EXHIBIT 3.13
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
CONFIDENTIAL PROVISIONS HAVE BEEN OBSCURED.
EXCLUSIVE LICENSE AGREEMENT
AGREEMENT, dated as of June 23, 2003 (the "Effective Date"), between THE
TRUSTEES OF COLUMBIA UNIVERSITY IN THE CITY OF NEW YORK, a New York non-profit
corporation ("Columbia"), and VIVENTIA BIOTECH, INC., a Canadian corporation
("Company").
WHEREAS, Columbia, has established a laboratory directed by ▇▇. ▇▇▇▇ ▇▇▇▇▇▇ at
its Health Sciences Division, engaged in research relating to the use of MFP-2
for human hybridoma production, and
WHEREAS, Company has supported ▇▇. ▇▇▇▇▇▇'▇ research relating to MFP-2 by
entering into a Research Agreement with Columbia dated March 1, 2002, as amended
by the First Amendment to Research Agreement effective as of February 28, 2003
(the "Research Agreement"), and obtained certain rights to such research as set
forth in that agreement, and
WHEREAS, Columbia is the owner of the United States issued patent and technology
incorporated and encompassed in the invention known as: United States Patent No.
6,197,582, entitled "Development of human monoclonal antibodies and uses
thereof", issued March 6, 2001, together with any additional inventions and
discoveries arising under and pursuant to the Research Agreement or to be made
hereunder (collectively referred to herein as "Columbia Technology"); and
WHEREAS, Columbia and Company entered into a License Option Agreement dated
March 1, 2002, which granted, inter alia, Company the exclusive option to enter
into an exclusive license of and under the Columbia Technology, and
WHEREAS, Company has herein exercised its exclusive rights to such exclusive
license, and the Company and Columbia further wish to continue the Research
Agreement as set forth in the First Amendment to Research Agreement effective as
of February 28, 2003;
NOW, for good and valuable consideration, Columbia and Company agree as follows:
1. DEFINITIONS.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
CONFIDENTIAL PROVISIONS HAVE BEEN OBSCURED.
a. "Affiliate" shall mean any corporation or other business entity that
directly or indirectly controls, is controlled by, or is under common control
with the Company. Control means ownership or other beneficial interest in 50% or
more of the voting stock or other voting interest of a corporation or other
business entity.
b. "MFP-2 Field" shall mean the treatment, diagnosis and imaging of
cancer, except the MFP-2 Field shall not include cancer vaccines based on
fusions of MFP-2 with a patient's autologous cells.
c. "Collaboration Field" shall mean the MFP-2 Field unless otherwise
expanded or modified by written agreement of the parties and amendment of this
Agreement.
d. "Licensed MFP-2 Patents" shall mean the United States patents, and
the United States, foreign, and international patent applications (including
provisional applications) listed in Exhibit A which is attached hereto and
incorporated as a part hereof; United States and foreign patents issuing from
the patent applications listed in Exhibit A and from any divisionals and
continuations of those applications, and any reissues of such United States
patents; claims of continuation-in-part applications, and patents directed to
subject matter specifically described in the patents and patent applications
listed in Exhibit A; claims of all foreign patent applications and patents or
related patent documents owned or controlled by Columbia which are directed to
subject matter specifically described in any United States patent, or any United
States or international patent application listed in Exhibit A, including any
provisionals, substitutes, renewals, reissues, extensions, confirmations,
reexaminations or registrations thereof; claims of all patent applications and
patents owned or controlled by Columbia directed to Licensed MFP-2 Products or
uses thereof; and claims of patent applications and patents owned or controlled
by Columbia directed to Licensed MFP-2 Technical Information. Exhibit A shall
only be amended to reflect: (i) the filing of any regular patent applications
claiming priority based on provisional applications listed therein, (ii) the
issuance or grant of any patents from United States, international or foreign
patent applications listed therein, (iii) the filing of any continuations or
divisionals of patent applications listed therein, (iv) the nationalization of
international patent applications listed therein, and (v) the filing of any
foreign or international patent applications corresponding to United States
patent applications listed therein. In the event that a Licensed MFP-2 Patent
also satisfies the definition of a Licensed Collaboration Patent, it shall be
treated for purposes of this Agreement as a Licensed Collaboration Patent.
e. "Licensed Collaboration Patents" shall mean United States, foreign,
and international patents and patent applications owned or controlled by
Columbia that disclose or claim "Inventions" made by Columbia in the course of
performance of, and as defined in the Research Agreement.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
CONFIDENTIAL PROVISIONS HAVE BEEN OBSCURED.
f. "Licensed Patents" shall mean Licensed MFP-2 Patents and Licensed
Collaboration Patents.
g. "Licensed MFP-2 Products" shall mean: (i) any product within the
MFP-2 Field consisting of, including, incorporating, or derived from, in whole
or in part, MFP-2, the development, manufacture, use, sale, distribution, rental
or lease of which is covered by a claim of a Licensed MFP-2 Patent that has
neither expired nor has been declared invalid by a court from which no appeal
has been or can be taken, and/or, (ii) the development, manufacture, use, sale,
distribution, rental or lease of any product within the MFP-2 Field consisting
of, including, incorporating, or derived from, in whole or in part, the Licensed
MFP-2 Technical Information, including but not limited to MFP-2. In the event
that a Licensed MFP-2 Product also satisfies the definition of a Licensed
Collaboration Product, it shall be treated for purposes of this Agreement as a
Licensed Collaboration Product.
h. "Licensed Collaboration Products" shall mean (i) any product within
the Collaboration Field the development, manufacture, use, sale distribution,
rental or lease of which is covered by a claim of a Licensed Collaboration
Patent that has neither expired nor has been declared invalid by a court from
which no appeal has been or can be taken, and/or, (ii) the development,
manufacture, use, sale, distribution, rental or lease of any product within the
Collaboration Field consisting of, including, incorporating, or derived from, in
whole or in part, the Licensed Collaboration Technical Information.
i. "Licensed Products" shall mean Licensed MFP-2 Products and Licensed
Collaboration Products.
j. "Licensed MFP-2 Technical Information" shall mean all such know-how,
data, research, reports, formulations, confidential information, and physical
materials owned or controlled by Columbia existing as of the Effective Date
relating to MFP-2, and conveyed by Columbia to the Company, and all such
information owned or controlled by Columbia relating to the Licensed MFP-2
Patents, as generally set forth and listed in Exhibit B, which is attached
hereto and incorporated herein. In the event that any Licensed MFP-2 Technical
Information also satisfies the definition of Licensed Collaboration Technical
Information, it shall be treated for purposes of this Agreement as Licensed
Collaboration Technical Information.
k. "Licensed Collaboration Technical Information" shall mean all such
know-how, data, research, reports, formulations, confidential information, and
physical materials made by Columbia in the course of performance of the Research
Agreement including all such "Invention" and/or "Research Information" provided
to the Company under the Research Agreement and/or to be made under this
Agreement, and all such information owned or
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
CONFIDENTIAL PROVISIONS HAVE BEEN OBSCURED.
controlled by Columbia relating to the Licensed Collaboration Patents. For the
avoidance of doubt, Licensed Collaboration Technical Information shall also
include any and all data, research, reports, formulations, confidential
information, and physical materials furnished by Columbia to Company under the
Research Agreement or this Agreement.
l. "Licensed Technical Information" shall mean Licensed MFP-2 Technical
Information and Licensed Collaboration Technical Information.
m. "Company Net Sales" shall mean the total of all fees, amounts,
payments, and other consideration charged by the Company, any Affiliate, or a
Collaborative Sublicensee to a third party for the manufacture, use, sale,
rental or lease of Licensed Products, less returns and customary trade discounts
actually taken, outbound freight, value added, sales or use taxes, and custom
duties. In the case of transfers of Licensed Products by the Company to an
Affiliate or Collaborative Sublicensee for sale, rental, or lease of such
Licensed Products by such Affiliate or Collaborative Sublicensee to third
parties, Net Sales shall be based upon the greater of the total fees, amounts,
payments, and other consideration charged by the Company to the Affiliate or
Collaborative Sublicensee and the total fees, amounts, payments, and other
consideration charged by the Affiliate or Collaborative Sublicensee to third
parties, provided that the multiple sale, resale, or disposition of the same
unit of Licensed Products shall not be counted more than once in calculating
Company Net Sales.
n. "Sublicensee" shall mean any third party to whom the Company has
granted a sublicense pursuant to this Agreement. "Technology Sublicensee" shall
mean a Sublicensee to whom the Company has granted a naked sublicense, i.e.,
wherein the transaction between the Company and the Sublicensee is substantially
limited to a sublicense of the Licensed Patents and/or the Licensed Technical
Information and does not include, contemplate, or provide for (i) a transfer of
rights in or to a Licensed Product that has been developed or shown to be
feasible by the Company, (ii) joint or collaborative development of one or more
Licensed Products by the Company and the Sublicensee (which need not include
participation by the Company in the marketing, sale, or distribution of such
products), or (iii) other forms of joint or collaborative research, development,
or testing of Licensed Products or possible Licensed Products between the
Company and the Sublicensee. "Collaborative Sublicensee" shall mean a
Sublicensee that is not a Technology Sublicensee.
o. "Technology Sublicensee's Net Sales" shall mean the total of all
fees, amounts, payments, and other consideration charged by a Technology
Sublicensee for the manufacture, use, sale, rental or lease of Licensed
Products, less returns and customary trade discounts actually taken, outbound
freight, value added, sales or use taxes, and custom duties.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
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p. "Territory" shall mean the entire world, excluding The People's
Republic of China, Hong Kong and Taiwan (collectively "China").
q. "First Anniversary Date" shall mean the date occurring one year
after the Effective Date of this Agreement, and each such annual period ("Annual
Period") thereafter shall be defined as Second Anniversary Date, Third
Anniversary Date, etc.
r. "MFP-2" shall mean [
] and clones thereof, including but not limited to
MFP-2S, existing as of the Effective Date.
2. CONDUCT OF RESEARCH.
Columbia will continue the research specified under the Research
Agreement and otherwise conduct in a laboratory at its Health Sciences campus,
under the direction of ▇▇. ▇▇▇▇ ▇▇▇▇▇▇, the research set forth therein (the
"Research").
3. LICENSE GRANT.
a. Columbia grants to the Company, upon and subject to all the
terms and conditions of this Agreement:
i. an exclusive license under the Licensed MFP-2 Patents to
research, develop, manufacture, have made, use, sell, have sold, offer
for sale, import, distribute, rent or lease Licensed MFP-2 Products in
the MFP-2 Field throughout the Territory, together with a right to
grant sublicenses in accordance with subsection (b) below, and the
terms of this Agreement;
ii. an exclusive license under the Licensed Patents to
research, develop, manufacture, have made, use, sell, have sold, offer
for sale, import, distribute, rent or lease Licensed Collaboration
Products in the Collaboration Field throughout the Territory, together
with a right to grant sublicenses in accordance with subsection (b)
below, and the terms of this Agreement; provided further that in the
event the Collaboration Field is modified or amended so that it is
expanded beyond the MFP-2 Field, by written agreement of the parties,
Columbia reserves the right to revise or modify the royalty rate and
other payments due under Section 5 of this Agreement, subject to
Company's written agreement (which would be included as part of the
written agreement of the parties regarding expansion of the MFP-2
Field), with respect to such Licensed Collaboration Products in the
expanded Collaboration
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
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Field;
iii. an exclusive license to use Licensed MFP-2 Technical
Information to research, develop, manufacture, have made, use, sell,
have sold, offer for sale, import, distribute, rent or lease Licensed
MFP-2 Products in the MFP-2 Field throughout the Territory, together
with a right to grant sublicenses in accordance with subsection (b)
below, and the terms of this Agreement; and
iv. an exclusive license to use Licensed Technical Information
to research, develop, manufacture, have made, use, sell, have sold,
offer for sale, import, distribute, rent or lease Licensed Products in
the Field throughout the Territory, together with a right to grant
sublicenses in accordance with subsection (b) below, and the terms of
this Agreement.
b. Columbia grants to the Company the right to grant sublicenses to
third parties, provided that: (i) the Sublicensee agrees to abide by all
applicable terms and provisions of this Agreement; (ii) the Company remains
fully liable for the performance of its and its Sublicensee's obligations
hereunder; (iii) each such sublicense is royalty-bearing or otherwise provides
for is supported by consideration; and (iv) no such sublicense shall relieve the
Company of its obligations under Section 7 hereof concerning diligence to
develop and market Licensed Products, nor relieve Company of its obligations to
pay Columbia any license fees, royalties and other payments under Section 5 of
the Agreement.
c. All rights granted by Columbia to the Company under this Agreement
are subject to, and shall be construed in accordance with, the requirements of
35 U.S.C. Sections 200 et seq., as amended, and its implementing regulations and
policies and, to the extent applicable, the requirements of Internal Revenue
Procedure 97-14 as regards royalty rates on any Licensed Collaboration Products.
Without limitation of the foregoing, the Company agrees that, to the extent
required under applicable law, any Licensed Products used, sold, distributed,
rented or leased by the Company, an Affiliate or a Sublicensee in the United
States will be manufactured substantially in the United States. To the extent
that such laws, regulations, or policies apply to the Licensed Patents and/or
the Licensed Technical Information, as of the Effective Date, the funding
agreements concerning same are listed in Exhibit C to this Agreement.
d. All rights not specifically granted in this Agreement are reserved
to Columbia.
4. RESERVATION OF RIGHTS FOR RESEARCH PURPOSES; FREEDOM OF PUBLICATION.
a. Columbia reserves the right to use the Licensed Patents and Licensed
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
CONFIDENTIAL PROVISIONS HAVE BEEN OBSCURED.
Technical Information solely for its own academic, noncommercial research
purposes in the Field and to permit other academic research entities or
personnel in active collaboration with Columbia in such research to use such
Licensed Patents and Licensed Technical Information solely for academic,
noncommercial research purposes in the Field. Columbia shall first obtain from
all entities or individuals who are to be given permission to use the Licensed
Patents and Licensed Technical Information a written agreement, in a form
reasonably acceptable to the Company, to limit such use to academic,
noncommercial research purposes and shall inform the Company of the identity of
all such entities and individuals. Nothing in this Agreement shall be
interpreted to limit in any way the right of Columbia, and/or its employees to
use the Licensed Patents and Licensed Technical Information for any purpose
outside the Field, or to license or permit such use outside the Field by third
parties.
b. The Company acknowledges that Columbia is dedicated to free
scholarly exchange and to public dissemination of the results of its scholarly
activities. Columbia acknowledges that the premature publication or
dissemination of information may jeopardize or detract from the value of the
Licensed Patents or the Licensed Technical Information relating to the Field, to
the detriment of the Company. To balance these interests, Columbia and its
faculty and employees shall have the right to publish, disseminate or otherwise
disclose the Licensed Patents or Licensed Technical Information relating to the
Field, but shall not do so without first providing the Company with a reasonable
opportunity to review the proposed publication and sufficient time to apply for
a patent. Prior to any public disclosure of information within the Licensed
Patents or Licensed Technical Information relating to the Field, whether in a
publication, abstract, conference, poster, grant application, or otherwise,
Columbia shall provide the Company with a copy of the proposed disclosure. The
Company shall have thirty (30) days to review said proposed disclosure. If
within such 30-day review period the Company determines to file a patent
application, public disclosure will be delayed until a patent application is
filed, which will be accomplished within 90 days of the end of the 30-day review
period Columbia will provide prompt and timely cooperation with the Company in
order to assure the expeditious filing of the patent application.
5. ROYALTIES AND PAYMENTS.
a. In consideration of the licenses granted under this Agreement, the
Company shall pay to Columbia:
i. License Fees: Within thirty (30) days of the Effective
Date, the non-refundable sum of [ ] shall be paid to
Columbia by Company.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
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ii. Royalties: Company, Affiliate and its Sublicensees shall
pay to Columbia a royalty of [ ] percent on Company, Affiliate
and Technology and/or Collaborative Sublicensee Net Sales, provided
that in the event that with respect to any Licensed Product, Company,
Affiliate and/or Collaborative Sublicensee, as the case may be, shall
be entitled to deduct the amount that it is obligated to pay under
other agreements it enters into with third parties for technology
necessary to secure patent or other intellectual property rights,
without which Company would not be permitted under law to make, use,
and/or sell the Licensed Product(s), and provided further that such
deduction shall in no case reduce the royalty owed to Columbia under
this Agreement to less than [ ]% on Company Net Sales of Licensed
Products in the Territory, and further provided that all such rates and
minimums shall be reduced by one-half for Net Sales in countries where
the manufacture, use, or sale of Licensed Products, although not within
the scope of the Licensed Patents, uses Licensed Technical Information.
b. Technology Sublicense Royalties/Fees: In consideration of the
Company's right to grant sublicenses to Technology Sublicensees under this
Agreement, Company shall make the following payments:
i. [ ]% of all royalties received by the Company on account
of a Technology Sublicensee's Net Sales, and
ii. [ ]% of all other gross revenues, fees, payments and
consideration (including any debt and/or equity securities or
instruments, but not consideration received by Company as a bona fide
debt or equity investment in the Company), or any part thereof,
received by Company from a Technology Sublicensee in consideration for
the grant of a sublicense hereunder.
c. Milestone Payments: Company shall pay Columbia the following
payments upon meeting the following milestones:
i. for diagnostic or imaging products, the sum of [
] upon the first (but not subsequent) [
] of each Licensed Product by Company or a Collaborative
Sublicensee;
ii. for therapeutic products, [ ] upon the first
(but not subsequent) entry into [ ]
Licensed Product by Company or a Collaborative Sublicensee;
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
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iii. [ ] upon the first (but not subsequent) entry
into [ ] Licensed Product by Company or
a Collaborative Sublicensee; and
iv. [ ] upon the first (but not subsequent)
[
] Licensed Product by
Company or a Collaborative Sublicensees.
d. Currency conversion: With respect to revenues obtained by the
Company outside the United States, the Company shall make royalty payments to
Columbia in the United States in United States dollars. Royalty payments for
transactions outside the United States shall first be determined in the currency
of the country in which they are earned, and then converted to United States
dollars using the buying rates of exchange quoted by Citibank, N.A. (or its
successor) in New York, New York for the last business day of the calendar
quarter in which the royalties were earned.
6. REPORTS AND PAYMENTS.
a. On or before the last business day of each calendar quarter of each
Annual Period of this Agreement in which there has been a commercial sale of a
Licensed Product or receipt of consideration from a Technology and/or
Collaborative Sublicensee, the Company shall submit to Columbia a written report
with respect to the preceding calendar quarter (the "Payment Report") stating:
i. Company Net Sales during such quarter;
ii. In the case of transfers of Licensed Products by the
Company to an Affiliate for sale, rental, or lease of such Licensed
Products by the Affiliate to third parties, Net Sales by the Company to
the Affiliate and Net Sales by the Affiliate to third parties during
such quarter;
iii. Amounts accruing to, and received by, the Company from
its Technology Sublicensees during such quarter;
iv. Technology Sublicensees' Net Sales during such quarter;
and
v. A calculation of the amounts due to Columbia, making
reference to the application of each subsection thereof.
b. Simultaneously with the submission of each Payment Report, the
Company
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
CONFIDENTIAL PROVISIONS HAVE BEEN OBSCURED.
shall make payments to Columbia of the amounts due for the calendar quarter
covered by the Payment Report. Payment shall be by check payable to The Trustees
of Columbia University in the City of New York and sent to the following
address:
Columbia Innovation Enterprise
Science and Technology Ventures
General Post Office
▇.▇. ▇▇▇ ▇▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
or to such other address as Columbia may specify by notice hereunder.
c. The Company shall maintain at its principal office usual books of
account and records showing its actions under this Agreement. Upon reasonable
notice, such books and records shall be open to inspection and copying, during
usual business hours, by an independent certified public accountant to whom the
Company has no reasonable objection, for three years after the calendar quarter
to which they pertain (but not more than once per year), for purposes of
verifying the accuracy of the amounts paid by the Company under this Agreement.
In the event that such review reveals that any payment to Columbia was
understated by more than 5%, the Company shall pay, within ten days after demand
by Columbia, the reasonable cost of such review.
7. DILIGENCE.
a. The Company shall use reasonable commercial efforts to research,
develop and market at least one Licensed Product for commercial sale and
distribution in the Territory.
b. Commencing on the First Anniversary Date of this Agreement, and
continuing for each Annual Period up to the eighth Anniversary Date of this
Agreement, Company shall be required to demonstrate to the reasonable
satisfaction of Columbia that it has expended or caused to be expended no less
than [ ] in direct expenditures (not including salaries, overhead and the
like) during each such Annual Periods for the bona fide research and development
of Licensed Products, including but not limited to the conduct of clinical
trials.
c. In addition, Company shall use its best efforts to make a [
] Anniversary
Date of this Agreement.
d. No less often than every twelve (12) months after the Effective Date
of this Agreement, the Company shall report in writing to Columbia on progress
made toward the
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
CONFIDENTIAL PROVISIONS HAVE BEEN OBSCURED.
diligence objectives set forth above, including updated development plans,
together with the amount of research and development monies related to Licensed
Products and expended during that time period.
e. In the event of failure to achieve any of Company's diligence
obligations under this Section, Columbia and the Company shall review the causes
for such failure and establish new Diligence obligations. Failure by Company to
achieve the modified diligence obligations shall result in Columbia having the
option of terminating all of the exclusive licenses granted hereunder in
accordance with Section 16 of this Agreement, or converting any or all of such
exclusive licenses to nonexclusive licenses.
8. DISCLAIMER OF WARRANTY; LIMITATIONS OF LIABILITY.
a. Nothing in this Agreement shall be construed as a warranty or
representation by either party as to the validity of any Licensed Patent.
Nothing in this Agreement shall be construed as a warranty or representation by
either party that anything developed, manufactured, used, sold, rented, leased,
or otherwise disposed of under any license granted under this Agreement is or
will be free from infringement of domestic or foreign patents or other
proprietary interests (including copyright) of other parties. COLUMBIA IS
LICENSING THE LICENSED PATENTS, LICENSED TECHNICAL INFORMATION, AND THE SUBJECT
OF ANY OTHER LICENSE HEREUNDER TO THE COMPANY, ON AN "AS IS" BASIS. COLUMBIA
MAKES NO WARRANTIES EITHER EXPRESS OR IMPLIED OF ANY KIND, AND HEREBY EXPRESSLY
DISCLAIMS ANY WARRANTIES, REPRESENTATIONS OR GUARANTEES OF ANY KIND (EXCEPT
TITLE) AS TO THE LICENSED PATENTS, LICENSED TECHNICAL INFORMATION, THE SUBJECT
OF ANY LICENSE HEREUNDER AND/OR LICENSED PRODUCTS, INCLUDING BUT NOT LIMITED TO,
ANY WARRANTIES OF MERCHANTABILITY, FITNESS, ADEQUACY OR SUITABILITY FOR A
PARTICULAR PURPOSE, USE OR RESULT, AND ANY WARRANTIES OF FREEDOM OF INFRINGEMENT
OF ANY PATENTS, COPYRIGHTS, TRADE SECRETS OR OTHER PROPRIETARY RIGHTS. NEITHER
COLUMBIA, NOR ANY EMPLOYEE OR AGENT OF COLUMBIA, SHALL HAVE ANY LIABILITY TO THE
COMPANY, ITS AFFILIATES OR ANY OTHER PERSON ARISING OUT OF THE USE OF LICENSED
PATENTS, LICENSED TECHNICAL INFORMATION, THE SUBJECT OF ANY LICENSE HEREUNDER OR
LICENSED PRODUCTS BY COMPANY, ITS AFFILIATES, OR ANY OTHER PARTY FOR ANY REASON,
INCLUDING BUT NOT LIMITED TO THE UNMERCHANTABILITY, INADEQUACY OR UNSUITABILITY
OF THE LICENSED PATENTS, LICENSED TECHNICAL INFORMATION, THE SUBJECT OF ANY
LICENSE HEREUNDER OR LICENSED PRODUCTS FOR ANY PARTICULAR PURPOSE OR TO PRODUCE
ANY PARTICULAR RESULT, OR FOR ANY LATENT DEFECTS THEREIN.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
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b. In no event will Columbia, or its respective trustees, officers,
agents or employees be liable to the Company or to any other party, for any loss
or damages, consequential, incidental, indirect or otherwise, including, but not
limited to time, money, or good will, arising from the use, operation or
application of the Licensed Patents, Licensed Technical Information, the subject
of any license hereunder or Licensed Products by the Company or its Affiliates.
In no event shall Columbia's liability to the Company exceed the payments made
to Columbia by Company under this Agreement. The parties expressly acknowledge
and agree that this limitation of liability has been negotiated for and that
without such limitation of liability the consideration charged by Columbia to
Company under this Agreement would be substantially greater.
9. PROHIBITION AGAINST USE OF COLUMBIA'S NAME.
Except as may be required by law or regulation, or in connection with
factual reports of its license and sublicensing rights hereunder, the Company
will not use the name, insignia, or symbols of Columbia, its respective
faculties or departments, or any variation or combination thereof, or the name
of any trustee, faculty member, other employee, or student of Columbia for any
purpose whatsoever without Columbia's prior written consent, such consent not to
be unreasonably withheld.
10. COMPLIANCE WITH GOVERNMENTAL OBLIGATIONS.
a. Notwithstanding any provision in this Agreement, Columbia disclaims
any obligation or liability arising under the license provisions of this
Agreement if the Company is charged in a governmental action for not complying
with or fails to comply with governmental regulations in the course of taking
steps to bring any Licensed Products to a point of practical application.
b. The Company shall comply upon reasonable notice from Columbia with
all governmental requests directed to either Columbia or the Company and provide
all information and assistance necessary to comply with the governmental
requests.
c. The Company shall insure that research, development, manufacturing
and marketing under this Agreement complies with all government regulations in
force and effect including, but not limited to, Federal, state, and municipal
legislation.
11. PATENT PROSECUTION, MAINTENANCE AND INFRINGEMENT.
a. Columbia, by counsel it selects to whom the Company has no
reasonable
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objection, in cooperation and consultation with counsel appointed by the
Company, will prepare, file, prosecute and maintain all Licensed Patents in
Columbia's name (or in the name of both Columbia and the Company in the case of
joint inventorship by Columbia and the Company) and in countries designated by
the Company. Company will reimburse Columbia for all out-of-pocket expenses it
has incurred prior to the Effective Date of this Agreement and will pay expenses
incurred following the Effective Date of this Agreement in filing, prosecuting
and maintaining such Licensed Patents, including attorneys' fees, the costs of
any interference proceedings, reexaminations, or any other ex parte or inter
partes administrative proceeding before patent offices, taxes, annuities, issue
fees, working fees, maintenance fees and renewal charges, provided, however,
that if any Licensed Patent is licensed by Columbia to a third party or third
parties, the expenses incurred after the effective date of such license to such
third party in filing, prosecuting and maintaining such Licensed Patent in any
country covered by such license shall be shared equally by Company and the third
party or third parties.
b. Any reimbursable patent expenses under this Section 11 shall be
invoiced by and reimbursed to Columbia by Company on a semiannual basis.
c. If the Company does not wish to have a Licensed Patent application
filed or prosecution continued in a particular country or countries, Columbia
may file such application or continue prosecution at its own expense, and
Columbia will be free to enter into a licensing agreement for or otherwise
dispose of such application or patent, except, in the case of joint inventorship
by Columbia and the Company, then Columbia shall have such rights only to the
extent of its interest in such application or patent.
d. Except as provided in paragraph (e) below, Columbia will have the
right to protect its Licensed Patents from infringement and prosecute infringers
at its own expense when in its sole judgment such action may be reasonably
necessary, proper, and justified.
e. If the Company shall have supplied Columbia with written evidence
reasonably demonstrating the likely infringement or future infringement of a
claim of a Licensed Patent by a third party selling products in competition with
the Company or any of its Affiliates or Sublicensees, the Company may by notice
request that Columbia take steps to assert the Licensed Patent. In the event
that Columbia initiates legal proceedings under this subsection (e), any
recovery shall first be used to reimburse Columbia for its reasonable costs and
legal fees incurred to conduct such proceedings. The balance shall be divided
[ ]% to the Company and [ ]% to Columbia. Unless Columbia shall within ninety
(90) days of the receipt of such notice either: (i) cause such infringement to
terminate or (ii) initiate legal proceedings against the infringer, the Company,
upon notice to Columbia, may initiate legal proceedings against the infringer at
the Company's expense. In such event the Company may deduct from payments due
hereunder to Columbia reasonable costs and
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
CONFIDENTIAL PROVISIONS HAVE BEEN OBSCURED.
legal fees incurred to conduct such proceedings, but in no event shall any
payment due in any calendar quarter be reduced by more than [ ]% of the amount
otherwise due to Columbia hereunder. Any recovery by the Company in such
proceedings shall first be used to reimburse the Company for its reasonable
costs and legal fees incurred to conduct such proceedings and next to pay to
Columbia an amount equal to all amounts withheld from Columbia by the Company
under this Section 11 during the pendency of the proceedings. The balance shall
be retained by Company and such balance amount shall be deemed to be Company Net
Sales of such Licensed Products (s) and shall be subject to Company's royalty
and other payment obligations to Columbia with respect to Company Net Sales as
set forth in this Agreement.
f. In the event one party shall initiate or carry on legal proceedings
to enforce any Licensed Patent against an alleged infringer, the other party
shall use its best efforts to reasonably cooperate fully with and shall supply
all assistance reasonably requested by the party initiating or carrying on such
proceedings. The party that institutes any proceeding to protect or enforce a
Licensed Patent shall have sole control of that proceeding and shall be
responsible for the reasonable expenses incurred by said other party in
providing such assistance and cooperation as is requested pursuant to this
paragraph. In no event shall Company settle any action or claim hereunder
without Columbia's written consent where (a) such settlement would include any
admission of liability on the part of Columbia, (b) such settlement would impose
any restrictions on Columbia's conduct of its activities; or (c) such settlement
would not include an unconditional release of Columbia from all liability of all
claim(s) that are the subject matter of the settled action or claim.
g. For the avoidance of doubt, nothing in this Agreement shall be
deemed to grant Columbia the right to control or direct prosecution of, or legal
proceedings on, any patent or patent application solely owned by Viventia, or to
grant Columbia a license or other rights in or to any such patent or patent
application.
12. INDEMNITY AND INSURANCE.
a. The Company will indemnify and hold Columbia harmless against any
and all third-party actions, suits, claims, demands, prosecutions, liabilities,
costs, expenses, damages, deficiencies, loss or obligations (including
reasonable attorneys' fees) based on or arising out of this Agreement,
including, without limitation, (i) the development, manufacture, packaging, use,
sale, rental or lease of Licensed Products, even if altered for use for a
purpose not intended, (ii) the use of Licensed Patents or Licensed Technical
Information by the Company, its Affiliates, its Sublicensees or its (or their)
customers and (iii) any representation made or warranty given by the Company,
its Affiliates or Sublicensees with respect to Licensed Products, Licensed
Patents or Licensed Technical Information. The Company will reimburse Columbia
for any out-of-pocket costs incurred by
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
CONFIDENTIAL PROVISIONS HAVE BEEN OBSCURED.
Columbia in enforcing this paragraph 12(a).
b. The Company shall maintain, during the term of this Agreement,
commercial general liability insurance, including product liability insurance,
with reputable and financially secure insurance carriers to cover the activities
of the Company, its Affiliates and its Sublicensees, for minimum limits of
[ ] combined single limit for bodily injury and property damage per
occurrence and in the aggregate. Such insurance shall include Columbia, its
respective trustees, directors, officers, employees and agents as additional
insureds. The Company shall furnish a certificate of insurance evidencing such
coverage, with thirty (30) days' written notice to Columbia of cancellation or
material change.
c. The Company's insurance shall be primary coverage; any insurance
Columbia may purchase shall be excess and noncontributory. Such insurance shall
be written to cover claims incurred, discovered, manifested, or made during or
after the expiration of this Agreement.
13. PATENT MARKING.
To the extent required by and in conformance with any applicable laws,
the Company will, prior to the issuance of patents, ▇▇▇▇ Licensed Products made,
sold, or otherwise disposed of by it under the license granted in this Agreement
with the words "Patent Pending," and following the issuance of one or more
patents, with the numbers of such patents. Company shall use its reasonable
efforts to ensure that all Licensed Products bear all other notices and legends
required by applicable laws to preserve and protect the validity of the Licensed
Patents and Licensed Technical Information and Columbia's rights therein.
14. EXPORT CONTROL LAWS.
This Agreement is made subject to any restrictions concerning the
export of products or technical information from the United States of America
which may be imposed from time to time by the government of the United States of
America. Furthermore, each party hereto agrees that it will not export or
re-export, directly or indirectly, any technical information acquired from the
other under this Agreement or any products using such technical information to
any country for which the United States government or any agency thereof at the
time of export requires an export license or other governmental approval,
without first obtaining the written consent to do so from the Department of
Commerce or other agency of the United States government when required by an
applicable statute or regulation.
15. BREACH AND CURE.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
CONFIDENTIAL PROVISIONS HAVE BEEN OBSCURED.
a. In addition to applicable legal standards, the Company shall be
considered to be in material breach of this Agreement for: (i) failure to pay
fully and promptly amounts due pursuant to Section 5 and payable pursuant to
Section 6 of this Agreement; (ii) failure of the Company to meet its obligations
under Section 7 of this Agreement; (iii) failure to reimburse Columbia for or
pay fully and promptly the costs of prosecuting and maintaining Licensed Patents
pursuant to Section 11; or (iv) failure to comply with governmental requests
directed to Columbia or the Company pursuant to Section 10(b).
b. Either party shall have the right to cure its material breach. The
cure shall be effected within a reasonable period of time but in no event later
than sixty (60) days after notice of any breach given by the non-breaching
party, provided that, in the case of failure of the Company to meet its
obligations under Section 7 of this Agreement, such period shall be six (6)
months plus any period for which such failure was beyond the Company's
reasonable control, and the Company shall have the right to further extend such
period by one (1) year upon payment to Columbia of a one-time fee of [ ]
that shall not be creditable against any amounts owed by Company to Columbia
under this Agreement.
16. TERM OF AGREEMENT.
a. This Agreement shall be effective as of the date first set forth
above and shall continue in full force and effect until its expiration or
termination in accordance with this Section 16.
b. Unless terminated earlier under any provision of this Agreement, the
term of the licenses granted hereunder shall extend, on a country-by country
basis, until the date of expiration of the last to expire of the Licensed
Patents, at which time the licenses granted hereunder shall become fully
paid-up.
c. The license granted under this Agreement may be terminated by
Columbia: (i) upon thirty (30) days written notice to the Company if Columbia
elects to terminate in accordance with Section 7(e); (ii) upon written notice to
the Company for the Company's material breach of this Agreement and the
Company's failure to cure such material breach in accordance with Section 15(b);
or (iii) should the Company commit any act of bankruptcy, become insolvent, file
a petition under any bankruptcy or insolvency act or have any such petition
filed against it.
d. Notwithstanding the foregoing, Company shall have the right, on a
country-by-country basis, to terminate, upon ninety (90) days written notice to
Columbia, the license rights granted under Section 3 of this Agreement with
respect to any Licensed Patent(s) and/or Licensed Technical Information. In such
event, such license rights granted to
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
CONFIDENTIAL PROVISIONS HAVE BEEN OBSCURED.
Company under Section 3 of this Agreement, with respect to such Licensed
Patent(s), Licensed Technical Information and/or specific country in the
Territory shall terminate, and Columbia shall be free, in the exercise of its
sole discretion, to license or otherwise transfer such right(s) to any party as
it deems appropriate. In the event of such termination by Company under this
subsection (d), all other terms and conditions of this Agreement shall remain in
full force and effect.
e. Upon any termination of this Agreement pursuant to Section 16(c),
any Sublicensees of Company under this Agreement shall survive and shall be
assigned to Columbia.
f. Sections 4, 8, 9, 10, 12, 16(f), 17, and 22 will survive any
termination or expiration of this Agreement.
17. NOTICES.
Any notice required or permitted to be given under this Agreement shall
be sufficient if in writing and shall be considered given: (i) when mailed by
certified mail (return receipt requested), postage prepaid, or (ii) on the date
of actual delivery by hand or overnight delivery, with receipt acknowledged,
if to Columbia, to: Executive Director
Science and Technology Ventures
Columbia Innovation Enterprise
Columbia University
Engineering Terrace, Suite 363
500 West 120th Street, Mail Code ▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
--
copy to: General Counsel
Columbia University
▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇ ▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇, Mail Code ▇▇▇▇
▇▇▇ ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇
--
if to Company, to: Vice President, Corporate Development
Viventia Biotech, Inc.
▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇
▇▇▇▇▇▇
copy to: Chief Financial Officer
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
CONFIDENTIAL PROVISIONS HAVE BEEN OBSCURED.
Viventia Biotech, Inc.
▇▇ ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇
▇▇▇▇▇▇
or to such other address as a party may specify by notice hereunder.
18. ASSIGNMENT.
This Agreement and all rights and obligations hereunder may not be
assigned by either party without the written consent of the other party, such
consent not to be unreasonably withheld; except no consent shall be required for
the Company to assign to an Affiliate or to a purchaser of all or substantially
all of the assets of Company related to the subject matter hereof or to the
purchaser of rights in or to a Licensed Product. Any attempt to assign without
compliance with this provision shall be void.
19. WAIVER.
The failure of any party to insist upon strict adherence to any term of
this Agreement on any occasion shall not be considered a waiver or deprive that
party thereafter of the right to insist upon strict adherence to that term or
any other term of this Agreement. All waivers must be in writing and signed by
an authorized representative of the party against which such waiver is being
sought.
20. NO AGENCY OR JOINT VENTURE.
Company is not an agent, joint venturer, or partner of Columbia, and
the parties have not created and do not intend to create an agency, joint
venture, or partner relationship.
21. ENTIRE AGREEMENT; AMENDMENT.
This Agreement, together with the Exhibits, sets forth the entire
agreement between the parties concerning the subject matter hereof and
supersedes all previous agreements, written or oral, concerning such subject
matter. This Agreement may be amended only by written agreement duly executed by
the parties.
22. GOVERNING LAW.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
CONFIDENTIAL PROVISIONS HAVE BEEN OBSCURED.
This Agreement shall be governed by New York Law applicable to
agreements made and to be performed in New York.
IN WITNESS THEREOF, Columbia and the Company have caused this Agreement to be
executed by their duly authorized representatives as of the day and year first
written above.
THE TRUSTEES OF COLUMBIA UNIVERSITY
IN THE CITY OF NEW YORK
By: /s/▇▇▇▇▇▇▇ ▇▇▇▇▇▇
--------------------------------------------
Executive Director,
Science and Technology Ventures
Columbia Innovation Enterprise
VIVENTIA BIOTECH, INC.
By: /s/▇▇▇▇ ▇▇▇▇▇▇
--------------------------------------------
Name: ▇▇▇▇ ▇▇▇▇▇▇, Ph.D.
Title: Vice President, Corporate Development
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
CONFIDENTIAL PROVISIONS HAVE BEEN OBSCURED.
EXHIBIT A
1. ▇▇▇▇ ▇▇▇▇▇▇ and ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇, "Development of Human Monoclonal
Antibodies Directed To Tumor-associated Antigens, Tumor Cells Infectious Agents,
Infection-specific Antigens, etc.", U.S. Serial No. 09/040,833, filed March 18,
1998, now U.S. Patent No. 6,197,582, issued March 6, 2001.
2. PCT International Application No. PCT/US99/05828, filed March 8, 1999.
3. Canadian Patent Application No. 2,323,681, filed March 18, 1999.
4. European Patent Application No. 99913925.6, filed March 18, 1999.
5. Japanese Patent Application No. 2000-537073, filed March 18, 1999.
6. ▇▇▇▇ ▇▇▇▇▇▇, "Development of Human Monoclonal Antibodies And Uses
Thereof," U.S. Serial No. 09/664,485, filed September 18, 2000, continuation of
PCT International Application No. PCT/US99/05828, filed March 18, 1999, on
behalf of The Trustees of Columbia University in the City of New York, claiming
priority of and a continuation-in-part of U.S. Serial No. 09/040,833, filed
March 18, 1998.
7. ▇▇▇▇ ▇▇▇▇▇▇, "Development of Human Monoclonal Antibodies And Uses
Thereof," U.S. Serial No. 09/767,578, filed January 23, 2001, a continuation of
U.S. Serial No. 09/040,833, filed March 18, 1998, now allowed.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
CONFIDENTIAL PROVISIONS HAVE BEEN OBSCURED.
EXHIBIT B
1. Hybridoma cell lines generated using MFP-2 that are producing
potentially useful antibodies.
2. Reasonable quantities of purified antibodies for further
characterization by the Company.
3. Information on the identity of antigens recognized by selected
monoclonal antibodies generated as a
result of research sponsored by the Company.
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CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR PORTIONS OF THIS DOCUMENT.
CONFIDENTIAL PROVISIONS HAVE BEEN OBSCURED.
EXHIBIT C
No related Federal funding as of Effective Date.
22