Collaboration Agreement |
9 Months Ended | ||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2011 | |||||||||||||||||||||
Collaboration Agreement [Abstract] | |||||||||||||||||||||
COLLABORATION AGREEMENT |
3. COLLABORATION AGREEMENT
On December 20, 2009, the Company, through its wholly-owned subsidiary, OncoGenex Technologies,
entered into a Collaboration Agreement with Teva Pharmaceutical Industries Ltd., or Teva, for the
development and global commercialization of custirsen (and related compounds), a pharmaceutical
compound designed to inhibit the production of clusterin, a protein we believe is associated with
cancer treatment resistance, or the Licensed Product. Under the Collaboration Agreement, Teva paid
the Company upfront payments in the aggregate amount of $50 million and has agreed to pay up to
$370 million upon the achievement of developmental and commercial milestones and royalties at
percentage rates ranging from the mid-teens to mid-twenties on net sales, depending on aggregate
annual net sales of the Licensed Product.
On the same date, the Company and Teva also entered into a stock purchase agreement, or Stock
Purchase Agreement, pursuant to which Teva made an additional $10 million equity investment in the
Company at a 20% premium to a thirty-day average closing price, resulting in the issuance of
267,531 of our common shares purchased at a price of $37.38 per share. The 20% share premium was
included as consideration for the custirsen license and has been included in collaboration revenue.
In connection with the Collaboration Agreement and pursuant to the terms of agreements between the
Company and Isis Pharmaceuticals, Inc., or Isis, relating to custirsen, the Company paid Isis $10
million which was recorded as research and development expense in 2009. The Company also paid
approximately $333,333 to the University of British Columbia, or UBC, pursuant to the terms of
their license agreement relating to custirsen, which has been recorded as research and development
expense in 2009. Pursuant to the terms of the agreements, the Company anticipates that it would be
required to pay third parties 31% of any milestone payments that are not based on a percentage of
net sales of the Licensed Product. Pursuant to the terms of these agreements, the Company
anticipates it will pay royalties to third-parties of 4.88% to 8.00% of net sales, unless the
Company’s royalties are adjusted for competition from generic compounds, in which case royalties to
third parties will also be subject to adjustment on a country-by-country basis. Certain third-party
royalties are tiered based on the royalty rate received by the Company. Minimum royalty rates
payable by the Company assume certain third-party royalties are not paid at the time that the
Licensed Product is marketed due to the expiration of patents held by such third parties. Maximum
royalty rates assume all third-party royalty rates currently in effect continue in effect at the
time the Licensed Product is marketed.
Teva has the exclusive worldwide right and license to develop and commercialize products containing
custirsen and related compounds. The Company has an option to co-promote any Licensed Product in
the United States and Canada.
Teva is responsible for all costs relating to product commercialization including costs incurred in
relation to the Company’s co-promotion option, except for start-up costs in advance of
commercialization.
Teva and the Company have developed a Clinical Development Plan under which three phase 3 clinical
trials will be initiated:
Teva will be responsible for conducting any other studies and development work necessary to obtain
required regulatory approvals. The Company may assume some of these activities if assigned by the
joint steering committee. Teva will be responsible for all such costs. The joint steering committee
will oversee the development and regulatory approval of any Licensed Product. The Company may
terminate its participation in the joint steering committee at any time.
Funding responsibilities for the Clinical Development Plan will be allocated as follows:
The Collaboration Agreement will remain in effect, on a country-by-country basis, until the
expiration of the obligation of Teva to pay royalties on sales of the Licensed Product in such
country (or earlier termination under its terms). After the completion of all three phase 3
clinical trials set forth in the Clinical Development Plan, or upon early termination due to a
material adverse change in the Company’s patent rights related to custirsen or safety issues or
“futility” as defined in the Collaboration Agreement, Teva may terminate the Collaboration
Agreement at its sole discretion upon three months’ notice if notice is given prior to regulatory
approval of a Licensed Product and upon six months’ notice if notice is given after such regulatory
approval. If Teva terminates the Collaboration Agreement for any reasons other than an adverse
change in custirsen patent rights, safety issues or “futility” determination as previously
described, it will remain responsible for paying for any remaining costs of all three phase 3
clinical trials, except for specified development expenses that are the responsibility of the
Company. Either party may terminate the Collaboration Agreement for an uncured material breach by
the other party or upon the bankruptcy of either party. If the Collaboration Agreement is
terminated by the Company for other than an uncured material breach by Teva, the Company will pay
Teva a royalty on sales of Licensed Products. The percentage rates of such royalties (which are in
the single digits) vary depending on whether termination occurs prior to the first regulatory
approval in the United States or a primary European Market or after one of these approvals. These
royalties would expire on a country-by-country basis on the earlier of ten years after the first
commercial sale of a Licensed Product or certain thresholds related to generic competition.
In the event of a change of control of the Company, within 90 days of the change of control, Teva
may terminate the joint steering committee at its sole discretion, terminate the co-promotion
option at its sole discretion if the option has not been exercised by the Company or, if exercised,
but not yet executed by the Company, or terminate the co-promotion option if in its commercially
reasonable opinion co-promotion with the Company’s successor would be materially detrimental to
Teva’s interests.
Upon entering into the Collaboration Agreement, the Company assessed whether withholding taxes were
owed to the Israeli Tax Authority, or ITA, resulting from the Collaboration Agreement. It was the
Company’s position that withholdings taxes were not owed, and a claim was issued to the ITA
accordingly. For accounting purposes, management concluded that the withholdings tax claim was an
uncertain tax position, and $3 million, which represented the potential withholdings tax
obligation, once received from Teva was initially recorded as restricted cash pending the ITA
review of our claim and a corresponding liability of $3 million was included in accounts payable
and accrued liabilities. In June 2010, the Company received approval from the ITA for our request
for a withholdings tax exemption on amounts received from Teva in relation to the Collaboration
Agreement. Following receipt of this approval from the ITA the $3 million was released to the
Company from escrow. Subsequently, the Company released the $3 million liability and recorded a $3
million income tax recovery in the second quarter of 2010.
Revenue for the three and nine months ended September 30, 2011 was $1.2 million and $4.3 million
respectively, which consists of partial recognition of deferred collaboration revenue representing
OncoGenex’s contribution to the custirsen phase 3 development plan under our Collaboration
Agreement with Teva and custirsen manufacturing costs incurred by OncoGenex in the year ended
December 31, 2010 that are reimbursable from Teva. At September 30, 2011, a remaining balance of
$19.0 million of the up-front payment was recorded in deferred collaboration revenue. There was
$4.9 million and $11.3 million in revenue recorded in the three and nine months ended September 30,
2010 as a result of the Collaboration Agreement with Teva.
|