EXHIBIT 3.15
CONFIDENTIAL TREATMENT HAS
BEEN REQUESTED FOR PORTIONS
OF THIS DOCUMENT.
CONFIDENTIAL PROVISIONS
HAVE BEEN OBSCURED.
LICENSE AGREEMENT BETWEEN
MCGILL UNIVERSITY
AND
NOVOPHARM LIMITED
EFFECTIVE THE TWENTY-EIGHTH (28TH) DAY OF APRIL, 1994
1 PREAMBLE
1.1 IDENTIFICATION OF THE PARTIES
1.1.1 This LICENSE AGREEMENT is entered into between MCGILL
UNIVERSITY (hereinafter referred to as "MCGILL"), with principal offices
at 845 Sherbrooke St. W., Montreal, Quebec, Canada H3A 2T5, and NOVOPHARM
LIMITED (hereinafter referred to as "NOVOPHARM"), a pharmaceutical company
having its principal office at 30 Nably Court, Scarborough, Ontario,
Canada M1B 2K9.
1.1.2 This LICENSE AGREEMENT is effective as of the twenty-
eighth (28th) day of April, 1994.
1.2 LICENSEE REPRESENTATIONS
NOVOPHARM desires to obtain exclusive license rights to
the LICENSED TECHNOLOGY, under the terms and conditions of this LICENSE
AGREEMENT.
1.3 LICENSOR REPRESENTATIONS
1.3.1 MCGILL is the owner of the entire right, title and
interest in the LICENSED TECHNOLOGY.
1.3.2 Dr. G.B. Price of the McGill Cancer Centre, the original
inventor of the ideas embodied in the LICENSED TECHNOLOGY, as defined
herein, has assigned his interest(s) in the LICENSED TECHNOLOGY to MCGILL
which has the exclusive right to issue this LICENSE AGREEMENT granting
NOVOPHARM rights to the LICENSED TECHNOLOGY.
1.3.3 MCGILL is an institution of higher education and is not
in the business of commercially developing ideas, inventions, or other
types of intellectual properties which are a by-product of research
performed to further MCGILL's goals and objectives.
1.4 NOW THEREFORE
In consideration of the foregoing premises, the mutual
covenants and obligations hereinafter contained, and other good and
valuable consideration, MCGILL and NOVOPHARM agree as follows:
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2 DEFINITIONS
2.1 USAGE
For the purposes of this LICENSE AGREEMENT, the
following terms, words, and phrases, when used in the singular or plural,
shall have the meanings given to them in this Section.
2.2 LICENSOR
"MCGILL UNIVERSITY," as abbreviated "MCGILL," means the
university by that name having its principal office at 845 Sherbrooke St.
W., Montreal, Quebec, Canada H3A 2T5, and shall also include all
AFFILIATES. MCGILL is the licensor in this LICENSE AGREEMENT.
2.3 LICENSEE
"NOVOPHARM LIMITED," as abbreviated "NOVOPHARM," means
the pharmaceutical company by that name having its principal office at 30
Nably Court, Scarborough, Ontario, Canada M1B 2K9 and shall also include
all AFFILIATES. NOVOPHARM is the licensee in this LICENSE AGREEMENT.
2.4 TECHNOLOGY TO BE LICENSED
The intellectual property licensed in this LICENSE
AGREEMENT shall be known as a myeloma-like cell line [ ] which is
identified in the publication entitled [
] with a similar pattern of reactivity against a panel
of human tumor cell lines and a lack of reaction with normal human
astrocytes.
2.5 AFFILIATE
"AFFILIATE" means, with respect to a party of this
LICENSE AGREEMENT, any individual or entity which directly or indirectly
controls, is controlled by, or is under common control with such party.
The term "control" means possession, direct or indirect, of the powers to
direct or cause the direction of the management or policies of a person or
entity; whether through ownership of equity participation, voting
securities, or beneficial interests; by contract; by Agreement; or
otherwise.
2.6 CALENDAR YEAR
"CALENDER YEAR" means a period of twelve (12) months in
the Gregorian Calender beginning on January 1 and ending on December 31.
2.7 DATE OF COMMERCIALIZATION
"DATE OF COMMERCIALIZATION" means the date that the
LICENSED PRODUCT(S) are first marketed or publicly made available.
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2.8 EFFECTIVE DATE
"EFFECTIVE DATE" means the twenty-eighth (28th) day of
April, 1994, which is the date upon which this LICENSE AGREEMENT becomes
effective.
2.9 FAIR MARKET VALUE
"FAIR MARKET VALUE" means the gross sales price or value
which NOVOPHARM would realize from an unaffiliated, unrelated buyer in an
arm's length sale or exchange of consideration for an identical item or
service sold or provided in the same quantity and at the same time and
place as the sale or exchange for which the FAIR MARKET VALUE is to be
determined.
2.10 GROSS REVENUES
"GROSS REVENUES" means all sales, revenues, receipts,
monies, and considerations, directly or indirectly, collected or received
by NOVOPHARM from the sale, lease, or other transfer of LICENSED PRODUCTS,
whether such is received in cash or by way of other benefit, advantage, or
concession. If received in a form other than cash, the applicable revenue
will be the monetary equivalent or FAIR MARKET VALUE of the benefit,
advantage, or concession.
2.11 LICENSE AGREEMENT
"LICENSE AGREEMENT" means the license agreement, defined
by the document in which this paragraph appears. This LICENSE AGREEMENT is
between MCGILL UNIVERSITY, as licensor, and NOVOPHARM LIMITED as licensee.
Also included in this LICENSE AGREEMENT are all Exhibits attached hereto
and all amendments which may be made thereto.
2.12 LICENSED PRODUCT
"LICENSED PRODUCT" means any product, apparatus, method,
or SERVICE the production, manufacture, sale, lease, USE, or practice of
which incorporates or makes USE of any part (including progeny, mutants,
derivatives or part thereof) of the LICENSED TECHNOLOGY.
2.13 LICENSED TECHNOLOGY
"LICENSED TECHNOLOGY" means all technology within the
scope of the [ ] cell line, owned or controlled by MCGILL, as of
the EFFECTIVE DATE with the exclusion of the [ ]
already covered, by the Sponsored Research and [
] more specifically, [
] and since abandoned.
2.14 NET SALES
"NET SALES" means the gross sales price or fees; whether
or not invoiced, billed, or received by NOVOPHARM from a third party
attributable to NOVOPHARM's sale, lease, or transfer of any LICENSED
PRODUCT; less qualifying costs directly attributable to such USE, sales,
lease, or transfer and actually allowed and borne by NOVOPHARM. Such
qualifying costs shall be limited to costs of the following:
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2.14.1 Credits or refunds, not exceeding the original or
customary billing or invoice amount, for claims or returns.
2.14.2 Packaging.
2.14.3 Prepaid transportation insurance premiums.
2.14.4 Prepaid outbound transportation expenses.
2.14.5 Handling charges.
2.14.6 Taxes; including sales, use, turnover, excise, import,
export, and other taxes or duties, separately billed or invoiced, and
borne by NOVOPHARM, imposed by a government agency on such sales, lease,
or transfer.
2.14.7 Samples and discounts, in amounts customary in the
trade, for quantity purchases, cash payments, prompt payments, wholesalers
and distributors.
2.15 OCCURRENCE OF SALE
A LICENSED PRODUCT shall be deemed sold, leased, or
transferred at the time NOVOPHARM bills, invoices, ships, or receives
payment for such LICENSED PRODUCT, whichever event occurs first.
2.16 INCORPORATION OF LICENSED PRODUCT
In the event any LICENSED PRODUCT is incorporated into a
larger product or broader use, not considered in its totality to be a
LICENSED PRODUCT, the monetary value of such incorporated LICENSED PRODUCT
shall be the higher of (A) the money received by NOVOPHARM for similar
LICENSED PRODUCT in an equivalent quantity and in an arm's length
transaction, with a nonaffiliated third party, occurring, at or near the
same time and location; or (B) after taking into consideration NOVOPHARM's
cost of the larger product or service without the incorporated LICENSED
PRODUCT as compared to their cost of the larger product or service without
the incorporated LICENSED PRODUCT as compared to their cost of the larger
product or service with the incorporated LICENSED PRODUCT, that portion of
the money or monetary equivalent of the larger product or service, fairly
attributable to the value added or saved by incorporation of the LICENSED
PRODUCT.
2.17 SERVICE
"SERVICE" means, if used as a verb, to repair, adjust,
maintain or otherwise recondition a licensed product after it has been
USED, sold, leased or transferred, directly or indirectly, by NOVOPHARM.
"SERVICE" means, if used as a noun, any USE of the LICENSED TECHNOLOGY by
NOVOPHARM, or any other party authorized, directly or indirectly, by
NOVOPHARM with rights to USE the LICENSED TECHNOLOGY to facilitate the
desires of another party.
2.18 TERRITORY
"TERRITORY" means the world.
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2.19 USE
"USE" means any form of practice or utilization of the
LICENSED TECHNOLOGY, LICENSED PRODUCT(S), or any portion thereof.
3 GRANT
3.1 GRANT OF RIGHTS
Subject to the terms and conditions of this LICENSE
AGREEMENT, MCGILL hereby grants to NOVOPHARM exclusive royalty bearing
license rights to sell in the TERRITORY, where MCGILL may lawfully grant
such license rights, the LICENSED TECHNOLOGY for the term of this LICENSE
AGREEMENT.
3.2 RIGHTS RESERVED
Notwithstanding the exclusive license granted herein,
MCGILL specifically reserves the rights to USE the LICENSED TECHNOLOGY for
its own internal purposes, including continuing research, development,
testing, and all other related USES.
4 TERM AND TERMINATION
4.1 TERM OF AGREEMENT
The term of this LICENSE AGREEMENT shall commence on its
EFFECTIVE DATE and this LICENSE AGREEMENT shall terminate ten (10) years
from the DATE OF COMMERCIALIZATION of the first LICENSED PRODUCT or on the
twentieth (20th) year anniversary of the EFFECTIVE DATE, whichever date
shall occur first, unless this LICENSE AGREEMENT earlier terminates by
operation of law or by acts of the parties in accordance with the terms of
this LICENSE AGREEMENT.
4.2 LICENSEE'S RIGHTS TO TERMINATION
NOVOPHARM may terminate this LICENSE AGREEMENT after it
has been in effect for one year. In order to terminate, NOVOPHARM must
give written notice of its intent to terminate at least sixty (60) days
prior to actual termination.
4.3 LICENSOR'S RIGHTS TO TERMINATION
4.3.1 Upon any material breach of or default under this
LICENSE AGREEMENT by NOVOPHARM, MCGILL may terminate this LICENSE
AGREEMENT.
4.3.2 MCGILL shall give NOVOPHARM written notice of
termination prior to terminating this LICENSE AGREEMENT. Such notice shall
state the cause(s) for termination and the procedures, if any, NOVOPHARM
must follow to prevent such termination. NOVOPHARM shall have thirty (30)
days after the effective date of the notice to remedy the stated cause(s)
for termination, according to the procedures stated, otherwise this
LICENSE AGREEMENT and all rights granted NOVOPHARM, shall automatically
terminate at the end of the thirtieth (30th) day.
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4.3.3 In the event NOVOPHARM ceases conducting business in
a normal course, becomes insolvent, makes a general assignment for the
benefit of creditors, suffers or permits the appointment of a receiver for
its business or assets, or avails itself of, or becomes subject to, any
proceeding under the Federal Bankruptcy Act or any other statute of any
state or country relating to insolvency or the protection of creditor
rights, this LICENSE AGREEMENT shall immediately and automatically
terminate at the occurrence of any such event.
4.4 RESULTS OF TERMINATION
4.4.1 Termination of this LICENSE AGREEMENT shall not release
MCGILL or NOVOPHARM from any obligation or liability to the other which
shall have matured prior to termination, nor shall termination rescind or
require repayment of any payment or consideration made or given by either
party, except as otherwise provided herein. If the terms of this LICENSE
AGREEMENT expressly state that a right or obligation shall survive
termination of this LICENSE AGREEMENT, such right or obligation shall
survive termination to the degree necessary to allow complete fulfillment
or discharge of the right or obligation. The following rights and
obligations, in addition to others as provided herein, shall survive
termination. (A) NOVOPHARM shall make all reports as required herein
prior to termination, and additionally shall prepare a termination report
as reasonably required by MCGILL. (B) NOVOPHARM shall pay all royalties or
other payments due MCGILL accrued or accruable for payment prior to or
after termination, and all such royalties and payments accruable prior to
termination shall become immediately due and payable at the time of
termination. (C) At all times, both before and after termination,
NOVOPHARM shall maintain all records required to be kept herein and shall
allow MCGILL audit privileges as defined herein, upon fifteen (15) days'
prior written notice to NOVOPHARM. (D) All claims and causes of action
MCGILL may have against NOVOPHARM shall survive termination of this
LICENSE AGREEMENT.
4.4.2 Should this LICENSE AGREEMENT be terminated for any
reason, excepting a material breach by MCGILL, NOVOPHARM shall cease all
USE of the LICENSED TECHNOLOGY, and excepting sales of inventory, which
shall be subject to the terms of this LICENSE AGREEMENT, NOVOPHARM shall
cease all sale or transfer of the LICENSED PRODUCT(S).
5 LICENSING CONSIDERATION
5.1 LICENSE ISSUE FEE
In consideration of the license granted herein, the costs
incurred and services rendered by MCGILL, NOVOPHARM shall, on the
EFFECTIVE DATE, pay to MCGILL a license issue fee of [
] The license issue fee shall be nonrefundable and may not be credited
toward the payment of any royalties or other consideration required by
this LICENSE AGREEMENT.
6 ROYALTIES
6.1 EARNED ROYALTIES
In consideration for the license granted in this LICENSE
AGREEMENT,
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NOVOPHARM shall make payments to MCGILL in the manner designated below, an
earned royalty of 3% of NET SALES beginning on the DATE OF
COMMERCIALIZATION and continuing until termination of this LICENSE
AGREEMENT.
6.2 ANNUAL MAINTENANCE FEES
6.2.1 In order to maintain the license granted herein,
NOVOPHARM shall pay to MCGILL an assessed minimum annual maintenance fee
of [ ] on the second and each succeeding anniversary of the EFFECTIVE
DATE, for as long as this LICENSE AGREEMENT is in effect.
6.2.2 Annual maintenance fees shall be nonrefundable and shall
be credited only against earned royalties payable by NOVOPHARM to MCGILL
in the calendar year for which the minimum is payable and shall not be
commuted from one calendar year to the next.
6.3 DILIGENCE PAYMENTS
If NOVOPHARM has not filed [
] with the Canadian Dept.
of Health and Welfare and/or the U.S. Food and Drug Administration,
relating to the LICENSED PRODUCT, within forty-eight (48) months of the
EFFECTIVE DATE, NOVOPHARM shall pay MCGILL [ ] in
order to maintain rights under this LICENSE AGREEMENT.
If NOVOPHARM has not commenced [ ] on
LICENSED PRODUCT within [ ] of the EFFECTIVE DATE,
NOVOPHARM shall pay MCGILL [ ] in order to
maintain rights under this LICENSE AGREEMENT.
If NOVOPHARM has not commenced [ ] on
LICENSED PRODUCT within [ ] of the EFFECTIVE DATE,
NOVOPHARM shall pay MCGILL [ ] in order to
maintain rights under this LICENSE AGREEMENT.
6.4 MILESTONE PAYMENTS
NOVOPHARM shall, upon meeting the following development
milestones, immediately make payments to MCGILL of the amounts listed
below:
<Table>
<Caption>
Event Amount
----- ------
Filing of [ ] on LICENSED PRODUCT [ ]
[ ] submission on [ ]
LICENSED PRODUCT
[ ] Approval of LICENSED PRODUCT [ ]
</Table>
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6.5 RESEARCH PROGRAM
Contemporaneously with this Agreement NOVOPHARM shall
enter into a Research Agreement with MCGILL in the form attached hereto as
EXHIBIT A.
7 PAYMENTS AND REPORTS
7.1 PAYMENTS
7.1.1 Any amount due MCGILL as the result of each LICENSED
PRODUCT being USED, sold, leased, or transferred pursuant to the license
rights granted through this LICENSE AGREEMENT; shall accrue at the time
NOVOPHARM USES or performs SERVICES USING such LICENSED PRODUCT, bills,
invoices, ships, or receives payment for such LICENSED PRODUCT; whichever
event occurs first. All amounts accrued for the benefit of MCGILL shall
be deemed held in trust for the benefit of MCGILL until payment of such
amounts is made pursuant to this LICENSE AGREEMENT.
7.1.2 Unless otherwise specified in this LICENSE AGREEMENT,
all payment amounts due MCGILL under this LICENSE AGREEMENT shall be paid
within thirty (30) days following the end of the CALENDAR YEAR in which
such payment accrues or NOVOPHARM otherwise incurs the obligation to pay
such amounts.
7.1.3 All such payments shall be remitted to MCGILL's address
given in the notification provision of this LICENSE AGREEMENT or to such
other address as MCGILL shall direct.
7.1.4 NOVOPHARM shall pay to MCGILL a one-time late fee of 20%
of any payment required under this LICENSE AGREEMENT, if the payment is
more than fifteen (15) days late. Such late fee shall be paid within
thirty (30) days after the date on which the required payment was due. In
addition, NOVOPHARM shall pay to MCGILL interest on any amounts not paid
when due. Such interest will accrue from the fifteenth (15th) day after
the payment was due at a rate of five percent (5%) per annum, and the
interest payment will be due and payable on the first day of each month
after interest begins to accrue until full payment of all amounts due
MCGILL is made.
7.2 PAYMENTS IN CANADIAN DOLLARS
NOVOPHARM shall make payment of any amounts due MCGILL
under this LICENSE AGREEMENT in Canadian dollars.
7.3 REPORTS
7.3.1 NOVOPHARM shall keep, at its own expense, accurate books
of account, using accepted accounting procedures, detailing all data
necessary to calculate and easily audit any payments due MCGILL from
NOVOPHARM under this LICENSE AGREEMENT.
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7.3.2 Each payment made to MCGILL shall be accompanied by a
written report summarizing, in sufficient detail to allow MCGILL to verify
all payment amounts, the data used to calculate the amounts paid. Each
report pertaining to royalty payments for the applicable accounting period
shall specifically include the following, as applicable:
(A) NET SALES amounts.
(B) Royalties due.
7.3.3 Each periodic payment and associated written report
shall be certified as true, complete, and accurate by a statement signed
by one of NOVOPHARM's directors or officers.
8 PERFORMANCE
During the term of this LICENSE AGREEMENT, NOVOPHARM
shall use its best efforts to commercialize the LICENSED TECHNOLOGY within
the TERRITORY.
9 WARRANTIES
9.1 NO WARRANTY OF MERCHANTABILITY OF LICENSED TECHNOLOGY
MCGILL MAKES NO WARRANTIES, EXPRESS, IMPLIED OR
STATUTORY, WITH RESPECT TO THE LICENSED TECHNOLOGY, NOT EXPRESSLY SET
FORTH IN THIS AGREEMENT. ALL MCGILL DELIVERABLES ARE MADE AVAILABLE TO
NOVOPHARM STRICTLY ON AN "AS IS" BASIS. MCGILL DOES NOT WARRANT THAT THE
LICENSED TECHNOLOGY IS ERROR FREE OR THAT IT WILL MEET NOVOPHARM
REQUIREMENTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A
PARTICULAR PURPOSE ARE EXPRESSLY DISCLAIMED AND EXCLUDED. THE ENTIRE RISK
AS TO THE RESULTS AND PERFORMANCE OF LICENSED TECHNOLOGY, DELIVERABLES,
AND ANY PRODUCTS, SERVICES OR METHODS BASED ON THE LICENSED TECHNOLOGY IS
ASSUMED BY NOVOPHARM.
9.2 NO WARRANTY OF LIABILITY FOR LICENSED PRODUCT
MCGILL MAKES NO REPRESENTATIONS, EXTENDS NO
WARRANTIES,EXPRESS OR IMPLIED, AND ASSUMES NO LIABILITIES OR
RESPONSIBILITIES WITH RESPECT TO THE USE, SALE, OR OTHER DISPOSITION BY
NOVOPHARM, ANY AFFILIATE, VENDEES OR TRANSFEREES OF LICENSED PRODUCT(S)
OR THE LICENSED TECHNOLOGY.
10 GENERAL PROVISIONS
10.1 ASSIGNMENT
This LICENSE AGREEMENT may not be assigned or
transferred by NOVOPHARM without the prior written consent of MCGILL. Such
consent shall not be unreasonably withheld.
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10.2 ATTORNEYS' FEES
In the event any suit or other proceeding is reasonably
necessary and is commenced to construe, enforce, or terminate any
provision of this LICENSE AGREEMENT, the nonprevailing party shall pay the
prevailing party, in addition to all other amounts to which the prevailing
may be entitled, a reasonable sum for attorneys' fees and costs incurred
by the prevailing party in such suit or proceeding.
10.3 ENTIRE AGREEMENT
This LICENSE AGREEMENT constitutes the entire agreement
and understanding between MCGILL and NOVOPHARM with respect to the
LICENSED TECHNOLOGY, and any modification of this LICENSE AGREEMENT shall
be in writing and shall be signed by a duly authorized representative of
both MCGILL and NOVOPHARM. There are no understandings, representations,
or warranties between MCGILL and NOVOPHARM concerning the LICENSED
TECHNOLOGY except as expressly set forth in this LICENSE AGREEMENT.
10.4 GOVERNING LAW
This LICENSE AGREEMENT shall be deemed to have been made
in Province of Ontario and shall be governed and construed in accordance
with the laws of the Province of Ontario.
10.5 FORCE MAJEURE
Neither MCGILL not NOVOPHARM shall be in default of the
terms of this LICENSE AGREEMENT because the party delays performance or
fails to perform such terms; provided such delay or failure is not the
result of the party's intentional or negligent acts or omissions, but the
result of causes beyond the reasonable control of such party. Causes
reasonably beyond the control of MCGILL and NOVOPHARM shall include, but
not be limited to, revolutions; civil disobedience; fires; acts of God,
war, or public enemies; blockades; embargoes; strikes; labor disputes;
laws; governmental, administrative or judicial orders, proclamations,
regulations, ordinances, demands, or requirements; delays in transit or
deliveries; or inability to secure necessary permits, permissions, raw
materials, or equipment.
10.6 MEDIATION
Any disputes which arise between the parties under this
LICENSE AGREEMENT, shall be referred to the senior staff of both parties
respectively, who shall meet and make a good faith effort to resolve the
matter. In the event the parties fail to resolve such dispute by
negotiations the matter shall be submitted first to mediation by a
mediator chosen jointly by the parties involved. If after ninety (90)
days the dispute has not been resolved by mediation, the dispute shall
automatically go to arbitration.
10.7 ARBITRATION
10.7.1 Arbitration shall be governed by the International
Commercial Arbitration Act (Ontario) and shall take place in Toronto,
Ontario if the party desiring arbitration is MCGILL and shall take place
in Montreal, Quebec if the party desiring arbitration is NOVOPHARM and the
arbitrators shall apply Ontario law in reaching decisions.
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10.7.2 The party desiring such arbitration shall give written
notice to that effect and shall in such notice appoint as one of the
arbitrators a disinterested person of recognized competence in the medical
field, who shall have experience in arbitrating disputes arising under
agreements dealing with subject matters similar to the subject matter
hereof. Within fifteen (15) business days thereafter, the other party
shall, by written notice to the originating party, appoint as one of the
arbitrators a second disinterested person having the foregoing
qualifications. Unless the parties have agreed upon and appointed a third
arbitrator within ten (10) business days of the appointment of the second
arbitrator, the two arbitrators appointed by NOVOPHARM and MCGILL shall
select a third disinterested person having the foregoing qualifications
within twenty (20) business days of the appointment of the second
arbitrator. If the two arbitrators fail to agree upon the selection of
such third arbitrator within such twenty (20) business day period, either
NOVOPHARM or MCGILL upon written notice to the other may apply to the
Ontario Court (General Division) for the appointment of a third
arbitrator. If the second arbitrator shall not have been appointed as
aforesaid, the first arbitrator shall proceed to determine the matter in
dispute. The arbitrators thus appointed shall use all reasonable efforts
to determine the matter in dispute as soon as practicable and in any event
within thirty (30) business days of the appointment of the third
arbitrator.
10.7.3 Each party shall be entitled to present evidence and
argument to the arbitrators. The arbitrators shall have the right only to
interpret and apply (and not change) the provisions of this LICENSE
AGREEMENT and may not deprive NOVOPHARM or MCGILL of any right or remedy
provided by this LICENSE AGREEMENT or at law.
10.7.4 The determination of the majority of the arbitrators
shall be conclusive and binding upon the parties and judgment upon the
same may be entered in any court having jurisdiction. The arbitrators
shall give written notice to the parties stating their determination and
shall furnish to each party a signed copy of such determination.
10.7.5 In the event of failure, refusal or inability of any
arbitrator to act, a new arbitrator shall be appointed in his stead, which
appointment shall be made in the same manner as provided above for the
appointment of the arbitrator so failing, refusing or unable to act.
10.7.6 The expenses of any arbitration hereunder shall be borne
as awarded by the arbitrators, or, in the absence of such an award, shall
be borne equally by NOVOPHARM and MCGILL.
10.7.7 The parties shall act in good faith and shall act
diligently to proceed with and complete the arbitration proceedings.
10.8 HEADINGS
The section and subsection titles and headings contained
in this LICENSE AGREEMENT are for convenience and reference only. Such
titles and headings do not form a part of this LICENSE AGREEMENT, shall
not define or limit the scope of the sections or subsections, and shall
not affect the construction or interpretation of any of the sections or
subsections.
10.9 NOTICES
All notices, reports, payments, requests, consents,
demands and other communications between MCGILL and NOVOPHARM, pertaining
to subjects related to this
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LICENSE AGREEMENT, shall be in writing and shall be deemed duly given and
effective (A) when actually received by mail or personal delivery, or (B)
when mailed by prepaid registered or certified mail to the receiving party
at the address set faith below, or to such other address as may be later
designated by written notice from either party to the other party, or (C)
when sent by telecopier, telex or other similar means of electronic
communication on the second day following the sending thereof:
MCGILL's Notification Address:
Director, Office of Technology Transfer, MCGILL
UNIVERSITY, 3550 University St., Montreal, Quebec, Canada H3A 2A7; tel.
(514) 398-4201, fax. (514) 398-8479.
NOVOPHARM's Notification Address:
President, NOVOPHARM LIMITED, 30 Nably Court,
Scarborough, Ontario, Canada M1B 2K9; tel. (416) 291-8876, fax. (416)
291-2162.
10.10 USE OF NAME
NOVOPHARM shall not, without prior written consent from
MCGILL in each specific case, use MCGILL's name, trademark(s), or any
adaptations thereof.
10.11 CONFIDENTIALITY
10.11.1 MCGILL and NOVOPHARM agree that, except as may otherwise
be required by applicable laws, regulations, or orders, no information
concerning this LICENSE AGREEMENT, and the transactions contemplated
herein shall be made public by either party without the prior written
consent of the other.
10.11.2 MCGILL and NOVOPHARM agree that they shall be released
from their respective obligations under this section 10.11 hereof on the
date when, through no fault or omission of the party seeking such release,
such information (A) is disclosed in published literature; or (B) is
generally available to the relevant industry; or (C) is obtained by the
party seeking such release from a third party without binder of secrecy,
provided, however, that such third party has no confidentiality
obligations to the other party to this LICENSE AGREEMENT.
10.12 PUBLICATION
In the event that MCGILL wishes to publish or make
available to the public, any material with respect to (without
limitation), the LICENSED TECHNOLOGY and/or the LICENSED PRODUCT, MCGILL
shall furnish to NOVOPHARM a copy of such proposed publication at least
thirty (30) days in advance of the proposed publication date. NOVOPHARM
shall have the right to object to said publication if, in NOVOPHARM's
opinion, the aforesaid publication may result in a disclosure of
confidential information or information that may be detrimental to the
sale of the LICENSED PRODUCT, NOVOPHARM shall provide to MCGILL within the
said thirty (30) days, particulars of its objections to said publication.
Upon receiving such notification from NOVOPHARM, MCGILL shall edit the
information to NOVOPHARM's satisfaction prior to publication.
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10.13 WAIVER OF RIGHTS
In order to be effective, any waiver, by either party,
of any right under this LICENSE AGREEMENT, must be in writing signed by an
authorized representative of the party making the waiver. No such waiver
or failure of MCGILL or NOVOPHARM to enforce a right or strict performance
under this LICENSE AGREEMENT shall be deemed to be a waiver or forbearance
which would in any way prevent MCGILL or NOVOPHARM from subsequently
asserting or exercising any such rights, making a claim not specifically
waived, or requiring strict performance of this LICENSE AGREEMENT. No such
waiver or failure to enforce shall affect the validity of this LICENSE
AGREEMENT or be a continuing waiver excusing compliance with any provision
of this LICENSE AGREEMENT in the future.
10.14 LANGUAGE
The parties hereto hereby acknowledge that they have
required this LICENSE AGREEMENT to be drawn up in the English language.
Les parties reconnaissent avoir demande que le present contrat de licence
soit redige en langue anglaise.
10.15 SIGNATURES
IN WITNESS WHEREOF, MCGILL and NOVOPHARM have caused
this LICENSE AGREEMENT to be executed in duplicate originals by their duly
authorized representative.
LICENSOR: LICENSEE:
MCGILL UNIVERSITY NOVOPHARM LIMITED
Representing Licensor: Representing Licensee:
/s/ R.D. Brassinga /s/ Leslie L. Dan
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Signature Signature
April 26, 1994 April 28, 1994
- ---------------------- -----------------------
Date Date
R.D. Brassinga Leslie L. Dan
- ---------------------- -----------------------
Name of Representative Name of Representative
Assoc. Dir., OTT Chairman and CEO
- ---------------------- -----------------------
Title of Representative Title of Representative
/s/ Gerald B. Price /s/ Amita Kent
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Witness Witness
13
EXHIBIT A
SPONSORED RESEARCH AGREEMENT - MCGILL UNIVERSITY
This will confirm the agreement between NOVOPHARM LTD. of Scarborough, Ontario
M1P 2Y1 ("NOVOPHARM") and McGill University ("MCGILL") whereby NOVOPHARM is
prepared to support studies conducted at MCGILL on "An exploration of the
regulation of polyamine transport in human disease" ("Project") as described in
Appendix A, under the direction of Dr. G.B. Price of the McGill Cancer Centre.
Dr. G.B. Price will direct and conduct the research in accordance with the
research policy and guidelines of MCGILL.
DURATION
Funding under this Agreement is awarded to conduct research for a twenty
four-month period starting April 28, 1994.
ALLOTTED FUNDS
The total amount of funding shall not exceed Cdn [ ] except with the
prior written approval of NOVOPHARM. Funding includes expenses for personnel,
animals, equipment, consumables and administration (as described in Appendix B).
Payments shall be received in two bi-annual instalments commencing with the
starting date of the Project. The execution of the research may also be
supported by funds from other research organizations and the University. The
investigator shall have freedom within the allotted amount to rebudget within
the categories outlined in Appendix B in order to utilize funds in the best
interest of the study.
REPORTING
NOVOPHARM shall receive a comprehensive report on the activities and results of
the research project no later than 90 days after its completion. A report of
expenditure shall accompany this report. If the project period exceeds 12
months, NOVOPHARM shall receive brief annual reports on the progress of the
research.
INVENTIONS, DISCOVERIES AND OTHER INTELLECTUAL PROPERTY
All inventions, discoveries, and other intellectual property resulting from
research supported under this Agreement shall belong to the investigator and
MCGILL.
OPTION TO LICENSE
During the period of support, NOVOPHARM shall receive an option to exclusively
license from MCGILL
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(under terms to be negotiated) inventions and other useful results derived from
the project.
CONFIDENTIAL MATERIAL
In the course of the research project, MCGILL and NOVOPHARM may share
confidential materials and data with each other. Such materials shall be kept
confidential for a period of five years and shall not be disclosed to anyone
without a "need to know" within NOVOPHARM or MCGILL. Each party shall also
strictly protect such information from disclosure to third parties. The
obligation to keep confidential shall however not apply to information which:
a) is already known to the party to which it is disclosed;
b) becomes part of the public domain without breach of this Agreement;
c) is obtained from third parties which have no obligations to keep
confidential to NOVOPHARM and MCGILL.
PUBLICATION
MCGILL and the principal investigator shall have the right to publish any
material resulting from Research under this Agreement. In this regard, the
investigator shall furnish NOVOPHARM with a copy of any proposed publication at
least 30 days in advance of the proposed publication date. Within this 30-day
period, NOVOPHARM shall review said proposed publication for the disclosure of
any NOVOPHARM confidential information, and shall inform MCGILL in writing of
the location and content of such specific information. Upon receiving the
appropriate written notification from NOVOPHARM, the investigator shall edit the
information before publication. NOVOPHARM shall have the option of receiving an
acknowledgement in the publication of its sponsorship of the research.
TERMINATION
NOVOPHARM agrees to support the research for twenty four months. MCGILL shall
promptly inform NOVOPHARM of any events (death or departure of Principal
Investigator) that could prevent the project from being continued as proposed.
Upon such notification, NOVOPHARM and MCGILL will attempt to agree upon an
investigator to be named to continue the research project. If the parties fail
to agree on an alternate investigator within 30 days after notice from MCGILL,
NOVOPHARM may terminate this Agreement and will be obligated to pay MCGILL only
for costs and expenses which have already been incurred or which cannot be
reasonably avoided.
LIABILITY AND INDEMNITY
i) NOVOPHARM agrees to hold MCGILL and its staff free and harmless from any
and all claims or rights of action which may result from the use by
NOVOPHARM, or its customers or licensees, of project results developed
under this Agreement.
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ii) MCGILL shall indemnify NOVOPHARM against all costs, suits or claims on
account of injuries (including death) to persons participating in the
conduct of the Project or damage to MCGILL property during the performance
of this Agreement.
FORCE MAJEURE:
Neither party to this Agreement shall be liable to the other for any failure or
delay in performance caused by circumstances beyond its control, including but
not limited to, acts of God, fire, labor difficulties or governmental action.
PUBLICITY:
NOVOPHARM will not use the name of MCGILL nor of any member of its staff in any
publicity without prior written approval of an authorized representative of
MCGILL.
NOTICES:
MCGILL notices shall be sent to:
McGill University
The Office of Technology Transfer
Attention: Director
3550 University St.
Montreal, Quebec H3A 2A7
Tel.: (514) 398-4201
Fax: (514) 398-8479
NOVOPHARM notices shall be sent to:
Novopharm Limited
Attention: President
30 Nably Court
Scarborough, Ontario M1B 2K9
Tel.: (416) 291-8876
Fax : (416) 291-2162
MCGILL payments shall be sent to:
McGill University
Accounting Department, Special Funds
Attention: Mr. Terry Monteiro
James Administration Building
853 Sherbrooke Street West
Montreal, Quebec H3A 2T5
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GENERAL
This Agreement will be governed by and construed in accordance with the laws of
the Province of Quebec.
The parties confirm hereby that they each required that this Agreement and all
documents and notices in connection therewith be drawn up in English.
Les parties reconnaissent par Ies presentes que chacune d'elles a exige que
cette convention et tout document ou avis y afferent soient rediges en anglais.
Executed at Montreal this twenty-eighth day of April, 1994.
NOVOPHARM LTD. MCGILL UNIVERSITY
By: /s/ Leslie L. Dan By: /s/ Gerald B. Price
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Name: LESLIE L. DAN Name: Gerald B. Price
Title: CHAIRMAN AND CEO Title: Principal Investigator
Date: April 28, 1994 Date: April 26, 1994
By: /s/ R.D. Brassinga
----------------------
Name: R.D. Brassinga
Title: Assoc. Dir., OTT
Date: April 26, 1994
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1
APPENDIX A
AN EXPLORATION OF THE REGULATION OF POLYAMINE TRANSPORT
IN HUMAN DISEASE
Polyamines are now known to be critical in the growth and differentiation
of many normal and malignant tissues. In particular, various neurologic
disorders and malignancies have been associated with disruption of the
regulation of polyamine levels through biosynthesis and transport. Whereas some
of the genes important in the biosynthesis and regulation of polyamine Ievels
have been characterized, no polyamine transport gene has yet been characterized
in mammals. In some of our recent work, we believe that we have identified a
potential probe for a human polyamine transport protein. The expression of mRNA
homologous with this probe has been shown to be distributed among human tissues
similarly to known levels of polyamine and polyamine metabolism; furthermore,
exposure of various types of cells to either mitogens or poisons of polyamine
metabolism resulted in the anticipated up- or down-regulation of the expression
of the gene homologous to the putative human polyamine transport probe.
In order to verify the identity of the gene homologous to this probe as a
regulator of polyamine transport, we will identify the yeast gene and its
location (preliminary data suggests that the yeast gene can be readily
identified and cloned; the yeast gene is undoubtedly nearly identical to the
human gene and will make it possible to quickly obtain the exact human gene(s).)
In addition, we are proceeding to "knock-out" the yeast gene in order to
unequivocally prove the function as a transport protein for polyamines. In the
first year, we would hope to complete the yeast work and begin, if not conclude,
the cloning of the putative human polyamine transport protein. During the rest
of the first and in the second year, we would expect to use the probe on various
cell lines and tissues (in Northern blot and FISH, fluorescence in situ
hybridization, assays) to demonstrate the role played by this putative polyamine
transport in nonmalignant neurologic disorders like Alzheimer's Disease as well
as malignancies of the brain, colon, prostate, skin, etc.
The isolation and demonstration of the identity of this human polyamine
transport protein would provide diagnostic and research tools. In addition, the
characterization of the gene and its regulatory control would be crucial to the
design of chemotherapeutic agents to modify disease conditions. Finally, the
isolation of the gene would provide an opportunity to consider the use of gene
therapy to selectively knockout or up-regulate polyamine levels as may be needed
to normalize tissue and organ function.
EXAMPLES OF PERTINENT REFERENCES:
Casero RA Jr. Pegg AE. Spermidine/spermine N1-acetyltransferase--the turning
point in polyamine metabolism. [Review] FASEB Journal. 7(8):653-61, 1993 May.
Basu HS. Pellarin M. Feuerstein BG. Shirahata A. Samejima K. Deen DF. Marton LJ.
Interaction of a polyamine annalogue, 1,19-bis-(ethylamino)-5,10,
15-triazanonadecane (BE-4-4-4-4), with DNA and effect on growth, survival, and
polyamine levels in seven human brain tumor cell lines [published erratum
appears in Cancer Res 1993 Oct I5;53(20):5063] Cancer Research. 53(17):3948-55,
1993 Sep 1.
Basu HS. Pellarin M. Feuerstein BG. Deen DF. Marton LJ. Effects of the polyampol
analogs BE-3-7-3, 3-8-3, and BE-3-8-3 on human brain tumor cell growth and
survival. Anticancer Research. 13(5A):1525-32, 1993 Sep-Oct.
Quemener V. MoulinouJP. Lucas J. Khan N. Darcel F. Martin LA. Primault R.
Seiler N. The effects of structural analogs of putrescine on proliferation,
morphology and karyotype of glioblastoma cells in culture. Biology of the Cell.
77(2):195-9, 1993.
2
Kurihara H. Matsuzaki S. Yamazaki H. Tsukahara T. Tamura M. Relationship between
tissue polyamine levels and malignancy in primary brain tumors. Neurosurgery.
32(3):372-5, 1993 Mar.
(SEE ALSO JOURNAL OF NEUROONCOLOGY 16:243-272,1993.)
McGarrity TJ. Peiffer LP. Hartle RJ. Effect of selenium on growth,
S-adenosylmethionine and polyamine biosynthesis in human colon cancer cells.
Anticancer Research. 13(3):811-5,1993 May-Jun.
Cipolla B. Guille F. MoulinouJP. Quemener V. Staerman F. Corbel L. Lobel B.
Polyamines and prostatic carcinoma: clinical and therapeutic implications.
European Urology. 24(1):124-31, 1993.
Snyder RD. Schroeder KK. Radiosensitivity of polyamine-depleted HeLa cells and
modulation by the aminothiol WR-1065. Radiation Research. 137(1):67-75, 1994
Jan.
Palmer AM. Burns MA. Preservation of redox, polyamine, and glycine modulatory
domains of the N-methyl-D-aspartate receptor in Alzheimer's disease. Journal of
Neurochemistry. 62(1): 187-96, 1994 Jan.
Morrison LD. Bergeron C. Kish SJ. Brain S-adenosylmethionine decarboylase
activity is increased in Alzheimer's disease. Neuroscience Letters.
154(1-2):141-4, 1993 May 14.
Sjoholm A. Role of polyamines in the regulation of proliferation and hormone
production by insulin-secreting cells. [Review] American Journal of Physiology.
264(3 Pt 1):C501-18, 1993 Mar.
APPENDIX B
BUDGET
1st year 2nd year
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[ ] [ ] [ ]
B. Stipends to graduate students and postdoctoral -- --
fellows
C. Fringe benefits [ ] [ ]
D. Purchase or rental of equipment [ ] [ ]
E. Materials, supplies and incidentals [ ] [ ]
F. Travel -- --
G. Computing costs -- --
H. Others (specify) -- --
I. Indirect costs [ ] [ ]
TOTAL [ ] [ ]