(Mark One) | ||
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OFTHE SECURITIES EXCHANGE ACT OF 1934 |
Delaware (State or other jurisdiction of incorporation or organization) |
33-0728374 (IRS Employer Identification No.) |
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EXHIBIT 10.20 | ||||||||
EXHIBIT 10.21 | ||||||||
EXHIBIT 10.22 | ||||||||
EXHIBIT 10.23 | ||||||||
EXHIBIT 10.24 | ||||||||
EXHIBIT 10.25 | ||||||||
EXHIBIT 10.26 | ||||||||
EXHIBIT 10.27 | ||||||||
EXHIBIT 10.28 | ||||||||
EXHIBIT 10.29 | ||||||||
EXHIBIT 21.1 | ||||||||
EXHIBIT 31.1 | ||||||||
EXHIBIT 31.2 | ||||||||
EXHIBIT 32.1 | ||||||||
EXHIBIT 32.2 |
2
3
June 30, | December 31, | |||||||
2006 | 2005 | |||||||
(unaudited) | (Note 1) | |||||||
Assets |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 10,090 | $ | 8,725 | ||||
Marketable securities |
31,613 | 66,385 | ||||||
Investments held by Symphony Dynamo, Inc. |
19,044 | | ||||||
Restricted cash |
408 | 408 | ||||||
Accounts receivable |
710 | 689 | ||||||
Prepaid expenses and other current assets |
1,275 | 1,277 | ||||||
Total current assets |
63,140 | 77,484 | ||||||
Property and equipment, net |
4,986 | 2,197 | ||||||
Goodwill |
2,312 | | ||||||
Other intangible assets, net |
4,884 | | ||||||
Other assets |
1,302 | 412 | ||||||
Total assets |
$ | 76,624 | $ | 80,093 | ||||
Liabilities, noncontrolling interest and stockholders equity |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,417 | $ | 952 | ||||
Accrued liabilities |
6,195 | 3,841 | ||||||
Deferred revenues |
829 | 750 | ||||||
Total current liabilities |
8,441 | 5,543 | ||||||
Other long-term liabilities |
152 | 187 | ||||||
Noncontrolling interest in Symphony Dynamo, Inc. |
9,728 | | ||||||
Commitments and contingencies |
||||||||
Stockholders equity: |
||||||||
Preferred stock: $0.001 par value; 5,000 shares authorized and no
shares issued and outstanding at June 30, 2006 and December 31,
2005 |
| | ||||||
Common stock: $0.001 par value; 100,000 shares authorized at June
30, 2006 and December 31, 2005; 30,588 and 30,482 shares issued
and outstanding at June 30, 2006 and December 31, 2005,
respectively |
31 | 30 | ||||||
Additional paid-in capital |
197,620 | 192,840 | ||||||
Deferred stock compensation |
| (2,467 | ) | |||||
Accumulated other comprehensive loss: |
||||||||
Unrealized loss on marketable securities available-for-sale |
(72 | ) | (144 | ) | ||||
Cumulative translation adjustment |
60 | (5 | ) | |||||
Accumulated other comprehensive loss |
(12 | ) | (149 | ) | ||||
Accumulated deficit |
(139,336 | ) | (115,891 | ) | ||||
Total stockholders equity |
58,303 | 74,363 | ||||||
Total liabilities, noncontrolling interest and stockholders equity |
$ | 76,624 | $ | 80,093 | ||||
4
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2006 | 2005 | 2006 | 2005 | |||||||||||||
Revenues: |
||||||||||||||||
Collaboration revenue |
$ | | $ | | $ | | $ | 12,199 | ||||||||
Services and license revenue |
224 | | 224 | | ||||||||||||
Grant revenue |
305 | 953 | 593 | 1,452 | ||||||||||||
Total revenues |
529 | 953 | 817 | 13,651 | ||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
10,762 | 7,493 | 17,354 | 13,148 | ||||||||||||
General and administrative |
3,380 | 2,473 | 5,983 | 4,813 | ||||||||||||
Acquired in-process research and development |
4,180 | | 4,180 | | ||||||||||||
Amortization of intangible assets |
196 | | 196 | | ||||||||||||
Total operating expenses |
18,518 | 9,966 | 27,713 | 17,961 | ||||||||||||
Loss from operations |
(17,989 | ) | (9,013 | ) | (26,896 | ) | (4,310 | ) | ||||||||
Interest and other income, net |
685 | 434 | 1,420 | 801 | ||||||||||||
Loss including noncontrolling interest in Symphony Dynamo, Inc. |
(17,304 | ) | (8,579 | ) | (25,476 | ) | (3,509 | ) | ||||||||
Loss attributed to noncontrolling interest in Symphony
Dynamo, Inc. |
2,031 | | 2,031 | | ||||||||||||
Net loss |
$ | (15,273 | ) | $ | (8,579 | ) | $ | (23,445 | ) | $ | (3,509 | ) | ||||
Basic and diluted net loss per share |
$ | (0.50 | ) | $ | (0.35 | ) | $ | (0.77 | ) | $ | (0.14 | ) | ||||
Shares used to compute basic and diluted net loss per share |
30,536 | 24,745 | 30,524 | 24,734 | ||||||||||||
5
Six Months Ended | ||||||||
June 30, | ||||||||
2006 | 2005 | |||||||
Operating activities |
||||||||
Net loss |
$ | (23,445 | ) | $ | (3,509 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation and amortization |
(827 | ) | 387 | |||||
Loss attributed to noncontrolling interest in Symphony Dynamo, Inc. |
(2,031 | ) | | |||||
Acquired in-process research and development |
4,180 | | ||||||
Amortization of intangible assets |
196 | | ||||||
Gain on disposal of property and equipment |
(50 | ) | | |||||
Accretion and amortization on marketable securities |
169 | 640 | ||||||
Realized loss on sale of marketable securities |
23 | | ||||||
Interest accrued on notes receivable from stockholders |
| (12 | ) | |||||
Stock-based compensation expense |
1,396 | 653 | ||||||
Changes in operating assets and liabilities: |
||||||||
Accounts receivable |
468 | 2,387 | ||||||
Prepaid expenses and other current assets |
2 | (740 | ) | |||||
Other assets |
(505 | ) | (10 | ) | ||||
Accounts payable |
242 | 229 | ||||||
Accrued liabilities |
2,354 | 178 | ||||||
Deferred revenues |
(87 | ) | (6,952 | ) | ||||
Net cash used in operating activities |
(17,915 | ) | (6,749 | ) | ||||
Investing activities |
||||||||
Purchases of investments held by Symphony Dynamo, Inc. |
(19,044 | ) | | |||||
Cash paid for acquisition, net of cash acquired |
(14,045 | ) | | |||||
Purchases of marketable securities |
(7,653 | ) | (35,712 | ) | ||||
Maturities and sales of marketable securities |
42,305 | 31,190 | ||||||
Disposal (purchases) of property and equipment |
41 | (363 | ) | |||||
Net cash provided by (used in) investing activities |
1,604 | (4,885 | ) | |||||
Financing activities |
||||||||
Proceeds from purchase of noncontrolling interest by preferred
shareholders in Symphony Dynamo, Inc., net of fees |
17,405 | | ||||||
Proceeds from employee stock purchase plan |
57 | 66 | ||||||
Exercise of stock options |
149 | 6 | ||||||
Repayment of notes receivable from stockholders |
| 92 | ||||||
Net cash provided by financing activities |
17,611 | 164 | ||||||
Effect of exchange rate on cash and cash equivalents |
65 | (4 | ) | |||||
Net increase (decrease) increase in cash and cash equivalents |
1,365 | (11,474 | ) | |||||
Cash and cash equivalents at beginning of period |
8,725 | 16,590 | ||||||
Cash and cash equivalents at end of period |
$ | 10,090 | $ | 5,116 | ||||
Supplemental disclosure of non-cash investing and financing activities |
||||||||
Warrants issued in conjunction with the Symphony Dynamo, Inc. transaction |
$ | 5,646 | $ | | ||||
Change in unrealized loss on marketable securities |
$ | 72 | $ | (18 | ) | |||
Change in cumulative translation adjustment |
$ | 65 | $ | (4 | ) | |||
Exercise of stock options |
$ | | $ | 200 | ||||
Repurchase of common stock for exercise of stock options |
$ | | $ | (200 | ) | |||
6
7
8
| significant changes in the strategy for our overall business; | ||
| significant underperformance relative to expected historical or projected future operating results; | ||
| significant changes in the manner of our use of acquired assets; | ||
| significant negative industry or economic trends; | ||
| significant decline in our stock price for a sustained period; and | ||
| our market capitalization relative to net book value. |
Consideration and acquisition costs: | ||||
Cash paid for common stock |
$ | 7,925 | ||
Cash paid to satisfy outstanding debt |
4,550 | |||
Employee costs |
745 | |||
Acquisition costs |
1,338 | |||
Total purchase price |
$ | 14,558 | ||
9
Allocation of purchase price: | ||||
Cash and cash equivalents |
$ | 513 | ||
Accounts receivable |
489 | |||
Other current assets |
385 | |||
Property, plant and equipment |
3,092 | |||
Goodwill |
2,312 | |||
Intangible assets |
5,080 | |||
In-process research and development |
4,180 | |||
Accounts payable |
(273 | ) | ||
Deferred revenue |
(166 | ) | ||
Other current liabilities |
(1,054 | ) | ||
Total purchase price |
$ | 14,558 | ||
Estimated Useful Life | ||||||
Intangible Assets | (in Years) | Amount | ||||
Manufacturing process |
5 | $ | 3,670 | |||
Customer relationships |
5 | 1,230 | ||||
Developed technology |
7 | 180 | ||||
Total |
$ | 5,080 | ||||
Accumulated | ||||||||||||
June 30, 2006 | Gross | Amortization | Net | |||||||||
Manufacturing process |
$ | 3,670 | $ | 143 | $ | 3,527 | ||||||
Customer relationships |
1,230 | 48 | 1,182 | |||||||||
Developed technology |
180 | 5 | 175 | |||||||||
Total |
$ | 5,080 | $ | 196 | $ | 4,884 | ||||||
Year ending December 31, | ||||
2006 (remaining six months) |
$ | 503 | ||
2007 |
1,006 | |||
2008 |
1,006 | |||
2009 |
1,005 | |||
2010 |
1,005 | |||
Thereafter |
359 | |||
Total |
$ | 4,884 | ||
10
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2006 | 2005 | 2006 | 2005 | |||||||||||||
Revenues |
$ | 571 | $ | 1,702 | $ | 1,503 | $ | 15,182 | ||||||||
Net loss |
$ | (15,794 | ) | $ | (9,764 | ) | $ | (25,733 | ) | $ | (5,907 | ) | ||||
Basic and diluted earnings per share |
$ | (0.52 | ) | $ | (0.39 | ) | $ | (0.84 | ) | $ | (0.24 | ) |
11
Year ending December 31, | ||||
2006 |
$ | 1,051 | ||
2007 |
2,139 | |||
2008 |
2,192 | |||
2009 |
1,487 | |||
$ | 6,869 | |||
12
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2006 | 2005 | 2006 | 2005 | |||||||||||||
Numerator: |
||||||||||||||||
Net loss |
(15,273 | ) | (8,579 | ) | (23,445 | ) | (3,509 | ) | ||||||||
Denominator: |
||||||||||||||||
Weighted-average
common shares
outstanding used
for basic and
diluted net loss
per share |
30,536 | 24,745 | 30,524 | 24,734 |
13
Three Months Ended | Six Months Ended | |||||||
June 30, | June 30, | |||||||
2005 | 2005 | |||||||
Net loss, as reported |
$ | (8,579 | ) | $ | (3,509 | ) | ||
Add: Stock-based employee compensation expense included in net loss |
336 | 668 | ||||||
Less: Stock-based employee compensation expense determined under
the fair value based method |
(716 | ) | (1,410 | ) | ||||
Net loss, pro forma |
$ | (8,959 | ) | $ | (4,251 | ) | ||
Net loss per share: |
||||||||
Basic and diluted net loss, as reported |
$ | (0.35 | ) | $ | (0.14 | ) | ||
Basic and diluted net loss, pro forma |
$ | (0.36 | ) | $ | (0.17 | ) | ||
Employee Stock | ||||||||||||||||||||||||
Employee Stock Options | Purchase Plan | |||||||||||||||||||||||
Three Months Ended | Six Months Ended | Six Months Ended | ||||||||||||||||||||||
June 30, | June 30, | June 30, | ||||||||||||||||||||||
2006 | 2005 | 2006 | 2005 | 2006 | 2005 | |||||||||||||||||||
Weighted-average fair value |
$ | 3.79 | $ | 2.28 | $ | 3.99 | $ | 3.85 | $ | 2.65 | $ | 3.68 | ||||||||||||
Risk-free interest rate |
5.1 | % | 3.9 | % | 4.8 | % | 3.5 | % | 4.7 | % | 3.2 | % | ||||||||||||
Expected life (in years) |
5.8 | 4 | 5.7 | 4 | 1.2 | 1.7 | ||||||||||||||||||
Volatility |
0.8 | 0.7 | 0.8 | 0.7 | 0.7 | 0.7 | ||||||||||||||||||
Expected dividends |
| | | | | |
Three Months Ended | Six Months Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2006 | 2005 | 2006 | 2005 | |||||||||||||
Employee and director stock-based compensation expense |
$ | 731 | $ | 336 | $ | 1,388 | $ | 668 | ||||||||
Non-employee stock-based compensation expense |
(1 | ) | | 8 | (15 | ) | ||||||||||
Total |
$ | 730 | $ | 336 | $ | 1,396 | $ | 653 | ||||||||
14
Weighted-Average | ||||||||||||
Options Available | Number of Options | Exercise Price Per | ||||||||||
for Grant | Outstanding | Share | ||||||||||
Balance at December 31, 2005 |
2,831,668 | 2,598,797 | $ | 4.43 | ||||||||
Options authorized |
400,000 | | | |||||||||
Options granted |
(1,271,600 | ) | 1,271,600 | $ | 5.72 | |||||||
Options exercised |
| (94,268 | ) | $ | 1.56 | |||||||
Options cancelled: |
||||||||||||
Options forfeited (unvested) |
195,077 | (195,077 | ) | $ | 5.20 | |||||||
Options expired (vested) |
59,459 | (59,459 | ) | $ | 3.27 | |||||||
Balance at June 30, 2006 |
2,214,604 | 3,521,593 | $ | 4.95 | ||||||||
Weighted- Average | ||||||||||||||||
Weighted-Average | Remaining | |||||||||||||||
Exercise Price Per | Contractual Term | Aggregate Intrinsic | ||||||||||||||
Number of Shares | Share | (in years) | Value | |||||||||||||
Outstanding options (vested and expected to vest) |
3,124,807 | $ | 4.86 | 8.3 | $ | 1,696,121 | ||||||||||
Options exercisable |
1,241,250 | $ | 3.98 | 7.2 | $ | 1,291,032 |
15
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18
| significant changes in the strategy for our overall business; | ||
| significant underperformance relative to expected historical or projected future operating results; | ||
| significant changes in the manner of our use of acquired assets; | ||
| significant negative industry or economic trends; | ||
| significant decline in our stock price for a sustained period; and | ||
| our market capitalization relative to net book value. |
Three Months Ended | Increase (Decrease) | Six Months Ended | Increase (Decrease) | |||||||||||||||||||||||||||||
June 30, | from 2006 to 2005 | June 30, | from 2006 to 2005 | |||||||||||||||||||||||||||||
2006 | 2005 | $ | % | 2006 | 2005 | $ | % | |||||||||||||||||||||||||
Revenues: |
||||||||||||||||||||||||||||||||
Collaboration revenue |
$ | | $ | | $ | | | % | $ | | $ | 12,199 | $ | (12,199 | ) | (100 | )% | |||||||||||||||
Services and license
revenue |
224 | | 224 | 100 | % | 224 | | 224 | 100 | % | ||||||||||||||||||||||
Grant revenue |
305 | 953 | (648 | ) | (68 | )% | 593 | 1,452 | (859 | ) | (59 | )% | ||||||||||||||||||||
Total revenues |
$ | 529 | $ | 953 | $ | (424 | ) | (44 | )% | $ | 817 | $ | 13,651 | $ | (12,834 | ) | (94 | )% | ||||||||||||||
19
Three Months Ended | Increase (Decrease) | Six Months Ended | Increase (Decrease) | |||||||||||||||||||||||||||||
June 30, | from 2006 to 2005 | June 30, | from 2006 to 2005 | |||||||||||||||||||||||||||||
Research and development: | 2006 | 2005 | $ | % | 2006 | 2005 | $ | % | ||||||||||||||||||||||||
Compensation and
related personnel costs |
$ | 3,069 | $ | 2,131 | $ | 938 | 44 | % | $ | 5,544 | $ | 4,284 | $ | 1,260 | 29 | % | ||||||||||||||||
Outside services |
6,180 | 4,334 | 1,846 | 43 | % | 9,046 | 6,826 | 2,220 | 33 | % | ||||||||||||||||||||||
Facility costs |
1,241 | 885 | 356 | 40 | % | 2,208 | 1,756 | 452 | 26 | % | ||||||||||||||||||||||
Non-cash stock-based
compensation |
272 | 143 | 129 | 90 | % | 556 | 282 | 274 | 97 | % | ||||||||||||||||||||||
Total research and
development |
$ | 10,762 | $ | 7,493 | $ | 3,269 | 44 | % | $ | 17,354 | $ | 13,148 | $ | 4,206 | 32 | % | ||||||||||||||||
Three Months Ended | Increase (Decrease) | Six Months Ended | Increase (Decrease) | |||||||||||||||||||||||||||||
June 30, | from 2006 to 2005 | June 30, | From 2006 to 2005 | |||||||||||||||||||||||||||||
General and administrative: | 2006 | 2005 | $ | % | 2006 | 2005 | $ | % | ||||||||||||||||||||||||
Compensation and related
personnel costs |
$ | 1,641 | $ | 1,095 | $ | 546 | 50 | % | $ | 2,805 | $ | 2,188 | $ | 617 | 28 | % | ||||||||||||||||
Outside services |
784 | 720 | 64 | 9 | % | 1,464 | 1,329 | 135 | 10 | % | ||||||||||||||||||||||
Legal and patent costs, net |
348 | 342 | 6 | 2 | % | 632 | 677 | (45 | ) | (7 | )% | |||||||||||||||||||||
Facility costs |
149 | 122 | 27 | 21 | % | 293 | 248 | 45 | 17 | % | ||||||||||||||||||||||
Gain on disposal of property and
equipment |
| | | | % | (50 | ) | | (50 | ) | (100 | )% | ||||||||||||||||||||
Non-cash stock-based compensation |
458 | 193 | 265 | 138 | % | 839 | 371 | 468 | 126 | % | ||||||||||||||||||||||
Total general and administrative |
$ | 3,380 | $ | 2,473 | $ | 908 | 37 | % | $ | 5,983 | $ | 4,813 | $ | 1,170 | 24 | % | ||||||||||||||||
20
Three Months Ended | Increase (Decrease) | Six Months Ended | Increase (Decrease) | |||||||||||||||||||||||||||||
June 30, | from 2006 to 2005 | June 30, | from 2006 to 2005 | |||||||||||||||||||||||||||||
2006 | 2005 | $ | % | 2006 | 2005 | $ | % | |||||||||||||||||||||||||
Interest and other income, net |
$ | 685 | $ | 434 | $ | 251 | 58 | % | $ | 1,420 | $ | 801 | $ | 619 | 77 | % |
21
Payments Due by Period | ||||||||||||||||
Contractual Obligations: | Total | Less than 1 Year | 1-3 Years | 4-5 Years | ||||||||||||
Future minimum payments under our operating lease |
$ | 6,869 | $ | 1,051 | $ | 4,331 | $ | 1,487 | ||||||||
Total |
$ | 6,869 | $ | 1,051 | $ | 4,331 | $ | 1,487 | ||||||||
22
23
24
| demonstrating in clinical trials that our product candidates are safe and effective, in particular, in the current and planned trials for TOLAMBA and HEPLISAV; | ||
| obtaining regulatory approvals for our product candidates; | ||
| entering into collaborative relationships on commercially reasonable terms for the development, manufacturing, sales and marketing of our product candidates, and then successfully managing these relationships; and | ||
| obtaining commercial acceptance of our products, in particular TOLAMBA and HEPLISAV. |
25
| adversely affect our ability to timely and successfully commercialize or market these product candidates; | ||
| result in significant additional costs; | ||
| potentially diminish any competitive advantages for those products; | ||
| adversely affect our ability to enter into collaborations, receive milestone payments or royalties from potential collaborators; | ||
| cause us to abandon the development of the affected product candidate; or | ||
| limit our ability to obtain additional financing on acceptable terms, if at all. |
26
27
28
29
30
| the difficulty of managing geographically distant operations, including recruiting and retaining qualified employees, locating adequate facilities and establishing useful business support relationships in the local community; | ||
| compliance with varying international regulatory requirements; | ||
| securing international distribution, marketing and sales capabilities; | ||
| adequate protection of our intellectual property rights; | ||
| difficulties and costs associated with complying with a wide variety of complex international laws and treaties; | ||
| legal uncertainties and potential timing delays associated with tariffs, export licenses and other trade barriers; | ||
| adverse tax consequences; | ||
| the fluctuation of conversion rates between foreign currencies and the U.S. dollar; and | ||
| geopolitical risks. |
31
| difficulties in integrating the operations, technologies, products and personnel of Rhein; | ||
| difficulties in successfully utilizing Rheins manufacturing capabilities to produce materials for our existing product candidates in lieu of purchasing such materials from third party vendors; | ||
| diversion of managements attention from normal daily operations of the business; | ||
| potential difficulties in integrating different projects; | ||
| difficulties in entering markets in which we have no or limited direct prior experience and where competitors in such markets have stronger market positions; | ||
| insufficient revenues to offset increased expenses associated with the acquisition; and | ||
| potential loss of key employees of Rhein. |
| assume liabilities some of which may be unknown at the time of such acquisitions; | ||
| record certain intangible assets in conjunction with our accounting for the transaction in the second quarter of 2006 that may be subject to immediate write-off, ongoing impairment testing, or potential periodic impairment charges, or may cause us to incur future amortization expenses; or | ||
| become subject to unknown litigation. |
32
| obtain and protect commercially valuable patents or the rights to patents both domestically and abroad; | ||
| operate without infringing upon the proprietary rights of others; and | ||
| prevent others from successfully challenging or infringing our proprietary rights. |
| we might not have been the first to make the inventions covered by each of our pending patent applications and issued patents; | ||
| we might not have been the first to file patent applications for these inventions; | ||
| the pending patent applications we have filed or to which we have exclusive rights may not result in issued patents or may take longer than we expect to result in issued patents; | ||
| the claims of any patents that are issued may not provide meaningful protection; | ||
| our issued patents may not provide a basis for commercially viable products or may not be valid or enforceable; | ||
| we might not be able to develop additional proprietary technologies that are patentable; | ||
| the patents licensed or issued to us or our collaborators may not provide a competitive advantage; | ||
| patents issued to other companies, universities or research institutions may harm our ability to do business; | ||
| other companies, universities or research institutions may independently develop similar or alternative technologies or duplicate our technologies and commercialize discoveries that we attempt to patent; and | ||
| other companies, universities or research institutions may design around technologies we have licensed, patented or developed. |
33
| progress or results of any of our clinical trials, in particular any announcements regarding the progress or results of our planned trials for TOLAMBA and HEPLISAV; | ||
| progress of regulatory approval of our product candidates, in particular TOLAMBA and HEPLISAV, and compliance with ongoing regulatory requirements; | ||
| our ability to establish collaborations for the development and commercialization of our product candidates; | ||
| market acceptance of our product candidates; | ||
| our ability to raise additional capital to fund our operations, whether through the issuance of equity securities or debt; | ||
| technological innovations, new commercial products or drug discovery efforts and preclinical and clinical activities by us or our competitors; | ||
| changes in our intellectual property portfolio or developments or disputes concerning the proprietary rights of our products or product candidates; | ||
| our ability to obtain component materials and successfully enter into manufacturing relationships for our product candidates or establish manufacturing capacity on our own; | ||
| our ability to form strategic partnerships or joint ventures; | ||
| maintenance of our existing licensing agreements with the Regents of the University of California; | ||
| changes in government regulations; | ||
| issuance of new or changed securities analysts reports or recommendations; | ||
| general economic conditions and other external factors; | ||
| actual or anticipated fluctuations in our quarterly financial and operating results; and | ||
| volume of trading liquidity in our common stock |
34
| authorizing our Board of Directors to issue additional preferred stock with voting rights to be determined by the Board of Directors; | ||
| limiting the persons who can call special meetings of stockholders; | ||
| prohibiting stockholder actions by written consent; | ||
| creating a classified board of directors pursuant to which our directors are elected for staggered three year terms; | ||
| providing that a supermajority vote of our stockholders is required for amendment to certain provisions of our certificate of incorporation and bylaws; and | ||
| establishing advance notice requirements for nominations for election to our Board of Directors or for proposing matters that can be acted on by stockholders at stockholder meetings. |
35
For | Withhold | |||||||
Daniel S. Janney |
25,986,718 | 226,048 | ||||||
Arnold L. Oronsky |
26,102,663 | 110,103 |
For | Against | Abstain | ||||||
26,180,441 |
24,810 | 7,515 |
Exhibit | ||
Number | Document | |
10.19
|
2004 Non-employee Director Option Program (Revised) and 2005 Non-employee Director Cash Compensation Program, effective April 14, 2005 and amended February 23, 2006. | |
10.20*
|
Summary of Düsseldorf Lease Agreement as of August 14, 1990, as amended | |
10.21*
|
Definitive Commercial Agreement, dated April 21, 2006, among Dynavax Technologies Corporation, Rhein Biotech NV and Rhein Biotech GmbH | |
10.22*
|
Exclusive License Agreement, dated April 21, 2006, between Green Cross Vaccine Corp. and Rhein Biotech GmbH | |
10.23*
|
Share Sale and Purchase Agreement, dated March 27, 2006, between Dynavax Technologies Corporation and Rhein Biotech N.V. | |
10.24*
|
License and Supply Agreement, dated February 28, 2002, between Corixa Corporation and Rhein Biotech N.V. | |
10.25*
|
Purchase Option Agreement, dated as of April 18, 2006, among Dynavax Technologies Corporation, Symphony Dynamo Holdings LLC and Symphony Dynamo, Inc. | |
10.26*
|
Registration Rights Agreement, dated as of April 18, 2006, between Dynavax Technologies Corporation and Symphony Dynamo Holdings LLC | |
10.27*
|
Warrant Purchase Agreement, dated as of April 18, 2006, between Dynavax Technologies Corporation and Symphony Dynamo Holdings LLC | |
10.28*
|
Amended and Restated Research and Development Agreement, dated as of April 18, 2006, among Dynavax Technologies Corporation, Symphony Dynamo Holdings LLC and Symphony Dynamo, Inc. | |
10.29*
|
Novated and Restated Technology License Agreement, dated as of April 18, 2006, among Dynavax Technologies Corporation, Symphony Dynamo Holdings LLC and Symphony Dynamo, Inc. | |
21.1*
|
List of Subsidiaries | |
31.1*
|
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | |
31.2*
|
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
36
Exhibit | ||
Number | Document | |
32.1*
|
Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | |
32.2*
|
Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
* | Filed herewith | |
| We have been granted confidential treatment with respect to certain portions of this agreement. Omitted portions have been filed separately with the Securities and Exchange Commission. |
37
DYNAVAX TECHNOLOGIES CORPORATION |
||||
By: | /s/ DINO DINA, M.D. | |||
Dino Dina, M.D. | ||||
President, Chief Executive Officer and Director (Principal Executive Officer) | ||||
By: | /s/ DEBORAH A. SMELTZER | |||
Deborah A. Smeltzer | ||||
Vice President, Operations and Chief Financial Officer (Principal Financial Officer) |
||||
By: | /s/ TIMOTHY G. HENN | |||
Timothy G. Henn | ||||
Vice President, Finance and Administration and
Chief Accounting Officer (Principal Accounting Officer) |
||||
38
Amendment No. 1 Undated | ||
Amendment No. 2 Dated 03/24/1997 | ||
Amendment No. 3 Dated 07/03/1999 | ||
Amendment No. 4 Dated 10/11/2002 | ||
Amendment No. 5 Dated 07/02/2003 | ||
Amendment No. 6 Dated 5/17/2004 | ||
Landlord:
|
The name of the landlord effective April 2006 is: HBI Düsseldorf S.a.r.l. They are represented by Halverton Real Estate Investment Management GmbH, Friedrichstraße 185-187, D-10117 Berlin. | |
Term:
|
The current term expires on August 31, 2009. The Lease Agreement provides an option for the Company to extend the term an additional 5 years; provided that the option is exercised not later than 18 months from the scheduled expiration date. |
39
40
1.
1.1 | Affiliate means, as to any person or entity, any other person or entity, which controls, is controlled by, or is under common control with such person or entity. A person or entity shall be regarded as in control of another entity only if it owns or controls, directly or indirectly, at least fifty percent (50%) of the equity securities or other ownership interests in the subject entity entitled to vote in the election of directors or with the power to direct or elect management of such subject entity. Affiliates of RBNV include Parent, Green Cross Vaccine Corp. (an entity organized under the laws of the Republic of Korea), Rhein Vaccines B.V., Berna Biotech A.G., and Crucell Holland B.V.,. Affiliation shall be determined based on RBG being wholly owned by Dynavax, and not owned at all by RBNV. | ||
1.2 | Alum means any composition that is or contains aluminum in any form, regardless of whether [ * ] | ||
1.3 | Asian Country means any country geographically located on the continent of Asia. To be clear, the Asian Countries exclude Australia and New Zealand. | ||
1.4 | Closing Date means the first date set forth above. | ||
1.5 | Control means, with respect to a particular item of know-how or a particular Patent at a given date, the ownership of or a license under, together with the right to grant a license or sublicense of the scope set forth in the Agreement under, such item of know-how or Patent, without breaching any written agreement with a third party in existence as of such date. | ||
1.6 | Cytovax means the prophylactic cytomegalovirus vaccine currently under development in NovoVacs BV. | ||
1.7 | Cytovax Program Products means [ * ] , including Cytovax. | ||
1.8 | Definitive Agreements means (i) the Share Sale and Purchase Agreement (parties are RBNV and Dynavax) dated as of March 27, 2006; (ii) this Agreement (parties are RBNV, RBG, and Dynavax); (iii) the Supervax Exclusive License Agreement dated as of the Closing Date (parties are RBNV, RBG and Green |
2.
Cross); (iv) the Termination Agreement dated as of the Closing Date (parties are Berna and Dynavax); and (v) the Waiver Agreement relating to the employee stock plans (by managers and employees of RBG) dated as of the Closing Date. | |||
1.9 | [ * ] | ||
1.10 | Dynavax Notice has the meaning given in the first paragraph of Section 3.1. | ||
1.11 | Existing Contracts has the meaning given in Section 2.1. | ||
1.12 | Heplisav means Dynavaxs current Hepatitis B vaccine containing Hepatitis B surface antigen and Dynavaxs 1018 ISS. | ||
1.13 | Heplisav Program Product means [ * ] In this context, [ * ] The product Heplisav is included among the Heplisav Program Products. | ||
1.14 | [ * ] | ||
1.15 | High Cost Registration European Countries means all countries that are members of the European Union as of the Closing Date, and Norway, Switzerland and Iceland, other than the Low Cost Registration European Countries. | ||
1.16 | Know How means all materials, information, experience and data, formulae, procedures, results and specifications, in written or electronic form, that (i) are Controlled by RBG or RBNV as of the Closing Date, (ii) are not generally known and (iii) are not subject to a third party confidentiality obligation that prevents RBG or RBNV from disclosing the same. Know How includes the Master Cell Line. | ||
1.17 | Low Cost Registration European Countries means any country within the European Union as of the Closing Date, and Norway, Switzerland and Iceland, in which the approval for marketing of a vaccine product [ * ] | ||
1.18 | Master Cell Line means the [ * ] strain, designated as [ * ] that exists as master cell banks designated as [ * ] and working cell banks designated as [ * ] as such cell line is described and referred to in the following IND filed with the FDA: [ * ] This strain is referred to between the Parties as the [ * ] strain. | ||
1.19 | Patents means all granted patents, including utility models and certificates of invention, and reissues, reexaminations, supplementary protection certificates, extensions, and term restorations thereof, and patent applications, including any continuations, continuations-in-parts, divisionals thereof, and the like. | ||
1.20 | [ * ] is defined by reference to [ * ] it [ * ] to [ * ] or [ * ] for a [ * ] |
(a) | [ * ] means to [ * ] and [ * ] a [ * ] or [ * ] of [ * ] are [ * ] pursuant to a [ * ] that provides that [ * ] of [ * ] as a [ * ] from [ * ] |
3.
(b) | [ * ] to [ * ] or [ * ] for [ * ] of a [ * ] in [ * ] or [ * ] for the [ * ] of [ * ] the [ * ] in a [ * ] for [ * ] which [ * ] is [ * ] of this definition [ * ] qualify [ * ] |
1.21 | RBG IP means RBG Patents and the related Know How, both as of the Closing Date. | ||
1.22 | RBG Patents means Patents Controlled by RBG as of the Closing Date that are listed in Exhibit 1.16. | ||
1.23 | Supervax shall mean the current prophylactic two dose Hepatitis B vaccine that includes the [ * ] adjuvant. [ * ] | ||
1.24 | Supervax Program Products means all prophylactic Hepatitis B vaccines that contain all of the following: [ * ] The Supervax Program Products include Supervax. | ||
1.25 | Theravax means a therapeutic Hepatitis B vaccine that contains all of [ * ] | ||
1.26 | Theravax Program Products means all therapeutic Hepatitis B vaccines that contain all of [ * ] The Theravax Program Products include Theravax. | ||
1.27 | Traditional Hepatitis B Vaccine means any vaccine that contains [ * ] For the avoidance of doubt, Traditional Hepatitis B Vaccine includes the following Hepatitis B vaccines registered at Closing: [ * ] |
2.1 | Confirmation of Existing Contract Obligations. Except for the March 1, 2005 Agreement between RBG, RBNV and Berna (which is terminated by the Share Sale and Purchase Agreement), and except to the extent specifically modified herein and/or by a separate amendment attached hereto as an Exhibit, all terms of pre-existing (prior to the Closing Date) contracts among RBG on the one hand and RBNV, and its Affiliates, on the other hand the Existing Contracts; the Existing Contracts exclude the Definitive Agreements), are hereby confirmed and remain in full force and effect. | ||
2.1.1 | The Parties hereby agree that this Agreement sets forth the entire understanding between the Parties and their Affiliates with respect to the ownership of, all licenses to, and all rights to use and practice, the RBG IP and the [ * ] strain (here and everywhere else used in this Agreement where we refer to [ * ] we mean the strain [ * ] as described in [ * ] Release Testing, Genetic and Product Characterisation). That is to say, where we refer above to except to the extent |
4.
specifically modified hereunder, the grants of licenses under and rights to use and practice the RBG IP set forth in this Agreement is, together with the remainder of this Section 2.1.1 and Sections 2.4 and 2.5, are intended to supersede all prior understandings with respect to the ownership of, licenses under, and rights to use RBG IP and the [ * ] strain, and to set forth the Parties entire agreement with respect to all of the foregoing matters mentioned in this sentence. RBNV and its Affiliates hereby acknowledge that they have no ownership or license rights in the RBG IP (excluding the Master Cell Line) and the [ * ] strain other than the license rights set forth in this Agreement. RBNV acknowledge that they have no financial interest in the RBG IP or [ * ] strain other than as set forth in Section 2.4 and 2.5. | |||
2.2 | Termination of Berna Agreement. The Termination Agreement between Dynavax and Berna, which sets forth the Parties mutual agreement to terminate the License and Supply Agreement, dated November 19, 2003, is attached as Exhibit 2.2. Thus, such License and Supply Agreement is terminated. Section 2.1 of this Agreement shall not viewed or deemed in any way to resurrect it. | ||
2.3 | Assignment of Supervax Trademark Rights. The Supervax Trademark Assignment Agreement between RBG and Berna is attached as Exhibit 2.3. | ||
2.4 | Fully Paid-Up License Rights. All Patent and Know-How rights, including RBG Patents rights, granted to RBNV, RBG, and their Affiliates, in pre-existing agreements between or among RBNV, RBG and their Affiliates, are hereby paid-up and royalty-free at the Closing Date. With the exception of (1) any outstanding invoices at Closing, (2) the arrangements specifically made and/or referenced in the Definitive Agreements executed at Signing and/or Closing (such as the profit share for Supervax, the loan repayments, any outstanding accounts payable, any open invoices, and the payments under Section 2.5) and (3) the [ * ] between RBG and RBNV described in the October 1, 2005 Addendum to License Agreement (between RBG and GCVC dated June 30, 1998) with respect to the License and Technology Transfer Agreement between [ * ] sharing arrangement is also referred to at the end of Section 2.5). RBG and RBNV hereby waive all rights to any and all claims to all monies owed under such pre-existing agreements. If RBNV or RBG requests in writing, RBG or RBNV, respectively, shall promptly execute, and deliver to the other, any formal amendment documents confirming the waiver of any monetary obligations owing thereto and/or to its Affiliates and specific to the aforesaid pre-existing documents. Such confirmations must be consistent with this Agreement and the other Definitive Agreements. Such confirmations shall not have any force of effect to the extent inconsistent with this Agreement and/or any of the other Definitive Agreements. | ||
2.5 | RBNV Rights to RBG Third Party License Revenues. RBG shall pay to RBNV all monies (excluding those already included in RBGs accounts receivable as of the Closing Date) received by RBG from third parties pursuant to obligations in license agreements with RBG, which agreements exist on the Closing (other than current licenses with RBNV and its Affiliates and specifically |
5.
excluding [ * ] and the License and Technology Transfer Agreement between [ * ] ) (Current Licenses), to the extent that such monies exceed [ * ] annually after adjustment for payments owed (a) based on agreements existing at Closing, to other third parties from such monies (including any royalties due to such other third parties on in-licensed IP sublicenses to the RBG licensees), and (b) for intellectual property that becomes licensed under the Current Licenses due to RBG obtaining control thereof after the Closing Date, to such third parties pursuant to the written agreement by which RBG obtains such control. For the purposes of clarity, these payments shall not include any payments received by RBG with respect to its Supervax Program Products, Theravax Program Products and Cytovax Program Products. RBNV shall have reasonable audit access to records of such payments on reasonable terms and at reasonable times. Such audits must be performed by a reputable certified public accountant, under appropriate obligations of confidentiality. Such audits shall not be made more frequently than once annually, no later than three (3) years after the payment period being audited. |
(a) | [ * ] | ||
(b) | [ * ] |
3.1 | European Countries (other then Low Cost Registration European Countries). Dynavax, or an Affiliate thereof, shall promptly notify RBNV in writing within [ * ] of taking its decision to develop the first Supervax Program Product (and thereafter within [ * ] after it takes such decision with respect to each subsequent Supervax Program Product not already (at the time of such decision) subject to a pre-existing third party agreement) for any High Cost Registration European Countries (Dynavax Notice). Dynavax, and/or an Affiliate thereof, shall not [ * ] the (i) development and commercialization (including marketing and selling), and/or (ii) distribution and/or sale of such Supervax Program Product(s) for and in High Cost Registration European Countries until after the Parties have exercised their commercially reasonable efforts according to this Section 3.1 (unless RBNV fails to provide within the time period stated in Section 3.1.1 a notice that RBNV wishes to negotiate with Dynavax or its Affiliate under that Section). | ||
3.1.1 | Schedule and Procedure. Within [ * ] of receiving notification pursuant to Section 3.1, RBNV, or an Affiliate thereof, may notify Dynavax in writing of RBNVs, or an Affiliates, intention to negotiate a development and commercialization agreement with Dynavax or an Affiliate thereof (the RBNV |
6.
Notice). If RBNV, or an Affiliate thereof, does not provide the RBNV Notice, then Dynavax may deem the failure to answer as a negative response and shall be free to proceed with third-party transactions regarding such Supervax Program Product rights in any and/or all of the countries mentioned in the Dynavax notice, without restriction. | |||
3.1.2 | Within [ * ] of receiving the RBNV Notice, Dynavax, or an Affiliate thereof, shall provide RBNV with a good faith written proposal for a development and commercialization agreement (at a term sheet or greater level of detail, but not required to be at the level of a fully drafted agreement), which may, at Dynavaxs discretion, [ * ] for such Supervax Program Product in the specific country or countries (Dynavax Proposal). | ||
3.1.3 | Within [ * ] of receipt by RBNV of the Dynavax Proposal (Negotiation Period), RBNV and Dynavax, or their designated Affiliates, shall exercise their commercially reasonable efforts to negotiate, [ * ] the terms of such development and commercialization arrangement, including [ * ] . | ||
3.1.4 | Dynavax, or an Affiliate thereof, shall not offer more favorable terms, such as an offer that does not require the sharing of development costs (if the offer to RBNV included such sharing), than those offered to RBNV under Section 3.1.2 (if a proposal under such Section was required of Dynavax), within [ * ] from the expiration of the Negotiation Period, unless those terms have first been offered to, and rejected by, RBNV, which rejection or approval shall be provided within [ * ] of notification. A failure to respond within such [ * ] shall be considered a rejection. After such [ * ] period, Dynavax, RBG and their Affiliates shall be free to proceed with third-party transactions regarding such Supervax Program Products rights in any and/or all of the countries mentioned in the Dynavax notice, without restriction. |
3.2 | Asian Countries and Low Cost Registration European Countries. Dynavax, or an Affiliate thereof, shall promptly notify RBNV in writing within [ * ] of taking its decision to [ * ] in any Asian Country(ies) and/or Low Cost Registration European Country(ies). Such decision must only be made if the Supervax Program Product and data regarding it is such that it shall be at a stage |
7.
that it would be reasonable to [ * ] it being understood and agreed that if in the particular country it is customary that [ * ] Dynavax, and/or an Affiliate thereof, shall not [ * ] any third party for the sale and/or distribution of Supervax for and in any Asian Country(ies) and/or Low Cost Registration European Country(ies) until after the Parties have exercised their commercially reasonable efforts according to this Section 3.2 (unless RBNV fails to provide a notice that it wishes to negotiate with Dynavax or its Affiliate under Section 3.2.1 within the deadline stated in such Section in which case Dynavax and RBG are free to proceed regarding such Supervax Program Product rights for the country(ies) mentioned in the notice, without restriction). | |||
3.2.1 | Schedule and Procedure. Within [ * ] of receiving notification pursuant to Section 3.2, RBNV, or an Affiliate thereof, may notify Dynavax in writing of RBNVs, or an RBNV Affiliates, intention to negotiate a commercialization agreement with Dynavax, or an Affiliate thereof, with respect to the Asian Country(ies) and/or Low Cost Registration European Country(ies) mentioned in Dynavaxs or its Affiliates notice (such notice from RBNV, the RBNV Notice). If RBNV, or an Affiliate thereof, does not provide the RBNV Notice, then Dynavax may deem the failure to answer as a negative response. In that case, Dynavax and RBG are free to proceed regarding such Supervax Program Product rights for the country(ies) mentioned in their notice, without restriction. | ||
3.2.2 | Within [ * ] of receipt of the RBNV Notice, RBNV and Dynavax, or their designated Affiliates, shall exercise their commercially reasonable efforts to negotiate, [ * ] in good faith, the essential terms and conditions of sales and distribution, including [ * ] . | ||
3.2.3 | In case negotiations under Section 3.2.2 (if required to be initiated thereunder) do not result, within the specified [ * ] in an agreement as specified in Section 3.2.2, Dynavax, or an Affiliate thereof, may [ * ] provided that Dynavax, or an Affiliate thereof, shall not offer to such third parties more favorable terms than those offered to RBNV, within [ * ] after the end of discussions under Section 3.2.2 without first offering such more favorable terms to RBNV. RBNV is obliged to respond yes or no to the more favorable terms within [ * ] A failure to respond within such [ * ] is considered a rejection. |
3.3 | First Negotiation. Dynavax and RBNV agree that, for [ * ] after the Closing Date, neither Party nor their Affiliates, shall negotiate with any third parties, without first negotiating and discussing in good faith with each other, any possible joint development, research, collaboration and/or marketing agreement for [ * ] |
8.
4.1 | Supervax. RBG hereby confirms its exercise of the exclusive (even as to the grantor) license option in the License Option Agreement Supervax dated November 9, 2005, between RBG and Green Cross Vaccine Corporation (the Superseded Option). The terms of such resulting exclusive license are described in the Exclusive License Agreement attached hereto as Exhibit 4.1, which terms supersede the Superseded Option. | ||
4.2 | Master Cell Line and Hepatitis B Surface Antigen [ * ] . Subject to any pre-existing third party agreements and the terms of this Agreement (including the covenants specified in Section 6 hereof), RBNV and its Affiliates, hereby with respect to Section 4.2.1 agree that RBG and Dynavax have, and with respect to Section 4.2.2 grant, and confirm the grant, to RBG and Dynavax, of the following rights: | ||
4.2.1 | The right to use the Master Cell Line for Hepatitis B surface antigen ([ * ] ) currently in RBGs possession (including progeny of such cell line) for any and all permitted purposes, including clinical and commercial production. Permitted purposes in this context means all activities outside the scope of the exclusive license of Section 4.3.2, other than activities forbidden in Section 6, during the time period forbidden therein. | ||
4.2.2 | A non-exclusive license under all Patents (if any) owned, or controlled with the right to sublicense, by RBNV to develop, make, have made, use, offer to sell, sell, store and import Hepatitis B surface antigen ([ * ] ) produced on the Master Cell Line, but while the license of Section 4.3.2 is in effect only outside the scope of the exclusive license of Section 4.3.2; and excluding activities forbidden in Section 6, during the time period forbidden therein. | ||
4.2.3 | Sublicense Rights. The rights and licenses specified in 4.2.1 and 4.2.2 above are sublicensable without RBNVs and its Affiliates consent through one or more tiers or layers of sublicensees to RBGs and Dynavaxs Affiliates, third party contract manufacturers, contract clinical and analytical service providers, distributors, and commercial development and/or marketing partners (including licensees). | ||
4.2.4 | The rights and licenses granted in this Section 4.2 are royalty-free and fully paid-up as far as any payments to RBNV and its Affiliates are concerned, and are perpetual. | ||
4.3 | RBG License Grants to RBNV. Subject to the terms of this Agreement and any restrictions stated in in-licenses by which RBG acquired Control of any RBG IP that is not owned by RBG, RBG hereby grants to RBNV and its Affiliates, and RBNV and its Affiliates shall hereby receive, the following rights: | ||
4.3.1 | a fully paid-up, royalty-free, non-exclusive, license under RBG IP, in perpetuity, to develop, make, have made, use, sell, offer to sell, store, import and export any |
9.
and all products, except for Supervax Program Products, Theravax Program Products, Cytovax Program Products and Heplisav Program Products. |
4.3.1.1 | The exclusion of Supervax Program Products, Theravax Program Product, Cytovax Program Products and Heplisav Program Products from the foregoing license means (without limitation) that such license does not extend to the making and selling of Hepatitis B surface antigen (or any other ingredient covered by or made using the RBG IP) for inclusion (or under contractual terms that would permit their inclusion) in any Supervax Program Product(s), Theravax Program Product(s), Cytovax Program Product(s) and/or Heplisav Program Product(s). Accordingly, RBNV and their Affiliates shall only supply Hepatitis B surface antigen, made using RBG IP, and such other ingredients to third parties under circumstances in which such third parties (and any entities to which they may transfer such antigen and other ingredients) are legally forbidden and precluded from making Supervax Program Products, Theravax Program Products, Cytovax Program Product and Heplisav Program Products using the supplied quantities of such antigen and other ingredients. Notwithstanding the foregoing, RBNV and its Affiliates shall not be required to amend their existing agreements to comply with the restrictions specified in this Section 4.3.1, but shall exert its reasonable diligent efforts, which do not adversely financially impact RBNV, to include such terms upon amendment thereof and shall include them on any voluntary extension to the relationship (i.e. one that is not required without RBNVs or its Affiliates consent under the contract that exists as of the Closing Date). |
4.3.2 | a fully paid-up exclusive license under RBG IP, to develop, make, use, offer to sell, store, sell and import Traditional Hepatitis B Vaccines (such as [ * ] and any combination vaccines (containing two (2) or more vaccines directed against diseases caused by independent agents) that (a) include a Traditional Hepatitis B Vaccine (such as [ * ] ), but (b) exclude Heplisav Program Products. Such license shall be exclusive, even as to Dynavax and RBG, for a term lasting until the longer of the end of ten years or the life of the last-to-expire applicable RBG Patent. |
4.3.2.1 | The foregoing license explicitly does not extend to the making and selling of Hepatitis B surface antigen (or any other ingredient covered by or made using the RBG IP) for inclusion (or under contractual terms that would permit their inclusion) in any Supervax Program Product(s), Theravax Program Product(s), Cytovax Program Product(s) and/or Heplisav Program Products. Accordingly, RBNV and their Affiliates shall only supply Hepatitis B surface antigen, made using RBG IP, and such other ingredients to third parties under circumstances in which such third parties (and any entities to which they may transfer such antigen and other ingredients) are legally forbidden and precluded from making Supervax Program Products, Theravax Program Products, Cytovax Program Product and Heplisav Program Products using the supplied quantities of such |
10.
antigen and other ingredients. Notwithstanding the foregoing, RBNV and its Affiliates shall not be required to amend their existing agreements to comply with the restrictions specified in this Section 4.3.2, but shall exert its reasonable diligent efforts, which do not adversely financially impact RBNV, to include such terms upon amendment thereof and shall include them on any voluntary extension to the relationship (i.e. one that is not required without RBNVs or its Affiliates consent under the contract that exists as of the Closing Date). |
4.3.3 | For the avoidance of doubt, the licenses of Section 4.3.1 and 4.3.2 do not in any way diminish the scope of RBGs rights to the Supervax Program Products, Theravax Program Products and Cytovax Program Products. | ||
4.3.4 | Sublicense Rights and Restrictions. The licenses of both Sections 4.3.1 and 4.3.2 are subject to restrictions on RBGs ability to license and sublicense pursuant to pre-existing third-party agreements (i.e. agreements with entities other than Affiliates). Other than such third party licensing restrictions: |
(1) | RBNVs non-exclusive license rights provided in subsection 4.3.1 above are sublicensable in conjunction with the grant of a license or sublicense under [ * ] | ||
(2) | RBNVs exclusive license rights provided in subsection 4.3.2 above, are sublicensable [ * ] without any requirement that RBNV license other intellectual property in conjunction with the grant of the sublicense. | ||
(3) | To avoid any doubt, any sublicensees under the license of subsection 4.3.1 and any sublicensees under the license of Section 4.3.2 shall be subject to the same restrictions as stated in Sections 4.3.1.1 and 4.3.2.1, respectively, as if such sublicensees were RBNV or an RBNV Affiliate. |
4.3.5 | RBG Obligation to Secure Third Party Licensor Consent. At RBNVs written request, RBG shall promptly notify each third party licensor of RBG IP, of RBGs obligation under Section 4.3 to sublicense rights in such RBG IP to RBNV, and if consent or amendment under the appropriate license agreement is required, then RBG shall [ * ] to obtain written consent from each such third party licensor. Promptly upon securing each required consent from a third party licensor, if the terms of the consent are acceptable to RBNV, then the Parties shall execute a formal sublicense agreement with RBNV providing for (1) the sublicense of RBG IP rights to RBNV, and (2) the assumption of obligations by RBNV as provided for in such third party license agreements. If any such sublicense requires the payment of monies to the third party licensor (including any payment in the form of an amendment that results in a payment of less money to RBG under the contract than without such amendment), RBNV shall be informed in writing of such potential financial obligation, and RBNV shall be responsible for the payment of all such fees to said third party licensor. RBNV shall be entitled to terminate such sublicense in accordance with its terms, but shall not in this manner be able to avoid responsible for any non-cancelable sublicensing-related fees. |
11.
4.3.6 | Licensed RBG Patent Maintenance. Given the non-exclusive nature of the license of Section 4.3.1, RBG and Dynavax will be under no requirement to prosecute or maintain RBG Patents, which do not specifically claim [ * ] If RBG and Dynavax elect to abandon any RBG Patent, RBG and/or Dynavax will first give RBNV reasonable notice of such intention and the opportunity to prosecute or maintain such RBG Patent. In this case, optionally, at RBNVs sole discretion, RBNV may do so in its own name; provided that RBG and Dynavax will receive a non-exclusive license to such RBG Patents, consistent with the licenses granted herein and with any pre-existing third party agreements (i.e. if 3rd party obligations exist that apply to the practice of the inventions claimed in the RBG Patents taken over by RBNV, then RBNV must comply with such 3rd party license obligations respecting such practice). If RBG and Dynavax choose, as part of a strategic move, to abandon a particular RBG Patent, which does not claim specifically [ * ] and which would reasonably benefit the RBG Patent portfolio, then the Parties will diligently [ * ] | ||
4.4 | Defense of Patent Litigation. If either Party after the Closing is warned or sued by a third party alleging or charging infringement of any Patents claiming the licensed Know How or the use thereof by either Party or its Affiliates, then the Party that was warned or sued shall notify promptly the other Party. Except only if, as and to the extent otherwise provided in Article 8, each Party shall be responsible, at its expense, for settling and/or defending such warning, allegation or charge (including associated litigation) to the extent relating to such Partys or its Affiliates use of the licensed Know-How. [ * ] Upon a Partys reasonable request, the other Party agrees to reasonably assist in any such defense on mutually agreed reasonable terms, provided that the requesting Party agrees to reimburse the other Party for the reasonable out of pocket expenses incurred by the other Party for the provision of such assistance. Dynavax and RBG are considered a single Party for purposes of this Section 4.4. | ||
4.5 | Patent Enforcement. | ||
4.5.1 | Notification. In the event that a Party obtains actual knowledge that a third partys activities likely infringe one or more of the RBG Patents within the scope of the exclusive license granted in Section 4.3.2, it shall promptly notify the other Party of any such likely infringement. | ||
4.5.2 | Control of Suit: |
4.5.2.1 | As to the infringement of exclusively licensed RBG Patents pursuant to Section 4.3.2, RBG shall have the first right to effect termination of such infringement, including bringing suit or other proceedings against the infringer in its own name and the other Parties hereto shall be kept informed at all times of all such proceedings taken by RBG. If RBNV, or |
12.
another Party licensee, requests, such Party may join with RBG as a Party to the lawsuit or other proceeding in a monitoring capacity only at its own expense. However, even if RBNV chooses to join the suit in such a monitoring capacity, RBG shall retain sole control of the prosecution of such suit or proceedings, as the case may be. | |||
4.5.2.2 | If (a) RBG elects not to file legal proceedings against a third party within [ * ] such possible infringing activities, and has not engaged in, or has terminated, reasonably diligent business discussions to terminate such infringement, and (b) the infringement involves the commercialization of a product that competes directly with any then-marketed product of RBNV or any of its Affiliates, and if the alleged infringement is likely to have a more than insignificant impact on RBNVs business in the country(ies) where sales of allegedly infringing product is occurring, then RBNV shall have the right to effect termination of such infringement, including bringing suit or other proceedings against the infringer in its own name. The other Parties hereto shall be kept informed at all times of all such proceedings taken by RBNV. RBNV shall not be authorized to make any admission, consent, or other representation during the proceeding, which would admit the invalidity or unenforceability of an RBG Patent, without the advice and consent, in writing, from RBG, which RBG is entitled to withhold in its reasonable discretion. If RBG (or an RBG Affiliate) requests, such entity may join with RBNV as a party to the lawsuit or other proceeding at its own expense. In this case, RBNV shall retain control of the prosecution of such suit or proceedings, as the case may be, except that RBG shall have the sole right to control the prosecution of such suit or proceedings as regards all matters affecting validity and/or enforceability of the RBG Patent(s). |
4.5.3 | Costs and Monetary Recovery: Each Party shall bear all its costs incurred in connection with such lawsuit or other proceeding. Any monetary recovery shall first be paid to the Parties (and their Affiliates) to reimburse their legal and other costs associated with the legal proceeding. [ * ] remaining recovery shall be paid to or retained by RBNV, [ * ] remaining recovery shall be paid to or retained by RBG. | ||
4.5.4 | Disclaimer. Nothing in this Agreement shall be construed as obligating any Party the right, to proceed against a third party infringer. | ||
4.5.5 | Area of No RBNV Enforcement Rights. RBNV and its Affiliates shall not have any right to enforce the RBG Patents outside the scope of the exclusive license in Section 4.3.2 during the time period while it remains exclusive. Without limitation, this means that RBNV and its Affiliates have no right to enforce the RBG Patents within the scope of the non-exclusive license of Section 4.3.1, to the extent broader than the license of Section 4.3.2 (i.e. outside of any overlap between Section 4.3.1 and Section 4.3.2). |
13.
5.1 | Master Cell Line Issues-Cooperation. Dynavax and RBNV acknowledge that the Master Cell Line is (1) used by RBNV and its Affiliates for the production of products that are approved by Governmental Authorities, and that are currently on the market, and (2) is confidential and of crucial importance to the Parties. Accordingly, [ * ] ensure the best and most informed approach. To avoid any doubt, [ * ] Dynavax and RBNV further agree to use reasonable efforts to promptly notify the other party of any and all communications to and from Governmental Authorities relating to the safety of the Master Cell Line, as well as of any communication and/or concerns expressed by such regulatory authority relating to the safety, quality or characterization of the Master Cell Line, and agree to consult promptly with each other to resolve any such concerns with the FDA or such other Governmental Authorities. The Parties agree to share all safety, toxicity and tumorogenicity data regarding the Master Cell Line that any of them (or their Affiliates) generates (or receives or contracts for) [ * ] | ||
5.2 | Production Technology Assistance. RBG will provide to RBNV and to its Affiliates reasonable access to assistance regarding the Hepatitis B and Hansensula polymorpha production technologies as in existence at RBG on the Closing (with no updating), as follows: | ||
5.2.1 | Troubleshooting. For a period of [ * ] after Closing, RBG will make available for general diagnosis and troubleshooting, in each year during this [ * ] period up to [ * ] at a cost of [ * ] per FTE month, which cost may be adjusted for inflation every year, plus all travel and related expenses, provided that RBNV provides RBG at least [ * ] advance notice of such request. [ * ] RBGs technical personnel supplied by RBG for such general diagnosis and troubleshooting. | ||
5.2.2 | Long Term Projects. For a period of [ * ] after Closing, RBG will make available for long term projects, including training of Parents personnel, up to an aggregate of [ * ] of which no more then [ * ] within [ * ] at a cost of [ * ] per FTE month, which cost may be adjusted for inflation every year, plus all travel and related expenses, provided that Parent provides RBG at least [ * ] advance notice of such request. [ * ] RBG technical personnel supplied by RBG for such long term projects. | ||
5.2.3 | The aggregate FTEs stated in Sections 5.2.1 and 5.2.2 are stated collectively for RBNV and its Affiliates together. They are not each separately entitled to this number of FTEs. | ||
5.3 | No Transfer or Supply Obligations. Other than is mentioned in Sections 5.1 and 5.2, there are no obligations for RBG or RBNV to supply each other or their Affiliates, Know How, products or other materials pursuant to the license grants herein. Any such existing obligations are hereby waived. The Parties remain free to contract in writing for new such obligations in the future in their sole discretions. |
14.
6.1 | [ * ] RBG and Dynavax, for [ * ] after Closing, will not develop and/or market, and/or license others to develop and/or market, for [ * ] Hepatitis B vaccine, other than Heplisav Program Products. | ||
6.2 | [ * ] RBG and Dynavax, for [ * ] after Closing, will not develop and/or market, and/or license others to develop and/or market, [ * ] other than Heplisav Program Products. |
7.1 | RBG warrants and represents to RBNV that any and all RBG IP rights licensed from third parties, which rights are necessary for the research, development, manufacture, marketing, sale or importation of the products known as (a) [ * ] and/or (b) HepavaxGene, are sublicensable, and have been sublicensed, to RBNV and its Affiliates, without the need to secure the prior consent from such third parties. | ||
7.2 | RBNV, RBG and Dynavax warrant and represent to each other that (i) it has the full right and authority to enter into this Agreement and to grant the rights granted herein; (ii) it has not previously granted any rights to third parties in conflict with the rights and options granted herein; (iii) it shall not violate the law or existing contractual obligations by executing this Agreement; (iv) it is not bound by any obligations to third parties that would impair its ability to perform its obligations or grant the licenses contemplated herein; and (v) it has duly executed this Agreement. UNLESS OTHERWISE EXPRESSLY PROVIDED FOR IN THIS AGREEMENT, EACH PARTY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT, PATENT VALIDITY, TECHNICAL FEASIBILITY, FITNESS FOR ANY PARTICULAR PURPOSE, AND ANY WARRANTIES CONCERNING THE INHERENT PROPERTIES OF KNOW HOW AND RBG IP SUPPLIED OR LICENSED UNDER THIS AGREEMENT. EACH PARTY MAKES NO WARRANTY AS TO THE MERCHANTABILITY OF THE PRODUCTS, ITS LICENSED KNOW HOW OR LICENSED PATENTS. |
8.1 | Licensee Third Party Responsibilities. | ||
8.1.1 | Dynavax/RBG Responsibility. Dynavax and RBG shall be responsible, and shall hold RBNV harmless for: (i) all financial obligations to third parties (i.e. parties that are not Parties hereto and Affiliates thereof) due to the receipt or exercise by Dynavax or RBG of the rights addressed in section 4.2; and (ii) all requirements in relation to RBNVs existing (as of the Closing Date) third-party licenses, arising out of Dynavaxs or RBGs receipt or exercise of the rights addressed in section 4.2 of which RBNV informs Dynavax (i.e. if third-party |
15.
obligations exist (meaning that they are provided for in a written agreement with a third party executed before the Closing Date) for the use of the Master Cell Line by RBG and Dynavax under the license of Section 4.2, then fulfillment of those obligations shall not be RBNVs responsibility, but RBNV must inform RBG and Dynavax of such third-party obligations in order for RBG and Dynavax to be able to fulfill them). For the avoidance of any doubt, RBNV shall not be liable for any financial obligations to third parties, including for example upstream royalties or other payments, arising out of Dynavaxs, RBGs or their Affiliates exercise of rights to third-party technology the rights in which have been sublicensed hereunder. | |||
8.1.2 | RBNV/Affiliate Responsibility. RBNV is responsible, and shall hold RBG and Dynavax harmless for: (i) all financial obligations to third parties (i.e. parties that are not Parties hereto and Affiliates thereof) due to the receipt or exercise by RBNV and its Affiliates of the license of subsection 4.3.1 and/or 4.3.2, and (ii) all requirements in relation to RBGs existing (as of the Closing Date) third-party licenses for RBG IP, arising out of RBNVs or its Affiliates receipt or exercise of the licenses of subsections 4.3.1 and 4.3.2 of which RBG and/or Dynavax informs RBNV (i.e. if third-party obligations exist (meaning that they are provided for in a written agreement with a third party executed before the Closing Date) for the exercise of the licenses of Sections 4.3.2 and 4.3.2 shall not be Dynavaxs nor RBGs responsibility, but Dynavax or RBG must inform RBNC of such third-party obligations in order for RBNV and its Affiliates to be able to fulfill them. For the avoidance of any doubt, RBG and Dynavax shall not be liable for any financial obligations to third parties, including for example upstream royalties or other payments, arising out of RBNVs or its Affiliates exercise of rights to third-party RBG IP sublicensed hereunder. | ||
8.1.3 | Cooperation. The Parties shall cooperate in the mechanics of making payment to any upstream licensors. This includes that the sublicensing Party will forward payments and reports received from the sublicensed Party to the third-party licensor, promptly after receipt, and will share promptly all notices of delinquency and non-payment received. | ||
8.2 | General Product Indemnification. |
(a) | Each licensing Party herein (Licensor) shall not be liable for, and each licensed Party herein (Licensee) shall defend indemnify and hold Licensor together with its Affiliates and the directors, officers and employees of all of them (the Licensor Indemnitees) harmless against, any and all liabilities (including product liability and infringement of third party Patents insofar as such infringement relates to activities carried out by Licensee under this Agreement), damages, losses costs, and expenses, including reasonable attorneys fees (collectively Damages), resulting in any manner from third-party claims, demands and actions (collectively, Claims) arising out of (a) the use by Licensee or its Affiliates of the Master Cell Line and/or the licensed Know How, or (b) the Licensees |
16.
other activities in exercise of a license granted it hereunder, including the development or manufacture of licensed (hereunder) prototypes or clinical supplies by Licensee or its Affiliates, or the use of any licensed (hereunder) product manufactured, or used by Licensee or its Affiliates by any human being regardless of whether such use was contemplated by the Parties, except in the case of each (a) and (b) to the extent such liabilities result from (x) the willful misconduct, or gross negligence by the Licensor Indemnitees and/or (y) the Licensors breach of its representations and warranties under this Agreement. For purposes of illustration, Dynavax shall not be responsible and shall be defended and held harmless by RBNV for product liabilities relating to [ * ] while RBNV shall not be responsible for and shall be defended and held harmless by Dynavax and RBG for product liabilities relating to Supervax Program Products, Theravax Program Products and Cytovax Program Products. RBG is the Licensor, and RBNV and its Affiliates are the Licensees, regarding the licenses of Section 4.3. RBNV is the Licensor, and RBG, Dynavax and their Affiliates are the Licensees, regarding the licenses of Section 4.2. | |||
(b) | RBG hereby agrees to indemnify, defend and hold harmless RBNV and its Licensor Indemnitees from and against all Damages resulting from Claims to the extent arising out of (1) a breach of RBGs representations and warranties under this Agreement, and/or (2) RBG Indemnitees willful misconduct, or gross negligence. Likewise, RBNV hereby agrees to indemnify, defend and hold harmless RBG and its Licensor Indemnitees (including Dynavax and its people) from and against all Damages resulting from Claims to the extent arising out of (1) a breach of RBNVS representations and warranties under this Agreement, and/or (2) RBNV Indemnitees willful misconduct, or gross negligence. |
8.3 | Indemnification Procedure. If a Party (the Indemnitee) intends to claim indemnification under Section 8, Indemnitee shall promptly notify the other Party (the Indemnitor) of any claim, demand, action, or other proceeding for which the Indemnitee intends to claim such indemnification. The Indemnitor shall have the right to participate in, and to the extent the Indemnitor so desires jointly with any other Indemnitor similarly noticed, to assume the defense thereof with counsel selected by the Indemnitor; provided, however, that the Indemnitee shall have the right to retain its own counsel at Indemnitees own expense. The indemnity obligations under this Article 8 shall not apply to amounts paid in settlement of any claim, demand, action or other proceeding if such settlement is effected without the prior express written consent of the Indemnitor, which consent shall not be unreasonably withheld or delayed. The failure to deliver notice to the Indemnitor within a reasonable time after notice of any such claim or demand, or the commencement of any such action or other proceeding, only to the extent actually prejudicial to its ability to defend such claim, demand, action or other proceeding, shall relieve such Indemnitor of any liability to the Indemnitee under this Article 8 with respect thereto, but the omission so to deliver notice to the Indemnitor shall not relieve it of any liability that it may have to the |
17.
Indemnitee otherwise than under this Article 8. The Indemnitor may not settle or otherwise consent to an adverse judgment in any such claim, demand, action or other proceeding, that diminishes the rights or interests of the Indemnitee without the prior express written consent of the Indemnitee, which consent shall not be unreasonably withheld or delayed. The Indemnitee, its Affiliates, and all of their employees and agents, shall reasonably cooperate with the Indemnitor and its legal representatives in the investigation of any claim, demand, action or other proceeding covered by this Section 8. |
8.4 | Insurance. Each Party shall maintain insurance against all foreseeable risks and claims arising from its performance of activities licensed hereunder. | ||
8.5 | Limitation of Liability. EXCEPT TO THE EXTENT A PARTY MAY BE REQUIRED TO INDEMNIFY THE OTHER FOR AMOUNTS PAID TO THIRD PARTIES OR AS REGARDS A BREACH OF A CONFIDENTIALITY OBLIGATION, NEITHER PARTY (NOR ITS AFFILIATES) SHALL BE LIABLE TO THE OTHER PARTY (NOR ITS AFFILIATES) FOR PUNITIVE, EXEMPLARY, MULTIPLIED OR CONSEQUENTIAL DAMAGES (SUCH AS LOST PROFITS, OPPORTUNITY COSTS, MISSED BUSINESS OPPORTUNITIES, OR OTHER THINGS CAUSED BUT NOT PROXIMATELY CAUSED BY ANY BREACH OR DEFAULT UNDER THIS AGREEMENT, WHETHER THE THEORY OF LIABILITY IS GROUNDED IN CONTRACT, TORT (INCLUDING NEGLIGENCE) PRODUCT LIABILITY OR OTHERWISE). EACH PARTY HEREBY IRREVOCABLY WAIVES ANY RIGHT TO SEEK SUCH DAMAGES. |
9.1 | Governing Law. This Agreement will be governed by the laws of [ * ] (without giving effect to its conflict of law rules and regulations). Any dispute shall be resolved by arbitration before the London Court of International Arbitration in accordance with the [ * ] applying the substantive law of [ * ] excluding conflicts of law rules. | ||
9.2 | Arbitration Procedure. | ||
Any controversy, dispute or claim which may arise out of or in connection with this Agreement, including the exhibits attached hereto, or the interpretation, enforceability, performance, breach, termination or validity thereof, including disputes relating to alleged breach or termination of the foregoing, but excluding any determination as to the infringement, validity or claim interpretation of Patents of each Party related to the subject matter hereof and/or the misuse and/or |
18.
misappropriation of a Partys Information, (each a Dispute) shall be resolved by binding arbitration in accordance with the [ * ] except where this rules conflict with this provision, in which case this provision controls. The Arbitration shall be held in English and shall take place in London. The Dispute shall be construed in accordance with the laws of [ * ] exclusive of conflicts of law rules. The arbitration tribunal shall consist of three neutral arbitrators, each of whom shall be an attorney who (a) has at least fifteen (15) years of experience in the biopharmaceutical field in a law firm or corporate law department of over twenty-five (25) lawyers or (b) was a judge of a court of general jurisdiction. However: (X) at least one of the arbitrators must be an attorney described in clause (a) of the foregoing sentence; (Y) at least one of the arbitrators must be trained in [ * ] and have been admitted to practice in [ * ] ; and (Z) at least one of the arbitrators must be a native English speaker. The arbitrators shall be neutral, independent, disinterested, and impartial. Each Party shall nominate in the request for arbitration and the answer thereto one arbitrator and the two arbitrators so named will then jointly appoint the third arbitrator as chairman of the arbitration tribunal. After appointment, the Parties shall have no ex-parte communication with their proposed arbitrator. If one Party fails to nominate its arbitrator or, if the Parties arbitrators cannot agree on the person to be named as chairman within [ * ] the President of the London Court of International Arbitration shall make the necessary appointments. Within [ * ] of initiation of arbitration, the Parties shall reach agreement upon and thereafter follow procedures assuring that the arbitration will be concluded and the award rendered within no more than eight months from selection of the arbitrators. Failing such agreement, the Arbitration Rules of the London Court of International Arbitration will control the procedures and scheduling and the Parties will follow procedures that meet such a time schedule. Each Party has the right before or, if the arbitrators cannot hear the matter within an acceptable period, during the arbitration to seek and obtain from the appropriate court provisional remedies such as attachment, preliminary injunction, replevin, etc., to avoid irreparable harm, maintain the status quo or preserve the subject matter of the arbitration. Any request for such provisional measures by a Party to a court shall not be deemed a waiver of this agreement to arbitrate. In addition, the Arbitrator Tribunal may, at the request of a Party, order provisional or conservatory measures (including, without limitation, preliminary injunctions to prevent breaches hereof) and the Parties shall be able to enforce the terms and provisions of such orders in any court having jurisdiction. The decision of the arbitration tribunal must be in writing and must specify the basis on which the decision was made, and 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. AS IS CONSISTENT WITH SECTION 8.5, THE ARBITRATOR SHALL BE EMPOWERED TO AND SHALL NOT AWARD ANY PARTY PUNITIVE, EXEMPLARY, MULTIPLIED OR CONSEQUENTIAL DAMAGES (SUCH AS LOST PROFITS, OPPORTUNITY COSTS, MISSED BUSINESS OPPORTUNITIES, OR OTHER THINGS CAUSED BUT NOT PROXIMATELY CAUSED BY ANY BREACH OR |
19.
DEFAULT UNDER THIS AGREEMENT, WHETHER THE THEORY OF LIABILITY IS GROUNDED IN CONTRACT, TORT (INCLUDING NEGLIGENCE) PRODUCT LIABILITY OR OTHERWISE), AND EACH PARTY HEREBY IRREVOCABLY WAIVES ANY RIGHT TO SEEK SUCH DAMAGES. NO PARTY MAY SEEK OR OBTAIN PREJUDGMENT INTEREST OR ATTORNEYS FEES OR COSTS. | |||
9.3 | Notice and Reports. All notices required by this Agreement shall be in writing. All notices and reports shall be sent by fax followed by overnight courier to the Parties at the following addresses or such other addresses as may be designated in writing by the respective Parties: |
To RBNV: | Rhein Biotech NV | |||
Oude Maasstraat 47, | ||||
NL 6229 BC Maastricht, | ||||
The Netherlands | ||||
[ * ] | ||||
To RBG: | Rhein Biotech GmbH | |||
Eichsfelder Strasse 11 | ||||
Dusseldorf 40595 | ||||
Germany | ||||
[ * ] | ||||
To Dynavax: | Dynavax Technologies Corporation | |||
2929 Seventh Street, Suite 100 | ||||
Berkeley, CA 94710 | ||||
USA | ||||
[ * ] | ||||
ATTN: CEO | ||||
With a required copy to Dynavax at the same address and fax, to ATTN: LEGAL DEPARTMENT. |
9.4 | Priority of Agreement. The Parties agree and acknowledge that this Agreement supersedes any and all prior written or oral agreements between the Parties and any of their affiliates concerning the subject matter of this Agreement. In particular, this Agreement supersedes the Letter of Intent in all respects regarding the subject matter of this Agreement. The Letter of Intent shall not be used to interpret or deemed to limit or modify the terms of this Agreement. However, the Confidentiality Agreement will remain in effect and will not be superseded by this Agreement; provided, however, that information exchanged between the Parties |
20.
(with each Party for this purpose being deemed to include its Affiliates) shall be deemed exchanged under the Confidentiality Agreement) and protected thereunder; and provided, further, that notwithstanding any restriction on use stated in such Confidentiality Agreement, the right of a Party and its Affiliates to use items of confidential information, materials and know-how as stated in this Agreement shall not be restricted by such Confidentiality Agreement within the scope of a right or license granted hereunder to such Party and its Affiliates and instead the Parties (and their Affiliates) rights stated in this Agreement shall prevail. This Agreement and the Exclusive License Agreement between Green Cross and RBG and the Trademark Assignment Agreement both signed on the Closing Date together state the Parties entire agreement with respect to Supervax Program Products, as if they were a single agreement, with none of such agreement superseding any of the others of them. | |||
9.5 | Assignability. This Agreement may not be assigned without the prior written consent of the other Party, except (i) to an Affiliate, (ii) upon merger of a Party, or (iii) upon the sale of all or substantially all of Licensees assets relating to the manufacture of antibodies or proteins. Any attempted assignment contrary to the terms of this provision shall be void. | ||
9.6 | Force Majeure. Neither Party or its Affiliates shall be liable for any unforeseeable event beyond its reasonable control not caused by the fault or negligence of such Party, which causes such Party to be unable to perform its obligations under this Agreement, and which it has been unable to overcome by the exercise of due diligence. In the event of the occurrence of such a force majeure event, the Party unable to perform shall promptly notify the other Party. It shall further use its best efforts to resume performance as quickly as possible and shall suspend performance only for such period of time as is necessary as a result of the force majeure event | ||
9.7 | Expenses. Each Party shall bear its own expenses, if not expressly agreed otherwise in this Agreement. | ||
9.8 | Amendment and Waiver. This Agreement may be amended or modified only by a writing executed by each of the Parties. No waiver of any breach of this Agreement will be deemed to constitute a continuing waiver of any subsequent breach, whether of the same or of any other provision hereof. | ||
9.9 | Severability. If any provision of this Agreement is held or found to be unenforceable, such provision shall be deemed severed and stricken from this Agreement, but the remainder of this Agreement shall under all circumstances remain in full force and effect. The Parties intend that even is a provision is found to be unenforceable and thus deemed severed and stricken from this Agreement, the remaining terms of this Agreement shall continue in effect in all cases, and there shall be no right to rescind or terminate this Agreement. | ||
9.10 | Counterparts. This Agreement may be executed in multiple counterparts, each |
21.
of which will constitute an original, but all of which when taken together will constitute a single agreement. Delivery of an executed counterpart signature page of this Agreement by facsimile, email or other electronic transmission will be effective as delivery of a manually executed counterpart of this Agreement. |
22.
For RBNV: | ||||
By:
|
/s/ P.G.J. Heijmanns | |||
Name:
|
P.G.J. Heijmanns | |||
Title:
|
Managing Director | |||
For Dynavax: | ||||
By:
|
/s/ Dino Dina | |||
Name:
|
Dino Dina, M.D. | |||
Title:
|
President and CEO | |||
For RBG: | ||||
By:
|
/s/ Frank Ubags | |||
Name:
|
Frank Ubags | |||
Title:
|
CEO |
23.
24.
1. | Pursuant to Section 15.2 of the November 19 Agreement, the Parties mutually agree to terminate the November 19 Agreement as of the Effective Date. | ||
2. | With the exceptions of (a) any payments already made under the November 19 Agreement, (b) any payments due and owed as of Closing to Berna, and (c) the Parties obligations under Section 14 of the November 19 Agreement, all financial and other obligations based on the November 19 Agreement are forever waived and forgiven. |
25.
3. | Without limiting the generality of the foregoing, neither Party shall be bound by the surviving Sections 4.4 thorough 4.9, 8, 9 through 13 and 16 of the November 19 Agreement, notwithstanding Section 15.6 of the November 19 Agreement. The confidentiality clause 14 shall, however, survive termination. |
4. | Any and all rights of the Parties relating to the subject matter of the November 19 Agreement, shall be only as set forth in the Definitive Commercial Agreement dated as of the Effective Date, among Dynavax, RBG and Rhein Biotech NV. |
26.
/s/ Dino, Dina | ||||||||
By:
|
Dino Dina, M.D. | By: | blank | |||||
Title:
|
President & CEO | Title: | blank | |||||
Date:
|
blank | Date: | blank | |||||
/s/ René Beukema | ||||||||
By:
|
René Beukema | By: | blank | |||||
Title:
|
General Counsel & Corporate | |||||||
Secretary of Crucell Holland, B.V. | Title: | blank | ||||||
Date:
|
21 April, 2006 | Date: | blank | |||||
27.
1. | For good and valuable consideration, the receipt of which is hereby acknowledged, Assignor does hereby assign to Assignee all rights, title and interest in and to said Trademark, the goodwill of the business symbolized by said mark, along with the registrations thereof worldwide. | ||
2. | Assignor shall cooperate with all of Assignees reasonable requests for the execution of formal documents, which Assignee may require to record its title to said registrations with, and assume responsibilities for representation before, the trademark office authorities of the various countries in which the Trademark is registered. | ||
3. | As of Closing, Assignee shall assume all responsibilities for the filing, prosecution, and maintenance of the Trademark worldwide. |
28.
4. | The terms and conditions of this Assignment Agreement, including the Attachments hereto, constitute the entire agreement and understanding of the Parties, supersede all previous communications, whether oral or written, between the Parties, including any previous agreement or understanding varying or extending the same. There are no further or other agreements or understandings, written or oral, in effect between the Parties with respect to the subject matter hereof. | ||
5. | This Agreement may be released, discharged, abandoned, changed or modified in any manner, only by an instrument in writing of equal formality, signed by the duly authorized officer or representative of the Parties. | ||
6. | Notices. All notices required by this Agreement shall be in writing. All notices shall be sent by fax followed by overnight courier to the Parties at the following addresses or such other addresses as may be designated in writing by the respective Parties: |
To Berna: | Berna Biotech AG Rehhagstrasse 79 CH-3018 Berne Switzerland [ * ] |
||
To RBG: | Rhein Biotech GmbH Eichsfelder Strasse 11 Dusseldorf 40595 Germany [ * ] |
Any notices shall be deemed given when received by the other Party. | |||
7. | Force Majeure. No Party, or its Affiliates, shall be liable for any failure or delay in performance under this Agreement which is due in whole or in part directly or indirectly to any cause of any nature beyond the reasonable control of such Party or its Affiliate. |
29.
/s/ Frank Ubags | /s/ Z. Janowicz | |||||||
By:
|
Frank Ubags | By: | Z. Janowicz | |||||
Title:
|
managing director | Title: | COO | |||||
Date:
|
21 April, 2006 | Date: | 21 April, 2006 |
/s/ René Beukema | ||||||||
By:
|
René Beukema | By: blank | ||||||
Title:
|
General Counsel & Corporate | |||||||
Secretary of Crucell Holland, B.V. | Title: blank | |||||||
Date:
|
21 April 2006 | Date: blank |
30.
WHEREAS, | Berna Biotech AG (Berna) is the owner of substantially all of the share capital of (1) Rhein Biotech NV, incorporated under the laws of the Netherlands having its registered office at Oude Maasstraat 47, NL 6229 BC Maastricht, The Netherlands (hereinafter RBNV), which prior to the Effective Date owned 100 percent of the share capital of RBG and of (2) Rhein Vaccines B.V., which owns 100% of the share capital of Licensor; |
WHEREAS, | the Parties entered into a Development agreement dated January 1, 2003 (Development Agreement), whereby Licensee provided services for the development of Supervax (defined below) for and on behalf of Licensor; and subsequent thereto, the Parties enter into the License Option Agreement Supervax dated November 9, 2005 (Option Agreement), which grants the Licensee an exclusive worldwide option to an exclusive license for Supervax; |
WHEREAS, | Dynavax, a vaccine company based in the USA, and RBNV entered into a Letter of Intent dated March 10, 2006, to sell RBG to Dynavax (the Letter of Intent); |
WHEREAS, | among other things the Letter of Intent also provided certain licensing terms regarding Supervax, which licensing terms regarding Supervax are being superseded by this Agreement; |
WHEREAS, | as an ancillary condition to the sale of RBG to Dynavax, Dynavax shall cause RBG to exercise the exclusive license option in the Option Agreement, and Licensor shall grant such exclusive license as provided for hereinbelow. |
Plural used in this Agreement shall mean singular and vice versa. The following initially capitalized terms shall have the following meanings when used in this Agreement (and derivative forms of them will be interpreted accordingly): | ||
1.1 | Actual Cost for Filling and Packaging of vials shall mean the cost [ * ] | |
1.2 | Affiliate shall mean (i) any corporation or business entity of which fifty percent (50%) or more of the securities or other ownership interests representing the equity, the voting stock or general partnership interest are owned, controlled or held, directly or indirectly, by a Party; or (ii) any corporation or business entity which, directly or indirectly, owns, controls or holds fifty percent (50%) (or the maximum ownership interest permitted by law) or more of the securities or other ownership interests representing the equity, the voting stock or, if applicable, the general-partnership interest, of a Party. Affiliates of Licensor include Crucell N.V., a Dutch corporation; RBNV; Rhein vaccines B.V.; and Berna Biotech AG. Affiliation shall be determined based on RBG being wholly owned by Dynavax, and not owned at all by RBNV. | |
1.3 | Cost for Registration shall mean all costs related to entering into registrations, or obtaining regulatory approvals (such as BLAs and NDAs in the U.S. and regulatory approvals have a similar effect in other countries), in each case for Supervax for prophylactic applications or indications, including all direct, indirect, internal and external costs related to: |
The Parties recognize that there is some overlap among different categories included in (a) (b). Individual costs, however, shall not be double-counted across multiple categories. Any overlap between the categories shall not, however, be used or interpreted to narrow any of (a) (b). | ||
1.4 | Cost for Technology Transfer shall mean all [ * ] respecting Supervax. | |
1.5 | Development Agreement shall have the meaning given in the second recital above. | |
1.6 | Effective Date shall have the meaning stated above in the first paragraph of this Agreement. | |
1.7 | Field means the prevention (or prophylaxis) of disease in humans. | |
1.8 | Letter of Intent shall have the meaning given in the third recital above. |
1.9 | License Revenues shall mean all [ * ] in respect of such sublicense. To be clear, the following, even if received from a Sublicensee pursuant to such an agreement, are excluded from License Revenues: |
As regards (c) and (d), the recovered (through the payment from the Sublicensee) expenses shall not then be included under any cost category that is included as a deduction to arrive at Net Profit. As regards (a), [ * ] As regards (b), [ * ] As regards (c), this exclusion from License Revenues is limited to actual cost and as regards internal personnel costs is limited to reasonable FTE rates at the rate of [ * ] adjusted for inflation every year by reference to [ * ] with the first adjustment to be made with respect to FTEs devoted in [ * ] plus all materials, travel and related expenses. | ||
1.10 | Marketing, Sales & Distribution Expenses shall mean Licensees and its Affiliates direct, indirect, internal and external costs to market, sell and distribute Supervax Program Products, including the following types of such costs: [ * ] | |
1.11 | Net Profit shall mean the sum of [ * ] minus all of the following: [ * ] | |
To the extent such calculation results in a negative number (i.e., a loss) for the applicable reporting period, then [ * ] | ||
Internal costs included in Net Sales shall be accounted for based on actual cost, with internal labor costs being billed at a rate of [ * ] adjusted for inflation every year by reference to [ * ] with the first adjustment to be made with respect to FTEs devoted in [ * ] External costs shall be accounted for at the amount equal to amounts paid out to third parties. RBG is entitled to do all accounting hereunder in accordance with U.S. generally accepted accounting principles, consistently applied. | ||
If there is any overlap among different cost deduction categories used in the calculation of Net Sales and Net Profits, such individual costs, however, shall not be double-counted across multiple such deducted categories. Any overlap between the categories shall not be used or interpreted to narrow, however, any such deducted cost category. | ||
1.12 | Net Sales shall mean the gross invoice price of sales of Supervax Program Products made by Licensee, and its Affiliates to third parties (including distributors and Sublicensees) less deductions for [ * ] Sales made by third parties, such as Sublicensees, which sales are used to calculate the payment of License Revenues to Licensee, shall not be included in Net Sales. Sales from Licensee or its Affiliate to third-party selling agents or contractors, where Licensee or its Affiliate has no royalty or profit interest in the resales by the such agents or contractors (as in the case of a traditional distributor), shall be included in the calculation of Net Sales (although resales by such agents or contractors shall not be). | |
1.13 | Option Agreement shall have the meaning given in the second recital above. | |
1.14 | Patent shall mean granted patents, including utility models and certificates of invention, and reissues, re-examinations, supplementary protection certificates, |
extensions, and term restorations thereof, and patent applications therefor, including any continuations, continuations-in-parts, divisionals thereof, and the like. | ||
1.15 | Patent Costs shall mean all direct, indirect, internal and external patent preparation, prosecution, extension and maintenance costs specifically relating to Supervax Program Products or the manufacture, use, clinical testing thereof, including fees to patent offices and outside and counsel, and a reasonable accounting of internal legal resources, together with those costs referred to in the last sentence of Section 4.2 below as well as those referred to in the last sentence of Section 8.1.1 below. | |
1.16 | Payment Term means, for a given country, the period from first commercial sale of the first Supervax Program Product in a given country, to [ * ] thereafter. Payment Term is determined on a country-by-country basis. | |
1.17 | Supervax Technology shall mean all materials, information, experience and data, formulae, procedures, culture medium and growth conditions, results and specifications, manufacturing processes, equipment specifications, purification processes, regulatory filings, and rights of reference thereto, product registrations, and vaccine-related clinical and pre-clinical data, in written or electronic form, which are related specifically to Supervax, which (i) are in the possession of Licensor at the Effective Date, and/or has been transferred to Licensee prior to the Effective Date pursuant to the obligations of preceding Research/License Agreement, and the Development Agreement (as defined herein), (ii) are necessary or useful in connection with the research, development, manufacture of Supervax, (iii) are not subject to a third party confidentiality obligation that prevents Licensor from disclosing the same, and (iv) are not generally known or published. Schedule 1.11 provides an exemplary list of Supervax Know How. This list is not all-inclusive. Items otherwise fitting within the foregoing definition but not stated on such list remain nevertheless included in the Supervax Technology. | |
1.18 | Sublicensee shall mean a third party to whom Licensee has granted a license and/or sublicense under the Supervax Technology to make, use, offer to sell, import, use or sell Supervax in the Field. | |
1.19 | Supervax shall mean the current prophylactic two dose Hepatitis B vaccine that includes the [ * ] adjuvant. [ * ] | |
1.20 | Supervax Program Products means all prophylactic Hepatitis B vaccines that contain all of the following: [ * ] The Supervax Program Products include Supervax. | |
In addition, throughout this Agreement the words include (and all conjugations of it), such as and for example shall each be deemed to be followed by the words without limitation, but without limitation, or similar language against construing the language as limiting. |
2.1 | Exclusive License. Licensor grants to Licensee and its Affiliates a profit share-bearing (solely as set forth in this Agreement), worldwide, exclusive (even as to Licensor and its Affiliates) license under the Supervax Technology to develop, make, have made, use, sell, offer to sell, store, import, export and distribute Supervax Program Products in the Field for the Term. | |
2.1.1 | Sublicense Right. The license grant of Section 2.1 shall include the right to sublicense third parties (through one or more tiers or layers of sublicensees without consent from Licensor) the right to develop, make, have made, use, offer for sale, store, sell, import and/or export Supervax Program Products in the Field in one (1) or more countries of the world. | |
2.2 | Retained Rights. Licensor shall retain the right to use the Supervax Technology to perform and have performed research and development in the Field, and any other activities, including commercial activities, provided the subject matter of such other activities are not [ * ] Supervax Program Products in the Field. As long as the exclusive license is in effect, the right to reference product registration files is not included. However to the extent any third party may reference such regulatory file for a generic marketing approval (i.e. an ANDA-like filing) Licensor may do the same, provided that it is understood and agreed Licensor must derive rights thereto in the same manner as third parties, and does not obtain any additional rights or access to such data through this agreement. | |
2.3 | License Field Restrictions. The license grant of Section 2 is restricted by Section 6 of the Definitive Commercial Agreement among Licensee, RBNV, and Dynavax Technologies Corporation, of even date herewith, as quoted below: |
3.0 | Definition of Efforts. Commercially Reasonable Diligent Efforts shall mean a reasonable level of efforts, commensurate with the efforts that a similarly situated biotechnology company would devote to a product of similar potential and having similar commercial advantages and disadvantages, taking into account all relevant commercial factors such as: [ * ] In assessing Commercially Reasonable Diligent Efforts |
Efforts RBG and its Affiliates will ignore any negative impact to RBG and its Affiliates of Licensors Net Profit share or RBNVs rights set forth in Section 3.1 and 3.2 of the Definitive Commercial Agreement among RBG, RBNV and Dynavax of even date with this Agreement. | ||
3.1 | Exertion of Efforts. RBG, and/or its Affiliates, shall exert Commercially Reasonable Diligent Efforts to develop and commercialize Supervax in those countries where it is reasonable in applying the Commercially Reasonable Diligent Efforts standard to do, including via the following kinds of activities: | |
3.1.1 | progress a Supervax Program Product through development to registration, including conducting clinical trials and preparing and filing applications for registration; | |
3.1.2 | scaling up the manufacturing process for a Supervax Program Product to the scale required for the clinical trials of Section 3.1.1; | |
3.1.3 | developing a commercial production process for a Supervax Program Product, and implementing the same in a commercial manufacturing facility; and | |
3.1.4 | marketing, offering to sell, selling, importing and distributing Supervax. | |
3.2 | Decision as to for which Countries to Develop and Commercialize Supervax. | |
3.2.1 | Licensee is entitled to decide for which countries it wishes to develop and commercialize Supervax, provided such decision is consistent with the Commercially Reasonable Diligent Efforts standard. | |
3.3 | If Licensee takes the decision to file for marketing approval, and/or to market, no Supervax Program Product in any particular country in or for which Licensee has made a contrary decision for a Heplisav Program Product, and the Commercially Reasonable Diligent Efforts standard would require marketing Supervax in such country (taking into account all factors provided for in the definition of such standard above, including gray market effects on countries where Licensee will be marketing a Supervax Program Product and the potential impact on the selling price in such countries), then Licensee shall promptly inform Licensor in writing. Licensor may then inform Licensee, that for such country, Licensees exclusive license is revoked, and, thereafter Licensor or an Affiliate theoreof, will have the rights to register, market, offer to sell and sell Supervax in such country. Licensor shall have the right to reference regulatory dossiers useful for registration in such market. Licensor shall in this case be entitled under its license in Section 4.3.1 of the Definitive Commercial Agreement between the Parties of even date with this Agreement to manufacture Supervax Program Product solely to supply itself solely for such reverted countries. In addition, Licensee agrees to discuss in good faith with Licensor the possibility of Licensee supplying Licensor with quantities of Supervax Program Product for Licensors sales in any such reverted countries, but Licensor shall not be required to supply Licensor unless the Parties reach written agreement as to such supply and in any case Licensee shall not be required under any circumstances to prioritize supply for the reverted countries ahead of supply for countries where Licensee retains its license nor shall Licensee be required to increase its capacity for production of |
Supervax Program Products. Licensor will owe Licensee and shall pay Licensee [ * ] of Net Profits on Supervax in each reverted country (if there ever are any), applying the cost definitions and mechanics of set forth in this Agreement mutatis mutandis to calculate Licensors Net Profits and provide for it to pay Licensees share of it to Licensee. | ||
3.4 | Commercial Partners/Sublicensee Efforts. Licensees Affiliates, Sublicensees and distributors efforts shall count as Licensees efforts for purposes of evaluating diligence under this Article 3. | |
3.5 | Tolling in Case of [ * ] Licensees diligence obligations under this Article 3 shall be tolled for the period of any [ * ] of [ * ] of the [ * ] from [ * ] that [ * ] | |
3.6 | Sole Diligence Obligations. Licensees sole obligations to practice or work the licensed technology and to diligently develop and commercialize hereunder shall be those explicitly set forth above in this Article 3. No other such obligations of any kind shall be imposed on License or any of its Affiliates, whether implied at law or in equity, or provided in statute. |
4.1 | Profit Sharing. The Parties hereby agree to share the Net Profits realized from the sale and licensing of Supervax in accordance with the following: | |
4.1.1 | Development Reimbursement Share. Licensee shall pay Licensor [ * ] of the Net Profit until Licensee has paid Licensor an amount equal to the principal development investment made by Licensor pursuant to the Development Agreement, plus accumulated interest at [ * ] per annum, as per Schedule 1. Payment for Supervax attached hereto (Development Investment). This [ * ] share of Net Profits is payable until the Development Investment has been fully repaid to Licensor, even if [ * ] | |
4.1.2 | Fully Reimbursed Share. During the Payment Term but after Licensees payments of Net Profit have equaled the Development Investment, Licensee shall pay Licensor [ * ] of the Net Profit earned in such time period. | |
4.1.3 | No More Profit-Sharing After the Payment Term, Except to Reimburse the Development Investment. Except as provided in Section 4.1.1, Licensee shall not owe Licensor any further Net Profit with respect to each country in which the Payment Term has expired. | |
4.2 | Licensee Obligations. Licensee shall be solely responsible for the payment of any royalties, license fees, and milestone or other payments due to third parties contracted by Licensee under licenses or similar agreements necessary to allow the manufacture, use or sale of Supervax in the Field. However, these amounts shall be included as a deduction in the calculation of Net Profits. |
5.1 | Net Profit Reports and Payments. After the first Net Sale is recorded, Licensee agrees to submit quarterly written reports to Licensor within ninety (90) days after the end of each calendar quarter (December 31, April 1, July 1, and October 1), stating in each such report the number, description, and aggregate Net Sales sold during the calendar quarter by Licensee and its Affiliates (if applicable), the Net Profit and the amount owed to Licensor. Concurrently with the submission of such reports, Licensee, as the case may be, shall pay the Net Profit Share in accordance with Section 4.1. | |
5.2 | Method of Payment. | |
5.3 | All payments due hereunder to Licensor shall be paid in Euros in immediately available funds, for Licensors account, to a bank designated in writing by Licensor. | |
5.4 | Interest. If any payment under this Agreement is not made by the date on which the same becomes due and payable, the late Party shall owe the other Party interest at the rate of LIBOR plus two percent (2%) per annum on any outstanding amount until payment is made in full. | |
5.5 | No Refunds. Payments referred to herein shall not be refundable. | |
5.6 | Currency Conversion. If any currency conversion shall be required in connection with the calculation of Profit Share hereunder, such conversion shall be calculated at the published rate of [ * ] for such period. | |
5.7 | Withholding Taxes. If Licensee is required by law to withhold taxes from any payments due hereunder to Licensor, then Licensee shall be entitled to deduct the entire amount of the required withholding from the amount otherwise due hereunder, shall pay the amount required to be withheld to the relevant tax authority, and shall provide evidence of such payment to Licensor within sixty (60) days thereafter. Licensee agrees to reasonably cooperate with Licensor as to from what country payments required hereunder are made, provided that any change in country requested by Licensor does not have a negative impact on taxes due by Licensee (i.e., does not cause Licensee to owe greater taxes) that Licensor is unwilling to reimburse Licensee. | |
5.8 | Records; Inspection. Licensee, its Affiliates and their Sublicensees, shall keep complete, true, and accurate books of account and records for the purpose of determining the Profit Share amounts payable under this Agreement. Such books and records shall be kept at the principal place of business of Licensee, or its Affiliate, or Sublicensee, as the case may be, for at least three (3) years following the end of the calendar quarter to which they pertain. Such records will be open for inspection during such three (3) year period by an independent public accounting firm of national prominence retained by the other Party for the purpose of verifying the Net Profit Share statements, no more than once per set of records. Such inspections may be made no more than once each calendar year, at reasonable times mutually agreed by Licensee and Licensor. The Licensors representative or agent will be obliged to execute a reasonable confidentiality agreement prior to commencing any such inspection. Inspections conducted under this Section shall be at the expense of the |
Licensor, unless a variation or error producing an increase exceeding [ * ] of the amount stated for any period covered by the inspection is established in the course of any such inspection, whereupon all costs relating to the inspection for such period will be paid the Licensee. |
6.1 | This section 6 amends and restates the confidentiality provisions, as they pertain solely to Supervax, pursuant to (1) Section 4.1 of the Research License Agreement dated October 16, 1992, (2) Section 5a. of the Development Agreement dated January 1, 2003, and (3) Section 7 of the License Option Agreement Supervax dated November 9, 2005, each of (1), (2) and (3) between Licensee and Licensors Affiliate, Green Cross Vaccine Corp. | |
6.2 | All documents, materials and know-how which may be furnished to the receiving Party hereto (the Recipient) by the disclosing Party hereto (the Disclosing Party) pursuant to this Agreement, and the predecessor agreements referred to in Section 6.1 hereinabove, shall be, if suitably marked or designated in tangible form, deemed the Disclosing Partys Proprietary Information and, therefore, considered confidential and shall not be used by Recipient other than for the purposes licensed under this Agreement and for the exercise of the Recipients rights under this Agreement. Recipient shall use the same degree of care regarding Disclosing Partys Proprietary Information as it uses in protecting and preserving its own proprietary/confidential information of like kind to avoid disclosure or dissemination thereof, but no less than a reasonable degree of care. Information which is disclosed orally or otherwise than in tangible form shall be considered Proprietary Information if: (a) the information is identified as confidential at the time of disclosure and a written summary is provided to the Recipient within thirty (30) days thereafter, or (b) the information is identified as confidential in writing and provided to the Recipient prior to or at the time of disclosure by the Disclosing Party. | |
6.3 | This confidentiality obligation shall not apply to information if the information: (a) is publicly known or which the Recipient has documentary records which establish its or its Affiliates knowledge prior to this disclosure; (b) subsequently becomes publicly known and/or published through no fault of the Recipient; (c) is independently developed without use or reference to the other Partys Proprietary Information; (d) is required by operation of law or requirement of a governmental authority or rules of any securities exchange having jurisdiction to be disclosed (provided that the Party making the required disclosure gives reasonable (under the circumstances) advance notice of the required disclosure and all reasonable assistance to seek confidential treatment or a protective order if appropriate ); or (e) is or was brought to the Recipients attention by a third Party who has a legal right to do so. |
7.1 | Each Party agrees not to use the name of the other Party or any member of its staff in sales promotion work or advertising, or in any other form of publicity, without the written permission of the other Party. | |
7.2 | Neither Party shall disclose in any press release, public statement, or public release, the terms of this Agreement or any information with respect to this Agreement (including, without limitation, any release of information in connection with any scientific and medical conference) without the other Partys express written permission. The foregoing shall not apply to disclosures under an understanding of confidentiality or to information, which had theretofore been disclosed by or with the consent of the other Party. Either Party will be free to publish the results of the Supervax project after providing the other Party with a [ * ] (which period shall commence to the date that the other Party receives the text which is to be published and a summary of the manner of intended publication) in which to review and approve each publication, which approval shall not be unreasonably withheld. In any such publication by Licensor, Licensees contribution shall be acknowledged by Licensor. Notwithstanding any of the foregoing, nothing in this Agreement shall be deemed to prevent a Party (or its Affiliate) from complying with its reporting requirements as part of its responsibilities as a public company. This includes public company reporting requirements of Dynavax Technologies Corporation, a Delaware corporation. Accordingly, while Licensee will attempt to give Licensor advance notice of any such required disclosures, and will reasonably consider Licensees comments thereon if provided on a timeline that is reasonable in view of the required disclosure, Licensee and its Affiliates retain the right to make all legally required disclosures (including as legally required based on SEC interpretations), based on the good faith advice of its outside corporate counsel. |
8.1 | Defense of Third Party Infringement Claims. | |
8.1.1 | Infringement Claims. If the production, sale or use of any Supervax in the Field results in a claim, suit or proceeding alleging patent infringement against Licensee or Licensor (or their respective Affiliates or Sublicenses), such Party shall promptly notify the other Party hereto in writing setting forth the facts of such claim in reasonable detail. The Party subject to such claim shall have the exclusive right to defend and control the defense of any such claim, suit or proceeding, at its own expense, using counsel of its own choice, provided, however, it shall not enter into any settlement which admits or concedes that any aspect of the Patent or Know How of the other Party hereto is invalid or unenforceable without the prior written consent of such other Party. Such Party shall keep the other Party hereto reasonably informed of all material developments in connection with any such claim, suit or proceeding. All liabilities under this Section are and shall be deemed deductible costs in the calculation of Net Profits via inclusion within the Patent Costs. |
9.1 | Disclaimer. UNLESS EXPRESSLY STATED HEREIN, LICENSOR DISCLAIMS ALL WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, AS TO ANY MATTER, INCLUDING BUT NOT LIMITED TO WARRANTIES OF FITNESS FOR A PARTICULAR PURPOSE, OR MERCHANTABILITY CONCERNING THE SUPERVAX KNOW HOW, AND THAT LICENSEES USE OF SUPERVAX KNOW HOW WILL BE FREE FROM INFRINGEMENT OF PATENTS OF THIRD PARTIES. | |
9.2 | Warranties and Representations. | |
9.2.1 | Both Parties. Licensor and Licensee warrant and represent that: (i) they have the power and authority to enter into this Agreement and perform the responsibilities and obligations herein and the execution and delivery of this Agreement has been duly authorized; (ii) they have the power to carry out their obligations under this Agreement; and (iii) nothing in this Agreement or in the execution or performance thereof shall constitute a breach, violation or default of any provision contained in such Partys certificate or articles of incorporation or other organizing instruments nor violate any contract or other commitment of such Party. |
9.2.2 | Licensor Representations. Licensor represents and warrants to Licensee the following: | |
9.2.2.1 | Licensor shall not grant, during the Term, any rights to third parties, or take any actions or fail to take any actions, which grant or action(s) would impair the rights granted to Licensee herein. | |
9.2.2.2 | As of the Effective Date, Licensor has sufficient legal and/or beneficial title to, and/or the right to license, the Supervax Technology necessary for the purposes contemplated under this Agreement and to grant the licenses contained herein, including those items of Supervax Technology listed in Schedule 1.1. | |
9.2.2.3 | As of the Effective Date, Licensor is not aware, nor should it be aware, of any third party communications alleging that any Supervax Technology licensed under this Agreement would infringe any valid patent rights of any third party. | |
9.2.2.4 | As of the Effective Date, Licensor does not own, does not control, and has not filed, any Patent that claims one or more inventions relating to the composition, formulation, manufacture and/or the use, of Supervax Program Products, and is not entitled to assignment from any other entity any Patent claiming an invention made prior to the Effective Date which invention relates to the composition, formulation, manufacture and/or use of Supervax Program Products. |
9.3 | Indemnification. | |
9.3.1 | Except to the extent resulting from the willful misconduct or gross negligence, or breach of representation and warranty of Licensor or any of its Affiliates, Licensor shall not be liable for and Licensee shall indemnify and hold Licensor harmless against any and all liabilities, damages, losses, costs, and expenses, whether direct or indirect, consequential, incidental, including reasonable attorneys fees, in all cases that are paid |
to third parties (Damages), resulting from claims, demands, actions, other proceedings and judgments in all cases brought or obtained by third parties (Third-Party Claims) arising out of: the offer for sale, sale, manufacture, importation and/or use of Supervax by Licensee, its licensees, distributors, employees, consultants and investigators, or agents during or after Licensee-authorized pre-clinical and clinical studies, and as a result of the manufacture and/or sale of Supervax. |
9.3.2 | Licensor shall indemnify, defend and hold harmless Licensee and its Affiliates and their directors, officers and employees from and against all Damages to the extent resulting from Third-Party Claims arising out of the willful misconduct or gross negligence, or breach of representation and warranty of, Licensor and/or any of its Affiliates. | |
9.4 | Indemnification Procedure. If a Party (the Indemnitee) intends to claim indemnification hereunder, Indemnitee shall promptly notify the other Party (the Indemnitor) of any claim, demand, action, or other proceeding for which the Indemnitee intends to claim such indemnification. The Indemnitor shall have the right to participate in, and to the extent the Indemnitor so desires jointly with any other Indemnitor similarly noticed, to assume the defense thereof with counsel selected by the Indemnitor; provided, however, that the Indemnitee shall have the right to retain its own counsel at Indemnitees own expense. The indemnity obligations under Section 9.3 shall not apply to amounts paid in settlement of any claim, demand, action or other proceeding if such settlement is effected without the prior express written consent of the Indemnitor, which consent shall not be unreasonably withheld or delayed. The failure to deliver notice to the Indemnitor within a reasonable time after notice of any such claim or demand, or the commencement of any such action or other proceeding, only to the extent actually prejudicial to its ability to defend such claim, demand, action or other proceeding, shall relieve such Indemnitor of any liability to the Indemnitee under Section 9.3 with respect thereto, but the omission so to deliver notice to the Indemnitor shall not relieve it of any liability that it may have to the Indemnitee otherwise than under Section 9.3. The Indemnitor may not settle or otherwise consent to an adverse judgment in any such claim, demand, action or other proceeding, that diminishes the rights or interests of the Indemnitee without the prior express written consent of the Indemnitee, which consent shall not be unreasonably withheld or delayed. The Indemnitee, its Affiliates, and all of their employees and agents, shall reasonably cooperate with the Indemnitor and its legal representatives in the investigation of any claim, demand, action or other proceeding covered by this Section 9.4. | |
If the Parties cannot in good faith agree as to the application of Section 9.3s subsections to any particular Claim, then each Party may the conduct its own defense of such Claim and reserves the right to claim indemnification (to the extent provided for in Section 9.3) from the other Party upon resolution of the underlying Claim. | ||
9.5 | LIMITATION OF LIABILITY. EXCEPT TO THE EXTENT A PARTY IS REQUIRED TO INDEMNIFY THE OTHER FOR AMOUNTS PAID TO THIRD PARTIES OR AS REGARDS THE BREACH OF ANY CONFIDENTIALITY |
OBLIGATION, PUNITIVE, EXEMPLARY, MULTIPLIED OR CONSEQUENTIAL DAMAGES (SUCH AS LOST PROFITS, OPPORTUNITY COSTS, MISSED BUSINESS OPPORTUNITIES, OR OTHER THINGS CAUSED BUT NOT PROXIMATELY CAUSED BY ANY BREACH OR DEFAULT UNDER THIS AGREEMENT, WHETHER THE THEORY OF LIABILITY IS GROUNDED IN CONTRACT, TORT (INCLUDING NEGLIGENCE) PRODUCT LIABILITY OR OTHERWISE), AND EACH PARTY HEREBY IRREVOCABLY WAIVES ANY RIGHT TO SEEK SUCH DAMAGES. NO PARTY MAY SEEK OR OBTAIN PREJUDGMENT INTEREST OR ATTORNEYS FEES OR COSTS. To be clear, this does not negate Licensors right to its direct damages equal to its share of Net Profits as provided for hereunder, if notwithstanding earning such Net Profits Licensee does not pay to Licensor the required share. |
10.1 | Term. This Agreement shall become effective as of the Effective Date and, unless earlier terminated pursuant to the other provisions of this Section 10, shall continue in full force and effect in perpetuity, even though the payment obligation under Section 4.1.1 ends once the Development Investment has been repaid and the obligations to pay a share of Net Profits in Section 4.1.2 ends on a country-by-country basis as the Payment Term expires in each country. | |
10.2 | Termination for Cause. Either Party to this Agreement may terminate this Agreement in the event the other Party shall be in material breach of this Agreement (including by default), and such material breach shall have continued uncured for [ * ] after written notice thereof was provided to the breaching Party by the non-breaching Party. Any termination shall become effective at the end of such [ * ] period unless the breaching Party (or any other Party on its behalf) has cured any such breach or default prior to the expiration of the [ * ] period, or in the case of a breach incapable of cure during such time period, delivered a plan to cure the breach as promptly as practicable by the application of Commercial Reasonable Diligent Efforts, together with an undertaking to carry out such plan. However, if Licensee terminates this Agreement due to Licensor being in material breach of this Agreement, which breach cannot be or is not cured as provided in this Section, the licenses granted by Licensor in Section 2.1 shall continue after such termination. | |
10.3 | Entire Agreement. Licensee and Licensor may terminate this Agreement upon mutual agreement at any time. |
10.4 | Termination Upon Insolvency or Bankruptcy. The Parties acknowledge that the Supervax Technology are intellectual property for purposes of Section 365(n) of the U.S. Bankruptcy Code and that Licensee will have the ability to exercise all rights provided by Section 365(n) with respect to the Supervax Technology licensed hereunder. In this regard, the Parties agree that Section 365(n) of the U.S. Bankruptcy Code will govern Licensees and Licensors rights to intellectual property licensed under this Agreement in the event Licensor files for or is placed in bankruptcy. The Parties explicitly intend that to the extent the laws of another country whose laws govern the bankruptcy (or similar status) of Licensor afford or allow for similar protection of a license in bankruptcy, such protection shall extend to the license granted in Section 2.1 hereof and such license shall not be terminated based on the bankruptcy (or similar status) of Licensor. | |
10.5 | Rights and Obligations on Term, Termination, or Suspension. | |
10.5.1 | Termination by either Party pursuant to this Article shall not prejudice any other remedy that a Party might have. Termination of this Agreement for any reason shall not release any Party hereto from any liability which, at the time of such termination, has already accrued to the other Party or which is attributable to a period prior to such termination nor preclude either Party from pursuing all rights and remedies it may have hereunder or at law or in equity with respect to any breach of this Agreement. | |
10.5.2 | Except for termination by Licensee pursuant to Section 10.2, upon termination of this Agreement by either Party, at Licensors written request, Licensee and its Affiliates shall destroy all supplies of Supervax Technology, and all documents describing Supervax Technology, and shall promptly thereafter confirm such destruction in writing to Licensor. | |
10.5.3 | Return of Materials. Upon any termination of this Agreement, Licensee and Licensor shall promptly return to the other all Confidential Information received from the other (except one copy of which may be retained for archival purposes). | |
10.5.4 | Stock on Hand. In the event this Agreement is terminated for any reason, the Licensee and their respective Affiliates and Sublicenses shall have the right to sell or otherwise dispose of the stock of any Supervax then on hand, subject to the payment of Profit Share as provided herein. | |
10.5.5 | Survival on Termination. If this Agreement terminates or expires for any reason, Sections 1, 5.8, 6, 7, 8 (as applied to Damages resulting from Third-Party Claims arising out of activities occuring during the term of the Agreement and 9-12 shall survive such termination or expiration. | |
10.5.6 | No Prejudice of Rights. Termination by either Party pursuant to this Article shall not prejudice any other remedy that a Party might have, nor shall it affect either Partys accrued rights. |
11.1 | Disputes. The Parties recognize that disputes as to certain matters may from time to time arise during the Term, which disputes relate to either Partys rights and/or |
obligations hereunder. It is the objective of the Parties to establish procedures to facilitate the resolution of disputes arising under this Agreement in an expedient manner by mutual cooperation and without resort to litigation. To accomplish this objective, the Parties agree to follow the procedures set forth in this Section 11 if and when a dispute arises under this Agreement. Unless otherwise specifically recited in this Agreement, disputes between the Parties will be resolved as recited in this Section 11. |
11.2 | Dispute Resolution through Party Management. If the Parties are unable to resolve a dispute within thirty (30) days of being requested by a Party to resolve a dispute, any Party may, by written notice to the other, have such dispute referred to their respective chief executive officers or duly authorized designees, for attempted resolution by good faith negotiations within thirty (30) days after such notice is received. In the event the designated executive officers are not able to resolve such dispute within such period, either Party may at anytime after the thirty (30) day period invoke the provisions of Section 11.3 hereinafter. | |
11.3 | Arbitration. Any controversy, dispute or claim which is not resolved pursuant to Section 11.2 and which may arise out of or in connection with this Agreement, including the exhibits attached hereto, or the interpretation, enforceability, performance, breach, termination or validity thereof, including disputes relating to alleged breach or termination of the foregoing (each a Dispute) shall be resolved by binding arbitration in accordance with the Rules of the London Court of International Arbitration then pertaining, except where this rules conflict with this provision, in which case this provision controls. The Arbitration shall be held in English and shall take place in London. Subject to Section 11.6, the Dispute shall be construed in accordance with the laws of [ * ] exclusive of its conflicts of law rules. The arbitration tribunal shall consist of three neutral arbitrators, each of whom shall be an attorney who has at least fifteen (15) years of experience in the biopharmaceutical field with a law firm or corporate law department or was a judge of a court of general jurisdiction who has at least fifteen (15) years of experience in the biopharmaceutical field. However: (X) at least one of the arbitrators must be an attorney described in clause (a) of the foregoing sentence; (Y) at least one of the arbitrators must be trained in [ * ] law and have been admitted to practice in [ * ] ; and (Z) at least one of the arbitrators must be a native English speaker. The arbitrators shall be neutral, independent, disinterested, and impartial. Each Party shall nominate in the request for arbitration and the answer thereto one arbitrator and the two arbitrators so named will then jointly appoint the third arbitrator as chairman of the arbitration tribunal. After appointment, the Parties shall have no ex-parte communication with their proposed arbitrator. If one Party fails to nominate its arbitrator or, if the Parties arbitrators cannot agree on the person to be named as chairman within thirty (30) days, the President of the London Court of International Arbitration shall make the necessary appointments. Within thirty (30) days of initiation of arbitration, the Parties shall reach agreement upon and thereafter follow procedures assuring that the arbitration will be concluded and the award rendered within no more than eight (8) months from selection of the arbitrators. Failing such agreement, the Arbitration [ * ] will control the procedures and scheduling and the Parties will follow such procedures and meet |
such a time schedule. Each Party has the right before or, if the arbitrators cannot hear the matter within an acceptable period, during the arbitration to seek and obtain from any court of competent jurisdiction provisional remedies such as attachment, preliminary injunction, replevin, etc., to avoid irreparable harm, maintain the status quo or preserve the subject matter of the arbitration. Any request for such provisional measures by a Party to a court shall not be deemed a waiver of this agreement to arbitrate. In addition, the Arbitrator Tribunal may, at the request of a Party, order provisional or conservatory measures (including, without limitation, preliminary injunctions to prevent breaches hereof) and the Parties shall be able to enforce the terms and provisions of such orders in any court having jurisdiction. The decision of the arbitration tribunal must be in writing and must specify the basis on which the decision was made, and 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. THE ARBITRATOR SHALL NOT AWARD ANY PARTY PUNITIVE, EXEMPLARY, MULTIPLIED OR CONSEQUENTIAL DAMAGES, AND EACH PARTY HEREBY IRREVOCABLY WAIVES ANY RIGHT TO SEEK SUCH DAMAGES. NO PARTY MAY SEEK OR OBTAIN PREJUDGMENT INTEREST OR ATTORNEYS FEES OR COSTS. |
11.4 | Enforcement. The arbitral award, including any injunctive relief granted, may be enforced in any court of competent jurisdiction (i.e. any court having subject matter jurisdiction over the dispute and personal jurisdiction over the Parties). | |
11.5 | Confidential Information. With respect to any dispute relating to the misuse and/or misappropriation of a Partys Confidential Information, in each case, a Party may seek preliminary injunctive relief pending resolution of the Dispute under Section 11.3, and submit such dispute to any court of competent jurisdiction (i.e. any court having subject matter jurisdiction over the dispute and personal jurisdiction over the Parties). |
12.1 | Entire Agreement. This Agreement, together with the Definitive Commercial Agreement, contains the entire agreement of the Parties regarding the subject matter hereof and supersedes all prior agreements, understandings, and negotiations regarding the license rights to Supervax, including the Development Agreement, the Letter of Intent and the Option Agreement. Such superseded agreements shall not be used to interpret this Agreement. This Agreement may not be changed, modified, amended, or supplemented except by a written instrument signed by both Parties hereto. | |
12.2 | Severability. If any portion of this Agreement shall be finally determined by any court or governmental agency of competent jurisdiction to violate applicable law or otherwise not to conform to requirements of law, then the remainder of the Agreement shall not be affected thereby; provided, however, that if any provision hereof is invalid or unenforceable, then a suitable and equitable provision shall be substituted therefore |
in order to carry out,so far as may be valid and enforceable, the intent and purpose of the Agreement including the invalid or unenforceable provision. | ||
12.3 | Force Majeure. Neither Party or its Affilaites shall be liable for any unforeseeable event beyond its reasonable control not caused by the fault or negligence of such Party, which causes such Party to be unable to perform its obligations under this Agreement, and which it has been unable to overcome by the exercise of due diligence. In the event of the occurrence of such a force majeure event, the Party unable to perform shall promptly notify the other Party. It shall further use its best efforts to resume performance as quickly as possible and shall suspend performance only for such period of time as is necessary as a result of the force majeure event.. | |
12.4 | Independent Contractors. Both Parties are independent contractors under this Agreement. Nothing contained in this Agreement is intended nor is to be construed so as to constitute Licensee and Licensor as partners or joint venturers with respect to this Agreement. Neither Party hereto shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement, or undertaking with any third party. | |
12.5 | Notices Any notices required by this Agreement shall be in writing, shall specifically refer to this Agreement and shall be forwarded to the respective addresses set forth below unless subsequently changed by written notice to the other Party: |
If to Licensor: | Green Cross Vaccine Corp. | |||||
227-3, Kugai-Ri, Kiheung-Eup | ||||||
Yongin City | ||||||
Kyounggi Province | ||||||
Republic of Korea | ||||||
[ * ] | ||||||
Required copy to Rhein Biotech NV: | ||||||
Rhein Biotech NV | ||||||
Oude Maasstraat 47, | ||||||
NL 6229 BC Maastricht, | ||||||
The Netherlands | ||||||
[ * ] | ||||||
If to Licensee: | Rhein Biotech GmbH | |||||
Eichsfelder Strasse 11 | ||||||
Dusseldorf 40595 | ||||||
Germany | ||||||
[ * ] | ||||||
Required copy to Dynavax Technologies Corporation: | ||||||
Dynavax Technologies Corporation | ||||||
2929 Seventh Street, Suite 100 | ||||||
Berkeley, CA 94710 | ||||||
USA |
[ * ] | ||||
ATTN: LEGAL DEPARTMENT |
12.6 | Headings. The paragraph headings herein are inserted for convenience only and shall not be construed to limit or modify the scope of any provision of this Agreement. | |
12.7 | Assignment and Successors Rights/Waiver. Except in connection with a sale by a Party of all or substantially all of its assets to which this Agreement relates, or a Partys merger with another entity, or an assignment to a Partys Affiliate, this Agreement may not be assigned without the prior written consent of either Party, and is binding upon and shall inure to the benefit of the Parties hereto, their representatives, successors and permitted assigns. No failure or successive failures on the part of either Party, its successors or permitted assigns, to enforce any covenant or agreement, and no waiver or successive waivers on its or their part of any condition of this Agreement, shall operate as a discharge of such covenant, agreement or condition, or render the same invalid, or impair the right of either Party, its successors and permitted assigns to enforce the same in the event of any subsequent breach or breaches by the other Party, its successors or permitted assigns. | |
12.8 | Choice of Law. Subject to the bankruptcy treatment of intellectual property pursuant to Section 11.6, this Agreement shall be exclusively governed by and construed in accordance with the laws of [ * ] (without giving effect to its conflict of law rules and regulations). |
/s/ Frank Ubags | ||||||||
By:
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Frank Ubags | By: | blank | |||||
Title:
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CEO | Title: | blank | |||||
Date:
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21 April, 2006 | Date: | blank |
/s/ C.P.E. Moonen | ||||||||
By:
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C.P.E. Moonen | By: | blank | |||||
Title:
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Managing Director | Title: | blank | |||||
Date:
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21 April, 2006 | Date: | blank |
Page | ||||
Clause |
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ARTICLE 1 - DEFINITIONS AND INTERPRETATION |
3 | |||
ARTICLE 2 - SALE AND PURCHASE OF THE SHARE |
3 | |||
ARTICLE 3 - CONSIDERATION |
3 | |||
ARTICLE 4 - CONDITIONS PRECEDENT |
5 | |||
ARTICLE 5 - CLOSING |
7 | |||
ARTICLE 6 - ACTION BEFORE CLOSING |
9 | |||
ARTICLE 7 - REPRESENTATIONS AND WARRANTIES |
13 | |||
ARTICLE 8 - REMEDIES FOR BREACHES |
14 | |||
ARTICLE 9 - OTHER CONVENANTS |
17 | |||
ARTICLE 10 - ACCESS TO INFORMATION |
18 | |||
ARTICLE 11 - RESTRICTIONS ON ANNOUNCEMENTS |
18 | |||
ARTICLE 12 - CONFIDENTIAL INFORMATION |
18 | |||
ARTICLE 13 - MISCELLANEOUS |
19 | |||
ARTICLE 14 - NOTICES |
20 | |||
ARTICLE 15 - GOVERNING LAW AND ARBITRATION |
22 | |||
Schedules |
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SCHEDULE 1.1 DEFINITIONS |
24 | |||
SCHEDULE 3.3 PRELIMINARY CDWC CALCULATION |
34 | |||
SCHEDULE 4.3(D) LEGAL OPINION ON RBNV |
36 | |||
SCHEDULE 4.4(C) LEGAL OPINION ON DYNAVAX |
38 | |||
SCHEDULE 5.2(B)(I) NOTARIAL TRANSFER DEED |
39 | |||
SCHEDULE 5.2(B) (II) NOTIFICATION OF TRANSFER |
42 | |||
SCHEDULE 5.2 (B) (III) COMMERCIAL AGREEMENT |
43 | |||
SCHEDULE 5.2 (B) (IV) EMMP AGREEMENT |
114 | |||
SCHEDULE 5.3(C) (V)(I) WAIVER AGREEMENT |
117 | |||
SCHEDULE 5.3(C)(V)(II) WAIVER AGREEMENT |
119 | |||
SCHEDULE 7.1 COMPANY WARRANTIES |
121 | |||
SCHEDULE 7.2 DISCLOSURE LETTER |
173 | |||
SCHEDULE 7.3 SELLERS WARRANTIES |
237 | |||
SCHEDULE 7.4 PURCHASERS WARRANTIES |
238 | |||
SCHEDULE 7.5 SELLER ADDITIONAL AGREEMENT |
239 | |||
SCHEDULE 11.1 JOINT STATEMENT |
241 |
(1) | Dynavax Technologies Corporation, a corporation organized and existing under the laws of the State of Delaware, having its registered and business offices at 2929 Seventh Street, Suite 100, Berkeley, CA 94710, United States of America (Purchaser); | |
and | ||
(2) | Rhein Biotech N.V., a public limited liability company organized and existing under the laws of The Netherlands, with its corporate seat at Maastricht and its registered office at Oude Maasstraat 47, 6229 BC Maastricht, The Netherlands (Seller); |
(A) | The Seller is the legal and beneficial owner of the entire issued share capital of Rhein Biotech Gesellschaft für Neue Biotechnologische Prozesse und Produkte m.b.H., a private limited liability company organized and existing under the laws of Germany (Gesellschaft mit beschränkter Haftung), registered with the commercial register of the local court of Düsseldorf under HRB 20023, with its corporate seat at Düsseldorf, Germany and its principal place of business at Eichfelder Strasse 11, 40595 Düsseldorf, Germany (Company), with a registered share capital (Stammkapital) of [ * ] , consisting of 1 share, with a nominal value of [ * ] (the Share). | |
(B) | The Company is involved in the business of the development of biotechnological processes and products. | |
(C) | The Purchaser is in the business of discovering, developing, and commercializing innovative products to treat and prevent allergies, infectious diseases, cancer and chronic inflammatory diseases. | |
(D) | The Seller and the Purchaser have entered into a confidentiality and standstill agreement effective as of March 10, 2006, pursuant to which certain confidential information relating to the Company was made available to (representatives of) the Purchaser. | |
(E) | The Seller and the Purchaser have laid down certain basic terms and conditions related to the purchase, sale and transfer of the Share in a non-binding and conditional letter of intent dated March 10, 2006. |
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(F) | The Purchaser has performed, with the assistance of professional advisers, a due diligence investigation with respect to the Company and its business, on the basis of the information provided by the Seller and the senior management of the Company, including legal, financial, technical and tax information. | |
(G) | The Seller and the Purchaser have agreed that the Seller shall sell and transfer the Share to the Purchaser and the Purchaser shall purchase and acquire the Share from Seller, for the consideration and on the terms and subject to the conditions contained in this Agreement. |
1.1 | Definitions. In this Agreement, unless the context otherwise requires the words and expressions used in this Agreement shall have the meanings set out in Schedule 1.1. | |
1.2 | Headings. Headings are inserted for convenience only and shall not affect the construction of this Agreement. |
2.1 | Sale and Purchase. Seller hereby, subject to the terms and conditions of the Agreement, sells the Share to Purchaser, and agrees to transfer the Share to Purchaser at the Closing, free and clear of Encumbrances, and Purchaser hereby, subject to the terms and conditions of this Agreement, purchases the Share from Seller and agrees to accept the transfer of the Share at the Closing. |
3.1 | Consideration. The consideration payable by Purchaser to Seller for the Share shall be the Euro equivalent of CHF 10,000,000., payable in euros by using the conversion rate between Swiss Franks and the Euros being fixed two business days prior to the Closing at the close of business as published by the Wall Street Journal, subject to an adjustment, if applicable, pursuant to Articles 3.2 through 3.7, the Consideration. | |
3.2 | Adjustment of Consideration. The Consideration shall be adjusted as follows: |
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The Consideration shall be increased by the amount by which the working capital of the Company as at the March 31, 2006 (the March 2006 Working Capital) exceeds (is less negative) than [ * ] and decreased by the amount by the Closing Date Working Capital is less (more negative) than [ * ] (Working Capital Adjustment). For the avoidance of doubt the Parties confirm and acknowledge that the Consideration will not change due to the Working Capital Adjustment in case the Closing Date Working Capital is equal to an amount between [ * ] and [ * ] . | ||
3.3 | The Sellers good-faith estimate and projection of the March 2006 Working Capital amounts to
[ * ] , as reflected in an un-audited special purpose statement of the relevant assets and
liabilities of the Company (Preliminary WC
Calculation), attached hereto as Schedule 3.3. |
|
3.4 | Not later than on April 6, 2006, the Purchaser shall cause the Seller to deliver an un-audited special purpose statement of the relevant assets and liabilities of the Company as of March 31, 2006, prepared in accordance with the Preliminary WC Calculation (Proposed WC Calculation), setting forth the amount of March 2006 Working Capital. | |
3.5 | Seller and Purchaser shall endeavor to agree on a definitive March 2006 Working Capital Calculation (Final WC Calculation) prepared in accordance with the Preliminary WC Calculation, prior to the Closing Date. | |
3.6 | If Seller and Purchaser fail so to agree prior to the Closing Date (which failure, however, will not constitute a cause for postponing the Closing), the parties will agree to refer any dispute for resolution to a reputable Big Four international accounting firm (other than the existing auditors of Seller or Purchaser) appointed (i) by Seller and Purchaser or (ii) in default of agreement on such appointment within 7 days, by the President for the time being of the Netherlands Institute for Chartered Accountants (NIVRA). Such accounting firm shall be instructed to render its opinion as soon as practicable and in any event within 30 days after being instructed. In making such determination such accounting firm shall act as an expert and not as an arbitrator and its decision shall (in the absence of manifest error) be final and binding on the parties hereto. The expenses of such accounting firm shall be borne by the Seller and Purchaser in proportion to the allocation of the amounts in dispute between the Seller and Purchaser as made by such accounting firm, such that the prevailing party pays the less proportion of the fees and expenses. The Proposed WC Calculation shall be adjusted on the basis of such accounting firms resolution of such dispute and as so adjusted shall become the Final WC Calculation. | |
3.7 | After the Final WC Calculation has been agreed in accordance with Article 3.5, or has been finally determined in accordance with Article 3.6, the Working Capital Adjustment shall to the extent applicable be computed on the basis of the Final WC Calculation as so determined. To the extent the amount paid by Purchaser to Seller at Closing, as computed |
4
4.1 | Conditions Precedent to the Obligations of Parties. The obligation of Seller and Purchaser to affect the Closing is conditional upon fulfillment or waiver (to the extent legally possible) by the relevant Party of the conditions precedent (opschortende voorwaarden) described in articles 4.2 and 4.3 (Conditions). | |
4.2 | Conditions to the Obligations of Seller and Purchaser. The obligation of Seller and Purchaser to effect the Closing is conditional upon fulfillment or waiver by both Parties of the following conditions: |
a. | Legal Requirements. No Legal Requirement shall be in effect and no proceeding is pending or threatened in writing by a Governmental Authority at the Closing Date which in itself, or is reasonably and substantially likely to, prohibits or materially restricts the consummation of the transactions contemplated by this Agreement, or which otherwise in itself, or is reasonably and substantially likely to, adversely affects in any material respect the right or ability of Purchaser to own, operate or control the Company, in whole or material part. | ||
b. | Shareholders Approval. The Sellers shareholders meeting (the Shareholders Meeting) shall have given its approval to the transactions contemplated hereby (the Transaction), it being understood that a Sellers shareholders meeting shall be convened to be held on [ * ] to resolve on such approval; |
4.3 | Conditions to the Obligations of Purchaser. The obligation of Purchaser to effect the Closing is conditional upon fulfillment or waiver by the Purchaser of the following conditions: |
a. | Representations and Warranties. The Warranties of Seller set forth in this Agreement, or in any written statement or certificate that shall be delivered to Purchaser by Seller under this Agreement at Closing, shall be true and correct on and as of the date made and as of the Closing Date as if made on the date thereof, except (i) to the extent such representation or warranty specifies an earlier date, and (ii) where the failure of such representations and warranties to be so true and correct would not have individually, or in the aggregate, a Material Adverse Effect, and Purchaser shall have received a |
5
certificate to such effect as set forth in Section 5.2(d) of this agreement. For the avoidance of doubt, the effecting of the Closing by Purchaser shall not limit or otherwise affect the Purchasers rights under the Warranties given by the Seller. | |||
b. | Performance of Obligations. Seller shall have performed all obligations and covenants (other than under Article 4.3.a) required to be performed by it prior to the Closing Date under this Agreement and any other agreement or document referenced herein and entered into in connection herewith. | ||
c. | No Material Adverse Change. That during the period between the date of this Agreement and the Closing Date, no event shall have occurred that has a Material Adverse Effect. | ||
d. | Legal Opinion. Baker & McKenzie Amsterdam NV has delivered its legal opinion in relation to Seller, substantially in form of Schedule 4.3(d). |
4.4 | Conditions to the Obligation of Seller. The obligation of Seller to effect the Closing is conditional upon fulfillment or waiver by the Seller of the following Conditions: |
(a) | Supervisory Board approval. The Sellers supervisory board shall have given its final approval to the transactions contemplated hereby, it being understood that Sellers supervisory board has convened a meeting to be held on the Date of this Agreement to resolve on such approval; and | ||
(b) | Performance of Obligations. Purchaser shall have performed all obligations and covenants required to be performed by it prior to the Closing Date under this Agreement and any other agreement or document referenced herein and entered into in connection herewith; | ||
(c) | Legal Opinion. Morrison Foerster LLP has delivered its legal opinion
in relation to Purchaser, substantially in form of Schedule 4.4(c). |
4.5 | Notice. If a Party becomes aware of a circumstance which will or may prevent the fulfillment of a Condition to its obligations to effect the Closing, it will notify the other Party thereof in writing without delay. | |
4.6 | Fulfillment Date. If any of the conditions to a Partys obligation to effect the Closing shall for reasons other than breach by such Party of its obligations hereunder not be fulfilled on or before April 30, 2006 then such party may at its option and without prejudice to any of its other rights and claims (including, even if this Agreement is terminated, any right to payment of Damages), by notifying the other Party: |
(a) | to the extent permitted by applicable law, waive the unfulfilled conditions; or |
6
(b) | postpone Closing. |
If any Party postpones Closing, this Agreement shall apply as if the postponed Closing were the original Closing, provided however that if Closing has not occurred by April 30, 2006, either Party may terminate this Agreement by written notice to the other Party unless the failure of the Closing to occur by such date is the result of a breach by the former Party of its obligations hereunder. | ||
4.7 | Effect of Termination. Without prejudice to Article 4.6, if either Party terminates this Agreement, this Agreement shall cease to have any effect, (i) except Article 13.1 (Parties Costs), Article 14 (Notices), Article 11 (Restriction on Announcements), Article 12 (Confidential Information) and Article 15 (Governing Law and Arbitration) which shall remain in full force and effect, and (ii) save in respect of claims for costs, damages, compensation or otherwise arising out of any breach of the terms of this Agreement. |
5.1 | Time and Place of Closing. Subject to the provisions Article 4, the Closing shall take place simultaneously at the offices of Baker & McKenzie Amsterdam N.V. and the Civil Law Notary, at 10:00 A.M. on the 2nd Business Day following the date upon which all of the Conditions to the obligations of the Parties to effect the Closing are satisfied or waived or at such other place and time as shall be mutually agreed between the Parties, where all (and not some only) of the events described in this Article 5 shall occur. | |
5.2 | Sellers Closing Obligations. At Closing, the Seller shall: |
(a) | deliver or cause to be delivered to the Purchaser evidence satisfactory to the Purchaser of the satisfaction of the Conditions to Sellers obligation to effect the Closing, being a copy of the minutes of the meeting of the Supervisory Board and of the shareholders meeting of the Seller approving the sale of the Share; | ||
(b) | execute: |
(i) | the Notarial Transfer Deed in the form of Schedule 5.2(b)(i) attached hereto; | ||
(ii) | the notification of the transfer of the Share to the Company according to § 16 of the Act on Companies with Limited Liability (GmbHG), in the form of Schedule 5.2(b) (ii) attached hereto; |
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(iii) | the commercial agreement, together with the further agreements and documents referred to therein (jointly the Commercial Agreement), in the form of Schedule 5.2 (b) (iii) attached hereto; | ||
(iv) | the agreement with regard to employee and management participation plan (the EMPP Agreement), in the form of Schedule 5.2 (b) (iv) attached hereto; |
(c) | cause a managing director of the Company to submit the new list of shareholders to the commercial register pursuant to § 40 GmbHG; | ||
(d) | deliver a certificate executed on behalf of Seller by its managing director, certifying to the matters set forth in section 4.3 (a), (b) and (c). |
5.3 | Purchasers Closing Obligations. At Closing, the Purchaser shall: |
(a) | pay the Consideration on the Notary Account, such that the relevant amount shall have arrived at the Notary Account with a value date not being later than the Closing Date; | ||
(b) | cause the Company to repay all of its debts to Seller (the Seller Debts), the principal amount of which is [ * ] which the Seller agrees will be satisfaction in full of all the Seller Debts, and to the extent necessary make available to the Company sufficient funds in order to enable the Company to repay such debts, the amount of which repayment shall be paid on the Notary Account, such that the relevant amount shall have arrived at the Notary Account with a value date not being later than the Closing Date; | ||
(c) | (cause to) execute: |
(i) | the Funds Flow Letter thus authorizing the release of the Consideration and the amount in relation to the debts repayment by the Company from the Notary Account to such bank account{s} designated by the Seller; | ||
(ii) | the Notarial Transfer Deed; | ||
(iii) | the Commercial Agreement; | ||
(iv) | the EMPP Agreement; | ||
(v) | the waiver agreements entered into between (i) Purchaser and the Companys management personnel, in the form of Schedule 5.3(c)(v)(i) attached hereto and (ii) Purchaser and the Company, in the form of Schedule 5.3(c)(v)(ii) attached hereto ; |
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(d) | deliver a certificate executed on behalf of Purchaser by its Chief Executive Officer or Chief Financial Officer, certifying to the matters set forth in sections 4.4 (a), (b) or (c). |
5.4 | Non-Compliance. If the Seller or Purchaser fails to perform any action required from it under Article 5.2 and 5.3, the other Party may, at its option and without prejudice to any of its other rights and claims (including, also if this Agreement is terminated, any right to payment of damages): |
(a) | demand that the defaulting Party performs the relevant actions on a day and at a time to be determined by the non-defaulting Party; or | ||
(b) | terminate this Agreement by written notice (without any liability towards the defaulting Party). |
6.1 | Conduct of Business. From the date of this Agreement until the Closing Date, Seller shall use its commercially reasonable efforts in order to cause the Company to be operated only in the ordinary course of business and in a manner consistent with past practice, and that the Company shall preserve substantially intact the business organization of Company, to keep available the services of the current officers, employees and consultants of Company and to preserve the current relationships of Company with customers, partners, suppliers and other persons with which Seller has significant business relations. Seller shall promptly notify Purchaser of any event or occurrence not in the ordinary course of business of Company, and any event of which it is aware which reasonably would be expected to have a Material Adverse Effect on the Company (even if the likelihood of such event has previously been disclosed or could result from any item set forth in the Disclosure Letter). Without limiting the generality of the foregoing, except as expressly contemplated by this Agreement or disclosed in the Disclosure Letter, Seller shall not, from the date of this Agreement until the Closing Date, directly or indirectly, cause, or permit the Company to do any of the following without the prior written consent of Purchaser: |
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(i) | amend its articles of association or other constitutional documents; | ||
(ii) | issue, sell, or dispose of any shares in its capital, any options, warrants or rights of any kind to acquire any shares in its capital or any securities which are convertible into or exchangeable for any shares in its capital; | ||
(iii) | split, combine or reclassify any shares in its capital, declare, set aside or pay any dividend or other distribution (whether in cash, stock or property or any combination thereof) in respect of any shares in its capital, or redeem or otherwise acquire any shares in its capital; | ||
(iv) | create, incur, or guarantee long-term indebtedness for borrowed money or short-term indebtedness for borrowed money which in the aggregate exceeds Euro 50,000.; | ||
(v) | mortgage or encumber any of its assets or properties which are material to the Company; | ||
(vi) | enter into any commitment or transaction not in the ordinary course of business; | ||
(vii) | terminate any employees or grant severance or termination pay to any director, officer, employee or consultant; | ||
(viii) | enter into any transaction with its officers, directors or stockholders or their Affiliates; | ||
(ix) | mend or otherwise modify the material terms of any material contract of Company or Governmental Approval; | ||
(x) | other than pursuant to the Commercial Agreement, Transfer to any person or entity any rights to Companys Intellectual Property Rights; | ||
(xi) | sell, lease, license or otherwise dispose of any of Companys assets outside of the ordinary course of business; | ||
(xii) | Commence a legal proceeding other than for the routine collection of bills or in connection with routine labor (employee dismissal) disputes; |
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(xiii) | Acquire or agree to acquire by merging, consolidating or entering into a joint venture arrangement with, or by purchasing a substantial portion of the assets of, or by any other manner, any business or any corporation, partnership, association or other business organization or division thereof, or otherwise acquire or agree to acquire any assets which are material, individually or in the aggregate, to the financial condition, results of operations, business or properties of Company taken as a whole; | ||
(xiv) | adopt, amend or terminate any employee benefit plans, programs, policies or other arrangements, or enter into any employment contract, pay any special bonus or special remuneration to any director, employee or consultant, or increase the salaries, bonuses or wage rates of its directors, officers, or employees; | ||
(xv) | revalue any of its assets, including writing down the value of inventory or writing off notes or accounts receivable other than in the ordinary course of business and consistent with past practice; | ||
(xvi) | pay, discharge or satisfy any Liability, other than the payment, discharge or satisfaction of obligations in the ordinary course of business or liabilities reflected or reserved against in the Financial Statements; | ||
(xvii) | make any material tax election other than in the ordinary course of business and consistent with past practice, change any material tax election, adopt any material tax accounting method other than in the ordinary course of business and consistent with past practice, change any material tax accounting method, file any material tax return (other than any estimated tax returns, payroll tax returns or sales tax returns) or any amendment to a material tax return, enter into any closing agreement, settle any tax claim or assessment, or consent to any extension or waiver of the limitation period, applicable to any tax claim or assessment; | ||
(xviii) | fail to pay or otherwise satisfy its monetary obligations as they become due, except such as are being contested in good faith; | ||
(xix) | forgive any indebtedness owed to Company; | ||
(xx) | cancel, materially amend or renew any insurance policy other than in the ordinary course of business; |
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(xxi) | take any action or intentionally fail to take any action that would cause a Material Adverse Effect; or | ||
(xxii) | enter into any contract or agree, in writing or otherwise, to take any of the actions described above in this Section 6.1, or any action that would make any of its representations or warranties contained in this Agreement untrue or incorrect in any material respect or prevent it from performing or cause it not to perform its covenants hereunder. |
6.2 | Certain Notifications. Seller shall give prompt notice to Purchaser, and Purchaser shall give prompt notice to Seller, of: |
(i) | the occurrence or non-occurrence of any event, the occurrence or non-occurrence of which reasonably could be expected to cause any representation or warranty of such party contained in this Agreement to be untrue or inaccurate in any material respect at or prior to the Closing Date, and | ||
(ii) | any failure of Seller or Purchaser, as the case may be, to comply with or satisfy any covenant, condition or agreement to be complied with or satisfied by it hereunder; provided, that the delivery of any notice pursuant to this Section 6.2 shall not limit or otherwise affect any remedies available to the party receiving such notice. |
6.3 | Access to Information. From the date of this Agreement until the Closing Date, upon reasonable notice, Seller shall cause the Company to cooperate with Purchaser in the development of integration plans for implementation by Purchaser following the Closing, and in connection therewith give Purchaser, upon its reasonable request, access to Companys buildings, offices, and other facilities, and to its books and records, whether located on the Companys premises or at another location; provided, that no investigation pursuant to this Section 6.3 shall affect or be deemed to modify any representation or warranty made by Seller or Buyer herein. |
6.4 | Consents. Seller will use best efforts to obtain prior to Closing all Consents from Governmental Authorities. At the request of Seller, Purchaser shall provide Seller with such assistance and information as is reasonably requested by Seller to obtain such Consents. Any costs incurred in obtaining the Consents shall be borne by the Seller. |
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6.5 | Best Efforts. From the date of this Agreement until the Closing, each of Seller and Purchaser shall use their respective best efforts to cause to be fulfilled and satisfied all of the other partys conditions to Closing set forth in Article 4. | |
6.6 | Shareholders Meeting. The Seller, acting through its management board and/or supervisory board, shall, subject to and according to applicable law and its articles of incorporation, promptly and duly call, give notice of, convene and hold as soon as practicable to ensure obtaining requisite shareholder approval following the date hereof, the Shareholders Meeting for the purpose of voting to approve and adopt the Transaction (the Seller Voting Proposal). The board of directors of the Seller shall, subject to the fiduciary duties of the management board and supervisory board of the Seller under applicable Law, (i) recommend approval and adoption of the Seller Voting Proposal by the stockholders of the Seller and include in the related Shareholder Circular to the stockholders of the Company such recommendation and (ii) take all reasonable and lawful action to solicit and obtain such approval and take all other action necessary or advisable to secure the vote or consent of the Sellers stockholders required by Netherlands Law or applicable Frankfurt Exchange requirements to obtain such approval. The Seller represents that the Seller stockholder vote required for the approval of the Seller Voting Proposal shall be a majority of the outstanding shares of Seller Common Stock on the record date for the Shareholders Meeting. | |
6.7 | Seller Debts. Prior to the Closing Date, Seller has taken all legal actions and has executed all documents and certificates and has made such filings with any applicable Governmental Authorities, so that (i) any obligations of the Company to Seller under the Seller Debts have been terminated and extinguished in full, and (ii) any legal rights that Seller has with respect to the Company relating to such Seller Debts have been terminated and extinguished in full, including without limitation any the removal of any Liens or Encumbrances Seller may have in connection therewith. |
7.1 | Warranties. The Seller represents, warrants and undertakes (verklaart, staat er voor in en garandeert") to the Purchaser that each of the representations and warranties relating to the Company as set forth in Schedule 7.1 (Warranties) is at the date of this Agreement and as of the Closing Date true and accurate. | |
The Purchaser acknowledges and agrees that: |
a. | the Warranties are the only representations, warranties or other assurances of any kind in relation to the Share, the Company and its business and its assets and liabilities given or made by or on behalf of the Seller on which the Purchaser may rely (and has relied upon) in entering into this Agreement. The Purchaser acknowledges that no |
13
representations or warranties, express or implied, have been or are given in relation thereto other than the Warranties; | |||
b. | unless expressly and explicitly provided for in other provision of this Agreement, no forward-looking statement, projection, promise, forecast or estimate (whether oral or in writing) made by or on behalf of the Seller or the Company shall form a basis of any claim by the Purchaser in connection with this Agreement; | ||
c. | unless expressly and explicitly provided for in other provision of this Agreement, the Seller makes no representation nor any warranty, nor accepts any duty of care in relation to the Purchaser as to the accuracy or completeness of information insofar as it concerns projections, forecasts, estimates, statements of intent or statements of opinion howsoever provided to the Purchaser, whether contained in presentations, information memoranda, in the information disclosed to it or otherwise; | ||
d. | at the time of entering into this Agreement it is not aware of any matter or thing which constitutes a Breach of the Warranties. |
7.2 | Disclosures. The Warranties are limited by, and the Seller shall not be in Breach in respect of, any specific exceptions and qualifications to the Warranties set forth or referred to in the Disclosure Letter attached hereto as Schedule 7.2. | |
7.3 | Sellers Warranties. The Seller represents and warrants that each of the representations and warranties relating to the Seller as set forth in Schedule 7.3 (Sellers Warranties) is at the date of this Agreement and as of the Closing Date true and accurate. | |
7.4 | Purchasers Warranties. The Purchaser represents and warrants that each of the representations and warranties relating to the Purchaser as set forth in Schedule 7.4 (Purchasers Warranties) is at the date of this Agreement and as of the Closing Date true and accurate. | |
7.5 | Seller Additional Agreement. Seller hereby agrees to the representations, warranties, covenants and agreements set forth in Schedule 7.5. |
8.1 | Remedies. In the event of a breach of any of the Warranties given by the Seller (Breach") or in the event of a default in the compliance by Seller of any other obligations under this Agreement (Default"), the Seller shall reimburse and hold harmless the Purchaser for all direct Damages suffered by the Purchaser as a result of such Breach or Default, subject to the provisions of Article 8.3 through 8.5, and it furthermore being understood that the Seller shall in no event be liable towards the Purchaser for any Damages suffered or incurred by the Purchaser as a result of any breach by the Seller under this Agreement or otherwise: |
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1. | to the extent that Damages include any derived, punitive, special, indirect, incidental damages or any consequential damages, including but not limited to damage to reputation and goodwill, loss of profits (actual, anticipated or otherwise) or savings or expected future business of any of the Company or the Purchaser; | ||
2. | if and to the extent that the matter giving rise to a Breach or Damages results in an adjustment of the Purchase Price or has been taken into account in calculating and deciding on the Purchase Price or any part thereof; | ||
3. | to the extent that a claim is based upon a liability that is contingent only, except to the extent that such contingent liability has resulted in Damages to Purchaser; | ||
4. | to the extent that a claim relates to any Damages which are recovered by the Purchaser or the Company from its insurers, provided, however, that any rights an insurer may have to be subrogated to the rights of Purchaser shall be preserved; | ||
5. | if and to the extent that such Damages have been recovered by the Purchaser or the Company from any third party, whereby the person so entitled shall use its reasonable commercial efforts to recover that sum, shall be repaid to the Seller; | ||
6. | if and to the extent that Damages relate to any matter included as a liability in the Financial Statements and/or are covered by means of a reserve or provision in the Financial Statements; | ||
7. | if and to the extent that any Damages result from the failure by the Purchaser or the Company to ensure that all reasonable steps are taken to prevent or mitigate any Damages that could give rise to a claim; | ||
8. | if and to the extent that the act, omission, event, circumstance or Breach giving rise to such Damages was disclosed to the Purchaser in the Agreement and/or the Disclosure Letter; | ||
9. | to the extent that Damages or the liability therefore occurs or is increased as a result of (i) changes in any legislation or regulations, or (ii) any legislation or regulations or other action of any governmental authority not in force on the date hereof, or (iii) any change in case-law after the such date. |
The Purchaser shall not be entitled to recover from the Seller more than once in respect of any one matter even if more than one Warranty is breached. Any payment made by the Seller in respect of a Breach or Default shall be deemed to be a reduction of the Consideration that the Seller has received hereunder. To the extent any applicable law would entitle the Purchaser to enforce additional rights against the Seller with respect to this Agreement other than the ones explicitly granted to Purchaser herein, including but not limited to any rights to rescind or cancel this Agreement (other than in the absence of fraud or intentional misstatements), Parties hereby exclude such rights, and to the extent such rights are incapable of being excluded the Purchaser hereby waives such rights, which waiver is hereby accepted by the Seller. | ||
8.2 | Breaches of Sellers Warranties and Purchasers Warranties. In the event of a breach of any of the Sellers Warranties or the Purchasers Warranties, covenants, or other |
15
agreements in this Agreement, the Party in breach shall reimburse and hold harmless the other Party for all Damages suffered by such Party. | ||
8.3 | Survival. All Warranties shall survive the Closing Date for 18 months, except for fraud or intentional misstatements. All such Warranties shall expire after said 18 months period, except for Claims asserted by the Purchaser prior to such date. | |
8.4 | Threshold. |
(a) | The Purchaser shall not be entitled to seek indemnification for any individual Claim unless the amount of Damages relating to such Claim exceeds [ * ] , and until the aggregate amount of all indemnifiable Claims exceeds [ * ] and then the Purchaser shall be entitled to recover all Claims in excess of the above amount. | ||
(b) | None of the thresholds set forth in Article 8.4(a) shall apply to fraud, intentional Breaches and Defaults, or to the provisions set forth in Article 7.5 and Schedule 7.5. | ||
(c) | For purposes of this Article 8.4, the existence and extent of any Breach shall be determined by reading the relevant Warranties as if all materiality standards contained in such Warranties (i.e. without reference to the qualifier material, materially, in all material respects, in any material respect, material adverse effect or similar qualifiers), have been deleted from such representation and warranty in its entirety. | ||
(d) | Limitation of Liability. The aggregate amount to which the Purchaser shall be subject pursuant to this indemnification provision shall be limited to [ * ] , except that such limit will not apply in case of any of the following (and any payments by Seller to Purchaser relating to the following): |
a. | fraud or intentional misstatements by Seller; | ||
b. | breaches of Sellers covenants or other agreement in this Agreement; | ||
c. | any breach relating to the matters set forth in Article 7.5 and Schedule 7.5. |
8.5 | Claim Procedure. |
(a) | The Purchaser shall give the Seller written notice (Indemnification Notice) of any facts and the circumstances giving rise to a Claim promptly after the Purchaser becoming aware of the facts and circumstances giving rise to such Claim, but the failure to notify the Seller will not relieve the Seller of any liability that it may have |
16
to Purchaser, except to the extent that the Seller demonstrates that the defense of such action is prejudiced by the Purchasers failure to give such notice. | |||
(b) | If the Claim relates to a claim or the commencement of an action or proceeding (a Proceeding) by a Third Party against the Company and/or the Purchaser, then the Seller shall have, upon request within 20 business days after receipt of the Indemnification Notice, the right to defend, at its own expense and by its own counsel (and such counsel reasonably satisfactory to Purchaser), any such matter involving the asserted liability of the Company and/or the Purchaser. If the Seller assumes the defense of such a Claim, no compromise or settlement of such Claim may be effected by the Seller without the Purchasers consent (which may not be unreasonably withheld) unless (i) the sole relief provided is monetary damages that are paid in full by Seller, and (ii) the Purchaser will have no liability with respect to any compromise or settlement of such Claim effected without its consent. Notwithstanding the foregoing, if Purchaser determines in good faith that there is a reasonable probability that a Proceeding may adversely affect it or its affiliates (other than as a result of monetary damages for which it would be entitled to indemnification under this Agreement), the Purchaser may, by notice to the Seller assume the exclusive right to defend, compromise or settle such Proceeding, but the Seller will not be bound by and determination of a Proceeding so defended or any compromise or settlement effected without its consent (which may not be unreasonably withheld). | ||
(c) | If the Claim does not relate to a claim or the commencement of a Proceeding by a Third Party, the Seller shall have 20 business days after receipt of the Indemnification Notice during which it shall have the right to object to the subject matter and the amount of the Claim set forth in the Indemnification Notice by delivering written notice thereof to the Purchaser. If the Seller sends notice to the Purchaser objecting to the matters set forth in the Indemnification Notice, the Seller and the Purchaser shall use their best efforts to settle the Claim. If the Seller and the Purchaser are unable to settle the Claim, the matter shall be resolved in the manner set forth in Article 15 of this Agreement. | ||
(d) | The provisions of sections 8.5 shall not apply to the provisions set forth in Article 7.5 and Schedule 7.5. |
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11.1 | The Parties undertake that upon the execution of this Agreement their public statements in the form of Schedule 11.1 attached will be issued to conform with the rules applicable to the Parties due to their listings at the Frankfurt (Seller) and NASDAQ (Purchaser) stock exchanges. | |
11.2 | Each of the Parties hereto undertake that prior to Closing and thereafter it will not (save as mentioned in Article 11.1 or required by law) make any announcement in connection with this Agreement, unless the other Party hereto shall have given its written consent to such announcement (which consent may not be unreasonably withheld and may be given either generally or in a specific case or cases and may be subject to conditions). |
12.1 | Non-disclosure. The Parties undertake that they shall treat as strictly confidential all Confidential Information received or obtained by them or their employees, agents or advisers as a result of entering into or performing this Agreement including information relating to the provisions of this Agreement, the negotiations leading up to this Agreement, the subject matter of this Agreement or the business or affairs of each of the Parties or any member of their group, and subject to the provisions of Article 12.2 that they will not at any time hereafter make use of or disclose or divulge to any person any such Confidential Information |
18
and shall use their best endeavors to prevent the publication or disclosure of any such information. In addition, from and after Closing, Seller shall treat as confidential all information relating to the Company, as if such information had been disclosed to Seller by Purchaser pursuant to the confidentiality and standstill agreement dated as of March 10, 2006. | ||
12.2 | Exceptions. The restrictions contained in Article 12.1 shall not apply so as to prevent the Parties from making any disclosure required by law or by any securities exchange or supervisory or regulatory or governmental body pursuant to rules to which the relevant Party is subject or from making any disclosure to any professional adviser for the purposes of obtaining advice (provided always that the provisions of this Article shall apply to and the Parties shall procure that they apply to, and are observed in relation to, the use or disclosure by such professional adviser of the information provided to him) nor shall the restrictions apply in respect of any information which comes into the public domain otherwise than by a breach of this Article by the Parties. |
13.1 | Parties Costs. Each Party to this Agreement shall pay its own costs and disbursements of and incidental to this Agreement and the sale and purchase of the Share, provided that all costs associated with the Notarial Transfer Deed shall be borne by the Purchaser. | |
13.2 | Waiver. No failure or delay by the Purchaser in exercising any right, power or remedy under this Agreement shall operate as a waiver thereof, nor shall any single or partial exercise of the same preclude any further exercise thereof or the exercise of any other right, power or remedy. Without limiting the foregoing, no waiver by the Purchaser of any breach by the Seller of any provision hereof shall be deemed to be a waiver of any subsequent breach of that or any other provision hereof. | |
13.3 | Assignment. The Seller and the Purchaser may not assign this Agreement (contractsoverneming) or assign or encumber its rights there under, without the prior written consent of the other Party, which shall not be unreasonably withheld. Subject to the preceding sentence, this Agreement will apply to, be binding in all respects upon, and inure to the benefit of the successors and permitted assigns of the Parties, pursuant to a merger, de-merger, acquisition, sale of substantially all the assets or other type of reorganization. Nothing expressed or referred to in the Agreement will be construed to give any Person other than the parties to this Agreement any legal or equitable right, remedy, or claim under or with respect to this Agreement or any provision of this Agreement. | |
13.4 | Entire Agreement. This Agreement (together with any documents referred to herein or executed contemporaneously or at Closing by the Parties in connection herewith) |
19
constitutes the whole agreement between the Parties and supersedes any previous agreements or arrangements between them relating to the subject matter of this Agreement (including without limitation that certain Letter of Intent entered into between the parties, effective as of March 10, 2006 relating to the subject matter of this Agreement) and it is expressly declared that no variations of this Agreement shall be effective unless made in writing and executed by the Parties. | ||
13.5 | Continuity of obligations. All the provisions of this Agreement shall remain in full force and effect notwithstanding Closing (except insofar as they set out obligations that have been fully performed at Closing). | |
13.6 | Severability. If any provision or part of a provision of this Agreement shall be, or be found by any authority or court of competent jurisdiction to be, invalid or unenforceable, such invalidity or unenforceability shall not affect the other provisions or parts of such provisions of this Agreement, all of which shall remain in full force and effect. | |
13.7 | Further acts. Upon and after Closing the Seller shall do and execute or cause to be done and executed all such further acts, deeds, documents and things as may be necessary to give effect to the terms of this Agreement. | |
13.8 | Interpretation. This Agreement shall constitute an allocation of risks between the parties. The Parties deem the security they may derive from the provisions of this Agreement essential. | |
13.9 | Third Party Beneficiary Rights. Unless this Agreement explicitly provides otherwise, it contains no stipulations for the benefit of a Third Party which could be invoked by a Third Party against a Party. | |
13.10 | Counterparts. The Agreement may be entered into in any number of counterparts, all of which taken together shall constitute one and the same instrument. Any Party may enter into this Agreement by signing any such counterpart. |
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To the Purchaser: | Dynavax Technologies Corporation | |||
Address: | 2929 Seventh Street, Suite 100, | |||
Berkeley, CA 94710, USA | ||||
Telephone No: | +1 (510) 848 5100 | |||
[ * ] | ||||
Attention: | Chief Financial Officer | |||
With a copy to: | Morrison & Foerster LLP | |||
Address: | 425 Market Street, 33rd Floor | |||
San Franciso, CA 94131, USA | ||||
[ * ] | ||||
No: | ||||
[ * ] | ||||
Attention: | John W. Campbell III | |||
To the Seller: | Rhein Biotech N.V. | |||
Address: | Oude Maasstraat 47, | |||
6229 BC Maastricht, the Netherlands | ||||
[ * ] | ||||
No: | ||||
[ * ] | ||||
Attention: | Managing Director | |||
With a copy to: | Baker & McKenzie Amsterdam NV | |||
Address: | Leidseplein 29 | |||
1017 PS Amsterdam, the Netherlands | ||||
[ * ] | ||||
No: | ||||
[ * ] No: | ||||
Attention: | Edwin T.H. Liem |
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15.1 | Governing Law. This Agreement shall be governed by and construed in accordance with the laws of [ * ] . | |
15.2 | Arbitration. All disputes arising in connection with this Agreement, or further agreements or contracts resulting thereof, shall be finally settled in accordance with the Arbitration [ * ] . The arbitral tribunal shall be composed of three arbitrators. The place of arbitration shall be [ * ] . The arbitral procedure shall be conducted in the English language. The arbitral tribunal shall decide according to the rules of law (naar de regelen des rechts). Consolidation of the arbitral proceedings with other arbitral proceedings pending in [ * ] , as provided in [ * ] is excluded. |
22
/s/ Dino Dina | blank | |||||||||
By:
|
Dino Dina | By: | blank | |||||||
Title:
|
CEO | Title: | blank |
/s/ C.P.E. Moonen | /s/ P.G.J. Heijmanns | |||||||||
By:
|
C.P.E. Moonen | By: | P.G.J. Heijmanns | |||||||
Title:
|
Managing Director | Title: | Managing Director |
23
Act | Means the Federal Food Drug and Cosmetics Act in the U.S., its implementing regulations and FDA guidances, and all counterparts outside the U.S. to each of the foregoing, including International Conference on Harmonization guidelines. | |||
Agreement | Means this share sale and purchase agreement, including all schedule and annexes thereto; | |||
Affiliate | Means, with respect to a company, (i) any Person (directly or indirectly) in Control of such company, (ii) any Person (directly or indirectly) under Control by such company or (iii) any Person (directly or indirectly) under common Control with such company, and (iv) any Affiliate of a natural person (directly or indirectly) in Control of such company; for the purposes of this definition with respect to any natural person Affiliate means (x) the spouse of such natural person, (y) any other natural person related to such first-mentioned natural person, or such first-mentioned natural persons spouse or registered partner, by blood or marriage in the third degree or closer; | |||
Berna Agreement | Means that certain License and Supply Agreement between the Purchaser and Berna Biotech AG dated October 28, 2003. | |||
Breach | Has the meaning ascribed to it in Article 8.1; | |||
Business Day | Means any day on which the banks are not required or authorized to be closed for business in The Netherlands, excluding Saturdays and Sundays; | |||
Civil Law Notary | Means the civil law notary who shall execute the Notarial Transfer Deed; | |||
Claim | any notice provided under the notice provisions of the Agreement pursuant to which either party asserts a claim under Article 8; |
24
Clinical Data | Means all laboratory, analytical, pre-clinical and clinical data prepared by, for or on behalf of Company or its Affiliates or in Companys and/or its Affiliates or suppliers or distributors possession in any form, or to which any of them has rights, which data is with respect to hepatitis B surface antigen or any Product. | |||
Closing | Means completion of the sale and purchase of the Shares as specified in Article 4; | |||
Closing Date | Means the date on which the Closing occurs; | |||
Closing Date Working Capital | Has the meaning ascribed to it in Article 3.2 | |||
Commercial Agreement | Means the agreement setting forth certain commercial arrangements between the Seller on the one hand and the Company and the Purchaser, on the other hand; | |||
Company | Has the meaning ascribed to it in the Recitals, and shall also be deemed to include Novovacs BV for purposes of the Company Warranties set forth in Schedule 7.1. | |||
Conditions | Has the meaning ascribed to it in Article 4.1; | |||
Confidential Information | Means any and all data and information relating to the Company and/or to the business and affairs of a Party that may be provided, orally, in writing or digitally, to the other Party that is marked or expressly stated as being confidential; | |||
Contract | Means any agreement, contract, consensual obligation, promise, understanding, arrangement, commitment or undertaking of any nature (whether written or oral and whether express or implied), whether or not legally binding. | |||
Control | Person or Persons (each a controller) shall be taken to have Control of another Person (the controlled person) if one or more of the controllers, whether by law or in fact has, or is entitled to acquire, the right or the power to secure whether directly or indirectly, that the controlled persons affairs are conducted in accordance with the wishes of the controller and in particular, but without prejudice to the generality of the foregoing, if one or more of the controllers holds: |
25
(i) | the greater part of the share capital of the controlled person or of the voting rights attaching to the controlled persons shares; or | ||
(ii) | the power to control the composition of any board of directors or governing body of the controlled person; |
For the purposes of the foregoing and without limitation there shall be attributed to any controller: |
(i) | any rights or powers which another Person possesses on his behalf or is or may be required to exercise on his direction or behalf; and | ||
(ii) | all rights and powers of any body corporate of which any controller alone or together with another or other controllers has control or of any two or more such bodies corporate; |
Consideration | Has the meaning ascribed to it in Article 3.1; | |||
Damages | Has the meaning of damages (schade) as defined in [ * ] , subject to any limitations set forth in the Agreement; | |||
DCC | Means the [ * ] ; | |||
Default | Has the meaning ascribed to it in Article 8.1; | |||
Disclosure Letter | Means the disclosure from the Seller to the Purchaser disclosing information constituting exceptions to the Warranties; | |||
Encumbrance | Means any mortgage, assignment of receivables, debenture, lien, charge, pledge, title retention, right to acquire, security interest, option, right of first refusal, pre-emption righ, usufruct (vruchtgebruik) or limited right (beperkt recht) and any other encumbrance, attachment (beslag) or condition whatsoever; | |||
EMPP Agreement | Has the meaning ascribed to it in Article 5.2(b) (iv) | |||
Environment | Means any ambient workplace or indoor air, surface water, drinking water supply, groundwater, land surface or subsurface strata, river sediment and buildings, structures and fixtures. | |||
Environmental Claim | Means any Action, or demand from any Governmental |
26
Entity or any Person alleging Liability under Environmental Law, resulting from or based upon: | ||||
(a) the failure to comply with Environmental Law; (b) the failure to comply with any Environmental Permit; (c) the presence in the Environment or Release of, or human exposure to, any Regulated Substance or any other substance, material or waste alleged to be toxic, hazardous or dangerous; or (d) the obligation to conduct any Remedial Action. | ||||
Environmental Contamination | Means (i) the pollution of the soil (schädliche Bodenverunreinigung) within the meaning of Section 2 para. 3 Federal Soil Protection Act (Bundesbodenschutzgesetz), (ii) the pollution or contamination of, or the presence of Regulated Substances (Schadstoffe), or (iii) the pollution or contamination by or the presence of Regulated Substances (Schadstoffe) in the ground water or surface water beneath or on real property, provided, however, that in each case such Environmental Contamination existed at, or prior to, the Closing Date. | |||
Environmental Matters | Means:
(i) the disposal, release, spillage, deposit,
escape, discharge, leak or emission of, contact with
and/or exposure of any person or the environment to
Regulated Substances or waste;
(ii) the creation of any odocer, emissions to air,
noise, vibration, radiation, dust, legal or
statutory nuisance, or other adverse impact on the
environment; and
(iii) any other matter relating to the condition,
protection, maintenance, restoration or replacement
of the environment or any part of it arising
directly or indirectly out of the manufacturing,
processing, treatment, keeping, handling, use
(including as a building material), possession,
distribution, disposal, supply, receipt, sale,
purchase, import, export, transportation or presence
of Regulated Substances or waste and any risk
relating thereto. |
|||
Environmental Permit | Means any permit, registration, approval, identification number, license or other authorization required under or issued pursuant to any Environmental Law. | |||
Euro or EUR | Means Euro, the lawful currency of certain participating States members of the European Union; |
27
Final CDWC Calculation | Has the meaning ascribed to it in Article 3.5 | |||
Financial Statements | Has the meaning ascribed to it in Section 3 of the Warranties Schedule; | |||
Funds Flow Letter | Means the letter executed by the Seller and the Purchaser setting out flow of funds at Closing; | |||
GAAP | Means the generally accepted accounting principles of Germany; | |||
GMP or cGMP | Means current good manufacturing practices within the meaning of the Act. | |||
Governmental Authority | Means any: (a) nation, principality, state, commonwealth, province, territory, county, municipality, district or other jurisdiction of any nature; (b) federal, state, parliament, local, municipal, foreign or other government; (c) governmental or quasi governmental authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, board, instrumentality, officer, official, representative, organization, unit, body or Entity and any court or other tribunal), including any Regulatory Agency, whether domestic or foreign; (d) multinational organization or body; or (e) individual, Entity or body exercising, or entitled to exercise, any executive, legislative, judicial, administrative, regulatory, police, military or taxing authority or power of any nature. | |||
Governmental Rule | Means any applicable law (Gesetz, Verordnung Satzung), judgment, order, decree, statute, ordinance, directive, rule or regulation issued, rendered or promulgated by any Governmental Authority. | |||
Indemnification Notice | Has the meaning ascribed to it in Article 8.6; | |||
Insurance Policies | Has the meaning ascribed to it in Section 10 of the Warranties Schedule; | |||
IP Rights | Has the meaning ascribed to it in Section 7 of the Warranties Schedule; | |||
IT System | Has the meaning ascribed to it in Section 8 of the Warranties Schedule; |
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Legal Requirement | Means any federal, state, local, municipal, foreign or other law, statute, legislation, constitution, principle of common law, resolution, ordinance, code, Order, edict, decree, proclamation, treaty, convention, rule, regulation, permit, ruling, directive, pronouncement, requirement (licensing or otherwise), specification, determination, decision, opinion or interpretation that is, has been or may in the future be issued, enacted, adopted, passed, approved, promulgated, made, implemented or otherwise put into effect by or under the authority of any Governmental Authority. | |||
Liabilities | Means any and all debts, liabilities and obligations, whether accrued or fixed, absolute or contingent, direct or indirect, primary or secondary, matured or unmatured, or determined or determinable, known or unknown, including those arising under any Governmental Rule, Contract, or otherwise. | |||
Licensed Rights | Has the meaning ascribed to it in Section 7 of the Warranties Schedule; | |||
Material Adverse Effect | Means any event, change, circumstance or effect that when taken individually or together with all other adverse events, changes and effects, is or is reasonably likely (a) to be materially adverse to the condition (financial or otherwise), properties, assets, liabilities, business, operations, results of operations or prospects of the Company; or (b) to prevent or materially delay consummation of the Transaction or otherwise to prevent the Seller from performing its obligations under this Agreement or the other Transaction Documents, but excluding any change, circumstance or effect caused by or relating to: (i) changes in conditions generally affecting (A) the healthcare or biotechnology industry or (B) the economies in which the Companies operates, or world economy or securities markets; and (ii) the execution or announcement of this Agreement or the consummation of the transactions contemplated hereby, and (iii) the deterioration of the working capital of the Company substantially from the amount set forth in Section 3.3 of the Agreement. |
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Manufacturing Specifications | Has the meaning ascribed to it in Section 10(g) of the Warranties Schedule. | |||
Material Contracts | Has the meaning set forth in Section 9(a) of the Warranties Schedule. | |||
Non-Registered IP Rights | Has the meaning ascribed to it in Section 7 of the Warranties Schedule; | |||
Notary Account | Means the trust account of the Civil Law Notary | |||
Notarial Transfer Deed | Means the notarial deed executed by a civil law notary authorized in Germany pursuant to which the Shares are transferred; | |||
Order | Means any: (a) temporary, preliminary or permanent order, judgment, injunction, edict, decree, ruling, pronouncement, determination, decision, opinion, verdict, sentence, stipulation, subpoena, writ or award that is or has been issued, made, entered, rendered or otherwise put into effect by or under the authority of any court, administrative agency or other Governmental Authority or any arbitrator or arbitration panel; or (b) Contract with any Governmental Authority that is or has been entered into in connection with any Proceeding. | |||
Party | Means any Party in this Agreement; | |||
Permits | Has the meaning ascribed to it in Section 7 of the Warranties Schedule; | |||
Person | Means any legal entity, firm, corporation, partnership or other business or legal person, as well as any natural person; | |||
Preliminary CDWC Calculation | Has the meaning ascribed to it in Article 3.3 | |||
Proposed CDWC Calculation | Has the meaning ascribed to it in Article 3.4 | |||
Products | Means Cytovax Program Products, Supervax Program Products and Theravax Program Products, as each is defined in the Commercial Agreement. | |||
Purchaser | Has the meaning ascribed to on page 2; | |||
Purchasers Warranties | Has the meaning ascribed to it in Article 7.4; | |||
Real Property Leased | Has the meaning ascribed to it in Section 5 of the Warranties Schedule; |
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Recitals | Means the recitals of this Agreement; | |||
Real Property Owned | Has the meaning ascribed to it in Section 5 of the Warranties Schedule; | |||
Registered IP Rights | Has the meaning ascribed to it in Section 7 of the Warranties Schedule; | |||
Regulated Substance | Means any substance and/or material that in relevant quantity, form or concentration is listed, defined or regulated as a pollutant, contaminant, hazardous, dangerous or toxic substance, material or waste pursuant to any Environmental Law, including any explosives, radon, radioactive materials, asbestos, urea formaldehyde foam insulation, polychlorinated biphenyls, petroleum and petroleum products (including waste petroleum and petroleum products) as well as any material which without being listed, defined or regulated in the above described manner is hazardous, dangerous or toxic relating to soil, groundwater, surface-water, noise, air (emissions), which is capable of causing harm or damage to property, human health, environment or to men or any other organisms protected by Environmental Law including, without limitation, mineral oils, solvents, substances (including liquids, solids, gases, noises), pollutants, contaminants, petroleum, petroleum products and radioactive materials. | |||
Regulatory Agency | Means any Governmental Entity whether foreign, domestic, national, regional or provincial that regulates the safety, efficacy, reliability, manufacture, investigation, sale, marketing or promotion of pharmaceuticals, medical products, biologics or biopharmaceuticals, including the FDA, the EMEA, and their counterparts. | |||
Regulatory Applications | Means (a) all applications for Regulatory Approval for the Products anywhere in the world, and (b) all applications and/or licenses required to legally clinically test in humans Products anywhere in the world, such as investigational new drug applications in the U.S. | |||
Regulatory Approvals | Means all approvals to legally sell the Products as a pharmaceutical. |
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Release | Means any release, spill, emission, discharge, leaking, pumping, injection, deposit or disposal (as those terms are defined in any Environmental Law) at, into or onto the Environment. | |||
Remedial Action | Means any Action, including any capital expenditure, which the Company is required to undertake pursuant to Environmental Law to (a) investigate, monitor, clean up, remove or treat any Regulated Substance in the Environment; or (b) prevent the Release or threat of Release, or minimize the further Release, of any Regulated Substance so it does not endanger or threaten to endanger the Environment or public health or welfare. | |||
Research and Development Materials | Means all research and development materials used in or related to the Companys business with respect to hepatitis B surface antigen production or Products. This includes (without limitation) all production and other cell lines expressing any Products active ingredient. | |||
Seller | Has the meaning ascribed to on page 2; | |||
Sellers knowledge. Sellers awareness, Sellers best knowledge or words of similar import | Means (i) the actual knowledge of the Sellers statutory directors or after having made reasonable enquiries into the affairs of the Company in respect of the relevant matter to which this qualification applies, with the managing directors of the Company, but no other enquiries have been made by such Sellers statutory directors, and (ii) the actual knowledge of the Companys statutory directors, managing directors, and manager and higher level employees (including any outside consultants of the Company performing functions of such employees). | |||
Share | Has the meaning ascribed to in the Recitals; | |||
Tax or Taxes | Means all forms of taxation, duties and levies including public impositions deriving from the refunding of subsidies or grants, whether in Germany or elsewhere, including but not limited to income tax (including amounts equivalent to or in respect of income tax required to be deducted or withheld |
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from or accounted for in respect of any payment), corporate taxes, trade tax, wealth tax, wage tax, value added tax, customs and other import or export duties, excise duties, stamp duty, stamp duty reserve tax, development land tax, national insurance, customs, social security or other similar contributions, and any interest, penalty, surcharge or fine in connection with it. | ||||
Third Party | Means any person who is not a Party; | |||
Transaction Agreements | Means this Agreement, the Commercial Agreement, the | |||
Warranties | Has the meaning ascribed to it in Article 7.1. | |||
Warranties Schedule | Means Schedule 7.1 to the Agreement. | |||
Working Capital Adjustment | Has the meaning ascribed to it in Article 3.2 |
2. | An action taken by a person will be deemed to have been taken in the ordinary course of business only if such action is consistent with the past practices of such person and is taken in the ordinary course of the normal day-to-day operations of such person. | |
3. | Where any obligation is qualified or phrased by reference to use reasonable endeavors, best efforts or wording of a similar nature, it means the efforts that a person desirous of achieving a result would use in similar circumstances to ensure that such result is achieved as expeditious as possible and, regard shall be had, among other factors, to (i) the price, financial interest and other terms of the obligation; (ii) the degree of risk normally involved in achieving the expected result; (iii) the ability of an unrelated person to influence the performance of the obligation. | |
4. | The singular shall include the plural and vice versa and references to words importing one gender will include both genders. |
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1. | Dynavax Technologies Corporation, a corporation organized and existing under the laws of the State of Delaware, having its registered and business offices at 2929 Seventh Street, Suite 100, Berkeley, CA 94710, United States of America (Transferee), | |
by virtue of Power of Attorney dated , the original of which has been submitted and a certified copy of which is attached to this Notarial Protocol as Annex 1 | ||
and | ||
2. | Rhein Biotech N.V., a public limited liability company organized and existing under the laws of The Netherlands, with its corporate seat at Maastricht and its registered office at Oude Maasstraat 47, 6229 BC Maastricht, The Netherlands (Transferor); | |
by virtue of Power of Attorney dated , the original of which has been submitted and a certified copy of which is attached to this Notarial Protocol as Annex 2. |
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1.1 | The Transferor is the legal owner of the entire issued share capital of Rhein Biotech Gesellschaft für Neue Biotechnologische Prozesse und Produkte m.b.H., a private limited liability company organized and existing under the laws of Germany (Gesellschaft mit beschränkter Haftung), with its corporate seat at Düsseldorf, Germany and its principal place of business at Eichfelder Strasse 11, 40595 Düsseldorf, Germany (Company), consisting of 1 share, with a nominal value of [ * ] (the Share). |
2.1 | Transferor hereby transfers the Shares to Transferee. Transferee hereby accepts such transfer. | |
2.2 | The transfer of the Shares shall include any and all rights pertaining to the Shares as at the date and time of transfer. |
3.1 | The underlying contract (Verpflichtungsgeschäft) for the sale and purchase of the shares has been concluded and documented in a separate document, being the Share Sale and Purchase Agreement dated (the Sale and Purchase Agreement). | |
3.2 | This notarial deed effects only the transfer of the shares (Verfügungsgeschäft), and all rights and obligations of the Transferor and Transferee relating to the sale and purchase of the Share are governed exclusively by the Sale and Purchase Agreement. |
4.1 | Each Party to this deed hall bear its own costs and expenses in connection with the preparation, execution and consummation of this deed, including, without limitation, any and all professional fees and charges of its advisors. | |
4.2 | The costs of the notarisation of this deed shall be borne by . | |
4.3 | Any transfer taxes including, without limitation, real estate transfer tax (Grunderwerbssteuer) which are triggered by the execution of this deed shall be borne as stipulated in the Sale and Purchase Agreement. |
5.1 | This deed contains all of the terms and conditions relating to the subject matter of this deed. | |
5.2 | If any provision of this deed shall be invalid or unenforceable for any reason whatsoever, the remaining provisions of this deed shall not be affected thereby. The invalid or unenforceable provision shall be replaced by a valid and enforceable provision in order to achieve the intent of the Parties to the fullest extent possible. |
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8.3 | All changes and amendments to this deed shall require written form unless notarial form is required by law. This requirement shall also apply to any changes or amendments to the provision contained in the foregoing sentence. |
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1.1 | Affiliate means, as to any person or entity, any other person or entity, which controls, is controlled by, or is under common control with such person or entity. A person or entity shall be regarded as in control of another entity only if it owns or controls, directly or indirectly, at least fifty percent (50%) of the equity securities or other ownership interests in the subject entity entitled to vote in the election of directors or with the power to direct or elect management of such subject entity. Affiliates of RBNV include Parent, Green Cross Vaccine Corp. (an entity organized under the laws of the Republic of Korea), Rhein Vaccines B.V., Berna Biotech A.G., and Crucell Holland B.V.,. Affiliation shall be determined based on RBG being wholly owned by Dynavax, and not owned at all by RBNV. | ||
1.2 | Alum means any composition that is or contains aluminum in any form, regardless of whether [ * ] | ||
1.3 | Asian Country means any country geographically located on the continent of Asia. To be clear, the Asian Countries exclude Australia and New Zealand. | ||
1.4 | Closing Date means the first date set forth above. | ||
1.5 | Control means, with respect to a particular item of know-how or a particular Patent at a given date, the ownership of or a license under, together with the right to grant a license or sublicense of the scope set forth in the Agreement under, such item of know-how or Patent, without breaching any written agreement with a third party in existence as of such date. | ||
1.6 | Cytovax means the prophylactic cytomegalovirus vaccine currently under development in NovoVacs BV. | ||
1.7 | Cytovax Program Products means [ * ] , including Cytovax. | ||
1.8 | Definitive Agreements means (i) the Share Sale and Purchase Agreement (parties are RBNV and Dynavax) dated as of March 27, 2006; (ii) this Agreement (parties are RBNV, RBG, and Dynavax); (iii) the Supervax Exclusive License Agreement dated as of the Closing Date (parties are RBNV, RBG and Green Cross); (iv) the Termination Agreement dated as of the Closing Date (parties are Berna and Dynavax); and (v) the Waiver Agreement relating to the employee stock plans (by managers and employees of RBG) dated as of the Closing Date. | ||
1.9 | [ * ] | ||
1.10 | Dynavax Notice has the meaning given in the first paragraph of Section 3.1. | ||
1.11 | Existing Contracts has the meaning given in Section 2.1. | ||
1.12 | Heplisav means Dynavaxs current Hepatitis B vaccine containing Hepatitis B surface antigen and Dynavaxs 1018 ISS. |
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1.13 | Heplisav Program Product means [ * ] In this context, [ * ] The product Heplisav is included among the Heplisav Program Products. | ||
1.14 | [ * ] | ||
1.15 | High Cost Registration European Countries means all countries that are members of the European Union as of the Closing Date, and Norway, Switzerland and Iceland, other than the Low Cost Registration European Countries. | ||
1.16 | Know How means all materials, information, experience and data, formulae, procedures, results and specifications, in written or electronic form, that (i) are Controlled by RBG or RBNV as of the Closing Date, (ii) are not generally known and (iii) are not subject to a third party confidentiality obligation that prevents RBG or RBNV from disclosing the same. Know How includes the Master Cell Line. | ||
1.17 | Low Cost Registration European Countries means any country within the European Union as of the Closing Date, and Norway, Switzerland and Iceland, in which the approval for marketing of a vaccine product [ * ] | ||
1.18 | Master Cell Line means the [ * ] strain, designated as [ * ] that exists as master cell banks designated as [ * ] and working cell banks designated as [ * ] as such cell line is described and referred to in the following IND filed with the FDA: [ * ] This strain is referred to between the Parties as the [ * ] strain. | ||
1.19 | Patents means all granted patents, including utility models and certificates of invention, and reissues, reexaminations, supplementary protection certificates, extensions, and term restorations thereof, and patent applications, including any continuations, continuations-in-parts, divisionals thereof, and the like. | ||
1.20 | [ * ] is defined by reference to [ * ] it [ * ] to [ * ] or [ * ] for a [* ] | ||
[ * ] means to [ * ] and [ * ] a [ * ] or [ * ] of [ * ] are [ * ] pursuant to a [ * ] that provides that [ * ] of [ * ] as a [ * ] from [ * ] to [ * ] or [ * ] for [ * ] of a [ * ] in [ * ] or [ * ] for the [ * ] of [ * ] the [ * ] in a [ * ] for [ * ] which [ * ] is [ * ] of this definition [ * ] qualify [ * ] | |||
1.21 | RBG IP means RBG Patents and the related Know How, both as of the Closing Date. | ||
1.22 | RBG Patents means Patents Controlled by RBG as of the Closing Date that are listed in Exhibit 1.16. | ||
1.23 | Supervax shall mean the current prophylactic two dose Hepatitis B vaccine that includes the [ * ] adjuvant. [ * ] | ||
1.24 | Supervax Program Products means all prophylactic Hepatitis B vaccines that contain all of the following: [ * ] The Supervax Program Products include Supervax. |
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1.25 | Theravax means a therapeutic Hepatitis B vaccine that contains all of [ * ] | ||
1.26 | Theravax Program Products means all therapeutic Hepatitis B vaccines that contain all of [ * ] The Theravax Program Products include Theravax. | ||
1.27 | Traditional Hepatitis B Vaccine means any vaccine that contains [ * ] For the avoidance of doubt, Traditional Hepatitis B Vaccine includes the following Hepatitis B vaccines registered at Closing: [ * ] |
2.1 | Confirmation of Existing Contract Obligations. Except for the March 1, 2005 Agreement between RBG, RBNV and Berna (which is terminated by the Share Sale and Purchase Agreement), and except to the extent specifically modified herein and/or by a separate amendment attached hereto as an Exhibit, all terms of pre-existing (prior to the Closing Date) contracts among RBG on the one hand and RBNV, and its Affiliates, on the other hand the Existing Contracts; the Existing Contracts exclude the Definitive Agreements), are hereby confirmed and remain in full force and effect. | ||
2.1.1 | The Parties hereby agree that this Agreement sets forth the entire understanding between the Parties and their Affiliates with respect to the ownership of, all licenses to, and all rights to use and practice, the RBG IP and the [ * ] strain (here and everywhere else used in this Agreement where we refer to [ * ] we mean the strain [ * ] as described in [ * ] Release Testing, Genetic and Product Characterisation). That is to say, where we refer above to except to the extent specifically modified hereunder, the grants of licenses under and rights to use and practice the RBG IP set forth in this Agreement is, together with the remainder of this Section 2.1.1 and Sections 2.4 and 2.5, are intended to supersede all prior understandings with respect to the ownership of, licenses under, and rights to use RBG IP and the [ * ] strain, and to set forth the Parties entire agreement with respect to all of the foregoing matters mentioned in this sentence. RBNV and its Affiliates hereby acknowledge that they have no ownership or license rights in the RBG IP (excluding the Master Cell Line) and the [ * ] strain other than the license rights set forth in this Agreement. RBNV acknowledge that they have no financial interest in the RBG IP or [ * ] strain other than as set forth in Section 2.4 and 2.5. | ||
2.2 | Termination of Berna Agreement. The Termination Agreement between Dynavax and Berna, which sets forth the Parties mutual agreement to terminate the License and Supply Agreement, dated November 19, 2003, is attached as |
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Exhibit 2.2. Thus, such License and Supply Agreement is terminated. Section 2.1 of this Agreement shall not viewed or deemed in any way to resurrect it. | |||
2.3 | Assignment of Supervax Trademark Rights. The Supervax Trademark Assignment Agreement between RBG and Berna is attached as Exhibit 2.3. | ||
2.4 | Fully Paid-Up License Rights. All Patent and Know-How rights, including RBG Patents rights, granted to RBNV, RBG, and their Affiliates, in pre-existing agreements between or among RBNV, RBG and their Affiliates, are hereby paid-up and royalty-free at the Closing Date. With the exception of (1) any outstanding invoices at Closing, (2) the arrangements specifically made and/or referenced in the Definitive Agreements executed at Signing and/or Closing (such as the profit share for Supervax, the loan repayments, any outstanding accounts payable, any open invoices, and the payments under Section 2.5) and (3) the [ * ] between RBG and RBNV described in the October 1, 2005 Addendum to License Agreement (between RBG and GCVC dated June 30, 1998) with respect to the License and Technology Transfer Agreement between [ * ] sharing arrangement is also referred to at the end of Section 2.5). RBG and RBNV hereby waive all rights to any and all claims to all monies owed under such pre-existing agreements. If RBNV or RBG requests in writing, RBG or RBNV, respectively, shall promptly execute, and deliver to the other, any formal amendment documents confirming the waiver of any monetary obligations owing thereto and/or to its Affiliates and specific to the aforesaid pre-existing documents. Such confirmations must be consistent with this Agreement and the other Definitive Agreements. Such confirmations shall not have any force of effect to the extent inconsistent with this Agreement and/or any of the other Definitive Agreements. | ||
2.5 | RBNV Rights to RBG Third Party License Revenues. RBG shall pay to RBNV all monies (excluding those already included in RBGs accounts receivable as of the Closing Date) received by RBG from third parties pursuant to obligations in license agreements with RBG, which agreements exist on the Closing (other than current licenses with RBNV and its Affiliates and specifically excluding [ * ] and the License and Technology Transfer Agreement between [ * ] ) (Current Licenses), to the extent that such monies exceed [ * ] annually after adjustment for payments owed (a) based on agreements existing at Closing, to other third parties from such monies (including any royalties due to such other third parties on in-licensed IP sublicenses to the RBG licensees), and (b) for intellectual property that becomes licensed under the Current Licenses due to RBG obtaining control thereof after the Closing Date, to such third parties pursuant to the written agreement by which RBG obtains such control. For the purposes of clarity, these payments shall not include any payments received by RBG with respect to its Supervax Program Products, Theravax Program Products and Cytovax Program Products. RBNV shall have reasonable audit access to records of such payments on reasonable terms and at reasonable times. Such audits must be performed by a reputable certified public accountant, under appropriate obligations of confidentiality. Such audits shall not be made more frequently than once annually, no later than three (3) years after the payment period being audited. |
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Current Licenses specifically exclude the following: |
With respect to such [ * ] the [ * ] referred to in the October 1 2005 Addendum to License Agreement (between RBG and GCVC dated June 30, 1998) shall continue in full force and effect. |
3.1 | European Countries (other then Low Cost Registration European Countries). Dynavax, or an Affiliate thereof, shall promptly notify RBNV in writing within [ * ] of taking its decision to develop the first Supervax Program Product (and thereafter within [ * ] after it takes such decision with respect to each subsequent Supervax Program Product not already (at the time of such decision) subject to a pre-existing third party agreement) for any High Cost Registration European Countries (Dynavax Notice). Dynavax, and/or an Affiliate thereof, shall not [ * ] the (i) development and commercialization (including marketing and selling), and/or (ii) distribution and/or sale of such Supervax Program Product(s) for and in High Cost Registration European Countries until after the Parties have exercised their commercially reasonable efforts according to this Section 3.1 (unless RBNV fails to provide within the time period stated in Section 3.1.1 a notice that RBNV wishes to negotiate with Dynavax or its Affiliate under that Section). | ||
3.1.1 | Schedule and Procedure. Within [ * ] of receiving notification pursuant to Section 3.1, RBNV, or an Affiliate thereof, may notify Dynavax in writing of RBNVs, or an Affiliates, intention to negotiate a development and commercialization agreement with Dynavax or an Affiliate thereof (the RBNV Notice). If RBNV, or an Affiliate thereof, does not provide the RBNV Notice, then Dynavax may deem the failure to answer as a negative response and shall be free to proceed with third-party transactions regarding such Supervax Program Product rights in any and/or all of the countries mentioned in the Dynavax notice, without restriction. | ||
3.1.2 | Within [ * ] of receiving the RBNV Notice, Dynavax, or an Affiliate thereof, shall provide RBNV with a good faith written proposal for a development and commercialization agreement (at a term sheet or greater level of detail, but not required to be at the level of a fully drafted agreement), which may, at Dynavaxs discretion, [ * ] for such Supervax Program Product in the specific country or countries (Dynavax Proposal). | ||
3.1.3 | Within [ * ] of receipt by RBNV of the Dynavax Proposal (Negotiation Period), RBNV and Dynavax, or their designated Affiliates, shall exercise their commercially reasonable efforts to negotiate, [ * ] the terms of such development and commercialization arrangement, including [ * ] . | ||
3.1.4 | Dynavax, or an Affiliate thereof, shall not offer more favorable terms, such as an |
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offer that does not require the sharing of development costs (if the offer to RBNV included such sharing), than those offered to RBNV under Section 3.1.2 (if a proposal under such Section was required of Dynavax), within [ * ] from the expiration of the Negotiation Period, unless those terms have first been offered to, and rejected by, RBNV, which rejection or approval shall be provided within [ * ] of notification. A failure to respond within such [ * ] shall be considered a rejection. After such [ * ] period, Dynavax, RBG and their Affiliates shall be free to proceed with third-party transactions regarding such Supervax Program Products rights in any and/or all of the countries mentioned in the Dynavax notice, without restriction. |
3.2 | Asian Countries and Low Cost Registration European Countries. Dynavax, or an Affiliate thereof, shall promptly notify RBNV in writing within [ * ] of taking its decision to [ * ] in any Asian Country(ies) and/or Low Cost Registration European Country(ies). Such decision must only be made if the Supervax Program Product and data regarding it is such that it shall be at a stage that it would be reasonable to [ * ] it being understood and agreed that if in the particular country it is customary that [ * ] Dynavax, and/or an Affiliate thereof, shall not [ * ] any third party for the sale and/or distribution of Supervax for and in any Asian Country(ies) and/or Low Cost Registration European Country(ies) until after the Parties have exercised their commercially reasonable efforts according to this Section 3.2 (unless RBNV fails to provide a notice that it wishes to negotiate with Dynavax or its Affiliate under Section 3.2.1 within the deadline stated in such Section in which case Dynavax and RBG are free to proceed regarding such Supervax Program Product rights for the country(ies) mentioned in the notice, without restriction). | ||
3.2.1 | Schedule and Procedure. Within [ * ] of receiving notification pursuant to Section 3.2, RBNV, or an Affiliate thereof, may notify Dynavax in writing of RBNVs, or an RBNV Affiliates, intention to negotiate a commercialization agreement with Dynavax, or an Affiliate thereof, with respect to the Asian Country(ies) and/or Low Cost Registration European Country(ies) mentioned in Dynavaxs or its Affiliates notice (such notice from RBNV, the RBNV Notice). If RBNV, or an Affiliate thereof, does not provide the RBNV Notice, then Dynavax may deem the failure to answer as a negative response. In that case, Dynavax and RBG are free |
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to proceed regarding such Supervax Program Product rights for the country(ies) mentioned in their notice, without restriction. | |||
3.2.2 | Within [ * ] of receipt of the RBNV Notice, RBNV and Dynavax, or their designated Affiliates, shall exercise their commercially reasonable efforts to negotiate, [ * ] in good faith, the essential terms and conditions of sales and distribution, including [ * ] . | ||
3.2.3 | In case negotiations under Section 3.2.2 (if required to be initiated thereunder) do not result, within the specified [ * ] in an agreement as specified in Section 3.2.2, Dynavax, or an Affiliate thereof, may [ * ] provided that Dynavax, or an Affiliate thereof, shall not offer to such third parties more favorable terms than those offered to RBNV, within [ * ] after the end of discussions under Section 3.2.2 without first offering such more favorable terms to RBNV. RBNV is obliged to respond yes or no to the more favorable terms within [ * ] A failure to respond within such [ * ] is considered a rejection. |
3.3 | First Negotiation. Dynavax and RBNV agree that, for [ * ] after the Closing Date, neither Party nor their Affiliates, shall negotiate with any third parties, without first negotiating and discussing in good faith with each other, any possible joint development, research, collaboration and/or marketing agreement for [ * ] |
4.1 | Supervax. RBG hereby confirms its exercise of the exclusive (even as to the grantor) license option in the License Option Agreement Supervax dated November 9, 2005, between RBG and Green Cross Vaccine Corporation (the Superseded Option). The terms of such resulting exclusive license are described in the Exclusive License Agreement attached hereto as Exhibit 4.1, which terms supersede the Superseded Option. | ||
4.2 | Master Cell Line and Hepatitis B Surface Antigen [ * ] . Subject to any pre-existing third party agreements and the terms of this Agreement (including the covenants specified in Section 6 hereof), RBNV and its Affiliates, hereby with respect to Section 4.2.1 agree that RBG and Dynavax have, and with respect to Section 4.2.2 grant, and confirm the grant, to RBG and Dynavax, of the following rights: | ||
4.2.1 | The right to use the Master Cell Line for Hepatitis B surface antigen ([ * ] ) currently in RBGs possession (including progeny of such cell line) for any and all permitted purposes, including clinical and commercial production. Permitted purposes in this context means all activities outside the scope of the exclusive |
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license of Section 4.3.2, other than activities forbidden in Section 6, during the time period forbidden therein. |
4.2.2 | A non-exclusive license under all Patents (if any) owned, or controlled with the right to sublicense, by RBNV to develop, make, have made, use, offer to sell, sell, store and import Hepatitis B surface antigen ([ * ] ) produced on the Master Cell Line, but while the license of Section 4.3.2 is in effect only outside the scope of the exclusive license of Section 4.3.2; and excluding activities forbidden in Section 6, during the time period forbidden therein. | ||
4.2.3 | Sublicense Rights. The rights and licenses specified in 4.2.1 and 4.2.2 above are sublicensable without RBNVs and its Affiliates consent through one or more tiers or layers of sublicensees to RBGs and Dynavaxs Affiliates, third party contract manufacturers, contract clinical and analytical service providers, distributors, and commercial development and/or marketing partners (including licensees). | ||
4.2.4 | The rights and licenses granted in this Section 4.2 are royalty-free and fully paid-up as far as any payments to RBNV and its Affiliates are concerned, and are perpetual. | ||
4.3 | RBG License Grants to RBNV. Subject to the terms of this Agreement and any restrictions stated in in-licenses by which RBG acquired Control of any RBG IP that is not owned by RBG, RBG hereby grants to RBNV and its Affiliates, and RBNV and its Affiliates shall hereby receive, the following rights: | ||
4.3.1 | a fully paid-up, royalty-free, non-exclusive, license under RBG IP, in perpetuity, to develop, make, have made, use, sell, offer to sell, store, import and export any and all products, except for Supervax Program Products, Theravax Program Products, Cytovax Program Products and Heplisav Program Products. |
4.3.1.1 | The exclusion of Supervax Program Products, Theravax Program Product, Cytovax Program Products and Heplisav Program Products from the foregoing license means (without limitation) that such license does not extend to the making and selling of Hepatitis B surface antigen (or any other ingredient covered by or made using the RBG IP) for inclusion (or under contractual terms that would permit their inclusion) in any Supervax Program Product(s), Theravax Program Product(s), Cytovax Program Product(s) and/or Heplisav Program Product(s). Accordingly, RBNV and their Affiliates shall only supply Hepatitis B surface antigen, made using RBG IP, and such other ingredients to third parties under circumstances in which such third parties (and any entities to which they may transfer such antigen and other ingredients) are legally forbidden and precluded from making Supervax Program Products, Theravax Program Products, Cytovax Program Product and Heplisav Program Products using the supplied quantities of such antigen and other ingredients. Notwithstanding the foregoing, RBNV and its Affiliates shall not be required to amend |
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their existing agreements to comply with the restrictions specified in this Section 4.3.1, but shall exert its reasonable diligent efforts, which do not adversely financially impact RBNV, to include such terms upon amendment thereof and shall include them on any voluntary extension to the relationship (i.e. one that is not required without RBNVs or its Affiliates consent under the contract that exists as of the Closing Date). |
4.3.2 | a fully paid-up exclusive license under RBG IP, to develop, make, use, offer to sell, store, sell and import Traditional Hepatitis B Vaccines (such as [ * ] and any combination vaccines (containing two (2) or more vaccines directed against diseases caused by independent agents) that (a) include a Traditional Hepatitis B Vaccine (such as [ * ] ), but (b) exclude Heplisav Program Products. Such license shall be exclusive, even as to Dynavax and RBG, for a term lasting until the longer of the end of ten years or the life of the last-to-expire applicable RBG Patent. |
4.3.2.1 | The foregoing license explicitly does not extend to the making and selling of Hepatitis B surface antigen (or any other ingredient covered by or made using the RBG IP) for inclusion (or under contractual terms that would permit their inclusion) in any Supervax Program Product(s), Theravax Program Product(s), Cytovax Program Product(s) and/or Heplisav Program Products. Accordingly, RBNV and their Affiliates shall only supply Hepatitis B surface antigen, made using RBG IP, and such other ingredients to third parties under circumstances in which such third parties (and any entities to which they may transfer such antigen and other ingredients) are legally forbidden and precluded from making Supervax Program Products, Theravax Program Products, Cytovax Program Product and Heplisav Program Products using the supplied quantities of such antigen and other ingredients. Notwithstanding the foregoing, RBNV and its Affiliates shall not be required to amend their existing agreements to comply with the restrictions specified in this Section 4.3.2, but shall exert its reasonable diligent efforts, which do not adversely financially impact RBNV, to include such terms upon amendment thereof and shall include them on any voluntary extension to the relationship (i.e. one that is not required without RBNVs or its Affiliates consent under the contract that exists as of the Closing Date). |
4.3.3 | For the avoidance of doubt, the licenses of Section 4.3.1 and 4.3.2 do not in any way diminish the scope of RBGs rights to the Supervax Program Products, Theravax Program Products and Cytovax Program Products. | ||
4.3.4 | Sublicense Rights and Restrictions. The licenses of both Sections 4.3.1 and 4.3.2 are subject to restrictions on RBGs ability to license and sublicense pursuant to pre-existing third-party agreements (i.e. agreements with entities other than Affiliates). Other than such third party licensing restrictions: |
(1) | RBNVs non-exclusive license rights provided in subsection 4.3.1 above |
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are sublicensable in conjunction with the grant of a license or sublicense under [ * ] | |||
(2) | RBNVs exclusive license rights provided in subsection 4.3.2 above, are sublicensable [ * ] without any requirement that RBNV license other intellectual property in conjunction with the grant of the sublicense. | ||
(3) | To avoid any doubt, any sublicensees under the license of subsection 4.3.1 and any sublicensees under the license of Section 4.3.2 shall be subject to the same restrictions as stated in Sections 4.3.1.1 and 4.3.2.1, respectively, as if such sublicensees were RBNV or an RBNV Affiliate. |
4.3.5 | RBG Obligation to Secure Third Party Licensor Consent. At RBNVs written request, RBG shall promptly notify each third party licensor of RBG IP, of RBGs obligation under Section 4.3 to sublicense rights in such RBG IP to RBNV, and if consent or amendment under the appropriate license agreement is required, then RBG shall [ * ] to obtain written consent from each such third party licensor. Promptly upon securing each required consent from a third party licensor, if the terms of the consent are acceptable to RBNV, then the Parties shall execute a formal sublicense agreement with RBNV providing for (1) the sublicense of RBG IP rights to RBNV, and (2) the assumption of obligations by RBNV as provided for in such third party license agreements. If any such sublicense requires the payment of monies to the third party licensor (including any payment in the form of an amendment that results in a payment of less money to RBG under the contract than without such amendment), RBNV shall be informed in writing of such potential financial obligation, and RBNV shall be responsible for the payment of all such fees to said third party licensor. RBNV shall be entitled to terminate such sublicense in accordance with its terms, but shall not in this manner be able to avoid responsible for any non-cancelable sublicensing-related fees. |
4.3.6 | Licensed RBG Patent Maintenance. Given the non-exclusive nature of the license of Section 4.3.1, RBG and Dynavax will be under no requirement to prosecute or maintain RBG Patents, which do not specifically claim [ * ] If RBG and Dynavax elect to abandon any RBG Patent, RBG and/or Dynavax will first give RBNV reasonable notice of such intention and the opportunity to prosecute or maintain such RBG Patent. In this case, optionally, at RBNVs sole discretion, RBNV may do so in its own name; provided that RBG and Dynavax will receive a non-exclusive license to such RBG Patents, consistent with the licenses granted herein and with any pre-existing third party agreements (i.e. if 3rd party obligations exist that apply to the practice of the inventions claimed in the RBG Patents taken over by RBNV, then RBNV must comply with such 3rd party license obligations respecting such practice). If RBG and Dynavax choose, as part of a strategic move, to abandon a particular RBG Patent, which does not claim specifically [ * ] and which would reasonably benefit the RBG Patent portfolio, then the Parties will diligently [ * ] |
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4.4 | Defense of Patent Litigation. If either Party after the Closing is warned or sued by a third party alleging or charging infringement of any Patents claiming the licensed Know How or the use thereof by either Party or its Affiliates, then the Party that was warned or sued shall notify promptly the other Party. Except only if, as and to the extent otherwise provided in Article 8, each Party shall be responsible, at its expense, for settling and/or defending such warning, allegation or charge (including associated litigation) to the extent relating to such Partys or its Affiliates use of the licensed Know-How. [ * ] Upon a Partys reasonable request, the other Party agrees to reasonably assist in any such defense on mutually agreed reasonable terms, provided that the requesting Party agrees to reimburse the other Party for the reasonable out of pocket expenses incurred by the other Party for the provision of such assistance. Dynavax and RBG are considered a single Party for purposes of this Section 4.4. | ||
4.5 | Patent Enforcement. | ||
4.5.1 | Notification. In the event that a Party obtains actual knowledge that a third partys activities likely infringe one or more of the RBG Patents within the scope of the exclusive license granted in Section 4.3.2, it shall promptly notify the other Party of any such likely infringement. | ||
4.5.2 | Control of Suit: |
4.5.2.1 | As to the infringement of exclusively licensed RBG Patents pursuant to Section 4.3.2, RBG shall have the first right to effect termination of such infringement, including bringing suit or other proceedings against the infringer in its own name and the other Parties hereto shall be kept informed at all times of all such proceedings taken by RBG. If RBNV, or another Party licensee, requests, such Party may join with RBG as a Party to the lawsuit or other proceeding in a monitoring capacity only at its own expense. However, even if RBNV chooses to join the suit in such a monitoring capacity, RBG shall retain sole control of the prosecution of such suit or proceedings, as the case may be. | ||
4.5.2.2 | If (a) RBG elects not to file legal proceedings against a third party within [ * ] such possible infringing activities, and has not engaged in, or has terminated, reasonably diligent business discussions to terminate such infringement, and (b) the infringement involves the commercialization of a product that competes directly with any then-marketed product of RBNV or any of its Affiliates, and if the alleged infringement is likely to have a more than insignificant impact on RBNVs business in the country(ies) where sales of allegedly infringing product is occurring, then RBNV shall have the right to effect termination of such infringement, including bringing suit or other proceedings against the infringer in its own name. The other Parties hereto shall be kept informed at all times of all such proceedings taken by RBNV. RBNV shall not be authorized to make any admission, consent, or other representation during the proceeding, which |
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would admit the invalidity or unenforceability of an RBG Patent, without the advice and consent, in writing, from RBG, which RBG is entitled to withhold in its reasonable discretion. If RBG (or an RBG Affiliate) requests, such entity may join with RBNV as a party to the lawsuit or other proceeding at its own expense. In this case, RBNV shall retain control of the prosecution of such suit or proceedings, as the case may be, except that RBG shall have the sole right to control the prosecution of such suit or proceedings as regards all matters affecting validity and/or enforceability of the RBG Patent(s). |
4.5.3 | Costs and Monetary Recovery: Each Party shall bear all its costs incurred in connection with such lawsuit or other proceeding. Any monetary recovery shall first be paid to the Parties (and their Affiliates) to reimburse their legal and other costs associated with the legal proceeding. [ * ] remaining recovery shall be paid to or retained by RBNV, [ * ] remaining recovery shall be paid to or retained by RBG. | ||
4.5.4 | Disclaimer. Nothing in this Agreement shall be construed as obligating any Party the right, to proceed against a third party infringer. | ||
4.5.5 | Area of No RBNV Enforcement Rights. RBNV and its Affiliates shall not have any right to enforce the RBG Patents outside the scope of the exclusive license in Section 4.3.2 during the time period while it remains exclusive. Without limitation, this means that RBNV and its Affiliates have no right to enforce the RBG Patents within the scope of the non-exclusive license of Section 4.3.1, to the extent broader than the license of Section 4.3.2 (i.e. outside of any overlap between Section 4.3.1 and Section 4.3.2). |
5.1 | Master Cell Line Issues-Cooperation. Dynavax and RBNV acknowledge that the Master Cell Line is (1) used by RBNV and its Affiliates for the production of products that are approved by Governmental Authorities, and that are currently on the market, and (2) is confidential and of crucial importance to the Parties. Accordingly, [ * ] ensure the best and most informed approach. To avoid any doubt, [ * ] Dynavax and RBNV further agree to use reasonable efforts to promptly notify the other party of any and all communications to and from Governmental Authorities relating to the safety of the Master Cell Line, as well as of any communication and/or concerns expressed by such regulatory authority relating to the safety, quality or characterization of the Master Cell Line, and agree to consult promptly with each other to resolve any such concerns with the FDA or such other Governmental Authorities. The Parties agree to share all safety, toxicity and tumorogenicity data regarding the Master Cell Line that any of them (or their Affiliates) generates (or receives or contracts for) [ * ] | ||
5.2 | Production Technology Assistance. RBG will provide to RBNV and to its Affiliates reasonable access to assistance regarding the Hepatitis B and |
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Hansensula polymorpha production technologies as in existence at RBG on the Closing (with no updating), as follows: | |||
5.2.1 | Troubleshooting. For a period of [ * ] after Closing, RBG will make available for general diagnosis and troubleshooting, in each year during this [ * ] period up to [ * ] at a cost of [ * ] per FTE month, which cost may be adjusted for inflation every year, plus all travel and related expenses, provided that RBNV provides RBG at least [ * ] advance notice of such request. [ * ] RBGs technical personnel supplied by RBG for such general diagnosis and troubleshooting. | ||
5.2.2 | Long Term Projects. For a period of [ * ] after Closing, RBG will make available for long term projects, including training of Parents personnel, up to an aggregate of [ * ] of which no more then [ * ] within [ * ] at a cost of [ * ] per FTE month, which cost may be adjusted for inflation every year, plus all travel and related expenses, provided that Parent provides RBG at least [ * ] advance notice of such request. [ * ] RBG technical personnel supplied by RBG for such long term projects. | ||
5.2.3 | The aggregate FTEs stated in Sections 5.2.1 and 5.2.2 are stated collectively for RBNV and its Affiliates together. They are not each separately entitled to this number of FTEs. | ||
5.3 | No Transfer or Supply Obligations. Other than is mentioned in Sections 5.1 and 5.2, there are no obligations for RBG or RBNV to supply each other or their Affiliates, Know How, products or other materials pursuant to the license grants herein. Any such existing obligations are hereby waived. The Parties remain free to contract in writing for new such obligations in the future in their sole discretions. |
6.1 | [ * ] RBG and Dynavax, for [ * ] after Closing, will not develop and/or market, and/or license others to develop and/or market, for [ * ] Hepatitis B vaccine, other than Heplisav Program Products. | ||
6.2 | [ * ] RBG and Dynavax, for [ * ] after Closing, will not develop and/or market, and/or license others to develop and/or market, [ * ] other than Heplisav Program Products. |
7.1 | RBG warrants and represents to RBNV that any and all RBG IP rights licensed from third parties, which rights are necessary for the research, development, manufacture, marketing, sale or importation of the products known as (a) [ * ] and/or (b) HepavaxGene, are sublicensable, and have been sublicensed, to RBNV and its Affiliates, without the need to secure the prior consent from such third parties. |
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7.2 | RBNV, RBG and Dynavax warrant and represent to each other that (i) it has the full right and authority to enter into this Agreement and to grant the rights granted herein; (ii) it has not previously granted any rights to third parties in conflict with the rights and options granted herein; (iii) it shall not violate the law or existing contractual obligations by executing this Agreement; (iv) it is not bound by any obligations to third parties that would impair its ability to perform its obligations or grant the licenses contemplated herein; and (v) it has duly executed this Agreement. UNLESS OTHERWISE EXPRESSLY PROVIDED FOR IN THIS AGREEMENT, EACH PARTY DISCLAIMS ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT, PATENT VALIDITY, TECHNICAL FEASIBILITY, FITNESS FOR ANY PARTICULAR PURPOSE, AND ANY WARRANTIES CONCERNING THE INHERENT PROPERTIES OF KNOW HOW AND RBG IP SUPPLIED OR LICENSED UNDER THIS AGREEMENT. EACH PARTY MAKES NO WARRANTY AS TO THE MERCHANTABILITY OF THE PRODUCTS, ITS LICENSED KNOW HOW OR LICENSED PATENTS. |
8.1 | Licensee Third Party Responsibilities. | ||
8.1.1 | Dynavax/RBG Responsibility. Dynavax and RBG shall be responsible, and shall hold RBNV harmless for: (i) all financial obligations to third parties (i.e. parties that are not Parties hereto and Affiliates thereof) due to the receipt or exercise by Dynavax or RBG of the rights addressed in section 4.2; and (ii) all requirements in relation to RBNVs existing (as of the Closing Date) third-party licenses, arising out of Dynavaxs or RBGs receipt or exercise of the rights addressed in section 4.2 of which RBNV informs Dynavax (i.e. if third-party obligations exist (meaning that they are provided for in a written agreement with a third party executed before the Closing Date) for the use of the Master Cell Line by RBG and Dynavax under the license of Section 4.2, then fulfillment of those obligations shall not be RBNVs responsibility, but RBNV must inform RBG and Dynavax of such third-party obligations in order for RBG and Dynavax to be able to fulfill them). For the avoidance of any doubt, RBNV shall not be liable for any financial obligations to third parties, including for example upstream royalties or other payments, arising out of Dynavaxs, RBGs or their Affiliates exercise of rights to third-party technology the rights in which have been sublicensed hereunder. | ||
8.1.2 | RBNV/Affiliate Responsibility. RBNV is responsible, and shall hold RBG and Dynavax harmless for: (i) all financial obligations to third parties (i.e. parties that are not Parties hereto and Affiliates thereof) due to the receipt or exercise by RBNV and its Affiliates of the license of subsection 4.3.1 and/or 4.3.2, and (ii) all requirements in relation to RBGs existing (as of the Closing Date) third-party licenses for RBG IP, arising out of RBNVs or its Affiliates receipt or exercise of the licenses of subsections 4.3.1 and 4.3.2 of which RBG and/or Dynavax informs RBNV (i.e. if third-party obligations exist (meaning that they are provided for in a |
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written agreement with a third party executed before the Closing Date) for the exercise of the licenses of Sections 4.3.2 and 4.3.2 shall not be Dynavaxs nor RBGs responsibility, but Dynavax or RBG must inform RBNC of such third-party obligations in order for RBNV and its Affiliates to be able to fulfill them. For the avoidance of any doubt, RBG and Dynavax shall not be liable for any financial obligations to third parties, including for example upstream royalties or other payments, arising out of RBNVs or its Affiliates exercise of rights to third-party RBG IP sublicensed hereunder. | |||
8.1.3 | Cooperation. The Parties shall cooperate in the mechanics of making payment to any upstream licensors. This includes that the sublicensing Party will forward payments and reports received from the sublicensed Party to the third-party licensor, promptly after receipt, and will share promptly all notices of delinquency and non-payment received. |
8.2 | General Product Indemnification. |
(a) | Each licensing Party herein (Licensor) shall not be liable for, and each licensed Party herein (Licensee) shall defend indemnify and hold Licensor together with its Affiliates and the directors, officers and employees of all of them (the Licensor Indemnitees) harmless against, any and all liabilities (including product liability and infringement of third party Patents insofar as such infringement relates to activities carried out by Licensee under this Agreement), damages, losses costs, and expenses, including reasonable attorneys fees (collectively Damages), resulting in any manner from third-party claims, demands and actions (collectively, Claims) arising out of (a) the use by Licensee or its Affiliates of the Master Cell Line and/or the licensed Know How, or (b) the Licensees other activities in exercise of a license granted it hereunder, including the development or manufacture of licensed (hereunder) prototypes or clinical supplies by Licensee or its Affiliates, or the use of any licensed (hereunder) product manufactured, or used by Licensee or its Affiliates by any human being regardless of whether such use was contemplated by the Parties, except in the case of each (a) and (b) to the extent such liabilities result from (x) the willful misconduct, or gross negligence by the Licensor Indemnitees and/or (y) the Licensors breach of its representations and warranties under this Agreement. For purposes of illustration, Dynavax shall not be responsible and shall be defended and held harmless by RBNV for product liabilities relating to [ * ] while RBNV shall not be responsible for and shall be defended and held harmless by Dynavax and RBG for product liabilities relating to Supervax Program Products, Theravax Program Products and Cytovax Program Products. RBG is the Licensor, and RBNV and its Affiliates are the Licensees, regarding the licenses of Section 4.3. RBNV is the Licensor, and RBG, Dynavax and their Affiliates are the Licensees, regarding the licenses of Section 4.2. | ||
(b) | RBG hereby agrees to indemnify, defend and hold harmless RBNV and its |
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Licensor Indemnitees from and against all Damages resulting from Claims to the extent arising out of (1) a breach of RBGs representations and warranties under this Agreement, and/or (2) RBG Indemnitees willful misconduct, or gross negligence. Likewise, RBNV hereby agrees to indemnify, defend and hold harmless RBG and its Licensor Indemnitees (including Dynavax and its people) from and against all Damages resulting from Claims to the extent arising out of (1) a breach of RBNVS representations and warranties under this Agreement, and/or (2) RBNV Indemnitees willful misconduct, or gross negligence. |
8.3 | Indemnification Procedure. If a Party (the Indemnitee) intends to claim indemnification under Section 8, Indemnitee shall promptly notify the other Party (the Indemnitor) of any claim, demand, action, or other proceeding for which the Indemnitee intends to claim such indemnification. The Indemnitor shall have the right to participate in, and to the extent the Indemnitor so desires jointly with any other Indemnitor similarly noticed, to assume the defense thereof with counsel selected by the Indemnitor; provided, however, that the Indemnitee shall have the right to retain its own counsel at Indemnitees own expense. The indemnity obligations under this Article 8 shall not apply to amounts paid in settlement of any claim, demand, action or other proceeding if such settlement is effected without the prior express written consent of the Indemnitor, which consent shall not be unreasonably withheld or delayed. The failure to deliver notice to the Indemnitor within a reasonable time after notice of any such claim or demand, or the commencement of any such action or other proceeding, only to the extent actually prejudicial to its ability to defend such claim, demand, action or other proceeding, shall relieve such Indemnitor of any liability to the Indemnitee under this Article 8 with respect thereto, but the omission so to deliver notice to the Indemnitor shall not relieve it of any liability that it may have to the Indemnitee otherwise than under this Article 8. The Indemnitor may not settle or otherwise consent to an adverse judgment in any such claim, demand, action or other proceeding, that diminishes the rights or interests of the Indemnitee without the prior express written consent of the Indemnitee, which consent shall not be unreasonably withheld or delayed. The Indemnitee, its Affiliates, and all of their employees and agents, shall reasonably cooperate with the Indemnitor and its legal representatives in the investigation of any claim, demand, action or other proceeding covered by this Section 8. |
If the Parties cannot in good faith agree as to the application of Section 8.2 to any particular Claim, then each Party may the conduct its own defense of such Claim and reserves the right to claim indemnification (to the extent provided for in Section 8.2) from the other Party upon resolution of the underlying Claim. |
8.4 | Insurance. Each Party shall maintain insurance against all foreseeable risks and claims arising from its performance of activities licensed hereunder. | ||
8.5 | Limitation of Liability. EXCEPT TO THE EXTENT A PARTY MAY BE REQUIRED TO INDEMNIFY THE OTHER FOR AMOUNTS PAID TO |
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THIRD PARTIES OR AS REGARDS A BREACH OF A CONFIDENTIALITY OBLIGATION, NEITHER PARTY (NOR ITS AFFILIATES) SHALL BE LIABLE TO THE OTHER PARTY (NOR ITS AFFILIATES) FOR PUNITIVE, EXEMPLARY, MULTIPLIED OR CONSEQUENTIAL DAMAGES (SUCH AS LOST PROFITS, OPPORTUNITY COSTS, MISSED BUSINESS OPPORTUNITIES, OR OTHER THINGS CAUSED BUT NOT PROXIMATELY CAUSED BY ANY BREACH OR DEFAULT UNDER THIS AGREEMENT, WHETHER THE THEORY OF LIABILITY IS GROUNDED IN CONTRACT, TORT (INCLUDING NEGLIGENCE) PRODUCT LIABILITY OR OTHERWISE). EACH PARTY HEREBY IRREVOCABLY WAIVES ANY RIGHT TO SEEK SUCH DAMAGES. |
9.1 | Governing Law. This Agreement will be governed by the laws of [ * ] (without giving effect to its conflict of law rules and regulations). Any dispute shall be resolved by arbitration before the London Court of International Arbitration in accordance with the [ * ] applying the substantive law of [ * ] excluding conflicts of law rules. | ||
9.2 | Arbitration Procedure. | ||
Any controversy, dispute or claim which may arise out of or in connection with this Agreement, including the exhibits attached hereto, or the interpretation, enforceability, performance, breach, termination or validity thereof, including disputes relating to alleged breach or termination of the foregoing, but excluding any determination as to the infringement, validity or claim interpretation of Patents of each Party related to the subject matter hereof and/or the misuse and/or misappropriation of a Partys Information, (each a Dispute) shall be resolved by binding arbitration in accordance with the [ * ] except where this rules conflict with this provision, in which case this provision controls. The Arbitration shall be held in English and shall take place in London. The Dispute shall be construed in accordance with the laws of [ * ] exclusive of conflicts of law rules. The arbitration tribunal shall consist of three neutral arbitrators, each of whom shall be an attorney who (a) has at least fifteen (15) years of experience in the biopharmaceutical field in a law firm or corporate law department of over twenty-five (25) lawyers or (b) was a judge of a court of general jurisdiction. However: (X) at least one of the arbitrators must be an attorney described in clause (a) of the foregoing sentence; (Y) at least one of the arbitrators must be trained in [ * ] and have been admitted to practice in [ * ] ; and (Z) at least one of the arbitrators must be a native English speaker. The arbitrators shall be neutral, independent, disinterested, and impartial. Each Party shall nominate in the request for arbitration and the answer thereto one arbitrator and the two arbitrators so named will then jointly appoint the third arbitrator as chairman of the arbitration tribunal. After appointment, the Parties shall have no ex-parte communication with their proposed arbitrator. If one Party fails to nominate its arbitrator or, if the Parties arbitrators cannot agree on the person to be named as chairman within |
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[ * ] the President of the London Court of International Arbitration shall make the necessary appointments. Within [ * ] of initiation of arbitration, the Parties shall reach agreement upon and thereafter follow procedures assuring that the arbitration will be concluded and the award rendered within no more than eight months from selection of the arbitrators. Failing such agreement, the Arbitration Rules of the London Court of International Arbitration will control the procedures and scheduling and the Parties will follow procedures that meet such a time schedule. Each Party has the right before or, if the arbitrators cannot hear the matter within an acceptable period, during the arbitration to seek and obtain from the appropriate court provisional remedies such as attachment, preliminary injunction, replevin, etc., to avoid irreparable harm, maintain the status quo or preserve the subject matter of the arbitration. Any request for such provisional measures by a Party to a court shall not be deemed a waiver of this agreement to arbitrate. In addition, the Arbitrator Tribunal may, at the request of a Party, order provisional or conservatory measures (including, without limitation, preliminary injunctions to prevent breaches hereof) and the Parties shall be able to enforce the terms and provisions of such orders in any court having jurisdiction. The decision of the arbitration tribunal must be in writing and must specify the basis on which the decision was made, and 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. AS IS CONSISTENT WITH SECTION 8.5, THE ARBITRATOR SHALL BE EMPOWERED TO AND SHALL NOT AWARD ANY PARTY PUNITIVE, EXEMPLARY, MULTIPLIED OR CONSEQUENTIAL DAMAGES (SUCH AS LOST PROFITS, OPPORTUNITY COSTS, MISSED BUSINESS OPPORTUNITIES, OR OTHER THINGS CAUSED BUT NOT PROXIMATELY CAUSED BY ANY BREACH OR DEFAULT UNDER THIS AGREEMENT, WHETHER THE THEORY OF LIABILITY IS GROUNDED IN CONTRACT, TORT (INCLUDING NEGLIGENCE) PRODUCT LIABILITY OR OTHERWISE), AND EACH PARTY HEREBY IRREVOCABLY WAIVES ANY RIGHT TO SEEK SUCH DAMAGES. NO PARTY MAY SEEK OR OBTAIN PREJUDGMENT INTEREST OR ATTORNEYS FEES OR COSTS. |
9.3 | Notice and Reports. All notices required by this Agreement shall be in writing. All notices and reports shall be sent by fax followed by overnight courier to the Parties at the following addresses or such other addresses as may be designated in writing by the respective Parties: |
To RBNV: | Rhein Biotech NV | |||||||
Oude Maasstraat 47, | ||||||||
NL 6229 BC Maastricht, | ||||||||
The Netherlands | ||||||||
[ * ] | ||||||||
To RBG: | Rhein Biotech GmbH |
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Eichsfelder Strasse 11 Dusseldorf 40595 |
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Germany | ||||||||
[ * ] | ||||||||
To Dynavax: | Dynavax Technologies Corporation 2929 Seventh Street, Suite 100 Berkeley, CA 94710 USA |
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[ * ] | ||||||||
ATTN: CEO | ||||||||
With a required copy to Dynavax at the same | ||||||||
address and fax, to ATTN: LEGAL | ||||||||
DEPARTMENT. |
9.4 | Priority of Agreement. The Parties agree and acknowledge that this Agreement supersedes any and all prior written or oral agreements between the Parties and any of their affiliates concerning the subject matter of this Agreement. In particular, this Agreement supersedes the Letter of Intent in all respects regarding the subject matter of this Agreement. The Letter of Intent shall not be used to interpret or deemed to limit or modify the terms of this Agreement. However, the Confidentiality Agreement will remain in effect and will not be superseded by this Agreement; provided, however, that information exchanged between the Parties (with each Party for this purpose being deemed to include its Affiliates) shall be deemed exchanged under the Confidentiality Agreement) and protected thereunder; and provided, further, that notwithstanding any restriction on use stated in such Confidentiality Agreement, the right of a Party and its Affiliates to use items of confidential information, materials and know-how as stated in this Agreement shall not be restricted by such Confidentiality Agreement within the scope of a right or license granted hereunder to such Party and its Affiliates and instead the Parties (and their Affiliates) rights stated in this Agreement shall prevail. This Agreement and the Exclusive License Agreement between Green Cross and RBG and the Trademark Assignment Agreement both signed on the Closing Date together state the Parties entire agree |