form10q_06302008.htm
FORM
10-Q
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
(Mark
One)
[X] QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the
quarterly period ended June 30, 2008
OR
[ ] TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the
transition period from _ to
Commission
file number 1-12830
BioTime,
Inc.
(Exact
name of registrant as specified in its charter)
California
|
94-3127919
|
(State
or other jurisdiction of incorporation or organization)
|
(IRS
Employer Identification No.)
|
1301
Harbor Bay Parkway, Suite 100
Alameda,
California 94502
(Address
of principal executive offices)
(510)
521-3390
(Registrant's
telephone number, including area code)
6121
Hollis Street
Emeryville,
California 94608
(Former
address, changed since last report)
Indicate by check mark whether the
registrant (1) has filed all reports required to be filed by Section 13 or 15(d)
of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and
(2) has been subject to such filing requirements for the past 90
days.
:Yes 9
No
Indicate by check mark whether the
registrant is a large accelerated filer, an accelerated filer, a non-accelerated
filer, or a smaller reporting company. See the definitions of “large
accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule
12b-2 of the Exchange Act).
Large accelerated filer 9 Accelerated filer 9
Non-accelerated filer 9
(Do not check if a smaller
reporting company) Smaller reporting company :
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
9Yes :No
APPLICABLE
ONLY TO CORPORATE ISSUERS:
Indicate the number of shares
outstanding of each of the issuer's classes of common stock, as of the latest
practicable date. 23,694,374 common shares, no par value, as of June
30, 2008.
PART
1--FINANCIAL INFORMATION
Statements made in this Report that are
not historical facts may constitute forward-looking statements that are subject
to risks and uncertainties that could cause actual results to differ materially
from those discussed. Such risks and uncertainties include but are
not limited to those discussed in this report under Item 1 of the Notes to
Financial Statements, and in BioTime's Annual Report on Form 10-K filed with the
Securities and Exchange Commission. Words such as “expects,” “may,” “will,”
“anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” and similar
expressions identify forward-looking statements.
Item
1. Financial Statements
BIOTIME,
INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
ASSETS
|
|
June
30,
2008
(unaudited)
|
|
|
December
31, 2007
|
|
CURRENT
ASSETS:
|
|
|
|
|
|
|
Cash
and cash equivalents
|
|
$ |
172,461 |
|
|
$ |
9,501 |
|
Accounts
receivable
|
|
|
4,095 |
|
|
|
3,502 |
|
Prepaid
expenses and other current assets
|
|
|
150,626 |
|
|
|
128,643 |
|
Total
current assets
|
|
|
327,182 |
|
|
|
141,646 |
|
|
|
|
|
|
|
|
|
|
Equipment,
net of accumulated depreciation of $588,318 and $585,765,
respectively
|
|
|
11,316 |
|
|
|
12,480 |
|
Advance
license fee and others
|
|
|
270,976 |
|
|
|
20,976 |
|
TOTAL
ASSETS
|
|
$ |
609,474 |
|
|
$ |
175,102 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND SHAREHOLDERS' DEFICIT
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
|
|
|
|
Accounts
payable and accrued liabilities
|
|
$ |
623,065 |
|
|
$ |
480,374 |
|
Lines
of credit payable
|
|
|
1,924,156 |
|
|
|
716,537 |
|
Deferred
license revenue, current portion
|
|
|
293,070 |
|
|
|
261,091 |
|
Total
current liabilities
|
|
|
2,840,291 |
|
|
|
1,458,002 |
|
|
|
|
|
|
|
|
|
|
LONG-TERM
LIABILITIES:
|
|
|
|
|
|
|
|
|
Stock
appreciation rights compensation liability
|
|
|
52,603 |
|
|
|
13,151 |
|
Deferred
license revenue, net of current portion
|
|
|
1,630,122 |
|
|
|
1,740,702 |
|
Other
liabilities
|
|
|
7,347 |
|
|
|
9,636 |
|
Total
long-term liabilities
|
|
|
1,690,072 |
|
|
|
1,763,489 |
|
|
|
|
|
|
|
|
|
|
COMMITMENTS
AND CONTINGENCIES
|
|
|
|
|
|
|
|
|
SHAREHOLDERS'
DEFICIT:
|
|
|
|
|
|
|
|
|
Common
shares, no par value, authorized 50,000,000 shares; issued and outstanding
23,694,374 and 23,034,374 shares at June 30, 2008 and December 31, 2007,
respectively
|
|
|
40,968,465 |
|
|
|
40,704,136 |
|
Contributed
capital
|
|
|
93,972 |
|
|
|
93,972 |
|
Accumulated
deficit
|
|
|
(44,983,326 |
) |
|
|
(43,844,497 |
) |
Total
shareholders' deficit
|
|
|
(3,920,889 |
) |
|
|
(3,046,389 |
) |
TOTAL
LIABILITIES AND SHAREHOLDERS' DEFICIT
|
|
$ |
609,474 |
|
|
$ |
175,102 |
|
See
accompanying notes to the condensed consolidated financial
statements.
BIOTIME,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
|
|
Three
Months Ended
|
|
|
Six
Months Ended
|
|
|
|
June
30, 2008
|
|
|
June
30, 2007
|
|
|
June
30, 2008
|
|
|
June
30, 2007
|
|
REVENUES:
|
|
|
|
|
|
|
|
|
|
|
|
|
License
fees
|
|
$ |
67,725 |
|
|
$ |
47,065 |
|
|
$ |
133,908 |
|
|
$ |
93,499 |
|
Royalties
from product sales
|
|
|
341,153 |
|
|
|
163,676 |
|
|
|
650,053 |
|
|
|
362,940 |
|
Other
revenue
|
|
|
1,685 |
|
|
|
— |
|
|
|
7,620 |
|
|
|
— |
|
Total
revenues
|
|
|
410,563 |
|
|
|
210,741 |
|
|
|
791,581 |
|
|
|
456,439 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
EXPENSES:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
|
(416,978 |
) |
|
|
(210,767 |
) |
|
|
(764,129 |
) |
|
|
(554,317 |
) |
General
and administrative
|
|
|
(532,358 |
) |
|
|
(293,772 |
) |
|
|
(968,297 |
) |
|
|
(711,552 |
) |
Total
expenses
|
|
|
(949,336 |
) |
|
|
(504,539 |
) |
|
|
(1,732,426 |
) |
|
|
(1,265,869 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from operations
|
|
|
(538,773 |
) |
|
|
(293,798 |
) |
|
|
(940,845 |
) |
|
|
(809,430 |
) |
Interest
expenses and other income
|
|
|
(124,007 |
) |
|
|
(50,279 |
) |
|
|
(197,983 |
) |
|
|
(88,509 |
) |
Net
Loss
|
|
$ |
(662,780 |
) |
|
$ |
(344,077 |
) |
|
$ |
(1,138,828 |
) |
|
$ |
(897,939 |
) |
Loss
per common share – basic and diluted
|
|
$ |
(0.03 |
) |
|
$ |
(0.02 |
) |
|
$ |
(0.05 |
) |
|
$ |
(0.04 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average number of common shares outstanding – basic and
diluted
|
|
|
23,694,374 |
|
|
|
22,828,879 |
|
|
|
23,368,660 |
|
|
|
22,788,518 |
|
See
accompanying notes to the condensed consolidated financial
statements.
BIOTIME,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
Six
Months Ended
|
|
|
|
June
30, 2008
|
|
|
June
30, 2007
|
|
CASH
FLOWS FROM OPERATING ACTIVITIES:
|
|
|
|
|
|
|
Net
loss
|
|
$ |
(1,138,828 |
) |
|
$ |
(897,939 |
) |
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
|
|
|
|
|
|
|
|
Depreciation
|
|
|
2,553 |
|
|
|
3,233 |
|
Amortization
of deferred finance cost on lines of credit
|
|
|
128,220 |
|
|
|
11,997 |
|
Interest
on royalty obligation
|
|
|
– |
|
|
|
83,437 |
|
Interest
on lines of credit
|
|
|
21,895 |
|
|
|
6,370 |
|
Common
stock issued for services
|
|
|
43,500 |
|
|
|
– |
|
Stock-based
compensation
|
|
|
107,080 |
|
|
|
68,319 |
|
Changes
in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
Accounts
receivable
|
|
|
(593 |
) |
|
|
1,262 |
|
Prepaid
expenses and other current assets
|
|
|
890 |
|
|
|
1,371 |
|
Accounts
payable and accrued liabilities
|
|
|
133,491 |
|
|
|
59,774 |
|
Deferred
license revenue
|
|
|
(78,601 |
) |
|
|
(71,498 |
) |
Deferred
rent
|
|
|
6,911 |
|
|
|
1,678 |
|
Net
cash used in operating activities
|
|
|
(773,482 |
) |
|
|
(731,996 |
) |
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Payments
of royalty fees
|
|
|
(250,000 |
) |
|
|
– |
|
Purchase
of equipment
|
|
|
(1,389 |
) |
|
|
(1,779 |
) |
Net
cash used in investing activities
|
|
|
(251,389 |
) |
|
|
(1,779 |
) |
|
|
|
|
|
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Repayments
of line of credit
|
|
|
(12,169 |
) |
|
|
– |
|
Borrowings
under lines of credit
|
|
|
1,200,000 |
|
|
|
300,000 |
|
Net
cash provided by financing activities
|
|
|
1,187,831 |
|
|
|
300,000 |
|
|
|
|
|
|
|
|
|
|
NET
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS:
|
|
|
162,960 |
|
|
|
(433,775 |
) |
Cash
and cash equivalents at beginning of period
|
|
|
9,501 |
|
|
|
561,017 |
|
Cash
and cash equivalents at end of period
|
|
$ |
172,461 |
|
|
$ |
127,242 |
|
Supplemental
disclosure of cash flow statement
|
|
|
|
|
|
|
|
|
Cash
paid for interest
|
|
$ |
55,510 |
|
|
$ |
– |
|
NON-CASH
FINANCING AND INVESTING ACTIVITIES:
|
|
|
|
|
|
|
|
|
Issuance
of stock related to line of credit agreement
|
|
$ |
(153,200 |
) |
|
$ |
– |
|
Issuance
of stock related to outside services
|
|
$ |
(43,500 |
) |
|
$ |
– |
|
See
accompanying notes to the condensed consolidated financial
statements.
BIOTIME,
INC.
NOTES
TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
1. Organization
General - BioTime, Inc.
(“BioTime”) was organized November 30, 1990 as a California corporation. BioTime
is a biomedical organization which is engaged in the research and development of
synthetic plasma expanders, blood volume substitute solutions, and organ
preservation solutions, for use in surgery, trauma care, organ transplant
procedures, and other areas of medicine. In October 2007, BioTime
announced its entry into the field of regenerative medicine by initiating the
development of advanced human stem cell products and technology for diagnostic,
therapeutic and research use. Regenerative medicine refers to
therapies based on human embryonic stem cell technology that are designed to
rebuild cell and tissue function lost due to degenerative disease or
injury. Human embryonic stem cells are the first human cells ever
discovered that are capable of infinite cell division while possessing the
potential to differentiate into all of the cell types of the human body.
Stem cells may also have commercial uses in screening for the discovery of
experimental new drugs.
The
unaudited condensed balance sheet as of June 30, 2008, the unaudited condensed
statements of operations for the three and six months ended June 30, 2008 and
2007, and the unaudited condensed statements of cash flows for the six months
ended June 30, 2008 and 2007 have been prepared by BioTime’s management in
accordance with the instructions from the Form 10-Q and Article 8-03 of
Regulation S-X. In the opinion of management, all adjustments
(consisting only of normal recurring adjustments) necessary to present fairly
the financial position, results of operations, and cash flows at June 30, 2008
and for all interim periods presented have been made. The balance
sheet as of December 31, 2007 is derived from the Company's audited financial
statements as of that date. The results of operations for the three
and six months ended June 30, 2008 and 2007 are not necessarily indicative of
the operating results anticipated for the full year.
Certain
information and footnote disclosures normally included in financial statements
prepared in accordance with generally accepted accounting principles have been
condensed or omitted as permitted by regulations of the Securities and Exchange
Commission except for the condensed consolidated balance sheet as of December
31, 2007, which was derived from audited financial
statements. Certain previously furnished amounts have been
reclassified to conform with presentations made during the current
periods. It is suggested that these condensed consolidated financial
statements be read in conjunction with the annual audited financial statements
and notes thereto included in BioTime's Form 10-KSB for the year ended December
31, 2007.
Principles of Consolidation –
The accompanying condensed consolidated financial statements include the
accounts of Embryome Sciences, Inc. (“Embryome Sciences”), a wholly-owned
subsidiary of BioTime. As of June 30, 2008, there was only one
significant transaction with respect to this subsidiary: a Product Production
and Distribution Agreement was executed with Lifeline Cell Technology, LLC, for
the production and marketing of embryonic progenitor cells or progenitor cell
lines, and products derived from those embryonic progenitor
cells. See
Note 4 to
the condensed consolidated financial statements. All intercompany
accounts and transactions have been eliminated in consolidation.
Certain Significant Risks and
Uncertainties - BioTime’s operations are subject to a number of factors
that can affect its operating results and financial condition. Such factors
include but are not limited to the following: the results of clinical trials of
BioTime’s pharmaceutical products; BioTime’s ability to obtain United States
Food and Drug Administration and foreign regulatory approval to market its
pharmaceutical products; BioTime’s ability to develop new stem cell research
products and technologies; competition from products manufactured and sold or
being developed by other companies; the price and demand for BioTime products;
BioTime’s ability to obtain additional financing and the terms of any such
financing that may be obtained; BioTime’s ability to negotiate favorable
licensing or other manufacturing and marketing agreements for its products; the
availability of ingredients used in BioTime’s products; and the availability of
reimbursement for the cost of BioTime’s pharmaceutical products (and related
treatment) from government health administration authorities, private health
coverage insurers and other organizations.
Liquidity and Going Concern -
The accompanying unaudited condensed financial statements have been prepared
assuming BioTime will continue as a going concern. At June 30, 2008,
BioTime had $172,461 of cash on hand and negative working capital of $2,513,109,
a shareholders’ deficit of $3,920,889 and an accumulated deficit of
$44,983,326. BioTime will continue to need additional capital and
greater revenues to continue its current operations and to continue to conduct
its product development and research programs. Sales of additional equity
securities could result in the dilution of the interests of present
shareholders. BioTime is also continuing to seek new agreements with
pharmaceutical companies to provide product and technology licensing fees and
royalties. The availability and terms of equity financing and new
license agreements are uncertain. The unavailability or inadequacy of
additional financing or future revenues to meet capital needs could force
BioTime to modify, curtail, delay or suspend some or all aspects of its planned
operations. To mitigate these factors, management has instituted a
cost-cutting plan which included a reduction in discretionary general and
administrative expenses such as public relations. Additionally, in
October 2007 and again in March 2008, BioTime’s line of credit for working
capital was increased and the maturity date was extended (see Note
3). BioTime will continue to seek additional financing or capital as
well as additional licensing revenues from its current and future
patents. In view of the matters described above, BioTime’s continued
operations are dependent on its ability to raise additional capital, obtain
additional financing, reduce its operating costs, and succeed in generating more
revenue from its operations. The condensed consolidated financial
statements do not include any adjustments relating to the recoverability and
classification of recorded asset amounts and classification of liabilities
should BioTime be unable to continue as a going concern.
2. Summary
of Select Significant Accounting Policies
Financial Statement Estimates
- - The preparation of unaudited condensed consolidated financial statements in
conformity with accounting principles generally accepted in the United States of
America requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets
and liabilities at the date of the unaudited condensed consolidated financial
statements and the reported amounts of
revenues
and expenses during the reporting period. Actual results could differ
from those estimates.
Revenue Recognition – BioTime
complies with the Securities and Exchange Commission’s (“SEC”) Staff Accounting
Bulletin (“SAB”) No. 101, Revenue Recognition, as amended by SAB No. 104.
Royalty and license fee revenues consist of product royalty payments and fees
under license agreements and are recognized when earned and reasonably
estimable. BioTime recognizes revenue in the quarter in which the
royalty report is received rather than the quarter in which the sales took
place, as it does not have sufficient sales history to accurately predict
quarterly sales. Up-front nonrefundable fees where BioTime has no
continuing performance obligations are recognized as revenues when collection is
reasonably assured. In situations where continuing performance
obligations exist, up-front nonrefundable fees are deferred and amortized
ratably over the performance period. If the performance period cannot
be reasonably estimated, BioTime amortizes nonrefundable fees over the life of
the contract until such time that the performance period can be more reasonably
estimated. Milestones, if any, related to scientific or technical
achievements are recognized in income when the milestone is accomplished if (a)
substantive effort was required to achieve the milestone, (b) the amount of the
milestone payment appears reasonably commensurate with the effort expended and
(c) collection of the payment is reasonably assured.
BioTime
also defers costs, including finders’ fees, which are directly related to
license agreements for which revenue has been deferred. Deferred
costs are charged to expense proportionally and over the same period that
related deferred revenue is recognized as revenue. Deferred costs are
net against deferred revenues in BioTime’s balance sheet.
Grant
income is recognized as revenue when earned.
Recently Adopted Accounting Pronouncements – On December
21, 2007, the SEC issued SAB No. 110, which amends SAB No. 107 to allow for the
continued use of the simplified method to estimate the expected term in valuing
stock options beyond December 31, 2007. The simplified method can
only be applied to certain types of stock options for which sufficient exercise
history is not available. The Company has concluded that its
historical share option exercise experience does not provide a reasonable basis
upon which to estimate the expected term due to the significant structural
changes in its business. Therefore, the Company will continue to use the
"simplified" method in developing its estimate of the expected term of "plain
vanilla" share options.
In
September 2006, the FASB issued FASB Statement No. 157, Fair Value Measurements
(“SFAS No. 157”), which defines fair value, establishes a framework for
measuring fair value under GAAP, and expands disclosures about fair value
measurements. SFAS No. 157 applies to other accounting pronouncements
that require or permit fair value measurements. The new guidance is
effective for financial statements issued for fiscal years beginning after
November 15, 2007, and for interim periods within those fiscal
years. The Company adopted SFAS No. 157 during the quarter ended
March 31, 2008 which had no impact on its condensed balance sheets, condensed
statement of operations, condensed statement of stockholders' equity and cash
flows.
In
February 2007, the FASB issued SFAS No. 159, “The Fair Value Option for
Financial Assets and Financial Liabilities.” SFAS No. 159 permits entities
to choose to measure many financial instruments, and certain other items, at
fair value. SFAS No. 159 was effective January 1, 2008. The adoption of
SFAS No. 159 did not have an impact on the consolidated financial statements
since the Company did not elect the fair value option for any of its existing
assets or liabilities.
Recently Issued Accounting
Pronouncements –
In May 2008, the Financial Accounting Standards Board ("FASB") issued FASB Staff
Position ("FSP") Emerging Issues Task Force ("EITF") No. 03-6-1, "Determining
Whether Instruments Granted in Share-Based Payment Transactions Are
Participating Securities" ("EITF 03-6-1"). EITF 03-6-1 addresses whether
instruments granted in share-based payment transactions, with rights to
dividends or dividend equivalents, are participating securities prior to vesting
and, therefore, need to be included in the earnings allocation in computing
earnings per share ("EPS") under the two-class method described in FASB
Statement No. 128, "Earnings per Share." Unvested share-based payment awards
that contain nonforfeitable rights to dividends or dividend equivalents (whether
paid or unpaid) are participating securities and shall be included in the
computation of EPS pursuant to the two-class method. In contrast, the right to
receive dividends or dividend equivalents that the holder will forfeit if the
award does not vest does not constitute a participation right. EITF 03-6-1 is
effective for financial statements issued for fiscal years beginning after
December 15, 2008, and interim periods within those fiscal years. All
prior-period EPS data presented shall be adjusted retrospectively (including
interim financial statements, summaries of earnings, and selected financial
data). Early adoption of EITF 03-6-1 is prohibited. The Company will adopt EITF
03-6-1 as of January 1, 2009, and does not currently believe that the adoption
will have a material impact on its consolidated financial
statements.
In
December 2007, the FASB issued SFAS No. 141R (revised 2007), “Business Combinations” (“SFAS
No. 141R”), which replaces SFAS No. 141. SFAS No. 141R establishes
the principles and requirements for how an acquirer: (i) recognizes and measures
in its financial statements the identifiable assets acquired, the liabilities
assumed, and any non-controlling interest in the acquiree; (ii) recognizes and
measures the goodwill acquired in the business combination or a gain from a
bargain purchase; and (iii) determines what information to disclose to enable
users of the financial statements to evaluate the nature and financial effects
of the business combination. Additionally, SFAS No. 141R requires
that acquisition-related costs be expensed as incurred. The
provisions of SFAS No. 141R will become effective for acquisitions completed on
or after January 1, 2009; however, the income tax provisions of SFAS No. 141R
will become effective as of that date for all acquisitions, regardless of the
acquisition date. SFAS No. 141R amends SFAS No. 109, to require the acquirer to
recognize changes in the amount of its deferred tax benefits recognizable due to
a business combination either in income from continuing operations in the period
of the combination or directly in contributed capital, depending on the
circumstances. SFAS No. 141R further amends SFAS No. 109 and FIN 48,
to require, subsequent to a prescribed measurement period, changes to
acquisition-date income tax uncertainties to be reported in income from
continuing operations and changes to acquisition-date acquiree deferred tax
benefits to be reported in income from continuing operations or directly in
contributed capital, depending on the circumstances. BioTime is
currently evaluating the impact SFAS No. 141R will have on its future business
combinations.
In
December 2007, the FASB issued SFAS No. 160, “Non-controlling Interests in
Consolidated Financial Statements—An Amendment of ARB No. 51” (“SFAS No.
160”). SFAS No. 160 establishes new accounting and reporting
standards for the non-controlling interest in a subsidiary and for the
deconsolidation of a subsidiary. SFAS No. 160 is effective for fiscal
years beginning on or after December 15, 2008. BioTime does not
believe the adoption of this statement will have a material effect on its
financial position, results of operations, and cash flows.
In March
2008, the FASB issued SFAS No. 161, “Disclosures about Derivative
Instruments and Hedging Activities—An Amendment of FASB Statement No. 133”
(“SFAS No. 161”). SFAS No. 161 applies to all derivative
instruments and related hedged items accounted for under FASB Statement No. 133,
Accounting for Derivative
Instruments and Hedging Activities. It requires entities to
provide greater transparency about (a) how and why an entity uses derivative
instruments, (b) how derivative instruments and related hedged items are
accounted for under Statement No. 133 and its related interpretations, and (c)
how derivative instruments and related hedged items affect an entity’s financial
position, results of operations, and cash flows. SFAS No. 161 is
effective for fiscal years and interim periods beginning after November 15,
2008. BioTime does not believe the adoption of this statement will
have a material effect on the results of operations or financial
condition.
Business Segments - The Company operates in
one segment and therefore segment information is not presented.
BioTime
has a revolving line of credit Agreement (the “Credit Agreement”) with certain
private lenders. In 2008, the Credit Agreement was amended
twice. In the first amendment, the line of credit was increased from
$1,000,000 to $1,100,000, and BioTime agreed to issue to the new lender 10,000
common shares in return for making the additional credit available; the market
value for those shares was $3,200 on the date of issue, and that cost was fully
amortized over the life of the Credit Agreement. The Credit Agreement
was subsequently amended to permit BioTime to borrow up to a total of
$2,500,000, and the maturity date of revolving line of credit was extended to
November 15, 2008. The loans may become payable prior to the maturity date if
BioTime receives an aggregate of $4,000,000 through (A) the sale of capital
stock, (B) the collection of license fees, signing fees, milestone fees, or
similar fees (excluding royalties) in excess of $2,500,000 under any present or
future agreement pursuant to which BioTime grants one or more licenses to use
its patents or technology, (C) funds borrowed from other lenders, or (D) any
combination of sources under clauses (A) through (C).
In
consideration for making the additional credit available and for extending the
maturity date of outstanding loans, BioTime agreed to issue the lenders one
common share for each $5 principal amount of their loan
commitment. In total, 500,000 shares were issuable on March 31, 2008;
those shares had a market value of $150,000 on that date, and the cost is being
amortized over the life of the Credit Agreement. Unamortized cost of
$90,000 is included in prepaid expenses and other current assets as of June 30,
2008.
The
lenders have been given the right to exchange their line of credit promissory
notes for BioTime’s common shares at a price of $1.00 per share, and/or for
common stock of BioTime’s subsidiary, Embryome Sciences, Inc., at a price of
$2.00 per share.
At June
30, 2008, BioTime had drawn $1,825,000 under the Credit Agreement.
BioTime
also obtained a line of credit from American Express in August 2004, which
allows for borrowings up to $43,600; at June 30, 2008, BioTime had drawn $25,629
against this line. Interest is paid monthly on borrowings at a total rate equal
to the prime rate plus 3.99%; however, regardless of the prime rate, the
interest rate payable will at no time be less than 9.49%.
BioTime
also secured a line of credit from Advanta in November 2006, which allows for
borrowings up to $35,000; at June 30, 2008, BioTime had drawn $32,138 against
this line. Interest is payable on borrowings at a Variable Rate
Index, which will at no time be less than 8.25%.
The Company has accrued interest of
$41,389 as of June 30, 2008.
4.
License and Collaboration Agreements
In December 2004, BioTime entered into
an agreement with Summit Pharmaceuticals International Corporation (“Summit”) to
co-develop Hextend and PentaLyte for the Japanese market. Under the
agreement, BioTime received $300,000 in December 2004, $450,000 in April 2005,
and $150,000 in October 2005. The payments represent a partial
reimbursement of BioTime’s development cost of Hextend and
PentaLyte. In June 2005, following BioTime’s approval of Summit’s
business plan for Hextend, BioTime paid to Summit a one-time fee of $130,000 for
their services in preparing the plan. The agreement states that
revenues from Hextend and PentaLyte in Japan will be shared between BioTime and
Summit as follows: BioTime 40% and Summit 60%. Additionally, BioTime
will pay Summit 8% of all net royalties received from the sale of PentaLyte in
the United States.
The accounting treatment of the
payments from Summit fell under the guidance of Emerging Issues Task Force
(“EITF”) Issue No. 88-18, “Sales of Future Revenues.” EITF No. 88-18
addresses the accounting treatment when an enterprise (BioTime) receives cash
from an investor (Summit) and agrees to pay to the investor a specified
percentage or amount of the revenue or a measure of income of a particular
product line, business segment, trademark, patent, or contractual right. The
EITF reached a consensus on six independent factors that would require
reclassification of the proceeds as debt. BioTime met one of the
factors: BioTime was determined to have had significant continuing involvement
in the generation of the cash flows to the investor due to BioTime’s supervision
of the Phase II clinical trials of PentaLyte. As a result, BioTime
initially recorded the net proceeds from Summit to date of $770,000 as long-term
debt to comply with EITF No. 88-18 even though BioTime is not legally indebted
to Summit for that amount.
In July 2005, Summit sublicensed the
rights to Hextend in Japan to Maruishi. In consideration for the
license, Maruishi agreed to pay Summit a series of milestone payments: Yen
70,000,000, (or $593,390 based on foreign currency conversion rates at the time)
upon executing the agreement, Yen 100,000,000 upon regulatory filing in Japan,
and Yen 100,000,000 upon regulatory approval of Hextend in
Japan. Consistent with the terms of the BioTime-Summit agreement,
Summit paid 40% of that amount, or $237,356, to BioTime during October
2005. BioTime does not expect the regulatory filing and approval
milestones to be attained for
several
years.
The initial accounting viewed the
potential repayment of the $770,000 imputed debt to come only from the 8% share
of U.S. PentaLyte revenues generated by BioTime and paid to
Summit. BioTime first became aware of the terms of the Maruishi and
Summit agreement during the fourth quarter of 2005, prepared an estimate of the
future cash flows, and determined that Summit would earn a majority of their
return on investment from their agreement with Maruishi, and not the 8% of
BioTime’s U.S. PentaLyte sales. Considering this, the $770,000 was
viewed as a royalty obligation which would be reduced by Summit’s 8% share of
BioTime’s U.S. PentaLyte sales plus Summit’s 60% share of Japanese
revenue. Accordingly, BioTime recorded the entire amount paid by
Maruishi to Summit for the sublicense of $593,390 as deferred revenue, to be
amortized over the remaining life of the patent through
2019. BioTime’s 40% share of this payment was collected in October
2005 and the remaining 60% share was recorded as a reduction of the long-term
royalty obligation of BioTime to Summit. Interest on the long-term
royalty obligation was accrued monthly using the effective interest method
beginning October 2005, using a rate of 25.2% per annum, which BioTime had
determined was the appropriate interest rate when the future cash flows from the
transaction were considered.
In 2007, BioTime completed its Phase II
trials of PentaLyte, however was unable to find a suitable licensing agreement
for the product. At this time, BioTime has deemed the continuation of
the clinical trials necessary to bring this product to market to be a
significantly lower priority than it had been in the
past. Correspondingly, it is less likely that proceeds from the 8% of
PentaLyte U.S. sales will be sufficient to pay down the Summit Royalty
Obligation prior to the expiration of the patents. As a result of
this change in accounting estimates, BioTime has reevaluated treatment of this
transaction. The transaction no longer meets any of the factors that
require it to fall under the guidance from EITF 88-18. Consequently,
BioTime has reclassified the royalty obligation to deferred revenue and is
amortizing it over the remaining life of the underlying patents.
On January 3, 2008, BioTime
entered into a Commercial License and Option Agreement with Wisconsin Alumni
Research Foundation (“WARF”). The WARF license permits BioTime to use
certain patented and patent pending technology belonging to WARF, as well as
certain stem cell materials, for research and development purposes, and for the
production and marketing of products used as research tools, including in drug
discovery and development.
BioTime
will pay WARF a license fee of $225,000 in two installments. The
first installment, in the amount of $10,000, was paid and charged to operations
during February 2008. The remaining $215,000 is due on the earlier of
(i) thirty (30) days after BioTime raises $5,000,000 or more of new equity
financing, or (ii) January 3, 2009. A maintenance fee of $25,000 will
be due annually on January 3 of each year during the term of the
License.
BioTime
or Embryome Sciences will pay WARF royalties on the sale of products and
services using the technology or stem cells licensed from WARF. The
royalty will range from 2% to 4%, depending on the kind of products
sold. The royalty rate is subject to certain reductions if BioTime
also becomes obligated to pay royalties to a third party in order to sell a
product.
BioTime
will also pay WARF $25,000 toward reimbursement of the costs associated with
preparing, filing and maintaining the licensed WARF patents. That fee
is payable in two installments. The first installment of $5,000 was
paid and charged to operations during February 2008, and the remaining $20,000
is due on the earlier of (i) thirty (30) days after BioTime raises $5,000,000 or
more of new equity financing, or (ii) January 3, 2009.
On June
24, 2008, BioTime, along with its subsidiary, Embryome Sciences, entered into a
Product Production and Distribution Agreement with Lifeline Cell Technology, LLC
for the production and marketing of embryonic progenitor cells or progenitor
cell lines, and products derived from those embryonic progenitor
cells. The products developed under the agreement with Lifeline will
be produced and sold for research purposes, such as drug discovery and drug
development uses.
The
proceeds from the sale of products to certain distributors with which Lifeline
has a pre-existing relationship will be shared equally by Embryome Sciences and
Lifeline, after deducting royalties payable to licensors of the technology used,
and certain production and marketing costs. The proceeds from
products produced for distribution by both Embryome Sciences and Lifeline, and
products produced by one party at the request of the other party, will be shared
in the same manner. Proceeds from the sale of other products, which
are produced for distribution by one party, generally will be shared 90% by the
party that produced the product for distribution, and 10% by the other party
after deducting royalties payable to licensors of technology used. In
the case of the sale of these products, the party that produces the product and
receives 90% of the sales proceeds will bear all of the production and marketing
costs of the product.
The
products will be produced using technology and stem cell lines licensed from
WARF, technology developed by Embryome Sciences, technology developed by
Lifeline, and technology licensed from Advanced Cell Technology,
Inc. WARF and Advanced Cell Technology will receive royalties from
the sale of the products developed using their licensed technology and stem
cells.
BioTime
and Embryome Sciences paid Lifeline $250,000, included in advanced license fee
and others, to facilitate their product production and marketing
efforts. Embryome Sciences will be entitled to recover that amount
from the share of product sale proceeds that otherwise would have been allocated
to Lifeline.
5. Shareholders’
Deficit
During April 1998, BioTime entered into
a financial advisory services agreement with Greenbelt Corp. (“Greenbelt”), a corporation controlled by Alfred D.
Kingsley and Gary K. Duberstein, who are also shareholders of BioTime. BioTime agreed
to indemnify Greenbelt and its officers, affiliates,
employees, agents, assignees, and controlling person from any liabilities
arising out of or in connection with actions taken on BioTime's behalf under the
agreement. The agreement was renewed annually through March 31,
2007. BioTime paid Greenbelt $90,000 in cash and issued 200,000
common shares for the twelve months ending March 31,
2007. Greenbelt permitted BioTime to defer paying
certain cash fees until October 2007. In return for allowing the
deferral, Greenbelt was issued an additional 60,000 common
shares by BioTime.
On March
31, 2008, BioTime entered into an amendment to its financial adviser agreement
with Greenbelt, renewing that agreement through December 31, 2008. Under
the amendment, BioTime will pay Greenbelt a total fee of $135,000 in cash and
will issue a total of 300,000 common shares. BioTime issued 150,000
common shares to Greenbelt on April 1, 2008, and will issue 75,000 common shares
on October 1, 2008, and 75,000 common shares on January 2, 2009. The
cash fee is payable in three equal installments of $45,000 each on July 1, 2008,
October 1, 2008, and January 2, 2009. BioTime may elect to defer
until January 2, 2009 the cash payments due on July 1, 2008 and October 1, 2008,
and if it does so, BioTime will issue to Greenbelt 30,000 additional common
shares for each payment deferred. In accordance with these
provisions, BioTime did elect to defer the July 1, 2008 payment until January 2,
2009, and as such, will issue 30,000 additional common shares to Greenbelt when
that cash payment is made.
The
agreement will terminate on December 31, 2008, unless BioTime or Greenbelt
terminates it on an earlier date. In the event of an early
termination, BioTime will pay Greenbelt a pro rata portion of the cash and
shares earned during the calendar quarter in which the agreement terminated,
based upon the number of days elapsed.
Activity
related to the Greenbelt agreement is presented in the table below:
|
Balance
included in Accounts Payable at January 1,
|
Add:
Cash-based
expense accrued
|
Add:
Stock-based
expense accrued
|
Less:
Cash
payments
|
Less:
Value
of stock-based payments
|
Balance
included in Accounts Payable at June 30,
|
2008
|
$90,000
|
$67,500
|
$43,500
|
$(0)
|
$(43,500)
|
$157,500
|
2007
|
$108,000
|
$22,500
|
$62,500
|
$(0)
|
$(103,000)
|
$90,000
|
6.
Loss Per Share
Basic
loss per share excludes dilution and is computed by dividing net loss by the
weighted average number of common shares outstanding during the
period. Diluted loss per share reflects the potential dilution from
securities and other contracts which are exercisable or convertible into common
shares. For the three and six months ended June 30, 2008 and 2007,
options to purchase 3,653,332 and 1,691,644 common shares, respectively, and
warrants to purchase 7,847,867 common shares in both years were excluded from
the computation of loss per share as their inclusion would be
antidilutive. As a result, there is no difference between basic and
diluted calculations of loss per share for all periods presented.
7.
Subsequent Events
BioTime received royalties in the
amount of $341,391 from Hospira in August 2008 and in the amount of $24,143 from
CJ CheilJedang Corp. in July 2008. These amounts are based on sales
of Hextend made by Hospira in the second quarter of 2008, and will be reflected
in BioTime’s consolidated financial statements for the third quarter of
2008.
On July
10, 2008, BioTime’s subsidiary Embryome Sciences entered into a
License
Agreement
with Advanced Cell Technology, Inc. (“ACT”) under which Embryome Sciences
acquired exclusive world-wide rights to use ACT’s “ACTCellerate” technology for
methods to accelerate the isolation of novel cell strains from pluripotent stem
cells. The licensed rights include pending patent applications,
know-how, and existing cells and cell lines developed using the
technology.
Embryome
Sciences has paid ACT a $250,000 license fee and will pay an 8% royalty on sales
of products, services, and processes that utilize the licensed
technology. Once a total of $1,000,000 of royalties has been paid, no
further royalties will be due.
ACT
may reacquire royalty free, world wide licenses to use the technology for
retinal pigment epithelial cells, hemangioblasts, and myocardial cells, on an
exclusive basis, and for hepatocytes, on a non-exclusive basis, for human
therapeutic use. ACT will pay Embryome Sciences $5,000 for each
license that it elects to reacquire.
Embryome
Sciences has also now begun marketing cell growth media called ESpanTM
in collaboration with Lifeline Cell Technology, LLC. These growth
media are designed for the growth of human embryonic progenitor
cells. In addition, Embryome Sciences is developing a product called
ESpyTM
cell lines, which will be derivatives of hES cells that send beacons of light in
response to the activation of particular genes. The ESpy™ cell lines
will be developed in conjunction with Lifeline using the ACTCellerate technology
licensed from ACT and other technology sublicensed from Lifeline.
Also on
July 10, 2008, BioTime sent out new draw requests totaling $225,000 under its
current Credit Agreement. At the date of filing of this report, BioTime has
received all funds so requested.
On July
31, 2008, BioTime’s Board of Directors elected Dr. Robert N. Butler as a
director. Dr. Butler is the President and CEO of the U.S. branch of the
International Longevity Center (ILC), a policy research and education center. He
is also a Professor of Geriatrics at Mount Sinai Medical Center and Co-Chair of
the Alliance for Health and the Future of the International Longevity Center,
which focuses on Europe. He is a physician, gerontologist, psychiatrist, and
Pulitzer-Prize winning author who is perhaps best known for his advocacy of the
medical and social needs and rights of the elderly and his research on healthy
aging and the dementias.
In
consideration of Dr. Butler joining BioTime’s Board of Directors, the company
granted him options to purchase 25,000 common shares under its 2002 Stock Option
Plan, as amended, at an exercise price of $ 0.68, which was the closing price of
the common shares on the OTC Bulletin Board on the date of grant. The option
grant is subject to shareholder approval of an amendment increasing the number
of shares available under the Option Plan. The options granted are presently
exercisable with respect to 15,000 shares, and will vest and thereby become
exercisable for the remaining 10,000 shares in equal monthly installments on the
last day of each calendar month, through December 2008, for which Dr. Butler
completes a month of service on the Board of Directors.
Item
2. Management's Discussion and Analysis of Financial Condition and
Results of Operations.
MANAGEMENT'S
DISCUSSION AND ANALYSIS OF
FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
Overview
Since our
inception in November 1990, we have been engaged primarily in research and
development activities, which have culminated in the commercial launch of
Hextend®,
our lead product, and a clinical trial of PentaLyte®. Our
operating revenues have been generated primarily from licensing fees and from
royalties on the sale of Hextend. During October 2007, we entered the
field of regenerative medicine where we plan to develop stem cell related
products and technology for diagnostic, therapeutic and research
use. Our ability to generate substantial operating revenue depends
upon our success in developing and marketing or licensing our plasma volume
expanders, stem cell products, and organ preservation solutions and technology
for medical and research use.
Plasma
Volume Expander Products
Our
principle product, Hextend, is a physiologically balanced blood plasma volume
expander, for the treatment of hypovolemia. Hextend is being
distributed in the United States by Hospira, Inc. and in South Korea by CJ
CheilJedang Corp. (“CJ”) under exclusive licenses from us. Summit
Pharmaceuticals International Corporation (“Summit”) has a license to develop
Hextend and PentaLyte in Japan, the People’s Republic of China, and
Taiwan. Summit has entered into sublicenses with Maruishi
Pharmaceutical Co., Ltd. (“Maruishi”) to obtain regulatory approval,
manufacture, and market Hextend in Japan, and Hextend and PentaLyte in China and
Taiwan.
Hextend
has become the standard plasma volume expander at a number of prominent teaching
hospitals and leading medical centers and is part of the Tactical Combat
Casualty Care protocol. We believe that as Hextend use proliferates
within the leading U.S. hospitals, other smaller hospitals will follow their
lead, contributing to sales growth.
Under our
license agreements, Hospira and CJ will report sales of Hextend and pay us the
royalties and license fees due on account of such sales after the end of each
calendar quarter. We recognize such revenues in the quarter in which
the sales report is received, rather than the quarter in which the sales took
place.
Our
royalty revenues for the three months ended June 30, 2008 consist of royalties
on sales of Hextend made by Hospira and CJ during the period beginning January
1, 2008 and ending March 31, 2008. Royalty revenues recognized for
that three-month period were $341,153, a 108% increase from the $163,676 of
royalty revenue during the same period last year. The increase in
royalties reflects an increase in sales both to hospitals and to the United
States Armed Forces. Purchases by the Armed Forces generally take the
form of intermittent, large volume orders, and cannot be predicted with
certainty.
We received royalties of $341,391 from Hospira during August 2008, based on
Hextend sales during the three months ended June 30, 2008. This
represents an 86% increase from royalty revenues of $183,093 received
during the same period last year. The increase in royalties is due to
increased sales to the United States Armed Forces. This revenue will
be reflected in our financial statements for the third quarter of
2008.
We have
completed a Phase II clinical trial of PentaLyte in which PentaLyte was used to
treat hypovolemia in cardiac surgery. Our ability to commence and
complete additional clinical studies of PentaLyte depends on our cash resources
and the costs involved, which are not presently determinable as we do not know
yet the actual scope or cost of the clinical trials that the FDA will require
for PentaLyte.
Stem
Cells and Products for Regenerative Medicine Research
We are
conducting our stem cell business through our new, wholly-owned subsidiary,
Embryome Sciences, Inc. (“Embryome Sciences”). We plan to focus our
initial efforts in the regenerative medicine field on the development and sale
of advanced human stem cell products and technology for diagnostic, therapeutic
and research use. Regenerative medicine refers to therapies based on
human embryonic stem (“hES”) cell technology that are designed to rebuild cell
and tissue function lost due to degenerative disease or injury. Our
initial marketing efforts will be directed to researchers at universities and
other institutions, to companies in the bioscience and biopharmaceutical
industries, and to other companies that provide research products to companies
in those industries.
Embryome Sciences has already
introduced its first stem cell research products, and is implementing plans to
develop additional research products over the next two years. Our
first products include a relational database, available at our website
embryome.com, that will permit researchers to chart the cell lineages of human
development, the genes expressed in those cell types, and antigens present on
the cell surface of those cells that can be used in
purification. This database will provide the first detailed map of
the embryome, thereby aiding researchers in navigating the complexities of human
development and in identifying the many hundreds of cell types coming from
embryonic stem cells.
Embryome Sciences is also now marketing
cell growth media called ESpanTM
in collaboration with Lifeline Cell Technology, LLC. These growth
media are designed for the growth of human embryonic progenitor
cells. Additional new products that Embryome Sciences has targeted
for development are ESpyTM
cell lines, which will be derivatives of hES cells that send beacons of light in
response to the activation of particular genes. The ESpy™ cell lines
will be developed in conjunction with Lifeline using the ACTCellerate technology
licensed from ACT and other technology sublicensed from
Lifeline. Embryome Sciences also plans to bring to market other new
growth and differentiation factors that will permit researchers to manufacture
specific cell types from embryonic stem cells, and purification tools useful to
researchers in quality control of products for regenerative
medicine. As new products are developed, they will become available
for purchase on embryome.com.
We are in
the process of launching our first products for stem cell research, and did not
have stem cell products on the market during the first quarter of
2008. We cannot predict the amount of revenue that the new products
we offer might generate.
Hextend®,
PentaLyte®, and HetaCool® are registered trademarks of BioTime, Inc., and
ESpanTM and
EspyTM
are trademarks of Embryome Sciences, Inc.
Results
of Operations
We
incurred a net loss of $662,780 during the three months, and a net loss of
$1,138,828 during the six months, ended June 30, 2008. Because our
research and development expenses, clinical trial expenses, and production and
marketing expenses will be charged against earnings for financial reporting
purposes, management expects that there will be losses from operations in the
near term.
Revenues
For the
three months ended June 30, 2008, we recognized $341,153 in royalty revenue,
whereas we recognized $163,676 for the three months ended June 30,
2007. This increase of 108% in royalties is attributable to an
increase in product sales by Hospira, and reflects an increase in sales both to
hospitals and to the United States Armed Forces.
We
recognized $67,725 and $47,065 of license fees from CJ and Summit during the
three months ended June 30, 2008 and the three months ended June 30, 2007,
respectively. These licensing fee amounts were received in earlier
accounting periods, but full recognition of license fees has been deferred, and
is being recognized over the life of the contract, which has been estimated to
last until approximately 2019 based on the current expected life of the
governing patent covering our products in Korea and Japan. See Notes
2 and 4 to the condensed consolidated financial statements.
Operating
Expenses
Research
and development expenses were $416,978 for the three months ended June 30, 2008,
compared to $210,767 for the three months ended June 30, 2007. This
increase is primarily attributable to a $66,927 increase in salaries allocated
to research and development, an increase of $21,268 in payroll fees and taxes
allocated to research and development expense, an increase of $14,193 in
insurance costs allocated to research and development expense, an increase of
$32,771 in expenditures made to cover laboratory expenses and supplies, and an
increase of $56,101 in rent costs allocated to research and development
expense. Research and development expenses were $764,129 for the six
months ended June 30, 2008, compared to $554,317 for the six months ended June
30, 2007. This increase is primarily attributable to a $106,280
increase in salaries allocated to research and development, an increase of
$41,973 in payroll fees and taxes allocated to research and development expense,
an increase of $29,122 in insurance costs allocated to research and development
expense, an increase of $71,714 in expenditures made to cover laboratory
expenses and supplies, and an increase of $58,207 in rent costs allocated to
research and development expense; these increases were offset to some
extent
by a
decrease of $108,766 in expenses paid for outside research. Research
and development expenses include laboratory study expenses, salaries, and
consultants’ fees.
General
and administrative expenses increased to $532,358 for the three months ended
June 30, 2008, from $293,772 for the three months ended June 30,
2007. This increase is primarily
attributable to an increase of $50,232 in stock-based expense allocated to
general and administrative costs, an increase of $21,766 in legal fees, an
increase of $35,281 in travel and entertainment expenses, an increase of $8,160
in expenses related to outside services, an increase of $29,964 in accounting
fees, an increase of $25,414 in office expenses, an increase of $14,025 in rent
costs allocated to general and administrative expense, and an increase of
$40,260 in general and administrative consulting fees. General and
administrative expenses increased to $968,297 for the six months ended June 30,
2008, from $711,552 for the six months ended June 30, 2007. This
increase is
primarily attributable to an increase of $83,560 in stock-based expense
allocated to general and administrative costs, an increase of $71,023 in legal
fees, an increase of $56,645 in travel and entertainment expenses, an increase
of $13,730 in expenses related to outside services, an increase of $15,000 in
licensing fees, an increase of $28,815 in office expenses, an increase of
$14,551 in rent costs allocated to general and administrative expense, an
increase of $21,699 in payroll fees and taxes allocated to general and
administrative expense, and an increase of $28,460 in general and administrative
consulting fees; these increases were offset to some extent by a decrease of
$30,009 in accounting fees, and by a decrease of $36,529 in patent
expenses.
Research
and development expenses and general and administrative expenses for the three
months and six months ended June 30, 2008 increased over the same periods in
2007 due primarily to our entry into the fields of stem cell research and
regenerative medicine.
Interest
and Other Income (Expense)
For the three months ended June 30,
2008, we incurred a total of $124,821 of
net interest expense, compared to net interest expense of $50,279 for
the three months ended June 30, 2007. For the six months ended June
30, 2008, we incurred a total of $200,443 of
net interest expense, compared to net interest expense of $88,509 for
the six months ended June 30, 2007.
Income
Taxes
During the three months ended June 30,
2008, we incurred no foreign withholding taxes. With respect to
Federal and state income taxes, our effective income tax rate differs from the
statutory rate due to the 100% valuation allowance established for our deferred
tax assets, which relate primarily to net operating loss carryforwards, as
realization of such benefits is not deemed to be likely.
Liquidity
and Capital Resources
The major
components of our net cash used in operations of approximately $773,000 in the
six months ended June 30, 2008 can be summarized as follows: net loss of
approximately $1,139,000 was reduced by non-cash expenses of approximately
$303,000, resulting in the cash loss of approximately $836,000 which was partly
funded with a net overall change in current assets and current liabilities of
approximately $63,000.
At June
30, 2008, we had $172,461 cash and cash equivalents on hand, and lines of credit
for $2,578,600, from which $1,882,767 had been drawn. On July 10,
2008, our subsidiary Embryome Sciences entered into a License Agreement with
Advanced Cell Technology, Inc. (“ACT”) under which Embryome Sciences acquired
exclusive world-wide rights to use ACT’s “ACTCellerate” technology for methods
to accelerate the isolation of novel cell strains from pluripotent stem
cells. We have paid ACT a $250,000 license fee. Also on
July 10, 2008, we sent out new draw requests totaling $225,000 under our current
Revolving Line of Credit Agreement. At the date of filing of this
report, we have received all funds so requested. See Note 7 to the
condensed consolidated financial statements for additional
information.
We have a
Revolving Line of Credit Agreement (the “Credit Agreement”) with certain private
lenders that is collateralized by a security interest in our right to receive
royalty and other payments under our license agreement with
Hospira. We may borrow up to $2,500,000 under the Credit
Agreement. The maturity date of revolving line of credit loans is
November 15, 2008 but the loans may become payable prior to the maturity date if
we receive an aggregate of $4,000,000 through (A) the sale of capital stock, (B)
the collection of license fees, signing fees, milestone fees, or similar fees
(excluding royalties) in excess of $2,500,000 under any present or future
agreement pursuant to which we grant one or more licenses to use its patents or
technology, (C) funds borrowed from other lenders, or (D) any combination of
sources under clauses (A) through (C).
The
lenders have been given the right to exchange their line of credit promissory
notes for our common shares at a price of $1.00 per share, and/or for common
stock of our subsidiary, Embryome Sciences, Inc., at a price of $2.00 per
share.
We also
obtained a line of credit from American Express in August 2004, which allows for
borrowings up to $43,600; at June 30, 2008, we had drawn $25,629 against this
line. See Note 3 to the condensed consolidated financial statements
for additional information.
We also
secured a line of credit from Advanta in November 2006, which allows for
borrowings up to $35,000; at June 30, 2008, we had drawn $32,138 against this
line. See Note 3 to the condensed consolidated financial statements
for additional information.
Since
inception, we have primarily financed our operations through the sale of equity
securities, licensing fees, royalties on product sales by our licensees, and
borrowings. The amount of license fees and royalties that may be
earned through the licensing and sale of our products and technology, the timing
of the receipt of license fee payments, and the future availability and terms of
equity financing, are uncertain. The unavailability or inadequacy of
financing or revenues to meet future capital needs could force us to modify,
curtail, delay or suspend some or all aspects of our planned
operations. Sales of additional equity securities could result in the
dilution of the interests of present shareholders.
We will
depend upon royalties from the sale of Hextend by Hospira and CJ as our
principal source of revenues for the near future. Those royalty
revenues will be supplemented by any revenues that we may receive from our stem
cell research products, and by license fees if we enter into new commercial
license agreements for our products.
The
amount and pace of research and development work that we can do or sponsor, and
our ability to commence and complete the clinical trials that are required in
order for us to obtain FDA and foreign regulatory approval of products, depend
upon the amount of money we have. Future research and clinical study
costs are not presently determinable due to many factors, including the inherent
uncertainty of these costs and the uncertainty as to timing, source, and amount
of capital that will become available for these projects. We have
already curtailed the pace of our plasma volume expander development efforts due
to the limited amount of funds available, and we may have to postpone further
laboratory and clinical studies, unless our cash resources increase through
growth in revenues, the completion of licensing agreements, additional equity
investment, borrowing, or third party sponsorship.
We have
no contractual obligations as of June 30, 2008, with the exception of two
facilities lease agreements. We currently have a fixed,
non-cancelable operating lease on our office and laboratory facilities in
Emeryville, California (the “Emeryville lease”). Under the Emeryville
lease, we are committed to make payments of $11,127 per month, increasing 3%
annually, plus our pro rata share of operating costs for the building and office
complex, through May 31, 2010. We plan to sublet our Emeryville
facility if we are able to find a suitable subtenant. In April 2008,
we entered into a sublease of approximately 11,000 square feet of office and
research laboratory spaced at 1301 Harbor Bay Parkway, in Alameda, California
(the “Alameda sublease”). We have now moved our headquarters to this
new facility. The Alameda sublease will expire on November 30,
2010. Base monthly rent will be $22,000 during 2008, $22,600 during
2009, and $23,340 during 2010. In addition to base rent, we will pay
a pro rata share of real property taxes and certain costs related to the
operation and maintenance of the building in which the subleased premises are
located.
Item 3. Quantitative and Qualitative
Disclosures About Market Risk.
We did not hold any market risk
sensitive instruments as of June 30, 2008, December 31, 2007, or June 30,
2007.
Item
4T. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
It is
management’s responsibility to establish and maintain adequate internal control
over all financial reporting pursuant to Rule 13a-15 under the Securities
Exchange Act of 1934 (the “Exchange Act”). Our management, including
our principal executive officer, our principal operations officer, and our
principal financial officer, have reviewed and evaluated the effectiveness of
our disclosure controls and procedures as of a date within ninety (90) days of
the filing date of this Form 10-Q quarterly report. Following this
review and evaluation,
management collectively determined that our disclosure controls and
procedures are effective to ensure that information required to be disclosed by
us in reports that we file or submit under the Exchange Act (i) is recorded,
processed, summarized and reported within the time periods specified in SEC
rules and forms, and (ii) is accumulated and communicated to management,
including our chief executive officer, our chief operations officer, and our
chief financial officer, as appropriate to allow timely decisions regarding
required disclosure.
Changes
in Internal Controls
There
were no changes in our internal control over financial reporting that occurred
during the period covered by this Quarterly Report on Form 10-Q that have
materially affected, or are reasonably likely to materially affect, our internal
control over financial reporting.
PART
II - OTHER INFORMATION
Item
2. Unregistered Sale of Equity Securities and Use of
Proceeds.
During
April 2008 we issued a total of 150,000 common shares to our financial advisor
under the terms of our Financial Advisor Agreement. These shares were
issued in reliance upon an exemption from registration under Section 4(2) of the
Securities Act of 1933, as amended.
Item
5. Other Information.
Our Board of Directors has set
Thursday, October 30, 2008, at 10:00 a.m. as the date of our next annual meeting
of shareholders. Any shareholder who desires to submit a proposal for
consideration and approval by the shareholders at the annual meeting and who
wishes to have that proposal included in our proxy statement under SEC Rule
14a-8, must submit their proposal to us no later than September 1,
2008. Any proposal received from a shareholder after that date will
not be included in our proxy statement, and notice of the proposal will be
considered untimely under SEC Rule 14a-5(e)(2).
Item
6. Exhibits
Exhibit
Numbers Description
3.1
Articles of Incorporation.†
3.2
Amendment of Articles of Incorporation.***
3.3
By-Laws, As Amended.#
4.1
Specimen of Common Share Certificate.+
4.2
|
Form
of Warrant Agreement between BioTime, Inc. and American Stock Transfer
& Trust Company++
|
|
4.3
|
Form
of Amendment to Warrant Agreement between BioTime, Inc. and American Stock
Transfer & Trust Company. +++
|
10.1 Intellectual
Property Agreement between BioTime, Inc. and Hal Sternberg.+
10.2 Intellectual
Property Agreement between BioTime, Inc. and Harold Waitz.+
10.3 Intellectual
Property Agreement between BioTime, Inc. and Judith Segall.+
10.4 Intellectual
Property Agreement between BioTime, Inc. and Steven
Seinberg.*
10.5 Agreement
between CMSI and BioTime Officers Releasing Employment Agreements, Selling
Shares, and Transferring Non-Exclusive License.+
10.6
|
Agreement
for Trans Time, Inc. to Exchange CMSI Common Stock for BioTime, Inc.
Common Shares.+
|
10.7 2002
Stock Option Plan, as amended.##
10.8
|
Exclusive
License Agreement between Abbott Laboratories and BioTime,
Inc. (Portions of this exhibit have been omitted pursuant to a
request for confidential
treatment).###
|
10.9
|
Modification
of Exclusive License Agreement between Abbott Laboratories and BioTime,
Inc. (Portions of this exhibit have been omitted pursuant to a request for
confidential treatment).^
|
10.10
|
Exclusive
License Agreement between BioTime, Inc. and CJ
Corp.**
|
10.11
|
Hextend
and PentaLyte Collaboration Agreement between BioTime, Inc. and Summit
Pharmaceuticals International
Corporation.‡
|
10.12
|
Lease
dated as of May 4, 2005 between BioTime, Inc. and Hollis R& D
Associates ‡‡
|
10.13
|
Addendum
to Hextend and PentaLyte Collaboration Agreement Between BioTime Inc. And
Summit Pharmaceuticals International
Corporation‡‡‡
|
10.14
|
Amendment
to Exclusive License Agreement Between BioTime, Inc. and Hospira,
Inc.††
|
10.15
|
Hextend
and PentaLyte China License Agreement Between BioTime, Inc. and Summit
Pharmaceuticals International
Corporation.†††
|
10.16
|
Revolving
Credit Line Agreement between BioTime, Inc, Alfred D. Kingsley, Cyndel
& Co., Inc., and George Karfunkel, dated April 12,
2006.††††
|
10.17
|
Security
Agreement executed by BioTime, Inc., dated April 12,
2006.††††
|
10.18
|
Form
of Revolving Credit Note of BioTime, Inc. in the principal amount of
$166,666.67 dated April 12,
2006.††††
|
10.19
|
First
Amended and Restated Revolving Line of Credit Agreement, dated October 17,
2007. ####
|
10.20
|
Form
of Amended and Restated Revolving Credit Note.
####
|
10.21
|
Form
of Revolving Credit Note. ####
|
10.22
|
First
Amended and Restated Security Agreement, dated October 17, 2007.
####
|
10.23
|
Employment
Agreement, dated October 10, 2007, between BioTime, Inc. and Michael D.
West++++
|
10.24
|
Commercial
License and Option Agreement between BioTime and Wisconsin
Alumni Research
Foundation.****
|
10.25
|
Second
Amended and Restated Revolving Line of Credit Agreement, dated February
15, 2008.‡‡‡‡
|
10.26 Form
of Amended and Restated Revolving Credit Note.‡‡‡‡
10.27 Second
Amended and Restated Security Agreement, dated February 15,
2008.‡‡‡‡
10.28 Third
Amended and Restated Revolving Line of Credit Agreement, March 31,
2008.~
10.29 Third
Amended and Restated Security Agreement, dated March 31, 2008.~
10.30 Sublease
Agreement between BioTime, Inc. and Avigen, Inc.++++
10.31
|
License,
Product Production, and Distribution Agreement, dated June 19, 2008, among
Lifeline Cell Technology, LLC, BioTime, Inc., and Embryome Sciences, Inc.
^^
|
10.32
|
License
Agreement, dated July 10, 2008, between Embryome Sciences, Inc. and
Advanced Cell Technology, Inc. ^^
|
31
Rule 13a-14(a)/15d-14(a) Certification^^
32
|
Section
1350 Certification^^
|
†Incorporated
by reference to BioTime’s Form 10-K for the fiscal year ended June 30,
1998.
+
Incorporated by reference to Registration Statement on Form S-1, File Number
33-44549 filed with the Securities and Exchange Commission on December 18, 1991,
and Amendment No. 1 and Amendment No. 2 thereto filed with the Securities and
Exchange Commission on February 6, 1992 and March 7, 1992,
respectively.
#
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.
++
Incorporated by reference to Registration Statement on Form S-2, File Number
333-109442, filed with the Securities and Exchange Commission on October 3,
2003, and Amendment No.1 thereto filed with the Securities and Exchange
Commission on November 13, 2003.
+++Incorporated
by reference to Registration Statement on Form S-2, File Number 333-128083,
filed with the Securities and Exchange Commission on September 2,
2005.
##
Incorporated by reference to Registration Statement on Form S-8, File Number
333-101651 filed with the Securities and Exchange Commission on December 4, 2002
and Registration
Statement
on Form S-8, File Number 333-122844 filed with the Securities and Exchange
Commission on February 23, 2005.
###
Incorporated by reference to BioTime’s Form 8-K, filed April 24,
1997.
^
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended June 30,
1999.
*
Incorporated by reference to BioTime’s Form 10-K for the year ended December 31,
2001.
**
Incorporated by reference to BioTime’s Form 10-K/A-1 for the year ended December
31, 2002.
‡
Incorporated by reference to BioTime’s Form 8-K, filed December 30,
2004
‡‡
Incorporated by reference to Post-Effective Amendment No. 3 to Registration
Statement on Form S-2 File Number 333-109442, filed with the Securities and
Exchange Commission on May 24, 2005
‡‡‡
Incorporated by reference to BioTime’s Form 8-K, filed December 20,
2005
††
Incorporated by reference to BioTime’s Form 8-K, filed January 13,
2006
†††
Incorporated by reference to BioTime’s Form 8-K, filed March 30,
2006
††††
Incorporated by reference to BioTime’s Form 10-K for the year ended December 31,
2005
***
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended June 30,
2006.
****
Incorporated by reference to BioTime’s Form 8-K, filed January 9,
2008.
‡‡‡‡
Incorporated by reference to BioTime’s Form 8-K, filed March 10,
2008.
~
Incorporated by reference to BioTime’s Form 8-K filed April 4,
2008.
++++
Incorporated by reference to BioTime’s Form 10-KSB for the year ended December
31, 2007.
^^ Filed
herewith
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has
duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
BIOTIME,
INC.
|
|
|
|
|
|
Date: August
14, 2008
|
/s/
Michael D. West
|
|
Michael
D. West
|
|
Chief
Executive Officer
|
|
|
|
|
Date: August
14, 2008
|
/s/
Steven A. Seinberg
|
|
Steven
A. Seinberg
|
|
Chief
Financial Officer
|
Exhibit
Numbers Description
3.1 Articles
of Incorporation.†
3.2 Amendment
of Articles of Incorporation.***
3.3 By-Laws,
As Amended.#
4.1 Specimen
of Common Share Certificate.+
4.2
|
Form
of Warrant Agreement between BioTime, Inc. and American Stock Transfer
& Trust Company++
|
|
4.3
|
Form
of Amendment to Warrant Agreement between BioTime, Inc. and American Stock
Transfer & Trust Company. +++
|
10.1 Intellectual
Property Agreement between BioTime, Inc. and Hal Sternberg.+
10.2 Intellectual
Property Agreement between BioTime, Inc. and Harold Waitz.+
10.3 Intellectual
Property Agreement between BioTime, Inc. and Judith Segall.+
10.4 Intellectual
Property Agreement between BioTime, Inc. and Steven Seinberg.*
10.5
|
Agreement
between CMSI and BioTime Officers Releasing Employment Agreements, Selling
Shares, and Transferring Non-Exclusive
License.+
|
10.6
|
Agreement
for Trans Time, Inc. to Exchange CMSI Common Stock for BioTime, Inc.
Common Shares.+
|
10.7 2002
Stock Option Plan, as amended.##
10.8
|
Exclusive
License Agreement between Abbott Laboratories and BioTime,
Inc. (Portions of this exhibit have been omitted pursuant to a
request for confidential
treatment).###
|
10.9
|
Modification
of Exclusive License Agreement between Abbott Laboratories and BioTime,
Inc. (Portions of this exhibit have been omitted pursuant to a request for
confidential treatment).^
|
10.10
|
Exclusive
License Agreement between BioTime, Inc. and CJ
Corp.**
|
10.11
|
Hextend
and PentaLyte Collaboration Agreement between BioTime, Inc. and Summit
Pharmaceuticals International
Corporation.‡
|
10.12
|
Lease
dated as of May 4, 2005 between BioTime, Inc. and Hollis R& D
Associates ‡‡
|
10.13
|
Addendum
to Hextend and PentaLyte Collaboration Agreement Between BioTime Inc. And
Summit Pharmaceuticals International
Corporation‡‡‡
|
10.14
|
Amendment
to Exclusive License Agreement Between BioTime Inc.
and Hospira, Inc.††
|
10.15
|
Hextend
and PentaLyte China License Agreement Between BioTime, Inc. and Summit
Pharmaceuticals International
Corporation.†††
|
10.16
|
Revolving
Credit Line Agreement between BioTime, Inc, Alfred D. Kingsley, Cyndel
& Co., Inc., and George Karfunkel, dated April 12,
2006.††††
|
10.17
|
Security
Agreement executed by BioTime, Inc., dated April 12,
2006.††††
|
10.18
|
Form
of Revolving Credit Note of BioTime, Inc. in the principal amount of
$166,666.67 dated April 12,
2006.††††
|
10.19
|
First
Amended and Restated Revolving Line of Credit Agreement, dated October 17,
2007. ####
|
10.20
|
Form
of Amended and Restated Revolving Credit Note.
####
|
10.21
|
Form
of Revolving Credit Note. ####
|
10.22
|
First
Amended and Restated Security Agreement, dated October 17, 2007.
####
|
10.23
|
Employment
Agreement, dated October 10, 2007, between BioTime, Inc. and Michael D.
West.++++
|
10.24
|
Commercial
License and Option Agreement between BioTime and Wisconsin Alumni Research
Foundation.****
|
10.25
|
Second
Amended and Restated Revolving Line of Credit Agreement, dated February
15, 2008.‡‡‡‡
|
10.26 Form
of Amended and Restated Revolving Credit Note.‡‡‡‡
10.27 Second
Amended and Restated Security Agreement, dated February 15,
2008.‡‡‡‡
10.28 Third
Amended and Restated Revolving Line of Credit Agreement, March 31,
2008.~
10.29 Third
Amended and Restated Security Agreement, dated March 31, 2008.~
10.30 Sublease
Agreement between BioTime, Inc. and Avigen, Inc.++++
10.31
|
License,
Product Production, and Distribution Agreement, dated June 19, 2008, among
Lifeline Cell Technology, LLC, BioTime, Inc., and Embryome Sciences, Inc.
^^
|
10.32 License
Agreement, dated July 10, 2008, between Embryome Sciences, Inc. and Advanced
Cell Technology, Inc. ^^
31
Rule 13a-14(a)/15d-14(a) Certification^^
32
|
Section
1350 Certification^^
|
†Incorporated
by reference to BioTime’s Form 10-K for the fiscal year ended June 30,
1998.
+
Incorporated by reference to Registration Statement on Form S-1, File Number
33-44549 filed with the Securities and Exchange Commission on December 18, 1991,
and Amendment No. 1 and Amendment No. 2 thereto filed with the Securities and
Exchange Commission on February 6, 1992 and March 7, 1992,
respectively.
#
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.
++
Incorporated by reference to Registration Statement on Form S-2, File Number
333-109442, filed with the Securities and Exchange Commission on October 3,
2003, and Amendment No.1 thereto filed with the Securities and Exchange
Commission on November 13, 2003.
+++Incorporated
by reference to Registration Statement on Form S-2, File Number 333-128083,
filed with the Securities and Exchange Commission on September 2,
2005.
##
Incorporated by reference to Registration Statement on Form S-8, File Number
333-101651 filed with the Securities and Exchange Commission on December 4, 2002
and Registration Statement on Form S-8, File Number 333-122844 filed with the
Securities and Exchange Commission on February 23, 2005.
###
Incorporated by reference to BioTime’s Form 8-K, filed April 24,
1997.
^
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended June 30,
1999.
*
Incorporated by reference to BioTime’s Form 10-K for the year ended December 31,
2001.
**
Incorporated by reference to BioTime’s Form 10-K/A-1 for the year ended December
31, 2002.
‡
Incorporated by reference to BioTime’s Form 8-K, filed December 30,
2004
‡‡
Incorporated by reference to Post-Effective Amendment No. 3 to Registration
Statement on Form S-2 File Number 333-109442, filed with the Securities and
Exchange Commission on May 24, 2005
‡‡‡
Incorporated by reference to BioTime’s Form 8-K, filed December 20,
2005
††
Incorporated by reference to BioTime’s Form 8-K, filed January 13,
2006
†††
Incorporated by reference to BioTime’s Form 8-K, filed March 30,
2006
††††
Incorporated by reference to BioTime’s Form 10-K for the year ended December 31,
2005
***
Incorporated by reference to BioTime’s Form 10-Q for the quarter ended June 30,
2006.
****
Incorporated by reference to BioTime’s Form 8-K, filed January 9,
2008.
‡‡‡‡
Incorporated by reference to BioTime’s Form 8-K, filed March 10,
2008.
~
Incorporated by reference to BioTime’s Form 8-K filed April 4,
2008.
++++
Incorporated by reference to BioTime’s Form 10-KSB for the year ended December
31, 2007.
^^ Filed
herewith
30
ex10_31.htm
Exhibit
10.31
LICENSE, PRODUCT PRODUCTION,
AND DISTRIBUTION AGREEMENT
This Agreement is made and entered into
this 19th day of June 2008 (the "EFFECTIVE DATE"), by and among LifeLine Cell
Technology, LLC, a California limited liability company with offices located at
2595 Jason Court, Oceanside, CA 92056 (“Lifeline”), BioTime, Inc., a California
corporation with offices located at 1301 Harbor Bay Parkway, Suite 100 Alameda,
California 94502 (“BioTime”), and Embryome Sciences, Inc., a California
corporation and subsidiary of BioTime with offices located at 1301 Harbor Bay
Parkway, Suite 100, Alameda, California 94502 (“ES”) Lifeline, BioTime, and ES
are sometimes hereinafter referred to as the “Parties.”
RECITALS
A. Lifeline
has rights to use certain cell technology licensed from Advanced Cell
Technology, Inc. (“ACT”), and the expertise and facilities to produce in
commercial quality and quantity cells and media optimized for cells derived from
or based on that technology.
B. BioTime
and ES have rights to embryonic stem technology, and cells produced from that
technology, under a license from WARF.
C. Lifeline
also has marketing and distribution capability and a pre-existing relationship
with certain major distributors of cells and media, which have been disclosed to
BioTime and ES.
D. ES
has both marketing and distributing capability for cell-based products for the
research-only market, particularly through its proprietary “Embryome.com” data
base technology, its proprietary “Embryomics” cell isolation and propagation
technology, and has access to embryonic stem technology under a license from
WARF.
NOW, THEREFORE, in consideration of the
premises and the mutual covenants contained herein, the parties hereto agree as
follows:
ARTICLE 1 -
DEFINITIONS
1.1 Definitions. For
the purposes of this Agreement, the following words and phrases shall have the
following meanings:
(a) “Cell
Technology” means technology under patents and know-how licensed or sublicensed
by Lifeline from Advanced Cell Technology, Inc. under the license agreements
listed on Schedule 1.
(b) “ES
Products” means cells and cell lines developed by ES without the use of Cell
Technology.
(c) “ES
Technology” means cell isolation and propagation technology that is proprietary
to ES or BioTime, and may include patents, patent applications, and
trade-secrets.
(d) “Lifeline
Products” means cells and cell lines developed using Lifeline Technology, but
not ES Technology, WARF Technology, and/or WARF Materials.
(e) “Lifeline
Technology” means technology other than Cell Technology that is proprietary to
Lifeline, and may include patents, patent applications, and
trade-secrets.
(f) “Joint
Products” means (i) clonally or oligoclonally derived embryonic progenitor cells
or progenitor cell lines produced using Cell Technology and WARF Technology,
WARF Materials, or ES Technology, and (ii) products derived from the progenitor
cells described in clause (i).
(g) “Marketing
Cost” means, the reasonable costs associated with promoting, selling, packaging,
transferring title and moving Joint Products to the customer and include direct
costs and overhead costs. Direct costs of marketing include but are
not limited to: market research; advertising; development, printing and
distribution of collateral materials; selling expenses including salaries,
benefits, commissions and sales-related expenses, and reimbursements paid to
sales employees, customer service employees, and accounting employees involved
with invoicing and accounts receivables, and an overhead burden of 15% of the
employee component of direct cost. The initial percentage of overhead
costs allocated to marketing will be revised and agreed upon between the Parties
on a periodic basis according to Section 5.11.
(h) “Production
Cost” means the reasonable costs associated with (i) the initial production and
testing of a new Joint Product in the laboratory, (ii) the preparation of
equipment and procedures for the production of a new Joint Product on a
commercial scale, and (iii) producing, testing and packaging of Joint Products
for distribution and sale. Production Costs include direct costs and
overhead costs. Direct costs of production include but are not
limited to: laboratory supplies and materials, WARF Materials, commercial
production and quality control supplies and materials; salaries and benefits
paid to production and quality control employees; and payments to independent
contractors, and an overhead burden of 30% of the employee component of direct
cost. The
initial estimate of overhead costs allocated to production will be revised and
agreed upon between the parties on a periodic basis according to Section
5.11.
(i) Net
Revenues means the gross revenues from the sale of Joint Products, less all (i)
shipping costs (including packaging, freight, and insurance costs invoiced to
purchasers), (ii) discounts, (iii) sales, VAT and similar taxes, (iv) returns
and other credits actually allowed to purchasers, and (v) uncollected
accounts.
(j) “WARF”
means Wisconsin Alumni Research Foundation.
(k) “WARF
Technology” means technology under patents licensed by BioTime from
WARF.
(l) “WARF
Materials” means cells or cell lines obtained by BioTime or ES under a license
from WARF.
ARTICLE 2 – PRODUCTION OF
JOINT PRODUCTS
2.1 Production of Joint Products
By ES. ES shall produce the Joint Products subject to the
rights of Lifeline in Section 2.2:
2.2. Production of Joint
Products.
(a) Lifeline
may also produce Joint Products if (a) ES fails to offer for sale a minimum of
12 new Joint Products per year beginning in 2009, or (b) ES consents to Lifeline
producing a Joint Product.
(b) Lifeline
may produce any new Joint Product that Lifeline conceives of and offers to ES to
produce but which ES declines to produce, or any other Joint Product the
production of which ES has determined to discontinue. In this regard,
if Lifeline desires ES to produce a new Joint Product, Lifeline shall provide ES
with written information describing the new Joint Product, including the method
of production, use, and proposed price of the new Joint Product. The
information from Lifeline shall be in sufficient detail to permit ES to make an
informed decision to produce or not produce the new Joint
Product. Within thirty (30) days after receipt of such information
from Lifeline, ES shall notify Lifeline of ES’s election to produce the new
Joint Product. If ES fails to so notify Lifeline, ES shall be deemed
to have elected not to produce the new Joint Product.
(c) If
Lifeline uses any WARF Technology or WARF Materials to produce any Joint Product
under paragraph (a) or (b) of this Section, ES shall collaborate with Lifeline
by providing technical advice through the review and comment on development
plans and methods, but ES shall not be required to (i) utilize its laboratory or
production facilities, materials, or equipment for the production of the Joint
Product; and (ii) provide personnel to staff laboratory or production
functions. ES’s cost of providing the services described in this
paragraph shall be deemed Production Costs.
(d) Lifeline
shall not be deemed to have jointly produced stem cells from the H9 stem cell
line previously cultured by BioTime or ES with assistance from
Lifeline.
2.3 Use of Cell
Technology. Lifeline hereby grants ES an exclusive sublicense
to use of Cell Technology to the extent required for the purpose of producing,
making, and distributing Joint Products, but, except as required for such
purpose, no other license or sublicense of Cell Technology is granted or shall
be implied by this Agreement. Lifeline will provide ES with a license
to use Lifeline Technology to permit ES to practice the Cell Technology for the
purpose of producing Joint Products.
2.4 Facilities and
Personnel. Lifeline will provide laboratory and production
facilities and personnel, as reasonably requested by ES to produce, make, or
distribute Joint Products.
Lifeline
shall use its own laboratory and production facilities and personnel for the
production of any Joint Products that Lifeline produces. ES will make
available at the Lifeline facilities the services of Dr. Michael West and other
ES personnel as needed to assist Lifeline personnel in developing the techniques
needed to produce a Joint Product. Lifeline will make available at
the ES facilities the services of Lifeline personnel as needed to assist ES in
developing and implementing standard operating procedures for production Joint
Products, procedures for distribution of Joint Products, and procedures for
Production Cost tracking, accounting and controls. The Parties
acknowledge and agree that their personnel will not be providing assistance to
each other on a full-time basis, but only to the extent necessary (and subject
to their availability taking into account scheduling issues and their other time
commitments) to permit each Party to commence production of a Joint Product and
to develop and implement operating procedures for commercial production and
distribution of a Joint Product, and to track and account for related Production
Costs, using their own personnel. Moreover, the assistance of ES
personnel may be limited to the matters described in Section 2.2(c) in cases in
which that paragraph applies.
2.5 WARF and ES
Technology. ES grants Lifeline a sublicense to use WARF
Technology, and WARF Materials and ES Technology for the purpose of producing,
making, and distributing any Joint Products that Lifeline is entitled to
produce, make, and distribute but, except as required for such purpose, no other
license or sublicense of WARF Technology, WARF Materials, or ES Technology is
granted or shall be implied by this Agreement. Lifeline agrees that
(a) WARF Technology and WARF Materials may be used by Lifeline only for the
purpose of producing, making, and distributing Joint Products under this
Agreement; (b) Lifeline shall not sell, use, or transfer WARF Materials to any
third party except as permitted by the WARF license; (c) Lifeline shall not use
WARF Technology or WARF Materials in any manner not permitted by the WARF
license, and (d) Lifeline’s right to use WARF Technology and WARF Materials
shall terminate upon the termination of the WARF license.
ARTICLE 3 – MARKETING; SALES
AND DISTRIBUTION
3.1 Marketing
Efforts. The Parties shall each use commercially reasonable
efforts to market and sell Joint Products through each Party’s sales force and
distributor network, and shall use best efforts to collaborate in marketing
Joint Products jointly where appropriate so as to avoid conflicts between the
parties’ sales efforts.
3.2 Embryome.com. Pricing
and terms of marketing and sale of Joint Products through Embryome.com
technology shall be subject to ES’s approval.
3.3 Branding. Joint
Products shall be sold under the Lifeline or ES brand as the Parties shall
determine by mutual agreement.
3.4 Use of Joint
Products. Joint Products will be produced, marketed,
distributed, and sold as research tools only, including in drug discovery and
development, and not for the treatment of disease in humans, or for diagnosis,
prognosis, screening or detection of disease in humans. Each Party
shall sell Joint Products on terms that provided that the Joint Products will be
used by the purchaser only for the purposes permitted in this
paragraph.
3.5 Limit of
Obligations. Nothing in this Agreement shall require either
Party to sell Joint Products produced by the other Party. Any Party
that produces, markets, or distributes a Joint Product may, upon thirty days
notice to the other Parties, discontinue production, marketing, or distribution
of the Joint Product.
3.6 Costs and
Expenses. Except for royalties payable to WARF and ACT,
Production Costs, and Marketing Costs, which shall be reimbursed as provided in
Article 5, each Party shall pay its own costs and expenses incurred in
connection with the performance of its obligations under this Agreement, unless
otherwise expressly provided in this Agreement.
3.7 Competition. Nothing
in this Agreement shall prevent, preclude, or limit the right of the parties to
compete with each other in the development, licensing, production, marketing,
distribution, and sale of technology and products, including products that may
directly compete with Joint Products. Lifeline shall have no interest
in or right to participate in revenues or profits from the sale of ES Products
or from the licensing or sublicensing of ES Technology or WARF Technology by ES
or BioTime, or in any production, marketing, and/or sales agreements ES or
BioTime may make, except to the extent that Net Revenues from sale of Joint
Products are generated through such agreements, in which event such Net Revenues
shall be shared as provided herein. ES and BioTime shall have no
interest in or right to participate in revenues from the sale of Lifeline
Products or from the licensing or sublicensing of Lifeline Technology or Cell
Technology by Lifeline, or in any production, marketing, and/or sales agreements
Lifeline may make, except to the extent that Net Revenues from sale of Joint
Products are generated through such agreements, in which event such Net Revenues
shall be shared as provided herein.
ARTICLE 4—CAPITAL
PAYMENT
4.1 Payment to
Lifeline. Within two business days after the Parties have
executed and delivered this Agreement, BioTime or ES will pay Lifeline $250,000
to enable Lifeline to engage in the production, making, and distribution of
Joint Products.
ARTICLE 5 – NET
REVENUES
5.1 Certain
Distributors. Regardless of which Party produces the Joint
Product, Net Revenues from the sale of a Joint Product sold to or through those
distributors with which Lifeline has a pre-existing relationship (which have
been disclosed to ES and BioTime by confidential memorandum), shall be allocated
between, and paid to, the Parties as follows:
(a) First,
to the Parties in an amount equal to their respective royalty obligations under
Article 7 with respect to the sale of the Joint Product;
(b) Second,
to the Party or Parties that produced the Joint Product, to reimburse their
Production Costs, and to the Parties that marketed the Joint Product, to
reimburse their Marketing Costs; and
(c) Finally,
50% to ES and 50% to Lifeline.
5.2 Joint
Production. Net Revenues from the sale of a Joint Product not
covered by Section 5.1 but which is produced by both ES and Lifeline shall be
shall be allocated between, and paid to, the Parties in the manner provided in
Section 5.1.
5.3 Production Requested by
Other Party. Net Revenues from the sale of a Joint Product not
covered by Section 5.1 or Section 5.2 and which was initially produced by one
Party but which is produced for distribution by the other Party at the request
of the Party that initially produced the Joint Product shall be allocated
between, and paid to, the Parties in the manner provided in Section
5.1.
5.4 Other
Cases. In the absence of a supplemental agreement between the
Parties, Net Revenues from the sale of a Joint Product not covered by Section
5.1, Section 5.2 or Section 5.3 shall be shall be allocated between, and paid
to, the Parties as follows:
(a) First,
to the Parties in an amount equal to their respective royalty obligations under
Article 7 with respect to the sale of the Joint Product;
(b) Second,
subject to Section 5.6(b), to the Party that produced the Joint Product for
distribution, an amount equal to the greater of (i) 90% of the Net Revenues
remaining after the allocation under clause (a) of this Section, and (ii) the
amount that would have been allocated to the Party if the provisions of Section
5.1 applied; and
(c) The
balance of the Net Revenue will be allocated to the Party that did not produce
the Joint Product for distribution
5.5 Reimbursement
Payment. The first $250,000 of Net Revenues that otherwise
would be allocated to Lifeline under Section 5.1(c) (including Net Revenues from
Joint Products described in Sections 5.1, 5.2, and 5.3) or Section 5.4(c) shall
be allocated instead to ES as a priority return on its capital investment under
Article 4.
5.6 Recovery of
Costs.
(a) To
the extent that Net Revenues during any calendar quarter are less than the
Production Costs, Marketing Costs, and royalty payments incurred by the Party
during that period, the unrecovered costs will be carried forward into each
successive calendar quarter until paid from Net Revenues, before Net Revenues
are otherwise allocated to and shared by the Parties.
(b) If
ES provides collaborative technical assistance to Lifeline under Section 2.2(c),
the Production Cost incurred by ES shall be reimbursed to ES from a portion of
the Net
Revenue
allocable to Lifeline under Section 5.4(b), and such reimbursement shall be paid
contemporaneously with the allocation of Net Revenues to Lifeline.
5.7 Allocation of Net
Revenue. Net Revenues shall be allocated between the Parties
in the manner provided in this Article 5 regardless of which Party or Parties
sold the Joint Product(s), such that each Party shall pay over to the other
Party such share of Net Revenue as may be required to effect the allocation of
Net Revenues determined under Sections 5.1 through 5.4, as applicable, subject
to Section 5.5 and Section 5.6.
5.8 Payment Due
Date. Not later than 25 days after the end of each calendar
quarter, the Parties will reconcile accounts of Joint Products sold and shall
remit to each other the other Party’s share of Net Revenue.
5.9 Currency. All
payments due hereunder shall be paid in United States dollars. If any
currency conversion shall be required in connection with the payment of Net
Revenues or other amounts due under this Agreement, such conversion shall be at
the rate of conversion reported in the Wall Street Journal on the last working
day of the calendar quarter to which the payment relates.
5.10 Late
Payment. If any Net Revenue is not paid by a Party to the
other Party when due, interest shall accrue on the overdue amount at the Prime
Rate plus two percent, or the maximum rate allowed under applicable law,
whichever is less, from the date when such payment should have been made until
paid in full. Such interest shall be paid with the past due Net
Revenue. The Prime Rate shall be the interest rate reported as the
“prime rate” in The
Wall Street Journal on the date the payment was due.
5.11 Overhead
Costs. Parties will meet, initially on a quarterly basis and
less often upon mutual consent, to: work together in good faith to share
financial information and calculations, within the constraints of SEC rules,
related to: the allocation of overhead costs; develop and agree upon accounting
methods of allocating overhead costs in accordance with Generally Accepted
Accounting Principles; and review and revise the percentage figures used to
allocate overhead costs to Marketing Cost and Production Cost.
ARTICLE 6 - REPORTS AND
RECORDS
6.1 Maintenance of
Records. Each Party shall keep complete and accurate records
and accounts of all Joint Products sold by the Party, all royalties payable by
the Party to ACT or WARF, the Party’s Production Costs and Marketing
Costs.
6.2 Monthly
Reports. Each Party shall provide each other Party with a
monthly report of Joint Product sales, including a description of each Joint
Product sold, the amount (units) of the Joint Product sold, and the gross sales
price, each deduction from gross sales made in the calculation of Net Revenues,
all royalties paid or payable, and all Production Costs and Marketing
Costs. The monthly report shall be delivered no later than 15 days
after the end of each calendar month.
6.3 Audit
Rights. Each Party’s records and accounts of Joint Products
sold shall be kept at their principal place of business or at such other
location as may be agreed upon by the Parties. Said records and
accounts shall be open, upon reasonable advance notice (and no more frequently
than once per calendar year), for three (3) years following the end of the
calendar year to which they pertain, to the inspection of the other Party or its
agents for the purpose of verifying Net Revenues, Production Costs, and
Marketing Costs, or compliance in other respects with this
Agreement. If any such audit determines that the reported sales or
Net Revenues were less than 90% of the actual amount for the period in question,
or that royalties paid or Production Costs or Marketing Costs, were less than
90% of the amount reported for the period, the Party whose records were audited
shall bear the cost of such audit.
ARTICLE
7—SALE OF ES PROUCTS AND LIFELINE PRODUCTS
7.1 Sale of ES Products by
Lifeline. Lifeline may sell, for its own account and under
either ES brand names or Lifeline brand names, ES Products consisting of (a)
human embryonic stem cells, (b) differentiated human stem cells, (c) media for
the growth of human embryonic stem cells or differentiated human stem cells, and
(d) materials useful for the culture of cells. ES agrees to sell ES
Products described in this paragraph to Lifeline at prices to be determined by
mutual agreement, plus shipping, applicable sales and VAT taxes, and
insurance. This Section 7.1 shall not apply to any ES Product
acquired or developed by ES under a license or other agreement with a third
party that would prohibit ES from selling the ES Product to Lifeline under the
terms of this Section 7.1.
7.2 Sale of Lifeline Products by
ES. ES may sell, for its own account and under either ES brand
names or Lifeline brand names, Lifeline Products consisting of (a) human
embryonic stem cells, (b) differentiated human stem cells, (c) media for the
growth of human embryonic stem cells or differentiated human stem cells, and (d)
materials useful for the culture of cells. Lifeline agrees to sell
Lifeline Products described in this paragraph to ES at prices to be determined
by mutual agreement, plus shipping, applicable sales and VAT taxes, and
insurance. This Section 7.2 shall not apply to any Lifeline Product
acquired or developed by Lifeline under a license or other agreement with a
third party that would prohibit Lifeline from selling the Lifeline Product to ES
under the terms of this Section 7.2.
7.3 Payment
of the purchase price for ES Products sold to Lifeline shall be on such terms as
ES may require. Payment of the purchase price for Lifeline Products
sold to ES shall be on such terms as Lifeline may require. Neither
party shall be obligated to extend credit to the other party.
7.4
The Provisions of Article 5 shall not apply to sales of ES Products by Lifeline,
or sales of Lifeline Products sold by ES, under this Article 7.
ARTICLE 8 – LICENSED
TECHNOLOGY AND PATENT RIGHTS
8.1 WARF
License. BioTime and ES shall fully and timely perform their
respective obligations under its license agreement with WARF in order to keep
its license to use WARF Technology and WARF Materials in full force and
effect. BioTime or ES shall promptly notify Lifeline of any material
change in the terms of the WARF license, or the termination of the WARF
license.
(a) ES
shall be responsible for the payment of all royalties owed to WARF from the sale
of Joint Products, as provided in the license agreement between BioTime and
WARF, and such royalties shall be reimbursed from Net Revenues as provided in
Article 5.
8.2 Cell Technology
Licenses. Lifeline shall fully and timely perform its
obligations under its license agreements with Advanced Cell Technology, Inc.
(“ACT”) in order to keep its licenses to use Cell Technology in full force and
effect. Lifeline shall promptly notify BioTime and ES of any material
change in the terms of the Cell Technology license, or the termination of the
Cell Technology license.
(a) Lifeline
shall be responsible for the payment of all royalties owed to ACT from the sale
of Joint Products, as provided in the license agreements between Lifeline and
ACT, and such royalties shall be reimbursed from Net Revenues as provided in
Article 5.
(b) LifeLine
shall notify BioTime and ES of the occurrence of (i) any failure of LifeLine to
make any payment or to perform any other obligation under the Cell Technology
license agreements, and (ii) the receipt of any notice from ACT stating that any
breach or default under any of the Cell Technology license agreements has
occurred. Such notice shall be given to BioTime and ES within five
(5) days after the occurrence of the applicable event. BioTime and ES
shall have the right (but not the obligation) to make any payment or to take any
other action required to cure any default or potential default by LifeLine under
the Cell Technology license agreements. If BioTime or ES makes any
payment or incurs any expense to cure or prevent a breach or default by LifeLine
under any of the Cell Technology license agreements (“Default Cure Payments”),
120% of the amount of such Default Cure Payments shall be reimbursed to BioTime
and ES upon demand, and if such amount is not paid to BioTime or ES within five
days of a demand for payment, the unpaid amount shall accrue interest at the
rate of 15% per annum until paid in full. Until 120% of all Default
Cure Payments, with interest accrued, have been repaid to BioTime and ES, Net Revenues that
otherwise would be allocated to Lifeline under Section 5.1(c) (including Net
Revenues from Joint Products described in Sections 5.1, 5.2, and 5.3) or Section
5.4(c) shall be allocated instead to BioTime and ES until BioTime and ES
have received a return of 120% of the Default Cure Payments, plus accrued
interest. LifeLine agrees that the payment of Default Cure Payments
will impose a financial burden on BioTime and ES and will provide an economic
benefit to LifeLine beyond the financial obligations and benefits that the
Parties have agreed to allocate among themselves under this Agreement, and that
LifeLine estimates that the economic benefit that will inure to it from a cure
of its default will equal or exceed 120% of the Default Cure
Payment.
8.3 Ownership of
Patents. Any invention or discovery, whether or not
patentable, and any patents, patent applications, or technical know-how
developed through the efforts of any Party to produce a Joint Product shall be
owned by the Party or Parties that employ the inventors. That is to
say, if all of the inventors on a patent or patent application are employed by
one Party, then the patent or patent application will be owned by that one
Party. If inventors are listed from two or more Parties, then the patent or
patent application shall be jointly owned by the Parties whose employees are so
listed as inventors.
8.4 License of
Patents. If a Party obtains a patent covering a Joint Product,
the other Party shall have a non-exclusive license to use such patent for the
purpose of producing, distributing and marketing the Joint Product to the extent
permitted under, and subject to the terms of, this Agreement.
8.5 Certain
Acknowledgements. Lifeline acknowledges that the WARF license
agreement permitting the use of WARF Technology and WARF Materials is
non-exclusive, and grants WARF a non-exclusive license to use for non-commercial
purposes Joint Products and any other materials and patents developed using WARF
Materials and WARF Technology. BioTime and ES acknowledge that the
Lifeline’s right to some aspects of the Cell Technology is non
exclusive.
8.8 Licenses of Intellectual
Property; Bankruptcy Code. The Parties agree that the
sublicenses granted to BioTime and ES by Lifeline to use Cell Technology, the
license granted by Lifeline to ES and BioTime to use Lifeline know-how, the
sublicenses granted by BioTime and ES to use WARF Technology, the license
granted by ES to Lifeline to use ES Technology, the license granted by Lifeline
to ES to use Lifeline Technology, and any and all licenses granted by any Party
to the other Party under Section 8.4, constitute licenses of “intellectual
property” as defined in the United States Bankruptcy Code (the “Bankruptcy
Code”) and as used in Section 365(n) of the Bankruptcy Code. The
Parties agree that the know-how included in Cell Technology sublicensed to
BioTime and ES by Lifeline, the Lifeline Technology licensed by Lifeline to ES
under this Agreement, and the ES Technology licensed by ES to Lifeline under
this Agreement includes trade secrets. The Parties also agree that
the payments of Net Revenues required to be made by the Parties to each other
under Article 5 of this Agreement constitute “royalties” under Section 365(n) of
the Bankruptcy Code.
ARTICLE 9 - PROSECUTION OF
INFRINGERS
AND DEFENSE OF PATENT
RIGHTS
9.1 Notice. The
Parties agree to notify each other in writing of (a) any actual or threatened
infringement, by a third person, of any patents covering Cell Technology, WARF
Technology, ES Technology or any other patent pertaining to a Joint Product, or
(b) any claim of invalidity or unenforceability of any patent owned by a Party
covering a Joint Product.
9.2 Prosecution and Defense of
Patent Rights. The Party or Parties owning the patent covering
a Joint Product shall have the right (but not the obligation) to prosecute any
infringement or defend any claims, as applicable, pertaining to such
patent. Each Party shall, at
the
expense of the owner of the patent, provide reasonable assistance to the other
Party in connection with the prosecution or defense of such claims.
9.3 Judgments and
Awards. Any judgment, award, or settlement proceeds arising
from any claim, demand, lawsuit or other proceeding commenced or joined by
either Party against any third person infringing or allegedly infringing a
patent covering a Joint Product (“Proceeds”) shall be allocated between the
Parties in the following manner: (a) first (in the ratio of expenses
incurred by each Party in the action) to reimburse each Party for any expenses
incurred in the action; and (b) any Proceeds on account of the Party’s
respective lost profits shall be treated as Net Revenues, and shall be allocated
between the Parties in the manner provided in Article 5 for the allocation of
Net Revenues from the sale of such Joint Product; provided, that if royalties
payable, Production Costs, or Marketing Costs were taken into account in
determining the Proceeds, those costs shall not be deducted again in allocating
the Proceeds among the Parties.
9.4 Alleged Infringement of
Patents or Trade Secrets. If a claim or lawsuit is brought
against a Party (“Defendant”) alleging infringement of any patent or
misappropriation of any trade secret owned by a third person arising from the
production, distribution, sale or use of any Joint Product, the Defendant shall
promptly give each other Party written notice to of such infringement claim and
shall provide to each other Party all information in the Defendant’s possession
regarding such infringement claim, within sixty (60) days after receiving such
notice. Each Party shall advise the other of the course of action it
intends to take to defend such infringement claim, and shall keep the other
Party informed of the progress of any litigation arising from the infringement
claim. No Party shall enter into any settlement, consent judgment, or
other voluntary final disposition of any infringement action that admits the
invalidity or unenforceability of any patent pertaining to a Joint Product or
that would adversely affect the rights of any other Party, without the prior
written consent of the other Party whose rights are so affected, which consent
may not be unreasonably withheld, conditioned or delayed.
ARTICLE 10 – INDEMNIFICATION
AND
LIMITATION OF
LIABILITY
10.1 Indemnification. BioTime
and ES agree to indemnify, defend and hold harmless Lifeline from and against
all liabilities of any kind whatsoever, including legal expenses and reasonable
attorneys' fees, arising out of or in connection with any breach of any
representation or warranty of BioTime or ES under this
Agreement. Lifeline agrees to indemnify, defend and hold harmless
BioTime and ES from and against all liabilities of any kind whatsoever,
including legal expenses and reasonable attorneys' fees, arising out of any
breach of any representation or warranty of Lifeline under this
Agreement. If a claim for indemnification relates to any claim or
lawsuit by a third person against the indemnified Party, any indemnification
obligations set forth in this Agreement shall be subject to the following
conditions: (i) the indemnified Party shall notify the indemnifying Party in
writing promptly upon learning of any claim or lawsuit for which indemnification
is sought; (ii) the indemnifying Party shall have control of the defense or
settlement, provided
that the indemnified Party shall have the right (but not the obligation)
to participate in such defense or settlement with counsel at its selection and
at its sole expense; and
(iii) the
indemnified Party shall reasonably cooperate with the defense, at the
indemnifying Party’s expense.
10.2 Disclaimer of
Warranties. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS
AGREEMENT, EACH PARTY, AND ITS DIRECTORS, MANAGERS, OFFICERS, EMPLOYEES, AND
AFILIATES, MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND,
EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF PATENT RIGHTS
CLAIMS, ISSUED OR PENDING, AND THE ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER
OR NOT DISCOVERABLE, WITH RESPECT TO ANY JOINT PRODUCT.
NOTHING IN THIS AGREEMENT SHALL BE
CONSTRUED AS A REPRESENTATION MADE OR WARRANTY GIVEN BY BIOTIME OR ES THAT THE
PRACTICE OF THE WARF TECHNOLOGY OR ES TECHNOLOGY SHALL NOT INFRINGE THE PATENT
RIGHTS OF ANY THIRD PARTY.
NOTHING IN THIS AGREEMENT SHALL BE
CONSTRUED AS A REPRESENTATION MADE OR WARRANTY GIVEN BY LIFELINE THAT THE
PRACTICE OF THE CELL TECHNOLOGY SHALL NOT INFRINGE THE PATENT RIGHTS OF ANY
THIRD PARTY.
10.3 Limitation on
Liability. IN NO EVENT SHALL ANY PARTY, OR ITS DIRECTORS,
MANAGERS, OFFICERS, EMPLOYEES AND AFFILIATES, BE LIABLE FOR INCIDENTAL OR
CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING ECONOMIC DAMAGE OR INJURY TO
PROPERTY AND LOST PROFITS ARISING FROM THE PRODUCTION AND SALE OF JOINT PRODUCTS
UNDER THIS AGREEMENT.
ARTICLE 11 –
TERMINATION
11.1 Expiration. This
Agreement shall be effective on the Effective Date and shall terminate in twenty
(20) years or upon the expiration of the last to expire of the patents covering
Cell Technology, WARF Technology, or any Joint Product, whichever is later,
unless sooner terminated as provided in this Article 11.
11.2 Breach. Any
Party may terminate this Agreement and the rights, privileges and license
granted hereunder by written notice upon a breach or default of this Agreement
by the other Party, subject to the following notice and cure
provisions:
(a) If
the breach is non-payment of any amount due, the breach is not cured within
thirty (30) days of receipt of written notice of such non-payment;
or
(b) If
the breach is one other than non-payment of any amount due, the breach is not
cured within thirty (30) days of a written request to remedy such breach, or if
the breach
cannot be
cured within said thirty (30) day period, the failure of the Party in breach,
within said thirty (30) day period, to commence action necessary to cure the
breach, and to proceed with reasonable diligence thereafter to cure the
breach.
Such
termination shall become automatically effective unless the Party in breach
shall have cured the breach prior to the expiration of the applicable cure
period.
11.3 Other Grounds for
Termination.
(a) BioTime
and ES shall have the right to terminate this Agreement at any time immediately
upon notice to Lifeline if any claim is brought against BioTime or ES alleging
that the use of Cell Technology, WARF Technology, or WARF Materials infringes on
the patent or other intellectual property rights of any third
person. Notwithstanding any such notice of termination, BioTime and
ES shall remain obligated to pay all amounts due Lifeline under this Agreement
through the effective date of the termination.
(b) Lifeline
shall have the right to terminate this Agreement at any time immediately upon
notice to BioTime and ES if any claim is brought against Lifeline alleging that
the use of ES Technology, WARF Technology, or WARF Materials infringes on the
patent or other intellectual property rights of any third
person. Notwithstanding any such notice of termination, Lifeline
shall remain obligated to pay all amounts due BioTime and ES under this
Agreement through the effective date of the termination.
11.4 Survival. Upon
termination of this Agreement for any reason, nothing herein shall be construed
to release either Party from any obligation that matured prior to the effective
date of such termination. Article1, Article 10, Article 12, Article
13, Article 14, Section 6.2, and this Section 11.4, and any other Sections or
provisions which by their nature are intended to survive termination, shall
survive any such termination.
ARTICLE 12 -
CONFIDENTIALITY
12.1 Confidential
Information “Confidential Information” means (a) confidential
or proprietary information of BioTime or ES (including scientific knowledge,
know-how, methods, processes, inventions, techniques, and formulae) relating to
ES Technology, (b) confidential or proprietary information relating to Cell
Technology licensed to Lifeline and designated as being confidential or secret
under the Cell Technology license agreement, (c) confidential or proprietary
information relating to WARF Technology or WARF Materials licensed to BioTime or
ES and designated as being confidential or secret under the WARF Technology
license agreement, (d) confidential or proprietary information developed by a
Party (including scientific knowledge, know-how, methods, processes, inventions,
techniques, and formulae) relating to the use of Cell Technology or WARF
Technology in the production or use of a Joint Product, (e) confidential or
proprietary information (including scientific knowledge, know-how, methods,
processes, inventions, techniques, and formulae) developed by a Party relating
to the production or use of a Joint Product, other than information described in
clause (d), (f) Joint Product sales data, (g) marketing plans, methods, and
studies, (h) the identity of customers and customer
requirements,
(i) Production Costs, and (j) such other information that is designated as
Confidential Information in this Agreement, or that a Party maintains as
confidential and designates as Confidential Information in a writing delivered
to another Party. Confidential Information may be in written,
graphic, oral or physical form and may include designs, sketches, photographs,
drawings, specifications, reports, data, plans or other records, biological
materials, and/or software. Confidential Information shall not
include:
|
(a)
|
information
which is, or later becomes, generally available to the public through no
fault of the recipient;
|
|
(b)
|
information
which is provided to the recipient by an independent third party having no
obligation to a Party or to WARF or ACT to keep the information
secret;
|
|
(c)
|
information
which the recipient can establish by written documentation was previously
known to it;
|
|
(d)
|
information
which the recipient can establish by written documentation was
independently developed by it without reference to the Confidential
Information of any other Party; or
|
|
(e)
|
information
required to be disclosed by a Party under any law or government
regulation, or under any order of any court, government agency, or other
adjudicative or administrative body having jurisdiction over the
Party.
|
12.2 Protection of Confidential
Information. During the term of this Agreement, the Parties
may provide each other with Confidential Information. Each Party
intends to maintain the confidential or trade secret status of its Confidential
Information. Each Party shall exercise reasonable care, and not less
than the standard of care it exercises in protecting the secrecy of its own
Confidential Information, to protect the Confidential Information received from
the other Party from disclosure to third persons. Neither Party shall
disclose Confidential Information (other than the Party’s own Confidential
Information) to any third person without the written permission of the other
Party (or ACT in the case of Confidential Information described in clause (b) of
Section 12.1, or WARF in the case of Confidential Information described in
clause (c) of Section 12.1); provided, that each Party may disclose Confidential
Information to the Party’s employees, officers, directors, attorneys, and
contractors who have a need to know such information in connection with the
performance of services for the Party. Upon termination or expiration
of this Agreement, each Party shall comply with the other’s written request to
return all of the other Party’s Confidential Information that is in written or
tangible form. No Party is granted any license to use another Party’s
Confidential Information for any purpose other than the production, marketing,
distribution, and sale of Joint Products under this Agreement or the enforcement
of a Party’s rights under this Agreement. The obligations of the
Parties under this Article 12 shall survive any expiration or termination of
this Agreement.
ARTICLE 13 - PAYMENTS,
NOTICES, AND OTHER COMMUNICATIONS
Any payment, notice or other
communication required or otherwise given pursuant to this Agreement shall be in
writing and sent by certified first class mail, return receipt requested,
postage prepaid, or by nationally recognized next business day delivery service
addressed to the parties at the following addresses or such other addresses as
such party furnishes to the other party in accordance with this
paragraph. Such notices, payments or other communications shall be
effective upon receipt.
If to
Lifeline: LifeLine
Cell Technology, LLC,2595 Jason Court
Oceanside, CA 92056
Attention: Jeffrey
Janus
If to
BioTime: BioTime,
Inc.
|
1301
Harbor Bay Parkway, Suite 100
|
|
Alameda,
California 94502
|
|
Attention:
Michael D. West, CEO
|
If
to ES:
|
Embryome
Sciences, Inc.
|
|
1301
Harbor Bay Parkway, Suite 100
|
|
Alameda,
California 94502
|
|
Attention:
Michael D. West, CEO
|
|
ARTICLE 14 -
REPRESENTATIONS AND
WARRANTIES
|
14.1 Enforceable
Agreement--Lifeline. Lifeline represents and warrants that (a)
it has licensed the Cell Technology, (b) it has the full legal and contractual
right and power to grant the sublicenses granted hereunder, (c) this Agreement
constitutes the binding, legal agreement of Lifeline, enforceable in accordance
with its terms, (d) the execution and delivery of this Agreement by Lifeline,
and the performance of Lifeline’s obligations under this Agreement, will not
violate, contravene or conflict with (i) any other agreement to which Lifeline
is a party or by which it is bound, or (ii) any law, rule or regulation
applicable to Lifeline.
14.2 No Infringement—Cell
Technology. To the best of Lifeline’s knowledge, the use of
the Cell Technology to produce, make, and distribute Joint Products will not
infringe on any patent or trade secret or other intellectual property right of
any third person. Lifeline has never received any complaint, claim,
demand, or notice alleging that the Cell Technology infringes on any patent or
trade secret or other intellectual property right of any third
person.
14.3 Enforceable
Agreement--BioTime. BioTime represents and warrants that (a) it has
licensed the WARF Technology, (b) it has the full legal and contractual right
and power to grant the sublicenses granted hereunder, (c) this Agreement
constitutes the binding, legal agreement of BioTime, enforceable in accordance
with its terms, and (d) the execution and delivery of this Agreement by BioTime,
and the performance of BioTime’s obligations under this
Agreement,
will not
violate, contravene or conflict with (i) any other agreement to which BioTime is
a party or by which it is bound, or (ii) any law, rule or regulation applicable
to BioTime.
14.4 Enforceable
Agreement--ES. ES represents and warrants that (a) this
Agreement constitutes the binding, legal agreement of ES, enforceable in
accordance with its terms, and (b) the execution and delivery of this Agreement
by ES, and the performance of ES’s obligations under this Agreement, will not
violate, contravene or conflict with (i) any other agreement to which ES is a
party or by which it is bound, or (ii) any law, rule or regulation applicable to
ES.
14.5 No Infringement—WARF
Technology. To the best of BioTime’s knowledge, the use of the
WARF Technology and ES Technology to develop Joint Products will not infringe on
any patent or trade secret or other intellectual property right of any third
person. BioTime has never received any complaint, claim, demand, or
notice alleging that the WARF Technology or the ES Technology infringes on any
patent or trade secret or other intellectual property right of any third
person.
14.6 Survival. This
Article 14 shall survive expiration or termination of this
Agreement.
ARTICLE 15 - MISCELLANEOUS
PROVISIONS
15.1 Compliance With
Law. Each party shall comply with all local, state, federal
and international laws and regulations relating to the production, sale, use,
distribution, and export of Joint Products.
15.2 No Partnership or
Agency. Nothing herein shall be deemed to constitute any Party
as the agent or representative of any other Party. Each Party shall
be an independent contractor, not an employee or partner of any other Party, and
the manner in which each Party renders its services under this Agreement shall
be within its sole discretion. A Party shall not be responsible for
the acts or omissions of any other Party, nor shall a Party have authority to
speak for, represent or obligate any other Party in any way without prior
written authority from the other Party.
15.3 Patent
Marking. To the extent commercially feasible, and consistent
with prevailing business practices, all Joint Products distributed or sold under
this Agreement will be marked (or will be contained in packaging that is labeled
or marked) with the number of each issued patent that applies to such Joint
Product.
15.4 Applicable
Law. This Agreement shall be construed, governed, interpreted
and applied in accordance with the laws of the State of California, without
regard to principles of conflicts of law thereof.
15.5 Entire Agreement;
Amendment. This Agreement sets forth the entire agreement and
understanding of the Parties as to the subject matter of this
Agreement. This Agreement shall not be amended or modified except by
the execution of a written instrument subscribed to by the Party to be
charged.
15.6 Severability. The
provisions of this Agreement are severable, and in the event that any provisions
of this Agreement shall be determined to be invalid or unenforceable under any
controlling body of the law, such invalidity or unenforceability shall not in
any way affect the validity or enforceability of the remaining provisions
hereof.
15.7 Waiver. The
failure of a Party to assert a right under this Agreement or to insist upon
compliance with any term or condition of this Agreement shall not constitute a
waiver of that right or excuse a similar subsequent failure to perform any such
term or condition by the other Party, in the absence of an express written
waiver signed by the Party to be charged.
15.8 Parties. This
Agreement shall be binding on, and shall inure to the benefit of, Lifeline,
BioTime, and ES, and their respective successors and assigns.
15.9 Sublicense and
Assignment. BioTime and ES shall not sublicense or assign any
rights to use Cell Technology without first obtaining (a) the prior written
consent of LifeLine, and (b) any consent of ACT required under the ACT license
agreements. LifeLine shall not sublicense or assign any right to use
WARF Technology or WARF Materials without (a) the prior written consent of
BioTime and ES, and (b) any consent of WARF required under the WARF license
agreement. LifeLine shall not sublicense or assign any right to use
ES Technology without obtaining the prior written consent of ES. The
foregoing provisions of this Section 15.9 shall not restrict the rights of the
Parties to sell Joint Products under the terms of this Agreement.
15.10 Counterparts. This
Agreement may be executed in any number of counterparts, each of which shall be
deemed an original but all of which together shall constitute one and the same
instrument. Any document, including, without limitation, counterparts
of this Agreement, may be transmitted by facsimile or other electronic means and
upon receipt shall be deemed an original; provided that upon demand of the
recipient, the sender within a reasonable time of such demand shall mail or
deliver an originally signed copy of such document.
15.11 Persons. All
references to a “person” shall include a natural person or a corporation,
partnership, limited liability company, trust, or other legal
entity.
IN WITNESS WHEREOF, the Parties have
duly executed this Agreement as of the Effective Date set forth
above.
LifeLine
Cell Technology, LLC
By: /s/
Jeffrey
Janus
Printed
Name: Jeffrey
Janus
Title: CEO
BioTime,
Inc.
By: /s/
Michael
West
Printed
Name: Michael
West
Title: CEO
Embryome
Sciences, Inc.
By: /s/
Michael
West
Printed
Name: Michael
West
Title: CEO
SCHEDLUE
1
Exclusive
License Agreement dated May 14, 2004 by and between Advanced Cell Technology,
Inc., and PacGen Cellco, LLC, as amended, August 25, 2005, pertaining to certain
patents and know-how owned by ACT.
Exclusive
License Agreement dated May 14, 2004 by and between Advanced Cell Technology,
Inc., and PacGen Cellco, LLC, as amended, August 25, 2005, pertaining to certain
patents and know-how owned by Infigen and licensed to ACT.
Exclusive
License Agreement dated May 14, 2004 by and between Advanced Cell Technology,
Inc., and PacGen Cellco, LLC, as amended, August 25, 2005, pertaining to certain
patents and know-how owned by the University of Massachusetts and licensed to
ACT.
19
ex10_32.htm
EXCLUSIVE LICENSE
AGREEMENT
This Exclusive License Agreement
(“Agreement”) is made and entered into as of the 10th day of July, 2008 (the
“Effective Date”), by and between Advanced Cell Technology, Inc., a Delaware
corporation with offices located at 11100 Santa Monica Blvd, Suite 850, Los
Angeles, CA 90025 (“ACT”), Embryome Sciences, Inc., a California corporation
(“LICENSEE”), with offices located at 1301 Harbor Bay Parkway, Suite 100,
Alameda, California 94502. ACT and LICENSEE are sometimes hereinafter referred
to as the “Parties”.
WITNESSETH
WHEREAS, ACT owns or has licensed with
a sublicensable interest the CELLS, PATENT RIGHTS and KNOW-HOW; and
WHEREAS, LICENSEE desires to obtain an
exclusive license from ACT to use the CELLS, PATENT RIGHTS and KNOW-HOW upon the
terms and conditions set forth in this Agreement; and
WHEREAS, ACT is willing to grant such a
license to LICENSEE upon the terms and conditions set forth in this
Agreement;
NOW, THEREFORE, in consideration of the
premises and the mutual covenants contained herein, the Parties hereto agree as
follows:
ARTICLE 1 -
DEFINITIONS
For the purposes of this Agreement, the
following words and phrases shall have the following meanings:
1.1 “AFFILIATE”
means any corporation, limited liability company, limited partnership or other
entity in control of, controlled by, or under common control with
LICENSEE.
1.2 “CELLS
or CELL LINES” means the cells and cell lines identified in Exhibit A attached
hereto that are covered by (i.e., made or developed using) the PATENT RIGHTS or
KNOW-HOW and/or are provided to LICENSEE by ACT in accordance with the
provisions of Articles 2 or 3, as applicable, of this Agreement.
1.3 “COMBINATION
PRODUCT” means a product that contains a LICENSED PRODUCT component and at least
one other component that has independent research, diagnostic or therapeutic
utility, could reasonably be sold separately and has economic value of its
own.
1.4 “CONFIDENTIAL
INFORMATION” means confidential or proprietary information of ACT or LICENSEE
relating to the PATENT RIGHTS, KNOW-HOW, LICENSED PROCESSES, LICENSED SERVICES
or LICENSED PRODUCTS. CONFIDENTIAL INFORMATION may be in written,
graphic, oral or physical form and may include scientific knowledge, know-how,
processes, inventions, techniques, formulae, products, business operations,
customer requirements, designs, sketches, photographs, drawings, specifications,
reports, studies, findings, data, plans or other records,
biological
materials, and/or software. CONFIDENTIAL INFORMATION shall not
include: (a) information which is, or later becomes, generally
available to the public through no fault of the recipient; (b) information which
is provided to the recipient by an independent third party having no obligation
to keep the information secret; (c) information which the recipient can
establish by written documentation was previously known to it; or (d)
information which the recipient can establish by written documentation was
independently developed by it without reference to the CONFIDENTIAL
INFORMATION.
1.5 “KNOW-HOW”
means all compositions of matter, techniques and data and other know-how and
technical information including inventions (whether or not patentable),
improvements and developments, practices, methods, concepts, trade secrets,
documents, computer data, computer slide illustrations, computer code,
apparatus, test data, analytical and quality control data, formulation,
manufacturing, patent data or descriptions, development information, drawings,
specifications, designs, plans, proposals and technical data and manuals and all
other CONFIDENTIAL INFORMATION that is owned or controlled by ACT as of the
Effective Date, and that specifically relates to the subject matter (a)
described in or claimed by the PATENT RIGHTS, (b) described in or claimed by the
abandoned provisional applications including but not limited to: "Methods to
accelerate the isolation of novel cell strains from pluripotent stem cells and
cells obtained thereby" applications numbers 103080-P66-071,103080-P67-071), and
(c) disclosed in the published paper and associated supplementary information
(West, M.D., Sargent, R.G., Long, J., Brown, C., Chu, J-S., Kessler, S.,
Derugin, N., Sampathkumar, J., Burrows, C., Vaziri, H., Williams, R., Chapman,
K.B., Larocca, D., Loring, J.F., and Murai, J. 2008. The ACTCellerate
Initiative: large-scale combinatorial cloning of novel human embryonic stem cell
derivatives. Reg. Med. 3(3): 287-308.).
1.6 “LICENSED
PROCESS” means any process or method, the development, use, practice,
or sale of which (1) is covered in whole or in part by, or cannot be performed
without infringing, a VALID CLAIM of the PATENT RIGHTS in the country in which
such LICENSED PROCESS is practiced or sold, or (2) otherwise utilizes the
KNOW-HOW.
1.7 “LICENSED
PRODUCT” means any product, or part thereof or derived therefrom, the
development, manufacture, sale, lease, or use of which (1) is covered in whole
or in part by, or cannot be performed without infringing, a VALID CLAIM of the
PATENT RIGHTS in the country in which any such product or part thereof is
developed, made, used, sold or imported by LICENSEE or (2) otherwise utilizes
the KNOW-HOW. By way of illustration but not limitation, the Parties
agree that LICENSED PRODUCTS include Cells and any other single cell-derived
cultures of human embryonic progenitor cell lines made utilizing the KNOW-HOW or
methods covered by VALID CLAIMS described in the patent applications and patents
included in the PATENT RIGHTS.
1.8 “LICENSED
SERVICES” means any service, the development, use, performance, or sale of which
is covered in whole or in part by, or cannot be performed without infringing, a
VALID CLAIM of the PATENT RIGHTS in the country in which any such service is so
developed, used, performed, sold, offered for sale, imported or exported by
LICENSEE or otherwise utilizes the KNOW-HOW.
1.9 “NET
SALES” means the invoiced amount on sales by LICENSEE or its Affiliates of
LICENSED PRODUCTS, LICENSED SERVICES or LICENSED PROCESSES less (to the extent
applicable and appropriately documented) (i) sales, tariff and import duties,
use and other taxes directly
imposed
with reference to particular sales, (ii) discounts, rebates, and similar credits
and chargebacks actually allowed and taken (regardless of whether taken or paid
at the time of sale or paid or credited to the buyer at a subsequent date), and
(iii) amounts allowed or credited on returns; provided, any such allowed
deductions shall be listed on the invoice for the applicable LICENSED PRODUCT,
LICENSED PROCESS or LICENSED SERVICE or otherwise documented in the ordinary
course of business, and (b) any Sublicense Revenue.
In the
case of Combination Products, Net Sales means the total invoice amount earned on
sales of Combination Products by LICENSEE or its Affiliates to any third person
or entity, less, to the extent applicable, the deductions set forth above,
multiplied by a proration factor that is determined as follows:
(i) If
all components of the Combination Product were sold separately during the same
or immediately preceding calendar quarter, the proration factor shall be
determined by the formula [A/(A+B)], where A is the average invoice amount
earned on the Licensed Product during such period when sold separately in
finished form, and B is the average invoice amount earned on all other active
components of the Combination Product during such period when sold separately in
finished form; or
(ii) if
all components of the Combination Product were not sold separately during the
same or immediately preceding calendar quarter, the proration factor shall be
determined by the formula [C/(C+D)], where C is the average fully absorbed cost
of the Licensed Product component during the prior quarter and D is the average
fully absorbed cost of all other active components of the Combination Product
during the prior quarter.
1.10 “PATENT
RIGHTS” means the patents and patent applications identified on Exhibit B attached
hereto, and any divisional, continuation or continuation-in-part of those
applications, but only to the extent the claims in said applications are
directed to subject matter specifically described in the patents and patent
applications identified on Exhibit B, as well as
any patents issued on these patent applications, and any reissues,
reexaminations, extensions and substitutions (or the equivalent) thereof and any
foreign counterparts to those patents and patent applications. The
parties agree that Exhibit B may be
revised from time to time after the EFFECTIVE DATE to reflect changes
thereto.
1.11 “SUBLICENSEE”
means a sublicensee of the rights granted LICENSEE under this Agreement, as
further described in Article 2.
1.12 “SUBLICENSE
REVENUE” means consideration that LICENSEE receives for the sublicense of rights
that are granted LICENSEE under Article 2, including
without limitation license fees, milestone payments, up front fees, success
fees, and license maintenance fees, but not capital contributions or payments
for costs incurred in research and development.
1.13 “VALID
CLAIM” means (a) a claim of any issued and unexpired United States or foreign
patent included in the PATENT RIGHTS which has not lapsed or become abandoned or
been declared invalid or unenforceable by a court of competent jurisdiction or
an administrative agency from which no appeal can be or has been taken within
the time allowed for such appeal and which has not been disclaimed or admitted
to be invalid or unenforceable through reissue, disclaimer or otherwise, or (b)
to the extent rights are granted by a governmental patent authority thereunder
(i.e., to the extent that
the owner
would be able to enforce a right to a patent royalty thereunder under applicable
patent law), a claim of a pending patent application included in the PATENT
RIGHTS.
For
purposes of this Agreement, except as otherwise expressly provided herein or
unless the context otherwise requires: (a) the use herein of the
plural shall include the single and vice versa and the use of the
masculine shall include the feminine; (b) unless otherwise set forth herein, the
use of the term “including” or “includes” means “including [includes] but [is]
not limited to”; and (c) the words “herein,” “hereof,” “hereunder” and other
words of similar import refer to this Agreement as a whole and not to any
particular provision. Additional terms may be defined throughout this
Agreement.
ARTICLE 2 – LICENSE
GRANT
2.1 Grant of
Rights. ACT hereby grants to LICENSEE, and LICENSEE accepts,
subject to the terms and conditions of this Agreement, a royalty-bearing,
worldwide, exclusive license, with the right to sublicense, to use
the PATENT RIGHTS and KNOW-HOW to (a) research, develop, make, have made, use,
sell, have sold, offer for sale, have offered for sale, import, have imported,
export and have exported LICENSED PRODUCTS, (b) research, develop, use,
practice, sell, have sold, offer for sale, have offered for sale, import, have
imported, export and have exported LICENSED PROCESSES, and (c) develop, use,
perform, sell, have sold, offer for sale, have offered for sale, import, have
imported, export and have exported LICENSED SERVICES.
2.2 Sublicense
Rights. LICENSEE shall have the right to grant sublicenses of
its rights under Section 2.1 without the consent or approval of ACT; provided
however, that LICENSEE agrees to provide ACT with (a) a draft copy of any
sublicense agreement to ACT at least thirty (30) days before execution to allow
ACT to comment on the terms of the sublicense if ACT chooses to comment; and (b)
a fully executed copy of all sublicense agreements within thirty (30) days after
execution.
2.3 Knowledge
Transfer. Within ten (10) days of the Effective Date, ACT
shall provide, deliver, and transfer to LICENSEE all information and data
relating to the PATENT RIGHTS and KNOW-HOW as may be reasonably necessary to
allow LICENSEE to exploit the licenses granted hereunder. Such transfer shall be
made free and clear of all liens, security interests, encumbrances, and claims
of any kind by any third party. ACT shall bear all costs of so
delivering the KNOW HOW to LICENSEE. ACT shall not retain any copies
(in any format or media) of the KNOW HOW.
ARTICLE 3 – MATERIAL
TRANSFER
3.1 In
consideration of the payment of the License Fee under Section 5.1, ACT hereby
transfers and assigns to LICENSEE all of ACT’s right, title and interest in and
to the CELLS and CELL LINES, wherever located. Within ten (10) days
after the Effective Date, ACT shall deliver to LICENSEE all CELLS and CELL
LINES. Such transfer and assignment is made free and clear of all
liens, security interests, encumbrances, and claims of any kind by any third
party. ACT shall bear all costs of delivering the CELLS
and CELL LINES to LICENSEE. ACT shall not retain any CELLS or CELL
LINES at its own facilities or at the facilities of any third
party. All CELLS and CELL LINES shall be delivered to LICENSEE
between the hours of 9:00 a.m. and 5:00 p.m. on a weekday (other than a Federal
or California state holiday) at the address shown in Article 11 of this
Agreement, upon twenty
four
hours oral or written notice to LICENSEE. All CELLS and CELL LINES
shall be contained in cryovials and packaging suitable for the purpose of
storage and delivery. ACT will cooperate with LICENSEE in transferring title of
CELLS and CELL LINES held at the American Type Culture Collection to
LICENSEE.
ARTICLE 4 –
COMMERCIALIZATION OBLIGATIONS
4.1 LICENSEE
intends to use, or to cause its Sublicensees to use, commercially reasonable and
diligent efforts to bring one or more LICENSED PRODUCTS, LICENSED PROCESSES and
LICENSED SERVICES to market through an active and diligent program for
exploitation of the PATENT RIGHTS and KNOW-HOW and to continue active, diligent
marketing efforts for one or more LICENSED PRODUCTS, LICENSED PROCESSES and
LICENSED SERVICES throughout the life of this Agreement. LICENSEE
makes no representation, guaranty, or warranty that it or its Sublicensees will
be successful in developing or bringing to market any LICENSED PRODUCT, LICENSED
PROCESS or LICENSED SERVICES.
ARTICLE 5 -
CONSIDERATION
5.1 Initial License
Fee. In partial consideration of the rights and licenses
granted to LICENSEE by ACT in this Agreement, LICENSEE shall pay to ACT on the
Effective Date a license fee equal to Two Hundred Fifty Thousand
Dollars (U.S.) ($250,000) (the “License Fee”). The License Fee is not
refundable and is not creditable against other payments due to ACT under this
Agreement. The License Fee shall be paid to ACT upon ACT’s delivery
of the KNOW HOW, CELLS, and CELL LINES pursuant to Section 2.3 and Section
3.1.
5.2 Royalties and other
Consideration.
(a) As
additional consideration of the license granted to LICENSEE from ACT in Article
2 of this Agreement, LICENSEE shall pay to ACT a royalty equal to 8% of (i) the
Net Sales received by LICENSEE and its AFFILIATES for all LICENSED PRODUCTS,
LICENSED PROCESS or LICENSED SERVICE sold, performed, or leased by LICENSEE or
any AFFILIATE, and (ii) all Sublicense Revenue received by LICENSEE and its
AFFILIATES. The obligation of LICENSEE to pay royalties shall
terminate (a) with respect to NET SALES and Sublicense Revenue arising in any
country concurrently with the expiration or termination of the last applicable
VALID CLAIM within the PATENT RIGHTS in such country in which the LICENSED
PRODUCT, LICENSED PROCESS or LICENSED SERVICE is, (as applicable), performed,
sold, leased, or manufactured, or in which the PATENT RIGHTS are licensed, and
(b) in any and all cases when royalty payments to ACT by LICENSEE total One
Million Dollars (U.S.) ($1,000,000.00); provided, however, that such $1,000,000
of royalties shall be reduced to $500,000 if LICENSEE, at LICENSEE’S option,
pays ACT $250,000 in cash within thirty (30) days after the execution of this
Agreement in addition to the License fee payable under Section 5.1 (such that
the License Fee, additional $250,000 payment, and potential future royalties
will total $1,000,000).
(b) No
multiple royalties shall be payable on the basis that any LICENSED PRODUCT,
LICENSED PROCESS or LICENSED SERVICE, its manufacture, use, lease, sale or
performance are or shall be covered by (a) more than one patent or patent
application within the
PATENT
RIGHTS, or (b) any other patent or know how under a license or sublicense from
ACT. In the case of the use of patents or know how licensed or
sublicensed by ACT under other agreements, LICENSEE and ACT’s other licensees or
sublicensees shall have the right to credit against the royalties owing to ACT,
under this Agreement and under such other license or sublicense agreements, any
royalty payments received by ACT with respect to the sale or lease of any
product or performance of any service (regardless of whether LICENSEE or another
licensee or sublicensee of ACT patents or know how pays the royalty), such that
in no event shall the total of royalty payments that are due to ACT in any
royalty period under this Agreement and under such other license or sublicense
agreements exceed the highest applicable royalty rate among this Agreement
and such other license or sublicense agreements. By way of example
only, if a product is produced by LICENSEE or LifeLine Cell Technology, LLC
(“LifeLine”) under that certain License, Product Production and Distribution
Agreement among BioTime, Inc. (“BT”), LICENSEE, and LifeLine (the “LifeLine
Agreement”), and that product uses PATENT RIGHTS under this Agreement and
patents licensed under a license or sublicense agreement between ACT and
LifeLine, (i) only one royalty would be paid to ACT on sales of the product,
(ii) the royalty rate would be the higher of the royalty rate applicable under
this Agreement or under ACT’s license or sublicense agreement with LifeLine, and
(iii) the royalty payment (whether paid by LICENSEE or by LifeLine) will be
credited toward royalties payable under this Agreement and under the ACT license
or sublicense agreement with LifeLine for the sale of the product.
5.3 Payment
Method. All payments due under this Agreement shall be paid to
ACT in Los Angeles, California, U.S.A., and shall be made in United
States currency without deduction for taxes, assessments, exchanges, collection
or other charges of any kind. Conversion of foreign currency to U.S. dollars
shall be made at the conversion rate reported in The Wall Street Journal on the
last working day of the calendar quarter to which the payment
relates.
5.4 Late
Fee. LICENSEE shall pay ACT interest on any overdue amounts at
the rate of one percent (1%) per month (twelve percent (12%) per annum), from
the date when such payment should have been made.
ARTICLE 6 - REPORTS AND
RECORDS
6.1 LICENSEE
shall maintain complete and accurate records of LICENSED PRODUCTS, LICENSED
SERVICES and LICENSED PROCESSES that are sold, performed, or, leased by LICENSEE
or its AFFILIATES under this Agreement, and all Sublicense Revenue
received by LICENSEE and its AFFILIATES. LICENSEE shall keep, and
shall cause its AFFILIATES and SUBLICENSEES to keep, full, true and accurate
books of account containing all particulars that may be necessary for the
purpose of showing the amounts payable to ACT hereunder and LICENSEE’s
compliance with the terms and conditions of this Agreement. Said
books of account shall be kept at LICENSEE’s principal place of business or at
such other location as may be agreed upon by the parties. Said books
and the supporting data shall be open upon reasonable advance notice (and no
more frequently than once per calendar year) for three (3) years following the
end of the calendar year to which they pertain, to the inspection of ACT or its
agents for the purpose of verifying LICENSEE’s royalty statement or compliance
in other respects with this Agreement. If any such audit determines
that the reported payments to ACT were less than ninety percent (95%) of the
actual amount due to ACT for the period in question, LICENSEE shall bear the
cost of such audit (without limiting ACT’s other remedies with respect
thereto).
6.2 After
the first commercial sale of a LICENSED PRODUCT, LICENSED SERVICE or LICENSED
PROCESS by LICENSEE any AFFILIATE, or any SUBLICENSEE, or LICENSEE’S
receipt of any Sublicense Revenue, LICENSEE, within forty-five (45) days after
March 31, June 30, September 30 and December 31, of each year, shall deliver to
ACT a true and accurate report of all NET SALES and License Revenue during the
preceding three-month period under this Agreement as shall be pertinent to a
royalty accounting hereunder. Each such report shall include at least
the following:
|
(a)
|
number(s)
and type(s) of LICENSED PRODUCTS, LICENSED PROCESSES and LICENSED SERVICES
sold, leased, or performed by LICENSEE and/or its
AFFILIATES;
|
|
(b)
|
total
billings and payments received for LICENSED PRODUCTS, LICENSED PROCESSES
and LICENSED SERVICES performed, sold, or leased by LICENSEE and its
AFFILIATES, and/or Sublicense Revenue received from
its SUBLICENSEES; and
|
|
(c)
|
deductions
applicable as provided in Section
1.9;
|
6.3 With
each such report submitted, LICENSEE shall pay to ACT the royalties and other
payments due and payable under this Agreement. If no royalties or
other payments shall be due, LICENSEE shall so report.
6.4 LICENSEE’s
reporting obligations hereunder shall terminate when LICENSEE’S obligation to
pay royalties to ACT terminates.
ARTICLE 7 - PATENT
RIGHTS
7.1 Responsibility for the
PATENT RIGHTS. Subject to the terms of this Agreement,
LICENSEE shall be primarily responsible after the Effective Date for the
preparation, filing, prosecution and maintenance of the PATENT RIGHTS listed on
Exhibit B. The
costs of such filing, prosecution and maintenance (including without limitation
the payment of all government fees in any given country required to maintain the
PATENT RIGHTS) after the Effective Date shall be borne by
LICENSEE. LICENSEE agrees to use reasonable commercial efforts to
prosecute U.S. patents covering the inventions disclosed in the patent
applications included in the PATENT RIGHTS. LICENSEE shall not be
obligated to reimburse ACT for any costs or expenses incurred by ACT prior to
the Effective Date with respect to the preparation, filing, and prosecution of
any patent applications.
7.2 ACT’s
Participation. ACT’s patent counsel shall be given a
reasonable opportunity to comment, at ACT’s expense, on all proposed patent
filings and responses to patent office actions or other patent office
communications that may affect the PATENT RIGHTS, and LICENSEE will not
unreasonably refuse to accept any suggestions of ACT’s patent
counsel; provided, however, that
LICENSEE will have the final decision on the incorporation of any comments of
ACT’s patent counsel.
7.3 Abandonment. LICENSEE
will not allow any patent or patent application within the PATENT RIGHTS to
become expired or abandoned, or fail to diligently pursue patent protection for
any invention within the PATENT RIGHTS, without giving (a) written notice to ACT
at least thirty (30)
business
days prior to the next due date for any required communication, response to
office action, filing, or payment, failure to meet which would result in
expiration or abandonment, including but not limited to provisional abandonment,
of the patent or patent application, and (b) ACT the right to assume
responsibility for such patent or patent application. If ACT so
elects, (i) LICENSEE will execute such documents and otherwise perform such acts
and make all filings as may be reasonably required to permit ACT or its
designees to prosecute and maintain such patent or application in such
jurisdiction(s) and transact all matters connected therewith (including, as
necessary, appointing ACT’s patent counsel as associate attorneys of record, and
changing address of the patent attorney of record with the appropriate patent
authorities), (ii) ACT will thereafter assume control thereof and all expenses
(arising thereafter) for such prosecution and maintenance by ACT, and (iii)
LICENSEE’s rights and the licenses granted to LICENSEE with respect to all such
patents and patent applications shall automatically terminate upon ACT’s
assumption of control thereof.
7.4 Enforcement of the PATENT
RIGHTS. The Parties agree to notify each other in writing of
any actual or threatened infringement by a third party of the PATENT RIGHTS or
of any third-party claim of invalidity or unenforceability of the PATENT RIGHTS,
or of any interference or other proceeding affecting the PATENT
RIGHTS. LICENSEE shall have the first right to prosecute and defend
such claims under its sole control and at its sole expense. If
LICENSEE does proceed with such prosecution or defense, ACT shall provide
reasonable assistance to LICENSEE at LICENSEE’s request, provided LICENSEE pays
ACT for the reasonable out-of-pockets costs incurred by ACT in providing such
assistance. Any recovery obtained in an action under this Section 7.4
shall be distributed as follows, in this order: (i) LICENSEE shall be reimbursed
for any expenses incurred in the action; and (ii) LICENSEE shall receive the
remaining recovery, less a reasonable approximation of the royalties that
LICENSEE would have paid to ACT if LICENSEE had received the amount awarded as
ordinary damages as Net Sales of LICENSED PRODUCTS sold by LICENSEE.
7.5 ACT Rights to
Enforce. In the event that LICENSEE fails to initiate an
infringement action within a reasonable time (but no more than one hundred
eighty (180) days) after LICENSEE becomes aware of the basis for such action
(e.g., the actual or threatened infringement) or fails to answer a declaratory
judgment action or interference proceeding within a reasonable time (but no more
than ninety (90) days) after LICENSEE receives or becomes aware of such
infringement or action or proceeding, ACT shall have the right, after notifying
LICENSEE in writing, to prosecute such infringement or answer such declaratory
judgment action or interference proceeding, under its sole control and at its
sole expense. If ACT does proceed with such prosecution or defense,
LICENSEE shall provide reasonable assistance to ACT at ACT’s request, provided
ACT pays LICENSEE for its reasonable out-of-pockets costs incurred in such
assistance. Any recovery obtained in an action under this Section 7.5
shall be distributed as follows, in this order: (i) ACT shall be reimbursed for
any expenses incurred in the action; (ii) as to ordinary damages, LICENSEE shall
receive an amount equal to lost profits or a reasonable royalty on the
infringing sales (whichever measure the court applied), less a reasonable
approximation of the royalties that LICENSEE would have paid to ACT if LICENSEE
had received such amount as Net Sales of LICENSED PRODUCTS sold by LICENSEE; and
(iii) as to any additional damages, 100% to ACT, unless LICENSEE joins ACT in
the prosecution at its own expense at which point the parties will share equally
in any award.
7.6. Cooperation. ACT
and LICENSEE agree to reasonably cooperate in connection with the preparation,
filing, prosecution, and maintenance of the PATENT
RIGHTS. Cooperation includes,
without
limitation, (a) promptly executing all papers and instruments or requiring
employees of ACT or LICENSEE to execute papers and instruments as reasonably
appropriate to enable LICENSEE to file, prosecute, and maintain PATENT RIGHTS in
any country; and (b) promptly informing LICENSEE of matters that may affect
preparation, filing, prosecution, or maintenance of PATENT RIGHTS (such as
becoming aware of an additional inventor who is not listed as an inventor in a
patent application). Additionally, in the event either party
exercises its rights hereunder to proceed with any prosecution of infringement
or defense of the PATENT RIGHTS, such party shall consult with the other party
regarding the course of such proceedings and shall not enter into any
settlement, consent judgment, or other voluntary final disposition of any
infringement action that admits the invalidity or unenforceability of any PATENT
RIGHTS or that would adversely affect the rights of the other party without the
prior written consent of the other party, which consent may not be unreasonably
withheld, conditioned or delayed. Without limiting the generality of
the provisions of this Section 7.6, concurrently with the execution and delivery
of this Agreement ACT shall execute, acknowledge, and deliver to LICENSEE the
documents attached to this Agreement as Exhibit C.
7.7 New Patents, Inventions, and
Discoveries. LICENSEE shall have the right to file and
prosecute new patent applications (and to obtain new patents) covering LICENSED
PRODUCTS, LICENSED PROCESSES, AND LICENSED SERVICES, and any other subject
matter, with respect to any KNOW HOW and any other technology, invention, or
discovery made by LICENSEE or any of its Affiliates or Sublicensees using PATENT
RIGHTS and KNOW HOW. ACT shall acquire no rights with respect to such
new patents, inventions, discoveries, or technology not included within the
PATENT RIGHTS and KNOW HOW licensed to LICENSEE by ACT.
ARTICLE 8 –
INDEMNIFICATION,
LIMITATION OF LIABILITY AND
INSURANCE
8.1 LICENSEE
shall at all times during the term of this Agreement and thereafter, indemnify,
defend and hold harmless ACT and its affiliates, successors, assigns, agents,
officers, directors, shareholders and employees (each, an “Indemnified Party”),
at LICENSEE’s sole cost and expense, against all liabilities of any kind
whatsoever, including legal expenses and reasonable attorneys’ fees, arising out
of the death of or injury to any person or persons or out of any damage to
property resulting from the production, manufacture, sale, use, lease,
performance, consumption or advertisement of the LICENSED PRODUCTS, LICENSED
PROCESSES or LICENSED SERVICES or arising from any obligation, act or omission,
or from a breach of any representation or warranty of LICENSEE hereunder,
excepting only claims that result from (a) the willful misconduct or gross
negligence of ACT, (b) any
material breach by ACT of its representations and warranties under this
Agreement, and (c) claims alleging that the use of any of the PATENT RIGHTS or
KNOW-HOW infringe upon any patent, trade secret, or moral right of any third
party. The indemnification obligations set forth herein are
subject to the following conditions: (i) the Indemnified Party shall notify
LICENSEE in writing promptly upon learning of any claim or suit for which
indemnification is sought; (ii) LICENSEE shall have control of the defense or
settlement, provided
that the Indemnified Party shall have the right (but not the obligation)
to participate in such defense or settlement with counsel at its selection and
at its sole expense; and (iii) the Indemnified Party shall reasonably cooperate
with the defense, at LICENSEE’s expense.
8.2 EXCEPT
AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, ACT, ITS DIRECTORS,
OFFICERS, AGENTS, SHAREHOLDERS, EMPLOYEES, AND AFFILIATES MAKE NO
REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED,
INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, VALIDITY OF PATENT RIGHTS CLAIMS, ISSUED OR PENDING, AND THE
ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE. NOTHING IN THIS
AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION MADE OR WARRANTY GIVEN BY ACT
THAT THE PRACTICE BY LICENSEE OF THE LICENSE GRANTED HEREUNDER SHALL NOT
INFRINGE THE PATENT RIGHTS OF ANY THIRD PARTY. IN NO EVENT SHALL ACT,
ITS DIRECTORS, OFFICERS, AGENTS, SHAREHOLDERS, EMPLOYEES AND AFFILIATES BE
LIABLE FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING ECONOMIC
DAMAGE OR INJURY TO PROPERTY AND LOST PROFITS, REGARDLESS OF WHETHER ACT SHALL
BE ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE
POSSIBILITY OF SUCH DAMAGES.
8.3 LICENSEE
agrees to maintain insurance or self-insurance that is reasonably adequate to
fulfill any potential obligation to the indemnified parties. LICENSEE
shall continue to maintain such insurance or self-insurance during the term of
this Agreement and after the expiration or termination of this Agreement for a
period of five (5) years.
ARTICLE 9 –
TERMINATION
9.1 This
Agreement shall be effective on the Effective Date and shall extend twenty (20)
years or until the expiration of the last to expire of the PATENT RIGHTS,
whichever is later, unless sooner terminated as provided in this Article
9.
9.2 ACT
may terminate this Agreement and the rights, privileges and license granted
hereunder by written notice upon a breach or default of this Agreement by
LICENSEE, as follows:
|
(i)
|
non-payment
of any amounts due which is not cured within thirty (30) days of receipt
of written notice of such non-payment wherein said notice is delivered by
registered mail; or
|
|
(ii)
|
breach
of any obligation which is not cured within thirty (30) days of a written
request to remedy such breach wherein said request is delivered by
registered mail, or if the breach cannot be cured within said thirty (30)
day period, failure of LICENSEE within said thirty (30) day period to
proceed with reasonable promptness thereafter to cure the
breach.
|
Such
termination shall become automatically effective unless LICENSEE shall have
cured any such material breach or default prior to the expiration of the
applicable cure period.
9.3 LICENSEE
shall have the right to terminate this Agreement at any time on three (3)
months’ prior notice to ACT, and upon payment of all amounts due ACT through
the
effective
date of the termination.
9.4 Upon
termination of this Agreement for any reason, nothing herein shall be construed
to release either party from any obligation that matured prior to the effective
date of such termination; and Sections 6.1,Article 8, Article 10, Article 12,
Section 13.4, Section 13.5, and Section 13.6, and any other Sections
or provisions which by their nature are intended to survive termination, shall
survive any such termination.
|
ARTICLE 10 -
CONFIDENTIALITY
|
10.1 During
the course of this Agreement, ACT and LICENSEE may provide each other with
CONFIDENTIAL INFORMATION. CONFIDENTIAL INFORMATION may be disclosed
in oral, visual or written form, and includes such information that is
designated in writing as such by the discloser at the time of disclosure, orally
disclosed information that is designated in writing as confidential within 30
days after such oral disclosure, or information which, under all of the given
circumstances ought reasonably be treated as CONFIDENTIAL INFORMATION of the
disclosing party. ACT and LICENSEE each intend to maintain the confidential or
trade secret status of their CONFIDENTIAL INFORMATION. Each shall
exercise reasonable care to protect the CONFIDENTIAL INFORMATION of the other
from disclosure to third parties; no such disclosure shall be made without the
other’s written permission. Upon termination or expiration of this
Agreement, ACT and/or LICENSEE shall comply with the other’s written request to
return all CONFIDENTIAL INFORMATION that is in written or tangible
form. Except as expressly provided herein, neither ACT nor LICENSEE
is granted any license to use the other’s CONFIDENTIAL
INFORMATION. The obligations of ACT and LICENSEE under this Article
10 shall survive any expiration or termination of this
Agreement. Notwithstanding the preceding provisions of this Section
10.1, until such time as this Agreement is terminated: (a) KNOW HOW
and the content of any patent application relating to or included in PATENT
RIGHTS shall be deemed to be the LICENSEE’s CONFIDENTIAL INFORMATION rather than
ACT’s CONFIDENTIAL INFORMATION; (b) LICENSEE shall have the right to disclose
KNOW HOW and the content of patent applications related to or included in PATENT
RIGHTS to third parties without restriction under this Agreement; and (c)
LICENSEE shall not have any obligation to ACT to treat KNOW HOW or the content
of any patent application related to or included in PATENT RIGHTS as ACT’s
CONFIDENTIAL INFORMATION.
10.2 The
parties agree that the specific terms (but not the overall existence) of this
Agreement shall be considered CONFIDENTIAL INFORMATION; provided, however, that
the parties may disclose the terms of this Agreement to investors or potential
investors, potential business partners, potential Sublicensees and assignees,
potential co-developers, manufacturers, marketers, or distributors of any
LICENSED PRODUCT, LICENSED PROCESS, or LICENSED SERVICE, and in any prospectus,
offering, memorandum, or other document or filing required by applicable
securities laws or other applicable law or regulation. The parties
may also disclose CONFIDENTIAL INFORMATION that is required to be disclosed to
comply with applicable law or court order, provided that the recipient gives
reasonable prior written notice of the required disclosure to the discloser and
reasonably cooperates with the discloser’s efforts to prevent such
disclosure.
ARTICLE 11 - PAYMENTS,
NOTICES, AND OTHER COMMUNICATIONS
Any payment, notice or other
communication required to be given to any party will be deemed to have been
properly given and to be effective (a) on the date of delivery if delivered by
hand, recognized national next business day delivery service, confirmed
facsimile transmission, or confirmed electronic mail, or five (5) days after
mailing by registered or certified mail, postage prepaid, return receipt
requested, to the respective addresses given below, or to another address as it
shall designate by written notice given to the other party in the manner
provided in this Section.
In the case of
ACT: Advanced
Cell Technology, Inc.
11100 Santa Monica Blvd, Suite
850
Los Angeles, CA 90025
Attention: William M.
Caldwell, IV
With a copy
to: Pierce
Atwood LLP
One Monument Square
Portland, ME 04101
Attention: William L.
Worden, Esq.
In the case of
LICENSEE Embryome
Sciences, Inc.
1301 Harbor Bay Parkway, Suite 100
Alameda, California 94502
Attention: Michael D. West
With a
copy
to:
Richard S. Soroko, Esq.
Lippenberger, Thompson, Welch, Soroko & Gilbert LLP
201 Tamal Vista Blvd.
Corte Madera, California 94925
ARTICLE 12 - REPRESENTATIONS
AND WARRANTIES
12.1 LICENSEE
represents and warrants that it has full corporate power and authority to enter
into this Agreement, that this Agreement constitutes the binding legal
obligation of LICENSEE, enforceable in accordance with its terms, and that the
execution and performance of this Agreement by LICENSEE will not violate,
contravene or conflict with any other agreement to which LICENSEE is a party or
by which it is bound or with any law, rule or regulation applicable to LICENSEE,
and that any permits, consents or approvals necessary or appropriate for
LICENSEE to enter into this Agreement have been obtained.
12.2 LICENSEE
is an entity duly incorporated or otherwise organized, validly existing and in
good standing under the laws of the jurisdiction of its incorporation or
organization, with the requisite power and authority to own and use its
properties and assets and to carry on its business as currently
conducted.
12.3 ACT
represents and warrants that (a) it owns the PATENT RIGHTS and KNOW HOW, (b) it
has the full legal right and power to grant the licenses granted hereunder, (c)
that this Agreement constitutes the binding legal obligation of ACT, enforceable
in accordance with its terms, (c) the execution, delivery, and performance of
this Agreement by ACT will not violate, contravene or
conflict
with any other agreement to which ACT is a party or by which it is bound or with
any law, rule or regulation applicable to ACT, and (d) any permits, consents or
approvals necessary or appropriate for ACT to enter into this Agreement have
been obtained.
12.4 ACT
represents and warrants that, to the best of its knowledge, the use of the
PATENT RIGHTS and KNOW HOW by LICENSEE or any Sublicensee for any purposes
contemplated or permitted by this Agreement, will not infringe in any way any
claim under any patent held by any third party.
12.5 ACT
represents and warrant that the use of the PATENT RIGHTS and KNOW-HOW by
LICENSEE or any Sublicensee for any purposes contemplated or permitted by this
Agreement, will not infringe in any way any claim under any patent held by ACT
or under any patent that may issue from any ACT patent application now pending,
or under any patent that ACT may in the future obtain, or any other intellectual
property rights of ACT.
12.6 ACT
further represents, warrants and agrees, that it shall not make any claim or
demand, or commence any lawsuit or other proceeding, alleging that use of the
PATENT RIGHTS, KNOW-HOW, CELLS, and CELL LINES by LICENSEE or any Sublicensee
for any purpose contemplated or permitted by this Agreement infringes in any way
any claim under any patent held by ACT or under any patent that may issue from
any ACT patent application now pending, or under any patent that ACT may in the
future obtain, or any other intellectual property rights of ACT. The
provisions of this Section 12.5 shall pertain as well to all subsidiaries of ACT
and all patents and patent applications of ACT subsidiaries. ACT and
its subsidiaries shall cause the provisions of this Section 12.6, as they
pertain to refraining from asserting claims and demands or commencing lawsuits
and proceedings, to be including in all licenses and assignments of ACT’s
patents and patent applications.
12.7 ACT
represents and warrants that all of the patent applications of ACT and its
subsidiaries pertaining to the processes or technology needed (alone or together
with the KNOW-HOW) to make or develop CELLS and CELL LINES are identified on
Exhibit
B.
12.8 This
Article 12 shall survive expiration or termination of this
Agreement.
ARTICLE 13 – ACT
OPTIONS
13.1 ACT shall have the option to acquire
from LICENCEE an exclusive, royalty free, world-wide license to use PATENT
RIGHTS and KNOW-HOW to research, develop, make, have made, use, sell, have sold,
offer for sale, have offered for sale, import, have imported, export and have
exported LICENSED PRODUCTS consisting of retinal pigment epithelial
cells, hemangioblasts, and myocardial cells for human therapeutic use, and a
non-exclusive, royalty free, world-wide license to use PATENT RIGHTS and
KNOW-HOW to research, develop, make, have made, use, sell, have sold, offer for
sale, have offered for sale, import, have imported, export and have exported
LICENSED PRODUCTS consisting of hepatocytes for human
therapeutic use.
13.2 The
options granted to ACT under this Section 13.1 are exercisable by ACT
individually, with respect to each cell type, so that ACT may elect to exercise
its option with respect to all or with respect to one or more of such cell
types, but each such exercise shall require payment of the
Exercise
Price with respect to each such cell type. The Exercise Price shall
be $5,000 for each cell type. ACT may exercise its option with respect to a
particular cell type by delivering to LICENSEE written notice of such exercise,
specifying the cell type(s) and accompanied by payment of the Exercise Price for
each such cell type as to which the option is being exercised.
13.3 The
option granted to ACT under this Article 13 with respect to a particular cell
type may be exercised by ACT during a 12 month period commencing on the date on
which LICENSEE gives ACT notice of the first VALID CLAIM under a patent is
issued in any country covering LICENSED PRODUCTS of any kind that would include
that cell type, and ending on the day immediately preceding the first
anniversary of the date on which such notice was given by
LICENSEE. ACT may not exercise the option after such 12 month period
expires. Notwithstanding any other provision of this Article 13, ACT
may not exercise its option if ACT is in breach or default of any of its
agreements, covenants, representations, or warranties under this
Agreement.
13.4 If
ACT exercises an option and acquires a license under this Article 13, ACT shall
at all times during the term of this Agreement and thereafter, indemnify, defend
and hold harmless LICENSEE and LICENSEE’s Affiliates, successors, assigns,
agents, officers, directors, shareholders and employees (each, a “LICENSEE
Indemnified Party”), at ACT’s sole cost and expense, against all liabilities of
any kind whatsoever, including legal expenses and reasonable attorneys’ fees,
arising out of the death of or injury to any person or persons or out of any
damage to property resulting from the production, manufacture, sale, use, lease,
performance, consumption or advertisement of the LICENSED PRODUCTS under such
license, The indemnification obligations set forth herein are subject
to the following conditions: (i) the LICENSEE Indemnified Party shall notify ACT
in writing promptly upon learning of any claim or suit for which indemnification
is sought; (ii) ACT shall have control of the defense or settlement, provided that the
LICENSEE Indemnified Party shall have the right (but not the obligation) to
participate in such defense or settlement with counsel at its selection and at
its sole expense; and (iii) the LICENSEE Indemnified Party shall reasonably
cooperate with the defense, at ACT’s expense.
13.5 EXCEPT
AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, LICENSEE, ITS DIRECTORS,
OFFICERS, AGENTS, SHAREHOLDERS, EMPLOYEES, AND AFFILIATES MAKE NO
REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED,
INCLUDING BUT NOT LIMITED TO WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE, VALIDITY OF PATENT RIGHTS CLAIMS, ISSUED OR PENDING, AND THE
ABSENCE OF LATENT OR OTHER DEFECTS, WHETHER OR NOT DISCOVERABLE. NOTHING IN THIS
AGREEMENT SHALL BE CONSTRUED AS A REPRESENTATION MADE OR WARRANTY GIVEN BY ACT
THAT THE PRACTICE BY ACT OF ANY LICENSE GRANTED HEREUNDER SHALL NOT INFRINGE THE
PATENT RIGHTS OF ANY THIRD PARTY. IN NO EVENT SHALL LICENSEE, ITS
DIRECTORS, OFFICERS, AGENTS, SHAREHOLDERS, EMPLOYEES AND AFFILIATES BE LIABLE
FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING ECONOMIC DAMAGE
OR INJURY TO PROPERTY AND LOST PROFITS, REGARDLESS OF WHETHER LICENSEE SHALL BE
ADVISED, SHALL HAVE OTHER REASON TO KNOW, OR IN FACT SHALL KNOW OF THE
POSSIBILITY OF SUCH DAMAGES.
13.6 ACT
agrees to maintain insurance or self-insurance that is reasonably adequate to
fulfill
any
potential obligation to the LICENSEE Indemnified Parties. ACT shall
continue to maintain such insurance or self-insurance during the term of each of
its licenses and after the expiration or termination of the licenses for a
period of five (5) years.
ARTICLE 14 - MISCELLANEOUS
PROVISIONS
14.1 Nothing
herein shall be deemed to constitute either party as the agent or representative
of the other party.
14.2 To
the extent commercially feasible, and consistent with prevailing business
practices, all products manufactured or sold under this Agreement will be marked
with the number of each issued patent that applies to such product.
14.3 This
Agreement shall be construed, governed, interpreted and applied in accordance
with the laws of California, without regard to principles of conflicts of law
thereof, except that questions affecting the construction and effect of any
patent shall be determined by the law of the country in which the patent was
granted.
14.4 The
parties hereto acknowledge that this Agreement (including the Exhibits hereto)
sets forth the entire Agreement and understanding of the parties hereto as to
the subject matter hereof, and shall not be subject to any change or
modification except by the execution of a written instrument subscribed to by
the parties hereto.
14.5 The
provisions of this Agreement are severable, and in the event that any provisions
of this Agreement shall be determined to be invalid or unenforceable under any
controlling body of the law, such invalidity or unenforceability shall not in
any way affect the validity or enforceability of the remaining provisions
hereof.
14.6 The
failure of either party to assert a right hereunder or to insist upon compliance
with any term or condition of this Agreement shall not constitute a waiver of
that right or excuse a similar subsequent failure to perform any such term or
condition by the other party.
[The next
page is the signature page]
IN WITNESS WHEREOF, the parties have
duly executed this Agreement as of the Effective Date set forth
above.
ADVANCED
CELL TECHNOLOGY, INC.
By: /s/
William M. Caldwell,
IV
Printed
Name: William M. Caldwell, IV
Title: Chairman
& CEO
By:
Printed
Name:
Title: Secretary
EMBRYOME
SCIENCES, INC.
By: /s/
Michael D.
West
Printed
Name: Michael D. West
Title:
Chief Executive Officer
By: /s/
Judith
Segall
Printed
Name: Judith Segall
Title:
Secretary
EXHIBIT
A
ACTC
No.
|
Cell
Line
|
NA
|
Parental
hES Cells
|
A
|
Parental
hES Cells
|
50
|
B-26
|
51
|
B-2
|
52
|
B-29
|
53
|
B-7
|
54
|
B-17
|
55
|
B-3
|
56
|
B-6
|
57
|
B-25
|
58
|
B-11
|
59
|
B-16
|
60
|
B-28
|
61
|
B-30
|
62
|
2-2
(Rep1)
|
62
|
2-2
(Rep2)
|
63
|
2-1
|
64
|
6-1
|
65
|
B-12
|
66
|
B-4
|
67
|
B-14
|
68
|
5-4
|
69
|
4-2
|
70
|
2-3
|
71
|
B-15
|
72
|
CM50-4
|
ACTC
No.
|
Cell Line
|
73
|
CM0-3
|
74
|
CM0-5
|
75
|
CM50-5
|
76
|
CM50-2
|
77
|
CM0-2
|
78
|
CM30-2
|
79
|
CM20-4
|
80
|
E26
|
81
|
E71
|
82
|
4-D20-9
|
83
|
4-SKEL-19
|
84
|
4-D20-8
|
85
|
E34
|
86
|
E51
|
87
|
C4.4
|
88
|
E3
|
89
|
E73
|
90
|
E93
|
91
|
E57
|
92
|
C4
ELSR #14
|
93
|
E76
|
94
|
E17
|
95
|
E40
|
96
|
E8
|
97
|
E67
|
98
|
E15
|
99
|
E45
|
100
|
E72
|
101
|
E69
|
ACTC No. |
Cell
Line |
102
|
E75
|
103
|
M10
|
104
|
M13
|
105
|
E19
|
106
|
T44
|
107
|
E61
|
108
|
C4
ELSR #18
|
109
|
RA-SKEL-8
|
110
|
4-SKEL-8
|
111
|
RA-PEND-15
|
112
|
E108
|
113
|
E35
|
114
|
E33
|
115
|
E80
|
116
|
E84
|
117
|
E109
|
118
|
C4
ELS5 #6
|
119
|
J8
|
120
|
T43
|
121
|
E10
|
122
|
RA-PEND-6
|
123
|
RA-PEND-10
|
124
|
RA-SKEL-3
|
125
|
RA-SKEL-21
|
126
|
4-SKEL-4
|
127
|
4-SKEL-20
|
128
|
RA-PEND-4
|
129
|
RA-PEND-18
|
130
|
C4
ELS5 #1
|
ACTC
No.
|
Cell Line |
131
|
C4
ELSR #12
|
132
|
E163
|
133
|
C4
Mesen. #3
|
134
|
G6
|
135
|
C4
ELS5 #5
|
136
|
J16
|
137
|
SK46
|
138
|
SK47
|
139
|
EN2
|
140
|
EN26
|
141
|
EN31
|
142
|
SM2
|
143
|
SM4
|
144
|
EN4
|
145
|
EN5
|
146
|
SK52
|
147
|
SK43
|
148
|
SK30
|
149
|
SM42
|
150
|
SM28
|
151
|
SM49
|
152
|
C4
ELSR #10
|
153
|
RA-SKEL-11
|
154
|
RA-SMO-12
|
155
|
RA-D20-16
|
156
|
SM22
|
157
|
SK5
|
158
|
SK18
|
159
|
SK50
|
ACTC No.
|
Cell
Line
|
160
|
SK54
|
161
|
J4
|
162
|
SK17
|
163
|
SK26
|
164
|
SK31
|
165
|
SK32
|
166
|
SM25
|
167
|
C4
ELSR #2 (Bio 1)
|
167
|
C4
ELSR #2 (Bio 2)
|
167
|
C4
ELSR #2 (Bio 3)
|
168
|
SK3
|
169
|
SK53
|
170
|
E44
|
171
|
E65
|
172
|
J13
|
173
|
EN1
|
174
|
EN13
|
175
|
EN42
|
176
|
EN47
|
177
|
SM27
|
178
|
E50
|
179
|
E30
(Bio1)
|
179
|
E30
(Bio2)
|
180
|
E122
|
181
|
SK61
|
182
|
SM17
|
183
|
SM33
|
184
|
EN7
|
185
|
EN55
|
ACTC No.
|
Cell
Line
|
186
|
T7
|
187
|
EN22
|
188
|
SK58
|
189
|
MW2
|
190
|
SK8
|
191
|
SK20
|
192
|
SK60
|
193
|
MW6
|
194
|
Z11
(Rep 1)
|
194
|
Z11
(Rep 2)
|
195
|
Z6
|
196
|
W10
|
197
|
W11
|
198
|
T36
|
199
|
EN27
|
200
|
Z7
|
201
|
SM44
|
202
|
EN38
|
203
|
SK1
|
204
|
SK44
|
205
|
SK57
|
206
|
J2
|
207
|
E68
|
208
|
E169
|
209
|
E164
|
210
|
T42
|
211
|
T14
|
212
|
RA-D20-6
|
213
|
Z8
|
ACTC
No.
|
Cell
Line
|
214
|
SK40
|
215
|
EN11
|
216
|
EN18
|
217
|
EN23
|
218
|
SK14
|
219
|
SK10
|
220
|
EN51
|
221
|
EN16
|
222
|
E53
|
223
|
E111
|
224
|
SK49
|
225
|
SM8
|
226
|
RA-D20-5
|
227
|
RA-D20-24
|
228
|
W7
|
229
|
4-D20-14
|
230
|
RA-D20-19
|
231
|
T20
|
232
|
RA-SMO-19
|
233
|
M11
|
234
|
EN9
|
235
|
Q7
|
236
|
U31
|
237
|
EN19
|
238
|
C4
ELS5 #8
|
239
|
Q8
|
240
|
SK25
|
241
|
EN20
|
242
|
MW1
|
ACTC
No.
|
Cell
Line
|
243
|
C4
ELSR #13
|
244
|
Z3
|
245
|
W8
(Rep 1)
|
245
|
W8
(Rep 2)
|
246
|
SK28
|
247
|
E120
|
248
|
SM51
|
249
|
EN8
|
250
|
SK11
|
251
|
EN43
|
252
|
4-D20-3
|
253
|
EN44
|
254
|
EN50
|
255
|
Z2
|
256
|
SM30
|
257
|
EN53
|
258
|
SK27
|
259
|
U18
|
260
|
SM35
|
261
|
EN25
|
262
|
C4
ELSR 6
|
263
|
Z1
|
264
|
F15
|
265
|
RA-SKEL-9
|
266
|
E85
|
267
|
W4
|
268
|
MEL-2
|
269
|
LS2
|
270
|
7-SKEL-4
|
ACTC
No.
|
Cell
Line
|
271
|
7-SKEL-7
|
272
|
7-PEND-9
|
273
|
7-PEND-16
|
274
|
7-SKEL-6
|
275
|
LS3
|
276
|
7-SMOO-19
|
277
|
7-SMOO-29
|
278
|
7-SMOO-32
|
279
|
7-SMOO-33
|
280
|
7-SMOO-4
|
281
|
7-SMOO-9
|
282
|
7-SMOO-17
|
283
|
7-PEND-24
|
284
|
7-SKEL-32
|
285
|
7-SMOO-13
|
286
|
7-SMOO-25
|
287
|
7-SMOO-12
|
288
|
7-PEND-30
|
289
|
7-SKEL-25
|
290
|
7-SMOO-6
|
291
|
7-SMOO-26
|
292
|
7-SMOO-22
|
293
|
7-SMOO-8
|
294
|
7-SKEL-14
|
295
|
7-SKEL-11
|
296
|
7-SKEL-2
|
297
|
7-SKEL-22
|
298
|
7-SMOO-7
|
299
|
7-PEND-12
|
ACTC
No.
|
Cell Line
|
300
|
7-SMOO-27
|
301
|
7-PEND-13
|
302
|
7-PEND-11
|
303
|
7-PEND-15
|
304
|
7-PEND-32
|
305
|
7-PEND-26
|
306
|
7-SKEL-24
|
307
|
7-PEND-10
|
308
|
7-PEND-23
|
309
|
10-RPE-9
|
310
|
10-RPE-8
|
311
|
RA-PEND-19
|
NA
|
X4.1
|
NA
|
X4.3
|
NA
|
B-10
|
NA
|
B-1
|
NA
|
X4
|
NA
|
X5
|
NA
|
B-20
|
NA
|
B-22
|
NA
|
X6
|
NA
|
CM10.1
|
NA
|
X2
|
NA
|
B-27
|
NA
|
B-9
|
NA
|
X4.4
|
NA
|
E31
|
NA
|
CM10-4
|
NA
|
CM30-5
|
ACTC
No.
|
Cell
Line
|
NA
|
EN28
|
NA
|
Q4
|
NA
|
Q6
|
NA
|
RA-PEND-17
(Bio 1)
|
NA
|
RA-PEND-17
(Bio 2)
|
NA
|
RA-SKEL-18
(Rep 1)
|
NA
|
RA-SKEL-18
(Rep 2)
|
NA
|
RA-SKEL-6
|
NA
|
SM19
|
NA
|
SM29
|
NA
|
SM40
|
NA
|
T23
|
NA
|
T4
|
NA
|
U30
|
NA
|
W2
|
NA
|
W3
|
NA
|
E11
|
NA
|
SK15
|
NA
|
E55
|
NA
|
E132
|
NA
|
RA-SMO-10
|
NA
|
RA-SMO-14
|
NA
|
W9
|
NA
|
MW4
|
NA
|
SK16
|
.
.
.
[Attach
complete list of ACTCellerate cell lines (200+ lines)]
EXHIBIT
B
PATENT
RIGHTS
103080-069-WO1 (PCT/US06/13519,
filed on 4-11-06): NOVEL USES OF CELLS WITH PRENATAL PATTERNS OF GENE
EXPRESSION, published as WO2007/058671
103080-071-P61 (USSN
60/791,400, filed on Apr. 11, 2006): METHODS TO ACCELERATE THE ISOLATION OF
NOVEL CELL STRAINS FROM PLURIPOTENT ST
103080-071-P66 (USSN
60/850,294, filed on Oct. 6, 2006), METHODS TO ACCELERATE THE ISOLATION OF NOVEL
CELL STRAINS FROM PLURIPOTENT STEM CELLS
103080-071-P01
(USSN 11/604,047, filed on Nov. 21, 2006), METHODS TO ACCELERATE THE ISOLATION
OF NOVEL CELL STRAINS FROM PLURIPOTENT STE...
PCT is
103080-071-WO2 (PCT/US2006/45352, filed on Nov. 21, 2006), published as WO
2007/062198.
Subsequent
provisional filings of CIPs of the above through February 2007.
EXHIBIT
C
POWERS OF ATTORNEY AND OTHER
AUTHTORIZATIONS RELATING TO PATENT RIGHTS
ex31.htm
Exhibit
31
CERTIFICATIONS
I,
Michael D. West, certify that:
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 (first) 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.
Date: August
14, 2008
|
|
|
|
/s/ Michael D. West
|
|
Michael
D. West
|
|
Chief
Executive Officer
|
|
Exhibit
31
CERTIFICATIONS
I, Steven
A. Seinberg, certify that:
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 (first) 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.
Date: August
14, 2008
|
|
|
|
/s/ Steven A. Seinberg
|
|
Steven
A. Seinberg
|
|
Chief
Financial Officer
|
|
ex32.htm
Exhibit
32
CERTIFICATION
PURSUANT TO 18 U.S.C. SECTION 1350,
AS
ADOPTED PURSUANT TO
SECTION
906 OF THE SARBANES-OXLEY ACT OF 2002
In
connection with the Quarterly Report on Form 10-Q of BioTime, Inc. (the
“Company”) for the quarter ended June 30, 2008 as filed with the Securities and
Exchange Commission on the date hereof (the “Report”), we, Michael D. West,
Chief Executive Officer, and Steven A. Seinberg, Chief Financial Officer of the
Company, certify pursuant to 18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002, that:
1. The
Report fully complies with the requirements of Section 13(a) or 15(d) of the
Securities Exchange Act of 1934, as amended; and
2. The
information contained in the Report fairly presents, in all material respects,
the financial condition and results of operations of the Company.
Date: August
14, 2008
/s/ Michael D. West
|
|
Michael
D. West
|
|
Chief
Executive Officer
|
|
|
|
|
|
/s/ Steven A. Seinberg
|
|
Steven
A. Seinberg
|
|
Chief
Financial Officer
|
|