DISTRIBUTION AGREEMENT BY AND BETWEEN ALTAREX MEDICAL CORP. AND DOMPÉ INTERNATIONAL S.A.
June
8,
2004
BY
AND
BETWEEN
ALTAREX
MEDICAL CORP.
AND
DOMPÉ
INTERNATIONAL S.A.
page
1 of
35
TABLE
OF CONTENTS
| ARTICLE | PAGE NO | |
|
Article
1.
|
Appointment.
|
4
|
|
Article
2.
|
Purchases
of Product by Distributor.
|
5
|
|
Article
3.
|
Responsibilities.
|
10
|
|
Article
4.
|
Promotion;
Trials; Training.
|
13
|
|
Article
5.
|
New
Products.
|
15
|
|
Article
6.
|
Limited
Warranty; Indemnifications.
|
16
|
|
Article
7.
|
Limitations
on Liability.
|
18
|
|
Article
8.
|
Term
and Termination.
|
19
|
|
Article
9.
|
General
Provisions.
|
20
|
|
Article
10.
|
Language
of Agreement.
|
23
|
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35
COLLABORATION
AND DISTRIBUTION AGREEMENT
This
Distribution Agreement is entered into this ____ day of _________, 2004 (the
“Effective Date”) by and between AltaRex Medical Corp. a Canadian Corp., having
offices at 1123 Dentistry/Pharmacy Building, University of Alberta, Xxxxxxxx,
Xxxxxxx, X0X 0X0, Xxxxxx (hereinafter “AltaRex”) and Dompé International S.A., a
company incorporated under the laws of Switzerland, having offices at World
Trade Center, Avenue de Xxxxxx Xxxxxx, 1-2, CH 1000 Xxxxxxxx 00, Xxxxxxxxxxx
(hereinafter “Distributor”).
WITNESSETH:
WHEREAS
AltaRex is engaged in the business of manufacturing and selling antibodies
for
cancer and related products.
WHEREAS
the product covered by this Agreement is specified on Annex A
hereto
and referred to herein as the “Product.”
WHEREAS
AltaRex desires to distribute and sell the Product in Switzerland, Austria,
Spain, Portugal and certain Eastern European countries (Ukraine, Belarus,
Hungary, Poland, Czech Republic, Italy, Republic of San Marino and Vatican
City
Yugoslavia, Lithuania, Estonia and Latvia) (each such jurisdiction referred
to
as a “Market” and collectively as the “Territory”)
WHEREAS
Distributor is in the business of selling and distributing products in the
Territory.
WHEREAS
Distributor desires to distribute the Product in the Territory and to perform
all necessary and appropriate marketing and customer service
functions.
WHEREAS
AltaRex has entered and will enter into distributor agreements for the Product
with other third parties for distribution in other areas outside of the
Territory.
WHEREAS
AltaRex has not yet identified the location and the factory where to manufacture
the Product.
WHEREAS
AltaRex has not decided yet whether the final packaging will be manufactured
in
US or in Europe.
NOW,
THEREFORE, intending to be legally bound hereby, AltaRex and Distributor
(the
“Parties”) agree as follows:
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35
|
ARTICLE1.
|
APPOINTMENT.
|
1.1 Appointment.
(a) AltaRex
appoints Distributor as its exclusive distributor during the term of this
Agreement for the purpose of selling and distributing the Product in the
Territory, and Distributor hereby accepts such appointment.
Such
appointment shall be subject to the terms and conditions set forth in this
Agreement. Distributor may market, promote, distribute and sell the Product
either directly or through a third party in the Territory, so long as (i)
AltaRex has approved in writing Distributor’s use of such third party as a
subdistributor, such approval not to be unreasonably withheld or delayed
by
AltaRex; and (ii) such third party has acknowledged in writing that it shall
comply with the terms and conditions of this Agreement. A third party that
AltaRex has so approved and which has provided the written acknowledgement
described in part (ii) above shall hereafter be referred to as a
“Subdistributor.” Distributor hereby guarantees that each Subdistributor shall
comply with the terms and conditions set forth in this Agreement.
The
Product shall be sold in the Territory under the name of Distributor or
Subdistributor, as the case may be, with attribution to AltaRex in accordance
with AltaRex’s written instructions.
Should
AltaRex or other Third Parties connected with Altarex develop new dosage
and/or
formulations of the Product, the Agreement will be automatically extended
to
include such improvements without changing the economics of this
Agreement.
Since
AltaRex has not identified yet the production source of the Product and has
not
decided yet whether the final packaging shall be made in US or directly in
Europe (by Distributor), all the conditions governing the manufacturing,
forecast and purchases could be subject to renegotiation by the Parties without
affecting the percentage of cost agreed in this Agreement.
1.2 Territorial
Limitations.
(a) Distributor
shall not establish or maintain any branch, warehouse or distribution facility
for the Product outside of the Territory. Distributor shall not engage in
any
promotional activities relating to the Product directed primarily to customers
outside the Territory. Distributor shall not solicit orders from any prospective
purchaser located outside the Territory.
(b) If
Distributor receives any order from a prospective purchaser outside the
Territory, Distributor shall immediately refer that order to AltaRex.
Distributor shall not accept any such orders. Distributor may not deliver
or
tender (or cause to be delivered or tendered) any Product outside of the
Territory. The Distributor shall not sell or cause to be sold or knowingly
participate in an endeavour that will see Products sold or distributed outside
of Territory.
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ARTICLE
2.
|
PURCHASES
OF PRODUCT BY DISTRIBUTOR.
|
2.1 Purchases
and Shipments.
(a) Distributor
and its Subdistributors shall purchase and maintain an inventory of the Product
sufficient to meet the reasonable needs of their respective customers, but
in no
event shall such inventory be less than the projected 30-day purchase
requirements of their then-current customers. Purchase orders for the Product
shall be in form and substance satisfactory to AltaRex, and shall be subject
to
written acceptance by AltaRex. Distributor shall purchase all of its
requirements for Product as well as those of its Subdistributors from
AltaRex.
(b) AltaRex
shall sell each unit of Product to the Distributor at a price equal to the
greater of:
|
i)
|
40%
of the Retail Selling Price (as hereafter defined);
or
|
|
ii)
|
$720.00
(USD);
|
(the
“Supply Price”).
AltaRex
shall be responsible for all packaging costs, transportation and insurance
costs
for shipping the Product to the F.O.B. location hereinafter specified; and
all
governmental taxes, duties and customs applicable for shipping the Product
to
such F.O.B. locations; provided
that
, the
Distributor shall be responsible for the payment, collection and remittance
of
all sales or value-added taxes that may arise in respect of the
Product.
Should
AltaRex not be in the position to find a supplier that will commit to supplying
Product to AltaRex at a price and on terms and conditions satisfactory to
AltaRex, acting reasonably, then the Parties shall convene in order to discuss
in good faith how to proceed. If a satisfactory compromise is not reached
between the Parties within nine (9) months starting from the beginning of
the
negotiations, Distributor is entitled to terminate the Agreement with immediate
effect without paying any indemnification to AltaRex and without AltaRex
having
any obligation to indemnify the Distributor or any Subdistributor.
The
Retail Selling Price for each unit will be set in US Dollars, for each Market,
based on the quoted exchange rates between U.S. Dollars and the local currencies
as of the date the Retail Selling Price is set in each Market by the State;
provided, however, that if the Retail Selling Price in a Market is or becomes
lower than $1,800 (USD) (such price being set in U.S. Dollars as per the
preceding mechanism) or if there is a dramatic (more than 5%) change in the
average quoted exchange rates (i.e. the simple average of the U.S. Dollar
and
the local currency over a 10 day period) between U.S. Dollars and the local
currency after the date the Retail Selling Price is set in the Market as
hereinbefore provided; then, the parties will negotiate an appropriate solution
in good faith. The parties further agree that they shall only be able to
rely
upon the foregoing proviso to negotiate an appropriate solution in good faith
up
to two times per Marketing Year (as hereafter defined), and not more frequently,
due to a dramatic change in the average quoted exchange rates. Provided,
however,
that if
the parties do not agree upon such a solution in writing within one hundred
and
twenty (120) days after AltaRex requests such a negotiation, then AltaRex
may ,
effective immediately, remove from the Territory that Market for which the
parties cannot reach a solution. Quoted exchange rates shall be determined
by
referencing the most recently quoted exchange rates in the Wall
Street Journal,
New York
Edition.
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Distributor
may from time to time request that AltaRex reduce its Supply Price in light
of
current conditions on a Market-by-Market basis, and AltaRex agrees to negotiate
in good faith with Distributor in those situations. All orders received by
AltaRex from Distributor and accepted by AltaRex shall be delivered F.O.B.
through an as yet to be determined European location designated by AltaRex
as
soon as practicable; provided,
however,
AltaRex
shall not be responsible for delays, at its facilities or those of any custom
third manufacturer of the Product, caused by governmental orders or
requirements, transportation conditions, labeling or material shortages,
strikes, fires or any other cause beyond AltaRex’s control.
Distributor
and its Subdistributors expressly release AltaRex from any and all liabilities
for any loss or damage arising from the inability of AltaRex (1) to fill
or
accept any orders which are not submitted within the required lead time as
specified in this Section 2.1; or (2) to fill or accept orders due to documented
unavailability of the Product from AltaRex’s suppliers; provided, however, that
if AltaRex is not able to fill the entire amount of one of Distributor’s orders
submitted within the required lead time due to such unavailability, AltaRex
shall allocate the quantity of Product which is then available between
Distributor and AltaRex’s other distributors and customers in Europe and the
Middle East (A) during the first Marketing Year, on a pro rata basis, in
accordance with the rolling forecasts of Distributor in accordance with Section
2.1(f) below, on one hand, and the forecasts and/or purchases (as the case
may
be) of AltaRex’s other distributors and customers, on the other hand, in Europe
for the Product; and (B) thereafter on a pro rata basis, in accordance with
the
actual sales in the immediately preceding twelve (12) month period.
For
the
purposes of this Agreement, “Retail Selling Price” means the:
|
i)
|
“ex-factory
reimbursement price” that the state initially sets or thereafter resets or
recognizes (as published in applicable journals of each applicable
Market)
in each Market where the state agrees to reimburse for the Product;
or
|
|
ii)
|
“ex-factory
price” which is the actual retail selling price, in each Market, where
the
state does not agree to reimburse for the Product, at which the
Distributor sells the Product to the
patient.
|
The
Distributor hereby confirms, and otherwise covenants with AltaRex, that
applicable laws in each Market require that the Product offered from AltaRex
for
a particular Market at the Retail Selling Price, applicable for such Market,
shall only be sold in that Market.
(c) First
Year Estimate. Distributor
shall, within six (6) months after AltaRex has filed its Market Authorization
Application (“MAA”) with the European Agency for the Evaluation of Medicinal
Products (“EMEA”) or upon AltaRex obtaining approval of such application,
whichever occurs first, provide AltaRex with a written estimate of the quarterly
product requirements of Distributor and its Subdistributors to be supplied
by
AltaRex for the following 12-month period for each Market in the Territory,
based on the applicable labeling and delivery dates. AltaRex acknowledges
that
such quantities are estimates only and are non-binding.
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(d) First
Order. AltaRex
and Distributor shall cooperate fully in estimating and scheduling production
for the first commercial order for product in accordance with Section 2.1(c)
above for each Market in the Territory, based on the applicable labeling
and
delivery dates.
(e) First
Firm Order. Distributor
shall place its first firm order three (3) months in advance of the requested
delivery date. At the same time, Distributor shall provide to AltaRex an
estimate of its the quarterly requirements of Distributor and its
Subdistributors to be supplied by AltaRex for the following twelve- (12)
calendar month period for each Market in the Territory, based on the applicable
labeling and delivery dates.
(f) Rolling
Forecast. Thereafter,
Distributor shall provide quarterly to AltaRex a rolling twelve (12) month
projection of Distributor’s and its Subdistributors’ requirements to be supplied
by AltaRex, with the first three (3) months of such projection consisting
of
firm purchase orders and the remaining nine (9) months of such projection
consisting of Distributor’s best estimate forecast of those
requirements.
(g) Purchase
Order Acceptance. Within
ten (10) days after receipt of firm purchase orders, AltaRex shall confirm
to
Distributor its acceptance of the purchase order, delivery date and quantity
ordered by Distributor. AltaRex will be entitled to reject an order only
(1) for
Force Majeure reasons, (2) if such order is not submitted with the required
lead
time as specified in this Section 2.1 or (3) if AltaRex is not required to
fill
or accept such order due to documented unavailability, in accordance with
Section 2.1(b). Upon acceptance of the order, AltaRex shall deliver the
quantities ordered in accordance with Section 2.1(b) above.
(h) Firm
Order Changes. If,
due
to significant unforeseen circumstances, Distributor requests changes to
firm
orders within the three (3) month firm purchase order timeframe, AltaRex
shall
attempt, without incurring any additional cost or expense for either Party,
to
accommodate the changes within reasonable manufacturing capabilities and
efficiencies.
(i) Distributor
may not cancel any purchase order or part thereof covered by this
Agreement.
(j) Product
ordered by Distributor shall be packed for shipment and storage in accordance
with the packaging requirements imposed by relevant governmental authorities
in
the Territory. AltaRex shall pack the Product in accordance with Distributor’s
written instructions complying with local governmental regulations which
are
communicated to AltaRex from time to time with respect to such packaging
requirements. AltaRex shall bear the cost of complying with such packaging
requirements, so long as AltaRex’s costs are not greater than ten (10%) percent
of the costs which AltaRex would have incurred if it had packed the Product
in
compliance with the EMEA packaging requirements for the Product. For the
sake of
clarification, AltaRex shall absorb this additional cost up to 10% above
its
EMEA packaging costs, without increasing the price of the Product to
Distributor. To the extent that those local packaging requirements impose
additional costs on AltaRex of greater than ten (10%) percent of the costs
which
AltaRex would have incurred if it had just packed the Product in compliance
with
the EMEA packaging requirements for the Product, then the parties agree to
divide those additional costs equally between them. AltaRex shall deliver
the
Product into the possession of a common carrier designated by Distributor
at the
F.O.B. point as yet to be determined European location designated by AltaRex;
provided,
however,
if
Distributor does not designate a common carrier by the delivery date of a
purchase order, AltaRex may do so on their behalf. Risk of loss and damage
to a
Product shall pass to Distributor, as the case may be, upon the delivery
of such
Product to the designated location. All claims for non-conforming shipments
must
be made in writing to AltaRex within fifteen working days (15) days after
receipt of the Product by Distributor at the agreed location. Any claims
not
made within such period shall be deemed waived and released.
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If
the
Parties fail to agree as to whether a delivered quantity of Product is in
compliance with the relevant specifications, then the Parties agree to have
said
quantity analysed by a recognised independent testing laboratory selected
upon
mutual agreement. The laboratory’s conclusion as to the claimed defect of
non-compliance shall be deemed final. If the claimed defect of non-compliance
is
confirmed, AltaRex will bear the cost of such testing. If said quantity is
determined to be non-defective and compliant, then Distributor shall bear
all
cost of the independent laboratory testing.
(k) Distributor
understands that the Product to be purchased may require a validated export
license to be obtained by AltaRex from the United States Department of Commerce.
Distributor and its Subdistributors agree to assist AltaRex in obtaining
any
such required license by supplying appropriate documentation requested by
AltaRex. Distributor and its Subdistributors also agree to comply with United
States Export Administration Regulations as in effect from time to time and
will
not re-export the Product anywhere outside of the Territory. . Where required,
Distributor and its Subdistributors agree to obtain similar assurances from
their respective customers. Distributor and its Subdistributors will also
maintain the necessary records to comply with United States Export
Administration Regulations. Distributor agrees to indemnify and hold harmless
AltaRex from any and all costs and expenses incurred by AltaRex as a result
of
the Distributor’s or any of its Subdistributor’s breach of this Section 2.1(k).
Any order which has been accepted by AltaRex but which cannot be fulfilled
due
to decrees, statutes, rules and regulations of the United States shall be
considered to have been rejected when submitted to AltaRex.
(l) In
the
event of any discrepancy between any purchase order accepted by AltaRex and
this
Agreement, the terms of this Agreement shall govern.
2.2 Purchase
Minimum.
During
the twelve (12) month period commencing on the date on which the first Product
is launched in any Market in the Territory (such period hereinafter referred
to
as a “Marketing Year”) and then for the following two (2) Marketing Years,
Distributor agrees to purchase a designated number of units (“Purchase Minimum”)
of the Product in the amounts set out for each region as identified in Annex
B
(to be mutually agreed on between Manufacturer, Distributor and Subdistributor
for Spain and Portugal no later than six (6) months from the Effective Date
and
attached hereto; provided,
however,
that if
such Purchase Minimums are not agreed to by that date, this Agreement expires,
effective immediately and without notice. Distributor shall launch the Product
in the Territory as soon as possible after receiving Marketing Approval in
any
Market in the Territory and after publication of the applicable decree in
the
official gazette for such Market, but in no event later than 60 days after
such
publication. On or before the date which is six (6) months prior to the end
of
the third (3rd)
Marketing Year, the Parties shall negotiate in good faith on Purchase Minimums
for each of the fourth (4th)
and
subsequent Marketing Years. If the Parties cannot agree on such Purchase
Minimums by the end of the third (3rd)
Marketing Year, the Purchase Minimum shall be (i) for the 4th
Marketing Year, equal to the higher of the Purchase Minimum for the
3rd
Marketing Year or 110% of amounts actually sold during the 3rd
Marketing Year; (ii) for the 5th
Marketing Year, equal to the higher of the Purchase Minimum for the
4th
Marketing Year or 105% of amounts actually sold during the 4th
Marketing Year; and (iii) for the 6th
and all
subsequent Marketing Years, the Purchase Minimum for the 5th
Marketing Year.
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XxxxXxx
agrees to discuss in good faith modifications to the Purchase Minimum in
the
event that: (a) a product problem arises; or (b) competition develops; or
(c)
regulatory restrictions are imposed.
Notwithstanding
anything in this Section 2.2 to the contrary, (A) if AltaRex is unable to
supply
Product to Distributor due to unavailability, as described in Section 2.1(b)(2)
above, then the amount of any of Distributor’s or its Subdistributors’ orders
submitted within the required lead time as specified in this Section 2.1
which
is not filled or accepted shall be credited towards the Purchase Minimum
described above, as if it has been purchased by Distributor; and (B) if during
any Marketing Year the number of units of Product sold in each Market of
the
Territory by Distributor and its Subdistributors as a percentage of the total
ovarian cancer population in the Territory (“Market Penetration Rate”) equals or
exceeds the unweighted average of the Market Penetration Rate as calculated
in
similar manner for the same Marketing Year for Germany and France and Italy,
then Distributor shall not be deemed to be in breach of its obligation under
this Section 2.2.
2.3 Manufacturing
improvements.
In case
of improvements of the current manufacturing process of the Product, Distributor
shall have the right to directly use and benefit from such new manufacturing
processes of the Product at no charge.
2.4 Payments.
All
amounts due and payable with respect to a Product delivered by AltaRex in
accordance with this Agreement shall be paid in full, within ninety (90)
days
after AltaRex delivers that Product at the FOB point in accordance with Section
2.1(b) above. All such amounts shall be paid to the bank and for the account
indicated in the invoice Whenever any amount hereunder is due on a day that
is
not a working day, such amount shall be paid on the next such working day.
Amounts hereunder shall be considered to be paid as of the day on which funds
are received by AltaRex’s bank. All amounts due and owing to AltaRex hereunder
but not paid by Distributor on the due date thereof shall bear interest at
the
rate of the lesser of: (i) the . Bank of Canada prime rate as published in
the
New York edition of the Wall Street Journal, plus 100 basis points (i.e,
1.0%);
and
(ii) the
maximum lawful interest rate permitted under applicable law. Such interest
shall
accrue on the balance of unpaid amounts from time to time outstanding, from
the
date on which portions of such amounts become due and owing until payment
thereof in full; provided, however, that if an unpaid amount is disputed,
interest shall not accrue on such amount unless such dispute is resolved
in
favor of AltaRex (in which case the interest shall accrue from the original
due
date).
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|
ARTICLE
3.
|
RESPONSIBILITIES.
|
3.1 Scope
of Distributor Responsibility.
Distributor shall use reasonable commercial efforts(for the purposes herein
“reasonable commercial efforts” shall mean in respect of an objective the
reasonable, diligent, good faith efforts to accomplish such objective as
the
Distributor would normally use to accomplish a similar objective in similar
circumstances) in
the
promotion, marketing, distributing and sale of the Product in the Territory
and
in providing services to all customers and prospective customers for the
Product. Distributor shall comply with all policies that are established
from
time to time by AltaRex with respect to its distributors and the sale and
marketing of the Product. Specifically, Distributor shall:
(a) Maintain
suitable sales offices and Product inventory storage facilities;
(b) Employ
and assign adequate personnel to sales and promotion activities with respect
to
the Product in the Territory; furnish such personnel with adequate supplies
of
the Product for demonstrations to and evaluations by potential customers;
and
provide training for such personnel as to the use of the Product and cause
such
personnel to attend training schools or meetings, to support and aid in the
sale
of Product, including without limitation as specified in Section 4.4
hereof; (c) Contact
promptly any prospective customer whose name is furnished to Distributor
by
AltaRex;
(d) The
Distributor covenants to store, care, handle and keep Products in a manner
consistent with all applicable laws, EMEA and any relevant health authority’s
regulations, directives, etc. for each applicable Market. Further, the
Distributor shall only represent and warrant performance characteristics,
mode
of use, efficacy of treatment matters, etc. in respect of the Product to
the end
users of the Product in the manner that may be authorized by the respective
health authorities in each Market.
(e) Promptly
provide reports reasonably required by AltaRex related to any regulatory
recalls
and product notices no later than fifteen (15) days after any such request,
specifying the purchaser, the date of sale and AltaRex’s serial or lot number of
the Product sold (so as to facilitate AltaRex’s ability to maintain records
concerning product traceability). For Product resold by a Subdistributor,
Distributor shall require such Subdistributor to provide AltaRex with the
same
reports within the same time period, as may be reasonably required by AltaRex
related to any regulatory recalls and product notices.
(f) Arrange
for the preparation and submission of import licenses for the import of the
Product into each Market, as necessary; provided,
however,
that
AltaRex is responsible for obtaining relevant product certifications
(e.g.,
UL, CE,
ISO 9001), where required. The testing and the shipment expenses incurred
by
Distributor in connection with the preparation and submission of the import
licenses (beyond testing and expenses related to product certifications)
shall
be borne by Distributor. Distributor shall receive the importer’s portion of all
such import licenses and AltaRex shall receive the exporter’s portion of all
such import licenses.
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35
(g) Submit
to
AltaRex a detailed marketing plan for each Marketing Year, including without
limitation all relevant product and marketing information. AltaRex shall
review
each such marketing plan in good faith and shall offer comments to the extent
that it deems appropriate.
(h) During
the first five (5) years following the date on which Distributor obtains
Marketing Approval in any Market in the Territory, not manufacture, purchase,
sell or resell monoclonal antibody products in the Territory which are used
to
treat indications for which the Product has received Marketing Approval in
any
Market in the Territory.
3.2 Establish
Pricing.
Distributor, with the assistance of AltaRex, shall be responsible for obtaining
pricing authorization in each Market in the Territory; provided,
however,
that
Distributor shall be free to establish its own pricing for Product which
it
resells. Distributor shall consult with AltaRex prior to establishing such
pricing, but shall have no obligation to follow recommendations made by AltaRex
with respect to pricing.
3.3 Costs
and Expenses.
All
costs to Distributor of discharging the responsibilities set forth above
shall
be borne by Distributor. AltaRex shall not reimburse Distributor for any
expenses which Distributor might incur in connection with: (a) soliciting
sales
of the Product; or (b) otherwise discharging its responsibilities under this
Agreement, unless expressly agreed to by the Parties prior to incurring such
expense.
3.4 Regulatory
Requirements
(a) AltaRex
will comply with the applicable U.S. Food and Drug Administration (“FDA”) and
EMEA regulations or other applicable regulatory agency in each country of
the
Territory with respect to each Product purchased by Distributor under the
terms
hereof. AltaRex shall maintain serial number records such that the serial
number
for each Product can, if necessary for tracing or recall purposes, be identified
back to the manufacturing lot. Distributor shall maintain and cause its
Subdistributors to maintain, serial number records such that a serial number
for
each product can, if necessary for tracing or recall purposes, be identified
for
each end purchaser.
(b) Distributor
shall supply any information in Distributor’s possession with respect to Product
adverse events, Product complaint history and with any other information
that
AltaRex may reasonably request, for the Product in order to enable AltaRex
to
obtain Marketing Approvals in each Market. AltaRex at its own cost will
be
responsible for obtaining Marketing Approvals in the Territory. Distributor
shall furnish assistance to AltaRex in its efforts to obtain Marketing Approval
from EMEA, and Marketing Approval for each Market in the Territory from the
applicable government authorities in each such Market. Distributor shall
cooperate fully with AltaRex in AltaRex’s submitting and prosecuting
applications for such Marketing Approvals, including without limitation a
coordinated approach for achieving an accelerated approval with EMEA and
in the
various Markets of the Territory.
(c) Distributor
shall be responsible for obtaining and maintaining in good standing all required
permits, licenses and regulatory approvals (other than Marketing Approvals)
necessary or advisable to import, market, sell and distribute the Product
in all
Markets of the Territory. Distributor shall be responsible for completing
all
work necessary to obtain all required regulatory approvals (other than Marketing
Approvals) for the Product in all Markets of the Territory. AltaRex shall
be
solely responsible for compliance with the laws of the Territory with respect
to
the Product, including but not limited to those relating to design, testing,
packaging, sterilization, and delivery of each Product, and Distributor does
not
assume any risk arising out of AltaRex’s failure to comply with said
laws.
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35
(d) Distributor
shall be responsible for including any and all applicable patent numbers
on
Product labeling, promotional literature and other public domain documents
as
requested by AltaRex and shall otherwise comply with applicable patent marking
laws in each Market where products are sold.
3.5
Documentation;
Reports; Review, Access to Data.
(a) No
later
than ten (10) working days after the end of each calendar month, Distributor
shall provide AltaRex with a written report specifying the actual sales of
each
Product in the Territory by Distributor and its Subdistributors during the
prior
calendar month. Distributor shall provide AltaRex with such documentation
and
other reports regarding those activities as AltaRex may reasonably
request.
(b) Distributor
shall immediately report to AltaRex (but not later than three (3) working
days
after the date of notice to Distributor), any customer complaints or adverse
event reports reported to Distributor or any of its Subdistributors, or of
which
Distributor or any of its Subdistributors or agents, including sales
representatives, are otherwise made aware. Distributor shall also provide
any
follow-up information regarding any complaint or customer report as reasonably
requested by AltaRex.
(c) AltaRex
shall permit Distributor, upon reasonable notice and at Distributor’s expense,
to examine, review and audit AltaRex’s facilities, processes, suppliers (in the
case of suppliers the Distributor shall only perform such inspection if it
is in
the presence of a representative of AltaRex), in a manner to be determined
by
AltaRex acting reasonably and any information prepared and maintained by
AltaRex
in connection with its activities described in this Agreement in order to
determine and verify AltaRex’s and/or its suppliers’ compliance with Good
Manufacturing Practices and the Medical Device Directive. Conversely, the
Distributor shall permit AltaRex, upon reasonable notice and at AltaRex’s
expense, to examine, review and audit the Distributor’s facilities in a manner
to be determined by AltaRex acting reasonably, and any information prepared
and
maintained by AltaRex in connection with its activities described in this
Agreement in order to verify Distributor’s compliance with Good Manufacturing
Practices and the Medical Device Directive.
(d) Distributor
shall be given access to clinical and other data available to AltaRex and
its
other distributors and other resellers, to the extent such data may be useful
in
order to obtain required approvals in the Territory and for marketing purposes.
Likewise, AltaRex shall be given access to clinical and other data available
to
the Distributor, to the extent such data may be useful in order to obtain
required approvals outside the Territory, to comply with reporting requirements
imposed by regulatory authorities in and outside the Territory (including
without limitation reporting on adverse events) and for marketing purposes.
Each
Party shall have a non-exclusive, royalty-free, perpetual right to use data
which it receives during the term of this Agreement in connection with obtaining
and maintaining required approvals and making related regulatory filings
and for
marketing purposes.
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(e) AltaRex
shall provide to the Distributor a copy of each “Product Safety Update Report”
submitted to EMEA and other summary information in such detail as AltaRex
shall
determine is reasonable and appropriate regarding Adverse Events that have
occurred worldwide.(f) The
Distributor shall maintain at its principal place of business, or such other
place as may be most convenient, separate accounts and records of business
done
pursuant to this Agreement, such accounts and records to be in sufficient
detail
to enable proper reports to be made under this Agreement. The books and records
shall be maintained in accordance with generally accepted accounting principles
applied on a consistent basis. The Distributor shall retain the accounts
and
records referred to herein for at least six (6) years after the date upon
which
they were made and shall permit a duly authorized representative of AltaRex
to
inspect such accounts and records during normal business hours of the
Distributor at AltaRex’s expense. The Distributor shall furnish such reasonable
evidence as such representative will deem necessary to verify the reports
received hereunder have been prepared properly and will permit such
representative to make copies or extracts from such accounts, records and
agreements at AltaRex’s expense. AltaRex shall have the right on an annual basis
to fully audit the Distributor’s accounts, records and accounting during normal
business hours. If any such annual audit discloses that the gross sales of
the
Distributor reported to AltaRex have been understated by more than 5%, the
Distributor shall pay all costs associated with the audit; otherwise, AltaRex
shall pay all costs.
3.6 Obligations
Imposed by AltaRex’s Licensor.
AltaRex
manufactures the Product pursuant to an amended and restated license agreement
granted between AltaRex and Biomira, Inc (“Biomira”) as of September 3, 1999
(the “Biomira License Agreement”). As a condition to that license, AltaRex is
required to impose on its various distributors the obligations set out in
Annex
C hereto. Distributor hereby agrees to abide by and comply with each of those
obligations. Distributor and its Subdistributors shall have no obligation
to:
(i) pay any amounts directly to Biomira pursuant to the Biomira License
Agreement; or (ii) to pay any additional amounts to AltaRex pursuant to the
Biomira License Agreement.
|
ARTICLE
4.
|
PROMOTION;
TRIALS; TRAINING.
|
4.1 Promotional
Materials.
AltaRex
may from time to time provide to Distributor, materials and guidelines,
brochures, videos, literature or other promotional material prepared or used
by
AltaRex to market the Product (“Marketing Materials”), but such items shall
remain the property of AltaRex. Distributor shall not make any change or
modification to any such Marketing Materials without the prior written approval
of AltaRex, which shall not be unreasonably withheld. Distributor agrees
to use
such Marketing Materials to the best advantage in promoting sales of the
Product
in the Territory.
4.2 Trial
Materials.
If
AltaRex is required to conduct additional clinical trials in Spain and Portugal
in order to gain Regulatory Approval, and upon the availability of cell
culture-produced Product, AltaRex will supply cell culture-produced Product
for
and conduct a 35 patient trial of the Product in Spain and Portugal at
Distributor’s expense. AltaRex shall supply, at no charge to the Distributor,
enough cell-culture produced Product for this 35 patient trial. Such separate
trial shall be conducted by Distributor using a protocol supplied by AltaRex
and
agreed upon by the Parties. Any and all costs for either trial (other than
the
Product, as described above) will be borne exclusively by the Distributor.
The
data resulting from any such trial, and any other pertinent information thereto,
will be the property of AltaRex.
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Distributor
shall be given access to clinical and other data available to AltaRex and
its
other licensees and resellers, to the extent such data may be useful in order
to
obtain required pricing approval in the Territory and for marketing purposes;
provided that, AltaRex does not breach other third party contracts in providing
such information and, upon request, AltaRex shall provide reasonable written
evidence of such contractual limitation.
4.3 Performance
Claims and Warranties.
With
respect to all units of the Product bought by Distributor from AltaRex
hereunder, Distributor shall, upon its resale thereof to its customers, deliver
to such customers such printed warranties with respect to the Product as
shall
be furnished by AltaRex to Distributor for that purpose. AltaRex’s obligations
with respect to the Product shall be limited to those furnished by AltaRex
in
writing to Distributor.
4.4 Trademarks,
Service Marks and Trade Names.
(a) Right
to Use.
Distributor may use AltaRex’s trademarks, trade names and service marks listed
in Annex D
attached
hereto (hereinafter referred to as the “Trademarks”) in the Territory on an
exclusive basis (except for Trademarks specified in Annex D as being granted
on
a non-exclusive basis) only for the duration of this Agreement and solely
for
display or marketing purposes in connection with selling and distributing
the
Product in accordance with this Agreement. Distributor shall not at any time
do
or permit any act to be done which may in any way impair the rights of AltaRex
in the Trademarks. Distributor shall promptly and completely apprise AltaRex
of
any actual, threatened or suspected infringement in the Territory of any
Trademarks and/or the use of confusingly similar names and/or marks, and
shall
take, at AltaRex’s expense, any and all actions which AltaRex may reasonably
instruct the Distributor to take in order to terminate such infringements
and/or
the use of confusingly similar names and/or marks; provided,
however,
that
Distributor shall not take any action to terminate such infringements and/or
the
use of confusingly similar names and/or marks without AltaRex’s prior written
consent or pursuant to AltaRex’s prior written instructions. Except as provided
above, the Distributor has no rights in the Trademarks or of any goodwill
associated therewith and the Distributor agrees that, except as expressly
provided in this Agreement, it shall not acquire any rights in respect thereof
and that all such rights and goodwill are, and shall remain, vested in
AltaRex.
(b) Quality
Control.
In
order to comply with AltaRex’s quality control standards, the Distributor shall:
(i) use the Trademarks in compliance with all relevant laws and regulations
in
force in the Territory; (ii) obtain AltaRex’s prior written approval of each use
of the Trademarks, which approval shall not be unreasonably withheld by AltaRex;
(iii) accord AltaRex the right to request samples in order to confirm that
the
Distributor’s use of such Trademarks is in compliance with AltaRex’s standards
and guidelines then in effect; and (iv) not modify any of the Trademarks
in any
way and not use any of the Trademarks on or in connection with any goods
or
services other than the Product. AltaRex shall retain the ultimate discretion
in
determining how its trademarks should be displayed on the Product packaging
and
all marketing materials used for the Product.
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(c) Promotion
on Internet.
Distributor shall not engage in any marketing activities in respect of the
Product on the Internet.
(d) Domain
Names, Marks, Corporate Names and Meta-Tags.
In no
event shall Distributor: (i) establish, operate, sponsor or contribute content
to any site on the Internet which incorporates the word “AltaRex,” any of
AltaRex’s trademarks, service marks or trade names (the “Marks”) or any
variation or part of such word or Xxxx as its URL address or any part of
such
address; (ii) register any domain name which incorporates the Marks (and
Distributor hereby agrees to transfer such domain name to AltaRex if it breaches
this provision); (iii) register any of AltaRex’s Marks or any Marks that are
confusingly similar to any of AltaRex’s Marks; (iv) form (or change the name of)
any corporation or other entity under or to a name which incorporates any
of
AltaRex’s Marks; or (v) upon termination or expiration of this Agreement, use
“AltaRex,” any Marks or any variation thereof or part thereof as a meta-tag in
order to attract visitors to any site on the Internet.
4.5 Training. Distributor
shall provide sales training to all personnel and representatives of Distributor
engaged in the sale and distribution of the Product and ensure that qualified
sales and distribution representatives are marketing and selling the Product
in
the Market. AltaRex may provide Distributor with (i) AltaRex’s standard sales
training manuals; and (ii) in-person sales training support by AltaRex’s
personnel knowledgeable about the Product as agreed by the Parties from time
to
time. AltaRex shall advise Distributor of AltaRex’s scheduled sales training
meetings in Canada or such other locations and shall invite Distributor’s and
Subdistributor’s personnel and representatives to attend such meetings.
Distributor and Subdistributor shall bear all costs associated with the travel
and lodging of Distributor’s and Subdistributor’s personnel and representatives
in connection with such sales training meetings.
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ARTICLE
5.
|
NEW
PRODUCTS.
|
For
the
purposes of this Article 5, “Other Product” shall mean each additional antibody
for cancer which is under development by AltaRex during the term of this
Agreement, once such antibody enters Phase II clinical trials in the United
States or Europe. As of the Effective Date, “Other Products” includes BrevaRex®,
AR54, ProstaRex™ and GivaRex™ antibodies.
Should
AltaRex decide to market and distribute an Other Product, prior to negotiating
with third parties, AltaRex will invite Distributor to enter into negotiations
with AltaRex regarding those distribution rights. Should AltaRex and Distributor
not come to an agreement within 90 days, AltaRex shall be free to enter into
negotiations with third parties with respect to distribution rights for such
Other Product; provided,
however,
that if
the terms and conditions ultimately agreed to by AltaRex and such third party
are less favorable to AltaRex than terms and conditions last offered by AltaRex
to Distributor during the 90 day negotiation period described above, then
AltaRex shall offer those less favorable terms and conditions to Distributor
before entering into any such agreement with such third party. If Distributor
does not indicate any acceptance or rejection of such offer in writing within
fifteen (15) working days after receipt thereof, then Distributor shall be
deemed to have rejected such offer.
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ARTICLE
6.
|
LIMITED
WARRANTY; INDEMNIFICATIONS.
|
6.1 AltaRex
warrants that on the date of delivery of each unit of the Product to the
designated location and for the shelf life of the Product when stored and
handled in accordance with the specifications and labelled conditions approved
by the relevant governmental authorities the Product (i) shall meet all
specifications for the shelf life, (ii) shall not be adulterated or misbranded
at the time of shipment, and (iii) shall be packaged, labeled and suitable
for
promotion and sale for the indication in accordance with the applicable
Marketing Approval, in each case as in effect at the time of shipment. AltaRex
will, within a reasonable period of time (in no event longer than 45 days)
and
without charge, replace at its cost any non-conforming Product. Such replacement
shall be Distributor’s exclusive remedy and AltaRex’s sole liability under this
limited warranty. To bring a claim under this Limited Warranty, Distributor
should contact AltaRex to obtain information on warranty performance;
Distributor must be given a Return Authorization Number by AltaRex before
returning any Product to AltaRex.
6.2 AltaRex
warrants that to the best of its knowledge no applied or issued patent and/or
trademark would infringe or would be infringed by the promotion, distribution
or
sale of the Product in the Territory as contemplated by the Agreement;
provided,
however,
that so
long as AltaRex satisfies its indemnification obligations under Section 6.4
below, Distributor agrees that it will not have any right to recover further
damages.
6.3 No
Other Warranties.
THE
PROVISIONS OF THE FOREGOING WARRANTIES ARE IN LIEU OF ANY OTHER WARRANTY,
WHETHER EXPRESS OR IMPLIED, WRITTEN OR ORAL (INCLUDING ANY WARRANTY OF
MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE OR
NON-INFRINGEMENT).
6.4 Indemnifications.
(a) Distributor
hereby agrees to indemnify, defend and hold harmless AltaRex, its Affiliates
and
all officers, directors, employees and agents thereof from all liabilities,
claims, damages, losses, costs, expenses, demands, suits and actions (including
without limitation legal fees (on a solicitor and client full indemnity basis),
expenses and settlement costs) (collectively, “Damages”) arising out of: (i)
Distributor’s breach of any of its obligations under this Agreement; (ii)
Distributor’s failure to comply with applicable laws and regulations in the
Market where the Product is resold or (iii) Distributor’s making representations
or warranties which are not authorized by AltaRex hereunder.
(b) AltaRex
hereby agrees to indemnify, defend and hold harmless Distributor, its Affiliates
and all officers, directors, employees and agents thereof from all Damages
arising out of: (i) AltaRex’s breach of any of its obligations under this
Agreement; (ii) the Product infringing on the intellectual property rights
of
third parties or misappropriating any trade secrets of third parties; (iii)
personal injuries or damages suffered by third parties due to the Product
not
compliant to the warranty set forth in Section 6.1 hereto; or (iv) personal
injuries or damages suffered by third parties due to intrinsic or hidden
defects
of the Products.
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(c) In
the
event a claim is based partially on an indemnified claim described in Sections
6.3(a) and/or 6.3(b) above and partially on a non-indemnified claim, or is
based
partially on a claim described in Section 6.3(a) above and partially on a
claim
described in Section 6.3(b) above, any payments and reasonable legal fees
incurred in connection with such claims are to be apportioned between the
Parties in accordance with the degree of cause attributable to each
Party.
(d) The
indemnified Party under this Section 6.3 hereby agrees that (i) the indemnified
Party shall provide prompt written notice of any such claim to the indemnifying
Party; (ii) the indemnifying Party shall have sole control and authority
with
respect to the defense or settlement of any such claim; and (iii) the
indemnified Party shall cooperate fully with the indemnifying Party, at the
indemnifying Party’s sole cost and expense, in the defense of any such claim.
Any settlement of any such claims that imposes any liability or limitation
on
the indemnified Party shall not be entered into without the prior written
consent of the indemnified Party.
(e) In
the
event that any Product is held in a suit or proceeding to infringe any
intellectual property rights or misappropriate any trade secrets of a third
party and the use of such Product is enjoined, or AltaRex reasonably believes
that it is likely to be found to infringe or likely to be enjoined, then
AltaRex
shall, at its sole cost and expense, either (i) procure for Distributor the
right to continue distributing such Product; or (ii) modify such Product
so that
it becomes non-infringing. If AltaRex determines, in its sole discretion,
that
neither (i) nor (ii) are commercially practicable, then AltaRex may terminate
this Agreement with respect to such Product upon giving Distributor ninety
(90)
days prior written notice, and, upon any such termination, repurchase the
Products which Distributor purchased from AltaRex and which are unaltered
and in
saleable condition, at the price which Distributor paid AltaRex for such
Products, upon delivery of such Products to AltaRex's designated facility,
at
AltaRex's expense, as well as transportation expenses paid by Distributor
in
order to withdraw such Product.
(f) AltaRex
shall have no obligation for any claim of infringement arising from: (i)
any
combination of the Product with products not supplied or approved in writing
by
AltaRex, where such infringement would not have occurred but for such
combination; (ii) the adaptation or modification of the Product not performed
by
AltaRex, where such infringement would not have occurred but for such adaptation
or modification; (iii) the use of the Product in an application for which
it was
not designed, where such infringement would not have occurred but for such
use;
or (iv) a claim based on intellectual property rights owned by Distributor,
its
Subdistributors or any of their Affiliates.
(g) This
Section 6.4 is the Distributor’s and its Subdistributors’ sole and exclusive
remedy in the event that a Product infringes on the intellectual property
right
of, or misappropriates the trade secrets of, any third party.
(h) The
Distributor shall give AltaRex notice of any acts of infringement by third
parties involving AltaRex’s technology, the Product or AltaRex’s patent rights
of which the Distributor receives knowledge and AltaRex need not consult
with
the Distributor to determine the course of action, if any, to be taken in
such
circumstances. AltaRex shall use all reasonable efforts to defend the AltaRex
technology, the Product or AltaRex’s patent rights against any such infringement
at AltaRex’s sole expense. The Distributor may, at its sole discretion, assist
AltaRex in proceeding against an infringer. Any compensation received in
a
settlement or any legal proceedings shall, after the Distributor and AltaRex
have covered their respective reasonable third party costs, legal costs (on
a
solicitor and client full indemnity basis) and expenses related to such action,
be paid entirely to AltaRex.
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(i) If
AltaRex fails to bring suit or take action against such third party, the
Distributor may elect to take action and AltaRex shall within thirty (30)
days
of such election provide the Distributor with all relevant information about
the
circumstance of such infringement or unauthorized use, including such evidence
of infringement as AltaRex may possess. Any suit or action by the Distributor
shall be either in the name of the Distributor, or in the name of AltaRex,
or
jointly by the Distributor and AltaRex. AltaRex shall provide all reasonable
assistance to the Distributor, including without limitation executing all
documents as may be reasonably requested by the Distributor in connection
with
such suit or action. Any compensation received in a settlement or any legal
proceedings shall, after the Distributor and AltaRex have covered their
respective reasonable third party costs, legal costs (on a solicitor and
client
full indemnity basis) and expense related to such action, be entirely for
the
Distributor.
(j) Each
party shall promptly notify the other in the event of the receipt of notice
of
any action, suit or claim alleging infringement by the Product of a patent
held
by a third party. AltaRex shall use all reasonable commercial efforts to
defend
any action, suit or claim brought against the Distributor as a result of
such
infringement and bear all costs and expenses related thereto. The Distributor
shall, at AltaRex’s expense, provide reasonable assistance to AltaRex including,
without limitation, executing all documents as may be reasonably requested
by
AltaRex in connection with such suit or action. In the event that the
Distributor should incur liability against any third party or any third party
should be awarded damages against the Distributor in any such action, suit
or
claim AltaRex shall indemnify and hold the Distributor harmless against all
such
liability or damages.
|
ARTICLE
7.
|
LIMITATIONS
ON LIABILITY.
|
7.1 Indirect
Damages.
IN NO
EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR ANY OTHER PERSON
OR
ENTITY FOR SPECIAL, INCIDENTAL, CONSEQUENTIAL, EXEMPLARY OR OTHER INDIRECT
DAMAGES, OR FOR LOSS OF PROFITS, LOSS OF DATA OR LOSS OF USE DAMAGES, ARISING
OUT OF THE MANUFACTURE, USE, SALE, SUPPLYING OR FAILURE OR DELAY IN SUPPLYING
OF
THE PRODUCT, WHETHER BASED XXXX XXXXXXXX, XXXXXXXX, XXXX, XXXXXX LIABILITY
OR
OTHERWISE, EVEN IF SUCH PARTY HAD BEEN ADVISED OF THE POSSIBILITY OF SUCH
DAMAGES OR LOSSES.
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ARTICLE
8.
|
TERM
AND TERMINATION.
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8.1 Term.
This
Agreement shall be effective from the Effective Date and thereafter this
Agreement shall remain in effect for periods commencing from the beginning
of
the first Marketing Year for each Market and ending on the eleventh
(11th)
anniversary from the beginning of the first Marketing Year (the “Initial Term”)
for each relevant Market, unless terminated earlier as provided herein, and
shall automatically renew for additional two (2) year periods (an “Extension
Term”) unless either Party objects to such renewal in writing, with or without
cause, at least twenty-four (24) months before the end of the Initial Term
or
twelve (12) months before the end of the then-current Extension Term, as
the
case may be.
8.2 Default
Termination.
In the
event of a breach of this Agreement by either Party and such Party fails
to
remedy such breach within thirty (30) days (and with respect to payment
obligations, fifteen (15) days)) after receiving written notice from the
non-breaching Party which specifies the circumstances that constitute the
breach, then the non-breaching Party may terminate this Agreement with immediate
effect upon written notice to the defaulting Party.
8.3 Termination
upon Bankruptcy.
This
Agreement may be terminated by AltaRex with immediate effect upon written
notice
to Distributor in the event of the cessation of business, bankruptcy or
insolvency of Distributor, or a material adverse change in Distributor’s
business or financial condition.
8.4 Mutual
Agreement.
This
Agreement may be terminated at any time by mutual agreement of the
Parties.
8.5 Buyback
of Distributor’s Inventory.
If this
Agreement is terminated by either Party for cause pursuant to Section 8.2
above
or by mutual agreement, AltaRex shall repurchase and Distributor shall sell
to
AltaRex Distributor’s and those Subdistributors’ unused inventory at their
original cost if and to the extent that such unused inventory remains packaged
in unopened full boxes and is deemed by AltaRex in its reasonable discretion
to
be commercially saleable. Repurchased inventory shall be shipped by Distributor
freight prepaid, according to AltaRex’s instructions. AltaRex shall pay
Distributor for such repurchased Product within thirty (30) days after AltaRex
receives such Product at its designated facility.
8.6 No
Damages for Termination or Expiration.
In the
event of a termination pursuant to any of Sections 8.2, 8.3 or 8.4 above
or upon
expiration of this Agreement pursuant to Section 8.1 above, the parties hereto
shall not be liable to each other for special damages incidental, consequential,
exemplary or other indirect damages, or for loss of profits arising as a
result
of such termination of expiration.
8.7 Payment
Obligations Continue.
Termination or expiration of this Agreement shall not affect the obligation
of
Distributor to pay AltaRex all amounts owing or to become owing as a result
of
units of the Product delivered by AltaRex on or before the date of such
termination, as well as interest thereon to the extent any such amounts are
paid
after the date they became or will become due pursuant to this
Agreement.
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8.8 Survival
of Provisions.
Notwithstanding anything else in this Agreement to the contrary, the Parties
agree that Sections 6, 7, 8, 9 and 10 shall survive the termination or
expiration of this Agreement, as the case may be.
|
ARTICLE
9.
|
GENERAL
PROVISIONS.
|
9.1 Distributor
Not an Agent.
Distributor shall be considered to be an independent contractor. The
relationship between AltaRex and Distributor shall not be construed to be
that
of employer and employee, nor to constitute a partnership, joint venture
or
agency of any kind. Neither Party has any express or implied authority by
virtue
of this Agreement to bind the other Party in any manner.
9.2 Assignments.
This
Agreement may be assigned by Distributor to one of its Affiliates as defined
in
Section 9.13 below, with previous notification to AltaRex, so long as
Distributor remains responsible for such Affiliate’s performance of the terms
and conditions of this Agreement. This Agreement shall not otherwise be assigned
by Distributor without AltaRex’s prior written consent, which shall not be
unreasonably withheld or delayed. This Agreement may be assigned by AltaRex.
This Agreement shall enure to the benefit of the permitted successors and
permitted assigns of each Party.
9.3 No
Implied Waivers.
The
failure of either Party at any time to require performance by the other Party
of
any provision hereof shall in no way affect the full right to require such
performance at any thereafter; nor shall the waiver by either Party of a
breach
of any provision hereof constitute a waiver of any succeeding breach of the
same
or any other such provision, nor constitute a waiver of the provision
itself.
|
9.4
|
Notices.
|
(a) All
notices, request, demands, and other communications under this Agreement
or in
connection herewith shall be given to or made upon the respective Parties
at the
addresses and to the individuals set forth above, unless by such notice a
different address or individual shall have been designated.
(b) Any
notice so given shall be effective (i) when personally delivered, (ii) if
given
by telex or fax, when such telex or fax is transmitted to the number specified
above and the appropriate answer back or confirmation of receipt is received,
or
(iii) in case of registered airmail letter, return receipt requested, upon
addressee’s receipt. A return receipt shall be sufficient to prove receipt of
notice.
9.5 Choice
of Law; Jurisdiction.
This
Agreement shall be governed by and construed in accordance with, and any
arbitration hereunder shall apply, the laws of the Province of Alberta. The
parties hereby irrevocably attorn to the jurisdiction of the Courts of
Alberta.
9.6 Arbitration
Clause.
All
disputes arising out of or relating to this Agreement shall be finally resolved
by arbitration conducted in the English language in Milan if initiated by
AltaRex and in Edmonton if initiated by Distributor under the commercial
arbitration rules of the International Chamber of Commerce (the “Rules”). Each
party shall appoint an arbitrator and the two arbitrators so appointed shall
jointly appoint a third arbitrator; provided,
however,
that if
they cannot agree (or if one party refuses to appoint an arbitrator), then
this
third arbitrator shall be appointed in accordance with the Rules . Both parties
shall bear equally the cost of the arbitration. All decisions of the
arbitrator(s) shall be final and binding on both parties and enforceable
in any
court of competent jurisdiction. Notwithstanding anything contained in this
Section to the contrary, each Party shall have the right to institute judicial
proceedings against the other Party or anyone acting by, through or under
such
other Party, in order to enforce the instituting Party’s rights hereunder
through reformation of contract, specific performance, injunction or similar
equitable relief.
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9.7 Entire
Agreement.
This
Agreement, and all Annexes and Schedules attached hereto, cancel and supersede
any prior agreements or understandings, whether oral, written or implied,
between the Parties. The sole and complete agreement of the Parties is as
expressly set forth herein, and there are no more rights or obligations to
be
considered or construed therewith. No alterations, changes or amendments
hereto
shall be effective unless the same are made in writing and signed by both
Parties.
9.8 Compliance
with Laws.
Each of
the Parties covenants that all of its activities under or pursuant to this
Agreement shall comply with all applicable laws, rules and regulations. In
particular, but without limitation, Distributor shall be responsible for
obtaining all licenses, permits and approvals which are necessary or advisable
for sales of the Product in various jurisdictions and for the performance
of its
duties hereunder. If the Parties discover that any term or condition of this
Agreement is not in compliance with applicable laws, rules or regulations
of any
jurisdiction, they will amend such term or condition retroactively to bring
it
into full compliance.
9.9 Severability.
If any
provision of this Agreement is declared invalid or unenforceable by a court
having competent jurisdiction, it is mutually agreed that this Agreement
shall
endure except for the part declared invalid or unenforceable by order of
such
court. The Parties shall consult and use their best efforts to agree upon
a
valid and enforceable provision which shall be a reasonable substitute for
such
invalid or unenforceable provision in light of the intent of this
Agreement.
9.10 Agreement
Registration.
In the
event that this Agreement is required to be registered with any governmental
authority in the Territory, Distributor shall cause such registration to
be made
and shall bear any expense or tax payable in respect thereof.
9.11 Counterparts.
This
Agreement may be executed in one or more counterparts, each of which shall
be
deemed an original, but all of which together shall constitute one and the
same
instrument.
9.12 Confidentiality
(a)
AltaRex
has a proprietary interest in any information which it provides to Distributor
hereunder, whether in connection with this Agreement or otherwise, and whether
in written or oral form, which is (i) a trade secret, confidential or
proprietary information, and (ii) not publicly known, and (iii) annotated
by a
legend, stamp or other written identification as confidential or proprietary
information or if disclosed orally or visually is designated in writing as
confidential or proprietary within thirty (30) days after such disclosure
(hereinafter referred to as “Proprietary Information”). Distributor shall
disclose the Proprietary Information of AltaRex only to those of Distributor’s
Subdistributors, agents and employees as well as Affiliates to whom it is
necessary in order properly to carry out their duties as limited by the terms
and conditions hereof. Both during and after the term of this Agreement,
all
disclosures of AltaRex’s Proprietary Information by Distributor to Distributor’s
Subdistributors, agents and employees shall be held in strict confidence
by such
agents and employees. During and after the term of this Agreement, Distributor,
its Subdistributors, agents and employees shall not use the Proprietary
Information for any purpose other than in connection with and as necessary
to
carry out their duties as limited by the terms and conditions hereof.
Distributor shall, at its expense, return to AltaRex its Proprietary Information
as soon as practicable after the termination or expiration of this Agreement.
All such Proprietary Information shall remain the exclusive property of AltaRex
during the term of this Agreement and thereafter. This Section shall also
apply
to any consultants or subcontractors that Distributor or its Subdistributors
may
engage in connection with its obligations under this Agreement.
page
21 of
35
(b) Notwithstanding
anything contained in this Agreement to the contrary, Distributor shall not
be
liable for a disclosure of the Proprietary Information of AltaRex, if the
information so disclosed: (i) was in the public domain at the time of disclosure
or thereafter becomes part of the public domain through no fault of Distributor;
or (ii) was known to or contained in the records of Distributor from a source
other than AltaRex at the time of disclosure by AltaRex to Distributor and
can
be so demonstrated; or (iii) becomes known to Distributor from a third party
without breach of any confidentiality obligation between AltaRex and such
third
party and can be so demonstrated; or (iv) was disclosed pursuant to court
order
or as otherwise compelled by law, after giving AltaRex prior written notice
of
such required disclosure and after assisting AltaRex in its reasonable efforts
to prevent or limit such disclosure.
9.13 Definition
of Affiliate.
For the
purposes of this Agreement, an “Affiliate” of a Party to this Agreement shall
mean any company, natural person, partnership or other business entity
controlled by, under common control with or controlling such Party.
Notwithstanding this definition DOMPE’ FARMACEUTICI, DOMPE’ BIOTEC and DOMPE’
s.p.a. are expressly considered for the purposes of this Agreement to be
Affiliates of Distributor.
9.14 Force
Majeure.
Neither
party shall be responsible for any delay or failure to perform its obligations
under the Agreement (excluding payment obligations) or shall be liable to
the
other for loss or damages for any default or delay caused by conditions beyond
its reasonable control, including but not limited to, acts of God, governmental
restrictions, wars or insurrections, strikes, floods, work stoppages, lack
of
materials if any of the parties affected shall give prompt written notice
of
such cause to the other party. The party giving such notice shall thereupon
be
excused from such of its obligations hereunder as it is thereby disabled
from
performing for so long as it is so disabled, provided,
however,
that
such affected party commences and continues to take reasonable and diligent
actions to cure such cause.
page
22 of
35
|
Article
10.
|
Language
of Agreement.
|
The
Parties agreed that this Agreement be prepared in the English language. All
correspondence, notices and other communications between the Parties (whether
oral or written) shall be in the English language.
IN
WITNESS WHEREOF, the Parties hereunto have executed this Agreement under
seal as
of the day and year first above written.
|
ALTAREX MEDICAL
CORP.
By: signed
“Xxxxxxx Xxxxxxx”
Name: X.
Xxxxxxx
Title: President
& CEO
|
DOMPÉ
INTERNATIONAL S.A.
|
page
23 of
35
| AnnexA |
Product
|
| Annex B | Purchase Minimums |
| Annex C | Obligations Imposed by AltaRex’s Licensor |
| Annex D | Trademarks |
page
24 of
35
ANNEX
A
Description
of Product
OvaRex®
MAb
B43.13 (oregovomab) with specificity for the tumor associated antigen (TAA)
CA
125.
page
25 of
35
ANNEX
B
Purchase
Minimums
|
Region
1
|
Xxxxxx
0
|
Xxxxxx
0
|
||||||||
|
(Xxxxx,
Xxxxxxxx)
|
(Xxxxxxx,
Xxxxxxxxxxx)
|
(Rest
of the countries in the Territory)
|
||||||||
|
Marketing
|
||||||||||
|
Year
|
||||||||||
|
First
|
||||||||||
|
Second
|
||||||||||
|
Third
|
||||||||||
page
26 of
35
ANNEX
C
Obligations
Imposed by AltaRex’s Licensor
Definitions
The
following terms used in this Annex C shall have the meanings ascribed to
them,
as set out below.
Affiliate.
“Affiliate”
has the meaning ascribed to that term in the Canada
Business Corporations Act (Canada).
AltaRex
Information.
“AltaRex Information” shall mean all information of a confidential nature of
AltaRex or any of its Affiliates including, without limiting the generality
of
the foregoing, all biological material, plant, animal and human laboratory
and
clinical data, technical information, Know-How, inventions, techniques,
processes, systems, formulae, results of experimentation, designs, statistics
and records.
Anti-Idiotype
Applications.
“Anti-Idiotype Applications” shall mean the induction of anti-idiotype and/or
cellular immune response by administration of a formulation containing an
antibody, antibody fragment or antibody derivative for the treatment or
prevention of disease. Without limiting the generality of the foregoing,
Anti-Idiotype Applications specifically includes the administration of the
X00
Xxxxxxxx for therapeutic or prophylactic purposes.
X00
Xxxxxxxx.
“
X00
Xxxxxxxx” shall mean the murine antibody MAb B43.13.
B43
Working Cell Bank.
“B43
Working Cell Bank” shall mean Biomira’s murine working hybridoma cell bank
B43.13 of the murine hybridoma clone B43.13 such cell bank being produced
at the
Xxxxxxx River Laboratories and used in the OVAREX™ program as of
November 24, 1995.
Biomira
Information.
“Biomira Information” shall mean all information of a confidential nature of
Biomira or any of its Affiliates including, without limiting the generality
of
the foregoing, all Biomira Technology, biological material, plant, animal
and
human, laboratory and clinical data, technical information, Know-How inventions,
techniques, processes, systems, formulae, results of experimentation, designs,
statistics and records.
Biomira
Technology.
“Biomira Technology” means all Know-How, technical expertise, information,
inventions and discoveries, whether patentable or not, and all copyrights,
patents, trademarks, industrial designs, and other intellectual property
rights
or benefits made, authored, conceived, created, compiled or developed by
or for,
or acquired by Biomira or any of its Affiliates.
Confidential
Information.
“Confidential Information” shall mean any and all Biomira Information or AltaRex
Information, as the case may be, and any and all information of a confidential
nature relating to Biomira, AltaRex, the relationship among the parties to
this
Agreement and the terms and subject matter of the Biomira License
Agreement.
page
27 of
35
Data.
“Data”
shall mean, as of November 24, 1995, the experimental and clinical
data and
records of Biomira or Biomira Research, Inc. relating to the X00 Xxxxxxxx,
the
B43 Working Cell Bank and the product OVAREX™ owned by Biomira or Biomira
Research, Inc.
Distributor.
“Distributor” shall mean Dompé International X.X.X.
First
Commercial Sale.
“First
Commercial Sale” shall mean, on a country-by-country basis, the first commercial
sale of a Product in a country, excluding sales for clinical trial
purposes.
Know-How.
“Know-How” shall mean, with respect to AltaRex or Biomira as the case may be,
all technical information, expertise, know-how and information including
without
limitation all data, results of experiments, formulae, specifications,
procedures, tests, compounds, cell lines, cultures, constructs, effectors,
development strains, micro-organisms, assay systems, assay protocol and assay
supporting material, fermentation and purification material and
techniques.
Multi-Epitopic
Patent Rights.
“
Multi-Epitopic Patent Rights” shall mean International Application
PCT/IB96/00461 and any national stage application claiming priority thereof,
and
any continuations, divisionals, continuations-in-part thereof, and any foreign
equivalents, and any patents issuing therefrom, including any reissues
thereof.
Net
Sales Revenues.
“Net
Sales Revenues” shall mean the aggregate of the gross amounts received from all
sales, uses or other dispositions of Products by Distributor or any Sublicensee
after deducting (i) customary trade, cash and quantity discounts actually
allowed and taken, (ii) tariffs, duties, excises, sales tax or other
taxes
imposed upon and paid with respect to the production, sale, delivery or use
of
any product (excluding income-based taxes), and (iii) amounts actually paid
or
credited to unrelated purchasers in accordance with normal commercial practice
by reason of (A) rejections, defects, recalls or returns, or (B) chargebacks,
refunds, rebates or retroactive price reductions, and then crediting any
refund
of taxes deducted (all as determined in accordance with Canadian generally
accepted accounting principles applied on a consistent basis). In the event
a
Product is sold as part of a Combination Product (as defined below), the
Net
Sales Revenue from the Combination Product, for the purposes of determining
royalty payments, shall be determined by multiplying the Net Sales Revenue
of
the Combination Product (as defined in the foregoing Net Sales Revenue
definition), during the applicable royalty reporting period, by the fraction,
A/A+B, where A is the average sale price of the Product when sold separately
in
finished form in the country in which the Combination Product is sold and
B is
the average sale price of the other pharmaceutical product(s) included in
the
Combination Product when sold separately in finished form in the country
in
which the Combination Product is sold, in each case during the applicable
royalty reporting period or, if sales of both the Product and the other
pharmaceutical product(s) did not occur in such period, then in the most
recent
royalty reporting period in which sales of both occurred. In the event that
such
average sale price cannot be determined for both the Product and all other
pharmaceutical products(s) included in the Combination Product, Net Sales
Revenue for the purposes of determining royalty payments shall be calculated
by
multiplying the Net Sales Revenue of the Combination Product by the fraction
of
C/C+D where C is the fair market value of the Product in the country in which
the Combination Product is sold and D is the fair market value of all other
pharmaceutical product(s) included in the Combination Product in the country
in
which the Combination Product is sold. In such event, Distributor shall in
good
faith make a determination of the respective fair market values of the Product
and all other pharmaceutical products included in the Combination Product,
and
shall notify Biomira and AltaRex of such determination and provide Biomira
and
AltaRex with data to support such determination. Biomira and AltaRex shall
have
the right to review such determination and supporting data, and to notify
AltaRex and Distributor, respectively, if it disagrees with such determination.
If Biomira or AltaRex does not agree with such determination, then AltaRex
and
Distributor shall attempt to reach agreement in good faith as to such respective
fair market values.
page
28 of
35
As
used
above, the term “Combination Product” means any product which comprises the
Product and other distinct pharmaceutical products;
The
sale
or disposition of a Product by Distributor to or among its Sublicensees shall
not be subject to royalties based upon Net Sales Revenue, unless such
Sublicensee is the end user of the Product, but rather shall be calculated
upon
the sale or disposition of a Product by any such Sublicensee to an independent
third party. If the Sublicensee is the end user of the Product and the
transaction with such Sublicensee is not an “arms’ length” transaction, then the
“amount received” shall be the greater of (a) the actual amount received, or (b)
the amount which would have been received had such sale or other disposition
of
the Product been to a person at arms’ length with the seller.
Patent
Rights.
“Patent
Rights” shall mean the patent applications referred to in Exhibit
A
to the
Biomira License Agreement, together with all continuations, divisionals,
continuations-in-part, and any foreign equivalents, and any patents issuing
therefrom, including any reissues thereof, related to the Products and
Technology.
Proprietary
Rights.
“Proprietary Rights” shall mean the Patent Rights and all copyrights,
trademarks, industrial designs and other intellectual property rights or
benefits (including Know-How) specifically relating to Anti-Idiotype
Applications of the X00 Xxxxxxxx, the B43 Working Cell Bank and the Data,
in
each case owned or controlled by Biomira or Biomira Research, Inc., but
excluding the Multi-Epitopic Patent Rights.
Sublicensees.
“Sublicensees” shall mean any person to whom Distributor or any such person,
directly or indirectly, transfers any rights or privileges granted under
this
Agreement, by sublicense or otherwise, to, among other things, enable such
person to sell Products.
Technology.
“Technology” shall mean collectively the X00 Xxxxxxxx, the B43 Working Cell
Bank, the Data and the Proprietary Rights as they relate to Anti-Idiotype
Applications.
1. Distributor,
on behalf of itself and its Affiliates, expressly agrees not to disclose
or
provide rights to any technology of Biomira other than the Technology (and
with
respect to the Technology only upon the terms set forth in this Agreement),
or
to make, or permit their respective employees, agents or consultants to make,
any statements with respect to Biomira or any technology of Biomira other
than
the Technology (and with respect to the Technology only as specifically
authorized in this Agreement), or other than with respect to information
which
is already fully in the public domain through no fault of Distributor or
its
Sublicensees. Distributor shall, and shall require each Sublicensee to, include
in any sublicense agreement a provision binding upon the Sublicensee that
is
substantially similar to the provisions of this Paragraph 1.
page
29 of
35
2. Distributor
shall within ten (10) days after the Effective Date provide Biomira with
a
written commitment to abide by all terms and conditions of this Annex C.
In
addition, Distributor shall promptly notify Biomira and AltaRex in writing
of
any sublicense or other transfer of all or any of the rights granted by AltaRex
under this Agreement and shall ensure that the written commitment of each
Sublicensee (as a term of the agreement with the Sublicensee) is obtained
to
abide by all terms and conditions of this Annex C.
3. Distributor
shall, and shall cause each Sublicensee (by ensuring that the written commitment
of the Sublicensee is obtained as a term of the agreement granting the subject
rights to the Sublicensee) to, cooperate with and provide reasonable assistance
to Biomira in connection with protecting the Technology and other rights
granted
by Biomira under the Biomira License Agreement including, without limitation,
in
relation to infringement actions against third parties.
4. Within
ten (10) days after Distributor or any of its Sublicensees grants a sublicense
to a Sublicensee, Distributor shall provide extracts from such sublicense
agreement to AltaRex and Biomira. Such extracts shall consist of the following
provisions of the sublicense agreement: (i) the identity of the Sublicensee;
(ii) the scope/field of the use of the Sublicensee under the sublicense
agreement; and (iii) the provisions and definitions of this Annex C and a
termination provision similar to that set forth in Section 2.3 of the Biomira
License Agreement. The provisions of the sublicense agreement referred to
in
this Paragraph 4, subsection (iii) are referred to as the “Designated Sublicense
Provisions.”
5. Distributor
agrees to ensure that the Designated Sublicense Provisions are included in
each
sublicense agreement with a Sublicensee (whether granted by Distributor or
a
Sublicensee) and that such Designated Sublicense Provisions will not be amended
(except for an amendment which in no way derogates from Distributor’s
obligations under Paragraphs 4, 5 and 6 of this Annex C) or deleted prior
to the
termination of the sublicense in question. Distributor shall use commercially
reasonable efforts to enforce or cause to be enforced the Designated Sublicense
Provisions against Sublicensees. Distributor shall in a timely manner keep
Biomira informed as to any breaches by any Sublicensee of the Designated
Sublicense Provisions. In the event that Biomira believes that a Sublicensee
has
breached any of the Designated Sublicense Provisions, it may, in its discretion,
provide notice of such claimed breach to Distributor and Distributor shall,
within fifteen (15) days after receipt of such notice, use commercially
reasonable efforts to cause the Sublicensee to comply with the applicable
Designated Sublicense Provisions and Distributor shall take or cause to be
taken
such other steps as may be commercially reasonable under the circumstances,
including the exercise of the termination remedies in the applicable sublicense
agreement with respect to a Sublicensee which has breached any of the Designated
Sublicense Provisions. In the event that Distributor fails to enforce or
cause
to be enforced the Designated Sublicense Provisions against the relevant
Sublicensees, despite having used commercially reasonable efforts, Biomira
shall
have the right to seek an injunction and/or bring an action(s) for damages
and/or specific performance against such Sublicensees and, in order to enable
Biomira to carry out the foregoing, Distributor shall, as directed by Biomira,
either assign or cause to be assigned to Biomira in a timely manner any and
all
actions or causes of action(s) relating to the claimed breach of the Designated
Sublicense Provisions or permit Biomira or cause Biomira to be permitted
to
pursue such action(s) in the name of Distributor or other applicable party.
In
no event, however, shall the foregoing be construed to permit or provide
Biomira
with the right to itself directly exercise the termination remedies in the
applicable sublicense agreement.
page
30 of
35
6. Distributor
agrees that its obligations under this Annex C in relation to sublicensing
of
any rights granted under the Biomira License Agreement (including without
limitation the obligations with respect to the Designated Sublicense Provisions
and Biomira’s rights under Paragraph 5 above) shall apply mutatis mutandis to
any other transfer by assignment or otherwise of any rights or privileges
granted by Biomira under the Biomira License Agreement.
7. Distributor,
on behalf of itself and its Affiliates, agrees to comply in all material
respects with any and all applicable local, state, provincial, national,
federal
and/or international laws and regulations pertaining to the development,
testing, manufacture, promotion, sale and disposition of Products and to
xxxx
all Products or their packaging with all applicable patent numbers and similarly
to indicate “patent pending” status and to make such other markings as are
necessary to preserve the Patent Rights.
8. Within
forty-five (45) days of June 30 and December 31 in each calendar year following
the First Commercial Sale of Products, Distributor shall provide to AltaRex
and
Biomira a written report, certified by a senior officer of Distributor, showing
in reasonable detail and in such form as Biomira may reasonably request:
(1) the
Net Sales Revenue (including Net Sales Revenue by Sublicensees) during the
preceding six-month period; (2) the basis for the calculation of all royalties
and other amounts payable by AltaRex to Biomira pursuant to the Biomira License
Agreement; and (3) such other reasonable information with respect to the
foregoing as Biomira or AltaRex may request.
9. Distributor
shall maintain adequate and complete records (and shall require its Sublicensees
to maintain such records) showing: (1) the Net Sales Revenue received by
Distributor or any Sublicensees; and (2) the basis for the calculation of
all
royalties and other amounts payable by AltaRex to Biomira pursuant to the
Biomira License Agreement. Distributor shall retain such records (and shall
require each Sublicensee to retain such records) for a period of five (5)
years
from the date of their making.
10. Audit
Inspection
|
(1)
|
Distributor
and its Affiliates shall make available the records referred to
in
Paragraph 9 above for the prior five (5) year period on reasonable
notice
during Distributor’s normal business hours for inspection by a national
firm of chartered accountants or certified public accountants on
behalf of
Biomira PROVIDED HOWEVER no one will be allowed to inspect any
records of
Distributor and its Affiliates without having first signed a
confidentiality agreement provided by Distributor which shall contain
only
terms which are consistent with industry standards in similar
circumstances and which will not restrict the accountants in question
from
pursuing the inspection rights hereunder and reporting to Biomira
and
AltaRex. Any such inspection shall be made at the expense of Biomira
unless it is determined that Biomira was entitled to receive a
sum which
varied greater than ten (10%) percent from the amount reported
by AltaRex
as due and payable to Biomira for the period covered by the inspection
and
such variance is attributable to underreporting of Net Sales Revenues
by
Distributor, in which case Distributor shall reimburse AltaRex
for its
payments to Biomira of the reasonable costs of such inspection
and
interest, as provided in Section 4.4 of the Biomira License
Agreement. Distributor and its Affiliates shall cooperate fully
with the
chartered accountants or certified public accountants conducting
the
inspection provided for in this Paragraph
10.
|
page
31 of
35
|
(2)
|
In
the event that Distributor conducts an audit of the records and
books of
account of a Sublicensee, the audit report shall be provided to
Biomira
and AltaRex by the chartered accountant or certified public accountant
at
the same time that such report is provided to Distributor. In addition,
in
the event that Biomira believes that it would be appropriate to
conduct an
audit of the records and books of account of a Sublicensee (other
than an
Affiliate of Distributor), Biomira shall notify Distributor and
Distributor shall promptly use commercially reasonable efforts
to cause
such audit to be conducted, with the audit report to be provided
simultaneously to Distributor, AltaRex and Biomira. Distributor
shall
obtain the written agreement of each Sublicensee to permit the
conduct of
such audits and the provision of the audit report to Biomira and
AltaRex.
Biomira and AltaRex agrees to treat each such audit report as Confidential
Information of Distributor. In addition, Distributor hereby agrees
to
permit (a) the conduct of such audits of the records and books
of account
of Distributor, and (b) the provision of the audit report to Biomira
and
AltaRex. Biomira also agrees to treat each such audit report with
respect
to Distributor as Confidential Information of
XxxxXxx.
|
00.
Confidentiality
|
(1)
|
All
Confidential Information shall be held in strict confidence by
Distributor
and Distributor shall employ or cause to be employed diligent efforts
and
reasonable care in order to ensure that such Confidential Information
is
not made available to any third party excepting only as required
under the
Biomira License Agreement, or to the directors, officers, employees
and
consultants of Distributor whose duties require disclosure of the
same and
then (in any such case) only if the parties to whom such Confidential
Information is being disclosed have given to Distributor and Biomira
an
enforceable undertaking (in form acceptable to Biomira and Distributor,
acting reasonably) not to disclose such Confidential Information
to any
other party, provided that
Distributor may disclose Confidential Information to a Sublicensee
so long
as such Sublicensee has agreed to treat the Confidential Information
in
the manner provided in this Paragraph
11.
|
|
(2)
|
Subject
to Paragraph 11(3) below, Confidential Information which is obtained
by
Distributor from a third party without obligation of confidence
(provided,
however, that such third party has no obligation of confidence
to Biomira
or AltaRex) or which becomes public knowledge otherwise than through
the
fault of Distributor or any of Distributor’s directors, officers, agents,
consultants, servants or employees, shall be deemed to be in the
public
domain and accordingly Paragraph 11(1) above shall not apply to
such
portion of the Confidential Information which has been so obtained
or
which has become public knowledge.
|
page
32 of
35
|
(3)
|
Confidential
Information which is specific shall not be deemed to be within
the public
domain merely because it is embraced by general knowledge in the
public
domain. Further, any Confidential Information dealing with any
combination
of features of a specific matter shall not be deemed to be within
the
public domain, unless the combination of features and the principle
of
operation are in the public domain.
|
|
(4)
|
Distributor
shall, upon the termination of the Biomira License Agreement, return
all
corporate Confidential Information to the owner of such Confidential
Information with a written undertaking that no copies, duplicates
or
progeny have been retained.
|
|
(5)
|
Distributor
acknowledges that Biomira would suffer irreparable harm as a result
of the
breach of any of the non-disclosure and confidentiality obligations
set
forth in this Paragraph 11 and that legal remedies are inadequate;
therefore, Distributor agrees that, in addition to any damages
and other
remedies that Biomira may be entitled to as a result of such a
breach,
Biomira shall be entitled to an order from a court of competent
jurisdiction restraining Distributor from breaching or continuing
to
breach any of the provisions of this Paragraph
11.
|
|
(6)
|
The
covenants of Distributor under this Paragraph 11 shall continue
in full
force and effective notwithstanding the termination of the Biomira
License
Agreement by effluxion of time or
otherwise.
|
|
(7)
|
In
the event Distributor is required by law or any governmental or
regulatory
authority having jurisdiction to disclose any information Distributor
has
the right to do so subject to Distributor using its best efforts
to take
all reasonably available means to keep details of the Biomira License
Agreement and its terms and the Confidential Information of Biomira
confidential.
|
|
(8)
|
Nothing
in this Annex C shall prevent Distributor through its officers,
employees
or agents from presenting or publishing such information related
to the
Technology as is necessary for the commercialization of Products,
including, but not limited to, communications with regulatory authorities,
scientific publications and presentations and marketing materials;
PROVIDED THAT Distributor shall ensure that in doing so, no Biomira
Confidential Information other than Biomira Confidential Information
relating to the Technology will be disclosed without Biomira’s prior
written consent which may be unreasonably
withheld.
|
12. As
Is
Basis.
|
(1)
|
Distributor
has agreed to acquire the rights granted under the Biomira License
Agreement, and all of the data and other materials acquired hereunder
on
an “as is” basis. Distributor shall, and shall require each Sublicensee
to, include a provision in each agreement with a Sublicensee acknowledging
the prior sentence. Accordingly, Distributor shall accept the entire
responsibility related to or arising out of the use by Distributor
or any
Sublicensee of the Technology or the development, manufacture,
use or sale
of any product based on the Technology. Except as set forth in
Section 2.3
of the Biomira License Agreement, Biomira makes no warranties,
whether
expressed or implied, as to any matter whatsoever to Distributor
or any
third parties with respect to the Technology, any Product or any
aspect
thereof, including without limitation, as to the validity of any
right
granted by Biomira under the Biomira License Agreement or that
any such
right or Product will be free from infringement of the rights of
third
parties. If Distributor or any Sublicensee receives written notice
that
any Product or right granted under the Biomira License Agreement
constitutes an infringement of the rights of a third party, Distributor
shall, if it or any Sublicensee intends to continue to sell such
Product,
within fifteen (15) days after receipt of such notice, provide
to Biomira
a means reasonably satisfactory to Biomira, whereby Biomira shall
be fully
protected from damages, actions, claims, costs and expenses which
may
arise as a result of the decision of Distributor or any Sublicensee
to
continue to sell the Product or to use such right. If, after complying
with the preceding sentence, Distributor or any Sublicensee continues
to
sell the Product or use such right, Distributor or such Sublicensee
does
so at its own risk and Distributor will and does hereby indemnify
Biomira
for any damages, actions, claims, costs and expenses incurred by
Biomira,
except as provided in Section 2.3 of the Biomira License Agreement,
which
may arise as a result of Distributor, its Affiliates or Sublicensees
continuing to sell the Product or use such
right.
|
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35
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(2)
|
Distributor,
on behalf of itself and its Affiliates, acknowledges that the Technology
is the property of Biomira and that Biomira has made no representations
or
warranties to Distributor in connection with the Technology under
the
Biomira License Agreement or this Agreement and Distributor hereby
agrees
that it will not make any claim or demand against Biomira or any
of its
officers, directors, employees, agents or consultants for any loss,
cost,
damage or expense, whether direct or indirect or consequential,
suffered
or sustained by Distributor or any person claiming through Distributor,
which is based upon, arises out of or is connected with the Technology
and
Distributor hereby waives as against Biomira, its officers, directors,
employees, agents and consultants all such claims and demands.
In any
agreement with a Sublicensee, Distributor shall secure or cause
to be
secured a similar covenant from such
Sublicensee.
|
|
(3)
|
This
Paragraph 12 shall have no effect on AltaRex’s indemnification obligations
to Distributor in accordance with Section 6.4(b) of the
Agreement.
|
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35
ANNEX
D
Trademarks,
Trade Names and Service Marks
OvaRex®
MAb
Any
other
Trademarks developed from time to time during the term of this Agreement
by
AltaRex for use with the Product.
Non-Exclusive
Trademarks, Trade Names and Service Xxxx
AltaRex
page
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35
