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 June 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
(State or other jurisdiction of incorporation or organization)
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68-0359556
(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 July 27, 2007, 39,658,307 shares of the issuers common stock, par value $0.01 per
share, were outstanding.
INDEX
SANGAMO BIOSCIENCES, INC.
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3 |
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3 |
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3 |
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4 |
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5 |
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6 |
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13 |
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18 |
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19 |
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20 |
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20 |
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20 |
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31 |
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31 |
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32 |
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33 |
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CERTIFICATIONS |
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34 |
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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. |
EXHIBIT 10.1 |
EXHIBIT 31.1 |
EXHIBIT 31.2 |
EXHIBIT 32.1 |
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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June 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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$ |
9,672 |
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$ |
12,702 |
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Marketable securities |
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34,895 |
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41,218 |
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Interest receivable |
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18 |
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55 |
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Accounts receivable |
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160 |
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487 |
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Prepaid expenses |
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1,009 |
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594 |
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Total current assets |
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45,754 |
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55,056 |
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Property and equipment, net |
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1,133 |
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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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$ |
46,936 |
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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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$ |
2,768 |
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$ |
1,726 |
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Accrued compensation and employee benefits |
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644 |
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878 |
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Deferred revenue |
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2,861 |
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2,596 |
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Total current liabilities |
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6,273 |
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5,200 |
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Deferred revenue, non current portion |
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729 |
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1,875 |
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Total liabilities |
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7,002 |
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7,075 |
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Stockholders equity: |
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Common stock, $0.01 par value; 80,000,000
shares authorized, 35,242,359 and 35,045,398
shares issued and outstanding at June 30,
2007 and December 31, 2006, respectively |
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352 |
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350 |
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Additional paid-in capital |
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178,264 |
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176,513 |
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Accumulated deficit |
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(138,812 |
) |
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(128,272 |
) |
Accumulated other comprehensive income |
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130 |
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114 |
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Total stockholders equity |
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39,934 |
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48,705 |
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Total liabilities and stockholders equity |
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$ |
46,936 |
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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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Six months ended |
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June 30, |
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June 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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$ |
1,461 |
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$ |
1,431 |
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$ |
2,611 |
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$ |
3,304 |
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Research grants |
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1,123 |
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346 |
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1,395 |
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609 |
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Total revenues |
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2,584 |
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1,777 |
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4,006 |
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3,913 |
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Operating expenses: |
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Research and development |
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6,309 |
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4,028 |
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11,739 |
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7,617 |
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General and administrative |
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2,113 |
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1,821 |
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4,112 |
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3,576 |
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Total operating expenses |
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8,422 |
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5,849 |
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15,851 |
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11,193 |
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Loss from operations |
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(5,838 |
) |
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(4,072 |
) |
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(11,845 |
) |
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(7,280 |
) |
Interest and other income, net |
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657 |
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745 |
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1,305 |
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1,209 |
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Net loss |
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$ |
(5,181 |
) |
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$ |
(3,327 |
) |
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$ |
(10,540 |
) |
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$ |
(6,071 |
) |
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Basic and diluted net loss per share |
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$ |
(0.15 |
) |
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$ |
(0.11 |
) |
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$ |
(0.30 |
) |
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$ |
(0.20 |
) |
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Shares used in computing basic and diluted net loss per share |
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35,136 |
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31,312 |
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35,097 |
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30,959 |
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See accompanying notes.
4
SANGAMO BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
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Six months ended |
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June 30, |
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2007 |
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2006 |
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Operating Activities: |
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Net loss |
|
$ |
(10,540 |
) |
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$ |
(6,071 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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110 |
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92 |
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Amortization of premium on investments |
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(953 |
) |
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(108 |
) |
Realized (gain) / loss on investments |
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16 |
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(29 |
) |
Stock-based compensation |
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1,074 |
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|
950 |
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Changes in operating assets and liabilities: |
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Interest receivable |
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37 |
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|
48 |
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Accounts receivable |
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|
327 |
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|
743 |
|
Prepaid expenses and other assets |
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(415 |
) |
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(348 |
) |
Accounts payable and accrued liabilities |
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1,042 |
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|
(581 |
) |
Accrued compensation and employee benefits |
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(234 |
) |
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(331 |
) |
Deferred revenue |
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(881 |
) |
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(2,594 |
) |
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Net cash used in operating activities |
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(10,417 |
) |
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(8,229 |
) |
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Investing Activities: |
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Purchases of investments |
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(36,375 |
) |
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(16,016 |
) |
Maturities of investments |
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43,651 |
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|
14,243 |
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Purchases of property and equipment |
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(568 |
) |
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(137 |
) |
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Net cash provided by / (used in) investing activities |
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6,708 |
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(1,910 |
) |
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Financing Activities: |
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Proceeds from issuance of common stock |
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679 |
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20,470 |
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Net cash provided by financing activities |
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679 |
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20,470 |
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Net (decrease)/increase in cash and cash equivalents |
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(3,030 |
) |
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|
10,331 |
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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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$ |
9,672 |
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$ |
28,838 |
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See accompanying notes.
5
SANGAMO BIOSCIENCES, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
June 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 six months ended June 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 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, 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
Employee stock-based compensation expenses recognized in the three-month and six-month periods
ended June 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 six-month periods ended June
30, 2007 and 2006 (in thousands):
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Three months ended |
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Six months ended |
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|
June 30, |
|
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June 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: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
325 |
|
|
$ |
310 |
|
|
$ |
668 |
|
|
$ |
627 |
|
General and administrative |
|
|
202 |
|
|
|
184 |
|
|
|
398 |
|
|
|
297 |
|
|
|
|
|
|
|
|
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|
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|
|
Total stock-based compensation expense |
|
$ |
527 |
|
|
$ |
494 |
|
|
$ |
1,066 |
|
|
$ |
924 |
|
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|
There was no capitalized stock-based employee compensation cost as of June 30, 2007 and 2006.
There were no recognized tax benefits during the three month and six month periods ended June 30,
2007 and 2006.
As of June 30, 2007, total compensation cost related to nonvested stock options to be recognized in
future periods was $5.6 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. 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.
The weightedaverage assumptions used for estimating the fair value of the employee stock options
are as follows:
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|
Three months ended |
|
Six months ended |
|
|
June 30, |
|
June 30, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
|
Risk-free interest rate |
|
|
4.99 |
% |
|
|
5.10 |
% |
|
|
4.58-4.99 |
% |
|
|
5.00-5.02 |
% |
Expected life of option |
|
6.25 years |
|
6.25 years |
|
6.25 years |
|
6.25 years |
Expected dividend yield of stock |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
Expected volatility |
|
|
.92 |
|
|
|
.97 |
|
|
|
.92-.93 |
|
|
|
.91-.97 |
|
7
The weightedaverage assumptions used for estimating the fair value of the employees
purchase rights are as follows:
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|
|
Three months ended |
|
Six months ended |
|
|
June 30, |
|
June 30, |
|
|
2007 |
|
2006 |
|
2007 |
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Risk-free interest rate |
|
|
3.60-5.10 |
% |
|
|
4.75-5.17 |
% |
|
|
3.60-5.10 |
% |
|
|
4.75-5.17 |
% |
Expected life of option |
|
0.5-2 years |
|
0.5-2 yrs |
|
.5-2 yrs |
|
0.5-2 yrs |
Expected dividend yield of stock |
|
|
0.0 |
|
|
|
0.0 |
|
|
|
0.0 |
|
|
|
0.0 |
|
Expected volatility |
|
|
.46-.77 |
|
|
|
.41-.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 |
|
|
(391,250 |
) |
|
|
391,250 |
|
|
$ |
7.10 |
|
|
|
|
|
Options exercised |
|
|
|
|
|
|
(135,766 |
) |
|
$ |
3.82 |
|
|
|
|
|
Options canceled |
|
|
187,894 |
|
|
|
(187,894 |
) |
|
$ |
5.90 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2007 |
|
|
3,421,665 |
|
|
|
4,215,402 |
|
|
$ |
5.86 |
|
|
|
6.26 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options exercisable at June 30, 2007 |
|
|
|
|
|
|
2,618,931 |
|
|
$ |
5.86 |
|
|
|
4.76 |
|
There were no shares subject to Sangamos right of repurchase as of June 30, 2007. The intrinsic
value of options exercised were $382,000 and $269,000 for the three months ended June 30, 2007 and
2006, respectively, and $463,000 and $1,059,000 for the six months ended June 30, 2007 and 2006,
respectively.
The weighted-average estimated fair value per share of options granted during the three months and
six months ended June 30, 2007 and 2006 were $5.74 and $5.80, respectively, and $5.58 and $5.44,
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 six months ended June 30, 2007 and 2006 were $2.36 and $2.23, respectively, and $2.36
and $2.17, 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 June 30,
2007:
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
|
|
|
|
Weighted Average |
|
|
|
|
|
|
Remaining |
|
|
Number |
|
Contractual Life |
Range of Exercise Price |
|
of Shares |
|
(In Years) |
$0.05 $0.17 |
|
|
431,583 |
|
|
|
0.89 |
|
$0.23 $3.87 |
|
|
440,133 |
|
|
|
5.94 |
|
$3.95 $4.11 |
|
|
549,196 |
|
|
|
8.15 |
|
$4.15 $5.18 |
|
|
224,148 |
|
|
|
6.98 |
|
$5.19 $5.19 |
|
|
453,996 |
|
|
|
6.76 |
|
$5.30 $6.77 |
|
|
241,396 |
|
|
|
6.93 |
|
$6.82 $6.82 |
|
|
450,000 |
|
|
|
9.45 |
|
$6.88 $7.49 |
|
|
812,750 |
|
|
|
6.77 |
|
$7.56 $14.60 |
|
|
509,200 |
|
|
|
4.88 |
|
$14.87 $38.00 |
|
|
103,000 |
|
|
|
3.61 |
|
|
|
|
|
|
|
|
|
|
|
|
|
4,215,402 |
|
|
|
6.26 |
|
|
|
|
|
|
|
|
|
|
8
At June 30, 2007, the aggregate intrinsic values of the outstanding and exercisable options were
$11.7 million and $8.1 million, respectively.
Sangamo did not grant any stock option to consultants during the three months ended June 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 $4,000 and $5,000 for the three month periods ended June 30, 2007 and 2006,
respectively, and $8,000 and $26,000 for the six month periods ended June 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
Basic earnings (loss) per share is calculated based on the weighted average number of shares
of common stock outstanding during the period. Diluted earnings (loss) per share is calculated
based on the weighted average number of shares of common stock and dilutive securities, such as
stock options and equivalents, outstanding during the period. 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 earnings (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 (loss) per share would have included the shares
used in the computation of basic net loss per share as well as an additional 2,214,731 shares and
1,898,378 shares for the six months ended June 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):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended |
|
|
Six months ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(5,181 |
) |
|
$ |
(3,327 |
) |
|
$ |
(10,540 |
) |
|
$ |
(6,071 |
) |
Changes in
unrealized gain
(loss) on
securities
available-for-sale |
|
|
18 |
|
|
|
(18 |
) |
|
|
16 |
|
|
|
(29 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
$ |
(5,163 |
) |
|
$ |
(3,345 |
) |
|
$ |
(10,524 |
) |
|
$ |
(6,100 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
9
NOTE 4-MAJOR CUSTOMERS, PARTNERSHIPS AND STRATEGIC ALLIANCES
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.
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 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 $157,000 during the three months
ended June 30, 2007 and 2006, respectively. Revenues for the six-month periods ended June 30, 2007
and 2006 were $50,000 and $307,000, respectively. Related research and development costs and
expenses performed under the Pfizer agreement were $113,000 and $98,000 during the three months
ended June 30, 2007 and 2006, respectively, and $247,000 and $155,000 during the six months ended
June 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, Company
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 Agreements
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.
10
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 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.
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 June 30, 2007
and 2006 and $1.3 million during both the six months ended June 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 June 30, 2007 and 2006 and $1.0 million during both the
six months ended June 30, 2007 and 2006. Revenues attributable to milestone payments were $290,000
during both the three and six month periods ended June 30, 2007. Related costs and expenses
incurred under the DAS agreement were $500,000 during both the three months ended June 30, 2007 and
2006 and $1.0 million and $1.4 million during the six months ended June 30, 2007 and 2006,
respectively.
11
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 award over a period of two years.
Revenues attributable to research and development performed under the MJFF partnership were
$134,000 and $184,000 during the three months and six months ended June 30, 2007, respectively.
Related costs and expenses incurred under the MJFF partnership were $134,000 and $184,000 during
the three month and six month periods ended June 30, 2007, respectively.
The Juvenile Diabetes Research Foundation International
On October 26, 2006, we announced a partnership with the Juvenile Diabetes Research Foundation
International (JDRF) to provide financial support 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 us, 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 six months ended June 30, 2007, the Company received $500,000 and
$1.0 million from JDRF upon the achievement of two milestones. Revenues attributable to research
and development performed under the JDRF partnership were $830,000 during the three months ended
June 30, 2007. Related costs and expenses incurred under the Phase 2 clinical trial of SB-509 were
$764,000 and $2.0 million during the three months and six months ended June 30, 2007, respectively.
NOTE 5-STOCKHOLDERS EQUITY
In December 2006, Sangamo issued 1,000,000 shares of common stock to Edwards as partial
consideration for the purchase of Edwards angiogenesis program. The issuance was exempt for the
registration requirement pursuant to Section 4(2) of the Securities Act of 1933, as amended and,
Rule 506 of Regulation D promulgated pursuant to such Act. 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 and recorded as a
research and development expense in 2006 consolidated statement of operations.
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.
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.
12
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.
NOTE 7-SUBSEQUENT EVENT
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-Aldrich Corporation
(Sigma). Under the agreement, Sangamo will provide Sigma with access to Sangamos proprietary
zinc finger DNA-binding protein (ZFP) technology and the exclusive right to use Sangamo 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. Pursuant to the agreement, Sangamo issued one million shares of common stock at a price of $7.75 per share
to Sigma, resulting in gross proceeds of approximately $7.75 million and will receive an additional $5.75 million as an upfront license fee.
Sangamo is also eligible to receive development and commercial milestone payments and royalties on product sales.
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 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 June 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 June 30, 2007, we had an accumulated deficit of $138.8 million.
Our revenues have consisted primarily of revenues from our corporate partners for ZFP TFs and
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.
13
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 six
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.
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. The Company is
also developing ZFNs for therapeutic gene correction and therapeutic gene modification as a
treatment for certain monogenic and infectious diseases. 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 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
evaluates our estimates on an ongoing basis. Actual results could differ from those estimates under
different assumptions or conditions. Sangamo believes the following critical accounting policies
have significant effect in the preparation of our consolidated financial statements.
Revenue Recognition
In accordance with Staff Accounting Bulletin No. 104, Revenue Recognition, revenue from
research activities made under strategic partnering 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
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 research expenses
are incurred. Grant reimbursements are typically received on a quarterly basis and are subject to
the issuing agencys right of audit.
Sangamo recognizes revenue from its Therapeutic and Enabling Technology collaborations when
ZFP-based products are delivered to the collaborators, persuasive evidence of an agreement exists,
there are no unfulfilled obligations, the price is fixed and determinable, and collectibility is
reasonably assured. Generally, Sangamo receives partial payments from these collaborations prior to
the delivery of ZFP-based products and the recognition of these revenues is deferred until the
ZFP-based products are delivered, the risk of ownership has passed to the collaborator and all
performance obligations have been satisfied. Upfront or signature payments received upon the
signing of an Enabling Technology agreement are generally recognized ratably over the applicable
period of the agreement, which currently ranges between 12 and 15 months, or as ZFP-based products
are delivered.
14
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 further significant 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 criterion is considered separately for each of the separate units of
accounting.
15
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.
As of June 30, 2007, total compensation cost related to nonvested stock options to be recognized in
future periods was $5.6 million, which is expected to be expensed over a weighted average period of
48 months.
RESULTS OF OPERATIONS
Three and six months ended June 30, 2007 and 2006
Revenues
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
|
|
(in thousands, except percentage values) |
|
|
(in thousands, except percentage values) |
|
|
|
2007 |
|
|
2006 |
|
|
Change |
|
|
% |
|
|
2007 |
|
|
2006 |
|
|
Change |
|
|
% |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration agreements |
|
$ |
1,461 |
|
|
$ |
1,431 |
|
|
$ |
30 |
|
|
|
2 |
% |
|
$ |
2,611 |
|
|
$ |
3,304 |
|
|
$ |
(693 |
) |
|
|
(21 |
%) |
Research grants |
|
|
1,123 |
|
|
|
346 |
|
|
|
777 |
|
|
|
(225 |
%) |
|
|
1,395 |
|
|
|
609 |
|
|
|
786 |
|
|
|
129 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
2,584 |
|
|
$ |
1,777 |
|
|
$ |
807 |
|
|
|
(45 |
%) |
|
$ |
4,006 |
|
|
$ |
3,913 |
|
|
$ |
93 |
|
|
|
2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues increased to $2.6 million for the three months ended June 30, 2007 from $1.8
million in the corresponding period in 2006. The increase for the three months ended June 30, 2007
was principally due to revenues of $830,000 in connection with our JDRF grant. Total revenues
increased to $4.0 million for the six months ended June 30, 2007 from $3.9 million in the
corresponding period in 2006. The increase for the six months ended June 30, 2007 was principally
due to revenues of $830,000 in connection with our JDRF grant, offset by decreased
collaboration-related revenues of approximately $300,000, $257,000 and $158,000 from Johnson &
Johnson, Pfizer and DAS, respectively. We anticipate continued revenues from collaboration
agreements through the end of 2008, 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.
16
Operating Expenses
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
|
|
(in thousands, except percentage values) |
|
|
(in thousands, except percentage values) |
|
|
|
2007 |
|
|
2006 |
|
|
Change |
|
|
% |
|
|
2007 |
|
|
2006 |
|
|
Change |
|
|
% |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
6,309 |
|
|
$ |
4,028 |
|
|
$ |
2,281 |
|
|
|
57 |
% |
|
$ |
11,739 |
|
|
$ |
7,617 |
|
|
$ |
4,122 |
|
|
|
54 |
% |
General and administrative |
|
|
2,113 |
|
|
|
1,821 |
|
|
|
292 |
|
|
|
16 |
% |
|
|
4,112 |
|
|
|
3,576 |
|
|
|
536 |
|
|
|
15 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses |
|
$ |
8,422 |
|
|
$ |
5,849 |
|
|
$ |
2,573 |
|
|
|
44 |
% |
|
$ |
15,851 |
|
|
$ |
11,193 |
|
|
$ |
4,658 |
|
|
|
42 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
Over the past three fiscal years, 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 second quarter of 2007 increased to $6.3 million
compared to $4.0 million for the second quarter of 2006. The increase in research and development
expenses for the three months ended June 30, 2007 was primarily attributable to increased external
development expenses of $1.2 million, primarily associated with clinical trials and manufacturing
cost of our diabetic neuropathy program, and increased personnel and laboratory supply expenses of
$427,000 and $329,000, respectively, primarily due to increased headcount, and increased
facility-related and licensing expenses of $124,000 and $114,000, respectively. Research and
development expenses for the first six months of 2007 increased to $11.7 million compared to $7.6
million for the corresponding period of 2006. The increase in research and development expenses for
the six months ended June 30, 2007 was primarily attributable to increased external development
expenses of $2.3 million, primarily associated with clinical trials and manufacturing cost of our
diabetic neuropathy program, increased personnel and laboratory supply expenses of $801,000 and
$574,000, respectively, due to increased headcount, and increased facility-related expenses of
$189,000.
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 $2.1 million for the three months ended June 30,
2007, as compared to $1.8 million during the corresponding period of 2006. This increase is
primarily related to increased professional service-related expenses of $228,000. General and
administrative expenses were $4.1 million for the six months ended June 30, 2007, as compared to
$3.6 million during the corresponding period of 2006. This increase is primarily related to
increased expenses related to professional services and employee stock-based compensation of
$430,000 and $101,000, respectively.
Interest income, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
Six months ended June 30, |
|
|
(in thousands, except percentage values) |
|
(in thousands, except percentage values) |
|
|
2007 |
|
2006 |
|
Change |
|
% |
|
2007 |
|
2006 |
|
Change |
|
% |
Interest and other income, net |
|
$ |
657 |
|
|
$ |
745 |
|
|
$ |
(88 |
) |
|
|
(12 |
%) |
|
$ |
1,305 |
|
|
$ |
1,208 |
|
|
$ |
97 |
|
|
|
8 |
% |
Interest and other income, net, decreased to $657,000 for the three months ended June 30, 2007
from $745,000 in the corresponding period in 2006. The decrease was primarily related to a decrease
of foreign currency translation gain of $59,000 during the quarter ended June 30, 2007. Interest
and other income, net, increased to $1.3 million for the six months ended June 30, 2007
from $1.2 million in the corresponding period of 2006. The increase was primarily related to a
increase interest income of $184,000 related to higher average investment balances during the six
months ended June 30, 2007 from the June 2006 equity financing. This increase was partially offset
by a decrease foreign currency translation gain of $86,000 during the six months ended June 30,
2007.
17
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 June 30, 2007, we had cash, cash equivalents, investments and interest receivable
totaling $44.6 million. On May 18, 2007, we entered into a sales agreement with Cantor Fitzgerald &
Co., as sales agent, pursuant to which we may issue and sell, from time to time through Cantor
Fitzgerald & Co, up to 3,000,000 shares of common stock. No shares of common stock have been sold
under this agreement. On July 10, 2007, in connection with a license agreement with Sigma, Sangamo
issued one million shares of common stock at a price of $7.75 per share to Sigma, resulting in
gross proceeds of approximately $7.75 million and will receive an additional $5.75 million as an
upfront license fee. 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 net proceeds of approximately $28.0
million.
Net cash used for operating activities was $10.4 million for the six months ended June 30,
2007. Net cash used consisted of the net loss for the six-month period of $10.5 million,
amortization of premium on investment of $953,000 and a net change of $124,000 in operating assets
and liabilities. This was partially offset by stock-based compensation charges of $1.1 million and
depreciation and amortization of $110,000. Net cash used for operating activities was $8.2 million
for the six months ended June 30, 2006. Net cash used consisted primarily of the net loss for the
six-month period of $6.1 million, a net change of $3.1 million in operating assets and liabilities
and amortization of premium on investment of $108,000. This was partially offset by stock-based
compensation charges of $950,000 and depreciation and amortization of $92,000.
Net cash provided by investing activities was $6.7 million for the six months ended June 30,
2007 and was primarily comprised of proceeds associated with maturities of investments $43.7
million, partially offset by cash used to purchase investments and fixed assets of $36.4 million
and $568,000, respectively. Net cash used in investing activities was $1.9 million for the six
months ended June 30, 2006 and was primarily comprised of cash used to purchase investments and
fixed assets of $16.0 million and $137,000, respectively, partially offset by cash proceeds
associated with maturities of investments of $14.2 million.
Net cash provided by financing activities for the six-month period ended June 30, 2007 was
$679,000. Proceeds were solely related to proceeds from the issuance of common stock related to
stock option exercises. Net cash provided by financing activities for the six month period ended
June 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 six months of 2006 were
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.
Our market risks at June 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.
18
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 are 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.
19
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 2007 as we prosecute our first 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
have designed our initial Phase 2 clinical
20
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. |
21
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 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
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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 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.
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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 or clinical development or commercialization of the affected product candidates or research
programs could be delayed or terminated.
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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.
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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 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, strategic partnering agreements, research grants and grants
awarded by research foundations. As of June 30, 2007, we had an accumulated deficit of
approximately $138.8 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 June 30, 2007, our stock
price range from a low of $6.57 to high of $8.54. 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 the Company, management or
directors; future sale or liquidation of our common stock by institutional investors with
large holding of our stock; and |
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decreases in our cash balances. |
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Our common stock is relatively thinly traded, which means large transactions in our common
stock may be difficult to conduct in a short time frame. We have a relatively low 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 July 27, 2007 was approximately 591,390 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 July 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, scientific advisors,
or directors, 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 or directors 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 agreement with
Sigma, Sigma may terminate our agreement and Sangamos 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 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 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. Royalties for the longer of (i) the expiration of the
last to expire valid claim of such licensed product and (ii) the 15th anniversary of the
effective date. 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, Sangamos 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.
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
29
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.
30
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 16% 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 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
As of June 30, 2007, Sangamo has used the net proceeds from its initial public offering,
registered direct offering and underwritten public offering of common stock to invest in short-term
and long-term, interest bearing, investment-grade securities and has used its existing cash
balances to fund general operations. The proceeds are being used for general corporate purposes,
including working capital and product development. A portion of the net proceeds will also be used
to acquire or invest in complementary businesses or products or to obtain the right to use
complementary technologies. Sangamo has no agreements or commitments with respect to any such
acquisition and is not currently engaged in any material negotiations with respect to any such
transaction.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
The annual meeting of shareholders was held on June 7, 2007. Two matters were voted on and each was
approved. The results are as follows:
31
PROPOSAL I
The following directors were elected at the meeting to serve until our annual meeting following the
end of fiscal year 2007 or until their successors are duly elected and qualified:
|
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NOMINEE |
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VOTES FOR |
|
VOTES WITHHELD |
Edward O. Lanphier, II |
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29,366,806 |
|
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308,236 |
|
William G. Gerber, M.D. |
|
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29,395,465 |
|
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279,577 |
|
John W. Larson |
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26,929,253 |
|
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2,745,789 |
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Margaret A. Liu, M.D. |
|
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29,431,946 |
|
|
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243,096 |
|
Steven J. Mento, Ph.D. |
|
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29,435,046 |
|
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239,996 |
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H. Ward Wolff |
|
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29,429,216 |
|
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245,826 |
|
Michael C. Wood |
|
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29,324,941 |
|
|
|
350,101 |
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PROPOSAL II
The proposal to ratify the selection of Ernst & Young LLP as the Companys independent registered
public accounting firm for the fiscal year ending December 31, 2007 was approved.
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FOR |
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AGAINST |
|
ABSTAINED |
|
NON VOTES |
29,368,082
|
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247,564 |
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59,396 |
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0 |
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ITEM 6. EXHIBITS
(a) Exhibits:
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10.1(+)
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Research and License Agreement dated April 27, 2007 between Genentech, Inc., and Sangamo
BioSciences, Inc. |
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10.2
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Sales Agreement by and between Sangamo BioSciences, Inc. and Cantor Fitzgerald & Co. dated
May 18, 2007. (incorporated by reference to Exhibit 10.1 to the Form 8-K filed on May 18,
2007. |
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31.1
|
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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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(+) |
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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.
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Dated: August 8, 2007 |
SANGAMO BIOSCIENCES, INC.
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/s/ Greg S. Zante
|
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Greg S. Zante |
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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.
Research and License Agreement
Between
Genentech, Inc.
And
Sangamo BioSciences, Inc.
TABLE OF CONTENTS
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Page |
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Article 1. |
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Definitions |
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1 |
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1.1 |
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Accept the [***] Evidence |
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1 |
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1.2 |
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Affiliate |
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1 |
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1.3 |
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[***] Gene |
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1 |
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1.4 |
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[***] Gene |
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2 |
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1.5 |
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BLA |
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2 |
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1.6 |
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Caltech Agreement |
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2 |
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1.7 |
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CHO |
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2 |
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1.8 |
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Collaboration Partner |
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2 |
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1.9 |
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Commercially Diligent Efforts |
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2 |
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1.10 |
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Confidential Information |
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2 |
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1.11 |
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Confidentiality Agreement |
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3 |
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1.12 |
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Controlled by |
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3 |
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1.13 |
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Covering |
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3 |
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1.14 |
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[***] Evidence |
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3 |
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1.15 |
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Delivery Days to Genentech |
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3 |
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1.16 |
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Designated Gene |
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3 |
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1.17 |
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Donor Sequence |
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3 |
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1.18 |
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Executive |
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4 |
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1.19 |
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Existing Third Party Licenses |
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4 |
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1.20 |
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First Commercial Sale |
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4 |
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1.21 |
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Functional [***] |
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4 |
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1.22 |
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Genentech CHO Cell Line |
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4 |
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1.23 |
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Genentech CHO DNA Extract |
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4 |
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1.24 |
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Genentech Deliverables |
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4 |
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1.25 |
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Genentech License |
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4 |
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1.26 |
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Genentech Materials |
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4 |
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1.27 |
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Identified Patents |
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4 |
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1.28 |
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Improved ZFN Reagent |
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4 |
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1.29 |
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Improvement |
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4 |
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1.30 |
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Invention |
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5 |
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1.31 |
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JHU Agreement |
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5 |
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1.32 |
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Know-How |
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5 |
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1.33 |
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Liaison |
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5 |
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1.34 |
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Licensed Product |
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5 |
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1.35 |
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Marketing Approval |
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5 |
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1.36 |
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Milestone Event |
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5 |
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1.37 |
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Milestone Payment |
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5 |
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1.38 |
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MIT Agreement |
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5 |
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1.39 |
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Modified Cell Line |
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5 |
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1.40 |
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Modified Genentech CHO Cell Line |
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6 |
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1.41 |
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Other Modified Cell Line |
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6 |
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1.42 |
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Patents |
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6 |
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*** |
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CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION |
-i-
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Page |
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1.43 |
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Phase I Clinical Trial |
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6 |
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1.44 |
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Phase III Clinical Trial |
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6 |
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1.45 |
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Research |
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6 |
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1.46 |
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Research Period |
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6 |
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1.47 |
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Research Plan |
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6 |
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1.48 |
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Research Results |
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6 |
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1.49 |
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Research Stage |
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6 |
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1.50 |
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Sangamo Deliverables |
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6 |
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1.51 |
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Sangamo IP Rights |
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6 |
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1.52 |
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Sangamo Know-How |
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7 |
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1.53 |
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Sangamo Patents |
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7 |
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1.54 |
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Scripps Agreement |
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7 |
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1.55 |
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Select Sangamo Licensors |
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7 |
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1.56 |
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Sublicense Agreement |
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7 |
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1.57 |
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Success Milestone Payment |
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7 |
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1.58 |
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Third Party |
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7 |
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1.59 |
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Third Party License |
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7 |
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1.60 |
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Utah Agreement |
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7 |
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1.61 |
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Valid Claim |
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7 |
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1.62 |
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ZFN |
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7 |
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1.63 |
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ZFN Modified Cell Line |
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7 |
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1.64 |
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ZFN Reagent |
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7 |
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Article 2. |
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Research Program |
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8 |
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2.1 |
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Liaisons. |
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8 |
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2.2 |
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Diligence; Decision Making; Research Plan. |
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8 |
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2.3 |
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[***] Evidence. |
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8 |
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2.4 |
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Non-Exclusive Relationship. |
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9 |
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2.5 |
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Improvements. |
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9 |
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Article 3. |
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Fees and Milestone Payments |
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10 |
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3.1 |
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Payments Generally. |
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10 |
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3.2 |
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Up-Front Fee. |
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10 |
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3.3 |
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Technology Access Fees. |
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10 |
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3.4 |
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Research Milestone Payments. |
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10 |
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3.5 |
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Success Milestone Payment. |
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11 |
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3.6 |
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Development and Commercial Milestone Payments. |
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11 |
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3.7 |
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Taxes. |
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12 |
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Article 4. |
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Intellectual Property |
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12 |
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4.1 |
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Disclosure of Inventions. |
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12 |
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4.2 |
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Ownership of Inventions; Cooperation. |
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12 |
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4.3 |
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Obtaining Patents. |
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12 |
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4.4 |
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Other Genentech Owned Inventions. |
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12 |
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4.5 |
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Enforcement of Sangamo Patents. |
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13 |
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*** |
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CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION |
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Page |
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Article 5. |
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Licenses |
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13 |
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5.1 |
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License to Genentech. |
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13 |
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5.2 |
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License to Sangamo. |
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15 |
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5.3 |
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No Implied Licenses. |
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15 |
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5.4 |
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Third Party Licenses. |
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15 |
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Article 6. |
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Confidential Information |
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15 |
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6.1 |
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Obligations. |
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15 |
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6.2 |
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General Exceptions. |
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16 |
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6.3 |
|
Disclosures Required by Law. |
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16 |
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6.4 |
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Disclosures to Third Party Licensors. |
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16 |
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6.5 |
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Termination of Prior Agreement. |
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16 |
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6.6 |
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Continuing Obligation. |
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17 |
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Article 7. |
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Genentech Materials and Related Information |
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17 |
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7.1 |
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Ownership. |
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17 |
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7.2 |
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Use. |
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17 |
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7.3 |
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Return or Destruction. |
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17 |
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Article 8. |
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Term and Termination |
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17 |
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8.1 |
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Term. |
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17 |
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8.2 |
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Termination by Either Party for Cause. |
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18 |
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8.3 |
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Termination of Research by Genentech for Cause. |
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18 |
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8.4 |
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Termination by Genentech for Convenience. |
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18 |
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8.5 |
|
Licenses. |
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18 |
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8.6 |
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Effects of Termination. |
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19 |
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8.7 |
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Survival. |
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19 |
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Article 9. |
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Indemnification; Limitation on Liability |
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19 |
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9.1 |
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Indemnification. |
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19 |
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9.2 |
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Limitation on Liability. |
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20 |
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Article 10. |
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Dispute Resolution |
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21 |
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10.1 |
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Internal Resolution. |
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21 |
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10.2 |
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Arbitration. |
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21 |
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10.3 |
|
Patent Disputes. |
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21 |
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10.4 |
|
Continued Performance. |
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22 |
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Article 11. |
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Public Disclosures; Use of Names |
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22 |
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11.1 |
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Publicity and Other Public Disclosures. |
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22 |
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11.2 |
|
Use of Names. |
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23 |
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Article 12. |
|
Warranties |
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23 |
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12.1 |
|
Mutual Warranties. |
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23 |
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12.2 |
|
Sangamo Warranties. |
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23 |
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12.3 |
|
Disclaimers. |
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24 |
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Article 13. |
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Notices |
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24 |
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Article 14. |
|
General Provisions |
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|
25 |
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14.1 |
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Governing Law. |
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25 |
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14.2 |
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Assignment. |
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|
25 |
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14.3 |
|
Entire Agreement. |
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25 |
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14.4 |
|
Amendment; Waiver. |
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25 |
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14.5 |
|
Severability. |
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25 |
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14.6 |
|
Construction. |
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25 |
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14.7 |
|
Captions. |
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26 |
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14.8 |
|
Relationship of the Parties. |
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|
26 |
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14.9 |
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Force Majeure. |
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26 |
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14.10 |
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Counterparts; Facsimiles. |
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26 |
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Exhibits |
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Exhibit A |
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Research Plan |
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Exhibit B |
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Designated Gene Sequences |
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Exhibit C |
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Identified Patents |
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Exhibit D |
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Press Release and Form 8-K Text |
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Exhibit E |
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Certain Agreements Relating to Third Party Licenses |
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Exhibit F |
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Certain Provisions of Third Party Licenses |
-iv-
Research and License Agreement
This Research and License Agreement (Agreement) is made and entered into, effective
as of April 27, 2007 (Effective Date), by and between Genentech, Inc., having a principal place
of business at 1 DNA Way, South San Francisco, California 94080, (Genentech) and Sangamo
BioSciences, Inc., having a principal place of business at Point Richmond Tech Center, 501 Canal
Boulevard, Suite A100, Richmond, California 94804 (Sangamo), (collectively, the Parties or
individually, a Party).
Recitals
Whereas, Genentech discovers, develops, manufactures, markets and sells human
pharmaceuticals on a worldwide basis;
Whereas, Sangamo has certain proprietary technology for modifying genes, which is of
interest to Genentech; and
Whereas, the Parties desire that Sangamo perform certain research using Sangamos
proprietary technology and one of Genentechs proprietary cell lines in accordance with the
research plan under this Agreement.
Agreement
Now, therefore, for good and valuable consideration, the receipt and sufficiency of
which is hereby acknowledged, Genentech and Sangamo agree as follows:
Article 1. Definitions
Capitalized terms used in this Agreement, whether used in the singular or plural, shall have
the meanings set forth below, unless otherwise specifically indicated herein.
1.1
Accept the [***] Evidence (and grammatical variations thereof) is defined in
the first paragraph under the heading Genentech Responsibilities (Research Stage 2) in the
Research Plan. Accept the [***] Evidence includes those cases in which Genentech is deemed to
Accept the [***] Evidence (including, without limitation, under Section 2.3).
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 this definition, the word control (including, with correlative
meaning, the terms controlled by or under the common control with) means (a) the direct or
indirect ownership of fifty percent (50%) or more of the stock having the right to vote for
directors thereof; or (b) 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 [***] Gene means a gene or genomic region whose translation product contains a portion that is
greater than 60% identical to a portion, consisting of contiguous residues of at
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-1-
least 30% of the total length, of one or more of the [***] sequences provided in Exhibit B, and any intronic,
transcriptional, or regulatory sequences that modulate the expression of such gene or genomic
region. For the purposes of this definition, alignment shall be performed by Sangamo using tBLASTn
(i.e., Basic Local Alignment Search Tool with a protein query and translated nucleotide database)
and default parameters. Notwithstanding the foregoing, but only for the purposes of the Research
Plan, the research milestone payments (under Section 3.4) and the Success Milestone Payment (under
Section 3.5), [***] Gene means only the CHO gene whose cDNA coding sequence is provided to Sangamo
in the Genentech Deliverables (at beginning of Research Stage 1).
1.4 [***] Gene means a gene or genomic region whose translation product contains
a portion that is greater than 60% identical to a portion, consisting of contiguous residues of at
least 30% of the total length, of one or more of the [***] sequences provided in Exhibit B, and any
intronic, transcriptional, or regulatory sequences that modulate the expression of such gene or
genomic region. For the purposes of this definition, alignment shall be performed by Sangamo using
tBLASTn (i.e., Basic Local Alignment Search Tool with a protein query and translated nucleotide
database) and default parameters. Notwithstanding the foregoing, but only for the purposes of the
Research Plan, the research milestone payments (under Section 3.4) and the Success Milestone
Payment (under Section 3.5), [***] Gene means only the CHO gene whose cDNA coding sequence is
provided to Sangamo in the Genentech Deliverables (at beginning of Research Stage 1).
1.5 BLA means a Biologics License Application or other such application (other
than a supplemental application) filed with the U.S. Food and Drug Administration (or any successor
entity thereto performing similar functions) for the purpose of obtaining Marketing Approval for a
Licensed Product in the United States.
1.6 Caltech Agreement means the Third Party License between Sangamo and the
California Institute of Technology, dated November 1, 2003, as amended as of the Effective Date,
and prior to any amendments after the Effective Date.
1.7 CHO means Chinese hamster ovary.
1.8 Collaboration Partner means, with respect to a given Licensed Product, a
Third Party to which Genentech has granted a license to use, sell, offer for sale and/or import
such Licensed Product, whether or not such license includes the right to make such Licensed
Product.
1.9 Commercially Diligent Efforts means, (a) with respect to Sangamo, efforts
and resources comparable to those expended by Sangamo on its projects for a Third Party of a
similar nature (i.e., protein production projects) and (b) with respect to Genentech, efforts and
resources comparable to those expended by Genentech on its internal process development projects of
comparable value to Genentech.
1.10 Confidential Information means a Partys nonpublic information that is disclosed to the other Party in connection
with this Agreement (including, without limitation, information regarding such Partys research,
technology, assays, protocols, methods, processes,
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-2-
data, products and business information or objectives), provided that any such information disclosed in written, electronic or other tangible
form is marked as confidential or with a similar legend. Nonpublic information of a Party that
is disclosed other than in tangible form (e.g., disclosed orally or by observation of the other
Party) shall be considered Confidential Information of such Party only if so identified in writing
to the other Party within thirty (30) days after initial disclosure and such writing identifies
such Confidential Information with particularity. Notwithstanding the foregoing marking
requirement, Genentechs Confidential Information shall include (a) the identity of the Designated
Genes as the focus of this Agreement; (b) Genentechs interest in the Designated Genes as potential
targets for modification to enhance the protein production of cell lines; (c) the Research Plan;
(d) the Research Results; and (e) all information in the Genentech Deliverables, whether or not any
of the foregoing information in (a) through (e) is so marked. The terms and conditions of this
Agreement (including, without limitation, the financial terms) shall be the Confidential
Information of both Parties.
1.11 Confidentiality Agreement is defined in Section 6.5.
1.12 Controlled by means the rightful possession by a Party of the ability to
grant a license, sublicense or other right to exploit, as provided in this Agreement, without
violating the terms of any agreement with any Third Party.
1.13 Covering (and grammatical variations thereof) means that, with respect to a given Licensed Product, a
protein contained in such Licensed Product was expressed by a Modified Cell Line and (a) the making
or use of such Modified Cell Line fell within the scope of a Valid Claim (in the country of such
making or use) at the time of such making or use; and/or (b) if such Modified Cell Line is a ZFN
Modified Cell Line, the making or use of a ZFN Reagent used to create such Modified Cell Line fell
within the scope of a Valid Claim (in the country of such making or use) at the time of such making
or use.
1.14 [***] Evidence is defined under the heading Sangamo Deliverables (at end
of Research Stage 2) in the Research Plan.
1.15 Delivery Days to Genentech means the number of days in the period starting
on the Effective Date and ending on the date on which Genentech has received all of the [***]
Evidence for both Designated Genes (regardless of how much time lapses before Genentech Accepts the
[***] Evidence). If Genentech does not ultimately Accept the [***] Evidence for both Designated
Genes, the Delivery Days to Genentech shall be deemed to be zero.
1.16 Designated Gene means [***].
1.17 Donor Sequence means, with respect to a given Designated Gene, a DNA sequence sharing homology with
sequences upstream and downstream of a ZFN cutting site in such Designated Gene, where such
sequences are of sufficient length [***] to allow homologous recombination to occur at an
efficiency of [***]. The Donor Sequence for a given Designated Gene shall also contain a DNA
sequence for insertion into such Designated Gene via homologous recombination, and such DNA
sequence may contain [***], as agreed to by the Liaisons.
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1.18 Executive means, in the case of Sangamo, its Chief Executive Officer and,
in the case of Genentech, a Senior Vice President, or their respective designees. Notwithstanding
the foregoing, in the event of a dispute arising under Section 2.3(c), Executive means, in the
case of Sangamo, its Chief Scientific Officer and, in the case of Genentech, its Senior Vice
President of Research Drug Discovery or its Executive Vice President of Research.
1.19 Existing Third Party Licenses means the Caltech Agreement, the JHU
Agreement, the MIT Agreement, the Scripps Agreement and the Utah Agreement.
1.20 First Commercial Sale means the first bona fide commercial sale of a
product in a country following Marketing Approval for such product in such country by or under
authority of Genentech or its sublicensees.
1.21 Functional [***] (and grammatical variations thereof) means the targeted
alteration of DNA sequences in [***] of a Designated Gene, where such alteration [***].
1.22 Genentech CHO Cell Line means the CHO cell line provided to Sangamo in the
Genentech Deliverables.
1.23 Genentech CHO DNA Extract means the extract of purified genomic DNA from
the Genentech CHO Cell Line that is provided to Sangamo in the Genentech Deliverables.
1.24 Genentech Deliverables means those materials, information, reports and
other items that Genentech provides to Sangamo under this Agreement including, without limitation,
those identified under the heading Genentech Deliverables in the various Research Stages of the
Research Plan.
1.25 Genentech License is defined in Section 5.1(a).
1.26 Genentech Materials means tangible materials included in the Genentech
Deliverables including, without limitation, the Genentech CHO Cell Line and the Genentech CHO DNA
Extract. Genentech Materials also include tangible biological materials derived physically from
Genentech Materials including, without limitation, ZFN Modified Cell Lines derived from the
Genentech CHO Cell Line or from another Genentech proprietary cell line.
1.27 Identified Patents means those patents and patent applications identified
on Exhibit C (including those owned and those in-licensed by Sangamo).
1.28 Improved ZFN Reagent means a ZFN Reagent that incorporates or is made using
an Improvement.
1.29 Improvement means any improvement made by or on behalf of Sangamo during the term of the Agreement
(whether or not such improvement is patentable) to ZFNs and associated reagents (including, without
limitation, expression plasmids and Donor Sequences) and/or Sangamo Know-How (including
methodologies/protocols for creating ZFN Modified Cell Lines), where such improvement would improve
by [***] the (a) efficiency of creating ZFN Modified Cell Lines; (b) time taken to create ZFN
Modified Cell Lines; and/or (c) activity of any ZFN Reagent. For purposes of this definition,
efficiency refers to: (i) transfer
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-4-
efficiency, in terms of percent of cells that uptake ZFN
Reagents by transfection or comparable procedure; or (ii) frequency of targeted alteration in a
Designated Gene within a population of cells, after delivery of ZFN Reagent(s) to such population.
For purposes of this definition, time taken refers to the time taken from delivery of a ZFN
Reagent(s) to a cell line to the identification of a clone in which a Designated Gene has been
Functionally [***]. For purposes of this definition, activity refers to: (i) DNA binding
activity or strength of the DNA binding domain of a ZFN; (ii) DNA cleavage activity of the nuclease
domain of a ZFN Reagent; (iii) in vivo activity in terms of percent of cells in which a Designated
Gene has been Functionally [***], after delivery of ZFN Reagent(s) to such cells; or (iv) frequency
of homologous recombination with Donor Sequences.
1.30 Invention is defined in Section 4.1.
1.31 JHU Agreement means the Third Party License between Sangamo and Johns
Hopkins University, dated June 29, 1995, as amended as of the Effective Date, and prior to any
amendments after the Effective Date.
1.32 Know-How means information or materials including, without limitation,
sequence information, data, assays, protocols, methods, processes, techniques, models, designs,
libraries and trade secrets.
1.33 Liaison is defined in Section 2.1.
1.34 Licensed Product means a product that contains a protein expressed by a
Modified Cell Line.
1.35 Marketing Approval means all approvals, licenses, registrations or
authorizations of any federal, state or local regulatory agency, department, bureau or other
governmental entity, necessary for the manufacturing, use, storage, import, transport and sale of a product in a regulatory
jurisdiction. For countries where governmental approval is required for pricing or reimbursement
for such product to be reimbursed by national health insurance, Marketing Approval shall not be
deemed to occur until such pricing or reimbursement approval is obtained.
1.36 Milestone Event means a milestone event identified in the table in Section
3.6(b).
1.37 Milestone Payment means a milestone payment identified in the table in
Section 3.6(b).
1.38 MIT Agreement means the Third Party License between Sangamo and the
Massachusetts Institute of Technology, dated May 9, 1996, as amended as of the Effective Date, and
prior to any amendments after the Effective Date.
1.39 Modified Cell Line means a ZFN Modified Cell Line or an Other Modified Cell Line.
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1.40 Modified Genentech CHO Cell Line means a ZFN Modified Cell Line derived
from the Genentech CHO Cell Line.
1.41 Other Modified Cell Line means a cell line that contains one or more
targeted alterations in the genomic DNA (when compared with the parental cell line from which it
was derived) of either or both of the Designated Genes, where no alterations in the genomic DNA of
such cell line are the result of using ZFN Reagents.
1.42 Patents means all United States and foreign patents and patent applications
and any patents issuing therefrom, and any reissues, extensions, registrations, continuations,
divisions, continuations-in-part, reexaminations, substitutions or renewals thereof, and
supplementary protection certificates based thereon.
1.43 Phase I Clinical Trial means a human clinical trial, the principal purpose
of which is preliminary determination of safety in healthy individuals or patients as described in
21 C.F.R. §312.21, or a similar clinical study in a country other than the United States.
1.44 Phase III Clinical Trial means a human clinical trial that is prospectively
designed to demonstrate statistically whether a product is safe and effective for use in humans in
a manner sufficient to obtain regulatory approval to market such product in patients having the
disease or condition being studied as described in 21 C.F.R. §312.21, or a similar clinical study
in a country other than the United States.
1.45 Research means the research activities set forth in the Research Plan.
1.46 Research Period means the period during which research activities under the
Research Plan are ongoing.
1.47 Research Plan means the plan for the research activities to be performed by
the Parties under this Agreement, as outlined in Exhibit A.
1.48 Research Results means all (a) data (including, without limitation, the
underlying data, summarized data and reports); and (b) Know-How related specifically to the
Genentech Materials, in each case, generated in the course of and/or drawn from the Research by
either Party.
1.49 Research Stage means a particular stage of the Research, as identified in
the Research Plan.
1.50 Sangamo Deliverables means those materials, information, reports and other
items that Sangamo provides to Genentech under this Agreement including, without limitation, those
identified under the heading of Sangamo Deliverables in the various Research Stages of the
Research Plan.
1.51 Sangamo IP Rights means Sangamos intellectual property rights in the
Sangamo Know-How and the Sangamo Patents.
-6-
1.52 Sangamo Know-How means Know-How that is Controlled by Sangamo, existing as
of the Effective Date or thereafter, to the extent necessary or reasonably useful to make or use
(including for validation purposes) ZFN Reagents and/or ZFN Modified Cell Lines.
1.53 Sangamo Patents means Patents that are Controlled by Sangamo, existing as
of the Effective Date or thereafter, having one or more claims that encompass (a) ZFN Reagents
and/or ZFN Modified Cell Lines; and/or (b) the making and/or use of ZFN Reagents and/or ZFN
Modified Cell Lines. Sangamo Patents include, without limitation, the Identified Patents.
1.54 Scripps Agreement means the Third Party License between Sangamo and the
Scripps Research Institute, dated March 14, 2000, prior to any amendments after the Effective Date.
1.55 Select Sangamo Licensors means the Massachusetts Institute of Technology
and its trustees, directors, officers, employees and affiliates, and Johns Hopkins University and
its trustees, officers, employees, students and affiliates.
1.56 Sublicense Agreement is defined in Section 5.1(c).
1.57 Success Milestone Payment is defined in Section 3.5.
1.58 Third Party means any entity other than Sangamo or Genentech.
1.59 Third Party License is defined in Section 5.4(a).
1.60 Utah Agreement means the Third Party License between Sangamo and the
University of Utah Research Foundation, dated September 8, 2004, as amended as of the Effective
Date, and prior to any amendments after the Effective Date.
1.61 Valid Claim means a claim of an issued and unexpired patent that (a) is
within the Sangamo Patents; and (b) has not been found to be unpatentable, invalid or unenforceable
by a decision of a court or other authority in the country of the patent, from which decision no
appeal is taken or can be taken.
1.62 ZFN means a (a) zinc-finger nuclease protein or (b) nucleic acid coding
sequence that encodes such a nuclease.
1.63 ZFN Modified Cell Line means a cell line that contains one or more targeted
alterations in the genomic DNA (when compared with the parental cell line from which it was
derived) of either or both of the Designated Genes, where at least one (1) of such alterations in
such Designated Genes is the result of using ZFN Reagents.
1.64 ZFN Reagent means, with respect to a given Designated Gene, (a) a ZFN that
specifically targets such Designated Gene; and/or (b) any Donor Sequence for such Designated Gene,
in each case, where such ZFN and/or Donor Sequence is one that is provided by Sangamo to Genentech
under this Agreement. ZFN Reagents also include Improved ZFN Reagents and copies of ZFN Reagents,
whether made by Sangamo, Genentech or a Third Party.
-7-
Article 2. Research Program
2.1 Liaisons. Promptly following the Effective Date, each Party shall designate
an individual to act as the primary contact for such Party for matters related to this Agreement
(referred to in this Agreement as such Partys Liaison), unless another contact is expressly
provided herein. Until the completion of the activities in Research Stage 2, the Liaisons shall
schedule teleconferences or meetings at least every four (4) weeks or as otherwise agreed. In
addition, at any time during the Research Period, upon Genentechs reasonable request, the Parties
shall discuss the results of activities under the Research Plan thus far obtained by telephone or
as otherwise agreed.
2.2 Diligence; Decision Making; Research Plan. Each Party shall perform its
respective obligations under the Research Plan using Commercially Diligent Efforts. Sangamos
Liaison shall have final decision making authority with respect to [***]; Genentechs Liaison shall
have final decision making authority with respect to [***]. No change in the Research Plan or
funding shall be permitted without the prior written agreement of the Parties. In the event of any
conflict or inconsistency between the main body of this Agreement and the Research Plan, the terms
and conditions of the main body shall prevail.
2.3 [***] Evidence.
(a) Review and Notice. As set forth under the heading Genentech Responsibilities
(Research Stage 2) in the Research Plan, Genentech shall review the [***] Evidence for a given
Designated Gene. Within three (3) weeks after receipt of such [***] Evidence (for purposes of this
Section 2.3, the Review Period), Genentech shall notify Sangamo as to whether or not Genentech
Accepts such [***] Evidence. If Genentech does not notify Sangamo as to whether or not it Accepts
such [***] Evidence by the end of such Review Period, Sangamo shall send a reminder notice to
Genentech that a response is due, and the initial Review Period shall be automatically extended
until the date that is one (1) week from the date Sangamos reminder notice is received by
Genentech. If Genentech does not notify Sangamo as to whether or not it Accepts such [***]
Evidence by the end of such extended Review Period, Genentech shall be deemed to Accept such [***]
Evidence.
(b) Rejection of [***] Evidence. If Genentech notifies Sangamo under Section
2.3(a) that Genentech does not Accept such [***] Evidence, Genentechs notice shall specifically
identify the reason(s) for the rejection. If such rejection is because Sangamo did not provide all
of the required [***] Evidence, and Sangamo does not dispute such rejection, Sangamo shall provide
the missing [***]Evidence and the initial Review Period (and review procedures under Section
2.3(a)) shall begin again upon Genentechs receipt of such additional [***] Evidence.
(c) Disputed Rejection of [***] Evidence. In the event that Sangamo believes that
Genentechs rejection (for any reason) of given [***] Evidence is not justified, the Parties shall
attempt to resolve such dispute through amicable discussions between the Parties respective
Liaisons. In the event that the Liaisons are unable to resolve such dispute within [***] weeks
after Genentechs notice of rejection, [***].
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-8-
(d) Other Research Stage 2 Sangamo Deliverables. Unless and until Genentech
Accepts the [***] Evidence with respect to a given Designated Gene, Sangamo shall not have any
obligation to provide to Genentech those ZFN Reagents and Modified Genentech CHO Cell Lines for
such Designated Gene, or any Sangamo Know-How or training, as described under the heading Sangamo
Deliverables (at end of Research Stage 2) in the Research Plan for such Designated Gene.
2.4 Non-Exclusive Relationship.
(a) ZFN Reagents and ZFN Modified Cell Lines. Excluding Modified Genentech CHO
Cell Lines, and subject to this Section 2.4 and other provisions of this Agreement, Sangamo retains
the right to (i) make and use ZFN Reagents and ZFN Modified Cell Lines for itself and others; (ii)
sell or otherwise transfer ZFN Reagents and ZFN Modified Cell Lines to Third Parties; and (iii)
grant licenses to Third Parties with respect to ZFN Reagents and ZFN Modified Cell Lines.
(b) Delivery Times to Third Parties. With respect to ZFN Reagents other than
Improved ZFN Reagents, Sangamo shall not provide such ZFN Reagents to any Third Party [***].
Further, Sangamo shall not provide Improved ZFN Reagents to any Third Party [***]; after the end of
such period, Sangamo may provide Improved ZFN Reagents to Third Parties at any time. For clarity,
in the event that Genentech does not ultimately Accept the [***] Evidence for [***], this Section
2.4(b) shall place no restriction on Sangamos ability to provide ZFN Reagents (including Improved
ZFN Reagents) to Third Parties.
(c) [***]. Sangamo shall not provide any ZFN Reagents and/or grant licenses under
the Sangamo IP Rights with respect to the Designated Genes that are [***]. Any election to make
such substitution shall be made by Genentech (if at all) in writing within thirty (30) days after
Genentech receives such notice. If such substitution results in
[***],
the amount of [***] within thirty (30) days after
Sangamos receipt of Genentechs written election to make such substitution. If [***]
the amount of [***] shall be [***] under this Agreement.
2.5 Improvements.
(a) Notices; Payments to Third Parties. During the Research Period, Sangamo shall notify
Genentech of any Improvements at least on a [***] basis; thereafter, such notice shall be at least
on a [***] basis. Such notice for a given Improvement shall (i) identify the [***] and (ii)
include, if applicable, the same notice that Sangamo would provide under Section 2.5(d).
Thereafter, Genentech may request that Sangamo provide Improvements to Genentech by notifying
Sangamo of the particular Improvement(s) being requested. [***]. Nothing in this Section 2.5
shall be interpreted as obligating Sangamo to take any action that would constitute a breach of any
agreement with any Third Party.
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(b) Provision of Improvements. If Sangamo makes an Improvement to a ZFN Reagent
for a Designated Gene, Sangamo shall provide the applicable Improved ZFN Reagent to Genentech
([***])). If Sangamo makes an Improvement that is not to a ZFN Reagent for a Designated Gene,
[***]. If Sangamo makes an Improvement to methodologies/protocols for using ZFN Reagents, Sangamo
shall provide such methodologies/protocols to Genentech. Sangamo shall also provide to Genentech
any and all Sangamo Know-How that is necessary to enable Genentech to use Improved ZFN Reagents to
create ZFN Modified Cell Lines. Other than [***] agreed to by Genentech under Section 2.5(a), any
Improved ZFN Reagents, materials or Sangamo Know-How provided to Genentech under this Section
2.5(b) shall be [***] to Genentech and shall be provided promptly after Genentechs request for a
particular Improvement under Section 2.5(a).
(c) Training. If requested by Genentech, for each Improvement, Sangamo shall
provide to Genentech researcher(s) (at Sangamos research site in Richmond, CA) up to [***] of
training in the making and use of Improved ZFN Reagents at Sangamos then current FTE (i.e., full
time equivalent) rates.
(d) Notice of Third Party IP. Sangamo shall promptly notify Genentech if Sangamo
learns of any Third Party intellectual property that, in Sangamos reasonable opinion, could
potentially be infringed by the making or use of an Improvement or an Improved ZFN Reagent provided
to Genentech under Section 2.5(b).
Article 3. Fees and Milestone Payments
3.1 Payments Generally. Each payment due under this Article 3 (including, without
limitation, Milestone Payments) shall be paid to Sangamo within [***] days of receipt of an invoice
from Sangamo to be sent to Genentech following the achievement of the event triggering such
payment. All invoices shall identify the event triggering the payment being invoiced and, unless
otherwise requested by Genentech in writing, shall be sent to Genentech at the address in the
preamble of this Agreement, to the attention of Group Controller, [***]. All payments due under
this Agreement shall be paid in U.S. dollars in immediately available funds by wire transfer to an
account to be identified by the payee and shall be non-refundable and non-creditable against any
other payment due Sangamo under this Agreement, except as provided under Section 2.4(c).
3.2 Up-Front Fee. Upon the signing of this Agreement by both Parties, Genentech
shall pay to Sangamo an up-front fee of $[***].
3.3 Technology Access Fees. Three (3) months after the Effective Date, Genentech
shall pay to Sangamo an initial technology access fee of $[***]. Thereafter, on each anniversary
of the Effective Date (starting with the first anniversary) prior to the First Commercial Sale of
the first Licensed Product, Genentech shall pay to Sangamo an annual technology access fee of
$[***].
3.4
Research Milestone Payments. For each Designated Gene, if Genentech (a) [***] for such Designated Gene; (b) [***] for
such Designated Gene; and (c) [***] for such Designated Gene, Genentech shall notify Sangamo
(within [***] days of the achievement of all
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of such events) and pay to Sangamo a research milestone payment of $[***].
Notwithstanding the payment provisions of Section 3.1, if the [***], such payment shall not be due
until [***] days after Genentechs receipt of replacement ZFN Reagents that are not defective.
3.5 Success Milestone Payment. Upon Genentechs successful in-house generation
[***], Genentech shall notify Sangamo (within [***] days of the achievement of such event) and pay
to Sangamo a success milestone payment of $[***] (Success Milestone Payment); if Genentech,
despite its Commercially Diligent Efforts, does not [***], no Success Milestone Payment shall be
due.
3.6 Development and Commercial Milestone Payments.
(a) Payments Generally. Upon the first achievement of each Milestone Event with
respect to a given Licensed Product by or on behalf of Genentech (or a Collaboration Partner),
Genentech shall notify Sangamo (within [***] days of when Genentech becomes aware of the
achievement of such event) and pay (or cause to be paid) to Sangamo the corresponding Milestone
Payment, subject to the other provisions of this Section 3.6. For purposes of this Agreement, a
given Licensed Product shall be treated as different from another Licensed Product if the marketing
of each of such Licensed Products in the United States would require separate BLA submissions.
(b) Milestone Events and Milestone Payments.
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(#1)[***]
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(#2) [***]
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(#3) [***]
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(#4) [***]
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(#5) [***]
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(#6) [***]
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(c) Term of Milestone Payment Obligation. Genentechs obligation to make
Milestone Payments for a given Licensed Product under this Section 3.6 shall be in accordance with
the following:
(i) [***]; or
(ii) [***].
(d) Retroactive Payments. [***]
(e) Single Milestone Payment. In no event shall a particular Milestone Payment be due to
Sangamo more than once with respect to a given Licensed Product, even if
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such Licensed Product
contains more than one (1) protein expressed by a Modified Cell Line or is Covered by more than one
Valid Claim.
3.7 Taxes. Each Party shall comply with applicable laws and regulations regarding
filing and reporting for income tax purposes. Neither Party shall treat their relationship under
this Agreement as a pass through entity for tax purposes. All payments made under this Agreement
shall be free and clear of any and all taxes, duties, levies, fees or other charges, except for
withholding taxes. Each Party shall be entitled to deduct from its payments to the other Party
under this Agreement the amount of any withholding taxes required to be withheld, to the extent
paid to the appropriate governmental authority on behalf of the other Party (and not refunded or
reimbursed). Each Party shall deliver to the other Party, upon request, proof of payment of all
such withholding taxes. Each Party shall provide reasonable assistance to the other Party in
seeking any benefits available to such Party with respect to government tax withholdings by any
relevant law, regulation or double tax treaty.
Article 4. Intellectual Property
4.1 Disclosure of Inventions. Invention means any invention or discovery
(including any Know-How), whether or not patentable, that is discovered, conceived or reduced to
practice in the course of performing activities under the Research Plan. Sangamo shall promptly
disclose to Genentech Inventions that are discovered, conceived or reduced to practice by or on
behalf of Sangamo (whether solely or jointly with another party).
4.2 Ownership of Inventions; Cooperation. Except as otherwise expressly provided
in this Agreement, ownership of Inventions will follow inventorship, as determined by the
respective patent counsel of the Parties in accordance with United States patent law. Each Party
shall reasonably cooperate with and assist the other Party, at such other Partys request, in
connection with the filing and prosecution of patent applications for Inventions owned by such
other Party including, without limitation, by making scientists and scientific records reasonably
available to such other Party.
4.3 Obtaining Patents. Sangamo shall, at its expense, use commercially reasonable
efforts to obtain patent protection covering (a) the ZFN Reagents (other than Improved ZFN
Reagents); (b) the use of such ZFN Reagents in CHO cell lines to create ZFN Modified Cell Lines;
and (c) ZFN Modified Cell Lines. Sangamo may, at its sole discretion, use the Research Results to
fulfill its obligations
under the preceding sentence. Further, in consultation with Genentech, Sangamo shall, at its
expense, use commercially reasonable efforts to file a patent application that specifically claims
[***]. Sangamo shall assign any such application to Genentech, and Genentech shall control
prosecution of such application.
4.4
Other Genentech Owned Inventions. If Sangamo files any patent application that claims an invention that is specifically
related to the Genentech CHO Cell Line or the Genentech CHO DNA Extract (including sequence
information derived therefrom), and such invention is not generally applicable to CHO cells or CHO
DNA, Sangamo shall (a) cancel any claims to such invention in such patent application; (b) file
such claims in a subsequent divisional or continuation application; (c) assign such subsequent
application to Genentech; and (d) transfer control of prosecution of such subsequent application to
Genentech. If the Parties
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disagree, Genentech shall bear the burden of demonstrating that such
invention is specifically related to the Genentech CHO Cell Line or the Genentech CHO DNA Extract
and is not generally applicable to CHO cells or CHO DNA.
4.5 Enforcement of Sangamo Patents. If either Party learns of any alleged
infringement of any Sangamo Patents by a Third Partys making of Licensed Products for commercial
purposes, that Party shall promptly notify the other Party of such alleged infringement. Sangamo
shall retain the sole right, at its sole discretion, to enforce the Sangamo Patents against such
alleged Third Party infringers. However, if Sangamo fails to abate any such alleged infringement
of the Sangamo Patents involving modification of the genomic DNA of either or both of the
Designated Genes in a manufacturing cell line within [***] after receipt of notice (by either
Party) under this Section 4.5, Genentech shall be entitled to reduce the Milestone Payments by
[***] of the payments that would otherwise be due until such time as Sangamo abates such
infringement or until a final determination regarding such alleged infringement has been reached
(i.e., a final non-appealable court action or settlement).
Article 5. Licenses
5.1 License to Genentech.
(a) Genentech License. Sangamo hereby grants to Genentech a non-exclusive,
worldwide, sublicensable (in accordance with Section 5.1(b)) license, under the Sangamo IP Rights,
(i) to make, use and import ZFN Reagents (and any associated expression plasmids provided by
Sangamo to Genentech under this Agreement) solely for the purpose of altering the genomic DNA of
either or both of the Designated Genes in a cell line to create ZFN Modified Cell Lines; (ii) to
alter the genomic DNA of either or both of the Designated Genes in a cell line to create Modified
Cell Lines; and (iii) to make, use and import Modified Cell Lines created under clauses (i) and
(ii) solely for the purpose of making Licensed Products. The foregoing license is referred to in
this Agreement as the Genentech License. Notwithstanding anything
to the contrary in this Agreement, the Genentech License does not include a license to alter
any genomic DNA other than the genomic DNA of a Designated Gene. The Genentech License is subject
to the provisions of Section 5.4(a).
(b) Right to Grant Sublicenses. Subject to Section 5.1(d), Genentech has the right to grant
sublicenses under the Genentech License to a Third Party(ies) if (i) such sublicense is related to
particular Licensed Product(s) that were the subject of Genentechs research and/or development or
were in-licensed by Genentech (and not related to Licensed Products in general); and (ii) Genentech
has previously granted or concurrently grants (i.e., together with the grant of such sublicense) to
such Third Party a license, under intellectual property rights other than the Genentech License,
related to such particular Licensed Product(s) or to product(s) that contain the same protein(s) as
such particular Licensed Product(s). Subject to Section 5.1(d), any such sublicense may be further
sublicensed by a sublicensee to multiple tiers of sublicensees, subject to the same requirement
regarding a previously or concurrently granted license by such sublicensee. In addition, Genentech
has the right to grant sublicenses under the Genentech License to a Third Party(ies) if Genentech
receives the prior written consent of Sangamo, which shall not be unreasonably withheld.
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(c) Requirements for Sublicense Agreements. Each agreement granting a sublicense
under the Genentech License (each such agreement, a Sublicense Agreement) shall require that the
relevant sublicensee agrees in writing that the sublicense granted in such Sublicense Agreement is
subject to those terms and conditions of the Third Party Licenses that are set forth in Exhibit E
mutatis mutandis (e.g., as if applicable references to Genentech, this Agreement and the
Genentech License were, respectively, references to such sublicensee, such Sublicense Agreement
and such sublicense) with respect to each Third Party License sublicensed thereunder. Genentech
shall provide to Sangamo copies of any Sublicense Agreements (which shall be deemed to be the
Confidential Information of Genentech, whether or not so marked) promptly after execution thereof;
provided, however, Genentech may redact such copies to delete any provisions that are not relevant
to this Agreement or a Third Party License. Sangamo may disclose such copies of Sublicense
Agreements (or summaries of their terms) to the applicable Third Party licensor, in accordance with
Section 6.4.
(d) Caltech IP. Sangamo hereby notifies Genentech that, pursuant to Section 2.3
of the Caltech Agreement, Genentech does not have the right to grant sublicenses under the
intellectual property licensed to Sangamo pursuant to the Caltech Agreement. Upon Genentechs
written request, Sangamo shall promptly grant (not subject to any additional terms and conditions
including, without limitation, any additional payments or other consideration) a non-exclusive
license, under the intellectual property licensed to Sangamo pursuant the Caltech Agreement, to any
Third Party to which Genentech is permitted under Section 5.1(b) of this Agreement to grant a
sublicense. The scope of such license shall satisfy the requirement set forth in Section 5.1(b)(i)
and shall in no event be greater than the scope of the Genentech License.
(e) Exercise of License Rights by a Third Party. Third Parties may exercise the
make and/or use license rights granted to Genentech (or a sublicensee) under the
Genentech License on Genentechs (or such sublicensees) behalf without the grant of a
sublicense of such rights.
(f) Materials. Genentech shall not modify the ZFN Reagents in any way or create
any derivatives or sequence variants thereof (other than for the purpose of creating Improved ZFN
Reagents); provided, however, Genentech may transfer the ZFNs from ZFN Reagents into different
expression plasmids. As between Genentech and Sangamo, Genentech shall own any ZFN Reagents and
ZFN Modified Cell Lines made by Genentech, a sublicensee under the Genentech License or a Third
Party on behalf of Genentech or such sublicensee; provided, however, such ownership is with respect
to the tangible materials and does not imply ownership of intellectual property pertaining to or
embodied in such tangible materials, which shall be in accordance with the other provisions of this
Agreement.
(g) Fully Paid. Upon the expiration of Genentechs obligation to make Milestone
Payments for a given Licensed Product, the Genentech License (including any sublicenses granted
thereunder) with respect to such Licensed Product shall be fully-paid and irrevocable.
(h) No Non-Permitted Use. Genentech hereby covenants that it shall not willfully,
nor shall it expressly cause or permit any Third Party, (i) to make, use, import, modify
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or reverse
engineer ZFN Reagents and any associated expression plasmids for any purpose other than creating
ZFN Modified Cell Lines; or (ii) to practice any invention claimed in a Sangamo Patent for the
purpose of altering genomic DNA other than the genomic DNA of a Designated Gene.
5.2 License to Sangamo. Genentech hereby grants to Sangamo a non-exclusive,
non-sublicensable license, under intellectual property rights Controlled by Genentech, solely for
the purpose of performing Sangamos activities under the Research Plan.
5.3 No Implied Licenses. Except to the limited extent necessary for a Party to
perform its obligations under this Agreement, or as otherwise expressly provided herein, this
Agreement does not grant any right or license under any intellectual property rights of a Party, or
otherwise, and no other right or license is to be inferred from any provision of this Agreement or
by the conduct of the Parties.
5.4 Third Party Licenses.
(a) Performance Under Third Party Licenses. The Genentech License includes
sublicenses under Sangamo IP Rights licensed (as of the Effective Date or thereafter) to Sangamo
pursuant to agreements with Third Parties (each such agreement, a Third Party License). As a
result, this Agreement and the Genentech License are subject to those terms and conditions of the
Third Party Licenses that are set forth in Exhibit E. Except to the extent set forth in Exhibit E, Sangamo
shall be responsible for performing all obligations under the
Third Party Licenses including, without limitation, any payment obligations, even if such payment
arises as a result of Genentechs (or its sublicensees) activities under this Agreement.
(b) Maintenance. With respect to each Third Party License, Sangamo shall not (i)
commit any acts or omissions that reasonably could cause a breach of such Third Party License; (ii)
amend or terminate such Third Party License; or (iii) exercise or waive any rights it may have
under such Third Party License, in each of the foregoing cases, in any way that reasonably could
adversely affect the Genentech License (including any sublicenses granted thereunder) or impose
additional obligations on Genentech. In the event that Sangamo receives a notice of a breach of a
Third Party License that reasonably could adversely affect the Genentech License, Genentech shall
reasonably cooperate with Sangamo to cure such breach.
(c) Notices. With respect to each Third Party License, Sangamo shall notify
Genentech within ten (10) business days after Sangamo first obtains knowledge or any information
regarding any events or circumstances relating to such Third Party License that reasonably could
adversely affect the Genentech License including, without limitation, (i) any notice of breach or
termination, or any threat of breach or termination, of such Third Party License; and (ii) any
communication regarding the scope of the rights granted in such Third Party License.
Article 6. Confidential Information
6.1 Obligations. Each Party agrees (a) to use the other Partys Confidential
Information solely for the purposes of, and in accordance with, this Agreement; and (b) except as
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otherwise expressly permitted in this Agreement, to not disclose the other Partys Confidential
Information to any Third Party without the other Partys prior written consent. Sangamo hereby
consents that Sangamos Confidential Information may be disclosed to Third Parties to which a
sublicense (under the Genentech License) is granted under Section 5.1(b) or Third Parties that may
exercise license rights (under the Genentech License) under Section 5.1(e), provided that any such
Third Party has a need to know such Confidential Information and is subject to obligations of
confidentiality and limitations on use to substantially the same extent as required by the
provisions of this Article 6.
6.2 General Exceptions. The obligations under Section 6.1 do not pertain to any
Confidential Information that a Party establishes by documentary evidence (a) was already known to
such Party, other than under an obligation of confidentiality, at the time of disclosure by the
other Party; (b) was generally available to the public or otherwise part of the public domain at
the time of its disclosure to such Party; (c) became generally available to the public or otherwise
part of the public domain after its disclosure and other than through any act or omission of such
Party in breach of this Agreement; (d) was disclosed to such Party, other than under an obligation
of confidentiality, by a Third Party who had no obligation to the other Party not to disclose such
information to others; or (e) was independently developed by or on behalf of such Party
without use of the other Partys Confidential Information.
6.3 Disclosures Required by Law. Notwithstanding any other provision of this
Agreement, a Party may disclose Confidential Information of the other Party if such disclosure is
required by law, rule or regulation (including, without limitation, to comply with any court order
or governmental regulation, including the duty to disclose Confidential Information material to
patentability under 37 CFR §1.56), provided that the Party making such disclosure shall give
reasonable advance written notice to the other Party of such requirement and, at such other Partys
request, shall cooperate with such other Partys efforts to limit such disclosure or to secure
confidential treatment of such Confidential Information through protective orders or otherwise.
6.4 Disclosures to Third Party Licensors. Notwithstanding any other provision of
this Agreement, Sangamo may disclose this Agreement or a Sublicense Agreement (or a summary of
their terms) to a Third Party licensor with respect to a given Third Party License, provided that
(a) such disclosure is limited to the extent required by such Third Party License (e.g., financial
provisions are redacted to the extent possible); (b) the identity of the Designated Genes, the
Research Plan and information about the intellectual property licensed under this Agreement or a
Sublicense Agreement (other than the intellectual property licensed under such Third Party License)
are not disclosed; and (c) such Third Party licensor is subject to obligations of confidentiality
and limitations on use to substantially the same extent as required by the provisions of this
Article 6. Prior to making any disclosure under this Section 6.4, Sangamo shall notify Genentech
of its intent to make such disclosure and provide to Genentech a copy of any summary of terms
provided to such Third Party licensor.
6.5 Termination of Prior Agreement. As of the Effective Date, this Agreement
supersedes and terminates the Mutual Confidentiality Agreement between the Parties, effective as of
January 20, 2005 (Confidentiality Agreement). All INFORMATION (as defined in the
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Confidentiality Agreement) exchanged between the Parties there under shall be deemed Confidential
Information hereunder and shall be subject to the provisions of this Article 6.
6.6 Continuing Obligation. The provisions of this Article 6 shall continue for a
period of fifteen (15) years after termination or expiration of this Agreement.
Article 7. Genentech Materials and Related Information
7.1 Ownership. Genentech shall own the Genentech Materials and all tangible materials included in the Sangamo
Deliverables. The ownership of any tangible materials (including, without limitation, ZFN Modified
Cell Lines derived from the Genentech CHO Cell Line) is with respect to such tangible materials and
does not imply ownership of intellectual property pertaining to or embodied in such tangible
materials, which shall be in accordance with the other provisions of this Agreement.
7.2 Use. Sangamo agrees that it shall use the Genentech Materials solely for the
purpose of performing activities under the Research Plan and it shall not transfer any Genentech
Materials to any Third Party without Genentechs prior written consent. Genentech hereby consents
that Sangamo may transfer the Genentech CHO DNA Extract to a Third Party solely to enable such
Third Party to perform [***] on Sangamos behalf, for the benefit of Genentech. Sangamo agrees
that any Third Party for which Genentech consents to the transfer of Genentech Materials shall be
contractually bound in writing (a) to limitations on the use of such Genentech Materials at least
as restrictive as those set forth in this Section 7.2; (b) to not further transfer such Genentech
Materials; and (c) to confidentiality and limitation on use obligations at least as restrictive as
those set forth in Article 6 with respect to any information generated or otherwise acquired by
such Third Party as a result of its possession or use of such Genentech Materials (and any such
information shall be included in the Research Results). Sangamo shall be jointly and severally
liable for any misuse by a Third Party of Genentech Materials received from Sangamo.
7.3 Return or Destruction. Within thirty (30) days following the end of the
Research Period or the expiration or termination of this Agreement, Sangamo shall promptly return
or destroy, as instructed by Genentech, all (a) Genentech Materials remaining in Sangamos
possession or the possession of any Third Party that received such Genentech Materials from Sangamo
hereunder; and (b) Know-How and other information provided to Sangamo in the Genentech Deliverables
(at beginning of Research Stage 1) and any other information related to the Genentech Materials
provided by Genentech to Sangamo. After such return or destruction, Sangamo shall provide written
certification to Genentech that all such remaining Genentech Materials and all such information
have been returned or destroyed (as applicable).
Article 8. Term and Termination
8.1 Term. This Agreement shall be effective as of the Effective Date. Unless
sooner terminated as provided in this Article 8, this Agreement shall remain in effect until
Sangamo is no longer entitled (in fact or potentially) to receive Milestone Payments from Genentech
pursuant to Section 3.6.
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8.2 Termination by Either Party for Cause. Either Party may terminate this Agreement for a material breach by the other Party of the
provisions hereof. Any such termination shall be effective sixty (60) days after written notice to
such other Party specifying such breach if the specified breach is not cured before the effective
date of termination. In addition, Genentech may terminate the Research (but not the entire
Agreement) if the specified breach is not cured before the effective date of termination. Sangamo
agrees that any breach of this Agreement that materially adversely affects the Genentech License
(including, without limitation, a material breach of Section 5.4(b)) is a material breach of this
Agreement.
8.3 Termination of Research by Genentech for Cause. Genentech may terminate the
Research (but not the entire Agreement) effective immediately, by providing written notice to
Sangamo at any time, if Sangamo has not provided to Genentech all of the Sangamo Deliverables due
under Research Stage 2 (other than the training of Genentechs researcher(s)) within twelve (12)
months of the Effective Date. If Genentech terminates the Research pursuant to this Section 8.3,
no further payments under Sections 3.4 or 3.5 shall be due.
8.4 Termination by Genentech for Convenience. Genentech may terminate this
Agreement for its own convenience, effective on or after three (3) months following the Effective
Date, by providing thirty (30) days written notice to Sangamo.
8.5 Licenses.
(a) Research Results License. Sangamo agrees to grant and hereby grants Genentech
a non-exclusive, worldwide, sublicensable, fully-paid, perpetual, irrevocable license, under
Research Results Patents, to make, use, sell, offer for sale and import Other Modified Cell Lines
solely for the purpose of making, using, offering for sale, selling and importing Licensed
Products; provided, however, the foregoing license shall only be effective upon the expiration or
termination of this Agreement for any reason. For purposes of this Section 8.5(a), a patent shall
be considered a Research Results Patent only if Sangamo reproduced any of the Research Results in
the specification of a patent application for such patent or if Sangamo submitted any of the
Research Results to the applicable patent authority in connection with the filing or prosecution of
patent applications for such patent.
(b) Retention of Rights. In the event Sangamo seeks or is involuntarily placed
under the protection of the Bankruptcy Code (i.e., Title 11, U.S. Code), and the trustee in
bankruptcy, or Sangamo as a debtor-in-possession, rejects this Agreement, Genentech hereby elects,
pursuant to Section 365(n) of the Bankruptcy Code, to retain all licenses of rights to
intellectual property (as defined under the Bankruptcy Code) granted to it under this Agreement
to the extent permitted by law.
(c) Survival of Sublicenses. Following the Research Period, upon the termination
of this Agreement by either Party under Section 8.2, a given existing sublicense granted to a
sublicensee under the Genentech License, if any, shall continue, provided that such sublicensee is
in good standing at the time of such termination and such sublicensee agrees in writing to pay
directly to Sangamo (i) in the case of a Collaboration Partner, all Milestone Payments due from
such Collaboration Partner related to such sublicense; and (ii) in all cases,
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any annual technology
access fees due under Section 3.3, if such fees have not previously been paid by Genentech or
another sublicensee.
(d) Fully-Paid Genentech License. In the event that Genentech terminates this
Agreement under Section 8.2 due to a Materially Adverse Breach (as defined in the next sentence),
the Genentech License (including any sublicenses granted thereunder) with respect to all Licensed
Products shall be fully-paid and irrevocable. For purposes of this Section 8.5(d), a Materially
Adverse Breach means (i) a material breach by Sangamo of Sections [***]; or (ii) a breach of
Sangamos representations and warranties under Section [***], in each case of (i) or (ii), that
results or is reasonably likely to result in a material adverse effect upon the Genentech License
(unless Genentech is fully compensated for such material adverse effect by Sangamo, under Section
9.1(c) or otherwise). In the event that Genentech is awarded economic damages pursuant to an
action against Sangamo for a material breach of this Agreement that is a Materially Adverse Breach,
Genentech shall be required to either (A) accept such damage award, in which event the milestones
due under in this Agreement shall be reinstated, the Genentech License shall cease to be fully-paid
and irrevocable, and Genentech shall pay Sangamo any past due milestones or (B) forgo such damage
award, in which event the Genentech License shall continue to be fully-paid and irrevocable.
Genentech shall choose between the remedies described in clauses (A) and (B) of the preceding
sentence, and provide Sangamo with written notice of such choice along with any payments that may
be due under clause (A), no later than one hundred and eighty (180) days after such damages are
awarded.
8.6 Effects of Termination. Except as otherwise expressly provided herein,
termination of this Agreement shall not affect the rights and obligations of the Parties that
accrued prior to the effective date of such termination.
8.7 Survival. The provisions of Sections 4.2 and 4.4; Article 6; Article 7;
Sections 8.5, 8.6 and 8.7; Article 9; Article 10 (except for Section 10.4); Article 11; Section
12.2; Article 13 and Article 14 (as applicable) shall survive any termination or expiration of this
Agreement.
Article 9. Indemnification; Limitation on Liability
9.1 Indemnification.
(a) Claims Defined. For purposes of this Section 9.1, the term Claims means any
and all liabilities, obligations, penalties, claims, judgments, demands, actions, disbursements of
any kind and nature, suits, losses, damages, costs and expenses (including, without limitation,
reasonable attorneys fees).
(b) Indemnification by Genentech. Genentech shall indemnify, defend and hold harmless
Sangamo and its directors, officers and employees, and the Select Sangamo Licensors, from and
against any Third Party Claims (i) arising from any injury or damage arising out of or in
connection with the negligence or willful misconduct of Genentech or its consultants,
subcontractors or agents related to the performance of this Agreement or the breach by Genentech of
its obligations under this Agreement, except to the extent that such Claims arise from the
negligence or willful misconduct of the foregoing indemnified parties or the breach by
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Sangamo of
its obligations under this Agreement; (ii) [***]; (iii) arising from the manufacture, use,
handling, storage, importation, exportation, or other transportation of Modified Cell Line(s) by
Genentech or its sublicensees, subcontractors or agents, except to the extent that such Claims
arise from Sangamos breach of its representations and warranties under Article 12; (iv) arising
from the manufacture, use, handling, storage, importation, exportation, offer for sale, sale, or
other disposition of Licensed Product(s) by Genentech or its sublicensees, subcontractors or
agents, except to the extent that such Claims arise from Sangamos breach of its representations
and warranties under Article 12; or (v) arising from the use by a Third Party of any Licensed
Product sold or otherwise provided by Genentech or its sublicensees, subcontractors or agents.
(c) Indemnification by Sangamo. Sangamo shall indemnify, defend and hold harmless
Genentech and its directors, officers and employees from and against any Third Party Claims (i)
arising from any injury or damage arising out of or in connection with the negligence or willful
misconduct of Sangamo or its consultants, subcontractors or agents related to the performance of
this Agreement or the breach by Sangamo of its obligations under this Agreement, except to the
extent that such Claims arise from the negligence or willful misconduct of the foregoing
indemnified parties or the breach by Genentech of its obligations under this Agreement; (ii) that
the technology and materials (other than the Genentech Deliverables) used by Sangamo in performing
activities under the Research Plan or the use of such technology and materials (other than the
Genentech Deliverables) in performing such activities infringes or misappropriates the intellectual
property rights of such Third Party; or (iii) that ZFN Reagents or their use by Genentech or its
sublicensees, subcontractors or agents under the Genentech License infringes or misappropriates the
intellectual property rights of such Third Party, except to the extent that such infringement or
misappropriation is due to the identity, sequence or other characteristics of either Designated
Gene or is due to an Improvement that is incorporated in or used to make an Improved ZFN Reagent.
(d) Indemnification Procedures. In the event that a Party seeks indemnification
under this Section 9.1, such Party shall (i) promptly notify the other Party as soon as it becomes
aware of a claim or suit for which indemnification may be sought pursuant hereto, (ii) cooperate as
reasonably requested (at the expense of the indemnifying Party) with the indemnifying Party in the
defense of such claim or suit; and (iii) permit the indemnifying Party to control the defense of
such claim or suit with counsel mutually satisfactory to the Parties. In no event, however, may
the indemnifying Party compromise or settle any claim or suit in a
manner that admits fault or negligence on the part of the indemnified Party without the prior
written consent of the indemnified Party. The indemnifying Party shall have no liability under
this Section 9.1 with respect to claims or suits settled or compromised without its prior written
consent, which consent shall not be unreasonably withheld.
9.2
Limitation on Liability. IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR LOSS OF PROFITS, LOSS OF GOODWILL OR ANY
CONSEQUENTIAL, INCIDENTAL OR INDIRECT DAMAGES OF ANY KIND, EXCEPT TO THE EXTENT THAT SUCH DAMAGES
(A) ARE AN ELEMENT OF THE DAMAGES AWARDED BY A COURT OF COMPETENT JURISDICTION TO A THIRD PARTY IN
CONNECTION WITH A CLAIM WITH RESPECT TO WHICH A PARTY IS ENTITLED TO INDEMNIFICATION PURSUANT TO
SECTION 9.1; OR (B) ARISE FROM THE MISUSE OR
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MISAPPROPRIATION OF THE OTHER PARTYS CONFIDENTIAL
INFORMATION OR THE GENENTECH MATERIALS.
Article 10. Dispute Resolution
10.1 Internal Resolution. Except as otherwise expressly provided in this
Agreement, in the event of any controversy, claim or other dispute arising out of or relating to
any provision of this Agreement or the interpretation, enforceability, performance, breach,
termination or validity hereof, such dispute shall be first referred to the Executives of each
Party for resolution, prior to proceeding under the following provisions of this Article 10. A
dispute shall be referred to the Executives upon one Party providing the other Party with written
notice that such dispute exists, and the Executives shall attempt to resolve such dispute through
good faith discussions. In the event that the Executives cannot resolve such dispute within thirty
(30) days of such other Partys receipt of such written notice, either Party may initiate the
dispute resolution procedures set forth in Section 10.2.
10.2 Arbitration. Except as otherwise expressly provided in this Agreement, the
Parties agree that any dispute not resolved internally by the Parties pursuant to Section 10.1,
shall be resolved through binding arbitration in accordance with the then prevailing Commercial
Arbitration Rules of the American Arbitration Association, except as modified in this Agreement,
applying the substantive law specified in Section 14.1. A Party may initiate an arbitration by
written notice to the other Party of its intention to arbitrate, and such demand notice shall
specify in reasonable detail the nature of the dispute. Each Party shall select one (1)
arbitrator, and the two (2) arbitrators so selected shall choose a third arbitrator, and all three
(3) shall serve as neutrals. If a Party fails to nominate its arbitrator, or if the Parties
arbitrators cannot agree on the third arbitrator, the necessary appointments shall be made in
accordance with the then prevailing Commercial Arbitration Rules. Within three (3) months of the
conclusion of an arbitration proceeding, the arbitration decision shall be rendered in writing and
shall specify the basis on which the decision was made. The award of the arbitration tribunal
shall be final and judgment
upon such an award may be entered in any competent court or application may be made to any
competent court for judicial acceptance of such an award and order of enforcement. Unless
otherwise agreed upon by the Parties, the arbitration proceedings shall be conducted in San
Francisco, California. The Parties agree that they shall share equally the cost of the arbitration
filing and hearing fees, and the cost of the three (3) arbitrators. Each Party shall bear its own
attorneys fees and associated costs and expenses.
10.3 Patent Disputes. Notwithstanding the other provisions of this Article 10, any
dispute that involves the validity, infringement or claim interpretation of a patent (a) that is
issued in the United States shall be subject to actions before the United States Patent and
Trademark Office and/or submitted exclusively to a federal court having jurisdiction; and (b) that
is issued in any other country shall be brought before an appropriate regulatory or administrative
body or court in that country, and the Parties hereby consent to the jurisdiction and venue of such
courts and bodies. For the sake of clarity, such patent disputes shall not be subject to the
provisions of Section 10.2.
-21-
10.4 Continued Performance. Provided the Agreement has not terminated, the Parties
agree to continue performing under the Agreement in accordance with its provisions, pending the
final resolution of any dispute.
Article 11. Public Disclosures; Use of Names
11.1 Publicity and Other Public Disclosures.
(a) Generally. Subject to the other provisions of this Section 11.1, neither
Party shall issue press releases or make any other public disclosures relating to this Agreement
for any purpose whatsoever without the other Partys prior written approval. Each Party agrees
that the other Party shall have no less than five (5) business days to review and provide comments
regarding any such proposed public disclosure (even if such disclosure is required by law, rule or
regulation), unless a shorter review time is agreed to by both Parties. If the disclosing Party
requests a shorter review time, the other Party shall agree to such requested shorter review time
if (i) such shorter review time is necessitated by an applicable disclosure law, rule or
regulation; and (ii) the disclosing Party made such request and provided such proposed public
disclosure for review as soon as reasonably practicable after the disclosing Party knew of the
event necessitating such shorter review time. The provisions of this Section 11.1 are in addition
to the provisions of Article 6.
(b) Approved Public Disclosures. Genentech hereby approves of the following
public disclosures by Sangamo: (i) issuing the press release set forth in Exhibit D, following the
signing of this Agreement by both Parties; (ii) including Genentech on a list of Sangamos partners
or licensees/licensors, without identifying any subject matter of this Agreement; and (iii)
including the text set forth in Exhibit D in Sangamos Form 8-K filings. Sangamo hereby approves
of the following public disclosures by Genentech (i) including Sangamo on a list of Genentechs
partners or licensees/licensors and (ii) disclosing that Sangamo is providing technology to
Genentech for the improvement of protein production.
(c) Public Disclosures Required by Law. In the event that one Party reasonably
concludes that a public disclosure relating to this Agreement is required by law, rule or
regulation (including, without limitation, the disclosure requirements of the Securities and
Exchange Commission or the securities exchange or other stock market on which such Partys
securities are traded (for purposes of this Section 11.1, collectively, an Exchange)) and the
other Party would prefer not to make such disclosure, the Party seeking such disclosure shall
either (i) limit such disclosure to address the concerns of the other Party or (ii) provide a
written explanation from counsel stating why such limited disclosure is not sufficient to comply
with the applicable law, rule or regulation. Provided that the Party seeking such disclosure
complies with the preceding sentence, such Party shall be permitted to make such disclosure. Each
Party agrees that it shall obtain its own legal advice with regard to its compliance with
securities laws, rules and regulations, and will not rely on any statements made by the other Party
relating to such securities laws, rules and regulations.
(d) Filing of Agreement. With respect to complying with the disclosure
requirements of an Exchange, in connection with any required filing of this Agreement with such
Exchange, the filing Party shall, at the request of the other Party, seek confidential treatment of
-22-
portions of this Agreement from such Exchange and shall provide the other Party with the
opportunity, for at least fifteen (15) days, to review and comment on any such proposed filing, and
shall thereafter provide reasonable advance notice and opportunity for comment on any subsequent
changes to such filing. Sangamo shall, whether or not requested by Genentech, redact and request
confidential treatment for (i) all references to the identity of the Designated Genes; (ii) the
sequences in Exhibit B; and (iii) any financial terms, other than those disclosed in accordance
with Section 11.1(c).
11.2 Use of Names. Except as expressly provided herein, no right, express or
implied, is granted by the Agreement to use in any manner the name of Sangamo, Genentech or any
other trade name or trademark of the other Party in connection with the performance of this
Agreement.
Article 12. Warranties
12.1 Mutual Warranties. Each Party represents and warrants to the other Party
that: (a) it has full corporate authority to execute this Agreement and to perform its obligations
under this Agreement; (b) in performing hereunder it will not violate any other agreement to which
it is a party or subject; (c) in performing hereunder it will not violate any federal, state or
local laws, requirements or regulations; and (d) it shall provide personnel, as necessary, to
perform its obligations hereunder.
12.2 Sangamo Warranties. Sangamo represents and warrants to Genentech that:
(a) as of the Effective Date, all Patents owned by Sangamo that have one or more
claims that encompass (i) ZFN Reagents and/or ZFN Modified Cell Lines and/or (ii) the making and/or
use of ZFN Reagents and/or ZFN Modified Cell Lines are, in all cases, Controlled by Sangamo;
(b) as of the Effective Date, all of the Identified Patents (other than those
Identified Patents with a status of Revoked on Exhibit C) are Controlled by Sangamo, and Sangamo
will not, during the term of this Agreement, grant (or purport to grant) any rights or take any
other actions that are inconsistent with the Genentech License;
(c) all Sangamo employees and any Third Parties working on its behalf that perform
activities under the Research Plan are obligated (or will be obligated, prior to commencing such
activities) to assign any Inventions to Sangamo and to cooperate with Sangamo in connection with
obtaining patent protection therefor;
(d) Genentech has the right to grant sublicenses under the Genentech License to
one or more Third Parties, subject to Sections 5.1(b), 5.1(c) and 5.1(d); and
(e) with respect to rights sublicensed to Genentech by Sangamo under each of the
Caltech Agreement, the MIT Agreement and the Utah Agreement, Genentechs sublicense to such rights
(including any further sublicenses thereunder) shall survive (as a direct license from the
applicable Third Party licensor or otherwise) in the event that the applicable Third Party
-23-
licensor terminates Sangamos license to such rights for any reason, subject to any provisions related to
such direct license that are set forth in Exhibit E.
12.3 Disclaimers. EXCEPT AS OTHERWISE EXPRESSLY STATED IN THE AGREEMENT, NEITHER
PARTY MAKES ANY REPRESENTATION OR WARRANTY OF ANY KIND AND EXPRESSLY DISCLAIMS ALL IMPLIED OR
STATUTORY WARRANTIES INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE AND NON-INFRINGEMENT.
Article 13. Notices
Except as otherwise expressly provided in the Agreement, any notice required under this
Agreement shall be in writing and shall specifically refer to this Agreement. Notices shall be
sent via one of the following means and will be effective (a) on the date of delivery, if delivered
in person; (b) on the date of receipt, if sent by a facsimile (with delivery confirmed); or (c) on
the date of receipt, if sent by private express courier or by first class certified mail, return
receipt requested (or its equivalent). Any notice sent via facsimile shall be followed by a copy
of such notice by private express courier or by first class mail. Notices shall be sent to the
other Party at the addresses set forth below. Either Party may change its addresses for purposes
of this Article 13 by sending written notice to the other Party.
To Sangamo:
Sangamo BioSciences, Inc.
Point Richmond Tech Center II
501 Canal Blvd, Suite A100
Richmond, CA 94804
Attn: Chief Executive Officer
Telephone: (510) 970-6000
Facsimile: (510) 236-8951
To Genentech:
Genentech, Inc.
1 DNA Way
South San Francisco, CA 94080
Attn: Corporate Secretary
Telephone: (650) 225-1000
Facsimile: (650) 467-9146
with a required copy to:
Genentech, Inc.
1 DNA Way
South San Francisco, CA 94080
Attn: VP, Alliance Management and
Pipeline Strategy Support
Telephone: (650) 225-1000
Facsimile: (650) 467-3294
-24-
Article 14. General Provisions
14.1 Governing Law. This Agreement shall be governed by and construed under the
laws of the State of California and the United States without regard to the conflict of laws
provisions thereof.
14.2 Assignment. During the Research Period, Sangamo shall not assign or delegate
any of its rights or obligations under this Agreement without the prior written consent of
Genentech. After the Research Period, Sangamo may, without Genentechs consent, assign this
Agreement and its rights and obligations hereunder to (a) any successor in interest by way of
merger, acquisition or sale of all or substantially all of its assets to which this Agreement
relates; or (b) an Affiliate of Sangamo. At any time, Genentech may, without Sangamos consent,
assign this Agreement and its rights and obligations hereunder to (a) any successor in interest by
way of merger, acquisition or sale of all or substantially all of its assets to which this
Agreement relates; or (b) an Affiliate of Genentech. Any attempt to assign or delegate any portion
of this Agreement in violation of this Section 14.2 shall be void. Subject to the foregoing
provisions of this Section 14.2, this Agreement shall be binding upon and inure to the benefit of
the Parties hereto and their respective successors and assigns.
14.3 Entire Agreement. This Agreement, including all Exhibits attached hereto,
which are hereby incorporated by reference, contains the entire understanding between the Parties
hereto with respect to the subject matter hereof and supersedes and terminates all prior
agreements, understandings and arrangements between the Parties (including any prior
representations or warranties made by either Party), whether written or oral with respect to such
subject matter including, without limitation, the Confidentiality Agreement.
14.4 Amendment; Waiver. Except as otherwise expressly provided herein, no
alteration of or modification to this Agreement shall be effective unless made in writing and
executed by an authorized representative of each Party. No course of dealing or failure of either
Party to strictly enforce any term, right or condition of this Agreement in any instance shall be
construed as a general waiver or relinquishment of such term, right or condition. The observance
of any provision of this Agreement may be waived (either generally or any given instance and either retroactively
or prospectively) only with the written consent of the Party granting such waiver.
14.5 Severability. The Parties do not intend to violate any rule, law or
regulation. If any of the provisions of this Agreement are held to be void or unenforceable, then
such void or unenforceable provisions shall be replaced by valid and enforceable provisions that
will achieve as far as possible the economic business intentions of the Parties.
14.6 Construction. The Parties mutually acknowledge that they and their attorneys
have participated in the negotiation and preparation of this Agreement. Ambiguities, if any, in
this Agreement shall not be construed against any Party, irrespective of which Party may be deemed
to have drafted the Agreement or authorized the ambiguous provision.
-25-
14.7 Captions. Titles, headings and other captions are for convenience only and
are not to be used for interpreting this Agreement.
14.8 Relationship of the Parties. The Parties hereto are independent contractors
and nothing contained in this Agreement shall be deemed or construed to create a partnership, joint
venture, employment, franchise, agency or fiduciary relationship between the Parties.
14.9 Force Majeure. Failure of either Party to perform under this Agreement shall
not subject such Party to any liability to the other if such failure is caused by acts of God, acts
of terrorism, earthquake, fire, explosion, flood, drought, war, riot, sabotage, embargo, compliance
with any order or regulation of any government entity, or by any cause beyond the reasonable
control of the affected Party, whether or not foreseeable, provided that written notice of such
event is promptly given to the other Party.
14.10 Counterparts; Facsimiles. This Agreement may be executed in two (2) or more
counterparts, each of which will be deemed an original, but all of which together will constitute
one and the same instrument. For purposes hereof, a facsimile copy of this Agreement, including
the signature pages hereto, will be deemed to be an original. Notwithstanding the foregoing, the
Parties shall deliver original execution copies of this Agreement to one another as soon as
practicable following execution thereof.
In agreement with the foregoing, the Parties have caused this Agreement to be signed
by their respective duly authorized representatives as set forth below.
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Genentech, Inc. |
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Sangamo BioSciences, Inc. |
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By:
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/s/ Susan Desmond - Hellmann |
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By: |
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/s/ Edward O. Lanphier
II |
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Name:
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Susan
Desmond - Hellmann |
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Name: |
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Edward O. Lanphier II |
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Title:
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President
of Product Development
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Title:
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President and Chief Executive
Officer
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-26-
Exhibit A
Research Plan
[***]
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*** |
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CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION |
A-1
[***]
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*** |
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CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION |
A-2
[***]
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*** |
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CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION |
A-3
[***]
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*** |
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CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION |
A-4
[***]
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*** |
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CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION |
A-5
[***]
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*** |
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CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION |
A-6
[***]
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*** |
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CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION |
A-7
Exhibit B
Designated Gene Sequences
[***]
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*** |
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CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION |
B-1
[***]
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*** |
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CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION |
B-2
[***]
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*** |
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CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION |
B-3
[***]
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*** |
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CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION |
B-4
Exhibit C
Identified Patents
(Sangamo Owned and In-Licensed)
SANGAMO OWNED
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Serial No. |
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Filing date |
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Title |
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Status |
AU 32291/95
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Aug. 17, 1995
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Improvements in
binding proteins
for recognition of
DNA
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AU Pat. No. 698152
(2/4/99) |
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AU 10037/99
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Jan. 6, 1999
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Improvements in
binding proteins
for recognition of
DNA
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AU Pat. No. 726759
(3/8/01) |
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CA 2,196,419
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Aug. 17, 1995
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Improvements in
binding proteins
for recognition of
DNA
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Pending |
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EP 95928576.8
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Aug. 17, 1995
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Improvements in
binding proteins
for recognition of
DNA
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Pending |
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JP 507857/1996
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Aug. 17, 1995
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Improvements in
binding proteins
for recognition of
DNA
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Pending |
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US 09/139,762
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Aug. 25, 1998
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Binding proteins
for recognition of
DNA
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US Pat. No.
6,013,453 (1/11/00) |
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US 10/033,129
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Dec. 27, 2001
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Relating to Binding
proteins for
recognition of DNA
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US Pat. No. RE
39,229 (8/8/06) |
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US 10/309,578
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Dec. 3, 2002
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Design of binding
proteins for
recognition of DNA
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Pending |
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US 10/397,930
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Mar. 25, 2003
|
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Relating to Binding
proteins for
recognition of DNA
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Pending |
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US 10/400,017
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Mar. 25, 2003
|
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Relating to Binding
proteins for
recognition of DNA
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Pending |
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AU 2001 226935
|
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Jan. 19, 2001
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Nucleic Acid
Binding
Polypeptides
(2-finger modules)
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Allowed |
C-1
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Serial No. |
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Filing date |
|
Title |
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Status |
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CA 2,398,155
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Jan. 19, 2001
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Nucleic Acid
Binding
Polypeptides
(2-finger modules)
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Pending |
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EP 01 901 276.4
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Jan. 19, 2001
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Nucleic Acid
Binding
Polypeptides
(2-finger modules)
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Allowed |
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US10/198,677
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Jan. 19, 2001
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Nucleic Acid
Binding
Polypeptides
(2-finger modules)
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Pending |
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US 10/222,614
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Aug. 15, 2002
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Cells comprising
zinc finger
nucleases
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Allowed |
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US 10/395,816
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Mar. 20, 2003
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Methods and
compositions for
using zinc finger
endonucleases to
enhance homologous
recombination
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Pending |
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AU 2003 218382
|
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Mar. 20, 2003
|
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Methods and
compositions for
using zinc finger
endonucleases to
enhance homologous
recombination
|
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Pending |
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CA 2,479,858
|
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Mar. 20, 2003
|
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Methods and
compositions for
using zinc finger
endonucleases to
enhance homologous
recombination
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Pending |
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EP 03 714 379.9
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Mar. 20, 2003
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Methods and
compositions for
using zinc finger
endonucleases to
enhance homologous
recombination
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Pending |
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US 10/912,932
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Aug. 6, 2004
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Methods and
compositions for
targeted cleavage
and recombination
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Pending |
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US 11/304,981
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Dec. 15, 2005
|
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Targeted deletion
of cellular DNA
Sequences
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Pending |
C-2
|
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Serial No. |
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Filing date |
|
Title |
|
Status |
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AU 2004 263865
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Aug. 6, 2004
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Methods and
compositions for
targeted cleavage
and recombination
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Pending |
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CA 2,534,296
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Aug. 6, 2004
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Methods and
compositions for
targeted cleavage
and recombination
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Pending |
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EP 04 780 272.3
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Aug. 6, 2004
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Methods and
compositions for
targeted cleavage
and recombination
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Pending |
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IL 173460
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Aug. 6, 2004
|
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Methods and
compositions for
targeted cleavage
and recombination
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Pending |
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JP 2006-523239
|
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Aug. 6, 2004
|
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Methods and
compositions for
targeted cleavage
and recombination
|
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Pending |
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|
|
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KR 2006-7002703
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Aug. 6, 2004
|
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Methods and
compositions for
targeted cleavage
and recombination
|
|
Pending |
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|
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SG 2006 00748-8
|
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Aug. 6, 2004
|
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Methods and
compositions for
targeted cleavage
and recombination
|
|
Pending |
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AU 2005 220148
|
|
Feb. 3, 2005
|
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Methods and
compositions for
targeted cleavage
and recombination
|
|
Pending |
|
|
|
|
|
|
|
CA 2,534,296
|
|
Feb. 3, 2005
|
|
Methods and
compositions for
targeted cleavage
and recombination
|
|
Pending |
|
|
|
|
|
|
|
EP 05 756 438.7
|
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Feb. 3, 2005
|
|
Methods and
compositions for
targeted cleavage
and recombination
|
|
Pending |
|
|
|
|
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|
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[***]
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[***]
|
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[***]
|
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[***] |
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|
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|
|
US 11/221,683
|
|
Sept. 8, 2005
|
|
Compositions and
methods for protein
production
|
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Pending |
|
|
|
*** |
|
CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION |
C-3
|
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Serial No. |
|
Filing date |
|
Title |
|
Status |
|
|
|
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PCT US05/32157
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Sept. 8, 2005
|
|
Compositions and
methods for protein
production
|
|
WO 06/033859 (3/30/06) |
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|
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US 11/493,423
|
|
July 26, 2006
|
|
Targeted
integration and
expression of
exogenous nucleic
acid sequences
|
|
Pending |
|
|
|
|
|
|
|
PCT US06/29027
|
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July 26, 2006
|
|
Targeted
integration and
expression of
exogenous nucleic
acid sequences
|
|
Pending |
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|
|
[***]
|
|
[***]
|
|
[***]
|
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[***] |
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*** |
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CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION |
C-4
IN-LICENSED*
|
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|
Caltech =
|
|
in-licensed under the Caltech Agreement |
JHU =
|
|
in-licensed under the JHU Agreement |
MIT =
|
|
in-licensed under the MIT Agreement |
Scripps =
|
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in-licensed under the Scripps Agreement |
Utah =
|
|
in-licensed under the Utah Agreement |
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Serial No. |
|
|
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|
(*Third Party License) |
|
Filing date |
|
Title |
|
Status |
US 07/862,831
(JHU)
|
|
Apr. 3, 1992
|
|
Functional domains in
FokI restriction
endonuclease
|
|
US Pat. No. 5,356,802
(10/18/94) |
|
|
|
|
|
|
|
US 08/126,564
(JHU)
|
|
Sept. 27, 1993
|
|
Functional domains in
FokI restriction
endonuclease
|
|
US Pat. No. 5,436,150
(7/25/95) |
|
|
|
|
|
|
|
US 08/346,293
(JHU)
|
|
Nov. 23, 1994
|
|
Insertion & Deletion
Mutants of FokI
restriction endonuclease
|
|
US Pat. No. 5,487,994
(1/30/96) |
|
|
|
|
|
|
|
CA 2,154,581
(JHU)
|
|
Feb. 10, 1994
|
|
Functional domains in
FokI restriction
endonuclease
|
|
Pending |
|
|
|
|
|
|
|
EP 94 909 526.9
(JHU)
|
|
Feb. 10, 1994
|
|
Functional domains in
FokI restriction
endonuclease
|
|
Europ. Pat. No. 0 682
699 (5/7/03) Revoked |
|
|
|
|
|
|
|
CH
(JHU)
|
|
|
|
Functional domains in
FokI restriction
endonuclease
|
|
Europ. Pat. No. 0 682
699 (5/7/03) Revoked |
|
|
|
|
|
|
|
DE
(JHU)
|
|
|
|
Functional domains in
FokI restriction
endonuclease
|
|
Europ. Pat. No. 0 682
699 (5/7/03) Revoked |
|
|
|
|
|
|
|
FR
(JHU)
|
|
|
|
Functional domains in
FokI restriction
endonuclease
|
|
Europ. Pat. No. 0 682
699 (5/7/03) Revoked |
|
|
|
|
|
|
|
GB
(JHU)
|
|
|
|
Functional domains in
FokI restriction
endonuclease
|
|
Europ. Pat. No. 0 682
699 (5/7/03) Revoked |
|
|
|
|
|
|
|
IE
(JHU)
|
|
|
|
Functional domains in
FokI restriction
endonuclease
|
|
Europ. Pat. No. 0 682
699 (5/7/03) Revoked |
|
|
|
|
|
|
|
EP 03 010009.3
(JHU)
|
|
Feb. 10, 1994
|
|
Functional domains in
FokI restriction
endonuclease
|
|
Pending |
C-5
|
|
|
|
|
|
|
Serial No. |
|
|
|
|
|
|
(*Third Party License) |
|
Filing date |
|
Title |
|
Status |
|
|
|
|
|
|
|
JP 7-510290
(JHU)
|
|
Aug.23, 1994
|
|
Functional domains in
FokI restriction
endonuclease
|
|
Pending |
|
|
|
|
|
|
|
JP 2006-143294
(JHU)
|
|
Aug. 23, 1994
|
|
Functional domains in
FokI restriction
endonuclease
|
|
Pending |
|
|
|
|
|
|
|
US 08/575,361
(JHU)
|
|
Dec. 20, 1995
|
|
General method to clone
hybrid restriction
endonucleases using lig
gene
|
|
US Pat. No. 5,792,640
(8/11/98)
Reexamination Requested |
|
|
|
|
|
|
|
US 08/647,449
(JHU)
|
|
May 7, 1996
|
|
Methods for inactivating
target DNA and for
detecting conformational
change in a nucleic acid
|
|
US Patent No.
5,916,794 (Jun. 29,
1999) |
|
|
|
|
|
|
|
US 09/281,792
(JHU)
|
|
Mar. 31, 1999
|
|
Methods for inactivating
target DNA and for
detecting conformational
change in a nucleic acid
|
|
US Patent No.
6,265,196 (Jul. 24,
2001)
Reexamination Requested |
|
|
|
|
|
|
|
US 08/676,318
(Scripps)
|
|
Jan. 18, 1995
|
|
Zinc finger protein
derivatives and methods
therefor
|
|
U.S. Patent No. 6,242,568 (6/5/01) |
|
|
|
|
|
|
|
US 08/863,813
(Scripps)
|
|
May 27, 1997
|
|
Zinc finger protein
derivatives and methods
therefor
|
|
U.S. Patent No. 6,140,466 (10/31/00) |
|
|
|
|
|
|
|
US 09/500,700
(Scripps)
|
|
Feb. 9, 2000
|
|
Zinc finger protein
derivatives and methods
therefor
|
|
U.S. Patent No. 6,790,941 (9/14//04) |
|
|
|
|
|
|
|
AU 16865/95
(Scripps)
|
|
Jan. 18, 1995
|
|
Zinc finger protein
derivatives and methods
therefor
|
|
AU Patent No. 704601 (4/29/99) |
|
|
|
|
|
|
|
CA 2,181,548
(Scripps)
|
|
Jan. 18, 1995
|
|
Zinc finger protein
derivatives and methods
therefor
|
|
Pending |
|
|
|
|
|
|
|
EP 95 908 614.1
(Scripps)
|
|
Jan. 18, 1995
|
|
Zinc finger protein
derivatives and methods
therefor
|
|
Europ. Pat. No. 0 770 129 (11/23/05) |
|
|
|
|
|
|
|
FR
(Scripps)
|
|
Jan. 18, 1995
|
|
Zinc finger protein
derivatives and methods
therefor
|
|
Europ. Pat. No. 0 770 129 (11/23/05) |
C-6
|
|
|
|
|
|
|
Serial No. |
|
|
|
|
|
|
(*Third Party License) |
|
Filing date |
|
Title |
|
Status |
|
|
|
|
|
|
|
GB
(Scripps)
|
|
Jan. 18, 1995
|
|
Zinc finger protein
derivatives and methods
therefor
|
|
Europ. Pat. No. 0 770 129 (11/23/05) |
|
|
|
|
|
|
|
FI 962879
(Scripps)
|
|
Jan. 18, 1995
|
|
Zinc finger protein
derivatives and methods
therefor
|
|
Pending |
|
|
|
|
|
|
|
JP 07-519231
(Scripps)
|
|
Jan. 18, 1995
|
|
Zinc finger protein
derivatives and methods
therefor
|
|
Pending |
|
|
|
|
|
|
|
NO 1996 2991
(Scripps)
|
|
Jan. 18, 1995
|
|
Zinc finger protein
derivatives and methods
therefor
|
|
Pending |
|
|
|
|
|
|
|
AU 2002 300619
(Scripps)
|
|
May 27, 1998
|
|
Zinc finger protein
derivatives and methods
therefor
|
|
Pending |
|
|
|
|
|
|
|
CA 2,291,861
(Scripps)
|
|
May 27, 1998
|
|
Zinc finger protein
derivatives and methods
therefor
|
|
Pending |
|
|
|
|
|
|
|
EP 98 926 088.0
(Scripps)
|
|
May 27, 1998
|
|
Zinc finger protein
derivatives and methods
therefor
|
|
Pending |
|
|
|
|
|
|
|
JP 11-500870
(Scripps)
|
|
May 27, 1998
|
|
Zinc finger protein
derivatives and methods
therefor
|
|
Pending |
|
|
|
|
|
|
|
US 09/260,629
(MIT)
|
|
Mar. 1, 1999
|
|
Poly-Zinc Finger Proteins
with improved linkers
|
|
U.S. Pat. No.
6,479,626 (Nov. 12,
2002) |
|
|
|
|
|
|
|
US 10/146,221
(MIT)
|
|
May 13, 2002
|
|
Poly-Zinc Finger Proteins
with improved linkers
|
|
U.S. Pat. No.
6,903,185 (June 7,
2005) |
|
|
|
|
|
|
|
US 11/110,594
(MIT)
|
|
April 20,2005
|
|
Poly-Zinc Finger Proteins
with improved linkers
|
|
US Patent No 7,153,949
(Dec. 26, 2006) |
|
|
|
|
|
|
|
US 11/639,363
(MIT)
|
|
Dec. 14, 2006
|
|
Poly-Zinc Finger Proteins
with improved linkers
|
|
Pending |
|
|
|
|
|
|
|
AU 28849/99
(MIT)
|
|
Mar. 1, 1999
|
|
Poly-Zinc Finger Proteins
with improved linkers
|
|
AU Pat. No. 746454
(August 15, 2002) |
|
|
|
|
|
|
|
CA 2,321,938
(MIT)
|
|
Mar. 1, 1999
|
|
Poly-Zinc Finger Proteins
with improved linkers
|
|
Pending |
C-7
|
|
|
|
|
|
|
Serial No. |
|
|
|
|
|
|
(*Third Party License) |
|
Filing date |
|
Title |
|
Status |
|
|
|
|
|
|
|
EP 99909701.7
(MIT)
|
|
Mar. 1, 1999
|
|
Poly-Zinc Finger Proteins
with improved linkers
|
|
Pending |
|
|
|
|
|
|
|
JP 2000-534663
(MIT)
|
|
Mar. 1, 1999
|
|
Poly-Zinc Finger Proteins
with improved linkers
|
|
Pending |
|
|
|
|
|
|
|
AU 2003 25128
(Utah)
|
|
Jan. 22, 2003
|
|
Targeted chromosomal
mutagenesis using zinc
finger nucleases
|
|
Pending |
|
|
|
|
|
|
|
CA 2,474,486
(Utah)
|
|
Jan. 22, 2003
|
|
Targeted chromosomal
mutagenesis using zinc
finger nucleases
|
|
Pending |
|
|
|
|
|
|
|
EP 03 746 527.5
(Utah)
|
|
Jan. 22, 2003
|
|
Targeted chromosomal
mutagenesis using zinc
finger nucleases
|
|
Allowed |
|
|
|
|
|
|
|
US 10/502,565
(Utah)
|
|
Jan. 22, 2003
|
|
Targeted chromosomal
mutagenesis using zinc
finger nucleases
|
|
Pending |
|
|
|
|
|
|
|
US 10/656,531
(Caltech)
|
|
Sept. 5, 2003
|
|
Use of chimeric nucleases
to stimulate gene
targeting
|
|
Pending |
|
|
|
|
|
|
|
AU 2003 298574
(Caltech)
|
|
Sept. 5, 2003
|
|
Use of chimeric nucleases
to stimulate gene
targeting
|
|
Pending |
|
|
|
|
|
|
|
CA 2,497,913
(Caltech)
|
|
Sept. 5, 2003
|
|
Use of chimeric nucleases
to stimulate gene
targeting
|
|
Pending |
|
|
|
|
|
|
|
EP 03 796 324.6
(Caltech)
|
|
Sept. 5, 2003
|
|
Use of chimeric nucleases
to stimulate gene
targeting
|
|
Pending |
|
|
|
|
|
|
|
JP 2005-501601
(Caltech)
|
|
Sept. 5, 2003
|
|
Use of chimeric nucleases
to stimulate gene
targeting
|
|
Pending |
C-8
Exhibit D
Press Release and Form 8-K Text
D-1
Exhibit E
Certain Agreements Relating to Third Party Licenses
Sangamo hereby notifies Genentech that (except as otherwise noted) a full and complete copy of
each of the provisions explicitly referenced below in this Exhibit E is set forth in Exhibit F:
1. Caltech Agreement. Genentech acknowledges and agrees that Genentech 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, as of the date of 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; (b) Sangamo shall
remain responsible for all obligations to Genentech (other than those requiring Sangamo to hold a
license under the Caltech Agreement, unless Caltech (at its discretion) elects to assume such
obligations); and (c) Sangamo shall inform Genentech in writing (with a copy to Caltech) that
Genentechs obligations pursuant to (a) and (b) are in effect as a result of such termination.
2. JHU Agreement. The obligations to Johns Hopkins University of Articles II, VIII, IX, X,
XIII and XV and Paragraphs 5.1 and 5.2 of the JHU Agreement are binding upon Genentech and any of
Genentechs sublicensees under the rights licensed to Sangamo under the JHU Agreement as if each
were a party to the JHU Agreement. The Parties agree that, in the event that the JHU Agreement is
amended after the Effective Date, the provisions of this paragraph shall apply only to the extent
required in any such amendment.
3. MIT Agreement. The provisions of 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 Genentech and any of Genentechs sublicensees under the rights licensed to Sangamo
under the MIT Agreement (but in each case solely to the extent such provisions are applicable to
the rights granted in this Agreement) as if each were a party to the MIT Agreement. Any sublicense
granted by Sangamo to Genentech will survive as a direct license from the Massachusetts Institute
of Technology (MIT) to Genentech pursuant to Paragraph 13.6 of the MIT Agreement provided that
Genentech is not then in default under this Agreement and agrees to assume the rights and
obligations of such direct license. If Genentech agrees to assume such rights and obligations, (a)
such direct license shall be subject to the same non-financial terms and conditions as those in the
MIT Agreement and (b) Genentech (or if there is at such time more than one sublicensee under the
MIT Agreement, Genentech and all other sublicensees severally and jointly) shall pay any annual
fees due pursuant to Paragraph 4.1(b) of the MIT Agreement. If Genentech becomes a direct licensee
of MIT, Genentech shall make any monetary payment(s) that, had the MIT Agreement not been
terminated, Sangamo would have been required to make under the MIT Agreement as a result of the
activities of Genentech. The Parties agree that, in the event that the MIT Agreement is amended
after the Effective Date, the provisions of this paragraph shall apply only to the extent required
in any such amendment.
4. Scripps Agreement. Genentech acknowledges and agrees that any sublicense granted by
Sangamo to Genentech 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). The Parties agree that, in the event that the Scripps Agreement is amended after the
Effective Date, the provisions of
E-1
this paragraph shall apply only to the extent required in any such amendment. [NOTE: Section
2.2 of the Scripps Agreement is not included in Exhibit F.]
5. Utah Agreement. [***] of the Utah Agreement as a result of any
sublicenses granted by Genentech under the Genentech License or any further sublicenses under the
Genentech License granted by Genentechs sublicensees. [***] prior to the applicable deadlines set forth in Section [***] of the Utah Agreement. Any sublicense granted by Sangamo to Genentech will survive as a
direct license from the University of Utah (Utah) to Genentech pursuant to Section 13.4 of the
Utah Agreement provided that Genentech is in good standing under this Agreement and agrees to
assume the rights and obligations of such direct license. If Genentech agrees to assume such
rights and obligations, (a) such direct license shall be subject to the same non-financial terms
and conditions as those in the Utah Agreement and (b) Genentech (or if there is at such time more
than one sublicensee under the Utah Agreement, Genentech and all other sublicensees severally and
jointly) shall make any annual maintenance payments due pursuant to Section 6.2 of the Utah
Agreement. If Genentech becomes a direct licensee of Utah, Genentech shall make any monetary
payment(s) that, had the Utah Agreement not been terminated, Sangamo would have been required to
make under the Utah Agreement as a result of the license to, or activities of, Genentech, including
without limitation the annual sublicensee fees due pursuant to Section 4.3(ii) of the Utah
Agreement with respect to Genentech (which for clarity shall continue notwithstanding the
conversion of Genentechs sublicense to a direct license from Utah). The Parties agree that, in
the event that the Utah Agreement is amended after the Effective Date, the provisions of this
paragraph shall apply only to the extent required in any such amendment.
|
|
|
*** |
|
CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION |
E-2
Exhibit F
Certain Provisions of Third Party Licenses
Copy of Selected Provisions from the 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. LICENSEE
agrees that any sublicenses granted by it shall provide that the obligations to JOHNS HOPKINS of
Articles II, VIII, IX, X, XIII, XV, and Paragraphs 5.1 and 5.2 of this Agreement shall be binding
upon the sublicensees as if it were a party to this Agreement. LICENSEE further agrees to attach
copies of these Articles to sublicense agreements.
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,
F-1
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.
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. |
F-2
|
(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 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
F-3
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.
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.
F-4
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.
13.7 [NOTE: As amended in Amendment No. 1 to the JHU Agreement.] The provisions of Paragraph
8.1, Article IX and Article X, Paragraph 4.5 and Paragraph 6.6 shall survive termination of this
Agreement.
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.
F-5
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 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 [NOTE: As amended in Amendment No. 1 to the JHU Agreement.] 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.
F-6
Copy
of Selected Provisions from the MIT Agreement
2 GRANT
2.1 M.I.T. hereby grants to LICENSEE the right and license in the TERRITORY to practice under
the PATENT RIGHTS and, to the extent not prohibited by other patents, to make, have made, use,
lease, sell and import LICENSED PRODUCTS and to practice the LICENSED PROCESSES, until the
expiration of the last to expire of the PATENT RIGHTS, unless this Agreement shall be sooner
terminated according to the terms hereof.
2.2 LICENSEE agrees that LICENSED PRODUCTS leased or sold in the United States shall be
manufactured substantially in the United States.
2.3 In order to establish exclusivity in the FIELDS OF USE for LICENSEE, M.I.T. hereby agrees
that it shall not grant any other license to make, have made, use, lease, sell and import LICENSED
PRODUCTS or to utilize LICENSED PROCESSES subject to the royalty-free, nonexclusive license rights
of the United States Government per FAR 52.227-11, in the TERRITORY for the FIELDS OF USE.
2.4 [NOTE: As amended in the First Amendment to the MIT Agreement.] LICENSEE and M.I.T. agree
that neither party shall assert the Patent Rights against not-for-profit institutions in their
conduct of research, provided, however, that if a not-for-profit institution practices under the
Patent Rights to conduct high throughput drug screening on behalf of a commercial entity, then the
Patent Rights may be asserted against that institution.
2.5 M.I.T. reserves the right to practice under the PATENT RIGHTS and to allow third parties
to practice under the PATENT RIGHTS in all fields of use for noncommercial research purposes.
2.6 LICENSEE shall have the right to enter into sublicensing agreements for the rights,
privileges and licenses granted hereunder only in the FIELDS OF USE. Upon any termination of this
Agreement, sublicensees rights shall also terminate, subject to Paragraph 13.6 hereof.
2.7 [NOTE: As amended in the Eighth Amendment to the MIT Agreement.] With respect to each
sublicense agreement [in the Reagent Field], LICENSEE agrees to do the following:
(a) incorporate the language of Article 2 (other than Paragraph 2.8), Article 9, Article 10,
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 they 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 Paragraph 2.8 and Articles 5, 7, 12, 13 and 15
(other than Paragraph 15.4);
(c) use commercially reasonable effort to obtain a indemnity from the applicable sublicensee
in favor of LICENSEE that is substantially similar in scope of the indemnity set forth in
F-7
Article 8, and include M.I.T. as an indemnified party under any such indemnity on the same terms as
LICENSEE.
2.8 [NOTE: Intentionally omitted.]
2.9 Nothing in this Agreement shall be construed to confer any rights upon LICENSEE by
implication, estoppel or otherwise as to any technology or patent rights of M.I.T. or any other
entity other than the PATENT RIGHTS, regardless of whether such patent rights shall be dominant or
subordinate to any PATENT RIGHTS.
PARAGRAPH 4.1(b)
4.1 [NOTE: As amended in the Fifth Amendment to the MIT Agreement.] For the rights,
privileges and license granted hereunder, LICENSEE shall pay royalties to M.I.T. in the manner
hereinafter provided to the end of the term of the PATENT RIGHTS or until this Agreement shall be
terminated:
b. License Maintenance Fees of (i) $[***] per year on January 1, 2002 and each January 1
thereafter until the January 1 following the issuance of the first protein DNA claims
and; (ii) $[***] per year beginning the January 1 following the issuance of the first of
the protein-DNA claims and every January 1 thereafter; provided, however, License
Maintenance Frees may be credited to Running Royalties subsequently due on NET SALES for
each said year, if any. License Maintenance Fees paid in excess of Running Royalties
shall not be creditable to Running Royalties for future years.
9 EXPORT CONTROLS
LICENSEE acknowledges that it 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 United States Department of Commerce Export
Administration Regulations). The transfer of such items 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.
M.I.T. neither represents that a license shall not be required nor that, if required, it shall be
issued.
10 NON-USE OF NAMES
LICENSEE shall not use the names or trademarks of the Massachusetts Institute of Technology or
Lincoln Laboratory, nor any adaptation thereof, nor the names of any of their employees, in any
advertising, promotional or sales literature without prior written consent obtained from M.I.T., or
said employee, in each case, except that LICENSEE may state that it is licensed by M.I.T. under one
or more of the patents and/or applications comprising the PATENT RIGHTS.
PARAGRAPH 13.6
13.6 [NOTE: As amended in the Eighth Amendment to the MIT Agreement.] Upon termination
of this Agreement for any reason, any sublicensee not then in default shall have the right to seek
a
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*** |
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CONFIDENTIAL PORTIONS OMITTED AND FILED SEPARATELY WITH THE COMMISSION |
F-8
license from M.I.T. M.I.T. agrees to negotiate such licenses in good faith under reasonable terms
and conditions. In addition, in the event that M.I.T. terminates this Agreement pursuant to
Paragraph 13.1, 13.2, or 13.3, each sublicense granted by LICENSEE to a sublicensee not then in
default will survive such termination (as a direct license from M.I.T.), provided that such direct
license shall be subject to the same non-financial terms and conditions as those in this Agreement
and such sublicensee (or if there is at such time more than one such sublicensee, such sublicensees
severally and jointly) shall be required to make any annual fees due pursuant to Paragraph 4.1(b)
and each such sublicensee shall be required to make any 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.
F-9
Copy
of Selected Provisions from the Utah Agreement
4.3 For each SUBLICENSE granted by LICENSEE under the terms of this AGREEMENT, LICENSEE shall
pay to LICENSOR (i) a sublicense fee of twenty thousand dollars ($20,000) within thirty (30) days
of execution of each sublicense and (ii) an annual sublicense fee of ten thousand dollars ($10,000)
for each year (excluding the first year) that such sublicense is in effect, payable within thirty
(30) days of each anniversary of the effective date of such sublicense agreement.
6.2 As consideration for the license under this AGREEMENT, LICENSEE shall pay to LICENSOR an
annual maintenance fee of twenty thousand dollars ($20,000) on or before each anniversary of the
EFFECTIVE DATE of this AGREEMENT.
13.1 If LICENSEE should: (a) fail to deliver to LICENSOR any statement or report required
hereunder when due (except where such payment is being contested in good faith); (b) fail to make
any payment at the time that the same should be due; (c) violate or fail to perform any covenant,
condition, or undertaking of the AGREEMENT to be performed by it hereunder; or (d) file a
bankruptcy action, or have a bankruptcy action against it (which action remains undismissed for a
period of sixty (60) days), or become insolvent; enter into a composition with creditors or have a
receiver appointed for it; then LICENSOR may give written notice of such default, and its intent to
terminate this AGREEMENT, to LICENSEE. If LICENSEE should fail to cure such default within thirty
(30) days of such notice, the rights, privileges, and license granted hereunder shall automatically
terminate; provided, however, that the cure period may be extended by sixty (60) days if LICENSEE
conveys a written statement of its intent and plan to cure such default, and such plan is accepted
by the LICENSOR, within thirty (30) days of the automatic termination date.
13.2 If LICENSEE shall cease to carry on its business with respect to the rights granted in
this AGREEMENT, this AGREEMENT shall terminate upon thirty (30) days written notice by LICENSOR.
13.4 [NOTE: As amended in the (first) Amendment (dated February 22, 2007) to the Utah
Agreement.] Notwithstanding anything to the contrary in this AGREEMENT, in the event that LICENSOR
terminates this AGREEMENT pursuant to Section 13.1 or 13.2, each sublicense granted by LICENSEE to
a SUBLICENSEE then in good standing under the terms of its sublicense agreement will survive such
termination (as a direct license from LICENSOR), provided that (a) such direct license shall be
subject to the same non-financial terms and conditions as those in this AGREEMENT, and LICENSOR
shall not have any obligations to such SUBLICENSEE other than LICENSORs obligations to LICENSEE as
set forth herein; (b) such SUBLICENSEE (or if there is at such time more than one such SUBLICENSEE,
such SUBLICENSEES severally and jointly) shall be required to make any annual maintenance payments
due pursuant to Section 6.2; and (c) each such SUBLICENSEE shall be required to make any 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 license to, or activities of, such SUBLICENSEE, including
without limitation the annual sublicensee fees due pursuant to Section 4.3(ii) with respect to such
SUBLICENSEE (which for clarity shall continue notwithstanding the conversion of such SUBLICENSEEs
sublicense to a direct license from LICENSOR). Each such SUBLICENSEE shall be an intended
third-party beneficiary of this Section 13.4.
F-10
exv31w1
Exhibit 31.1
CERTIFICATION
I, Edward O. Lanphier II, 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. |
Date: August 8, 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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34
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; |
|
|
4. |
|
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: |
|
(a) |
|
Designed such disclosure controls and procedures, or caused such disclosure
controls and procedures to be designed under our supervision, to ensure that material
information relating to the registrant, including its consolidated subsidiaries, is
made known to us by others within those entities, particularly during the period in
which 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. |
Date: August 8, 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
(Principal Financial and Accounting Officer) |
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35
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 June 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 |
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President and Chief Executive
Officer
(Principal Executive Officer) |
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Date: August 8, 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
(Principal Financial and Accounting Officer) |
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Date: August 8, 2007
36