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Exhibit 10.6
LICENSE
AGREEMENT
Agreement
("AGREEMENT"), effective as of November 22, 1996 ("Effective
Date") by and between Biomira, Inc., a corporation
incorporated pursuant to the Canadian Business Corporations Act,
with its principal place of business at Edmonton Research Park,
2011 - 94 Street, Edmonton, Alberta, T6N 1H1,
Canada, (hereinafter referred to as "Biomira") and the DANA-FARBER
CANCER INSTITUTE, INC., a Massachusetts non-profit
corporation, with its principal place of business at 44 Binney
Street, Boston, Massachusetts, 02115 (hereinafter referred to as
"DFCI").
WITNESSETH:
WHEREAS, DFCI
is the legal and beneficial owner of certain rights in technology
as later defined herein, subject only to a royalty-free,
nonexclusive license heretofore granted to the United States
Government; and
WHEREAS, DFCI
desires to have such rights utilized to promote the public interest
by granting a license hereunder;
WHEREAS,
Biomira has represented to DFCI that Biomira is experienced in the
development of therapeutic products, based on technologies similar
to the technology which is the subject of this AGREEMENT, and has
the financial capacity and the strategic commitment to facilitate
the transfer of such technology for the public interest;
and
WHEREAS,
Biomira desires to obtain from DFCI and DFCI has agreed to grant to
Biomira a license to said rights upon the terms and conditions
hereinafter set forth;
NOW THEREFORE,
in consideration of the mutual covenants herein contained and
intending to be legally bound hereby, the parties hereto agree as
follows:
ARTICLE
I—Definitions
- 1.1
- "Patent Rights" shall mean US Patents [+] as set
forth in Appendix A.
- 1.2
- "Invention" shall mean the inventions claimed or
described in Patent Rights.
- 1.3
- "Peptide" shall mean any peptide, polypeptide or
protein or glycosylated forms thereof, or any chemically modified
or conjugated derivative thereof, which may be made by solid phase
or solution phase synthesis techniques, by in vitro recombinant expression
techniques, or through the use of gene expression systems.
- 1.4
- "Licensed Product" shall mean any product which
incorporates or consists of a Peptide that includes a portion of an
amino acid sequence described in Patent Rights, wherein said
Peptide is formulated with or without adjuvant for direct
administration to a patient or for ex
vivo exposure to cells obtained from a
patient where such cells will be re-administered to the patient
following such exposure. Such Peptide may, for example, be
formulated in solution or conjugated to a carrier molecule, or
incorporated into or in an inert delivery vehicle such as
liposomes. Licensed Products do not include Invention(s) described
in Patent Rights, or products based on or incorporating such
Invention(s), which comprise nucleic acids prepared or otherwise
formulated for gene therapy or administration as vaccines,
in vivo or
ex vivo .
- 1.5
- "Field of Use" shall mean in vivo , ex vivo , or in vitro prophylactic or
therapeutic uses of Licensed Product in the treatment or prevention
of cancer in humans.
- 1.6
- "Territory" shall mean the United States of
America and its territories and possessions.
- 1.7
- "Milestone Payments" shall mean one-time
payments made or payable by Biomira to DFCI pursuant to
Section 4.4 herein.
[+] DESIGNATES PORTIONS OF THIS DOCUMENT THAT
HAVE BEEN OMITTED FOR CONFIDENTIALITY PURPOSES
- 1.8
- "End User" shall mean any organization or
individual that provides or administers a Licensed Product to a
patient, including but not limited to hospitals, pharmacies and
physicians.
- 1.9
- "Net Sales Revenue" shall mean the gross revenue
derived by Biomira, its Affiliates or its Sublicensee(s) from the
sale, use or disposition of Licensed Products to End Users in the
Territory, less the following items but only insofar as they
actually pertain to the sale, use or disposition of such Licensed
Products by Biomira, its Affiliates or its Sublicensee(s) and are
included in such gross revenue:
- (a)
- transportation charges or allowances;
- (b)
- trade, quantity, cash or other discounts
allowed;
- (c)
- credits or allowances made or given on account
of rejects, returns or retroactive price reductions;
- (d)
- Any tax or governmental charge including without
limitation sales and excise taxes;
All as
determined in accordance with Canadian generally accepted
accounting principles applied on a consistent basis.
- 1.10
- "Sublicensee" shall mean any corporation,
partnership or business organization, other than an End User or an
Affiliate, to whom Biomira transfers any rights or privileges
granted hereunder to enable said party to make and/or sell Licensed
Products.
- 1.11
- "Affiliate" shall mean any corporation or other
business entity which assumes the rights and obligations of Biomira
hereunder and which is controlled by, controlling, or under common
control with Biomira. For this purpose "control" means direct or
indirect beneficial ownership of at least fifty percent (50%)
interest in the income or stock of such corporation or other
business.
- 1.12
- "ICRT" shall mean Imperial Cancer Research
Technology, Ltd.
- 1.13
- "ICRT Patent Rights" shall mean patent
application U.S.S.N. 08/456,919.
ARTICLE
II—Grant
- 2.1
- DFCI hereby grants to Biomira, subject to all
the terms and conditions of this AGREEMENT, including a
nonexclusive license heretofore granted to the United States
Government as described in section 2.2 herein, the exclusive
right and license, with the right to sublicense as provided for in
section 2.6 herein, to make, have made, use, lease and sell
the Licensed Products in the Territory for the Field of Use for the
term of this AGREEMENT unless this grant is sooner terminated
according to the terms hereof.
- 2.2
- Biomira hereby acknowledges that DFCI has
heretofore granted the United States government a non-exclusive,
non-transferable, irrevocable, paid-up license pursuant to 37 CFR
401 (Part 401 of Chapter IV of Title 37, Code of Federal
Regulations), to practice Patent Rights, or have Patent Rights
practiced, for or on behalf of the United States throughout the
world.
- 2.3
- Notwithstanding the provisions of
Section 2.1., DFCI shall retain the right within the Field of
Use, to make, use and practice the Invention for its own
non-commercial research purposes, and to convey to other
organizations at no charge other than shipping fees the Invention
for use in non-commercial research. DFCI agrees that any such
transfer by DFCI to another organization of materials embodying the
Invention for use in non-commercial research shall be made under
the terms of a written agreement, specifying, inter alia , that the materials
shall be used solely by the named investigator and those conducting
their research activities under his or her direct supervision, and
will not be used for testing in human subjects. Upon becoming aware
of any material breach of such written agreement by another
organization, DFCI shall cooperate with
[+] DESIGNATES PORTIONS OF THIS DOCUMENT THAT
HAVE BEEN OMITTED FOR CONFIDENTIALITY PURPOSES
2
- Biomira and take reasonable measures to enforce
the provisions of said agreement on said organization. This Section
does not affect DFCI's rights to use and/or convey the Invention
outside the licensed Field of Use.
- 2.4
- To comply with United States Government
regulations for the licensing of federally funded inventions,
Biomira agrees that Licensed Products leased or sold in the United
States shall be manufactured substantially in the United States.
Notwithstanding the foregoing, in the event that Biomira provides
compelling evidence to DFCI that such manufacture in the United
States would impose an extraordinary and/or commercially
unreasonable burden on Biomira, DFCI shall agree to seek a waiver
from the United States Government with respect to the requirement
that Licensed Products for lease or sale in the United States be
manufactured substantially in the United States. Biomira hereby
acknowledges that DFCI cannot guarantee that such a waiver can be
obtained. Biomira shall bear all reasonable costs associated with
the seeking of such a waiver by DFCI. If a waiver is sought,
Biomira shall also provide DFCI with evidence required to seek such
a waiver. Biomira shall bear primary responsibility for preparing
the paperwork necessary to obtain such waiver.
- 2.5
- Biomira agrees to comply with any and all
applicable local, state, national, federal and/or international
laws and regulations pertaining to the development, testing,
manufacture, promotion and sale of Licensed Products.
- 2.6
- (a) Biomira shall have
the right, subject to the terms of this Section, to enter into
sublicensing agreements with any entity, whether or not an
Affiliate, for the rights, privileges and licenses granted
hereunder at royalty rates not less than those delineated in
Section 4.5 hereof. DFCI shall be informed by written notice
of the identity of any prospective Sublicensee and shall have the
right to approve of said Sublicensee, which approval shall not be
unreasonably withheld. If DFCI does not object in writing within
thirty (30) days of said written notice, approval shall be
presumed conclusively to have been given.
- (b)
- Biomira agrees that any sublicenses granted by
it shall provide that the obligations to DFCI contained in
Sections 2.1 through 2.5, 3.1, 5.1, 5.2, 10.1, 10.2, 13 and 14
of this AGREEMENT shall be binding upon the Sublicensee. Biomira
further agrees to include in each sublicense agreement a provision
requiring the Sublicensee to assume Biomira's obligations under
Article VIII of this AGREEMENT in the event that the
Sublicensee becomes a direct licensee of DFCI pursuant to
Section 7.7 hereunder, and to attach to each sublicense
agreement copies of those Sections of this AGREEMENT which DFCI,
acting reasonably, deems should be so attached, including as a
minimum those Sections expressly identified in this
Section 2.6(b).
- (c)
- With respect to sublicenses granted under this
Section, Biomira shall pay to DFCI [+] of all fees and lump sum
payments, including but not limited to technology access fees and
license issue fees, but excluding research support, received by
Biomira. Said payments by Biomira to DFCI shall be in addition to
Milestone Payments made pursuant to Section 4.4. Biomira's
obligation to make payments under this section 2.6(c) shall
cease if there is an Adverse Expedited Review Judgment (as
hereinafter defined, in Section 4.3).
- (d)
- Biomira, on behalf of itself and/or its
Affiliates and/or any other sublicensee(s), shall be responsible
for making all payments to DFCI of royalties on Net Sales due to
DFCI pursuant to Article IV.
- (e)
- Biomira agrees to forward promptly to DFCI a
copy of any and all fully executed sublicense agreements, and
further agrees to forward to DFCI annually a copy of such reports
received by Biomira from its Sublicensees during the preceding
twelve (12) month period under the sublicenses as shall be
pertinent to a royalty accounting under said sublicense
agreements.
[+] DESIGNATES PORTIONS OF THIS DOCUMENT THAT
HAVE BEEN OMITTED FOR CONFIDENTIALITY PURPOSES
3
-
- (f)
- Biomira hereby agrees that every sublicensing
agreement to which it shall be a part and which shall relate to the
rights, privileges and license granted hereunder shall contain a
statement setting forth the date upon which Biomira's exclusive
rights, privileges and license hereunder shall
terminate.
ARTICLE III—Due
Diligence
- 3.1
- Biomira agrees to use its reasonable efforts to
bring one or more Licensed Products to the marketplace in a timely
manner. Biomira shall use its reasonable efforts to achieve the
following milestones by the dates indicated:
- [+]
-
The dates set forth above for the achievement of
the specified milestones shall be adjusted appropriately at the
reasonable request of Biomira, subject to the prior written consent
of DFCI, which consent DFCI shall not unreasonably
withhold.
- 3.2
- Any disagreement between DFCI and Biomira
concerning Biomira's compliance with its diligence obligations
under Section 3.1 which cannot be resolved by good-faith
negotiations between the parties shall be referred to arbitration
pursuant to Article XII.
ARTICLE
IV—Payments
- 4.1
- In partial consideration for the license granted
hereunder, Biomira agrees to pay DFCI within thirty (30) days
of the Effective Date a license issuance royalty of [+] such
issuance royalty being in part to offset DFCI's legal and
administrative expenses arising from establishing a proprietary
position in the Invention and facilitating the transfer of the
Invention to the commercial marketplace.
- 4.2
- Commencing on the second anniversary of the
Effective Date, Biomira shall pay DFCI a license maintenance fee of
[+] on each anniversary of the Effective Date. Biomira's obligation
to pay such license maintenance fee shall cease on the date of
first commercial sale of Licensed Products. The cumulative total of
such fees paid prior to such date may be credited against royalties
due pursuant to Section 4.5, provided that the amount credited
in any one year shall not exceed [+] of the total royalties
otherwise due in said year.
- 4.3
- In partial consideration for the license granted
hereunder, Biomira also agrees to make Milestone Payments and pay
royalties to DFCI as set forth in Sections 4.4 and 4.5. In
stipulating the amounts of such Milestone Payments and royalties,
the parties recognize that a priority contest (an "Interference")
could arise between Patent Rights and ICRT Patent Rights, and agree
that in such event the amounts of such Milestone Payments and
royalties should be determined in part by the process by which such
Interference is resolved and by the outcome of such resolution. The
parties agree that it may be desirable to try to resolve such
Interference in an expeditious manner and that there are numerous
means for accomplishing that goal. In order to encourage such
expedition, the parties agree that in the event that an agreement
is reached to use an expedited review process, and that after such
process, a judgment is entered against all claims of the Patent
Rights that cover the manufacture, use and/or sale of any Licensed
Product (such a judgment under such circumstances hereinafter being
referred to as an "Adverse Expedited Review Judgment", and any
other outcome of an expedited review process being referred to as
"Favorable Expedited Review Outcome"), that DFCI shall still be
entitled to receive Milestone Payments and royalties, but in
reduced amounts, as set forth in Sections 4.4 and 4.5.
[+] DESIGNATES PORTIONS OF THIS DOCUMENT THAT
HAVE BEEN OMITTED FOR CONFIDENTIALITY PURPOSES
4
- 4.4
- (a) Biomira agrees to
make the following one-time Milestone Payments to DFCI, on the
dates indicated hereafter, in connection with the first occurrence
of the milestone events specified hereafter with respect to, and
only with respect to, whichever Licensed Product being developed by
Biomira or a Sublicensee is the first to reach such milestones: [+]
subject however to the provisions of Section 4.4 (b), (c), and
(d).
- (b)
- If by the time Approval is granted an
Interference has arisen, been resolved, and resulted in an Adverse
Expedited Review Judgment, then the amount which Biomira shall pay
to DFCI upon Approval shall be reduced to [+] said amount being
hereinafter referred to as the "Minimum Approval Milestone
Payment".
- (c)
- If at the time Approval is granted, proceedings
are in progress to resolve an Interference, then the amount which
Biomira shall pay to DFCI shall be the Minimum Approval Milestone
Payment. If subsequent resolution of the Interference results in an
Adverse Expedited Review Judgment, no further Milestone Payments
shall be due from Biomira to DFCI. If said resolution results in a
Favorable Expedited Review Outcome, then Biomira shall pay DFCI an
additional [+] subject however to the provisions of
Section 4.4 (d).
- (d)
- If the grant of Approval requires Biomira to
make a milestone payment to any third party, including but not
limited to ICRT and the total amount which would be due from
Biomira to DFCI in connection with said Approval, after giving
consideration to the provisions of Sections 4.4(c) and 4.4(d), is
larger than the Minimum Approval Milestone Payment, then said total
amount which Biomira shall pay to DFCI shall be reduced by [+] of
the amount owed and actually paid to such third party, provided,
however, that in no event shall the amount payable by Biomira to
DFCI after such reduction be less than [+].
- 4.5
- (a) In partial
consideration of the license to the Patent Rights granted hereunder
by DFCI to Biomira, and subject to the provisions of Sections
4.5(b) and 4.5(c), Biomira shall pay to DFCI during the term of
this AGREEMENT royalties amounting to [+] of Net Sales. Such
obligation shall commence on the date of first commercial sale of a
Licensed Product by Biomira, an Affiliate, or a Sublicensee.
- (b)
- With respect to Licensed Products upon which
Biomira is required to pay royalties to a third party, including
but not limited to ICRT, and subject to the provisions of
Section 4.5(c), the royalties payable by Biomira to DFCI on
Net Sales of such Licensed Products shall be reduced by [+] of the
royalties owed and actually paid to such third party, provided,
however, that in no event shall the royalties payable by Biomira to
DFCI with respect to such Licensed Products be less than [+] of Net
Sales of such Licensed Products.
- (c)
- In the event that an Interference arises and its
resolution results in an Adverse Expedited Review Judgment, DFCI
shall still be paid a royalty of [+] of Net Sales. This royalty
shall be paid for the same length of time the royalty would be due
and payable under the last to expire patent of the Patent Rights,
as if judgment had not been entered against that patent. If under
these circumstances Biomira is required to pay royalties to any
third party other than ICRT in order to make, use or sell Licensed
Products, the royalties payable by Biomira to DFCI on Net Sales of
such Licensed Products shall be reducible by [+] of the royalties
owed and actually paid to such third party, but in no event shall
the
[+] DESIGNATES PORTIONS OF THIS DOCUMENT THAT
HAVE BEEN OMITTED FOR CONFIDENTIALITY PURPOSES
5
-
- royalties payable by Biomira to DFCI be less
than [+] of Net Sales of such Licensed Products after such
off-set.
- 4.6
- Payment of royalties specified in Section 4
5 shall be made by Biomira to DFCI within forty-five (45) days
after March 31, June 30, September 30 and
December 31 each year during the term of this AGREEMENT
covering the quantity of Licensed Products sold by Biomira during
the preceding calendar quarter. The last such payment shall be made
within forty-five (45) days after termination of this
AGREEMENT.
- 4.7
- All payments to be made under this ARTICLE shall
be paid in United States dollars in Boston, Massachusetts, or at
such other place and in such other way reasonably acceptable to
Biomira as DFCI may reasonably designate, without deduction of
exchange, collection or other charges.
- 4.8
- Only a single royalty shall be paid with respect
to any Licensed Product under Section 4.5(a), 4.5(b) or
4.5(c), irrespective of the number of claims of Patent Rights
utilized.
- 4.9
- In the event that any payment due hereunder is
not made when due, the payment shall accrue interest beginning on
the first day following the due date as herein specified,
calculated at the annual rate of the sum of [+] plus (b), the prime
interest rate quoted by the Bank of Boston on the date said payment
is due, the interest being compounded on the last day of each
calendar quarter, provided that in no event shall said annual rate
exceed the maximu
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