Document:

exv10w7wa

Exhibit 10.7(a)

Execution Copy

First Amendment to Exclusive License Agreement

Between

University of Arizona and Oncothyreon, Inc.,

Effective 29 July 2004

     This First Amendment (“Amendment”), effective on the date of last authorized signature affixed
hereto (“Amendment Effective Date”), is by and between the Arizona Board of Regents on behalf of
the University of Arizona, having an office at 888 N. Euclid Avenue, Room 204, Tucson, Arizona
85721 (“LICENSOR”), and Oncothyreon, Inc., having its principal office at 2601 Fourth Avenue, Suite
500, Seattle, Washington 98121 (“LICENSEE”).

     WHEREAS, LICENSOR is authorized to act in this Amendment on behalf of the Burnham Institute
and the University of Pittsburgh of the Commonwealth System of Higher Education under an
Inter-institutional Agreement effective 9/28/2002; and

     WHEREAS, LICENSOR and Pro1X Pharmaceuticals Corporation, which was subsequently acquired by
LICENSEE, entered into an Exclusive License Agreement, effective 29 July 2004 (“Agreement”), that,
by assignment of the Agreement, granted to LICENSEE exclusive rights in Licensed Patents described
in Sec. 1.2 of the Agreement; and

     WHEREAS, LICENSOR and LICENSEE wish to amend Section 1.2 of the Agreement to add certain
Licensed Patents to the Agreement and to amend Section 4 Fees, Royalties, Payments And Milestones.

     All defined terms used herein that are not defined herein shall have the meaning ascribed to
them in the Agreement.

     NOW, THEREFORE, the parties agree as follows:

	 	1.	 	Sec. 1.2 shall be replaced in its entirety as follows:

	 	1.2	 	The LICENSOR wishes to exercise its right to administer and
license valuable intangible property rights in the patent rights described in
the following patent applications and issued patents:

	 	1.2.1	 	U.S. Patent No. 5,378,725 issued 1/3/1995
assigned to the Arizona Board of Regents and Eli Lilly and Company, now
abandoned;
	 
	 	1.2.2	 	U.S. Patent Application No. 10/245,780 filed
9/16/2002, now U.S. Patent No. 6,703,414 issued 3/09/2004 assigned to
Arizona Board of Regents, and The Burnham Institute;

 

 

	 	1.23	 	U.S. Patent Application No. 10/245,779 filed
9/16/2002, now U.S. Patent No. 7,081,475 issued 7/25/2006 assigned to
Arizona Board of Regents and University of Pittsburgh;
	 
	 	1.2.4	 	U.S. Patent Application No. 11/279,000 filed
4/07/2006, now U.S. Patent No. 7,335,679 issued 2/26/2008 assigned to
Arizona Board of Regents and University of Pittsburgh;
	 
	 	1.2.5	 	U.S. Patent Application No. 11/178,553 filed
7/11/2005, now U.S. Patent No. 7,446,124 issued 11/04/2008 assigned to
Arizona Board of Regents, Prolx Pharmaceuticals, Inc. and University of
Pittsburgh;
	 
	 	1.2.6.	 	U.S. Patent Application No. 11/618,036 filed 12/30/2005;
	 
	 	1.2.7	 	U.S. Patent Application No. 11/858,508 filed 9/20/2007;
	 
	 	1.2.8	 	U.S. Patent Application No. 12/235,730 filed 9/23/20008
	 
	 	1.2.9	 	U.S. Patent Application No. 12/752,935 filed 4/1/2010

	 	 	 	and any equivalent foreign patents and patent applications, including any reissues,
continuations, divisionals, and extensions, but excluding continuation-in-part
applications, based on the subject matter claimed in or covered therein.

     2. The last sentence of Section 3.2 is hereby deleted. The remainder of Section 3.2 shall
continue with full force and effect.

     3. Sec. 4 shall be replaced in its entirety as follows:

	 	4.1	 	In consideration for the licenses granted herein, LICENSEE has
paid in full an upfront License Fee of Ten Thousand Dollars ($10,000). One half
of the payment was due within fourteen (14) days of the Effective Date; the
balance was due six (6) months after the Effective Date.
	 
	 	4.2	 	LICENSEE agrees to pay an Amendment Fee of Thirty Thousand
Dollars ($30,000) for each issued patent, added to Section 1.2 of this Agreement
by mutual written consent of the parties after the Amendment Effective Date; and
LICENSEE agrees to pay an Amendment Fee of Fifteen Thousand Dollars ($15,000)
for each patent application, added to Section 1.2 of this Agreement by mutual
written consent of the parties after the Amendment Effective Date.
As such, as of the Amendment Effective Date, an Amendment Fee of Thirty
Thousand Dollars ($30,000) shall be payable by LICENSEE to LICENSOR within
thirty (30) days of LICENSEE’s receipt of the applicable invoice from
LICENSOR. For clarification, the Amendment Fee will be due only for the

 

 

	 	 	 	first issued patent, or first patent application, that covers an invention
that falls outside of patent rights described in Sec. 1.2 above. Additional
fees will not be required for equivalent foreign patents or patent
applications, or for any patents or applications for reissues, continuations,
divisional, or extensions.
	 
	 	4.3.	 	LICENSEE agrees to cover the costs incurred in connection with
the preparation, filing and prosecution of the Licensed Applications and the
maintenance of Licensed Patents. After the Effective Date, and during the term
of this Agreement, LICENSEE agrees to assume responsibility for future patent
prosecution and maintenance costs as provided in Section 7.1 of this License
Agreement.
	 
	 	4.4	 	LICENSEE shall pay to LICENSOR milestone royalties related to
Regulatory Approval for Licensed Products as follows:

	 	(1)	 	$25,000 within thirty (30) days after the first
Regulatory Approval of an Investigational New Drug (“IND”) or
equivalent;
	 
	 	(2)	 	$50,000 within thirty (30) days after the first
Regulatory Approval of any Phase II or equivalent tests; and

	 	 	 	With respect to each Licensed Product thereafter:

	 	(3)	 	$125,000 within thirty (30) days after the first
Regulatory Approval of any Phase III or equivalent tests and $62,500
within (30) days for each Licensed Product receiving Regulatory Approval
of any Phase III or equivalent test thereafter; and
	 
	 	(4)	 	$250,000 within thirty (30) days after the
approval of the first Regulatory Approval of any New Drug Approval
(“NDA”) or its equivalent and $125,000 within thirty (30) days for each
Licensed Product receiving Regulatory Approval of any NDA or its
equivalent thereafter.

	 	 	 	LICENSEE may investigate more than one Licensed Product through Phase II
tests without paying more than one set of milestone royalties. If LICENSEE
should choose to submit multiple NDAs covering the same Licensed Product or
an NDA covering more than one Licensed Product, then the milestone royalties
relating to additional Licensed Products are as set forth in 4.4(3) and (4)
above being reduced by fifty percent (50%) of the first amount due. If,
after obtaining Regulatory Approval for an NDA or its equivalent, LICENSEE
attempts to develop additional Licensed Products, milestone royalties
relating to such products will be reduced by fifty percent (50%).

 

 

	 	4.5	 	In addition, LICENSEE shall pay LICENSOR earned royalties on Net
Sales of Licensed Product sold by LICENSEE or any sublicensee, regardless of
tier, in the country in which the Licensed Product is made, used or sold. The
royalty shall be three percent (3%) of Net Sales for Licensed Products in the
field of diagnostics and four and one-half percent (4.5%) of Net Sales for
Licensed Products in the field of therapeutics.
	 
	 	4.6	 	LICENSEE shall pay LICENSOR ten percent (10%) of any SUBLICENSING
INCOME. For clarity, no amount shall be due to LICENSOR under this Section
until LICENSEE has recouped the costs incurred by LICENSEE in connection with
the research and development of Licensed Products prior to the grant of such
sublicense; accordingly, the total of such costs, as reasonably documented by
LICENSEE, shall be deducted from SUBLICENSING INCOME for purposes of calculating
the amounts due under this Section. In addition, to the extent SUBLICENSING
INCOME represents an unallocated combined payment for both a sublicense of the
Licensed Patents as well as other intellectual property, undertakings or subject
matter, such SUBLICENSING INCOME from such sublicensing arrangement for
calculating payments due to LICENSOR will be as reasonably allocated by LICENSEE
between such Licensed Patents and such other intellectual property, undertakings
or subject matter. Notwithstanding Section 16.3, if a dispute between the
parties arises as to the amount of SUBLICENSING INCOME payable to LICENSOR
hereunder, then, upon written request by either party, the matter shall be
resolved by final, binding arbitration conducted by the Judicial Arbitration and
Mediation Services, Inc. (or any successor entity thereto) (“JAMS”)
under its rules of arbitration then in effect by a single arbitrator. Unless
otherwise mutually agreed upon by the parties, the arbitration proceedings shall
be conducted in Tucson, Arizona. The parties shall share equally the cost of
the arbitration charged by JAMS. In the event of such dispute, LICENSEE shall
not be deemed in breach of this Agreement by reason of the disputed amount,
unless LICENSEE fails to pay the amount determined to be due within thirty (30)
days after the final written determination of the arbitrator. Furthermore,
payments due as a percentage of SUBLICENSING INCOME may be offset against any
payments due pursuant to this Agreement thereafter.
	 
	 	 	 	For the purposes of this Agreement, “SUBLICENSING INCOME” means the amount of
any cash payment actually received by LICENSEE during the term of this
Agreement from an unaffiliated third party in consideration for the
grant of a sublicense under the Licensed Patents, excluding the following:
(a) reimbursement or prepayment of costs incurred by LICENSEE or its
affiliates in performing obligations owed to the sublicensee under the
applicable sublicense agreement, including without limitation, in performing

 

 

	 	 	 	research, development, manufacture or other activities with respect to
Licensed Products, (b) a reasonable amount of any upfront payments, milestone
payments or other general payments that LICENSEE may set aside to offset any
otherwise unreimbursed costs and expenses that LICENSEE or its affiliates
expect to incur, but have not yet incurred, in the performance of their
responsibilities under the applicable sublicense agreement; (c) proceeds
derived from bona fide debt financing; (d) consideration received for the
purchase of an equity interest in LICENSEE; (e) amounts paid to LICENSEE as
dividends or profit distributions; (f) withholding taxes and other amounts
actually withheld or deducted from amounts paid to LICENSEE; and (g) amounts
paid to LICENSEE as earned royalties on sales by sublicensee(s) or otherwise
calculated on the basis of sales of Licensed Products.
	 
	 	47	 	LICENSEE shall pay to LICENSOR a minimum annual royalty of One
Hundred Thousand Dollars ($100,000) or twenty-five percent (25%) of Net Sales
for the same period, whichever is less, for the life of LICENSOR’s Licensed
Patents, beginning with the year of the First Commercial Sate of Licensed
Products. For the first year of commercial sales, the LICENSEE’s obligation to
pay the minimum annual royalty will be pro-rated for the number of months
remaining in that calendar year when commercial sales commence and shall be due
as specified under this Article. For subsequent years, the earned royalty shall
be paid to LICENSOR as specified in this Article and shall be credited against
the minimum annual royalty due for the calendar year in which the minimum
payment was made.
	 
	 	4.8	 	The royalty on sales in currencies other than U.S. Dollars shall
be calculated using the appropriate foreign exchange rate for such currency
quoted by the Wall Street Journal at the close of business on the last banking
day of each calendar quarter. Royalty payments to LICENSOR shall be in U.S.
Dollars.

	 	4.	 	Sec. 12.1(b) shall be replaced in its entirety as follows:

	 	12.1(b)	 	Subject to the provisions of Section 11.3 hereof, which describes the only
method by which LICENSOR shall be entitled to terminate this Agreement on the
basis of failure to use appropriate diligence, upon any material breach or
default under this Agreement by LICENSEE, LICENSOR may give written notice
thereof to LICENSEE, and LICENSEE shall have sixty (60) days thereafter to cure
such breach or default. If such breach or default is not so cured, LICENSOR may
then in its sole discretion and option (a) terminate this
Agreement and the licenses granted herein or (b) seek such other relief as
may be provided by law in such circumstances by giving written notice thereof
to LICENSEE. However, if LICENSEE disputes such alleged breach within such
sixty (60) day period, LICENSOR shall not have the right to terminate

 

 

	 	 	 	this
Agreement or seek such other relief as set forth in the previous sentence
unless it has been finally adjudicated and determined by a court of competent
jurisdiction that this Agreement was materially breached, and LICENSEE fails
to comply with its obligations hereunder within sixty (60) days after such
determination.

	 	5.	 	Sec. 12.1(e) shall be replaced in its entirety as follows:

	 	12.1(e)	 	 In the event of termination of this Agreement for any reason, any and all
rights granted LICENSEE hereunder shall cease and terminate, and all such rights
shall revert to LICENSOR. For clarity and notwithstanding anything herein to
the contrary, upon any such termination, any sublicense granted by LICENSEE
hereunder shall survive, provided that upon request by LICENSOR, such
sublicensee promptly agrees in writing to be bound by the applicable terms of
this Agreement. LICENSEE shall diligently thereafter return to LICENSOR, or to
LICENSOR’s designated attorneys, any files or other documents in its possession
or in the possession of its attorneys relating solely to pending or issued
Licensed Patent(s), except that one copy of each such documents may be retained
by LICENSEE and its designee for the purpose of ensuring compliance hereunder.
LICENSEE shall also execute any and all documents necessary to return control of
said Licensed Patent(s) until such time as control has properly been transferred
to LICENSOR. Further, LICENSEE shall immediately return to LICENSOR all
research data, biological and other material (including but not limited to
licensed cell lines), prototypes, process information, clinical data and the
like of LICENSOR in its possession.

	 	6.	 	All other terms of the Agreement shall remain the same.

[signature page follows]

 

 

     IN WITNESS WHEREOF, a duly authorized officer of each party hereto has executed this First
Amendment in duplicate originals by on the day and year below written.

	 	 	 	 	 
	ARIZONA BOARD OF REGENTS	 	ONCOTHYREON, INC.
	On behalf of

THE UNIVERSITY OF ARIZONA
	 	 	 
	 
	 	 	 	 
	By:  

	/s/ Patrick L. Jones, PhD, MBA	 	By:  	/s/ Robert L. Kirkman, MD
	 	 

	 	 	 
	 	Name: Patrick L. Jones, PhD, MBA

	 	 	Name: Robert L. Kirkman, MD
	 	Title:   Director, Office of Technology

            Transfer

	 	 	Title:   President and CEO
	 
	 	 	 	 
	Date: 27th September 2010

	 	Date: 24th September 2010exv10w10wa

Exhibit 10.10(a)

First Amendment to Exclusive License Agreement between

The University of Arizona and ProlX PHARMACEUTICALS, Inc.

Effective September 15, 2005

     This First Amendment to the Exclusive License Agreement between Prolx Pharmaceuticals, Inc.,
now Oncothyreon, Inc. (“LICENSEE”), and the Arizona Board of Regents on behalf of the University of
Arizona (“LICENSOR”) for an invention entitled “Method of Preselecting Patients for Anti-VEGF,
Anti-HIF-1 or Anti-Thioredoxin Therapy” (“Agreement”) is made effective as of the date of the last
authorized signature below.

     The Licensee and University agree to amend the Agreement, as follows:

	 	1.	 	Revise Section 4.1, as follows:
	 
	 	 	 	“4.1 LICENSEE agrees to pay LICENSOR an upfront License Fee of $5000 and a fee of
$5000 for the First Amendment. Amendments subsequent to the First Amendment may be
made without payment of a fee;”
	 
	 	2.	 	Add a new Section 4.7, as follows:
	 
	 	 	 	“4.7 In the event a Licensed Product is subject to any other royalty obligation
pursuant to an agreement between the LICENSOR and LICENSEE, LICENSEE shall pay
LICENSOR the greater of such applicable royalties for such Licensed Product, and in
no event shall the royalties due to LICENSOR for such Licensed Product be
cumulative;” and
	 
	 	3.	 	Replace Schedule A with the attached Revised Schedule A.

     All other terms of the Agreement shall remain the same.

Agreed to by and between the Parties:

	 	 	 	 	 	 	 

	ARIZONA BOARD OF REGENTS 

On behalf of the 

University of Arizona,	 	ONCOTHYREON INC.
	 
	 	 	 	 	 	 
	By:

	 	/s/ Patrick L. Jones, PhD, MBA
	 	By:
	 	/s/ Robert L. Kirkman, MD
	 

	 	 
	 	 	 	 
	 	 	Name: Patrick L. Jones, PhD, MBA	 	 	 	Name: Robert L. Kirkman, MD
	 	 	Title:   Director, Office of Technology Transfer	 	 	 	Title:   President and CEO
	 
	 	 	 	 	 	 
	Date: 5th September 2008	 	Date: 28th November 2008

 

 

Revised Schedule A

	 	 	 	 	 	 	 	 	 
	Serial No.	 	Territory	 	Title	 	Filing Date	 	Status
	10/288,888

	 	US
	 	N-Oxides and
Derivatives of
Melphalan for
Treating Diseased
States Associated
With Hypoxia
Inducible Factor
	 	11/6/2002
	 	Abandoned
	 
	 	 	 	 	 	 	 	 
	10/929,156

	 	US
	 	N-Oxides and
Derivatives of
Melphalan for
Treating Diseased
States Associated
With Hypoxia
Inducible Factor
	 	8/20/2004
	 	Pending
	 
	 	 	 	 	 	 	 	 
	2003291282

	 	AU
	 	N-Oxides and
Derivatives of
Melphalan for
Treating Diseased
States Associated
With Hypoxia
Inducible Factor
	 	11/3/2003
	 	Pending
	 
	 	 	 	 	 	 	 	 
	2504496

	 	CA
	 	N-Oxides and
Derivatives of
Melphalan for
Treating Diseased
States Associated
With Hypoxia
Inducible Factor
	 	11/3/2003
	 	Pending
	 
	 	 	 	 	 	 	 	 
	03768672.2

	 	EP
	 	N-Oxides and
Derivatives of
Melphalan for
Treating Diseased
States Associated
With Hypoxia
Inducible Factor
	 	11/3/2003
	 	Pending
	 
	 	 	 	 	 	 	 	 
	2004-551738

	 	JP
	 	N-Oxides and
Derivatives of
Melphalan for
Treating Diseased
States Associated
With Hypoxia
Inducible Factor
	 	11/3/2003
	 	Pending
	 
	 	 	 	 	 	 	 	 
	2005-004845

	 	MX
	 	N-Oxides and
Derivatives of
Melphalan for
Treating Diseased
States Associated
With Hypoxia
Inducible Factor
	 	11/3/2003
	 	Pending
	 
	 	 	 	 	 	 	 	 
	PCT/US03/35266

	 	PCT
	 	N-Oxides and
Derivatives of
Melphalan for
Treating Diseased
States Associated
With Hypoxia
Inducible Factor
	 	11/3/2003
	 	Pending
	 
	 	 	 	 	 	 	 	 
	60/487,562

	 	US
	 	Regulation of HIF
Protein Levels via
Deubiquination
Pathway
	 	7/14/2003
	 	Expired
	 
	 	 	 	 	 	 	 	 

 

 

	 	 	 	 	 	 	 	 	 
	Serial No.	 	Territory	 	Title	 	Filing Date	 	Status
	10/890,756

	 	US
	 	Regulation of HIF
Protein Levels via
Deubiquination
Pathway
	 	7/4/2004
	 	Pending
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	Regulation of HIF
Protein Levels via
Deubiquination
Pathway
	 	7/14/2004
	 	Pending
	 
	 	 	 	 	 	 	 	 
	60/602,151

	 	US
	 	Method of
Pre-selecting
Patients for
Anti-VEGF,
Anti-HIF-1 or
Anti-Thioredoxin
Therapy
	 	8/17/2004
	 	Expired
	 
	 	 	 	 	 	 	 	 
	60/602,163

	 	US
	 	Monitoring Effects
of PX-12 on Tumor
Vascular
Permeability
	 	8/17/2004
	 	Expired
	 
	 	 	 	 	 	 	 	 
	11/206,526

	 	US
	 	Method of
Preselecting
Patients for
Anti-VEGF,
Anti-HIF-1 or
Anti-Thioredoxin
Therapy
	 	8/17/2005
	 	Pending
	 
	 	 	 	 	 	 	 	 
	PCT/US06/29416

	 	PCT
	 	Method of
Preselection
Patients for
Anti-VEGF,
Anti-HIF-1 or
Anti-Thioredoxin
Therapy
	 	8/17/2005
	 	Reg./nat. Phases
entered
	 
	 	 	 	 	 	 	 	 
	2005277350

	 	AU
	 	Method of
Preselection
Patients for
Anti-VEGF,
Anti-HIF-1 or
Anti-Thioredoxin
Therapy
	 	8/17/2005
	 	Pending
	 
	 	 	 	 	 	 	 	 
	2,577,312

	 	CA
	 	Method of
Preselection
Patients for
Anti-VEGF,
Anti-HIF-1 or
Anti-Thioredoxin
Therapy
	 	8/17/2005
	 	Pending
	 
	 	 	 	 	 	 	 	 
	05808798.2

	 	EP
	 	Method of
Preselection
Patients for
Anti-VEGF,
Anti-HIF-1 or
Anti-Thioredoxin
Therapy
	 	8/17/2005
	 	Pending

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