AMENDED AND RESTATED COLLABORATION AGREEMENT (2006)
EXHIBIT
99.1
Β
Β
Β
AMENDED
AND RESTATED COLLABORATION AGREEMENT (2006)
Β
This
amended and restated agreement is between Biomira B.V. (formerly Biomira Europe
B.V.), a Netherlands corporation with offices located at Amsterdam, The
Netherlands ("BIOMIRA"), and Merck KGaA, a German corporation with offices
located at Darmstadt, Germany ("MERCK") and is effective as of March 1,
2006.
Β
WHEREAS
BIOMIRA and MERCK entered into an amended and restated collaboration agreement
effective as of May 7, 2001 (the "2001 COLLABORATION AGREEMENT") in relation
to,
inter alia, the development of BLP25;
Β
AND
WHEREAS BIOMIRA, Biomira International Inc. and MERCK entered into a letter
of
intent effective as of JanuaryΒ 26, 2006 to amend, inter alia, certain
provisions of the 2001 COLLABORATION AGREEMENT;
Β
AND
WHEREAS BIOMIRA and MERCK now wish to amend and restate the 2001 COLLABORATION
AGREEMENT in accordance with, inter alia, such letter of intent, all upon the
terms and subject to the conditions set forth in this AGREEMENT;
Β
NOW,
THEREFORE, in consideration of the premises and covenants contained herein
and
other good and valuable consideration, the receipt and sufficiency of which
is
hereby agreed to by the parties, and intending to be legally bound hereby,
the
parties hereto agree as follows:
Β
Β
ARTICLE
1
DEFINITIONS
Β
Section
1.1
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Meaning
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Whenever
a term is written in this AGREEMENT with all capital letters it shall have
the
following meaning:
Β
1.1.1Β Β
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"ADVERSE
EVENT" means, with respect to PRODUCT in a particular country in
the
TERRITORY, the occurrence of an adverse event with respect to PRODUCT
as
defined by applicable law or regulation in such
country;
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Β
1.1.2Β Β
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"AFFILIATES"
means any business entity that directly or indirectly controls,
is
controlled by, or is under common control with either party to
this
AGREEMENT.Β Β A business entity shall be deemed to "control"
another business entity if it owns, directly or indirectly, more
than
fifty (50%) percent of the outstanding voting securities, capital
stock,
or other comparable equity or ownership interest of such business
entity.Β Β If the laws of the jurisdiction in which such business
entity operates prohibit ownership by a party of more than fifty
percent
(50%), control shall be deemed to exist at the maximum level of
ownership
allowed by such jurisdiction;
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Β
1.1.3Β Β
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"AGREEMENT"
means this amended and restated collaboration agreement, together
with all
schedules and appendices hereto and any amendments to or restatements
of
this amended and restated collaboration
agreement;
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[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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1.1.4Β Β
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"BIOMIRA
COST OF GOODS" includes, but is not limited to, with respect to
PRODUCT in
relation to a particular country in the TERRITORY,
[+]
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Β
1.1.5Β Β
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"BIOMIRA
IMPROVEMENTS" has the meaning attributed to that term in section
9.2 of
this AGREEMENT;
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Β
1.1.6Β Β
|
"BIOMIRA
KNOW-HOW" means all proprietary information and data in the FIELD
including but not limited to compounds, formulae, protocols, methods,
techniques and results of experimentation and testing, which, except
for
published patent applications which are also included within this
definition, is generally not known to the public, and which are
owned by
BIOMIRA or licensed in by BIOMIRA with the right to sublicense
in the
manner contemplated by this AGREEMENT, and which directly relate
to
research, CLINICAL DEVELOPMENT, use and/or sale of PRODUCT.Β Β For
greater certainty, BIOMIRA KNOW-HOW shall include BIOMIRA IMPROVEMENTS
and
IMPROVEMENTS licensed in by BIOMIRA with the right to sublicense
in the
manner contemplated by this AGREEMENT, which arise or occur after
the
ORIGINAL EFFECTIVE DATE and which fall within the ambit of the
preceding
sentence.Β Β Notwithstanding the foregoing, BIOMIRA KNOW-HOW shall
not include any subsequently developed or acquired BIOMIRA KNOW-HOW
to the
extent covering any active compound that is separate and clearly
distinct
from PRODUCT, notwithstanding the fact that such active compound
may be
useful as part of a combination therapy with
PRODUCT;
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Β
1.1.7Β Β
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"BIOMIRA
PATENT RIGHTS" means all rights in the FIELD owned by BIOMIRA or
licensed
in by BIOMIRA with the right to sublicense in the manner contemplated
by
this AGREEMENT in any of the following patents: any patent issuing
on any
patent application identified in appendix 1, as well as any patent
issuing
from any continuing applications of the patents listed in appendix
2, such
applications including any divisions, continuations, and
continuation-in-part applications, as well as any patents issuing
on any
reissue and/or reexamination application, and including any patent
term
restoration of any such patents.Β Β BIOMIRA PATENT RIGHTS also
includes all rights in the FIELD owned by BIOMIRA or licensed in
by
BIOMIRA with the right to sublicense in the manner contemplated
by this
AGREEMENT in any foreign patents which correspond to those described
in
the preceding sentence and in any patents that claim BIOMIRA IMPROVEMENTS,
JOINT IMPROVEMENTS and/or IMPROVEMENTS.Β Β Notwithstanding the
foregoing, BIOMIRA PATENT RIGHTS shall not include any subsequently
developed or acquired BIOMIRA PATENT RIGHTS to the extent covering
any
active compound that is separate and clearly distinct from PRODUCT,
notwithstanding the fact that such active compound may be useful
as part
of a combination therapy with
PRODUCT;
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Β
1.1.8Β Β
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"BIOMIRA
TECHNOLOGY" means all BIOMIRA PATENT RIGHTS and/or BIOMIRA KNOW-HOW
in the
FIELD;
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Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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1.1.9Β Β
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"BLP25"
means BIOMIRA's immunotherapeutic vaccine composed of a 25-amino
acid
sequence of the MUC1 cancer mucin, which vaccine is combined with
the
adjuvant Lipid A and is encapsulated in a liposomal delivery system
,
together with (i) any IMPROVEMENTS thereto (such as liposomal IL-2
in a
kit, synthetic LipidΒ A, or new delivery formats such as unit dose
liquid formulations and unit dose syringes) owned by BIOMIRA or
licensed
in by BIOMIRA with the right to sublicense in the manner contemplated
by
this AGREEMENT and which BIOMIRA and MERCK agree in writing to
implement
and (ii) any PRODRUG thereof;
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Β
1.1.10Β Β
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"CLINICAL
DEVELOPMENT" means all activities required for MARKET APPROVAL
of PRODUCT
in the TERRITORY (including without limitation non-clinical and
clinical
trials, including but not limited to, toxicology and absorption,
distribution, metabolism and elimination studies), as well as all
clinical
activities desirable for optimized marketing of PRODUCT in the
TERRITORY
(including without limitation Phase IIIb and Phase IV
studies).Β Β This term does not include any activities necessary
for manufacture and/or supply of
PRODUCT;
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Β
1.1.11Β Β
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"COMMERCIAL
MANUFACTURING PLAN" shall mean the manufacturing plans reviewed
by the
STEERING COMMITTEE pursuant to section 3.2.2 of this
AGREEMENT;
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Β
1.1.12Β Β
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"COMPETITIVE
PRODUCT" [+]
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Β
1.1.13Β Β
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"CONFIDENTIAL
INFORMATION" has the meaning attributed to that term in section
8.1 of
this AGREEMENT;
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Β
1.1.14Β Β
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"CORIXA
LICENSE" means that certain adjuvant license agreement dated as
of
OctoberΒ 20, 2004 with Corixa Corporation, together with all schedules
thereto and any amendments to or restatements of such adjuvant
license
agreement;
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Β
1.1.15Β Β
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"XXXX-XXXXXX
LICENSE" means that certain license agreement dated NovemberΒ 22, 1996
with the Xxxx-Xxxxxx Cancer Institute, Inc., together with all
schedules
thereto and any amendments to or restatements of such license
agreement;
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Β
1.1.16Β Β
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"DEVELOPMENT
PLAN" shall mean the development plans reviewed by the STEERING
COMMITTEE
pursuant to section 3.2.1 of this
AGREEMENT;
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Β
1.1.17Β Β
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"DISTRIBUTOR"
means, with respect to PRODUCT in a particular country in the TERRITORY,
a
third party retained to market, promote and/or sell PRODUCT in
such
country, but excluding for greater certainty wholesalers and any
such
third party in circumstances where the laws of such country require
the
use of such third party to market, promote and/or sell PRODUCT
in such
country;
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[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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1.1.18Β Β
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"DOMAIN
NAMES" has the meaning attributed to that term in section 5.12.6
of this
AGREEMENT.
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Β
1.1.19Β Β
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"DOSE"
means, with respect to PRODUCT and for purposes of section 6.3
of this
AGREEMENT, the amount of PRODUCT currently (i.e., as at the date
of this
AGREEMENT) specified to be taken at one time (being four vials
each
containing 250 micrograms of
lipopeptide);
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Β
1.1.20Β Β
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"EFFECTIVE
DATE" shall mean March 1, 2006, or such other date as BIOMIRA and
MERCK
may agree upon in writing;
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Β
1.1.21Β Β
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"END
USER" shall mean, with respect to PRODUCT, any person at arm's
length with
MERCK and its AFFILIATES that acquires PRODUCT in final form for
end use,
including physicians and hospitals but excluding DISTRIBUTORS and
other
agents;
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Β
1.1.22Β Β
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"EXECUTION
DATE" shall mean the first day on which the waiting period under
the
Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended,
in relation to the notification and report of the parties with
respect to
this AGREEMENT has expired or been terminated, or such other date
as
BIOMIRA and MERCK may agree upon in
writing;
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Β
1.1.23Β Β
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"FIELD"
shall mean the use of BLP25 for the prevention and/or treatment
of cancers
in humans;
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Β
1.1.24Β Β
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"ICRT
LICENSE" means that certain amended and restated license agreement
dated
NovemberΒ 14, 2000 with Imperial Cancer Research Technology Limited
(now Cancer Research Technology Limited), together with all schedules
thereto and any amendments to or restatements of such license
agreement;
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Β
1.1.25Β Β
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"IFRS"
means international financial reporting standards, consistently
applied;
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Β
1.1.26Β Β
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"IMPROVEMENTS"
has the meaning attributed to that term in section 9.1 of this
AGREEMENT;
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Β
1.1.27Β Β
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"INDICATION"
means a specific health care indication (e.g., non-small cell lung
cancer)
for which PRODUCT is, as indicated on the label for the PRODUCT,
specified
for the treatment and/or prevention
thereof;
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Β
1.1.28Β Β
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"JOINT
IMPROVEMENT PATENT RIGHTS" has the meaning attributed to that term
in
section 10.1.1 of this AGREEMENT;
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Β
1.1.29Β Β
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"JOINT
IMPROVEMENTS" has the meaning attributed to that term in section
9.1 of
this AGREEMENT;
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Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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1.1.30Β Β
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"LAUNCH"
shall mean, with respect to PRODUCT in a particular country in
the
TERRITORY, the date of the first arms' length sale of PRODUCT in
such
country after receipt of MARKET APPROVAL for PRODUCT in such
country;
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Β
1.1.31Β Β
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"MAJOR
MARKET" shall mean any one of Germany, France, United Kingdom,
Italy,
Spain or Japan, and "MAJOR MARKETS" shall mean all of such
countries;
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Β
1.1.32Β Β
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"MANUFACTURING/CMC
PROJECT TEAM" has the meaning attributed to that term in section
3.2.4 of
this AGREEMENT;
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Β
1.1.33Β Β
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"MARKET
APPROVAL" shall mean, with respect to PRODUCT in a particular country
in
the TERRITORY, the date upon which the last of all governmental
or
regulatory approvals required for the sale of PRODUCT in that country
has
been granted, including price approval for the PRODUCT (if
required);
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Β
1.1.34Β Β
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"MARKETING
PLAN" shall mean the marketing plans reviewed by the STEERING COMMITTEE
pursuant to section 3.2.3 of this
AGREEMENT;
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Β
1.1.35Β Β
|
"MERCK
IMPROVEMENTS" has the meaning attributed to that term in section
9.3 of
this AGREEMENT;
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Β
1.1.36Β Β
|
"MUC1"
means cancer associated mucin-1;
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Β
1.1.37Β Β
|
"NA
TERRITORY" shall mean, collectively, Canada (including Quebec)
and its
territories and the United States of America and its
territories;
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Β
1.1.38Β Β
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"NET
SALES" shall mean, with respect to PRODUCT in a particular country,
the
sum of the gross amounts invoiced for all SALES (directly or indirectly)
by MERCK, its AFFILIATES and their respective sublicensees, DISTRIBUTORS,
assignees and transferees of PRODUCT to END USERS, less the following
deductions from such invoiced amounts which are actually incurred
in
accordance with IFRS:
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Β
1.1.38.1Β Β
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credits
or allowances actually granted for spoiled or damaged PRODUCT or
with
respect to returned or rejected PRODUCT, and for retroactive price
adjustments;
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Β
1.1.38.2Β Β
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normal
and customary trade, cash and quantity discounts, allowances, rebates
and
credits actually allowed, including allowances, adjustments,
reimbursements, discounts, chargebacks and rebates given to healthcare
organizations and any governmental or quasi-governmental body or
agency,
whether during the actual SALES/royalty period or
not;
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Β
1.1.38.3Β Β
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sales,
value added or similar taxes measured by the billing amount, when
included
in billing;
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Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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1.1.38.4Β Β
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freight,
postage, shipping, and insurance charges related to delivery of
PRODUCT
from the applicable MERCK/distributor warehouse measured by the
billing
amount, when included in billing;
and
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Β
1.1.38.5Β Β
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import
and export duties actually paid.
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Β
Any
refund or reimbursement of any of the foregoing amounts previously deducted
from
NET SALES shall be appropriately credited upon receipt thereof.
Β
If
PRODUCT is SOLD in combination with another product or products (for greater
certainty the use of adjuvant or other such PRODUCT enhancer stipulated to
be
mixed with PRODUCT shall not be considered to be "another product" for purposes
of this section 1.1.38), "NET SALES" under such circumstances shall be
calculated by multiplying the "NET SALES" of the combination by the fraction
A/(A + B), in which A is the amount invoiced for PRODUCT when SOLD separately,
and B is the total amount invoiced for any other product or products in
combination when SOLD separately;
Β
1.1.39Β Β
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"ORIGINAL
EFFECTIVE DATE" means May 7, 2001;
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Β
1.1.40Β Β
|
"PRODRUG"
means a chemical precursor of PRODUCT which is to be cleaved in
a human
being directly into PRODUCT and/or a metabolic intermediate thereof,
but
excluding for greater certainty, antigen
processing;
|
Β
1.1.41Β Β
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"PRODUCT"
shall mean BLP25;
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Β
1.1.42Β Β
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"ROW
TERRITORY" shall mean all countries in the world except the NA
TERRITORY;
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Β
1.1.43Β Β
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"SALE"
includes, with respect to PRODUCT, the sale thereof to an END USER,
and
"SOLD" and "SELL" have a corresponding
meaning;
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Β
1.1.44Β Β
|
"SALES
REPORT" has the meaning attributed to that term in section 7.2
of this
AGREEMENT;
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Β
1.1.45Β Β
|
"STEERING
COMMITTEE" has the meaning attributed to that term in section 3.1.1
of
this AGREEMENT;
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Β
1.1.46Β Β
|
"STOCK
PURCHASE AGREEMENT" means that certain agreement dated MayΒ 2, 2001
between Biomira Inc., Biomira International Inc. and MERCK relating
to the
purchase of Biomira Inc. common shares, together with all schedules
thereto and any amendments to or restatements of such
agreement;
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Β
1.1.47Β Β
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"SUPPLY
AGREEMENT" means that certain amended and restated supply agreement
of
even date herewith between MERCK and Biomira International Inc.
relating
to the supply of PRODUCT by Biomira International Inc. to MERCK,
together
with all schedules thereto and any amendments to or restatements
of such
amended and restated supply
agreement;
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[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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1.1.48Β Β
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"TERRITORY"
shall mean, collectively, the NA TERRITORY and the ROW
TERRITORY;
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Β
1.1.49Β Β
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"THIRD
PARTY LICENSES" means, collectively, the ICRT LICENSE, the XXXX-XXXXXX
LICENSE, the UΒ ofΒ A LICENSE and any other third party license or
sublicense of any technology included as part of the BIOMIRA TECHNOLOGY
and/or the BIOMIRA MANUFACTURING KNOW-HOW (as such term is defined
in the
SUPPLY AGREEMENT);
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Β
1.1.50Β Β
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"TRADEMARK"
means the trademarks and logos selected for BLP25 pursuant to section
5.12
of this AGREEMENT, being the trademarks STIMUVAX, [+], as well
as any
alternate trademarks for BLP25 agreed to in writing by BIOMIRA
and MERCK,
acting reasonably;
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Β
1.1.51Β Β
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"UΒ ofΒ A
LICENSE" means that certain license dated DecemberΒ 1, 2001 with the
University of Alberta in relation to the Xxxxxxx MUC1 liposomal
formulation patents, together with all schedules thereto and any
amendments to or restatements of such license agreement;
and
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Β
1.1.52Β Β
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"VALID
CLAIM" means, with respect to PRODUCT in a particular country in
the
TERRITORY, a claim of an issued and unexpired patent included within
the
BIOMIRA PATENT RIGHTS which has not been held unenforceable, unpatentable
or invalid by a decision of a court or other governmental agency
of
competent jurisdiction, unappealable or unappealed within the time
allowed
for appeal, and which has not been admitted to be invalid or unenforceable
through reissue, disclaimer or
otherwise.
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Β
Β
ARTICLE
2
LICENSE
GRANT
Β
Section
2.1
|
BIOMIRA
License Grant
|
Subject
to the terms and conditions of this AGREEMENT and only for the purpose of
MERCK
fulfilling its obligations and exercising its rights under this AGREEMENT,
BIOMIRA hereby grants to MERCK a license (or in the case of BIOMIRA TECHNOLOGY
that BIOMIRA has licensed from a third party, a sublicense) under the BIOMIRA
TECHNOLOGY to use, import, develop, market and SELL and have used, imported,
developed, marketed and SOLD PRODUCT in the FIELD in the NA TERRITORY and
the
ROW TERRITORY.Β Β Such license shall, except to the extent otherwise
provided in this AGREEMENT or otherwise required by applicable law or regulation
(as, for example, in the European Union under applicable competition law),
be
exclusive for the FIELD in the NA TERRITORY and in the ROW TERRITORY, subject
to
the rights of BIOMIRA under this AGREEMENT.
Β
MERCK
shall have no right to grant sublicenses under such licenses without the
prior
written consent of BIOMIRA (such consent not to be unreasonably withheld)
and,
to the extent applicable, complying with the provisions of the THIRD PARTY
LICENSES, except only for purposes of exercising its right to appoint
DISTRIBUTORS of PRODUCT in the TERRITORY including AFFILIATES of MERCK (but
again
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
Β
Section
2.2Β
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Term
of Grant
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The
licenses granted in sectionΒ 2.1 of this AGREEMENT shall remain in force and
effect on a country-by-country basis until the later of (a) [+] (b)
[+]Β Β Upon the expiration of any such license grant as aforesaid, MERCK
shall thereafter, subject to complying with any applicable provisions of
the
THIRD PARTY LICENSES (including the payment of any and all royalties and
other
amounts required to be paid thereunder), have a paid up, royalty free,
non-exclusive license under the BIOMIRA TECHNOLOGY to use, import, develop,
market and SELL, and have used, imported, developed, marketed and SOLD PRODUCT
in such country in the FIELD.
Β
Section
2.3
|
Third
Party Licenses and Corixa
License
|
With
respect to the THIRD PARTY LICENSES to the extent not waived in writing by
the
licensor under such THIRD PARTY LICENSES, BIOMIRA and MERCK hereby incorporate
by reference in this AGREEMENT any provisions specified in such THIRD PARTY
LICENSES to be included in sublicenses of the subject matter of such THIRD
PARTY
LICENSES and to make such other amendments to this AGREEMENT as may be required
in connection with the sublicensing of such THIRD PARTY LICENSES by BIOMIRA
to
MERCK.Β Β MERCK also agrees to cooperate with BIOMIRA and its AFFILIATES
in fully complying in a timely manner with the terms of such THIRD PARTY
LICENSES and the CORIXA LICENSE and, without limiting the generality of the
foregoing, MERCK shall provide to BIOMIRA or its designated AFFILIATE in
a
timely manner or assist BIOMIRA or its designated AFFILIATE in preparing
in a
timely manner any and all reports, data, confirmations, approvals and other
information that may be required by BIOMIRA or its designated AFFILIATE in
connection therewith.Β Β BIOMIRA shall provide MERCK with examples of
applicable reports previously utilized by BIOMIRA and/or its AFFILIATES for
such
purposes in order to assist MERCK in preparing the necessary
reports.
Β
Section
2.4
|
Bankruptcy
or Insolvency
|
All
rights and licenses granted to MERCK under this articleΒ 2 are, and shall be
deemed to be, for purposes of applicable bankruptcy law (including section
365(n) of the United States Bankruptcy Code), licenses of rights to
"intellectual property" (including as such term is defined under section
101(35A) of the United States Bankruptcy Code).Β Β The parties agree
that MERCK, as a licensee of such rights under this AGREEMENT, shall retain
and
may fully exercise all of its rights and elections under such applicable
bankruptcy law, including but not limited to MERCK's rights to continue to
exercise all rights licensed hereunder.
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
Section
2.5Β
|
BIOMIRA
and MERCK Rights
|
Notwithstanding
any provision to the contrary in this AGREEMENT, each of BIOMIRA and its
AFFILIATES and MERCK shall have the right at their own cost to carry out
research and clinical trials (up to but not including Phase III) in the FIELD
with respect to IMPROVEMENTS to PRODUCT.
Β
Section
2.6
|
Combination
Products
|
BIOMIRA
shall not prohibit MERCK from combining for use in the FIELD PRODUCT licensed
under this AGREEMENT with any other product.
Β
Section
2.7
|
Covenant
Not to Xxx or
Challenge
|
MERCK
(on behalf of itself and its AFFILIATES and their respective sublicensees)
agrees not to in any way challenge or contest (including by way of an allegation
of misuse or non-infringement), nor assist any other person to challenge
or
contest, the validity or enforceability of any of the BIOMIRA TECHNOLOGY
including, without limitation, the BIOMIRA PATENT RIGHTS.
Β
Β
ARTICLE
3
DEVELOPMENT
OVERSIGHT
Β
Section
3.1
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Steering
Committee
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3.1.1Β Β
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Formation.Β Β Within
thirty (30) days after the EXECUTION DATE, the parties shall re-constitute
a steering committee (the "STEERING COMMITTEE") for the purpose
of
overseeing and exchanging information with respect to the development,
(including CLINICAL DEVELOPMENT), manufacturing, marketing and
SALE of
PRODUCT in the TERRITORY, all as hereinafter specified in this
articleΒ 3.
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Β
3.1.2Β Β
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Membership.Β Β The
STEERING COMMITTEE shall be composed of three (3) representatives
of
BIOMIRA and its AFFILIATES and three (3) representatives of MERCK
and its
AFFILIATES, unless otherwise agreed to in writing by BIOMIRA and
MERCK
(but the number of representatives of BIOMIRA and its AFFILIATES
and the
number of representatives of MERCK and its AFFILIATES shall always
be
equal).Β Β The initial chair of the STEERING COMMITTEE shall be a
representative of BIOMIRA, and thereafter the chair of the STEERING
COMMITTEE shall alternate on the anniversary of the EXECUTION DATE
between
a representative of BIOMIRA and a representative of MERCK (i.e.,
the
second chair shall be a representative of MERCK, the third a
representative of BIOMIRA, and so on).Β Β The initial members of
the re-constituted STEERING COMMITTEE shall
be:
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Β
for
BIOMIRA:
member:Β Β [+]
member:Β Β [+]
member:Β Β [+]
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[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
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member:Β Β [+]
member:Β Β [+]
member:Β Β [+]
Β
3.1.3Β Β
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Member
Changes.Β Β Each party shall notify the other party in writing
of any changes in its representatives to the STEERING
COMMITTEE.
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Β
3.1.4Β Β
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Meetings.Β Β The
STEERING COMMITTEE shall meet not less than once per calendar quarter
during the period of CLINICAL DEVELOPMENT of PRODUCT and during
the period
of SALE of PRODUCT, on such dates and at such times and places
as are
agreed to by the members of the STEERING COMMITTEE, acting
reasonably.Β Β Responsibility for arranging such meetings,
including, at a minimum, providing notice and an agenda and providing
minutes of the meeting, shall alternate between the parties. The
first
meeting will take place as soon as practicable after the EXECUTION
DATE,
but in no event later than forty-five (45) days after the EXECUTION
DATE,
and will be organized by MERCK.Β Β Β Meetings may be conducted
in person or by telephone or video conference, and the STEERING
COMMITTEE
may act without a meeting if, prior to such action, a written consent
thereto is signed by each member of the STEERING COMMITTEE.Β Β The
STEERING COMMITTEE may amend or expand upon the foregoing procedures
for
its internal operation by written agreement of BIOMIRA and
MERCK.
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Β
3.1.5Β Β
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Expenses.Β Β Each
party shall be responsible for the costs and expenses (including
travel,
lodging and other such costs and expenses) associated with the
participation of its representatives on the STEERING
COMMITTEE.
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Β
3.1.6Β Β
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Minutes.Β Β The
party responsible for arranging a meeting of the STEERING COMMITTEE
as
provided for in section 3.1.4 of this AGREEMENT shall promptly
prepare and
deliver to the other party within thirty (30) days after the date
of each
meeting, minutes of such meeting setting forth a summary of all
matters
addressed at such meeting of the STEERING COMMITTEE in form and
content
reasonably acceptable to both parties.Β Β Such minutes shall
become official only upon written approval by the STEERING
COMMITTEE.
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Β
Section
3.2
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Functions
and Authority
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3.2.1Β Β
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Development
Plans.Β Β The parties acknowledge that MERCK will be
responsible for the development (including CLINICAL DEVELOPMENT)
of
PRODUCT to be SOLD in the NA TERRITORY and the ROW
TERRITORY.Β Β Notwithstanding the foregoing, MERCK shall present
to the STEERING COMMITTEE semi-annually for its review and consultation
a
DEVELOPMENT PLAN, and will not make any material revisions to a
previously
reviewed DEVELOPMENT PLAN without prior consultation with the STEERING
COMMITTEE.Β Β MERCK will consider seriously and in good faith any
comments that BIOMIRA representatives to
the STEERING COMMITTEE may have with respect to any such DEVELOPMENT
PLAN
or material revision thereto, provided, however, that the final
decision on any such matter shall be made by
MERCK.
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Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
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3.2.2Β Β
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Manufacturing.Β Β The
parties acknowledge that, except in the circumstances specified
in section
2.12 of the SUPPLY AGREEMENT, Biomira International Inc. or its
designated
AFFILIATE will be responsible for the manufacture and supply of
PRODUCT
for sale in the NA TERRITORY and the ROW TERRITORY, all as specified
in
the SUPPLY AGREEMENT.Β Β Notwithstanding the foregoing, Biomira
International Inc. or its designated AFFILIATE shall within six
(6) months
of the EXECUTION DATE provide a succinct (i.e., one or two pages)
status
report in relation to manufacturing to MERCK and meet with the
appropriate
manufacturing personnel of MERCK to discuss the timing and content
of a
COMMERCIAL MANUFACTURING PLAN.Β Β Commencing on the date agreed to
in writing by Biomira International Inc. or its designated AFFILIATE
and
MERCK during or following such discussions, Biomira International
Inc. or
its designated AFFILIATE shall thereafter present to the STEERING
COMMITTEE semi-annually for its review and consultation a COMMERCIAL
MANUFACTURING PLAN, and will not make any material revisions to
a
previously reviewed COMMERCIAL MANUFACTURING PLAN without prior
consultation with the STEERING COMMITTEE.Β Β Biomira International
Inc. or its designated AFFILIATE will consider seriously and in
good faith
any comments that MERCK representatives to the STEERING COMMITTEE
may have
with respect to any such COMMERCIAL MANUFACTURING PLAN or material
revision thereto, provided, however, that the final decision on
any such matter shall be made by Biomira International Inc. or
its
designated AFFILIATE.
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Β
3.2.3Β Β
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Marketing.Β Β The
parties acknowledge that, with respect to the NA TERRITORY and
the ROW
TERRITORY, MERCK will be responsible for the SALES and marketing
of
PRODUCT.Β Β Notwithstanding the foregoing, MERCK shall present to
the STEERING COMMITTEE semi-annually for its review and consultation,
beginning a reasonable period of time prior to LAUNCH of PRODUCT
in the NA
TERRITORY and/or the ROW TERRITORY, a MARKETING PLAN, and will
not make
any material revisions to a previously reviewed MARKETING PLAN
without
providing prior written notification (including particulars) to
the
STEERING COMMITTEE.Β Β MERCK will consider seriously and in good
faith any comments that BIOMIRA representatives to the STEERING COMMITTEE
may have with respect to any such MARKETING PLAN or material revision
thereto, provided, however, that the final decision on any such
matter shall be made by MERCK.
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Β
3.2.4Β Β
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Manufacturing/CMC
Project Team:Β Β The STEERING COMMITTEE will establish a
MANUFACTURING/CMC PROJECT TEAM.Β Β The STEERING COMMITTEE will
approve the members of the MANUFACTURING/CMC PROJECT TEAM comprising
an
equal number of individuals from BIOMIRA and its AFFILIATES and
from MERCK
and its AFFILIATES.Β Β The chairperson of the
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Β Β
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MANUFACTURING/CMC
COMMITTEE shall be a member from BIOMIRA and its AFFILIATES designated
by
BIOMIRA.Β Β The MANUFACTURING/CMC PROJECT TEAM shall, subject to
the final decision with respect to any manufacturing matter residing
with
Biomira International Inc. or its designated AFFILIATE as provided
for in
section 3.2.2, be responsible for (i) assuring the security of
supply of
PRODUCT, (ii) reviewing specifications, (iii) identifying and
resolving
quality issues, (iv) reviewing potential changes to the production
processes for PRODUCT, and (v) overseeing the implementation
of the
COMMERCIAL MANUFACTURING PLAN.
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Β
Β
ARTICLEΒ 4
DEVELOPMENT AND MARKET APPROVAL
DEVELOPMENT AND MARKET APPROVAL
β
NA TERRITORY AND ROW TERRITORY
Β
Section
4.1
|
CLINICAL
DEVELOPMENTΒ Studies and
Costs
|
Unless
otherwise agreed to in writing by BIOMIRA and MERCK, MERCK will be responsible
for conducting, or having conducted, all development (including CLINICAL
DEVELOPMENT) and MARKET APPROVAL (including the preparation, submission and
prosecution of all regulatory authority filings and applications required
to
obtain all necessary MARKET APPROVALS to SELL PRODUCT in, among others, the
NA
TERRITORY and the MAJOR MARKETS in the ROW TERRITORY) tasks (including all
studies) necessary and/or desirable for CLINICAL DEVELOPMENT of PRODUCT in
the
NA TERRITORY and the ROW TERRITORY.Β Β Without limiting the generality
of the foregoing, MERCK agrees to undertake the Phase III clinical trial
of
BLP25 in Stage III a/b non-small cell lung cancer described in the protocol
set
forth in appendix 3.Β Β MERCK will bear all costs in relation to all of
the foregoing.
Β
Section
4.2
|
Regulatory
Filings
|
MERCK
will, at MERCK's expense, use commercially reasonable efforts to diligently
pursue the preparation, submission and prosecution and maintenance of all
regulatory authority filings and applications required to obtain and maintain
all necessary and/or desirable MARKET APPROVALS to sell PRODUCT in each of
the
NA TERRITORY, the MAJOR MARKETS in the ROW TERRITORY and in such other countries
in the ROW TERRITORY in which MERCK, using reasonable business judgment,
determines to sell such PRODUCTS, all in a prudent and skilful manner in
accordance with all applicable laws and regulations.Β Β BIOMIRA shall
provide reasonable assistance to MERCK in connection with preparing and
supporting the Chemistry, Manufacturing and Control sections of applicable
PRODUCT market applications and in regard to post-MARKET APPROVAL requirements
in respect of Chemistry, Manufacturing and Control.Β Β MERCK shall keep
BIOMIRA informed in respect of the matters which are the subject of this
section
4.2 and shall give due consideration to any concerns and suggestions of BIOMIRA
with respect thereto, provided, however, that the final decision on the
specifics of the preparation, submission and prosecution and maintenance
of such
regulatory filings and applications shall be made by MERCK.Β Β Subject
to the terms and conditions of this AGREEMENT, BIOMIRA or its applicable
AFFILIATE shall take such actions as are required to be taken by it to transfer
to MERCK the then current United States IND held by BIOMIRA or such AFFILIATE
in
relation to BLP25 within ten (10) business days of MERCK's reasonable written
request to do so.
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
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Section
4.3Β
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Assistance
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BIOMIRA
agrees to use reasonable commercial efforts to provide such assistance as
is
reasonably requested by MERCK and as is reasonably necessary to be performed
by
BIOMIRA in connection with the preparation and prosecution of such filings
and
applications as described in section 4.1.Β Β BIOMIRA shall be
compensated by MERCK for such assistance on the basis set forth in
appendixΒ 4 to this AGREEMENT (as such amounts shall be adjusted annually to
account for normal wage increases), except to the extent that BIOMIRA is
specifically obligated under the SUPPLY AGREEMENT to provide manufacturing
assistance to MERCK without remuneration.
Β
Section
4.4
|
Reporting
|
At
least quarterly during the term of this AGREEMENT until all PRODUCT approvals
hereunder are obtained with respect to the NA TERRITORY and the ROW TERRITORY,
MERCK shall, with respect to the NA TERRITORY and the ROW TERRITORY, provide
BIOMIRA with a succinct written summary report (i.e., one to two pages) which
shall describe the progress of the following:Β Β the clinical
development and testing of PRODUCT in clinical trials, all regulatory filings
and submissions made and the status thereof, all approvals obtained and such
other information as BIOMIRA may from time to time reasonably request with
respect to the subject matter of articleΒ 4.Β Β Such reports and
information shall be received by BIOMIRA subject to the obligations of
articleΒ 8.Β Β Further, to the extent that any such report is
provided by MERCK to BIOMIRA at a meeting of the STEERING COMMITTEE, MERCK
shall
not be required to again provide such report to BIOMIRA under this section
4.4.
Β
Section
4.5Β
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MARKET
APPROVAL Owner
|
MERCK
shall be the record owner of all MARKET APPROVALS required for SALE of PRODUCT
in the NA TERRITORY and the ROW TERRITORY.Β Β Forthwith upon the
expiration or termination of this AGREEMENT with respect to PRODUCT in a
particular country in the ROW TERRITORY or the NA TERRITORY, or if any of
the
licenses granted by BIOMIRA to MERCK in this AGREEMENT become non-exclusive,
MERCK shall in a timely manner comply with section 11.6 of this AGREEMENT
in
relation to PRODUCT in such country.
Β
Β
ARTICLE
5Β
PRODUCT MARKETING β NA TERRITORY AND ROW TERRITORY
PRODUCT MARKETING β NA TERRITORY AND ROW TERRITORY
Β
Section
5.1
|
Costs
and Expenses
|
MERCK
shall bear all costs and expenses associated with the promoting, marketing,
distributing and SALE of PRODUCT in the TERRITORY.
Β
Section
5.2
|
Sales
Force Training
|
MERCK
shall be responsible for developing or having developed (in accordance with
all
applicable legal and regulatory requirements) training programs and materials
concerning promotion of PRODUCT in the TERRITORY.Β Β MERCK shall also be
responsible for developing or having developed (in accordance with all
applicable legal and regulatory requirements) training programs and materials
concerning technical aspects of PRODUCT.
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
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Section
5.3Β
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Costs
of Sales Representatives and Specialty
Personnel
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MERCK
shall be responsible for all costs and expenses related to its sales
representatives (whether employees or contracted) in the
TERRITORY.Β Β MERCK shall be responsible for all costs and expenses
related to "specialty" personnel (including managed care representatives,
professional relations, patient advocacy, reimbursement, specialty sales,
and
the like) in the TERRITORY.
Β
Section
5.4
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Distribution
|
MERCK
shall have the sole responsibility for distribution of PRODUCT in the
TERRITORY.Β Β In fulfilling its obligations with respect to the
distribution of PRODUCT in the TERRITORY, MERCK shall use commercially
reasonable efforts consistent with accepted pharmaceutical
practices.Β Β All costs incurred in relation to such distribution shall
be borne by MERCK.
Β
Section
5.5
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Label
Content
|
MERCK
shall be responsible for ensuring that the label and product insert for any
PRODUCT SOLD in the TERRITORY shall comply with all legal, governmental and
regulatory requirements.Β Β Insofar as it is not contrary to law or
regulation in any particular country in the TERRITORY, the box and package
insert, and the label to the extent that space permits, shall include prominent
reference to MERCK (or, if applicable, any AFFILIATE of MERCK designated
by
MERCK) as marketer and to Biomira International Inc. as manufacturer of the
PRODUCT.Β Β Any trademark or other content as may be from time to time
required pursuant to the CORIXA LICENSE shall be marked on every PRODUCT
label
and/or insert in the manner required under the CORIXA LICENSE.
Β
Section
5.6
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Product
Price
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MERCK
shall determine the SALES price for PRODUCT SOLD in the TERRITORY.
Β
Section
5.7Β
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Booking
Sales
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MERCK
shall book all SALES of PRODUCT in the TERRITORY.
Β
Section
5.8
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Advertising
and Promotion
|
MERCK
shall be responsible for determining the sales strategy for SALE of PRODUCT
in
the TERRITORY, and shall create, or have created all materials for advertising
and promotion of PRODUCT in the TERRITORY.Β Β All costs and expenses
incurred in relation to such advertising and promotion shall be borne by
MERCK.
Β
Section
5.9
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Customer
Complaints and Medical
Inquiries
|
MERCK
(or its designated AFFILIATE) shall be responsible for handling all customer
complaints and inquiries regarding PRODUCT in the TERRITORY.Β Β All
complaints and inquiries received by BIOMIRA or its agents shall be promptly
referred to MERCK for response according to applicable law.Β Β MERCK
shall use commercially reasonable efforts to handle such matters in a timely,
prudent and skilful manner, in compliance with applicable laws, regulations,
rules, policies and regulatory requirements and in accord with MERCK's standard
operating procedures.Β Β MERCK shall keep BIOMIRA informed in a timely
manner with respect to MERCK's activities in regard to customer complaints
and
inquiries for PRODUCT.Β Β All customer complaints specifically relating
to the manufacture of PRODUCT shall be referred to BIOMIRA and handled in
accordance with the terms of the SUPPLY AGREEMENT.Β Β All costs incurred
in responding to customer complaints and inquiries (other than those
specifically relating to the manufacture of PRODUCT by BIOMIRA and handled
in
accordance with the terms of the SUPPLY AGREEMENT) shall be borne by
MERCK.
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
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Section
5.10
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Adverse
Event Reporting
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MERCK
(or its designated AFFILIATE) shall be responsible for reporting all ADVERSE
EVENTS regarding PRODUCT to the appropriate regulatory authorities in the
TERRITORY.Β Β All information received by BIOMIRA or its agents shall be
promptly transferred according to applicable law to MERCK for
handling.Β Β MERCK shall handle such matter in a timely, prudent and
skilful manner, in compliance with all applicable laws, rules, policies,
regulations and regulatory requirements, and in accord with MERCK's standard
operating procedures.Β Β MERCK shall keep BIOMIRA informed in a timely
manner with respect to MERCK's activities with respect to ADVERSE EVENT
reporting for PRODUCT.Β Β All costs incurred in responding to and
reporting ADVERSE EVENTS regarding PRODUCT in the TERRITORY shall be borne
by
MERCK.Β Β In the event that the parties determine its necessity, then
further details shall be set forth in a pharmacovigilance data exchange
agreement to be entered into by the parties in due course.
Β
Section
5.11
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PRODUCT
Recall
|
MERCK
(or its designated AFFILIATE) shall be responsible for initiating and
implementing all PRODUCT recalls required by controlling regulatory agencies
and
for all voluntary PRODUCT market withdrawals in the TERRITORY.Β Β MERCK
shall handle such matters in a timely, prudent and skilful manner, in compliance
with all applicable laws, rules, policies, regulations and regulatory
requirements, and in accord with MERCK's standard operating
procedures.Β Β MERCK shall keep BIOMIRA informed in a timely manner with
respect to MERCK's activities in regard to recalls and market
withdrawals.Β Β All costs incurred in responding to recalls and market
withdrawals shall be borne by MERCK, except for a recall or voluntary withdrawal
which is attributable to the actions or omissions of BIOMIRA or its AFFILIATES,
in which case BIOMIRA shall be solely responsible for the costs of such recall
or market withdrawal.
Β
Section
5.12
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Trademarks
and Branding
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5.12.1Β Β
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Ownership
and Filing.Β Β PRODUCT shall be marketed and sold in the
TERRITORY under the applicable TRADEMARK.Β Β BIOMIRA acknowledges
that MERCK shall be the owner of the TRADEMARKS in the
TERRITORY.Β Β BIOMIRA shall not knowingly do or cause to be done
any act or thing contesting, challenging or, in any way, impairing
or
intending to impair any part of MERCK's right, title or interest
in the
TRADEMARKS for the duration of this AGREEMENT.Β Β Further, BIOMIRA
shall not use or register in the TERRITORY any trademark which
is similar
or identical to any of the TRADEMARKS on similar or identical goods
or
services to those which are the subject of this AGREEMENT for the
duration
of this AGREEMENT.Β Β MERCK shall diligently pursue the filing,
maintenance and defence of the TRADEMARKS in the TERRITORY.Β Β All
trademark-related costs (including, without limitation, legal,
third
party, branding, filing, maintenance and other such costs) of developing,
prosecuting, registering, maintaining and defending the TRADEMARKS
shall
be borne by MERCK as of the EFFECTIVE
DATE.
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5.12.2Β Β
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Trademark
License.Β Β MERCK hereby grants to BIOMIRA and its designated
AFFILIATES a royalty free, non-exclusive license to use, display,
reproduce and publish the TRADEMARKS in connection with the (i)
manufacture, and (ii) in the circumstances expressly described
in this
AGREEMENT, use, marketing, promotion, distribution and SALE of
PRODUCT in
any countries in the TERRITORY where BIOMIRA or an AFFILIATE of
BIOMIRA
has the right to SELL PRODUCT under this AGREEMENT for so long
as such
right to SELL exists under this AGREEMENT.Β Β BIOMIRA and its
designated AFFILIATES shall have no right to grant sublicenses
under such
license without the prior written consent of MERCK (such consent
not to be
unreasonably withheld).Β Β Any goodwill arising from the use of
the TRADEMARKS by BIOMIRA or its designated AFFILIATES shall inure
to the
benefit of MERCK.Β Β Further, such use shall be in accordance with
the applicable laws in the relevant jurisdiction, as well as with
any
reasonable requirements of any brand guide that may be provided
by MERCK
from time to time.Β Β When using any of the TRADEMARKS under
license, BIOMIRA and its designated AFFILIATES shall use the identifiers
Γ
or
Γ’,
as
appropriate.
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Β
5.12.3Β Β
|
Alternative
Trademarks.Β Β In the event that STIMUVAX, [+] cannot be used
for the PRODUCT in any country of the TERRITORY due to legal or
regulatory
or other valid reasons, MERCK shall at its discretion and cost
develop and
file one or several alternative trademarks in the relevant country,
which
will (once agreed to in writing by BIOMIRA, in a timely manner
acting
reasonably, as specified in section 1.1.50 of this AGREEMENT) be
considered TRADEMARKS under this
AGREEMENT.
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Β
5.12.4Β Β
|
such
third party.Β Β Further, BIOMIRA represents and warrants that, to
the knowledge of BIOMIRA, there is no action, suit, proceeding,
alternative dispute resolution, mediation or investigation pending
or
threatened against BIOMIRA relating to the trademarks
[+]Β Β Within forty-five (45) days of the EXECUTION DATE, MERCK
shall pay to and reimburse BIOMIRA or its designated AFFILIATE
for all
reasonable costs and expenses (other than internal costs and expenses)
incurred from the EFFECTIVE DATE up to and including the EXECUTION
DATE by
BIOMIRA and its AFFILIATES in connection with the TRADEMARKS, including,
without limitation, the [+] paid by BIOMIRA or its AFFILIATE to
MERCK in
respect of STIMUVAX (MERCK also confirms that BIOMIRA and its AFFILIATES
are released from all other obligations under the STIMUVAX letter
agreement dated December 21, 2004 including, without limitation,
[+]).
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[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR
CONFIDENTIALITY
PURPOSESΒ
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Β
Β
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such
third party.Β Β Further, BIOMIRA represents and warrants that, to
the knowledge of BIOMIRA, there is no action, suit, proceeding,
alternative dispute resolution, mediation or investigation pending
or
threatened against BIOMIRA relating to the trademarks
[+]Β Β Within forty-five (45) days of the EXECUTION DATE, MERCK
shall pay to and reimburse BIOMIRA or its designated AFFILIATE
for all
reasonable costs and expenses (other than internal costs and
expenses)
incurred from the EFFECTIVE DATE up to and including the EXECUTION
DATE by
BIOMIRA and its AFFILIATES in connection with the TRADEMARKS,
including,
without limitation, the [+] paid by BIOMIRA or its AFFILIATE
to MERCK in
respect of STIMUVAX (MERCK also confirms that BIOMIRA and its
AFFILIATES
are released from all other obligations under the STIMUVAX letter
agreement dated December 21, 2004 including, without limitation,
[+]).
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Β
5.12.5Β Β
|
Trademark
Infringement.Β Β For countries in which the TRADEMARKS are
used under license by BIOMIRA and/or its AFFILIATES, BIOMIRA shall
promptly report to MERCK particulars of any use by any other party
of a
trademark, trade name or mode of advertising which comes to BIOMIRA's
or
its designated AFFILIATES' attention and which might qualify as
an
infringement of the TRADEMARKS or as unfair competition.Β Β In the
event that it comes to the attention of BIOMIRA or its designated
AFFILIATES that any party alleges that the TRADEMARKS are invalid
or that
they infringe any rights of a third party, or that the TRADEMARKS
are open
to any other form of attack, BIOMIRA or its designated AFFILIATES
shall
promptly report the matter to MERCK.Β Β In any event described in
this section BIOMIRA shall not take any action, either amicably
or
legally, and shall let MERCK or a nominee of MERCK take any action
which
MERCK, acting reasonably, deems necessary, provided, however, that
nothing
herein shall prevent BIOMIRA from defending and/or protecting its
own
reasonable interests.Β Β BIOMIRA or its designated AFFILIATES,
upon MERCK's reasonable request and at MERCK's expense, shall cooperate
in
any action so taken to the extent that such cooperation is not
materially
adverse in interest to BIOMIRA and/or its
AFFILIATES.
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Β
5.12.6Β Β
|
Domain
Names.Β Β Any domain names (the "DOMAIN NAMES") related to the
TRADEMARKS in the TERRITORY shall be owned by MERCK.Β Β BIOMIRA
acknowledges that MERCK shall be the owner of the DOMAIN NAMES
in the
TERRITORY.Β Β BIOMIRA shall not knowingly do or cause to be done
any act or thing contesting, challenging or, in any way, impairing
or
intending to impair any part of MERCK's right, title or interest
in the
DOMAIN NAMES in the TERRITORY for the duration of this
AGREEMENT.Β Β Further, BIOMIRA shall not use or register in the
TERRITORY any domain name which is similar or identical to any
of the
DOMAIN NAMES on similar or identical goods or services which are
the
subject of this AGREEMENT for the duration of this
AGREEMENT.Β Β MERCK shall diligently pursue the filing,
maintenance and defence of the DOMAIN NAMES in the
TERRITORY.Β Β All domain name-related costs (including, without
limitation, legal, third party, filing, maintenance and other such
costs)
of prosecuting, registering, maintaining and defending the DOMAIN
NAMES or
any alternate or additional domain names shall be borne by
MERCK.
|
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
5.12.7Β Β
|
Domain
License.Β Β To the extent required, MERCK hereby grants to
BIOMIRA and its designated AFFILIATES a royalty free, non-exclusive
license to use, display, reproduce and publish the DOMAIN NAMES
or any
alternate or additional domain names in connection with the (i)
manufacturing, and (ii) in the circumstances expressly specified
in this
AGREEMENT, use, marketing, promotion, distribution and SALE of
PRODUCT in
any countries in the TERRITORY where BIOMIRA or an AFFILIATE of
BIOMIRA
has the right to SELL PRODUCT under this AGREEMENT for so long
as such
right to SELL exists under this
AGREEMENT.
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Β
Section
5.13Β
|
General
Diligence
|
Subject
to section 14.1 and without being limited by section 5.14, MERCK shall, at
MERCK's expense, [+].Β MERCK will bear all costs with respect
thereto.
Β
Section
5.14
|
Excused
Performance
|
In
addition to the terms of Section 14.1, each party's performance under this
AGREEMENT with respect to PRODUCT in a particular country is expressly
conditioned upon the continuing absence of any safety or efficacy or regulatory
event with respect to such PRODUCT in such country which materially limits,
reverses or restricts the development and/or marketing of such PRODUCT in
such
country.Β Β Each party's obligations to develop, promote and/or SELL
such PRODUCT in such country under this AGREEMENT shall be delayed or suspended
so long as any such condition exists.
Β
Section
5.15
|
Japanese
Market
|
Without
derogating from section 5.13, in relation to Japan, MERCK shall, as soon
as
reasonable considering the Japanese market and in any event no later than
[+],
commence discussions with the applicable Japanese regulatory authorities
with
respect to initiating any required clinical trials in Japan and finalize
a
comprehensive CLINICAL DEVELOPMENT plan for Japan for PRODUCT (which shall
include a reasonable timeframe for obtaining regulatory approval in Japan)
and
thereafter use commercially reasonable efforts to pursue such CLINICAL
DEVELOPMENT plan within the timeframes stipulated
therein.Β Β Notwithstanding any provision to the contrary in this
AGREEMENT, if MERCK fails to meet the requirements of this section 5.15 with
respect to Japan, then this AGREEMENT shall cease to apply to PRODUCT in
relation to Japan and all rights related to PRODUCT in Japan shall revert
to
BIOMIRA.
Β
Section
5.16
|
Cooperation
Between the Parties
|
The
parties agree to cooperate and cause their respective sales representatives
to
cooperate with one another with respect to the activities related to the
promotion of PRODUCT, including but not limited to changes in promotional
programs, recalls and communications with targeted customers.
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
CONSIDERATION
β NA TERRITORY AND ROW TERRITORY
Β
Section
6.1
|
Consideration
for Licenses Granted
|
In
consideration for the licenses granted by BIOMIRA to MERCK under article
2,
MERCK shall, [+]
Β
Section
6.2
|
Royalty
Payments
|
6.2.1Β Β
|
In
consideration for the licenses granted by BIOMIRA to MERCK under
article 2
and other benefits afforded MERCK under this AGREEMENT, MERCK shall
make
the payments specified in this sectionΒ 6.2 to
BIOMIRA.
|
Β
6.2.2Β Β
|
With
respect to BLP25 in a particular country in the NA TERRITORY, MERCK
shall,
until the later ofΒ Β (a) [+] (b) [+] pay to BIOMIRA on a
quarterly basis as specified in article 7 of this AGREEMENT a royalty
on
NET SALES of PRODUCT in such country calculated as
follows:
|
Β
6.2.2.1Β Β
|
[+]
and
|
Β
6.2.2.2Β Β
|
[+]
|
Β
[+]
Β
6.2.3Β Β
|
With
respect to BLP25 in a particular country in the ROW TERRITORY,
MERCK
shall, until the later of (a) [+] (b) [+] pay to BIOMIRA on a quarterly
basis as specified in article 7 of this AGREEMENT a royalty on
NET SALES
of such PRODUCT in such country calculated as
follows:
|
Β
6.2.3.1Β Β
|
[+]
|
Β
6.2.3.2Β Β
|
[+]
|
Β
6.2.3.3Β Β
|
[+]
|
Β
6.2.4Β Β
|
[+]
|
Β
6.2.5Β Β
|
[+]
|
Β
6.2.6Β Β
|
No
royalties under this section 6.2 shall be payable on PRODUCT used
solely
by or on behalf of the parties for tests or development purposes
or on
transfers between MERCK and its sublicensees who are not END
USERS.Β Β Unless BIOMIRA and MERCK otherwise agree in writing, no
samples of any PRODUCT shall be made available by MERCK to END
USERS.
|
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
6.2.7Β Β
|
In
establishing the royalty structure of this section 6.2, BIOMIRA
and MERCK
recognize, and MERCK acknowledges, the substantial value of the
various
actions and investments undertaken by BIOMIRA prior to the EFFECTIVE
DATE.Β Β Such value is significant and in addition to the value of
BIOMIRA's grant to MERCK of the license pursuant to section 2.1
of this
AGREEMENT, as it enables the rapid and effective development and
commercialization of PRODUCT in the TERRITORY.Β Β Therefore,
BIOMIRA and MERCK agree that the royalty payments calculated as
a
percentage of NET SALES (plus any other payments provided for elsewhere
in
this AGREEMENT) provide fair compensation to BIOMIRA for these
additional
benefits.
|
Β
Section
6.3
|
Deductions
|
MERCK
shall, when the PRODUCT in question has been SOLD to an END USER in the NA
TERRITORY and/or the ROW TERRITORY in accordance with this AGREEMENT, be
entitled to deduct from the royalties otherwise payable by MERCK to BIOMIRA
under section 6.2, the applicable amount invoiced by Biomira International
Inc.
to MERCK pursuant to section 2.6.4 of the SUPPLY AGREEMENT (but excluding,
for
greater clarity, the royalties payable by MERCK in relation to the CORIXA
LICENSE) with respect to such PRODUCT SOLD to an END USER in the NA TERRITORY
and/or the ROW TERRITORY or, in circumstances where section 2.12 of the SUPPLY
AGREEMENT is applicable and only when the PRODUCT in question has been SOLD
to
an END USER in the NA TERRITORY and/or the ROW TERRITORY in accordance with
this
AGREEMENT, the lesser of (on a per DOSE basis):Β Β (i) MERCK's actual
costs of manufacture (which shall be subject to audit by BIOMIRA in the manner
provided for in section 7.3 of this AGREEMENT), and (ii) the amount that
BIOMIRA
was paying to a third party contract manufacturing organization (CMO) at
the
time that MERCK became entitled to practice the manufacturing license under
section 2.12 of the SUPPLY AGREEMENT.Β Β For greater certainty, nothing
in this AGREEMENT (including this section 6.3) shall entitle MERCK to deduct
from the royalties otherwise payable by MERCK to BIOMIRA under section 6.2
the
royalties payable under the CORIXA LICENSE for which MERCK is responsible
under
section 6.2.5 of this AGREEMENT and section 2.6.1.3 of the SUPPLY
AGREEMENT.
Β
Β
ARTICLE
7
ACCOUNTING
RECORDS AND PROCEDURES
-
NA TERRITORY AND ROW TERRITORY
Β
Section
7.1
|
Royalty
Payments
|
MERCK
shall make royalty payments due BIOMIRA under article 6 of this AGREEMENT
on a
quarterly basis, within forty-five (45) days following the end of each calendar
quarter for which royalties are due.Β Β Each royalty payment shall be
accompanied by a SALES REPORT.
Β
Section
7.2
|
SALES
REPORTS
|
Within
forty-five (45) days after the end of each calendar quarter following the
first
sale of PRODUCT in the TERRITORY, MERCK shall provide BIOMIRA with a detailed
report (a "SALES REPORT") which will set forth in reasonable detail and with
reasonable supporting documentation on a country-by-country basis (for each
country in the TERRITORY):
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
7.2.1Β Β
|
the
number of units of PRODUCT sold during such calendar quarter in
such
country;
|
Β
7.2.2Β Β
|
the
total xxxxxxxx for PRODUCT during such calendar quarter in such
country
and in the TERRITORY;
|
Β
7.2.3Β Β
|
the
deductions applicable to the determination of NET SALES with respect
to
PRODUCT during such calendar quarter in such
country;
|
Β
7.2.4Β Β
|
the
NET SALES with respect to PRODUCT during such calendar quarter
in such
country;
|
Β
7.2.5Β Β
|
the
average sales price of PRODUCT during such calendar quarter in
such
country;
|
Β
7.2.6Β Β
|
the
total royalties due and the basis of the calculation thereof;
and
|
Β
7.2.7Β Β
|
such
other information as BIOMIRA may reasonably
request.
|
Β
Section
7.3
|
Records
and Audits
|
MERCK
will keep and maintain (and, to the extent applicable, will cause its AFFILIATES
and their respective sublicensees, distributors, assignees and transferees
to
keep and maintain) proper and complete records and books of account in such
form
and detail as is necessary for the determination of the amounts payable by
MERCK
(on behalf of itself and its AFFILIATES and their respective sublicensees,
distributors, assignees and transferees) to BIOMIRA under this AGREEMENT
and for
purposes of section 6.3 of this AGREEMENT.Β Β MERCK shall at least once
in each calendar year during normal business hours upon thirty (30) days
prior
written notice from BIOMIRA make those records (and, to the extent applicable,
those of its AFFILIATES and their respective sublicensees, distributors,
assignees and transferees) available for audit by an internationally recognized
accounting firm designated by BIOMIRA (except one to which MERCK shall have
objection, acting reasonably and provided such accounting firm agrees to
enter
into a confidentiality agreement with the audited party which provides
protection for confidential information which is similar to that provided
under
article 8 of this AGREEMENT) for the sole purpose of, and MERCK will only
be
required to disclose information related to, verifying such payments, revenues,
NET SALES, costs, expenses and deductions and the correctness of calculations
and classifications in respect thereof.Β Β MERCK shall preserve (and, to
the extent applicable, will cause its AFFILIATES and their respective
sublicensees, distributors, assignees and transferees to preserve) such records
made in any calendar year for a period of seven (7) years following the close
of
that calendar year.Β Β Results of any such examination shall be made
available to each of BIOMIRA and MERCK, but all backup documentation and
data
shall be made available only to such accounting firm for use only on the
premises of the audited party.Β Β In the event that such audit discloses
that the actual royalties or other amounts payable by MERCK to BIOMIRA are
greater than the royalties or other amounts paid by MERCK, then MERCK shall
pay
to BIOMIRA any additional royalties and other amounts based on the results
disclosed by such audit.Β Β In the event that such audit discloses that
the actual royalties or other amounts payable by MERCK to BIOMIRA are less
than
the royalties or other amounts paid by MERCK, then
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
Β
Section
7.4
|
Payments
from Germany
|
Unless
otherwise agreed to in writing by BIOMIRA and MERCK, MERCK will make all
payments and reimbursements to BIOMIRA under this AGREEMENT from
Germany.
Β
Section
7.5
|
Confidentiality
of Financial Reports
|
Except
as otherwise required for purposes of or permitted under this AGREEMENT and
except to the extent disclosure by BIOMIRA is required by law or any applicable
regulatory authority, BIOMIRA agrees to hold in confidence according to article
8 all information concerning royalty payments and financial reports, and
all
information learned in the course of any audit.Β Β If BIOMIRA believes,
acting reasonably, disclosure is required by law or any applicable regulatory
authority, BIOMIRA shall immediately so notify MERCK and shall provide
reasonable assistance to MERCK in maintaining MERCK's rights at MERCK's
expense.
Β
Β
ARTICLE
8
CONFIDENTIALITY
Β
Section
8.1
|
Definition
|
CONFIDENTIAL
INFORMATION is any and all information of a confidential nature including
without limitation DEVELOPMENT PLANS, COMMERCIAL MANUFACTURING PLANS, MARKETING
PLANS, any data and/or information generated under this AGREEMENT, any and
all
data and/or other information of a confidential nature which is proprietary
to
the disclosing party and not generally known (including without limitation
relating to the BIOMIRA TECHNOLOGY), and technological information not limited
to compound(s), composition(s), formulation(s) and/or, manufacturing
information, and including business information not limited to commercial
forecasts, sales, plans, programs, customers, assets, financial projections,
and
costs.
Β
Section
8.2
|
Obligations
|
Each
party agrees to hold all of the other party's CONFIDENTIAL INFORMATION received
or generated in connection with this AGREEMENT (either prior to, on, or after
the EFFECTIVE DATE) in confidence and neither disclose it to any third party
nor
allow any third party access to it nor use it for any purpose other than
as
specified by this AGREEMENT.Β Β Disclosure by a receiving party of
CONFIDENTIAL INFORMATION of the other party shall only be made to such of
its
directors, officers, employees, agents and consultants whose duties require
such
disclosure and then only if the persons to whom such CONFIDENTIAL INFORMATION
is
disclosed are bound by appropriate confidentiality undertakings.Β Β The
above notwithstanding, each of MERCK and BIOMIRA may disclose CONFIDENTIAL
INFORMATION of the other party to their respective AFFILIATES or distributors
on
a "need-to-know" basis provided such persons are bound by like terms of
confidentiality as those stated herein.
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
Section
8.3
|
Exceptions
|
These
obligations of non-disclosure and non-use shall not apply to CONFIDENTIAL
INFORMATION which:
Β
8.3.1Β Β
|
was,
at the time of disclosure, in the possession of the receiving party
(as
evidenced by its written records) and was not previously acquired
from or
on behalf of the disclosing party on a confidential
basis,
|
Β
8.3.2Β Β
|
was
in the public domain prior to disclosure, or became, after disclosure,
publicly known through no fault of the receiving party or any person
to
whom the receiving party directly or indirectly provided such CONFIDENTIAL
INFORMATION,
|
Β
8.3.3Β Β
|
was
received from a third party who rightfully made such
disclosure,
|
Β
8.3.4Β Β
|
was
approved for use or release by written authorization from the disclosing
party prior to such use or release by the receiving
party,
|
Β
8.3.5Β Β
|
is
required to be disclosed by operation of law, governmental regulation
or
court order provided the receiving party gives the disclosing party
written notice of such required disclosure prior to making such
disclosure, and the receiving party uses all reasonable effort
to
cooperate in securing confidential protection for such information;
or
|
Β
8.3.6Β Β
|
is
required to be disclosed to any governmental authority or regulatory
authority to the extent that such disclosure is reasonably necessary
to
obtain authorizations to conduct a clinical trial with and to market
commercially PRODUCTS, provided the disclosing party is otherwise
entitled
to engage in such activities under this
AGREEMENT.
|
Β
Any
specific CONFIDENTIAL INFORMATION shall not be deemed to fall within 8.3.1,
8.3.2, 8.3.3, 8.3.4, 8.3.5 or 8.3.6 above merely because it falls within
the
scope of more general information within one of these exceptions.
Β
Section
8.4
|
Term
of Confidentiality
|
These
obligations of confidentiality and non-use are binding throughout the duration
of this AGREEMENT and shall remain in force for a period of ten (10) years
from
the date of the expiration or termination of this AGREEMENT.
Β
Section
8.5
|
Return
of Information
|
Upon
termination and upon request from the disclosing party, the receiving party
agrees to promptly return all originals and copies of CONFIDENTIAL INFORMATION
received, as well as permanently delete all electronically or otherwise stored
CONFIDENTIAL INFORMATION
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
Β
Section
8.6
|
Publicity
|
8.6.1Β Β
|
Confidentiality.Β Β Neither
party may disclose any non-public information regarding the nature
and/or
occurrence of this transaction, or the nature and/or occurrence
of any
event or information occurring as a result of this transaction
without the
prior written consent of the other party (such consent not to be
unreasonably withheld), except that each of MERCK and BIOMIRA may
disclose
such information to their respective AFFILIATES that are under
like terms
of confidentiality as those stated herein without such consent
and any
such information that is required by law or any applicable regulatory
authority to be disclosed (to the extent required to be
disclosed).Β Β Where practicable, prior to any required submission
of the terms of this transaction to any governmental agency or
authority,
the disclosing party shall provide the other party with a copy
of such
submission including, without limitation, identification of any
portions
of this AGREEMENT which the disclosing party intends to redact
or intends
to request the governmental agency or authority to redact, so that
the
other party may review and comment on any such proposed
submission.Β Β The disclosing party shall initially redact
financial terms (and such other material terms as are appropriate
in the
circumstances) and will use commercially reasonable efforts to
obtain the
concurrence of the governmental agency or authority to such redaction
of
financial and other material terms.
|
Β
8.6.2Β Β
|
Press
Release.Β Β The parties shall agree on a press release to
announce the execution of this Agreement, and on a Question and
Answer
("Q&A") outline for use in responding to inquiries about this
AGREEMENT.Β Β With respect to xxxxxx xxxxx releases or other
public statements relating to the subject matter of this AGREEMENT,
including, but not limited to, webcast materials, press kits and
Q&A's, except to the extent dealing with subject matter already in
the
public domain or as required by law or any applicable regulatory
authority
(and even then to the extent practicable) and except with respect
to
information already in the public domain or previously approved
by the
other party, BIOMIRA and MERCK shall each provide to the other
party a
copy of any proposed press release and the other party shall provide
any
comments with respect thereto within the same period of time (which
shall
be specified, but shall not be less than twenty-four (24) hours)
as the
party proposing to issue such press release has permitted for its
own
internal review.Β Β If no comments are received by the issuing
party within the permitted review period, the press release in
question
shall be deemed to have been approved by the other party.Β Β If
comments are received by the issuing party within the permitted
review
period, then the issuing party shall seriously and in good faith
consider
such comments and, to the extent such comments are not incorporated
in
such press release, only the minimum legally or regulatorily required
disclosure shall be made with respect to such
matters.
|
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
8.6.3Β Β
|
Scientific
Publications.
|
Β
Each
of BIOMIRA and MERCK shall have the right to present at symposia, professional
meetings, and to publish in academic journals or other similar publications,
accounts of its research relating to the BIOMIRA TECHNOLOGY, the PRODUCT,
BIOMIRA IMPROVEMENTS, MERCK IMPROVEMENTS and JOINT IMPROVEMENTS which are
the
subject of this AGREEMENT, provided that the party proposing to present or
disclose as aforesaid shall have furnished a copy of the proposed disclosure
at
least sixty (60) days in advance of the presentation or publication date
to the
other party.Β Β Subject to article 9 of this AGREEMENT, the applicable
party(ies) shall use the sixty (60) day period to evaluate the disclosure
for
patentable content and to, if it so determines, pursue patent protection
with
respect thereto.Β Β The party proposing to present or disclose as
aforesaid shall cooperate in all respects in relation to pursuing such patent
protection on a worldwide basis.Β Β BIOMIRA or MERCK, as the case may
be, may request an additional thirty (30) day extension for obtaining patent
protection.
Β
Β
ARTICLE
9
INVENTIONS
AND PATENTS
Β
Section
9.1
|
JOINT
IMPROVEMENTS
|
All
inventions, discoveries, improvements or other technology in the FIELD and
all
processes or uses relating thereto, whether or not patentable, that arise
after
the EFFECTIVE DATE as a result of conduct under this AGREEMENT and which
BIOMIRA
and MERCK agree in writing to implement (collectively, the "IMPROVEMENTS")
made
jointly by employees or others (including, without limitation, AFFILIATES
of
MERCK) acting on behalf of BIOMIRA and MERCK (the "JOINT IMPROVEMENTS") shall
be
jointly owned by BIOMIRA and MERCK (each party shall have an undivided, one-half
interest).Β Β JOINT IMPROVEMENTS shall be managed pursuant to
sectionΒ 9.7.
Β
Section
9.2Β
|
BIOMIRA
IMPROVEMENTS
|
IMPROVEMENTS
made solely by employees or others acting on behalf of BIOMIRA (the "BIOMIRA
IMPROVEMENTS") shall be owned solely by BIOMIRA, and, in the circumstances
specified in the definition of BLP25, shall be subject to the licenses granted
to MERCK in article 2.Β Β BIOMIRA shall have the right to file,
prosecute and maintain patent protection for BIOMIRA IMPROVEMENTS to be licensed
hereunder and, with respect to such BIOMIRA IMPROVEMENTS licensed hereunder
which MERCK utilizes, MERCK shall pay one hundred percent (100%) of the
development (including clinical development), scale-up and other costs
associated therewith throughout the TERRITORY.
Β
Section
9.3Β
|
MERCK
IMPROVEMENTS
|
IMPROVEMENTS
made solely by employees or others (including, without limitation, AFFILIATES
of
MERCK) acting on behalf (including, without limitation, pursuant to any general
services or other similar agreement) of MERCK (the "MERCK IMPROVEMENTS")
shall
be owned solely by MERCK.Β Β BIOMIRA and its AFFILIATES shall have and
are hereby granted a non-exclusive, royalty-free license to practice any
such
MERCK IMPROVEMENTS that are useful in the development, manufacture or SALE
of
PRODUCTS, but only in the TERRITORY, during the term of this AGREEMENT and
solely for the purpose of exercising rights and performing obligations under
this AGREEMENT and the SUPPLY AGREEMENT.Β Β MERCK shall have the right
to file, prosecute and maintain at its cost patent protection for MERCK
IMPROVEMENTS.
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
Section
9.4
|
Determination
of Inventorship
|
Inventorship
shall be determined in accordance with U.S. patent law.
Β
Section
9.5
|
Invention
Disclosure
|
BIOMIRA
shall promptly disclose to MERCK and MERCK shall promptly disclose to BIOMIRA
any IMPROVEMENTS arising under this AGREEMENT.Β Β Each party agrees to
hold such disclosure from the other party on a confidential basis under the
same
terms regarding confidentiality as described in articleΒ 8.Β Β Each
party agrees to keep the other party informed of the filing and status of
any
patent application or patent pertaining to this AGREEMENT and shall consider
any
comments or suggestions from the other party with respect thereto.
Β
Section
9.6
|
Independent
Use of JOINT
IMPROVEMENTS
|
Within
the FIELD the use of JOINT IMPROVEMENTS shall only be for purposes of and
pursuant to the terms and conditions of this AGREEMENT and the SUPPLY
AGREEMENT.Β Β Outside of the FIELD the parties shall each be entitled to
use JOINT IMPROVEMENTS as such party determines, provided that prior to a
party
licensing any such JOINT IMPROVEMENT to a third party such party shall consult
with the other party with the aim of jointly licensing such JOINT IMPROVEMENT
to
such third party.Β Β In the absence of a joint license, neither party
may license a JOINT IMPROVEMENT to a third party without the prior written
consent of the other party.
Β
Section
9.7
|
Prosecution
and Maintenance of Joint
Patents
|
9.7.1Β Β
|
Filing,
Prosecution and Maintenance.Β Β BIOMIRA and MERCK shall
determine, with respect to each JOINT IMPROVEMENT, the procedure
and
responsibility for filing, prosecuting and maintaining patent applications
with respect to such JOINT IMPROVEMENTS.Β Β Unless otherwise
agreed in writing, all reasonable costs incurred with respect to
the
filing, prosecution and maintenance of patent applications and
patents
covering JOINT IMPROVEMENTS, including fees and expenses of patent
counsel, shall be borne equally by the parties.Β Β Notwithstanding
that one party may be delegated responsibility for filing, prosecuting
and
maintaining patent applications with respect to a particular JOINT
IMPROVEMENT, the other party must approve in writing the taking
of any
material action with respect thereto including without limitation
approving any patent application prior to filing.Β Β Both BIOMIRA
and MERCK shall have the right to participate fully in the formation
and
implementation of patent strategy.
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Β
9.7.2Β Β
|
Cooperation.Β Β Each
party shall reasonably make available to the other party or its
authorized
attorneys, agents or representatives, its employees, agents or
consultants
(including, without limitation, AFFILIATES of MERCK) necessary
or
appropriate to enable the appropriate party to file, prosecute
and
maintain patent applications and resulting patents with respect
to all
JOINT IMPROVEMENTS, for a period of time sufficient for such party
to
obtain the assistance it needs from such personnel.Β Β All
reasonable costs incurred by either party in providing such cooperation
shall be shared equally by the
parties.
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Β
9.7.3Β Β
|
Failure
to Agree.Β Β In the case of a failure of BIOMIRA and MERCK to
agree upon whether or in which countries patent applications should
be
filed and prosecuted for JOINT IMPROVEMENTS, the party which desires
to
proceed may file and prosecute the patent applications in its own
name and
at its own expense, and shall maintain such patents at its own
expense.Β Β If either BIOMIRA or MERCK wishes to discontinue its
portion of payment for maintenance of any patent on the JOINT
IMPROVEMENTS, such party may do so with prior written notice to
the other
party, and the other party may maintain such patent on the JOINT
IMPROVEMENTS at its own expense.Β Β Notwithstanding the foregoing,
either party may reacquire its rights in any patents or patent
applications in any country relating to the JOINT IMPROVEMENTS
by paying
its portion of any costs incurred by the other party to such other
party.
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Β
Section
9.8Β
|
No
Waiver
|
By
entering into this AGREEMENT, subject to the licenses granted in this AGREEMENT,
neither party waives or forfeits any of its rights to any patent that it
owns
and that exists at the EFFECTIVE DATE, or to any IMPROVEMENT that it owns
either
jointly or solely.
Β
Section
9.9
|
Cooperation
with respect to
Patents
|
The
parties acknowledge and agree that it is in their mutual interest to cooperate
with respect to the filing, prosecution and maintenance of the BIOMIRA PATENT
RIGHTS in the FIELD.Β Β Therefore, with respect to the BIOMIRA PATENT
RIGHTS in the FIELD, BIOMIRA agrees to keep MERCK informed on a regular basis
of
its patent strategy, proposed new patent applications and the filing and
status
of any patent application or patent and to consider in good faith any comments
or suggestions of MERCK with respect thereto, subject to MERCK agreeing to
appropriate safeguards with respect to the ownership of such proprietary
rights.Β Β MERCK agrees to hold such disclosure from BIOMIRA on a
confidential basis under the same terms regarding confidentiality as described
in articleΒ 8.
Β
Β
ARTICLE
10
PATENT
INFRINGEMENT
Β
Section
10.1
|
Infringement
by Third Parties
|
10.1.1Β Β
|
Notification.Β Β If
any claims in BIOMIRA PATENT RIGHTS licensed to MERCK hereunder
or in
patent rights covering a JOINT IMPROVEMENT ("JOINT IMPROVEMENT
PATENT
RIGHTS") are believed to be infringed by a third party in a country
where
PRODUCT is being or will be sold, the party first having knowledge
of such
infringement shall promptly so notify the other party in
writing.Β Β Such notice shall set forth in reasonable detail the
facts of that infringement as are then
known.
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Β
10.1.2Β Β
|
Initiating
Proceedings.Β Β BIOMIRA shall have the primary right, but not
the obligation, to initiate, prosecute, and control any action
or
proceeding with respect to such infringement.Β Β If BIOMIRA
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Β
Β
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fails
to initiate proceedings intended to remedy such infringement
within ninety
(90) days of receiving written notice of such infringement, then
MERCK may
bring and control any such action.Β Β If one party initiates
proceedings intended to remedy such infringement, then the other
party
shall be kept fully informed with respect to such proceedings
and shall be
consulted in relation to all material discussions concerning
such
proceedings.Β Β Further, the other party agrees to cooperate and
give reasonable assistance, including agreeing to be joined as
a party
plaintiff if suit is filed.Β Β The party which brings and controls
proceedings against an alleged infringer will do so at its own
expense.Β Β If the other party chooses to be represented by
counsel of its own choice in any such proceeding, then that party
may be
so represented, but at its own
expense.
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Β
10.1.3Β Β
|
Distribution
of Awards.Β Β Any monetary award received as a result of
proceedings contemplated by this section 10.1 shall
[+]
|
Β
10.1.4Β Β
|
Voluntary
Disposition.Β Β No settlement or consent judgment or other
voluntary final disposition of a suit under this section 10.1 may
be
entered into by either party without the prior consent of the other
party,
such consent not to be unreasonably
withheld.
|
Β
Section
10.2
|
Claims
Against BIOMIRA TECHNOLOGY and JOINT
TECHNOLOGY
|
10.2.1Β Β
|
Notice.
|
Β
10.2.1.1Β Β
|
If
a third party asserts that a patent or other right owned by it
is
infringed by BIOMIRA's and/or MERCK's use or sale in the manner
prescribed
in this AGREEMENT of any BIOMIRA PATENT RIGHTS, the party first
obtaining
knowledge of such claim shall immediately provide the other party
with
written notice of such claim and the related facts as are then
known, in
reasonable detail.Β Β BIOMIRA shall have the primary right, but
not the obligation to, control the defense and settlement of any
such
claim at its expense.Β Β If BIOMIRA fails to assume the control
and settlement of any such claim within ninety (90) days of receiving
written notice thereof, then MERCK may control the defense and
settlement
of such action.Β Β The controlling party shall keep the
non-controlling party fully informed with respect to all matters
in
relation to such claim and shall consult with the non-consulting
party in
relation to all material discussions concerning such claim and
the defense
thereof.Β Β The non-controlling party agrees to cooperate and
provide reasonable assistance in defending such claims.Β Β No
settlement shall be entered into without the prior written consent
of
BIOMIRA and MERCK, such consent not to be unreasonably
withheld.
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Β
10.2.1.2Β Β
|
If
a third party asserts that a patent or other right owned by it
is
infringed by the use, in the manner prescribed in this AGREEMENT,
of any
JOINT IMPROVEMENTS, the party first obtaining knowledge of such
claim
shall immediately provide the other party with written notice of
such
claim and the related facts as are then known, in reasonable
detail.Β Β Both parties shall share in the
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Β
Β
|
control
of the defense and settlement of any such claim.Β Β Each party
shall keep the other party fully informed with respect to all
matters in
relation to such claim and shall consult with the other party
in relation
to all material discussions concerning such claim and the defense
thereof.Β Β The parties agree to cooperate and provide reasonable
assistance to the other in defending such claims.Β Β No settlement
shall be entered into without the prior written consent of BIOMIRA
and
MERCK, such consent not to be unreasonably
withheld.
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Β
10.2.2Β Β
|
Damages.
|
Β
10.2.2.1Β Β
|
After
complying fully with the procedures set forth in section 10.2.1.1,
any
damages or other payments that result from a claim of infringement
as
specified in section 10.2.1.1 that are required to be paid as a
result of
reaching a settlement with a third party in the manner prescribed
in
section 10.2.1.1 or as a result of a judgment from a competent
court
(which is unappealable or with respect to which the appeal period
has
expired), shall be [+]
|
Β
10.2.2.2Β Β
|
[+]
|
Β
10.2.3Β Β
|
Royalty
Payable to Third Party.
|
Β
[+]
Β
Β
ARTICLE
11
TERM
AND TERMINATION
Β
Section
11.1
|
Term
and Expiration
|
This
AGREEMENT shall be effective as of the EFFECTIVE DATE and, unless terminated
earlier pursuant to this article 11, this AGREEMENT shall remain in force
and
effect on a country-by-country basis until the later ofΒ Β (a) [+] (b)
[+]
Β
Section
11.2
|
Early
Termination
|
This
AGREEMENT may be terminated as follows:
Β
11.2.1Β Β
|
by
mutual written agreement of BIOMIRA and MERCK, effective as of
the time
specified in such written agreement;
or
|
Β
11.2.2Β Β
|
by
either party, upon any breach of this AGREEMENT by the other party
of any
obligation to make payments required hereunder, which failure to
make
payment is not the subject of a legitimate, good faith dispute
between the
parties, provided, however, that the party alleging such breach
must first give the other party written notice thereof, which notice
must
identify the breach in reasonable detail and that the party giving
such
notice views such alleged breach as a basis for terminating this
AGREEMENT
under this section 11.2.2 and the party receiving such notice must
have
failed to cure such alleged breach within forty-five (45) days
after
receipt of such notice; or
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[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
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11.2.3Β Β
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by
either party, upon any material breach of this AGREEMENT by the
other
party, provided, however, that the party alleging such material
breach
must first give the other party written notice thereof, which notice
must
identify the breach in reasonable detail and that the party giving
such
notice views such alleged material breach as a basis for terminating
this
AGREEMENT under this section 11.2.3 and the party receiving such
notice
must have failed to cure such alleged material breach within ninety
(90)
days after receipt of such notice or, such longer period of time
as the
party alleging such material breach may agree to in writing as
a result of
the good faith efforts of the other party to resolve such material
breach
in a timely manner; or
|
Β
11.2.4Β Β
|
by
either party, in the event that the other party institutes any
proceedings
under any statute or otherwise relating to insolvency or bankruptcy,
or
should any proceedings under any such statute or otherwise be instituted
against such party and not be dismissed or vacated within ninety
(90) days
of the date of commencement of such
proceedings;
|
Β
11.2.5Β Β
|
by
MERCK upon thirty (30) days prior written notice to BIOMIRA if,
in the
exercise of MERCK's reasonable judgment, MERCK determines that
there are
issues concerning the safety or efficacy of PRODUCT which materially
adversely affects PRODUCT's medical, economic or competitive viability,
provided that if BIOMIRA does not agree with such determination
and
notifies MERCK to that effect within ten (10) days following receipt
by
BIOMIRA of MERCK's written notice of termination, the matter shall
be
submitted to binding arbitration before an expert or expert panel
in the
field of clinical drug development, such expert or expert panel
to be
appointed by BIOMIRA and MERCK in accordance with the procedure
under
section 14.7 of this AGREEMENT.
|
Β
Section
11.3Β
|
Continuing
Liability
|
Termination
of this AGREEMENT for any reason shall not release any party from any liability,
obligation or agreement which has already accrued nor affect the survival
of any
provision hereof which is expressly stated to survive such
termination.Β Β Termination of this AGREEMENT for any reason shall not
constitute a waiver or release of, or otherwise be deemed to prejudice or
adversely affect, any rights, remedies or claims, whether for damages or
otherwise, which a party may have hereunder or which may arise out of or
in
connection with such termination.
Β
Section
11.4
|
Disposition
of Inventory
|
MERCK
may dispose of its inventory of PRODUCT on hand as of the effective date
of
termination, and may fill any orders for PRODUCT accepted prior to the effective
date of termination, for a period of twelve (12) months after the effective
date
of termination, and, within thirty (30) days after disposition of such inventory
and fulfilment of such orders (and in any event within fourteen (14) months
after termination) MERCK will forward to BIOMIRA a final report and pay all
royalties or other amounts due for NET SALES in such period.
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
Section
11.5
|
Rights
and Cooperation on
Termination
|
Upon
the termination of this AGREEMENT in its entirety, or with respect to a
particular country, the parties shall cooperate so as to minimize the impact
of
such termination on both parties and BIOMIRA and its AFFILIATES shall have
the
right to use any and all preclinical and clinical trial results and related
data
relating to PRODUCT that are developed by or on behalf of BIOMIRA and/or
MERCK
(including, without limitation, MERCK's AFFILIATES) after the ORIGINAL EFFECTIVE
DATE pursuant to this AGREEMENT (including without limitation all such results
and data used or developed by MERCK in support of applications for MARKET
APPROVAL) and all MARKET APPROVALS shall be assigned to BIOMIRA or its
designated AFFILIATE by MERCK.Β Β To the extent required in connection
with the foregoing, MERCK hereby grants to BIOMIRA and its AFFILIATES an
irrevocable, non-exclusive royalty free license to use such results and data
in
the TERRITORY.
Β
Section
11.6
|
Rights
and Cooperation on
Expiration
|
Upon
expiration of this AGREEMENT with respect to a particular country as provided
for in section 11.1 of this AGREEMENT, or earlier if required to enable a
party
to continue to market PRODUCT in such country without interruption upon
expiration of this AGREEMENT with respect to PRODUCT in such country, or
if any
of the licenses granted by BIOMIRA to MERCK in this AGREEMENT with respect
to
PRODUCT in such country become non-exclusive, MERCK shall permit BIOMIRA
or its
designated AFFILIATE to utilize all MARKET APPROVALS owned by MERCK with
respect
to PRODUCT in such country and shall take all other actions reasonably necessary
to (i) in the case of MERCK, to permit MERCK to market PRODUCT in the NA
TERRITORY and the ROW TERRITORY with respect to PRODUCT in such country and
(ii)
in the case of BIOMIRA, to permit BIOMIRA or its designated AFFILIATE to
commence marketing and market such PRODUCT in the NA TERRITORY and the ROW
TERRITORY.Β Β Such actions may include, but shall not be limited to, the
filing of duplicate MARKET APPROVALS upon the other party's request and at
its
sole expense, and granting the other party permission to cross-reference,
copy
and duplicate the MARKET APPROVALS.
Β
Β
ARTICLE
12
REPRESENTATIONS
AND WARRANTIES
Β
Section
12.1
|
Corporate
Existence and Power
|
Each
party represents and warrants to the other party that, as of the EXECUTION
DATE,Β Β (a) it is a corporation duly organized and validly existing and
in good standing, under the laws of the jurisdiction of its
incorporation;Β Β (b) it has the corporate power and authority and the
legal right to own its property and assets, to lease the property and assets
it
operates under lease, and to carry on its business as it is now being conducted;
andΒ Β (c) it is in compliance with all requirements of applicable law,
except to the extent that any non-compliance would not have a material adverse
effect on the properties, business, financial or other condition of such
party
and would not materially adversely affect such party's ability to perform
its
obligations under this AGREEMENT.
Β
Section
12.2
|
Authorization
and Enforcement of
Obligations
|
Each
party represents and warrants to the other party that, as of the EXECUTION
DATE,
it has the corporate power and authority and legal right to enter into this
AGREEMENT and to perform its obligations
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
Β
Section
12.3
|
Consents
|
Subject
to section 2.3 of this AGREEMENT, each party represents and warrants to the
other party that, as of the EXECUTION DATE, all necessary consents, approvals
and authorizations of all governmental authorities and others required to
be
obtained by such party in connection with this AGREEMENT have been
obtained.
Β
Section
12.4
|
No
Conflict
|
Subject
to section 2.3 of this AGREEMENT, each party represents and warrants to the
other party that, as of the EXECUTION DATE, the execution and delivery of
this
AGREEMENT and the performance of such party's obligations hereunder do not
conflict with or violate any requirement of applicable laws or regulations,
and
do not conflict with, or constitute a default under any contractual obligation
of such party.
Β
Section
12.5
|
Authorization
of Obligations
|
The
execution, delivery and performance by each party of this AGREEMENT have
been
duly authorized by all necessary corporate action and do not and will not
(a)
require any consent or approval of its stockholders or, subject to section
2.3
of this AGREEMENT, any other third party that has not been received by the
EXECUTION DATE, (b) violate any provision of any law, rule, regulation, order,
writ, judgment, injunction, decree, determination or award presently in effect
that have applicability to it or any provision of its charter documents or
(c)
result in a breach of or constitute a default under any material agreement,
mortgage, lease, license, permit or other instrument or obligation to which
it
is a party or by which it or its properties may be bound or
affected.
Β
Section
12.6
|
BIOMIRA
Representations
|
12.6.1Β Β
|
BIOMIRA
represents and warrants to MERCK that as of the ORIGINAL EFFECTIVE
DATEΒ (but subject to section 2.3 and the need to
obtain the consents of the licensees under the THIRD PARTY
LICENSES):
|
Β
12.6.1.1Β Β
|
to
BIOMIRA's knowledge after due inquiry, BIOMIRA is the sole owner
of, or
the exclusive licensee or sublicensee (on the terms described in
the
applicable licensee agreement) in the NA TERRITORY and the ROW
TERRITORY
of the BIOMIRA PATENT RIGHTS and the BIOMIRA KNOW-HOW in existence
as at
the ORIGINAL EFFECTIVE DATE, with the right to grant to MERCK the
rights
granted in this AGREEMENT, free and clear (except to the extent
specified
in the THIRD PARTY LICENSES) of any liens or encumbrances which
would
prevent or impair the grant of such
rights;
|
Β
12.6.1.2Β Β
|
BIOMIRA
has not assigned or conveyed any interest in the BIOMIRA PATENT
RIGHTS or
the BIOMIRA KNOW-HOW in existence as at the ORIGINAL EFFECTIVE
DATE and
licensed to MERCK under this AGREEMENT, or entered into any agreement
or
made any commitment which is inconsistent with or in derogation
of the
rights granted to MERCK hereunder;
|
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[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
12.6.1.3Β Β
|
as
at the ORIGINAL EFFECTIVE DATE, BIOMIRA has not received from any
third
party any written notice to the effect that the BIOMIRA PATENTS
or the
BIOMIRA KNOW-HOW infringe the proprietary rights of any such third
party;
|
Β
12.6.1.4Β Β
|
there
is no action, suit, proceeding, alternative dispute resolution,
mediation
or investigation pending or, to the knowledge of BIOMIRA, threatened
against BIOMIRA relating to the BIOMIRA PATENT RIGHTS or the BIOMIRA
KNOW-HOW;
|
Β
12.6.1.5Β Β
|
to
BIOMIRA's knowledge after due inquiry, no third party rights are
required
in order to enable MERCK to enjoy the licenses granted by BIOMIRA
to MERCK
under this AGREEMENT;
|
Β
12.6.1.6Β Β
|
to
BIOMIRA's knowledge after due inquiry, the ICRT LICENSE and the
XXXX-XXXXXX LICENSE are in full force and effect and BIOMIRA has
no
knowledge of any breach or action by BIOMIRA which might give rise
to a
breach under such licenses.
|
Β
12.6.2Β Β
|
BIOMIRA
represents and warrants to MERCK that as of the EXECUTION DATE,
to
BIOMIRA's knowledge after due inquiry, BIOMIRA has disclosed and/or
transferred to MERCK all material BIOMIRA KNOW-HOW in BIOMIRA's
possession
as at the EXECUTION DATE required, in BIOMIRA's opinion, acting
reasonably, to enable MERCK to assume the additional rights and
obligations under this AGREEMENT to be assumed by MERCK as specified
in
the letter of intent dated January 26, 2006 referred to in the
third
recital to this AGREEMENT.
|
Β
Section
12.7
|
No
Further Representations or
Warranties
|
Except
as expressly provided in this article 12 or any other provision of this
AGREEMENT, neither party makes any representation or warranty of any kind
to the
other party, express or implied.
Β
Section
12.8
|
Survival
of Representations and
Warranties
|
The
representations and warranties contained in this AGREEMENT shall survive
the
ORIGINAL EFFECTIVE DATE or the EXECUTION DATE, as applicable, for a period
of
one (1) year.
Β
Β
ARTICLE
13
INDEMNIFICATION
INDEMNIFICATION
Β
Section
13.1
|
Indemnification
by BIOMIRA
|
Subject
to the terms and conditions of this AGREEMENT, BIOMIRA shall indemnify and
hold
MERCK (and any affiliated corporation and their respective officers, directors,
shareholders, employees and agents) (collectively, the "MERCK INDEMNITEES"),
free and harmless from any and all claims, demands, liabilities, losses,
actions
or causes of actions, and any and all expenses associated therewith
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
Β
Section
13.2
|
Indemnification
by MERCK
|
Subject
to the terms and conditions of this AGREEMENT, MERCK shall indemnify and
hold
BIOMIRA (and any affiliated corporation and their respective officers,
directors, shareholders, employees and agents) (the "BIOMIRA INDEMNITEES"),
free
and harmless from any and all claims, demands, liabilities, losses, actions
or
causes of actions, and any and all expenses associated therewith (including,
without limiting the generality of the foregoing, reasonable defenses costs
and
attorney's fees), arising out of or in connection with, or that are the result
of, or are otherwise related to:Β Β (i) actions and proceedings brought
by any regulatory authority against any of the BIOMIRA INDEMNITEES concerning
PRODUCT, for or on account of the alleged unapproved or unauthorized
introduction by MERCK, its AFFILIATES or their respective distributors,
sublicensees and agents of PRODUCT in interstate or intrastate commerce anywhere
in the world;Β Β (ii) any claim, complaint, suit, proceeding or cause of
action against any of the BIOMIRA INDEMNITEES alleging physical injury,
including death as a result of the acts or omissions of MERCK, its AFFILIATES
or
their respective employees, distributors, sublicensees and agents, except
to the
extent attributable to any one or more of the BIOMIRA
INDEMNITEES;Β Β (iii) MERCK's, its AFFILIATES' or their respective
distributors', sublicensee's or agents' non-compliance with any applicable
laws
or regulations, except to the extent attributable to any one or more of the
BIOMIRA INDEMNITEES;Β Β (iv) any failure of MERCK to perform, in whole
or in part, any of its obligations hereunder, except to the extent attributable
to any one or more of the BIOMIRA INDEMNITEES;Β Β Β (v) MERCK's, its
AFFILIATES' or their respective distributors', sublicensee's or agents'
marketing and SALE of PRODUCT, except to the extent attributable to any one
or
more of the BIOMIRA INDEMNITEES; orΒ Β (vi) for the period specified in
section 12.8, any breach by MERCK of any of its representations or warranties
under this AGREEMENT.
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
Section
13.3
|
Procedure
|
The
indemnified party shall give prompt written notice to the indemnifying
party(ies) of any suits, claims or demands by third parties or the indemnified
party which may give rise to any loss for which indemnification may be required
under this article 13; provided, however,Β that failure to
give such notice shall not impair the obligation of the indemnifying party
to
provide indemnification hereunder except if and to the extent that such failure
materially impairs the ability of the indemnifying party to defend the
applicable suit, claim or demand.Β Β The indemnifying party shall be
entitled to assume the defense and control of any suit, claim or demand of
any
third party at its own cost and expense; provided, however, that the
other party shall have the right to be represented by its own counsel at
its own
cost in such matters.Β Β In the event that the indemnifying party shall
decline to assume control of any such suit, claim or demand, the party entitled
to indemnification shall be entitled to assume such control, conduct the
defense
of, and settle such suit, claim or action, all at the sole cost and expense
of
the indemnifying party.Β Β Neither the indemnifying party nor the
indemnified party shall settle or dispose of any such matter in any manner
which
would adversely impact the rights or interests of the other party without
the
prior written consent of the indemnified party, which shall not be unreasonably
withheld.Β Β Each party shall cooperate with the other party and its
counsel in the course of the defense of any such suit, claim or demand, such
cooperation to include using reasonable efforts to provide or make available
documents, information and witnesses.
Β
Β
ARTICLE
14
MISCELLANEOUS
Β
Section
14.1
|
Force
Majeure
|
Any
delay in the performance of any of the obligations of either party (except
for
the payment of money) shall not be considered a breach of this AGREEMENT
and the
time required for performance shall be extended for a period equal to the
period
of such delay, provided that such delay has been caused by or is the result
of
(including without limitation in relation to third party contractors and
suppliers) any act of God, acts of the public enemy; insurrections; riots;
embargoes; labour disputes such as strikes, lockouts or boycotts; fires;
explosions; floods; earthquakes; mudslides; or other unforeseeable causes
beyond
the control of the party so affected.Β Β The party so affected shall
give prompt notice to the other party of such cause, and shall take whatever
reasonable steps are necessary to relieve the effect of such cause as rapidly
as
reasonable.
Β
Section
14.2
|
Independent
Contractor
|
Execution
of each party's responsibilities under this AGREEMENT is solely under the
direction and control of each respective party as an independent contractor,
and
not as an employee or agent of the other party.
Β
Section
14.3
|
Survival
|
Such
provisions of this AGREEMENT that, by their nature, would be expected to
survive
termination of this AGREEMENT, including without limitation sections 7.3,
7.5,
11.3, 11.4, 11.5, 11.6, 14.6, 14.9 and 14.14 and articles 8 and 13 shall
survive
any such termination.
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
Section
14.4
|
Notice
|
Whenever
any notice is to be given hereunder, it shall be in writing and shall be
deemed
received on the day delivered, if delivered by courier on a business day,
or if
sent by first-class certified or registered mail, postage prepaid, to the
following addresses:
Β
BIOMIRA:
Biomira
B.V.
575
A Boelelaan
1082
RM Amsterdam
The
Netherlands
Attention:Β Β Office
Administrator
Facsimile:Β Β 020-540-8909
Β
with
a copy to:
0000
- 00 Xxxxxx
Xxxxxxxx,
XxxxxxxΒ Β X0X
0X0
Xxxxxx
Attention:Β Β President
Facsimile:Β Β (000)
000-0000
Β
MERCK:
Merck
XXxX
Xxxxxxxxxxx
Xxxxxxx 000
D-64293
Darmstadt
Germany
Attention:Β Β Corporate
Legal
Department
Facsimile:Β Β x00-0000-00-0000
Β
Section
14.5
|
Waivers
|
No
waiver of any term, provision, or condition of this AGREEMENT, whether by
conduct or otherwise, in any one or more instances, shall be deemed to be
construed as a further or continuing waiver of any such term, provision,
or
condition of this AGREEMENT unless reduced to writing signed by an authorized
representative of each party.
Β
Section
14.6
|
Applicable
Law
|
This
agreement shall be construed under the substantive laws of England, without
reference to its conflicts of laws provisions.
Β
Section
14.7Β
|
Dispute
Resolution
|
Should
any dispute arise between the parties concerning this AGREEMENT, the parties
agree to first attempt to resolve the dispute in good faith.Β Β If
within fifteen (15) days of one party providing written notice of such dispute
to the other party such dispute is not resolved, then the parties agree to
continue to attempt to resolve the dispute in good faith through meetings
between a member of MERCK's Pharmaceutical Executive Management Board and
the
President of BIOMIRA before resorting to any other forum for a
remedy.Β Β If resolution of the dispute is not reached between the
Presidents within twenty (20) days of either party submitting such dispute
in
writing to the Presidents, then the parties shall within the next following
fifteen (15) day period initiate binding arbitration in London, England under
the rules
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
Β
Section
14.8
|
Assignment
|
The
parties agree that this AGREEMENT is personal in nature and, except for transfer
by BIOMIRA to any of BIOMIRA's AFFILIATES, this AGREEMENT may not be assigned
or
otherwise transferred, nor may any right or obligations hereunder be assigned
or
transferred directly or indirectly by either party, whether voluntary, by
operation of law or otherwise, without the written consent of the other party,
such consent not to be unreasonably withheld.Β Β In connection with
BIOMIRA determining whether to consent to an assignment, the parties agree
that
BIOMIRA shall be deemed to be acting reasonably if it withholds its consent
in
circumstances where the proposed assignee is not a corporation of equal or
greater financial resources, marketing strength and expertise (including
in the
cancer area), and stature in the pharmaceutical industry as
MERCK.Β Β Any purported assignment in violation of this section 18.8
shall be void.Β Β Notwithstanding the foregoing, either party may,
without such consent, assign or novate this AGREEMENT and its rights and
obligations hereunder in connection with the transfer or sale of all or
substantially all of its business, through merger, consolidation or change
in
control or similar transaction after first giving the other party written
notice
of such event.Β Β Pursuant to any such assignment, any permitted
assignee shall assume all rights of the assignor under this AGREEMENT, and
pursuant to any such novation, any permitted novatee shall assume all rights
and
obligations of the novator under this AGREEMENT.
Β
Section
14.9
|
Standstill
|
14.9.1Β Β
|
Subject
to sections 14.9.3 and 14.9.4 of this AGREEMENT and the equity
issuance
provisions of the STOCK PURCHASE AGREEMENT, MERCK undertakes and
agrees
that, without the express prior written consent of BIOMIRA, it
shall not
directly, or indirectly through any associate, Affiliate or otherwise,
at
any time hereafter and prior to the date which is six (6) years
after the
ORIGINAL EFFECTIVE DATE:
|
Β
14.9.1.1Β Β
|
acquire,
agree to acquire or make any proposal or offer to acquire, directly
or
indirectly or in any manner, legal or beneficial ownership of or
an option
or other right to acquire:
|
Β
14.9.1.1.1Β Β
|
any
securities of BIOMIRA or any of its AFFILIATES;
or
|
Β
14.9.1.1.2Β Β
|
any
assets of BIOMIRA or any of its AFFILIATES from any person which
has
itself acquired such assets by reason of its acquisition of securities
of
BIOMIRA or any of its AFFILIATES where such person's acquisition
of
securities of BIOMIRA or any of its AFFILIATES was pursuant to
an
understanding, whether formal or informal, that MERCK would or
may acquire
such assets from such person;
|
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
14.9.1.2Β Β
|
make
any "solicitation" of "proxies" (as such terms are used under United
States securities laws) to vote, or seek to advise or influence
any person
with respect to the voting of, any securities of BIOMIRA or any
of its
AFFILIATES;
|
Β
14.9.1.3Β Β
|
institute
any shareholder proposal in respect of BIOMIRA or any of its
AFFILIATES;
|
Β
14.9.1.4Β Β
|
propose
any combination, directly or indirectly, of the business or assets
of
BIOMIRA or any of its AFFILIATES by way of arrangement, merger,
takeover
bid, amalgamation or otherwise;
|
Β
14.9.1.5Β Β
|
otherwise
attempt to influence or control the conduct of the security holders
of
BIOMIRA or any of its AFFILIATES;
or
|
Β
14.9.1.6Β Β
|
engage
in any discussions or negotiations with or enter into any agreement,
commitment or understanding, whether formal or informal, with or
otherwise
act jointly or in concert with any person or persons with respect
to any
of the foregoing.
|
Β
14.9.2Β Β
|
The
rights and restrictions set forth in this section 14.9 shall, at
MERCK's
option, terminate ifΒ Β (i) any person (other than MERCK directly
or indirectly through any associate, AFFILIATE or otherwise) acquires
nineteen percent (19%) or more of the common shares of Biomira
Inc.,
orΒ Β (ii) a formal "take-over bid" (as defined under Alberta
securities legislation) is made by a person (other than MERCK directly
or
indirectly through any associate, AFFILIATE or otherwise) for fifty
percent (50%) or more of the voting securities of Biomira
Inc.Β Β Additionally, BIOMIRA shall advise MERCK upon becoming
aware of any person (other than MERCK directly or indirectly through
any
associate, AFFILIATE or otherwise) who acquires ten percent (10%)
or more
of the common shares of Biomira
Inc.
|
Β
14.9.3Β Β
|
BIOMIRA
shall have the right to waive or terminate this section 14.9 at
any time
upon written notice to MERCK.
|
Β
14.9.4Β Β
|
Notwithstanding
the provisions of this section 14.9, nothing in this section 14.9
shall be
construed as prohibiting MERCK from acquiring up to nineteen percent
(19%)
of the common shares of Biomira
Inc.
|
Β
Section
14.10
|
Currency
|
All
payments to be made under this AGREEMENT shall be made in United States
dollars.Β Β The currency in which NET SALES were invoiced shall be
converted to United States dollars on the date of payment of the royalty
due
using the applicable commercial rate of exchange for buyingUS
dollars with the currency that is the average of the closing buying rates
for
such currency for the quarter for which such payments are due, quoted as
local
currency per US $1, as established and published by the European Central
Bank.
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
Section
14.11
|
Payment
of taxes
|
Each
of BIOMIRA and MERCK shall be responsible for any and all taxes and other
similar levies or charges properly assessed against payments received by
such
party from the other party under this AGREEMENT.Β Β If applicable laws
or regulations require that taxes be withheld on such payments, the withholding
party will in a timely manner notify the other party in writing specifying
the
details thereof and shall:
Β
14.11.1Β Β
|
deduct
those taxes from the amount of such payment due to the receiving
party,
|
Β
14.11.2Β Β
|
pay
the taxes to the proper taxing authority in a timely manner,
and
|
Β
14.11.3Β Β
|
send
proof of payment to the receiving party within sixty (60) days
following
that payment.
|
Β
The
parties agree to cooperate to reduce the amount of any such deductions and
to
obtain the benefit of any tax treaty with respect to such
deductions.Β Β Further, the withholding party shall cooperate with the
receiving party in obtaining for the receiving party a credit or refund for
any
such taxes, levies or charges.Β Β Neither party shall be required under
this concluding paragraph of section 14.11 to act in a manner which is
financially detrimental from a taxation perspective to such party.
Β
Section
14.12
|
Interest
|
Any
late payments of any nature under this AGREEMENT shall bear interest, running
from the date such payment was due until such payment is made in full, at
a rate
per annum equal to the average three (3) month US dollar LIBOR rate (as
published from time to time by Reuters) plus one percent (1%).
Β
Section
14.13
|
Sublicensees
|
In
addition to the requirements of sections 2.1 and 2.3 of this AGREEMENT, in
the
event MERCK utilizes any AFFILIATE or third party to distribute PRODUCT
(directly or indirectly) for MERCK in the TERRITORY or otherwise sublicenses
any
of the licensed rights under this AGREEMENT, the agreement with such AFFILIATE
or third party shall include an obligation for such third party to comply
with
the provisions of this AGREEMENT on the same basis as if such SALES were
made by
MERCK, and MERCK shall for all purposes under this AGREEMENT treat the net
sales
of PRODUCT of the sublicensee as NET SALES of MERCK.
Β
Section
14.14
|
Limitation
|
Notwithstanding
any other provision to the contrary in this AGREEMENT, other than with respect
to applicable third party product liability and patent infringement claims,
the
maximum aggregate liability of BIOMIRA under this AGREEMENT and the SUPPLY
AGREEMENT shall not exceed the amounts paid by MERCK to BIOMIRA up to the
time
in question under this AGREEMENT and the SUPPLY AGREEMENT (including, for
greater certainty, payments by MERCK under this AGREEMENT and the SUPPLY
AGREEMENT with respect to shared costs, equity purchases and
milestones).Β [+]
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
Section
14.15
|
Severability
|
If
any provision of this AGREEMENT is held to be illegal or unenforceable, that
provision shall be limited to the minimum extent necessary or, if necessary,
eliminated, so that this AGREEMENT shall otherwise remain enforceable and
in
full force and effect
Β
Section
14.16
|
Integration
Clause
|
This
agreement is the sole agreement with respect to the subject matter hereof,
and
supersedes all proposals, negotiations, conversations, discussions, agreements
and/or representations, whether oral or written, including any industry custom
or past dealing between the parties relating to the subject matter of this
AGREEMENT.Β Β The parties agree that any and all obligations between the
parties that are outside the terms of this AGREEMENT and that relate to the
subject matter of this AGREEMENT that preceded
theΒ EFFECTIVE DATE of this AGREEMENT have been
satisfactorily executed or are null and void.
Β
Section
14.17
|
U.S.
Dollars
|
Unless
otherwise provided, any reference in this AGREEMENT to dollars shall be to
U.S.
dollars.
Β
Section
14.18
|
Indirect
Costs
|
Except
to the extent specifically otherwise set forth in this AGREEMENT, any provision
of this AGREEMENT requiring costs or expenses to be shared by BIOMIRA and
MERCK
or to be paid or reimbursed by one party to the other shall be read as referring
to direct costs and/or expenses and as excluding indirect costs (including
administration, support, depreciation, facility rental, repair and maintenance,
utilities, insurance, taxes, cost of capital, and the like) except to the
extent
that the STEERING COMMITTEE determines that to exclude a particular indirect
cost is inequitable as between BIOMIRA and MERCK.
Β
Section
14.19Β
|
Amendment
of Agreement
|
No
change, modification, extension, termination, waiver or other amendment of
this
AGREEMENT or any of the provisions contained herein, shall be valid unless
made
in writing and signed by a duly authorized representative of each
party.
Β
Section
14.20
|
Third
Parties
|
A
person who is not a party to this AGREEMENT has no rights under the Contracts
(Rights of Third Parties) Xxx 0000 to enforce any term of this
AGREEMENT.
Β
Section
14.21
|
No
Further Representations or
Warranties
|
Each
party acknowledges that it has not relied on or been induced to enter this
AGREEMENT by a representation or warranty other than those expressly set
out in
this AGREEMENT.Β Β A party is not liable to the other party for a
representation or warranty that is not set out in this AGREEMENT, including
any
warranty implied by statute.
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
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Β
Section
14.22Β
|
Acknowledgement
|
Notwithstanding
that the parties have attempted to make specific reference in certain provisions
of this AGREEMENT, MERCK acknowledges and agrees that, to the extent that
MERCK
retains or uses AFFILIATES or third parties to perform services or obligations
on behalf of MERCK for purposes of this AGREEMENT, MERCK shall ensure for
the
benefit of BIOMIRA that, in such circumstances, the same rights are extended
to
BIOMIRA as if the services or obligations in question had been performed
directly by MERCK.Β Β Similarly, BIOMIRA acknowledges and agrees, to the
extent that BIOMIRA retains or uses AFFILIATES or third parties to perform
services or obligations on behalf of BIOMIRA for purposes of this AGREEMENT,
BIOMIRA shall ensure for the benefit of MERCK that, in such circumstances,
the
same rights are extended to MERCK as if the services or obligations in question
had been performed directly by BIOMIRA.
Β
Section
14.23Β
|
Non-solicitation
|
During
the term of this AGREEMENT, without the prior written consent of the other
party, neither party shall knowingly solicit for hire any existing employee
of
the other party.
Β
Section
14.24
|
Counterparts
|
This
AGREEMENT may be executed in several counterparts, each of which when so
executed shall be deemed to be an original and shall have the same force
and
effect as an original but such counterparts together shall constitute but
one
and the same instrument.
Β
This
AGREEMENT is agreed to and accepted by:
Β
Merck
KGaA
Β
By:__________________________________
Β
Title:_________________________________
Β
AND
Β
By:__________________________________
Β
Title:_________________________________
Β
|
Biomira
B.V.
Β
By:__________________________________
Β
Title:_________________________________
Β
Β
Β
Β
[IN
DUPLICATE]
Β
|
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR CONFIDENTIALITY
PURPOSESΒ
|
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Β
BIOMIRA KNOW-HOW
[+]
Β
Β
Β
Β
Β
Β
Β
Β
Β
Β
Β
Β
Β
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR
CONFIDENTIALITY
PURPOSESΒ
|
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Β
Β
[+]
Β
Β
Β
Β
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR
CONFIDENTIALITY
PURPOSESΒ
|
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Β
BIOMIRA PATENT RIGHTS
[+]
Β
Β
Β
Β
Β
Β
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR
CONFIDENTIALITY
PURPOSESΒ
|
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Β
Β
PROTOCOL
FOR PHASE III CLINICAL TRIAL OF BLP25 FOR NON-SMALL CELL LUNG
CANCER
Β
[+]
Β
Β
Β
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR
CONFIDENTIALITY
PURPOSESΒ
|
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Β
COMPENSATION
Β
Β |
Hourly
|
Daily
|
Weekly
|
Monthly
|
Executive
|
[+]
|
[+]
|
[+]
|
[+]
|
Management
|
[+]
|
[+]
|
[+]
|
[+]
|
Professional
|
[+]
|
[+]
|
[+]
|
[+]
|
Technical
|
[+]
|
[+]
|
[+]
|
[+]
|
Support
|
[+]
|
[+]
|
[+]
|
[+]
|
*
All amounts in the above table are in U.S. dollars.
Β
Executive
Β Β Β Β Β Β Β Β Vice
Presidents
Β Β Β Β Β Β Β Β Senior
Director,
Clinical Operations
Β
Management
Β Β Β Β Β Β Β Β Directors,
Project
Management
Β Β Β Β Β Β Β Β Manager,
Financial
Planning & Analysis
Β Β Β Β Β Β Β Β Director,
Regulatory
Affairs
Β Β Β Β Β Β Β Β Manager,
Regulatory
Affairs
Β Β Β Β Β Β Β Β Director,
Immunology
Β Β Β Β Β Β Β Β Director,
Quality
Β Β Β Β Β Β Β Β Director,
Biopharmaceutical Development
Β Β Β Β Β Β Β Β Director,
Product
Development & Manufacturing
Β Β Β Β Β Β Β Β Manager,
Quality
Assurance & Compliance
Β Β Β Β Β Β Β Β Manager,
Quality
Control
Β Β Β Β Β Β Β Β Manager,
Chemical
Development
Β Β Β Β Β Β Β Β Manager,
Analytical
Development
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Professional
Β Β Β Β Β Β Β Β Accountants
Β Β Β Β Β Β Β Β Quality
Specialists
Β Β Β Β Β Β Β Β Quality
Control
Specialists
Β Β Β Β Β Β Β Β Development
Scientists
Β Β Β Β Β Β Β Β Manufacturing
Specialists
Β Β Β Β Β Β Β Β Research
Scientists
Β
Technical
Β Β Β Β Β Β Β Β Quality
Control
Analysts
Β Β Β Β Β Β Β Β Development
Specialists
Β Β Β Β Β Β Β Β Development
TechniciansΒ Β Β Β Β Β
Β
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PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR
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PURPOSESΒ
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Β Β Β Β Β Β Β Β Research
Associates
Β
Support
Β Β Β Β Β Β Β Β Documentation
Analysts
Β Β Β Β Β Β Β Β Administrative
Assistants
Β
Β
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TRADEMARKS
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TRADE-XXXX
STATUS FOR STENVAX
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[+]
Β
TRADE-XXXX
STATUS FOR STIMRIS
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[+]
Β
Β
[+]Β Β Β Β Β Β Β Β Β Β Β DESIGNATES
PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED FOR
CONFIDENTIALITY
PURPOSESΒ
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