Code) shall be delivered by Mount Sinai to LifeMap (and shall be held strictly confidential by LifeMap in accordance with Article 8; provided, however, LifeMap may disclose such information, subject to reasonable confidentiality provisions, or as otherwise reasonably appropriate, with respect to the development and commercialization of the Licensed Products and Licensed Services); provided that, if reasonable, only the Improvements need be delivered. If LifeMap requires a full copy of any of the foregoing, Mount Sinai shall reasonably comply.
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Licensed Products
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Products or part(s) thereof, that are made, made for, Used (including used), imported, sold or offered for sale by LifeMap, its Distributors (as defined below), or its Sublicensees: (i) where in the absence of the definitive license agreement, such activity would infringe at least one Valid Claim; or (ii) where such products arise or are derived from the use of, or otherwise incorporate, Technical Information, Logic, LMN Components, and/or Mount Sinai Background Intellectual Property, including, for the avoidance of doubt, Code and the LMN Engine (to the extent, with respect to all of the foregoing, not solely owned by LifeMap).
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Licensed Service
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Any service, including without limitation database access, provided by LifeMap, its Distributors (as defined below), or its Sublicensees to a third party in exchange for consideration where such service makes use of Licensed Product(s) or otherwise exploits or monetizes Mount Sinai Technical Information, Logic, LMN Components, and/or Background Intellectual Property, including, for the avoidance of doubt, Code and the LMN Engine (to the extent, with respect to all of the foregoing, not solely owned by LifeMap).
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License Grant
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Subject to agreement on final terms, Mount Sinai and its Affiliates will grant to LifeMap, and LifeMap will accept, a worldwide exclusive, right and license during the Term of the definitive license agreement, with the right to sublicense through multiple tiers, under the Patent Rights and Mount Sinai’s rights (which “rights” as used in this Section, shall include, Intellectual Property Rights), including rights in the Results, and Mount Sinai’s rights in Joint Intellectual Property and Joint Results, the LMN Engine, and the Code and any related Documentation (to the extent, with respect to all of the foregoing, not solely owned by LifeMap) (i) to research, discover, develop, make, have made, Use, have used, import, have imported, lease, sell, have sold and offer for sale Licensed Products and Licensed Services in the Field of Use and throughout the Territory; and (ii) to Use (including use) the Mount Sinai Technical Information to research, discover, develop, make, have made, Use, have used, import, have imported, lease, sell, have sold and offer for sale Licensed Products and Licensed Services in the Field of Use and throughout the Territory.
Notwithstanding the foregoing, the Parties acknowledge and agree any exclusive license granted to Mount Sinai’s rights outlined above, expressly excludes (a) an exclusive license to EMR Data and/or LMN Components contained and/or incorporated in the LMN Engine or any Improvements thereto; (b) the Non-Exclusive Rights; and (c) the right to sell any of Mount Sinai’s Results and EMR Data, except to the extent incorporated in a physical Licensed Product for use as part of such Licensed Product.
Subject to agreement on final terms, Mount Sinai and its Affiliates will grant to LifeMap, and LifeMap will accept, a worldwide non-exclusive, right and license during the Term of the definitive license agreement, with the right to sublicense through multiple tiers, under the Patent Rights and Mount Sinai’s rights to (i) the Mount Sinai Background Intellectual Property; (ii) the Non-Exclusive Rights; (iii) the Logic, and (iv) EMR Data and/or LMN Components contained and/or incorporated in the LMN Engine (which LMN Engine is exclusively licensed under the definitive license agreement with respect to its components that are not EMR Data and/or LMN Components (to the extent such EMR Data and/or LMN Components is necessary to drive the LMN Engine, as applicable), and any related Documentation, to research, discover, develop, make, have made, Use, have used, import, have imported, lease, sell, have sold and offer for sale Licensed Products and Licensed Services in the Field of Use and throughout the Territory.
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Use
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Defined in Article 1 of the Agreement.
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Term
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Subject to the terms of the Agreement, and as further specified in this Attachment, from the Effective Date of the definitive license agreement until the expiration of the Royalty Term.
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Territory
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Worldwide
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Consumer
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Defined in Article 1 of the Agreement.
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User Data
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Defined in Article 1 of the Agreement.
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Mobile User Application
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Defined in Article 1 of the Agreement.
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Field of Use
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Consumer applications (including, for clarity, Internet, Web-based, mobile user and Mobile User Applications, databases and software products), based on interpretation and/or presentation of Wide Scale Health Related Information which is defined as one or more components of genetic information, clinical data and other information of individuals relating to human disease, health and/or wellness, in which the genetic information component (if such component is available) involves [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
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Business Development Plan
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Prior to execution of a definitive license, LifeMap shall provide Mount Sinai with a detailed business development plan. The Parties shall discuss in good faith any of Mount Sinai’s requests for additional details or clarifications to such business development plan.
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Due Diligence
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LifeMap shall use reasonable commercial efforts to develop and commercialize Licensed Products. LifeMap shall be required to demonstrate suitable investment in the development of Licensed Products. The Parties shall negotiate in good faith defined diligence milestones and timelines to be included in the definitive license agreement to ensure such Licensed Products are being diligently developed.
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Diligence Milestone
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Due Date
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Documentation of at least [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] in funding [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] committed by LifeMap to fund development of Licensed Products (the investment made into LifeMap prior to the due date will be counted toward the funding sum above)
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[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] months after execution of definitive license agreement
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Prototype complete
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[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] months after execution of definitive license agreement
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Beta launch
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[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] months after execution of definitive license agreement
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Public product launch
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[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] months after execution of definitive license agreement
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If LifeMap fails to meet such diligence milestones as defined in the definitive license agreement, Mount Sinai can convert said license to a non-exclusive license provided that any delays caused by Mount Sinai will extend the foregoing due dates on a day-for-day basis.
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Copies of the Code and Documentation
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Copies of the Code and Documentation shall be delivered by Mount Sinai to LifeMap not less than every [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] days (and shall be held strictly confidential by LifeMap in accordance with Article 8; provided, however, LifeMap may disclose such information, subject to reasonable confidentiality provisions, or as otherwise reasonably appropriate, with respect to the development and commercialization of the Licensed Products and Licensed Services); provided that, if there are only Improvements and if reasonable, only the Improvements need be delivered. If LifeMap requires a full copy of any of the foregoing, Mount Sinai shall reasonably comply.
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Patent Maintenance and Reimbursement
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[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
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Patent Extension
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LifeMap shall promptly notify Mount Sinai of any marketing authorization for any Licensed Product for which an application for patent term extension may be based, including any third-party product, or any other event in any country that would enable Mount Sinai or LifeMap as appropriate to apply for patent term extension. For clarity, LifeMap will notify Mount Sinai of an opportunity to apply for patent term extensions as soon as the event triggering the opportunity for application has occurred. LifeMap agrees to cooperate fully with Mount Sinai to provide any information or documentation necessary to support an application for patent term extension.
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Royalty Term
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On a Licensed Product-by-Licensed Product or Licensed Service-by-Licensed Service and country-by-country basis, from first commercial sale or commercial license, whichever comes first, until the later of: (a) expiration of the last Patent Rights covering such Licensed Product or Licensed Service in such country; (b) expiration of any market exclusivity period granted by a regulatory agency with respect to such Licensed Product or Licensed Service in such country; or (c) LifeMap’s final discontinuation of sale or commercial licensing of a Licensed Product or Licensed Service in such country. For clarity, should LifeMap discontinue sale of a Licensed Product or Licensed Service in a country and later resume sale of such Licensed Product or Licensed Service in said country, LifeMap would still be subject to the royalty obligations hereunder and its license rights hereunder.
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Net Sales
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The gross amount, prior to any discounts or other list price reductions, invoiced by LifeMap and its Affiliates and its Sublicensee(s) for sales of Licensed Products or Licensed Services for end use or consumption by third parties that are not Affiliates or Sublicensees of the selling party (unless such purchasing Affiliate or Sublicensee is the end user of the Licensed Product or Licensed Service, in which case the amount billed therefore shall be deemed to be the same amount that would be billed to a third-party end user in an arm’s-length transaction) less the total of the following deductions to the extent they are included in the gross invoiced sale price of the Licensed Products or Licensed Services or otherwise directly paid or incurred by LifeMap or its Affiliates or its Sublicensees with respect to the sale of the Licensed Product or Licensed Services to such third party:
(a) normal and customary quantity and/or cash discounts and sales returns and allowances, including, without limitation, those granted on account of price adjustments, billing errors, rejected goods, damaged goods, returns, rebates actually allowed and taken, administrative or other fees or reimbursements of similar payments to wholesalers or other distributors, buying groups, or other institutions;
(b) any rebates or similar payments made with respect to sales paid for by any governmental or regulatory authority such as, by way of illustration and not in limitation of the Parties’ rights hereunder, Federal or state Medicaid, Medicare or similar state program or equivalent foreign governmental program;
(c) customs or excise duties or other duties directly imposed and related to the sales making up the gross invoice amount;
(d) sales and other taxes and duties directly related to the sale, to the extent that such items are included in the gross invoice price (but not including taxes assessed against the income derived from such sale);
(e) freight, postage, shipping, and insurance expenses (if separately identified in such invoice).
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Running Royalties
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LifeMap will pay to Mount Sinai a quarterly royalty of [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] percent ([*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]%) of Net Sales of all Licensed Products and Licensed Services that are sold by LifeMap, its Affiliates, and/or Sublicensees.
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Reports and Records
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· Royalty Reports: Within [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] days after the end of each calendar quarter following first commercial sale or commercial licensing of a Licensed Product or Licensed Service, LifeMap will deliver to Mount Sinai a detailed report, certified by the chief financial officer of LifeMap, detailing the calculation of all royalties and fees due to Mount Sinai for such quarter. The report will include, at a minimum: (a) the number of Licensed Products or Licensed Services involved in sales, listed by product and by country; (b) gross consideration invoiced, billed or received for sales in such quarter; (c) Net Sales, listed by product or service and by country including an itemized list of all deductions permitted in the definition of Net Sales; (e) sublicense fees and other consideration received by LifeMap from Sublicensees, listed by product and by country; and (f) royalties and fees owed to Mount Sinai, listed by category, by product or service, and by country.
· Development Reports: LifeMap will provide Mount Sinai annually with detailed written progress reports discussing the development, evaluation, testing, and commercialization of all Licensed Products or Licensed Services and development plans for the upcoming year. Within [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] days of receipt of such development report, Mount Sinai can request additional information and clarification and LifeMap shall provide to Mount Sinai a revised development report addressing Mount Sinai’s request for additional information and clarification within [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] days of Mount Sinai’s request.
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· Records: LifeMap will maintain, and will cause its Affiliates and Sublicensees to maintain, complete and accurate books and records to verify Net Sales, and all of the royalties, fees, and other payments payable under the definitive license Agreement. The records for each calendar quarter will be maintained for at least [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] years after the calendar quarter to which they pertain.
· Audit Rights: Upon reasonable prior written notice to LifeMap, LifeMap and its Affiliates and Sublicensees will provide Mount Sinai and its accountants with access to all of the books and records required by the definitive license agreement to conduct a review or audit of all of the royalties, fees, and other payments payable under the definitive license agreement. Access will be made available: (a) during normal business hours; (b) in a manner reasonably designed to facilitate Mount Sinai’s review or audit without unreasonable disruption to LifeMap’s business; and (c) no more than once each calendar year during the term of the definitive license agreement and for a period of [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] years thereafter. LifeMap will promptly pay to Mount Sinai the amount of any underpayment determined by the review or audit plus accrued interest unless such amount is subject to a good faith dispute, which dispute shall be settled in accordance with the dispute resolution process. If the review or audit determines that LifeMap has underpaid any royalty payment by [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] percent ([*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]%) or more, then LifeMap will also promptly pay the costs and expenses of Mount Sinai and its accountants in connection with the review or audit. [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] an independent audit of all of the royalties, fees, and other payments payable under the definitive license agreement. Promptly after completion of the audit, LifeMap will provide to Mount Sinai a copy of the report of the independent auditors.
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Sublicensee and Distributor
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A “Sublicensee” shall be any third party (other than end users or Affiliates) granted the right by LifeMap to develop, use, make, sell, offer for sale, or import Licensed Products or Licensed Service or otherwise make use of, monetize, and/or exploit the Patent Rights, Mount Sinai Technical Information, Logic, LMN Components, and/or Mount Sinai Background Intellectual Property.
A “Distributor” shall be any third party (other than end users or Affiliates) granted the right by LifeMap to distribute, sell, import or offer for sale Licensed Products or Licensed Service. For clarity, a Distributor shall not be granted the right by LifeMap to develop, use, or make Licensed Products or Licensed Service or otherwise make use of, monetize, and/or exploit the Patent Rights, Mount Sinai Technical Information, Logic, LMN Components, and/or Mount Sinai Background Intellectual Property.
For clarity, the Parties acknowledge and agree that the term “sublicense” or “sublicense agreement,” as used in the definitive license agreement, shall mean any license by and between LifeMap and a Sublicensee or Distributor under which LifeMap grants to such Sublicensee or Distributor the rights outlined above and such “sublicense” will be subject to the “Sublicensing Obligations” and the “Sublicensing Revenue”, as applicable to whether such “sublicense” is to a Sublicensee or a Distributor in accordance with the terms of the definitive license agreement as outlined herein.
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Sublicensing Revenue
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LifeMap will pay Mount Sinai the following percentages of all consideration, based on timing of Sublicensing, other than running royalties or an advancement payment creditable against future Net Sales (“Royalty Advance”) received by LifeMap from Sublicensees, and/or Distributors, within [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] days of receipt of such consideration. Any non-cash consideration received by LifeMap from such Sublicensees and/or Distributor will be valued at its fair market value as of the date of receipt.
For sublicenses to Sublicensees:
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
For sublicenses Distributors:
[*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]
For further clarity, royalties shall be payable in accordance with the terms of the definitive license agreement for all Net Sales by a Sublicensee and/or Distributor as if it were Company.
The Parties acknowledge and agree that any Royalty Advance received by Company from a Sublicensee and/or Distributor shall be subject to Company’s Running Royalty obligation
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Compelled Sublicensing
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In the event that at any time [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] or more years after the effective date of the definitive license agreement Mount Sinai is given a written offer by an entity to license the Patent Rights or Technical Information to develop and commercialize a Licensed Product or Licensed Service in the Field of Use that is not being developed or commercialized by LifeMap (an “Underdeveloped Indication”), then the rights to develop such Licensed Product or Licensed Service for such Undeveloped Indication shall automatically revert to Mount Sinai unless LifeMap, within [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] days of the date Mount Sinai provides LifeMap with a written notice identifying such entity and describing in reasonable detail such written offer, either (a) offers a sublicense to such entity for such Undeveloped Indication on reasonable commercial terms; or (b) presents to Mount Sinai a credible development plan reasonably acceptable to Mount Sinai acting in good faith to pursue development of such Licensed Product for such Undeveloped Indication and begins to execute that plan.
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No Warranty
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Subject to the following, the Patent Rights, Technical Information, Logic, and Background Intellectual Property are provided on an “as is” basis, and each Party makes no representations or warranties, express or implied. EXCEPT AS EXPRESSLY SET FORTH HEREIN, EACH PARTY MAKES NO WARRANTIES, EXPRESS OR IMPLIED, AS TO ANY MATTER WHATSOEVER, INCLUDING, WITHOUT LIMITATION, WARRANTIES WITH RESPECT TO THE CONDUCT, COMPLETION, SUCCESS OR PARTICULAR RESULTS, OR THE SCIENTIFIC OR COMMERCIAL VALUE OF THE DEVELOPMENT ACTIVITIES, OR THE CONDITION, OWNERSHIP, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR THE OUTCOME OF DEVELOPMENT ACTIVITIES. WITHOUT LIMITING THE FOREGOING, EACH PARTY DOES NOT GUARANTEE THAT ANY PATENT OR OTHER INTELLECTUAL PROPERTY RIGHTS SHALL RESULT FROM THE DEVELOPMENT ACTIVITIES, THAT THE SCOPE OF ANY PATENT OR OTHER INTELLECTUAL PROPERTY RIGHTS THAT MAY RESULT THEREFROM WILL COVER THE OTHER PARTY’S INTERESTS, OR THAT ANY SUCH PATENT OR OTHER INTELLECTUAL PROPERTY RIGHTS SHALL BE FREE OF DOMINANCE BY OTHER PATENTS, INCLUDING PATENTS BASED UPON INVENTIONS MADE BY OTHER INVENTORS AT SUCH PARTY INDEPENDENTLY OF THE DEVELOPMENT ACTIVITIES. EXCEPT IN THE CASE OF A BREACH OF THE FOLLOWING SENTENCE, EACH PARTY SHALL NOT BE LIABLE FOR ANY DIRECT, INDIRECT, CONSEQUENTIAL, PUNITIVE OR OTHER DAMAGES SUFFERED BY THE OTHER PARTY OR ANY OTHER PERSON RESULTING FROM THE DEVELOPMENT ACTIVITIES OR THE USE OF THE OTHER PARTY’S INTELLECTUAL PROPERTY PRODUCT. NOTWITHSTANDING THE FOREGOING, (i) EACH PARTY HERETO REPRESENTS THAT IT HAS NO ACTUAL KNOWLEDGE THAT ANY OF THE INTELLECTUAL PROPERTY RIGHTS TO BE UTILIZED HEREUNDER INFRINGE THE ACTIVITIES OF ANY THIRD PARTIES AND AGREES THAT IN UNDERTAKING THE OBLIGATIONS CONTAINED HEREIN IT SHALL NOT KNOWINGLY INFRINGE ANY SUCH THIRD PARTY INTELLECTUAL PROPERTY RIGHTS; AND (ii) MOUNT SINAI AGREES THAT IN ITS PERFORMANCE HEREUNDER IT SHALL NOT MAKE ANY CONTRIBUTIONS TO THE DEVELOPMENT ACTIVITIES THAT REQUIRE ANY MOUNT SINAI BACKGROUND INTELLECTUAL PROPERTY OR OTHER MOUNT SINAI INTELLECTUAL PROPERTY RIGHTS THAT ARE NOT LICENSED HEREUNDER.
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Indemnification
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LifeMap will indemnify, defend and hold harmless Mount Sinai from and against any and all liability, loss, damage, action, claim or expense that results from or arises out of: (a) the development, use, manufacture, promotion, sale or other disposition of any Licensed Products or Licensed Services by LifeMap or Sublicensees or other third parties, including end users, except as a result of, or to the extent caused by, the action or inaction of Mount Sinai; and (b) any breach by LifeMap or its Sublicensees of the definitive license agreement.
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Insurance
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LifeMap will procure and maintain policies of insurance, including [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission]. Each policy shall be written on an occurrence basis and shall name Mount Sinai as additional insured on a primary and non-contributory basis.
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Legal Jurisdiction and Venue
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The definitive license agreement shall be construed and enforced in accordance with the laws of the State of New York without regard to any choice or conflict of laws. Any suit to enforce the agreement will be brought in the federal or state courts located in the State of New York.
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Non-Use of Name
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Except as otherwise provided in Article 10 of the Agreement, neither Party, nor its employees and agents will use the other Party’s name, seal, logo, trademark, or service mark, or any adaptation thereof, or the name, mark, or logo of the other Party in any way, except as may be required by applicable law, without the prior written consent of the other Party whose name is to be used. If Mount Sinai uses the Developed Intellectual Property outside the Field of Use, it will give credit as appropriate regarding LifeMap’s involvement in the creation of such Developed Intellectual Property.
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Assignment
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LifeMap may assign the definitive license agreement or substantially all of the license agreement, either directly or by merger or operation of law, without the prior written consent of Mount Sinai, as long as: (a) at least [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] days before the proposed transaction, LifeMap gives Mount Sinai written notice and such background information as may be reasonably necessary to enable Mount Sinai to give an informed consent; (b) the assignee agrees in writing to be legally bound by this Agreement; and (c) the assignee agrees to deliver to Mount Sinai an updated business development plan within [*Certain information has been omitted under a request for confidential treatment, and the omitted information has been filed with the Commission] days after the closing of the proposed transaction. Any permitted assignment will not relieve LifeMap of responsibility for performance of any obligation of LifeMap that has accrued at the time of the assignment. Any prohibited assignment will be null and void. Notwithstanding the foregoing, LifeMap shall be permitted to assign the definitive license agreement to LifeMap Sciences to the extent LifeMap and LifeMap Sciences will have fulfilled the obligations outlined under (a) and (b) above.
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Global Social Responsibility
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LifeMap and Mount Sinai shall take into consideration the principle of “Global Social Responsibility” when executing the full license agreement. “Global Social Responsibility” means facilitating the availability of Licensed Products in Developing Countries (i.e., The World Bank’s listing of “Low Income Economies”) at locally affordable prices to improve access to such Licensed Products or Licensed Services in Developing Countries.
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Additional Terms
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Additional terms to be negotiated in good faith include, without limitation, termination, payment/interest, infringement obligations, confidentiality obligations, and miscellaneous legal provisions (independent contractor language, legal compliance, waivers, notices, severability, dispute resolution, etc.).
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| X (a) | Purchaser 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 Purchaser’s principal residence and excluding mortgage debt secured by Purchaser’s principal residence up to the estimated fair market value of the home, except that any mortgage debt incurred by you within 60 days prior to the date of this Agreement shall not be excluded from the determination of your net worth unless such mortgage debt was incurred to acquire the residence). |
| X (b) | Purchaser 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. |
| X (c) | Purchaser 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) | Purchaser is an executive officer of the Company. |
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(a)
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Address: ___________________________________________________
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(b)
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email: ______________________________________________________
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(c)
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Telephone: (______)___________________________________________
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(d)
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Social Security Number: ________________________________________
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(e)
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State of Residence_____________________________________________
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Dated: June 12, 2014
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s/Pedro Lichtinger
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Pedro Lichtinger
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Dated: June 12, 2014
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ASTERIAS BIOTHERAPEUTICS, INC.
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By:
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R.W. Peabody
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Title:
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Chief Financial Officer
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Name:
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Broadwood Partners, L.P.
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Address:
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c/o Broadwood Capital, Inc.
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724 Fifth Avenue, 9th Floor, New York, NY 10019
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email:
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Social Security or U.S. Taxpayer Identification Number:
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State of Residence or Principal Place of Business:
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Delaware
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Country of Residence if other than United States:
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Information from Corporations, Partnerships, Limited Liability Companies, Trusts, or Other Entity Investors:
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Date of Formation:
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1/1/89
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Name and title of person authorized to bind the entity:
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Neal C. Bradsher, President of the General Partner
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Broadwood Partners, L.P.
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By:
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Broadwood Capital, Inc.
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General Partner
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By:
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s/Neal C. Bradsher
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Title:
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President
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Dated: June 13, 2014
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ASTERIAS BIOTHERAPEUTICS, INC.
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By:
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s/Pedro Lichtinger
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Title:
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President and CEO
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Name:
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The George Karfunkel 2007 Grantor Trust #1
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Address:
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1671 52 Street
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Brooklyn, NY 11204
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email:
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Social Security or U.S. Taxpayer Identification Number:
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State of Residence or Principal Place of Business:
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NY
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Country of Residence if other than United States:
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Information from Corporations, Partnerships, Limited Liability Companies, Trusts, or Other Entity Investors:
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Date of Formation:
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8-14-2007
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Name and title of person authorized to bind the entity:
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Jay J. Miller, Esq.
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Dated: June 12, 2014
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s/Jay J. Miller
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Jay J. Miller, Trustee of the
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George Karfunkel 2007 Grantor Trust #1
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Dated: June 13, 2014
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ASTERIAS BIOTHERAPEUTICS, INC.
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By:
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s/Pedro Lichtinger
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Title:
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President and CEO
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1.
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Definitions and Interpretations.
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2.
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General; Securities Subject to this Agreement
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3.
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Registration Procedures
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4.
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Indemnification; Contribution
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5.
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Reports Under Exchange Act
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6.
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Miscellaneous
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Asterias Biotherapeutics, Inc.
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230 Constitution Drive
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Menlo Park, California 95402
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Attention: Robert Peabody, Chief Financial Officer
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rpeabody@biotimemail.com
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with a copy to:
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235 Pine Street, 13th Floor
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San Francisco, California 94104
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Attention: Richard S. Soroko
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By:
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s/Pedro Lichtinger
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Pedro Lichtinger
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Title: President and Chief Executive Officer
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SHAREHOLDERS:
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s/Jay J. Miller
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Jay J. Miller, Trustee of the
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George Karfunkel 2007 Grantor Trust #1
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Broadwood Partners, L.P.
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By:
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Broadwood Capital, Inc.
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General Partner
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By:
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s/Neal C. Bradsher
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Neal C. Bradsher
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Title: President
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Yours sincerely,
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Name:
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Title:
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1.
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Engagement; Position and Duties.
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2.
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Compensation
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4.
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Inventions/Intellectual Property/Confidential Information
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EXECUTIVE:
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s/Pedro Lichtinger
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Pedro Lichtinger
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Address:
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322 W.57th Street, Apt 35B
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New York, NY 10019
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ASTERIAS:
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Asterias Biotherapeutics, Inc.
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By:
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s/Alfred D. Kingsley
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Title:
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Chairman
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Address:
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230 Constitution Drive
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Menlo Park, California 94025
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1.
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Purpose and Eligibility
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2.
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Administration
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3.
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Stock Available for Awards
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4.
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Stock Options
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5.
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Restricted Stock
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6.
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Other Stock-Based Awards
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7.
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General Provisions Applicable to Awards
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8.
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Miscellaneous
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COMPANY:
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LifeMap Solutions, Inc.
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By
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Title
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By
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Title
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EMPLOYEE:
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(Signature)
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(Please Print Name)
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COMPANY:
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LifeMap Solutions, Inc.
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By
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Title
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By
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Title
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OPTIONEE:
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(Signature)
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(Please Print Name)
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| 1. | I have reviewed this quarterly report on Form 10-Q of BioTime, Inc. |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rule 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which 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. |
| 5. | The registrant's other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of registrant's board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting. |
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Date: August 11, 2014
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/s/ Michael D. West
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Michael D. West
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Chief Executive Officer
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| 1. | I have reviewed this quarterly report on Form 10-Q of BioTime, Inc. |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rule 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which 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. |
| 5. | The registrant's other certifying officers and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of registrant's board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting. |
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Date: August 11, 2014
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/s/ Robert W. Peabody
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Robert W. Peabody
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Chief Financial Officer
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| 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. |
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Date: August 11, 2014
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/s/ Michael D. West
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Michael D. West
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Chief Executive Officer
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/s/ Robert W. Peabody
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Robert W. Peabody
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Chief Financial Officer
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