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Delaware
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51-0596811
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(State or Other Jurisdiction of
Incorporation or Organization)
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(IRS Employer
Identification No.)
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100 Acorn Park Drive
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Cambridge, Massachusetts
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02140
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(Address of Principal Executive Offices)
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(Zip Code)
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Large accelerated filer
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¨
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Accelerated filer
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x
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Non-accelerated filer
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¨
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(Do not check if a smaller reporting company)
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Smaller reporting company
|
¨
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•
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the timing of results of our ongoing and planned clinical trials;
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•
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our planned clinical trials for GEN-003;
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•
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our estimates regarding the amount of funds we require to complete our clinical trials for GEN-003 and to continue our investments in immuno-oncology;
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•
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our estimate for when we will require additional funding;
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•
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our plans to commercialize GEN-003 and our other vaccine candidates;
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•
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the timing of, and our ability to, obtain and maintain regulatory approvals for our product candidates;
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•
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the rate and degree of market acceptance and clinical utility of any approved product candidate;
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•
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the potential benefits of strategic partnership agreements and our ability to enter into strategic partnership arrangements;
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•
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our ability to quickly and efficiently identify and develop product candidates;
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•
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our commercialization, marketing and manufacturing capabilities and strategy;
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•
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our intellectual property position; and
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•
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our estimates regarding expenses, future revenues, capital requirements, the sufficiency of our current and expected cash resources and our need for additional financing.
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Page
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September 30, 2016
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|
December 31, 2015
|
||||
Assets
|
|
|
|
|
|
||
Current assets:
|
|
|
|
|
|
||
Cash and cash equivalents
|
$
|
26,417
|
|
|
$
|
17,259
|
|
Investments, current portion
|
49,044
|
|
|
77,069
|
|
||
Prepaid expenses and other current assets
|
950
|
|
|
865
|
|
||
Total current assets
|
76,411
|
|
|
95,193
|
|
||
Property and equipment, net
|
5,034
|
|
|
4,083
|
|
||
Restricted cash
|
316
|
|
|
316
|
|
||
Investments, net of current portion
|
—
|
|
|
12,104
|
|
||
Other non-current assets
|
1,108
|
|
|
446
|
|
||
Total assets
|
$
|
82,869
|
|
|
$
|
112,142
|
|
|
|
|
|
|
|
||
Liabilities and stockholders’ equity
|
|
|
|
|
|
||
Current liabilities:
|
|
|
|
|
|
||
Accounts payable
|
$
|
1,888
|
|
|
$
|
1,757
|
|
Accrued expenses and other current liabilities
|
3,641
|
|
|
3,975
|
|
||
Deferred revenue
|
—
|
|
|
235
|
|
||
Current portion of long-term debt
|
1,559
|
|
|
—
|
|
||
Total current liabilities
|
7,088
|
|
|
5,967
|
|
||
Non-current liabilities:
|
|
|
|
|
|
||
Long-term debt
|
15,274
|
|
|
16,477
|
|
||
Other non-current liabilities
|
158
|
|
|
37
|
|
||
Total liabilities
|
22,520
|
|
|
22,481
|
|
||
Commitments and contingencies (Note 5)
|
|
|
|
|
|
||
Stockholders’ equity:
|
|
|
|
|
|
||
Preferred stock
|
—
|
|
|
—
|
|
||
Common stock
|
28
|
|
|
28
|
|
||
Additional paid-in-capital
|
251,762
|
|
|
247,550
|
|
||
Accumulated other comprehensive income (loss)
|
8
|
|
|
(7
|
)
|
||
Accumulated deficit
|
(191,449
|
)
|
|
(157,910
|
)
|
||
Total stockholders’ equity
|
60,349
|
|
|
89,661
|
|
||
Total liabilities and stockholders’ equity
|
$
|
82,869
|
|
|
$
|
112,142
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Grant revenue
|
$
|
—
|
|
|
$
|
213
|
|
|
$
|
235
|
|
|
$
|
449
|
|
|
|
|
|
|
|
|
|
||||||||
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development
|
8,811
|
|
|
6,058
|
|
|
22,821
|
|
|
21,536
|
|
||||
General and administrative
|
3,619
|
|
|
3,645
|
|
|
11,569
|
|
|
10,206
|
|
||||
Refund of research and development expense
|
—
|
|
|
—
|
|
|
(1,592
|
)
|
|
—
|
|
||||
Total operating expenses
|
12,430
|
|
|
9,703
|
|
|
32,798
|
|
|
31,742
|
|
||||
Loss from operations
|
(12,430
|
)
|
|
(9,490
|
)
|
|
(32,563
|
)
|
|
(31,293
|
)
|
||||
Other income and expense:
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income
|
103
|
|
|
39
|
|
|
323
|
|
|
70
|
|
||||
Interest expense
|
(438
|
)
|
|
(320
|
)
|
|
(1,299
|
)
|
|
(946
|
)
|
||||
Total other income and expense
|
(335
|
)
|
|
(281
|
)
|
|
(976
|
)
|
|
(876
|
)
|
||||
Net loss
|
$
|
(12,765
|
)
|
|
$
|
(9,771
|
)
|
|
$
|
(33,539
|
)
|
|
$
|
(32,169
|
)
|
Other comprehensive income (loss):
|
|
|
|
|
|
|
|
|
|
|
|
||||
Unrealized (loss) gain on available-for-sale securities
|
(9
|
)
|
|
10
|
|
|
15
|
|
|
24
|
|
||||
Comprehensive loss
|
$
|
(12,774
|
)
|
|
$
|
(9,761
|
)
|
|
$
|
(33,524
|
)
|
|
$
|
(32,145
|
)
|
Net loss per share - basic and diluted
|
$
|
(0.45
|
)
|
|
$
|
(0.37
|
)
|
|
$
|
(1.18
|
)
|
|
$
|
(1.38
|
)
|
Weighted-average number of common shares used in computing net loss per share
|
28,370
|
|
|
26,610
|
|
|
28,267
|
|
|
23,228
|
|
|
Nine Months Ended September 30,
|
||||||
|
2016
|
|
2015
|
||||
Operating activities
|
|
|
|
|
|
||
Net loss
|
$
|
(33,539
|
)
|
|
$
|
(32,169
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities
|
|
|
|
|
|
||
Depreciation and amortization
|
1,309
|
|
|
661
|
|
||
Stock-based compensation
|
3,113
|
|
|
2,824
|
|
||
Net amortization of premium on investments
|
—
|
|
|
25
|
|
||
Non-cash interest expense
|
356
|
|
|
269
|
|
||
Changes in operating assets and liabilities
|
(1,342
|
)
|
|
17
|
|
||
Net cash used in operating activities
|
(30,103
|
)
|
|
(28,373
|
)
|
||
Investing activities
|
|
|
|
|
|
||
Purchases of property and equipment
|
(1,968
|
)
|
|
(1,849
|
)
|
||
Proceeds from maturities of investments
|
58,891
|
|
|
16,000
|
|
||
Purchases of investments
|
(18,755
|
)
|
|
(58,698
|
)
|
||
Net cash provided by (used in) investing activities
|
38,168
|
|
|
(44,547
|
)
|
||
Financing activities
|
|
|
|
|
|
||
Proceeds from equity offerings, net of issuance costs
|
815
|
|
|
95,216
|
|
||
Proceeds from exercise of stock options
|
166
|
|
|
354
|
|
||
Proceeds from the issuance of common stock under ESPP
|
112
|
|
|
119
|
|
||
Net cash provided by financing activities
|
1,093
|
|
|
95,689
|
|
||
Net increase in cash and cash equivalents
|
$
|
9,158
|
|
|
$
|
22,769
|
|
Cash and cash equivalents at beginning of period
|
17,259
|
|
|
20,058
|
|
||
Cash and cash equivalents at end of period
|
$
|
26,417
|
|
|
$
|
42,827
|
|
Supplemental cash flow information
|
|
|
|
|
|
||
Cash paid for interest
|
$
|
943
|
|
|
$
|
661
|
|
Property and equipment included in accounts payable and accrued expenses
|
$
|
293
|
|
|
$
|
531
|
|
•
|
Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
|
•
|
Level 2—Valuations based on quoted prices for similar assets or liabilities in markets that are not active or for which all significant inputs are observable, either directly or indirectly.
|
•
|
Level 3—Valuations that require inputs that reflect the Company’s own assumptions that are both significant to the fair value measurement and unobservable.
|
Standard
|
|
Description
|
|
Effect on the financial statements
|
ASU 2016-09,
Compensation — Stock Compensation (Topic 718)
|
|
In March 2016, the FASB issued ASU 2016-09, which provides for improvements to employee share-based payment accounting. The areas for simplification in this update involve several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows.
ASU 2016-09 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2016.
|
|
The Company early adopted ASU 2016-09 as of June 30, 2016. In connection with the early adoption, the Company elected an accounting policy to record forfeitures as they occur. There was no financial statement impact upon adoption as the Company had estimated a forfeiture rate of zero given that most options awards vest on a monthly basis. ASU 2016-09 also provides that companies no longer record excess tax benefits or certain tax deficiencies in additional paid-in capital (APIC). Instead, all excess tax benefits and tax deficiencies are recorded as income tax expense or benefit in the income statement. There was no financial statement impact of adopting this provision of the ASU as the Company is in a net operating loss (NOL) position and all excess tax benefits that exist from options previously exercised require a full valuation allowance. As such, the adoption of this standard did not have a material impact on the financial statements.
For the nine month period ending September 30, 2016, the Company did not record an income statement benefit for excess tax benefits as a valuation allowance is also required on these amounts.
|
Standard
|
|
Description
|
|
Effect on the financial statements
|
ASU 2014-09,
Revenue from Contracts with Customers (Topic 606)
|
|
The standard will replace existing revenue recognition standards and significantly expand the disclosure requirements for revenue arrangements. It may be adopted either retrospectively or on a modified retrospective basis to new contracts and existing contracts with remaining performance obligations as of the effective date.
In July 2015, the FASB affirmed its proposal to defer the effective date of the new revenue standard for all entities by one year. As a result, public business entities will be required to apply the new revenue standard to annual reporting periods beginning after December 15, 2017. The standard will become effective for us on January 1, 2018 (the first quarter of our 2018 fiscal year).
|
|
At this time, the Company has not decided on which method it will use to adopt the new standard, nor has it determined the effects of the new guidelines on its results of operations and financial position as the Company does not currently have any arrangements that would be impacted by the new standard. As a result, the Company is continuing to evaluate the method of adoption and the impact of this standard on its consolidated financial statements.
|
ASU 2014-15,
Presentation of Financial Statements — Going Concern (Subtopic 205-40)
|
|
In August 2014, the FASB issued ASU 2014-15, Disclosures of Uncertainties about an Entity’s Ability to Continue as a Going Concern. The standard requires an evaluation of whether there are conditions or events, considered in the aggregate, that raise substantial doubt about an entity’s ability to continue as a going concern. Substantial doubt about an entity’s ability to continue as a going concern exists when relevant conditions and events, considered in the aggregate, indicate that it is probable that the entity will be unable to meet its obligations as they become due within one year after the date that the financial statements are issued.
ASU 2014-15 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2016.
|
|
Management has evaluated ASU 2014-15 and believes it could have an impact on the Company’s financial statement disclosures in future reporting periods. Refer to the Liquidity section in Footnote 1 for further details regarding the Company’s liquidity.
|
ASU 2016-02,
Leases (Topic 842)
|
|
In February 2016, the FASB issued ASU 2016-02, which replaces the existing lease accounting standards.
The new standard requires a dual approach for lessee accounting under which a lessee would account for leases as finance (also referred to as capital) leases or operating leases. Both finance leases and operating leases will result in the lessee recognizing a right-of-use asset and corresponding lease liability. For finance leases the lessee would recognize interest expense and amortization of the right-of-use asset and for operating leases the lessee would recognize straight-line total lease expense.
ASU 2016-02 is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018.
|
|
The Company generally does not finance purchases of equipment but it does lease office and lab facilities. The Company is in the process of evaluating the effect that this ASU will have on its consolidated financial statements and related disclosures.
|
|
|
|
Quoted prices in active markets
|
|
Significant other observable inputs
|
|
Significant unobservable inputs
|
||||||||
|
Total
|
|
(Level 1)
|
|
(Level 2)
|
|
(Level 3)
|
||||||||
September 30, 2016
|
|
|
|
|
|
|
|
||||||||
Money market funds, included in cash equivalents
|
$
|
24,460
|
|
|
$
|
24,460
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Investments - U.S treasuries
|
16,523
|
|
|
16,523
|
|
|
—
|
|
|
—
|
|
||||
Investments - certificates of deposit
|
32,521
|
|
|
—
|
|
|
32,521
|
|
|
—
|
|
||||
Total
|
$
|
73,504
|
|
|
$
|
40,983
|
|
|
$
|
32,521
|
|
|
$
|
—
|
|
|
|
|
|
|
|
|
|
||||||||
December 31, 2015
|
|
|
|
|
|
|
|
||||||||
Money market funds, included in cash equivalents
|
$
|
14,207
|
|
|
$
|
14,207
|
|
|
$
|
—
|
|
|
$
|
—
|
|
U.S treasuries, included in cash equivalents
|
2,203
|
|
|
2,203
|
|
|
—
|
|
|
—
|
|
||||
Investments - U.S. treasuries
|
27,924
|
|
|
27,924
|
|
|
—
|
|
|
—
|
|
||||
Investments - certificates of deposit
|
61,249
|
|
|
—
|
|
|
61,249
|
|
|
—
|
|
||||
Total
|
$
|
105,583
|
|
|
$
|
44,334
|
|
|
$
|
61,249
|
|
|
$
|
—
|
|
|
Contracted
Maturity |
|
Amortized
Cost |
|
Unrealized
Gains |
|
Unrealized
Losses |
|
Fair Value
|
||||||||
U.S. Treasuries
|
123-273 days
|
|
$
|
16,515
|
|
|
$
|
8
|
|
|
$
|
—
|
|
|
$
|
16,523
|
|
Certificates of deposit
|
3-182 days
|
|
32,521
|
|
|
—
|
|
|
—
|
|
|
32,521
|
|
||||
Total
|
|
|
$
|
49,036
|
|
|
$
|
8
|
|
|
$
|
—
|
|
|
$
|
49,044
|
|
|
September 30,
2016 |
||
2016
|
$
|
—
|
|
2017
|
3,149
|
|
|
2018
|
6,659
|
|
|
2019
|
8,034
|
|
|
Total
|
$
|
17,842
|
|
|
September 30, 2016
|
||
2016
|
$
|
316
|
|
2017
|
1,550
|
|
|
2018
|
1,607
|
|
|
2019
|
1,637
|
|
|
2020
|
274
|
|
|
Total
|
$
|
5,384
|
|
|
Nine Months Ended September 30,
|
||||
|
2016
|
|
2015
|
||
Warrants
|
78
|
|
|
78
|
|
Outstanding options
|
3,794
|
|
|
2,716
|
|
Outstanding ESPP
|
21
|
|
|
13
|
|
Total
|
3,893
|
|
|
2,807
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Research and development
|
$
|
428
|
|
|
$
|
380
|
|
|
$
|
1,234
|
|
|
$
|
1,245
|
|
General and administrative
|
691
|
|
|
498
|
|
|
1,879
|
|
|
1,579
|
|
||||
Total
|
$
|
1,119
|
|
|
$
|
878
|
|
|
$
|
3,113
|
|
|
$
|
2,824
|
|
|
Shares
|
|
Weighted-
Average Exercise Price |
|
Weighted-
Average Remaining Contractual Term (years) |
|
Aggregate
Intrinsic Value |
|||||
Outstanding at December 31, 2015
|
2,723
|
|
|
$
|
7.60
|
|
|
7.61
|
|
$
|
2,840
|
|
Granted
|
1,472
|
|
|
$
|
3.51
|
|
|
|
|
|
|
|
Exercised
|
(56
|
)
|
|
$
|
2.96
|
|
|
|
|
|
|
|
Canceled
|
(345
|
)
|
|
$
|
8.46
|
|
|
|
|
|
|
|
Outstanding at September 30, 2016
|
3,794
|
|
|
$
|
6.01
|
|
|
7.74
|
|
$
|
4,708
|
|
Exercisable at September 30, 2016
|
1,763
|
|
|
$
|
6.09
|
|
|
6.47
|
|
$
|
2,627
|
|
Vested or expected to vest at September 30, 2016
|
3,794
|
|
|
$
|
6.01
|
|
|
7.74
|
|
$
|
4,708
|
|
|
Placebo
|
60 µg per protein /
50 µg of Matrix-M2
|
60 µg per protein /
75 µg of Matrix-M2
|
||||
Endpoint
|
Post dose 3
|
Post dose 3
|
6 months
|
12 months
|
Post dose 3
|
6 months
|
12 months
|
Viral shedding rate reduction
(1)
|
-4%
|
41%
|
47%
|
66%
|
55%
|
58%
|
55%
|
Poisson mixed effect model (Old Model)
(2)
|
|
|
|
|
|
|
|
p-value vs baseline
|
0.48
|
<0.0001
|
<0.0001
|
<0.0001
|
<0.0001
|
<0.0001
|
<0.0001
|
p-value vs placebo
|
NA
|
<0.0001
|
NA
|
NA
|
<0.0001
|
NA
|
NA
|
Poisson mixed effect model with Empirical Variance
(New Model)
(3)
|
|
|
|
|
|
|
|
p-value vs baseline
|
0.88
|
0.01
|
0.0004
|
<0.0001
|
0.006
|
<0.0001
|
0.01
|
p-value vs placebo
|
NA
|
0.04
|
NA
|
NA
|
0.01
|
NA
|
NA
|
% patients lesion free
|
NA
|
68%
|
36%
|
30%
|
68%
|
30%
|
21%
|
Genital lesion rate reduction
(1)
|
60%
|
69%
|
50%
|
65%
|
60%
|
43%
|
47%
|
Poisson mixed effect model (Old Model)
(2)
|
|
|
|
|
|
|
|
p-value vs baseline
|
<0.0001
|
<0.0001
|
<0.0001
|
<0.0001
|
<0.0001
|
<0.0001
|
<0.0001
|
p-value vs placebo
|
NA
|
0.3
|
NA
|
NA
|
0.79
|
NA
|
NA
|
Poisson mixed effect model with Empirical Variance
(New Model) (3) |
|
|
|
|
|
|
|
p-value vs baseline
|
0.0002
|
0.0005
|
0.01
|
0.003
|
0.02
|
0.03
|
0.02
|
p-value vs placebo
|
NA
|
0.59
|
NA
|
NA
|
0.85
|
NA
|
NA
|
|
Placebo
|
60/50 Dose
|
60/75 Dose
|
Viral shedding rate reduction
(1)
|
6%
|
-40%
|
-27%
|
Poisson mixed effect model with Empirical Variance
(New Model) (2)(3) |
|
|
|
p-value vs. baseline
|
0.76
|
0.03
|
0.16
|
p-value vs. placebo
|
NA
|
0.05
|
0.20
|
•
|
personnel-related expenses, including salaries, benefits, stock-based compensation expense and travel;
|
•
|
expenses incurred under agreements with contract research organizations ("CROs"), contract manufacturing organizations ("CMOs"), consultants and other vendors that conduct our clinical trials and preclinical activities;
|
•
|
costs of acquiring, developing and manufacturing clinical trial materials and lab supplies; and
|
•
|
facility costs, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other supplies.
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
||||||||||||
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
Genital herpes (GEN-003)(1)
|
$
|
4,979
|
|
|
$
|
2,955
|
|
|
$
|
11,339
|
|
|
$
|
12,582
|
|
Other research and development (2)
|
3,832
|
|
|
3,103
|
|
|
11,482
|
|
|
8,954
|
|
||||
Total research and development
|
$
|
8,811
|
|
|
$
|
6,058
|
|
|
$
|
22,821
|
|
|
$
|
21,536
|
|
(1)
|
Includes direct and indirect internal costs and external costs such as CMO and CRO costs.
|
(2)
|
Includes costs related to other product candidates and certain technology platform development costs related to ATLAS. Additionally, costs that are not specifically allocated by project including facilities costs, depreciation expense, and non-project specific costs incurred by R&D personnel, are included in this line item.
|
|
Three Months Ended
September 30, |
|
Increase
|
||||||||
(in thousands)
|
2016
|
|
2015
|
|
(Decrease)
|
||||||
Grant revenue
|
$
|
—
|
|
|
$
|
213
|
|
|
$
|
(213
|
)
|
|
|
|
|
|
|
||||||
Operating expenses:
|
|
|
|
|
|
|
|||||
Research and development
|
8,811
|
|
|
6,058
|
|
|
2,753
|
|
|||
General and administrative
|
3,619
|
|
|
3,645
|
|
|
(26
|
)
|
|||
Total operating expenses
|
12,430
|
|
|
9,703
|
|
|
2,727
|
|
|||
Loss from operations
|
(12,430
|
)
|
|
(9,490
|
)
|
|
(2,940
|
)
|
|||
Other income and expenses:
|
|
|
|
|
|
||||||
Interest income
|
103
|
|
|
39
|
|
|
64
|
|
|||
Interest expense
|
(438
|
)
|
|
(320
|
)
|
|
(118
|
)
|
|||
Total other income and expense
|
(335
|
)
|
|
(281
|
)
|
|
(54
|
)
|
|||
Net loss
|
$
|
(12,765
|
)
|
|
$
|
(9,771
|
)
|
|
$
|
(2,994
|
)
|
|
Nine Months Ended
September 30, |
|
Increase
|
||||||||
(in thousands)
|
2016
|
|
2015
|
|
(Decrease)
|
||||||
Grant revenue
|
$
|
235
|
|
|
$
|
449
|
|
|
$
|
(214
|
)
|
|
|
|
|
|
|
||||||
Operating expenses:
|
|
|
|
|
|
|
|||||
Research and development
|
22,821
|
|
|
21,536
|
|
|
1,285
|
|
|||
General and administrative
|
11,569
|
|
|
10,206
|
|
|
1,363
|
|
|||
Refund of research and development expense
|
(1,592
|
)
|
|
—
|
|
|
(1,592
|
)
|
|||
Total operating expenses
|
32,798
|
|
|
31,742
|
|
|
1,056
|
|
|||
Loss from operations
|
(32,563
|
)
|
|
(31,293
|
)
|
|
(1,270
|
)
|
|||
Other income and expenses:
|
|
|
|
|
|
|
|
|
|||
Interest income
|
323
|
|
|
70
|
|
|
253
|
|
|||
Interest expense
|
(1,299
|
)
|
|
(946
|
)
|
|
(353
|
)
|
|||
Total other income and expense
|
(976
|
)
|
|
(876
|
)
|
|
(100
|
)
|
|||
Net loss
|
$
|
(33,539
|
)
|
|
$
|
(32,169
|
)
|
|
$
|
(1,370
|
)
|
•
|
the timing and costs of our ongoing and planned clinical trials for GEN-003;
|
•
|
the progress, timing and costs of manufacturing GEN-003 for current and planned clinical trials;
|
•
|
the initiation, progress, timing, costs and results of preclinical studies and clinical trials for our other product candidates and potential product candidates;
|
•
|
the outcome, timing and costs of seeking regulatory approvals;
|
•
|
the costs of commercialization activities for GEN-003 and other product candidates if we receive marketing approval, including the costs and timing of establishing product sales, marketing, distribution and manufacturing capabilities;
|
•
|
the receipt of marketing approval;
|
•
|
revenue received from commercial sales of our product candidates;
|
•
|
the terms and timing of any future collaborations, grants, licensing, consulting or other arrangements that we may establish;
|
•
|
the amount and timing of any payments we may be required to make, or that we may receive, in connection with the licensing, filing, prosecution, defense and enforcement of any patents or other intellectual property rights, including milestone and royalty payments and patent prosecution fees that we are obligated to pay pursuant to our license agreements;
|
•
|
the costs of preparing, filing and prosecuting patent applications, maintaining and protecting our intellectual property rights and defending against intellectual property related claims; and
|
•
|
the extent to which we in-license or acquire other products and technologies.
|
|
Nine Months Ended September 30,
|
||||||
|
2016
|
|
2015
|
||||
Net cash used in operating activities
|
$
|
(30,103
|
)
|
|
$
|
(28,373
|
)
|
Net cash provided by (used in) investing activities
|
38,168
|
|
|
(44,547
|
)
|
||
Net cash provided by financing activities
|
1,093
|
|
|
95,689
|
|
||
Net increase in cash and cash equivalents
|
$
|
9,158
|
|
|
$
|
22,769
|
|
Exhibit
Number
|
|
Exhibit
|
|
|
|
10.1*
|
|
Amended and Restated Exclusive License Agreement between Children’s Medical Center Corporation and Genocea Biosciences, Inc., dated March 23, 2012.
|
|
|
|
10.2*
|
|
Amended and Restated License Agreement between Genocea Biosciences, Inc. and President and Fellows of Harvard College, dated November 19, 2013.
|
|
|
|
10.3*
|
|
License and Collaboration Agreement between Genocea Biosciences, Inc. and Isconova AB, dated August 5, 2009, as amended on March 19, 2010, June 18, 2010, August 17, 2010, October 19, 2011, February 6, 2012 and October 21, 2014.
|
|
|
|
10.4*
|
|
Exclusive License Agreement for Escherichia Coli K12 to Deliver Protein to the Macrophage Cytosol between Genocea Biosciences, Inc. and the Regents of the University of California, dated August 18, 2006.
|
|
|
|
31.1
|
|
Certification pursuant to Section 302 of Sarbanes Oxley Act of 2002 by Chief Executive Officer
|
|
|
|
31.2
|
|
Certification pursuant to Section 302 of Sarbanes Oxley Act of 2002 by Chief Financial Officer
|
|
|
|
32.1
|
|
Certification of periodic financial report pursuant to Section 906 of Sarbanes Oxley Act of 2002 by Chief Executive Officer
|
|
|
|
32.2
|
|
Certification of periodic financial report pursuant to Section 906 of Sarbanes Oxley Act of 2002 by Chief Financial Officer
|
|
|
|
101
|
|
The following materials from the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Consolidated Balance Sheets as of September 30, 2016 and December 31, 2015, (ii) Condensed Consolidated Statements of Operations and Comprehensive Income for the three and nine months ended September 30, 2016 and 2015, (iii) Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2016 and 2015 and (iv) Notes to Unaudited Condensed Consolidated Financial Statements
|
|
Genocea Biosciences, Inc.
|
|
|
|
|
Date: November 4, 2016
|
By:
|
/s/ WILLIAM D. CLARK
|
|
|
William D. Clark
|
|
|
President and Chief Executive Officer and Director
(Principal Executive Officer)
|
|
|
|
Date: November 4, 2016
|
By:
|
/s/ JONATHAN POOLE
|
|
|
Jonathan Poole
|
|
|
Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)
|
ARTICLE I.
|
DEFINITIONS 3
|
ARTICLE II.
|
GRANT 9
|
ARTICLE III.
|
DUE DILIGENCE AND RELATED MATTERS 15
|
ARTICLE IV.
|
ROYALTIES AND OTHER PAYMENTS 17
|
ARTICLE V.
|
REPORTS, RECORDS AND RELATED MATTERS 20
|
ARTICLE VI.
|
PATENT PROSECUTION 23
|
ARTICLE VII.
|
INFRINGEMENT 25
|
ARTICLE VIII.
|
UNIFORM INDEMNIFICATION AND INSURANCE PROVISIONS 27
|
ARTICLE IX.
|
COMPLIANCE WITH LAWS; EXPORT CONTROLS 30
|
ARTICLE X.
|
NON-USE OF NAMES AND PUBLICATIONS 31
|
ARTICLE XI.
|
ASSIGNMENT 31
|
ARTICLE XII.
|
DISPUTE RESOLUTION AND ARBITRATION 32
|
ARTICLE XIII.
|
TERM AND TERMINATION 33
|
ARTICLE XIV.
|
OWNERSHIP 35
|
ARTICLE XV.
|
PAYMENTS, NOTICES, AND OTHER COMMUNICATIONS 35
|
ARTICLE XVI.
|
GENERAL PROVISIONS 36
|
ARTICLE XVII.
|
CONFIDENTIALITY 38
|
ARTICLE I.
|
DEFINITIONS
|
A.
|
"Affiliate" shall mean any company or other legal entity actually controlling, controlled by or under common control with a Party. For purposes of the definition of "Affiliate" the term "control" shall mean: (i) in the case of a corporate entity, the ability to effect the election of directors, or in the case of a for-profit entity direct or indirect ownership of at least a majority of the stock or participating shares entitled to vote for the election of directors of that entity, in any case coupled with active managerial involvement and accountability for directing the business and affairs of that entity; (ii) in the case of a partnership, the power customarily held by a managing partner to direct the management and policies of such partnership, provided that such power is actively exercised; or (iii) in the case of a joint venture, whether in corporate, partnership or other legal form, a prevailing joint economic interest coupled with a managerial role entailing active direction, control and accountability with respect to the business and affairs of the entity.
|
B.
|
"Chargeback Payments" shall mean payments made by Licensee, its Affiliates, its agents, or its Sublicensees to wholesalers to cover the difference between the
|
C.
|
"Combination Product(s) or Process(es)" shall mean a product or process that includes a Licensed Product or Licensed Process sold in combination with another component(s) whose manufacture, use or sale by an unlicensed party would not constitute an infringement of the Patent Rights licensed in this Agreement.
|
D.
|
"Commercially Reasonable Efforts" shall mean, with respect to the efforts to be expended by Licensee to any objective for maintaining the priority of rapid and effective development, Licensee shall use diligent efforts and resources consistent with practices used in the Licensee's industry for a product which is of similar commercial potential at a similar state in its development or product life, taking into account issues of efficacy, safety, market size, the competitiveness of alternative products in the marketplace, any legal or technical difficulties directly related to such product development, the patent and other proprietary position of the product, regulatory approvals, and the actual and/or projected profitability of the product. It is understood that, for the purposes of this definition of "Commercially Reasonable Efforts", the commercial potential of a product may change from time to time based upon certain changing considerations, including without limitation changing scientific, business, marketing and return on investment considerations.
|
E.
|
"Developing Countries" shall mean (i) those countries identified by the World Bank as of June 19, 2008 as having "low income economies" or "lower-middle income economies" and (ii) Argentina, Brazil, Chile, Mexico, and South Africa, provided these five countries specifically listed herein are not reclassified as "high
|
F.
|
"Fair Market Value" shall mean, with respect to a valuation required by any provision of this Agreement, the price which a willing buyer would pay, on an arm's length basis, for all rights and related intellectual property assets which comprise the assets, data, or rights being valued, in light of all relevant factors including, without limitation, the status of development and reasonably anticipated risks and costs of further development and the market potential for the commercialization of such assets, data or rights. In any case where Fair Market Value must be determined but is not determined by good faith negotiations between the Parties in sixty (60) days, the determination will be made by an independent third party accounting firm to be mutually agreed upon by the Parties. In the event that the Parties cannot agree upon an independent third party accounting firm within twenty (20) days, Fair Market Value will be determined by a panel of three (3) independent third party accounting firms, one chosen by Licensee, one chosen by CMCC and one chosen at the mutual agreement of the two chosen firms. Any such determination will be binding and conclusive upon the Parties and the Parties will split the costs of such determination.
|
G.
|
"Field of Use" shall mean the prevention and treatment of
Streptococcus
pneumoniae
.
|
H.
|
"First Commercial Sale" shall mean, with respect to each country: (i) the first sale of any Licensed Product or Licensed Process by Licensee or any Sublicensee, following approval of such Licensed Product's or Licensed Process's marketing by the appropriate governmental agency, if any such approval is necessary, for the country in which the sale is to be made; or (ii) when governmental approval is not required, the first sale by Licensee or any Sublicensee in that country of the Licensed Product or Licensed Process.
|
I.
|
"Licensed Product" shall mean:
|
1.
|
Any product or part thereof in the Field of Use the manufacture, use or sale of which is covered by any Valid Claim in the country in which it is manufactured, used or sold; or
|
2.
|
Any product or part thereof in the Field of Use the manufacture or use of which uses a "Licensed Process" as that term shall be defined hereafter; or
|
3.
|
Any service provided for or on behalf of a third party on a fee-for-service basis that entails the practice of a Licensed Process.
|
J.
|
"Licensed Process" shall mean any process the practice of which is covered by any Valid Claim.
|
K.
|
"Licensee" shall mean Licensee and its successors and assignees permitted by this Agreement (including Affiliates where they are assignees permitted by this Agreement).
|
L.
|
"Net Sales" shall mean the gross amounts recognized for sales, leases, or other transfers of Licensed Products by Licensee, its Affiliates, its agents, or its Sublicensees for any Licensed Products to a final customer who will be an end user of the Licensed Product and is not an Affiliate or Sublicensee, in accordance with generally accepted accounting principles or the then-current internal accounting standard used by the Licensee and/or its Affiliates, less the following amounts (if not previously deducted from gross amounts invoiced):
|
1.
|
credits and allowances for price adjustment, rejection, uncollectible amounts or return of Licensed Products previously sold;
|
2.
|
Chargeback Payments, fees, rebates, and quantity and cash discounts to purchasers allowed and taken, including, without limitation, payments made to buying groups;
|
3.
|
amounts for third party transportation, insurance, handling or shipping charges to purchasers;
|
4.
|
taxes, duties and other governmental charges levied on or measured by the sale of Licensed Products, whether absorbed by Licensee or paid by the purchaser so long as Licensee's price is reduced thereby, but not franchise or income taxes of any kind whatsoever;
|
5.
|
for any sale in which the United States government, on the basis of its royalty-free license pursuant to 35 USC Sec. 202(c) to any Patent Right, requires that the gross sales price of any Licensed Product subject to such Patent Right, be reduced by the amount of such royalty owed Licensor, the amount of such royalty.
|
M.
|
"Patent Rights" shall mean all of the following intellectual property which CMCC owns or has rights to during the Term of this Agreement as hereafter defined:
|
1.
|
The United States and foreign patent applications listed in Appendix 1 attached hereto and incorporated herein by reference and divisionals and continuations thereof.
|
2.
|
The United States and foreign patents issued from the applications listed in Appendix 1 and from divisionals and continuations of those applications.
|
3.
|
Claims of United States and foreign continuation-in-part applications, and of the resulting patents, which are directed to the subject matter specifically described in the United States and foreign patent applications described in Appendix 1.
|
4.
|
Claims of all later filed foreign patent applications, and of the resulting patents, which are directed to the subject matter specifically described in the United States patent and/or patent applications described in subparagraphs 1, 2 or 3 of this ARTICLE I, Paragraph M.
|
5.
|
Any reissues, divisions, amendments or extensions of the United States or foreign patents described in subparagraphs 1, 2, 3 or 4 of this ARTICLE I, Paragraph M.
|
N.
|
"PVS License" shall mean the non-exclusive license granted by CHB to PVS pursuant to the Collaboration Agreement, as attached and incorporated herein as Appendix 4. Such rights to PVS include a non-exclusive royalty-free license, with the right to sublicense, to (i) develop, make or have made, and use a pneumococcal T cell based protein vaccine in the world and (ii) use market,
|
O.
|
"Sublicensee" shall mean a person or entity unaffiliated with Licensee to whom Licensee has granted an arm's length sublicense under this Agreement.
|
P.
|
"Sublicensee Payments" shall mean any payments received by Licensee from a Sublicensee (whether in the form of cash, Fair Market Value of cash equivalents or Fair Market Value of securities of Sublicensee or any other third party) in consideration of permitting the Sublicensee to practice the Patent Rights licensed to Licensee hereunder, including but not limited to sublicense issue fees, any lump sum payments, milestone payments, technology transfer payments or other similar fees;
provided
,
however
, that Sublicensee Payments shall not include any (i) royalty or profit-sharing payments;
provided
further
,
however
, that Sublicensee Payments shall include profit-sharing payments if Licensee receives royalty payments based on Net Sales of Licensed Products in addition to profit-sharing payments from a Sublicensee in a contractual arrangement with such Sublicensee, (ii) reimbursement of patent prosecution expenses that have not been recovered prior to the sublicense, (iii) funded research arrangements after the Effective Date of this Agreement (including without limitation any amounts received by Licensee from PVS), (iv) amounts received by Licensee for the Fair Market Value of the sale of its equity securities to Sublicensee, or (5) the attributed value of any cross-license granted by a Sublicensee to Licensee to the extent such cross-license provides Licensee with freedom to operate with respect to a Licensed Product or Licensed Process (but not excluding any monetary consideration actually received from such Sublicensee on account of such cross-license).
|
Q.
|
"Territory" shall mean world-wide.
|
R.
|
"Term" shall have the meaning stated in Paragraph A of ARTICLE XIII.
|
S.
|
"Valid Claim" means an issued, unexpired claim or pending claim of a Patent Right, which issued claim or pending claim has not been revoked or held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction, which is not appealable or has not been appealed within the time allowed for appeal, and which has not been abandoned, disclaimed, denied or admitted to be invalid or unenforceable through reissue, re-examination or disclaimer or other final, irrevocable action.
|
ARTICLE II.
|
GRANT
|
A.
|
Subject to the terms of this Agreement, CMCC hereby grants to Licensee, under CMCC's one-half ownership interest in the Patent Rights, subject to the rights granted to PVS under the PVS License as set forth in Appendix 4 and the rights retained by CMCC pursuant to ARTICLE II, Paragraph B below, the worldwide right and exclusive license, with the right to sublicense, to import, make, have made, use, lease, offer for sale, sell and otherwise export the Licensed Products, and to practice the Licensed Processes, in the Territory for the Field of Use during the Term, unless sooner terminated as provided in this Agreement.
|
B.
|
Notwithstanding anything above to the contrary, CMCC shall retain a royalty-free, non-exclusive, right to practice and use, and to license for a nominal fee (such as shipping and handling charges) to academic nonprofit research organizations to practice and/or use the Patent Rights for their own Licensed Products and Licensed Processes, for research, educational, clinical and/or charitable purposes only. Any such license shall specifically exclude and prohibit any commercialization of the Patent Rights, including any of such organization's own Licensed Products and Licensed Processes. For clarity, nothing in this Paragraph B or elsewhere in this Agreement obligates Licensee or any Sublicensee to transfer or otherwise provide any of their respective Licensed Products or Licensed Processes to CMCC or any other third party.
|
C.
|
Notwithstanding any other provision of this Agreement, the license and any sublicense shall be subject to the rights of the United States government, if any, under Public Law 96-517, 97-226, and 98-620, codified at 35 U.S.C. sec. 200-212 and any regulations promulgated thereunder; the obligations of CMCC under applicable laws and regulations; and Licensee's warranty to comply with all applicable laws and regulations.
|
D.
|
Licensee agrees that Licensed Products leased or sold in the United States shall be manufactured substantially in the United States to the extent required by applicable law. Upon the First Commercial Sale and thereafter, Licensee's annual report to CMCC shall substantiate Licensee's compliance with this provision. To support exclusivity for Licensee consistent with this Agreement, CMCC hereby agrees that, except as provided in Paragraph B of this ARTICLE II, and the grant under the PVS License, it shall not, without Licensee's prior written consent (which Licensee shall have no obligation to give and shall be given at Licensee's sole discretion) grant to any other commercial party a license to make, have made, use, lease and/or sell Licensed Products, or to use the Licensed Processes in the Field of Use, during the period of time in which this Agreement is in effect, except as required by laws affecting the rights of the United States Government.
|
E.
|
The license granted hereunder shall not be construed to confer any rights upon Licensee by implication, estoppel or otherwise as to any inventions, discoveries, know-how, technology or other intellectual property not described in Paragraph A of this ARTICLE II.
|
F.
|
In the event that Licensee uses any non-public information it has acquired in the course of prosecution of the Patent Rights from CMCC and/or patent counsel prosecuting the Patent Rights, or non-public information Licensee has provided, or recommendations made by Licensee that have been implemented in whole or in part with respect to prosecution of the Patent Rights, to formally challenge
|
G.
|
Nothing in this Agreement shall be construed to limit or constrain CMCC, or any officer, director, employee, member of its medical staff, or of any CMCC Affiliate, from continuing to engage in related research; or from the development of related or unrelated inventions, discoveries, rights or technology, and from practicing, licensing or sublicensing related or unrelated intellectual property rights arising from their own inventions occurring after the Effective Date of this Agreement; or from academic publication related thereto; or from entering into agreements and other relationships with other persons or organizations related to matters not regarding the Patent Rights, Licensed Products and Licensed Processes in the Field of Use and matters otherwise not within the scope of this Agreement.
|
H.
|
If, during the Term of this Agreement, CMCC makes any discovery or invention that CMCC reasonably believes to be patentable that is not included within the scope of the license to the Patent Rights granted hereunder but is dominated by the Patent Rights, CMCC shall use reasonable efforts to offer Licensee an option to exclusively license CMCC's rights to such discovery or invention, whether or not patentable, under which license Licensee may fully exploit (including without limitation, develop, manufacture and commercialize) such discovery or invention on an exclusive basis. Upon Licensee's acceptance of such option, which acceptance must be made within forty-five (45) days of receipt of notice from CMCC of any such discovery or invention, CMCC and Licensee shall negotiate the terms of such exclusive license in good faith for at least one hundred and
|
I.
|
Licensee shall have the right to enter into sublicensing agreements with respect to any of the rights, privileges, and licenses granted hereunder, subject to the terms and conditions hereof: CMCC agrees that, in the event CMCC terminates this Agreement for any reason provided hereafter, then CMCC shall provide to known Sublicensees, no less than thirty (30) days prior to the effective date of said termination, written notice of said termination at the address specified by Licensee in the notice provided to CMCC under Paragraph J of this ARTICLE II. If the Sublicensee, during that thirty (30) day period, provides to CMCC authorized and written notice that the Sublicensee: (i) reaffirms the terms and conditions of this Agreement as it relates to the rights the Sublicensee has been granted under the sublicense; (ii) agrees to abide by all of the terms and conditions of this Agreement applicable to Sublicensees and to discharge directly all pertinent obligations of Licensee which Licensee is obligated hereunder to discharge; and (iii) acknowledges that CMCC shall have no obligations to the Sublicensee other than its pertinent obligations set forth in this Agreement with regard to Licensee, then, provided that the Sublicensee has fulfilled (i), (ii) and (iii) herein and Sublicensee is not in material breach of its sublicense, CMCC shall grant to such Sublicensee a license with rights and on terms equivalent to the sublicense rights and terms which the Licensee shall have previously granted to said Sublicensee, to the extent that those rights were granted by CMCC to the Licensee under this Agreement. In any event, the Sublicensee shall remain a Sublicensee under this Agreement for a period of at least sixty (60) days
|
J.
|
In any event, Licensee agrees that any sublicense granted by it shall impose obligations on the Sublicensee consistent with Licensee's obligations to CMCC under ARTICLES II (Grant), VII (Infringement), VIII (Uniform Indemnification and Insurance Provisions), IX (Compliance with Laws; Export Controls), and X, Paragraph A, (Non-Use of Names and Publications) of this Agreement (such flow-down obligations collectively, the "CMCC Obligations"). The CMCC Obligations shall be binding upon the Sublicensee for the benefit of CMCC and Licensee. In addition, every sublicense shall (1) contain requirements for commercially reasonable due diligence efforts from the Sublicensees in the development or exploitation of the Patent Rights, or the sale of Licensed Products, as specifically applicable, and (2) obligate Licensee to use Commercially Reasonable Efforts to enforce those provisions consistent with achieving Licensee's obligations pursuant to this Agreement. The Licensee's sublicenses shall also make CMCC a third-party beneficiary of the sublicense, with the right, but not the obligation, to enforce the CMCC Obligations in the event Licensee fails to, provided that CMCC has provided Licensee sixty (60) days' written notice to Licensee of CMCC's belief that Sublicensee has not complied with CMCC Obligations and within such sixty (60) day period, Licensee has not either (i) reasonably shown that such CMCC Obligations are being complied with or such non-compliance is immaterial or (ii) made reasonable efforts to enforce such CMCC Obligations with respect to the defaulting Sublicensee. Licensee agrees to provide to CMCC notice of any sublicense granted hereunder or amendments related thereto and to forward to CMCC a copy of any and all fully executed sublicense agreements or amendments within thirty (30) days after execution.
|
K.
|
Licensee shall advise CMCC in writing of any consideration received from Sublicensees, and, at CMCC's reasonable request, provide such information in an electronic or other format recognizable by CMCC's data processing systems. Licensee shall not accept from any Sublicensee anything of value in lieu of cash payments to discharge Sublicensee's payment obligations (if any) under any sublicense granted under this Agreement, without the express written permission of CMCC, which permission shall not be unreasonably withheld but may take into account a reasonable valuation for purposes of Licensee's payment obligations to CMCC.
|
ARTICLE III.
|
DUE DILIGENCE AND RELATED MATTERS
|
A.
|
Licensee, upon execution of this Agreement, shall use Commercially Reasonable Efforts in good faith to bring at least one (1) Licensed Product to market as soon as reasonably practicable, consistent with sound and legal business practices and judgment, through a program using Commercially Reasonable Efforts for the exploitation of the Patent Rights. Licensee shall use Commercially Reasonable Efforts to obtain all necessary government approvals for the manufacture, use, sale and distribution of Licensed Products. Thereafter, Licensee agrees that until expiration or termination of this Agreement, Licensee shall use Commercially Reasonable Efforts to keep Licensed Products reasonably available to the public, in quantities sufficient to meet market demand, in the Territory. In the event
|
B.
|
Licensee shall use Commercially Reasonable Efforts to accomplish the specific tasks set forth in Appendix 2 attached hereto in accordance with the timeframe set forth therein (such Appendix 2 is hereby incorporated by reference and is referred to herein as the "Development Plan")
|
C.
|
Licensee shall use Commercially Reasonable Efforts to accomplish the specific requirements of the Development Plan, including the Diligence Specifications set forth in this Paragraph C (the "Diligence Specifications"). The Diligence Specifications shall be part of the Development Plan and the timeframes for such Diligence Specifications shall be treated as definitive.
|
1.
|
Determine protective efficacy of Licensed Products in mouse colonization or systemic models within [* * *]. The Parties acknowledge and agree that Licensee has completed this Diligence Specification as of [* * *].
|
2.
|
Nominate top 2-3 Licensed Products for vaccine formulation within [* * *] of accomplishing Diligence Specification 1.
|
3.
|
Final formulation of Licensed Product for pre-IND studies within [* * *] of accomplishing Diligence Specification 2.
|
4.
|
Completion of toxicology lots of nominated Licensed Products for
in vivo
toxicology studies within [* * *] of accomplishing Diligence Specification 3.
|
D.
|
In the event Licensee fails to meet any of the objective(s) set forth in the Development Plan, including without limitation the Diligence Specifications, in a timely manner, CMCC shall notify Licensee thereof in writing, and Licensee shall have sixty (60) days following such notification to establish to the reasonable satisfaction of CMCC that (i) it has met such objective(s); or (ii) a revision to the Development Plan is necessary and appropriate as contemplated below in Paragraph E. In the event Licensee fails to establish the same to CMCC's reasonable satisfaction, CMCC shall have the right in its sole discretion to terminate in whole or in part the license granted to Licensee under this Agreement effective immediately.
|
E.
|
Notwithstanding anything above to the contrary, CMCC shall not unreasonably withhold its consent to any revision of the objective(s) or timing of the Development Plan, when requested in writing in advance by Licensee and the request is supported by evidence reasonably acceptable to CMCC: (i) of technical difficulties or delays that Licensee could not reasonably have avoided; (ii) that Licensee is proposing and will implement satisfactory and effective means of addressing such difficulties or delays, including sufficient financial and technical resources; and (iii) that Licensee, its Affiliates and/or Sublicensees have in good faith made Commercially Reasonable Efforts and expended commercially reasonable and adequate resources to meet said objective and will continue to do so.
|
F.
|
If, during the Term of this Agreement, Licensee makes any discovery or invention that Licensee reasonably believes to be patentable and is not within the scope of the license to the Patent Rights granted to it hereunder but is dominated by the Patent Rights, Licensee shall, as a condition of this license, confidentially disclose such discovery or invention to CMCC, on usual and customary terms necessary to protect its patentability or its confidentiality as a trade secret. CMCC shall have
|
ARTICLE IV.
|
ROYALTIES AND OTHER PAYMENTS
|
A.
|
For the rights, privileges and exclusive license granted hereunder, Licensee shall pay to CMCC the following amounts in the manner hereinafter provided. Unless expressly stated otherwise in this Agreement, periodic payment obligations listed below shall endure through the Term of this Agreement, unless this Agreement shall be sooner terminated as hereinafter provided.
|
1.
|
A license amendment fee of [* * *], and such fee is due within thirty (30) days after the Effective Date of this Agreement.
|
2.
|
As of the Effective Date Licensee has paid in full the license issue fee of [* * *], which license issue fee was deemed earned and due within thirty (30) days of the effective date of the Original Agreement.
|
3.
|
Licensee shall make the following one-time payments to CMCC in connection with the first occurrence of the following events ("Milestones"):
|
(a)
|
[* * *] upon the [* * *] by Licensee or any Sublicensee with respect to a Licensed Product;
|
(b)
|
[* * *] upon the [* * *] by Licensee or any Sublicensee with respect to a Licensed Product; and
|
(c)
|
[* * *] upon the [* * *] of a Licensed Product.
|
B.
|
During the Term, Licensee shall pay CMCC running royalties in an amount equal to [* * *] of Net Sales of Licensed Products or Licensed Processes used, leased or sold by and/or for Licensee (including its Affiliates) or any Sublicensees ("Running Royalties");
provided
,
however
, to the extent that a license or licenses is required by Licensee to third party patents or other intellectual property (i) in order to practice the Patent Rights, or (ii) in order to manufacture or sell Licensed Products without such activities (as described in clause (i) or (ii) of this sentence) resulting in the infringement of such third party intellectual property, Licensee may, for each such required license, deduct from the Running Royalties owed to CMCC an amount up to [* * *] of the royalties due to each third party for such intellectual property rights;
provided
further
, that no single Running Royalty payment owed to CMCC may be reduced by more than [* * *] as a result of any such deduction. Licensee may not deduct, as a result of any such required third party license, a greater percentage of royalties from those owed to CMCC than the
|
1.
|
No multiple royalties shall be payable on account of any Licensed Product or Licensed Process, its manufacture, use, lease or sale being covered by more than one Patent Rights patent application or Patent Rights issued patent licensed under this Agreement. In the event that any patent or claim thereof included within the Patent Rights is no longer a Valid Claim, then all obligations to pay royalties based on that patent or claim or any claim patentably indistinct therefrom will cease as of the date such patent or claim is no longer a Valid Claim.
|
2.
|
For purposes of calculating royalties, in the event that a Licensed Product includes [* * *], then Net Sales of the [* * *] shall be calculated using one of the following methods:
|
(a)
|
[* * *]; or
|
(b)
|
In the event that no such [* * *] during the applicable accounting period, Net Sales for purposes of determining royalties payable hereunder shall be calculated by [* * *].
|
C.
|
In the event Licensee has granted sublicenses under this Agreement, Licensee shall pay to CMCC the relevant percentage as set forth below of Sublicensee Payments: (i) [* * *] of Sublicensee Payments received by Licensee any time prior to [* * *]; and (ii) [* * *] of Sublicensee Payments received by Licensee any time after [* * *].
|
D.
|
Royalty payments shall be paid in United States dollars in Boston, Massachusetts, or at such other place as CMCC may reasonably designate consistent with the laws and regulations controlling in any foreign country. If currency conversion shall be required in connection with the payments of royalties or other amounts hereunder, the conversion shall be made by using the exchange rate prevailing at Bank of America on the last business day of the calendar quarterly reporting period to which such royalty payments relate.
|
E.
|
Licensee shall make payment of the amounts specified in this ARTICLE IV to CMCC within forty-five (45) days after March 31, June 30, September 30 and December 31 each year during the Term of this Agreement, covering the quantity of Licensed Products sold by Licensee during the preceding calendar quarter (in the case of royalties payable under ARTICLE IV, Paragraph B) and covering the percentage of any Sublicensee Payment (as calculated in accordance with ARTICLE IV, Paragraph C) received during the preceding calendar quarter. The last such payment shall be made within forty-five (45) days after termination of this Agreement. The royalty payments set forth in this Agreement shall, if overdue, bear interest until payment at a per annum rate of two and a half percent (2.5%) above the prime rate in effect at Bank of America on the due date. The payment of such interest shall not foreclose CMCC from exercising any other rights it may have as a consequence of the lateness of any payment.
|
ARTICLE V.
|
REPORTS, RECORDS AND RELATED MATTERS
|
A.
|
Licensee shall keep, and shall require its Affiliates and Sublicensees to keep, full, true and accurate books and records, including books of account in accordance with generally accepted accounting principles, in sufficient detail to enable CMCC to determine Licensee's compliance with this Agreement, including diligence with respect to development, and the royalty and other amounts payable to CMCC under this Agreement. Said books and records, including books of
|
B.
|
CMCC shall have the right to inspect, copy and audit, on five (5) business days' notice, the books described above from time to time to verify the reports provided for herein or compliance in other respects with this Agreement. CMCC or its agents shall perform such inspection, copying and auditing at CMCC's expense during Licensee's regular business hours. CMCC may exercise its rights under this Paragraph B of ARTICLE V no more than one (1) time in any twelve-month period unless for cause.
|
C.
|
Until the later of First Commercial Sale of a Licensed Product or the achievement of the last development Milestone, and for such later periods as CMCC shall by written request from time to time require, Licensee shall provide to CMCC, at least annually, reasonable detail regarding the activities of Licensee and Licensee's Affiliates and Sublicensees relative to achieving the objectives set forth in the Development Plan in a timely manner, including but not limited to, financial expenditures to achieve said objectives; research and development activities; names, addresses and actions of all Sublicensees and Affiliates; the progress of obtaining regulatory approvals; strategic alliances and manufacturing, sublicensing and marketing efforts. Licensee shall report no more than quarterly.
|
D.
|
After First Commercial Sale, within ninety days (90) after the end of each calendar quarter, Licensee shall deliver to CMCC, at Licensee's expense, true and accurate reports for the said preceding quarter, giving such particulars of the business conducted by Licensee, its Affiliates and its Sublicensees under this Agreement as shall be pertinent to CMCC determining compliance with this Agreement, including a royalty accounting hereunder and to verify Licensee's
|
1.
|
Number of Licensed Products and Licensed Processes manufactured and sold and a breakdown indicating numbers sold to CHB.
|
2.
|
Total Net Sales for Licensed Products and Licensed Processes sold, by country.
|
3.
|
Accounting for all Licensed Products and Licensed Processes disposed of for no consideration, such as those distributed for, as the case may be, test marketing, sampling and promotional uses, clinical trial purposes, regulatory approval or compliance, compassionate uses, global access programs intended to provide Licensed Product at reduced prices in the developing world, or other similar uses.
|
4.
|
Applicable deductions including but not limited to e.g. Chargeback Payments, and rebates.
|
5.
|
Total royalties payable to CMCC.
|
6.
|
Names and addresses of all Sublicensees of Licensee.
|
7.
|
Payments received by Licensee from Affiliates and Sublicensees.
|
8.
|
Licensed Products manufactured and sold to the U.S. Government, segregating those sold at a profit from those sold at cost in light of any royalty-free, non-exclusive license that may heretofore have been granted to the U.S. Government.
|
9.
|
A listing, with brief descriptions, of any intellectual property required to be disclosed pursuant to ARTICLE III, Paragraph F.
|
E.
|
On or before the ninetieth (90th) day following the close of Licensee's fiscal year, Licensee shall provide CMCC with Licensee's certified financial statements for the preceding fiscal year, including without limitation all statements reflecting profits and losses from operations, cash balances, and any management letter.
|
F.
|
Licensee acknowledges that policies of CMCC, Harvard Medical School and affiliated organizations, relating to, inter alia, conflicts of interest and intellectual property, may affect certain direct and indirect arrangements between inventors and Licensee or related organizations. During the Term of this Agreement and for so long as a CHB-inventor of the Patent Rights is affiliated with CHB or Harvard Medical School, Licensee shall notify CMCC in writing at least 30 days before Licensee, or any Affiliate of Licensee, or any organization owned, controlled or influenced by a substantial shareholder (>5%), officer or director of Licensee, enters into any agreement other than this Agreement with or involving such CHB-inventor, or his or her family, relatives or members or staff of his or her laboratory, whether relating to sponsored research, consulting, board membership, securities, or otherwise. Licensee's notice to CMCC shall include a detailed description of all proposed terms and conditions. Licensee shall not enter into such an agreement if it would violate such policies unless the terms and conditions of the agreement have been duly approved pursuant to such policies.
|
ARTICLE VI.
|
PATENT PROSECUTION
|
A.
|
Licensee shall apply for, seek prompt issuance of, and maintain during the Term of this Agreement the Patent Rights set forth in Appendix 1 using counsel reasonably acceptable to CMCC. The specifications of any such patent application and any patent issuing thereon shall state, to the extent applicable, "This invention was made with government support under [contract] awarded by
|
B.
|
Licensee shall reimburse CMCC for all patent costs, past, present and future incurred by CMCC for the preparation, filing, prosecution and maintenance of patents underlying the Patent Rights. After the Effective Date, CMCC shall not incur any such patent prosecution expenses related to the Patent Rights without Licensee's prior written consent except for those Patent Rights CMCC has the right to prosecute pursuant to Paragraph C and D of this ARTICLE VI. Upon request of CMCC, and only upon such request, Licensee agrees to have CMCC's patent counsel directly bill Licensee and Licensee shall directly pay such invoices in compliance with such counsel's customary business terms, but in any event within thirty (30) days.
|
C.
|
If, in any country, Licensee elects to no longer pay the expenses of a patent application or patent included within Patent Rights, Licensee shall notify CMCC not less than thirty (30) days prior to such action (but no less than sixty (60) days prior to the date that a response related to such patent application or patent is due) and, in such event, the license granted to Licensee hereunder with respect to such patent or patent application in such country will immediately cease. Such notice shall not relieve Licensee from responsibility to pay such patent related expenses incurred by Licensee prior to the expiration of the notice period (or such longer period specified in Licensee's notice). CMCC may elect to continue paying such
|
D.
|
In the event Licensee elects not to pursue, maintain or retain a particular Patent Right(s) listed in Appendix 1 in any country in the Territory, then Licensee shall immediately notify CMCC in writing and, subject to the rights of the United States government and any other contractual obligations to research sponsors, Licensee will authorize CMCC to assume the filing, prosecution and/or maintenance of such application or patent in such country at CMCC's expense. In such event, Licensee shall provide to CMCC any authorization necessary to permit CMCC to pursue and/or maintain such Patent Right and Licensee's license under this Agreement to that Patent Right in such country will immediately cease. CMCC shall then be free to license its one-half ownership interest in the applicable Patent Right(s) to any third party without any obligations to Licensee (other than those obligations with respect to Joint Inventions as set forth in the MTA and ARTICLE XIV of this Agreement).
|
ARTICLE VII.
|
INFRINGEMENT
|
A.
|
Licensee and CMCC shall each inform the other promptly in writing of any alleged infringement by a third party of the Patent Rights in the Field of Use and of any available evidence thereof.
|
B.
|
During the Term of this Agreement, CMCC shall have the right, but shall not be obligated, to prosecute at its own expense any infringement of the Patent Rights and, in furtherance of such right, Licensee hereby agrees that CMCC may include Licensee as a party plaintiff in any such suit, without expense to Licensee. No settlement, consent judgment or other voluntary final disposition of the suit that adversely affects the rights of Licensee under this Agreement may be entered into
|
C.
|
If within three (3) months after having been notified with sufficient facts of any alleged infringement, CMCC shall have been unsuccessful in persuading the alleged infringer to desist and shall not have brought and shall not be diligently prosecuting an infringement action, or if CMCC notifies Licensee of its intention not to bring suit against any alleged infringer then, provided that the exclusive license granted to Licensee in ARTICLE II is still in effect for such relevant Patent Rights, Licensee shall have the right, but shall not be obligated, to prosecute at its own expense any infringement of the Patent Rights. CMCC hereby agrees that Licensee may include CMCC as a party plaintiff in any such suit, without expense to CMCC. No settlement, consent judgment or other voluntary final disposition of the suit may be entered into without the consent of CMCC, which consent shall not be unreasonably withheld. Licensee shall indemnify CMCC against any order for costs that may be made against CMCC in such proceedings to the extent that such order does not relate to or arise from CMCC's negligence, reckless misconduct or intentional misconduct during such proceeding.
|
D.
|
In the event Licensee shall undertake the enforcement and/or defense of the Patent Rights by litigation pursuant to Paragraph C of this ARTICLE VII, Licensee may withhold up to fifty percent (50%) of the payments otherwise thereafter due to CMCC under ARTICLE IV above and apply the same toward reimbursement of up to fifty percent (50%) of Licensee's expenses, including reasonable attorney's
|
E.
|
In the event that a declaratory judgment action alleging invalidity or non-infringement of any of the Patent Rights shall be brought against Licensee, CMCC, at its option, shall have the right, within thirty (30) days after commencement of such action, to intervene and participate along with Licensee in the defense of the action at its own expense.
|
F.
|
In any infringement suit which either Party may institute to enforce the Patent Rights pursuant to this Agreement, the other Party hereto shall cooperate in all reasonable respects and, to the extent reasonably possible, have its employees testify when requested and make available relevant records, papers, information, samples, specimens, and the like.
|
G.
|
Licensee shall, during the exclusive period of this Agreement, have the sole right subject to the terms and conditions hereof to sublicense any alleged infringer for future use of the Patent Rights to the extent licensed by this Agreement. Any upfront fees paid to Licensee as part of such a sublicense shall be shared between Licensee and CMCC in accordance with the terms of ARTICLE IV, Paragraph C as if they were Sublicensee Payments under this Agreement.
|
ARTICLE VIII.
|
UNIFORM INDEMNIFICATION AND INSURANCE PROVISIONS
|
A.
|
Licensee shall indemnify, defend and hold harmless CMCC, its Affiliates, current or future directors, trustees, officers, faculty, medical and professional staff, employees, students and agents and their respective successors, heirs and assigns (the "Indemnitees"), against any claim, liability, cost, damage, deficiency, loss, expense or obligation of any kind or nature (including without limitation reasonable attorneys' fees and other costs and expenses of litigation) incurred by or imposed upon the Indemnitees or any one of them in connection with any claims, suits, actions, demands or judgments arising out of any theory of product liability (including, but not limited to, actions in the form of tort, warranty, or strict liability) concerning any product, process or service made, used or sold by the Licensee, its Affiliates or its Sublicensees or any agents thereof pursuant to any right or license granted to the Licensee under this Agreement.
|
B.
|
Licensee's indemnification under ARTICLE VIII, Paragraph A above shall not apply to any liability, damage, loss or expense to the extent that it is directly attributable to the negligent activities, reckless misconduct or intentional misconduct of the Indemnitees.
|
C.
|
Licensee agrees, at its own expense, to provide attorneys reasonably acceptable to CMCC to defend against any actions brought or filed against any party indemnified hereunder with respect to the subject of indemnity contained herein, whether or not such actions are rightfully brought.
|
D.
|
Beginning at the time as any such product, process or service is being commercially distributed or sold (other than for the purpose of obtaining regulatory approvals) by Licensee or by a Sublicensee, Affiliate or agent of Licensee, Licensee shall, at its sole cost and expense, procure and maintain commercial general liability insurance in amounts not less than $2,000,000 per incident and $2,000,000 annual aggregate and naming the Indemnitees as additional insureds. Such commercial general liability insurance shall provide (i)
|
E.
|
Licensee shall provide CMCC with written evidence of such insurance upon request of CMCC. Licensee shall provide CMCC with written notice at least fifteen (15) days prior to the cancellation, non-renewal or material change in such insurance. Notwithstanding any other term of this Agreement, if Licensee does not obtain replacement insurance providing comparable coverage within such fifteen (15) day period, CMCC shall have the right to terminate this Agreement effective at the end of such fifteen (15) day period without notice of any additional waiting periods.
|
F.
|
Licensee shall maintain such commercial general liability insurance during (i) the period that any such product, process or service is being commercially distributed or sold (other than for the purpose of obtaining regulatory approvals) by Licensee or by a Sublicensee, Affiliate or agent of Licensee and (ii) a reasonable period after the period referred to above, which in no event shall be less than fifteen (15) years.
|
G.
|
The provisions of this ARTICLE VIII shall survive expiration or termination of this Agreement.
|
H.
|
CMCC MAKES NO WARRANTY, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY EXPRESS OR IMPLIED WARRANTY OF MERCHANTABILITY OR ANY EXPRESS OR IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE, OR WARRANTY OF NON-INFRINGEMENT, WITH RESPECT TO ANY MATTER WITHIN THE SCOPE OF THIS AGREEMENT, INCLUDING WITHOUT LIMITATION ANY WARRANTY WITH RESPECT TO THE PATENT RIGHTS, LICENSED PRODUCTS, OR ANY PATENT, TRADEMARK, SOFTWARE, TRADE SECRET, TANGIBLE RESEARCH PROPERTY, INFORMATION OR DATA LICENSED OR OTHERWISE PROVIDED TO LICENSEE HEREUNDER, AND HEREBY DISCLAIMS THE SAME.
|
ARTICLE IX.
|
COMPLIANCE WITH LAWS; EXPORT CONTROLS
|
ARTICLE X.
|
NON-USE OF NAMES AND PUBLICATIONS
|
A.
|
Licensee represents and agrees that it will not use the name, names, logos or trademarks of the CMCC or any of its Affiliates, nor the name or photograph or other depiction of any employee or member of the staff of CMCC or such Affiliates, nor any adaptation of any of the foregoing, in any advertising, promotional, or sales literature without, in each case, prior written consent from CMCC and from the individual staff member, employee, or student if such individual's name, photograph or depiction is used. Notwithstanding the above, Licensee may state that it is licensed by CMCC under one or more patents and/or applications consistent with this Agreement, and Licensee may comply with disclosure requirements of all applicable laws relating to its business, including United States and state security laws. In addition, Licensee may refer to publications by employees of CMCC in the scientific literature.
|
B.
|
CMCC agrees to use reasonable efforts to provide Licensee with any draft publications or presentations that are submitted to the Technology & Innovation Development Office of CMCC by Dr. Richard Malley directly related to the Patent Rights under CMCC's retained rights under ARTICLE II, Paragraph B at least thirty (30) days prior to its anticipated publication or presentation. Licensee shall have the right to review such publication or presentation to identify Licensee's non-public information.
|
ARTICLE XI.
|
ASSIGNMENT
|
A.
|
CMCC may assign this Agreement at any time without the prior consent of Licensee. Except as otherwise provided herein, this Agreement is not assignable or delegable, in whole or in part, by Licensee without the prior written consent of CMCC acting through an authorized designee, and any purported assignment otherwise shall be void and of no effect.
|
B.
|
Notwithstanding the foregoing, in the event Licensee merges with another entity, is acquired by another entity, or sells all or substantially all of its assets to another entity, Licensee may assign its rights and obligations hereunder to the surviving or acquiring entity if: (i) Licensee is not then in breach of this Agreement; (ii) the proposed assignee has, or will have, immediately upon assignment, sufficient available resources to carry out the Development Plan; (iii) Licensee provides to CMCC written notice of the assignment at least five (5) days prior to the effective date of the assignment; and, CMCC receives from the assignee, in writing, at least five (5) days prior to the effective date of the assignment, a reaffirmation of the terms of this Agreement, an agreement to be bound by the terms of this Agreement and an agreement to perform the obligations of Licensee under this Agreement.
|
C.
|
In addition, the license granted to Licensee under ARTICLE II shall include the right to have some or all of Licensee's rights or obligations under this Agreement performed or exercised by one or more of Licensee's Affiliates, provided that any act or omission taken or made by an Affiliate of Licensee under this Agreement shall be deemed an act or omission by Licensee under this Agreement.
|
ARTICLE XII.
|
DISPUTE RESOLUTION AND ARBITRATION
|
A.
|
Any and all claims, disputes or controversies arising under, out of, or in connection with this Agreement, which have not been resolved by good faith negotiations between the Parties shall be resolved by final and binding arbitration in Boston, Massachusetts in accordance with the rules then obtaining applicable to
|
B.
|
Notwithstanding the foregoing, nothing in this Agreement shall be construed to waive any rights or timely performance of any obligations existing under this Agreement, including without limitation Licensee's obligations to make royalty and other payments, and also, unless the license granted in ARTICLE II has been terminated, Licensee's obligation to continue due diligence and development obligations. Notwithstanding any other provision of this Agreement, Licensee agrees that it shall not withhold or offset such payments, and agrees that Licensee's sole remedy for alleged breaches by CMCC is pursuant to this ARTICLE XII.
|
ARTICLE XIII.
|
TERM AND TERMINATION
|
A.
|
The "Term" of this Agreement shall be fifteen (15) years or upon the expiration of the last expiring Patent Right, whichever period is the longer term.
|
B.
|
Notwithstanding ARTICLE XII of this Agreement, CMCC may terminate this Agreement immediately upon the bankruptcy, judicially declared insolvency, liquidation, dissolution or cessation of operations of Licensee; or the filing of any voluntary petition for bankruptcy, dissolution, liquidation or winding-up of the affairs of Licensee; or any assignment by Licensee for the benefit of creditors; or the filing of any involuntary petition for bankruptcy, dissolution, liquidation or winding-up of the affairs of Licensee which is not dismissed within ninety (90)
|
C.
|
CMCC may terminate this Agreement upon thirty (30) days prior written notice in the event of Licensee's failure to pay to CMCC royalties or any payments due and payable hereunder in a timely manner, unless Licensee shall make all such payments to CMCC within said thirty (30) day period. Notwithstanding ARTICLE XII of this Agreement upon the expiration of the thirty (30) day period, if Licensee shall not have made all such payments to CMCC, the rights, privileges and licenses granted hereunder shall terminate without further action by CMCC.
|
D.
|
Except as otherwise provided in Paragraphs B and C above, in the event that Licensee shall default in the performance of any of its material obligations under this Agreement, and the default has not been remedied to CMCC's reasonable satisfaction within sixty (60) days after the date of CMCC's notice to Licensee in writing of such default, CMCC may, by written notice to Licensee, terminate this Agreement effective immediately or upon such date as CMCC, in its sole discretion, shall designate in such notice.
|
E.
|
Licensee shall have the right to terminate this Agreement in its entirety, or on a country-by-country and Licensed Product-by-License Product basis, at any time upon ninety (90) days' prior written notice to CMCC, upon payment by Licensee of all amounts due CMCC through the effective date of termination. This right is
|
F.
|
Upon expiration or termination of this Agreement for any reason, all of the rights, privileges and licenses granted hereunder shall terminate without further action by either Party, except that nothing herein shall be construed to release either Party from any obligation that matured prior to the effective date of, or that expressly survives, such termination or expiration. For clarity, upon expiration or termination of this Agreement for any reason, Licensee's obligation to pay royalties or any other amount to CMCC under this Agreement (other than any such payments that matured prior to the effective date of such termination) shall immediately cease.
|
G.
|
If Licensee terminates this Agreement due to adverse results in clinical or other testing of Licensed Products or Licensed Processes, Licensee shall make available to CMCC, for purposes of its evaluation of the future viability of the technology, a summary of such results together with copies of any government-mandated reports, such as FDA safety reports, made in connection with the decision to terminate development.
|
ARTICLE XIV.
|
OWNERSHIP
|
ARTICLE XV.
|
PAYMENTS, NOTICES, AND OTHER COMMUNICATIONS
|
ARTICLE XVI.
|
GENERAL PROVISIONS
|
A.
|
All rights and remedies hereunder will be cumulative and not alternative. This Agreement shall be construed and governed by the laws of the Commonwealth of Massachusetts.
|
B.
|
This Agreement may be amended only by written agreement signed by the Parties.
|
C.
|
It is expressly agreed by the Parties hereto that CMCC and Licensee are independent contractors and nothing in this Agreement is intended to create an employer relationship, joint venture, or partnership between the Parties. No Party has the authority to bind the other.
|
D.
|
This Agreement constitutes the entire agreement between the Parties with respect to the subject matter hereof and supersedes all proposals, representations, negotiations, agreements and other communications between the Parties, whether written or oral, with respect to the subject matter hereof. Where inconsistent with the terms of any contemporaneous related agreements (such as sponsored research agreements), terms in this Agreement shall control.
|
E.
|
If any provisions of this Agreement shall be held to be invalid, illegal or unenforceable, the Parties hereto shall substitute, by mutual consent, valid provisions for such invalid, illegal or unenforceable provisions, which valid provisions in their effect are sufficiently similar to the invalid, illegal or unenforceable provisions that it can be reasonably assumed that the Parties would have entered into this Agreement with such valid provisions. In the event such valid provisions cannot be agreed upon, the invalidity, illegality or
|
F.
|
This Agreement may be executed in any number of counterparts, each of which shall be deemed an original as against the Party whose signature appears thereon, but all of which taken together shall constitute but one and the same instrument.
|
G.
|
The failure of either Party to assert a right to which it is entitled, or to insist upon compliance with any term or condition of this Agreement, shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other Party.
|
H.
|
Licensee agrees to mark any Licensed Products sold in the United States with all applicable United States patent numbers. All Licensed Products shipped to or sold in other countries shall be marked in such a manner as to conform with the patent laws and practices of the country of manufacture or sale.
|
I.
|
Each party hereto agrees to execute, acknowledge and deliver such further instruments as may be reasonably necessary to carry out the purposes and intent of this Agreement.
|
J.
|
The paragraph headings contained in this Agreement are for reference purposes only and shall not in any way affect the meaning or interpretation of this Agreement.
|
K.
|
The signatories below each warrant that he or she is duly authorized to execute this Agreement.
|
ARTICLE XVII.
|
CONFIDENTIALITY
|
A.
|
Each Party agrees, during the Term and for five (5) years after termination of this Agreement, to maintain and protect the confidentiality of the Confidential
|
B.
|
The Parties' obligations under this ARTICLE XVII shall not apply to any information which:
|
1.
|
at the time of disclosure is already in the public domain;
|
2.
|
after disclosure hereunder enters the public domain, except through breach of this Agreement by the Receiving Party;
|
3.
|
the Receiving Party can demonstrate was rightfully in the Receiving Party's possession prior to the time of disclosure by or on behalf of the Disclosing Party hereunder, and was not acquired directly or indirectly from the Disclosing Party;
|
4.
|
becomes available to the Receiving Party from a third-party who, to the knowledge of the Receiving Party, is not legally or contractually prohibited from disclosing such Confidential Information;
|
5.
|
the Receiving Party can demonstrate was developed by or for the Receiving Party independently of the disclosure of Confidential Information by the Disclosing Party or its Affiliates.
|
C.
|
Licensee and CMCC agree that the confidentiality obligations hereunder shall require that each Party use confidentiality procedures and practices to protect the other Party's Confidential Information as each would use for its own confidential information, but at least a reasonable degree of care.
|
D.
|
Licensee agrees that nothing herein shall prevent CMCC from disclosing or publishing CMCC's own Confidential Information (other than this Agreement), or create any legal liability to Licensee for doing so.
|
E.
|
The provisions of this ARTICLE XVII shall survive expiration or termination of this Agreement for the period of time specified in the first sentence of ARTICLE XVII, Paragraph A.
|
CHILDREN'S MEDICAL CENTER CORPORATION
|
GENOCEA BIOSCIENCES, INC.
|
By:
/s/ Erik Halvorsen
|
By:
/s/ Chip Clark
|
Name:
Erik Halvorsen, Ph.D.
Title:
Executive Director, TIDO
Date:
March 29, 2012
|
Name:
Chip Clark
Title:
President & CEO
Date:
March 23, 2012
|
|
|
Serial Number
|
Filing Type
|
Filing Date
|
[* * *]
|
|
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
|
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
|
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
|
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
|
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
|
|
[* * *]
|
[* * *]
|
[* * *]
|
CHILDREN’S HOSPITAL
By:
/s/ Carleen Brunelli, Ph.D., MBA
Title: Carleen Brunelli, Ph.D., MBA
Vice President of Research Administration
Date:
Sept 5, 2008
|
COMPANY
By:
/s/ Robert Paull
Title:
President
Date:
9.17.08
|
1.
|
Definitions.
|
2.
|
License Grants.
|
3.
|
Development and Commercialization.
|
4.
|
Consideration for Grant of License
|
5.
|
Reports; Payments; Records.
|
6.
|
Intellectual Property.
|
7.
|
Enforcement of Patent Rights.
|
8.
|
Warranties; Limitation of Liability.
|
9.
|
Indemnification.
|
10.
|
Term and Termination.
|
11.
|
Miscellaneous.
|
If to
Licensee: |
|
Genocea Biosciences, Inc.
Cambridge Discovery Park 100 Acorn Park Drive, 5 th Floor
Cambridge, Massachusetts 02140
|
|
|
|
|
|
Attn: President
|
|
|
|
If to Harvard:
|
|
Office of Technology Development
Harvard University Holyoke Center 727 1350 Massachusetts Avenue Cambridge, Massachusetts 02138
Attn.: Chief Technology Development Officer
|
|
|
|
|
|
|
President and Fellows of Harvard College
|
|
Genocea Biosciences, Inc.
|
|
|
|
|
|
|
By:
/s/ Cristin L. Rothfuss
___________
|
|
By:
/s/ Chip Clark
_________
|
|
|
|
Name:
Cristin L. Rothfuss
___________
|
|
Name:
Chip Clark
_______________
|
|
|
|
Title:
Director of Technology Transactions – Office of Technology Development – Harvard University
|
|
Title:
President and CEO
_____
|
a.
|
[* * *]
|
b.
|
[* * *]
|
c.
|
[* * *]
|
1.
|
Development Milestones for the First Type II Licensed Product
|
a.
|
[* * *]
|
b.
|
[* * *]
|
2.
|
Development Milestones for the Second Type II Licensed Product
|
a.
|
[* * *]
|
b.
|
[* * *]
|
c.
|
[* * *]
|
d.
|
[* * *]
|
Task
|
Completion Date
|
[* * *]
|
[* * *] months
|
[* * *]
|
[* * *] months
|
[* * *]
|
[* * *] months
|
[* * *]
|
[* * *] months
|
[* * *]
|
[* * *] months
|
|
|
1.
|
[†].
|
Term
|
Section
|
“620 Patents”
|
10.2.1
|
“703 Patents”
|
10.2.1
|
“Agreement”
|
Introduction
|
“Audited Party”
|
6.10.4(a)
|
“Auditing Party”
|
6.10.4(a)
|
“Breaching Party”
|
9.2
|
“Clinical Trial Data”
|
3.3.3
|
“CSL”
|
10.2.1
|
“CSL Allegations”
|
10.2.1
|
“Defending Party”
|
7.3.3
|
“Development Milestone”
|
6.3
|
“Development Milestone Payment”
|
6.3
|
“Disease Field Exchange Request”
|
2.2.3
|
“Effective Date”
|
Introduction
|
“Evaluation Supplies”
|
5.3.1
|
“Exchange Field Candidate”
|
2.2.3
|
“Final Decision”
|
6.11.1
|
“Genocea”
|
Introduction
|
“Genocea Indemnitees”
|
10.6.2
|
“Indemnitee”
|
10.6.3
|
“Infringement Claim”
|
7.3.1
|
“Initiation”
|
6.3
|
“Insolvent Party”
|
9.3
|
“IP”
|
9.9
|
Term
|
Section
|
“Isconova”
|
Introduction
|
“Isconova Indemnitees”
|
10.6.1
|
“JSC”
|
4.4
|
“License”
|
11.16
|
“Licensed Products”
|
Recitals
|
“Lock-Up Period”
|
11.2
|
“Losses”
|
10.6.1
|
“NewCo”
|
11.4
|
“Non-Exclusive Option Field”
|
2.1.3
|
‘
t
Non-Exclusive Option Field Candidate”
|
2.1.3(a)
|
“Non-Exclusive Option Field Selection Request”
|
2.1.3(a)
|
“Partnership”
|
6.4.1
|
“Party” or “Parties”
|
Introduction
|
“Prosecuting” or “Prosecution”
|
7.1.1(a)
|
“Royalty Report”
|
6.7
|
“Secondary Prosecution Activities”
|
7.1.1(e)
|
“SPC”
|
7.7
|
“Supply and Manufacturing Agreement”
|
5.3.3
|
“Time-Limited Exclusive Field Date”
|
2.1.2(a)
|
“Time-Limited Exclusive Option Field”
|
2.1.2
|
“Time-Limited Exclusive Option Field Candidate”
|
2.1.2(a)
|
“Time-Limited Exclusive Option Field Selection Request”
|
2.1.2(a)
|
“Trademarks”
|
3.1.4
|
Catchword
|
Full title
|
Claim category
|
First Priority date /Lapsing date
|
Number
|
Status
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
[* * *]
|
Definitions:
|
[* * *]
|
Firm Orders:
|
[* * *]
|
Availability:
|
[* * *]
|
Price for supplies of Research Reagents:
|
[* * *]
|
Price for supplies of Preclinical or Clinical Supplies:
|
[* * *]
|
Quantities of Clinical Supplies:
|
|
Delivery :
|
[* * *]
|
Number of Days Late
|
Late Delivery Credit
|
[* * *]
|
[* * *]% of the purchase price for late Licensed Adjuvants
|
[* * *]
|
[* * *]% of the purchase price for late Licensed Adjuvants
|
(i)
|
fatalities and/or significant injuries or occupational illness;
|
(ii)
|
property damage in excess of US$50,000;
|
(iii)
|
inspections by any environmental protection agency or occupational health and safety agency; or
|
(iv)
|
requests for information, notices of violations or other significant governmental and safety agency communications relating to environmental, occupational health and safety compliance.
|
1.
|
Commercial Partner hereby acknowledges that Isconova has licensed certain Licensed Technology, to Genocea Biosciences, Inc. within the Field (“Genocea”) relating to Licensed Adjuvants under a License Agreement effective as of [...], a copy of which is attached hereto (the ‘‘License”).
|
2.
|
The Parties hereby acknowledge that all terms not otherwise defined herein shall have the same meanings as set forth in the hereto-attached version of the License.
|
3.
|
Isconova agrees that, in the event that Genocea shall be found in material breach of its obligations to Isconova under the License and as a result of such material breach, the License is terminated by Isconova in accordance with its terms, Commercial Partner shall be allowed to continue to Develop, Manufacture and Commercialize as allowed hereunder and in the License, as long as Commercial Partner agrees to pay, directly to Isconova, all amounts (including royalties and milestone payments) to which Isconova would have been entitled to receive under the License as a result of Commercial Partner’s activities in association with the Licensed Products.
|
4.
|
If Commercial Partner is notified, by Isconova or Genocea or otherwise, that the License has been terminated, such termination shall not affect the rights of the Commercial Partner to Develop, Manufacture, and Commercialize Licensed Products in accordance with the terms of this Agreement. Further, from the effective date of such termination, Commercial Partner shall, if so requested by Commercial Partner in writing, automatically become a direct licensee of Isconova in relation to the Licensed Technology with respect to and on the same terms as the rights originally sublicensed to Commercial Partner by Genocea. Notwithstanding the foregoing, under no circumstances shall Isconova have obligations to Commercial Partner that are greater than those owed by Isconova to Genocea under the License as a result of the preceding sentence. To the extent that the foregoing constitutes a grant of rights under the Licensed Technology, such rights shall be contingent and, in the event of a failure to make any such payments or any other material breach by the Commercial Partner, terminate upon
|
5.
|
No more than once every year, in order to monitor the Commercial Partner’s royalty payments pursuant to Section 3 above, the Licensor may cause, at its own cost and expense, an independent certified public accountant to inspect during normal business hours the Commercial Partner’s records of sales of Licensed Products for the past three (3) years and any amounts paid or payable to Isconova in relation to such Licensed Products. The parties shall reconcile any underpayment or overpayment within thirty (30) days after the accountant delivers the results of the audit. In the event that any such audit performed reveals any underpayment in excess of five percent (5%) during any royalty period being subject to audit, then the Commercial Partner shall bear the full cost of any such audit.
|
6.
|
Except as required by law, no Party shall originate any publication, news release or other public announcement, written or oral, whether in the public press, or stockholders’ reports, or otherwise relating to the contents of this Commercial Partner Agreement without the prior written approval of the other Party, which approval shall not be unreasonably withheld.
|
7.
|
This Commercial Partner Agreement shall be governed by and construed in accordance with the laws of the Commonwealth of Massachusetts without reference to conflict of laws principles. All disputes arising out of or in connection with the present contract shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by one (1) arbitrator appointed in accordance with the said Rules. The costs of the arbitration, including administrative and arbitrator’s fees, as well as the other party’s reasonable attorneys’ fees and expert witness fees shall be borne by the losing party. The place of arbitration shall be Stockholm, Sweden. The arbitration proceedings shall be conducted in English.
|
Re:
|
License and Collaboration Agreement by and between Genocea Biosciences, Inc. and Isconova AB
|
Bob Farrell
|
From:
Staph Bakali
Sent:
Thursday, June 24, 2010 4:34 AM
To:
Lena Söderström
Cc:
Bob Farrell
Subject:
RE: Genocea Field Nominations: Strictly Confidential
Thanks Lena. You rapid response is much appreciated. All the best Staph
|
From:
Lena Söderström [mailto:Lena.Soderstrom@isconova.se]
Sent:
Thursday, June 24, 2010 3:50 AM
To:
Staph Bakali
Cc:
Bob Farrell
Subject:
SV: Genocea Field Nominations: Strictly Confidential Hi Staph,
Thanks for your nomination. I hereby confirm your nomination for the three time limited and one non-exclusive field - they are all available.
Looking forward to get more information about the plans for the future.
Have a nice week end.
Lena
|
Från:
Staph Bakali [staph.bakali@genocea.com]
Skickat:
den 18 juni 2010 17:44
Till:
Lena Söderström
Kopia:
Bob Farrell
Ämne:
Genocea Field Nominations: Strictly Confidential
Hi Lena,
Good to talk with you yesterday- please find attached our formal nomination for the 3 time limited exclusive fields and one non-exclusive field.
We look forward to your confirmation.
All the best
Staph
Staph Leavenworth Bakali
President & CEO
Genocea Biosciences
161 First Street, Suite 2C
Cambridge, MA 02142
617.876.8191 ext 201 (w)
617.599.4220 (c)
|
1.
|
Amendment:
The License Agreement is amended by the addition of this Exhibit F, the Safety Data Exchange Agreement (the “
Safety Data Exchange Agreement
”), which is hereby attached to and incorporated therein. Unless otherwise noted, defined terms not otherwise defined herein shall have the defined meaning in the License Agreement.
|
2.
|
Rationale and Definition
: Novavax and Collaborator agree to mutually disclose confidential clinical and non-clinical safety data (the “
Safety Data
”) as specified below. Sharing Safety Data ensures a high level of safety for the clinical trial subjects and complies with the current international and local guidelines for pharmacovigilance and risk management. Both parties may be required to inform Regulatory Authorities, ethical review boards, clinical investigators and in some cases clinical trial subjects of new and important safety information related to the Matrix-M™ adjuvant in connection with vaccines containing any formulation of the Matrix-M™ adjuvant. Sharing this Safety Data facilitates the maintenance of a comprehensive database of safety data to generate and submit information to Regulatory Authorities and for the information of clinical trial investigators and clinical trial subjects. This Safety Data information will be deemed to be “Confidential Information” subject to Article 8 of the License Agreement. Letters of authorization to cross reference Drug Master Files (DMFs), Investigational New Drug Applications (INDs) and IND amendments, Clinical Trial Applications (CTAs), or other clinical/regulatory filing will be provided so that regulatory agencies may review data solely for the exercise of each Party’s rights and the performance of each Party’s obligations under the License Agreement.
|
3.
|
Study Product:
For purposes of this Safety Data Exchange Agreement, “
Study Product
” means any test article that contains (or, if the study blind is not broke in a clinical trial, may contain) Matrix-M
TM
adjuvant administered in conjunction with vaccine antigens or alone.
|
4.
|
Scope:
The scope of the Safety Data information to be shared under the License Agreement encompasses, subject to the limitations cited below, the Matrix-M™ adjuvant as a standalone product and as incorporated into the formulation of any vaccines under development by either or both Parties, under the License Agreement or any subsequent agreement(s) between the Parties, and by any Third Party (including, but not limited to, a company, institution, or individual investigator) known to Novavax that has been granted a license to use Matrix-M™ in a vaccine formulation; provided that any Safety Data information from a Third Party is only included to the extent that a Party can share that Safety Data information without breaching any obligation owed to a Third Party.
This scope shall be deemed to include human clinical trial safety data, regardless of whether the vaccine antigen and adjuvant are co-formulated at time of manufacture or mixed at some other time prior to administration, data arising from GLP-compliant non-clinical safety studies and also any other non-clinical data which could be reasonably construed to contribute to the overall safety profile, whether originating in GLP-compliant or non-GLP-compliant safety studies.
|
5.
|
Limitations:
This Safety Data Exchange Agreement applies solely to products in non-clinical and clinical development. Products that attain marketing approval in any jurisdiction will be subject to a new agreement, put in place at or around the time of approval, which will specify the obligations and procedures relative to product-specific, post-marketing and pharmacovigilance programs required by the relevant jurisdiction.
|
6.
|
Obligations for Information Sharing Between the Parties:
|
a.
|
Collaborator Obligations:
Collaborator agrees to use Commercially Reasonable Efforts to (a) notify Novavax in writing prior to the start date of each GLP-compliant non-clinical safety study in animals and each clinical trial, and (b) provide to Novavax the following information arising from all development programs within the scope of this agreement as defined in Paragraph 2
and to the extent relating to the Matrix-M™ adjuvant, which information, in the case of clinical trials and safety reports arising from clinical trials, will not contain any “individually identifiable health information,” as that term is defined for purposes of the Health Insurance Portability and Accountability Act of 1996 and the regulations promulgated thereunder, as may be amended from time to time (“HIPAA”), except as expressly permitted by Applicable Law and with prior notice to the other Party:
|
1.
|
Non-Clinical Safety Studies
|
i.
|
In the case of GLP-compliant non-clinical safety studies in animals:
|
a.
|
A synopsis of the protocol design, prior to study start, including at least the test species, number and sex of test animals, route of administration and dose of Matrix-M™: number of total doses, nature of any co-administered antigen, and safety endpoints to be measured.
|
b.
|
Official summary excerpted from the study report within three (3) months of signature or delivery of audited draft report, whichever is earlier.
|
ii.
|
Observations arising from any GLP-compliant or non-GLP non-clinical safety studies which could be reasonably construed to negatively alter the overall safety profile of the Matrix-M™ adjuvant, shall be reported to Novavax within two (2) Business Days, of a non-clinical safety finding determined to require reporting to Regulatory Authorities.
|
2.
|
Clinical Trials
|
i.
|
A synopsis of the protocol design, prior to study start, including at least:
|
a.
|
The sample size, and age, sex, and key inclusion/exclusion criteria for study subjects,
|
b.
|
The treatment groups, including dose levels of Matrix-M™–containing groups,
|
c.
|
Number of doses and intervals,
|
d.
|
Safety endpoints to be monitored.
|
ii.
|
The final protocol, safety sections and supporting tables and listing of the final clinical study report to include all Adverse Events (AEs), Serious Adverse Events (SAEs), any separate tabulations of specific AE classes (e.g., auto-immune disease) and clinical safety laboratory data, within six (6) months or an alternatively agreed upon timeframe, of trial completion (defined as the last in-clinic visit of the last subject) or upon signature, whichever occurs first. SAS datasets as related to safety endpoints will be made available.
|
iii.
|
Notice of any clinical holds, voluntary treatment holds, or similar significant actions relating to the safety of Matrix-M™ that are taken by Collaborator or any Third Party including an investigational site, ethical review board, or safety monitoring body, or by a Regulatory Authority. Notice will be transmitted within one (1) Business Day after Collaborator becomes aware of the clinical hold or significant action.
|
iv.
|
Serious Adverse Event (“SAE”) reports according to the schedule below, which the Parties acknowledge may contain “individually identifiable health information” under HIPAA.
All assessments of causality will be based on the investigator’s assessment
, although the Collaborator may append any information which causes the Collaborator to propose an alternative causality assessment:
|
a.
|
For SAE reports that relate to events that are fatal or immediately life-threatening and assessed as “Related,” “Probably Related,” or “Possibly Related” to the Study Product
by the investigator
, Collaborator provides notification to Novavax within one (1)
|
b.
|
For all other SAE reports that relate to events that are Unexpected and Assessed as “Related,” “Probably Related,” or “Possibly Related” to the Study Product
by the investigator
, an initial a notification within one (1) Business Day of the date of first report receipt by the relevant Party accompanied by a MedWatch or CIOMS I Form, completed insofar as possible, within fifteen (15) calendar days after the date of first report receipt by the relevant Party, or at the time of submission to Regulatory Authorities, whichever comes first. Follow up information that represents a significant update or clarification will be provided concurrent with submission to Regulatory Authorities, which will be within fifteen (15) days of receipt of the relevant information.
|
c.
|
Other SAE reports, regardless of relationship, will be notified to Novavax by the 15
th
of each calendar month by means of a line listing to include all serious adverse event reports received by the Collaborator that month for recipients of any test article containing (or potentially containing, if blinded) Matrix-M™ adjuvant administered in conjunction with vaccine antigens or alone. This will include all reports sent according to Sections vi.a and vi.b above, as well as any remaining SAE reports. If applicable, a report that zero (0) SAE reports were received that month will be provided. Novavax will review the line listing received and confirm that all reports that required more detailed notification during the prior month were forwarded according to Sections vi.a and vi.b.
|
v.
|
A line listing of pregnancies that have occurred in clinical trial subjects that have received any test article containing Matrix-M™ adjuvant, and their outcomes, whether or not associated with an adverse outcome, to be updated monthly as per the listing of SAE reports.
|
vi.
|
The results of any safety signal detection analysis, within one (1) week of any new finding.
|
b.
|
Novavax Obligations:
Novavax agrees to use Commercially Reasonable Efforts to provide to Collaborator the following information arising from all development programs utilizing the Matrix-M™ adjuvant, which information, in the case of clinical trials and safety reports arising from clinical trials, will not contain any “individually identifiable health information,” as that term is defined for purposes of HIPAA, except as expressly permitted by Applicable Law and with prior notice to the other Party:
|
1.
|
A cumulative Matrix-M™ safety brochure, to be updated not less than annually and which will include:
|
i.
|
A brief summary of in-vitro or
in-vivo
data relating to the proposed mechanism of action of Matrix-M™;
|
ii.
|
A summary of any substantive manufacturing changes since the last edition;
|
iii.
|
A tabular summary of all known GLP-compliant non-clinical safety studies with number of animals, species/strain, number and timing of doses and dose level of Matrix-M™, antigen category (e.g., recombinant protein, inactivated whole virus, etc.) and summary results;
|
iv.
|
A summary of any safety signals arising from any GLP-compliant or non-GLP non-clinical safety studies,
|
v.
|
A tabular summary of all clinical trials using Matrix-M™ (whether sponsored by Novavax or a Collaborator) with number of subjects, age and gender, number and timing of doses and dose level of Matrix-M™, antigen category (e.g., recombinant protein, inactivated whole virus, etc.) and status (completed, in progress, etc.);
|
vi.
|
A summary of local and systemic solicited reactogenicity in completed studies including Matrix-M™ and carried out by Novavax (so limited so as to utilize a consistent panel of solicited terms and grading scale);
|
vii.
|
A summary of unsolicited adverse events in completed studies including Matrix-M™;
|
viii.
|
A tabulation of SAEs reported to Novavax in clinical trial subjects in completed clinical trials known to have received Matrix-M™, or a blinded treatment in an ongoing trial that may include Matrix-M™;
|
ix.
|
A summary of any clinical holds, voluntary treatment holds, or similar significant actions relating to the safety of Matrix-M™ that are taken by Novavax or any other Third Party including another Collaborator, an investigational site, ethical review board, or safety monitoring body, or by a Regulatory Authority.
|
2.
|
Reports of new Serious and Unexpected Serious Adverse Reactions (SUSARs) in Novavax clinical trials, or in clinical trials conducted by Third Parties and reported to Novavax, in the categories specified in section 6.A.2.iv.a and 6.A.iv.b. and within the time fames provided therein.
|
3.
|
Notice of any clinical holds, voluntary treatment holds, or similar significant actions relating to the safety of Matrix-M™ taken by Novavax or a Third party such as another Collaborator, an investigational site, ethical review board, safety monitoring body, or Regulatory Authority. Notice will be transmitted within one (1) Business Day after Novavax becomes aware of the clinical hold or significant action.
|
4.
|
The result of any safety signal detection analysis within one (1) week of any new finding.
|
7.
|
Obligations with Regard to Expedited Reporting of SAEs:
Each party will report serious and unexpected suspected adverse drug reactions (“
SUSARs
”) to relevant Regulatory Authorities on timelines which conform with requirements of the most current revision of ICH Harmonized Tripartite Guidelines E2A and E2B(R2), United States 21CFR312.32, or local requirements in any jurisdiction supporting clinical trials, whichever is more stringent. As per 21CFR 312.32, should either Party propose to withhold expedited reporting to a U.S. IND of any qualifying event which is assessed by
the investigator
as at least possibly related to Study Product, such Party will notify the other Party prior to expiration of the relevant reporting interval.
|
8.
|
Notification and Acknowledgement of Safety Information:
Notification will be made to each Party’s Contacts listed in Section 11. Each Party must acknowledge receipt of Safety Data, in writing by e-mail, within 24 hours. If receipt is not acknowledged within this timeframe, the Safety Data will be resent.
|
9.
|
Semi-annual Meetings:
The Parties agree to establish safety update meetings on at least a semiannual basis or more frequently as circumstances may necessitate. At these meetings, each Party will present, for each development program within the scope of this Safety Data Exchange Agreement:
|
a.
|
A summary of all serious adverse events, overall and during the period, in recipients of Matrix-M™ or a blinded treatment in an ongoing trial that may include Matrix-M™, including a separate summary of those SAEs that were either fatal or life threatening, or unexpected in nature, AND assessed by the investigator as possibly or probably related to a test article containing, or potentially containing, Matrix-M™ adjuvant;
|
b.
|
A summary of any completed GLP-compliant non-clinical safety studies;
|
c.
|
A summary of any safety signal detection exercise and/or any observed significant imbalances in adverse event rates observed in clinical trials, and;
|
d.
|
A summary of any reviews of, or actions regarding, product safety data carried out by third parties (sites, ethical review boards, safety monitoring committees, regulators).
|
10.
|
Binding on Affiliates and Sublicenses:
The terms of this Safety Data Exchange Agreement will be binding upon each Party’s Affiliates and Collaborator’s Sublicensees. Accordingly, each sublicense granted by Collaborator to a Sublicensee pursuant to the Section 3.1.5 of the License Agreement shall be subject and subordinate to the terms and conditions of this this Safety Data Exchange Agreement and contain terms and conditions consistent with those herein.
|
11.
|
Contacts:
Contact details for the exchange of the information specified in this Safety Data Exchange Agreement are provided below:
|
1.
|
BACKGROUND
|
1.1.
|
REGENTS has an assignment of the ESCHERICHIA COLI K12 TO DELIVER PROTEIN TO THE MACROPHAGE CYTOSOL invented by Daniel Portnoy, Ph.D. and Darren Higgins, Ph.D., employed by the University of California, Berkeley (the “INVENTION”), as described in REGENTS’ Case No. B98-039 and to the patents and patent applications under REGENTS’ PATENT RIGHTS as defined below, which are directed to the INVENTION.
|
1.2.
|
LICENSEE has discussed with REGENTS its commercialization strategy for the INVENTION and business strategy in order to evaluate its capabilities as a LICENSEE.
|
1.3.
|
The development of the INVENTION was sponsored in part by various grants by U.S. Government agencies, and as a consequence, REGENTS elected to retain title to the INVENTION subject to the rights of the U.S. Government under 35 USC 200-212 and implementing regulations, including that REGENTS, in turn, has granted back to the U.S. Government a non-exclusive, non-transferable irrevocable, paid-up license to practice or have practiced the INVENTION for or on behalf of the U.S. Government throughout the world. This U.S. Government grant is NIH Contract No. R01 A127655-10.
|
1.4.
|
REGENTS and LICENSEE wish to have the INVENTION perfected and marketed as soon as possible so that products resulting therefrom may be available for public use and benefit.
|
1.5.
|
LICENSEE wishes to acquire a license under REGENTS’ PATENT RIGHTS for the purpose of undertaking development and to manufacture, use, sell, offer for sale and import LICENSED PRODUCTS as defined below.
|
2.
|
DEFINITIONS
|
2.1.
|
“Regents’ Patent Rights” means the following patents and patent applications:
|
(a)
|
U.S. patent 6,004,815 (U.C. Case No.: B98-039-1) issued on Dec. 21, 1999 as “Bacteria Expressing Nonsecreted Cytolysin as Intracellular Microbial Delivery Vehicles to Eukaryotic Cells”; and
|
(b)
|
U.S. patent 6,287,556 (U.C. Case No.: B98-039-2) issued on Sept. 11, 2001 as “Intracellular Delivery Vehicles”; and
|
(c)
|
U.S. patent 6,599,502 (U.C. Case No.: B98-039-3) issued on July 29, 2003 as “Intracellular Delivery Vehicles”; and
|
(d)
|
U.S. patent application serial number 10/627,452 (U.C. Case No.: B98-039-4) entitled, “Intracellular Delivery Vehicles” filed on July 25, 2003 and any patents issuing therefrom; and
|
(e)
|
and/or any patents or patent applications, including, divisions, continuations, continued prosecution applications, all renewals, reissues, and extensions, re-examinations or claims in continuations-in-part applications, that are entitled to the priority filing date of any of the above-referenced U.S. patents or applications or substitutes for such patents or applications.
|
2.2.
|
“LICENSED PRODUCTS” means any product, apparatus, or kit or component part thereof or other material (i) produced by, or used in the practice of the Licensed Method, or (ii) the manufacture, sale, offer for sale or import of which, in either case in the absence of the license agreement, would be an infringement of:
|
(a)
|
A valid claim of any issued, unexpired patent within Regents’ Patent Rights. A claim within Regents’ Patent Rights shall be presumed to be valid unless and until it has been held to be invalid by a final judgment of a court of competent jurisdiction from which no appeal can be or is taken; or
|
(b)
|
A claim being prosecuted in a patent application that has been pending for less than five years (provided that Regents are pursuing such claim in good faith) within Regents’ Patent Rights directed to the Invention (collectively (a) and (b), a “Valid Claim”).
|
2.3.
|
“LICENSED METHOD” means any method or process that is covered by Regents’ Patent Rights, or any method or process the use or practice of which would constitute an infringement of any Valid Claims within Regents’ Patent Rights.
|
2.4.
|
“LICENSED FIELD OF USE” means all fields.
|
2.5.
|
“NET SALES” means the gross invoice amount actually received by, and the value of non-cash consideration actually supplied to, LICENSEE for SALES of LICENSED PRODUCTS, LICENSED SERVICES, and LICENSED METHODS, less the sum of the following actual and customary deductions where applicable: cash, trade or quantity discounts; sales, use, tariff, import/export duties or other excise taxes when included in gross sales, but not value-added taxes assessed or income taxes derived from such sales; transportation charges; and allowances or credits to customers because of rejections or returns. For purposes of calculating NET SALES, a SALE to a sublicensee for end use by the sublicensee will be treated as a SALE at list price.
|
2.6.
|
“AFFILIATE” of LICENSEE means any entity that, directly or indirectly, Controls LICENSEE, is Controlled by LICENSEE, or is under common Control with LICENSEE. “Control” means (i) having the actual, present capacity to elect a majority of the directors of such affiliate, (ii) having the power to direct more than fifty percent (50%) of the voting rights entitled to elect directors, or (iii) in any country where the local law will not permit foreign equity participation of a majority, ownership or control, directly or indirectly, of the maximum percentage of such outstanding stock or voting rights permitted by local law.
|
2.7.
|
“LICENSED TERRITORY” means United States of America, its territories and possessions, and any foreign countries where REGENTS’ PATENT RIGHTS are filed.
|
2.8.
|
“SALE” means, for LICENSED PRODUCTS and LICENSED SERVICES, the act of selling, leasing or otherwise transferring, providing, or furnishing such product or service, and for LICENSED METHOD, the act of performing such method, for any use or for any consideration. Correspondingly, “SELL” means to make or cause to be made a SALE, and “SOLD” means to have made or caused to be made a SALE.
|
2.9.
|
“LICENSED SERVICE” means a service provided using Licensed Products or Licensed Method. This excludes research funding, FTEs and like support.
|
2.10.
|
“DERIVED PRODUCT(S)” means any product which includes but is not limited to a polypeptide or nucleotide sequence, biological organism, or chemical entity identified in the practice of Licensed Method or Licensed Service(s).
|
2.11.
|
“Technology in Screening Capacity” means the practice of LICENSED METHOD to identify any polynucleotide, polypeptide, biological organism, or chemical entity in isolation or as a component of other matter.
|
3.
|
GRANT
|
3.1.
|
Subject to the limitations set forth in this Agreement, including the license granted to the U.S. Government and the rights reserved in Paragraph 3.3, REGENTS hereby grants and LICENSEE hereby accepts an exclusive license under REGENTS’ PATENT RIGHTS to make, use, offer for SALE, import, and SELL LICENSED PRODUCTS and LICENSED SERVICES, and to practice LICENSED METHOD, in the LICENSED FIELD OF USE in the LICENSED TERRITORY.
|
3.2.
|
The licenses under Paragraph 3.1 will be exclusive for a term commencing on the Effective Date and ending on the date of the last-to-expire patent or last to be abandoned patent application licensed under REGENTS’ PATENT RIGHTS, whichever is later.
|
3.3.
|
Nothing in this Agreement will be deemed to limit the right of REGENTS to publish any and all technical data resulting from any research performed by REGENTS relating to the INVENTION, and to make and use the INVENTION, LICENSED PRODUCTS, and LICENSED SERVICES and practice LICENSED METHOD and associated technology and to allow other educational and non-profit institutions to do so for educational and research purposes.
|
3.4.
|
LICENSEE will have a continuing responsibility to keep REGENTS informed of the large/small entity status, as defined in 15 U.S.C. 632, of itself and its sublicensees.
|
3.5.
|
The INVENTION was funded in part by the U.S. Government. In accordance with 35 USC 200-212 and implementing regulations, to the extent required by law or regulation, any products covered by patent applications or patents claiming the INVENTION and sold in the United States will be substantially manufactured in the United States.
|
4.
|
SUBLICENSES
|
4.1
|
REGENTS also grants to LICENSEE the right to sublicense to third parties the
|
(a)
|
a statement setting forth the date upon which LICENSEE’s exclusive rights, privileges, and license hereunder will expire; and
|
(b)
|
as applicable, all the rights of, and require the performance of all the obligations due to, REGENTS (and, if applicable, the United States Government) under this Agreement other than those rights and obligations specified in Article 5 (License Issue Fee) and Article 6 (Royalties and Milestones).
|
4.2.
|
LICENSEE will pay to REGENTS [* * *] of any cash consideration, and of the cash equivalent of all other consideration, due to LICENSEE for the grant of rights under each sublicense if the Sublicense only conveys rights to the Regents’ Patent Rights. If a Sublicense conveys rights to patents other than Regents’ Patent Rights then LICENSEE will pay to REGENTS [* * *] of any cash consideration, and of the cash equivalent of all other consideration that is due to LICENSEE. Sublicense revenue shall not include any amounts received by LICENSEE for equity, debt, research and development, the license or sublicense of any intellectual property other than the Regents’ Patent Rights, or reimbursement for patent or other expenses.
|
4.3.
|
LICENSEE will notify REGENTS of each sublicense granted hereunder and furnish to REGENTS a copy of each such sublicense agreement.
|
4.4.
|
For purposes of this Agreement LICENSEE shall be deemed to include all its AFFILIATES and SALES by AFFILIATES shall be treated the same as SALES by LICENSEE.
|
4.5.
|
For the purposes of this Agreement, the operations of all sublicensees and AFFILIATES shall be deemed to be the operations of LICENSEE, for which LICENSEE shall be responsible.
|
4.6.
|
LICENSEE will collect and guarantee payment of all monies and other consideration due REGENTS from sublicensees and AFFILIATES, and deliver all reports due REGENTS and received from sublicensees and AFFILIATES.
|
4.7.
|
Upon termination of this Agreement for any reason, all sublicenses that are granted by LICENSEE pursuant to this Agreement where the sublicensee is in compliance with its sublicense agreement as of the date of such termination will remain in effect and will be assigned to REGENTS, except that REGENTS will not be bound to perform any duties or obligations set forth in any sublicenses that extend beyond the duties and obligations of REGENTS set forth in this Agreement.
|
4.8.
|
If after five (5) years from Effective Date, REGENTS (to the extent of the actual knowledge of the licensing professional responsible for administration of this case) or a third party discovers and notifies that licensing professional that the INVENTION is useful for an application covered by the LICENSED FIELD OF USE other than human therapeutics, prophylactics or diagnostics or derivative animal therapeutics, prophylactics, or diagnostics (the “New Application”), but for which LICENSED PRODUCTS have not been developed or are not currently under development by LICENSEE, then REGENTS, as represented by the Office of Technology Licensing, shall give written notice to LICENSEE, except for: 1) information that is subject to restrictions of confidentiality with third parties, and 2) information which originates with REGENTS’ personnel who do not assent to its disclosure to LICENSEE, unless LICENSEE agrees to hold such information in confidence.
|
5.
|
LICENSE ISSUE FEE
|
5.1.
|
Upon execution of this Agreement, LICENSEE shall pay to REGENTS an upfront fee of $[* * *] due on the Effective Date of this Agreement.
|
6.
|
ROYALTIES AND MILESTONES
|
6.1.
|
In countries where manufacture, sale, offer for sale, import, or use of Licensed Products is [* * *], the royalty rate shall be:
|
6.2.
|
Combined Product Adjustment:
|
(a)
|
[* * *]; or
|
(b)
|
[* * *].
|
6.3.
|
Royalties to Third Parties:
|
6.4.
|
Royalties accruing to REGENTS will be paid to REGENTS quarterly within sixty (60) days after the end of each calendar quarter.
|
6.5.
|
LICENSEE shall pay a maintenance fee of $[* * *] due on the third anniversary of Effective Date and annually thereafter. No further maintenance fees shall be due following the first occurrence of Net Sales of Licensed Product(s) or Licensed Service(s) provided the annual Net Sales of Licensed Services exceed $[* * *].
|
6.6.
|
All payments due REGENTS will be payable in United States dollars. When LICENSED PRODUCTS, LICENSED SERVICES, or LICENSED METHOD are SOLD for monies other than United States dollars, earned royalties will first be determined in the foreign currency of the country in which the SALE was made and then converted into equivalent United States dollars. The exchange rate will be that rate quoted in the
Wall Street Journal
on the last business day of the reporting period.
|
6.7.
|
Payments due for SALES occurring in any country outside the United States will not be reduced by any taxes, fees, or other charges imposed by the government of such country on the remittance of royalty income. LICENSEE will also be responsible for all bank transfer charges.
|
6.8.
|
LICENSEE will make all payments under this Agreement by check payable to “The Regents of the University of California” and forward it to REGENTS at the address shown in Article 23 (Notices).
|
6.9.
|
If any patent or patent application, or any claim thereof, included within REGENTS’ PATENT RIGHTS expires or is held invalid in a final decision by a court of competent jurisdiction and last resort and from which no appeal has been or can be taken, all obligation to pay royalties based on such patent, patent application or claim, or any claims patentably indistinct therefrom will cease as of the date of such expiration or final decision. LICENSEE will not, however, be relieved from paying any royalties that accrued before such expiration or decision or that are based on another Valid Claim not expired or involved in such decision.
|
6.10.
|
No earned royalties will be collected or paid hereunder on SALES to, or for use by, the United States Government.
|
6.11.
|
Milestone Payments for Licensed Product(s):
|
(a)
|
Licensee shall pay to Regents a milestone payment of [* * *] upon [* * *] for the first Licensed Product by LICENSEE and [* * *] for [* * *] for each subsequent Licensed Product which is a chemically or biologically distinct compound or biologic by LICENSEE. The above payments in this Paragraph 6.11(a) for any given chemical or biological entity will only be paid once.
|
(b)
|
Licensee shall pay to Regents a milestone payment of [* * *] upon [* * *] by LICENSEE and [* * *] for [* * *] that is a chemically or biologically distinct compound or biologic by LICENSEE. The above payments for any given chemical or biological entity will only be paid once. The above payments in this Paragraph 6.11(b) for any given chemical or biological entity will only be paid once.
|
7.
|
DUE DILIGENCE
|
7.1.
|
LICENSEE shall provide Commercialization and Development plans to REGENTS in form similar to that provided to LICENSEE’s Board of Directors or investors.
|
7.2.
|
LICENSEE, upon execution of this Agreement, will diligently proceed with the development, manufacture, and SALE of LICENSED PRODUCTS, LICENSED SERVICES, and LICENSED METHOD, and will diligently market them in quantities sufficient to meet the market demand.
|
7.3.
|
LICENSEE shall be deemed to be diligently proceeding if it shall (i) fund research and/or development of technology that is reasonably necessary for commercialization of the Regents’ Patent Rights in each calendar year in at least the amounts provided below (such funding shall include internal or external research and/or development funded by or provided for the benefit of LICENSEE (“Research Funding”)), or (ii) successfully commercialize and obtain annual revenues from Licensed Services in at least the amounts provided below.
|
7.4.
|
Subject to overriding obligations to the U.S. Government, if LICENSEE is unable to meet any of its diligence obligations set forth in Paragraphs 7.1, 7.2, 7.3, or 7.4 then REGENTS will so notify LICENSEE of failure to perform. LICENSEE will have the right and option to extend the target date of any such due diligence obligation for a period of six (6) months upon the payment of [* * *] within thirty (30) days of the date to be extended for each such extension option exercised by LICENSEE. LICENSEE may further extend the target date of any diligence obligation for an additional six (6) months upon payment of an additional [* * *]. Additional extensions may be granted only by mutual written agreement of the parties to this Agreement. These payments are in addition to the minimum royalty payments specified in Paragraph 6.1. Should LICENSEE opt not to extend the diligence obligation or fail to meet it by the extended target date, then REGENTS will have the right and option either to terminate this Agreement at any time after 10 years from the effective date or to reduce LICENSEE’s exclusive license to a non-exclusive royalty-bearing license at any time after 3 years from the effective date. This right, if exercised by REGENTS, supersedes the rights granted in Article 3. The right to terminate this Agreement or reduce LICENSEE’s exclusive license granted hereunder to a non-exclusive license will be REGENTS sole remedy for breach of this Article 7.
|
7.5.
|
At the request of either party, any controversy or claim arising out of or relating to the diligence provisions of this Article 7 will be settled by arbitration conducted in San Francisco, California in accordance with the then current Licensing Agreement Arbitration Rules of the American Arbitration Association. Judgment upon the award rendered by the arbitrator(s) will be binding on the parties and may be entered by either party in the court or forum having jurisdiction. In determination of due diligence, the arbitrator may determine solely the issues of fact or law with respect to termination of LICENSEE’s rights under this Agreement but will not have the authority to award monetary damages or grant equitable relief.
|
7.6.
|
To exercise either the right to terminate this Agreement or to reduce the license to a non-exclusive license for lack of diligence under Paragraph 7.4, REGENTS will give LICENSEE written notice of the deficiency. LICENSEE thereafter has sixty (60) days to cure the deficiency or to request arbitration. If REGENTS has not received a written request for arbitration or satisfactory tangible evidence that the deficiency has been cured by the end of the sixty (60) - day period, then REGENTS may, at its option, either terminate the Agreement at any time after 10 years from the effective date or reduce LICENSEE’s exclusive license to a non-exclusive license at any time after 3 years from the effective date by giving written notice to LICENSEE. These notices will be subject to Article 23 (Notices).
|
8.
|
PROGRESS AND ROYALTY REPORTS
|
8.1.
|
For the period beginning January 1
st
2007, LICENSEE will submit to REGENTS a semi-annual progress report covering LICENSEE’s activities related to the development and testing of all LICENSED PRODUCTS, LICENSED SERVICES and LICENSED METHOD and the obtaining of necessary governmental approvals, if any, for marketing in the United States. These progress reports will be made for all development activities until the first SALE occurs in the United States.
|
8.2.
|
Each progress report will be a detailed summary of activities of LICENSEE’s progress in development of LICENSED PRODUCTS, LICENSED SERVICES, and LICENSED METHOD, and in meeting its diligence obligations under Article 7 similar in form to what LICENSEE presents to its Board of Directors or investors, and will include the following: summary of work completed and in progress; current schedule of anticipated events and milestones, including diligence milestones under Paragraph 7.4.
|
8.3.
|
LICENSEE also will report to REGENTS in its immediately subsequent progress and royalty reports, the date of first SALE.
|
8.4.
|
After the first SALE anywhere in the world, LICENSEE will make quarterly royalty reports to REGENTS within sixty (60) days after the quarters ending March 31, June 30, September 30, and December 31, of each year. Each such royalty report will include at least the following:
|
(a)
|
The number of LICENSED PRODUCTS manufactured and the number SOLD;
|
(b)
|
Gross revenue from SALE of LICENSED PRODUCTS, LICENSED SERVICES and LICENSED METHOD;
|
(c)
|
NET SALES pursuant to Paragraph 2.5;
|
(d)
|
Total royalties due REGENTS; and
|
(e)
|
Names and addresses of any AFFILIATES with activities falling under this Agreement, and new sublicensees along with a summary of the material terms of each new sublicense agreement entered into during the reporting quarter.
|
8.5.
|
If no SALES have occurred during the report period, a statement to this effect is required in the royalty report for that period.
|
9.
|
BOOKS AND RECORDS
|
9.1.
|
LICENSEE will keep full, true, and accurate books of accounts containing all particulars that may be necessary for the purpose of showing the amount of royalties payable to REGENTS and LICENSEE’s compliance with other obligations under this Agreement. Said books of accounts will be kept at LICENSEE’s principal place of business or the principal place of business of the appropriate division of LICENSEE to which this Agreement relates. Said books and the supporting data will be open at all reasonable times during normal business hours upon reasonable notice, for five (5) years following the end of the calendar year to which they pertain, to the inspection and audit by representatives of REGENTS for the purpose of verifying LICENSEE’s royalty statement or compliance in other respects with this Agreement but not more often than once in any twelve (12) month period. Such representative will be bound to hold all information in confidence except as necessary to communicate LICENSEE’s non-compliance with this Agreement to REGENTS.
|
9.2.
|
The fees and expenses of REGENTS’ representatives performing such an examination will be borne by REGENTS. However, if an error in underpaid royalties to REGENTS of more than five percent (5%) of the total royalties due for any year is discovered, then the fees and expenses of these representatives will be borne by LICENSEE.
|
10.
|
LIFE OF THE AGREEMENT
|
10.1.
|
Unless otherwise terminated by the operation of law or by acts of the parties in accordance with the terms of this Agreement, this Agreement will be in force from the Effective Date and will remain in effect for the life of the last-to-expire patent or last-to-be-abandoned patent application licensed under this Agreement, whichever is later.
|
10.2.
|
Any termination of this Agreement shall not affect the rights and obligations set forth in the following articles:
|
10.3.
|
Any termination of this Agreement will not relieve LICENSEE of its obligation to pay any monies due or owing at the time of such termination and will not relieve any obligations, of either party to the other party, established prior to termination.
|
11.
|
TERMINATION BY REGENTS
|
11.1.
|
If LICENSEE should violate or fail to perform any term of this Agreement in any material respect, then REGENTS may give written notice of such default (“Notice of Default”) to LICENSEE. If LICENSEE should fail to repair such default or to request arbitration in the case of breach of a diligence requirement under Article 7 within sixty (60) days of the effective date of such notice, REGENTS will have the right to terminate this Agreement and the licenses herein by a second written notice (“Notice of Termination”) to LICENSEE. If LICENSEE shall request arbitration in the case of breach of a diligence requirement under Article 7, this Agreement may not be terminated by REGENTS until such Arbitration is resolved. If a Notice of Termination is sent to LICENSEE, this Agreement will automatically terminate on the effective date of such notice. Such termination will not relieve LICENSEE of its obligation to pay any royalty or license fees owing at the time of such termination and will not impair any accrued rights of REGENTS. These notices will be subject to Article 23 (Notices).
|
12.
|
TERMINATION BY LICENSEE
|
12.1.
|
LICENSEE will have the right at any time to terminate this Agreement in whole or as to any portion of REGENTS’ PATENT RIGHTS by giving notice in writing to REGENTS. Such notice of termination will be subject to Article 23 (Notices) and termination of this Agreement will be effective thirty (30) days after the effective date of such notice.
|
12.2.
|
Any termination pursuant to Paragraph 12.1 will not relieve LICENSEE of any obligation or liability accrued hereunder prior to such termination or rescind anything done by LICENSEE or any payments made to REGENTS hereunder prior to the time such termination becomes effective, and such termination will not affect in any manner any rights of REGENTS arising under this Agreement prior to such termination.
|
13.
|
DISPOSITION OF LICENSED PRODUCTS UPON TERMINATION
|
13.1.
|
Upon termination of this Agreement, for a period of one hundred and eighty (180) days after the date of termination LICENSEE may complete and SELL any partially made LICENSED PRODUCTS and continue to render any previously commenced LICENSED SERVICES, and continue the practice of LICENSED METHOD only to the extent necessary to do so; provided, however, that all such SALES will be subject to the terms of this Agreement including, but not limited to, the payment of royalties at the rate and at the time provided herein and the rendering of reports thereon.
|
14.
|
PATENT PROSECUTION AND MAINTENANCE
|
14.1.
|
REGENTS will diligently prosecute and maintain the United States and foreign patent applications and patents under REGENTS’ PATENT RIGHTS, subject to LICENSEE’S reimbursement of REGENTS’ out of pocket costs, and all patent applications and patents under REGENTS’ PATENT RIGHTS will be held in the name of REGENTS. REGENTS will have sole responsibility for retaining and instructing patent counsel, but continued use of such counsel at any point in the patent prosecution process subsequent to initial filing of a U.S. patent application covering the INVENTION shall be subject to the approval of LICENSEE. If LICENSEE rejects three (3) of REGENTS’ choice of prosecution counsel, then REGENTS may select new prosecution counsel without LICENSEE’s consent. REGENTS shall promptly provide LICENSEE with copies of all relevant documentation so that LICENSEE may be currently informed and apprised of the continuing prosecution and LICENSEE agrees to keep this documentation confidential. LICENSEE may comment upon such documentation and REGENTS and its patent counsel shall consider such comments in good faith, provided, however, that if LICENSEE after having been provided such documentation has not commented upon such documentation in reasonable time for REGENTS to sufficiently consider LICENSEE’s comments prior to the deadline for filing a response with the relevant government patent office, REGENTS will be free to respond appropriately without consideration of LICENSEE’s comments. LICENSEE and LICENSEE’s patent counsel will have the right to consult with patent counsel chosen by REGENTS.
|
14.2.
|
REGENTS will use reasonable efforts to prepare or amend any patent application to include claims reasonably requested by LICENSEE to protect the LICENSED PRODUCTS contemplated to be SOLD or to be practiced under this Agreement.
|
14.3.
|
Subject to Paragraph 14.4, all past, present, and future costs for preparing, filing, prosecuting, and maintaining all United States and foreign patent applications, and patents under REGENTS’ PATENT RIGHTS will be borne by LICENSEE, so long as the licenses granted to LICENSEE herein are exclusive. LICENSEE will fully reimburse REGENTS for half of all outstanding patent costs within three (3) months of Effective Date and the remainder within nine (9) months of Effective Date.
|
14.4.
|
LICENSEE’s obligation to underwrite and to pay all domestic and foreign patent filing, prosecution, and maintenance costs will continue for so long as this Agreement remains in effect, provided, however, that LICENSEE may terminate its obligations with respect to any given patent application or patent in any or all designated countries upon three (3) months’ written notice to REGENTS. REGENTS will use its best efforts to curtail patent costs when such a notice is received from LICENSEE. REGENTS may continue prosecution and/or maintenance of such applications or patents at its sole discretion and expense; provided, however, that LICENSEE will have no further right or licenses thereunder.
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15.
|
MARKING
|
15.1.
|
LICENSEE will mark all products made, used or SOLD under this Agreement, or their containers, in accordance with applicable patent marking laws.
|
16.
|
USE OF NAMES AND TRADEMARKS
|
16.1.
|
Nothing contained in this Agreement will be construed as conferring any right to use in advertising, publicity or other promotional activities any name, trademark, trade name, or other designation of either party hereto by the other (including any contraction, abbreviation, or simulation of any of the foregoing). Unless required by law or consented to in writing by REGENTS, the use by LICENSEE of the name “The Regents of the University of California” or the name of any University of California campus in advertising, publicity or other promotional activities is expressly prohibited.
|
17.
|
LIMITED WARRANTIES
|
17.1.
|
REGENTS warrants to LICENSEE that it has the lawful right to grant this license and, to the extent of the actual knowledge of the licensing professional responsible for administering this Agreement as of the Effective Date, that it is the sole owner of all right, title, and interest in and to the Invention.
|
17.2.
|
This license and the associated INVENTION are provided WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESSED OR IMPLIED. REGENTS MAKES NO REPRESENTATION OR WARRANTY THAT THE INVENTION, REGENTS’ PATENT RIGHTS, LICENSED PRODUCTS, LICENSED SERVICES OR LICENSED METHOD WILL NOT INFRINGE ANY PATENT OR OTHER PROPRIETARY RIGHT.
|
17.3.
|
IN NO EVENT WILL REGENTS BE LIABLE FOR ANY INCIDENTAL, SPECIAL OR CONSEQUENTIAL DAMAGES RESULTING FROM EXERCISE OF THIS LICENSE OR THE USE OF THE INVENTION, REGENTS’ PATENT RIGHTS, LICENSED METHOD, LICENSED SERVICES OR LICENSED PRODUCTS.
|
17.4.
|
Nothing in this Agreement is or will be construed as:
|
(a)
|
A warranty or representation by REGENTS as to the validity, enforceability or scope of any REGENTS PATENT RIGHTS; or
|
(b)
|
A warranty or representation that anything made, used, or SOLD under any license granted in this Agreement is or will be free from infringement of patents of third parties; or
|
(c)
|
An obligation to bring or prosecute actions or suits against third parties for patent infringement, except as provided in Article 18; or
|
(d)
|
Conferring by implication. estoppel, or otherwise any license or rights under any patents of REGENTS other than REGENTS’ PATENT RIGHTS as defined herein, regardless of whether such patents are dominant or subordinate to REGENTS’ PATENT RIGHTS; or
|
(e)
|
An obligation to furnish any know-how not provided in the patents and patent applications under REGENTS’ PATENT RIGHTS.
|
18.
|
PATENT INFRINGEMENT
|
18.1.
|
In the event that LICENSEE learns of the substantial infringement of any REGENTS’ PATENT RIGHTS under this Agreement, LICENSEE will promptly provide REGENTS with notice and reasonable evidence of such infringement (“Infringement Notice”). During the period and in a jurisdiction where LICENSEE has exclusive rights under this Agreement, neither party will notify a third party, including the infringer, of the infringement without first obtaining consent of the other party, which consent will not be unreasonably withheld. Both parties will use diligent efforts, in cooperation with each other, to terminate such infringement without litigation.
|
18.2.
|
If the infringing activity of potential commercial significance has not been abated within ninety (90) days following the effective date of the Infringement Notice, LICENSEE may institute suit for patent infringement against the infringer. REGENTS may voluntarily join such suit at its own expense, but may not thereafter commence suit against the infringer for the acts of infringement that are the subject of LICENSEE’s suit or any judgment rendered in that suit. LICENSEE may not join REGENTS in a suit initiated by LICENSEE without REGENTS’ prior written consent. If, in a suit initiated by LICENSEE, REGENTS is involuntarily joined other than by LICENSEE, LICENSEE will pay any costs incurred by REGENTS arising out of such suit, including but not limited to, any legal fees of counsel that REGENTS selects and retains to represent it in the suit who shall be reasonably acceptable to LICENSEE, provided that if LICENSEE rejects two (2) of REGENTS choices of legal counsel then REGENTS may select such counsel without LICENSEE’S consent.
|
18.3.
|
If, within a hundred and twenty (120) days following the effective date of the Infringement Notice, the infringing activity of potential commercial significance has not been abated and if LICENSEE has not brought suit against the infringer, REGENTS may institute suit for patent infringement against the infringer. If REGENTS institutes such suit, LICENSEE may not join such suit without REGENTS’ consent and may not thereafter commence suit against the infringer for the acts of infringement that are the subject of REGENTS’ suit or any judgment rendered in that suit.
|
18.4.
|
Such legal action as is decided upon will be at the expense of the party on account of whom suit is brought and all recoveries recovered thereby will belong to such party, provided that legal action brought jointly by REGENTS and LICENSEE and participated in by both, will be at the joint expense of the parties and all recoveries will be allocated in the following order: a) to each party reimbursement in equal amounts of the attorney’s costs, fees, and other related expenses to the extent each party paid for such costs, fees, and expenses until all such costs, fees, and expenses are consumed for each party; and b) any remaining amount shared jointly by them in proportion to the share of expenses paid by each party, but in no event will REGENTS’ share be less than ten percent (10%) of such remaining amount if REGENTS is a party.
|
18.5.
|
Any agreement made by LICENSEE for the purposes of settling litigation or other dispute shall comply with the requirements of Article 4 (Sublicenses) of this Agreement.
|
19.
|
INDEMNIFICATION
|
19.1.
|
LICENSEE will, and will require its sublicensees to, indemnify, hold harmless, and defend REGENTS and its officers, employees, and agents; sponsor(s) of the research that led to the INVENTION; and the inventors of any patents and patent applications under REGENTS PATENT RIGHTS and their employers against any and all claims, suits, losses, damages, costs, fees, and expenses resulting from or arising out of exercise of this license or any sublicense. This indemnification will include, but not be limited to, any product liability.
|
19.2.
|
LICENSEE, at its sole cost and expense, will insure its activities in connection with any work performed hereunder and will obtain, keep in force, and maintain the following insurance:
|
(a)
|
Commercial Form General Liability Insurance (contractual liability included) with limits as follows:
|
(b)
|
Worker’s Compensation as legally required in the jurisdiction in which LICENSEE is doing business.
|
19.3.
|
The coverage and limits referred to in Subparagraphs 19.2a and 19.2b above will not in any way limit the liability of LICENSEE under this Article. Upon the execution of this Agreement, LICENSEE will furnish REGENTS with certificates of insurance evidencing compliance with all requirements. Such certificates will:
|
(a)
|
provide for thirty (30) days’ (ten (10) days for non-payment of premium) advance written notice to REGENTS of any cancellation of insurance coverages; LICENSEE will promptly notify REGENTS of any material modification of the insurance coverages;
|
(b)
|
indicate that REGENTS has been endorsed as an additional insured under the coverage described above in Subparagraph 19.2; and
|
(c)
|
include a provision that the coverage will be primary and will not participate with, nor will be excess over, any valid and collectable insurance or program of self-insurance maintained by REGENTS.
|
19.4.
|
REGENTS will promptly notify LICENSEE in writing of any claim or suit brought against REGENTS for which REGENTS intends to invoke the provisions of this Article 19. LICENSEE will keep REGENTS informed of its defense of any claims pursuant to this Article 19.
|
20.
|
EXPORT CONTROLS
|
20.1.
|
LICENSEE understands that REGENTS is subject to United States laws and regulations (including the Arms Export Control Act, as amended, and the Export Administration Act of 1979), controlling the export of technical data, computer software, laboratory prototypes and other commodities, and REGENTS’ obligations under this Agreement are contingent on compliance with such laws and regulations. The transfer of certain technical data and commodities may require a license from the cognizant agency of the United States Government and/or written assurances by LICENSEE that LICENSEE will not export such technical data and/or commodities to certain foreign countries without prior approval of such agency. REGENTS neither represents that a license will not be required nor that, if required, it will be issued.
|
20.2.
|
LICENSEE shall comply with all applicable international, national, state, regional, and local laws and regulations in performing its obligations hereunder and in its use, manufacture, Sale, or import of the LICENSED PRODUCTS, LICENSED SERVICES, or practice of the LICENSED METHOD. LICENSEE will observe all applicable United States and foreign laws with respect to the transfer of LICENSED PRODUCTS and related technical data and the provision of LICENSED SERVICES to foreign countries including without limitation, the International Traffic in Arms Regulations (ITAR) and the Export Administration Regulations. LICENSEE shall manufacture LICENSED PRODUCTS and practice the LICENSED METHOD in compliance with applicable government importation laws and regulations of a particular country for LICENSED PRODUCTS made outside the particular country in which such LICENSED PRODUCTS are used, Sold, or otherwise exploited.
|
21.
|
GOVERNMENT APPROVAL OR REGISTRATION
|
21.1.
|
If this Agreement or any associated transaction is required by the law of any nation to be either approved or registered with any governmental agency, LICENSEE will assume all legal obligations to do so. LICENSEE will notify REGENTS if it becomes aware that this Agreement is subject to a United States or foreign government reporting or approval requirement. LICENSEE will make all necessary filings and pay all costs including fees, penalties, and all other out-of-pocket costs associated with such reporting or approval process.
|
22.
|
ASSIGNMENT
|
22.1.
|
This Agreement is binding upon and shall inure to the benefit of REGENTS, its successors and assigns. This Agreement will be personal to LICENSEE and assignable by LICENSEE only with the written consent of REGENTS, except that LICENSEE may freely assign this Agreement to an acquirer of all or substantially all of LICENSEE’s stock, assets or the portion of LICENSEE’s business to which this Agreement relates.
|
23.
|
NOTICES
|
23.1.
|
All notices under this Agreement will be deemed to have been fully given and effective when done in writing and delivered in person, or mailed by registered or certified U.S. mail, or deposited with a carrier service requiring signature by recipient, and addressed as follows:
|
24.
|
LATE PAYMENTS
|
24.1.
|
If monies owed to REGENTS under this Agreement are not received by REGENTS when due, LICENSEE will pay to REGENTS interest charges at a rate of ten percent (10%) per annum. Such interest will be calculated from the date payment was due until actually received by REGENTS. Such accrual of interest will be in addition to, and not in lieu of, enforcement of any other rights of REGENTS related to such late payment. Acceptance of any late payment will not constitute a waiver under Article 25 (Waiver) of this Agreement.
|
25.
|
WAIVER
|
25.1.
|
The failure of either party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement will not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition by the other party. None of the terms and conditions of this Agreement can be waived except by the written consent of the party waiving compliance.
|
26.
|
CONFIDENTIALITY
|
26.1.
|
Each party will hold the other party’s proprietary business and technical information, patent prosecution material and other proprietary information, including the negotiated terms of this Agreement, in confidence and against disclosure to third parties with at least the same degree of care as it exercises to protect its own data and license agreements of a similar nature. This obligation will expire five (5) years after the termination or expiration of this Agreement.
|
26.2.
|
Nothing contained herein will in any way restrict or impair the right of LICENSEE or REGENTS to use, disclose, or otherwise deal with any information or data which:
|
(a)
|
at the time of disclosure to a receiving party is generally available to the public or thereafter becomes generally available to the public by publication or otherwise through no act of the receiving party;
|
(b)
|
the receiving party can show by written record was in its possession prior to the time of disclosure to it hereunder and was not acquired directly or indirectly from the disclosing party;
|
(c)
|
is independently made available to the receiving party without restrictions as a matter of right by a third party; or
|
(d)
|
is subject to disclosure under the California Public Records Act or other requirements of law.
|
26.3.
|
REGENTS will be free to release to the inventors and senior administrators employed by REGENTS the terms and conditions of this Agreement upon their request. If such release is made, REGENTS will inform such employees of the confidentiality obligations set forth above and will request that they do not disclose such terms and conditions to others. Should a third party inquire whether a license to REGENTS’ PATENT RIGHTS is available, REGENTS may disclose the existence of this Agreement and the extent of the grant in Articles 3 and 4 to such third party, but will not disclose the name of LICENSEE unless LICENSEE has already made such disclosure publicly.
|
26.4.
|
LICENSEE and REGENTS agree to destroy or return to the disclosing party proprietary information received from the other in its possession within fifteen (15) days following the effective date of termination of this Agreement. However, each party may retain one copy of proprietary information of the other solely for archival purposes in non-working files for the sole purpose of verifying the ownership of the proprietary information, provided such proprietary information will be subject to the confidentiality provisions set forth in Article 26. LICENSEE and REGENTS agree to provide each other, within thirty (30) days following termination of this Agreement, with a written notice that proprietary information has been returned or destroyed.
|
27.
|
FORCE MAJEURE
|
27.1.
|
Except for LICENSEE’s obligation to make any payments to REGENTS hereunder, the parties to this Agreement shall be excused from any performance required hereunder if such performance is rendered impossible or unfeasible due to any catastrophes or other major events beyond their reasonable control, including, without limitation, war, riot, and insurrection; laws, proclamations, edicts, ordinances, or regulations; strikes, lockouts, or other serious labor disputes; and floods, fires, explosions, or other natural disasters. When such events have abated, the parties respective obligations hereunder will resume.
|
28.
|
SEVERABILITY
|
28.1.
|
The provisions of this Agreement are severable, and in the event that any provision of this Agreement will be determined to be invalid or unenforceable under any controlling body of law, such invalidity or enforceability will not in any way affect the validity or enforceability of the remaining provisions hereof.
|
29.
|
APPLICABLE LAW; VENUE; ATTORNEYS’ FEES
|
29.1.
|
THIS AGREEMENT WILL BE CONSTRUED, INTERPRETED, AND APPLIED IN ACCORDANCE WITH THE LAWS OF THE STATE OF CALIFORNIA, excluding any choice of law rules that would direct the application of the laws of another jurisdiction, but the scope and validity of any patent or patent application under REGENTS’ PATENT RIGHTS will be determined by the applicable law of the country of such patent or patent application. Any legal action brought by the parties relating to this Agreement will be conducted in San Francisco, California. The prevailing party in any legal action under this Agreement will be entitled to recover its reasonable attorneys’ fees in addition to its costs and necessary disbursements.
|
30.
|
SCOPE OF AGREEMENT
|
30.1.
|
This Agreement incorporates the entire agreement between the parties with respect to the subject matter hereof, and this Agreement may be altered or modified only by written amendment duly executed by the parties hereto.
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Genocea Biosciences, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
/s/ WILLIAM D. CLARK
|
|
William D. Clark
|
|
President & Chief Executive Officer
|
|
|
Date: November 4, 2016
|
|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Genocea Biosciences, Inc.;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a)
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b)
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c)
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures as of the end of the period covered by this report based on such evaluation; and
|
d)
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a)
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b)
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
/s/ JONATHAN POOLE
|
|
Jonathan Poole
|
|
Chief Financial Officer
|
Date: November 4, 2016
|
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
|
/s/ WILLIAM D. CLARK
|
|
William D. Clark*
|
|
President &Chief Executive Officer
|
|
|
Date: November 4, 2016
|
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
|
/s/ JONATHAN POOLE
|
|
Jonathan Poole*
|
|
Chief Financial Officer
|
|
|
Date: November 4, 2016
|
|