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Exhibit 10.1
TECHNOLOGY LICENSE AGREEMENT
This Technology License Agreement (this "Agreement") is made as of the 31st
day of March, 1998 among BioChem Pharma Inc., a Canadian corporation
("BioChem"), each BioChem Affiliate listed on the signature page hereto (each a
"BioChem Affiliate") and CliniChem Development Inc., a Canadian corporation
("CliniChem").
RECITALS
A. CliniChem has been formed for the purpose of (i) conducting
research and development of potential human therapeutic products primarily for
the treatment of cancer and HIV infection and vaccine products for the
prevention of certain infectious diseases, including products using BioChem
Technology (as defined below) and (ii) commercializing such products.
B. BioChem is engaged in the research, development and marketing of
therapeutic products and the research, development, manufacturing and marketing
of vaccine and diagnostic products for a wide range of infectious and other
diseases.
C. BioChem and CliniChem have entered into the Research and
Development Agreement (as defined below) for the conduct by BioChem, on behalf
of CliniChem, of research, development and related activities in connection with
the CliniChem Programs (as defined below).
D. BioChem and the BioChem Affiliates are willing to grant to CliniChem a
license to use BioChem Technology (as defined below) solely for the purposes set
forth above on the terms set forth herein and in the Research and Development
Agreement and the Product Option Agreement (each as defined below).
NOW, THEREFORE, in consideration of the various premises and undertakings
set forth herein and for other good and valuable consideration, the receipt and
sufficiency of which is hereby acknowledged, the parties agree as follows:
1. DEFINITIONS.
For the purposes of this Agreement, the following terms shall have the
meanings set forth below:
1.1 "Affiliate" shall mean a corporation or any other entity that
directly, or indirectly through one or more intermediaries, controls, is
controlled by, or is under common control with, the designated party. "Control"
shall mean ownership of shares to which are attached more than fifty percent
(50%) of the votes that may be cast for the election of directors in the case of
a corporation, and at least fifty percent (50%) of the interests in profits in
the case of a business entity other than a corporation. BioChem and CliniChem
shall not be considered Affiliates of each other.
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1.2 "BioChem Technology" shall mean all Proprietary Rights (whether
patented or unpatented), owned by, licensed to (including pursuant to those
agreements listed on Exhibit B hereto) or controlled by BioChem or a BioChem
Affiliate, as of the date of this Agreement or during the term of the Research
and Development Agreement, relating to the CliniChem Programs, including any
Developed Technology, and including those patents and patent applications
indicated by reference to BioChem docket numbers on Exhibit A hereto. "BioChem
Technology" shall also include any additional technology which BioChem or a
BioChem Affiliate designates expressly in a writing delivered to CliniChem as
BioChem Technology for purposes of this Agreement. Notwithstanding the
foregoing, however, except as set forth in Section 2.2(a) hereof, in no event
shall "BioChem Technology" include the Proprietary Rights licensed to BioChem or
any BioChem Affiliate under the Excluded Agreements.
1.3 "Biovector Agreement" shall mean that certain Collaboration
Agreement dated May 5, 1997 by and between IAF BioVac Inc. (now known as
BioChem Vaccines Inc.) and Biovector Therapeutics, S.A. as amended from time to
time.
1.4 "CliniChem Product" shall mean any human therapeutic or vaccine
product developed according to the terms of the Research and Development
Agreement and pursuant to the CliniChem Programs in the applicable Fields of
Use.
1.5 "CliniChem Program" shall mean any of the therapeutic and vaccine
product development programs listed on Exhibit C in the applicable Fields of Use
indicated on such Exhibit C, and any additional or modified development programs
recommended by BioChem or a BioChem Affiliate and accepted by CliniChem's Board
of Directors for research and development pursuant to the Research and
Development Agreement.
1.6 "Confidential Information" shall mean all information received by
one party with respect to the research, intellectual property or business of the
other and it shall include, without limiting the generality of the foregoing,
the BioChem Technology, all documents, data and other technical information,
such as know-how, formulae, processes, models, manufacturing techniques,
research projects, information management systems and software, as well as
information relating to the management and financial affairs of such party, such
as figures relating to profits, markets, sales, business, marketing and
development plans, client lists, supplier lists and information of a similar
nature.
1.7 "Developed Technology" shall mean Proprietary Rights that (a) are
first generated, conceived or reduced to practice, as the case may be, by
BioChem, a BioChem Affiliate or by any third party in the course of performing
activities undertaken pursuant to the Research and Development Agreement or (b)
are acquired from a third party by BioChem or a BioChem Affiliate during the
term of the Research and Development Agreement for use, in whole or in part, in
the conduct of the CliniChem Programs or the commercialization of CliniChem
Products.
1.8 "Distribution" shall mean the distribution by BioChem as a
dividend-in-kind of all of the issued and outstanding Class A Common Shares in
the share capital of CliniChem to the holders of record of Common Shares of
BioChem on the date selected as the record date by the Board of Directors of
BioChem.
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1.9 "Distribution Agreement" shall mean the Distribution Agreement
dated as of the date hereof by and between BioChem and CliniChem, as amended
from time to time.
1.10 "Distribution Date" shall mean the proposed date of effecting the
Distribution.
1.11 "Excluded Agreements" shall mean, collectively, the BioVector
Agreement, the Pharmadigm Agreement and the UGARF/Yale Agreement.
1.12 "Field of Use" shall mean the treatment of a particular disease or,
in the case of a vaccine, vaccination against a particular bacterium. The
applicable Field of Use for each CliniChem Program is set forth in Exhibit C.
1.13 "Infringing Product" shall mean any product manufactured, used,
offered for sale or sold by a third party, other than pursuant to an agreement
with CliniChem, BioChem or a BioChem Affiliate, which infringes or is alleged to
infringe any patent or patents licensed to CliniChem hereunder containing claims
which cover a CliniChem Product.
1.14 "Pharmadigm Agreement" shall mean that certain License Agreement
dated May 10, 1996 by and between IAF BioVac Inc. (now known as BioChem
Vaccines Inc.) and Pharmadigm Biosciences, Inc. as amended from time to time.
1.15 "Product Option" shall mean the option granted to BioChem and certain
of the BioChem Affiliates pursuant to the Product Option Agreement, as amended
from time to time.
1.16 "Product Option Agreement" shall mean the Product Option Agreement
dated as of the date hereof by and between BioChem, certain of the BioChem
Affiliates and CliniChem, as amended from time to time.
1.17 "Pre-Existing Rights" shall mean the rights of each party other than
BioChem or a BioChem Affiliate under the agreements listed in Exhibit B.
1.18 "Proprietary Rights" shall mean data, inventions, information,
processes, know-how and trade secrets, and patents or patent applications
claiming any of the foregoing, owned by, licensed to or controlled by a person
and which such person has the right to license or sublicense without the consent
of any third party and without incurring additional liability to any third
party. Proprietary Rights shall not include trademarks or copyrights.
1.19 "Purchase Option" shall mean the option contained in the Articles of
Incorporation of CliniChem, as amended or restated from time to time, pursuant
to which BioChem (as the holder of the majority of the outstanding Class B
Common Shares in the share capital of CliniChem) has the right to acquire all
(but not less than all) of the outstanding Class A Common Shares in the share
capital of CliniChem.
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1.20 "Research and Development Agreement" shall mean the Research and
Development Agreement dated as of the date hereof by and between BioChem and
CliniChem, as amended from time to time.
1.21 "Services Agreement" shall mean the Services Agreement dated as of
the date hereof by and between BioChem and CliniChem, as amended from time to
time.
1.22 "Technology Fee" shall mean those payments to be made by CliniChem
to BioChem or a BioChem Affiliate pursuant to Section 3.2 hereof.
1.23 "UGARF/Yale Agreement" shall mean that certain License Agreement
dated January 3, 1996 (as amended June 30, 1996) by and among University of
Georgia Research Foundation, Inc., Yale University, BioChem Pharma Inc., Tanaud
Holdings (Barbados) Limited and Tanaud L.L.C. as amended from time to time.
2. LICENSE.
2.1 GRANT OF LICENSE. Subject to the Pre-Existing Rights and except as
set forth in Section 2.2 below, BioChem and the BioChem Affiliates hereby grant
to CliniChem, on the terms and conditions of this Agreement, a worldwide,
exclusive license, in perpetuity, with the right to sublicense (as set forth in
Sections 2.3 and 2.4 hereof), to use the BioChem Technology to (a) conduct
research and development and related activities including, without limitation,
compassionate access programs, in connection with the CliniChem Programs (to
the extent such license is necessary for such conduct under applicable law) and
(b) to manufacture, have manufactured and commercialize CliniChem Products, but
for no other purposes whatsoever; provided, however, that with respect to the
CliniChem Product BCH-4556, such license shall be granted by (i) BioChem for the
territory of Canada, (ii) Tanaud Ireland Inc. for the territory of the United
States of America and (iii) Tanaud International B.V. for the remainder of the
world. Such license is limited, for each CliniChem Program and each CliniChem
Product, to the Field of Use designated on Exhibit C.
2.2 LIMITATIONS ON LICENSE.
(a) EXCLUDED AGREEMENTS. Notwithstanding anything in this Agreement
to the contrary, nothing herein shall constitute a grant of a sublicense to
CliniChem of any Proprietary Rights licensed to BioChem or any BioChem Affiliate
under the Excluded Agreements unless and until BioChem or the appropriate
BioChem Affiliate obtains the consent of the applicable third party licensor.
BioChem or the appropriate BioChem Affiliate shall use commercially reasonable
efforts to obtain any consents necessary (1) to grant a sublicense to CliniChem
(on commercial terms reasonably acceptable to BioChem) to any adjuvant licensed
pursuant to the Pharmadigm Agreement and incorporated in a CliniChem Product,
(2) to grant a sublicense to CliniChem (on commercial terms reasonably
acceptable to BioChem) to any biovector licensed pursuant to the Biovector
Agreement and incorporated in a CliniChem Product, and (3) to grant a sublicense
to CliniChem (on commercial terms reasonably acceptable to BioChem) under the
UGARF/Yale Agreement in connection with the BCH-4556 CliniChem Product,
provided, in each case, that (i) the relevant CliniChem Product has received
regulatory approval for commercial marketing in at least one
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country for which neither BioChem nor a BioChem Affiliate has exercised the
applicable Product Option and (ii) BioChem has not exercised the Purchase
Option. CliniChem shall pay any costs associated with obtaining such consents or
required pursuant to the sublicenses, and any such sublicenses shall terminate
upon the exercise by BioChem of the worldwide Product Option for such product or
the Purchase Option. Once any such consent is obtained, the sublicensed patents
and technology shall be deemed to be included in the definition of "BioChem
Technology."
(b) MANUFACTURING. CliniChem shall have the right to obtain its
manufacturing requirements of any CliniChem Product from a third party subject,
however, to the following terms and conditions:
(i) In the event CliniChem determines not to conduct its own
manufacturing of any CliniChem Product, CliniChem shall provide BioChem the
opportunity to fulfill CliniChem's manufacturing requirements for such CliniChem
Product.
(ii) In the event BioChem and CliniChem are unable to reach
agreement as to the commercial terms for BioChem's manufacture of such CliniChem
Product after fifteen (15) days of good faith negotiation, CliniChem shall have
the right to negotiate an arrangement for the manufacture of such CliniChem
Product with a third party, subject to rights under the Excluded Agreements, if
any.
(iii) At least thirty (30) days prior to entering into any
definitive agreement with a third party in respect of any such manufacturing
arrangement, CliniChem shall first provide notice of such proposed arrangement
to BioChem, which notice shall include an offer for BioChem to provide such
manufacturing on terms and conditions generally not less advantageous to
CliniChem than those offered by such third party, taking into account not only
pricing, but all relevant factors. BioChem shall have the right to accept or
reject such offer in its sole discretion.
(iv) In the event that BioChem rejects or fails to accept such
offer within such thirty (30) day period, CliniChem shall have the right
(subject to subsection (v) below) to enter into manufacturing arrangements with
such third party or any other third party on the terms and conditions contained
in the offer described in subsection (iii) or manufacturing terms and conditions
which are in the aggregate no more favorable to the proposed manufacturer than
those contained in the offer described in subsection (iii); it being understood
that CliniChem shall not have the right to enter into any manufacturing
arrangement on terms more favorable to the proposed manufacturer without first
offering such terms to BioChem, which offer shall again be subject to the
provisions of this Section 2.2(b).
(v) In the event BioChem does not exercise such right of first
refusal, BioChem shall have the right to approve any proposed manufacturer,
which approval may be withheld only if any such manufacturer has insufficient
manufacturing capability (including lack of compliance with current good
manufacturing practice regulations) or if any such manufacturer's activities are
likely to have a material adverse effect on BioChem's overall competitive
position in the pharmaceutical industry.
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(vi) In the event BioChem exercises its right to reject a
manufacturer with respect to a CliniChem Product, BioChem shall be obligated to
manufacture or obtain manufacturing for any such CliniChem Product for CliniChem
at prevailing market rates but not less than BioChem's standard cost of
manufacture plus fifteen percent (15%) of such cost.
(vii) Notwithstanding anything in this Section 2.2(b) to the
contrary, it is understood and agreed between the parties that, pursuant to the
terms of an agreement between BioChem and Patheon Inc. dated October 29, 1997,
Patheon Inc. holds a conditional right of first refusal to bid for the
commercial manufacturing of the CliniChem Product BCH-10652 in dosage form and,
as a result, CliniChem's license to manufacture and have manufactured such
CliniChem Product is subject to Patheon's pre-existing conditional rights
pursuant to that agreement.
2.3 PERMITTED SUBLICENSES. CliniChem shall not sublicense any BioChem
Technology to, or enter into other arrangements with respect to any BioChem
Technology with, any third party for any purpose except as set forth in this
Section 2.3 and in Section 2.4 and subject to the limitations of Section 2.5.
(a) Except as set forth in Section 2.3(b) hereof, during the term of
the Research and Development Agreement CliniChem shall grant BioChem a
sublicense to use the BioChem Technology for the purpose of performing
activities in connection with the CliniChem Programs pursuant to the terms of
the Research and Development Agreement (to the extent such license is necessary
to conduct such activities under applicable law). Following termination or
expiration of the Research and Development Agreement, CliniChem shall have the
right, but shall not be obligated to, grant BioChem a sublicense to the BioChem
Technology to perform activities in connection with the CliniChem Programs.
(b) If the Product Option with respect to any CliniChem Product in
one or more countries expires unexercised, from and after expiration of such
Product Option in any such country, CliniChem may sublicense BioChem Technology
to a third party or third parties solely to the extent necessary to complete the
development of, or to make (or have made) and use such CliniChem Product, or to
sell (or have sold) such CliniChem Product in such country; provided, however,
that BioChem shall have the right to approve any proposed sublicensee or any
manufacturer on behalf of a sublicensee; provided, further, that such approval
may only be withheld if any such sublicensee or manufacturer has insufficient
manufacturing capability (including lack of compliance with current good
manufacturing practice regulations) or if any such sublicensee's or
manufacturer's activities are likely to have a material adverse effect on
BioChem's overall competitive position in the pharmaceutical industry.
2.4 SUBLICENSE TO WHOLLY OWNED SUBSIDIARY. CliniChem may grant a
non-transferrable sublicense of the BioChem Technology to a direct or indirect
wholly-owned subsidiary of CliniChem; provided that the terms of any such
sublicense shall require that the sublicense automatically terminate should the
relevant CliniChem subsidiary cease to be a direct or indirect wholly owned
subsidiary of CliniChem.
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2.5 CONDITIONS OF SUBLICENSES. Each sublicensee (other than BioChem or a
BioChem Affiliate) shall execute such agreements as BioChem reasonably deems
appropriate to protect the BioChem Technology and to protect BioChem's rights
under all agreements between BioChem and CliniChem and under the Purchase
Option. Each sublicensee shall have all the duties of CliniChem hereunder with
respect to such sublicense, and each sublicensee shall acknowledge these duties
to BioChem in writing. No sublicense shall have the effect of relieving
CliniChem of any of its obligations hereunder.
2.6 PRIOR AND FUTURE GRANTS. CliniChem understands and acknowledges that
BioChem and certain of the BioChem Affiliates are in the business of researching
and developing products incorporating the BioChem Technology for their own
account and under arrangements with third parties, and as a result, the license
granted hereunder is limited strictly to use the BioChem Technology in
connection with the CliniChem Programs and commercializing the CliniChem
Products. CliniChem acknowledges that BioChem, and the BioChem Affiliates may
use and may grant third party licenses to use the BioChem Technology for any and
all other purposes and in any Fields of Use other than those set out in Exhibit
C for each CliniChem Program.
3. COVENANTS OF CLINICHEM.
3.1 DILIGENCE. CliniChem promptly shall commence and shall use diligent
efforts to have developed CliniChem Products in accordance with approved work
plans and cost estimates under the Research and Development Agreement, subject
to BioChem complying with its obligations thereunder.
3.2 TECHNOLOGY FEE. In partial consideration for the license granted by
BioChem and the BioChem Affiliates to CliniChem hereunder, CliniChem shall pay
in arrears the following Technology Fee payments:
(a) five hundred thousand dollars ($500,000) thirty (30) days after
the Distribution Date and five hundred thousand dollars ($500,000) on the same
day of each of the next eleven (11) months payable as follows: to BioChem three
hundred fifty-eight thousand dollars ($358,000), to Tanaud Ireland Inc.
forty-two thousand dollars ($42,000), and to Tanaud International B.V. one
hundred thousand dollars ($100,000);
(b) four hundred eight thousand three hundred thirty-three dollars
($408,333) per month on the same day of each of the next twelve (12) months
payable as follows: to BioChem two hundred ninety-two thousand, three hundred
thirty-three dollars ($292,333); to Tanaud Ireland Inc. thirty-four thousand
dollars ($34,000), and to Tanaud International B.V. eighty-two thousand dollars
($82,000);
(c) three hundred thousand dollars ($300,000) per month on the same
day of each of the next twelve (12) months payable as follows: to BioChem two
hundred fifteen thousand dollars ($215,000), to Tanaud Ireland Inc. twenty-five
thousand dollars ($25,000), and to Tanaud International B.V. sixty thousand
dollars ($60,000); and
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(d) two hundred thousand dollars ($200,000) per month on the same day
of each of the next twelve (12) months payable as follows: to BioChem one
hundred forty three thousand dollars ($143,000), to Tanaud Ireland Inc.
seventeen thousand dollars ($17,000), and to Tanaud International B.V. forty
thousand dollars ($40,000);
provided, however, that CliniChem shall not be obligated to make such payments
beginning with any month following the date on which the sum of the number of
CliniChem Products under development by CliniChem pursuant to the Research and
Development Agreement plus the number of CliniChem Products that have been
acquired by BioChem or a BioChem Affiliate pursuant to BioChem's exercise of
the Product Option is less than two (2).
All payments to be made by CliniChem to Tanaud International B.V. and
Tanaud Ireland Inc. shall be made net of any Canadian withholding tax
applicable to such payments.
3.3 PRE-EXISTING OBLIGATIONS. CliniChem agrees to take no action
inconsistent with any restrictions on or obligations of BioChem contained in the
agreements listed in Exhibit B.
4. PATENT INFRINGEMENT.
4.1 NOTICE. Each party shall promptly notify the other in writing of any
infringement or alleged infringement known to such party of any patent included
within the BioChem Technology, by the manufacture, use, sale or offer for sale
by a third party of any Infringing Product.
4.2 ACTION BY BIOCHEM. Subject to the provisions of the Research and
Development Agreement and the Product Option Agreement, in the event of any such
alleged infringement, BioChem or a BioChem Affiliate shall have the right, at
its own expense and with the right to all recoveries (except as provided in
Section 6.2 of the Product Option Agreement), to take appropriate action to
restrain such alleged infringement and for damages. If BioChem or a BioChem
Affiliate takes any such action, CliniChem shall cooperate fully with BioChem or
such BioChem Affiliate in its pursuit thereof, at BioChem or such BioChem
Affiliate's expense, to the extent reasonably required by BioChem or such
BioChem Affiliate.
4.3 ACTION BY CLINICHEM. If (a) the Infringing Product is substantially
similar to a CliniChem Product for which the Product Option has expired
unexercised and (b) within ninety (90) days after the written notice from either
party described above (or at any time thereafter), BioChem or a BioChem
Affiliate has not begun to take appropriate action to attempt to restrain such
alleged infringement, and (c) at such time, the annualized unit sales volume of
such Infringing Product in a country over a period of at least two calendar
quarters equals or exceeds twenty-five percent (25%) of the annualized unit
sales volume of the related CliniChem Product in such country during the same
period, then CliniChem shall have the right, at its own expense and with the
right to all recoveries, to take such action as it deems appropriate to restrain
such alleged infringement. If CliniChem takes any such action, BioChem and the
BioChem Affiliates shall cooperate with CliniChem in its pursuit thereof, at
CliniChem's expense, to the extent reasonably requested by CliniChem. If the
third party in any such action brings a counteraction for invalidation or misuse
of a patent covering the BioChem Technology or the CliniChem Product, CliniChem
shall promptly
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notify BioChem, and BioChem or a BioChem Affiliate may, within six months after
the notification, join and participate in such action at its own expense.
CliniChem shall not settle any such action relating to any alleged infringement
which in any manner would adversely affect BioChem Technology without the prior
written consent of BioChem or a BioChem Affiliate, which consent shall not be
unreasonably withheld or delayed.
5. CONFIDENTIALITY OF INFORMATION.
5.1 CONFIDENTIALITY. During the term of this Agreement and for a
period of ten (10) years following its termination, CliniChem shall maintain in
confidence all Confidential Information of BioChem; provided, however, that
nothing contained herein shall prevent CliniChem from disclosing any
Confidential Information to the extent such Confidential Information (a) is
required to be disclosed in connection with researching or developing CliniChem
Products, securing necessary governmental authorization for the marketing of
CliniChem Products, or directly or indirectly making, using or selling CliniChem
Products, as permitted or provided for in the agreements between the parties,
(b) is required to be disclosed by law for the purpose of complying with
governmental regulations, (c) is disclosed in connection with any sublicense
permitted hereunder, (d) is lawfully disclosed to CliniChem by a third party
having the right to disclose such information to CliniChem, or (e) either before
or after the time of disclosure to CliniChem, becomes known to the public other
than by an unauthorized act or omission of CliniChem or any of CliniChem's
employees or agents. Any disclosure of Confidential Information to third parties
shall be made subject to similar obligations of confidentiality on the part of
such third parties. The obligations of CliniChem pursuant to this Section 5.1
shall survive the termination of this Agreement for any reason. Any breach of
this Section 5.1 may result in irreparable harm to BioChem, and in the event of
a breach, BioChem shall be entitled to seek injunctive relief (without the need
to post a bond) in addition to any other remedies available at law or in equity.
6. DISCLAIMER.
6.1 DISCLAIMER CONCERNING BIOCHEM TECHNOLOGY. BIOCHEM AND EACH BIOCHEM
AFFILIATE DISCLAIM ANY EXPRESS OR IMPLIED WARRANTY (A) THAT ANY BIOCHEM
TECHNOLOGY, OR THE USE THEREOF, OR ANY PRODUCTS INCORPORATING OR MANUFACTURED BY
THE USE THEREOF, WILL BE FREE FROM CLAIMS OF PATENT INFRINGEMENT, INTERFERENCE
OR UNLAWFUL USE OF PROPRIETARY INFORMATION OF ANY THIRD PARTY AND (B) OF THE
ACCURACY, RELIABILITY, TECHNOLOGICAL OR COMMERCIAL VALUE, COMPREHENSIVENESS OR
MERCHANTABILITY OF THE BIOCHEM TECHNOLOGY OR ITS SUITABILITY OR FITNESS FOR ANY
PURPOSE WHATSOEVER INCLUDING, WITHOUT LIMITATION, THE DESIGN, RESEARCH,
DEVELOPMENT, MANUFACTURE, USE OR SALE OF CLINICHEM PRODUCTS. BIOCHEM AND EACH
BIOCHEM AFFILIATE DISCLAIM ALL OTHER WARRANTIES OF WHATEVER NATURE, EXPRESS OR
IMPLIED.
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7. REPORTS OF ADVERSE REACTIONS.
7.1 REPORTS OF ADVERSE REACTIONS. During the term of this Agreement,
each party shall promptly inform the other party of any information that it
obtains or develops regarding the efficacy or safety of a CliniChem Product and
shall promptly report to the other party any information or notice of adverse or
unexpected reactions or side effects related to the utilization or medical
administration of a CliniChem Product. Further, during the term of this
Agreement, each party shall promptly inform the other of any information that it
obtains or develops regarding the safety of any BioChem Technology as related to
the CliniChem Products. Each such party shall permit the other to comply with
the adverse reaction reporting obligations under the United States Food, Drug
and Cosmetic Act or similar applicable Canadian or foreign statutory provisions,
and regulations thereunder and shall assist the other party in complying
therewith, with respect to the CliniChem Products. When appropriate, the parties
will execute a standard operating procedure to cover the foregoing. CliniChem
agrees and acknowledges that BioChem and the BioChem Affiliates may provide
information it obtains under this Section 7.1 to third parties developing and/or
commercializing products incorporating the same BioChem Technology as is
incorporated in the CliniChem Products.
8. TERM AND TERMINATION.
8.1 TERM. This Agreement shall become effective on the Distribution
Date (the "Effective Date") and shall continue thereafter in perpetuity unless
terminated in accordance with the provisions hereof.
8.2 TERMINATION FOR BREACH. BioChem and CliniChem may terminate this
Agreement effective upon the giving of written notice of such termination to the
other party in the event such other party breaches any of its material
obligations hereunder or under the Product Option Agreement and such breach
continues for a period of sixty (60) days after written notice thereof by the
terminating party to the other party.
8.3 AUTOMATIC TERMINATION. This Agreement shall automatically
terminate (a) upon termination of the Research and Development Agreement
pursuant to Section 10.2 thereof and other than due to a breach by BioChem, or
(b) upon termination by BioChem of the Research and Development Agreement due to
a breach thereof by CliniChem.
8.4 TERMINATION UPON EXERCISE OF PRODUCT OPTION. This Agreement shall
terminate on a product-by-product and country-by-country basis upon BioChem or a
BioChem Affiliate's corresponding exercise of the Product Option with respect to
any CliniChem Product and in any country.
8.5 TERMINATION OF SUBLICENSES. Termination by BioChem or a BioChem
Affiliate of this Agreement shall automatically terminate any sublicenses
granted by CliniChem hereunder.
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9. FORCE MAJEURE.
9.1 FORCE MAJEURE. No party to this Agreement shall be liable for
failure or delay in the performance of any of its obligations hereunder if such
failure or delay is due to causes beyond its reasonable control, including,
without limitation, acts of God, earthquakes, fires, strikes, acts of war, or
intervention of any governmental authority, but any such delay or failure shall
be remedied by such party as soon as possible after the removal of the cause of
such failure or delay.
10. INDEMNIFICATION.
10.1 INDEMNIFICATION BY CLINICHEM. CliniChem shall indemnify, defend
and hold BioChem and its Affiliates, and each of their officers, directors,
employees and agents, harmless from and against any and all losses, liabilities,
claims, demands, damages, costs, expenses (including reasonable attorneys' fees)
and money judgments incurred by or rendered against BioChem or its Affiliates,
which arise out of the use, design, labeling, manufacture, processing,
packaging, sale or commercialization of any CliniChem Product by CliniChem, its
Affiliates and permitted subcontractors and sublicensees (other than BioChem and
its Affiliates, subcontractors, sublicensees, distributors and others operating
under arrangements with or through BioChem or its Affiliates). BioChem shall
permit CliniChem's attorneys, at CliniChem's discretion and cost, to control the
defense of any claims or suits as to which BioChem may be entitled to indemnity
hereunder, and BioChem agrees not to settle any such claims or suits without the
prior written consent of CliniChem, which consent shall not be unreasonably
withheld. BioChem shall have the right to participate, at its own expense and
through its own counsel (provided such counsel is reasonably acceptable to
CliniChem), in the defense of any such claim or demand to the extent it so
desires.
10.2 NOTICE. BioChem shall give CliniChem prompt notice in writing, in
the manner set forth in Section 11.7 below, of any claim or demand made against
BioChem or any of its Affiliates for which BioChem or its Affiliates may be
entitled to indemnification under Section 10.1.
11. MISCELLANEOUS.
11.1 AMENDMENT AND WAIVER. This Agreement may be amended and any
provision of this Agreement may be waived; provided that any such amendment or
waiver shall be binding upon BioChem and the BioChem Affiliates only if set
forth in a writing executed by authorized representatives of BioChem and the
BioChem Affiliates and referring specifically to the provision alleged to have
been amended or waived and any such amendment or waiver shall be binding upon
CliniChem only if set forth in a writing executed by an authorized
representative of CliniChem and referring specifically to the provision alleged
to have been amended or waived. A waiver by any party hereto of any terms and
conditions of this Agreement in any one instance shall not be deemed or
construed to be a waiver of such terms and conditions for any similar instance
in the future. No course of dealing between or among any persons having any
interest in this Agreement shall be deemed effective to modify, amend or
discharge any part of this Agreement or any rights or obligations of any person
under or by reason of this Agreement.
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11.2 ASSIGNMENT. None of the parties may assign its rights and
obligations hereunder without the prior written consent of the other parties,
which consent may not be unreasonably withheld; provided, however, that BioChem
or a BioChem Affiliate may assign such rights and obligations hereunder to an
Affiliate of BioChem or such BioChem Affiliate or to any person or entity with
which BioChem or the relevant BioChem Affiliate is merged or consolidated or
which acquires all or substantially all of the assets of BioChem or the relevant
BioChem Affiliate.
11.3 DISPUTE RESOLUTION. Any controversy, claim or dispute arising out
of or relating to this Agreement, including the interpretation, breach,
termination or invalidity thereof (a "Dispute") shall be definitively settled by
arbitration, in accordance with the provisions on arbitration found in the Code
of Civil Procedure of Quebec (the "CCP").
Prior to resorting to arbitration, the parties shall refer the Dispute
to the Chairman of the Board of BioChem (as representative of BioChem and any
Affiliate of BioChem) and a director of CliniChem who has not been appointed by
BioChem for attempted resolution of such Dispute. The party wishing to initiate
negotiations shall send to the other party a notice of negotiation, briefly
identifying the object of the Dispute. If the parties fail to resolve a Dispute
within thirty (30) days of receipt by the second party of such notice of
negotiation, each party shall then have the right to refer such Dispute to
arbitration, unless the parties agree in writing to extend such thirty (30) day
negotiation period. The seat of arbitration shall be in Montreal and the
proceedings shall be in English.
There shall be three (3) arbitrators. Each party shall appoint one
arbitrator, and the two (2) arbitrators thus appointed shall designate the third
arbitrator within fifteen (15) days of the appointment of the second arbitrator.
The third arbitrator shall serve as President of the arbitral tribunal. Should
a party fail to designate an arbitrator within the delay specified in the
applicable provisions of the CCP, such arbitrator shall be appointed by the
highest ranking officer of the Quebec National and International Commercial
Arbitration Centre ("Centre"). The two (2) arbitrators thus appointed shall
designate the third arbitrator within fifteen (15) days of the appointment of
the second arbitrator, failing which the third arbitrator shall be designated by
the Centre.
The arbitral tribunal shall render any final award or decision within
thirty (30) days following the completion of evidence and argument on
substantive issues in dispute between the parties. The parties recognize and
agree that any award rendered by the arbitral tribunal shall be final and
binding on the parties who hereby expressly waive, to the fullest extent
permitted by law, all rights of appeal or recourse to any court. The
apportionment of costs of any arbitration pursuant to this agreement shall be
left to the discretion of the arbitral tribunal. Nothing in this article has
the effect, or should be interpreted as having the effect of limiting the right
of one of the parties to obtain, from a common law court, a seizure before
judgment, an injunction or any other extraordinary recourse as defined by the
CCP.
11.4 COUNTERPARTS. This Agreement may be executed in any number of
counterparts, each of which when so executed shall be deemed to be an original
and all of which when taken together shall constitute this Agreement.
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11.5 GOVERNING LAW. This Agreement shall be governed by and construed
in accordance with the laws of the Province of Quebec and the federal laws of
Canada applicable therein, and shall be treated in all respects as a Quebec
contract.
11.6 HEADINGS. The section headings contained in this Agreement are
included for convenience only and form no part of the Agreement between the
parties.
11.7 NOTICES. Notices required under this Agreement shall be in writing
and sent by registered or certified mail, postage prepaid, or by facsimile and
confirmed by registered or certified mail and addressed as follows:
IF TO BIOCHEM:
BioChem Pharma Inc.
275 Armand-Frappier Blvd.
Laval, Quebec, Canada H7V 4A7
Facsimile: (514) 978-7994
Attention: Vice-President Legal Affairs and Corporate Secretary
IF TO CLINICHEM:
CliniChem Development Inc.
275 Armand-Frappier Blvd.
Laval, Quebec, Canada H7V 4A7
Facsimile: (514) 978-7994
Attention: General Counsel and Secretary
All notices shall be deemed to be effective upon receipt unless such notice
is delivered or transmitted by facsimile, in which case, if it is delivered or
transmitted before 4:00 PM on a business day, it shall be deemed to have been
given and received on such day; in any other case, it will be deemed to have
been given and received on the first business day following the day on which it
is delivered or transmitted by facsimile. Either party may change the address
at which notice is to be received by written notice pursuant to this Section
11.7. Any notice sent to any BioChem Affiliate shall be sent care of BioChem to
BioChem's address given above.
11.8 SEVERABILITY. If any provision of this Agreement is held by a
court of competent jurisdiction to be invalid or unenforceable, it shall be
modified, if possible, to the minimum extent necessary to make it valid and
enforceable or, if such modification is not possible, it shall be stricken and
the remaining provisions shall remain in full force and effect.
11.9 RELATIONSHIP OF THE PARTIES. For purposes of this Agreement,
CliniChem (as one party) and BioChem and the BioChem Affiliates (as the other
party) shall be deemed to be independent contractors, and anything in this
Agreement to the contrary notwithstanding, nothing herein shall be deemed to
constitute CliniChem, and BioChem and the BioChem Affiliates, as partners, joint
venturers, co-owners, an association or any entity separate and apart from each
party itself, nor shall this Agreement constitute any party hereto an employee
or agent, legal or otherwise, of the other party for any purposes whatsoever.
Neither party hereto is authorized to make any
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statements or representations on behalf of the other party or in any way
obligate the other party, except as expressly authorized in writing by the other
party. Anything in this Agreement to the contrary notwithstanding, no party
hereto shall assume or be liable for any liabilities or obligations of the other
party, whether past, present or future.
11.10 SURVIVAL. The provisions of Sections 5, 6, 10, 11.1, 11.3, 11.5,
11.7, 11.9 and this Section 11.10 shall survive the termination for any reason
of this Agreement. Any payments due under this Agreement with respect to any
period prior to its termination shall be made notwithstanding the termination of
this Agreement. Neither party shall be liable to the other for consequential
damages (including loss of good will and anticipated profits) due to the
termination of this Agreement as provided herein.
11.11 ENTIRE AGREEMENT. This Agreement, the Research and Development
Agreement, the Services Agreement and the Product Option Agreement contain the
entire agreement and understanding between the parties hereto with respect to
the subject matter hereof and supersede all prior agreements and understandings,
whether written or oral, relating to such subject matter.
* * * * *
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of
the date first set forth above.
BIOCHEM PHARMA INC.
By: _____________________________
Title: __________________________
By: _____________________________
Title: __________________________
BIOCHEM AFFILIATES:
BIOCHEM VACCINES INC.
By: _____________________________
Title: __________________________
By: _____________________________
Title: __________________________
BIOCHEM THERAPEUTIC INC.
By: _____________________________
Title: __________________________
By: _____________________________
Title: __________________________
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TANAUD HOLDINGS (BARBADOS) LIMITED
By: _____________________________
Title: __________________________
By: _____________________________
Title: __________________________
TANAUD INTERNATIONAL B.V.
By: _____________________________
Title: __________________________
By: _____________________________
Title: __________________________
TANAUD IRELAND INC.
By: _____________________________
Title: __________________________
By: _____________________________
Title: __________________________
CLINICHEM DEVELOPMENT INC.
By: _____________________________
Title: __________________________
By: _____________________________
Title: __________________________
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EXHIBIT A
to the Technology License Agreement dated as of the 31st day of March, 1998 by
and between BioChem Pharma Inc., the BioChem Affiliates and CliniChem
Development Inc.
PATENTS AND PATENT APPLICATIONS
BIOCHEM DOCKET NUMBERS
IAF-002-002 IAF-009-019 IAF-13A-018
IAF-002-003 IAF-009-020 IAF-13A-019
IAF-002-004 IAF-009-021 IAF-13A-020
IAF-002-005 IAF-009-022 IAF-13A-021
IAF-002-006 IAF-009-023 IAF-13A-022
IAF-002-007 IAF-009-025 IAF-13A-023
IAF-002-008 IAF-009-026 IAF-13A-024
IAF-002-009 IAF-009-027 IAF-13A-025
IAF-002-010 IAF-009-028 IAF-13A-026
IAF-002-011 IAF-009-029 IAF-13A-027
IAF-002-012 IAF-009-030 IAF-13A-028
IAF-002-013 IAF-009-031 IAF-13A-029
IAF-002-014 IAF-009-032 IAF-13A-030
IAF-002-020 IAF-009-033 IAF-13A-031
IAF-002-021 IAF-009-034 IAF-13A-032
IAF-002-025 IAF-009-035 IAF-13A-033
IAF-002-026 IAF-009-036 IAF-13A-034
IAF-002-027 IAF-009-037 IAF-13A-035
IAF-002-028 IAF-009-038 IAF-13A-036
IAF-009-001 IAF-009-039 IAF-13A-037
IAF-009-002 IAF-13A-001 IAF-13A-038
IAF-009-003 IAF-13A-002 IAF-13A-039
IAF-009-004 IAF-13A-003 IAF-13A-040
IAF-009-005 IAF-13A-004 IAF-13A-041
IAF-009-006 IAF-13A-005 IAF-13A-042
IAF-009-007 IAF-13A-006 IAF-13A-043
IAF-009-008 IAF-13A-007 IAF-13A-044
IAF-009-009 IAF-13A-008 IAF-13A-045
IAF-009-010 IAF-13A-009 IAF-13A-046
IAF-009-011 IAF-13A-010 IAF-13A-047
IAF-009-012 IAF-13A-011 IAF-13A-048
IAF-009-013 IAF-13A-012 IAF-13A-051
IAF-009-014 IAF-13A-013 IAF-13A-052
IAF-009-015 IAF-13A-014 IAF-13A-053
IAF-009-016 IAF-13A-015 IAF-13A-054
IAF-009-017 IAF-13A-016 IAF-13A-055
IAF-009-018 IAF-13A-017 IAF-13A-056
18
IAF-13A-057 BIOV-001-030 BIOV-002-037
IAF-13A-058 BIOV-001-031 BIOV-003-001
IAF-13A-059 BIOV-001-032 BIOV-003-002
IAF-13A-060 BIOV-001-033 BIOV-004-001
IAF-13A-061 BIOV-001-034 BIOV-004-002
IAF-13A-062 BIOV-001-035 PHAR-042-001
IAF-13A-063 BIOV-001-036 PHAR-042-002
IAF-13A-064 BIOV-001-037 PHAR-042-003
IAF-13A-065 BIOV-002-001 PHAR-042-004
IAF-13A-066 BIOV-002-002 PHAR-042-005
IAF-13A-067 BIOV-002-003 PHAR-042-006
IAF-13A-068 BIOV-002-004 PHAR-042-007
IAF-13A-069 BIOV-002-005 PHAR-042-008
IAF-13A-070 BIOV-002-006 PHAR-042-009
IAF-13A-071 BIOV-002-007 PHAR-042-010
BIOV-001-001 BIOV-002-008 PHAR-042-011
BIOV-001-002 BIOV-002-009 PHAR-042-013
BIOV-001-003 BIOV-002-010 PHAR-042-014
BIOV-001-004 BIOV-002-011 PHAR-042-016
BIOV-001-005 BIOV-002-012 PHAR-042-017
BIOV-001-006 BIOV-002-013 PHAR-042-018
BIOV-001-007 BIOV-002-014 PHAR-042-019
BIOV-001-008 BIOV-002-015 PHAR-042-020
BIOV-001-009 BIOV-002-016 PHAR-042-021
BIOV-001-010 BIOV-002-017 PHAR-042-022
BIOV-001-011 BIOV-002-018 PHAR-042-023
BIOV-001-012 BIOV-002-019 PHAR-042-024
BIOV-001-013 BIOV-002-020 PHAR-042-025
BIOV-001-014 BIOV-002-021 PHAR-042-026
BIOV-001-015 BIOV-002-022 PHAR-042-027
BIOV-001-016 BIOV-002-023 PHAR-042-028
BIOV-001-017 BIOV-002-024 PHAR-042-029
BIOV-001-018 BIOV-002-025 PHAR-042-030
BIOV-001-019 BIOV-002-026 PHAR-042-031
BIOV-001-020 BIOV-002-027 PHAR-042-032
BIOV-001-021 BIOV-002-028 PHAR-042-033
BIOV-001-022 BIOV-002-029 PHAR-042-034
BIOV-001-023 BIOV-002-030 PHAR-042-035
BIOV-001-024 BIOV-002-031 PHAR-042-036
BIOV-001-025 BIOV-002-032 PHAR-042-037
BIOV-001-026 BIOV-002-033 PHAR-042-038
BIOV-001-027 BIOV-002-034 PHAR-042-039
BIOV-001-028 BIOV-002-035 PHAR-042-040
BIOV-001-029 BIOV-002-036 PHAR-042-041
Exhibit A
19
PHAR-042-042
PHAR-042-043
PHAR-042-044
PHAR-042-045
PHAR-042-046
PHAR-042-047
PHAR-042-048
PHAR-042-049
PHAR-042-050
PHAR-042-051
PHAR-042-052
PHAR-059-001
PHAR-059-002
PHAR-059-003
PHAR-059-004
PHAR-059-005
PHAR-059-006
Exhibit A
20
EXHIBIT B
to the Technology License Agreement dated as of the 31st day of March, 1998 by
and between BioChem Pharma Inc., the BioChem Affiliates and CliniChem
Development Inc.
PRE-EXISTING AGREEMENTS
BCH-4556:
Preclinical Research Services Agreement between BioChem Therapeutic Inc. and
CTRC Research Foundation, dated October 28, 1997.
Scientific Research Services
Contract between BioChem Therapeutic Inc. and Phoenix International Life
Sciences, dated August 13, 1996.
Scientific Research Services Contract between
BioChem Therapeutic Inc. and Phoenix International Life Sciences, dated
September 17, 1996.
Services Agreement between BioChem Therapeutic Inc. and
Phoenix International Life Sciences, dated January 30, 1997.
Services Agreement
between BioChem Therapeutic Inc. and Phoenix International Life Sciences, dated
April 21, 1997.
Services Agreement between BioChem Therapeutic Inc. and Phoenix
International Life Sciences, dated October 1, 1997.
Master Services Agreement
between BioChem Therapeutic Inc. and Quintiles Canada, Inc., dated June 17,
1997.
Services Agreement between BioChem Therapeutic Inc. and NCIC Clinical
Trials Group, Queens University dated November 12, 1996.
Services Agreement
between BioChem Therapeutic Inc. and Raylo Chemicals Inc. dated August 1, 1997.
Materials Transfer and Services Agreement between BioChem Therapeutic Inc. and
ITR Laboratories Canada Inc., dated May 23, 1997.
Memorandum of Agreement
between BioChem Therapeutic Inc. and Doctor Edward Chu, dated October 27, 1997.
BCH-10652:
Materials Transfer and Services Agreement between BioChem Therapeutic and the
Regents of the University of California, dated May 15, 1997.
Development and
Manufacturing Agreement between BioChem Therapeutic Inc. and Patheon Inc.,
dated October 29, 1997.
Materials Transfer and Services Agreement between
BioChem Therapeutic Inc. and BenVenue Laboratories Inc., dated October 30,
1997.
Materials Transfer and Services Agreement between BioChem Therapeutic
Inc. and Viromed Laboratories, Inc., dated June 19, 1997.
Research Master
Agreement between BioChem Therapeutic Inc. and Neuroscience Research Unit St.
Luc Pavilion, dated July 3, 1997, as amended.
21
Research Agreement between BioChem Therapeutic Inc. and MRC Collaborative
Center, dated November 9, 1997.
Materials Transfer Agreement between BioChem Therapeutic Inc. and Chiral
Technologies Inc., dated October 10, 1997.
Contrat de Recherche sous le Sceau de la Confidentialite et du Secret between
BioChem Therapeutic Inc. and Mark A. Wainberg, dated April 24, 1997.
Consultant Agreement between BioChem Therapeutic Inc. and Dr. Arnold Fridland,
dated November 4, 1997.
Consultant Agreement between BioChem Therapeutic Inc. and Dr. Murray Ducharme
dated August 31, 1997.
Materials Transfer and Services Agreement between BioChem Therapeutic Inc. and
ITR Laboratories Canada Inc., dated May 23, 1997.
ANGIOGENESIS INHIBITORS.
Collaborative Research Agreement between BioChem Pharma Inc. and Beth Israel
Hospital dated February 1, 1996, as amended on March 1, 1997.
Screening Collaboration between BioChem Therapeutic Inc. and Amrad Natural
Products Pty Ltd, dated January 7, 1997.
Convention de Services et de Transfert de Substances between BioChem Therapeutic
Inc. and Produits Chimiques Omega dated November 17, 1997.
VACCINES
License Agreement between IAF BioVac and the Minister of National Health and
Welfare Canada, dated December 13, 1995.
Contrat de Recherche et D'Exploitation De Technologie between IAF BioVac Inc.
and Le Centre de Recherche Du Centre Hospitalier De L'Universite Laval dated
March 23, 1995.
Contrat de Recherche et D'Exploitation De Technologie between IAF BioVac Inc.
and Le Centre de Recherche Du Centre Hospitalier De L'Universite Laval dated
January 1, 1999.
Research and Option Agreement between BioChem Vaccines Inc. and The UAB Research
Foundation, dated December 23, 1997
Entente de Recherche between BioChem Vaccines Inc., Le Centre Hospitalier
Universitaire de Quebec and Dr. Bernard Brodeur, dated December 8, 1997.
Materials Transfer and Services Agreement between BioChem Vaccines Inc. and Le
Centre Hospitalier Universitaire de Quebec, dated January 14, 1998.
Material Transfer Agreement and Option between IAF BioVac, Her Majesty the Queen
in Right of Canada as Represented by the Minister of Health, dated November 1,
1996.
22
EXHIBIT C
to the Technology License Agreement dated as of the 31st day of March, 1998 by
and between BioChem Pharma Inc., the BioChem Affiliates and CliniChem
Development Inc.
CLINICHEM PROGRAMS
PROGRAM FIELD OF USE
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1. Development of BCH-4556. Treatment of cancer.
2. Development of BCH-10652. Treatment of HIV infection.
3. Development of AvB3 antagonists to Treatment of cancer.
prevent angiogenesis.
4. The development of a recombinant To protect against infections by
protein vaccine to protect against NEISSERIA MENINGITIDIS.
infections by NEISSERIA MENINGITIDIS.
5. The development of a recombinant To protect against infections by
protein vaccine to protect against STREPTOCOCCUS PNEUMONIAE.
infections by STREPTOCOCCUS PNEUMONIAE.
6. The development of a recombinant To protect against infections by
protein vaccine to protect against NEISSERIA GONORRHOEAE.
infections by NEISSERIA GONORRHOEAE.
7. The development of a recombinant To protect against infections by
protein vaccine to protect against HAEMOPHILUS INFLUENZAE non typeable.
infections by HAEMOPHILUS INFLUENZAE
non typeable.
8. The development of a recombinant To protect against infections by
protein vaccine to protect against STREPTOCOCCUS Group B.
infections by STREPTOCOCCUS Group B.
9. The development of a recombinant To protect against infections by
protein vaccine to protect against CHLAMYDIA PNEUMONIAE.
infections by CHLAMYDIA PNEUMONIAE.