e10vq
FORM 10-Q
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF
1934 |
For the quarterly period ended September 30, 2007
OR
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o |
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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 000-30171
SANGAMO BIOSCIENCES, INC.
(exact name of small business issuer as specified in its charter)
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Delaware
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68-0359556 |
(State or other jurisdiction of incorporation or organization)
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(IRS Employer Identification No.) |
501 Canal Blvd, Suite A100
Richmond, California 94804
(Address of principal executive offices)
(510) 970-6000
(Registrants telephone number, including area code)
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 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 þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act.
Large accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No þ
As of October 26, 2007, 40,141,534 shares of the issuers common stock, par value $0.01 per
share, were outstanding.
INDEX
SANGAMO BIOSCIENCES, INC.
CERTIFICATIONS
Some statements contained in this report are forward-looking with respect to our operations,
research and development activities, operating results and financial condition. Statements that are
forward-looking in nature should be read with caution because they involve risks and uncertainties,
which are included, for example, in specific and general discussions about:
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our strategy; |
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product development and commercialization of our products; |
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clinical trials; |
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revenues from existing and new collaborations; |
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sufficiency of our cash resources; |
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our research and development and other expenses; |
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our operational and legal risks; and |
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our plans, objectives, expectations and intentions and any other statements that are not
historical facts. |
Various terms and expressions similar to them are intended to identify these cautionary statements.
These terms include: anticipates, believes, continues, could, estimates, expects,
intends, may, plans, seeks, should and will. Actual results may differ materially from
those expressed or implied in those statements. Factors that could cause these differences include,
but are not limited to, those discussed under Risk Factors and Managements Discussion and
Analysis of Financial Condition and Results of Operations. Sangamo undertakes no obligation to
publicly release any revisions to forward-looking statements to reflect events or circumstances
arising after the date of this report. Readers are cautioned not to place undue reliance on the
forward-looking statements, which speak only as of the date of this Quarterly Report on Form 10-Q.
2
PART 1. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
SANGAMO BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share amounts)
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September 30, |
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December 31, |
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2007 |
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2006 (1) |
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(unaudited) |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
16,894 |
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$ |
12,702 |
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Marketable securities |
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67,045 |
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41,218 |
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Interest receivable |
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217 |
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55 |
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Accounts receivable |
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20 |
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487 |
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Prepaid expenses |
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815 |
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594 |
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Total current assets |
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84,991 |
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55,056 |
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Property and equipment, net |
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1,304 |
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675 |
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Other assets |
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49 |
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49 |
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Total assets |
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$ |
86,344 |
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$ |
55,780 |
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Liabilities and stockholders equity |
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Current liabilities: |
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Accounts payable and accrued liabilities |
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$ |
1,830 |
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$ |
1,726 |
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Accrued compensation and employee benefits |
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902 |
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878 |
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Deferred revenue |
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5,313 |
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2,596 |
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Total current liabilities |
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8,045 |
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5,200 |
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Deferred revenue, non current portion |
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2,475 |
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1,875 |
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Total liabilities |
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10,520 |
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7,075 |
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Stockholders equity: |
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Common stock, $0.01 par value; 80,000,000
shares authorized, 39,963,425 and 35,045,398
shares issued and outstanding at September
30, 2007 and December 31, 2006, respectively |
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399 |
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350 |
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Additional paid-in capital |
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218,266 |
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176,513 |
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Accumulated deficit |
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(143,080 |
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(128,272 |
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Accumulated other comprehensive income |
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239 |
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114 |
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Total stockholders equity |
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75,824 |
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48,705 |
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Total liabilities and stockholders equity |
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$ |
86,344 |
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$ |
55,780 |
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(1) |
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Amounts derived from Audited Consolidated Financial Statements dated December 31, 2006 filed
as a part of our 2006 Annual Report on Form 10-K. |
See accompanying notes.
3
SANGAMO BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
(Unaudited)
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Three months ended |
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Nine months ended |
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September 30, |
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September 30, |
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2007 |
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2006 |
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2007 |
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2006 |
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Revenues: |
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Collaboration agreements |
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$ |
1,915 |
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$ |
1,431 |
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$ |
4,526 |
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$ |
4,735 |
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Research grants |
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410 |
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348 |
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1,805 |
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957 |
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Total revenues |
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2,325 |
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1,779 |
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6,331 |
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5,692 |
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Operating expenses: |
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Research and development |
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5,916 |
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3,853 |
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17,655 |
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11,470 |
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General and administrative |
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1,728 |
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1,569 |
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5,840 |
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5,145 |
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Total operating expenses |
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7,644 |
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5,422 |
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23,495 |
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16,615 |
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Loss from operations |
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(5,319 |
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(3,643 |
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(17,164 |
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(10,923 |
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Interest and other income, net |
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1,051 |
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798 |
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2,356 |
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2,007 |
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Net loss |
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$ |
(4,268 |
) |
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$ |
(2,845 |
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$ |
(14,808 |
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$ |
(8,916 |
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Basic and diluted net loss per share |
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$ |
(0.11 |
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$ |
(0.08 |
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$ |
(0.41 |
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$ |
(0.28 |
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Weighted average number of shares
used in computing basic and diluted
net loss per share |
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38,925 |
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33,939 |
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36,387 |
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31,960 |
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See accompanying notes.
4
SANGAMO BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
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Nine months ended |
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September 30, |
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2007 |
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2006 |
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Operating Activities: |
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Net loss |
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$ |
(14,808 |
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$ |
(8,916 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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187 |
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126 |
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Amortization of discount on investments |
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(1,514 |
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(399 |
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Stock-based compensation |
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1,640 |
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1,519 |
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Changes in operating assets and liabilities: |
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Interest receivable |
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(162 |
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108 |
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Accounts receivable |
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467 |
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698 |
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Prepaid expenses and other assets |
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(221 |
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(187 |
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Accounts payable and accrued liabilities |
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104 |
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(378 |
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Accrued compensation and employee benefits |
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24 |
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(98 |
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Deferred revenue |
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3,317 |
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(3,329 |
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Net cash used in operating activities |
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(10,966 |
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(10,856 |
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Investing Activities: |
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Purchases of investments |
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(86,088 |
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(39,596 |
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Maturities of investments |
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61,900 |
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27,728 |
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Purchases of property and equipment |
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(816 |
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(137 |
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Net cash used in investing activities |
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(25,004 |
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(12,005 |
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Financing Activities: |
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Issuance of common stock in connection with license agreement |
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8,550 |
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Proceeds from issuance of common stock |
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31,612 |
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20,471 |
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Net cash provided by financing activities |
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40,162 |
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20,471 |
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Net increase in cash and cash equivalents |
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4,192 |
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(2,390 |
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Cash and cash equivalents, beginning of period |
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12,702 |
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18,507 |
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Cash and cash equivalents, end of period |
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$ |
16,894 |
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$ |
16,117 |
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See accompanying notes. |
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Non-Cash Transactions: |
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Unrealized gains/(loss) on marketable securities |
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$ |
125 |
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$ |
47 |
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5
SANGAMO BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
September 30, 2007
NOTE 1-BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
BASIS OF PRESENTATION
The accompanying unaudited condensed consolidated financial statements of Sangamo BioSciences, Inc.
(Sangamo or the Company) have been prepared in accordance with generally accepted accounting
principles for interim financial information and pursuant to the rules and regulations of the
Securities and Exchange Commission (SEC). Accordingly, they do not include all of the information
and footnotes required by generally accepted accounting principles for complete financial
statements. In the opinion of management, all adjustments (consisting of normal recurring
adjustments) considered necessary for a fair presentation have been included. The condensed
consolidated financial statements include the accounts of Sangamo and its wholly-owned subsidiary,
Gendaq Limited, after elimination of all material intercompany balances and transactions. Operating
results for the nine months ended September 30, 2007 are not necessarily indicative of the results
that may be expected for the year ending December 31, 2007. These financial statements should be
read in conjunction with the financial statements and footnotes thereto for the year ended December
31, 2006, included in Sangamos Form 10-K as filed with the SEC.
USE OF ESTIMATES AND CLASSIFICATIONS
The preparation of financial statements in conformity with U.S. generally accepted accounting
principles requires management to make estimates and assumptions that affect the amounts reported
in the financial statements and the accompanying notes. Actual results could differ from those
estimates.
FOREIGN CURRENCY TRANSLATION
The Company records foreign currency transactions at the exchange rate prevailing at the date of
the transaction. Monetary assets and liabilities denominated in foreign currency are translated
into U.S. dollars at the exchange rates in effect at the balance sheet date. All currency
translation adjustments arising from foreign currency transactions are recorded through statements
of operations.
REVENUE RECOGNITION
In accordance with Staff Accounting Bulletin No. 104, Revenue Recognition, revenue from research
activities made under strategic partnering agreements and enabling technology collaborations is
recognized as the services are provided when there is persuasive evidence that an arrangement
exists, delivery has occurred, the price is fixed or determinable, and collectibility is reasonably
assured. Amounts received in advance under such agreements are deferred until the above criteria
are met and the research services are performed. Sangamos research grants are typically multi-year
agreements and provide for the reimbursement of qualified expenses for research and development as
defined under the terms of the grant agreement. Revenue under grant agreements is recognized when
the related qualified research expenses are incurred. Grant reimbursements are received on a
quarterly or monthly basis and are subject to the issuing agencys right of audit.
Milestone payments under research, partnering, or licensing agreements are recognized as revenue
upon the achievement of mutually agreed upon milestones, provided that (i) the milestone event is
substantive and its achievement is not reasonably assured at the inception of the agreement, and
(ii) there are no remaining performance obligations associated with the milestone payment.
In accordance with Emerging Issues Task Force Issue No. 00-21, Revenue Arrangements with Multiple
Deliverables, revenue arrangements entered into after June 15, 2003, that include multiple
deliverables, are divided into separate units of accounting if the deliverables meet certain
criteria, including whether the fair value of the delivered items can be determined and whether
there is evidence of fair value of the undelivered items. In addition, the consideration is
allocated among the separate units of accounting based on their fair values, and the applicable
revenue recognition criteria are considered separately for each of the separate units of
accounting.
6
RESEARCH AND DEVELOPMENT EXPENSES
Research and development expenses consist of costs incurred for Company-sponsored as well as
collaborative research and development activities. These costs include direct and research-related
overhead expenses, which include salaries and other personnel-related expenses, stock-based
compensation, pre-clinical and clinical studies, manufacturing costs, facility costs, laboratory
supplies and depreciation of facilities and laboratory equipment, as well as the cost of funding
research at universities and other research institutions, and are expensed as incurred. Costs to
acquire technologies that are utilized in research and development and that have no alternative
future use are expensed as incurred.
STOCK-BASED COMPENSATION
On January 1, 2006, we began accounting for employee stock-based compensation in accordance with
FAS 123R. Under the provisions of FAS 123R, employee stock-based compensation is estimated at the
date of grant based on the employee stock awards fair value using the Black-Scholes option-pricing
model and is recognized as expense ratably over the requisite service period in a manner similar to
other forms of compensation paid to employees. The Black-Scholes option-pricing model requires the
use of certain subjective assumptions. The most significant of these assumptions are our estimates
of the expected volatility of the market price of our stock and the expected term of the award. We
primarily base our determination of expected volatility through our assessment of the historical
volatility of our Common Stock. We do not believe that we are able to rely on our historical
exercise and post-vested termination activity to provide accurate data for estimating our expected
term for use in determining the fair value of these options. Therefore, as allowed by Staff
Accounting Bulletin (SAB) No. 107, Share-Based Payment, we have opted to use the simplified method
for estimating our expected term equal to the midpoint between the vesting period and the
contractual term. As required under the accounting rules, we review our valuation assumptions at
each grant date and, as a result, our valuation assumptions used to value employee stock-based
awards granted in future periods may change.
Employee stock-based compensation expenses recognized in the three-month and nine-month periods
ended September 30, 2007 and 2006 were calculated based on awards ultimately expected to vest and
has been reduced for estimated forfeitures. FAS 123R requires forfeitures to be estimated at the
time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from
those estimates.
The following table shows total stock-based employee compensation expense included in the condensed
consolidated statement of operations for the three-month and nine-month periods ended September 30,
2007 and 2006 (in thousands):
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Three months ended |
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Nine months ended |
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September 30, |
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September 30, |
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2007 |
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2006 |
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2007 |
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2006 |
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Costs and expenses: |
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Research and development |
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$ |
362 |
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$ |
247 |
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$ |
1,030 |
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$ |
874 |
|
General and administrative |
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|
202 |
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|
318 |
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|
600 |
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|
615 |
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Total stock-based compensation expense |
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$ |
564 |
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$ |
565 |
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$ |
1,630 |
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$ |
1,489 |
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There was no capitalized stock-based employee compensation cost as of September 30, 2007 and 2006.
There were no recognized tax benefits during the three-month and nine-month periods ended September
30, 2007 and 2006.
As of September 30, 2007, total compensation cost related to nonvested stock options to be
recognized in future periods was $5.0 million, which is expected to be expensed over a weighted
average period of 48 months.
Valuation Assumptions
The employee stock-based compensation expense recognized under FAS123R was determined using the
Black-Scholes option valuation model. Option valuation models require the input of subjective
assumptions and these assumptions can vary over time.
We primarily base our determination of expected volatility through our assessment of the historical
volatility of our Common Stock.
7
The weightedaverage assumptions used for estimating the fair value of the employee stock options
are as follows:
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Three months ended |
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Nine months ended |
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September 30, |
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September 30, |
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2007 |
|
2006 |
|
2007 |
|
2006 |
Risk-free interest rate |
|
|
4.37 |
% |
|
|
4.80 |
% |
|
|
4.37-4.99 |
% |
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|
4.80-5.10 |
% |
Expected life of option |
|
6.25 years |
|
6.25 years |
|
6.25 years |
|
6.25 years |
Expected dividend yield of stock |
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|
0.0 |
% |
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|
0.0 |
% |
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|
0.0 |
% |
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|
0.0 |
% |
Expected volatility |
|
|
.91 |
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|
.95 |
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|
.91-.93 |
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|
.91-.97 |
|
The weightedaverage assumptions used for estimating the fair value of the employees purchase
rights are as follows:
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|
Three months ended |
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Nine months ended |
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September 30, |
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September 30, |
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2007 |
|
2006 |
|
2007 |
|
2006 |
Risk-free interest rate |
|
|
4.42-5.01 |
% |
|
|
5.10-5.20 |
% |
|
|
3.64-5.10 |
% |
|
|
4.80-5.20 |
% |
Expected life of option |
|
0.5-2 years |
|
0.5-2 yrs |
|
0.5-2 yrs |
|
0.5-2 yrs |
Expected dividend yield of stock |
|
|
0.0 |
|
|
|
0.0 |
|
|
|
0.0 |
|
|
|
0.0 |
|
Expected volatility |
|
|
.50-.62 |
|
|
|
.50-.98 |
|
|
|
.46-.77 |
|
|
|
.41-.98 |
|
Stock Option Activity
A summary of Sangamos stock option activity follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
Shares Available |
|
|
|
|
|
Weighted-Average |
|
Weighted Average |
|
|
for Grant of |
|
Number of |
|
Exercise per |
|
Remaining |
|
|
Options |
|
Shares |
|
Share Price |
|
Contractual Term |
Balance at January 1, 2007 |
|
|
3,625,021 |
|
|
|
4,147,812 |
|
|
$ |
5.64 |
|
|
|
|
|
Options granted |
|
|
(406,250 |
) |
|
|
406,250 |
|
|
$ |
7.23 |
|
|
|
|
|
Options exercised |
|
|
|
|
|
|
(578,143 |
) |
|
$ |
5.98 |
|
|
|
|
|
Options canceled |
|
|
218,785 |
|
|
|
(218,785 |
) |
|
$ |
6.02 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2007 |
|
|
3,437,556 |
|
|
|
3,757,134 |
|
|
$ |
5.78 |
|
|
|
6.14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at
September 30, 2007 |
|
|
|
|
|
|
2,308,721 |
|
|
$ |
5.66 |
|
|
|
4.61 |
|
There were no shares subject to Sangamos right of repurchase as of September 30, 2007. The
intrinsic value of options exercised were $2,068,000 and $4,000 for the three months ended
September 30, 2007 and 2006, respectively, and $2,531,000 and $1,063,000 for the nine months ended
September 30, 2007 and 2006, respectively.
The weighted-average estimated fair value per share of options granted were $8.17 and $3.81 for the
three-month ended September 30, 2007 and 2006, respectively, and $5.68 and $5.23 for the nine-month
ended September 30, 2007 and 2006, respectively, based upon the assumptions in the Black-Scholes
valuation model described above.
The weighted-average estimated fair value per share of employee purchase rights during the three
months and nine months ended September 30, 2007 and 2006 were $2.51 and $1.11, respectively, and
$2.36 and $1.66, respectively, based upon the assumptions in the Black-Scholes valuation model
described above.
The following table summarizes information with respect to stock options outstanding at September
30, 2007:
8
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
Remaining |
|
|
Number |
|
Contractual Life |
Range of Exercise Price |
|
of Shares |
|
(In Years) |
$0.15 - $0.15 |
|
|
31,583 |
|
|
|
1.20 |
|
$0.17 - $0.17 |
|
|
400,000 |
|
|
|
0.60 |
|
$0.23 - $3.87 |
|
|
400,751 |
|
|
|
5.62 |
|
$3.95 - $4.11 |
|
|
509,279 |
|
|
|
8.01 |
|
$4.15 - $5.18 |
|
|
185,889 |
|
|
|
6.77 |
|
$5.19 - $5.19 |
|
|
429,079 |
|
|
|
6.44 |
|
$5.30 - $6.69 |
|
|
237,437 |
|
|
|
6.66 |
|
$6.82 - $6.82 |
|
|
450,000 |
|
|
|
9.20 |
|
$6.88 - $7.43 |
|
|
383,250 |
|
|
|
9.14 |
|
$7.49 - $38.00 |
|
|
729,866 |
|
|
|
4.42 |
|
|
|
|
|
|
|
|
|
|
|
|
|
3,757,134 |
|
|
|
6.14 |
|
|
|
|
|
|
|
|
|
|
At September 30, 2007, the aggregate intrinsic values of the outstanding and exercisable options
were $31.8 million and $20.0 million, respectively.
Sangamo did not grant any stock option to consultants during the three months and nine months ended
September 30, 2007. The Company granted 10,000 nonqualified stock options in July 2006. The
options generally vest over four years at a rate of 25 percent one year from grant date and
one-thirty-sixth per month thereafter and expire ten years after the grant date. The fair value of
these options was determined using the Black-Scholes Merton model. Total nonqualified stock-based
compensation expense was $2,000 and $4,000 for the three month periods ended September 30, 2007 and
2006, respectively, and $9,000 and $30,000 for the nine month periods ended September 30, 2007 and
2006, respectively.
RECENT ACCOUNTING PRONOUNCEMENT
In February 2007, the Financial Accounting Standards Board (FASB) issued Statement of Financial
Accounting Standards (SFAS) No. 159, The Fair Value Option for Financial Assets and Financial
Liabilities, Including an Amendment of FASB Statement No. 115, which will become effective in
2008. SFAS No. 159 permits entities to measure eligible financial assets, financial liabilities and
firm commitments at fair value, on an instrument-by-instrument basis, that are otherwise not
permitted to be accounted for at fair value under other generally accepted accounting principles.
The fair value measurement election is irrevocable and subsequent changes in fair value must be
recorded in earnings. The Company is evaluating what impact, if any; the adoption of this standard
will have on its financial position or results of operations.
In September 2006 the FASB issued FASB Statement No. 157, Fair Value Measurements, or SFAS 157.
The standard provides guidance for using fair value to measure assets and liabilities. The
standard also responds to investors requests for expanded information about the extent to which
companies measure assets and liabilities at fair value, the information used to measure fair value,
and the effect of fair value measurements on earnings. The standard applies whenever other
standards require or permit assets or liabilities to be measured at fair value. The standard does
not expand the use of fair value in any new circumstances. SFAS 157 must be adopted prospectively
as of the beginning of the year it is initially applied. SFAS 157 is effective for financial
statements issued for fiscal years beginning after November 15, 2007, and interim periods within
those fiscal years. The Company is evaluating what impact, if any; the adoption of this standard
will have on its financial position or results of operations.
NOTE 2-BASIC AND DILUTED NET LOSS PER SHARE
Net loss per share is calculated based on the weighted average number of shares of common stock
outstanding during the period. There are potential dilutive shares of common stock resulting from the
assumed exercise of outstanding stock options and equivalents.
Because Sangamo is in a net loss position, diluted loss per share excludes the effects of common
stock equivalents consisting of options, which are all antidilutive. Had Sangamo been in a net
income position, diluted earnings per share would have included the shares used in the computation
of basic net loss per share as well as an additional 2,089,721 shares and 2,185,930 shares for the
nine months ended September 30, 2007 and 2006, respectively, related to outstanding options.
NOTE 3-COMPREHENSIVE LOSS
Comprehensive loss is comprised of net loss and other comprehensive income (loss). Other
comprehensive loss includes certain changes in stockholders equity that are excluded from net
loss, which includes unrealized gains and losses on our available-for-sale securities.
Comprehensive loss and its components are as follows (in thousands):
9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Nine months ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,268 |
) |
|
$ |
(2,845 |
) |
|
$ |
(14,808 |
) |
|
$ |
(8,916 |
) |
Changes in
unrealized gain on
securities
available-for-sale |
|
|
110 |
|
|
|
76 |
|
|
|
125 |
|
|
|
47 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(4,158 |
) |
|
$ |
(2,769 |
) |
|
$ |
(14,683 |
) |
|
$ |
(8,869 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
10
NOTE 4-MAJOR CUSTOMERS, PARTNERSHIPS AND STRATEGIC ALLIANCES
Laboratory Research Reagents License Agreement
On July 10, 2007, Sangamo entered into a License Agreement with Sigma-Aldrich Corporation
(Sigma). Under the License Agreement, Sangamo will provide Sigma with access to Sangamos
proprietary zinc finger DNA-binding protein (ZFP) technology and the exclusive right to use
Sangamos ZFP technology to develop and commercialize products for use as research reagents and to
offer services in the research field, excluding certain agricultural research uses that Sangamo
previously licensed to Dow AgroSciences LLC.
The agreement provides for an initial three-year research term during which time Sangamo will work
with Sigma to develop laboratory research reagents using Sangamos ZFP technology. In addition,
for three years Sangamo will assist Sigmas efforts to market and sell services employing Sangamos
ZFP technology in the research field. Sangamo will transfer the ZFP manufacturing technology to
Sigma or to a mutually agreed-upon contract manufacturer upon Sigmas request. Prior to the
completion of this transfer, Sangamo will be responsible for supplying ZFPs for use by Sigma in
performing services in the research field.
Pursuant to the License Agreement, Sigma has paid Sangamo $13.5 million, which was comprised of an
equity investment by Sigma in 1.0 million shares of Sangamos common stock valued at $8.55
million, a $3.95 million license fee and $1.0 million of research funding. Under the License
Agreement, Sangamo may receive additional research funding of up to $2.0 million, development
milestone payments of up to $5.0 million, and commercial milestone payments based on net sales of
up to $17.0 million, subject to the continuation of the License Agreement. During the term of the
License Agreement Sigma is obligated to pay to Sangamo minimum annual payments, a share of certain
revenues received by Sigma from sublicensees, and royalty payments on the sale of licensed products
and services.
Sigma has the right to sublicense the ZFP technology for research reagent applications. Sangamo
will receive 50% of any sublicensing revenues in the first two years and 25% of any sublicensing
revenues thereafter.
Sangamo retains the sole right to use and license its ZFP technology for GMP production purposes,
for the production of materials used in or administered to humans, and for any other industrial
commercial use.
Revenues related to the research license under the Sigma agreement are being recognized ratably
over the three-year research term of the agreement and were $275,000 during the three months ended
September 30, 2007. Revenues attributable to collaborative research and development performed under
the Sigma agreement were $208,000 during the three months ended September 30, 2007. Related costs
and expenses incurred under the Sigma agreement were $208,000 during the three months ended
September 30, 2007.
Enabling Technology Collaborations for Pharmaceutical Protein Production
On April 27, 2007, Sangamo entered into a research and license agreement with the Genentech, Inc.
to provide Genentech with access to Sangamos proprietary zinc finger DNA-binding protein
technology. Under the agreement, Sangamo will design and engineer ZFP nucleases for Genentech to
evaluate and potentially use to generate cell lines with novel characteristics for protein
pharmaceutical production purpose. Upon successful development of such ZFNs, Sangamo will transfer
these ZFNs and the modified cell lines to Genentech and will provide technical support to Genentech
with respect to the use of the transferred ZFN technology. In consideration for the rights and
licenses granted to Genentech, as well as Sangamos development efforts, Genentech has paid Sangamo
an upfront fee and initial technology access fee. Genentech will also pay an ongoing annual
technology access fee. Genentech has also agreed to make certain payments upon on achievement of
specified milestones relating to the research of ZFNs and the development and commercialization of
products manufactured using a modified cell line created by ZFN technology or any other technology
covered by Sangamos intellectual property rights. Revenues attributable to collaborative research
and development performed under the Genentech agreement were $62,000 and $83,000 during the three
months and nine months ended September 30, 2007, respectively. Related research and development
costs and expenses performed under the Genentech agreement were $38,000 and $57,000 during the
three months and nine months ended September 30, 2007 respectively.
On December 2004, we announced a research collaboration agreement with Pfizer Inc to use our ZFP
technology to develop enhanced cell lines for protein pharmaceutical production. The scope of this
agreement was expanded in December 2006 and provided further research funding from Pfizer to
develop additional cell lines for enhanced protein production. Under the terms of the agreement,
Pfizer is funding research at Sangamo and Sangamo will provide our proprietary ZFP technology for
Pfizer to assess its feasibility for use in mammalian cell-based protein production. We are
generating novel cell lines for enhanced protein production as well as novel
11
technology for rapid
creation of new production cell lines. Revenues attributable to collaborative research and
development performed under the Pfizer agreement were $25,000 and $156,000 during the three months
ended September 30, 2007 and 2006, respectively. Revenues for the nine-month periods ended
September 30, 2007 and 2006 were $75,000 and $463,000, respectively. Related research and
development costs and expenses performed under the Pfizer agreement were $71,000 and $87,000 during
the three months ended September 30, 2007 and 2006, respectively, and $318,000 and $242,000 during
the nine months ended September 30, 2007 and 2006, respectively.
Terminated Strategic Partnership with Edwards Lifesciences
In December 2006, Sangamo entered into an Asset Purchase Agreement with Edwards Lifesciences LLC
(Edwards) to acquire all of the assets in Edwards ZFP TF angiogenesis program, including
regulatory filings, clinical data, and GMP product in exchange for one million shares of our
unregistered common stock and certain royalties. This transaction was valued at $5.8 million based
on the fair value of our publicly traded stock at the closing date of the transaction less a
discount for lack of marketability in the unregistered common stock. Under the agreement, Sangamo
agreed to pay Edwards royalties generated by the sales of certain human therapeutic products,
including products to treat ischemic cardiovascular and vascular disease and diabetic neuropathy,
based upon ZFP TF activation of the VEGF gene: the first product is not expected to be available
for sale before 2012. The amount of royalties payable to Edwards is equal to (i) five percent (5%)
of the net sales of each such product sold by Sangamo and (ii) the greater of (a) five percent (5%)
of the net sales of each such product sold by a sublicensee of Sangamo or (b) twenty-five percent
(25%) of the royalty payment received by Sangamo from its sublicensee on account of such product
sold by such sublicensee; provided that total royalties paid by Sangamo under the agreement shall
not exceed $20 million in any calendar year or $100 million in the aggregate. In connection with
this transaction, the Company and Edwards terminated their prior agreements entered in January
2000.
Plant Agriculture Agreement
Sangamo scientists and collaborators have shown that ZFP TFs and ZFP nucleases (ZFNs) can be used
to regulate and modify genes in plants with similar efficacy to that shown in various mammalian
cells and organisms. The ability to regulate gene expression with engineered ZFP TFs may lead to
the creation of new plants that increase crop yields, lower production costs, are more resistant to
herbicides, pesticides, and plant pathogens; and permit the development of branded agricultural
products with unique nutritional and processing characteristics. In addition, ZFNs may be used to
facilitate the efficient and reproducible generation of transgenic plants. Effective as of October
1, 2005, we entered into a Research License and Commercial Option Agreement with Dow AgroSciences
LLC (DAS), a wholly owned indirect subsidiary of Dow Chemical Corporation. Under this agreement,
we will provide DAS with access to our proprietary ZFP technology and the exclusive right to use
our ZFP technology to modify the genomes or alter the nucleic acid or protein expression of plant
cells, plants, or plant cell cultures. We will retain rights to use plants or plant-derived
products to deliver ZFP TFs or ZFNs into human or animals for diagnostic, therapeutic, or
prophylactic purposes.
Our agreement with DAS provides for an initial three-year research term during which time we will
work together to validate and optimize the application of our ZFP technology to plants, plant cells
and plant cell cultures. A joint committee having equal representation from both companies will
oversee this research. During the initial three-year research term, DAS will have the option to
obtain a commercial license to sell products incorporating or derived from plant cells generated
using our ZFP technology, including agricultural crops, industrial products and plant-derived
biopharmaceuticals. This commercial license will be exclusive for all such products other than
animal and human health products. In the event that DAS exercises this option, DAS may elect to
extend the research program beyond the initial three-year term on a year-to-year basis.
Pursuant to the Research License and Commercial Option Agreement, DAS made an initial cash payment
to us of $7.5 million and agreed to purchase up to $4.0 million of our common stock in the next
financing transaction meeting certain criteria. In November 2005, the Company sold approximately
1.0 million shares of common stock to DAS at a price of $3.85 per share, resulting in gross
proceeds of $3.9 million. In addition, DAS will provide between $4.0 million and $6.0 million in
research funding over the initial three-year research term and may make an additional payment of up
to $4.0 million in research milestone payments to us during this same period, depending on the
success of the research program. In the event that DAS elects to extend the research program beyond
the initial three-year term, DAS will provide additional research funding. If DAS exercises its
option to obtain a commercial license, we will be entitled to full payment of the $4.0 million in
research milestones, a one-time exercise fee of $6.0 million, minimum annual payments of up to
$25.25 million, development and commercialization milestone payments for each product, and
royalties on sales of products. Furthermore, DAS will have the right to sublicense our ZFP
technology to third parties for use in plant cells, plants, or plant cell cultures, and we will be
entitled to 25% of any cash consideration received by DAS under such sublicenses.
12
We have agreed to supply DAS and its sublicensees with ZFP TFs and/or ZFNs for both research and
commercial use. If DAS exercises its option to obtain a commercial license, DAS may request that we
transfer, at DASs expense, the ZFP manufacturing technology to DAS or to a mutually agreed-upon
contract manufacturer.
The Research License and Commercial Option Agreement will terminate automatically if DAS fails to
exercise its option for a commercial license by the end of the initial three-year research term.
DAS may also terminate the agreement at the end of the second year of the initial research term if
the joint committee overseeing the research determines that disappointing research results have
made it unlikely that DAS will exercise the option; we are guaranteed to receive $4.0 million in
research funding from DAS prior to such a termination. Following DASs exercise of the option and
payment of the exercise fee, DAS may terminate the agreement at any time. In addition, each party
may terminate the agreement upon an uncured material breach of the other party. In the event of any
termination of the agreement, all rights to use our ZFP technology will revert to us, and DAS will
no longer be permitted to practice our ZFP technology or to develop or, except in limited
circumstances, commercialize any products derived from our ZFP technology. Revenues related to the
research license under the DAS agreement are being recognized ratably over the initial three-year
research term of the agreement and were $625,000 during both the three months ended September 30,
2007 and 2006 and $1.9 million during both the nine months ended September 30, 2007 and 2006.
Revenues attributable to collaborative research and development performed under the DAS agreement
were $500,000 during both the three months ended September 30, 2007 and 2006 and $1.5 million and
$1.9 million during the nine months ended September 30, 2007 and 2006, respectively. Revenues
attributable to milestone payments were $220,000 and $510,000 during both the three and nine month
periods ended September 30, 2007. Related costs and expenses incurred under the DAS agreement were
$500,000 during both the three months ended September 30, 2007 and 2006 and $1.5 million and $1.9
million during the nine months ended September 30, 2007 and 2006, respectively.
13
Funding from Research Foundations
The Michael J. Fox Foundation
On January 23, 2007, Sangamo announced a partnership with the Michael J. Fox Foundation (MJFF) to
provide financial support of Sangamos ZFP TFsTM to activate the expression of glial
cell line-derived neurotrophic factor (GDNF) that has shown promise in preclinical testing to slow
or stop the progression of Parkinsons disease. Under the agreement with MJFF and subject to its
terms and conditions, MJFF will pay the Company $950,000 over a period of two years. Revenues
attributable to research and development performed under the MJFF partnership were $116,000 and
$300,000 during the three months and nine months ended September 30, 2007, respectively. Related
costs and expenses incurred under the MJFF partnership were $116,000 and $300,000 during the three
month and nine month periods ended September 30, 2007, respectively.
The Juvenile Diabetes Research Foundation International
On October 26, 2006, Sangamo announced a partnership with the Juvenile Diabetes Research Foundation
International (JDRF) to provide financial support to one of Sangamos Phase 2 human clinical
studies of SB-509, a ZFP Therapeutic that is in development for the treatment of diabetic
neuropathy. Under the agreement with JDRF and subject to its terms and conditions, including the
Companys achievement of certain milestones associated with the Companys Phase 2 clinical trial of
SB-509 for the treatment of mild to moderate diabetic neuropathy, JDRF will pay the Company an
aggregate amount of up to $3.0 million. After the first commercial launch of SB-509 in a major
market, JDRF has the right to receive, subject to certain limitations, annual payments from
Sangamo, until such time when the total amount paid to JDRF, including payments made on account of
certain licensing arrangements, equals three times the amount received by us from JDRF.
Under the agreement, we are obligated to use commercially reasonable efforts to carry out the Phase
2 trial and, thereafter, to develop and commercialize, a product containing SB-509 for the
treatment of diabetes and complications of diabetes. We are obligated to cover all costs of the
Phase 2 trial that are not covered by JDRFs grant. If we fail to satisfy these obligations, JDRF
may have the right, subject to certain limitations, to obtain an exclusive, sublicensable license,
to the intellectual property generated by us in the course of the Phase 2 trial, to make and
commercialize products containing SB-509 for the treatment of diabetes and complications of
diabetes. If JDRF obtains such a license, it is obligated to pay us a percentage of its revenues
from product sales and sublicensing arrangements. If JDRF fails to satisfy its obligations to
develop and commercialize a product containing SB-509 under the Agreement, then their license
rights will terminate and we will receive a non-exclusive, fully paid license, for any intellectual
property developed during JDRFs use of the license, to research, develop and commercialize
products containing SB-509 for the treatment of diabetes and complications of diabetes.
During the three months and nine months ended September 30, 2007, the Company received $500,000 and
$1.5 million, respectively from JDRF upon the achievement of three milestones. Revenues
attributable to research and development performed under the JDRF partnership were $295,000 and
$1.1 million, respectively, during the three months and nine months ended September 30, 2007.
Related costs and expenses incurred were $1.0 million and $3.0 million during the three months and
nine months ended September 30, 2007, respectively.
NOTE 5-STOCKHOLDERS EQUITY
On July 20, 2007, Sangamo completed a registered direct offering to a group of institutional
investors, in which Sangamo sold an aggregate of 3,278,689 shares of common stock at a price of
$9.15 per share to such investors, resulting in gross proceeds of approximately $30.0 million.
On July 10, 2007, Sangamo entered into a license agreement with Sigma. Under the agreement and a
related stock purchase agreement, Sangamo sold to Sigma 1.0 million shares of Sangamos common
stock valued at $8.55 million.
On April 30, 2007, Sangamo has issued 61,195 shares under companys employee stock purchase
program.
14
NOTE 6-INCOME TAXES
On January 1, 2007, the Company adopted the provisions of Financial Standards Accounting Board
Interpretation No. 48, Accounting for Uncertainty in Income Taxes-an interpretation of FASB
Statement No. 109 (FIN 48). There was no impact on the Companys financial statements upon
adoption. Because of the Companys historical significant net operating losses, it has not been
subject to income tax since inception. There were no unrecognized tax benefits during all the
periods presented.
We maintain deferred tax assets that reflect the net tax effects of temporary differences between
the carrying amounts of assets and liabilities for financial reporting purposes and the amounts
used for income tax purposes. These deferred tax assets include net operating loss carryforwards,
research credits and capitalized research and development. The net deferred tax asset has been
fully offset by a valuation allowance because of the Companys history of losses. Utilization of
operating losses and credits may be subject to substantial annual limitation due to ownership
change provisions of the Internal Revenue Code of 1986, as amended and similar state provisions.
The annual limitation may result in the expiration of net operating losses and credits before
utilization.
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The discussion in Managements Discussion and Analysis of Financial Condition and Results of
Operations contains trend analysis, estimates and other forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended. These forward-looking statements include, without limitation,
statements containing the words believes, anticipates, expects, continue, and other words
of similar import or the negative of those terms or expressions. Such forward-looking statements
are subject to known and unknown risks, uncertainties, estimates and other factors that may cause
the actual results, performance or achievements of the Company, or industry results, to be
materially different from any future results, performance or achievements expressed or implied by
such forward-looking statements. Actual results could differ materially from those set forth in
such forward-looking statements as a result of, but not limited to, the Risk Factors described
below. You should read the following discussion and analysis along with the consolidated financial
statements and notes attached to those statements included elsewhere in this report and in our
annual report on Form 10-K for the year ended December 31, 2006 as filed with the SEC on March 1,
2007.
Overview
We were incorporated in June 1995. From our inception through September 30, 2007, our activities
related primarily to establishing and operating a biotechnology research and development
organization and developing relationships with our corporate collaborators. Our scientific and
business development endeavors currently focus on the engineering of novel zinc finger DNA binding
proteins (ZFPs) for the regulation and modification of genes. We have incurred net losses since
inception and expect to incur losses in the future as we continue our research and development
activities. To date, we have funded our operations primarily through the issuance of equity
securities, borrowings, payments from research grants and from corporate collaborators and
strategic partners. As of September 30, 2007, we had an accumulated deficit of $143.1 million.
Our revenues have consisted primarily of revenues from our corporate partners for ZFP transcription
factors (ZFP TFs) and zincfinger nucleases (ZFNs), contractual payments from strategic partners
for research programs and research milestones, and research grant funding. We expect revenues will
continue to fluctuate from period to period and there can be no assurance that new collaborations
or partner fundings will continue beyond their initial terms.
Commencing in 2005, we have placed more internal emphasis on higher-value therapeutic product
development and less emphasis on non therapeutic programs. We believe this shift in emphasis has
the potential to increase the return on investment to our stockholders by allocating capital
resources to higher value, therapeutic product development activities. At the same time, it may
reduce our revenues over the next several years and it increases our financial risk by increasing
expenses associated with product development. We have filed an Investigational New Drug (IND)
application with the U.S. Food and Drug Administration (FDA) and have initiated two Phase 2
clinical trials of a ZFP Therapeutic in patients with diabetic neuropathy during the first nine
months of 2007. Development of novel therapeutic products is costly and is subject to a lengthy and
uncertain regulatory process by the FDA. Our future products are nucleic acid-based therapeutics.
Adverse events in both our own clinical program and other programs in gene therapy and RNAi may
have a negative impact on regulatory approval, the willingness of potential commercial partners to
enter into agreements and the perception of the public.
15
Research and development expenses consist primarily of salaries and related personnel expenses,
including stock-based compensation, clinical trials and manufacturing cost, laboratory supplies,
allocated facilities costs, subcontracted research expenses, trademark registration and technology
licenses. Research and development costs incurred in connection with collaborator-funded activities
are expensed as incurred. We believe that continued investment in research and development is
critical to attaining our strategic objectives. We expect these expenses will increase
significantly as we increase our focus on development of ZFP Therapeutics. We are also developing
ZFNs for therapeutic gene correction and therapeutic gene modification as a treatment for certain
monogenic and infectious diseases and cancer. Additionally, in order to develop ZFP TFs and ZFNs as
commercially relevant therapeutics, we expect to expend additional resources for expertise in the
manufacturing, regulatory affairs and clinical research aspects of biotherapeutic development.
General and administrative expenses consist primarily of salaries and related personnel expenses
for executive, finance and administrative personnel, stock-based compensation, professional fees,
patent prosecution expenses, allocated facilities costs and other general corporate expenses. As we
pursue commercial development of our therapeutic leads we expect the business aspects of the
Company to become more complex. We may be required in the future to add personnel and incur
additional costs related to the maturity of our business.
Critical Accounting Estimates
The preparation of financial statements in conformity with accounting principles generally accepted
in the United States 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 financial statements and the reported amounts of revenues and expenses during the reporting
period. Such estimates are described in Note 1, Basis of Presentation and Summary of Significant
Accounting Policies to the Unaudited Notes to Condensed Consolidated Financial Statements. We base
our estimates on historical experience and on various other assumptions that we believe to be
reasonable under the circumstances, the results of which form our basis for making judgments about
the carrying value of assets and liabilities that are not readily apparent from other sources, and
evaluate our estimates on an ongoing basis. Actual results could differ from those estimates under
different assumptions or conditions. We believe the critical accounting policies described in our
annual report on Form 10-K for the year ended December 31, 2007 have significant effect in the
preparation of our consolidated financial statements.
RESULTS OF OPERATIONS
Three and nine months ended September 30, 2007 and 2006
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
|
(in thousands, except percentage values) |
|
|
(in thousands, except percentage values) |
|
|
|
2007 |
|
|
2006 |
|
|
Change |
|
|
% |
|
|
2007 |
|
|
2006 |
|
|
Change |
|
|
% |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration agreements |
|
$ |
1,915 |
|
|
$ |
1,431 |
|
|
$ |
484 |
|
|
|
34 |
% |
|
$ |
4,526 |
|
|
$ |
4,735 |
|
|
$ |
(209 |
) |
|
|
(4 |
%) |
Research grants |
|
|
410 |
|
|
|
348 |
|
|
|
62 |
|
|
|
18 |
% |
|
|
1,805 |
|
|
|
957 |
|
|
|
848 |
|
|
|
89 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
2,325 |
|
|
$ |
1,779 |
|
|
$ |
546 |
|
|
|
31 |
% |
|
$ |
6,331 |
|
|
$ |
5,692 |
|
|
$ |
639 |
|
|
|
11 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues increased to $2.3 million for the three months ended September 30, 2007 from $1.8
million in the corresponding period in 2006. The increase in collaboration agreement revenues for
the three months ended September 30, 2007 was principally due to revenues of $483,000 in connection
with our License Agreement with Sigma, $220,000 from our collaboration with DAS and $62,000 with
Genentech, offset by decreased collaboration-related revenues of approximately $150,000 and
$131,000 from Johnson and Johnson and Pfizer, respectively. The increase in research grant
revenues for the three months ended September 30, 2007 was principally due to revenues of $295,000
in connection with our JDRF grant and $116,000 related to the MJFF grant, offset by decreased
revenues of approximately $286,000 and $63,000 from Advanced Technology Program ATP and other
research grants, respectively. Total revenues increased to $6.3 million for the nine months ended
September 30, 2007 from $5.7 million in the corresponding period in 2006. The decrease in
collaboration agreement revenues for the nine months ended September 30, 2007 was principally due
to revenues of $450,000 and $388,000 in connection with our Johnson & Johnson and Pfizer
collaboration agreements, respectively, offset by increased collaboration-related revenues of
approximately $483,000 and $83,000 from Sigma and Genentech, respectively. The increase of
research grant revenues for the nine months ended September 30, 2007 was principally due to
increased revenues of $1.1 million and $300,000 in connection with our JDRF grant and MJFF grant,
respectively, offset by decreased revenues
16
of approximately $427,000 and $149,000 from ATP and
other research grants, respectively. We anticipate continued revenues from collaboration
agreements through the end of 2010, and we have applied for, and plan to continue to apply for,
research grants in the future to support the development of applications of our technology
platform. Although we have negotiated collaboration agreements and received research grants in the
past, we cannot assure you that these efforts will be successful in the future.
17
Operating Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
|
Nine months ended September 30, |
|
|
|
(in thousands, except percentage values) |
|
|
|
(in thousands, except percentage values) |
|
|
|
2007 |
|
|
2006 |
|
|
Change |
|
|
% |
|
|
2007 |
|
|
2006 |
|
|
Change |
|
|
% |
|
|
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
5,916 |
|
|
$ |
3,853 |
|
|
$ |
2,063 |
|
|
|
54 |
% |
|
$ |
17,655 |
|
|
$ |
11,470 |
|
|
$ |
6,185 |
|
|
|
54 |
% |
General and administrative |
|
|
1,728 |
|
|
|
1,569 |
|
|
|
159 |
|
|
|
10 |
% |
|
|
5,840 |
|
|
|
5,145 |
|
|
|
695 |
|
|
|
14 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses |
|
$ |
7,644 |
|
|
$ |
5,422 |
|
|
$ |
2,222 |
|
|
|
41 |
% |
|
$ |
23,495 |
|
|
$ |
16,615 |
|
|
$ |
6,880 |
|
|
|
41 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
Research and development expenses have consisted primarily of salaries and related personnel
expenses including stock-based compensation as well as clinical trials and manufacturing cost,
laboratory supplies, allocated facilities costs, subcontracted research expenses, trademark
registration and technology licenses. We expect to continue to devote substantial resources to
research and development in the future and expect research and development expenses to increase in
the next several years if we are successful in advancing our ZFP Therapeutic product candidates
into and through clinical trials. To the extent we collaborate with others with respect to clinical
trials, increases in research and development expenses may be reduced or avoided.
Research and development expenses for the third quarter of 2007 increased to $5.9 million compared
to $3.9 million for the third quarter of 2006. The increase in research and development expenses
for the three months ended September 30, 2007 was primarily attributable to increased external
development expenses of $1.3 million, associated with clinical trials and manufacturing costs
related to our diabetic neuropathy program, increased personnel and facility-related expenses of
$261,000 and $136,000, respectively, primarily due to increased headcount, stock-based compensation
of $114,000 and licensing expenses of $125,000. Research and development expenses for the
nine-months ended September 30, 2007 increased to $17.7 million compared to $11.5 million for the
corresponding period of 2006. The increase in research and development expenses for the nine months
ended September 30, 2007 was primarily attributable to increased external development expenses of
$3.8 million, primarily associated with clinical trials and manufacturing cost related to our
diabetic neuropathy program, increased personnel and laboratory supply expenses of $1.1 million and
$546,000, respectively, due to increased headcount, increased facility-related expenses of $326,000
and increased licensing expenses of $221,000.
General and administrative
General and administrative expenses consist primarily of salaries and related personnel expenses
for executive, finance and administrative personnel, stock-based compensation, professional fees,
patent prosecution expenses, allocated facilities costs, other general corporate expenses and
stock-based compensation. As we pursue commercial development of our therapeutic leads, we expect
the business aspects of the Company to become more complex. We may be required in the future to add
personnel and incur additional costs related to the maturity of our business.
General and administrative expenses were $1.7 million for the three months ended September 30,
2007, as compared to $1.6 million during the corresponding period of 2006. This increase is
primarily related to increased professional service-related expenses of $209,000. General and
administrative expenses were $5.8 million for the nine months ended September 30, 2007, as compared
to $5.1 million during the corresponding period of 2006. This increase is primarily related to
increased expenses related to professional services and salary and benefit of $639,000 and $37,000,
respectively.
Interest income, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended September 30, |
|
Nine months ended September 30, |
|
|
(in thousands, except percentage values) |
|
(in thousands, except percentage values) |
|
|
|
2007 |
|
2006 |
|
Change |
|
% |
|
2007 |
|
2006 |
|
Change |
|
% |
|
Interest and other income, net |
|
$ |
1,051 |
|
|
$ |
798 |
|
|
$ |
253 |
|
|
|
32 |
% |
|
$ |
2,356 |
|
|
$ |
2,007 |
|
|
$ |
349 |
|
|
|
17 |
% |
Interest and other income, net, increased to $1.1 million for the three months ended September 30,
2007 from $798,000 in the corresponding period in 2006. The increase was primarily related to an
increase in interest income of $249,000 related to higher average investment balances during the
three months ended September 30, 2007. Interest and other income, net, increased to $2.4 million
for the nine months ended September 30, 2007 from $2.0 million in the corresponding period of 2006.
The increase was primarily related to an increase in interest income of $466,000 related to higher
average investment balances during the nine months
18
ended September 30, 2007. This increase was
partially offset by a decrease foreign currency translation gain of $109,000 during the nine months
ended September 30, 2007.
Liquidity and Capital Resources
Since inception, we have financed our operations primarily through the sale of equity securities,
payments from corporate collaborators, research grants and financing activities such as a bank line
of credit. As of September 30, 2007, we had cash, cash equivalents, investments and interest
receivable totaling $84.2 million. On July 10, 2007, we entered into a license agreement with
Sigma under which Sigma has paid us $13.5 million, which was comprised of an equity investment by
Sigma in our common stock valued at $8.55 million, a $3.95 million license fee and $1.0 million of
research funding. On July 20, 2007, we completed a registered direct offering to a group of
institutional investors, in which we sold an aggregate of 3,278,689 shares of common stock at a
price of $9.15 per share to such investors pursuant to an effective registration statement filed on
April 27, 2007, resulting in net proceeds of approximately $28.0 million.
Net cash used for operating activities was $11.0 million for the nine months ended September 30,
2007. Net cash used consisted of the net loss for the nine-month period of $14.8 million,
amortization of discount on investment of $1.5 million. This was partially offset by a net change
of $3.5 million in operating assets and liabilities, stock-based compensation charges of $1.6
million and depreciation and amortization of $187,000. Net cash used for operating activities was
$10.8 million for the nine months ended September 30, 2006. Net cash used consisted primarily of
the net loss for the nine-month period of $8.9 million, a net change of $3.2 million in operating
assets and liabilities and amortization of discount on investments of $399,000. This was partially
offset by stock-based compensation charges of $1.5 million and depreciation and amortization of
$126,000.
Net cash used by investing activities was $25.0 million for the nine months ended September 30,
2007 and was primarily comprised of purchases of investments and property and equipment of
$86.2 million and $816,000, respectively, partially offset by cash proceeds associated with
maturities of investments of $61.9 million. Net cash used in investing activities was $12.0
million for the nine months ended September 30, 2006 and was primarily comprised of cash used to
purchase investments and property and equipment of $39.6 million and $137,000, respectively,
partially offset by cash proceeds associated with maturities of investments of $27.7 million.
Net cash provided by financing activities for the nine-month period ended September 30, 2007 was
$40.1 million. Proceeds were related to net proceeds from the issuance of common stock related to a
registered direct offering to a group of institutional investors of $28.0 million, issuance of
common stock in connection with license agreement of $8.6 million and stock option exercises of
$3.6 million, respectively. Net cash provided by financing activities for the nine month period
ended September 30, 2006 was $20.5 million. In June 2006, in an underwritten public offering and
pursuant to an effective registration statement, we sold 3,100,000 shares of common stock at a
price of $6.75 per share, resulting in net proceeds of approximately $20.15 million after deducting
underwriters discount. All other cash provided by financing activities for the first nine months
of 2006 was related to proceeds from the issuance of common stock related to stock option
exercises.
While we expect our rate of cash usage to increase in the future, in particular, in support of our
product development endeavors, we believe that the available cash resources, funds received from
corporate collaborators, strategic partners and research grants will be sufficient to finance our
operations through 2009. We may need to raise additional capital to fund our ZFP Therapeutic
development activities. Additional capital may not be available in terms acceptable to us, or at
all. If adequate funds are not available, our business and our ability to develop our technology
and our ZFP Therapeutic products would be harmed.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Our exposure to market risk for changes in interest rates relates primarily to our cash equivalents
and investments. The investments are available-for-sale. We do not use derivative financial
instruments in our investment portfolio. We attempt to ensure the safety and preservation of our
invested funds by limiting default and market risks. Our cash and investments policy emphasizes
liquidity and preservation of principal over other portfolio considerations. We select investments
that maximize interest income to the extent possible within these guidelines. We satisfy liquidity
requirements by investing excess cash in securities with different maturities to match projected
cash needs and limit concentration of credit risk by diversifying our investments among a variety
of high credit-quality issuers. We mitigate default risk by investing in only investment-grade
securities. The portfolio includes marketable securities with active secondary or resale markets to
ensure portfolio liquidity. All investments have a fixed interest rate and are carried at market
value, which approximates cost.
19
Our market risks at September 30, 2007 have not changed materially from those discussed in Item 7A
of our Form 10-K for the year ended December 31, 2006 on file with the Securities and Exchange
Commission.
ITEM 4. CONTROLS AND PROCEDURES
(a) Evaluation of Disclosure Controls and Procedures
The Companys management, with the participation of the Companys Chief Executive Officer and
Principal Financial Officer, evaluated the effectiveness of the Companys disclosure controls and
procedures (as defined in Exchange Act Rule 13a-15(e) or 15d-15(e)) as of the end of the period
covered by this report. Based on that evaluation, the Chief Executive Officer and Principal
Financial Officer concluded that the Companys disclosure controls and procedures as of the end of
the period covered by this report were functioning effectively to provide reasonable assurance that
the information required to be disclosed by the Company in reports filed under the Securities
Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time
periods specified in the SECs rules and forms, and that such information is accumulated and
communicated to management, including our Chief Executive Officer and Principal Financial Officer,
or persons performing similar functions, as appropriate to allow timely decisions regarding
required disclosure.
(b) Change in Internal Control over Financial Reporting
No change in the Companys internal control over financial reporting occurred during the Companys
most recent fiscal quarter that has materially affected, or is reasonably likely to materially
affect, the Companys internal control over financial reporting.
20
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
We are not party to any material pending legal proceedings, other than routine litigation
incidental to our business.
ITEM 1A. RISKS FACTORS
This Form 10-Q contains forward-looking information based on our current expectations. Because our
actual results may differ materially from any forward-looking statements made by or on behalf of
Sangamo, this section includes a discussion of important factors that could affect our actual
future results, including, but not limited to, our revenues, expenses, net loss and loss per share.
We have increased the focus of our research and development programs on human therapeutics,
which will increase operating expenditures and the uncertainty of our business. We are increasing
the emphasis and focus of our internal research and development activities on ZFP Therapeutics and
have fewer resources invested in non therapeutic programs. In the short term, this change may
reduce our revenues and increase operating expenditures due to larger financial outlays to fund
preclinical studies, manufacturing, and clinical research. The focus on ZFP Therapeutics will also
increase the visibility of our lead therapeutic programs and the potential impact on the stock
price of news releases relating to these programs.
We are conducting proprietary research to discover ZFP Therapeutic product candidates. These
programs increase our financial risk of product failure, may significantly increase our research
expenditures, and may involve conflicts with our collaborators and strategic partners. Our
proprietary research programs consist of research which is funded largely by the Company and where
the Company retains exclusive rights to therapeutic products generated by the research. This is in
contrast to certain of our non therapeutic programs that may be funded by corporate partners and in
which we may share in the value of any resulting products. We have conducted proprietary research
since our inception; however, in the past several years, our strategy has shifted toward placing
greater emphasis on proprietary research and therapeutic development and we expect this trend will
continue in 2008 as we prosecute our ongoing Phase 2 clinical trials and bring new ZFP Therapeutics
into clinical trials. Conducting proprietary research programs may not generate corresponding
revenue and may create conflicts with our collaborators or strategic partners. The implementation
of this strategy will involve substantially greater business risks, the expenditure of
significantly greater funds than our historic research activities and will require substantial
commitments of time from our management and staff.
In addition, disagreements with our collaborators or strategic partners could develop over
rights to our intellectual property with respect to our proprietary research activities. Any
conflict with our collaborators or strategic partners could reduce our ability to enter into future
collaboration or strategic partnering agreements and negatively impact our relationship with
existing collaborators and strategic partners, which could reduce our revenue and delay or
terminate our product development.
We have initiated two Phase 2 clinical trials in our lead ZFP Therapeutic program, and ZFP
Therapeutics have undergone limited testing in humans. We have completed enrollment and treatment
of the patients in a Phase 1 clinical trial of SB-509 for diabetic neuropathy and thus far have not
observed any serious drug-related adverse events. However if our lead ZFP Therapeutic fails one of
its initial safety studies, it could reduce our ability to attract new investors and corporate
partners. In January 2005, we filed an IND with the FDA for SB-509, a ZFP TF activator of VEGF-A,
for the treatment of mild to moderate diabetic neuropathy. We have completed enrollment and
treatment of a Phase 1, single blind, dose-escalation trial to measure the laboratory and clinical
safety of SB-509 and initiated a Phase 2 clinical trial for this indication. In addition, Phase 1
clinical trials of an identical ZFP TF has been carried out in subjects with peripheral artery
disease. These early studies of a ZFP Therapeutic are a highly visible test of our ZFP Therapeutic
approach. Since we have increased our focus on ZFP Therapeutic research and development, investors
will increasingly assess the value of our technology based on the continued progress of ZFP
Therapeutic products into and through clinical trials. If the initial safety study of our lead
therapeutic was halted due to safety concerns or for other reasons, this would negatively affect
the value of our stock.
The results of our Phase 1 trials are based on a small number of patients over a short period
of time, and our progress may not be indicative of results in a large number of patients or of
long-term efficacy. The results in early phases of clinical testing are based upon limited numbers
of patients and a limited follow-up period. For example, the initial results from the Phase 1
clinical trial of our ZFP Therapeutic, SB-509, became available in the first half of 2006 and
additional data were presented in June 2007. The primary end point of the trial was clinical and
laboratory safety, however we collected some preliminary efficacy data that showed early evidence
of clinical improvement in some subjects. Typically, our Phase 1 clinical trials for indications of
safety enroll less than 50 patients. We
21
have designed our initial Phase 2 clinical trial for safety
and efficacy to enroll approximately 100 patients. Actual results with more data points may not
confirm the favorable results from earlier stage trials. A number of companies in the
pharmaceutical and biotechnology industries have suffered significant setbacks in late stage
clinical trials even after achieving promising results in earlier stage clinical trials. In
addition, we do not yet know if early results will be reproducible. If a larger population of
patients does not experience positive results, or if these results are not reproducible, our
products may not receive approval from the FDA. Failure to demonstrate the safety and effectiveness
of our ZFP Therapeutic products in larger patient populations could have a material adverse effect
on our business that would cause our stock price to decline significantly.
We have limited experience in conducting clinical trials. Our ZFP Therapeutics may fail to
show the desired safety and efficacy in initial clinical trials. We have completed a Phase 1 trial
and begun two Phase 2 clinical trials, however, the FDA will require additional clinical testing
which involves significantly greater resources, commitments and expertise that may require us to
enter into a collaborative relationship with a pharmaceutical company that could assume
responsibility for late-stage development and commercialization.
We may not be able to find acceptable patients or may experience delays in enrolling patients
for our clinical trials. We or the FDA may suspend our clinical trials at any time if either
believes that we are exposing the subjects participating in these trials to unacceptable health
risks. The FDA or institutional review boards and/or institutional biosafety committees at the
medical institutions and healthcare facilities where we sponsor clinical trials may suspend any
trial indefinitely if they find deficiencies in the conduct of these trials. The FDA and
institutional review boards may also require large numbers of patients, and the FDA may require
that we repeat a clinical trial.
Our potential therapeutic products are subject to a lengthy and uncertain regulatory process,
and we may encounter unanticipated toxicity or adverse events or fail to demonstrate efficacy,
causing us to delay, suspend or terminate the the development of a ZFP Therapeutics. If these
potential products are not approved, we will not be able to commercialize those products. The FDA
must approve any human therapeutic product before it can be marketed in the United States. The
process for receiving regulatory approval is long and uncertain, and a potential product may not
withstand the rigors of testing under the regulatory approval processes.
Before commencing clinical trials in humans, we must submit an Investigational New Drug (IND)
application to the FDA. The FDA has 30 days to comment on the IND. If the FDA does not comment on
the IND, we or our commercial partner may begin clinical trials.
Clinical trials are subject to oversight by institutional review boards and the FDA. In
addition, our proposed clinical studies will require review from the Recombinant DNA Advisory
Committee, or RAC, which is the advisory board to the National Institutes of Health, or NIH,
focusing on clinical trials involving gene transfer. We will typically submit a proposed clinical
protocol and other product-related information to the RAC three to six months prior to the expected
IND filing date.
Clinical trials:
|
|
|
must be conducted in conformance with the FDAs good clinical practices, ICH guidelines and
other applicable regulations; |
|
|
|
|
must meet requirements for institutional review board (IRB) oversight; |
|
|
|
|
must follow Institutional Biosafety Committee (IBC) and NIH RAC guidelines where applicable; |
|
|
|
|
must meet requirements for informed consent; |
|
|
|
|
are subject to continuing FDA oversight; |
|
|
|
|
may require large numbers of test subjects; and |
|
|
|
|
may be suspended by a commercial partner, the FDA, or us at any time if it is believed that
the subjects participating in these trials are being exposed to unacceptable health risks or
if the FDA finds deficiencies in the IND or the conduct of these trials. |
Clinical trials are lengthy and are typically conducted in three sequential phases, but the
phases may overlap or be combined. Each trial must be reviewed and approved by an independent
ethics committee or institutional review board before it can begin. Phase 1
22
usually involves the
initial introduction of the investigational drug into healthy volunteers or patients to evaluate
certain factors, including its safety, dosage tolerance and, if possible, to gain an early
indication of its effectiveness. Phase 2 usually involves trials in a limited patient population to
evaluate dosage tolerance and appropriate dosage, identify possible adverse effects and safety
risks, and evaluate preliminarily the efficacy of the drug for specific indications. Phase 3 trials
usually further evaluate clinical efficacy and test further for safety by using the drug in its
final form in an expanded patient population. Later clinical trials may fail to support the
findings of earlier trials, which would delay, limit or prevent regulatory approvals.
While we have stated our intention to file additional IND applications and conduct additional
clinical trial during the next several years, this is only a statement of intent, and we may not be
able to do so because the associated product candidates may not meet the necessary preclinical
requirements. In addition, there can be no assurance that, once filed, an IND application will
result in the actual initiation of clinical trials.
We cannot predict whether or when we will obtain regulatory approval to commercialize our
product candidates, therefore we cannot predict the timing of any future revenue from these product
candidates. We cannot commercialize any of our ZFP Therapeutics to generate revenue until the
appropriate regulatory authorities have reviewed and approved the applications for the product
candidates. We cannot assure you that the regulatory agencies will complete their review processes
in a timely manner or that we will obtain regulatory approval for any product candidate that we or
our collaborators develop. Satisfaction of regulatory requirements typically takes many years, is
dependent upon the type, complexity and novelty of the product and requires the expenditure of
substantial resources. Regulatory approval processes outside the United States include all of the
risks associated with the FDA approval process. In addition, we may experience delays or rejections
based upon additional government regulation from future legislation or administrative action or
changes in FDA policy during the period of product development, clinical trials and FDA regulatory
review.
Our collaborators may control aspects of our clinical trials, which could result in delays and
other obstacles in the commercialization of our proposed products. For some programs we may be
dependent on third party collaborators to design and conduct our clinical trials. As a result, we
may not be able to conduct these programs in the manner or on the time schedule we currently
contemplate. In addition, if any of these collaborative partners withdraw support for our programs
or proposed products or otherwise impair their development, our business could be negatively
affected.
Our gene regulation and gene modification technology is relatively new, and if we are unable
to use this technology in all our intended applications, it would limit our revenue
opportunities. Our technology involves a relatively new approach to gene regulation and gene
modification. Although we have generated ZFP TFs for thousands of gene sequences, we have not
created ZFP TFs for all gene sequences and may not be able do so, which could limit the usefulness
of our technology. In addition, while we have demonstrated the function of engineered ZFP TFs in
mammalian cell culture, yeast, insects, plants, and animals, we have not yet definitively done so
in humans, and the failure to do so could restrict our ability to develop commercially viable
products. If we, and our collaborators or strategic partners, are unable to extend our results to
new commercially important genes, experimental animal models, and human clinical studies, we may be
unable to use our technology in all its intended applications. Also, delivery of ZFP TFs and ZFNs
into cells and organisms, including humans, in these and other environments is limited by a number
of technical hurdles, which we may be unable to surmount. This is a particular challenge for
therapeutic applications of our technology that will require the use of gene transfer systems that
may not be effective for the delivery of our ZFP TFs or ZFNs in a particular therapeutic
application.
The expected value and utility of our ZFP TFs and ZFNs is in part based on our belief that the
targeted or specific regulation of gene expression and targeted gene modification may enable us to
develop a new therapeutic approach as well as to help scientists better understand the role of
human, animal, and other genes in disease and to aid their efforts in drug discovery and
development. We also believe that the regulation of gene expression and targeted gene addition will
have utility in agricultural applications. There is only a limited understanding of the role of
specific genes in all these fields. Life sciences companies have developed or commercialized only a
few products in any of these fields based on results from genomic research or the ability to
regulate gene expression. We, our collaborators, or our strategic partners, may not be able to use
our technology to identify and validate drug targets or to develop commercial products in the
intended markets.
We are currently engaged in the research and development of a new application of our
technology platform: ZFP-mediated gene modification using ZFNs to effect gene disruption, gene
correction or gene addition. Using this technique, Sangamo scientists have engineered ZFNs to cut
DNA at a specific site within a target gene, and to rejoin the two ends of the break which
frequently results in the disruption of the genes function; to correct the adjacent sequences with
newly synthesized DNA copied from an introduced DNA
23
template, resulting in gene correction; or to
specifically add a new DNA sequence into a target site. ZFP-mediated gene modification is at an
early stage of development. Our scientists have shown ZFP-mediated gene modification to work in
isolated cells; however, a significant amount of additional research will be needed before this
technique can be evaluated in animals or plants and subsequently tested for applications in human
healthcare and plant agriculture.
We may be unable to license gene transfer technologies that we may need to commercialize our
ZFP TF and ZFN technology. In order to regulate a gene in a cell, the ZFP TF or ZFN must be
efficiently delivered to the cell. We have licensed certain gene transfer technologies for use with
our non therapeutic programs, which are ZFP TFs and ZFNs used in pharmaceutical discovery research
and protein production. We are evaluating these systems and other technologies that may need to be
used in the delivery of ZFP TFs or ZFNs into cells for in vitro and in vivo applications, including
ZFP Therapeutics. However, we may not be able to license the gene transfer technologies required to
develop and commercialize our ZFP Therapeutics. We have not developed our own gene transfer
technologies, and where necessary we rely on our ability to enter into license agreements to
provide us with rights to the necessary gene transfer technology. The inability to obtain a license
to use gene transfer technologies with entities which own such technology on reasonable commercial
terms, if at all, could delay or prevent the preclinical evaluation, clinical testing, and/or
commercialization of our therapeutic product candidates.
We do not currently have the infrastructure or capability to manufacture therapeutic products
on a commercial scale. In order for us to commercialize these products directly, we would need to
develop, or obtain through outsourcing arrangements, the capability to execute all of these
functions. If we are unable to develop or otherwise obtain the requisite preclinical, clinical,
regulatory, manufacturing, marketing, and sales capabilities, we would be unable to directly
commercialize our therapeutics products which would limit our future growth.
Even if our technology proves to be effective, it still may not lead to commercially viable
products. Even if our collaborators or strategic partners are successful in using our ZFP
technology in research reagents, protein production, therapeutic development, or plant agriculture,
they may not be able to commercialize the resulting products or may decide to use other methods
competitive with our technology. To date, no company has received marketing approval or has
developed or commercialized any therapeutic or agricultural products based on our technology.
Should our technology fail to provide safe, effective, useful, or commercially viable approaches to
the discovery and development of these products, this would significantly limit our business and
future growth and would adversely affect our value.
Even if our product development efforts are successful and even if the requisite regulatory
approvals are obtained, our ZFP Therapeutics may not gain market acceptance among physicians,
patients, healthcare payers and the medical community. A number of additional factors may limit
the market acceptance of products including the following:
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rate of adoption by healthcare practitioners; |
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rate of a products acceptance by the target population; |
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timing of market entry relative to competitive products; |
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availability of alternative therapies; |
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price of our product relative to alternative therapies; |
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availability of third-party reimbursement; |
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extent of marketing efforts by us and third-party distributors or agents retained by
us; and |
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side effects or unfavorable publicity concerning our products or similar products. |
Adverse events in the field of gene therapy and siRNA may negatively impact regulatory
approval or public perception of our potential products. Our potential therapeutic products are
delivered to patients as nucleic acid-based drugs. The clinical and commercial success of our
potential products will depend in part on public acceptance of the use of gene therapy and siRNA
for the prevention or treatment of human diseases. Public attitudes may be influenced by claims
that gene therapy is unsafe or that siRNA is
24
ineffective, and, consequently, our products may not
gain the acceptance of the public or the medical community. Negative public reaction to gene
therapy in general could result in greater government regulation and stricter labeling requirements
of gene therapy products, including any of our products, and could cause a decrease in the demand
for any products we may develop.
Our stock price is also influenced by public perception. Reports of serious adverse events in
a retroviral gene transfer trial for infants with X-linked severe combined immunodeficiency
(X-linked SCID) in France and subsequent FDA actions putting related trials on hold in the United
States had a significant negative impact on the public perception and stock price of certain
companies involved in gene therapy. Stock prices of these companies declined whether or not the
specific company was involved with retroviral gene transfer for the treatment of infants with
X-linked SCID, or whether the specific companys clinical trials were placed on hold in connection
with these events. Other potential adverse events in the field of siRNA or gene therapy may occur
in the future that could result in greater governmental regulation of our potential products and
potential regulatory delays relating to the testing or approval of our potential products
We are at the development phase of operations and may not succeed or become profitable. We
began operations in 1995 and are in the early phases of ZFP Therapeutic product development. We
have incurred significant losses and our net losses for the past three fiscal years ended 2006,
2005 and 2004 were $17.9 million, $13.3 million and $13.8 million, respectively. To date, our
revenues have been generated from non therapeutic collaborations, strategic partners, and research
grants. Since 2005, we have placed more emphasis on higher-value therapeutic product development
and related strategic partnerships. This shift in emphasis has the potential to increase the return
on investment to our stockholders by allocating capital resources to higher value, therapeutic
product development activities. At the same time, it increases our financial risk by increasing
expenses associated with product development. In addition, the preclinical or clinical failure of
any single product may have a significant effect on the actual or perceived value of our shares.
Our business is subject to all of the risks inherent in the development of a new technology, which
included the need to:
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attract and retain qualified scientific and technical staff and management, particularly
scientific staff with expertise to develop our early-stage technology into therapeutic
products; |
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obtain sufficient capital to support the expense of developing our technology platform
and developing, testing, and commercializing products; |
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develop a market for our products; |
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successfully transition from a company with a research focus to a company capable of
supporting commercial activities; and |
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attract and enter into research collaborations with research and academic institutions
and scientists. |
Commercialization of our technologies will depend, in part, on strategic partnering with other
companies. If we are not able to find strategic partners in the future or our strategic partners do
not diligently pursue product development efforts, we may not be able to develop our technologies
or products, which could slow our growth and decrease our value. We expect to rely, to some
extent, on our strategic partners to provide funding in support of our research and to perform
independent research and preclinical and clinical testing. Our technology is broad based, and we do
not currently possess the resources necessary to fully develop and commercialize potential products
that may result from our technologies or the resources or capabilities to complete the lengthy
marketing approval processes that may be required for the products. Therefore, we plan to rely on
strategic partnerships to help us develop and commercialize ZFP Therapeutic products. If those
partners are unable or unwilling to advance our programs, or if they do not diligently pursue
product approval, this may slow our progress and defer our revenues. Our partners may sublicense or
abandon development programs or we may have disagreements with our partners, which would cause
associated product development to slow or cease. There can be no assurance that we will be able to
establish strategic collaborations for ZFP Therapeutic product development. We may require
significant time to secure collaborations or strategic partners because we need to effectively
market the benefits of our technology to these future collaborators and strategic partners, which
use the time and efforts of research and development personnel and our management. Further, each
collaboration or strategic partnering arrangement will involve the negotiation of terms that may be
unique to each collaborator or strategic partner. These business development efforts may not result
in a collaboration or strategic partnership.
The loss of any future strategic partnering agreements would not only delay or terminate the
potential development or commercialization of products we may derive from our technologies, but it
may also delay or terminate our ability to test ZFP TFs for specific genes. If any strategic
partner fails to conduct the collaborative activities successfully and in a timely manner, the
preclinical
25
or clinical development or commercialization of the affected product candidates or
research programs could be delayed or terminated.
If our competitors develop, acquire, or market technologies or products that are more
effective than ours, this would reduce or eliminate our commercial opportunity. Any products that
we or our collaborators or strategic partners develop by using our ZFP technology platform will
enter into highly competitive markets. Even if we are able to generate ZFP Therapeutics that are
safe and effective for their intended use, competing technologies may prove to be more effective or
less expensive, which, to the extent these competing technologies achieve market acceptance, will
limit our revenue opportunities. In some cases, competing technologies have proven to be
satisfactorily effective and less expensive. ZFP TFs and ZFNs have broad application in the life
sciences and compete with a broad array of new technologies and approaches being applied to genetic
research by many companies. Competing proprietary technologies with our product development focus
include:
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small molecule drugs; |
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monoclonal antibodies; |
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recombinant proteins; |
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gene therapy /cDNAs; |
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antisense; and |
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siRNA approaches. |
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For our non therapeutic applications: |
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For protein production: gene amplification, meganucleases, insulator technology,
mini-chromosomes; |
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For research reagents: antisense, siRNA; and |
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For plant agriculture: recombination approaches, mutagenesis approaches, meganucleases,
mini-chromosomes. |
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In addition to possessing competing technologies, our competitors include biotechnology
companies with: |
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substantially greater capital resources than ours; |
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larger research and development staffs and facilities than ours; and |
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greater experience in product development and in obtaining regulatory approvals and patent
protection. |
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These organizations also compete with us to: |
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attract qualified personnel; |
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attract parties for acquisitions, joint ventures or other collaborations; and |
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license the proprietary technologies of academic and research institutions that are
competitive with our technology, which may preclude us from pursuing similar opportunities. |
Accordingly, our competitors may succeed in obtaining patent protection or commercializing
products before us. In addition, any products that we develop may compete with existing products or
services that are well established in the marketplace.
Our collaborators or strategic partners may decide to adopt alternative technologies or may be
unable to develop commercially viable products with our technology, which would negatively impact
our revenues and our strategy to develop these products. Our
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collaborators or strategic partners
may adopt alternative technologies, which could decrease the marketability of ZFP technology.
Additionally, because many of our collaborators or strategic partners are likely to be working on
more than one development project, they could choose to shift their resources to projects other
than those they are working on with us. If they do so, this would delay our ability to test our
technology and would delay or terminate the development of potential products based on our ZFP
technology. Further, our collaborators and strategic partners may elect not to develop products
arising out of our collaborative and strategic partnering arrangements or to devote sufficient
resources to the development, manufacturing, marketing, or sale of these products. If any of these
events occur, we may not be able to develop our technologies or commercialize our products.
We anticipate continuing to incur operating losses for the next several years. If material
losses continue for a significant period, we may be unable to continue our operations. We have
incurred operating losses since we began operations in 1995. The extent of our future losses and
the timing of profitability are uncertain, and we expect to incur losses for the foreseeable
future. We have been engaged in developing our ZFP TF technology since inception, which has and
will continue to require significant research and development expenditures. In July 2007, we
completed a registered direct offering to a group of institutional investors, in which we sold an
aggregate of 3,278,689 shares of common stock at a price of $9.15 per share to such investors,
resulting in net proceeds of approximately $28.0 million. In June 2006, in an underwritten public
offering and pursuant to an effective registration statement, we sold 3,100,000 shares of common
stock at a public offering price of $6.75 per share, resulting in net proceeds of approximately
$20.15 million after deducting underwriters discount. In November 2005, we completed a registered
direct offering to institutional and strategic investors for a total of 5,080,000 shares of common
stock at a price of $3.85 per share to the investors, resulting in net proceeds to Sangamo of
approximately $18.2 million. To date, we have generated all other revenue from non therapeutic
collaborations, ZFP Therapeutic collabrations, strategic partnering agreements, research grants and
grants awarded by research foundations. As of September 30, 2007, we had an accumulated deficit of
approximately $143.1 million. We expect to incur losses for the foreseeable future. These losses
will increase as we expand and extend our research and development activities into human
therapeutic product development. If the time required to generate significant product revenues and
achieve profitability is longer than we currently anticipate or if we are unable to generate
liquidity through equity financing, we may not be able to sustain our operations.
We may be unable to raise additional capital, which would harm our ability to develop our
technology and products. We have incurred significant operating losses and negative operating cash
flows since inception and have not achieved profitability. We expect capital outlays and operating
expenditures to increase over the next several years as we expand our infrastructure and research
and ZFP Therapeutic product development activities. While we believe our financial resources will
be adequate to sustain our current operations at least through 2009, we may seek additional sources
of capital through equity or debt financing. In addition, as we focus our efforts on proprietary
human therapeutics, we will need to seek FDA approval of potential products, a process that could
cost in excess of $100 million per product. We cannot be certain that we will be able to obtain
financing on terms acceptable to us, or at all. If adequate funds are not available, our business
and our ability to develop our technology and ZFP Therapeutic products would be harmed.
Our stock price has been volatile and may continue to be volatile, which could result in
substantial losses for investors. During the quarter ended September 30, 2007, our stock price
ranged from a low of $8.36 to high of $14.11. During the past two years, our common stock price has
fluctuated significantly, ranging from a low of $4.10 to a high of $8.00 during the year ended
December 31, 2006, and a low of $3.54 to a high of $5.81 during the year ended December 31, 2005.
Volatility in our common stock could cause stockholders to incur substantial losses. An active
public market for our common stock may not be sustained, and the market price of our common stock
may continue to be highly volatile. The market price of our common stock has fluctuated
significantly in response to the following factors, some of which are beyond our control:
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announcements by us about the development and commercialization status of ZFP
Therapeutics; |
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changes in market valuations of similar companies; |
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deviations in our results of operations from the guidance given by us or estimates of
securities analysts; |
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announcements by us or our competitors of new or enhanced products, technologies or
services or significant contracts, acquisitions, strategic relationships, joint ventures or
capital commitments; |
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regulatory developments; |
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additions or departures of key personnel; |
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future sales of our common stock or other securities by us, management or directors; |
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future sale or liquidation of our common stock by investors with large holding of our
stock; and |
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decreases in our cash balances. |
Our common stock is relatively moderately traded, which means large transactions in our common
stock may be difficult to conduct in a short time frame. We have a relatively moderate volume of
daily trades in our common stock on the Nasdaq Global Market. For example, the average daily
trading volume in our common stock on the Nasdaq Global Market over the ten-day trading period
prior to October 26, 2007 was approximately 641,590 shares per day. Any large transactions in our
common stock may be difficult to conduct and may cause significant fluctuations in the price of our
common stock.
Failure to attract, retain, and motivate skilled personnel and cultivate key academic
collaborations will delay our product development programs and our research and development
efforts. We are a small company with 80 full-time employees as of October 31, 2007 and our success
depends on our continued ability to attract, retain, and motivate highly qualified management and
scientific personnel and our ability to develop and maintain important relationships with leading
research and academic institutions and scientists. Competition for personnel and academic and other
research collaborations is intense. The success of our technology development programs depends on
our ability to attract and retain highly trained personnel. We have experienced a rate of employee
turnover that we believe is typical of emerging biotechnology companies. If we lose the services of
personnel with the necessary skills, it could significantly impede the achievement of our research
and development objectives. We are not presently aware of any plans of specific employees to retire
or otherwise leave the company. If we fail to negotiate additional acceptable collaborations with
academic and other research institutions and scientists, or if our existing collaborations are
unsuccessful, our ZFP Therapeutic development programs may be delayed or may not succeed.
If conflicts arise between us and our collaborators, strategic partners, or scientific
advisors, these parties may act in their self-interest, which may limit our ability to implement
our strategies. If conflicts arise between our corporate or academic collaborators, strategic
partners, or scientific advisors and us, the other party may act in its self-interest, which may
limit our ability to implement our strategies. Some of our academic collaborators and strategic
partners are conducting multiple product development efforts within each area that is the subject
of the collaboration with us. Our collaborators or strategic partners, however, may develop, either
alone or with others, products in related fields that are competitive with the products or
potential products that are the subject of these collaborations. Competing products, either
developed by the collaborators or strategic partners or to which the collaborators or strategic
partners have rights, may result in the withdrawal of partner support for our product candidates.
Some of our collaborators or strategic partners could also become competitors in the future.
Our collaborators or strategic partners could develop competing products, preclude us from entering
into collaborations with their competitors, fail to obtain timely regulatory approvals, terminate
their agreements with us prematurely, or fail to devote sufficient resources to the development and
commercialization of products. Any of these developments could harm our product development
efforts.
Because it is difficult and costly to protect our proprietary rights, and third parties have
filed patent applications that are similar to ours, we cannot ensure the proprietary protection of
our technologies and products. Our commercial success will depend in part on obtaining patent
protection of our technology and successfully defending any of our patents that may be challenged.
The patent positions of pharmaceutical and biotechnology companies can be highly uncertain and can
involve complex legal and factual questions. No consistent policy regarding the breadth of claims
allowed in biotechnology patents has emerged to date. Accordingly, we cannot predict the breadth of
claims allowed in patents we own or license.
We are a party to various license agreements that give us rights under specified patents and
patent applications. Our current licenses, as our future licenses frequently will, contain
performance obligations. If we fail to meet those obligations, the licenses could be terminated. If
we are unable to continue to license these technologies on commercially reasonable terms, or at
all, we may be forced to delay or terminate our product development and research activities.
With respect to our present and any future sublicenses, since our rights derive from those
granted to our sublicensor, we are subject to the risk that our sublicensor may fail to perform its
obligations under the master license or fail to inform us of useful improvements in, or additions
to, the underlying intellectual property owned by the original licensor.
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We are unable to exercise the same degree of control over intellectual property that we
license from third parties as we exercise over our internally developed intellectual property. We
do not control the prosecution of certain of the patent applications that we license from third
parties; therefore, the patent applications may not be prosecuted exactly as we desire or in a
timely manner.
The degree of future protection for our proprietary rights is uncertain, and we cannot ensure
that:
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we or our licensors were the first to make the inventions covered by each of our pending
patent applications; |
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we or our licensors were the first to file patent applications for these inventions; |
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the patents of others will not have an adverse effect on our ability to do business; |
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others will not independently develop similar or alternative technologies or reverse
engineer any of our products, processes or technologies; |
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any of our pending patent applications will result in issued patents; |
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any patents issued or licensed to us or our collaborators or strategic partners will
provide a basis for commercially viable products or will provide us with any competitive
advantages; |
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any patents issued or licensed to us will not be challenged and invalidated by third
parties; or |
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we will develop additional products, processes or technologies that are patentable. |
Others have filed and in the future are likely to file patent applications that are similar to
ours. We are aware that there are academic groups and other companies that are attempting to
develop technology that is based on the use of zinc finger and other DNA binding proteins, and that
these groups and companies have filed patent applications. Several patents have been issued,
although we have no current plans to use the associated inventions. If these or other patents
issue, it is possible that the holder of any patent or patents granted on these applications may
bring an infringement action against our collaborators, strategic partners, or us claiming damages
and seeking to enjoin commercial activities relating to the affected products and processes. The
costs of litigating the claim could be substantial. Moreover, we cannot predict whether we, our
collaborators, or strategic partners would prevail in any actions. In addition, if the relevant
patent claims were upheld as valid and enforceable and our products or processes were found to
infringe the patent or patents, we could be prevented from making, using, or selling the relevant
product or process unless we could obtain a license or were able to design around the patent
claims. We can give no assurance that such a license would be available on commercially reasonable
terms, or at all, or that we would be able to successfully design around the relevant patent
claims. There may be significant litigation in the genomics industry regarding patent and other
intellectual property rights, which could subject us to litigation. If we become involved in
litigation, it could consume a substantial portion of our managerial and financial resources.
Third parties have challenged some of our intellectual property and we expect they will
continue to do so. We may not be successful in defending all of our intellectual property that is
challenged which could impede our ability to conduct our business and exclude potential competitors
from using our technology. One of our licensed patents, European Patent No. 0 682 699, entitled
Functional Domains in Flavobacterium Okeanokoites Restriction Endonuclease was granted on May 7,
2003 and contained claims covering technologies used in our programs in targeted recombination,
targeted integration and gene correction. In December 2005, an interlocutory decision revoking this
patent was issued by the European Patent Office and in March 2007, the European Patent Office
upheld its decision. We do not believe this decision will have a material impact on our ongoing
ability, both in Europe and the United States, to exclude potential competitors in the fields of
ZFNs and to develop, partner and commercialize our ZFP technology.
We rely on trade secrets to protect technology where we believe patent protection is not
appropriate or obtainable. Trade secrets, however, are difficult to protect. While we require
employees, academic collaborators, and consultants to enter into confidentiality agreements, we may
not be able to adequately protect our trade secrets or other proprietary information or enforce
these confidentiality agreements.
Our collaborators, strategic partners, and scientific advisors have rights to publish data and
information in which we may have rights. If we cannot maintain the confidentiality of our
technology and other confidential information in connection with our collaborations and strategic
partnerships, then we may not be able to receive patent protection or protect our proprietary
information.
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If we do not successfully commercialize ZFP based research reagents under our license
agreement with Sigma, or if Sigma terminates our agreement, our ability to generate revenue
under the license agreement may be limited. On July 10, 2007, we entered into a license agreement
with Sigma to collaborate in the application and development of ZFP-based products for use in the
laboratory research reagents markets. The license agreement provides Sigma with access to
Sangamos ZFP technology and the exclusive right to use Sangamos ZFP technology to develop and
commercialize products for use as research reagents and to offer services in related research
fields. In addition to an upfront payment of $13.5 million, Sangamo may also receive additional
license fees, shared sublicensing revenues, royalty payments and milestone payments depending on
the success of the development and commercialization of the licensed products and services. The
commercial milestones and royalties are based upon net sales of licensed products. We believe that
the last commercial milestone payment may not be received before 2011. Our right to receive
royalty payments from Sigma will continue until the later of (i) the expiration of the last to
expire valid claim of such licensed product and (ii) the 15th anniversary of the
effective date of the License Agreement. We cannot be certain that Sigma and Sangamo will succeed
in the development of commercially viable products in these fields of use, and there is no
guarantee that Sangamo and Sigma will achieve the milestones set forth in the license agreement.
To the extent Sangamo and Sigma do not succeed in developing and commercializing products or if
Sangamo and Sigma fail to achieve such milestones, our revenues and benefits under the license
agreement will be limited. In addition, the license agreement may be terminated by Sigma at any
time by providing us with a 90-day notice. In the event Sigma decides to terminate the license
agreement, our ability to generate revenue under the license agreement will cease.
If we do not successfully commercialize certain ZFP Therapeutic programs relating to diabetic
neuropathy under our agreement with JDRF, JDRF may have the right to continue to advance the
program and we may lose control of the intellectual property generated in the collaboration and
development of the product and may only receive a portion of the revenue generated if
commercialization by JDRF is successful. On October 24, 2006, we entered into a Research,
Development and Commercialization Agreement with JDRF. Under the agreement and subject to its
terms and conditions, including our achievement of certain milestones associated with our Phase 2
clinical trial of SB-509 for the treatment of mild to moderate diabetic neuropathy, JDRF will pay
us up to $3,000,000. We are obligated to cover the costs of the Phase 2 trial that are not covered
by JDRFs grant.
Under the agreement, we are obligated to use commercially reasonable efforts to carry out the
Phase 2 trial and, thereafter, to develop and commercialize, a product containing SB-509 for the
treatment of diabetes and complications of diabetes. If we fail to satisfy these obligations, JDRF
may have the right, subject to certain limitations, to obtain an exclusive, sublicensable license,
to the intellectual property generated by us in the course of the Phase 2 trial, to make and
commercialize products containing SB-509 for the treatment of diabetes and complications of
diabetes. If JDRF obtains such a license, it is obligated to pay us a percentage of its revenues
from product sales and sublicensing arrangements. If JDRF fails to satisfy its obligations to
develop and commercialize a product containing SB-509 under the Agreement, then their license
rights will terminate, all rights will be returned to Sangamo and we will receive a non-exclusive,
fully paid license, for any intellectual property developed during JDRFs use of the license, to
research, develop and commercialize products containing SB-509 for the treatment of diabetes and
complications of diabetes. There is no guarantee that we will be successful in commercializing a
product containing SB-509 in the future. If we fail to do so under the agreement with JDRF, we may
lose control of the intellectual property generated in the development of the product and may only
receive a portion of the revenue generated if commercialization by JDRF is successful.
Regulatory approval, if granted, may be limited to specific uses or geographic areas, which
could limit our ability to generate revenues. Regulatory approval will be limited to the indicated
use for which we can market a product. Further, once regulatory approval for a product is obtained,
the product and its manufacturer are subject to continual review. Discovery of previously unknown
problems with a product or manufacturer may result in restrictions on the product, manufacturer,
and manufacturing facility, including withdrawal of the product from the market. In Japan and
Europe, regulatory agencies also set or approve prices.
Even if regulatory clearance of a product is granted, this clearance is limited to those
specific states and conditions for which the product is useful, as demonstrated through clinical
trials. We cannot ensure that any ZFP Therapeutic product developed by us, alone or with others,
will prove to be safe and effective in clinical trials and will meet all of the applicable
regulatory requirements needed to receive marketing clearance in a given country.
Outside the United States, our ability to market a product is contingent upon receiving a
marketing authorization from the appropriate regulatory authorities, so we cannot predict whether
or when we would be permitted to commercialize our product. These foreign regulatory approval
processes include all of the risks associated with FDA clearance described above.
30
Our collaborations with outside scientists may be subject to change, which could limit our
access to their expertise. We work with scientific advisors and collaborators at academic research
institutions. These scientists are not our employees and may have other commitments that would
limit their availability to us. Although our scientific advisors generally agree not to do
competing work, if a conflict of interest between their work for us and their work for another
entity arises, we may lose their services. Although our scientific advisors and academic
collaborators sign agreements not to disclose our confidential information, it is possible that
some of our valuable proprietary knowledge may become publicly known through them.
Laws or public sentiment may limit the production of genetically modified agricultural
products in the future, and these laws could reduce our partners ability to sell these
products. Genetically modified products are currently subject to public debate and heightened
regulatory scrutiny, either of which could prevent or delay production of agricultural products.
Effective as of October 1, 2005, we entered into a Research License and Commercial Option Agreement
with DAS. Under this agreement, we will provide DAS with access to our proprietary ZFP technology
and the exclusive right to use our ZFP technology to modify the genomes or alter the nucleic acid
or protein expression of plant cells, plants, or plant cell cultures. The field-testing,
production, and marketing of genetically modified plants and plant products are subject to federal,
state, local, and foreign governmental regulation. Regulatory agencies administering existing or
future regulations or legislation may not allow production and marketing of our genetically
modified products in a timely manner or under technically or commercially feasible conditions. In
addition, regulatory action or private litigation could result in expenses, delays, or other
impediments to our product development programs or the commercialization of resulting products.
The FDA currently applies the same regulatory standards to foods developed through genetic
engineering as those applied to foods developed through traditional plant breeding. Genetically
engineered food products, however, will be subject to pre-market review if these products raise
safety questions or are deemed to be food additives. Governmental authorities could also, for
social or other purposes, limit the use of genetically modified products created with our gene
regulation technology.
Even if we are able to obtain regulatory approval for genetically modified products, our
success will also depend on public acceptance of the use of genetically modified products including
drugs, plants, and plant products. Claims that genetically modified products are unsafe for
consumption or pose a danger to the environment may influence public attitudes. Our genetically
modified products may not gain public acceptance. The subject of genetically modified organisms has
received negative publicity in the United States and particularly in Europe, and such publicity has
aroused public debate. The adverse publicity in Europe could lead to greater regulation and trade
restrictions on imports of genetically altered products. Similar adverse public reaction in the
United States to genetic research and its resulting products could result in greater domestic
regulation and could decrease the demand for our technology and products.
If we use biological and hazardous materials in a manner that causes injury or violates laws,
we may be liable for damages. Our research and development activities involve the controlled use
of potentially harmful biological materials as well as hazardous materials, chemicals, and various
radioactive compounds typically employed in molecular and cellular biology. We routinely use cells
in culture and gene delivery vectors, and we employ small amounts of radioisotopes in trace
experiments. Although we maintain up-to-date licensing and training programs, we cannot completely
eliminate the risk of accidental contamination or injury from the use, storage, handling, or
disposal of these materials. In the event of contamination or injury, we could be held liable for
damages that result, and any liability could exceed our resources. We currently carry insurance
covering claims arising from our use of these materials. However, if we are unable to maintain our
insurance coverage at a reasonable cost and with adequate coverage, our insurance may not cover any
liability that may arise. We are subject to federal, state, and local laws and regulations
governing the use, storage, handling, and disposal of these materials and specified waste products.
To date, we have not experienced significant costs in complying with regulations regarding the use
of these materials.
31
Anti-takeover provisions in our certificate of incorporation and Delaware law could make an
acquisition of the Company more difficult and could prevent attempts by our stockholders to remove
or replace current management. Anti-takeover provisions of Delaware law, our certificate of
incorporation and our bylaws may discourage, delay or prevent a change in control of our company,
even if a change in control would be beneficial to our stockholders. In addition, these provisions
may frustrate or prevent any attempts by our stockholders to replace or remove our current
management by making it more difficult for stockholders to replace members of our board of
directors. In particular, under our certificate of incorporation our board of directors may issue
up to 5,000,000 shares of preferred stock with rights and privileges that might be senior to our
common stock, without the consent of the holders of the common stock. Moreover, without any further
vote or action on the part of the stockholders, the board of directors would have the authority to
determine the price, rights, preferences, privileges, and restrictions of the preferred stock. This
preferred stock, if it is ever issued, may have preference over, and harm the rights of, the
holders of common stock. Although the issuance of this preferred stock would provide us with
flexibility in connection with possible acquisitions and other corporate purposes, this issuance
may make it more difficult for a third party to acquire a majority of our outstanding voting stock.
Similarly, our authorized but unissued common stock is available for future issuance without
stockholder approval.
In addition, our certificate of incorporation:
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states that stockholders may not act by written consent but only at a stockholders
meeting; |
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establishes advance notice requirements for nominations for election to the board of
directors or proposing matters that can be acted upon at stockholders meetings; and |
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limits who may call a special meeting of stockholders. |
We are also subject to Section 203 of the Delaware General Corporation Law, which provides,
subject to certain exceptions, that if a person acquires 15% of our voting stock, the person is an
interested stockholder and may not engage in business combinations with us for a period of
three years from the time the person acquired 15% or more or our voting stock.
Insiders have substantial control over Sangamo and could delay or prevent a change in
corporate control. The interest of management could conflict with the interest of our other
stockholders. Our executive officers and directors beneficially own, in the aggregate,
approximately 10% of our outstanding common stock. As a result, these stockholders, if they choose
to act together, will be able to have a material impact on all matters requiring stockholder
approval, including the election of directors and approval of significant corporate transactions.
This could have the effect of delaying or preventing a change of control of Sangamo, which in turn
could reduce the market price of our stock.
ITEM 6. EXHIBITS
(a) Exhibits:
10.1 (+) |
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License Agreement dated as of July 10, 2007 between Sigma-Aldrich Corporation., and
Sangamo BioSciences, Inc. |
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10.2 |
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Common Stock Purchase Agreement dated as of July 10, 2007 between Sigma-Aldrich Corporation
and Sangamo BioSciences, Inc. (incorporated by reference to Exhibit 10.1 to the Form 8-K filed
on July 10, 2007) |
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Rule 13a 14(a) Certification by President and Chief Executive Officer |
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31.2 |
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Rule 13a 14(a) Certification by Principal Financial and Accounting Officer |
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32.1 |
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Certification Pursuant to 18 U.S.C. Section 1350. |
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Confidential Treatment has been requested for certain information contained in this document.
Such information has been omitted and filed separately with the Securities and Exchange
Commission. |
32
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
SANGAMO BIOSCIENCES, INC. Dated: November 1, 2007
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/s/ Greg S. Zante
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Greg S. Zante
Vice President, Finance and Administration
(Principal Financial and Accounting Officer) |
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33
exv10w1
Exhibit 10.1
NOTE: Portions of this Exhibit are the subject of a Confidential Treatment
Request by the Registrant to the Securities and Exchange Commission (the Commission).
Such portions have been redacted and are marked with a [***] in place of the redacted language.
The redacted information has been filed separately with the Commission.
LICENSE AGREEMENT
This License Agreement (the Agreement) is made and
entered into as of July 10, 2007 (the Effective Date) by and between Sangamo BioSciences,
Inc., a Delaware corporation having its principal place of business at Point Richmond Tech
Center, 501 Canal Boulevard, Suite A100, Richmond, California 94804, and Sigma-Aldrich
Co., an Illinois corporation having its principal place of business at 3050 Spruce Street, St.
Louis, MO 63103. Sangamo (as defined below) and Sigma (as defined below) are sometimes referred to
herein individually as a Party and collectively as the Parties.
Recitals
A. Sangamo has expertise in, and proprietary technology relating to, zinc finger proteins and
their use to alter the genomes and/or protein expression capabilities of organisms and cells.
B. Sigma has expertise in the development and marketing of laboratory research reagents.
C. Sigma desires an exclusive license under Sangamos expertise and proprietary technology as
applied to the research market, and Sangamo desires to grant such a license.
Now, Therefore, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
1.1 Active Supplied ZFN shall mean a Supplied ZFN having demonstrated ability to modify at
least one allele of the applicable Target in a cell culture assay or other in vivo assay.
1.
1.2 Affiliate means, with respect to a particular Party, a person, corporation, partnership,
or other entity that controls, is controlled by or is under common control with such Party. For
the purposes of the definition in this Section 1.2, the word control (including, with correlative
meaning, the terms controlled by or under the common control with) means the actual power,
either directly or indirectly through one or more intermediaries, to direct the management and
policies of such entity, whether by the ownership of at least fifty percent (50%) of the voting
stock of such entity, or by contract or otherwise.
1.3 Annual FTE Rate means (a) from the Effective Date until the end of the [***] Year,
$[***] per FTE and (b) for each additional Year, $[***] per FTE plus an additional [***],
compounded annually, as a cost of living adjustment.
1.4 Bankrupt Party has the meaning set forth in Section 13.6(a).
1.5 Bona Fide Collaboration means any collaboration between Sangamo and a Third Party that
is a Therapeutic Collaboration or a Sangamo Internal Program Collaboration or in which neither
Sangamo nor a Sangamo Affiliate receives any compensation.
1.6 CEO means the chief executive officer of a Party (or his or her designee).
1.7 Claims has the meaning set forth in Section 12.1.
1.8 Clinical Development Payment means a payment to Sangamo from a Third Party pursuant to a
Sangamo Collaboration wherein such payment results from the filing of an IND or the initiation of,
completion of, enrollment of patients in, or disclosure of data from, a clinical trial, in each
case with respect to a therapeutic protein manufactured using a cell line that is licensed to such
Third Party pursuant to such Sangamo Collaboration. Notwithstanding the foregoing, Clinical
Development Payments shall expressly exclude payments based on (a) any regulatory event, such as
the filing of an application for, or receipt of, regulatory approval, (b) any manufacturing event,
(c) any commercial event such as first commercial sale or sales levels, or (d) any event (including
clinical trial-related events) occurring after regulatory approval for commercial marketing of the
applicable therapeutic protein.
1.9 Commercial Use means (i) use for GMP production of therapeutic, diagnostic,
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2.
prophylactic or other medicinal products intended for use in humans or non-human animals,
including the development of methods for such GMP production, or (ii) any other industrial use
solely to the extent involving commercial sale of a product or service (e.g., the production of
industrial enzymes for commercial sale). For clarity, if the molecule produced or any derivative
of such molecule is used in or administered to humans, then the production of such molecule shall
be deemed to be GMP production.
1.10 Committees has the meaning set forth in Section 3.1.
1.11 Confidential Information has the meaning set forth in Section 9.1.
1.12 Contract Manufacturer means one or more Third Party contractor(s) capable of carrying
out the Manufacture of ZFP Products at a quantity level and volume sufficient to supply Sigma for
its activities under this Agreement.
1.13 Control means, with respect to an item of Information or intellectual property right,
that a Party owns or has a license to such item or right and has the ability to disclose such item
and/or grant a license or sublicense as provided for in this Agreement under such item or right
without violating the terms of any agreement or other arrangement with any Third Party.
1.14 Custom Project Deliverable has the meaning set forth in Section 6.2(b).
1.15 Customer has the meaning set forth in Section 5.4.
1.16 Damages has the meaning set forth in Section 12.1.
1.17 Diligent Efforts means, with respect to a particular Party, the carrying out of
obligations or tasks in a commercially reasonable sustained manner consistent with the efforts such
Party devotes to a product or a project of similar market potential, profit potential or strategic
value resulting from its own efforts, based on conditions then prevailing. Diligent Efforts
requires that such Party use commercially reasonable efforts to: (a) promptly assign
responsibility for such obligations to specific employee(s) who are held accountable for progress
and monitor such progress on an on-going basis, (b) set and consistently seek to achieve specific
and meaningful objectives for carrying out such obligations, and (c) consistently make and
implement decisions and allocate resources designed to advance progress with respect to such
objectives.
3.
1.18 Dow AgroSciences means Dow AgroSciences LLC.
1.19 Dow AgroSciences Agreement means that Research and Commercial License Agreement dated
as of October 1, 2005 by and between Sangamo and Dow AgroSciences, as amended.
1.20 Escrow Materials has the meaning set forth in Section 6.4.
1.21 Existing Customer has the meaning set forth in Section 6.1(a).
1.22 Field means any use for research purposes. The Field shall exclude any Commercial Use
of Licensed Products and any use of Licensed Products for human healthcare (including prophylaxis
and diagnosis) or animal healthcare (including prophylaxis and diagnosis) (collectively, the
Excluded Fields). Notwithstanding the foregoing exclusion, the following uses are included in
the Field: (a) the use of transgenic animal models for research purposes; (b) the use (other than
Commercial Use) of Licensed Products in the research and non-clinical or pre-clinical development
of products that are intended for use in the Excluded Fields; (c) the research and development of
Licensed Products (but not any administration of Licensed Products to humans) in anticipation of
eventual use of such Licensed Products in the Excluded Fields (which use in the Excluded Fields
would, for the avoidance of doubt, require a separate license from Sangamo); and (d) use of
Licensed Products by or for Sigma to make products for commercial sale under a research use only
label.
1.23 Filing Party has the meaning set forth in Section 8.2(b).
1.24 First Tier Milestone means the actual receipt by Sigma of $[***] in cumulative Net
Sales from Sigma Custom Collaborations.
1.25 FTE means the equivalent of one employee or consultant of a Party working full time for
one twelve (12) month period.
1.26
GMP means the requirements for good manufacturing practice as set forth in (a) Title 21 of
the United States Code of Federal Regulations, Parts 210 and 211, as amended
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4.
from time to time, (b) Commission Directives 91/356/EEC and 2003/94/EC, as amended from time
to time or (c) any equivalent thereof in another country.
1.27 Improvement means any enhancement, modification, or improvement to the Sangamo
Technology, whether patentable or not, made during the term of this Agreement.
1.28 Improvement Patent means any patent or patent application in the United States or any
foreign jurisdiction claiming an Improvement.
1.29 IND means (a) an investigational new drug application, as defined in Title 21 of the
United States Code of Federal Regulations, Part 312 et seq., as amended from time to time, or (b)
any equivalent thereof in another country.
1.30 Indemnitee has the meaning set forth in Section 12.3.
1.31 Information means information, results and data of any type whatsoever, in any tangible
or intangible form whatsoever, including without limitation, databases, inventions, practices,
methods, techniques, specifications, formulations, formulae, knowledge, know-how, skill,
experience, test data including biological, chemical, and biochemical test data, analytical and
quality control data, stability data, studies and procedures, and patent and other legal
information or descriptions.
1.32 Infringement has the meaning set forth in Section 8.6.
1.33 Joint Improvement means an Improvement made by one or more employees, consultants, or
independent contractors of both Parties.
1.34 Joint Improvement Patent means a patent or patent application that claims a Joint
Improvement.
1.35 Joint Inventions means inventions, whether patentable or not, that are made by one or
more employees, consultants, or independent contractors of both Parties. For clarity, Joint
Inventions shall include Joint Improvements.
1.36 Joint Patent means a patent or patent application that claims a Joint Invention.
5.
1.37
Joint Steering Committee or JSC means the committee described in Sections 3.1 and
3.2.
1.38 Library Side Letter means that certain letter from Sangamo to Sigma dated as of the
Effective Date that sets forth certain understandings regarding Sangamos zinc-finger plasmid
library.
1.39 Licensed Product means (a) any product (i) the creation, development, manufacture, use,
importation, sale or offer for sale of which, in the absence of the licenses granted in this
Agreement, would infringe a Valid Claim or that (ii) incorporates Sangamo Know-How, or (b) any
Licensed Service.
1.40 Licensed Service means any fee-based service employing or involving use of any Sangamo
Know-How or which, in the absence of the licenses granted in this Agreement, would infringe a Valid
Claim.
1.41 Manufacture or Manufacturing means the design, optimization, construction,
production, and testing of one or more ZFP Products and, to the extent applicable, the use of such
ZFP Products in the Field to modify the protein expression in, or genome of, cell lines.
1.42 MFN Price has the meaning set forth in Section 2.7.
1.43 Minimum Annual Payment has the meaning set forth in Section 7.5(a).
1.44 Modified Cell Lines has the meaning set forth in Section 6.2.
1.45 Net Sales means the amount invoiced or otherwise billed by Sigma or its Sublicensees
for sales or other commercial disposition of a Licensed Product to a Third Party purchaser, less
the following to the extent included in such billing or otherwise actually allowed or incurred with
respect to such sales: (a) discounts, including cash, trade and quantity discounts, price reduction
programs, retroactive price adjustments with respect to sales of a product, charge-back payments
and rebates granted to trade customers; (b) credits or allowances actually granted upon rejections
or returns of Licensed Products, including for recalls or damaged goods; (c) freight, postage,
shipping and insurance charges actually allowed or paid for delivery of
6.
Licensed Products, to the extent billed; (d) customs duties, surcharges and other governmental
charges incurred in connection with the exportation or importation of a Licensed Product; (e)
taxes, duties or other governmental charges levied on, absorbed or otherwise imposed on sale of
Licensed Products, including without limitation value-added taxes, or other governmental charges
otherwise measured by the billing amount, when included in billing, as adjusted for rebates and
refunds, but specifically excluding taxes based on net income of the seller; and (f) a reasonable
allowance for bad debts (such allowance not to exceed 2% of gross sales) provided that all of the
foregoing deductions are calculated in accordance with generally accepted accounting principles
consistently applied throughout the selling partys organization.
1.46 Non-Filing Party has the meaning set forth in Section 8.2(b).
1.47 Party Indemnitees has the meaning set forth in Section 12.1.
1.48 Permitted Plant Product means any Plant Product that is a Licensed Product and (a) that
is used for diagnosis, treatment or prophylaxis of a disease or medical condition in a non-human
animal, for reducing or eliminating pathogens in a non-human animal, or for nutritional supplements
or food additives for nutritional enhancements in a non-human animal, (b) that is intended for the
diagnosis, treatment or prophylaxis of a disease or medical condition in a human, or (c) that is
extracted from plant material and intended to be ingested by or topically applied or otherwise
delivered or administered to humans, food, and food ingredients (e.g. oils), including without
limitation nutraceuticals, vitamins, nutritional supplements, food additives, shampoo, soap,
sunscreen, and cosmetics.
1.49 Permitted Plant Service means any fee-based service employing or involving a Permitted
Plant Product.
1.50 Plant Field means gene targeting and/or gene regulation using a ZFP Product to modify
the genome of a plant cell, plant, or plant cell culture (in each case, whether constituting or
derived from a vascular or non-vascular plant), or alter the nucleic acid or protein expression in
a plant cell, plant, or plant cell culture. For the purpose of this Agreement, non-vascular
plants shall include but not be limited to algae, moss, and fungi.
1.51 Plant Product means any product, other than a ZFP Product, that is created or
7.
produced directly or indirectly through use of Sangamo Technology in the Plant Field.
1.52 Projects Side Letter means that certain letter from Sangamo to Sigma dated as of the
Effective Date that contains certain information regarding custom service work being performed by
Sangamo for Third Parties, as described in more detail in Section 6.1.
1.53 Quarter Throughput Rate has the meaning set forth in Section 7.3(b).
1.54 Representatives has the meaning set forth in Section 13.1.
1.55 Research Costs means (a) the costs associated with a Partys FTEs performing work under
the Research Plan or otherwise under the direction of the JSC, as measured at the Annual FTE Rate,
(b) any out-of-pocket costs and expenses that such Party incurs as a result of such Partys
performance under the Research Plan or otherwise under the direction of the JSC (to the extent not
already included as part of the Annual FTE Rate), and (c) the costs described in Section 6.2(e).
1.56 Research Plan means the written plan describing the research program to be conducted by
Sangamo pursuant to Article 4. The parties have agreed upon an initial Research Plan which is set
forth in a separate side letter.
1.57 Research Plan Collaboration means all activities performed by or on behalf of Sangamo
or Sigma in the course of performing the activities described in, or fulfilling of their
obligations pursuant to, the Research Plan.
1.58 Research Term means the period of time commencing on the Effective Date and continuing,
unless the Agreement is earlier terminated pursuant to Article 10, until the third anniversary of
the Effective Date.
1.59 Rockefeller Agreement has the meaning set forth in Section 2.6(a).
1.60 Sangamo means Sangamo BioSciences, Inc., a Delaware corporation.
1.61
Sangamo Collaboration means the grant by Sangamo to a Third Party of a license to [***].
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8.
1.62 Sangamo Downstream Affiliate has the meaning set forth in Section 2.8.
1.63 Sangamo Improvements means (a) Improvements (other than Joint Improvements) that are
made by one or more employees, consultants, or independent contractors of Sangamo; and (b)
Improvements made by any Third Party or Affiliate to which Sangamo grants a license under the
Sangamo Technology.
1.64 Sangamo Indemnitees means Sangamo, its Affiliates, its licensees, and its and their
officers, directors, employees, consultants, contractors, sublicensees and agents.
1.65 Sangamo Internal Program Collaboration means any collaboration between Sangamo and a
Third Party where Sangamo [***].
1.66 Sangamo Know-How means all Information including Sangamo Improvements and Sangamos
interest in Joint Improvements (other than Sangamo Patents), that (a) is Controlled, during the
term of this Agreement, by (i) Sangamo, (ii) any entity that, as of the Effective Date, is a
Sangamo Affiliate, or (iii) a Sangamo Downstream Affiliate and (b) is reasonably necessary or
useful to make, use or sell ZFP Products in the Field. Sangamo Know-How shall not include any
Information licensed to Sangamo or a Sangamo Affiliate by a Third Party unless such Information is
licensed pursuant to a Third Party License and meets the aforementioned criteria for Sangamo
Know-How.
1.67 Sangamo Patent means any patent or patent application, including any patent or patent
application that claims a Sangamo Improvement or Joint Improvement, that (a) is Controlled by (i)
Sangamo, (ii) any entity that, as of the Effective Date, is a Sangamo Affiliate, or (iii) a Sangamo
Downstream Affiliate, and (b) claims the composition of matter, manufacture, or use of ZFP Products
useful in the Field. Sangamo Patents include, without limitation, the patents or patent
applications listed on Exhibit A. Notwithstanding the foregoing, Sangamo Patents shall not include
any patents or patent applications licensed to Sangamo or a Sangamo Affiliate by a Third Party
unless such patents or patent application are licensed pursuant to a Third Party License.
1.68 Sangamo Technology means the Sangamo Patents and the Sangamo Know-How.
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1.69 Second Tier Milestone means the actual receipt by Sigma of $[***] in cumulative Net
Sales from Sigma Custom Collaborations.
1.70 Sigma means Sigma-Aldrich Corporation, a Delaware corporation.
1.71 Sigma Custom Collaboration means a collaboration with a Third Party under which Sigma
(or Sangamo pursuant to Section 6.2) provides [***].
1.72 Sigma Improvement Patent means any Improvement Patent that claims a Sigma Improvement.
1.73 Sigma Improvements means (a) Improvements (other than Joint Improvements) that are made
by one or more employees, consultants, or independent contractors of Sigma or of any entity while
it is a Sigma Affiliate; and (b) Improvements made by Sublicensees, to the extent Controlled by
Sigma or any Sigma Affiliate. Notwithstanding the foregoing, an Improvement that satisfies the
foregoing definition solely because it was made by one or more employees, consultants, or
independent contractors of an entity while it is a Sigma Affiliate shall be deemed not to be a
Sigma Improvement if Sigma can demonstrate by competent evidence that such entity had no access to
the Sangamo Technology or to any other Improvements that are Sigma Improvements.
1.74 Sigma Indemnitees means Sigma, its Affiliates, its licensees, and its and their
officers, directors, employees, consultants, contractors, sublicensees and agents.
1.75 Sigma Share has the meaning set forth in Section 7.9(b).
1.76 Sublicense Agreement means any agreement, other than a Use License, under which Sigma
grants a Third Party or an Affiliate a sublicense under the Sangamo Technology.
1.77 Sublicensee means any Third Party to which Sigma grants a sublicense under the Sangamo
Technology.
1.78
Sublicensing Revenues means any consideration (other than royalties on sales) that Sigma
receives in return for the granting or practice of a sublicense under the Sangamo Technology
pursuant to a Sublicense Agreement, which may include (without limitation) upfront
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10.
license fees, annual license or maintenance payments, milestone payments, credits against
Sigmas future expenses, or reductions in royalties or other payments otherwise owed to the
Sublicensee. In the event that Sigma receives non-cash consideration from a Sublicensee for the
granting or practice of a sublicense under the Sangamo Technology, the Parties shall determine in
good faith the fair market value of such consideration, and such fair market value shall be
included in Sublicensing Revenues.
1.79 Supplied ZFN means [***].
1.80 Target means [***].
1.81 Therapeutic Collaboration means any collaboration between Sangamo and a Third Party in
which Sangamo receives revenue or other consideration for research directed at a therapeutic
product that is (a) [***] or (b) [***]. Notwithstanding the foregoing, none of the following will
be considered a Therapeutic Collaboration: (i) [***].
1.82 Third Party means any entity other than (a) Sangamo, (b) Sigma or (c) an Affiliate of
either Party.
1.83 Third Party License means (a) any of the agreements set forth in Exhibit B and (b) any
agreement that is deemed to be a Third Party License in accordance with the terms of Section 2.6 or
Section 8.9.
1.84 Third Tier Milestone means the actual receipt by Sigma of $[***] in cumulative Net
Sales from Sigma Custom Collaborations.
1.85 Title 11 has the meaning set forth in Section 13.6.
1.86 Use License has the meaning set forth in Section 5.4.
1.87
Valid Claim means (a) a claim of an issued and unexpired patent which has not been held
invalid or unenforceable by an un-appealable or un-appealed decision of a court or other government
agency or jurisdiction and has not been admitted to be invalid or unenforceable through reissue,
re-examination, disclaimer or otherwise; provided however, that if the holding of such court or
agency is later reversed by a court or agency with overriding authority, the claim
shall be reinstated as a Valid Claim after the date of such reversal, and (b) a claim of a
pending patent application, which application claims a filing date not more than seven (7) years
earlier.
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1.88 Validated Process means [***].
1.89 Validated Supplied ZFN shall mean [***].
1.90 Year means a twelve-month period commencing on the Effective Date or any anniversary of
the Effective Date. The first Year means the Year commencing on the Effective Date, the second
Year means the Year commencing on the first anniversary of the Effective Date, and so on.
1.91 ZFN Technology means technology relating to zinc finger proteins and their use to
alter the genomes and/or protein expression capabilities of organisms and cells.
1.92 ZFP Product means a zinc-finger protein (including a zinc-finger transcription factor
or a zinc-finger nuclease) or a nucleic acid encoding and capable of expressing such protein (for
example, in a cell or tissue), and services in connection therewith.
ARTICLE 2
LICENSES
2.1 License to Sigma.
(a)
License Grant. Subject to the terms and conditions of this Agreement, Sangamo hereby grants
to Sigma (i) a royalty-bearing, world-wide, exclusive (except as set forth below) license under the
Sangamo Technology (with the right to sublicense as provided below) to make, have made, use, sell,
offer for sale, and import Licensed Products and to provide Licensed Services (but excluding all
uses of Licensed Products or Sangamo Technology in the Plant Field and excluding all Plant
Products) in each case solely in the Field and (ii) a royalty-bearing, world-wide, co-exclusive
license under the Sangamo Technology (with the right to sublicense as provided below) to make, have
made, use, sell, offer for sale, and import Permitted Plant Products and to provide Permitted Plant
Services, in each case solely in the Field. The license granted to Sigma pursuant to Section
2.1(a)(i) is exclusive even as to Sangamo, subject to
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Sections 2.1(b) and 2.4. The license granted to Sigma pursuant to Section 2.1(a)(ii) is
co-exclusive (with Dow AgroSciences), meaning that, subject to Sections 2.1(b) and 2.4, Sigma and
Dow AgroSciences have the sole rights under the Sangamo Technology to make, have made, use, sell,
offer for sale, and import Permitted Plant Products and to provide Permitted Plant Services in the
Field. In the event that the Dow AgroSciences Agreement terminates, then the license granted
pursuant to Section 2.1(a)(ii) shall without further action convert to an exclusive license (even
as to Sangamo). Such licenses shall be freely sublicensable by Sigma, provided that Sigma complies
with Section 2.2. No Sigma sublicensee shall be permitted to grant further sublicenses without
Sangamos prior written approval.
(b) Exception to Exclusivity. Sigma acknowledges that, prior to the Effective Date, Sangamo
has performed or committed to perform for Third Parties certain custom services relating to the
Sangamo Technology and has delivered or committed to deliver to such Third Parties certain ZFP
Products and/or Licensed Products and has granted to such Third Parties the right to use such ZFP
Products and/or Licensed Products in the Field as listed in the Projects Side Letter. Sangamos
grant of an exclusive license in Section 2.1(a) is expressly subject to such previously granted
rights subject to the Projects Side Letter.
2.2 Sublicense Agreement. Sigma shall provide Sangamo with a copy of each executed Sublicense
Agreement within thirty (30) days after execution. Each such Sublicense Agreement so provided to
Sangamo shall be treated as Sigma Confidential Information. With respect to any Sublicense
Agreement that includes a sublicense under a Third Party License that requires Sangamo to provide
to the applicable Third Party licensor a copy of any Sublicense Agreement or a summary of the terms
of such Sublicense Agreement, Sangamo shall be permitted to provide such Third Party licensor with
such copy or summary. Sigma shall ensure that all Sublicense Agreements comply with the following
requirements:
(a) No Sublicense Agreement shall obligate (or purport to obligate) Sangamo, without Sangamos
express prior written consent.
(b) Each Sublicense Agreement shall require the relevant Sublicensee to:
(i) disclose in a timely fashion to Sigma any Improvement(s)
13.
made, conceived, or reduced to practice by the such Sublicensee in its activities under
the Sublicense Agreement; and
(ii) grant to Sangamo a fully paid, world-wide, irrevocable (subject to Section 10.3(f))
license under any such Improvements that is exclusive for uses outside the Field and is fully
sublicensable.
(c) Each Sublicense Agreement shall identify Sangamo as a third party beneficiary with respect
to the license set forth in Section 2.2(b)(ii).
(d) Each Sublicense Agreement shall require that the relevant Sublicensee (i) comply with the
relevant terms of Article 5 (as if such Sublicensee were Sigma), (ii) assume the obligations set
forth in Exhibit C (as if such Sublicensee were Sigma) with respect to each Third Party License
sublicensed thereunder, and (iii) acknowledge that the Sublicense Agreement is subject to the terms
and conditions of each such Third Party License.
2.3 Licenses to Sangamo.
(a) Manufacturing License. Subject to the terms and conditions of this Agreement, Sigma
hereby grants to Sangamo a non-exclusive worldwide, fully paid, license solely to Manufacture ZFP
Products in order to perform Sangamos obligations under Section 6.2. Such license shall be
sublicensable solely to a Contract Manufacturer acceptable to Sigma, which acceptance will not be
unreasonably withheld. The license granted under this Section 2.3(a) shall terminate upon the
transfer of Manufacturing technology to Sigma pursuant to Section 6.3.
(b) Licenses to Improvements. Subject to the terms and conditions of this Agreement, Sigma
hereby grants to Sangamo and its Affiliates (i) a worldwide, fully paid, perpetual, irrevocable
(subject to Section 10.3(f)), exclusive license (with the right to sublicense) to practice the
Sigma Improvements and Joint Improvements (and all patents and patent applications claiming the
same) for all purposes outside the Field; and (ii) a worldwide, fully paid, perpetual, irrevocable
(subject to Section 10.3(f)), non-exclusive license to practice the Sigma Improvements and Joint
Improvements in the Field (A) for its own internal use to identify and develop human and animal
therapeutics and (B) in Bona Fide Collaborations with Third
14.
Parties to identify and develop human and animal therapeutics (including the right to permit
the practice of Sigma Improvements in the Field by such Third Parties in such Bona Fide
Collaborations).
2.4 Sangamo Retained Rights. Notwithstanding anything to the contrary in this Agreement,
Sangamo and its Affiliates shall retain:
(a) the exclusive right to use, develop, manufacture, and commercialize (and to grant licenses
to use, develop, manufacture, and commercialize) the Sangamo Technology and Licensed Products
outside the Field;
(b) the non-exclusive right to use Sangamo Technology in the Field for their own internal use
or in Bona Fide Collaborations with Third Parties to identify and develop human and animal
therapeutics (including the right to permit the use of Sangamo Technology in the Field by such
Third Parties in such Bona Fide Collaborations); and
(c) the non-exclusive right to use Sangamo Technology in the Field to the extent necessary to
fulfill obligations under this Agreement or any agreement with a Third Party existing on the
Effective Date.
2.5 Negative Covenants.
(a) Sigma hereby covenants that it shall not use or practice, nor shall it cause or permit any
of its sublicensees (including Sublicensees) to use or practice, directly or indirectly, any
Sangamo Technology for any purpose other than those expressly permitted by this Agreement.
Notwithstanding the foregoing, such covenant shall not apply to any Sangamo Know-How that qualifies
for one of the exceptions set forth in Section 9.2.
(b) Sangamo hereby covenants that it shall not use or practice, nor shall it cause or permit
any of its any sublicensees to use or practice, directly or indirectly, any Sigma Improvement for
any purpose other than those expressly permitted by this Agreement or to use or practice, directly
or indirectly, or grant a license under, any Sangamo Know-How, Sangamo Patent, Sangamo Improvement,
or Joint Improvement in the Field in contravention of any licenses granted to Sigma hereunder.
Notwithstanding the foregoing, such covenant shall not
15.
apply to any Sigma Improvement that qualifies for one of the exceptions set forth in Section
9.2.
2.6 Third Party Licenses.
(a) The licenses granted to Sigma in Section 2.1 include sublicenses under Sangamo Technology
licensed to Sangamo pursuant to Third Party Licenses. Such sublicenses are subject to (i) the
limitations set forth in the Third Party Licenses (including without limitation any limitations on
the scope and exclusivity of the licenses granted to Sangamo thereunder and any constraints on
Sangamos ability to prosecute or enforce Sangamo Patents licensed pursuant to such Third Party
Licenses), (ii) Sigmas compliance with the payment obligations set forth in Section 7.10 with
respect to such Third Party Licenses, and (iii) Sigmas satisfaction of the non-financial terms and
conditions of the Third Party Licenses, including without limitation those terms set forth on
Exhibit C. Sigma understands and acknowledges that (1) the Collaborative Agreement between Gendaq
Limited and Rockefeller University dated September 1, 2000 (the Rockefeller Agreement) is not a
Third Party License, (2) the licenses granted to Sigma under Section 2.1 do not include sublicenses
of any licenses received by Sangamo under the Rockefeller Agreement as a result of Sangamos
acquisition of Gendaq Limited, and (3) with respect to any patents or patent applications included
within the Sangamo Patents that are addressed in the Rockefeller Agreement, the licenses granted to
Sigma in Section 2.1 to such patents and patent applications are only licenses under Sangamos
ownership interest in such patents and patent applications. Sigma further understands and
acknowledges that, notwithstanding the fact that the MIT Agreement (as such term is defined in
Exhibit B) is a Third Party License, (A) the licenses granted to Sigma under Section 2.1 do not
include sublicenses under the patents and patent applications licensed to Sangamo pursuant to the
Fifth Amendment to the MIT Agreement (such amendment being dated December 15, 2000) and (B) such
patents and patent applications are not Sangamo Patents.
(b) In the event that Sigma desires to license from Third Parties any intellectual property
relating to ZFP Products (including any patents described in Section 7.8), Sigma shall [***].
(c)
Licenses to any intellectual property relating to ZFP Products in the Field (including any
patents described in Section 7.8) granted to Sangamo shall be deemed to be a
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Third Party License to the extent the requirements set forth in Section 2.6(d) and/or (e) (as
applicable) are satisfied.
(d) An agreement entered into by Sangamo after the Effective Date and under which Sangamo
receives a license to certain Information shall only be deemed to be a Third Party License if:
(i) such Information is reasonably necessary or useful to practice the Sangamo Patents or
to make, use or sell ZFP Products in the Field, and Sangamos license thereto includes the
Field;
(ii) Sangamo discloses the substantive terms of such agreement to Sigma for review a
reasonable amount of time in advance of Sangamos anticipated entry into such a license
agreement (which Sangamo hereby covenants to do); and
(iii) Sigma provides Sangamo with written notice within 30 days following Sigmas receipt
from Sangamo of the substantive terms of such agreement, in which (1) Sigma consents to adding
such license agreement to the definition of Third Party License, (2) Sigma assumes the
obligations applicable to Sigma that are set forth in Section 7.10 with respect to such
license agreement as well as all other obligations of such license agreement that are
applicable to sublicensees thereunder, and (3) Sigma acknowledges in writing that its
sublicense under such license agreement (i) is limited to the Information licensed thereunder
but does not include any patents or patent applications licensed thereunder (except to the
extent Section 2.6(e) applies to such license agreement) and (ii) is subject to the terms and
conditions of such license agreement.
(e) An agreement entered into by Sangamo after the Effective Date and under which Sangamo
receives a license to certain patents or patent applications shall only be deemed to be a Third
Party License if:
(i)
such patent or patent application claims the composition of matter, manufacture, or use
of ZFP Products useful in the Field, and Sangamos license thereto includes the Field;
17.
(ii) Sangamo discloses the substantive terms of such agreement to Sigma for review a
reasonable amount of time in advance of Sangamos anticipated entry into such a license
agreement (which Sangamo hereby covenants to do); and
(iii) Sigma provides Sangamo with written notice within 30 days following Sigmas receipt
from Sangamo of the substantive terms of such agreement, in which (1) Sigma consents to adding
such license agreement to the definition of Third Party License, (2) Sigma assumes the
obligations applicable to Sigma that are set forth in Section 7.10 with respect to such
license agreement as well as all other obligations of such license agreement that are
applicable to sublicensees thereunder, and (3) Sigma acknowledges in writing that its
sublicense under such license agreement (i) is limited to the patents or patent applications
licensed thereunder but does not include any patents or patent applications licensed
thereunder (except to the extent Section 2.6(d) applies to such license agreement) and (ii) is
subject to the terms and conditions of such license agreement.
2.7 Therapeutic Collaborations. In the event that Sangamo enters into more than [***]
Therapeutic Collaborations during 2007 (after the Effective Date), [***] Therapeutic Collaborations
during 2008, or [***] Therapeutic Collaborations during 2009 or any subsequent calendar year, then
with respect to each such Therapeutic Collaboration beyond these limits, Sangamo shall, at
Sangamos option, (a) use Sigma as the supplier of ZFP Products or custom cell lines for such
Therapeutic Collaboration (in which case the maximum price charged by Sigma for such supply shall
be [***] (the MFN Price)) or (b) pay Sigma a fee equal to [***] of the MFN Price. For clarity,
any Therapeutic Collaboration in which Sigma supplies ZFP Products or custom cell lines or with
respect to which Sangamo makes the payment to Sigma described in subsection (b) above shall not be
counted towards the limit of [***] Therapeutic Collaborations (as the case may be) set forth above.
2.8
Sangamo Downstream Affiliates. In the event that (a) an entity becomes an Affiliate of
Sangamo after the Effective Date, (b) Sangamo controls (as such term is defined in Section 1.2)
such entity, and (c) such entity Controls Information, patents, or patent applications that would
satisfy the definition of Sangamo Know-How or Sangamo Patents (as the case may be) if such entity
had been an Affiliate of Sangamo as of the Effective Date, then Sangamo shall
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provide Sigma with written notice describing such Information, patents, or patent applications
in reasonable detail. If, within thirty (30) days thereafter, Sigma provides written notice to
Sangamo that Sigma would like to discuss the economic terms under which such Information, patents,
or patent applications would be included in the Sangamo Technology licensed under this Agreement,
the Parties shall negotiate such economic terms in good faith, taking into account the aggregate
cost to Sangamo of acquiring control (as such term is defined in Section 1.2) of such entity and
the value of such Information, patents, or patent applications in the Field relative to the total
value of the assets of such entity. Solely upon mutual written agreement of the Parties regarding
all such economic terms, such entity shall be deemed to a Sangamo Downstream Affiliate. If the
agreed-upon economic terms include the payment by Sigma of royalties on sales of a Licensed Product
in a particular country that are in addition to those royalties due to Sangamo pursuant to Section
7.7, Sigma shall be entitled to a credit, against the royalty payments due to Sangamo pursuant to
Section 7.7 upon sales of such Licensed Product in the applicable country, in an amount equal to
[***] of such additional royalties, provided that in no event shall the royalty rate due to Sangamo
pursuant to Section 7.7 be reduced to below [***] of the applicable royalty rates set out in
Section 7.7(a).
ARTICLE 3
MANAGEMENT OF THE RESEARCH PLAN COLLABORATION
3.1 Overall Management Structure. The management of the Research Plan Collaboration shall be
vested in a Joint Steering Committee (the JSC), with responsibilities, as further discussed in
Section 3.2. The JSC and any other committees established by the Parties in connection with the
Research Plan Collaboration (collectively, the Committees) shall each continue to exist until the
first to occur of (a) the Parties mutually agreeing to disband such Committee or (b) the
termination of the Research Term. Following such termination of the JSC, the JSC shall be
reconvened from time-to-time for the purpose set forth in Section 9.7.
3.2 Joint Steering Committee.
(a)
Membership. The JSC shall be composed of at least four (4) members, two (2) members appointed
by each Party. The JSC will consist of senior members from each
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Party authorized to make decisions with respect to matters including, but not limited to,
setting research goals, resolving disputes, and making strategic decisions. Promptly following the
Effective Date, each Party shall appoint its initial representatives to the JSC. Each Party may
replace its JSC representatives at any time upon written notice to the other Party. Sigma will
designate one of its representatives as the Chairperson of the JSC. The Chairperson shall be
responsible for scheduling meetings, preparing and circulating an agenda in advance of each
meeting, preparing and issuing minutes of each meeting within thirty (30) days thereafter, revising
such minutes to reflect timely comments thereon, overseeing the ratification of such revised
minutes and other administrative matters relating to the smooth functioning of the JSC.
(b) Meetings. During the Research Term, the JSC shall meet a minimum of one (1) time every
six (6) months. The Parties shall endeavor to schedule meetings of the JSC at least six (6) months
in advance. Meetings for the JSC shall be held on an alternating basis in Richmond, California (or
such other location in the continental United States as may be chosen by Sangamo) and St. Louis,
Missouri (or such other location in the continental United States as may be chosen by Sigma). With
the consent of the representatives of each Party serving on a particular committee, other
representatives of each Party may attend meetings of that committee as non-voting observers. A
meeting of the JSC or a subordinate committee may be held by audio or video teleconference with the
consent of each Party, provided that at least half of all meetings for that committee in each
calendar year shall be held in person. Meetings of the JSC or a subordinate committee shall be
effective only if at least one representative of each Party is present or participating. Each
Party shall be responsible for all of its own expenses of participating in the committee meetings.
(c) Responsibilities. The JSC shall:
(i) Manage and direct the implementation of the Research Plan Collaboration;
(ii) Have authority to establish one or more other committees that report to the JSC and
assist the JSC in managing and directing the Research Plan Collaboration. Any committees
formed beyond the JSC shall be subordinate to the JSC, shall have such membership and
responsibilities as the JSC shall determine, and may be
20.
disbanded by the JSC at any time. Each Party shall use good faith and cooperative
efforts to facilitate and assist the efforts of the JSC and all additional committees
established by the JSC. For clarity, the JSC does not have any authority beyond the specific
matters set forth in this Agreement, and cannot in any way amend or modify the terms or
provisions of this Agreement;
(iii) Resolve, or attempt to resolve any disputes not resolved by any subordinate
committees created by the JSC
(iv) Draft (or have drafted) and approve language for any and all Use Licenses pertaining
to Licensed Products, each of which Use Licenses shall, at minimum, incorporate the terms set
forth in Exhibit D;
(v) Have the authority to request the written reports contemplated by Sections 5.3(a) and
5.3(b);
(vi) Determine the format and frequency of summaries to be provided by Sigma pursuant to
Section 5.3(a); and
(vii) Perform such other functions as appropriate to further the purposes of the Research
Plan Collaboration and as allocated to it in writing by the Parties.
(d) Decision Making; Authority. The JSC shall make its decisions by consensus, with each
Partys representatives collectively having one vote. If the JSC is unable to reach consensus
regarding a matter before it, the issue shall be resolved pursuant to Section 13.1. The JSC does
not have any authority beyond the specific matters set forth in this Agreement, and cannot in any
way amend or modify the terms or provisions of this Agreement.
3.3 Research Plan Collaboration Guidelines.
(a) General. In all matters related to implementation of the Agreement, the Parties shall be
guided by standards of reasonableness in economic terms and fairness to each of the Parties,
striving to balance the legitimate interests and concerns of the Parties and further the Research
Plan Collaboration.
21.
(b) Independence. Subject to the terms of this Agreement, the activities and resources of
each Party shall be managed by such Party, acting independently and in its individual capacity.
The relationship between Sangamo and Sigma is that of independent contractors and neither Party
shall have the power to bind or obligate the other Party in any manner, other than as is expressly
set forth in this Agreement.
ARTICLE 4
RESEARCH PROGRAM
4.1 Research Term. The Research Plan shall remain in force during the Research Term and shall
terminate at the end of the Research Term.
4.2 Research Plan. The Parties have agreed upon an initial Research Plan, which is set forth
in a separate side letter. Within one hundred and twenty (120) days following the Effective Date,
the JSC shall update and finalize a new version of the Research Plan. During the Research Term,
the JSC shall review the Research Plan at least semiannually and may generate revised versions of
the Research Plan that are consistent with the terms of this Agreement and the goals of the
Research Plan Collaboration. Significant changes in the scope or direction of the work must be
approved by the JSC. Without such approval, the most recently approved Research Plan shall remain
in effect. Once approved by the JSC, such revised Research Plan shall replace the prior Research
Plan.
4.3 Use of Subcontractors. Sangamo may subcontract portions of its activities under the
Research Plan to a Third Party, provided that such Third Party receives the prior approval of the
JSC.
4.4 Reports to JSC. At each meeting of the JSC during the Research Term and within 30 days
following the end of the Research Term, Sangamo shall submit to the JSC a written progress report
summarizing the work performed under the Research Plan since the last meeting.
4.5 Conduct of Research Program. Sangamo shall use Diligent Efforts to conduct its tasks
assigned pursuant to the Research Plan and to attempt to achieve the objectives of the
22.
Research Plan efficiently and expeditiously. Sangamo shall conduct the Research Plan
activities in good scientific manner, and in compliance in all material respects with the
requirements of applicable laws, rules and regulations and all applicable good laboratory
practices. Sangamo personnel performing its responsibilities under the Research Plan shall be
reasonably acceptable to Sigma. For the avoidance of doubt, Sigma shall have no obligations under
the Research Plan.
4.6 Research Funding. In recognition of Sigmas payment of the license fee pursuant to
Section 7.2 (including, but not limited to, the license fee payments pursuant to Sections 7.2(b),
(c) and (d)) and Sigmas other obligations under this Agreement, Sangamo shall be solely
responsible for supporting the costs of its efforts under the Research Plan, including but not
limited to all costs and expenses associated with its personnel. During each Year of the Research
Term, Sangamo shall spend $[***] in Research Costs. Promptly following the completion of each such
Year, Sangamo shall provide Sigma with sufficient detail and documentation demonstrating the
specific basis of such expenses incurred by Sangamo in such Year. In no event shall Sangamo be
required, during any Year of the Research Term to incur more than $[***] of Research Costs. For
the avoidance of doubt, at the current Annual FTE Rate, and assuming no deduction of out-of-pocket
costs or expenses, $[***] in Research Costs is equivalent to [***] FTEs. Sangamo shall track and
calculate the number of its FTEs involved in work under the Research Plan in accordance with
Sangamos then-current accounting methodology.
ARTICLE 5
DEVELOPMENT AND COMMERCIALIZATION
5.1
General. Subject to the terms and conditions of this Agreement, Sigma shall have sole control
over, and responsibility for, the development and commercialization of any Licensed Products in the
Field, including the performance of Licensed Services in the Field for Third Parties, all of which
shall be carried out at Sigmas sole expense. Except as expressly set out in this Agreement,
Sangamo shall have no responsibility for any costs or expenses incurred by Sigma or any
Sublicensees in undertaking development or commercialization of Licensed Products.
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5.2 Diligence. Sigma shall use Diligent Efforts to develop and commercialize Licensed
Products in the Field.
5.3 Reports.
(a) Sigma shall keep the JSC informed regarding the overall progress and results of the
development and commercialization of any Licensed Products in the Field by Sigma, its Affiliates,
or its Sublicensees, including any written reports requested by the JSC. After the JSC ceases to
exist pursuant to Section 3.1, Sigma shall thereafter provide directly to Sangamo summaries of the
development and commercialization activities performed or anticipated to be performed by Sigma, its
Affiliates, or its Sublicensees with respect to Licensed Products in the Field, which summaries
shall be in a format and at a frequency decided by the JSC (i.e., prior to the time it ceases to
exist) or mutually agreed by the Parties.
(b) During the first Year, Sangamo shall keep the JSC informed regarding the overall progress
and results of any development and commercialization efforts undertaken by Sangamo pursuant to
Section 6.1(d), including any written reports requested by the JSC.
5.4 Product Licenses. Any sales of Licensed Products by Sigma under this Agreement to a Third
Party (each, a Customer) shall be made pursuant to a written limited use label license (a Use
License) approved by the JSC. Sigma agrees to label Licensed Products to reflect the terms of the
Use License in a manner reasonably consistent with similar labeled products sold by Sigma. Sigma
shall not be obligated to independently verify or confirm that its Customers are or will be in
compliance with such Use License, or otherwise independently verify or confirm that a Customers
use of Licensed Products falls within the scope of the Field. For clarity, nothing in the
foregoing sentence shall be interpreted to grant Sigma or its sublicensees any rights under the
Sangamo Technology outside the Field or to limit Sigmas obligations under Section 2.5(a). [***]
ARTICLE 6
TRANSITION OF CUSTOM ZFN TECHNOLOGY BUSINESS TO SIGMA
6.1
Custom Technology Projects. The Parties have agreed that the right to enter into agreements
with clients for custom services projects in the Field and to perform such custom
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service projects in the Field shall be transferred to Sigma as of the Effective Date. To that
end, the Parties further agree as follows as of the Effective Date:
(a) Sangamo shall remain responsible for performing those custom services projects with
respect to targets for which Sangamo entered into an agreement with a Third Party (an Existing
Customer) prior to the Effective Date, as set out in the Projects Side letter. All payments for
services performed and delivered with respect to such projects shall be payable to Sangamo.
(b) Sangamo shall refer all further prospective custom service projects in the Field to Sigma
including all such projects under negotiation and all such projects with any Existing Customer with
respect to targets that are not, as of the Effective Date, the subject of an agreement with such
Existing Customer.
(c) Sangamo shall not agree to provide custom services projects in the Field (other than to
provide custom services projects with respect to targets that, as of the Effective Date, are the
subject of an agreement with an Existing Customer, as listed in the Projects Side Letter).
(d) Sangamo shall use Diligent Efforts to provide Sigma with assistance with business
development efforts and closing custom projects during the first Year following the Effective Date
by making available for such purpose two Sangamo employees reasonably acceptable to Sigma (one such
employee with a technology focus; one with a business development focus). The initial two
employees are identified in the Projects Side Letter. The time spent by each such employee in
providing assistance to Sigma shall be at least equal to the time spent by such employee on custom
projects matters prior to the Effective Date. During the second and third Years following the
Effective Date, Sangamo shall use Diligent Efforts to provide Sigma with a reasonable level sales
and marketing support on a less than full-time basis.
(e) All custom services project agreements entered into following the Effective Date shall be
by and between Sigma and the Third Party. Sangamo shall not be a party to such agreements.
(f) Sangamo represents and warrants to Sigma that Sangamo has provided
25.
Sigma copies of all outstanding proposals presented to prospective customers (other than
proposals that cannot be so provided without violating a confidentiality agreement with a Third
Party); that the copies provided reflect all terms currently being discussed and Sangamos
understanding of the status of such discussions; and that Sangamo has no knowledge that the
relevant prospective customer has determined not to use the services set forth in the relevant
provided proposal or to use such services at a level other than as set forth in such provided
proposal.
(g) Sangamo represents and warrants to Sigma that the list of prospects (if any) provided to
Sigma in the Projects Side Letter represents bona fide prospects for services; that the status of
discussions with such prospects (if any) disclosed in the Projects Side Letter fairly presents the
status of discussions; and that Sangamo has no knowledge to the contrary.
(h) Sangamo shall receive no payment or other consideration from Sigma with respect to the
services that Sangamo provides pursuant to this Section 6.1, other than the consideration that
Sangamo is to receive pursuant to Article 7, including but not limited to the payment to Sangamo of
royalties pursuant to Section 7.7.
(i) For purposes of clarity, the Parties confirm that Sangamos activities pursuant to this
Section 6.1 are in addition to its obligations under Article 4, and further confirm that costs and
expenses incurred by Sangamo in the performance of its obligations under this Section 6.1 shall not
constitute Research Costs.
6.2 Supply of Supplied ZFNs for Customs Projects. Until such time as the transfer of
manufacturing technology from Sangamo to Sigma as set out in Section 6.3 has been completed,
Sangamo shall (i) Manufacture and supply to Sigma Active Supplied ZFNs and/or cell lines having the
genomic modifications requested pursuant to Section 6.2(a) (Modified Cell Lines), and (ii)
provide such other collaborative services reasonably necessary for the performance by Sigma of the
Custom Projects as set out in Section 6.1 as well as such additional custom service arrangements as
Sigma subsequently undertakes to perform. Such Manufacture and supply shall be pursuant to the
following terms and conditions:
(a) Sigma shall from time-to-time issue purchase orders to Sangamo
26.
identifying the Manufacture and supply services to be performed by Sangamo, including in the
case of Modified Cell Lines the particular genomic modification desired.
(b) Sangamo shall use Diligent Efforts to Manufacture and supply Active Supplied ZFNs and/or
Modified Cell Lines pursuant to the terms of those purchase orders that are accepted by Sangamo,
which acceptance will not be unreasonably withheld. Each Active Supplied ZFN or Modified Cell Line
specified in a purchase order accepted by Sangamo shall be referred to herein as a Custom Project
Deliverable. For the avoidance of doubt, such Diligent Efforts by Sangamo shall include providing
adequate resources to meet the Manufacture and supply obligations under the purchase orders.
Notwithstanding the foregoing, Sangamo shall have no obligation to supply Custom Project
Deliverables for more than [***]. To the extent that Sigma requests delivery of, and Sangamo
agrees to supply, Custom Project Deliverables for more than [***], Sigma shall pay $[***] for each
Custom Project Deliverable above such limit. To the extent that Sigma requests delivery of, and
Sangamo agrees to supply, Custom Project Deliverables for more than [***], Sigma shall pay $[***]
for each Custom Project Deliverable above such limit. To the extent that Sigma requests delivery
of, and Sangamo agrees to supply, Custom Project Deliverables for more than [***], Sigma shall pay
$[***] for each Custom Project Deliverable above such limit.
(c) The JSC shall establish a delivery date for each Custom Project Deliverables, taking into
account both Sangamos interest in having manageable Manufacture and supply obligations and Sigmas
interest in expanding its market and satisfying customer demand and requirements. The Parties
anticipate that the lead time for each Custom Project Deliverable will initially be approximately
[***]. The Parties agree to cooperate in good faith with a goal of reducing such lead time during
the term of this Agreement.
(d) Sangamo shall receive no payment or other consideration from Sigma with respect to the
services that Sangamo provides pursuant to this Section 6.2, other than the consideration set forth
in Section 6.2(b) and the consideration that Sangamo is to receive pursuant to Article 7, including
but not limited to the payment to Sangamo of royalties pursuant to Section 7.7.
(e) For purposes of clarity, the Parties confirm that Sangamos activities
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pursuant to this Section 6.2 are in addition to its obligations under Article 4, and further
confirm that costs and expenses incurred by up to one (1) Sangamo FTE in the performance of
Sangamos obligations under this Section 6.2 shall constitute Research Costs.
6.3 Transfer of Manufacturing Technology. At any time following the Effective Date, Sigma may
direct that Sangamo transfer the Manufacturing technology then in Sangamos possession and Control
either to Sigma or to a Contract Manufacturer selected by Sigma and approved by Sangamo, such
approval not to be unreasonably withheld, as provided in Exhibit G. The costs and expenses
incurred by Sangamo in carrying out such transfer shall be included in Sangamos Research Costs;
[***] Sangamos obligations under Section 6.2 shall cease upon completion of the Information
transfer contemplated by this Section 6.3. The Parties confirm their intent to complete the
Information transfer contemplated by this Section 6.3 on or about the third anniversary of the
Effective Date.
6.4 Technology Escrow. Within thirty (30) days of the Effective Date, Sangamo shall deposit in
escrow with a Third Party escrow company (i) [***] (collectively, the Escrow Materials). Sangamo
will update the Escrow Materials every [***] thereafter. In addition, Sangamo shall update the
Escrow Materials at [***] solely to the extent necessary to replace existing [***] with any
replacement versions generated pursuant to the Library Side Letter. The costs of establishing and
maintaining such escrow shall be borne entirely by Sigma. Sigma may access and use the Escrow
Materials upon occurrence of any of the following events:
(a) the adjudication of Sangamo as a bankrupt by any court of competent jurisdiction;
(b) the appointment of a trustee or receiver (or similar official) of all or a substantial
part of the property of Sangamo under the federal Bankruptcy Act or any state court receivership
proceedings, whether voluntary or involuntary, which appointment, if involuntary, is not removed
within sixty (60) days;
(c) the liquidation of Sangamo or its failure to continue in business (except in the event
that such business has been acquired or assumed by another entity);
(d) the filing by Sangamo of a voluntary petition in bankruptcy, or the consent
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to, or failure to dismiss within the time prescribed by law, of any bankruptcy proceedings
instituted against it; or
(e) refusal by Sangamo to allocate resources to Manufacture Supplied ZFNs for a period of 30
consecutive days or more or other breach of Sangamos obligations pursuant to this Article 6.
The technology escrow shall end, and the Escrow Materials shall be returned to Sangamo upon the
earlier of termination of this Agreement or completion of the Manufacturing technology transfer
described in Section 6.3.
ARTICLE 7
FINANCIAL TERMS
7.1 Equity. Subject to the terms of a separate stock purchase agreement executed no later
than thirty (30) days after the Effective Date (and other agreements and related documents executed
pursuant thereto), Sangamo shall issue to Sigma, and Sigma shall purchase, one million shares of
Sangamo common stock at a price per share equal to the average closing price of such stock as
quoted on the Nasdaq Global Market for the thirty (30) trading days prior to entry into such stock
purchase agreement.
7.2 License Fee. In consideration for the licenses to Sangamo Technology set forth in Article
2, Sigma shall pay Sangamo the following license fees:
(a) within [***] of the Effective Date, an amount equal to the difference between (i) twelve
million five hundred thousand dollars ($12,500,000) and (ii) the consideration paid by Sigma
pursuant to Section 7.1;
(b) within [***] of the Effective Date, one million dollars ($1,000,000);
(c) within [***] of the Effective Date, one million dollars ($1,000,000); and
(d)
within [***] of the Effective Date, one million dollars ($1,000,000).
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For the avoidance of doubt, the total amount payable by Sigma pursuant to Section 7.1 and this
Section 7.2 shall in no event exceed fifteen million five hundred thousand dollars ($15,500,000).
The license fee payments made by Sigma to Sangamo pursuant to this Section 7.2 shall be
noncreditable and nonrefundable.
7.3 Development Milestone Payments.
(a) Sigma shall make each of the milestone payments indicated below to Sangamo in accordance
with this Section 7.3 upon the first occurrence of the indicated milestone event:
(i) $[***] upon the later to occur of (A) Sangamos achievement, by [***], of a Quarter
Throughput Rate of at least [***] Validated Supplied ZFNs; (B) delivery of at least [***]
Active Supplied ZFNs to Sigma, of which at least [***] Validated Supplied ZFNs, as documented
by written evidence provided to Sigma; and (C) Sangamos completion of the transfer to Sigma
of the Validated Process used by Sangamo to achieve such Quarter Throughput Rate;
(ii) $[***] within ninety (90) days after the achievement of the milestone set forth in
Section 7.3(a)(i) unless, despite Sigmas Diligent Efforts, Sigma is unable to replicate
during such ninety (90) day period the Validated Process transferred to Sigma pursuant to
Section 7.3(a)(i), as shown by written evidence provided to Sangamo;
(iii) $[***] upon the later to occur of (A) Sangamos achievement, by the [***], of a
Quarter Throughput Rate of at least [***] Validated Supplied ZFNs; (B) delivery of at least
[***] Active Supplied ZFNs to Sigma, of which at least [***] Validated Supplied ZFNs, as
documented by written evidence provided to Sigma; and (C) Sangamos completion of the transfer
to Sigma of the Validated Process used by Sangamo to achieve such Quarter Throughput Rate;
(iv)
$[***] within ninety (90) days after the achievement of the milestone set forth in
Section 7.3(a)(iii) unless, despite Sigmas Diligent Efforts, Sigma is unable to reproduce
during such ninety (90) day period the Validated Process transferred to Sigma pursuant to
Section 7.3(a)(iii), as shown by written evidence provided to Sangamo;
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(v) $[***] upon the later to occur of (A) Sangamos achievement, by the [***], of a
Quarter Throughput Rate of at least [***] Validated Supplied ZFNs; (B) delivery of at least
[***] Active Supplied ZFNs to Sigma, of which at least [***] Validated Supplied ZFNs, as
documented by written evidence provided to Sigma; and (C) Sangamos completion of the transfer
to Sigma of the Validated Process used by Sangamo to achieve such Quarter Throughput Rate; and
(vi) $[***] within ninety (90) days after the achievement of the milestone set forth in
Section 7.3(a)(v) unless, despite Sigmas Diligent Efforts, Sigma is unable to reproduce
during such ninety (90) day period the Validated Process transferred to Sigma pursuant to
Section 7.3(a)(v), as shown by written evidence provided to Sangamo.
(b) For the purpose of this Section 7.3, the Quarter Throughput Rate means the number of
Validated Supplied ZFNs that can be generated during a ninety (90) day period by performing (from
start to finish during such period) both the Manufacturing of Active Supplied ZFNs and the
Validated Process with respect thereto, [***]
(c) The Parties agree that the transfer of a Validated Process to Sigma, as contemplated by
this Section 7.3, shall include both the transfer to Sigma of reasonably detailed written
documentation describing the Validated Process and a live demonstration by Sangamo to Sigma
personnel of Validated Process on a single Target and a single cell line. The JSC shall establish
technical requirements with respect to the content of such written documentation and each such live
demonstration, as well as objective criteria for determining whether the transfer of the Validated
Process to Sigma has been completed for the purpose of triggering the milestone payments set forth
in Section 7.3(a).
(d)
Sigma shall pay the indicated amounts within thirty (30) days of achievement of the milestone.
For clarity, in the event that Sangamo achieves the milestone described in Section 7.3(a)(iii),
Sangamo shall be deemed to have achieved the milestone set forth in Section 7.3(a)(i) (if not
previously achieved), and in the event that Sangamo achieves the milestone described in Section
7.3(a)(v), Sangamo shall be deemed to have achieved the milestones set forth in Sections 7.3(a)(i)
and 7.3(a)(iii) (if not previously achieved). For further clarity, achievement of the milestone
described in Section 7.3(a)(iv) shall trigger the milestone
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payment set forth in Section 7.3(a)(ii) (if not previously paid), and achievement of the
milestone described in Section 7.3(a)(vi) shall trigger the milestone payments set forth in
Sections 7.3(a)(ii) and 7.3(a)(iv) (if not previously paid).
(e) In no event will the total amount of milestone payments paid by Sigma pursuant to this
Section 7.3 exceed five million dollars ($5,000,000). All payments made by Sigma to Sangamo
pursuant to this Section 7.3 shall be noncreditable and nonrefundable.
7.4 Commercial Milestone Payments. Sigma shall make each of the milestone payments indicated
below to Sangamo within thirty (30) days after aggregate, cumulative Net Sales of all Licensed
Products in the Territory first reach the corresponding dollar values.
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$ [***]
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In no event will the total amount of milestone payments paid by Sigma pursuant to this Section 7.4
exceed seventeen million dollars ($17,000,000).
7.5 Minimum Annual Payments.
(a)
Sigma shall pay to Sangamo on or before each anniversary of the Effective Date up to and
including the tenth anniversary of the Effective Date, the minimum annual payment obligation set
forth in this Section 7.5 with respect to such anniversary. Such payment obligation for a
particular anniversary shall be reduced (but not below zero) by (i) any royalties owed to Sangamo
pursuant to Section 7.7 with respect to sales in the first quarter of the calendar year in which
such anniversary occurs or (ii) any payments owed to Sangamo pursuant to Section 7.6 with respect
to Sublicensing Revenue received by Sigma during the first quarter of such calendar year. Each
payment made by Sigma pursuant to this Section 7.5 is referred to as a
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Minimum Annual Payment.
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First, Second, Third |
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Fourth, Fifth, Sixth, Seventh |
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Eighth, Ninth, Tenth |
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(b) Each Minimum Annual Payment made by Sigma to Sangamo pursuant to this Section 7.5 shall be
nonrefundable but fully creditable against (i) any royalties owed to Sangamo pursuant to Section
7.7 with respect to sales in the second, third, and fourth quarters of the calendar year in which
such Minimum Annual Payment was made or (ii) any payments owed to Sangamo pursuant to Section 7.6
with respect to Sublicensing Revenue received by Sigma during the second, third, and fourth
quarters of such calendar year.
(c) For the avoidance of doubt, the failure of Sigma to achieve a level of Net Sales in any
year triggering payment of a Minimum Annual Payment for such year shall not be deemed to be a
breach of any obligation of Sigma under this Agreement.
7.6 Sublicensing Revenues. Within forty-five (45) days after the end of each calendar quarter
up to and including the calendar quarter in which the second anniversary of the Effective Date
falls, Sigma shall pay Sangamo an amount equal to fifty percent (50%) of the Sublicensing Revenues
received by Sigma during such calendar quarter. Within forty-five (45) days after the end of each
calendar quarter thereafter, Sigma shall pay Sangamo an amount equal twenty-five percent (25%) of
the Sublicensing Revenues received by Sigma during such calendar quarter. Each Sublicensing
Revenue payment shall be accompanied by a statement itemizing the amount and type (e.g., license
fee, milestone payment, etc.) of each payment received by Sigma from each Sublicensee during the
relevant calendar quarter. The Sublicensing Revenue payments made by Sigma to Sangamo pursuant to
this Section 7.6 shall be noncreditable (except as set forth in Section 7.5) and nonrefundable.
7.7 Royalties
(a)
Sigma shall pay royalties to Sangamo on Net Sales of each Licensed Products as follows:
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(i) at the rate of [***] of Net Sales of Licensed Product in any country where the creation,
development, manufacture, use or sale of such Licensed Product is covered by a Valid Claim or where
no Third Party is selling a product or service for use in the Field that competes with such
Licensed Product (which competition, for clarity, will be assessed on a product-by-product or
service-by-service basis and, solely in the case of products, shall require that such product and
such Licensed Product involve the targeting of the same gene (whether or not such targeting is
accomplished by the same mechanism));
(ii) at the rate of [***] of Net Sales of Licensed Products in all other cases.
(b) All royalties due under this Section 7.7 shall be paid quarterly, on a country-by-country
basis, within sixty (60) days of the end of the relevant calendar quarter for which royalties are
due. Such royalty payments shall be noncreditable (except as set forth in Section 7.5) and
nonrefundable.
(c) Sangamos right to receive royalties under this Section 7.7 with respect to a particular
country shall continue, on a Licensed Product-by-Licensed Product basis, for the longer of (i)
[***] (ii) the [***] anniversary of the Effective Date.
(d) Each royalty payment shall be accompanied by a statement that includes sufficient
information for Sangamo to understand Sigmas calculation of such royalty payment, including
without limitation the number, description, and gross sales and Net Sales, by country, of each
Licensed Product sold during the relevant calendar quarter. Each statement shall be deemed to be
Confidential Information of Sigma.
(e) For the avoidance of doubt, no multiple royalties will be required to be paid because a
Licensed Product or its manufacture, use, or sale is covered by more than one Valid Claim or patent
or patent application within the Sangamo Patents or Sangamo Know-How. For the avoidance of doubt,
no royalty shall be payable pursuant to Section 7.7(a)(ii) if a royalty is payable pursuant to
Section 7.7(a)(i).
7.8
Royalty Adjustment. If there exists in any country during the Term one or more patents of a
Third Party that cover ZFP Products or their use or manufacture and that would be
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infringed by the making, use or sale of a Licensed Product and it is necessary for Sigma or
Sangamo to obtain a royalty-bearing license from such Third Party under such patent(s) in a
particular country, then Sigma shall be entitled to a credit, against the royalty payments due to
Sangamo upon sales of such Licensed Product in the applicable country, in an amount equal to [***]
of any royalty paid to such Third Party by Sigma (including royalties paid pursuant to Third Party
Licenses) based upon the sales of the Licensed Product in such country, provided that in no event
shall the royalty rate due to Sangamo to be reduced to below [***] of the applicable royalty rates
set out in Section 7.7.
7.9 Certain Payments to Sigma.
(a) Sangamo shall pay Sigma an amount equal to the Sigma Share of any Clinical Development
Payment received by Sangamo under a Sangamo Collaboration. All payments under this Section 7.9(a)
shall be due no later than thirty (30) days after the end of the calendar quarter in which Sangamo
receives the applicable Clinical Development Payment.
(b) Sigma shall notify Sangamo in writing upon achieving each of the First Tier Milestone,
Second Tier Milestone, and Third Tier Milestone. The Sigma Share shall be determined as follows:
(i) Except as provided in Sections 7.9(b)(ii)-(iv), the Sigma Share shall be equal to [***].
(ii) In the event that Sigma achieves the First Tier Milestone, then, for any Sangamo
Collaborations that Sangamo enters into following Sangamos receipt of written notice of Sigmas
achievement of the First Tier Milestone and prior to Sangamos receipt of written notice of Sigmas
achievement of the Second Tier Milestone, the Sigma Share shall be equal to [***]
(iii)
In the event that Sigma achieves the Second Tier Milestone, then, for any Sangamo
Collaborations that Sangamo enters into following Sangamos receipt of written notice of Sigmas
achievement of the Second Tier Milestone and prior to Sangamos receipt of written notice of
Sigmas achievement of the Third Tier Milestone, the Sigma Share shall be equal to [***]. For
clarity, achievement and/or notice of the Second Tier Milestone shall
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not affect the Sigma Share applicable to any Sangamo Collaborations entered into prior to
Sangamos receipt of written notice of Sigmas achievement of the Second Tier Milestone.
(iv) In the event that Sigma achieves the Third Tier Milestone, then, for any Sangamo
Collaborations that Sangamo enters into following Sangamos receipt of written notice of Sigmas
achievement of the Third Tier Milestone, the Sigma Share shall be equal to [***]. For clarity,
achievement and/or notice of the Third Tier Milestone shall not affect the Sigma Share applicable
to any Sangamo Collaborations entered into prior to Sangamos receipt of written notice of Sigmas
achievement of the Third Tier Milestone.
7.10 Payments for Third Party Licenses.
(a) Sangamo Responsibilities. Sangamo (and not Sigma) shall be responsible for paying all
fees, milestones, royalties and other compensation owed to Third Parties pursuant to Third Party
Licenses identified in Exhibit B as of the Effective Date (including any post-Effective Date
amendments of such Third Party Licenses) on account of (i) the grant to Sigma of the licenses set
forth in Section 2.1 or (ii) the generation, development and/or commercialization of Licensed
Products by Sigma, but excluding any payments for which Sigma is responsible pursuant to Section
7.10(b). Sangamo and Sigma shall cooperate and provide such exchange of information as reasonably
necessary to enable Sigma to provide, at least ten (10) days in advance of the applicable due date,
with all information reasonably required by or useful to Sangamo to (A) ascertain when milestone
payments are owed under Third Party Licenses, (B) calculate the amounts of royalty payments due
under Third Party Licenses, and (C) provide required reports.
(b)
Sigma Responsibilities. Sigma shall be responsible for paying (i) any sublicense issuance and
sublicense maintenance fees owed to Third Parties pursuant to Third Party Licenses on account of
the grant of a sublicense by Sigma or its sublicensees and (ii) all milestones, royalties and other
compensation owed to Third Parties pursuant to post-Effective Date Third Party Licenses on account
of (A) the grant to Sigma of the licenses set forth in Section 2.1 or (B) the generation,
development and/or commercialization of Licensed Products by Sigma, its Affiliates, and
Sublicensees within the Field. Sigma shall provide and shall cause its Affiliates to provide
Sangamo at least ten (10) days in advance of the applicable due date,
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with all information reasonably required by or useful to Sangamo to (A) ascertain when
milestone payments are owed under Third Party Licenses, (B) calculate the amounts of royalty
payments due under such Third Party Licenses, and (C) provide required reports. Sangamo shall
cooperate with Sigma, and shall facilitate such exchange of information, in each case as reasonably
necessary to assist Sigma in complying with the foregoing obligation.
(c) Joint Responsibilities. Sigma and Sangamo shall reasonably allocate responsibility for
paying upfront fees or license maintenance fees (i.e., fees paid in consideration for the
continued license from the applicable Third Party licensor to Sangamo) owed to Third Parties
pursuant to post-Effective Date Third Party Licenses. Such allocation shall take into account the
relative value that the intellectual property licensed to Sangamo under the applicable Third Party
License contributes to, on the one hand, the rights granted to Sigma hereunder and, on the other
hand, all of Sangamos retained rights hereunder. Sangamo and Sigma shall cooperate and provide
such exchange of information as reasonably necessary with respect thereto.
(d) Sublicense Agreements. Sigma may structure each Sublicense Agreement so that the
applicable Sublicensee shall be responsible for paying some or all of the fees and other amounts
owed to Third Parties pursuant to Third Party Licenses. If Sigma elects to structure a Sublicense
Agreement in this manner, Sigma shall collect the relevant payments and reports from the applicable
Sublicensee and shall pay to Sangamo all such payments and shall provide Sangamo with any
corresponding reports at least ten (10) days in advance of the applicable due date. For the
avoidance of doubt, regardless of whether or not Sigma makes a Sublicensee responsible for fees and
other amounts owed to Third Parties pursuant to Third Party Licenses, Sigma shall remain
responsible for making any payments required by Section 7.10(b) and (c).
7.11 Payment Method. All payments due under this Agreement shall be made by bank wire
transfer in immediately available funds to an account designated by the Party to receive such
payment or by a Partys check payable to the receiving Party at such address as furnished by the
receiving Party from time to time. All payments hereunder shall be made in United States dollars.
37.
7.12 Taxes. The Party receiving payment hereunder shall pay any and all taxes levied on
account of all payments it receives under this Agreement. If laws or regulations require that
taxes be withheld, the Party making payment will (a) deduct those taxes from the remittable
payment, (b) pay the taxes to the proper taxing authority, and (c) send evidence of the obligation
together with proof of tax payment to the Party receiving payment within thirty (30) days following
that tax payment.
7.13 Foreign Exchange. Conversion of sales recorded in local currencies to United States
dollars will be performed in a manner consistent with the Party making payments normal practices
used to prepare its audited financial statements for internal and external reporting purposes,
which uses a widely accepted source of published exchange rates.
7.14 Records; Inspection. Each Party shall keep complete, true and accurate books of account
and records for the purpose of determining the payments to be made or received under this
Agreement, including without limitation records of Net Sales necessary to verify payments made
under Section 7.7 and to verify the achievement of the First Tier Milestone, Second Tier Milestone,
and Third Tier Milestone under Section 7.9. Such books and records shall be kept for at least
three (3) calendar years following the end of the calendar quarter to which they pertain. Such
records will open for inspection during such three (3) calendar year period by independent
accountants reasonably acceptable to the Party whose records are being inspected, solely for the
purpose of verifying payment statements hereunder. Such inspections shall be made no more than
once each calendar year, at reasonable time and on reasonable notice. Inspections conducted under
this Section 7.14 shall be at the expense of the inspecting Party, unless such inspection reveals
an underpayment by, or overpayment to, the Party whose records were inspected that exceeds five
percent (5%) of the amount paid by or to such Party whose records are inspected as the case may be
for any period covered by the inspection is established in the course of such inspection, whereupon
all costs relating to the inspection for such period will be paid promptly by the Party whose
records were inspected. The Party whose records were inspected shall promptly pay to the
inspecting Party any unpaid amounts and/or refund to the inspecting Party any excess payments made
by the inspecting Party (in each case, plus interest) that are discovered as a result of an
inspection hereunder.
38.
7.15 Interest. If a Party fails to make any payment due under this Agreement, then interest
shall accrue on a daily basis at a rate equal to [***] above the then-applicable prime commercial
lending rate of CitiBank, N.A., San Francisco, California, or at the maximum rate permitted by
applicable law, whichever is the lower.
7.16 Additional Provisions. For the avoidance of doubt, and subject to Section 10.4(c), Sigma
shall not be obligated to make any payment pursuant to this Agreement following the termination of
this Agreement, except for amounts payable under Sections 7.2, 7.3, 7.4, 7.5, 7.6 and 7.7 which
have fully accrued prior to such termination; termination shall not give rise to prorating of any
such payment that is not fully accrued at the time of termination. For clarity, any payments
payable under Section 6.2(a) shall be fully accrued upon delivery of the applicable Custom Project
Deliverable; any payments due under Section 6.3 shall be fully accrued upon Sangamo incurring the
applicable reimbursable costs or expenses; any payments payable under Section 7.9 shall be fully
accrued upon Sangamos receipt of the applicable Clinical Development Payment; any payments payable
under Section 7.10(b) shall be deemed to have been fully accrued prior to termination to the extent
that the triggering event occurred prior to termination and the corresponding payment obligation to
the relevant Third Party licensor comes due prior to, or remains due despite, termination of this
Agreement; any milestone payments payable under Section 7.3 or 7.4 shall be fully accrued upon
achievement of the applicable milestone event; any payments payable under Section 7.6 shall be
fully accrued upon Sigmas receipt of the applicable Sublicensing Revenue; and any royalty payments
payable under Section 7.7 shall be fully accrued on the date of the relevant invoice or other
billing giving rise to Net Sales.
ARTICLE 8
INTELLECTUAL PROPERTY
8.1 Disclosure of Improvements; Ownership of Intellectual Property.
(a)
At a regular interval to be agreed by the Parties (but no less than two times per Year) during
the Term, the Parties shall disclose to each other the making, development, conception, or
reduction to practice of all Improvements, to extent that any of the foregoing were
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made, developed, conceived, or reduced to practice since the previous new invention
disclosure.
(b) Ownership of the Sangamo Know-How and Sangamo Patents shall be and remain vested at all
times in Sangamo, subject to the license granted to Sigma pursuant to Section 2.1.
(c) Sigma Improvements and Sigma Improvement Patents shall be owned by Sigma, subject to the
license granted to Sangamo pursuant to Section 2.3.
(d) Joint Inventions and Joint Patents shall be jointly owed by Sigma and Sangamo, with each
Party having an undivided one-half interest in each Joint Invention and Joint Patent, subject to
the licenses granted pursuant to Sections 2.1 and 2.3. Each Party may practice and grant licenses
under each Joint Invention and Joint Patent without the consent of, or a duty of accounting to, the
other Party, provided that such practice and licenses are consistent with such Partys rights under
this Agreement. For the avoidance of doubt, Joint Inventions that are not Joint Improvements, and
Joint Patents that are not Joint Improvement Patents shall not be subject to the rights and
licenses set out in Sections 2.1 and 2.3.
(e) Ownership of Improvements made by Sublicensees will be governed by the applicable
Sublicense Agreement, but shall in every case be subject to the license granted to Sangamo pursuant
to Section 2.2(b)(ii).
8.2 Employees; Cooperation.
(a) Each Party represents and agrees that all employees or others acting on its behalf in
performing its obligations under this Agreement shall be obligated under a binding written
agreement to assign to such Party all inventions (and all related intellectual property) made or
conceived by such employee or other person during and in connection with the Research Plan
Collaboration. The Parties agree to undertake to enforce such agreements (including, where
appropriate, by legal action) considering, among other things, the commercial value of such
inventions.
(b) The Party responsible for filing, prosecution, or maintenance of a particular Sangamo
Patent, Improvement Patent, or Joint Patent pursuant to Section 8.3, 8.4, or
40.
8.5 (the Filing Party) shall consult with and keep other Party (the Non-Filing Party)
fully informed of all issues relating to the preparation, filing, prosecution and maintenance of
such patent, and shall furnish to the Non-Filing Party copies of all documents received from, and
filed in, the applicable Patent Office. The Filing Party shall provide to the Non-Filing Party
copies of documents relevant to such preparation, filing, prosecution or maintenance in sufficient
time prior to filing such document or making any payment due thereunder to allow for review and
comment by the Non-Filing Party, and the Filing Party shall consider such comments in good faith.
8.3 Filing, Prosecution and Maintenance of Sangamo Patents.
(a) As between the Parties, Sangamo shall have the first right to file, prosecute, and/or
maintain the Sangamo Patents (other than Joint Patents), for which it shall bear all associated
costs and expenses.
(b) Should Sangamo decide not to file or continue prosecuting or maintaining a particular
Sangamo Patent (other than a Joint Patent), it shall notify Sigma in writing promptly after such
decision is made and not less than sixty (60) days prior to any applicable deadline. Thereafter,
to the extent that no Third Party has a right to assume the prosecution and maintenance of such
Sangamo Patent, Sigma may assume such prosecution and maintenance at its sole cost and expense.
(c) Sigmas rights under this Section 8.3 with respect to any Sangamo Patent licensed to
Sangamo by a Third Party shall be subject to the rights of such Third Party to file, prosecute,
and/or maintain such Sangamo Patent.
8.4 Filing, Prosecution and Maintenance of Sigma Improvement Patents. Sigma shall have the
first right to file, prosecute, and/or maintain all Sigma Improvement Patents, for which it shall
bear all associated costs and expenses. Should Sigma decide not to file or continue prosecuting or
maintaining a particular Sigma Improvement Patent, it shall notify Sangamo in writing promptly
after such decision is made and not less than sixty (60) days prior to any applicable deadline.
Thereafter, Sangamo shall have the right, but not the obligation, to assume such filing,
prosecution and maintenance at its sole cost and expense.
41.
8.5 Filing, Prosecution and Maintenance of Joint Patents. Sangamo shall have the first right
to file, prosecute, and/or maintain all Joint Improvement Patents. The Parties shall determine on
a case-by-case basis, in good faith and by mutual agreement, the allocation of the associated costs
and expenses in connection therewith, which allocation shall take into account the relative value
of the applicable Joint Improvement Patent inside and outside the Field. The Parties shall
determine, in good faith and by mutual agreement, which of them should reasonably assume
responsibility for filing, prosecuting and maintaining other Joint Patents, and the Parties shall
share equally all associated costs and expenses in connection therewith. Should either Party
decide not to file or continue prosecuting or maintaining a particular Joint Patent, it shall
notify the other Party in writing promptly after such decision is made and not less than sixty (60)
days prior to any applicable deadline. Thereafter, the other Party shall have the right, but not
the obligation, to assume such filing, prosecution and maintenance at its sole cost and expense,
and if it does so, the declining Party shall assign to the other Party all its right, title and
interest to any such Joint Improvement Patent or Joint Patent in the applicable country, and upon
such assignment such Joint Patent in such country shall no longer be treated as a Joint Improvement
Patent or Joint Patent, respectively, hereunder but may be a Sangamo Patent or Sigma Improvement
Patent to the extent such former Joint Patent satisfies the definitions thereof (without giving
effect to the initial parenthetical in the definition of Sigma Improvements).
8.6 Enforcement of Sangamo Patents
(a) If either Party becomes aware of any Third Party activity in the Field (and outside the
Plant Field) that infringes a Sangamo Patent or any legal filing made by a Third Party with a court
or administrative agency alleging that a Sangamo Patent is invalid or unenforceable (collectively,
for the purpose of this Section 8.6, Infringement), then that Party shall give prompt written
notice to the other Party regarding such infringement.
(b) As between the Parties, Sangamo shall have the first right, but not the obligation, to
attempt to resolve such Infringement by commercially appropriate steps, including without
limitation the filing of an infringement suit using counsel of its own choice.
(c) If Sangamo fails to resolve such Infringement or to initiate a suit with respect thereto
within one hundred twenty (120) days after delivery of the notice set forth in
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Section 8.6(a), then upon Sigmas request and Sangamos written consent (not to be
unreasonably withheld), Sigma shall have the right, but not the obligation, to attempt to resolve
such Infringement by commercially appropriate steps, including without limitation the filing of an
infringement suit using counsel of its own choice.
(d) In any event, the Party not bringing an infringement action under this Section 8.6 agrees
to be joined as a party to the suit, at the request and expense of the Party bringing such action,
and to provide reasonable assistance in any such action. Neither Party shall settle or otherwise
compromise any such action in a way that adversely affects the other Partys intellectual property
rights without such Partys prior written consent.
(e) Any amounts recovered by the Party taking an action pursuant to this Section 8.6, whether
by settlement or judgment, shall be allocated first to reimburse each Party for any costs and
expenses incurred by such Party (and not otherwise reimbursed). Any remaining recovery shall be
shared by the Parties in proportion to the percentage of litigation expenses funded by each Party.
(f) Sigmas rights under this Section 8.6 with respect to any Sangamo Patent licensed to
Sangamo by a Third Party shall be subject to the rights of such Third Party to enforce such Sangamo
Patent.
8.7 Enforcement of Sigma Improvement Patents
(a) If either Party becomes aware of any Third Party activity that infringes a Sigma
Improvement Patent, then that Party shall give prompt written notice to the other Party regarding
such infringement.
(b) With respect to infringement involving Third Party activity outside the Field or in the
Plant Field, Sangamo shall have the first right, but not the obligation, to attempt to
resolve such infringement, whether by settlement or judgment. If Sangamo fails to resolve
such infringement or to initiate a suit with respect thereto within one hundred twenty
(120) days after delivery of the notice set forth in Section 8.7(a), then Sigma shall have
the right, but not the obligation, to attempt to resolve such infringement by commercially
appropriate steps, including without limitation the filing of an infringement suit using
counsel of its own choice.
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(c) With respect to infringement involving Third Party activity solely in the
Field (and not in the Plant Field), Sigma shall have the right, but not the obligation, to
attempt to resolve such infringement or allegation, whether by settlement or judgment.
(d) A Partys right to initiate a patent infringement suit under this Section 8.7 shall
include the right to resolve any allegation that a Sigma Improvement Patent is invalid or
unenforceable brought as a counterclaim in such suit.
(e) In any event, the Party not bringing an infringement action under this Section 8.7 agrees
to be joined as a party to the suit, at the request and expense of the Party bringing such action,
and to provide reasonable assistance in any such action, at the requesting Partys expense.
Neither Party shall settle or otherwise compromise any such action in a way that adversely affects
the other Partys intellectual property rights without such Partys prior written consent.
(f) Any amounts recovered by the Party taking an action pursuant to this Section 8.7, whether
by settlement or judgment, shall be allocated first to reimburse each Party for any costs and
expenses incurred by such Party (and not otherwise reimbursed). Any remaining recovery shall be
shared by the Parties in proportion to the percentage of litigation expenses funded by each Party.
8.8 Enforcement of Joint Patents.
(a) If either Party becomes aware of any Third Party activity that infringes a Joint Patent,
then that Party shall give prompt written notice to the other Party regarding such infringement.
(b) With respect to infringement of a Joint Improvement Patent involving Third Party activity
outside the Field or in the Plant Field:
(i) Sangamo shall have the right, but not the obligation, to attempt to resolve such
infringement by commercially appropriate steps, including without limitation the filing of an
infringement suit using counsel of its own choice. If Sangamo institutes such a suit with
respect to a Joint Patent, it will do so at its expense, and will be
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entitled to keep all recoveries.
(ii) If Sangamo fails to resolve such infringement or to initiate a suit with respect
thereto within one hundred twenty (120) days after delivery of the notice set forth in Section
8.8(a), then Sigma shall have the right, but not the obligation, to attempt to resolve such
infringement by commercially appropriate steps, including without limitation the filing of an
infringement suit using counsel of its own choice. If Sigma initiates such a suit with
respect to a Joint Patent it will do so at its own expense, and will be entitled to keep all
recoveries.
(c) With respect to infringement of a Joint Improvement Patent involving Third Party activity
in the Field (and not in the Plant Field):
(i) Sigma shall have the right, but not the obligation, to attempt to resolve such
infringement by commercially appropriate steps, including without limitation the filing of an
infringement suit using counsel of its own choice. If Sigma institutes such a suit with
respect to a Joint Patent, it will do so at its expense, and will be entitled to keep all
recoveries.
(ii) If Sigma fails to resolve such infringement or to initiate a suit with respect
thereto within one hundred twenty (120) days after delivery of the notice set forth in Section
8.8(a), then Sangamo shall have the right, but not the obligation, to attempt to resolve such
infringement by commercially appropriate steps, including without limitation the filing of an
infringement suit using counsel of its own choice. If Sangamo initiates such a suit with
respect to a Joint Patent it will do so at its own expense, and will be entitled to keep all
recoveries.
(d) If either Party becomes aware of any Third Party activity that infringes a Joint Patent
other than a Joint Improvement Patent, then that Party shall give prompt written notice to the
other Party regarding such infringement. The Parties shall then consult in good faith regarding
such asserted infringement and the reasonable actions that the Parties may take in connection
therewith.
(e) In any event, the Party not bringing an infringement action under this
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Section 8.8 agrees
to be joined as a party to the suit, at the request and expense of the Party
bringing such action, and to provide reasonable assistance in any such action, at the
requesting Partys expense. Neither Party shall settle or otherwise compromise any such action in
a way that adversely affects the other Partys intellectual property rights without such Partys
prior written consent.
8.9 Defense of Third Party Infringement Claims. If a Third Party asserts that a patent or
other right Controlled by it is infringed by activities in the Field or a Party becomes aware of a
patent or other right that might form the basis for such a claim, the Party first obtaining
knowledge of such a claim or such potential claim shall immediately provide the other Party with
notice thereof and the related facts in reasonable detail. The Parties shall discuss the merits of
such claim or potential claims and shall attempt, if they determine doing so to be reasonably
appropriate, in good faith to mutually agree whether to obtain a license from such Third Party. If
the intellectual property pertains to ZFP Products both inside and outside the Field, then, as
between the Parties, Sangamo shall be the party that enters into any license agreement with such
Third Party and Sigma shall be entitled to a sublicense in the Field under such license agreement
(or any license agreement entered into by Sangamo hereunder that pertains to ZFP Products in the
Field) if it follows the procedures therefor set forth in Section 2.6(d) and/or 2.6(e) (as
applicable). If the intellectual property pertains to ZFP Product inside but not outside the
Field, then Section 2.6(b) shall apply. In the event that Sigma is the party that enters into a
license agreement with such Third Party, Sigma shall be responsible for amounts payable with
respect to any such license; provided, however, that royalties paid by Sigma pursuant to such
license shall be creditable pursuant to Section 7.8 to the extent such royalties satisfy the terms
thereof. Neither Party shall be required to conduct any work under this Agreement which it
believes in good faith may infringe Third Party patent or other intellectual property rights.
Except as set forth in Article 12 or otherwise agreed in writing by the Parties, each Party shall
control and bear the expense of its own defense of such Third Party claim. The parties shall
discuss with each other on a regular basis all actions under and pursuant to this Section 8.9 in
order to endeavor in good faith to resolve any situation hereunder in a manner reasonably
satisfactory to both parties.
46.
ARTICLE 9
CONFIDENTIALITY
9.1 Nondisclosure of Confidential Information. All Information disclosed by one Party to the
other Party pursuant to this Agreement shall be Confidential Information for all purposes
hereunder. The Parties agree that during the term of this Agreement and for a period of seven (7)
years thereafter, a Party receiving Confidential Information of the other Party will (a) use
commercially reasonable efforts to maintain in confidence such Confidential Information (but not
less than those efforts as such Party uses to maintain in confidence its own proprietary industrial
information of similar kind and value) and not to disclose such Confidential Information to any
Third Party without prior written consent of the other Party, except for disclosures made in
confidence to any Third Party under terms consistent with this Agreement and made in furtherance of
this Agreement or of rights granted to a Party hereunder, and (b) not use such other Partys
Confidential Information for any purpose except those permitted by this Agreement (it being
understood that this subsection (b) shall not create or imply any rights or licenses not expressly
granted under Article 2). In any event, the Parties agree to take all reasonable action to avoid
disclosure of Confidential Information except as permitted hereunder.
9.2 Exceptions. The obligations in Section 9.1 shall not apply with respect to any portion of
the Confidential Information that the receiving Party can show by competent written proof:
(a) is publicly disclosed by the disclosing Party, either before or after it is disclosed to
the receiving Party hereunder; or
(b) was known to the receiving Party or any of its Affiliates, without obligation to keep it
confidential, prior to disclosure by the disclosing Party; or
(c) is subsequently disclosed to the receiving Party or any of its Affiliates by a Third Party
lawfully in possession thereof and without obligation to keep it confidential; or
(d) is published by a Third Party or otherwise becomes publicly available or enters the public
domain, either before or after it is disclosed to the receiving Party; or
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(e) has been independently developed by employees or contractors of the receiving Party or any
of its Affiliates without the aid, application or use of Confidential Information.
9.3 Authorized Disclosure. A Party may disclose the Confidential Information belonging to the
other Party to the extent such disclosure is reasonably necessary in the following instances:
(a) Disclosures required by operation of law or court order (provided the Party required to
disclose Confidential Information belonging to the other Party gives the other Party as much prior
notice as is reasonably practicable and discloses only such information as it is obligated to); and
(b) disclosures in connection with the performance of this Agreement to Affiliates and
then-current and potential collaborators, partners, licensees, research collaborators, investment
bankers, investors, lenders, acquirers, employees, consultants, agents, customers, sublicensees,
and contractors, each of whom prior to disclosure must be bound by similar obligations of
confidentiality and non-use at least equivalent in scope to those set forth in this Article 9.
9.4 Terms of Agreement. The Parties acknowledge that the terms of this Agreement shall be
treated as Confidential Information of both Parties. Such terms may be disclosed by a Party to
individuals or entities covered by Section 9.3(b) above, each of whom prior to disclosure must be
bound by similar obligations of confidentiality and non-use at least equivalent in scope to those
set forth in this Article 9. In addition, a copy of this Agreement may be filed by either Party
with the Securities and Exchange Commission. In connection with any such filing such Party shall
endeavor to obtain confidential treatment of economic and trade secret information, and shall keep
the other Party informed as the planned filing (including, but not limited to providing the other
Party with the proposed filing reasonably in advance of making the planned filing) and consider the
requests of the other Party regarding such confidential treatment. With respect to any Third Party
License that requires Sangamo to provide to the applicable Third Party licensor a copy of this
Agreement or a summary of the terms of this Agreement, Sangamo may provide such copy or summary to
such Third Party licensor in confidence.
48.
9.5 Termination of Prior Agreements. This Agreement supersedes the Confidential Disclosure
Agreement between Sangamo and the Biotechnology Division of Sigma-Aldrich Corporation, dated August
24, 2006. All Information exchanged between the Parties under such earlier agreement shall be
deemed Confidential Information of the disclosing Party and shall be subject to the terms of this
Article 9.
9.6 Publicity. The Parties agree that the public announcement of the execution of this
Agreement shall be substantially in the form of the press release attached as Exhibit E. Any other
publication, news release or other public announcement relating to this Agreement or to the
performance hereunder, shall first be reviewed and approved by both Parties, and neither Party
shall use the other Partys name in any such public disclosure without such other Partys prior
written consent. Notwithstanding the foregoing, any disclosure which is required by law as advised
by the disclosing Partys counsel may be made without the prior consent of the other Party,
although the other Party shall be given prompt notice of any such legally required disclosure and
to the extent practicable shall provide the other Party an opportunity to comment on the proposed
disclosure. The foregoing shall not be construed to prevent or restrict Sigma from making such
public disclosures as it considers reasonably appropriate with respect to the marketing and sales
of Licensed Products and Licensed Services; for the avoidance of doubt, notice to or approval by
Sangamo of such public disclosures shall not be required (subject, however, to any applicable terms
of Sections 9.1-9.4 and the restriction set forth above on the use of Sangamos name).
9.7 Publications. Subject to Section 9.3, each Party agrees to provide the other Party the
opportunity to review any proposed abstracts, manuscripts or presentations (including verbal
presentations) which relate to the use of Licensed Products in the Field at least thirty (30) days
prior to its intended submission for publication (or in the case of public disclosures by Sigma for
the marketing and sales of Licensed Products and Licensed Services, seven (7) days) and agrees,
upon request, not to submit any such abstract or manuscript for publication until the other Party
is given a reasonable period of time to secure patent protection for any material related to such
publication which it believes to be patentable. Both Parties understand that a reasonable
commercial strategy may require delay of publication of information or filing of patent
applications. The Parties agree to review and consider delay of publication and filing of patent
49.
applications under certain circumstances. The JSC will review such requests and recommend
subsequent action. Neither Party shall have the right to publish or present Confidential
Information of the other Party which is subject to Section 9.1.
9.8 Patents. If disclosure of Confidential Information of one Party is necessary or useful in
prosecution of a patent application being prosecuted by the other Party, the Party to whom the
Confidential Information belongs will, on request, consider permitting use of the information and
will provide the requesting party with a decision without undue delay.
ARTICLE 10
TERM AND TERMINATION
10.1 Term. This Agreement shall become effective on the Effective Date and shall expire upon
the last payment obligation as provided in Article 7, unless earlier terminated in accordance with
Section 10.2 or 10.3.
10.2 Termination at Will. Sigma may terminate this Agreement in its entirety at any time by
providing ninety (90) days written notice thereof to Sangamo. Such termination shall have the
following effects:
(a) all licenses and rights granted to Sigma under this Agreement (including without
limitation the licenses and rights set forth in Section 2.1) shall terminate;
(b) all sublicenses granted by Sigma or its sublicensees under the licenses and rights granted
to Sigma under this Agreement shall terminate;
(c) Sigma shall grant to Sangamo and its Affiliates a worldwide, fully paid, perpetual,
irrevocable, non-exclusive license (with the right to sublicense) to practice the Sigma
Improvements (and any patents and patent applications claiming Sigma Improvements) for all purposes
in the Field; and
(d) Sigma shall provide Sangamo with a complete and accurate list of (i) all
50.
projects in which Sigma, a Sigma Affiliate, or a Sublicensee (to the extent of Sigmas
knowledge) practiced the Sangamo Technology in the Field prior to the termination effective date
and (ii) all Licensed Products in existence as of the effective date of termination.
10.3 Termination for Material Breach.
(a) If either Party believes that the other Party is in material breach of this Agreement
(including without limitation any material breach of a representation or warranty made in this
Agreement), then the non-breaching Party may deliver notice of such breach to the other Party. In
such notice the non-breaching Party shall identify the actions or conduct that such Party would
consider to be an acceptable cure of such breach. For all breaches other than a failure to make a
payment set forth in Article 7, the allegedly breaching Party shall have sixty (60) days to either
cure such breach. For any breach arising from a failure to make a payment set forth in Article 7,
the allegedly breaching Party shall have thirty (30) days to cure such breach.
(b) If the Party receiving notice of breach fails to cure such breach within the 60-day period
or 30-day period (as applicable), the Party originally delivering the notice may terminate this
Agreement upon written notice.
(c) If a Party gives notice of termination under this Section 10.3 and the other Party
disputes in good faith whether such notice was proper, then the issue of whether this Agreement has
been terminated shall be resolved in accordance with Section 13.1. If as a result of such dispute
resolution process it is determined that the notice of termination was proper, then such
termination shall be deemed to have been effective if the breaching Party fails thereafter to cure
such breach in accordance with the determination made in the resolution process under Section 13.1
within the time period set forth in Section 10.3(a) for the applicable breach following such
determination. If as a result of such dispute resolution process it is determined that the notice
of termination was improper, then no termination shall have occurred and this Agreement shall have
remained in effect.
(d) Termination of this Agreement pursuant to this Section 10.3 shall have the following
effects:
(i) all licenses and rights granted to Sigma under this Agreement
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(including without limitation the licenses and rights set forth in Section 2.1) shall
terminate;
(ii) all sublicenses granted by Sigma or its sublicensees under the licenses and rights
granted to Sigma under this Agreement shall terminate;
(iii) the rights and obligations of the Parties set forth in Section 10.2(d) shall apply;
(e) if terminated as a result of breach by Sigma, the rights and obligations of the Parties
set forth in Section 10.2(c) shall also apply; and
(f) if terminated as a result of breach by Sangamo, all licenses and rights granted to Sangamo
as set forth in Section 2.3(b) shall terminate.
10.4 Effect of Termination; Survival.
(a) In addition to the specific items identified as effects of termination pursuant to Section
10.2 or 10.3, the following provisions of this Agreement shall survive any expiration or
termination of this Agreement, regardless of cause: Sections 2.3(b), 6.4 (last sentence only),
7.14, 7.15, 7.16, 8.1, 8.4 (except in the case of termination pursuant to Section 10.3 as a result
of a breach by Sangamo), 8.5, 8.7 (except in the case of termination pursuant to Section 10.3 as a
result of a breach by Sangamo), 8.8, 10.2, 10.3, 10.4, 13.1, 13.2, 13.3, 13.8, 13.11, 13.17, and
13.18, and Articles 9 (other than Sections 9.7 and 9.8) and 12.
(b) In any event, termination of this Agreement shall not relieve the Parties of any liability
which accrued hereunder prior to the effective date of such termination nor preclude either Party
from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to
any breach of this Agreement nor prejudice either Partys right to obtain performance of any
obligation.
(c) In the event this Agreement is terminated for any reason, Sigma shall cease, and shall
cause its Affiliates and sublicensees to cease, all development and commercialization of Licensed
Products, and Sigma shall not use or practice, nor shall it cause or permit any of its Affiliates
or such sublicensees to use or practice, directly or indirectly, any
52.
Sangamo Technology; provided, however, that Sigma shall have a six-month period following
termination to sell inventory of Licensed Products existing as of the date of termination and
perform previously agreed-upon Licensed Services subject to the payment obligations set forth in
Section 7.7 (subject to Sections 7.8 through 7.15).
ARTICLE 11
REPRESENTATIONS, WARRANTIES, AND COVENANTS
11.1 Mutual Authority. Sangamo and Sigma each represents and warrants to the other that: (i)
it has the authority and right to enter into and perform this Agreement, (ii) this Agreement is a
legal and valid obligation binding upon it and is enforceable in accordance with its terms, subject
to applicable limitations on such enforcement based on bankruptcy laws and other debtors rights,
and (iii) its execution, delivery and performance of this Agreement will not conflict in any
material fashion with the terms of any other agreement or instrument to which it is or becomes a
party or by which it is or becomes bound, nor violate any law or regulation of any court,
governmental body or administrative or other agency having authority over it.
11.2 Performance by Affiliates. The Parties recognize that each may perform some or all of
its obligations, or exercise some or all of its rights, under this Agreement through Affiliates
(without any requirement that such Affiliates be granted an express sublicense under any licenses
granted by the other Party), provided, however, that each Party shall remain responsible for and be
guarantor of such performance or exercise by its Affiliates and shall cause its Affiliates to
comply with the provisions of this Agreement in connection with such performance or exercise. In
particular, if any Affiliate of a Party performs some or all of a Partys obligations, or exercises
some or all of its rights, under this Agreement, (i) the restrictions of this Agreement which apply
to the activities of a Party under this Agreement shall apply equally to the activities of such
Affiliate, and (ii) the Party affiliated with such Affiliate shall assure, and hereby guarantees,
that any intellectual property developed by such Affiliate shall be governed by the provisions of
this Agreement (and subject to the licenses set forth in Article 2) as if such intellectual
property had been developed by the Party.
11.3 Third Party Rights. Except as already disclosed to the other party in writing,
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each Party represents and warrants to the other Party that, to its knowledge as of the
Effective Date, its performance of work under the Research Plan Collaboration as contemplated by
this Agreement will not infringe the patent, trade secret or other intellectual property rights of
any Third Party.
11.4 Additional Representations, Warranties and Covenants of Sangamo.
(a) Sangamo Know-How. Sangamo represents and warrants with respect to those items below that
pertain to current facts, and covenants with respect to those items below that pertain to future
actions:
(i) that Sangamo has the full right and power to grant to Sigma the licenses under such
Sangamo Know-How that are granted in Section 2.1 of this Agreement;
(ii) that such Sangamo Know-How is proprietary to Sangamo, and the conception and development
of such Sangamo Know-How by Sangamo has not, to the knowledge of Sangamo as of the Effective Date,
constituted or involved the misappropriation of trade secrets of any Third Party;
(iii) that Sangamo has taken commercially reasonably steps to protect those items within such
Sangamo Know-How that Sangamo has decided to maintain as trade secrets, and will continue to take
commercially reasonable steps to protect those items within such Sangamo Know-How that Sangamo
decides to maintain as trade secrets (it being understood that Sangamo may periodically re-evaluate
the value of maintaining such items as trade secrets as opposed to pursuing patent protection
therefor or permitting strategic disclosure thereof); and
(iv) that, to the knowledge of Sangamo as of the Effective Date, no pending claim has been
brought by any person or entity alleging that the Sangamo Know-How conflicts or interferes with any
intellectual property or proprietary right of any Third Party.
(b) Sangamo Patents. With respect to the Sangamo Patents that are owned by Sangamo, Sangamo
represents and warrants with respect to those items below that pertain to current facts, and
covenants with respect to those items below that pertain to future actions:
54.
(i) that it has the right to grant to Sigma the licenses under the Sangamo Patents that are
granted in Section 2.1 of this Agreement;
(ii) that it is not aware, as of the Effective Date, of any written assertions of invalidity
of those Sangamo Patents that issued prior to the Effective Date;
(iii) that, as of the Effective Date, it has not withheld any material references during
prosecution in the United States of those United States Sangamo Patents that issued prior to the
Effective Date;
(iv) that the conception, development, and reduction to practice of the inventions claimed in
the Sangamo Patents has not, to the knowledge of Sangamo as of the Effective Date, constituted or
involved the misappropriation or infringement of trade secrets or other intellectual property of
any Third Party;
(v) that, to the knowledge of Sangamo as of the Effective Date, there are no claims,
judgments, or settlements relating to the Sangamo Patents to be paid by Sangamo;
(vi) that, to the knowledge of Sangamo as of the Effective Date, no pending claim has been
brought by any person or entity alleging that the Sangamo Patents conflict or interfere with any
intellectual property or proprietary right of any Third Party; and
(vii) that Sangamo is not aware, as of the Effective Date, of any infringement of the Sangamo
Patents by a Third Party, other than those disclosed to Sigma in writing.
(c) Third Party Licenses. With respect to the Third Party Licenses set forth in Exhibit B as
of the Effective Date, Sangamo represents and warrants with respect to those items below that
pertain to current facts, and covenants with respect to those items below that pertain to future
actions:
(i) that, to its knowledge as of the Effective Date, it is not in material breach of its
obligations thereunder as of the Effective Date and it will continue to perform all of its
obligations thereunder that, if not performed, would have a material adverse effect on Sigmas
rights under this Agreement,
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(ii) that if it is unable to fulfill such obligations at any time, it will notify Sigma as
soon as practicable;
(iii) that it will not voluntarily terminate any Third Party License without the consent of
Sigma, such consent not to be unreasonably withheld, and it will use commercially reasonable
efforts to cure any material breach of any Third Party License during the life of this Agreement;
(iv) that Sangamo has the right to grant the sublicenses thereunder to Sigma that are granted
in Section 2.1 of this Agreement, except as set forth in Exhibit C;
(v) that, if Sigma cannot grant further sublicenses under a particular Third Party License,
then at Sigmas request in conjunction with Sigmas entry into a Sublicense Agreement, Sangamo will
grant a sublicense (within 30 days) under such Third Party License to the Sublicensee for such
Sublicense Agreement on terms that are consistent with such Sublicense Agreement and that do not
provide Sangamo with greater compensation than it would have received had such sublicense been
granted by Sigma; and
(vi) that the conception, development, and reduction to practice of the technology licensed in
the Field under Third Party Licenses is not known by Sangamo as of the Effective Date to have
constituted or involved the misappropriation or infringement of trade secrets or other intellectual
property of any Third Party.
(d) Sangamo Plant Product Licenses. Sangamo represents and warrants with respect to those
items below that pertain to current facts, and covenants with respect to those items below that
pertain to future actions:
(i) As of the Effective Date, the only license granted by Sangamo under the Sangamo Technology
to make, use and/or sell products in the Plant Field is the Dow AgroSciences Agreement.
(ii) Sangamo hereby covenants that for so long as the licenses granted under Section 2.1
continue in effect, Sangamo will grant no further licenses under the Sangamo Technology to make,
have made, use, sell, offer for sale, and import Plant Products and
56.
Permitted Plant Products and to provide Permitted Plant Services in the Field (other than any
licenses granted to Dow AgroSciences pursuant to the Dow AgroSciences Agreement).
(iii) Sangamo hereby covenants that it shall not, without Sigmas prior written consent, amend
the Dow AgroSciences Agreement in any manner that has a material adverse effect on Sigmas rights
under this Agreement.
11.5 Future Discussions.
(a) On written request by Sigma, Sangamo will discuss in good faith with Sigma an appropriate
accommodation (which may involve a reduction in certain future payments owed to Sangamo under this
Agreement) to reflect the reduced commercial value of the licenses granted to Sigma under this
Agreement as a result of activity in the Field by unlicensed Third Parties that has a material
adverse effect on Sigmas ability to exploit its rights under this Agreement.
(b) On the written request of either Party identifying changed circumstances that materially
affect the benefits or burdens of such Party under this Agreement, the Parties shall discuss in
good faith possible ways of addressing such changed circumstances.
(c) For the avoidance of doubt, if the Parties fail to agree on an appropriate accommodation
under Section 11.5(a) or on a manner of addressing changed circumstances under Section 11.5(b), the
Parties shall have no obligation to follow the dispute resolution procedure set forth in Section
13.1.
ARTICLE 12
INDEMNIFICATION
12.1 Mutual Indemnification. Subject to Section 12.3, each Party hereby agrees to indemnify,
defend and hold the other Party, its Affiliates, its licensees, and its and their officers,
directors, employees, consultants, contractors, sublicensees and agents (collectively, the Party
Indemnitees) harmless from and against any and all damages or other amounts payable to a Third
Party claimant, as well as any reasonable attorneys fees and costs of litigation incurred by
57.
such Party Indemnitee as to any such Claim (as defined in this Section 12.1) until the
indemnifying Party has acknowledged that it will provide indemnification hereunder with respect to
such Claim as provided below (collectively, Damages) to the extent resulting from claims, suits,
proceedings or causes of action (Claims) brought by such Third Party against such Party
Indemnitee based on: (a) a breach of warranty by the indemnifying Party contained in this
Agreement; (b) breach of this Agreement or applicable law by such indemnifying Party; (c)
negligence or willful misconduct of a Party, its Affiliates, or (sub)licensees, or their respective
employees, contractors or agents in the performance of this Agreement; and/or (d) breach of a
contractual or fiduciary obligation owed by it to a Third Party (including without limitation
misappropriation of trade secrets).
12.2 Additional Indemnification
(a) By Sigma. Subject to Section 12.3, Sigma hereby agrees to indemnify, defend and hold the
Sangamo Indemnitees harmless from and against any and all Damages resulting from Claims brought by
a Third Party to the extent resulting from the manufacture, use, handling, storage, marketing, sale
or other disposition of Licensed Products by Sigma, its Affiliates, agents or sublicensees
(including Sublicensees). Such indemnity obligation shall not apply to the extent such Losses
result from (a) a breach of warranty by Sangamo contained in this Agreement; (b) breach of this
Agreement or applicable law by Sangamo; (c) negligence or willful misconduct by Sangamo, its
Affiliates, or (sub)licensees, or their respective employees, contractors or agents in the
performance of this Agreement; and/or (d) breach of a contractual or fiduciary obligation owed by
Sangamo to a Third Party (including without limitation misappropriation of trade secrets).
(b) By Sangamo. Subject to Section 12.3, Sangamo hereby agrees to indemnify, defend and hold
the Sigma Indemnitees harmless from and against any and all Damages to the extent resulting from
Claims brought by a Third Party to the extent resulting from the manufacture, use, handling,
storage, marketing, sale or other disposition of products or services employing Sigma Improvements
by Sangamo, its agents or sublicensees. Such indemnity obligation shall not apply to the extent
such Losses result from (i) a breach of warranty by Sigma contained in this Agreement; (ii) breach
of this Agreement or applicable law by Sigma; (iii)
58.
negligence or willful misconduct by Sigma, its Affiliates, or (sub)licensees, or their respective
employees, contractors or agents in the performance of this Agreement; and/or (iv) breach of a
contractual or fiduciary obligation owed by Sigma to a Third Party (including without limitation
misappropriation of trade secrets).
12.3 Conditions to Indemnification. As used herein, Indemnitee shall mean a party entitled
to indemnification under the terms of Section 12.1 or 12.2. It shall be a condition precedent to
an Indemnitees right to seek indemnification under such Section 12.1 or 12.2 that such Indemnitee:
(a) inform the indemnifying Party of a Claim as soon as reasonably practicable after it
receives notice of the Claim;
(b) if the indemnifying Party acknowledges that such Claim falls within the scope of its
indemnification obligations hereunder, permit the indemnifying Party to assume direction and
control of the defense, litigation, settlement, appeal or other disposition of the Claim (including
the right to settle the claim solely for monetary consideration); provided, that the indemnifying
Party shall seek the prior written consent (not to be unreasonably withheld or delayed) of any such
Indemnitee as to any settlement which would materially diminish or materially adversely affect the
scope, exclusivity or duration of any Patents licensed under this Agreement, would require any
payment by such Indemnitee, would require an admission of legal wrongdoing in any way on the part
of an Indemnitee, or would effect an amendment of this Agreement; and
(c) fully cooperate (including providing access to and copies of pertinent records and making
available for testimony relevant individuals subject to its control) as reasonably requested by,
and at the expense of, the indemnifying Party in the defense of the Claim.
Provided that an Indemnitee has complied with the foregoing, the indemnifying Party shall provide
attorneys reasonably acceptable to the Indemnitee to defend against any such Claim. Subject to the
foregoing, an Indemnitee may participate in any proceedings involving such Claim using attorneys of
its/his/her choice and at its/his/her expense. In no event may an Indemnitee
59.
settle or compromise any Claim for which it/he/she intends to seek indemnification from the
indemnifying Party hereunder without the prior written consent of the indemnifying Party, or the
indemnification provided under such Section 12.1 or 12.2 as to such Claim shall be null and void.
12.4 Limitation of Liability. EXCEPT FOR AMOUNTS PAYABLE TO THIRD PARTIES BY A PARTY FOR
WHICH IT SEEKS REIMBURSEMENT OR INDEMNIFICATION PROTECTION FROM THE OTHER PARTY PURSUANT TO
SECTIONS 12.1 AND 12.2, AND EXCEPT FOR BREACH OF SECTION 9.1 HEREOF, IN NO EVENT SHALL EITHER
PARTY, ITS DIRECTORS, OFFICERS, EMPLOYEES, AGENTS OR AFFILIATES BE LIABLE TO THE OTHER PARTY FOR
ANY INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES, WHETHER BASED UPON
A CLAIM OR ACTION OF CONTRACT, WARRANTY, NEGLIGENCE, STRICT LIABILITY OR OTHER TORT, OR OTHERWISE,
ARISING OUT OF THIS AGREEMENT, UNLESS SUCH DAMAGES ARE DUE TO THE GROSS NEGLIGENCE OR WILLFUL
MISCONDUCT OF THE LIABLE PARTY. For clarification, the foregoing sentence shall not be interpreted
to limit or to expand the express rights specifically granted in the sections of this Agreement.
12.5 Disclaimer. EXCEPT AS PROVIDED IN ARTICLE 11 ABOVE, SIGMA EXPRESSLY DISCLAIMS ANY AND
ALL OTHER WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE WARRANTIES
OF DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND NONINFRINGEMENT OF THE
INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES WITH RESPECT TO ANY RESEARCH RESULTS, DATA, OR
INVENTIONS (AND ANY PATENT RIGHTS OBTAINED THEREON) IDENTIFIED, MADE OR GENERATED BY SIGMA AS PART
OF THE RESEARCH PLAN COLLABORATION OR OTHERWISE MADE AVAILABLE TO SANGAMO PURSUANT TO THE TERMS OF
THIS AGREEMENT. EXCEPT AS PROVIDED IN ARTICLE 11 ABOVE, SANGAMO EXPRESSLY DISCLAIMS ANY AND ALL
OTHER WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE WARRANTIES OF
DESIGN, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND
60.
NONINFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES WITH RESPECT TO ANY
RESEARCH RESULTS, ZFP PRODUCTS, DATA, OR INVENTIONS (AND ANY PATENT RIGHTS OBTAINED THEREON)
IDENTIFIED, MADE OR GENERATED BY SANGAMO AS PART OF THE RESEARCH PLAN COLLABORATION OR OTHERWISE
MADE AVAILABLE TO SIGMA PURSUANT TO THE TERMS OF THIS AGREEMENT.
ARTICLE 13
MISCELLANEOUS
13.1 Dispute Resolution. In the event of any controversy or claim arising out of, relating to
or in connection with any provision of this Agreement, other than a dispute addressed in Section
13.3, the Parties shall try to settle their differences amicably between themselves first, by
referring the disputed matter to the Senior Vice President of Business Development of Sangamo and
the President of the Research Biotech Unit of Sigma (or if either foregoing position does not exist
at such time, the closest successor in title to such position) (the Representatives) and, if not
resolved by such Representatives, by referring the disputed matter to the CEOs of the Parties or
their designees. In addition, the Parties shall endeavor to resolve disputes of a primarily
technical basis (for example, if technical milestones under Section 7.3 are payable) through formal
or informal dispute resolution involving technical experts. Either Party may initiate such
informal dispute resolution by sending written notice of the dispute to the other Party, and,
within twenty (20) days after such notice, the Representatives shall meet for attempted resolution
by good faith negotiations. If the Representatives are unable to resolve such dispute within
thirty (30) days of their first meeting for such negotiations, then the CEOs shall meet within
twenty (20) days thereafter for attempted resolution by good faith negotiations. If the CEOs are
unable to resolve such dispute within thirty (30) days of their first meeting for such
negotiations, either Party may seek to have such dispute resolved in any United States federal or
state court of competent jurisdiction and appropriate venue. To the extent permitted by law, the
Party that seeks such judicial resolution hereby consents to the other Partys forum of choice,
provided the choice is limited to California or Missouri.
61.
13.2 Governing Law. Resolution of all disputes arising out of or related to this Agreement or
the performance, enforcement, breach or termination of this Agreement and any remedies relating
thereto, shall be governed by and construed under the substantive laws of the State of Delaware,
without regard to conflicts of law rules that would cause the application of the laws of another
jurisdiction.
13.3 Patents and Trademarks. Any dispute, controversy or claim relating to the scope,
validity, enforceability or infringement of any patents or trademark rights shall be submitted to a
court of competent jurisdiction in the territory in which such patents or trademark rights were
granted or arose.
13.4 Entire Agreement; Amendment. This Agreement set forth the complete, final and exclusive
agreement and all the covenants, promises, agreements, warranties, representations, conditions and
understandings between the Parties hereto and supersedes and terminates all prior agreements and
understandings between the Parties. There are no covenants, promises, agreements, warranties,
representations, conditions or understandings, either oral or written, between the Parties other
than as are set forth herein and therein. No subsequent alteration, amendment, change or addition
to this Agreement shall be binding upon the Parties unless reduced to writing and signed by an
authorized officer of each Party.
13.5 Export Control. This Agreement is made subject to any restrictions concerning the export
of products or technical information from the United States of America or other countries which may
be imposed upon or related to Sangamo or Sigma from time to time. Each Party agrees that it will
not export, directly or indirectly, any technical information acquired from the other Party under
this Agreement or any products using such technical information to a location or in a manner that
at the time of export requires an export license or other governmental approval, without first
obtaining the written consent to do so from the appropriate agency or other governmental entity.
13.6 Bankruptcy
(a) All rights and licenses granted under or pursuant to this Agreement, including amendments
hereto, by each Party to the other Party are, for all purposes of
62.
Section 365(n) of Title 11 of the United States Code (Title 11), licenses of rights to
intellectual property as defined in Title 11. Each Party agrees during the term of this Agreement
to create and maintain current copies or, if not amenable to copying, detailed descriptions or
other appropriate embodiments, to the extent feasible, of all such intellectual property. If a
case is commenced by or against either Party (the Bankrupt Party) under Title 11, then, unless
and until this Agreement is rejected as provided in Title 11, the Bankrupt Party (in any capacity,
including debtor-in-possession) and its successors and assigns (including, without limitation, a
Title 11 Trustee) shall, at the election of the Bankrupt Party made within sixty (60) days after
the commencement of the case (or, if no such election is made, immediately upon the request of the
non-Bankrupt Party) either (i) perform all of the obligations provided in this Agreement to be
performed by the Bankrupt Party including, where applicable and without limitation, providing to
the non-Bankrupt Party portions of such intellectual property (including embodiments thereof) held
by the Bankrupt Party and such successors and assigns or otherwise available to them or (ii)
provide to the non-Bankrupt Party all such intellectual property (including all embodiments
thereof) held by the Bankrupt Party and such successors and assigns or otherwise available to them.
(b) If a Title 11 case is commenced by or against the Bankrupt Party and this Agreement is
rejected as provided in Title 11 and the non-Bankrupt Party elects to retain its rights hereunder
as provided in Title 11, then the Bankrupt Party (in any capacity, including debtor-in-possession)
and its successors and assigns (including, without limitations, a Title 11 Trustee) shall provide
to the non-Bankrupt Party all such intellectual property (including all embodiments thereof) held
by the Bankrupt Party and such successors and assigns or otherwise available to them immediately
upon the non-Bankrupt Partys written request therefor. Whenever the Bankrupt Party or any of its
successors or assigns provides to the non-Bankrupt Party any of the intellectual property licensed
hereunder (or any embodiment thereof) pursuant to this Section 13.6, the non-Bankrupt Party shall
have the right to perform the obligations of the Bankrupt Party hereunder with respect to such
intellectual property, but neither such provision nor such performance by the non-Bankrupt Party
shall release the Bankrupt Party from any such obligation or liability for failing to perform it.
(c) All rights, powers and remedies of the non-Bankrupt Party provided
63.
herein are in addition to and not in substitution for any and all other rights, powers and
remedies now or hereafter existing at law or in equity (including, without limitation, Title 11) in
the event of the commencement of a Title 11 case by or against the Bankrupt Party. The
non-Bankrupt Party, in addition to the rights, power and remedies expressly provided herein, shall
be entitled to exercise all other such rights and powers and resort to all other such remedies as
may now or hereafter exist at law or in equity (including, without limitation, under Title 11) in
such event. The Parties agree that they intend the foregoing non-Bankrupt Party rights to extend
to the maximum extent permitted by law and any provisions of applicable contracts with Third
Parties, including without limitation for purposes of Title 11, (i) the right of access to any
intellectual property (including all embodiments thereof) of the Bankrupt Party or any Third Party
with whom the Bankrupt Party contracts to perform an obligation of the Bankrupt Party under this
Agreement, and, in the case of the Third Party, which is necessary for the development,
registration and manufacture of Licensed Products and (ii) the right to contract directly with any
Third Party described in (i) in this sentence to complete the contracted work. Any intellectual
property provided pursuant to the provisions of this Section 13.6 shall be subject to the licenses
set forth elsewhere in this Agreement and the payment obligations of this Agreement, which shall be
deemed to be royalties for purposes of Title 11.
13.7 Force Majeure. Both Parties shall be excused from the performance of their obligations
under this Agreement to the extent that such performance is prevented by force majeure and the
nonperforming Party promptly provides notice of the prevention to the other Party. Such excuse
shall be continued so long as the condition constituting force majeure continues and the
nonperforming Party takes reasonable efforts to remove the condition. For purposes of this
Agreement, force majeure shall mean conditions beyond the control of the Parties, including
without limitation, an act of God, voluntary or involuntary compliance with any regulation, law or
order of any government, war, terrorism, civil commotion, labor strike or lock-out, epidemic,
failure or default of public utilities or common carriers, destruction of production facilities or
materials by fire, earthquake, storm or like catastrophe; provided, however, the payment of
invoices due and owing hereunder shall not be delayed by the payer because of a force majeure
affecting the payer.
13.8 Notices. Any notice required or permitted to be given under this Agreement shall
64.
be in writing, shall specifically refer to this Agreement and shall be deemed to have been
sufficiently given for all purposes if mailed by first class certified or registered mail, postage
prepaid, express delivery service or personally delivered. Unless otherwise specified in writing,
the mailing addresses of the Parties shall be as described below.
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For Sangamo:
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Sangamo BioSciences, Inc.
Point Richmond Tech Center
501 Canal Boulevard, Suite A100
Richmond, California 94804
Attention: Chief Executive Officer |
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With a copy to:
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Cooley Godward Kronish LLP
Five Palo Alto Square
3000 El Camino Real
Palo Alto, CA 94306
Attention: Marya A. Postner, Esq. |
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For Sigma:
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Sigma-Aldrich Corporation
3050 Spruce Street
St. Louis, Missouri 63103 Attention: General Counsel and Secretary |
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With a copy to:
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Sigma-Aldrich Corporation
3050 Spruce Street
St. Louis, Missouri 63103
Attention: President, Research Biotech Unit |
13.9 Maintenance of Records. Each Party shall keep and maintain all records required by law
or regulation with respect to Licensed Products and shall make copies of such records available to
the other Party upon request.
13.10 United States Dollars. References in this Agreement to dollars or $ shall mean the
legal tender of the United States of America.
13.11 No Strict Construction. This Agreement has been prepared jointly and shall not be
strictly construed against either Party. Ambiguities, if any, in this Agreement shall not be
construed against any Party, irrespective of which Party may be deemed to have authored the
ambiguous provision.
13.12 Assignment. Neither Party may assign or transfer this Agreement or any rights or
65.
obligations hereunder without the prior written consent of the other, except a Party may make
such an assignment without the other Partys consent to an Affiliate or to a Third Party successor
to substantially all of the business of such Party to which this Agreement relates, whether in a
merger, sale of stock, sale of assets or other transaction; provided that any such permitted
successor or assignee of rights and/or obligations hereunder is obligated, by reason of operation
of law or pursuant to a written agreement with the other Party, to assume performance of this
Agreement or such rights and/or obligations; and provided, further, that if assigned to an
Affiliate, the assigning Party shall remain jointly and severally responsible for the performance
of this Agreement by such Affiliate. Any permitted assignment shall be binding on the successors
of the assigning Party. Any assignment or attempted assignment by either Party in violation of the
terms of this Section 13.12 shall be null and void and of no legal effect.
13.13 Electronic Data Interchange. If both Parties elect to facilitate business activities
hereunder by electronically sending and receiving data in agreed formats (also referred to as
Electronic Data Interchange or EDI) in substitution for conventional paper-based documents, the
terms and conditions of this Agreement shall apply to such EDI activities.
13.14 Counterparts. This Agreement may be executed in two or more counterparts, each of which
shall be deemed an original, but all of which together shall constitute one and the same
instrument.
13.15 Further Actions. Each Party agrees to execute, acknowledge and deliver such further
instruments, and to do all such other acts, as may be necessary or appropriate in order to carry
out the purposes and intent of this Agreement.
13.16 Severability. If any one or more of the provisions of this Agreement is held to be
invalid or unenforceable by any court of competent jurisdiction from which no appeal can be or is
taken, the provision shall be considered severed from this Agreement and shall not serve to
invalidate any remaining provisions hereof. The Parties shall make a good faith effort to replace
any invalid or unenforceable provision with a valid and enforceable one such that the objectives
contemplated by the Parties when entering this Agreement may be realized.
13.17 Headings. The headings for each article and section in this Agreement have been
66.
inserted for convenience of reference only and are not intended to limit or expand on the
meaning of the language contained in the particular article or section.
13.18 No Waiver. Any delay in enforcing a Partys rights under this Agreement or any waiver
as to a particular default or other matter shall not constitute a waiver of such Partys rights to
the future enforcement of its rights under this Agreement, excepting only as to an express written
and signed waiver as to a particular matter for a particular period of time.
[Rest of Page Intentionally Left Blank]
67.
In Witness Whereof, the Parties have executed this License Agreement in duplicate
originals by their proper officers as of the date and year first above written.
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Sangamo BioSciences, Inc. |
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Sigma-Aldrich Co. |
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By:
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/s/ Edward O. Lanphier II
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By:
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/s/ David Smoller |
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Name:
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Edward O. Lanphier II
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Name:
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David Smoller |
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Title:
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President and Chief Executive Officer
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Title:
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President Research Biotechnology Business Unit |
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68.
Exhibit A
Sangamo Patents
[See following pages]
A-1.
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|
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Code |
|
Serial No. |
|
Filing date |
|
Title |
|
Status |
S1-US1 |
|
09/229,007 |
|
Jan. 12, 1999 |
|
Selection of Sites for ¼ |
|
US Patent No. 6,453,242 (Sept. 17, 2002) |
S1-US2 |
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09/825,242 |
|
Apr. 2, 2001 |
|
Selection of Sites for Targeting |
|
U.S. Patent No. 7,177,766 (February 13, 2007) |
S1-US3 |
|
10/113,424 |
|
Mar 28, 2002 |
|
¼ sites for targeting by
ZFPs |
|
US Patent No. 6,785,613 (Aug. 31, 2004) |
S1-US4 |
|
11/xxx,xxx |
|
Feb. 12, 2007 |
|
Selection of Sites for Targeting ¼ |
|
Pending |
S1-PCT |
|
US00/00388 |
|
Jan. 6, 2000 |
|
Selection of Sites for Targeting ¼ |
|
WO 00/42219 (National Phase) |
S1-AU |
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27220/00 |
|
Jan. 6, 2000 |
|
Selection of Sites for ¼ |
|
AU Patent No. 744171 (May 30, 2002) |
S1-CA |
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2,322,700 |
|
Jan. 6, 2000 |
|
Selection of Sites for Targeting ¼ |
|
Pending |
S1-EP1 |
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00 905 563.3 |
|
Jan. 6, 2000 |
|
Selection of Sites for Targeting |
|
EP1 075 540 (Sept. 10, 2003) |
S1-BE1 |
|
|
|
Jan. 6, 2000 |
|
Selection of Sites for Targeting |
|
European Patent No. 1 075 540 (Sept. 10, 2003) |
S1-CH1 |
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|
|
Jan. 6, 2000 |
|
Selection of Sites for Targeting |
|
European Patent No. 1 075 540 (Sept. 10, 2003) |
S1-DE1 |
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|
|
Jan. 6, 2000 |
|
Selection of Sites for Targeting |
|
European Patent No. 1 075 540 (Sept. 10, 2003) |
S1-FR1 |
|
|
|
Jan. 6, 2000 |
|
Selection of Sites for Targeting |
|
European Patent No. 1 075 540 (Sept. 10, 2003) |
S1-IE1 |
|
|
|
Jan. 6, 2000 |
|
Selection of Sites for Targeting |
|
European Patent No. 1 075 540 (Sept. 10, 2003) |
S1-EP2 |
|
03 015 798.6 |
|
Jan. 6, 2000 |
|
Selection of Sites for Targeting |
|
EP1 352 975 (Sept. 27, 2006) |
S1-BE2 |
|
|
|
Jan. 6, 2000 |
|
Selection of Sites for Targeting |
|
European Patent No 1 352 975 (Sept. 27, 2006) |
S1-CH2 |
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|
|
Jan. 6, 2000 |
|
Selection of Sites for Targeting |
|
European Patent No 1 352 975 (Sept. 27, 2006) |
S1-DE2 |
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|
|
Jan. 6, 2000 |
|
Selection of Sites for Targeting |
|
European Patent No 1 352 975 (Sept. 27, 2006) |
S1-FR2 |
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|
|
Jan. 6, 2000 |
|
Selection of Sites for Targeting |
|
European Patent No 1 352 975 (Sept. 27, 2006) |
S1-IE2 |
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|
|
Jan. 6, 2000 |
|
Selection of Sites for Targeting |
|
European Patent No 1 352 975 (Sept. 27, 2006) |
S1-GB1 |
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00 00651.0 |
|
Jan. 12, 2000 |
|
Selection of Sites for ¼ |
|
GB Patent No. 2 348 425 (Oct. 17, 2001) |
S1-GB2 |
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01 11280.4 |
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May 9, 2001 |
|
Selection of Sites for ¼ |
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GB Patent No. 2 360 285 (Feb. 27, 2002) |
A-2.
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|
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|
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Code |
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Serial No. |
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Filing date |
|
Title |
|
Status |
S1-JP1 |
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2000-593776 |
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Jan. 6, 2000 |
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Selection of Sites for Targeting ¼ |
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Pending |
S1-JP2 |
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2001-117552 |
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Jan. 6, 2000 |
|
Selection of Sites for Targeting ¼ |
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Pending |
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|
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|
|
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|
|
S2-US1 |
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09/229,037 |
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Jan. 12, 1999 |
|
Regulation of endogenous ¼ |
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US Patent No. 6,534,261 (March 18, 2003) |
S2-US2 |
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09/478,681 |
|
Jan. 6, 2000 |
|
¼ gene expression in cells ¼ |
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US Patent No. 6,607,882 (August 19, 2003) |
S2-US3 |
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09/706,243 |
|
Nov. 3, 2000 |
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using zinc finger proteins. |
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US Patent No. 6,824,978 (Nov. 30, 2004) |
S2-US4 |
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09/897,844 |
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July 2, 2001 |
|
¼ Regulation of endogenous ¼ |
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US Patent No. 6,979,539 (December 27, 2005) |
S2-US5 |
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09/942,087 |
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Aug 28, 2001 |
|
Mod of endog gene expr in cells |
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US Patent No. 6,933,113 (August 23, 2005) |
S2-US6 |
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10/222,614 |
|
Aug. 15, 2002 |
|
Cells Comprising ZFNs |
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US Patent No. 7,163,824 (January 16, 2007) |
S2-US7 |
|
10/245,415 |
|
Sep. 16, 2002 |
|
Regulation of endogenous ¼ |
|
US Patent No. 7,013,219 (March 14, 2006) |
S2-US8 |
|
10/845,384 |
|
May 13, 2004 |
|
Mod. of endog. gene expr. in cells |
|
Pending: ISSUE FEE paid January 11, 2007 |
S2-US9 |
|
10/984,304 |
|
Nov. 9, 2004 |
|
Regulation of endogenous gene ¼ |
|
Pending |
S2-US10 |
|
10/986,583 |
|
Nov. 12, 2004 |
|
Regulation of endogenous gene ¼ |
|
Pending |
S2-US11 |
|
11/148,794 |
|
June 8, 2005 |
|
Regulation of endogenous gene ¼ |
|
Pending |
S2-US12 |
|
11/505,044 |
|
Aug. 16, 2006 |
|
Regulation of endogenous gene ¼ |
|
Pending |
S2-US13 |
|
11/505,775 |
|
Aug. 17, 2006 |
|
Regulation of endogenous gene ¼ |
|
Pending |
S2-US14 |
|
11/521,291 |
|
Sept. 14, 2006 |
|
Regulation of endogenous gene ¼ |
|
Pending |
S2-US15 |
|
11/524,165 |
|
Sept. 20, 2006 |
|
Alteration of tumor growth
¼ |
|
Pending |
A-3.
|
|
|
|
|
|
|
|
|
Code |
|
Serial No. |
|
Filing Date |
|
Title |
|
Status |
S2-PCT |
|
US00/00409 |
|
Jan. 6, 2000 |
|
Regulation of endogenous gene ¼ |
|
WO 00/41566 (National Phase) |
S2-AU |
|
28470/00 |
|
Jan. 6, 2000 |
|
Regulation of endogenous ¼ |
|
AU Patent No. 745844 (July 25, 2002) |
S2-CA |
|
2,323,086 |
|
Jan. 6, 2000 |
|
Regulation of endogenous gene ¼ |
|
Pending |
S2-EP |
|
00 906 882.6 |
|
Jan. 6, 2000 |
|
Regulation of endogenous ¼ |
|
EP1 061 805 (Sept. 21, 2005) |
S2-AT |
|
|
|
Jan. 6, 2000 |
|
Regulation of endogenous ¼ |
|
European Patent No. 1 061 805 (Sept. 21, 2005) |
S2-BE |
|
|
|
Jan. 6, 2000 |
|
Regulation of endogenous ¼ |
|
European Patent No. 1 061 805 (Sept. 21, 2005) |
S2-CH |
|
|
|
Jan. 6, 2000 |
|
Regulation of endogenous ¼ |
|
European Patent No. 1 061 805 (Sept. 21, 2005) |
S2-CY |
|
|
|
Jan. 6, 2000 |
|
Regulation of endogenous ¼ |
|
European Patent No. 1 061 805 (Sept. 21, 2005) |
S2-DE1 |
|
|
|
Jan. 6, 2000 |
|
Regulation of endogenous ¼ |
|
European Patent No. 1 061 805 (Sept. 21, 2005) |
S2-DE2 |
|
|
|
Jan. 6, 2000 |
|
Regulation von endogenen Genen |
|
German Utility Model No. 200 23 745.4 |
S2-DK |
|
|
|
Jan. 6, 2000 |
|
Regulation of endogenous ¼ |
|
European Patent No. 1 061 805 (Sept. 21, 2005) |
S2-ES |
|
|
|
Jan. 6, 2000 |
|
Regulation of endogenous ¼ |
|
European Patent No. 1 061 805 (Sept. 21, 2005) |
S2-FI |
|
|
|
Jan. 6, 2000 |
|
Regulation of endogenous ¼ |
|
European Patent No. 1 061 805 (Sept. 21, 2005) |
S2-FR |
|
|
|
Jan. 6, 2000 |
|
Regulation of endogenous ¼ |
|
European Patent No. 1 061 805 (Sept. 21, 2005) |
S2-GR |
|
|
|
Jan. 6, 2000 |
|
Regulation of endogenous ¼ |
|
European Patent No. 1 061 805 (Sept. 21, 2005) |
S2-IE |
|
|
|
Jan. 6, 2000 |
|
Regulation of endogenous ¼ |
|
European Patent No. 1 061 805 (Sept. 21, 2005) |
S2-IT |
|
|
|
Jan. 6, 2000 |
|
Regulation of endogenous ¼ |
|
European Patent No. 1 061 805 (Sept. 21, 2005) |
S2-LU |
|
|
|
Jan. 6, 2000 |
|
Regulation of endogenous¼ |
|
European Patent No. 1 061 805 (Sept. 21, 2005) |
S2-MC |
|
|
|
Jan. 6, 2000 |
|
Regulation of endogenous ¼ |
|
European Patent No. 1 061 805 (Sept. 21, 2005) |
S2-NL |
|
|
|
Jan. 6, 2000 |
|
Regulation of endogenous¼ |
|
European Patent No. 1 061 805 (Sept. 21, 2005) |
S2-PT |
|
|
|
Jan. 6, 2000 |
|
Regulation of endogenous ¼ |
|
European Patent No. 1 061 805 (Sept. 21, 2005) |
A-4.
|
|
|
|
|
|
|
|
|
Code |
|
Serial No. |
|
Filing Date |
|
Title |
|
Status |
S2-SE |
|
|
|
Jan. 6, 2000 |
|
Regulation of endogenous ¼ |
|
European Patent No. 1 061 805 (Sept. 21, 2005) |
S2-GB |
|
0000650.2 |
|
Jan. 12, 2000 |
|
Regulation of endogenous ¼ |
|
GB Patent No. 2,348,424 (March 14, 2001) |
S2-JP1 |
|
2000-593186 |
|
Jan. 6, 2000 |
|
Regulation of endogenous gene ¼ |
|
Pending |
S2-JP2 |
|
2001-5820 |
|
Jan. 12, 2001 |
|
Regulation of endogenous gene ¼ |
|
Pending |
A-5.
|
|
|
|
|
|
|
|
|
Code |
|
Serial No. |
|
Filing Date |
|
Title |
|
Status |
S7-US1 |
|
09/395,448 |
|
Sep. 14, 1999 |
|
Functional Genomics ¼ |
|
US Patent No. 6,599,692 (July 29, 2003) |
S7-US2 |
|
09/925,796 |
|
Aug. 9, 2001 |
|
Functional Genomics ¼ |
|
US Patent No. 6,777,185 (August 17, 2004) |
S7-US3 |
|
09/941,450 |
|
Aug 28, 2001 |
|
Gene Identification ¼ |
|
US Patent No. 6,780,590 (August 24, 2004) |
S7-US5 |
|
10/843,944 |
|
May 12, 2004 |
|
Functional Genomics ¼ |
|
Pending |
S7-US6 |
|
10/922,546 |
|
Aug. 19, 2004 |
|
Meth. For Genome Annotation |
|
Pending |
S7-PCT1 |
|
US00/24897 |
|
Sept. 12, 2000 |
|
Functional Genomics ¼ |
|
WO 01/19981 (National Phase) |
S7-AU |
|
74787/00 |
|
Sept 12, 2000 |
|
Functional Genomics ¼ |
|
AU Patent No. 778964 (May 5, 2005) |
S7-CA |
|
2,383,926 |
|
Sept. 12, 2000 |
|
Functional Genomics ¼ |
|
Pending |
S7-EP |
|
00 963 362.9 |
|
Sep. 12, 2000 |
|
Funct. Genomics using ZFPs |
|
EP1 238 067 (Dec. 21, 2005) |
S7-BE |
|
|
|
Sep. 12, 2000 |
|
Funct. Genomics using ZFPs |
|
European Patent No. 1 238 067 (Dec. 21, 2005) |
S7-CH |
|
|
|
Sep. 12, 2000 |
|
Funct. Genomics using ZFPs |
|
European Patent No. 1 238 067 (Dec. 21, 2005) |
S7-DE |
|
|
|
Sep. 12, 2000 |
|
Funct. Genomics using ZFPs |
|
European Patent No. 1 238 067 (Dec. 21, 2005) |
S7-FR |
|
|
|
Sep. 12, 2000 |
|
Funct. Genomics using ZFPs |
|
European Patent No. 1 238 067 (Dec. 21, 2005) |
S7-GB |
|
|
|
Sep. 12, 2000 |
|
Funct. Genomics using ZFPs |
|
European Patent No. 1 238 067 (Dec. 21, 2005) |
S7-HK |
|
|
|
Sep. 12, 2000 |
|
Funct. Genomics using ZFPs |
|
European Patent No. 1 238 067 (Dec. 21, 2005) |
S7-IE |
|
|
|
Sep. 12, 2000 |
|
Funct. Genomics using ZFPs |
|
European Patent No. 1 238 067 (Dec. 21, 2005) |
S7-JP |
|
2001-523752 |
|
Sept. 12, 2000 |
|
Functional Genomics ¼ |
|
Pending |
S9-US2 |
|
09/731,558 |
|
Dec. 6, 2000 |
|
. . . Libraries of ZFPs for |
|
US Patent No. 6,503,717 (Jan. 7, 2003) |
S9-US3 |
|
10/337,216 |
|
Jan. 6, 2003 |
|
. . . the ID of gene function. |
|
Pending |
S9-US4 |
|
11/394,279 |
|
Mar. 29, 2006 |
|
Randomized Libraries of ZFPs |
|
Pending |
S9-US5 |
|
11/486,254 |
|
July 12, 2006 |
|
Randomized Libraries of ZFPs |
|
Pending |
S9-PCT |
|
US00/33086 |
|
Dec. 6, 2000 |
|
. . . the ID of Gene Function |
|
WO 01/40798 (National Phase) |
A-6.
|
|
|
|
|
|
|
|
|
Code |
|
Serial No. |
|
Filing Date |
|
Title |
|
Status |
S9-AU |
|
24278/01 |
|
Dec. 6, 2000 |
|
¼ Randomized Libraries¼ |
|
AU Patent No. 776576 (January 6, 2005) |
S9-CA |
|
2,394,850 |
|
Dec. 6, 2000 |
|
¼ Randomized Libraries ¼ |
|
Pending |
S9-EP |
|
00 988 019.6 |
|
Dec. 6, 2000 |
|
¼ Randomized Libraries ¼ |
|
EP1 236 045 (Nov. 9, 2005) |
S9-BE |
|
|
|
Dec. 6, 2000 |
|
¼ Randomized Libraries ¼ |
|
European Patent No. 1 236 045 (Nov. 9, 2005) |
S9-CH |
|
|
|
Dec. 6, 2000 |
|
¼ Randomized Libraries ¼ |
|
European Patent No. 1 236 045 (Nov. 9, 2005) |
S9-DE |
|
|
|
Dec. 6, 2000 |
|
¼ Randomized Libraries ¼ |
|
European Patent No. 1 236 045 (Nov. 9, 2005) |
S9-FR |
|
|
|
Dec. 6, 2000 |
|
¼ Randomized Libraries ¼ |
|
European Patent No. 1 236 045 (Nov. 9, 2005) |
S9-GB |
|
|
|
Dec. 6, 2000 |
|
¼ Randomized Libraries ¼ |
|
European Patent No. 1 236 045 (Nov. 9, 2005) |
S9-HK |
|
|
|
Dec. 6, 2000 |
|
¼ Randomized Libraries ¼ |
|
Hong Kong Patent No. 1 049 515 (Jan. 13,2006) |
S9-IE |
|
|
|
Dec. 6, 2000 |
|
¼ Randomized Libraries ¼ |
|
European Patent No. 1 236 045 (Nov. 9, 2005) |
S9-IL |
|
150069 |
|
Dec. 6, 2000 |
|
¼ Randomized Libraries ¼ |
|
Pending |
|
|
|
|
|
|
|
|
|
S10-US1 |
|
09/779,233 |
|
Feb. 8, 2001 |
|
Cells for Drug Discovery |
|
US Patent No. 6,689,558 (Feb. 10, 2004) |
S10-US2 |
|
10/412,109 |
|
Apr. 10, 2003 |
|
Cells for Drug Discovery |
|
US Patent No. 7,045,304 (May 16, 2006) |
S10-US3 |
|
10/412,105 |
|
Apr. 10, 2003 |
|
Cells for Drug Discovery |
|
US Patent No. 6,989,269 (January 24, 2006) |
S10-PCT |
|
US01/04301 |
|
Feb. 8, 2001 |
|
Cells for Drug Discovery |
|
WO 01/59450 (National Phase) |
S10-AU |
|
2001 250774 |
|
Feb. 8, 2001 |
|
Cells for Drug Discovery |
|
AU Patent No. 2001250774 (May 12, 2005) |
S10-CA |
|
2,398,590 |
|
Feb. 8, 2001 |
|
Cells for Drug Discovery |
|
Pending |
S10-EP |
|
01 924 089.4 |
|
Feb. 8, 2001 |
|
Cells for Drug Discovery |
|
Pending |
S10-JP1 |
|
2001-558729 |
|
Feb. 8, 2001 |
|
Cells for Drug Discovery |
|
Pending |
S10-JP2 |
|
2002-311841 |
|
Feb. 8, 2001 |
|
Cells for Drug Discovery |
|
Pending |
A-7.
|
|
|
|
|
|
|
|
|
Code |
|
Serial No. |
|
Filing Date |
|
Title |
|
Status |
S11-US3 |
|
09/990,186 |
|
Nov. 20, 2001 |
|
Position dep. recog. of GNN |
|
US Patent No. 7,030,215 (April 18, 2006) |
S11-US4 |
|
11/202,009 |
|
Aug. 11, 2005 |
|
Position dependent recog. of GNN |
|
Pending |
S11-US5 |
|
11/225,686 |
|
Sept. 12, 2005 |
|
Position dependent recog. of GNN |
|
Pending |
S11-PCT2 |
|
US01/43438 |
|
Nov. 20, 2001 |
|
Position dependent recog. of GNN |
|
WO 02/42459 (National Phase) |
S11-AU |
|
2002 239295 |
|
Nov. 20, 2001 |
|
Position dependent rec. of GNN |
|
AU Patent No. 2002 239295 (Sept. 21, 2006) |
S11-CA |
|
2,429,555 |
|
Nov. 20, 2001 |
|
Position dependent recog. of GNN |
|
Pending |
S11-EP |
|
01 987 037.7 |
|
Nov. 20, 2001 |
|
Position dep. recog. of GNN |
|
EP1 364 020 (Sept. 13, 2006) |
S11-BE |
|
|
|
Nov. 20, 2001 |
|
Position dep. recog. of GNN |
|
European Patent No. 1 364 020 (Sept. 13, 2006) |
S11-CH |
|
|
|
Nov. 20, 2001 |
|
Position dep. recog. of GNN |
|
European Patent No. 1 364 020 (Sept. 13, 2006) |
S11-DE |
|
|
|
Nov. 20, 2001 |
|
Position dep. recog. of GNN |
|
European Patent No. 1 364 020 (Sept. 13, 2006) |
S11-FR |
|
|
|
Nov. 20, 2001 |
|
Position dep. recog. of GNN |
|
European Patent No. 1 364 020 (Sept. 13, 2006) |
S11-GB |
|
|
|
Nov. 20, 2001 |
|
Position dep. recog. of GNN |
|
European Patent No. 1 364 020 (Sept. 13, 2006) |
S11-IE |
|
|
|
Nov. 20, 2001 |
|
Position dep. recog. of GNN |
|
European Patent No. 1 364 020 (Sept. 13, 2006) |
S11-HK |
|
|
|
Nov. 20, 2001 |
|
Position dep. recog. of GNN |
|
European Patent No. 1 364 020 (Sept. 13, 2006) |
|
|
|
|
|
|
|
|
|
S12-US1 |
|
09/844,662 |
|
Apr. 27, 2001 |
|
Methods for binding ¼ |
|
Pending |
S12-PCT |
|
US01/13631 |
|
Apr. 27, 2001 |
|
Methods for binding ¼ |
|
WO 01/83751 (National Phase) |
S12-AU |
|
2001 255748 |
|
Apr. 27, 2001 |
|
Methods for binding ¼ |
|
AU Patent No. 2001 255748 (Nov. 30, 2006) |
S12-CA |
|
2,407,695 |
|
Apr. 27, 2001 |
|
Methods for binding ¼ |
|
Pending |
S12-EP |
|
01 928 946.1 |
|
Apr. 27, 2001 |
|
Methods for binding ¼ |
|
Pending |
S12-JP |
|
2001-580358 |
|
Apr. 27, 2001 |
|
Methods for binding ¼ |
|
Pending |
A-8.
|
|
|
|
|
|
|
|
|
Code |
|
Serial No. |
|
Filing Date |
|
Title |
|
Status |
S14-US1 |
|
09/844,508 |
|
Apr. 27, 2001 |
|
Targeted modif. of chromatin ¼ |
|
US Patent No. 7,001,768 (Feb. 21, 2006) |
S14-US3 |
|
11/357,615 |
|
Feb. 16, 2006 |
|
Targeted modif. of chromatin ¼ |
|
Pending |
S14-PCT |
|
US01/40616 |
|
Apr. 27, 2001 |
|
Targeted modif. of chromatin ¼ |
|
WO 01/83793 (National Phase) |
S14-AU |
|
2001 253914 |
|
Apr. 27, 2001 |
|
Targeted modif. of chromatin ¼ |
|
AU Patent No. 2001 253914 (Sept. 21, 2006) |
S14-CA |
|
2,407,460 |
|
Apr. 27, 2001 |
|
Targeted modif. of chromatin ¼ |
|
Pending |
S14-EP |
|
01 927 467.9 |
|
Apr. 27, 2001 |
|
Targeted modif. of chromatin ¼ |
|
EP1 276 859 (Feb. 7, 2007) |
S14-BE |
|
|
|
Apr. 27, 2001 |
|
Targeted modif. of chromatin ¼ |
|
European Patent No. 1 276 859 (Feb. 7, 2007) |
S14-CH |
|
|
|
Apr. 27, 2001 |
|
Targeted modif. of chromatin ¼ |
|
European Patent No. 1 276 859 (Feb. 7, 2007) |
S14-DE |
|
|
|
Apr. 27, 2001 |
|
Targeted modif. of chromatin ¼ |
|
European Patent No. 1 276 859 (Feb. 7, 2007) |
S14-FR |
|
|
|
Apr. 27, 2001 |
|
Targeted modif. of chromatin ¼ |
|
European Patent No. 1 276 859 (Feb. 7, 2007) |
S14-GB |
|
|
|
Apr. 27, 2001 |
|
Targeted modif. of chromatin ¼ |
|
European Patent No. 1 276 859 (Feb. 7, 2007) |
S14-IE |
|
|
|
Apr. 27, 2001 |
|
Targeted modif. of chromatin ¼ |
|
European Patent No. 1 276 859 (Feb. 7, 2007) |
S16-US1 |
|
09/844,493 |
|
Apr. 27, 2001 |
|
Exogenous reg. molecule design |
|
US Patent No. 6,511,808 (Jan. 28, 2003) |
S19-US1 |
|
09/967,869 |
|
Sep. 28, 2001 |
|
Mod using ¼ localiz. domains |
|
US Patent No. 6,919,204 (July 19, 2005) |
S19-US2 |
|
11/045,828 |
|
Jan. 28, 2005 |
|
Mod using ¼ localiz. domains |
|
Pending |
|
|
|
|
|
|
|
|
|
S20-US |
|
09/716,637 |
|
Nov. 20, 2000 |
|
Iterative optimization ¼ |
|
US Patent No. 6,794,136 (Sept. 21, 2004) |
|
|
|
|
|
|
|
|
|
S21-PCT |
|
US01/44654 |
|
Nov. 28, 2001 |
|
¼ Insulator binding proteins |
|
WO 02/44376 (National Phase) |
S21-US |
|
10/446,901 |
|
Nov. 28, 2001 |
|
¼ Insulator binding proteins |
|
Pending |
A-9.
|
|
|
|
|
|
|
|
|
Code |
|
Serial No. |
|
Filing Date |
|
Title |
|
Status |
S25-US1 |
|
10/055,711 |
|
Jan. 22, 2002 |
|
Modified ZF binding proteins |
|
Pending |
S25-US2 |
|
11/486,158 |
|
July 13, 2006 |
|
Modified ZF binding proteins |
|
Pending |
S25-US3 |
|
11/485,946 |
|
July 13, 2006 |
|
Modified ZF binding proteins |
|
Pending |
S25-PCT |
|
US02/01893 |
|
Jan. 22, 2002 |
|
Modified ZF binding proteins |
|
WO 02/57293 (National Phase) |
S25-AU |
|
2002 241946 |
|
Jan. 22, 2002 |
|
Modified ZF binding proteins |
|
Pending |
S25-CA |
|
2,435,394 |
|
Jan. 22, 2002 |
|
Modified ZF binding proteins |
|
Pending |
S25-EP |
|
02 707 545.6 |
|
Jan. 22, 2002 |
|
Modified ZF binding proteins |
|
Pending |
S26-US1 |
|
10/055,713 |
|
Jan 22, 2002 |
|
ZFP for DB and gene reg in plants |
|
Pending |
S26-PCT |
|
US02/01906 |
|
Jan. 22, 2002 |
|
ZFP for DB and gene reg in plants |
|
WO 02/57294 (National Phase) |
S26-US2 |
|
10/470,180 |
|
Jan. 22, 2002 |
|
ZFP for DB and gene reg in plants |
|
Pending: ISSUE FEE paid March 21, 2007 |
S26-US3 |
|
11/511,106 |
|
Aug. 28, 2006 |
|
ZFP for DB and gene reg in plants |
|
Pending |
S26-US4 |
|
11/583,967 |
|
Oct. 19, 2006 |
|
ZFP for DB and gene reg in plants |
|
Pending |
|
|
|
|
|
|
|
|
|
S27-PCT |
|
US02/30413 |
|
Sept. 24, 2002 |
|
Mod. of stem cells using ZFPs |
|
WO 03/027247 (National Phase) |
S27-AU |
|
2002 330097 |
|
Sept. 24, 2002 |
|
Mod. of stem cells using ZFPs |
|
Pending |
S27-CA |
|
2,461,290 |
|
Sept. 24, 2002 |
|
Mod. of stem cells using ZFPs |
|
Pending |
S27-EP |
|
02 766 356.6 |
|
Sept. 24, 2002 |
|
Mod. of stem cells using ZFPs |
|
Pending |
S27-US |
|
10/490,787 |
|
Sept. 24, 2002 |
|
Mod. of stem cells using ZFPs |
|
Pending |
|
|
|
|
|
|
|
|
|
S28-US |
|
10/387,320 |
|
Mar. 11, 2003 |
|
Rapid ID of tx. reg. domains |
|
Pending |
|
|
|
|
|
|
|
|
|
S30-US1 |
|
10/456,444 |
|
June 5, 2003 |
|
Ligand-contr. reg. of endog ¼ |
|
US Patent No. 7,070,934 (July 4, 2006) |
A-10.
|
|
|
|
|
|
|
|
|
Code |
|
Serial No. |
|
Filing Date |
|
Title |
|
Status |
S32-US |
|
10/651,761 |
|
Aug. 29, 2003 |
|
Simultaneous mod. of mult. genes |
|
Pending |
|
|
|
|
|
|
|
|
|
S36-US1 |
|
10/912,932 |
|
Aug. 6, 2004 |
|
Meth & comp for targ cl & recomb |
|
Pending |
S36-US2 |
|
11/304,981 |
|
Dec. 15, 2005 |
|
Targ. Del. of Cellular DNA Seqs. |
|
Pending |
S36-PCT1 |
|
US04/25407 |
|
Aug. 6, 2004 |
|
Meth & comp for targ cl & recomb |
|
WO 2005/014791 (National Phase) |
S36-AU1 |
|
2004 263865 |
|
Aug. 6, 2004 |
|
Meth & comp for targ cl & recomb |
|
Pending |
S36-AU3 |
|
|
|
Aug. 6, 2004 |
|
Meth & comp for targ cl & recomb |
|
Pending |
S36-CA1 |
|
2,534,296 |
|
Aug. 6, 2004 |
|
Meth & comp for targ cl & recomb |
|
Pending |
S36-EP1 |
|
04 780 272.3 |
|
Aug. 6, 2004 |
|
Meth & comp for targ cl & recomb |
|
Pending |
S36-IL1 |
|
173460 |
|
Aug. 6, 2004 |
|
Meth & comp for targ cl & recomb |
|
Pending |
S36-JP1 |
|
2006-523239 |
|
Aug. 6, 2004 |
|
Meth & comp for targ cl & recomb |
|
Pending |
S36-KR1 |
|
2006-7002703 |
|
Aug. 6, 2004 |
|
Meth & comp for targ cl & recomb |
|
Pending |
S36-SG1 |
|
2006 00748-8 |
|
Aug. 6, 2004 |
|
Meth & comp for targ cl & recomb |
|
Pending |
S36-PCT2 |
|
US05/03245 |
|
Feb. 3, 2005 |
|
Meth & comp for targ cl & recomb |
|
WO 2005/084190 (National Phase) |
S36-AU2 |
|
2005 220148 |
|
Feb. 3, 2005 |
|
Meth & comp for targ cl & recomb |
|
Pending |
S36-CA2 |
|
2,554,966 |
|
Feb. 3, 2005 |
|
Meth & comp for targ cl & recomb |
|
Pending |
S36-EP2 |
|
05 756 438.7 |
|
Feb. 3, 2005 |
|
Meth & comp for targ cl & recomb |
|
Pending |
S36-US3 |
|
10/587,723 |
|
Feb. 3, 2005 |
|
Meth & comp for targ cl & recomb |
|
Pending |
A-11.
|
|
|
|
|
|
|
|
|
Code |
|
Serial No. |
|
Filing date |
|
Title |
|
Status |
S38-PCT |
|
US04/30606 |
|
Sept. 17, 2004 |
|
Eng. ZFPs for reg. of gene expr. |
|
WO 05/28630 (National Phase) |
S38-AU |
|
2004 274957 |
|
Sept. 17, 2004 |
|
Eng. ZFPs for reg. of gene expr. |
|
Pending |
S38-CA |
|
2,539,439 |
|
Sept. 17, 2004 |
|
Eng. ZFPs for reg. of gene expr. |
|
Pending |
S38-EP |
|
04 784 464.2 |
|
Sept. 17, 2004 |
|
Eng. ZFPs for reg. of gene expr. |
|
Pending |
S38-US |
|
10/572,886 |
|
Sept. 17, 2004 |
|
Eng. ZFPs for reg. of gene expr. |
|
Pending |
|
|
|
|
|
|
|
|
|
S43-US1 |
|
11/221,683 |
|
Sept. 8, 2005 |
|
C & M for Protein Production |
|
Pending |
S43-PCT |
|
US05/32157 |
|
Sept. 8, 2005 |
|
C & M for Protein Production |
|
WO 2006/033859 (National Phase) |
S43-AU |
|
2005 287278 |
|
Sept. 8, 2005 |
|
C & M for Protein Production |
|
Pending |
S43-CA |
|
|
|
Sept. 8, 2005 |
|
C & M for Protein Production |
|
Pending |
S43-CN |
|
|
|
Sept. 8, 2005 |
|
C & M for Protein Production |
|
Pending |
S43-EP |
|
|
|
Sept. 8, 2005 |
|
C & M for Protein Production |
|
Pending |
S43-IN |
|
|
|
Sept. 8, 2005 |
|
C & M for Protein Production |
|
Pending |
S43-KR |
|
|
|
Sept. 8, 2005 |
|
C & M for Protein Production |
|
Pending |
S43-SG |
|
|
|
Sept. 8, 2005 |
|
C & M for Protein Production |
|
Pending |
|
|
|
|
|
|
|
|
|
S46-US1 |
|
11/493,423 |
|
July 26, 2006 |
|
Targ Int & Exp Of Exog NA Seqs |
|
Pending |
S46-PCT |
|
US06/029027 |
|
July 26, 2006 |
|
Targ Int & Exp Of Exog NA Seqs |
|
Pending |
|
|
|
|
|
|
|
|
|
[***] |
|
[***] |
|
[***] |
|
[***] |
|
[***] |
|
|
|
|
|
|
|
|
|
[***] |
|
[***] |
|
[***] |
|
[***] |
|
[***] |
|
|
|
*** |
|
CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION |
A-12.
|
|
|
|
|
|
|
|
|
Code |
|
Serial No. |
|
Filing date |
|
Title |
|
Status |
G1-PCT |
|
GB95/01949 |
|
Aug 17, 1995 |
|
Improvements in ¼ |
|
WO 96/06166 (National Phase) |
G1-AU1 |
|
32291/95 |
|
Aug. 17, 1995 |
|
Improvements in ¼ |
|
AU Patent No. 698152 (Feb. 4, 1999) |
G1-AU2 |
|
10037/99 |
|
(Jan. 6, 1999) |
|
Improvements in ¼ |
|
AU Patent No. 726759 (March 8, 2001) |
G1-CA |
|
2,196,419 |
|
Aug. 17, 1995 |
|
Improvements in ¼ |
|
Pending |
G1-EP |
|
95928576.8 |
|
Aug. 17, 1995 |
|
Improvements in ¼ |
|
Pending |
G1-JP |
|
507857/1996 |
|
Aug. 17, 1995 |
|
Improvements in ¼ |
|
Pending |
G1-US1 |
|
08/793,408 |
|
Aug. 17, 1995 |
|
Relating to binding proteins ¼ |
|
US Patent No. 6,007,988 (Dec. 28, 1999) REISS. |
G1-US2 |
|
09/139,762 |
|
Aug. 25, 1998 |
|
Binding prots. for recog. of DNA |
|
US Patent No. 6,013,453 (Jan. 11, 2000) |
G1-US3 |
|
10/033,129 |
|
Dec. 27, 2001 |
|
Relating to Binding proteins ¼ |
|
US Patent No. RE 39,229 (Aug. 8, 2006) |
G1-US4 |
|
10/309,578 |
|
Dec. 3, 2002 |
|
Design of binding proteins ¼ |
|
Pending Reissue |
G1-US5 |
|
10/397,930 |
|
Mar. 25, 2003 |
|
Relating to Binding proteins ¼ |
|
Pending Reissue |
G1-US6 |
|
10/400,017 |
|
Mar. 25, 2003 |
|
Relating to Binding proteins ¼ |
|
Pending Reissue |
G1-US7 |
|
11/500,162 |
|
Aug. 7, 2006 |
|
Binding Prots. for Recog. of DNA. |
|
Pending Reissue |
A-13.
|
|
|
|
|
|
|
|
|
Code |
|
Serial No. |
|
Filing date |
|
Title |
|
Status |
G2-PCT |
|
GB98/01510 |
|
May 26, 1998 |
|
NA binding polypeptide library |
|
WO 98/53057 (National Phase) |
G2-AU |
|
75422/98 |
|
May 26, 1998 |
|
NA binding polypeptide library |
|
AU Patent No. 737756 (Dec. 13, 2001) |
G2-CA |
|
2,290,720 |
|
May 26, 1998 |
|
NA binding polypeptide library |
|
Pending |
G2-EP |
|
98922963.8 |
|
May 26, 1998 |
|
NA binding polypeptide library |
|
Pending |
G2-JP |
|
10-550153 |
|
May 26, 1998 |
|
NA binding polypeptide library |
|
Pending |
G2-US1 |
|
09/424,482 |
|
May 26, 1998 |
|
NA binding polypeptide library |
|
Pending |
G2-US2 |
|
11/514,850 |
|
Aug. 31, 2006 |
|
NA binding polypeptide library |
|
Pending |
G2-US3 |
|
11/514,671 |
|
Sept 1, 2006 |
|
NA binding polypeptide library |
|
Pending |
|
|
|
|
|
|
|
|
|
G3-PCT |
|
GB98/01512 |
|
May 26, 1998 |
|
Nucleic Acid Binding Proteins |
|
WO 98/53058 (National Phase) |
G3-CA |
|
2,290,717 |
|
May 26, 1998 |
|
Nucleic Acid Binding Proteins |
|
Pending |
G3-EP |
|
98922964.6 |
|
May 26, 1998 |
|
Nucleic Acid Binding Proteins |
|
Pending: Grant fees paid and translations filed |
G3-US1 |
|
09/424,487 |
|
May 26, 1998 |
|
Nucleic Acid Binding Proteins |
|
US Patent No. 6,746,838 (June 8, 2004) |
G3-US2 |
|
10/832,735 |
|
April 26, 2004 |
|
Nucleic Acid Binding Proteins |
|
Pending: ISSUE FEE paid April 10, 2007 |
G3-US3 |
|
11/486,962 |
|
July 14, 2006 |
|
Nucleic Acid Binding Proteins |
|
Pending |
A-14.
|
|
|
|
|
|
|
|
|
Code |
|
Serial No. |
|
Filing date |
|
Title |
|
Status |
G4-PCT |
|
GB98/01516 |
|
May 26, 1998 |
|
Nucleic Acid Binding Proteins |
|
WO 98/53060 (National Phase) |
G4-AU |
|
75426/98 |
|
May 26, 1998 |
|
Nucleic Acid Binding Proteins |
|
AU Patent No. 732017 (Jul. 26, 2001) |
G4-CA |
|
2,290,886 |
|
May 26, 1998 |
|
Nucleic Acid Binding Proteins |
|
Pending |
G4-EP |
|
98922967.9 |
|
May 26, 1998 |
|
Nucleic Acid Binding Proteins |
|
Pending: Grant fees paid and translations filed |
G4-JP |
|
10-550158 |
|
May 26, 1998 |
|
Nucleic Acid Binding Proteins |
|
Pending |
G4-US1 |
|
09/424,488 |
|
May 26, 1998 |
|
Nucleic Acid Binding Proteins |
|
US Patent No. 6,866,997 (March 15, 2005) |
G4-US2 |
|
10/853,437 |
|
May 24, 2004 |
|
Nucleic Acid Binding Proteins |
|
Pending: ISSUE FEE paid April 10, 2007 |
G4-US3 |
|
11/515,369 |
|
Aug. 31, 2006 |
|
Nucleic Acid Binding Proteins |
|
Pending |
G5-PCT |
|
GB99/00816 |
|
Mar. 17, 1999 |
|
Nucleic Acid Binding Proteins |
|
WO 99/47656 (National Phase) |
G5-AU |
|
29449/99 |
|
Mar. 17, 1999 |
|
Nucleic Acid Binding Proteins |
|
AU Patent No. 751487 (November 28, 2002) |
G5-CA |
|
2,323,064 |
|
Mar. 17, 1999 |
|
Nucleic Acid Binding Proteins |
|
Pending |
G5-EP |
|
99910512.5 |
|
Mar. 17, 1999 |
|
Nucleic Acid Binding Proteins |
|
EP1 064 369 (August 16, 2006) |
G5-GB |
|
|
|
Mar. 17, 1999 |
|
Nucleic Acid Binding Proteins |
|
European Patent No. 1 064 369 (Aug. 16, 2006) |
G5-IE |
|
|
|
Mar. 17, 1999 |
|
Nucleic Acid Binding Proteins |
|
European Patent No. 1 064 369 (Aug. 16, 2006) |
G5-LU |
|
|
|
Mar. 17, 1999 |
|
Nucleic Acid Binding Proteins |
|
European Patent No. 1 064 369 (Aug. 16, 2006) |
G5-MC |
|
|
|
Mar. 17, 1999 |
|
Nucleic Acid Binding Proteins |
|
European Patent No. 1 064 369 (Aug. 16, 2006) |
G5-NZ |
|
506987 |
|
Mar. 17, 1999 |
|
Nucleic Acid Binding Proteins |
|
NZ Patent No. 506987 (May 12, 2003) |
G5-US |
|
09/646,353 |
|
Mar. 17, 1999 |
|
Nucleic Acid Binding Proteins |
|
US Patent No. 6,977,154 (Dec. 20, 2005) |
A-15.
|
|
|
|
|
|
|
|
|
Code |
|
Serial No. |
|
Filing date |
|
Title |
|
Status |
G6-PCT |
|
GB99/03730 |
|
Nov. 9, 1999 |
|
Screening system for ZFPs ¼ |
|
WO 00/27878 (National Phase) |
G6-AU |
|
10613/00 |
|
Nov. 9, 1999 |
|
Screening system for ZFPs ¼ |
|
AU Patent No. 766572 (January 29, 2004) |
G6-NZ |
|
511564 |
|
Nov. 9, 1999 |
|
Screening system for ZFPs ¼ |
|
NZ Pat. No. 511564 (Feb. 3, 2003) |
G6-US |
|
09/851,271 |
|
Nov. 9, 1999 |
|
Screening system for ZFPs ¼ |
|
US Patent No. 6,733,970 (May 11, 2004) |
|
|
|
|
|
|
|
|
|
G7-PCT |
|
GB00/02071 |
|
May 30, 2000 |
|
Gene Switches |
|
WO 00/73434 (National Phase) |
G7-US |
|
09/995,973 |
|
(Nov 28, 2001) |
|
Gene Switches |
|
US Patent No. 6,706,470 (March 16, 2004) |
|
|
|
|
|
|
|
|
|
G8-PCT |
|
GB00/02080 |
|
May 30, 2000 |
|
Molecular Switches |
|
WO 01/00815 (National Phase) |
G8-AU1 |
|
50906/00 |
|
May 30, 2000 |
|
Molecular Switches |
|
AU Patent No. 778150 (April 14, 2005) |
G8-AU2 |
|
2005 200548 |
|
Feb. 9, 2005 |
|
Molecular Switches |
|
Pending |
G8-CA |
|
2,369,855 |
|
May 30, 2000 |
|
Molecular Switches |
|
Pending |
G8-US |
|
09/996,484 |
|
(Nov 28, 2001) |
|
Molecular Switches |
|
Pending |
A-16.
|
|
|
|
|
|
|
|
|
Code |
|
Serial No. |
|
Filing date |
|
Title |
|
Status |
G11-PCT |
|
GB01/00202 |
|
Jan. 19, 2001 |
|
NA Bind Polyp Char by Flex. Links |
|
WO 01/53480 (National Phase) |
G11-AU |
|
2001 226935 |
|
Jan. 19, 2001 |
|
Nucleic Acid Binding Polypeps. |
|
AU Patent No. 2001 226935 (Oct. 5, 2006) |
G11-CA |
|
2,398,155 |
|
Jan. 19, 2001 |
|
Nucleic Acid Binding Polypeptides |
|
Pending |
G11-EP |
|
01 901 276.4 |
|
Jan. 19, 2001 |
|
Nucleic Acid Binding Polypeps. |
|
EP 1 250 424 (February 28, 2007) |
G11-BE |
|
|
|
Jan. 19, 2001 |
|
NABPs Char by Flexible Linkers |
|
European Patent No. 1 250 424 (Feb. 28, 2007) |
G11-CH |
|
|
|
Jan. 19, 2001 |
|
NABPs Char by Flexible Linkers |
|
European Patent No. 1 250 424 (Feb. 28, 2007) |
G11-DE |
|
|
|
Jan. 19, 2001 |
|
NABPs Char by Flexible Linkers |
|
European Patent No. 1 250 424 (Feb. 28, 2007) |
G11-FR |
|
|
|
Jan. 19, 2001 |
|
NABPs Char by Flexible Linkers |
|
European Patent No. 1 250 424 (Feb. 28, 2007) |
G11-GB |
|
|
|
Jan. 19, 2001 |
|
NABPs Char by Flexible Linkers |
|
European Patent No. 1 250 424 (Feb. 28, 2007) |
G11-IE |
|
|
|
Jan. 19, 2001 |
|
NABPs Char by Flexible Linkers |
|
European Patent No. 1 250 424 (Feb. 28, 2007) |
G11-HK |
|
|
|
Jan. 19, 2001 |
|
NABPs Char by Flexible Linkers |
|
European Patent No. 1 250 424 (Feb. 28, 2007) |
G11-US |
|
10/198,677 |
|
Jan. 19, 2001 |
|
Nucleic Acid Binding Polypeptides |
|
Pending |
|
|
|
|
|
|
|
|
|
G19-PCT |
|
GB02/00246 |
|
Jan. 22, 2002 |
|
Nucleic Acid Binding Polypeptides |
|
WO 02/057308 (National Phase) |
G19-US |
|
10/470,065 |
|
Jan. 22, 2002 |
|
Modulation of HIV infection ¼ |
|
Pending |
G22-PCT |
|
US02/09703 |
|
Mar. 28, 2002 |
|
Gene Regulation II |
|
WO 02/079418 (National Phase) |
G22-US |
|
10/473,238 |
|
Mar. 28, 2002 |
|
Targ. gene reg. in transgenics |
|
Pending |
|
|
|
|
|
|
|
|
|
G23-PCT |
|
US02/22272 |
|
Apr. 4, 2002 |
|
Composite Binding Polypeptides |
|
WO 02/099084 (National Phase) |
G23-US |
|
10/474,282 |
|
Apr. 4, 2002 |
|
Composite Binding Polypeptides |
|
Pending |
A-17.
|
|
|
|
|
|
|
|
|
Code |
|
Serial No. |
|
Filing date |
|
Title |
|
Status |
L3-US1 |
|
10/395,816 |
|
Mar. 20, 2003 |
|
¼ for Using ZF Endonucleases |
|
Pending |
L3-PCT |
|
US03/09081 |
|
Mar. 20, 2003 |
|
¼ to Enhance Homol. Recomb. |
|
WO 03/80809 (National Phase) |
L3-AU1 |
|
2003 218382 |
|
Mar. 20, 2003 |
|
Methods and Compositions ¼ |
|
Pending |
L3-AU2 |
|
|
|
Mar. 20, 2003 |
|
Methods and Compositions ¼ |
|
Pending |
L3-CA |
|
2,479,858 |
|
Mar. 20, 2003 |
|
¼ for Using ZF Endonucleases ¼ |
|
Pending |
L3-EP |
|
03 714 379.9 |
|
Mar. 20, 2003 |
|
¼ to Enhance Homol. Recomb. |
|
Pending |
A-18.
Licensed from Massachusetts Institute of Technology
|
|
|
|
|
|
|
|
|
Code |
|
Serial No. |
|
Filing Date |
|
Title |
|
Status |
M1-US2 |
|
08/850,250 |
|
Apr. 18, 1997 |
|
ZFPs with high affinity new ¼ |
|
U.S. Patent No. 5,789,538 (Aug. 4, 1998) |
|
|
|
|
|
|
|
|
|
M2-US3 |
|
09/240,179 |
|
Jan. 29, 1999 |
|
General Strategy ¼ |
|
U.S. Patent No. 6,410,248 (June 25, 2002) |
|
|
|
|
|
|
|
|
|
M3-US1 |
|
09/260,629 |
|
Mar. 1, 1999 |
|
Poly-Zinc Finger Proteins ¼ |
|
U.S. Patent No. 6,479,626 (Nov. 12, 2002) |
M3-US2 |
|
10/146,221 |
|
May 13, 2002 |
|
Poly-Zinc Finger Proteins ¼ |
|
U.S. Patent No. 6,903,185 (June 7, 2005) |
M3-US3 |
|
11/110,594 |
|
April 20, 2005 |
|
NA Encoding Poly-ZFPs ¼ |
|
U.S. Patent No. 7,153,949 (Dec. 26, 2006) |
M3-US4 |
|
11/639,363 |
|
Dec. 14, 2006 |
|
Poly-Zinc Finger Proteins ¼ |
|
Pending |
M3-PCT |
|
US99/04441 |
|
Mar. 1, 1999 |
|
Poly-Zinc Finger Proteins ¼ |
|
WO 99/45132 (National Phase) |
M3-AU |
|
28849/99 |
|
Mar. 1, 1999 |
|
Poly-Zinc Finger Proteins ¼ |
|
AU Patent No. 746454 (August 15, 2002) |
M3-CA |
|
2,321,938 |
|
Mar. 1, 1999 |
|
Poly-Zinc Finger Proteins ¼ |
|
Pending |
M3-EP |
|
99909701.7 |
|
Mar. 1, 1999 |
|
Poly-Zinc Finger Proteins ¼ |
|
Pending |
M3-JP |
|
2000-534663 |
|
Mar. 1, 1999 |
|
Poly-Zinc Finger Proteins ¼ |
|
Pending |
|
|
|
|
|
|
|
|
|
M4-US1 |
|
09/636,243 |
|
Aug. 10, 2000 |
|
Dimerizing Peptides |
|
Pending |
A-19.
Licensed from the Scripps Research Institute
|
|
|
|
|
|
|
|
|
Code |
|
Serial No. |
|
Filing Date |
|
Title |
|
Status |
T1-US3 |
|
08/676,318 |
|
Jan. 18, 1995 |
|
Zinc finger protein derivatives¼ |
|
U.S. Patent No. 6,242,568 (June 5, 2001) |
T1-US4 |
|
08/863,813 |
|
May 27, 1997 |
|
Zinc finger protein derivatives¼ |
|
U.S. Patent No. 6,140,466 (Oct. 31, 2000) |
T1-US6 |
|
09/500,700 |
|
Feb. 9, 2000 |
|
Zinc finger protein derivatives¼ |
|
U.S. Patent No. 6,790,941 (Sept. 14, 2004) |
T1-PCT1 |
|
US95/00829 |
|
Jan. 18, 1995 |
|
Zinc finger protein derivatives¼ |
|
WO 95/19431 (National Phase) |
T1-AU1 |
|
16865/95 |
|
Jan. 18, 1995 |
|
Zinc finger protein derivatives¼ |
|
AU Patent No. 704601 (April 29, 1999) |
T1-CA1 |
|
2,181,548 |
|
Jan. 18, 1995 |
|
Zinc finger protein derivatives¼ |
|
Pending |
T1-EP1 |
|
95 908 614.1 |
|
Jan. 18, 1995 |
|
Zinc finger protein derivatives¼ |
|
EP 0 770 129 (Nov. 23, 2005) |
T1-FR1 |
|
95 908 614.1 |
|
Jan. 18, 1995 |
|
Zinc finger protein derivatives¼ |
|
European Patent No. 0 770 129 (Nov. 23, 2005) |
T1-GB1 |
|
95 908 614.1 |
|
Jan. 18, 1995 |
|
Zinc finger protein derivatives¼ |
|
European Patent No. 0 770 129 (Nov. 23, 2005) |
T1-FI |
|
962879 |
|
Jan. 18, 1995 |
|
Zinc finger protein derivatives¼ |
|
Pending |
T1-JP1 |
|
07-519231 |
|
Jan. 18, 1995 |
|
Zinc finger protein derivatives¼ |
|
Pending |
T1-NO |
|
1996 2991 |
|
Jan. 18, 1995 |
|
Zinc finger protein derivatives¼ |
|
Pending |
|
|
|
|
|
|
|
|
|
T1-PCT2 |
|
US98/10801 |
|
May 27, 1998 |
|
Zinc finger protein derivatives¼ |
|
WO 98/54311 (National Phase) |
T1-AU3 |
|
2002 300619 |
|
May 27, 1998 |
|
Zinc finger protein derivatives¼ |
|
Pending |
T1-CA2 |
|
2,291,861 |
|
May 27, 1998 |
|
Zinc finger protein derivatives¼ |
|
Pending |
T1-EP2 |
|
98 926 088.0 |
|
May 27, 1998 |
|
Zinc finger protein derivatives¼ |
|
Pending |
T1-JP2 |
|
11-500870 |
|
May 27, 1998 |
|
Zinc finger protein derivatives¼ |
|
Pending |
A-20.
Licensed from the Johns Hopkins University
|
|
|
|
|
|
|
|
|
Code |
|
Serial No. |
|
Filing Date |
|
Title |
|
Status |
J1-US1 |
|
07/862,831 |
|
Apr. 3, 1992 |
|
Functional domains in FokI¼ |
|
US Patent No. 5,356,802 (Oct. 18, 1994) |
J1-US3 |
|
08/126,564 |
|
Sept. 27, 1993 |
|
Functional domains in FokI¼ |
|
US Patent No. 5,436,150 (July 25, 1995) CIP of 2 |
J1-US4 |
|
08/346,293 |
|
Nov. 23, 1994 |
|
Insertion & Deletion Mutants¼ |
|
US Patent No. 5,487,994 (Jan. 30, 1996) CIP of 3 |
J1-PCT1 |
|
US94/01201 |
|
Feb. 10, 1994 |
|
Functional domains in FokI¼ |
|
WO 94/18313 (National Phase) |
J1-CA1 |
|
2,154,581 |
|
Feb. 10, 1994 |
|
Functional domains in FokI¼ |
|
Pending |
J1-EP3 |
|
03 010009.3 |
|
Feb. 10, 1994 |
|
Functional domains in FokI¼ |
|
Pending |
J1-PCT2 |
|
US94/01943 |
|
Aug.23, 1994 |
|
Functional domains in FokI¼ |
|
WO 95/09233 (National Phase) |
J1-JP2 |
|
7-510290 |
|
Aug. 23, 1994 |
|
Functional domains in FokI¼ |
|
Pending |
J1-JP3 |
|
2006-143294 |
|
Aug. 23, 1994 |
|
Functional domains in FokI¼ |
|
Pending |
J2-US1 |
|
08/575,361 |
|
Dec. 20, 1995 |
|
General method to clone ¼ |
|
US Patent No. 5,792,640 (August
11, 1998) Re-examination No. 90/008,524 (Mar. 12, 2007) |
J3-US1 |
|
08/647,449 |
|
May 7, 1996 |
|
Meth for inactivating target DNA |
|
US Patent No. 5,916,794 (Jun. 29, 1999) |
J3-US2 |
|
09/281,792 |
|
Mar. 31, 1999 |
|
Meth for inactivating target DNA |
|
US Patent No. 6,265,196 (Jul.
24, 2001) Re-examination No. 90/008,526 |
A-21.
Licensed from California Institute of Technology
|
|
|
|
|
|
|
|
|
Code |
|
Serial No. |
|
Filing date |
|
Title |
|
Status |
C1-US1 |
|
10/656,531 |
|
Sept. 5, 2003 |
|
Use of chimeric nucleases¼ |
|
Pending |
C1-PCT |
|
US03/27958 |
|
Sept. 5, 2003 |
|
. . . to stimulate gene targeting |
|
WO 2004/037977 (National Phase) |
C1-AU |
|
2003 298574 |
|
Sept. 5, 2003 |
|
Use of ¼ |
|
Pending |
C1-CA |
|
2,497,913 |
|
Sept. 5, 2003 |
|
. . . chimeric nucleases ¼ |
|
Pending |
C1-EP |
|
03 796 324.6 |
|
Sept. 5, 2003 |
|
. . . to stimulate ¼ |
|
Pending |
C1-JP |
|
2005-501601 |
|
Sept. 5, 2003 |
|
. . . gene targeting. |
|
Pending |
A-22.
Licensed from University of Utah Research Foundation
|
|
|
|
|
|
|
|
|
Code |
|
Serial No. |
|
Filing date |
|
Title |
|
Status |
U1-PCT |
|
US03/02012 |
|
Jan. 22, 2003 |
|
¼ using zinc finger nucleases |
|
WO 03/87341 (National Phase) |
U1-AU |
|
2003 251286 |
|
Jan. 22, 2003 |
|
Targeted chromosomal mutagenesis¼ |
|
Pending |
U1-CA |
|
2,474,486 |
|
Jan. 22, 2003 |
|
Targeted chromosomal mutagenesis¼ |
|
Pending |
U1-EP |
|
03 746 527.5 |
|
Jan. 22, 2003 |
|
Targeted chrom. mutagenesis¼
.. |
|
EP1 476 547 (Dec. 6, 2006) |
U1-BE |
|
|
|
|
|
Targeted chrom. mutagenesis¼
.. |
|
European Patent No. 1 476 547 (Dec. 6, 2006) |
U1-CH |
|
|
|
|
|
Targeted chrom. mutagenesis¼
.. |
|
European Patent No. 1 476 547 (Dec. 6, 2006) |
U1-DE |
|
|
|
|
|
Targeted chrom. mutagenesis¼
.. |
|
European Patent No. 1 476 547 (Dec. 6, 2006) |
U1-FR |
|
|
|
|
|
Targeted chrom. mutagenesis¼ |
|
European Patent No. 1 476 547 (Dec. 6, 2006) |
U1-GB |
|
|
|
|
|
Targeted chrom. mutagenesis¼ |
|
European Patent No. 1 476 547 (Dec. 6, 2006) |
U1-IE |
|
|
|
|
|
Targeted chrom. mutagenesis¼
.. |
|
European Patent No. 1 476 547 (Dec. 6, 2006) |
U1-NL |
|
|
|
|
|
Targeted chrom. mutagenesis¼ |
|
European Patent No. 1 476 547 (Dec. 6, 2006) |
U1-US1 |
|
10/502,565 |
|
Jan. 22, 2003 |
|
Targeted chromosomal mutagenesis |
|
Pending |
A-23.
Exhibit B
Third Party Licenses
Patent License Agreement by and between Massachusetts Institute of Technology and Sangamo
BioSciences, Inc. dated May 9, 1996 and amended December 10, 1997; December 2, 1998; September 1,
1999; February 10, 2000; November 15, 2000; September 1, 2005; October 27, 2006; and February 1,
2007 (the MIT Agreement).
License Agreement by and between The Johns Hopkins University and Sangamo BioSciences, Inc.
dated June 29, 1995 and amended June 1, 1998; July 26, 1999; March 15, 2000; and May 21, 2007 (the
JHU Agreement).
License Agreement by and between California Institute of Technology and Sangamo BioSciences,
Inc. dated November 1, 2003 and amended January 15, 2004 and February 28, 2005 (the CalTech
Agreement).
License Agreement by and between the University of Utah Research Foundation and Sangamo
BioSciences, Inc. dated September 8, 2004 and amended February 22, 2007 (the Utah Agreement).
License Agreement by and between the University of Utah Research Foundation and Sangamo
BioSciences, Inc. dated June 5, 2007 (the Plant Agreement).
License Agreement by and between the Scripps Research Institute and Sangamo BioSciences, Inc.
dated March 14, 2000 (the Scripps Agreement).
B-1.
Exhibit C
Certain Terms of Third Party Licenses
1. Sigma acknowledges and agrees that Sigma does not have the right to grant sublicenses under
the intellectual property licensed to Sangamo pursuant to the CalTech Agreement. The Parties
acknowledge and agree that, upon any termination of the CalTech Agreement (a) the California
Institute of Technology (CalTech) shall be a third party beneficiary of this Agreement as of the
date of such termination and thereafter, and (b) Sangamo shall remain responsible for all
obligations to Sigma (other than those requiring Sangamo to hold a license under the CalTech
Agreement, unless CalTech (at its discretion) elects to assume such obligations.
2. Sigma hereby agrees to comply, and to cause its applicable sublicensees to comply, with the
following referenced provisions of the JHU Agreement: Articles II, VIII, IX, X, XIII and XV and
Paragraphs 5.1 and 5.2. A copy of such provisions is attached to this Agreement as Exhibit F, and
such provisions and are binding upon Sigma and such sublicensees as if they were parties to the JHU
Agreement.
3. Article 2 (other than Paragraph 2.8), Article 9 and Article 10 of the MIT Agreement are
hereby incorporated by reference into this Agreement and are binding upon Sigma and any of Sigmas
sublicensees under the rights licensed to Sangamo under the MIT Agreement (as if each were a
LICENSEE under the MIT Agreement).
4. Sigma acknowledges and agrees that any sublicense granted by Sangamo to Sigma under the
Scripps Agreement shall be subject in all respects to the restrictions, exceptions, royalty
obligations, reports, termination provisions and other provisions contained in the
Scripps Agreement (but not including the payment of the license fee pursuant to Section 2.2 of the
Scripps Agreement).
C-1.
Exhibit D
Mandatory Terms for Limited Use License
(a) the Customer will not transfer the Licensed Product sold to it or any Licensed Product
derived therefrom to any other person or entity without prior written approval of Sigma and without
such other person or entity entering into a Use License with Sigma;
(b) the Customers use of all Licensed Products will be limited to the Field; and
(c) the Customer will not use Licensed Products in the Plant Field.
D-1.
Exhibit E
Press Release
E-1.
Exhibit F
Copy of Selected Provisions of JHU Agreement
ARTICLE II GRANT
2.1 JOHNS HOPKINS hereby grants to LICENSEE the exclusive worldwide right and license to make,
have made, use, lease and sell the Licensed Products, and to practice the Licensed Processes,
including the right to grant sublicenses, subject to 35USC200-211 and the regulations promulgated
thereunder, to the end of the term for which the Patent Rights are granted by the applicable
governmental authority, unless sooner terminated as hereinafter provided (the Term). JOHNS
HOPKINS reserves the non-transferable royalty-free right to practice the subject matter of any
claim within the Patent Rights for its own internal purposes. If Dr. Chandrasegaran leaves JOHNS
HOPKINS, he shall have the non-transferable, royalty-free right to practice any claim within the
Patent Rights for his own academic purposes.
2.2 In order to establish a period of exclusivity for LICENSEE, JOHNS HOPKINS hereby agrees
that it shall not grant any other license to make, have made, use, lease or sell Licensed Products
or to practice Licensed Processes except for its internal research activities during the period of
time (the Exclusive Period) commencing with the Effective Date of this Agreement and terminating
with expiration of the last-to-expire patent licensed under this Agreement, unless converted
earlier to a nonexclusive license pursuant to Paragraph 4.4 hereof or pursuant to a requirement by
the United States Government in accordance with 35USC200-211.
2.3 LICENSEE shall have the right to sublicense all or any part of this license. With respect
to each sublicense in the Research Reagent Field granted by it under this Agreement, LICENSEE shall
do the following:
|
(a) |
|
incorporate the language of Article II (other than Paragraph 2.4), Article X,
and Paragraph 15.4 into each sublicense agreement (but in each case solely to the
extent such language is applicable to the rights granted in such sublicense agreement),
so that these Articles shall be binding upon the applicable sublicensee as if it were a
party to this Agreement; |
|
|
(b) |
|
include in each such sublicense agreement, language that is reasonably
sufficient to enable LICENSEE to comply with its obligations under Paragraphs
2.4, 5.1, and 5.2 and Articles IX, XIII, and XV (other than Paragraph 15.4); and |
|
|
(c) |
|
obtain an indemnity from the applicable sublicensee in favor of LICENSEE
that is substantially similar in scope of the indemnity set forth in Article VIII
and that includes JOHNS HOPKINS as an indemnified party on the same terms as
LICENSEE. |
With respect to each sublicense in any field other than the Research Reagent Field granted by
it under this Agreement, LICENSEE agrees that such sublicense shall provide that the obligations to
JOHNS HOPKINS of Articles II, VIII, IX, X, XIII, XV and Paragraphs 5.1 and
F-1.
5.2 of this Agreement shall be binding upon such sublicensee as if such sublicensee was a
party to this Agreement. LICENSEE further agrees to attach copies of these Articles to such
sublicense agreement and to incorporate these by reference in such sublicense agreement. (as
amended on May 21, 2007)
2.4 LICENSEE agrees to forward to JOHNS HOPKINS a copy of any and all fully executed
sublicense agreements, and further agrees to forward to JOHNS HOPKINS, quarterly, pursuant to
Paragraph 5.2 a copy of such reports received by LICENSEE from its sublicensees during the
preceding twelve (12) month period under the sublicenses as shall be pertinent to a royalty
accounting under said sublicense agreements.
2.5 Subject to Sections 2.6, 2.7 and 15.7 below, the license granted hereunder shall not be
construed to confer any rights upon LICENSEE by implication, estoppel or otherwise as to any
technology not specifically set forth in Appendix A, Appendix B, Appendix C, and Appendix D hereof.
2.6 JOHNS HOPKINS hereby also grants to LICENSEE a right of first negotiation at then
commercially reasonable terms, to obtain an exclusive license to any Inventions, as previously
defined, developed during the term of this Agreement and any extension thereof and pursuant to any
Research Agreement between the parties hereto (Appendix D). JOHNS HOPKINS shall promptly give
LICENSEE written notice of any such Inventions, as defined, and LICENSEE shall have one hundred and
twenty (120) days from the date of receipt of such notice to give JOHNS HOPKINS written notice of
its intent to exercise such option and complete negotiations. JOHNS HOPKINS shall not negotiate
with any third party regarding these Inventions during the period of LICENSEES right to negotiate.
During the term of this Agreement and any extension thereof, Dr. Chandrasegaran shall be free to
pursue any scientific investigations of his choice through collaboration with colleagues. Should
any such collaboration involve a Licensed Product or Licensed Process, JOHNS HOPKINS will take the
initiative of promptly communicating with these colleagues for the purpose of using its reasonable
best efforts to have such colleagues agree to be bound by the terms of this Agreement with regard
to Licensed Products and Licensed Processes.
2.7 Appendix B attached hereto contains ideas conceived by Dr. Chandrasegaran for developing
laboratory reagents, diagnostics, and pharmaceuticals relating to chimeric restriction
endonucleases. Dr. Chandrasegaran shall give written notice of any Invention resulting under the
Advanced Technology Program within sixty (60) days of the completion of the funding of such
program. Any Invention resulting in whole or in part from said ideas which are made pursuant to an
award under the Advanced Technology Program where a grant application was filed on March 29, 1995
(Appendix C) shall be assigned to LICENSEE pursuant to Section 15.7 below and Dr. Chandrasegaran
will be named as sole inventor unless another individual makes a creative input to said Invention.
LICENSEE shall have the first right of negotiation, under then commercially reasonable terms, to
obtain an exclusive, royalty-bearing license under any Invention resulting from said ideas in
Appendix B made by Dr. Chandrasegaran with funding from a source other than the Advanced Technology
Program grant.
2.8 Each of LICENSEES sublicensee(s) shall have the right to grant further sublicenses of the
sublicense to the Patent Rights granted to it by LICENSEE, within the scope
F-2.
of such sublicense. Such further sublicenses shall include the provisions set forth in
Paragraph 2.3 of this Agreement that were included in the sublicense agreement between LICENSEE and
sublicensee and such provisions shall be binding on such further sublicensee as if such further
sublicensee were a party to this Agreement. LICENSEE shall forward a copy of all further
sublicense agreements granted by its sublicense(s) within thirty (30) days of LICENSEEs receipt of
a copy thereof. (as amended on May 21, 2007)
PARAGRAPHS 5.1 AND 5.2
5.1 LICENSEE shall keep full, true and accurate books of account containing all particulars
that may be necessary for the purpose of showing the amounts payable to JOHNS HOPKINS hereunder.
Said books of account shall be kept at LICENSEEs principal place of business or the principal
place of business of the appropriate Division of LICENSEE to which this Agreement relates. Said
books and the supporting data shall be open at all reasonable times for five (5) years following
the end of the calendar year to which they pertain, to the inspection of JOHNS HOPKINS or its
agents for the purpose of verifying LICENSEEs royalty statement or compliance in other respects
with this Agreement.
5.2 Commencing with the first commercial sale of a Licensed Product, LICENSEE, within sixty
(60) days after March 31, June 30, September 30 and December 31, of each year, shall deliver to
JOHNS HOPKINS true and accurate reports, giving such particulars of the business conducted by
LICENSEE, its Subsidiaries and its sublicensees during the preceding three-month period under this
Agreement as shall be pertinent to a royalty accounting hereunder. These shall include at least the
following:
|
(a) |
|
All Licensed Products manufactured and sold. |
|
|
(b) |
|
Total billings for Licensed Products sold. |
|
|
(c) |
|
Accounting for all Licensed Processes used or sold. |
|
|
(d) |
|
Deductions applicable as provided in Paragraph 1.6. |
|
|
(e) |
|
Total royalties due. |
|
|
(f) |
|
Names and addresses of all sublicensees of LICENSEE. |
Where reasonably practical, LICENSEE shall, to the best of its knowledge, subcategorize the
Licensed Products sold so as to assign the royalties paid to individual patent(s) of Appendix A.
Such subcategorization shall be for JOHNS HOPKINS administrative purposes only and shall in no way
affect any obligations of any part or the amounts of royalties to be paid under this Agreement.
Until there has been a first commercial sale of a Licensed Product, the LICENSEE shall give an
annual report of LICENSEEs efforts to achieve a first commercial sale.
ARTICLE VIII LIABILITY
8.1 Inasmuch as JOHNS HOPKINS will not, under the provisions of this Agreement or otherwise,
have control over the manner in which LICENSEE, or its Subsidiaries or its agents
F-3.
or its sublicensees or those operating for its account, or third parties who purchase Licensed
Products from any of the foregoing entities, practice any invention encompassed by the license
granted herein, LICENSEE shall defend and hold JOHNS HOPKINS, it trustees, officers, employees,
students, and affiliates harmless as against any judgments, fees, expenses or other costs
(including reasonable attorneys fees) arising from or incidental to any product liability or other
lawsuit brought as a consequence of the practice of said invention by any of the foregoing
entities, whether or not JOHNS HOPKINS is named as party defendant in any such lawsuit. LICENSEE
shall have the right to defend such a product liability lawsuit with counsel of its own choosing
and JOHNS HOPKINS will cooperate in the defense of such action at LICENSEEs expense. Practice of
the Invention encompassed by the license granted herein by a Subsidiary or an agent or a
sublicensee, or a third party on behalf of or for the account of LICENSEE or by a third party who
purchases Licensed Products from any of the foregoing shall be considered LICENSEEs practice of
said invention for purposes of this Paragraph 8.1. The provisions of this Paragraph 8.1 shall
survive termination of this Agreement.
8.2 LICENSEE shall maintain or cause to be maintained, prior to the first planned use of
Licensed Products or Licensed Processes in humans, product liability insurance or other protection
reasonably acceptable to JOHNS HOPKINS which shall protect LICENSEE and JOHNS HOPKINS in regard to
events covered by Paragraph 8.1 above. LICENSEE will disclose to JOHNS HOPKINS the amount and kind
of product liability insurance it obtains, will give JOHNS HOPKINS a copy of the certificate of
insurance, and will increase or change the kind of insurance at the reasonable request of JOHNS
HOPKINS, provided such insurance is available to LICENSEE at commercially reasonable rates.
8.3 Except as otherwise expressly set forth in this Agreement, JOHNS HOPKINS makes 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, and validity of Patent
Rights claims, issued or pending.
8.4 No liability under this Agreement shall result to a party from delay in performance caused
by force majeure, that is, circumstances beyond the reasonable control of the party affected
thereby, including, without limitation, acts of God, earthquake, fire, flood, war, government
regulations, labor unrest, or shortage of or an inability to obtain material or equipment.
ARTICLE IX EXPORT CONTROLS
It is understood that JOHNS HOPKINS is subject to United States laws and regulations
controlling the export of technical data, computer software, laboratory prototypes and other
commodities (including the Arms Export Control Act, as amended and the Export Administration Act of
1979), and that their obligations hereunder are contingent on compliance with applicable United
States export laws and regulations. The transfer of certain technical data and commodities may
require a license from the cognizant agency of the United States Government and/or written
assurances by LICENSEE that LICENSEE shall not export data or commodities to certain foreign
countries without prior approval of such agency. JOHNS HOPKINS neither represents that a license
shall not be required nor that, if required, it shall be issued.
F-4.
ARTICLE X NON-USE OF NAMES
LICENSEE shall not use the name of JOHNS HOPKINS, nor any of its employees, or any adaptation
thereof, in any advertising, promotional or sales literature without prior written consent obtained
from JOHNS HOPKINS in each case, except that LICENSEE may state that it is licensed by JOHNS
HOPKINS under one or more of the patents and/or applications comprising the Patent Rights.
ARTICLE XIII TERMINATION
13.1 This Agreement shall terminate if LICENSEE dissolves, unless this Agreement has been
assigned prior to the date of dissolution.
13.2 Should LICENSEE fail to pay JOHNS HOPKINS royalties due and payable hereunder, JOHNS
HOPKINS shall have the right to terminate this Agreement on sixty (60) days written notice, unless
LICENSEE shall pay JOHNS HOPKINS within the sixty (60) day period, all such royalties and interest
due and payable. Upon the expiration of the sixty (60) day period, if LICENSEE shall not have paid
all such royalties and interest due and payable, the rights, privileges and license granted
hereunder shall terminate.
13.3 Upon any material breach or default of this Agreement by LICENSEE other than those
occurrences set out in Paragraphs 13.1 and 13.2 hereinabove, which shall always take precedence in
that order over any material breach or default referred to in this Paragraph 13.3, JOHNS HOPKINS
shall have the right to terminate this Agreement and the rights, privileges and license granted
hereunder by giving ninety (90) days notice to LICENSEE. Such termination shall become effective
unless LICENSEE shall have cured any such breach or default prior to the expiration of the ninety
(90) day period.
13.4 LICENSEE shall have the right to terminate this Agreement at any time on six (6) months
notice to JOHNS HOPKINS and upon payment of all amounts due JOHNS HOPKINS.
13.5 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. LICENSEE and any Subsidiary and sublicensee thereof may, however, after the effective
date of such termination, sell all Licensed Products, and complete Licensed Products in the process
of manufacture at the time of such termination and sell the same, provided that LICENSEE shall pay
to JOHNS HOPKINS the royalties thereon as required by Article IV of this Agreement and shall submit
the reports required by Article V hereof on the sales of Licensed Products.
13.6 Upon termination of this Agreement for any reason during the Exclusive Period, any
sublicensee not then in default shall have the right to seek a license from JOHNS HOPKINS under the
same terms and conditions as set forth hereunder. In addition, in the event that JOHNS HOPKINS
terminates this Agreement pursuant to Paragraph 13.1, 13.2, or 13.3, each sublicense granted by
LICENSEE which complies with the sublicense requirements of Paragraph 2.3, is in full force and
effect and not then in default, will survive such termination of this Agreement and such
sublicensee shall become a direct licensee of JOHNS HOPKINS, provided that (a) JHUs obligations to
such sublicensee are no greater than JHUs obligations to LICENSEE under this
F-5.
Agreement, (b) the scope of such sublicensees rights with respect to the Patent Rights shall
remain unchanged and such sublicensee shall be subject to all other non-financial terms and
conditions in this Agreement that apply to such scope of rights, (c) all further sublicenses
granted by such sublicensee prior to termination of this Agreement shall also survive such
termination, (d) such sublicensee (or if there are at such time more than one such sublicensees,
such sublicensees severally and jointly) shall be required to make any minimum annual royalty
payments due pursuant to Paragraph 4.4 and (e) such sublicensee shall be required to make any other
monetary payment(s) that, had this Agreement not been terminated, LICENSEE would have been required
to make under this Agreement as a result of the activities of such sublicensee. Each such
sublicensee shall be an intended third-party beneficiary of the preceding sentence. LICENSEE shall
notify JOHNS HOPKINS of each non-defaulted sublicense in existence at the time of termination by
JOHNS HOPKINS pursuant to Paragraph 13.1, 13.2, or 13.3. (as amended on May 21, 2007)
13.7 The provisions of Paragraph 8.1, Article IX and Article X, Paragraph 4.5 and Paragraph
6.6, shall survive termination of this Agreement. (as amended on June 1, 1998)
ARTICLE XV MISCELLANEOUS PROVISIONS
15.1 This Agreement shall be construed, governed, interpreted and applied in accordance with
the laws of the State of Maryland, U.S.A., except that questions affecting the validity,
construction and effect of any patent licensed hereunder, shall be determined by the law of the
country in which the patent was granted.
15.2 The parties hereto acknowledge that this Agreement 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.
15.3 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.
15.4 LICENSEE agrees to mark the Licensed Products sold in the United States with all
applicable United States patent numbers. All Licensed Products shipped to or sold in other
countries shall be marked in such a manner as to conform with the patent laws and practice of the
country of manufacture or sale.
15.5 The failure of any 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.
15.6 Claims, disputes, or controversies concerning the validity, construction, or effect of
any patent licensed hereunder shall be resolved in any court having jurisdiction thereof.
15.7 A grant application under the Advanced Technology Program was filed on March 29, 1995
(Appendix C). If a grant is awarded, any Invention made pursuant thereto where an
F-6.
investigator at JOHNS HOPKINS is the sole inventor or a coinventor shall be assigned to LICENSEE.
Such Invention shall be assigned hereunder and shall thereafter fall within the definition of
Patent Rights and therefore shall be subject to Sections 3.2, 3.3 and 3.4 hereof and to the royalty
payments required by Sections 4.1(c)(i), 4.1(d) and 4.4 hereof as part of the rights licensed
hereunder.
15.8 With respect to Methods for Inactivating Target DNA and For Detecting Conformation
Change in a Nucleic Acid, Inventor, Srinivasan Chandrasegaran, US Patent Application SN
08/647,449, Filed 5/7/96 (JHU Docket: C-1288), LICENSEE hereby acknowledges and agrees that Dr.
Chandrasegaran is the sole inventor of this property. (as amended on June 1, 1998)
F-7.
EXHIBIT G
TRANSFER OF MANUFACTURING TECHNOLOGY
1. |
|
The following tangible properties shall be transferred to Sigma by Sangamo in [***] |
|
2. |
|
Sangamo shall transfer to Sigma all Information Controlled by Sangamo that is [***]. |
|
3. |
|
[***] |
|
4. |
|
[***] |
|
5. |
|
[***] |
|
6. |
|
[***] |
|
|
|
*** |
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CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION |
F-8.
exv31w1
Exhibit 31.1
CERTIFICATION
I, Edward O. Lanphier II, certify that:
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I have reviewed this quarterly report on Form 10-Q of Sangamo BioSciences, Inc. (the
registrant) |
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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; |
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3. |
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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; |
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4. |
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The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 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: |
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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 this report is being prepared; |
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(b) |
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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. |
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(c) |
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Evaluated the effectiveness of the registrants 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 |
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(d) |
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Disclosed in this report any change in the registrants internal control over
financial reporting that occurred during the registrants most recent fiscal quarter
(the registrants fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrants
internal control over financial reporting; and |
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The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the
audit committee of the registrants board of directors (or the persons performing the
equivalent functions): |
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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 registrants ability to record, process, summarize and report
financial information; and |
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(b) |
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Any fraud, whether or not material, that involves management or other
employees who have a significant role in the registrants internal control over
financial reporting. |
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Date: November 1, 2007
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/s/ Edward O. Lanphier II |
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Edward O. Lanphier II |
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President and Chief Executive Officer |
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exv31w2
Exhibit 31.2
CERTIFICATION
I, Greg S. Zante, certify that:
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1. |
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I have reviewed this quarterly report on Form 10-Q of Sangamo BioSciences, Inc. (the
registrant) |
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2. |
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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; |
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3. |
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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; |
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4. |
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The registrants other certifying officer and I are responsible for establishing and
maintaining disclosure controls and procedures (as defined in Exchange Act Rules 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: |
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(a) |
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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 this report is being prepared; |
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(b) |
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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. |
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(c) |
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Evaluated the effectiveness of the registrants 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 |
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(d) |
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Disclosed in this report any change in the registrants internal control over
financial reporting that occurred during the registrants most recent fiscal quarter
(the registrants fourth fiscal quarter in the case of an annual report) that has
materially affected, or is reasonably likely to materially affect, the registrants
internal control over financial reporting; and |
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5. |
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The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and
the audit committee of the registrants board of directors (or the persons performing the
equivalent functions): |
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(a) |
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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 registrants ability to record, process, summarize and report
financial information; and |
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(b) |
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Any fraud, whether or not material, that involves management or other
employees who have a significant role in the registrants internal control over
financial reporting. |
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Date: November 1, 2007
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/s/ Greg S. Zante |
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Greg S. Zante |
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Vice President, Finance and Administration |
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(Principal Financial and Accounting Officer) |
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exv32w1
Exhibit 32.1
Certification Pursuant to 18 U.S.C. §1350, as Adopted
Pursuant to §906 of the Sarbanes-Oxley Act of 2002
Each of the undersigned hereby certifies pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906
of the Sarbanes-Oxley Act of 2002 in his capacity as an officer of Sangamo BioSciences, Inc. (the
Company), that:
(1) the Quarterly Report of the Company on Form 10-Q for the quarterly period ended September 30,
2007, as filed with the Securities and Exchange Commission (the Report) fully complies with the
requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
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/s/ Edward O. Lanphier II
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Edward O. Lanphier II
President and Chief Executive Officer
(Principal Executive Officer) |
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Date: November 1, 2007 |
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/s/ Greg S. Zante |
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Greg S. Zante
Vice President, Finance and Administration
(Principal Financial and Accounting Officer) |
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Date: November 1, 2007 |
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