British Columbia, Canada
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980597776
|
|
(State or Other Jurisdiction of
Incorporation or Organization)
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(I.R.S. Employer
Identification No.)
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100-8900 Glenlyon Parkway, Burnaby, BC V5J 5J8
(Address of Principal Executive Offices)
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||
604-419-3200
(Registrant’s Telephone Number, Including Area Code):
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||
Securities registered pursuant to Section 12(b) of the Act:
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||
Title of Each Class
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Name of Each Exchange on Which Registered
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Common shares, without par value
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The NASDAQ Stock Market LLC
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Securities registered pursuant to Section 12(g) of the Act:
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Large accelerated filer
o
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Accelerated filer
ý
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Non-accelerated filer
o
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Smaller reporting company
o
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(Do not check if a smaller reporting company)
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Page
|
||
Item
1.
|
Business
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(1)
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Patent information current as of January 8, 2015.
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*
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Priority filing dates are based on the filing dates of provisional patent applications. Provisional applications expire unless they are converted to non-provisional applications within one year.
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**
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An “allowed” patent application is an active case that has been found by the patent office to contain patentable subject matter, subject to the payment of issue/grant fees by the applicant.
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*** | Once issued, the term of a US patent first filed after mid-1995 generally extends until the 20th anniversary of the filing date of the first non-provisional application to which such patent claims priority. It is important to note, however, that the United States Patent & Trademark Office, or USPTO, sometimes requires the filing of a Terminal Disclaimer during prosecution, which may shorten the term of the patent. On the other hand, certain patent term adjustments may be available based on USPTO delays during prosecution. Similarly, in the pharmaceutical area, certain patent term extensions may be available based on the history of the drug in clinical trials. We cannot predict whether or not any such adjustments or extensions will be available or the length of any such adjustments or extensions. |
Item 1A.
|
Risk Factors
|
·
|
execute research and development activities using RNAi technology; and technologies involved in the development of HBV therapeutics;
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·
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build, maintain and protect a strong intellectual property portfolio;
|
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·
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gain acceptance for the development and commercialization of any product we develop;
|
|
·
|
develop and maintain successful strategic relationships; and
|
|
·
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manage our spending and cash requirements as our expenses are expected to increase due to research and preclinical work, clinical trials, regulatory approvals, and commercialization and maintaining our intellectual property portfolio
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·
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we may not be able to attract and build a significant marketing or sales force;
|
|
·
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the cost of establishing a marketing or sales force may not be justifiable in light of the revenues generated by any particular product; and
|
|
·
|
our direct sales and marketing efforts may not be successful.
|
·
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revenues earned from our partners, including Alnylam, Spectrum, Monsanto, and Dicerna;
|
|
·
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revenues earned from our DoD contract to develop TKM-Ebola;
|
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·
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the extent to which we continue the development of our product candidates or form collaborative relationships to advance our products;
|
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·
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our decisions to in-license or acquire additional products or technology for development,
|
|
·
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our ability to attract and retain corporate partners, and their effectiveness in carrying out the development and ultimate commercialization of our product candidates;
|
|
·
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whether batches of drugs that we manufacture fail to meet specifications resulting in delays and investigational and remanufacturing costs;
|
|
·
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the decisions, and the timing of decisions, made by health regulatory agencies regarding our technology and products;
|
|
·
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competing technological and market developments; and
|
|
·
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prosecuting and enforcing our patent claims and other intellectual property rights.
|
·
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controlled research and human clinical testing;
|
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·
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establishment of the safety and efficacy of the product for each use sought;
|
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·
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government review and approval of a submission containing manufacturing, pre-clinical and clinical data;
|
|
·
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adherence to Good Manufacturing Practice Regulations during production and storage; and
|
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·
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control of marketing activities, including advertising and labelling
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·
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decreased demand for our product candidates;
|
|
·
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impairment of our business reputation;
|
|
·
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withdrawal of clinical trial participants;
|
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·
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costs of related litigation;
|
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·
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substantial monetary awards to patients or other claimants;
|
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·
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loss of revenues; and
|
|
·
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inability to commercialize our product candidates.
|
·
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some or all patent applications may not result in the issuance of a patent;
|
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·
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patents issued may not provide the holder with any competitive advantages;
|
|
·
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patents could be challenged by third parties;
|
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·
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the patents of others, including Alnylam, could impede our ability to do business;
|
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·
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competitors may find ways to design around our patents; and
|
|
·
|
competitors could independently develop products which duplicate our products.
|
·
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much greater financial, technical and human resources than we have at every stage of the discovery, development, manufacture and commercialization process;
|
|
·
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more extensive experience in pre-clinical testing, conducting clinical trials, obtaining regulatory approvals, and in manufacturing, marketing and selling pharmaceutical products;
|
|
·
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product candidates that are based on previously tested or accepted technologies;
|
|
·
|
products that have been approved or are in late stages of development; and
|
|
·
|
collaborative arrangements in our target markets with leading companies and research institutions.
|
·
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safety and effectiveness of our products
|
|
·
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ease with which our products can be administered and the extent to which patients and physicians accept new routes of administration;
|
|
·
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timing and scope of regulatory approvals for these products;
|
|
·
|
availability and cost of manufacturing, marketing and sales capabilities;
|
|
·
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price;
|
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·
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reimbursement coverage; and
|
|
·
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patent position.
|
•
|
discover, develop and commercialize drugs that are superior to other products in the market;
|
•
|
demonstrate through our clinical trials that our drug candidates are differentiated from existing and future therapies;
|
•
|
attract qualified scientific, product development and commercial personnel;
|
•
|
obtain patent or other proprietary protection for our drugs and technologies;
|
•
|
obtain required regulatory approvals;
|
•
|
successfully collaborate with pharmaceutical companies in the discovery, development and commercialization of new drugs; and
|
•
|
negotiate competitive pricing and reimbursement with third party payors.
|
·
|
general economic and political conditions in Canada, the United States and globally;
|
|
·
|
governmental regulation of the health care and pharmaceutical industries;
|
|
·
|
failure to achieve desired drug discovery outcomes by us or our collaborators;
|
|
·
|
failure to obtain industry partner and other third party consents and approvals, when required;
|
|
·
|
stock market volatility and market valuations;
|
|
·
|
competition for, among other things, capital, drug targets and skilled personnel;
|
|
·
|
the need to obtain required approvals from regulatory authorities;
|
|
·
|
revenue and operating results failing to meet expectations in any particular period;
|
|
·
|
investor perception of the health care and pharmaceutical industries;
|
|
·
|
limited trading volume of our Common Shares;
|
|
·
|
announcements relating to our business or the businesses of our competitors; and
|
|
·
|
our ability or inability to raise additional funds.
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Item 1B.
|
Unresolved Staff Comments
|
Item 2.
|
Properties
|
Item 3.
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Legal Proceedings
|
Item 4.
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Mine Safety Disclosures
|
Item 5.
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Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
|
|
NASDAQ
High
(US$)
|
|
NASDAQ
Low
(US$)
|
|
TSX
High
(C$)
|
|
TSX
Low
(C$)
|
|||||||||
Year Ended:
|
|
|
|
|
||||||||||||
December 31, 2014
|
|
$
|
31.48
|
|
|
$
|
7.65
|
|
|
$
|
34.66
|
|
|
$
|
8.14
|
|
December 31, 2013
|
|
$
|
11.42
|
|
|
$
|
4.18
|
|
|
$
|
11.62
|
|
|
$
|
4.31
|
|
Quarter Ended:
|
|
|
|
|
||||||||||||
December 31, 2014
|
|
$
|
29.93
|
|
|
$
|
12.54
|
|
|
$
|
33.69
|
|
|
$
|
14.37
|
|
September 30, 2014
|
|
$
|
26.05
|
|
|
$
|
8.86
|
|
|
$
|
28.56
|
|
|
$
|
9.55
|
|
June 30, 2014
|
|
$
|
24.47
|
|
|
$
|
10.20
|
|
|
$
|
26.99
|
|
|
$
|
11.08
|
|
March 31, 2014
|
|
$
|
31.48
|
|
|
$
|
7.65
|
|
|
$
|
34.66
|
|
|
$
|
8.14
|
|
December 31, 2013
|
|
$
|
11.42
|
|
|
$
|
6.93
|
|
|
$
|
11.62
|
|
|
$
|
7.16
|
|
September 30, 2013
|
|
$
|
7.72
|
|
|
$
|
4.70
|
|
|
$
|
7.90
|
|
|
$
|
4.96
|
|
June 30, 2013
|
|
$
|
5.25
|
|
|
$
|
4.25
|
|
|
$
|
5.34
|
|
|
$
|
4.35
|
|
March 31, 2013
|
|
$
|
5.53
|
|
|
$
|
4.18
|
|
|
$
|
5.45
|
|
|
$
|
4.31
|
|
Month Ended:
|
|
|
|
|
||||||||||||
February 28, 2015
|
|
$
|
25.49
|
|
|
$
|
17.50
|
|
|
$
|
33.76
|
|
|
$
|
17.05
|
|
January 31, 2015
|
|
$
|
26.73
|
|
|
$
|
14.50
|
|
|
$
|
32.19
|
|
|
$
|
21.90
|
|
Location
|
|
Number of Shares
|
|
Percentage of
Total Shares
|
Number of Registered
Shareholders of
Record
|
|||||||
Canada
|
|
15,776,736
|
|
|
33.9%
|
|
100
|
|
||||
United States
|
|
14,776,536
|
|
|
31.7%
|
22
|
|
|||||
Other
|
|
16,014,224
|
|
|
34.4%
|
4
|
|
|||||
|
|
|||||||||||
Total
|
|
46,567,496
|
|
|
100%
|
|
126
|
|
Item 6.
|
Selected Consolidated Financial Data
|
Year Ended December 31,
|
||||||||||||||||||||
2014
|
2013
|
2012
|
2011
|
2010
|
||||||||||||||||
$
|
$
|
$
|
$
|
$
|
||||||||||||||||
Operating Data
|
||||||||||||||||||||
Revenue
|
14,953
|
15,465
|
14,105
|
16,812
|
20,745
|
|||||||||||||||
Expenses
|
47,925
|
27,617
|
27,050
|
27,505
|
32,900
|
|||||||||||||||
Loss from operations
|
(32,972
|
)
|
(12,152
|
)
|
(12,945
|
)
|
(10,694
|
)
|
(12,155
|
)
|
||||||||||
Net income (loss)
|
(38,837
|
)
|
(14,063
|
)
|
29,611
|
(10,083
|
)
|
(12,058
|
)
|
|||||||||||
Weighted average number of common shares—basic
(1)
|
21,603
|
15,303
|
13,728
|
11,319
|
10,333
|
|||||||||||||||
Weighted average number of common shares—diluted
(1)
|
21,603
|
15,303
|
14,321
|
11,319
|
10,333
|
|||||||||||||||
Income (loss) per common share—basic
|
(1.80
|
)
|
(0.92
|
)
|
2.16
|
(0.89
|
)
|
(1.17
|
)
|
|||||||||||
Income (loss) per common share—diluted
|
(1.80
|
)
|
(0.92
|
)
|
2.07
|
(0.89
|
)
|
(1.17
|
)
|
|||||||||||
Balance Sheet Data
|
||||||||||||||||||||
Total current assets
|
116,418
|
70,343
|
51,243
|
11,594
|
18,006
|
|||||||||||||||
Total assets
|
118,178
|
71,716
|
52,595
|
13,758
|
21,136
|
|||||||||||||||
Total liabilities
|
30,143
|
12,522
|
11,676
|
8,531
|
10,345
|
|||||||||||||||
Share capital
|
316,212
|
242,045
|
206,572
|
200,965
|
196,393
|
|||||||||||||||
Total stockholders’ equity
|
88,035
|
59,194
|
40,919
|
5,227
|
10,791
|
|||||||||||||||
Number of shares outstanding
(1)
|
22,438
|
19,049
|
14,305
|
12,149
|
10,339
|
(1)
|
On November 4, 2010, Tekmira completed a consolidation of its common shares whereby five old common shares of Tekmira were exchanged for one new common share of Tekmira. Except as otherwise indicated, all references to common shares, common shares outstanding, average number of common shares outstanding, per share amounts and options in this document have been restated to reflect the common shares consolidation on a retroactive basis.
|
Item 7.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
Q4
|
Q3
|
Q2
|
Q1
|
Q4
|
Q3
|
Q2
|
Q1
|
|||||||||||||||||||||||||
2014
|
2014
|
2014
|
2014
|
2013
|
2013
|
2013
|
2013
|
|||||||||||||||||||||||||
Revenue
|
||||||||||||||||||||||||||||||||
Collaborations and contracts:
|
||||||||||||||||||||||||||||||||
DoD
|
$
|
2.8
|
$
|
1.5
|
$
|
0.9
|
$
|
3.2
|
$
|
2.6
|
$
|
2.8
|
$
|
2.4
|
$
|
1.9
|
||||||||||||||||
Monsanto
|
0.3
|
0.3
|
0.2
|
0.3
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||
Dicerna
|
0.3
|
0.2
|
—
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||
Other
|
—
|
1.6
|
—
|
0.2
|
(0.1)
|
0.1
|
0.4
|
0.2
|
||||||||||||||||||||||||
3.4
|
3.6
|
1.1
|
3.7
|
2.6
|
2.9
|
2.8
|
2.1
|
|||||||||||||||||||||||||
Alnylam milestone payments
|
—
|
—
|
—
|
0.2
|
5.0
|
—
|
—
|
—
|
||||||||||||||||||||||||
Monsanto licensing fees and milestone payments
|
0.9
|
0.7
|
0.6
|
0.5
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||
Spectrum milestone and royalty payments
|
0.1
|
0.1
|
0.0
|
0.0
|
—
|
—
|
—
|
—
|
||||||||||||||||||||||||
Total revenue
|
4.4
|
4.4
|
1.8
|
4.4
|
7.6
|
2.9
|
2.8
|
2.1
|
||||||||||||||||||||||||
Expenses
|
(15.1)
|
(11.2)
|
(11.2)
|
(10.4)
|
(9.9)
|
(6.6)
|
(5.9)
|
(5.1)
|
||||||||||||||||||||||||
Other income (losses)
|
4.5
|
(1.8)
|
3.3
|
(12.0)
|
(0.2)
|
(2.2)
|
0.1
|
0.5
|
||||||||||||||||||||||||
Net loss
|
(6.2)
|
(8.6)
|
(6.1)
|
(18.0)
|
(2.6)
|
(5.9)
|
(3.0)
|
(2.5)
|
||||||||||||||||||||||||
Basic net loss per share
|
$
|
(0.27)
|
$
|
(0.39)
|
$
|
(0.28)
|
$
|
(0.91)
|
$
|
(0.15)
|
$
|
(0.41)
|
$
|
(0.21)
|
$
|
(0.17)
|
||||||||||||||||
Diluted net loss per share
|
$
|
(0.27)
|
$
|
(0.39)
|
$
|
(0.28)
|
$
|
(0.91)
|
$
|
(0.15)
|
$
|
(0.41)
|
$
|
(0.21)
|
$
|
(0.17)
|
2014
|
2013
|
2012
|
||||||||||
Total revenue
|
15.0
|
15.5
|
14.1
|
|||||||||
Operating expenses
|
47.9
|
27.6
|
27.0
|
|||||||||
Loss from operations
|
(33.0
|
)
|
(12.2
|
)
|
(12.9
|
)
|
||||||
Net income (loss)
|
(38.8
|
)
|
(14.1
|
)
|
29.6
|
|||||||
Basic income (loss) per share
|
(1.80
|
)
|
(0.92
|
)
|
2.16
|
|||||||
Diluted income (loss) per share
|
(1.80
|
)
|
(0.92
|
)
|
2.07
|
|||||||
Total assets
|
118.2
|
71.7
|
52.6
|
|||||||||
Total liabilities
|
30.1
|
12.5
|
11.7
|
|||||||||
Total non-current liabilities
|
9.9
|
0.0
|
0.7
|
|||||||||
Deficit
|
(205.9
|
)
|
(167.0
|
)
|
(153.0
|
)
|
||||||
Accumulated other comprehensive loss
|
(22.3
|
)
|
(15.8
|
)
|
(12.7
|
)
|
||||||
Total stockholders’ equity
|
88.0
|
59.2
|
40.9
|
2014
|
% of Total
|
2013
|
% of Total
|
|||||||||||||
Collaborations and contracts
|
||||||||||||||||
DoD
|
8.4
|
56
|
%
|
9.8
|
63
|
%
|
||||||||||
Monsanto
|
1.1
|
7
|
%
|
-
|
-
|
|||||||||||
BMS
|
1.7
|
12
|
%
|
0.5
|
3
|
%
|
||||||||||
Other RNAi collaborators
|
0.5
|
3
|
%
|
0.1
|
1
|
%
|
||||||||||
Total collaborations and contracts
|
11.7
|
78
|
%
|
10.4
|
68
|
%
|
||||||||||
Monsanto licensing fees and milestone payments
|
2.7
|
19
|
%
|
-
|
-
|
|||||||||||
Alnylam milestone payments
|
0.2
|
1
|
%
|
5.0
|
32
|
%
|
||||||||||
Dicerna licensing fee
|
0.2
|
1
|
%
|
-
|
-
|
|||||||||||
Spectrum milestone and royalty payments
|
0.2
|
1
|
%
|
0.0
|
0
|
%
|
||||||||||
Total revenue
|
15.0
|
15.5
|
2014
|
% of Total
|
2013
|
% of Total
|
|||||||||||||
Research, development, collaborations and contracts
|
$
|
38.7
|
81
|
%
|
$
|
21.5
|
78
|
%
|
||||||||
General and administrative
|
8.7
|
17
|
%
|
5.5
|
20
|
%
|
||||||||||
Depreciation
|
0.5
|
1
|
%
|
0.6
|
2
|
%
|
||||||||||
Total operating expenses
|
$
|
47.9
|
$
|
27.6
|
2014
|
2013
|
|||||||
Interest income
|
$
|
0.9
|
$
|
0.5
|
||||
Foreign exchange gains
|
4.1
|
1.1
|
||||||
Increase in fair value of warrant liability
|
(10.4
|
)
|
(3.5
|
)
|
||||
Acquisition costs
|
(0.5
|
)
|
-
|
|||||
Total other income (losses)
|
$
|
(5.9
|
)
|
$
|
(1.9
|
)
|
2013
|
% of Total
|
2012
|
% of Total
|
|||||||||||||
Collaborations and contracts
|
||||||||||||||||
DoD
|
$
|
9.8
|
63
|
%
|
$
|
11.5
|
82
|
%
|
||||||||
BMS
|
0.5
|
3
|
%
|
0.4
|
3
|
%
|
||||||||||
Other RNAi collaborators
|
0.1
|
1
|
%
|
0.1
|
1
|
%
|
||||||||||
Total collaborations and contracts
|
10.4
|
68
|
%
|
12.1
|
86
|
%
|
||||||||||
Alnylam milestone payments
|
5.0
|
32
|
%
|
1.0
|
7
|
%
|
||||||||||
Spectrum milestone and royalty payments
|
0.0
|
0
|
%
|
1.0
|
7
|
%
|
||||||||||
Total revenue
|
$
|
15.5
|
$
|
14.1
|
2013
|
% of Total
|
2012
|
% of Total
|
|||||||||||||
Research, development, collaborations and contracts
|
$
|
21.5
|
78
|
%
|
$
|
18.0
|
67
|
%
|
||||||||
General and administrative
|
5.5
|
20
|
%
|
8.1
|
30
|
%
|
||||||||||
Depreciation
|
0.6
|
2
|
%
|
0.9
|
3
|
%
|
||||||||||
Total operating expenses
|
27.6
|
27.0
|
2013
|
2012
|
|||||||
Interest income
|
$
|
0.5
|
$
|
0.1
|
||||
Licensing settlement payment
|
-
|
65.0
|
||||||
Licensing settlement legal fees
|
-
|
(18.7
|
)
|
|||||
Foreign exchange gains
|
1.1
|
-
|
||||||
Increase in fair value of warrant liability
|
(3.5
|
)
|
(3.8
|
)
|
||||
Total other income (losses)
|
$
|
(1.9
|
)
|
$
|
42.6
|
Year ended December 31
|
||||||||||||
2014
|
2013
|
2012
|
||||||||||
Net (loss) income for the year
|
(38.8
|
)
|
(14.1
|
)
|
29.6
|
|||||||
Adjustments to reconcile net (loss) income to net cash (used in) provided by operating activities
|
9.9
|
5.0
|
5.7
|
|||||||||
Changes in operating assets and liabilities
|
16.6
|
2.3
|
(2.4
|
)
|
||||||||
Net cash (used in) provided by operating activities
|
(12.3
|
)
|
(6.7
|
)
|
32.9
|
|||||||
Net cash used in investing activities
|
(43.0
|
)
|
(0.7
|
)
|
(0.0
|
)
|
||||||
Net cash provided by financing activities
|
60.7
|
32.7
|
4.5
|
|||||||||
Effect of foreign exchange rate changes on cash & cash equivalents
|
(1.8
|
)
|
(3.6
|
)
|
0.5
|
|||||||
Net increase in cash and cash equivalents
|
3.5
|
21.7
|
38.0
|
|||||||||
Cash and cash equivalents, beginning of year
|
68.7
|
47.0
|
9.0
|
|||||||||
Cash and cash equivalents, end of year
|
72.2
|
68.7
|
47.0
|
|
·
|
the need for additional capital to fund future business development programs, including the merger with OnCore;
|
|
·
|
revenues earned form our current collaborative partnership and licensing agreements with Monsanto and Dicerna;
|
|
·
|
revenues earned from our DoD contract to develop TKM-Ebola and TKM-Ebola-Guinea;
|
|
·
|
revenues earned from our legacy collaborative partnerships and licensing agreements, including milestone payments from Alnylam and royalties from sales of Marqibo from Spectrum;
|
|
·
|
the extent to which we continue the development of our product candidates, add new product candidates to our pipeline, or form collaborative relationships to advance our products;
|
|
·
|
our decisions to in-license or acquire additional products or technology for development, in particular for our RNAi therapeutics programs;
|
|
·
|
our ability to attract and retain corporate partners, and their effectiveness in carrying out the development and ultimate commercialization of our product candidates;
|
|
·
|
whether batches of drugs that we manufacture fail to meet specifications resulting in delays and investigational and remanufacturing costs;
|
|
·
|
the decisions, and the timing of decisions, made by health regulatory agencies regarding our technology and products;
|
|
·
|
competing technological and market developments; and
|
|
·
|
costs associated with prosecuting and enforcing our patent claims and other intellectual property rights, including litigation and arbitration arising in the course of our business activities.
|
(in millions $)
|
Payments Due by Period
|
|||||||||||||||||||
Total
|
Less
than 1 year
|
1 – 3
years
|
3 – 5
years
|
More than
5 years
|
||||||||||||||||
Contractual Obligations
|
||||||||||||||||||||
Facility lease
|
5.1
|
1.1
|
2.2
|
1.8
|
—
|
|||||||||||||||
Technology license obligations
(1)
|
0.3
|
0.3
|
—
|
—
|
—
|
|||||||||||||||
Total contractual obligations
|
5.4
|
1.4
|
2.2
|
1.8
|
—
|
Item 7A.
|
Quantitative and Qualitative Disclosures about Market Risk
|
Item 8.
|
Financial Statements and Supplementary Data
|
Page
|
||
December 31
2014
|
December 31
2013
|
|||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$ | 72,187 | $ | 68,717 | ||||
Short-term investments (note 2)
|
39,974 | - | ||||||
Accounts receivable
|
1,903 | 117 | ||||||
Accrued revenue
|
538 | 212 | ||||||
Deferred expenses
|
- | 173 | ||||||
Investment tax credits receivable
|
86 | 40 | ||||||
Prepaid expenses and other assets (note 6(a))
|
1,730 | 1,084 | ||||||
Total current assets
|
116,418 | 70,343 | ||||||
Property and equipment (note 4)
|
12,959 | 13,039 | ||||||
Less accumulated depreciation (note 4)
|
(11,199 | ) | (11,666 | ) | ||||
Property and equipment, net of accumulated
depreciation (note 4)
|
1,760 | 1,373 | ||||||
Total assets
|
$ | 118,178 | $ | 71,716 | ||||
Liabilities and stockholders' equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable and accrued liabilities (note 10)
|
$ | 9,328 | $ | 3,680 | ||||
Deferred revenue (note 3)
|
5,779 | 3,463 | ||||||
Warrants (note 2 and 5)
|
5,099 | 5,379 | ||||||
Total current liabilities
|
20,206 | 12,522 | ||||||
Deferred revenue, net of current portion (note 3)
|
9,937 | - | ||||||
Total liabilities
|
30,143 | 12,522 | ||||||
Stockholders’ equity:
|
||||||||
Common shares (note 5)
|
||||||||
Authorized - unlimited number with no par value
|
||||||||
Issued and outstanding:
22,438,169 (December 31, 2013 - 19,048,900)
|
290,004 | 216,702 | ||||||
Additional paid-in capital
|
26,208 | 25,343 | ||||||
Deficit
|
(205,864 | ) | (167,027 | ) | ||||
Accumulated other comprehensive loss
|
(22,313 | ) | (15,824 | ) | ||||
Total stockholders' equity
|
88,035 | 59,194 | ||||||
Total liabilities and stockholders' equity
|
$ | 118,178 | $ | 71,716 |
Year ended
December 31
|
||||||||||||
2014
|
2013
|
2012
|
||||||||||
Revenue (note 3)
|
||||||||||||
Collaborations and contracts
|
$ | 11,738 | $ | 10,425 | $ | 12,105 | ||||||
Licensing fees, milestone and
royalty payments
|
3,215 | 5,040 | 2,000 | |||||||||
Total revenue
|
14,953 | 15,465 | 14,105 | |||||||||
Expenses
|
||||||||||||
Research, development, collaborations
and contracts
|
38,713 | 21,458 | 18,043 | |||||||||
General and administrative
|
8,683 | 5,546 | 8,141 | |||||||||
Depreciation of property and equipment
|
529 | 613 | 866 | |||||||||
Total expenses
|
47,925 | 27,617 | 27,050 | |||||||||
Loss from operations
|
(32,972 | ) | (12,152 | ) | (12,945 | ) | ||||||
Other income (losses)
|
||||||||||||
Interest income
|
853 | 540 | 138 | |||||||||
Licensing settlement payment (note 3(c))
|
- | - | 65,000 | |||||||||
Licensing settlement legal fees (note 3(c))
|
- | - | (18,738 | ) | ||||||||
Foreign exchange gains
|
4,127 | 1,079 | 25 | |||||||||
Warrant issuance costs (note 5)
|
- | - | (47 | ) | ||||||||
Increase in fair value of warrant liability (note 2)
|
(10,383 | ) | (3,530 | ) | (3,822 | ) | ||||||
Acquisition costs
|
(462 | ) | - | - | ||||||||
Net income (loss)
|
$ | (38,837 | ) | $ | (14,063 | ) | $ | 29,611 | ||||
Income (loss) per common share
|
||||||||||||
Basic
|
$ | (1.80 | ) | $ | (0.92 | ) | $ | 2.16 | ||||
Diluted
|
$ | (1.80 | ) | $ | (0.92 | ) | $ | 2.07 | ||||
Weighted average number of common shares
|
||||||||||||
Basic
|
21,603,136 | 15,302,680 | 13,727,925 | |||||||||
Diluted
|
21,603,136 | 15,302,680 | 14,320,814 | |||||||||
Comprehensive income (loss)
|
||||||||||||
Cumulative translation adjustment
|
(6,489 | ) | (3,135 | ) | 474 | |||||||
Comprehensive loss
|
$ | (45,326 | ) | $ | (17,198 | ) | $ | 30,085 |
Number
of shares
|
Share
capital
|
Additional paid-in
capital
|
Deficit
|
Accumulated
other comprehensive
|
Total
stockholders'
|
|||||||||||||||||||
Balance, December 31, 2011
|
12,148,635 | $ | 177,039 | $ | 23,927 | $ | (182,575 | ) | $ | (13,163 | ) | $ | 5,228 | |||||||||||
Stock-based compensation
|
- | - | 982 | - | - | 982 | ||||||||||||||||||
Issuance of common shares
pursuant to exercise of options
|
38,635 | 194 | (123 | ) | - | - | 71 | |||||||||||||||||
Issuance of common shares
pursuant to exercise of warrants
|
269,485 | 1,513 | - | - | - | 1,513 | ||||||||||||||||||
Issuance of common shares in conjunction with the private offering, net of issuance costs of $179,000 and net of initial fair value of warrants of $851,000
|
1,848,601 | 3,040 | - | - | - | 3,040 | ||||||||||||||||||
Currency translation adjustment
|
- | - | - | - | 474 | 474 | ||||||||||||||||||
Net income
|
- | - | - | 29,611 | - | 29,611 | ||||||||||||||||||
Balance, December 31, 2012
|
14,305,356 | $ | 181,786 | $ | 24,786 | $ | (152,964 | ) | $ | (12,689 | ) | $ | 40,919 | |||||||||||
Stock-based compensation
|
- | - | 903 | - | - | 903 | ||||||||||||||||||
Issuance of common shares
pursuant to exercise of options
|
125,596 | 735 | (346 | ) | - | - | 389 | |||||||||||||||||
|
||||||||||||||||||||||||
Issuance of common shares
pursuant to exercise of warrants
|
305,448 | 2,143 | - | - | - | 2,143 | ||||||||||||||||||
Issuance of common shares in conjunction with the
private offering, net of issuance costs of $
2,462,000
|
4,312,500 | 32,038 | - | - | - | 32,038 | ||||||||||||||||||
Currency translation adjustment
|
- | - | - | - | (3,135 | ) | (3,135 | ) | ||||||||||||||||
Net loss
|
- | - | - | (14,063 | ) | - | (14,063 | ) | ||||||||||||||||
Balance, December 31, 2013
|
19,048,900 | $ | 216,702 | $ | 25,343 | $ | (167,027 | ) | $ | (15,824 | ) | $ | 59,194 | |||||||||||
Stock-based compensation
|
- | - | 3,283 | - | - | 3,283 | ||||||||||||||||||
Issuance of common shares
pursuant to exercise of options
|
648,506 | 5,034 | (2,418 | ) | - | - | 2,616 | |||||||||||||||||
|
||||||||||||||||||||||||
Issuance of common shares
pursuant to exercise of warrants
|
615,763 | 11,791 | - | - | - | 11,791 | ||||||||||||||||||
Issuance of common shares in conjunction with the
private offering, net of issuance costs of $4,085,000
|
2,125,000 | 56,477 | - | - | - | 56,477 | ||||||||||||||||||
Currency translation adjustment
|
- | - | - | - | (6,489 | ) | (6,489 | ) | ||||||||||||||||
Net loss
|
- | - | - | (38,837 | ) | - | (38,837 | ) | ||||||||||||||||
Balance, December 31, 2014
|
22,438,169 | $ | 290,004 | $ | 26,208 | $ | (205,864 | ) | $ | (22,313 | ) | $ | 88,035 |
Year ended
December 31
|
||||||||||||
2014
|
2013
|
2012
|
||||||||||
OPERATING ACTIVITIES
|
||||||||||||
Net income (loss) for the period
|
$ | (38,837 | ) | $ | (14,063 | ) | $ | 29,611 | ||||
Items not involving cash:
|
||||||||||||
Depreciation of property and equipment
|
529 | 613 | 866 | |||||||||
Gain on sale of property and equipment
|
(80 | ) | - | - | ||||||||
Stock-based compensation - research, development, collaborations
and contract expenses
|
2,343 | 622 | 772 | |||||||||
Stock-based compensation - general and administrative expenses
|
940 | 281 | 210 | |||||||||
Unrealized foreign exchange (gains) losses
|
(4,218 | ) | (18 | ) | 29 | |||||||
Warrant issuance costs
|
- | 47 | ||||||||||
Change in fair value of warrant liability
|
10,383 | 3,530 | 3,822 | |||||||||
Net change in non-cash operating items:
|
||||||||||||
Accounts receivable
|
(1,887 | ) | 889 | (190 | ) | |||||||
Accrued revenue
|
(360 | ) | 2,008 | (2,188 | ) | |||||||
Deferred expenses
|
167 | 231 | 361 | |||||||||
Investment tax credits receivable
|
(52 | ) | (31 | ) | 323 | |||||||
Prepaid expenses and other assets
|
(773 | ) | (776 | ) | 97 | |||||||
Accounts payable and accrued liabilities
|
6,253 | 130 | (197 | ) | ||||||||
Deferred revenue
|
13,171 | (153 | ) | (655 | ) | |||||||
Net cash provided by (used in) operating activities
|
(12,421 | ) | (6,737 | ) | 32,908 | |||||||
INVESTING ACTIVITIES
|
||||||||||||
Acquisition of investments
|
(41,982 | ) | - | - | ||||||||
Proceeds from sale of property and equipment
|
80 | - | 3 | |||||||||
Acquisition of property and equipment
|
(1,056 | ) | (725 | ) | (15 | ) | ||||||
Net cash used in investing activities
|
(42,958 | ) | (725 | ) | (12 | ) | ||||||
FINANCING ACTIVITIES
|
||||||||||||
Proceeds from issuance of common shares, net of issuance costs
|
56,477 | 32,038 | 3,844 | |||||||||
Issuance of common shares pursuant to exercise of options
|
2,616 | 389 | 71 | |||||||||
Issuance of common shares pursuant to exercise of warrants
|
1,583 | 289 | 632 | |||||||||
Net cash provided by financing activities
|
60,676 | 32,716 | 4,547 | |||||||||
Effect of foreign exchange rate changes on cash and cash equivalents
|
(1,827 | ) | (3,561 | ) | 550 | |||||||
Increase (decrease) in cash and cash equivalents
|
3,470 | 21,693 | 37,993 | |||||||||
Cash and cash equivalents, beginning of period
|
68,717 | 47,024 | 9,031 | |||||||||
Cash and cash equivalents, end of period
|
$ | 72,187 | $ | 68,717 | $ | 47,024 | ||||||
Supplemental cash flow information
|
||||||||||||
Fair value of warrants exercised on a cashless basis
|
$ | 116 | $ | 1,404 | $ | 211 | ||||||
Investment tax credits received
|
$ | - | $ | 10 | $ | 323 | ||||||
Fair value of warrants issued in conjunction with public offering
|
$ | - | $ | - | $ | 851 |
1.
|
Nature
of business and future operations
|
2.
|
Significant accounting policies
|
•
|
Level 1 inputs are quoted market prices for identical instruments available in active markets.
|
•
|
Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability either directly or indirectly. If the asset or liability has a contractual term, the input must be observable for substantially the full term. An example includes quoted market prices for similar assets or liabilities in active markets.
|
•
|
Level 3 inputs are unobservable inputs for the asset or liability and will reflect management’s assumptions about market assumptions that would be used to price the asset or liability.
|
Level 1
|
Level 2
|
Level 3
|
December 31, 2014
|
|||||||||||||
Assets
|
||||||||||||||||
Cash and cash equivalents
|
$ | 72,187 | - | - | $ | 72,187 | ||||||||||
Guaranteed investment certificates
|
39,974 | - | - | 39,974 | ||||||||||||
Total
|
$ | 112,161 | - | - | $ | 112,161 | ||||||||||
Liabilities
|
||||||||||||||||
Warrants
|
- | - | $ | 5,099 | $ | 5,099 | ||||||||||
Financial instrument
|
- | - | - | - | ||||||||||||
Total
|
- | - | $ | 5,099 | $ | 5,099 |
Level 1
|
Level 2
|
Level 3
|
December 31, 2013
|
|||||||||||||
Assets
|
||||||||||||||||
Cash and cash equivalents
|
$ | 68,717 | - | - | $ | 68,717 | ||||||||||
Liabilities
|
||||||||||||||||
Warrants
|
- | - | $ | 5,379 | $ | 5,379 |
Liability at beginning
of the period
|
Opening liability of
warrants issued in
the period
|
Fair value of
warrants exercised
in the period
|
Increase in fair
value of warrants
|
Foreign exchange
(gain) loss
|
Liability at end
of the period
|
|||||||||||||||||||
Year ended December 31, 2012
|
$ | 202 | $ | 851 | $ | (881 | ) | $ | 3,822 | $ | 21 | $ | 4,015 | |||||||||||
Year ended December 31, 2013
|
$ | 4,015 | - | $ | (1,854 | ) | $ | 3,530 | $ | (312 | ) | $ | 5,379 | |||||||||||
Year ended December 31, 2014
|
$ | 5,379 | - | $ | (10,208 | ) | $ | 10,383 | $ | (455 | ) | $ | 5,099 |
Rate
|
|||
Laboratory equipment (years)
|
5
|
||
Computer and office equipment (years)
|
2
|
-
|
5
|
Furniture and fixtures (years)
|
5
|
For the year ended December 31
|
||||||||||||
2014
|
2013
|
2012
|
||||||||||
Numerator:
|
||||||||||||
Net income (loss)
|
$ | (38,837 | ) | $ | (14,063 | ) | $ | 29,611 | ||||
Denominator:
|
||||||||||||
Weighted average number of common shares
|
21,603,136 | 15,302,680 | 13,727,925 | |||||||||
Effect of dilutive securities:
|
||||||||||||
Warrants
|
- | - | 177,374 | |||||||||
Options
|
- | - | 415,515 | |||||||||
Diluted weighted average number of common shares
|
21,603,136 | 15,302,680 | 14,320,814 | |||||||||
Basic income (loss) per common share
|
$ | (1.80 | ) | $ | (0.92 | ) | $ | 2.16 | ||||
Diluted income (loss) per common share
|
$ | (1.80 | ) | $ | (0.92 | ) | $ | 2.07 |
3.
|
Collaborations, contracts and licensing agreements
|
Year ended December 31
|
||||||||||||
2014
|
2013
|
2012
|
||||||||||
Collaborations and contracts
|
||||||||||||
DoD (a)
|
$ | 8,407 | $ | 9,806 | $ | 11,536 | ||||||
Monsanto (b)
|
1,080 | - | - | |||||||||
Alnylam (c)
|
- | - | 10 | |||||||||
BMS (d)
|
1,741 | 526 | 440 | |||||||||
Dicerna (e)
|
510 | - | - | |||||||||
Other RNAi collaborators (g)
|
- | 93 | 119 | |||||||||
Total research and development collaborations and contracts
|
11,738 | 10,425 | 12,105 | |||||||||
Licensing fees, milestone and royalty payments
|
||||||||||||
Monsanto licensing fees and milestone payments (b)
|
2,744 | - | - | |||||||||
Alnylam milestone payments (c)
|
150 | 5,000 | 1,000 | |||||||||
Dicerna licensing fee (e )
|
131 | - | - | |||||||||
Spectrum royalty payments (f)
|
190 | 40 | 1,000 | |||||||||
Total licensing fees, milestone and royalty payments
|
3,215 | 5,040 | 2,000 | |||||||||
Total revenue
|
$ | 14,953 | $ | 15,465 | $ | 14,105 |
December 31, 2014
|
December 31, 2013
|
|||||||
DoD (a)
|
$ | 313 | $ | 1,655 | ||||
Monsanto current portion (b)
|
4,245 | - | ||||||
BMS current portion (d)
|
- | 1,808 | ||||||
Dicerna current portion (e)
|
1,221 | |||||||
Deferred revenue, current portion
|
5,779 | 3,463 | ||||||
Monsanto long-term portion (b)
|
8,666 | - | ||||||
Dicerna long-term portion (e)
|
1,271 | - | ||||||
Total deferred revenue
|
$ | 15,716 | $ | 3,463 |
4.
|
Property and equipment
|
December 31, 2014
|
Cost
|
Accumulated
depreciation
|
Net
book value
|
|||||||||
Lab equipment
|
$ | 5,021 | (4,451 | ) | $ | 570 | ||||||
Leashold improvements
|
5,281 | (4,796 | ) | 485 | ||||||||
Computer hardware and software
|
2,293 | (1,588 | ) | 705 | ||||||||
Furniture and fixtures
|
364 | (364 | ) | - | ||||||||
$ | 12,959 | (11,199 | ) | $ | 1,760 |
December 31, 2013
|
Cost
|
Accumulated
depreciation
|
Net
book value
|
|||||||||
Lab equipment
|
$ | 4,886 | (4,679 | ) | $ | 207 | ||||||
Leashold improvements
|
5,592 | (5,001 | ) | 591 | ||||||||
Computer hardware and software
|
1,992 | (1,590 | ) | 402 | ||||||||
Furniture and fixtures
|
396 | (396 | ) | - | ||||||||
Assets under construction
|
173 | - | 173 | |||||||||
$ | 13,039 | (11,666 | ) | $ | 1,373 |
5.
|
Share capital
|
Common shares
purchasable upon
exercise of
warrants
|
Weighted average
exercise price (C$)
|
Weighted
average exercise
price (US$)
|
Range of
exercise prices
(C$)
|
Range of
exercise prices
(US$)
|
Weighted average remaining contractual life (years)
|
Aggregate
intrinsic value
(C$)
|
Aggregate
intrinsic value
(US$)
|
|||||||||||||||||||||||||||
Balance, December 31, 2012
|
1,588,411 | $ | 3.00 | $ | 3.02 | $2.50 | - | $3.35 | $2.51 | - | $3.37 | 3.8 | $ | 3,141 | $ | 3,157 | ||||||||||||||||||
Exercised
|
(573,683 | ) | $ | 3.19 | $ | 3.00 | $2.60 | - | $3.35 | $2.44 | - | $3.15 | ||||||||||||||||||||||
Balance, December 31, 2013
|
1,014,728 | $ | 2.90 | $ | 2.72 | $2.60 | - | $3.35 | $2.44 | - | $3.15 | 2.7 | $ | 5,635 | $ | 5,298 | ||||||||||||||||||
Exercised
|
(616,478 | ) | $ | 3.09 | $ | 2.80 | $2.60 | - | $3.35 | $2.35 | - | $3.03 | ||||||||||||||||||||||
Balance, December 31, 2014
|
398,250 | $ | 2.95 | $ | 2.67 | $2.60 | - | $3.35 | $2.35 | - | $3.03 | 1.8 | $ | 5,902 | $ | 5,343 |
Year ended December 31
|
||||||||
2014
|
2013
|
|||||||
Dividend yield
|
0.00 | % | 0.00 | % | ||||
Expected volatility
|
85.22 | % | 47.03 | % | ||||
Risk-free interest rate
|
1.00 | % | 1.13 | % | ||||
Expected average term (years)
|
0.5
|
1.6
|
||||||
Fair value of warrants outstanding
|
$ | 12.80 | $ | 5.30 | ||||
Aggregate fair value of warrants outstanding
|
$ | 5,099 | $ | 5,379 | ||||
Number of warrants outstanding
|
398,250 | 1,014,728 |
Number of
optioned
|
Weighted
average exercise
|
Weighted
average exercise
|
Aggregate
intrinsic
|
Aggregate
intrinsic
|
||||||||||||||||
Balance, December 31, 2011
|
1,413,318 | $ | 5.32 | $ | 5.38 | $ | 2 | $ | 2 | |||||||||||
Options granted
|
326,300 | $ | 4.16 | $ | 4.16 | |||||||||||||||
Options exercised
|
(28,417 | ) | $ | 2.34 | $ | 2.34 | $ | 82 | $ | 82 | ||||||||||
Options forfeited, cancelled or expired
|
(62,355 | ) | $ | 21.27 | $ | 21.29 | ||||||||||||||
Balance, December 31, 2012
|
1,648,846 | $ | 4.54 | $ | 4.54 | $ | 2,300 | $ | 2,301 | |||||||||||
Options granted
|
270,250 | $ | 7.52 | $ | 7.30 | |||||||||||||||
Options exercised
|
(124,246 | ) | $ | 3.22 | $ | 3.13 | $ | 551 | $ | 535 | ||||||||||
Options forfeited, cancelled or expired
|
(64,085 | ) | $ | 21.87 | $ | 21.23 | ||||||||||||||
Balance, December 31, 2013
|
1,730,765 | $ | 4.45 | $ | 4.32 | $ | 7,030 | $ | 6,826 | |||||||||||
Options granted
|
431,125 | $ | 13.63 | $ | 12.34 | |||||||||||||||
Options exercised
|
(622,752 | ) | $ | 4.62 | $ | 4.18 | $ | 7,650 | $ | 6,926 | ||||||||||
Options forfeited, cancelled or expired
|
(9,000 | ) | $ | 8.20 | $ | 7.42 | ||||||||||||||
Balance, December 31, 2014
|
1,530,138 | $ | 6.95 | $ | 6.29 | $ | 16,573 | $ | 15,004 |
Options outstanding December 31, 2014
|
Options exercisable December 31, 2014
|
|||||||||||||||||||||||||||||
Range of
Exercise prices
|
Number
of options
|
Weighted
average
|
Weighted
average
|
Weighted
average
|
Number
of options
|
Weighted
average
|
Weighted
average
|
|||||||||||||||||||||||
$1.50 | to | $1.90 | 184,325 | 5.9 | $ | 1.71 | $ | 1.55 | 184,325 | $ | 1.71 | $ | 1.55 | |||||||||||||||||
$2.10 | to | $2.60 | 189,299 | 6.7 | $ | 2.32 | $ | 2.10 | 169,404 | $ | 2.35 | $ | 2.13 | |||||||||||||||||
$3.00 | to | $3.85 | 160,650 | 3.8 | $ | 3.57 | $ | 3.23 | 160,450 | $ | 3.57 | $ | 3.23 | |||||||||||||||||
$4.49 | to | $6.50 | 411,356 | 6.4 | $ | 5.21 | $ | 4.72 | 323,052 | $ | 5.20 | $ | 4.71 | |||||||||||||||||
$7.05 | to | $10.40 | 252,923 | 8.6 | $ | 8.78 | $ | 7.95 | 117,548 | $ | 8.81 | $ | 7.98 | |||||||||||||||||
$11.60 | to | $13.26 | 156,085 | 9.1 | $ | 12.89 | $ | 11.67 | 76,879 | $ | 12.68 | $ | 11.48 | |||||||||||||||||
$14.80 | to | $18.54 | 175,500 | 9.2 | $ | 16.67 | $ | 15.09 | 57,250 | $ | 16.45 | $ | 14.89 | |||||||||||||||||
$1.50 | to | $18.54 | 1,530,138 | 7.1 | $ | 6.95 | $ | 6.29 | 1,088,908 | $ | 5.43 | $ | 4.92 |
Number of
optioned
|
Weighted
average
|
Weighted
average
|
||||||||||
Non-vested at December 31, 2013
|
353,675 | $ | 5.44 | $ | 5.28 | |||||||
Options granted
|
431,125 | $ | 13.63 | 12.34 | ||||||||
Options vested
|
(334,994 | ) | $ | 8.35 | 7.56 | |||||||
Non-vested options forfeited
|
(8,576 | ) | $ | 6.89 | 6.24 | |||||||
Non-vested at December 31, 2014
|
441,230 | $ | 9.30 | $ | 8.42 |
Year ended December 31
|
||||||||||||
2014
|
2013
|
2012
|
||||||||||
Dividend yield
|
0.00 | % | 0.00 | % | 0.00 | % | ||||||
Expected volatility
|
101.08 | % | 111.61 | % | 120.40 | % | ||||||
Risk-free interest rate
|
2.25 | % | 2.39 | % | 1.56 | % | ||||||
Expected average option term (years)
|
8.8
|
9.6
|
8.2
|
|||||||||
Fair value of options granted (C$)
|
$ | 11.68 | $ | 6.96 | $ | 3.83 |
Year ended December 31
|
||||||||||||
2014
|
2013
|
2012
|
||||||||||
Research, development, collaborations
and contracts expenses
|
$ | 2,343 | $ | 622 | $ | 772 | ||||||
General and administrative expenses
|
940 | 281 | 210 | |||||||||
Total
|
$ | 3,283 | $ | 903 | $ | 982 |
Number of
Protiva
Options
|
Equivalent number
of Company
common shares
|
Weighted
average exercise
price (C$)
|
Weighted
average exercise
price (US$)
|
|||||||||||||
Balance, December 31, 2011
|
491,020 | 331,517 | $ | 0.30 | 0.30 | |||||||||||
Options exercised
|
(15,135 | ) | (10,218 | ) | 0.30 | 0.30 | ||||||||||
Options forfeited, cancelled or expired
|
- | - | - | - | ||||||||||||
Balance, December 31, 2012
|
475,885 | 321,299 | $ | 0.30 | $ | 0.30 | ||||||||||
Options exercised
|
(2,000 | ) | (1,350 | ) | 0.30 | 0.29 | ||||||||||
Options forfeited, cancelled or expired
|
(1,000 | ) | (675 | ) | 0.30 | $ | 0.29 | |||||||||
Balance, December 31, 2013
|
472,885 | 319,274 | $ | 0.30 | $ | 0.29 | ||||||||||
Options exercised
|
(38,145 | ) | (25,754 | ) | 0.30 | 0.27 | ||||||||||
Options forfeited, cancelled or expired
|
(1,000 | ) | (675 | ) | 0.30 | 0.27 | ||||||||||
Balance, December 31, 2014
|
433,740 | 292,845 | $ | 0.30 | 0.27 |
6.
|
Government grants and refundable investment tax credits
|
7.
|
Income taxes
|
Year ended December 31
|
||||||||||||
2014
|
2013
|
2012
|
||||||||||
Computed taxes (recoveries) at Canadian federal and provincial tax rates
|
$
|
(6,893
|
) |
$
|
(2,380
|
)
|
$
|
7,486
|
||||
Differences due to change in enacted tax rates
|
-
|
(6
|
)
|
781
|
||||||||
Difference due to change in tax rate on opening deferred taxes
|
-
|
-
|
2,720
|
|||||||||
Permanent and other differences
|
1,342
|
1,150
|
(1,195
|
) | ||||||||
Change in valuation allowance - other
|
5,551
|
1,236
|
798
|
|
||||||||
Change in valuation allowance - utilization of investment tax credits
|
- | - | (10,590 | ) | ||||||||
Income tax (recovery) expense
|
$
|
-
|
$
|
-
|
$
|
-
|
Year ended December 31
|
||||||||
2014
|
2013
|
|||||||
Deferred tax assets:
|
||||||||
Non-capital loss carryforwards
|
$
|
4,491
|
$
|
4,354
|
||||
Research and development deductions
|
9,562
|
8,859
|
||||||
Book amortization in excess of tax
|
1,874
|
2,171
|
||||||
Share issue costs
|
815
|
(136
|
)
|
|||||
Revenue recognized for tax purposes in excess of revenue recognized for accounting purposes
|
2,790
|
668
|
||||||
Tax value in excess of accounting value in lease inducements
|
45
|
(3
|
)
|
|||||
Federal investment tax credits
|
6,470
|
5,539
|
||||||
Provincial investment tax credits
|
3,347
|
2,391
|
||||||
Total deferred tax assets
|
29,394
|
23,843
|
||||||
Valuation allowance
|
(29,394
|
)
|
(23,843
|
)
|
||||
Net deferred tax assets
|
$
|
-
|
$
|
-
|
8.
|
Contingencies and commitments
|
Year ended December 31, 2015
|
$ | 1,119,000 | ||
Year ended December 31, 2016
|
1,119,000 | |||
Year ended December 31, 2017
|
1,119,000 | |||
Year ended December 31, 2018
|
1,119,000 | |||
Year ended December 31, 2019
|
653,000 | |||
$ | 5,129,000 |
9.
|
Concentrations of business risk
|
December 31, 2014
|
December 31, 2013
|
|||||||
Cash, cash equivalents and short-term investments
|
$ | 112,161 | $ | 68,717 | ||||
Less: Accounts payable and accrued liabilties
|
(9,328 | ) | (3,680 | ) | ||||
$ | 102,833 | $ | 65,037 |
(in C$)
|
December 31, 2014
|
December 31, 2013
|
||||||
Cash and cash equivalents and short-term investments
|
$ | 75,224 | $ | 38,901 | ||||
Accounts receivable
|
1,942 | 11 | ||||||
Accrued revenue
|
624 | 226 | ||||||
Accounts payable and accrued liabilities
|
(4,494 | ) | (1,889 | ) | ||||
$ | 73,296 | $ | 37,248 |
10.
|
Supplementary information
|
December 31, 2014
|
December 31, 2013
|
|||||||
Trade accounts payable
|
$ | 2,044 | $ | 1,217 | ||||
Research and development accruals
|
2,391 | 669 | ||||||
License fee accruals | 250 | - | ||||||
Professional fee accruals
|
1,294 | 247 | ||||||
Deferred lease inducements
|
250 | 16 | ||||||
Payroll accruals | 2,873 | 1,224 | ||||||
Other accrued liabilities
|
226 | 307 | ||||||
$ | 9,328 | $ | 3,680 |
11.
|
Interim financial data (unaudited)
|
2014
|
||||||||||||||||||||
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
||||||||||||||||
Revenue
|
4,430
|
1,811
|
4,362
|
4,350
|
14,953
|
|||||||||||||||
Loss from operations
|
(5,958
|
)
|
(9,423
|
)
|
(6,844
|
)
|
(10,747
|
)
|
(32,972
|
)
|
||||||||||
Net loss
|
(17,984
|
)
|
(6,081
|
)
|
(8,604
|
)
|
(6,168
|
)
|
(38,837
|
)
|
||||||||||
Basic and diluted net loss per share
|
$
|
(0.91
|
)
|
$
|
(0.28
|
)
|
$
|
(0.39
|
)
|
$
|
(0.27
|
)
|
$
|
(1.80
|
)
|
2013
|
||||||||||||||||||||
Q1
|
Q2
|
Q3
|
Q4
|
Total
|
||||||||||||||||
Revenue
|
2,132
|
2,844
|
2,963
|
7,52
|
15,465
|
|||||||||||||||
Loss from operations
|
(2,994
|
)
|
(3,071
|
)
|
(3,652
|
)
|
(2,435
|
)
|
(12,152
|
)
|
||||||||||
Net loss
|
(2,546
|
)
|
(3,015
|
)
|
(5,906
|
)
|
(2,596
|
)
|
(14,063
|
)
|
||||||||||
Basic and diluted net loss per share
|
$
|
(0.18
|
)
|
$
|
(0.21
|
)
|
$
|
(0.41
|
)
|
$
|
(0.15
|
)
|
$
|
(0.92
|
)
|
12.
|
Subsequent events
|
Consideration paid:
|
|
|||
Common shares issued without subjects
|
|
$
|
371,553
|
|
Common shares issued subject to repurchase provision
|
|
9,262
|
|
|
Common shares issuable for OnCore stock options
|
|
1,127
|
|
|
|
$
|
381,942
|
|
|
|
||||
Identifiable assets acquired and liabilities assumed:
|
|
|||
Cash
|
|
$
|
325
|
|
Prepaid expenses and other assets
|
|
125
|
|
|
Accounts receivable
|
|
7
|
|
|
Property and equipment
|
|
149
|
|
|
Acquired intangible assets from combined OnCore
|
|
393,192
|
|
|
Accounts payable and accrued liabilities
|
|
(3,182
|
)
|
|
Other noncurrent liabilities
|
|
(8,674
|
)
|
|
Total purchase price allocation
|
|
$
|
381,942
|
|
Item 9.
|
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
|
Item 9A.
|
Controls and Procedures
|
Item 9B.
|
Other Information
|
Item 10.
|
Directors, Executive Officers and Corporate Governance
|
Item 11.
|
Executive Compensation
|
Item 12.
|
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
|
Item 13.
|
Certain Relationships and Related Transactions, and Director Independence
|
Item 14.
|
Principal Accountant Fees and Services
|
Item 15.
|
Exhibits and Financial Statement Schedules
|
TEKMIRA PHARMACEUTICALS CORPORATION
|
||
By:
|
/s/ Mark Murray
|
|
Mark Murray
|
||
President and Chief Executive Officer
|
Signatures
|
Capacity in Which Signed
|
|
/s/ Vivek Ramaswamy
|
Director (Chairman)
|
|
Vivek Ramaswamy
|
||
/s/ Mark Murray
|
President and
Chief Executive Officer and Director
|
|
Mark Murray
|
(Principal Executive Officer)
|
|
/s/ Bruce Cousins
|
Executive Vice President, Finance and Chief Financial Officer
|
|
Bruce Cousins
|
(Principal Financial Officer and Accounting Officer)
|
|
/s/ Herbert J. Conrad
|
Director
|
|
Herbert J. Conrad
|
||
/s/ Richard C. Henriques
|
Director
|
|
Richard C. Henriques
|
||
/s/ Frank Karbe
|
Director
|
|
Frank Karbe
|
||
/s/ Keith Manchester
|
Director
|
|
Keith Manchester
|
|
|
/s/ William T. Symonds |
Chief Development Officer
|
|
William T. Symonds
|
Exhibit
Number
|
Description
|
|
2.1*
|
Subscription Agreement, between the Company and Alnylam Pharmaceuticals, Inc., dated March 28, 2008 (incorporated herein by reference to Exhibit 2.1 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2010 filed with the SEC on June 3, 2011).
|
|
2.2*
|
Subscription Agreement, between the Company and Roche Finance Ltd., dated March 31, 2008 (incorporated herein by reference to Exhibit 2.2 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2010 filed with the SEC on June 3, 2011).
|
|
2.3*
|
Agreement and Plan of Merger and Reorganization, dated January 11, 2015, by and among Tekmira Pharmaceuticals Corporation, TKM Acquisition Corporation and OnCore Biopharma, Inc. (incorporated herein by reference to Exhibit 2.1 to the Registrant’s Current Report on Form 8-K/A filed with the SEC on January 26, 2015).
|
|
3.1*
|
Notice of Articles and Articles of the Company (incorporated herein by reference to Exhibit 1.1 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2010 filed with the SEC on June 3, 2011).
|
|
3.2*
|
Amendment to the Articles of the Company dated May 14, 2013 (incorporated herein by reference to Exhibit 3.2 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2013 filed with the SEC on March 28, 2014).
|
|
3.3*
|
Governance Amendment to the Articles of the Company dated March 4, 2015, (incorporated herein by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on March 4, 2015).
|
|
3.4*
|
Approval of Quorum Policy of the Company, adopted January 31, 2015 (incorporated herein by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed with the SEC on February 5, 2015).
|
|
4.1*
|
Governance Agreement between the Company and Roivant Sciences Ltd., a Bermuda exempted company, dated January 11, 2015 (incorporated herein by reference to Exhibit 2.1 to the Registrant’s Current Report on Form 8-K/A filed with the SEC on January 26, 2015).
|
|
10.1†*
|
Amendment No. 1 to the Amended and Restated Agreement, between the Company (formerly Inex Pharmaceuticals Corporation) and Hana Biosciences, Inc., effective as of May 27, 2009 (incorporated herein by reference to Exhibit 4.1 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2010 filed with the SEC on June 3, 2011).
|
|
10.2†*
|
Amended and Restated License Agreement, between Inex Pharmaceuticals Corporation and Hana Biosciences, Inc., dated April 30, 2007 (incorporated herein by reference to Exhibit 4.2 to the Registrant’s Amendment No. 1 to Form 20-F for the year ended December 31, 2010 filed with the SEC on January 31, 2012).
|
|
10.3†*
|
Sublicense Agreement, between Inex Pharmaceuticals Corporation and Alnylam Pharmaceuticals, Inc., dated January 8, 2007 (incorporated herein by reference to Exhibit 4.3 to the Registrant’s Amendment No. 1 to Form 20-F for the year ended December 31, 2010 filed with the SEC on January 31, 2012).
|
|
10.4†*
|
Amended and Restated License and Collaboration Agreement, between the Company and Alnylam Pharmaceuticals, Inc., effective as of May 30, 2008 (incorporated herein by reference to Exhibit 4.4 to the Registrant’s Amendment No. 1 to Form 20-F for the year ended December 31, 2010 filed with the SEC on January 31, 2012).
|
|
10.5†*
|
Amended and Restated Cross-License Agreement, between Alnylam Pharmaceuticals, Inc. and Protiva Biotherapeutics Inc., dated May 30, 2008 (incorporated herein by reference to Exhibit 4.5 to the Registrant’s Amendment No. 1 to Form 20-F for the year ended December 31, 2010 filed with the SEC on January 31, 2012).
|
|
10.6†*
|
License Agreement, between Inex Pharmaceuticals and Aradigm Corporation, dated December 8, 2004 (incorporated herein by reference to Exhibit 4.6 to the Registrant’s Amendment No. 1 to Form 20-F for the year ended December 31, 2010 filed with the SEC on January 31, 2012).
|
|
10.7†*
|
Settlement Agreement, between Sirna Therapeutics, Inc. and Merck & Co., Inc. and Protiva Biotherapeutics Inc. and Protiva Biotherapeutics (USA), Inc., effective as of October 9, 2007 (incorporated herein by reference to Exhibit 4.7 to the Registrant’s Amendment No. 1 to Form 20-F for the year ended December 31, 2010 filed with the SEC on January 31, 2012).
|
|
10.8†*
|
Development, Manufacturing and Supply Agreement, between the Company and Alnylam Pharmaceuticals, Inc., dated January 2, 2009 (incorporated herein by reference to Exhibit 4.8 to the Registrant’s Amendment No. 1 to Form 20-F for the year ended December 31, 2010 filed with the SEC on January 31, 2012).
|
|
10.9†*#
|
Executive Employment Agreement with Ian Mortimer, dated March 26, 2008 (incorporated herein by reference to Exhibit 4.9 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2010 filed with the SEC on June 3, 2011).
|
|
10.10*#
|
Executive Employment Agreement with Ian MacLachlan, dated May 30, 2008 (incorporated herein by reference to Exhibit 4.10 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2010 filed with the SEC on June 3, 2011).
|
|
10.11*#
|
Executive Employment Agreement with Mark Murray, dated May 30, 2008 (incorporated herein by reference to Exhibit 4.11 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2010 filed with the SEC on June 3, 2011).
|
|
10.12*#
|
Executive Employment Agreement with Peter Lutwyche, dated January 1, 2009 (incorporated herein by reference to Exhibit 4.12 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2010 filed with the SEC on June 3, 2011).
|
|
10.13*#
|
Share Option Plan amended through May 12, 2009 (including form stock option agreements) (incorporated herein by reference to Exhibit 4.13 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2010 filed with the SEC on June 3, 2011).
|
|
10.14*
|
Lease Agreement with Canada Lands Company CLC Limited dated December 15, 1997, as amended (incorporated herein by reference to Exhibit 4.14 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2010 filed with the SEC on June 3, 2011).
|
|
10.15*#
|
Form of Indemnity Agreement (incorporated herein by reference to Exhibit 4.15 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2010 filed with the SEC on June 3, 2011).
|
|
10.16*
|
Award Contract with USASMDC/ARSTRAT effective date July 14, 2010 (incorporated herein by reference to Exhibit 4.16 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2010 filed with the SEC on June 3, 2011).
|
|
10.17†*
|
License Agreement between the University of British Columbia and Inex Pharmaceuticals Corporation executed on July 30, 2001 (incorporated herein by reference to Exhibit 4.17 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2010 filed with the SEC on June 3, 2011).
|
|
10.18†*
|
Amendment Agreement between the University of British Columbia and Inex Pharmaceuticals Corporation dated July 11, 2006 (incorporated herein by reference to Exhibit 4.18 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2010 filed with the SEC on June 3, 2011).
|
|
10.19†*
|
Second Amendment Agreement between the University of British Columbia and Inex Pharmaceuticals Corporation dated January 8, 2007 (incorporated herein by reference to Exhibit 4.19 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2010 filed with the SEC on June 3, 2011).
|
|
10.20†*
|
Consent Agreement of the University of British Columbia to Inex/Alnylam Sublicense Agreement dated January 8, 2007 (incorporated herein by reference to Exhibit 4.20 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2010 filed with the SEC on June 3, 2011).
|
|
10.21†*
|
Amendment No. 2 to the Amended and Restated Agreement, between the Company (formerly Inex Pharmaceuticals Corporation) and Hana Biosciences, Inc., effective as of September 20, 2010 (incorporated herein by reference to Exhibit 4.21 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2010 filed with the SEC on June 3, 2011).
|
|
10.22†*
|
License and Collaboration Agreement between the Company and Halo-Bio RNAi Therapeutics, Inc. as of August 24, 2011 (incorporated herein by reference to Exhibit 4.22 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2011 filed with the SEC on March 27, 2012).
|
|
10.23*
|
Loan Agreement with Silicon Valley Bank dated as of December 21, 2011 (incorporated herein by reference to Exhibit 4.23 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2011 filed with the SEC on March 27, 2012).
|
|
10.24*#
|
Employment Agreement with Paul Brennan dated August 24, 2010 (incorporated herein by reference to Exhibit 4.24 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2011 filed with the SEC on March 27, 2012).
|
|
10.25*#
|
Tekmira 2011 Omnibus Share Compensation Plan approved by shareholders on June 22, 2011 (incorporated herein by reference to Exhibit 4.25 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2011 filed with the SEC on March 27, 2012).
|
|
10.26†*
|
Settlement Agreement and General Release, by and among Tekmira Pharmaceuticals Corporation, Protiva Biotherapeutics Inc., Alnylam Pharmaceuticals, Inc., and AlCana Technologies, Inc., dated November 12, 2012 (incorporated herein by reference to Exhibit 4.26 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2012 filed with the SEC on March 27, 2013).
|
10.27†*
|
Cross-License Agreement by and among Alnylam Pharmaceuticals, Inc., Tekmira Pharmaceuticals Corporation and Protiva Biotherapeutics Inc., dated November 12, 2012(incorporated herein by reference to Exhibit 4.27 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2012 filed with the SEC on March 27, 2013).
|
|
10.28†*
|
License Agreement by and among Protiva Biotherapeutics Inc. and Marina Biotech, Inc. dated November 28, 2012 (incorporated herein by reference to Exhibit 4.28 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2012 filed with the SEC on March 27, 2013).
|
|
10.29*#
|
Employment Agreement with Diane Gardiner dated March 1, 2013 (incorporated herein by reference to Exhibit 4.29 to the Registrant’s Annual Report on Form 20-F for the year ended December 31, 2012 filed with the SEC on March 27, 2013).
|
|
10.30*#
|
Employment Agreement with Mark Kowalski dated August 12, 2013 (incorporated herein by reference to Exhibit 10.30 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2013 filed with the SEC on March 28, 2014).
|
|
10.31*#
|
Employment Agreement with Bruce Cousins dated October 7, 2013 (incorporated herein by reference to Exhibit 10.31 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2013 filed with the SEC on March 28, 2014).
|
|
10.32†*
|
Services Agreement by and among Protiva Biotherapeutics Inc., Protiva Agricultural Development Company Inc. and Monsanto Company dated January 12, 2014 (incorporated herein by reference to Exhibit 10.32 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2013 filed with the SEC on March 28, 2014).
|
|
10.33†*
|
Option Agreement by and among Tekmira Pharmaceuticals Corporation, Protiva Biotherapeutics Inc., Protiva Agricultural Development Company Inc. and Monsanto Canada Inc. dated January 12, 2014 (incorporated herein by reference to Exhibit 10.33 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2013 filed with the SEC on March 28, 2014).
|
|
10.34†*
|
License and Services Agreement by and among Protiva Biotherapeutics Inc., Protiva Agricultural Development Company Inc. and Tekmira Pharmaceuticals Corporation dated January 12, 2014 (incorporated herein by reference to Exhibit 10.34 to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2013 filed with the SEC on March 28, 2014).
|
|
10.35*
|
Forms of Lock-Up Agreement (incorporated herein by reference to Exhibit 2.1 to the Registrant’s Current Report on Form 8-K/A filed with the SEC on January 26, 2015).
|
|
10.36*
|
Form of Registration Rights Agreement (incorporated herein by reference to Exhibit 2.1 to the Registrant’s Current Report on Form 8-K/A filed with the SEC on January 26, 2015).
|
|
10.37*
|
Form of Standstill Agreement (incorporated herein by reference to Exhibit 2.1 to the Registrant’s Current Report on Form 8-K/A filed with the SEC on January 26, 2015).
|
|
10.38*
|
Form of Representation Letter (incorporated herein by reference to Exhibit 2.1 to the Registrant’s Current Report on Form 8-K/A filed with the SEC on January 26, 2015).
|
|
10.39**#
|
Executive Employment Agreement with Michael Abrams, dated November 14, 2013
|
|
10.40**#
|
Executive Employment Agreement with Kirk Rosemark, dated December 8, 2014
|
|
10.41**††
|
License Agreement, between Tekmira Pharmaceuticals and Protiva Biotherapeutics and Dicerna Pharmaceuticals dated November 16, 2014
|
|
10.42**††
|
Manufacturing and Clinical Trial Agreement between Tekmira Pharmaceuticals and Protiva Biotherapeutics and the Chancellor Masters and Scholars of the University of Oxford, dated December 18, 2014
|
|
10.43**
|
Modification Contract P0001, dated July 19, 2010, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.44**
|
Modification Contract P0002, dated April 15, 2011, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.45**
|
Modification Contract P0003, dated June 13, 2011, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.46**††
|
Modification Contract P0004, dated October 3, 2011, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.47**
|
Modification Contract P0005, dated December 2, 2011, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.48**
|
Modification Contract P0006, dated January 25, 2012, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.49**††
|
Modification Contract P0007, dated March 5, 2012, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.50**
|
Modification Contract P0008, dated April 23, 2012, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.51**
|
Modification Contract P0009, dated June 29, 2012, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.52**
|
Modification Contract P00010, dated July 16, 2012, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.53**
|
Modification Contract P00011, dated July 25, 2012, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.54**††
|
Modification Contract P00012, dated August 2, 2012, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.55**
|
Modification Contract P00013, dated August 27, 2012, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.56 **
|
Modification Contract P00014, dated August 31, 2012, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.57**
|
Modification Contract P00015, dated October 1, 2012, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.58**
|
Modification Contract P00016, dated October 2, 2012, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.59**
|
Modification Contract P00017, dated October 19, 2012, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.60**
|
Modification Contract P00018, dated December 31, 2012, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.61**
|
Modification Contract P00019, dated January 23, 2013, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.62 **
|
Modification Contract P00020, dated February 19, 2013, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.63 **
|
Modification Contract P00021, dated March 29, 2013, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.64**†† | Modification Contract P00022, dated April 30, 2013, to Award Contract, dated July 14, 2010 (Exhibit 10.16) | |
10.65**††
|
Modification Contract P00023, dated May 21, 2013, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.66 **
|
Modification Contract P00024, dated June 19, 2013, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.67**††
|
Modification Contract P00025, dated April 22, 2014, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.68**††
|
Modification Contract P00026, dated July 25, 2014, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.69**
|
Modification Contract P00027, dated July 25, 2014, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.70 **††
|
Modification Contract P00028, dated September 5, 2014, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.71 **
|
Modification Contract P00029, dated September 30, 2014, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.72**††
|
Modification Contract P00030, dated October 31, 2014, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.73**
|
Modification Contract P00031, dated November 17, 2014, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.74**††
|
Modification Contract P00032, dated March 4, 2015, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.75**††
|
Modification Contract P00033, dated March 4, 2015, to Award Contract, dated July 14, 2010 (Exhibit 10.16)
|
|
10.76**
|
Underwriting Agreement for 3,750,000 Common Shares with Stifel, Nicolaus & Company, dated October 17, 2013
|
|
10.77**
|
Underwriting Agreement for 2,125,000 Common Shares with Leerink Partners LLC, dated March 14, 2014
|
|
21.1**
|
List of Subsidiaries
|
|
23.1**
|
Consent of KPMG LLP, an Independent Registered Public Accounting Firm
|
|
31.1**
|
Certification of Chief Executive Officer pursuant to Rule 13a-14 or 15d-14 of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
31.2**
|
Certification of Chief Financial Officer pursuant to Rule 13a-14 or 15d-14 of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
32.1**
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
32.2**
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
|
|
101.INS**
|
XBRL Instance Document
|
|
101.SCH**
|
XBRL Taxonomy Extension Schema Document
|
|
101.CAL**
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
101.DEF**
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
101.LAB**
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
101.PRE**
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
*
**
|
Previously filed
Filed herewith
|
†
|
Confidential treatment granted as to portions of this exhibit.
|
††
#
|
Confidential treatment has been requested as to portions of this exhibit.
Management Contract
|
1.
|
EMPLOYMENT
|
(a)
|
The Executive will be employed by and will serve the Company as its
Executive
Vice
President
and
Chief
Discovery
Officer.
The Executive will report directly to the
President
and
Chief
Executive
Officer
of the Company and will perform the duties and responsibilities assigned to him from time to time by the Chief Executive Officer. The Executive will comply with all lawful instructions given by the Chief Executive Officer of the Company.
|
(b)
|
The terms and conditions of this Agreement will have effect as and from January 2, 2014 and the Executive's employment as
Executive
Vice
President
and
Chief
Discovery
Officer
will continue until tem1inated as provided for in this Agreement.
|
(c)
|
The Executive acknowledges and agrees that in addition to the tenns and conditions of this Agreement, his employment with the Company is subject to and governed by the Company's policies as established from time to time. The Executive agrees to comply with the terms of such policies so long as they are not inconsistent with any provisions of the Agreement. The Executive will inform himself of the details of such policies and amendments thereto established from time to time.
|
(d)
|
The Executive agrees that, as a high technology professional as defined in the Regulations to the
Employment
Standards
Act
of British Columbia, and an executive, his hours of work will vary and may be irregular and will be those hours required to meet the objectives of his employment. The Executive agrees that the compensation described in Section 2 of this Agreement compensates him in full for all hours worked.
|
(e)
|
The Executive will devote 80% of his time to the Company's business and will not be employed or engaged in any capacity in any other business without the prior permission of the Company, such permission not to be unreasonably withheld.
|
(f)
|
Concurrently with the execution and delivery of this Agreement and in consideration of his employment by the Company, the Executive and the Company will enter into a "Confidentiality and Assignment of Inventions Agreement" in the form attached hereto as Appendix A.
|
2.
|
REMUNERATION AND BENEFITS
|
(a)
|
The Company will pay the Executive an annual salary of $270,000 (Canadian funds), less required deductions (the "Base Salary"). The Base Salary will be payable semi-monthly.
|
(b)
|
The Base Salary will be reviewed on an annual basis. This review will not result in a decrease in the Base Salary nor will it necessarily result in an increase to the Base Salary.
|
(c)
|
The Executive will be eligible for an annual cash bonus of up to 40 percent of the Base Salary, if the Chief Executive Officer and the Board of Directors in their absolute discretion determine that the Executive has achieved the performance objectives agreed to between the Executive and the Chief Executive Officer. Any bonus payable during the first year of the Executive's employment will be pro rated. Payment of a bonus in any one year will not indicate the payment of a bonus in any other year.
|
(d)
|
The Company will facilitate the Executive's enrolment in the Company's insurance benefits plans, as amended from time to time. In all cases, eligibility to participate in the plans and to receive benefits under the plans will be subject to the terms and requirements of the plans themselves and/or the insurance provider.
|
(e)
|
The Executive will be eligible for participation in the Company's share incentive plan, subject to the terms of the plan.
|
(f)
|
The Company will reimburse the Executive for all reasonable expenses actually and properly incurred by the Executive in connection with the performance of his duties. The Executive will provide the Company with receipts supporting his claims for reimbursement.
|
3.
|
VACATION
|
4.
|
NON-COMPETITION AND NON-SOLICITATION
|
(a)
|
The biotechnology industry is highly competitive and employees leaving the employ of the Company have the ability to cause significant damage to the Company's interests if they join a competing business immediately upon leaving the Company.
|
(b)
|
Definitions:
|
(i)
|
"
Business"
or
"Business
of the
Company"
means:
|
(A)
|
the researching, developing, production and marketing of RNA interference drugs and delivery technology , as such business grows and evolves during this Agreement ; and
|
(B)
|
any other material business carried on from time to time by the Company or any subsidiary or affiliate of the Company.
|
(ii)
|
"Competing
Business"
means any endeavour, activity or business which is competitive in any material way with the Business of the Company worldwide.
|
(iii)
|
"
Custome
r
"
means any entity that is a customer of the Company that the Executive has been directly or indirectly, through his reports, involved in servicing on behalf of the Company.
|
(iv)
|
"Prospective
Customer"
means any entity during the course of his employment that was solicited by the Executive on behalf of the Company
|
(c)
|
The Executive shall not, during the term of this Agreement and for the Restricted Period (as defined below) following the termination of his employment for any reason, on his own behalf or on behalf of any entity, whether directly or indirectly, in any capacity whatsoever, alone, through or in connection with any entity, carry on or be employed by or engaged in or have any financial or other interest in or be otherwise commercially involved in a Competing Business. In this Agreement,
"Restricted
Period"
means: (i) in the event that the Executive is terminated pursuant to Section 6(b) of this Employment Agreement , a period equivalent to the amount of notice that the Executive is entitled pursuant to Section 6(b)(ii); or (ii) in the event that the Executive 's employment is terminated pursuant to a Change of Control (as defined below), a period of twelve (12) months.
|
(d)
|
The Executive shall, however, not be in default of Section 4(c) by virtue of the Executive:
|
(i)
|
following the termination of employment, holding, strictly for portfolio purposes and as a passive investor, no more than five percent (5%) of the issued and outstanding shares of, or any other interest in, any corporation or other entity that is a Competing Business; or
|
(ii)
|
during the course of employment, holding, strictly for portfolio purposes and as a passive investor, no more than five percent (5%) of the issued and outstanding shares of, or any other interest in, any corporation or other entity, the business of which corporation or other entity is in the same Business as the Company, and provided further that the Executive first obtains the Company's written consent, which consent will not be unreasonably withheld.
|
(e)
|
If the Executive holds issued and outstanding shares or any other interest in a corporation or other entity pursuant to Section 4(d)(ii) and following the acquisition of such shares or other interest the business of the corporation or other entity becomes a Competing Business, the Executive will promptly dispose of his shares or other interest in such corporation or other entity.
|
(f)
|
The Executive shall not, during this Agreement and for the Restricted Period following the termination of his employment, for whatever reason, on his own behalf or on behalf of or in connection with any other entity, without the prior written and informed consent of the Company, directly or indirectly, m any capacity whatsoever, alone, through or in connection with any entity:
|
(i)
|
canvass or solicit the business of (or procure or assist the canvassing or soliciting of the business of) any Customer or Prospective Customer of the Company, or otherwise solicit, induce or encourage any Customer or
|
(ii)
|
accept (or procure or assist the acceptance of) any business from any Customer or Prospective Customer of the Company which business is competitive with the Business; or
|
(iii)
|
supply (or procure or assist the supply of) any goods or services to any Customer or Prospective Customer of the Company for any purpose which is competitive with the Business; or
|
(iv)
|
employ, engage, offer employment or engagement to or solicit the employment or engagement of or otherwise entice away from or solicit, induce or encourage to leave the employment or engagement of the Company, any individual who is employed or engaged by the Company whether or not such individual would commit any breach of his contract or terms of employment or engagement by leaving the employ or the engagement of the Company; or
|
(v)
|
procure or assist any entity to employ, engage, offer employment or engagement or solicit the employment or engagement of any individual who is employed or engaged by the Company or otherwise entice away from the employment or engagement of the Company any such individual. Notwithstanding the foregoing, the Executive shall, be permitted to, solely in a personal capacity, provide letters of reference for individuals who are employed by the Company.
|
(g)
|
The Executive expressly recognizes and acknowledges that it is the intent of the parties that his activities following the termination of his employment with the Company be restricted in the manner described in this Agreement, and acknowledges that good, valuable, and sufficient consideration has been provided in exchange for such restrictions.
|
5.
|
INJUNCTIVE RELIEF
|
(a)
|
The Executive understands and agrees that the Company has a material interest in preserving the relationships it has developed with its executives, customers and suppliers against impairment by competitive activities of a former executive. Accordingly, the Executive agrees that the restrictions and covenants contained in Section 4 are reasonably required for the protection of the Company and its goodwill and that the Executive's agreement to those restrictions and covenants by the execution of this Agreement , are of the essence to this Agreement and constitute a material inducement to the Company to enter into this Agreement and to employ the Executive, and that the Company would not enter into this Agreement absent such an inducement.
|
(b)
|
The Executive understands and acknowledges that if the Executive breaches Section 4, that breach will give rise to irreparable injury to the Company for which damages are an inadequate remedy, and the Company may pursue injunctive relief for such breach in a court of competent jurisdiction.
|
6.
|
TERMINATION
|
(a)
|
The Executive may terminate his employment by giving at least three (3) months' advance notice in writing to the Company of the effective date of the resignation. The Company may waive such notice, in whole or in part, and if it does so, the Executive’s resignation will become effective and his employment will cease on the date set by the Company in the notice of waiver.
|
(b)
|
The Company may terminate the Executive's employment:
|
(i)
|
without notice or payment in lieu thereof, for just cause, which for the purposes of this Agreement will be defined to include but not be limited to the Executive's willful and continued failure to perform his duties hereunder and the Executive's willful engagement in conduct that is injurious to the Company, monetarily or otherwise; or
|
(ii)
|
at the Company's sole discretion for any reason, without cause, upon providing to the Executive:
|
(A)
|
an amount equal to twelve (12) months' Base Salary; plus
|
(B)
|
a bonus payment equal to the average of the actual bonus payments, if any, made to the Executive from the previous three
(3) calendar years preceding the date of termination of employment, pro-rated for the then current calendar year up to and including the day of termination; (collectively, the "Severance Amount"). The Company may pay the Severance Amount by way of one or more lump sum payments, by way of salary continuance or by a combination of both. The Severance Amount is inclusive of any entitlement to minimum standard severance under the
B.C.
Employment
Standards Act.
|
(c)
|
In this Agreement, "Change of Control" means the first occurrence of any one of:
|
(i)
|
the acquisition or continuing ownership by any person or persons acting jointly or in concert (as such phrase is defined in the
Securities
Act
(British Columbia)), directly or indirectly, of common shares or of convertible securities, which, when added to all other securities of the Company at the time held by such person or persons, or persons associated or affiliated with such person or persons within the meaning of the
|
(ii)
|
the sale, lease or exchange or other disposition of all or substantially all of the Company's assets;
|
(iii)
|
an amalgamation, merger, arrangement or other business combination (a
"Business
Combination")
involving the Company that results in the security holders of the parties to the Business Combination, other than the Company, owning, directly or indirectly, shares of the continuing entity that entitle the holders thereof to cast more than 50% of the votes attaching to all shares in the capital of the continuing entity that may be cast to elect directors; or
|
(iv)
|
the Company's Board of Directors, by resolution, determines that a Change of Control of the Company has occurred ."
|
(d)
|
If a Change of Control occurs and within twelve (12) months after the occurrence of a Change of Control, the Executive resigns his employment for Good Reason upon giving the Company not less than three (3) months' prior written notice of resignation; or at the Company's sole discretion, the Executive is terminated without cause within twelve (12) months after a Change of Control, the Executive will be entitled to receive the Change of Control Severance Amount (as defined below), which, in the case of termination , shall be instead of the Severance Amount. In this Agreement,
"G
ood
Reason"
means one or more of the following events occurring without the Executive's written consent:
|
(i)
|
a fundamental change in the Executive's status, position , remuneration, authority or responsibilities that does not represent a promotion from or represents an adverse change from the status, position, authority or responsibilities in effect immediately prior to the Change of Control;
|
(ii)
|
a fundamental reduction in the Base Salary or retirement plans, health benefits, bonus potential or other compensation plans, practices, policies or programs provided to the Executive immediately prior to the Change of Control;
|
(iii)
|
relocation of the Executive's principal place of employment to a place outside of Metro Vancouver;
|
(iv)
|
any request by the Company that the Executive participate in an unlawful act pursuant to the laws of British Columbia or Canada; or
|
(v)
|
any failure to secure the agreement of any successor company or other entity to the Company to fully assume the Company's obligations under this Agreement.
|
(e)
|
In this Agreement, the "Change of Control Severance Amount" means an amount calculated as follows:
|
(i)
|
an amount equal to:
|
(A)
|
twelve (12) months' Base Salary, in the event of tennination on or before January 2, 2016, or
|
(B)
|
eighteen (18) months' Base Salary, in the event of termination after January 2, 2016; plus
|
(ii)
|
a bonus payment equal to the average of the actual bonus payments, if any, made to the Executive from the previous three (3) calendar years preceding the date of termination of employment, pro-rated for the then current calendar year up to and including the day of termination.
|
(f)
|
No matter how the Executive's employment is terminated, the Executive will be entitled to any wages and bonus payable for service up to and including the day of termination.
|
7.
|
RETURN OF MATERIALS UPON TERMINATION OF EMPLOYMENT
|
8.
|
GENERAL PROVISIONS
|
(a)
|
Non-Waiver. Failure on the part of either party to complain of any act or failure to act of the other of them or to declare the other party in default of this Agreement, irrespective of how long such failure continues, will not constitute a waiver by such party of their rights hereunder or of the right to then or subsequently declare a default.
|
(b)
|
Severability.
In the event that any prov1s10n or part of this Agreement is determined to be void or unenforceable in whole or in part, the remammg provision s, or parts thereof, will be and remain in full force and effect.
|
(c)
|
Entire
Agreement.
This Agreement constitutes the entire agreement between the parties with respect to the employment of the Executive and supersedes any and all agreements, understandings, warranties or representations of any kind, written or oral, express or implied, including any relating to the nature of the position or its duration, and each of the parties releases and forever discharges the other of and from all manner of actions, causes of action, claim or demands whatsoever under or in respect of any agreement.
|
(d)
|
Survival.
The provisions of Sections I (f), 4 and 8(f) will survive the termination of this Agreement.
|
(e)
|
Modification
of
Agreement
.
Any modification of this Agreement must be in writing and signed by both the Company and the Executive or it will have no effect and will be void.
|
(f)
|
Disputes.
Except for disputes arising in respect of Section
4,
all disputes arising out of or in connection with this Agreement and the employment relationship between the parties, are to be referred to and finally resolved by arbitration administered by the British Columbia International Commercial Arbitration Centre, pursuant to its Rules. The place of arbitration will be Vancouver, British Columbia.
|
(g)
|
Governing
Law
.
This Agreement will be governed by and construed according to the laws of the Province of British Columbia, Canada.
|
(h)
|
Reimbursement
of
Legal
F
ees.
The Company will reimburse the Executive for all reasonable and receipted legal fees incurred by the Executive in the negotiation, drafting, and completion of this Agreement.
|
(i)
|
Independent
Legal
Advice.
The Executive agrees that the contents, terms and effect of this Agreement have been explained to his by a lawyer and are fully understood. The Executive further agrees that the consideration described aforesaid is accepted voluntarily for the purpose of employment with the Company under the terms and conditions described above.
|
SIGNED, SEALED AND DELIVERED | ||||
by Michael Abrams in the presence of: | /s/ Michael Abrams | |||
Michael Abrams | ||||
Witness: | ||||
Address: | ||||
Occupation: |
Per: | /s/ Mark J. Murray | |
Mark J. Murray |
1.
|
EMPLOYMENT
|
(a)
|
The Executive will be employed by and will serve the Company as its Senior Vice President, Regulatory Affairs and Quality Assurance. The Executive will report directly to the President and Chief Executive Officer of the Company and will perform the duties and responsibilities assigned to him from time to time by the Chief Executive Officer. The Executive will comply with all lawful instructions given by the Chief Executive Officer of the Company.
|
(b)
|
The terms and conditions of this Agreement will have effect as and from January 5,2015 and the Executive's employment as Senior Vice President, Regulatory Affairs & Quality will continue until terminated as provided for in this Agreement.
|
(c)
|
The Executive acknowledges and agrees that in addition to the terms and conditions of this Agreement, his employment with the Company is subject to and governed by the Company's policies as established from time to time. The Executive agrees to comply with the terms of such policies so long as they are not inconsistent with any provisions of the Agreement. The Executive will inform himself of the details of such policies and amendments thereto established from time to time.
|
(d)
|
The Executive will devote 100% of his time to the Company's business and will not be employed or engaged in any capacity in any other business without the prior permission of the Company, such permission not to be unreasonably withheld.
|
(e)
|
Concurrently with the execution and delivery of this Agreement and in consideration of his employment by the Company, the Executive and the Company will enter into a "Confidentiality and Assignment of Inventions Agreement" in the form attached hereto as Appendix A.
|
(f)
|
Notwithstanding anything to the contrary in this Agreement, the Executive acknowledges and agrees that he may be seconded, at any time, in the Company' sole discretion, to Tekmira Pharmaceuticals Corporation or Protiva Biotherapeutics Inc., both affiliates of the Company. For the avoidance of doubt, any such secondment shall not be considered a termination, constructive or outright, of employment with the Company.
|
2.
|
REMUNERATION AND BENEFITS
|
(a)
|
The Company will pay the Executive an annual base salary of S300,000, subject to withholdings and deductions as required or permitted by law (the "Base Salary"). The Base Salary will be paid in semi-monthly installments, in arrears. This is an exempt position and the Executive will not receive overtime compensation.
|
(b)
|
The Base Salary will be reviewed on an annual basis. This review will not result in a decrease in the Base Salary unless a material adverse change in the financial condition or operations of the Company has occurred or unless the Executive's responsibilities are altered to reflect less responsibility.
|
(c)
|
The Executive will be eligible for an annual cash bonus of up to 35 percent of the Base Salary, if the Chief Executive Officer and the Board of Directors in their absolute discretion determine that the Executive has achieved the performance objectives agreed to between the Executive and the Chief Executive Officer. Any bonus payable during the first year of the Executive's employment will be pro rated. Payment of a bonus in any one year will not indicate the payment of a bonus in any other year.
|
(d)
|
The Company will facilitate the Executive's enrolment in the Company's insurance benefits plans, as amended from time to time by the Company or the insurance carrier. In all cases, eligibility to participate in the plans and to receive benefits under the plans will be subject to the terms and requirements of the applicable insurance carrier in accordance with the formal benefits plan documents and policies. Any issues with respect to entitlement to or payment of benefits under the benefits package will be governed by the terms of such documents and policies. The Company is not responsible for the payment of benefits in any circumstance. Further, the Company reserves the right, in its sole discretion, to change any of the insurance benefit plans or providers, however, if the Company is unable to maintain similar coverage as to the insurance benefits plans or the providers, then the Executive will be provided with compensation to assist in securing his own coverage, such compensation to be determined by the Company.
|
(e)
|
The Executive will be eligible for participation in the Company's share incentive plan, subject to the terms of the plan.
|
(f)
|
The Company will reimburse the Executive for all reasonable expenses actually and properly incurred by the Executive in connection with the performance of his duties. The Executive will provide the Company with receipts supporting his claims for reimbursement.
|
(g)
|
By accepting this Agreement, the Executive agrees that the Company may deduct and set-off from any amounts the Company owes the Executive from time to time (including amounts owed to the Executive as wages or other compensation, fringe benefits or vacation pay, as well as any other amounts owed to the Executive by the Company), any amounts the Executive owes to the Company. Notwithstanding the any deduction or set-off made by the Company hereunder, if the Company does not recover by means of such deduction and set-off the full amount owed by the Executive, the Executive agrees to immediately pay the unpaid balance to the Company.
|
3.
|
VACATION
|
4.
|
NON-COMPETITION AND NON-SOLICITATION
|
(a)
|
The biotechnology industry is highly competitive and employees leaving the employ of the Company have the ability to cause significant damage to the Company's interests if they join a competing business immediately upon leaving the Company.
|
(b)
|
De
finiti
o
n
s
:
|
(i)
|
"
Busines
s
"
or
"
Business
of
the
Company"
means:
|
(A)
|
the researching, developing, production and marketing of RNA interference drugs and delivery technology, as such business grows and evolves during this Agreement; and
|
(B)
|
any other material business carried on from time to time by the Company or any Affiliate of the Company.
|
(ii)
|
"
Competing
Business"
means any endeavor, activity or business which is competitive in any material way with the Business of the Company worldwide.
|
(iii)
|
"
Contac
t
"
means any person, firm, corporation or other entity that was a client, customer, supplier, principal, shareholder, investor, collaborator, strategic partner, licensee, contact or prospect of the Company (or of its partners, funders or Affiliates) with whom the Executive dealt or otherwise became aware of during the term of his employment in any capacity with the Company.
|
(iv)
|
'
'Restrict
e
d
Period"
means:
|
(A)
|
in the event that the Executive is terminated pursuant to Section 6(b) of this Employment Agreement, a period of six (6) months; or
|
(B)
|
in the event that the Executive's employment is terminated pursuant to a Change of Control (as defined below), a period of twelve (12) months.
|
(c)
|
Reasonableness
. The Executive hereby acknowledges and agrees that:
|
(i)
|
both before and since the Effective Date the Company has operated and competed and will operate and compete worldwide, with respect to the Business of the Company;
|
(ii)
|
competitors of the Company and the Business are located worldwide;
|
(iii)
|
in order to protect the Company adequately, any enjoinder of competition would have to apply to any country in which the Company, during the term of the Executive's employment, had material business relationships;
|
(iv)
|
during the course of his employment with the Company, on behalf of the Company, the Executive .will acquire knowledge of, and will come into contact with, initiate and establish relationships with, both existing and new clients, customers, suppliers, principals, contacts and prospects of the Company, and that in some circumstances the Executive may become the senior or sole representative of the Company dealing with such persons; and
|
(v)
|
in light of the foregoing, the provisions of this Section 4 are reasonable and necessary for the proper protection of the Business of the Company.
|
(d)
|
Restrictive
Covenan
t. During the term of his employment and for the Restricted Period after the termination thereof, the Executive shall not, within the geographic scope of any country in which the Company, during the term of the Executive's employment, had material business relationships, carry on or be employed by or engaged in or have any financial or other interest in or be otherwise commercially involved in a Competing Business, directly or indirectly, either individually or in partnership or jointly or in conjunction with any person, firm, corporation or other entity, as principal, agent, consultant, advisor, employee, shareholder or in any manner whatsoever.
|
(e)
|
Exception
. The Executive shall not be in default of Section 4(d) by virtue of the Executive:
|
(i)
|
following the termination of employment, holding, strictly for portfolio purposes and as a passive investor, no more than five percent (5%) of the issued and outstanding shares of, or any other interest in, any corporation or other entity which is listed on any recognized stock exchange, that is a Competing Business; or
|
(ii)
|
during the term of his employment, holding, strictly for portfolio purposes and as a passive investor, issued and outstanding shares of, or any other interest in, any corporation or other entity, the business of which corporation or other entity is in the same Business as the Company provided such corporation is not a Competing Business, and provided further that the Executive first obtains the Company's written consent, which consent will not be unreasonably withheld.
|
(f)
|
Non-Solicitation
. The Executive shall not, during the term of his employment and for the Restricted Period after the termination thereof for any reason, whether
legal or illegal, either individually or in partnership or jointly or in conjunction with any person, firm, corporation or other entity, as principal, agent, consultant, advisor, employee, shareholder or in any manner whatsoever, without the prior written and informed consent of the Company, directly or indirectly:
|
(i)
|
canvass or solicit the business of (or procure or assist the canvassing or soliciting of the business of) any Contact, or otherwise solicit, induce or encourage any Contact to curtail or cease its relationship with the Company, for any purpose which is competitive with the Business; or
|
(ii)
|
accept (or procure or assist the acceptance of) any business from any Contact which business is competitive with the Business; or
|
(iii)
|
be employed by or supply (or procure or assist the supply of) any goods or services to any Contact for any purpose which is competitive with the Business; or
|
(iv)
|
employ, engage, offer employment or engagement to or solicit the employment or engagement of or otherwise entice away from or solicit, induce or encourage to leave the employment or engagement of the Company, any individual who is employed or engaged by the Company whether or not such individual would commit any breach of his contract or terms of employment or engagement by leaving the employ or the engagement of the Company, provided that the Executive shall be permitted, solely in a personal capacity, to provide letters of reference for individuals who are employed by the Company.
|
(g)
|
Validity
. The Executive expressly recognizes and acknowledges that it is the intent of the parties that his activities following the termination of his employment with the Company be restricted in the manner described in this Section 4, and acknowledges that good, valuable, and sufficient consideration has been provided in exchange for such restrictions. The Executive agrees that should any of the restrictions contained in this Section 4 be found to be unreasonable to any extent by a court of competent jurisdiction adjudicating upon the validity of the restriction, whether as to the scope of the restriction, the area of the restriction or the duration of the restriction, then such restriction shall be reduced to that which is in fact declared reasonable by such court, or a subsequent court of competent jurisdiction , requested to make such a declaration, in order to ensure that the intention of the parties is given the greatest possible effect.
|
5.
|
INJUNCTIVE RELIEF
|
(a)
|
The Executive understands and agrees that the Company has a material interest in preserving the relationships it has developed with its executives, customers and suppliers against impairment by competitive activities of a former executive. Accordingly, the Executive agrees that the restrictions and covenants contained in Section 4 are reasonably required for the protection of the Company and its goodwill and that the Executive's agreement to those restrictions and covenants by the execution of this Agreement, are of the essence to this Agreement and constitute a material inducement to the Company to enter into this Agreement and to employ the Executive, and that the Company would not enter into this Agreement absent such an inducement.
|
(b)
|
The Executive understands and acknowledges that if the Executive breaches Section 4, that breach will give rise to irreparable injury to the Company for which damages are an inadequate remedy, and the Company may pursue injunctive relief for such breach in a court of competent jurisdiction.
|
6.
|
TERMINATION
|
(a)
|
The Executive may terminate his employment by giving at least three (3) months' advance notice in writing to the Company of the effective date of the resignation. The Company may waive such notice, in whole or in part, and if it does so, the Executive's resignation will become effective and his employment will cease on the date set by the Company in the notice of waiver.
|
(b)
|
The Company may terminate the Executive's employment:
|
(i)
|
without notice or payment in lieu thereof, for Cause. "Cause" means the Company's reasonable belief that any of the following has occurred: any breach of this Agreement by the Executive; any failure to perform assigned job responsibilities that continues unremedied for a period of thirty (30) days after written notice to the Executive by the Company; commission of a felony or misdemeanor or failure to contest prosecution for a felony or misdemeanor; the Company's reasonable belief that the Executive engaged in a violation of any statute, rule or regulation, any of which in the judgment of the Company is harmful to the business or to Company's reputation; the Company's reasonable belief that the Executive engaged in unethical practices, dishonesty or disloyalty; or any reason that would constitute Cause under the laws the State of Washington. Upon termination of the Executive's employment hereunder for Cause or upon the death or disability of the Executive, the Executive will have no rights to any unvested benefits or any other compensation or payments after the termination date or the last day of the month in which the Executive's death or disability occurred. For purposes of this Agreement, "disability" means the incapacity or inability of the Executive, whether due to accident, sickness or otherwise, as determined by a medical doctor acceptable to the Board of Directors of the Company, and confirmed in writing by such doctor, to perform the essential functions of the Executive's position under this Agreement, with or without reasonable accommodation (provided that no accommodation that imposes undue hardship on the Company will be required) for an aggregate of ninety (90) days during any period of one hundred eighty (180) consecutive days, or such longer period as may be required under disability law; or
|
(ii)
|
at the Company's sole discretion for any reason, without cause, upon providing to the Executive an amount equal to twelve (12) months' Base Salary (the "Severance Amount '). The Company may pay the Severance Amount by way of one or more lump sum payments, by way of salary continuance or by a combination of both. The Executive shall only be entitled to the Severance Amount if, within thirty (30) days following the date of termination, the Executive executes and does not rescind, as may be permitted by law, a general release of claims in a form mutually acceptable to both parties.
|
(iii)
|
(c)
|
In this Agreement, "Change of Control'' means the first occurrence of any one of:
|
(i)
|
the acquisition or continuing ownership by any person or persons acting jointly or in concert, directly or indirectly, of common shares or of convertible securities, which, when added to all other securities of the Company at the time held by such person or persons, or persons associated or affiliated with such person (collectively, the "Acquirors"), and assuming the conversion, exchange or exercise of convertible securities beneficially owned by the Acquirors, results in the Acquirors beneficially owning shares that would, notwithstanding any agreement to the contrary, entitle the holders thereof for the first time to cast more than 50% of the votes attaching to all shares in the capital of the Company that may be cast to elect directors;
|
(ii)
|
the sale, lease or exchange or other disposition of all or substantially all of the Company's assets;
|
(iii)
|
an amalgamation, merger, arrangement or other business combination (a "Business Combination") involving the Company that results in the security holders of the parties to the Business Combination, other than the Company, owning, directly or indirectly, shares of the continuing entity that entitle the holders thereof to cast more than 50% of the votes attaching to all shares in the capital of the continuing entity that may be cast to elect directors; or
|
(iv)
|
the Company's Board of Directors, by resolution, determines that a Change of Control of the Company has occurred."
|
(d)
|
If a Change of Control occurs and within twelve (12) months after the occurrence of a Change of Control, the Executive resigns his employment for Good Reason upon giving the Company not less than three (3) months' prior written notice of resignation; or at the Company's sole discretion, the Executive is terminated without cause within twelve (12) months after a Change of Control, the Executive will be entitled to receive the Change of Control Severance Amount (as defined below), which, in the case of termination, shall be instead of the Severance Amount. In this Agreement, "Good Reason" means one or more of the following events occurring without the Executive's written consent:
|
(i)
|
a fundamental change in the Executive's status, position, remuneration, authority or responsibilities that does not represent a promotion from or represents an adverse change from the status, position, authority or responsibilities in effect immediately prior to the Change of Control;
|
(ii)
|
a fundamental reduction in the Base Salary or retirement plans, health benefits, bonus potential or other compensation plans, practices, policies or programs provided to the Executive immediately prior to the Change of Control;
|
(iii)
|
relocation of the Executive's principal place of employment to a place outside of the Seattle, Washington metropolitan area (which includes the City of Seattle, King County, Snohomish County and Pierce County within the Puget Sound region);
|
(iv)
|
any request by the Company that the Executive participate in an unlawful act pursuant to the laws of the State of Washington; or
|
(v)
|
any failure to secure the agreement of any successor company or other entity to the Company to fully assume the Company's obligations under this Agreement.
|
(e)
|
In this Agreement, the "Change of Control Severance Amount" means an amount calculated as follows:
|
(i)
|
an amount equal to twelve (12) months' Base Salary; plus
|
(ii)
|
a bonus payment equal to the average of the actual bonus payments, if any, made to the Executive from the previous three (3) calendar years preceding the date of termination of employment, pro-rated for the then current calendar year up to and including the day of termination.
|
7.
|
RETURN OF MATERIALS UPON TERMINATION OF EMPLOYMENT
|
8.
|
GENERAL PROVISIONS
|
(a)
|
Non-Waiver. Failure on the part of either party to complain of any act or failure to act of the other of them or to declare the other party in default of this Agreement, irrespective of how long such failure continues, will not constitute a waiver by such party of their rights hereunder or of the right to then or subsequently declare a default.
|
(b)
|
Severability. In the event that any provision or part of this Agreement is determined to be void or unenforceable in whole or in part, the remaining provisions, or parts thereof, will be and remain in full force and effect.
|
(c)
|
Entire
Agreement.
This Agreement constitutes the entire agreement between the parties with respect to the employment of the Executive and supersedes any and all agreements, understandings, warranties or representations of any kind, written or oral, express or implied, including any relating to the nature of the position or its duration, and each of the parties releases and forever discharges the other of and from all manner of actions, causes of action, claim or demands whatsoever under or in respect of any agreement.
|
(d)
|
Survival.
The provisions of Sections l(e), 4, 5, 7 and 8(t) will survive the termination of this Agreement.
|
(e)
|
Modification
o
f
Agreement.
Any modification of this Agreement must be in writing and signed by both the Company and the Executive or it will have no effect and will be void.
|
(t)
|
Disputes.
Except for the right of the Company and the Executive to seek injunctive relief in court, any controversy, claim or dispute of any type arising out of or relating to the Executive's employment or the provisions of this Agreement shall be resolved in accordance with this Section 8(t) regarding resolution of disputes, which will be the sole and exclusive procedure for the resolution of any disputes. This Agreement shall be enforced in accordance with the Federal
Arbitration
Act,
the enforcement provisions of which are incorporated herein by this reference. Matters subject to these provisions include, without limitation, claims or disputes based on statute, contract, common law and tort and will include, for example, matters pertaining to termination, discrimination, harassment, compensation and benefits. Matters to be resolved under these procedures also include claims and disputes arising out of statutes such as the
Fair
Labor
Standards
Act,
Title VII of the
Civil
Rights
Act,
the
Age
Discri
m
i
nation
in
Employment
A
c
t,
the Washington
Minimum
Wage
A
c
t,
and the Washington Law Against Discrimination. Nothing in this provision is intended to restrict the Executive from submitting any matter to an administrative agency with jurisdiction over such matter.
|
(i)
|
Mediation
. The Company and the Executive will make a good faith attempt to resolve any and all claims and disputes by submitting them to mediation in Seattle, Washington, USA, before resorting to arbitration or any other dispute resolution procedure. ·The mediation of any claim or dispute must be conducted in accordance with the then-current JAMS (formerly Judicial Arbitration and Mediation Services, Inc.) procedures for the resolution of employment disputes by mediation, by a mediator who has had both training and experience as a mediator of general employment and commercial matters. If the parties to this Agreement cannot agree on a mediator, then the mediator will be selected by JAMS in accordance with JAMS' strike list method. Within thirty (30) days after the selection of the mediator, the Company and the Executive and their respective attorneys will meet with the mediator for one (1) mediation session of at least four (4) hours duration. If the claim or dispute cannot be settled
|
(ii)
|
Arbitration
. If any claim or dispute has not been resolved in accordance with Section 8(f)(i), then the claim or dispute will be determined by arbitration in accordance with the then-current JAMS employment arbitration rules and procedures, except as modified herein. The arbitration will be conducted by a sole neutral arbitrator who has had both training and experience as an arbitrator of general employment and commercial matters and who is and for at least ten (10) years has been, a partner, a shareholder or a member in a law firm. If the Company and the Executive cannot agree on an arbitrator, then the arbitrator will be selected by JAMS in accordance with Rule 15 of the JAMS employment arbitration rules and procedures. No person who has served as a mediator under the mediation provision, however, may be selected as the arbitrator for the same claim or dispute. Reasonable discovery will be permitted and the arbitrator may decide any issue as to discovery. The arbitrator may decide any issue as to whether or as to the extent to which any dispute is subject to the dispute resolution provisions in this Section 8(f) and the arbitrator may award any relief permitted by law. The arbitrator must base the arbitration award on the provisions of this Section 8(t) and applicable law and must render the award in writing, including an explanation of the reasons for the award. Judgment upon the award may be entered by any court having jurisdiction of the matter, and the decision of the arbitrator will be final and binding. The statute of limitations applicable to the commencement of a lawsuit will apply to the commencement of an arbitration under this Section 8(f)(ii). The arbitrator's fees will be paid in equal portions by the Company and the Executive, unless the Company agrees to pay all such fees.
|
(g)
|
Governing
Law
. Except as provided in Section 8(f), above, the validity, construction and performance of this Agreement shall be governed by the laws of the State of Washington, USA without regard to the conflicts of law provisions of such laws. The King County Superior Court, Seattle, Washington, USA shall have exclusive jurisdiction of any lawsuit arising from or relating to the Executive's employment with, or termination from, the Company, or arising from or relating to this Agreement. The Executive consents to such venue and personal jurisdiction.
|
(h)
|
Reimbursement
of
Legal
Fees
. The Company will reimburse the Executive for all reasonable and receipted legal fees incurred by the Executive in the negotiation, drafting, and completion of this Agreement Unless otherwise agreed, the parties shall each bear their own costs and attorneys' fees incurred in any litigation or dispute relating to the interpretation or enforcement of this Agreement.
|
(i)
|
Tax
Considerations.
The Executive acknowledges that amounts paid pursuant to this Agreement may have tax consequences pursuant to the Code or under local, state or international tax laws. The Executive acknowledges that he is relying solely and exclusively on his own professional tax and investment advisors with respect to any and all such matters (and is not relying, in any manner, on the Company or any of its employees or representatives). The Executive understands and agrees that any and all tax consequences resulting from payments, or the right to payments, under this Agreement are solely and exclusively the responsibility of the Executive, without any expectation or understanding that the Company or any of its employees or representatives will pay or reimburse the Executive for such taxes. It is intended that this Agreement shall comply with Section 409A of the Code and Department of Treasury regulations and other interpretive guidance issued thereunder, and the provisions of this Agreement shall be construed and administered accordingly.
|
(
j)
|
Independent
Legal
Advice
. The Executive agrees that the contents, terms and effect of this Agreement have been explained to his by a lawyer and are fully understood. The Executive further agrees that the consideration described aforesaid is accepted voluntarily for the purpose of employment with the Company under the terms and conditions described above.
|
Signed, Sealed and Delivered by KIRK | ||||
ROSEMARK in the presence of: | /s/ Kirk Rosemark | |||
Kirk Rosemark | ||||
Witness: | ||||
Address: | ||||
Occupation: |
Per: | /s/ Mark J. Murray | |
Mark J. Murray |
|
1.1
|
General
|
2
|
|
1.2
|
Interpretation
|
9
|
|
ARTICLE II –
|
LICENSE GRANTS AND RELATED RIGHTS
|
10
|
|
2.1
|
License Grants to Dicerna
|
10
|
|
2.2
|
Sublicensing
|
10
|
|
2.3
|
Grant Back
|
11
|
|
2.4
|
Retained Rights
|
11
|
|
2.5
|
Rights in Bankruptcy
|
11
|
|
2.6
|
Contractors
|
11
|
|
ARTICLE III –
|
FINANCIAL PROVISIONS
|
12
|
|
3.1
|
Upfront Payment and Milestone Payments
|
12
|
|
3.2
|
Royalty Payments
|
13
|
|
3.3
|
Royalty Reports; Expense Reports; Records and Audits
|
13
|
|
3.4
|
Payment Procedure
|
14
|
|
3.5
|
Term of Payments
|
15
|
|
ARTICLE IV –
|
ADDITIONAL OBLIGATIONS
|
15
|
|
4.1
|
Obligations of Protiva
|
15
|
|
4.2
|
Obligations of Dicerna
|
15
|
|
4.3
|
Other Obligations and Agreements of the Parties
|
15
|
|
ARTICLE V –
|
INTELLECTUAL PROPERTY
|
16
|
|
5.1
|
Ownership
|
16
|
|
5.2
|
Prosecution and Maintenance of Patents
|
16
|
|
5.3
|
Third-Party Infringement of Protiva Patents and Tekmira Patents
|
16
|
|
5.4
|
Defense of Claims Brought by Third Parties
|
18
|
|
ARTICLE VI –
|
CONFIDENTIAL INFORMATION AND PUBLICITY
|
18
|
|
6.1
|
Limitation of Disclosure
|
18
|
|
6.2
|
Non-Disclosure of Confidential Information
|
18
|
|
6.3
|
Exceptions
|
19
|
|
6.4
|
Permitted Uses; Protection
|
19
|
|
6.5
|
Permitted Disclosures
|
20
|
|
6.6
|
Press Release
|
20
|
|
ARTICLE VII –
|
INDEMNIFICATION AND INSURANCE
|
20
|
|
7.1
|
Protiva Indemnification
|
20
|
|
7.2
|
Dicerna Indemnification
|
21
|
|
7.3
|
Tender of Defense; Counsel
|
21
|
|
7.4
|
Insurance
|
22
|
ARTICLE VIII –
|
TERM AND TERMINATION
|
22
|
|
8.1
|
Term
|
22
|
|
8.2
|
Termination for Material Breach
|
22
|
|
8.3
|
Termination for Failure to Actively Develop or Commercialize
|
23
|
|
8.4
|
Challenges of Protiva’s Patents or Tekmira Patents
|
23
|
|
8.5
|
Rights in Bankruptcy
|
23
|
|
8.6
|
Consequences of Termination; Survival
|
24
|
|
8.7
|
Remedies
|
24
|
|
ARTICLE IX –
|
MISCELLANEOUS
|
24
|
|
9.1
|
Representations and Warranties
|
24
|
|
9.2
|
Force Majeure
|
27
|
|
9.3
|
Consequential Damages
|
28
|
|
9.4
|
Assignment
|
28
|
|
9.5
|
Notices
|
28
|
|
9.6
|
Independent Contractors
|
29
|
|
9.7
|
Governing Law; Dispute Resolution; Arbitration
|
29
|
|
9.8
|
Severability
|
31
|
|
9.9
|
No Implied Waivers
|
31
|
|
9.10
|
Headings
|
31
|
|
9.11
|
Entire Agreement; Amendment
|
31
|
|
9.12
|
Waiver of Rule of Construction
|
31
|
|
9.13
|
No Third-Party Beneficiaries
|
31
|
|
9.14
|
Further Assurances
|
31
|
|
9.15
|
Performance by Affiliates
|
31
|
|
9.16
|
Counterparts
|
32
|
Milestone Event
|
Milestone Fee
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Royalty Table
|
|
Net Sales
|
Royalty
(Percent of Net Sales)
|
For all cumulative, worldwide Net Sales less than [***]
|
[***]
|
For cumulative, worldwide Net Sales equal to or exceeding [***] but less than [***]
|
[***]
|
For cumulative, worldwide Net Sales equal to or exceeding [***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Country Name
|
Status
|
Title
|
Serial #
|
Filed Date
|
Patent #
|
Issue Date
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Country Name
|
Status
|
Title
|
Serial #
|
Filed Date
|
Patent #
|
Issue Date
|
[***]
|
[***]
|
[***]
|
[***]
|
Country Name
|
Status
|
Title
|
Serial #
|
Filed Date
|
Patent #
|
Issue Date
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Country Name
|
Status
|
Title
|
Serial #
|
Filed Date
|
Patent #
|
Issue Date
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Country Name
|
Status
|
Title
|
Serial #
|
Filed Date
|
Patent #
|
Issue Date
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
||
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Country Name
|
Status
|
Title
|
Serial #
|
Filed Date
|
Patent #
|
Issue Date
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Country Name
|
Status
|
Title
|
Serial #
|
Filed Date
|
Patent #
|
Issue Date
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Country Name
|
Status
|
Title
|
Serial #
|
Filed Date
|
Patent #
|
Issue Date
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Country Name
|
Status
|
Title
|
Serial #
|
Filed Date
|
Patent #
|
Issue Date
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Name of Agreement
|
Parties
|
Effective Date
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
Not For Immediate Release | November 17, 2014 |
Investor Contacts:
Tekmira:
Julie P. Rezler
Director, Investor Relations
Phone: 604-419-3200
Email:
jrezler@tekmira.com
|
Media Contacts:
Tekmira:
Please direct all media inquiries to
media@tekmira.com
|
Article 1 Interpretation
|
1
|
1.1 Definitions
|
1
|
Article 2 Engagement
|
7
|
2.1 Appointment of TEKMIRA
|
7
|
2.2 Change Orders
|
7
|
2.3 OXFORD performance of the Clinical Trial
|
7
|
2.4 TEKMIRA performance of Clinical Trial activities
|
8
|
Article 3 Manufacturing Services
|
8
|
3.1 Use of Materials and Investigational Medicinal Product
|
8
|
3.2 Storage
|
8
|
3.3 Transport and Risk of Loss
|
8
|
3.4 Reporting and Records
|
9
|
Article 4 Compensation
|
9
|
4.1 Costs, Invoicing, Payment and Audit
|
9
|
4.2 Future Development and Use of the Investigational Medicinal Product
|
10
|
Article 5 Regulatory Compliance, Support and Responsibilities
|
10
|
5.1 Anti-Bribery
|
10
|
5.2 Clinical Samples
|
10
|
5.3 Regulatory Support
|
11
|
5.4 Responsibilities
|
11
|
5.5 Records, Audits and Inspections
|
11
|
5.6 Variation
|
12
|
Article 6 Clinical Trial
|
12
|
6.1 Protocol Development
|
12
|
6.2 Conduct of Clinical Trial
|
13
|
6.3 Personnel
|
13
|
6.4 Ethical and Regulatory Approvals
|
13
|
6.5 Trial Sites
|
14
|
6.6 Data Protection
|
14
|
6.7 Pharmacovigilance
|
14
|
6.8 Insurance
|
15
|
Article 7 Intellectual Property
|
15
|
7.1 Background IP
|
15
|
7.2 Arising IP
|
15
|
7.3 Perfection of Ownership Rights
|
16
|
Article 8 Confidentiality
|
16
|
8.1 Confidentiality Obligations
|
16
|
8.2 Publication
|
17
|
8.3 No License
|
18
|
8.4 Return of Confidential Information
|
19
|
Article 9 Representations, Warranties and Covenants
|
19
|
9.1 Mutual Representations and Warranties
|
19
|
9.2 Individual Representations and Warranties
|
19
|
9.3 Disclaimers
|
19
|
9.4 No Implied Warranties
|
20
|
Article 10 LIABILITY
|
20
|
10.1 OXFORD
|
20
|
10.2 TEKMIRA
|
20
|
10.3 Conditions
|
20
|
10.4 LIMITATION OF LIABILITY
|
21
|
Article 11 Term and Termination
|
22
|
11.1 Term
|
22
|
11.2 Cancellation or Termination by OXFORD
|
22
|
11.3 Termination for Cause
|
23
|
11.4 Other Remedies
|
23
|
11.5 Continuing Obligations
|
23
|
11.6 Alternate Remedies
|
23
|
Article 12 General Provisions
|
24
|
12.1 Publicity and Advertising
|
24
|
12.2 Amendment
|
24
|
12.3 Assignment and Subcontracting
|
24
|
12.4 Counterparts
|
24
|
12.5 Entire Agreement and Exhibits
|
24
|
12.6 Force Majeure
|
24
|
12.7 Further Acts
|
25
|
12.8 Governing Law
|
25
|
12.9 Sale of Goods
|
25
|
12.10 Notice
|
25
|
12.11 Severability
|
26
|
12.12 Waiver
|
26
|
12.13 Survivorship
|
26
|
A.
|
TEKMIRA is in the business of developing, testing, registering, and commercializing proprietary pharmaceutical products and is the developer of TKM-Ebola, an experimental drug product targeting the Ebola virus.
|
B.
|
OXFORD is established for the advancement of learning by teaching and research and its dissemination by every means; and it undertakes clinical research in relation to the diagnosis, treatment and prevention of disease and the improvement of healthcare.
|
C.
|
OXFORD wishes to conduct an investigator-led clinical trial currently entitled “Rapid Assessment of Potential Interventions & Drugs for Ebola (RAPIDE) – TKM” and wishes to purchase from TEKMIRA, and TEKMIRA wishes to manufacture and supply to OXFORD, TKM-Ebola and associated components for use in such clinical trial to be conducted by OXFORD or its designee in West Africa, all in accordance with the terms and conditions set forth in this Agreement.
|
1.1
|
Definitions
|
1.1.1
|
“
Academic and Research Purposes
” means research, teaching or other scholarly use which is undertaken for the purposes of education and research.
|
1.1.2
|
“
Affiliate
” means, with respect to any Person, any Persons directly or indirectly controlling, controlled by, or under common control with, such other Person. For purposes hereof, the term “controlled” (including the terms “controlled by” and “under common control with”), as used with respect to any Person, will mean the direct or indirect ability or power to direct or cause the direction of the management and policies of such Person or otherwise direct the affairs of such Person, whether through ownership of securities representing fifty percent (50%) or more of the votes that may be voted at a meeting of shareholders of such Person, by contract or otherwise.
|
1.1.3
|
“
Adequate Procedures
” has the meaning set out in section 7(2) of the Bribery Act 2010 and any guidance issued under section 9 of that Act.
|
1.1.4
|
“
Adverse Reaction
” means any untoward and unintended response in a Trial Subject to the Investigational Medicinal Product which is related to any dose administered to that Trial Subject.
|
1.1.5
|
“
Agreement
” means this Manufacturing and Clinical Trial Agreement and all Exhibits attached hereto.
|
1.1.6
|
“
Applicable Requirements
” means the terms of this Agreement, the terms of the Ethics Committee Opinion, the Protocol, the terms of the Regulatory Approval, and all applicable laws, regulations, professional standards and good practice (including, where applicable, GCP and cGMP).
|
1.1.7
|
“
Arising IP
” means any and all Intellectual Property Rights arising from the conduct of the Clinical Trial other than TEKMIRA IP.
|
1.1.8
|
“
Associated Person
” has the meaning set out in section 8 of the Bribery Act 2010.
|
1.1.9
|
Background IP
” means any and all Intellectual Property Rights owned by or licensed to a Party:
|
(a)
|
existing prior to the date of this Agreement; and/or
|
(b)
|
developed or acquired independently of this Agreement without use of or reliance upon the Confidential Information of the other Party.
|
1.1.10
|
“
Business Day
” means any day other than a Saturday, Sunday and statutory holiday in the Province of British Columbia, Canada and in London, England.
|
1.1.11
|
“
cGMP
” and “
current Good Manufacturing Practice
” means all applicable principles, guidelines and guidance for current good manufacturing practice as found in:
|
(a)
|
the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use
ICH Tripartite Guideline Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients Q7
(also published as CPMP/ICH/4106/00, 10 November 2000);
|
(b)
|
the applicable provisions of Directive 2003/94/EC and further guidance as published by the European Commission in Volume 4 of
The rules governing medicinal products in the European Union
;
|
(c)
|
foreign equivalents of the foregoing; and
|
(d)
|
all other legal provisions, regulations, decisions or guidance of competent authorities which are applicable to any sites involved in the manufacture, quality control, quality assurance or supply of the Investigational Medicinal Product.
|
1.1.12
|
“
Chief Investigator
” means Dr Peter Horby or any successor appointed by OXFORD in accordance with Section 6.3.1, who shall be the person who takes primary responsibility for the conduct of the Clinical Trial on behalf of OXFORD.
|
1.1.13
|
“
Clinical Patient Care
” means diagnosing, treating and/or managing the health of persons under the care of an individual having the right to use the Arising Intellectual Property.
|
1.1.14
|
“
Clinical Samples
” means any biological material collected from a Trial Subject in the course of conducting the Clinical Trial.
|
1.1.15
|
“
Clinical Trial
” means the clinical trial currently entitled “Rapid Assessment of Potential Interventions & Drugs for Ebola (RAPIDE) - TKM” as more fully described in the Protocol.
|
1.1.16
|
“
Confidential Information
” means all proprietary or confidential information and materials, patentable or otherwise, of a Party or any of its Affiliates which are disclosed by or on behalf of such Party or any of its Affiliates to the other Party under the Non-Disclosure Agreement, or this Agreement and in connection with the Clinical Trial and clearly identified as “confidential” at the time of disclosure (or, if disclosed orally, identified as “confidential” at the time of disclosure and confirmed as such in writing within thirty (30) days of such oral disclosure).
|
1.1.17
|
“
Consent Documents
” means the information sheet which is to be provided to prospective Trial Subjects and the consent form which is to be signed by Trial Subjects in order to indicate their willingness to participate in the Clinical Trial.
|
1.1.18
|
“
Consortium Collaborator
” means each of OXFORD’s
collaborators for the Clinical Trial
, which may include
Médecins Sans Frontières (MSF)
,
the World Health Organization (WHO)
,
Institut Pasteur, Institut Pasteur de Dakar, Fondation Mérieux, and such other Person(s) as OXFORD may collaborate with from time to time for purposes of the Clinical Trial
.
|
1.1.19
|
“
Contingency Fund
” shall have the meaning set forth in Section 4.1.3.
|
1.1.20
|
“
Damages
” means any costs, losses, claims, liabilities, fines, penalties, damages and expenses, court costs, and reasonable fees and disbursements of counsel, incurred by a Party hereto.
|
1.1.21
|
“
Data
” means all anonymous or pseudonymous information, which is not the product of analysis or interpretation, relating to the clinical findings or observations in the Clinical Trial necessary for the evaluation of the Investigational Medicinal Product, but excludes Safety Information and Trial Subject medical records located at the Trial Sites.
|
1.1.22
|
“
Data Controller
” has the meaning set out in section 1(1) of the DPA.
|
1.1.23
|
“
Deposit
” has the meaning set forth at Section 4.1.2.
|
1.1.24
|
“
Disclosing Party
” has the meaning set out in Section 8.1.3(b).
|
1.1.25
|
“
Dollars
” and “
$
” mean the lawful currency of the United States of America.
|
1.1.26
|
“
DPA
” means the Data Protection Act 1998.
|
1.1.27
|
“
DSUR
” means a development safety update report, prepared in accordance with applicable law and the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use
ICH Harmonized Tripartite Guideline: Development Safety Update Report E2F
(17 August 2010).
|
1.1.28
|
“
Ethics Committee
” means an independent body appointed in accordance with applicable law, whose responsibility is to protect the rights, safety and wellbeing of the Trial Subjects and to provide public assurance of that protection by, among other things, expressing an opinion on the Clinical Trial.
|
1.1.29
|
“
Ethics Committee Opinion
” means, in relation to the conduct of the Clinical Trial a current and valid favourable opinion expressed by an applicable Ethics Committee, setting out, among other things, the terms and conditions of its approval.
|
1.1.30
|
“
FOI Legislation
” means the Freedom of Information Act 2000 and the Environmental Information Regulations 2004.
|
1.1.31
|
“
Funding”
means the funding provided by the Wellcome Trust in support of the Clinical Trial (grant reference 106491/Z/14/Z).
|
1.1.32
|
“
GCP
” means all applicable principles, guidelines and guidance for current good clinical practice as found in:
|
(a)
|
the
Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects
, adopted by the World Medical Assembly in June 1964, as amended by the General Assembly of the Association in October 1975, October 1983, September 1989, and October 1996. The Parties acknowledge that later amendments have not been accepted under applicable law and are excluded from this Agreement until such time as they are accepted under applicable law;
|
(b)
|
the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use
ICH Tripartite Guideline for Good Clinical Practice E6(R1)
(also published as CMP/135/95, 1 July 1996);
|
(c)
|
the applicable provisions of the Medicines for Human Use (Clinical Trials) Regulations 2004 and further guidance as published by the UK Medicines and Healthcare products Regulatory Agency;
|
(d)
|
the applicable provisions of Directives 2001/20/EC and 2005/28/EC, and further guidance as published by the European Commission in Volume 10 of
The rules governing medicinal products in the European Union
; and;
|
(e)
|
all other legal provisions, regulations, decisions or guidance of competent authorities which are applicable to the conduct of the Clinical Trial.
|
1.1.33
|
“
Indemnified Person
” means a TEKMIRA Indemnitee or an OXFORD Indemnitee.
|
1.1.34
|
“
Infusion Kit
” means the infusion kit to be used for the administration of Investigational Medicinal Product and having the components described in
Exhibit 1.1.34
.
|
1.1.35
|
“
Intellectual Property
” means the patents, patent applications, including without limitation, Arising IP, TEKMIRA Arising IP, utility, model and design patents and certificates of invention and all divisionals, continuations, continuations-in-part, reissues, renewals, extensions (including supplemental protection certificates), additions, registrations or confirmations to or of any such patent applications and patents, trade names, trademarks, copyright, trade secrets, trade dress, industrial and other designs, trade secrets, improvements, Know-How, and other forms of intellectual property, all whether or not registered or protected, or capable of such registration or protection.
|
1.1.36
|
“
Investigational Medicinal Product Dossier
” means TEKMIRA’s dossier on each Investigational Medicinal Product to be used in the Clinical Trial, compiled in accordance with applicable law and submitted by TEKMIRA to the United States Food and Drug Administration or any successor agency thereof (“
FDA
”) in support of an application for Regulatory Approval.
|
1.1.37
|
“
Investigator
” means a person (including, if applicable, the Chief Investigator) responsible for the conduct of the Clinical Trial at a Trial Site and, if the Clinical Trial is conducted by a team of persons at a Trial Site, the person responsible for that team.
|
1.1.38
|
“
Investigational Medicinal
Product
” means TKM-Ebola presented in wet format, targeting the Guinea variant of the Ebola virus having the product description set forth in
Exhibit 1.1.38
.
|
1.1.39
|
“
Investigator Brochure
” means the investigator brochure provided by TEKMIRA containing a detailed description of the Investigational Medicinal Product’s chemical structure and siRNA sequence, and a summary of the clinical and non-clinical data related to TKM-Ebola provided by TEKMIRA prior to the commencement of the Clinical Trial, as well as any revisions thereto that may be delivered during the course of the Clinical Trial.
|
1.1.40
|
“
Know-How
” means, to the extent not generally known, any and all non-patentable technical, scientific and other know-how and information, trade secrets, knowledge, technology, means, methods, processes, procedures, practices, formulas, instructions, skills, and/or techniques (however recorded or preserved).
|
1.1.41
|
“
Manufacture
” or “
Manufacturing
” means, with respect to the Investigational Medicinal Product, all or a portion of the activities associated with the production and processing of such Investigational Medicinal Product, including without limitation, project planning, procurement of components, consumables and/or raw materials, vendor qualification, batch record development, manufacture, quality control testing, quality assurance, storage and shipping.
|
1.1.42
|
“
Non-Disclosure Agreement
” means the Non-Disclosure Agreement dated effective August 19, 2014 between TEKMIRA and the International Severe Acute Respiratory and Emerging Infection Consortium at OXFORD.
|
1.1.43
|
“
OXFORD Indemnitee
” has the meaning set forth in Section 10.2.
|
1.1.44
|
“
OXFORD Protocol
” and “
Protocol
” means the protocol to be used in the Clinical Trial, which protocol may be based in whole or in part on the TEKMIRA Protocol. For avoidance of doubt, all references to the term “
Protocol
” shall mean the OXFORD Protocol.
|
1.1.45
|
“
Party
” means OXFORD or TEKMIRA, and “
Parties
” means OXFORD and TEKMIRA.
|
1.1.46
|
“
Person
” means a natural person, corporation, partnership, trust, joint venture, limited liability company, non-governmental organization, or any other legal entity.
|
1.1.47
|
“
Personal Data
” has the meaning set out in section 1(1) of the DPA and relates only to Personal Data, or any part of such Personal Data, of which OXFORD is a Data Controller and which it has obtained in the course of conducting the Clinical Trial.
|
1.1.48
|
“
Personnel
” means the Chief Investigator and any Investigator or other individuals involved in the conduct of the Clinical Trial, whether or not employed by OXFORD.
|
1.1.49
|
“
Pharmacovigilance
” means the science and activities relating to the detection, assessment, understanding and prevention of adverse events or any other drug-related problem, or any updated definition published by the World Health Organization from time to time.
|
1.1.50
|
“
Tekmira Protocol
” means TEKMIRA’s treatment protocol entitled “Treatment Protocol for Use of TKM-130803 Injection in Patients with Confirmed or Suspected Ebola Virus Infection” provided by TEKMIRA to OXFORD.
|
1.1.51
|
“
Receiving Party
” has the meaning set out in Section 8.1.3(b).
|
1.1.52
|
“
Regulatory Approval
” means, in relation to the conduct of the Clinical Trial, any current and valid grant, renewal, validation, authorization, certificate and/or registration of a Regulatory Authority required under applicable law.
|
1.1.53
|
“
Regulatory Authorities
” means the United States Food and Drug Administration or any successor agency thereof (“
FDA
”), the European Medicines Agency (“
EMA
”) and any other like governmental authorities in West Africa regulating the importation, distribution, and/or use of therapeutic substances.
|
1.1.54
|
“
Relevant Requirements
” means all applicable laws relating to anti-bribery and anti-corruption, including the Bribery Act 2010, in connection with a Party’s conduct under this Agreement.
|
1.1.55
|
“
Representatives
” means, with respect to TEKMIRA, its Affiliate and their respective directors, officers, employees, consultants, advisors, contractors and agents; and with respect of OXFORD, each Consortium Collaborator and their respective directors, officers, employees, consultants, advisors, contractors and agents (including, where appropriate, students). For clarity, “Representatives” includes “Personnel” as defined above.
|
1.1.56
|
“
Regulatory Support
” means (a) the design and performance of stability studies for the Investigational Medicinal Product, and (b) the updating of Investigational Medicinal Product regulatory filings with data generated from said stability studies.
|
1.1.57
|
“
Results
” means any and all discoveries, theories, Know-How, computer software, notes, chemical compounds, biological material, models, prototypes, drawings, information, Data, analyses, case report forms, analytical results, interpretations, results and reports (other than Trial Subject medical records located at the Trial Sites) generated in the course of conducting the Clinical Trial, whether preliminary or final.
|
1.1.58
|
“
Safety Information
” means all filings, submissions and reports concerning the safety of the Investigational Medicinal Product or Pharmacovigilance with or to any Regulatory Authority or Ethics Committee, or a body designated or recognized by any Regulatory Authority or Ethics Committee for such purposes.
|
1.1.59
|
“
Service Fees
” means the fees in US Dollars to be paid by OXFORD to TEKMIRA for the provision of Services as more fully described in Section 4.1.
|
1.1.60
|
“
Services
” means the (a) Manufacture and supply of cGMP grade Investigational Medicinal Product sufficient to provide a full treatment course to one hundred (100) patients based on estimated batch yield and clinical dose as dictated by body weight, (b) supply of approximately one hundred (100) single use Infusion Kits necessary for gravity fed intravenous infusion, (c) Regulatory Support, and (d) provision of a TEKMIRA Protocol, Investigator Brochures, and instructions for the handling and storage of Investigational Medicinal Product and for the use of Infusion Kits.
|
1.1.61
|
“
Sponsor
” means OXFORD, as the Party taking responsibility for the initiation, management and financing (or arranging the financing) of the Clinical Trial, and the regulatory responsibilities which accompany the role.
|
1.1.62
|
“
TEKMIRA Arising IP
” means (a) any and all Arising IP relating directly to any development of the Investigational Medicinal Product that would, if practiced, infringe TEKMIRA’s Background IP in the Investigational Medicinal Product and (b) all improvements and/or modifications directed to Tekmira IP regardless of the Representative making such improvements and/or modifications.
|
1.1.63
|
“
TEKMIRA Confidential Information
” means the TKEMIRA Protocol, Investigator Brochure, TEKMIRA IP, TEKMIRA Arising IP, stability study design, data and results, and any part or whole of the sum of all images, data, records, reports, charts, information and documentation in physical, electronic or other form which are comprised of and/or derived from Confidential Information, Intellectual Property and/or materials disclosed or provided by or on behalf of TEKMIRA.
|
1.1.64
|
“
TEKMIRA Indemnitee
” has the meaning set forth in Section 10.1.
|
1.1.65
|
“
TEKMIRA IP
” means (a) all materials, information and Confidential Information disclosed and/or supplied by TEKMIRA or its Representatives to OXFORD or OXFORD’s Representatives, and (b) all patents and patent applications owned or controlled by TEKMIRA whether or not disclosed to OXFORD.
|
1.1.66
|
“
Term
” shall have the meaning set forth in Section 11.1.
|
1.1.67
|
“
Trial Site
” means any hospital, health centre, clinic, surgery or other establishment, treatment center or facility where the trial or any part of it is carried out.
|
1.1.68
|
“
Trial Site Agreement
” means the agreement entered into between OXFORD and each Trial Site (or the legal entity controlling the Trial Site) to govern the activities to be performed at that Trial Site in accordance with the Protocol.
|
1.1.69
|
Trial Subject
” means an individual, whether a patient or not, who participates in the Clinical Trial:
|
(a)
|
as a recipient of the Investigational Medicinal Product or of some other treatment or product; or
|
(b)
|
without receiving any treatment or product, as a control.
|
1.1.70
|
“
Wellcome Trust
” shall mean the UK charity who are providing funding to OXFORD in support of the Clinical Trial (including in support of the Services provided under this Agreement).
|
2.1
|
Appointment of TEKMIRA
|
2.2
|
Change Orders
|
2.3
|
OXFORD performance of the Clinical Trial
|
2.3.1
|
It is the intention that OXFORD shall be the Sponsor of Clinical Trials utilizing the Investigational Medicinal Product, subject to obtaining all required approvals and in accordance with applicable law and regulatory requirements. If OXFORD is not the Sponsor, TEKMIRA shall have the right to either approve the assignment of this Agreement by OXFORD, or enter into a Clinical Trial Agreement with the sponsor of the Clinical Trial. OXFORD shall use its best efforts to conduct the Clinical Trial in accordance with the Applicable Requirements.
|
2.3.2
|
Although Oxford will conduct any Clinical Trials in accordance with 2.3.1, the Parties acknowledge and agree that Oxford does not undertake that any work carried out under or pursuant to this Agreement will lead to any particular result, nor is the success of such work guaranteed.
|
2.4
|
TEKMIRA performance of Clinical Trial activities
|
2.4.1
|
To the extent that OXFORD delegates any activity to TEKMIRA under this Agreement for which OXFORD has regulatory responsibility under applicable law, TEKMIRA shall carry out such regulatory activity in accordance with the Applicable Requirements. The following activities are hereby delegated to TEKMIRA:
|
3.1
|
Use of Materials and Investigational Medicinal Product
|
3.1.1
|
control and use Investigational Medicinal Product, Infusion Kits and TEKMIRA Confidential Information in compliance with this Agreement;
|
3.1.2
|
use Investigational Medicinal Products, Infusion Kits and TEKMIRA Confidential Information solely in the performance of the Clinical Trial and for no other purpose whatsoever;
|
3.1.3
|
except with the prior written consent of TEKMIRA not distribute or release any Investigational Medicinal Product, Infusion Kits, TEKMIRA Confidential Information or TEKMIRA IP, to any Person other than those Persons who require access to same for the conduct of the Clinical Trial, unless to any Regulatory Authorities as part of a statutory request, in which latter case, OXFORD shall promptly notify TEKMIRA in writing of such request;
|
3.1.4
|
not duplicate or reverse engineer, or in any other way attempt to determine the identity, chemical composition or sequence of the Investigational Medicinal Product; and
|
3.1.5
|
inform each Consortium Collaborator in writing of their obligation to comply with this Section 3.1.
|
3.2
|
Storage
|
3.3
|
Transport and Risk of Loss
|
3.3.1
|
TEKMIRA will package, label and ship the Investigational Medicinal Product using TEKMIRA’s standard shipping, packaging and labeling procedures, which labeling procedures shall conform with FDA requirements, and shall ship Investigational Medicinal Product to the address specified in the Shipping Details (as defined in Exhibit 3.3.1), in accordance with TEKMIRA’s packing and shipping specifications. Shipment will be DAP (Incoterms 2010) and subject to the provisions of
Exhibit 3.3.1
.
|
3.3.2
|
TEKMIRA shall purchase sufficient insurance coverage for fire and related perils in respect of property damage for replacement value for the period of time during which raw materials and components funded by the Deposit is located at TEKMIRA’s facilities, which coverage includes, amongst other things, accidental damage, malicious damage, and fire.
|
3.4
|
Reporting and Records
|
3.4.1
|
OXFORD will keep TEKMIRA advised of the status of the Clinical Trial through regular telephone conversations and E-mails and will share with TEKMIRA in a timely manner, all Results and observations made during the Clinical Trial. OXFORD shall have the right to remove all patient identifiers prior to disclosure of any Results in accordance with the DPA and other privacy laws. In the event of a serious adverse event, OXFORD shall notify TEKMIRA immediately, but in no case more than twenty-four (24) hours following the occurrence of such serious adverse event.
|
3.4.2
|
OXFORD will keep complete and accurate written records of the status and progress of each patient in the Clinical Trial in accordance with the OXFORD Protocol and on the receipt and disposition of Investigational Medicinal Product, and make same available to TEKMIRA upon TEKMIRA’s reasonable request subject to OXFORD’s right to remove all patient identifiers prior to disclosure in accordance with the DPA and other privacy laws. For the purposes of the communications contemplated in this Section 3.4, OXFORD’s primary contact shall be Dr. Peter Horby, and TEKMIRA’s primary contact shall be Dr. Mark Kowalski.
|
4.1
|
[***]
|
4.1.1
|
[***].
|
4.1.2
|
[***].
|
4.1.3
|
[***].
|
4.1.4
|
[***].
|
4.1.5
|
[***].
|
4.1.6
|
[***].
|
4.2
|
Future Development and Use of the Investigational Medicinal Product
|
5.1
|
Anti-Bribery
|
5.1.1
|
Each Party shall:
|
(a)
|
comply with all Relevant Requirements;
|
(b)
|
have and shall maintain in place throughout the Term its own policies and procedures, including Adequate Procedures under the Relevant Requirements, to ensure compliance with the Relevant Requirements and will enforce them where appropriate; and
|
(c)
|
promptly report to the other Party any request or demand for any undue financial or other advantage of any kind received by it in connection with this Agreement.
|
5.1.2
|
Each Party shall ensure that any Associated Person who it involves in the performance of any obligations under this Agreement and/or the provision of support services does so only on the basis of a written agreement which imposes on and secures from such Associated Person terms equivalent to those imposed on the Parties under this Section 5.1.
|
5.1.3
|
The Parties acknowledge and agree that any breach of this Section 5.1 (however trivial) shall be deemed to be an irremediable material breach of this Agreement.
|
5.2
|
Clinical Samples
|
5.2.1
|
All Clinical Samples shall, unless otherwise agreed in writing, be held under the custodianship of OXFORD with any storage and transfer to be always in accordance with all Applicable Requirements. OXFORD shall exercise its rights and duties as custodian of the Clinical Samples in accordance with the relevant Trial Subject Consent Documents, any relevant Ethics Committee Opinion, Applicable Requirements and this Section 5.2.
|
5.2.2
|
All use of the Clinical Samples, other than for the purposes of the Clinical Trial, shall be subject to a determination as to the safety and scientific validity of the proposed use of the Clinical Samples (taking into account the quantity of the Clinical Samples available). The final decision in relation to such use shall be taken by OXFORD, as custodian of the Clinical Samples, always in accordance with the Trial Subject Consent Documents and all Applicable Requirements.
|
5.3
|
Regulatory Support
|
5.3.1
|
TEKMIRA will be responsible for (a) designing and implementing stability study protocols for the testing of Investigational Medicinal Product and reporting out-of-specification results, if any, to OXFORD during the duration of the Clinical Trial; and (b) updating TEKMIRA’s regulatory filings for the Investigational Medicinal Product with all results generated in the performance of the stability studies. Parameters for the stability study design are set forth in
Exhibit 5.3.1
attached hereto.
|
5.4
|
Responsibilities
|
5.4.1
|
TEKMIRA will be responsible for maintaining and fulfilling all cGMP requirements that are imposed upon TEKMIRA as the Manufacturer of the Investigational Medicinal Product.
|
5.4.2
|
OXFORD will be responsible for (a) obtaining and maintaining all applicable permits (including informed patient consent), licenses and such approvals to the extent necessary for the conduct of the Clinical Trial, and (b) complying with all applicable GCPs as well as local government laws and regulations in the conduct of the Clinical Trial.
|
5.5
|
Records, Audits and Inspections
|
5.5.1
|
Each Party shall maintain records in relation to the conduct of the Clinical Trial (appropriate to its role and responsibilities under this Agreement) in accordance with GCP and applicable law; and the Parties shall retain such records for the later of fifteen (15) years from the conclusion of the Clinical Trial (however determined) or such longer period of time as may be required by applicable law, including the record retention requirements of the United States Food and Drug Administration.
|
5.5.2
|
Each Party shall allow an independent auditor, appointed by mutual written agreement of the Parties, during normal working hours and upon reasonable written notice to inspect that portion of its facilities and records solely for the purpose of auditing the Party’s compliance with GCP, GMP and applicable law in relation to the manufacture and supply of the Investigational Medicinal Product and/or the conduct of the Clinical Trial. Any such auditor shall be accompanied by personnel of the audited Party at all times, shall be qualified to conduct such audits and shall comply with all applicable rules and regulations relating to facility security and health and safety.
|
5.5.3
|
Each Party shall make its facilities and records available for inspection by representatives of any Regulatory Authority in compliance with all applicable laws. A Party shall notify the other Party within three (3) days of its receipt of any correspondence, notice or any other indication whatsoever of Regulatory Authority inspection, investigation or other inquiry, or other notice or communication from any Regulatory Authority of any type, that could reasonably be expected to affect the manufacture and supply of the Investigational Medicinal Product and/or the conduct of the Clinical Trial in a material way.
|
5.5.4
|
To the extent that any inspection, investigation or other inquiry pursuant to Section 5.5.3 concerns the Investigational Medicinal Product supplied, or to be supplied, or the conduct of the Clinical Trial, the affected Party shall invite and allow representatives of the other Party to be present during the applicable portions of any such inspection, investigation or other inquiry. The affected Party shall consult with the other Party with respect to any response to observations and notifications received in connection with any such inspection, investigation or other inquiry and will give the other Party an opportunity to comment upon (which comments shall be considered by the affected Party in good faith) any proposed response before it is submitted; provided, however, that TEKMIRA shall not be required to disclose to or consult with OXFORD regarding any manufacturing or equipment specifications, processes, methods or Know-How covering the Investigational Medicinal Product.
|
5.6
|
Variation
|
5.6.1
|
any Regulatory Authority requires a Party to implement any changes to the Clinical Trial that affects this Agreement;
|
5.6.2
|
any Ethics Committee requires a Party to implement any changes to the Clinical Trial that affects this Agreement;
|
5.6.3
|
any changes to this Agreement are required in order to comply with changes to applicable law; or
|
5.6.4
|
any Party, in its reasonable opinion, considers it to be necessary to change this Agreement to ensure: (a) the safety of Trial Subjects; (b) the scientific validity of the Clinical Trial; or (c) that the conditions and principles of GCP and/or cGMP are satisfied or adhered to in relation to the Clinical Trial
|
6.1
|
Protocol Development
|
6.1.1
|
OXFORD and TEKMIRA will mutually agree upon the OXFORD Protocol, which will be designed utilizing the TEKMIRA Protocol for instructions related to Product administration.
|
6.1.2
|
Once the parties have mutually agreed upon the OXFORD Protocol, if OXFORD wishes to make further changes to the OXFORD Protocol after TEKMIRA’s approval has been granted, TEKMIRA shall again have the right receive, review, comment and approve in writing each new change. In this latter case, TEKMIRA may only withhold approval of the OXFORD Protocol for reasons relating to patient safety or data integrity, as determined by changes in mode or rate of drug administration, dosage, method of tracking and/or reporting patient adverse events, frequency or nature of safety monitoring, inclusion criteria, exclusion criteria, use of concomitant medications, randomization, stopping rules, use of placebo, or other elements relating to patient care.
|
6.1.3
|
TEKMIRA may, subject to Section 11.3.6 (return of Wellcome Trust funding), decline to ship Investigational Medicinal Product and terminate this Agreement in the event that the OXFORD Protocol or any further change thereto is not approved by TEKMIRA. If after shipment of the Investigational Medicinal Product, the OXFORD Protocol or any further change thereto is not approved by TEKMIRA, the Parties shall mutually terminate the Agreement, and subject to Section 11.3.6 (return of Wellcome Trust funding) OXFORD shall promptly return all Investigational Medicinal Product to TEKMIRA or destroy same and confirm destruction in writing, at TEKMIRA’s sole election.
|
6.2
|
Conduct of Clinical Trial
|
6.2.1
|
The Parties acknowledge and agree that OXFORD shall be the Sponsor of the Clinical Trial.
|
6.2.2
|
Nothing in this Agreement shall prevent OXFORD or its Representatives from taking appropriate urgent measures (including, if reasonably appropriate, suspension of the Clinical Trial) in order to protect Trial Subjects against any immediate hazard to their health or safety. If such measures are taken by OXFORD or its Representatives, it shall as soon as reasonably practicable give written notice to TEKMIRA of the measures taken and the circumstances giving rise to those measures.
|
6.2.3
|
Although OXFORD will conduct the Clinical Trial in accordance with Section 6.2.2 the Parties acknowledge and agree that OXFORD does not undertake that any work carried out under or pursuant to this Agreement will lead to any particular result, nor is the success of such work guaranteed.
|
6.2.4
|
TEKMIRA shall provide to OXFORD such information and cooperation as OXFORD may reasonably request to enable OXFORD to conduct the Clinical Trial.
|
6.3
|
Personnel
|
6.3.1
|
OXFORD shall use its reasonable endeavours to retain the services of the Chief Investigator during the Term; and to ensure that all Personnel are appropriately qualified by education, training and experience to perform the tasks given to them.
|
6.3.2
|
OXFORD shall use its reasonable endeavours to ensure that the Chief Investigator does not, during the Term, conduct any other clinical trial which might adversely affect OXFORD’s ability to perform its obligations under this Agreement.
|
6.3.3
|
OXFORD shall promptly notify TEKMIRA if at any time during the Term the Chief Investigator is unable or unwilling to continue the direction or supervision of the Clinical Trial. Within sixty (60) days after such incapacity or expression of unwillingness, OXFORD shall nominate a successor to be the Chief Investigator. TEKMIRA shall not unreasonably decline to accept the nominated successor, but if the successor is not acceptable to TEKMIRA on reasonable and substantial grounds, then either Party may terminate this Agreement on ninety (90) days’ written notice to the other Party.
|
6.4
|
Ethical and Regulatory Approvals
|
6.4.1
|
OXFORD and the Chief Investigator shall, subject to Section 6.4.2, be responsible for obtaining all necessary Ethics Committee Opinions and Regulatory Approvals. OXFORD shall provide to TEKMIRA written status reports on such applications at reasonable intervals.
|
6.4.2
|
TEKMIRA shall, in relation to the Investigational Medicinal Product, be responsible for compiling the Investigational Medicinal Product Dossier. TEKMIRA shall grant OXFORD, permission to provide the applicable Regulatory Authorities reference access to TEKMIRA’s Investigational Medicinal Product Dossier in a timely manner sufficient to meet OXFORD’s obligations under this Agreement.
|
6.4.3
|
The Parties acknowledge and agree that OXFORD cannot: (a) start the Clinical Trial or cause the Clinical Trial to be started; or (b) conduct the Clinical trial; unless the conditions set out in Section 6.4.4 have been satisfied.
|
6.4.4
|
The conditions referred to in Section 6.4.3 are:
|
(a)
|
the receipt of the relevant Ethics Committee Opinion by OXFORD; and
|
(b)
|
the receipt of the Regulatory Approval by OXFORD.
|
6.5
|
Trial Sites
|
6.5.1
|
OXFORD shall enter into Trial Site Agreements which set out the terms under which OXFORD as Sponsor and each Trial Site shall collaborate in the performance of the Clinical Trial.
|
6.5.2
|
The Parties acknowledge that it may not be possible to accurately forecast the recruitment of Trial Subjects, and that the number of Trial Sites may need to be reviewed from time to time.
|
6.5.3
|
OXFORD shall use its reasonable endeavours to select Trial Sites and Investigators who are experienced in, or shall be trained in, the conduct of clinical trials in the therapeutic field relevant to the Clinical Trial. OXFORD shall provide to TEKMIRA written status reports on the Trial Sites appointed by OXFORD at reasonable intervals.
|
6.5.4
|
The responsibilities of a Trial Site are detailed in the Protocol and shall be further detailed in the applicable Trial Site Agreement, which shall be consistent with the terms of this Agreement and impose consistent obligations on the Trial Sites.
|
6.6
|
Data Protection
|
6.6.1
|
The Parties acknowledge and agree that, notwithstanding any other provision contained in this Agreement, OXFORD shall not, and shall procure that any Representative of OXFORD does not, disclose any Personal Data of a Trial Subject to TEKMIRA, except where strictly necessary and where permitted by applicable law (including the DPA).
|
6.6.2
|
TEKMIRA undertakes, not to identify, or attempt to identify, a Trial Subject from any information supplied to it by OXFORD or its Representatives under this Agreement.
|
6.6.3
|
The Parties shall (and shall ensure that their respective Representatives shall) comply with the requirements of the DPA (and related legislation) in conducting the Clinical Trial or otherwise in connection with this Agreement.
|
6.7
|
Pharmacovigilance
|
6.7.1
|
OXFORD, as Sponsor, shall be responsible for reporting all Safety Information in relation to the Clinical Trial to the Regulatory Authority and/or the Ethics Committee in accordance with applicable law.
|
6.7.2
|
OXFORD shall report all Safety Information in relation to the Clinical Trial to TEKMIRA as soon as reasonably practicable and, in any event, not later than the date on which OXFORD reports any such Safety Information to the Regulatory Authority or, as the case may be, the Ethics Committee.
|
6.7.3
|
OXFORD shall, as soon as reasonably practical, during and after the conclusion of the Clinical Trial (however determined), provide TEKMIRA with access to all Safety Information and other data relating to Adverse Reactions (collected in accordance with the Protocol) in relation to the Clinical Trial (including the right to make copies) to the extent necessary for TEKMIRA’s preparation of the DSUR and for regulatory purposes only.
|
6.7.4
|
TEKMIRA shall, during the Term, promptly report to OXFORD all Safety Information relating to other clinical trials that test or use the Investigational Medicinal Product which it has contributed to the Clinical Trial and for which OXFORD is not the Sponsor.
|
6.7.5
|
TEKMIRA shall, in relation to the Investigational Medicinal Product, be responsible for compiling the DSUR during the Term and thereafter in relation to the DSUR required at the end of the then current reporting year. TEKMIRA shall provide each DSUR to OXFORD in a timely manner sufficient to meet OXFORD’s obligations under applicable law.
|
6.8
|
Insurance
|
7.1
|
Background IP
|
7.1.1
|
Nothing in this Agreement shall affect the ownership of any Background IP. Without limiting the generality of the foregoing, OXFORD acknowledges and agrees that all materials, information and Confidential Information disclosed and/or supplied by TEKMIRA or its Representatives to OXFORD or OXFORD’s Representatives are the exclusive property of TEKMIRA (collectively, “
TEKMIRA IP
”) and that TEKMIRA shall retain all right, title and interest, including all Intellectual Property rights in and to such TEKMIRA IP.
|
7.1.2
|
Each Party grants to the other Party a non-exclusive, worldwide, royalty-free license under its Background IP solely to the extent provided by a Party for use within the Clinical Trial and necessary for the other Party to perform its obligations under this Agreement. The license granted under this Section 7.1.2 shall be sub-licensable solely to the extent necessary for the conduct of the Clinical Trial in accordance with this Agreement.
|
7.2
|
Arising IP
|
7.2.1
|
All Arising IP shall be owned by OXFORD, except that all TEKMIRA Arising IP shall be owned by TEKMIRA.
|
7.2.2
|
OXFORD shall disclose in writing to TEKMIRA all TEKMIRA Arising IP of which OXFORD becomes aware, promptly but no later than fourteen (14) days following OXFORD becoming aware of same and shall assign and cause its Representatives to assign to TEKMIRA without additional consideration, all right, title and interest in and to TEKMIRA Arising IP.
|
7.2.3
|
OXFORD hereby grants to TEKMIRA, subject to Section 7.2.4, a non-exclusive, worldwide, perpetual, fully paid-up, royalty-free, sublicensable license under all Arising IP conceived or reduced to practice by OXFORD or its Representatives, for its own internal research and regulatory filings. If this Agreement is terminated for TEKMIRA’s material breach, this licensee will automatically terminate.
|
7.2.4
|
Subject to TEKMIRA calling for (in writing) and completing a license agreement within six months after the completion of the Clinical Trial (or by such other date as the Parties may agree), the OXFORD is willing to grant to TEKMIRA a license to make, have made, use and market products and services derived from the Arising IP. Subject to Section 7.2.6, the license would be exclusive. Under such license, TEKMIRA would agree to pay:
|
(a)
|
a reasonable proportion of all up front, milestone and other payments received by TEKMIRA and attributable in whole or in part to Arising IP;
|
(b)
|
reasonable royalties based on the net selling prices of all licensed products (that is to say, all products and services marketed by TEKMIRA or TEKMIRA’s sub-licensees and derived from, produced by, or containing Arising IP); and
|
(c)
|
reasonable royalties on any cross licensing and other non-monetary compensation received by TEKMIRA from the exploitation of Arising IP.
|
7.2.5
|
TEKMIRA hereby grants to OXFORD and each Consortium Collaborator, a non-exclusive, worldwide, perpetual, fully paid-up, royalty-free, sublicensable license under all TEKMIRA Arising IP (a) during the Clinical Trial, and (b) for any future administration of Investigational Medicinal Product supplied by TEKMIRA or TEKMIRA’s licensees or designees. If this Agreement is terminated for OXFORD’s material breach, this licensee will automatically terminate.
|
7.2.6
|
The University and its Representatives shall have the irrevocable right in perpetuity to use any and all Arising IP for Academic and Research Purposes and for the purpose of Clinical Patient Care.
|
7.3
|
Perfection of Ownership Rights
|
7.3.1
|
OXFORD agrees to and shall cause each Consortium Collaborator to:
|
(a)
|
report to TEKMIRA all TEKMIRA Arising IP created, conceived or reduced to practice by it or its Representatives as a result of conducting the Clinical Trial within fourteen (14) days of becoming aware of such discoveries or inventions;
|
(b)
|
cooperate and cause its Representatives to cooperate with TEKMIRA, at TEKMIRA’s expense, in perfecting TEKMIRA’s ownership and other proprietary rights in respect of any TEKMIRA Arising IP to which TEKMIRA is entitled pursuant to this Article 7; and
|
(c)
|
execute, assign and deliver, and cause its Representatives to execute, assign and deliver to TEKMIRA, at TEKMIRA’s expense, any documents and any other instruments of conveyance and transfer that TEKMIRA may reasonably require with respect to TEKMIRA’s rights to TEKMIRA Arising IP under this Article 7.
|
8.1
|
Confidentiality Obligations
|
8.1.1
|
OXFORD acknowledges and agrees that (a) all information provided by TEKMIRA in confidence to OXFORD or OXFORD’s Representatives under the Non-Disclosure Agreement constitutes TEKMIRA Confidential Information for the purposes of this Agreement, and (b) the provisions of this Article 8 shall apply to all TEKMIRA Confidential Information received by OXFORD or its Representatives on or after the effective date of the Non-Disclosure Agreement.
|
8.1.2
|
Each Party (the “Receiving Party”) will keep all Confidential Information received from the other Party (the “Disclosing Party”) in confidence for a period of seven (7) years from the date of receipt thereof and will not, without the Disclosing Party’s prior written consent, disclose any of the Disclosing Party’s Confidential Information to any person or entity, except to those of its Representatives who (i) require such Confidential Information for the performance of this Agreement or the conduct of the Clinical Trial, (ii) are made aware of the confidential nature of the Confidential Information, and (iii) are bound by obligations of confidentiality with regard to any Confidential Information received. Each Party shall remain liable for the uses and disclosures of its Representatives.
|
8.1.3
|
The obligation of confidentiality set out in Section 8.1.2 shall not apply to information that:
|
(a)
|
is already in the Receiving Party's or any of its Representatives’ possession at the time of disclosure, as can be demonstrated by the Receiving Party by written records;
|
(b)
|
is or later becomes part of the public domain other than as a consequence of a breach of an obligation of confidentiality owed to the Disclosing Party by the Receiving Party;
|
(c)
|
is received from a third party having no obligations of confidentiality to the Disclosing Party;
|
(d)
|
is independently developed by the Receiving Party or any of its Representatives as can be demonstrated by the Receiving Party by written records; or
|
(e)
|
is required by law or regulation to be disclosed by the Receiving Party, provided that as far as legally possible the Receiving Party shall first have given notice to the Disclosing Party and given the Disclosing Party a reasonable opportunity to oppose such disclosure and if disclosed, the Confidential Information disclosed shall be limited to that Confidential Information which is legally required to be disclosed in response to such law or regulation.
|
8.1.4
|
If OXFORD receives a request under the FOI Legislation to disclose any information which, under this Agreement, is TEKMIRA’s Confidential Information, it will notify TEKMIRA and will consult with TEKMIRA. TEKMIRA will respond to OXFORD within seven (7) Business Days after receiving OXFORD’s notice if that notice requests them to provide information to assist OXFORD to determine whether or not an exemption in the FOI Legislation applies to the information requested under the FOI Legislation.
|
8.1.5
|
The Receiving Party may disclose the Disclosing Party’s Confidential Information to the extent such Confidential Information is specifically required to be disclosed to the Ethics Committee or the Regulatory Authority. The Parties acknowledge that there is a general understanding that any such Ethics Committee and Regulatory Authority will keep information submitted to it confidential, and the Receiving Party shall mark any of the Disclosing Party’s Confidential Information disclosed in accordance with this Section 8.1.5 as “confidential”, but each Party accepts that the Receiving Party would be unable to impose any specific obligations upon such bodies.
|
8.1.6
|
The Parties acknowledge and agree that the Protocol shall not be regarded as Confidential Information under this Agreement.
|
8.2
|
Publication
|
8.2.1
|
TEKMIRA shall not prevent or hinder any registered student of OXFORD from submitting for a degree of OXFORD a thesis based on the Results, the examination of such a thesis by examiners appointed by OXFORD, or the deposit of such a thesis in accordance with the relevant procedures of OXFORD provided that TEKMIRA Confidential Information, TEKMIRA Arising IP and TEKMIRA IP receive the protections afforded under Article 7 (Intellectual Property) and Article 8 (Confidential Information);
|
8.2.2
|
in accordance with normal academic practice, all Personnel shall be permitted to publish the Results following the procedures laid down in Section 8.2.3;
|
8.2.3
|
subject to Section 8.2.7 below, where OXFORD, any registered student of OXFORD or any Personnel wishes, during the Term and for a period of three (3) years after, to submit for publication the Results, OXFORD will submit details of such Results to TEKMIRA in writing not less than ten (10) days in advance of the submission for publication. TEKMIRA may require OXFORD to (a) delay submission for publication if, in TEKMIRA’s reasonable opinion, such delay is necessary in order to seek patent or similar protection for the TEKMIRA Arising IP subsisting in such Results and/or (b) to redact any TEKMIRA Confidential Information or TEKMIRA IP. A delay imposed on submission for publication as a result of a requirement made by TEKMIRA shall not last longer than is absolutely necessary to seek the required protection, and therefore shall not exceed one (1) month from the date of receipt of OXFORD’s notice to publish, although OXFORD will not unreasonably refuse a request from TEKMIRA for additional delay in the event that the property rights of TEKMIRA would otherwise be lost. Notification of the requirement for delay in submission for publication must be received by OXFORD within thirty (30) days after the receipt of the notice to publish by TEKMIRA, failing which OXFORD, its registered students and its Personnel shall be free to assume that TEKMIRA has no objection to the proposed publication. OXFORD shall provide TEKMIRA a final copy of any pre-publication material to confirm the redaction of TEKMIRA Confidential Information or TEKMIRA IP required by TEKMIRA;
|
8.2.4
|
OXFORD shall register the Clinical Trial on a free-to-user, open access clinical trial databases (e.g. http://www.clinicaltrials.gov.uk) prior to the enrolment of the first Trial Subject. OXFORD shall use its reasonable endeavours to maintain and update the information on such database, as required, during the course of the Clinical Trial;
|
8.2.5
|
the Parties shall comply with recognized standards concerning publication and authorship, including the
Uniform Requirements for Manuscripts Submitted to Biomedical Journals
issued by the International Committee of Medical Journal Editors;
|
8.2.6
|
in accordance with the Funding terms and conditions, the Parties agree that all publications made of the Results of the Clinical Trial shall include the statement that “This work was supported by the Wellcome Trust and Tekmira Pharmaceuticals Corporation”; and
|
8.2.7
|
OXFORD and TEKMIRA acknowledge and agree that it is necessary for Results and data arising from the Clinical Trial to be made publicly available as soon as reasonably possible in recognition of the international public interest, and immediately provided to the relevant authorities and organizations involved in the implementation of responses to the current outbreak of Ebola Virus Disease, for the purposes of facilitating and informing such responses. OXFORD shall make relevant Results arising from the Clinical Trial (excluding Confidential Information provided by TEKMIRA, unless with TEKMIRA’s express advance consent) available to other research institutions and researchers engaging in research into Ebola Virus Disease as soon as reasonably possible (ideally on a “real time basis”), but always in accordance with the Applicable Requirements. OXFORD and TEKMIRA shall discuss such disclosures in advance and OXFORD shall take TEKMIRA’s reasonable comments into consideration prior to making any such disclosure.
|
8.3
|
No License
|
8.4
|
Return of Confidential Information
|
8.4.1
|
Within thirty (30) days following the completion of the Clinical Trial, OXFORD and each Consortium Collaborator will return to TEKMIRA or destroy and certify destruction in writing, at TEKMIRA’s sole discretion, all Confidential Information of TEKMIRA, including, to the extent practicable, all such information that is electronically stored by OXFORD or any Consortium Collaborator, all reproductions thereof.
|
8.4.2
|
To the extent it is required to do so under applicable laws or in order to ensure compliance with this Agreement, OXFORD and each Representative involved in the conduct of the Clinical Trial may retain one copy of TEKMIRA Confidential Information, provided that such copy is used or accessed solely for the purposes of determining OXFORD and such Representative’s compliance with applicable laws and with this Agreement
|
9.1
|
Mutual Representations and Warranties
|
9.1.1
|
it has the full power and right to enter into this Agreement and that there are no outstanding agreements, assignments, licenses, encumbrances or rights held by other parties, private or public, inconsistent with the provisions of this Agreement;
|
9.1.2
|
the Person executing this Agreement on its behalf has the full power and authority to enter into this Agreement on its behalf; and
|
9.1.3
|
it shall comply with all applicable laws in the performance of this Agreement.
|
9.2
|
Individual Representations and Warranties
|
9.2.1
|
TEKMIRA represents, warrants, and covenants to OXFORD that all Services shall be performed in compliance with cGMP requirements.
|
9.2.2
|
OXFORD represents, warrants, and covenants to TEKMIRA that OXFORD shall (a) comply with GCP and all local laws and regulations governing the conduct of the Clinical Trial, and (b) notify each Consortium Collaborator that each of them has the obligation to comply with GCP and all local laws and regulations governing the conduct of the Clinical Trial.
|
9.3
|
Disclaimers
|
9.3.1
|
OXFORD makes no representation or warranty that advice or information given by the Chief Investigator or any other Personnel, or the content or use of any Results provided in connection with the Clinical Trial, will not constitute or result in infringement of third-party rights.
|
9.3.2
|
OXFORD accepts no responsibility for any use which may be made of any work carried out under or pursuant to this Agreement, or of the Results, nor for any reliance which may be placed on such work or Results, nor for advice or information given in connection with them.
|
9.3.3
|
TEKMIRA makes no representations or warranties, express or implied, either in fact or by operation of law, by statute or otherwise, and specifically disclaims any and all implied or statutory warranties, including without limitation, any warranty of merchantability or fitness for a particular purpose, efficacy of the Investigational Medicinal Product or Infusion Kits, or warranty of non-infringement.
|
9.4
|
No Implied Warranties
|
10.1
|
OXFORD
|
10.2
|
TEKMIRA
|
10.3
|
Conditions
|
10.3.1
|
The indemnities set out in Section 10.1 and Section 10.2 shall not apply to any such claim or proceedings:
|
(a)
|
unless as soon as reasonably practicable following receipt of notice of such claim or proceedings, the Indemnified Person shall have notified the indemnifying Party in writing of it and shall, upon the indemnifying Party’s request and at that indemnifying Party’s cost, have permitted the indemnifying Party to have full care and control of the claim or proceedings using legal representation of its own choosing; or
|
(b)
|
if the Indemnified Person shall have made any admission in respect of such claim or proceedings or taken any action relating to such claim or proceedings prejudicial to the defence of it without the written consent of the indemnifying Party (such consent not to be unreasonably withheld or delayed), provided that no Indemnified Person shall be deemed to be in breach of this condition by any statement properly made by the Indemnified Person in connection with the operation of the Indemnified Person’s internal complaint procedures, accident reporting procedures, or disciplinary procedures, or where such a statement is required by law.
|
10.3.2
|
The indemnifying Party shall, in relation to any claim or proceedings it has assumed care and control of under Section 10.3.1(a):
|
(a)
|
keep the Indemnified Pperson fully informed of the progress of any claim or proceedings;
|
(b)
|
consult fully with the Indemnified Person on the nature of any defence to be advanced; and
|
(c)
|
not, without the prior written consent of the Indemnified Person (such consent not to be unreasonably withheld or delayed), enter into any settlement or compromise of such claim or proceedings which: (a) would result in injunctive or other relief being imposed against an Indemnified Person; or (b) does not include as an unconditional term the giving by the claimant to all applicable Indemnified Persons of a release from liability in relation to such claim or proceedings.
|
10.3.3
|
Each Party shall use its reasonable endeavours to inform the other Party promptly of any circumstances that are likely to give rise to a claim or proceedings in respect of which it may be entitled to indemnification under Section 10.1 or Section 10.2; and shall keep the other Party reasonably informed of developments in relation to any such claim or proceedings, even where the Party does not intend to make a claim under Section 10.1 or Section 10.2.
|
10.3.4
|
Each Party shall give to the indemnifying Party such assistance as it may reasonably require for the conduct and prompt handling of any such claim or proceedings.
|
10.3.5
|
Nothing in Section 10.1 or Section 10.2 shall restrict or limit an Indemnified Person’s general obligation at law to mitigate a loss it may suffer or incur as a result of an event that gives rise to a claim under Section 10.1 or Section 10.2.
|
10.4
|
LIMITATION OF LIABILITY
|
10.4.1
|
OTHER THAN AS EXPRESSLY SET OUT IN THIS AGREEMENT, AND SUBJECT TO SECTIONS 10.4.3 AND 10.4.4, NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY INDIRECT LOSS OR FOR ANY SPECIAL, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES SUFFERED BY THE OTHER PARTY, WHETHER SUCH LOSS ARISES FROM BREACH OF A DUTY IN CONTRACT, TORT, UNDER STATUTE OR IN ANY OTHER WAY INCLUDING, WITHOUT LIMITATION, LOSS ARISING FROM NEGLIGENCE, DEFAULT, BREACH OF DUTY, PRODUCT LIABILITY, STRICT LIABILITY, NON-DELIVERY, DELAY IN DELIVERY OR DEFECTS OR ERRORS IN THE WORK UNDERTAKEN PURSUANT TO THE TERMS OF THIS AGREEMENT, OR IN CONNECTION WITH ANY OTHER CLAIM REGARDLESS OF WHETHER ANY OTHER REMEDY PROVIDED HEREIN FALLS.
|
10.4.2
|
Each Party undertakes to make no claim in connection with this agreement or its subject matter against the other’s employees (apart from claims based on fraud or deliberate default). This undertaking is intended to give protection to individuals: it does not prejudice any right which either Party might have to claim against the other. The benefit conferred by this provision is intended to be enforceable by the persons referred to in it.
|
10.4.3
|
The maximum liability (other than as regards obligations to make payments under Article 4) of each Party to the other Party under or otherwise in connection with this Agreement or its subject matter shall not exceed £2,500,000 together with interest on the balance of such moneys from time to time outstanding, accruing from day to day at the Barclays Bank plc Base Rate from time to time in force and compounded annually as at 31 December. For the avoidance of doubt the indemnities set out in Section 10.1 shall be subject to the cap set out in this Section 10.4.3 of this Agreement.
|
10.4.4
|
Nothing in this Agreement limits or excludes a Party’s liability for: (a) death or personal injury resulting from its negligence; (b) any fraud or fraudulent misrepresentation; or (c) any sort of other liability which, by law, cannot be limited or excluded.
|
11.1
|
Term
|
11.2
|
Cancellation or Termination by OXFORD
|
11.2.1
|
OXFORD acknowledges that TEKMIRA must commit considerable resources in advance of Manufacturing the Investigational Medicinal Product and supplying the Infusion Kits by purchasing raw materials and components, and allocating lab space, time, equipment and human resources. Accordingly, if OXFORD cancels delivery of Investigational Medicinal Product and/or Infusion Kits, or terminates this Agreement for reasons other than TEKMIRA’s material breach of this Agreement, TEKMIRA shall have the right to retain all Investigational Medicinal Product and Infusion Kits under production and not yet shipped. For clarity, this right of TEKMIRA to retain or to have Investigational Medicinal Product returned for its exclusive use, is in addition to and not in substitution of TEKMIRA’s right to retain the Deposit, and any such use by TEKMIRA shall be subject to prior discussion with OXFORD and the Wellcome Trust (with Wellcome Trust approval being necessary prior to TEKMIRA’s use of the returned or retained Investigational Medicinal Product).
|
11.2.2
|
OXFORD shall have the right to reject any shipment of the Investigational Medicinal Product or Infusion Kits that does not conform with the requirements of this Agreement in all material respects. OXFORD shall not be required to pay any invoice with respect to any shipment of the Investigational Medicinal Product or the Infusion Kits properly rejected pursuant to this Section 11.2.2. At OXFORD's option, OXFORD shall be entitled either:
|
(a)
|
to a refund of all Service Fees paid by the University with respect to such rejected shipment (including the Deposit); or
|
(b)
|
to require TEKMIRA to replace such rejected shipment at no additional cost to OXFORD.
|
11.2.3
|
In the event that OXFORD selects the option under Section 11.2.2(b) with respect to any shipment of the Investigational Medicinal Product or the Infusion Kits:
|
(a)
|
TEKMIRA shall replace the rejected shipment as soon as reasonably practicable after the rejection; and
|
(b)
|
TEKMIRA shall provide OXFORD with updated delivery information (including estimated delivery dates of replacement product) upon it becoming available.
|
11.3
|
Termination for Cause
|
11.3.1
|
Either Party may terminate this Agreement:
|
(a)
|
for the other Party’s material or persistent breach of this Agreement. Prior to any such termination the Party seeking to terminate shall give the other Party thirty (30) days prior written notice of its intention to so terminate, which notice will set forth the default(s) which form the basis for such termination. If the defaulting Party fails to correct such default(s) within the thirty (30) day notice period, this Agreement shall automatically terminate;
|
(b)
|
with immediate effect on giving written notice to the other Party, if the other Party becomes insolvent, or if an order is made or a resolution is passed for its winding up (except for the purpose of solvent amalgamation or reconstruction), or if an administrator, administrative receiver or receiver is appointed over the whole or any part of the other Party’s assets, or if the other Party makes an arrangement with its creditors.
|
11.3.2
|
If the application of the Chief Investigator or, as the case may be, OXFORD in relation to the Ethics Committee Opinion and/or the Regulatory Authority is finally rejected, and there is no possibility of appeal against such rejection, either Party may terminate this Agreement with immediate effect by giving written notice to the other Party.
|
11.3.3
|
If, at any time during the Term, the Ethics Committee Opinion and/or the Regulatory Approval is suspended, revoked or otherwise terminated, and there is no possibility of appeal against such suspension, revocation or termination, either Party may terminate this Agreement with immediate effect by giving written notice to the other Party.
|
11.3.4
|
This Agreement may be terminated by either Party with immediate effect by giving written notice to the other Party if it has reasonable and substantial grounds for believing the Clinical Trial should cease in the interests of the health and safety of the Trial Subjects or Representatives working in such Clinical Trial.
|
11.3.5
|
The provisions of this Section 11.3 are without prejudice to Section 5.1.3 or any other rights a Party may have to terminate this Agreement.
|
11.3.6
|
[***].
|
11.4
|
Other Remedies
|
11.5
|
Continuing Obligations
|
11.6
|
Alternate Remedies
|
12.1
|
Publicity and Advertising
|
12.2
|
Amendment
|
12.3
|
Assignment and Subcontracting
|
12.4
|
Counterparts
|
12.5
|
Entire Agreement and Exhibits
|
12.6
|
Force Majeure
|
12.7
|
Further Acts
|
12.8
|
Governing Law
|
12.9
|
Sale of Goods
|
12.10
|
Notice
|
12.11
|
Severability
|
12.12
|
Waiver
|
12.13
|
Survivorship
|
·
|
Shipment of Investigational Medicinal Product and Infusion Kits will be made in two (2) lots;
|
·
|
Shipments will only be made following TEKMIRA’s receipt of OXFORD’s written shipping details as follows:
|
|
(a)
|
the relevant VAT number of the recipient for customs purposes;
|
|
(b)
|
full details of the shipment destination address; and
|
|
(c)
|
the personal name and mobile phone number of the individual authorized to receive such shipments;
|
|
(together, the “
Shipping Details
”).
|
·
|
Subject to TEKMIRA having received OXFORD’s Shipping Details on or before December 10, 2014, the first lot will be shipped on December 15, 2014 and the second lot will be shipped on January 3, 2015.
|
·
|
If TEKMIRA receives OXFORD’s Shipping Details after December 10, 2014, TEKMIRA will ship the first lot within ten (10) Business Days, and the second lot within fifteen (15) Business Days, following receipt of OXFORD’s Shipping Details. Notwithstanding anything to the contrary in the foregoing, for security of shipment receipt and handling, no lots will be shipped between the dates of December 16, 2014 and January 2, 2015 inclusive.
|
·
|
TEKMIRA shall not be liable for any delays arising from national or international government, customs or courier interactions.
|
·
|
[***]
|
·
|
[***]
|
·
|
[***]
|
EXCEPTION TO SF 30
|
30-105-04
|
ST ANDARD FORM 30 (Rev. 10-83)
|
APPROVED BY OIRM 11-84
|
Prescribed by GSA FAR (48 CFR) 53.243
|
EXCEPTION TO SF 30
|
30-105-04
|
ST ANDARD FORM 30 (Rev. 10-83)
|
APPROVED BY OIRM 11-84
|
Prescribed by GSA FAR (48 CFR) 53.243
|
|
The 'administered by' organization has changed from DCM SEATTLES4801A CORPORATE CAMPUS EAST III
|
DCMA AMERICAS CANDA
|
SCN01A 275 BANK ST, SUITE 200
|
|
The 'Payment will be made by' organization has changed from DFAS-COLUMBUS CENTER HQ0339
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
NSN
7540·01- 152-8070
PREVIOUS EDITION
UNUSABLE
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
1.
|
SECTION A - SOLICITATION/CONTRACT FORM
|
2.
|
The
'issued
by'
organization
has
changed
from
USASMDC/ARSTRA
T
SMDC-RDC-EB
64 THOMAS JOHNSON DRIVE
FREDERICK MD 21702-4300
to
NATICK CONTRACTING DIVISION
64 THOMAS JOHNSON DR
FREDERICK MD 21702-4300
|
3.
|
SECTION B - SUPPLIES OR SERVICES AND PRICES
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
1.
|
A proposed revised Statement of Work (if required).
|
2.
|
A proposed revised C\VBS which will include a detailed list of the affected C\VBS numbers and the cost and fee that are associated with these changes.
|
3.
|
A proposed revised Il\1S.
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
ITEM NO
|
SUPPLIES/SERVICES
|
QUANTITY
|
UNIT
|
UNIT PRICE
|
AMOUNT
|
000201
|
Job
|
$
0.00
|
|||
Funding for CLIN 0001 | |||||
FFP
|
|||||
FY12 Incremental funding
|
|||||
FOB: Destination
|
NET AMT |
$
0.00
|
|
ACRN AD
CIN:OOOOOOOOOOOOOOOOOOOOOOOOOOOOOO
|
$2,920,010.00 |
INSPECT AT | INSPECT BY | ACCEPT AT | ACCEPT BY |
N/A | N/A | N/A | Government |
Technical data
|
Asserted
|
Name of Person
|
|
to be Furnished
With Restrictions \ I/
|
B
asis
for
Assertion
\
2
1
|
Rights Category \3/
|
Asserting
Restrictions
\4/
|
(LIST)
|
(UST)
|
(LIST)
|
(UST)
|
Printed Name and Title | ||
Signature |
Contract No. | ||
Contractor Name | ||
Contractor Address | ||
Expiration Date |
Contract No. | ||
Contractor Name | ||
Contractor Address | ||
Technical Data or Computer
Software to be Furnished
With Restrictions *
|
Basis for Assertion ** | Asserted Rights Category *** |
Name of Person
Asserting
Restrictions ****
|
(UST) ***** | (LIST) | (UST) | (LIST) |
Printed Name and Title | ||
Signature |
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
ITEM NO
|
SUPPLIES/SERVICES
|
QUANTITY
|
UNIT
|
UNIT PRICE
|
AMOUNT
|
000105
|
$0.00
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
EXCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
|
SECTION B - SUPPLIES OR SERVICES AND PRICES
|
ITEM NO
|
SUPPLIES/SERVICES
|
QUANTITY
|
UNIT
|
UNIT PRICE
|
AMOUNT
|
000106
|
Job
|
$0.00
|
$0.00
|
INSPECT AT
|
INSPECT BY
|
ACCEPT AT
|
ACCEPT BY
|
N/A
|
N/A
|
N/A
|
Government
|
ACRN: AG
|
||
CIN: GFEBS001029985300001
|
||
Acctng Data: 097201320140400000265Y0440406255
|
A.0011315.3.1.1
|
6100.9000021001
|
Increase: $1,700,000.00
|
||
Total: $1,700,000.00
|
||
Cost Code: A5XAL
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
DELIVERY DATE
|
QUANTITY
|
SHIP TO ADDRESS
|
UIC
|
30-APR-2013
|
N/A
FOB: Destination
|
DELIVERY DATE
|
QUANTITY
|
SHIP TO ADDRESS
|
UIC
|
30-SEP-2014
|
N/A
FOB: Destination
|
Attachment No.
|
Description
|
Date
|
Number of Pages
|
1
|
Contractor’s Statement
|
8 Feb 2013
|
25
|
of Work
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
A.
|
The purpose of this modification is to 1) add CLIN 0006, as a [***] add value and funding to the contract for anticipated OH billing rate increases for FY12 through FY14 for efforts towards delivery of CLIN 0001. This value is non fee bearing and is subject to final audit. 3) [***] credits appearing on Vouchers BVN0040 and BVN0046 offered as consideration.
|
B.
|
All other terms and conditions of this contract are unchanged and in full force and effect.
|
C.
|
The parties hereto specifically agree that the changes effected by this modification constitute both the consideration and equitable adjustment due under any clause of this contract.
|
ITEM NO
|
SUPPLIES/SERVICES
|
QUANTITY
|
UNIT
|
UNIT PRICE
|
AMOUNT
|
0006
|
Job
|
$[***]
|
|||
[***] | |||||
[***] | |||||
[***] | |||||
FOB: Destination | |||||
PURCHASE REQUEST NUMBER: 0010481491-0002 |
ESTIMATED COST | $[***] | |
[***] | $[***] | |
TOTAL EST COST + FEE
|
$[***] | |
$[***] |
ITEM NO
|
SUPPLIES/SERVICES
|
QUANTITY
|
UNIT
|
UNIT PRICE
|
AMOUNT
|
0007
|
Job
|
$1,622,213.82
|
|||
OH Rate Increase CPIF | |||||
[***] for anticipated increase of OH rates is added to the contract value for CLIN 0001 efforts. This amount is subject to Final audit of indirect rates for FY12-14.
|
|||||
FOB: Destination
|
|||||
PURCHASE REQUEST NUMBER: 0010481491-0002
|
TARGET COST | $[***] | |
TARGET FEE | $[***] | |
TOTAL TGT COST + FEE
|
$[***] | |
MINIMUM FEE | $[***] | |
MAXIMUM FEE | $[***] | |
SHARE RATIO ABOVE TARGET | ||
SHARE RATIO BELOW TARGET | ||
ACRN AH
CIN: GFEBS001048149100002
|
$[***] |
INSPECT AT | INSPECT BY | ACCEPT AT | ACCEPT BY |
N/A | N/A | N/A | Government |
INSPECT AT | INSPECT BY | ACCEPT AT | ACCEPT BY |
N/A | N/A | N/A | Government |
CIN: GFEBS001048149100001
|
|
Acctng Data: 097201420150400000265Y0550506255
|
A.0011315.4.1.2.3
6100.9000021001
|
Increase: $[***]
|
|
Total: $[***]
|
|
Cost Code: A5XAH
|
ACRN: AH
|
|
CIN: GFEBS001048149100002
|
|
Acctng Data: 097201420150400000265Y0550506255
|
A.0011315.4.1.2.3 6100.9000021001 |
Increase: $[***]
|
|
Total: $[***]
|
|
Cost Code: A5XAH
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
DELIVERY DATE
|
QUANTITY
|
SHIP TO ADDRESS
|
UIC
|
30-SEP-2014
|
N/A
FOB: Destination
|
DELIVERY DATE
|
QUANTITY
|
SHIP TO ADDRESS
|
UIC
|
31-MAR-2015
|
N/A
FOB: Destination
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
ITEM NO
|
SUPPLIES/SERVICES
|
QUANTITY
|
UNIT
|
UNIT PRICE
|
AMOUNT
|
0008
|
|
$7,000,000.00
|
|||
Manufacture of TKM Ebola
|
|||||
CPFF
|
|||||
Manufacture of Ebola countermeasure targeting Guinea variant strain. Successful Production and fill/finish of [***], GMP grade (per CFR Parts 210 and 211), [***], suitable for administration to patients under an Emergency IND protocol. Includes relevant raw material and product release and stability testing and technology transfers, set-up and validation. In accordance with the revised SOW, paragraph 4.4.4., attached in Section J.
|
|||||
Cost: $[***]
|
|||||
Fixed Fee: $[***]
|
|||||
Total Cost and Fee: $7,000,000
|
|||||
FOB: Destination
|
ESTIMATED COST | $[***] | |||
FIXED FEE
|
$[***] | |||
TOTAL EST COST + FEE
|
$7,000,000.00
|
ITEM NO
|
SUPPLIES/SERVICES
|
QUANTITY
|
UNIT
|
UNIT PRICE
|
AMOUNT
|
000801
|
Job
|
$0.00
|
|||
Funding for CLIN 0008
|
|||||
COST
|
|||||
FOB: Destination
|
|||||
PURCHASE REQUEST NUMBER: 0010481491-0004
|
|||||
ESTIMATED COST
|
$0.00
|
||||
ACRN AH
|
$[***]
|
||||
CIN: GFEBS001048149100003
|
|||||
ITEM NO
|
SUPPLIES/SERVICES
|
QUANTITY
|
UNIT
|
UNIT PRICE
|
AMOUNT
|
000802
|
Job
|
$0.00
|
|||
Funding for CLIN 0008
|
|||||
COST
|
|||||
FOB: Destination
|
|||||
PURCHASE REQUEST NUMBER: 0010612797
|
|||||
ESTIMATED COST
|
$0.00
|
||||
ACRN AJ
|
|||||
CIN: GFEBS001061279700001
|
|||||
INSPECT AT | INSPECT BY | ACCEPT AT | ACCEPT BY |
N/A | N/A | N/A | Government |
INSPECT AT | INSPECT BY | ACCEPT AT | ACCEPT BY |
N/A | N/A | N/A | Government |
INSPECT AT | INSPECT BY | ACCEPT AT | ACCEPT BY |
N/A | N/A | N/A | Government |
ACRN: AH
|
|
CIN: GFEBS001048149100003
|
|
Acctng Data: 097201420150400000265Y0550506255
|
A.0011315.4.1.2.3
6100.9000021001
|
Increase: $658,576.68
|
|
Total: $658,576.68
|
|
Cost Code: A5XAH
|
ACRN: AJ
|
|
CIN: GFEBS001061279700001
|
|
Acctng Data: 097201520160400000265Y0550506255
|
A.0011315.4.1.3.1
6100.9000021001
|
Increase:
|
|
Total:
|
|
Cost Code: A5XAH
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
ACRN: AJ
|
||
ClN:GFEBS001061876900001
|
||
Acctng Data: 097201520160400000265Y0550506255
Increase:$6
,
341
,
423.32
|
A.0011315.4
.
1.3
.
l
|
6100.9000021001
|
Total: $6,341
,
423.32
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
E
XCEPTION TO SF 30
APPROVED BY OIRM 11-84
|
30-105-04
|
STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243
|
ITEM NO
|
SUPPLIES/SERVICES
|
QUANTITY
|
UNIT
|
UNIT PRICE
|
AMOUNT
|
000201
|
Job
|
$[***]
|
|||
Funding for CLIN 0002 | |||||
CPIF
|
|||||
FOB: Destination
|
|||||
PURCHASE REQUEST NUMBER: 0010662723
|
TARGET COST | $[***] | |
TARGET FEE | $[***] | |
TOTAL TGT COST + FEE
|
$[***] | |
MINIMUM FEE | $[***] | |
MAXIMUM FEE | $[***] | |
SHARE RATIO ABOVE TARGET | ||
SHARE RATIO BELOW TARGET | ||
ACRN AK
CIN: GFEBSOO I 06627230000 I
|
$[***] |
INSPECT AT | INSPECT BY | ACCEPT AT | ACCEPT BY |
N/A | N/A | N/A | Government |
DELIVERY DATE
|
QUANTITY
|
SHIP TO ADDRESS
|
UIC
|
29-JAN-2016
|
N/A
FOB: Destination
|
ACRN:AK
|
|
CIN:GFEBSOO 106627230000 I
|
|
Acctng Data: 097201520 I 60400000265Y0550506255
|
A.001 1315.4.1.3.4 6100.9000021001
|
Increase:$[***]
|
|
Total: $[***]
|
|
Cost Code: A5XAH
|
4.
|
Covenants.
The Company covenants and agrees with the several Underwriters as
|
6.
|
Indemnification and Contribution.
|
8.
|
Termination of this Agreement
.
|
9.
|
Default by the Company
|
Underwriter
|
Number of Firm Shares to be
P
urchased<
1
l
|
|
Stifel, Nicolaus
&
Company, Incorporated
|
2,625,000
|
|
Maxim Group LLC |
1,125,000
|
|
Total:
|
3,750,000
|
(1)
|
The Underwriters may purchase up to an additional 562,500 Option Shares, to the extent the option described in Section 3(b) of the Agreement is exercised, in the proportions and in the manner described in the Agreement.
|
|
documents incorporated
therein
by
reference and
the
documents
otherwise
deemed to
be
incorporated
by
reference
therein
pursuant
to
Canadian
Securities
Laws,
the
"Canadian
Preliminary
Prospectus
"
).
|
3.
|
Purchase, Sale and Delivery of Securities.
|
4.
|
Covenants.
The Company covenants and agrees with the Underwriter as follows:
|
|
earnings statement (which need not be audited) covering a 12-month period that shall satisfy the provisions of Section l l (a) of the Securities Act and Rule 158 of the Rules and Regulations.
|
(1)
|
The Underwriter shall have received all the Lock-Up Agreements referenced in
Section 4(j)
.
|
6.
|
Indemnification and Contribution.
|
8.
|
Termination
of
this
Agreement
.
|
Name
|
Date on which the entity
became Tekmira’s wholly
owned sub
|
Jurisdiction
|
Protiva Biotherapeutics Inc.
|
May 30, 2008
|
British Columbia, Canada
|
Protiva Biotherapeutics (USA), Inc.
|
May 30, 2008
|
Delaware, United States of America
|
Protiva Agricultural Development Company Inc.
|
Jan. 9, 2014
|
British Columbia, Canada
|
OnCore Biopharma, Inc.
|
Mar. 4, 2015
|
Delaware, United States of America
|
Enantigen Therapeutics, Inc.
|
Mar. 4, 2015
|
Delaware, United States of America
|
1.
|
I have reviewed this Form 10-K Tekmira Pharmaceuticals Corporation;
|
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, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(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 the 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/ Mark J. Murray
|
|||
Name:
|
Mark J. Murray
|
||
Title:
|
President and Chief Executive Officer
|
1.
|
I have reviewed this Form 10-K of Tekmira Pharmaceuticals Corporation;
|
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, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(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/ Bruce Cousins
|
|||
Name:
|
Bruce Cousins
|
||
Title:
|
Executive Vice President, Finance and
Chief Financial Officer
|
1.
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
2.
|
The information contained in the Report fairly represents, in all material respects, the financial condition and results of the operations of the Company.
|
/s/ Mark J. Murray
|
|||
Name:
|
Mark J. Murray
|
||
Title:
|
President and Chief Executive Officer
|
1.
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
2.
|
The information contained in the Report fairly represents, in all material respects, the financial condition and results of the operations of the Company.
|
/s/ Bruce Cousins
|
|||
Name:
|
Bruce Cousins
|
||
Title:
|
Executive Vice President, Finance and
Chief Financial Officer
|