Commitments And Contingencies |
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Sep. 30, 2011 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Commitments And Contingencies [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| COMMITMENTS AND CONTINGENCIES |
7. COMMITMENTS AND CONTINGENCIES
Teva Pharmaceutical Industries Ltd.
Under the Collaboration Agreement, Teva made upfront payments in the aggregate amount of $50
million, may make up to $370 million in additional payments upon the achievement of developmental
and commercial milestones and may be required in the future to pay royalties at percentage rates
ranging from the mid-teens to mid-twenties on net sales. The Company is required to contribute $30
million in direct and indirect costs towards the Clinical Development Plan. As of September 30,
2011, $11.0 million of these costs have been incurred by OncoGenex, resulting in a remaining
funding responsibility of $19.0 million which has been recorded under Deferred collaboration
revenue and Deferred collaboration revenue, less current portion as of September 30, 2011. Teva
will fund all other expenses under the Clinical Development Plan. See note 3 in the Notes to
Consolidated Financial Statements for further details on our Collaboration Agreement with Teva.
Isis Pharmaceuticals Inc. and University of British Columbia
To facilitate the execution and performance of the Collaboration Agreement with Teva, OncoGenex and
Isis agreed to amend the Isis License Agreement and the Company and UBC agreed to amend the UBC
License Agreement, in each case, effective December 19 and December 20, 2009, respectively.
The amendment to the Isis License Agreement provides, among other things, that if the Company is
the subject of a change of control with a third party, where the surviving company immediately
following such
change of control has the right to develop and sell the product, then (i) a milestone payment of
$20 million will be due and payable to Isis 21 days following the first commercial sale of the
product in the United States; and (ii) unless such surviving entity had previously sublicensed the
product and a royalty rate payable to Isis by the Company has been established, the applicable
royalty rate payable to Isis will thereafter be the maximum amount payable under the Isis License
Agreement. Any non-royalty milestone amounts previously paid will be credited toward the $20
million milestone if not already paid. As a result of the $10 million milestone payment payable to
Isis in relation to the Collaboration Agreement, the remaining amount owing in the event of change
of control discussed above is a maximum of $10 million. As the Company has now licensed the product
to Teva and established a royalty rate payable to Isis, no royalty rate adjustments would apply if
Teva acquires the Company and is the surviving company. If the $30 million in advanced
reimbursement of development activities has not been spent by OncoGenex prior to the third
anniversary of the Collaboration Agreement between OncoGenex and Teva, OncoGenex will pay Isis an
amount equal to 30% of any un-spent portion less $3.5 million.
In addition, we are required to pay to Isis 30% of all Non-Royalty Revenue we receive on custirsen
sales, as defined in the Amended Isis License Agreement. Isis has disclosed in its SEC filings that
it is entitled to receive 30% of the up to $370 million in milestone payments we may receive from
Teva as part of the Collaboration Agreement; however, we believe that certain of the milestone
payments related to sales targets may qualify as Royalty Revenue, as defined in the Amended Isis
License Agreement, and therefore be subject to the lesser payment obligations. No assurance can be
provided that we will be entitled to receive these milestone payments or, if we are, that the
applicable amount payable to Isis will be less than 30%.
Pursuant to license agreements the Company has with the UBC and Isis, the Company is obligated to
pay milestone payments of up to CAD $1.6 million and USD $7.75 million, respectively, upon the
achievement of specified product development milestones related to OGX-427 and OGX-225 and
royalties on future product sales. We paid UBC and Isis CAD $100,000 and USD $750,000,
respectively, in 2010 upon the initiation of a phase 2 clinical trial of OGX-427 in patients with
CRPC. We do not anticipate making any royalty payments to Isis in 2011.
Unless otherwise terminated, the Isis agreements for custirsen and OGX-427 will continue for each
product until the later of 10 years after the date of the first commercial product sale, or the
expiration of the last to expire of any patents required to be licensed in order to use or sell the
product, unless OncoGenex Technologies abandons either custirsen or OGX-427 and Isis does not elect
to unilaterally continue development. The Isis agreement for OGX-225 will continue into perpetuity
unless OncoGenex Technologies abandons the product and Isis does not elect to unilaterally continue
development.
We are also obligated to pay to UBC certain patent costs and annual license maintenance fees for
the extent of the patent life of CAD $8,000 per year relating to custirsen, OGX-427 and OGX-225.
The UBC agreements have effective dates ranging from November 1, 2001 to April 5, 2005 and each
agreement expires upon the later of 20 years from its effective date or the expiry of the last
patent licensed thereunder, unless otherwise terminated.
Bayer HealthCare LLC
On August 7, 2008, Sonus completed an exclusive in-licensing agreement with Bayer HealthCare LLC,
or Bayer, for the right to develop, commercialize or sublicense a family of compounds known as
caspase activators presently in pre-clinical research. Under terms of the agreement, Sonus was
granted exclusive rights to develop two core compounds for all prophylactic and therapeutic uses in
humans. Additionally, Sonus was granted rights to all other non-core compounds covered under the
patents for use in oncology.
Under the terms of the agreement, Bayer received an upfront license fee of $450,000. OncoGenex will
make annual payments to Bayer on the anniversary dates, which are referred to as Anniversary
Payments, with an initial payment of $100,000 paid in 2008. The payments increase by $25,000 each
year until the
initiation of the first phase 3 clinical trial, at which point the Anniversary Payments reset to
$100,000 each year and increase by $25,000 until the Company achieves either the first New Drug
Application, or NDA, filing in the United States or the European Union. OncoGenex is obligated to
pay royalties on net future product sales in addition to aggregate milestone payments of up to
$14,000,000 for clinical development and regulatory milestones. No milestone payments are triggered
prior to the initiation of a phase 3 clinical trial. OncoGenex has the option to terminate this
contract upon 60 days written notice to Bayer.
Lease Arrangements
The Company has an operating lease agreement for office space in Vancouver, Canada, which expires
in September 2014.
Future minimum annual lease payments under the Vancouver lease are as follows (in thousands):
In November 2006, prior to the Arrangement, Sonus entered into a non-cancellable operating
lease agreement for office space in Bothell, Washington, expiring in 2017 (note 6). In connection
with the lease, Sonus was required to provide a cash security deposit of approximately $497,000,
which is included in Other Long Term Assets. In addition, a standby letter of credit for $377,000
is deposited in a restricted money market account as collateral. The Company is currently in the
process of evaluating opportunities to exit or sublet portions of the leased space and has recorded
a liability in the excess facilities lease charge of $7,215,000 as at September 30, 2011 (note 6).
If the Company is unable to exit or sublet portions of this leased space, the future minimum annual
lease payments are as follows (in thousands):
Consolidated rent expense relating to both the Vancouver, Canada and Bothell, Washington
offices in use periods ended September 30, 2011 and 2010 was $1,971,000 and $1,715,000
respectively.
Guarantees and Indemnifications
OncoGenex indemnifies its officers and directors for certain events or occurrences, subject to
certain limits, while the officer or director is or was serving at our request in such capacity.
The term of the indemnification period is equal to the officer’s or director’s lifetime.
The maximum amount of potential future indemnification is unlimited; however, we have obtained
director and officer insurance that limits our exposure and may enable us to recover a portion of
any future amounts paid. We believe that the fair value of these indemnification obligations is
minimal. Accordingly, we have not recognized any liabilities relating to these obligations as of
September 30, 2011.
We have certain agreements with certain organizations with which we do business that contain
indemnification provisions pursuant to which we typically agree to indemnify the party against
certain types of third-party claims. We accrue for known indemnification issues when a loss is
probable and can be reasonably estimated. There were no accruals for or expenses related to
indemnification issues for any period presented.
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