EXHIBIT 4.29
STRATEGIC ALLIANCE AGREEMENT
PROMETIC BIOSCIENCES INC.
- and -
HEMOSOL LP.
----------------------------
June 1st, 2004
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TABLE OF CONTENTS
DEFINITIONS
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1.1 Defined Terms.........................................................2
ARTICLE 2
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GOALS AND OBJECTIVES
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2.1 Objectives............................................................8
ARTICLE 3
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GOVERNANCE
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3.1 Project Leaders.......................................................9
3.2 Steering Committee....................................................9
3.3 CEO Council..........................................................10
3.4 Technical Working Group..............................................10
ARTICLE 4
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ESTABLISHMENT OF WORKPLANS
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4.1 Description of Workplan..............................................10
ARTICLE 5
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DEVELOPMENT PHASE
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5.1 Development Phase....................................................12
5.2 Intellectual Property................................................13
ARTICLE 6
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COMMERCIALIZATION PHASE
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6.1 Commercialization Responsibilities...................................14
ARTICLE 7
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ALLOCATION OF REVENUES
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7.1 Guidelines...........................................................14
7.2 Royalties............................................................15
ARTICLE 8
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OTHER BUSINESS OPPORTUNITIES
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8.1 Clinical Materials...................................................16
8.2 ProMetic as Hemosol's Client.........................................16
8.3 Engineering Services.................................................17
8.4 Other Coordinated Business Activity..................................17
ARTICLE 9
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COMPLIANCE WITH LAWS
--------------------
9.1 Approvals and Business Conduct.......................................18
ARTICLE 10
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BOOKS AND RECORDS
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10.1 Non-Financial Records................................................18
10.2 Financial Records....................................................18
ARTICLE 11
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REPRESENTATIONS AND WARRANTIES
------------------------------
11.1 By each Party........................................................18
11.2 No Other Representations or Warranties...............................19
11.3 Survival of Representation and Warranties............................19
ARTICLE 12
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INDEMNIFICATION AND CONFIDENTIALITY
-----------------------------------
12.1 Infringement of Intellectual Property Rights.........................20
12.2 General Indemnification..............................................20
12.3 Patent Indemnity.....................................................21
12.4 Notice of Claim......................................................21
12.5 Direct Claims........................................................21
12.6 Third Party Claims...................................................22
12.7 Settlement of Third Party Claims.....................................22
12.8 Cooperation..........................................................23
12.9 Survival 23
12.10 Maintenance of Confidentiality.......................................23
12.11 Exceptions...........................................................24
12.12 Non-disclosure of Agreement..........................................24
12.13 Compliance with Confidentiality Obligations..........................25
12.14 Injunction...........................................................25
ARTICLE 13
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FORCE MAJEURE
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13.1 Force Majeure........................................................25
ARTICLE 14
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TERM AND EARLY TERMINATION
--------------------------
14.1 Termination of Agreement.............................................26
14.3 Termination of Development or Commercialization
Phase of a System...................................................28
14.4 Notice of Termination................................................29
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ARTICLE 15
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DISPUTE RESOLUTION
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15.1 By Arbitration.......................................................29
15.2 Injunction...........................................................30
ARTICLE 16
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APPLICABLE LAW
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16.1 Governing Law........................................................30
16.2 Scope of Authority and Relationship..................................30
16.3 Assignment; Successors and Assigns...................................31
16.4 Extended Meanings....................................................31
16.5 Headings 31
16.6 Language 31
16.7 Entire Agreement.....................................................32
16.8 Currency 32
16.9 Notices 32
16.10 Amendment of Agreement...............................................33
16.11 Waiver and Notice of Breach..........................................33
16.12 Further Assurances...................................................33
16.13 Third Parties........................................................33
16.14 Costs of Operations..................................................33
16.15 Severability.........................................................34
16.16 Counterparts and Fax Signatures......................................34
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STRATEGIC ALLIANCE AGREEMENT
THIS AGREEMENT is made as of the lst day of June, 2004,
BETWEEN:
PROMETIC BIOSCIENCES INC., a company existing under the laws of
Canada
("ProMetic"),
- and -
HEMOSOL LP.,
a limited partnership existing under the laws of the Province of
Ontario
("Hemosol"),
WHEREAS:
(c) ProMetic and Hemosol have entered into a license agreement (the
"License Agreement") dated as of the date hereof whereby Hemosol has
been granted certain rights in and to the Cascade Process to, among
other things, manufacture and sell products resulting therefrom, all
in accordance with the terms and conditions set forth therein;
(d) in addition to the business opportunities contemplated by the License
Agreement, the Parties wish to further leverage Hemosol's engineering
and process development expertise, production facility and rights in
and to the Cascade Process under the License Agreement, together with
ProMetic's expertise and Platform Technology, in the field of plasma
protein extraction through various additional business opportunities
to create short and long term value for both ProMetic and Hemosol;
(e) the respective corporate strategies of Hemosol and ProMetic are
compatible to jointly develop and commercialize innovative, practical
and high quality next-generation plasma products and the intellectual
property relating thereto and achieve a prominent position in the
field of plasma proteins extraction;
(f) in furtherance of the foregoing, the Parties wish to establish a
strategic business alliance upon the terms and conditions set forth
herein to govern such joint development and commercialization of
business opportunities,
NOW THEREFORE IN CONSIDERATION of the mutual promises and covenants
contained in this Agreement, and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, the Parties hereby
agree as follows:
ARTICLE 1
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DEFINITIONS
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1.1 Defined Terms
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Capitalized terms used in this Agreement and defined below shall have
the following meanings, respectively:
1.1.1 "Additional Primary Step" means new capture steps added to
the Preferred Sequence for the recovery of any Additional
Proteins from the Raw Material and described from time to
time when applicable in Schedule 1.1.1;
1.1.2 "Additional Proteins" means proteins in bulk active form,
other than the Proteins, that may be isolated from Raw
Material using an Additional Primary Step under the
Cascade Process;
1.1.3 "Affected Party" has the meaning given to such term in
Section 13.1;
1.1.4 "Agreement" means this strategic alliance agreement,
including all schedules attached hereto, as modified,
amended, supplemented or restated from time to time;
1.1.5 "Alternate Project Leader" has the meaning given to such
term in Section 3.1;
1.1.6. "Cascade Process" means the aggregate of the Primary
Steps, but for greater certainty may include only some of
them, presented in the Preferred Sequence for the capture
of each Protein from the Raw Material in a successive
manner to meet the agreed target proteins recovery
percentage set forth in the License Agreement, including:
any Additional Primary Step, Improvement and the Cascade
Process Intellectual Property made by ProMetic alone or
with any other licensees of Cascade Process, its
affiliates or the ARC) and owned by, or under exclusive
rights in favour of, ProMetic;
1.1.7 "Cascade Process Documentation" means copies of all
Patents, publications and technical and operational
details relating to the Cascade Process and any of its
components, including any master files related thereto;
1.1.8. "Cascade Process Intellectual Property" means the Patents,
the Trademarks and the Know-How and all copyrights, ideas,
inventions, results, designs, patterns, diagrams,
drawings, documentation, data, plans, reports and other
like information or items, whether or not patentable, in
any way relating to the Cascade Process;
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1.1.9. "Claim" has the meaning given to such term in Section
12.4;
1.1.10. "Co-developed Additional Primary Steps" means any new
capture steps developed jointly by the Parties in
accordance with this Agreement, with or without the
collaboration of Third Parties, to recover Other Proteins;
1.1.11. "Co-developed Bioprocess" means any bioprocess (for
greater certainty, not including the Cascade Process)
developed jointly by the Parties under this Agreement,
with or without the collaboration of Third Parties, in
favour of a Third Party that is involved in plasma-derived
products development, in research and development of
biologicals, or which has manufacturing needs in relation
to plasma-derived biopharmaceuticals that can be filled
with the combination of Hemosol's manufacturing
infrastructure and ProMetic's Platform Technology
including, for example the removal of contaminants,
hyper-immune globulin G for SARS, West Nile virus and
other applications;
1.1.12. "Co-developed Secondary Process" means a Secondary Process
developed jointly by the Parties in accordance with this
Agreement;
1.1.13. "Commercialization Phase" means, with respect to a System,
the period of time from the date on which the Steering
Committee agree to make such System and the related System
Products generally available for commercial use, sale,
distribution or licensing to Third Parties (other than for
testing or regulatory approval purposes) until the
termination of the commercial life of such System and/or
the related System Products as determined by the Steering
Committee;
1.1.14. "Confidential Information" means that information of a
party, in any form and regardless of whether it was
developed by such party or acquired through a license,
agreement or otherwise, which is not generally known to
the public, including, without limitation, any Cascade
Process Intellectual Property (other than the Patents or
Trademarks), research program, material, data, know-how,
formulations, techniques, equipment, methods, results,
information regarding sources of supply, business plans,
partners, clients, potential agreements and the existence,
scope and activities of any research, development,
manufacturing, marketing, or other projects, patent
applications, trade secrets and other similar information
with like characteristics. All information exchanged in
writing between the Parties before the date of this
Agreement and relating to the subject matter of this
Agreement or if exchanged verbally, which has been
confirmed in writing to be confidential, shall be deemed
Confidential Information under this Agreement.
Confidential Information does not include any information
that (i) is or becomes generally available to the public
other than as a result of a disclosure in violation of
this Agreement or any other agreement between the Parties;
(ii) was known by the recipient on a non-confidential
basis prior to its disclosure to the recipient by the
disclosing party; or (iii) is or becomes available to the
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recipient on a non-confidential basis from a source other
than the disclosing party unless the recipient knows that
such source is prohibited from disclosing the information
to the recipient by a contractual, fiduciary or other
legal obligation to the disclosing party;
1.1.15. "Development Phase" means, with respect to a System, the
period of time from the date on which the Steering
Committee approves a Workplan for the development of such
System until the beginning of the Commercialization Phase
therefor;
1.1.16. "Direct Claim" has the meaning given to such term in
Section 12.4;
1.1.17. "Force Majeure" has the meaning given to such term in
Section 13.1;
1.1.18. "Improvements" means all improvements, developments,
enhancements, design changes and modifications to the
Cascade Process, including a new preferred sequence, which
relates to the capture of Proteins or Additional Proteins
from Raw Material;
1.1.19. "Indemnified Party" has the meaning given to such term in
Section 12.4;
1.1.20. "Indemnifying Party" has the meaning given to such term in
Section 12.4;
1.1.21. "Infringer" has the meaning given to such term in Section
12.1;
1.1.22. "Intellectual Property" means any and all Intellectual
Property Rights, ideas, inventions, formulations,
concepts, results, discoveries, designs, patterns,
devices, diagrams, charts, drawings, documentation, data,
plans, reports, technical information, manufacturing
technology procedures, processes, trade secrets, methods,
practices, techniques, specifications, know-how and other
like information or items;
1.1.23. "Intellectual Property Claim" has the meaning given to
such term in Section 12.3;
1.1.24. "Intellectual Property Rights" means all rights derived
from any form of Intellectual Property, worldwide, whether
arising under statutory or common law or otherwise, and
whether or not filed, issued, registered or otherwise
perfected including, without limitation, (i) all patents,
patent applications and patent rights, (ii) all rights
associated with works of authorship including copyrights,
copyright applications, copyright registrations,
trademarks and tradenames, (iii) all rights relating to
the protection of trade secrets and confidential
information, (iv) all rights analogous to those set forth
in this definition and all other rights relating to
intangible property and (v) additions, divisions,
continuations, continuations in-part, substitutions,
reissues, re-examinations, extensions, registrations,
patent term extensions, supplementary protection
certificates and renewals of the foregoing filed, issued,
acquired, granted or otherwise existing at any time;
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1.1.25. "Intermediates" means residual depleted plasma concentrate
obtained by Hemosol following the extraction of one or
more Proteins, Additional Proteins or System Products from
the Raw Material through the use of one or more Primary
Steps, Additional Primary Steps, Systems or the entire
Cascade Process;
1.1.26. "Joint Intellectual Property" shall have the meaning set
forth in Section 5.2 (d)
1.1.27. "Know-How" means the technical information, standard
operating procedures, trade secrets, methods, and other
information and specifications relating to the Cascade
Process;
1.1.28. "License Agreement" has the meaning given to such term in
the preamble hereof and includes any amendment, or
supplement thereto or restatement thereof;..
1.1.29. "Losses" has the meaning given to such term in Section
12.2;
1.1.30. "Non-Affected Party" has the meaning given to such term in
Section 13.1;
1.1.31. "Notice of Breach" has the meaning given to such term in
Section 14.3;
1.1.32. "Other Co-developed Opportunity" means any other business
opportunity, which the Steering Committee may agree from
time to time to develop or commercialize pursuant to a
Workplan prepared and approved in accordance with this
Agreement;
1.1.33. "Other Proteins" means any protein other than the Protein
or the Additional Proteins.
1.1.34. "Other Products" means all products that include,
incorporate or that are derived from any Other Proteins.
1.1.35. "Other Territory" means each country in the world, other
than the Territory;
1.1.36. "Patents" means any and all patents and patent
applications issued or filed in the Territory along with
any and all additions, divisions, continuations,
continuations in-part, substitutions, re-issues,
re-examinations, extensions, registrations, patent term
extensions, supplementary protection certificates and
renewals of any of the foregoing in the Territory,;
1.1.37. "Party" means Hemosol or ProMetic, and when used in the
plural, shall mean both Hemosol and ProMetic;
1.1.38. "Plasma Derived Products" means all products deriving or
resulting from a Co-Developed Bioprocess.
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1.1.39. "Platform Technology" or sometimes "ProMetic's Platform
Technology" means a platform technology and know-how owned
and/or controlled or developed by ProMetic or on its
behalf, comprised of:
(a) affinity ligands including, without limitation,
ProMetic's Chemical Combinatorial Libraries(R) and
Mimetic LigandsTM, matrix support including agarose
beads, and affinity adsorbents (i.e. ligand attached to
a support matrix);
(b) the Cascade Process and its components;
(c) other proprietary bioseparation media, including
peptides and ion exchangers;
(d) all techniques for (i) the synthesis and screening of
ligand libraries, (ii) selecting ligands, (iii) the
synthesis and attachment of ligands to matrix supports,
(iv) performing surface chemistry and (v) developing
and manufacturing Resin, and other proprietary
bioseparation media; (vi) the isolation,
characterization, separation, purification,
identification or quantification of biomolecules, and
(vii) the development of chromatographic parameters
related to the foregoing;
(e) bioseparation process design, development, operation
and scaling-up, including characterization,
verification and validation of chromatography units
operation, and analytical tools and techniques
associated thereto;
(f) development of regulatory support files;
(g) the Intellectual Property relating to any of the
foregoing;
(h) all improvements, developments, enhancements, design
changes and modifications relating to any of the
foregoing; and
(i) any uses or applications of the foregoing;
1.1.40. "Preferred Sequence" means the preferred sequence of
Primary Steps for the capture of each and all Proteins
from the Raw Material in a successive manner;
1.1.41. "Primary Step" means each of the proprietary capture steps
using a Resin to recover the Proteins from the Raw
Material;
1.1.42. "Production Facility" means the manufacturing facility of
Hemosol located at 0000 Xxxxxxxxxx Xxxx., Xxxxxxxxxxx,
Xxxxxxx X0X 0X0;
1.1.43. "Products" means all products that include, incorporate or
which are derived from any Proteins or Additional
Proteins;
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1.1.44. "Project Leader" means a project leader named by a Party
in accordance with Section 3.1;
1.1.45. "Proteins" shall mean alphaone protease inhibitor,
intravenous immunoglobulin, fibrinogen, apolipoprotein,
human serum albumin, Vol Willebrand/factor VIII derived
from Raw Material;
1.1.46. "Prototype" means a System Product or a System, including
any component thereof, in the Development Phase, which
meets some or all of the specifications set forth in the
applicable Workplan;
1.1.47. "Raw Material" means human blood plasma recovered from
whole blood donations or sourced by plasmapharesis
procedures;
1.1.48. "Resin" means each of the affinity adsorbents (i.e. ligand
attached to a support matrix) and bioseparation media
(e.g. ion exchanges) for the isolation and purification of
proteins and other molecules;
1.1.49. "Secondary Processes" means the secondary steps and
processes, whether currently known or to be developed, to
which any Proteins or Additional Proteins isolated at any
level in the Cascade Process are or may be subjected in
order to ensure that the yields or the level of
purification, viral safety, quality assurance and control
and processing are (i) satisfactory to the FDA or any
other Regulatory Body having jurisdiction over these
material for use in humans, or (ii) generally requested in
the market in which Proteins, Additional Proteins, Other
Proteins, Products or Other Products are intended to be
used in humans, whether arising by law, regulations,
directives, norms, guidelines, market practices or under
any regulatory approvals;
1.1.50. "Steering Committee" means the joint steering committee
formed by the Parties pursuant to Section 3.2.
1.1.51. "System" means any Co-developed Secondary Process,
Co-developed Additional Primary Step, Co-developed
Bioprocess or Other Co-developed Opportunity;
1.1.52. "System Products" means all products manufactured using or
derived from a System, without regard to their form, other
than the Proteins, the Additional Proteins and the
Products;
1.1.53. "Technical Working Group" means the technical working
group formed pursuant to Section 3.4;
1.1.54. "Territory" means Canada, the United States of America and
Mexico, and for greater certainty, shall include all
provinces, states and other political subdivisions within
each such country;
1.1.55. "Third Party Claim" has the meaning given to such term in
Section 12.4;
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1.1.56. "Third Party Intellectual Property" means any and all
Intellectual Property owned, controlled or used by a Third
Party (other than an affiliate of a Party) and which the
Steering Committee determines to be useful in connection
with a System;
1.1.57. "Third Party Licensee" means any Third Party other than
the American Red Cross or any with whom ProMetic enters
into a license or any type of agreement for the use of the
Cascade Process, or any agreement whereby such Third Party
agrees to in-license the Cascade Process;
1.1.58. "Trademarks" means any trademarks or service marks
relating to the Cascade Process owned by ProMetic or in
which ProMetic as a right to use and to license to Hemosol
in the manner contemplated hereunder;
1.1.59. "Workplan" means a development and/or commercialization
plan for a System prepared and approved in accordance with
Section 4.
ARTICLE 2
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GOALS AND OBJECTIVES
--------------------
2.1 Objectives
----------
The Parties have agreed upon the following goals and objectives for
this Agreement:
(a) to work together on a non-exclusive basis using a combination of
ProMetic's protein purification expertise and Hemosol's
engineering and process expertise and infrastructure to jointly
develop and commercialize certain Systems in accordance with this
Agreement;
(b) to generally outline the roles, rights and obligations of each
Party in connection with the development and commercialization of
such Systems and System Products;
(c) to establish guidelines for determining allocation of costs and
distribution of revenues relating to or derived from Systems and
System Products;
(d) to establish guidelines regarding the evaluation, potential
acquisition and further development of Third Party Intellectual
Property; and
(e) to provide a smooth transition for winding down this Agreement at
its termination or expiration, including the continuation of the
then existing rights and obligations of each Party with respect
to Systems and System Products developed or commercialized at or
prior to such time.
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ARTICLE 3
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GOVERNANCE
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3.1 Project Leaders
---------------
Each of the Parties hereby appoints its representative named on
Schedule 3.1 (each a "Project Leader") who will be responsible for the ongoing
management of this Agreement and the development and commercialization of
Systems and System Products approved by the Steering Committee. The Project
Leaders will communicate directly with each other and will be responsible for
responding in a timely manner to all requests made by the other. Each of the
Parties may designate a new Project Leader from lime to time by providing
written notice to the other of such designation. In addition, each of the
Parties may designate an alternate project leader (an "Alternate Project
Leader") from time to time by providing written notice to the other of such
designation.
3.2 Steering Committee
------------------
(a) Formation. The Parties hereby establish a steering committee (the
"Steering Committee") consisting of at least six members, with an equal number
of representatives from each Party. At all times, each Party shall nominate at
least one senior business executive and the Project Leader of such Party to the
Steering Committee. Each Party shall from time to time designate its
representatives on the Steering Committee by providing written notice to the
other of such designation.
(b) Responsibilities. The responsibilities of the Steering Committee
will include the following:
(i.) develop, review and approve Workplans and any revisions
thereto;
(ii.) oversee the implementation of Workplans;
(iii.) ensure sufficient and continued communications between
ProMetic and Hemosol, including the provision of reasonable
advance notice of significant business planning initiatives
or changes in technology relating to the Systems;
(iv.) monitor and support collaboration and supply relationship
between the Parties under this Agreement;
(v.) ensure that all audit findings, intellectual property,
development, manufacture and commercialization issues are
effectively resolved and to attempt to resolve disputes
under this Agreement in good faith by mutual agreement, with
escalation when necessary to the CEO of each Party in
accordance with Section 3.3;
(vi.) semi-annually review this Agreement and negotiate in good
faith and thereafter recommend any amendments to this
Agreement to reflect any new business context or
opportunities not previously contemplated by the Parties;
(vii.) annually review the responsibilities of each Party
hereunder; and
(viii.) undertake such other responsibilities as the Parties may
agree upon from time to time.
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(c) Meetings. The Steering Committee will meet at least once per
calendar month at locations selected by each Party, alternately. All Steering
Committee meetings shall be governed by the following procedures:
(i.) a quorum for meetings shall consist of at least two
representatives of each Party attending in person or by
conference call; and
(ii.) all issues, questions and decisions for consideration at
the meeting will be determined by the unanimous agreement of
all attending members.
3.3 CEO Council
-----------
(a) Formation. The Parties hereby establish a CEO Council (the "CEO
Council") consisting of the chief executive officer of each Party or, if there
is no chief executive officer of a Party, another senior officer occupying
similar functions.
(b) Responsibilities. CEO Council will be responsible for reviewing
and attempting to resolve by mutual agreement any issues or disputes which may
be escalated to them by the Steering Committee or that could have a serious
impact on the business relationship between the Parties.
(c) Decision Making. All questions, issues or decisions posed for
consideration to the CEO Council shall be determined by unanimous agreement.
3.4 Technical Working Group
-----------------------
In connection with each Workplan, the Parties shall commit all of the
resources determined to be required pursuant to such Workplan and shall
establish a technical working group (the "Technical Working Group") to work
under the supervision of the Project Leaders.
ARTICLE 4
---------
ESTABLISHMENT OF WORKPLANS
--------------------------
4.1 Description of Workplan
-----------------------
Within 30 days following the date hereof and as soon as reasonably
feasible thereafter following a request by a Party to the other during the term
of this Agreement, the Steering Committee shall hold one or more meetings and
use commercially reasonable efforts to prepare a development and
commercialization plan (a "Workplan") for each agreed System that the Parties
agree to co-develop. As of the date hereof, such Workplan contemplated by the
parties include (i) a Workplan for developing Secondary Processes for the
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Proteins and (ii) Co-Developed Additional Primary Steps and/or Secondary
Processes for the capture and purification of paraoxinase, plasmin and
plasminogen. Each Workplan shall be signed by the representative of each Party
and shall, include details of and specify in reasonable details the
responsibilities and entitlements of each Party with respect to the following:
(a) the obtaining of the necessary regulatory approvals for the System and
related System Products;
(b) the development and commercialization timelines and milestones, including
an estimated development schedule;
(c) the identification of each Party's Intellectual Property, available public
know-how and Third Party Intellectual Property required with respect to the
System and the methods for their sharing and acquisition, to the extent
different than those set out in this Agreement;
(d) the proposed manufacturing, marketing and commercialization strategy and,
as circumstances warrant, business plan, including a comprehensive
assessment and strategic analysis of scientific and business trends and
directions, recommendations regarding price, performance and technology
trends (taking into account the business priorities, strategies, forecasted
demands and competitive market position of each Party);
(e) the anticipated resources and personnel commitments from the Parties,
including a description of the personnel skills and abilities required to
develop and commercialize the System and related System Products;
(f) the anticipated budget and cost allocation relating to additional
equipment, or other capital expenditures required to develop, manufacture
and commercialize the System and related System Products;
(g) the proposed distribution of revenues in accordance with the guidelines set
forth in Section 7, taking into account:
i) the relative contribution of each party;
ii) the benefits to be derived by each party; and
iii) the costs of obtaining any additional regulatory approval
for the System or related System Products.
(h) the sharing of documentation and data available form each party;
(i) the supply of resin by Prometic to Hemosol for the use in connection with
the System;
(j) the impact of the proposed System on the existing relationships between the
parties; and
(k) any other consideration which the Steering Committee determines to be
relevant.
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ARTICLE 5
---------
DEVELOPMENT PHASE
-----------------
5.1 Development Phase
-----------------
(a) During the Development Phase of a System, the Parties will use
commercially reasonable efforts to develop one or more Prototypes with
the objective of designing at least one commercializable version of
such System.
(b) Unless otherwise provided for in a Workplan, (i) ProMetic will oversee
the development of validation assays, bulk formulation and the
development, manufacturing and supply of Resin to Hemosol for use in
connection with the Development Phase and (ii) Hemosol will oversee
the development and implementation of filtration, viral inactivation
steps, assembly or optimization of known and publicly available
chromatographic steps (other than those under ProMetic's Platform
Technology for which ProMetic shall be responsible), engineering
(plant, process) and initial testing of any Prototype and System in
the Production Facility.
(c) During the Development Phase, each Party shall use commercially
reasonable efforts to perform its responsibilities and obligations in
accordance with the applicable Workplan and to support the other
Party's development efforts.
(d) Detailed written information regarding material modifications by the
representatives of each Party on the Technical Working Group to any
System or Prototype being developed will be transmitted to the
representatives of the other Party on the Technical Working Group as
soon as possible and in any event no later than at the next meeting of
the Steering Committee. Each Party will make reasonable efforts to
explain the purpose and, if applicable, the benefits of any such
modification.
(e) During the Development Phase for each System, the Parties will each
have access to Prototypes. Each Party will cooperate to have the most
recent Prototypes made available to the other Party. Without the prior
written consent of the other Party, neither Party shall permit any
Third Party to have access to the subject System, including
Prototypes, except as determined in any Workplan.
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5.2 Intellectual Property
---------------------
(a) Each Party will operate during the Development Phase for each System
under a royalty-free and non-assignable license from the other Party
in and to the other Party's Intellectual Property Rights to the extent
reasonably necessary to satisfy its obligations set forth in Section
5.1 (b) as further detailed in the applicable Workplan.
(b) All Intellectual Property developed under this Agreement relating to
the Production Facility and Hemosol's engineering services, authored
plans, methodologies and diagrams, operational parameters of the
Production Facility and other similar information shall be the
exclusive property of Hemosol. ProMetic will and, in the event that an
employee or contractor of ProMetic is an inventor, ProMetic will cause
such inventor to, assign all rights in such Intellectual Property to
Hemosol and cooperate with Hemosol in perfecting Hemosol's rights in
such Intellectual Property.
(c) All Intellectual Property developed under this Agreement relating to
the Cascade Process and/or ProMetic's Platform Technology, including
Resin shall become the exclusive property of ProMetic. Hemosol will,
and in the event that an employee or contractor of Hemosol is an
inventor, Hemosol will cause such inventor to, assign all rights in
such Intellectual Property to ProMetic and cooperate with ProMetic in
perfecting ProMetic's rights in such Intellectual Property.
(d) All other Intellectual Property (the "Joint Intellectual Property")
developed under this Agreement relating to a System will be jointly
and equally owned by each Party and each Party shall have the right to
exploit such Intellectual Property.
(e) The Parties will use reasonable efforts to report developments and
inventions relating to the Intellectual Property relating to each
System to each other using invention disclosure forms. The Party
owning the Intellectual Property shall make reasonable efforts to
protect such Intellectual Property at its own expense and to
reasonably enforce the related Intellectual Property Rights and report
from time to time to the other Party the progress of such efforts. The
protection and enforcement of jointly owned Intellectual Property
shall be subject to the mutual agreement of the Parties and shall be
protected and enforced at their mutual expense.
(f) Nothing contained in this Section 5.2 shall be deemed to grant a
license, or any rights, to either Party in respect of the Intellectual
Property Rights of the other Party, except as explicitly set forth in
this Section 5.2.
13
ARTICLE 6
---------
COMMERCIALIZATION PHASE
-----------------------
6.1 Commercialization Responsibilities
----------------------------------
(a) Unless otherwise provided for in a Workplan, the Parties shall be
responsible jointly to commercialize, under the supervision of
the Steering Committee, the System Products and Systems in the
Territory, excluding any Co-Developed Secondary Processes and
Co-Developed Additional Primary Steps used or to be used in
connection with the Cascade Process which shall be commercialized
in accordance with the terms and conditions of the License
Agreement.
(b) ProMetic shall be the Party responsible for the commercialization
of the System and the related System Products in Other
Territories and for the manufacture and supply of any Resin and
other like material to users of any systems, either in the
Territory or outside the Territory. Any agreement with a Third
Party, including an affiliate of Hemosol or ProMetic for the use,
sale, license, transfer or other commercialization of any System
or the related System Products other than a Co-Developed
Secondary Process or a Co-Develop Additional Primary Step used or
to be used with the Cascade Process in accordance with the
License Agreement, shall be subject to such terms and conditions
as may be agreed upon between the Parties acting reasonably.
(c) Each party agrees to sign and execute and cause any of its
affiliates to sign and execute any document reasonably required
to give effect to the foregoing, including the grant of the
necessary rights in its Intellectual Property to the other party
to give effect to the commercialisation rights set forth in this
Section 6.
ARTICLE 7
---------
ALLOCATION OF REVENUES
----------------------
7.1 Guidelines
----------
In order to establish the basis for sharing revenues derived from the
development and commercialization of Systems and related System Products, the
Steering Committee shall, in connection with the establishment of a Workplan
under Section 4.1, give consideration to the following criteria:
7.1.1. Guidelines for any use of a System by a Party
---------------------------------------------
(a) any Co-developed Secondary Processes used by Hemosol in
connection with Proteins, Additional Proteins or Products shall
be subject to the payment of royalties in accordance with the
terms and conditions of the License Agreement; and
(b) any other Systems used by either Party, shall be subject to a
royalty payment to the other Party on net sales of related System
Products.
14
7.1.2. Guidelines for any use of a System by a Third Party
---------------------------------------------------
(a) Subject to paragraph 7.1.2 (b), any technological transfer of
rights in a System to a Third Party, will trigger the right for
the Parties to participate in the Revenues deriving therefrom in
a proportion of up to 50/50, taking into account each party's
investment in such System.
(b) notwithstanding paragraph 7.1.2 (a), any technological transfer
in the Territory to a Third Party of rights in the Cascade
Process to which is added one or more Systems shall be subject to
the terms and conditions set forth in the License Agreement.
7.2 Royalties
---------
(a) Any royalty payable by a Party to the other pursuant to a
Workplan shall be calculated and payable quarterly no later than
the twenty-fifth day of the month following the end of each
calendar quarter, provided that (a) each such quarterly payment
will reflect adjustments, if any, from prior periods and (b)
annual adjustments to such royalty shall be made following the
end of each calendar year to reflect final adjustments in such
calendar year and shall be payable at the same time as the first
quarterly instalment of the royalty is payable in the subsequent
calendar year.
(b) Any other amount payable by a Party to the other shall be payable
in accordance with the terms and conditions of the applicable
Workplan.
(c) Interest on all payments shall be charged at the rate of 1% above
the prime rate for Canadian dollar commercial loans made in
Canada quoted from time to time by Canadian Imperial Bank of
Commerce at its main branch in Toronto from the date on which
such payments are due until such payments are received.
(d) On or before April 30 of each year, each Party shall supply the
other Party with a statement of such first Party's regular
auditors certifying the amount received by such Party from
Systems and related System Products, the amount of gross
revenues, gross sales and net sales for such items as applicable,
as well as freight, duties, insurance, charges for returned goods
and other expense items deducted from gross sales to reach net
sales and the royalty, if any, payable with respect to the prior
calendar year.
(e) Each Party shall be entitled to appoint accountants acceptable to
the other Party acting reasonably to audit on an annual basis the
records related to the subject matters set forth hereunder, and
such other Party shall give reasonable access to such records and
supporting documentation and otherwise reasonably assist in such
audit. In the event that any such audit reveals an error in
favour of the auditing Party in the statement referred to in
paragraph (d) for the year in question, then the audited Party
shall promptly pay to the auditing Party the amount owing
together with interest thereon calculated from the dates the
amounts were due at the rate specified in paragraph (c) and, if
such error is greater than $50,000, the cost of such audit.
15
(f) Any royalty payments payable by Hemosol or ProMetic under this
Agreement shall be paid (i) in US dollars if the basis of
calculation of such payment is Net Sales or other revenues
received in US dollars by the payor, (ii) in Canadian dollars if
the basis of calculation of such payment is net sales or other
revenues received in Canadian dollars by the payor and (iii) in
GBP if the basis of calculation of such payment is net sales or
other revenues received in GBP by the payor. Any other payment
required to be made hereunder for which the basis of computation
is a foreign currency shall be converted into and paid in
Canadian dollars, or such other currency agreed to by the
Parties, based on the average of the prevailing "buying" and
"selling" foreign exchange rates for Canadian dollars at the main
branch in Toronto of Canadian Imperial Bank of Commerce on the
date any such payment is due. Any payment shall be made by wire
transfer at such account or accounts at such bank or banks as the
payee may in its sole discretion designate in writing to the
payor from time to time.
ARTICLE 8
---------
OTHER BUSINESS OPPORTUNITIES
----------------------------
8.1 Clinical Materials
------------------
The Parties agree that any Third Party Licensee might require
clinical materials derived from the Cascade Process for product registration,
process or plant validation or regulatory approval purposes, and Hemosol shall
be the preferred supplier of all Third Party Licensees of the Cascade Process
for such clinical materials. With respect to each of such Third Party Licensee
and each blood agency that require clinical materials derived from the Cascade
Process, ProMetic and Hemosol shall negotiate in good faith to enter into an
agreement with such Third Party Licensee or blood agency whereby Hemosol would
supply, on commercially reasonable terms and conditions, such clinical materials
to such licensee or blood agency for the purposes described above. It is also
agreed that until such time a Third Party is identified in Other Territories,
Hemosol shall be entitled to market, sell and distribute Proteins, Additional
Proteins and Other Proteins, coming out of the Cascade in such Other Territories
on a non exclusive basis, in accordance with a commercialisation plan agreed to
with ProMetic. The objective of the Parties is to leverage their own
capabilities and generate revenue for both companies following the successful
implementation of the Cascade Process at the Production Facility. Hemosol agrees
to cease such commercial activities upon receiving written notification from
ProMetic informing Hemosol that a Third Party Licensee is identified (subject to
Hemosol's right to supply such Third Party Licensee with clinical material as
mentioned in this Section 8.1.).
16
8.2 ProMetic as Hemosol's Client
----------------------------
Upon request from ProMetic, Hemosol and ProMetic shall enter into
good faith discussions to negotiate the terms and conditions upon which ProMetic
shall become a client of Hemosol for the purchase by ProMetic of Proteins,
Additional Proteins or Products manufactured by Hemosol pursuant to the License
Agreement.
8.3 Engineering Services
--------------------
It is the intention of the Parties to leverage the knowledge and
experience that is gained during the implementation of the Cascade Process at
the Production Facility to assist ProMetic in securing licensees in Other
Territories and to assist such licensees in the implementation of the Cascade
Process. ProMetic and Hemosol may jointly develop and offer a package of
engineering services to such licensees to assist in the implementation or
optimization of the Cascade Process in their facilities. The development of such
package will be governed by a Workplan under this Agreement. Such Workplan will
address financial consideration for Hemosol's services and guidelines set forth
in Section 7.1 when applicable.
8.4 Other Coordinated Business Activity
-----------------------------------
(a) ProMetic shall, when and as requested by Hemosol, assist Hemosol in:
(i.) the negotiation and execution of one or more agreements between
Hemosol and the ARC for the supply of Raw Material by the ARC to
Hemosol for processing under the Cascade Process and the purchase
by the ARC from Hemosol of resulting products, which shall
include:
(a) the supply of Raw Material by the ARC to Hemosol in an
annual target volume of 500,000 litres;
(b) the purchase by the ARC from Hemosol of IVIG (intravenous
immunoglobulin), FVIII (haemophillic factor VIII and A1P1
(alphaone protease inhibitor) isolated from such Raw
Material at pre- determined prices; and
(c) the purchase by the ARC on commercially reasonable terms of
additional products that may be isolated from such Raw
Material.
(ii.)financing efforts to fund the activities described in this
Agreement and the License Agreement, including the participation
by ProMetic's representatives in road shows and the entering into
by the Parties of amendments to this Agreement and the License
Agreement to implement requests made by potential or existing
lenders and other stakeholders having a financial interest in
Hemosol; and
(iii.) reasonable efforts to facilitate the participation of, or
endorsement from, senior officers of the ARC in financing and
investor communication activities; and
17
(b) ProMetic shall use its best efforts to secure the assistance of the
ARC with respect to the licensing of the Production Facility by the
FDA and such other Regulatory Body as may have jurisdiction over the
production or commercialization of any products intended to be
manufactured and sold by Hemosol.
ARTICLE 9
---------
COMPLIANCE WITH LAWS
--------------------
9.1 Approvals and Business Conduct
------------------------------
Each Party shall procure and maintain all approvals, licenses,
permissions, permits and other rights necessary to the performance of its
obligations under this Agreement and shall conduct its business in a manner so
as not to injure the reputation of the Systems, related System Products or the
other Party. Each Party shall comply with all laws and regulations as may apply
where Systems or related System Products are developed, used, sold, distributed
or otherwise commercialized by such Party or jointly by the Parties.
ARTICLE 10
----------
BOOKS AND RECORDS
-----------------
10.1 Non-Financial Records
---------------------
Each Party shall keep at its principal place of business records
accurate in all material respects relating to all Systems and related System
Products including, without limitation, manufacturing records, test records and,
where applicable, clinical records (including adverse events) in accordance with
such Party customary practices, but in any event for a minimum of five years
from the date of their origin or any longer period required by applicable laws
or by any applicable requirement of a Regulatory Body having jurisdiction.
10.2 Financial Records
-----------------
Each Party shall keep at its principal place of business financial
records accurate in all material respects relating to the commercialization of
all Systems and related System Products in accordance with such Party customary
practices, but in any event for a minimum of five years from the date of their
origin. The records shall show all gross sales and net sales in each country, as
well as cost of sales in sufficient detail to enable the payments due under this
Agreement to be correctly ascertained in all material respects.
ARTICLE 11
----------
REPRESENTATIONS AND WARRANTIES
------------------------------
11.1 By each Party
-------------
Each Party hereby represents and warrants to the other Party as
follows and acknowledges that the other Party is relying upon such
representations and warranties in entering into this Agreement:
18
(a) (i) it is a corporation duly organized, validly existing, and in good
standing under the laws of its jurisdiction of incorporation, and (ii)
it is duly qualified as a corporation and in good standing under the
laws of each jurisdiction where its ownership or lease of property or
the conduct of its business requires such qualification, or where the
failure to be so qualified would have a material adverse effect on its
financial condition or its ability to perform its obligations
hereunder,
(b) its execution, delivery and performance of this Agreement and all
documents to be delivered by it hereunder: (i) are within its
corporate power; (ii) have been duly authorized by all necessary or
proper corporate action; (iii) are not in contravention of any
provision of its certificate of incorporation or by-laws; (iv) do not
violate any law or regulation or any order or decree of any court or
governmental instrumentality; (v) do not violate the terms of any
indenture, mortgage, deed of trust, lease, agreement, instrument or
any other commercial agreement to which it is a party or by which it
or any of its property is bound; and (vi) do not require any filing or
registration with or the consent or approval of, any governmental
body, agency, authority or any other Person, which has not been made
or obtained previously;
(c) this Agreement has been duly executed and delivered by it and
constitutes its legal, valid and binding obligation, enforceable
against it in accordance with its terms, subject to legal principles
of general application; and
(d) its employees, consultants, advisors, contractors and other Persons
associated with the performance of this Agreement by such Party have
executed agreements whereby all right, title and interest of such
employees, consultants, advisors, contractors and other Persons in any
technology and inventions relating to this Agreement have been and
will be assigned to such Party.
11.2 No Other Representations or Warranties
--------------------------------------
Except as otherwise expressly set forth in this Article 11, neither
Party makes any representations and extends any conditions or warranties of any
kind, either express or implied, in relation to itself.
11.3 Survival of Representation and Warranties
-----------------------------------------
The representations and warranties of the Parties in this Article 11
shall be deemed to be repeated on each day during which this Agreement is in
effect and shall survive the termination of this Agreement.
19
ARTICLE 12
INDEMNIFICATION AND CONFIDENTIALITY
12.1 Infringement of Intellectual Property Rights
--------------------------------------------
If a Party becomes aware of any infringement of any Intellectual
Property Right relating to a System or System Product, such Party shall promptly
notify the other Party thereof. If requested by the other Party to do so, the
Party that is the owner of, or controls, the affected Intellectual Property
Right (the "Controlling Party") shall bring suit against the Person infringing
or passing off (the "Infringer") and, if necessary to the suit and if requested
so to do by the requesting Party, the other Party shall agree to be joined or to
join as a party in such suit. If the other Party elects to do so, it may be
represented in such proceedings by its own counsel at its own expense. In every
case of reported infringement or passing off, the Controlling Party shall be
allowed a reasonable time to investigate the situation, to come to an
independent conclusion on the question of infringement or passing off and the
advisability of starting suit, to correspond and negotiate with the Infringer,
to engage counsel and to start legal proceedings. In the event the Controlling
Party does not bring suit in any such instance within a reasonable time and in
any event within 60 days after becoming aware of the alleged infringement or
passing off, the other Party shall have the right during the term of this
Agreement to xxx in its own name or, with the approval of the Controlling Party
or if necessary to the suit, jointly with the Controlling Party, for present and
past infringement or passing off. The Controlling Party shall be kept informed
at all times of all such proceedings taken by the other Party. If Controlling
Party elects to do so, it may be represented in such proceedings by its own
counsel at its own expense. The Controlling Party shall bear all costs incurred
in connection with such infringement and passing off proceedings. In the event
that any such action is successfully prosecuted against an Infringer, any
damages, accounting of profits or other recovery shall be applied first to
reimburse the Parties for their respective legal expenses in connection with the
prosecution, and any remaining amounts shall then be divided between the Parties
in proportion to the damages suffered by each of them subject to dispute
resolution pursuant to this Agreement if the Parties are unable to agree upon
such proportion. In the event that any such action is unsuccessful, the
Controlling Party shall be responsible for paying any costs which may be awarded
to the successful defendant. Notwithstanding the foregoing, if the affected
Intellectual Property Right is jointly owned by the Parties, the Parties shall
collaborate to determine the best course of action in the applicable
circumstances.
12.2 General Indemnification
-----------------------
(a) Each Party hereby agrees to indemnify and hold harmless the other
Party and its directors, officers, employees, affiliates, sublicensees
and distributors from and against all liabilities, losses, damages,
costs and expenses, including court or arbitral tribunal fees and
costs, reasonable legal fees and expenses and amounts paid in
settlement as permitted hereby (collectively, the "Losses") arising
out of or relating to:
(i.) any claim of bodily injury or similar claims in the nature of
product liability resulting directly or indirectly from the
development or commercialization of any System or the related
System Products; or
20
(ii.) any misrepresentation made by such Party herein, or any breach
by such Party of or failure by such Party to perform its
obligations under, this Agreement;
provided, however, that the obligations of a Party to indemnify the other and
hold it harmless shall not include any loss or liability against which the other
Party is obligated to indemnify and hold the first Party harmless hereunder.
12.3 Patent Indemnity
----------------
Each Party hereby agrees to indemnify and hold harmless the other
Party and its directors, officers, employees, affiliates, sublicensees and
distributors from and against all Losses incurred by the Indemnified Party
(which shall include for the purposes of this Section 12.3 any running or other
royalties or other payments, however characterized, paid under any agreement or
arrangement entered into by a Party in connection with the settlement or other
resolution of an Intellectual Property Claim (as defined below) as permitted
hereby) arising out of or relating to any claim made at any time by any Third
Party of patent infringement or trade secret misappropriation ("Intellectual
Property Claim") by reason of any activities of the Indemnified Party permitted
under this Agreement that are alleged to infringe any Intellectual Property
owned or controlled by the Indemnifying Party.
12.4 Notice of Claim
---------------
In the event that a Party entitled to indemnification hereunder (the
"Indemnified Party") shall become aware of any claim, proceeding or other matter
(a "Claim") in respect of which the other Party (the "Indemnifying Party") has
agreed to indemnify the Indemnified Party pursuant to this Agreement, the
Indemnified Party shall promptly give written notice thereof to the Indemnifying
Party. Such notice shall specify whether the Claim arises as a result of a claim
by a Third Party against the Indemnified Party (a "Third Party Claim") or
whether the Claim does not so arise (a "Direct Claim"), and shall also specify
with reasonable particularity (to the extent that the information is available)
the factual basis for the Claim and the amount of the Claim, if known. The
failure to promptly give such notice or the failure of such notice to identify
the Claim with sufficient particularity shall not relieve the Indemnifying Party
of any of its indemnification obligations contained herein if the Indemnified
Party has actually given written notice to the Indemnifying Party and has
otherwise complied with the provisions of this Article 12 except where, and
solely to the extent that, such failure actually prejudices the rights of such
Indemnifying Party.
12.5 Direct Claims
-------------
With respect to any Direct Claim, following receipt of notice from
the Indemnified Party of the Claim, the Indemnifying Party shall promptly make
such investigation of the Claim as is considered necessary or desirable. For the
purpose of such investigation, the Indemnified Party shall make available to the
Indemnifying Party the information relied upon by the Indemnified Party to
substantiate the Claim, together with all such other information available to
21
the Indemnified Party as the Indemnifying Party may reasonably request. If both
Parties agree at or prior to the expiration of 60 days (or any mutually agreed
upon extension thereof) following such notice to the validity and amount of such
Claim, the Indemnifying Party shall immediately pay to the Indemnified Party the
full agreed upon amount of the Claim, failing which the matter shall be referred
to arbitration as provided herein.
12.6 Third Party Claims
------------------
With respect to any Third Party Claim, the Indemnifying Party shall
have the right, at its expense and with counsel of its choice satisfactory to
the Indemnified Party, acting reasonably, to defend and, upon written request
from the Indemnified Party, shall defend the Claim (including the negotiation
and settlement thereof). If the Indemnifying Party elects or is required to
assume such defence, the Indemnified Party shall have the right to participate
in the negotiation, settlement or defence of such Third Party Claim and to
retain separate counsel to act on its behalf, provided that the fees and
disbursements of such separate counsel shall be paid by the Indemnified Party
unless the Indemnifying Party consents to the retention of such counsel or
unless the named Parties to any action or proceeding include both the
Indemnifying Party and the Indemnified Party and representation of both the
Indemnifying Party and the Indemnified Party by the same counsel would be
inappropriate due to the actual or potential conflicting interests between them
(such as the availability of different defences). If the Indemnifying Party,
having assumed such control, thereafter fails to defend the Third Party Claim
within a reasonable time, the Indemnified Party shall be entitled to assume
control of such defence and the Indemnifying Party shall be bound by the results
obtained by the Indemnified Party with respect to such Third Party Claim. If any
Third Party Claim is of a nature such that the Indemnified Party is required by
applicable law to make a payment to any Third Party with respect to the Third
Party Claim before the completion of settlement negotiations or related legal
proceedings, the Indemnified Party may make such payment and the Indemnifying
Party shall, forthwith after demand by the Indemnified Party, reimburse the
Indemnified Party for such payment. If the amount of any liability of the
Indemnified Party under the Third Party Claim in respect of which such payment
was made, as finally determined, is less than the amount that was paid by the
Indemnifying Party to the Indemnified Party, the Indemnified Party shall,
forthwith after receipt of the difference from the Third Party, pay the amount
of such difference, without interest, to the Indemnifying Party.
12.7 Settlement of Third Party Claims
--------------------------------
If the Indemnifying Party does not elect to assume control of the
defence of any Third Party Claim or, after request by the Indemnified Party,
fails to do so, the Indemnified Party shall have (but shall not otherwise have)
the exclusive right to contest, settle or pay the amount claimed and any Losses
incurred by the Indemnified Party in connection with such contest, settlement or
payment shall be conclusive as to the existence and amount of any liability of
the Indemnifying Party to the Indemnified Party hereunder. Whether or not the
Indemnifying Party assumes control of the negotiation, settlement or defence of
any Third Party Claim, the Indemnifying Party shall not settle any Third Party
Claim, without the written consent of the Indemnified Party, which consent shall
not be unreasonably withheld or delayed; provided, however, that (A) no
Indemnified Party shall be obligated to consent to any compromise or settlement
that does not provide for a complete release of the Claim against the
Indemnified Party, and (B) the liability of the Indemnifying Party shall be
limited to the proposed settlement amount if any such consent is not obtained
for any reason other than the failure of such settlement to conform to the
requirements of the preceding clause (A).
22
12.8 Cooperation
-----------
The Indemnified Party and the Indemnifying Party shall co-operate
fully with each other with respect to Third Party Claims, and shall keep each
other fully advised with respect thereto (including supplying copies of all
correspondence, demands, pleadings and other relevant documentation promptly as
it becomes available). The Indemnified Party and the Indemnifying Party shall
each use all reasonable efforts to mitigate Losses arising out of any Claim for
which indemnity is sought hereunder.
12.9 Survival
--------
This Article 12 shall survive any termination or expiry of this
Agreement. No liability or obligation of any Party shall be deemed to arise in
respect of any claim or potential claim subject to indemnification pursuant to
this Article 12 unless and until a notice of such claim has been given by the
Party requesting indemnification. Without limiting the generality of the
foregoing, each Party irrevocably waives, and agrees not to assert in any
proceeding, whether by way of defence, set-off, counterclaim or otherwise, that
the other Party knew, or that a reasonable Person with the abilities and in the
circumstances of such other Party ought to have known, any or all of the
elements of a claim made pursuant to this Article 12 prior to the date on which
such notice is given. In addition, each Party irrevocably agrees that any matter
as to which a claim has been asserted by notice to the other Party that is
pending or unresolved at the end of any applicable limitation period shall
continue to be covered by this Article 12 until such matter is finally
terminated or otherwise resolved by the Parties under this Agreement or by
arbitration as herein provided and any amounts payable hereunder are finally
determined and paid and each Party further agrees not to raise, assert or rely
on the expiry of any limitation period in any such arbitration or other
proceeding.
12.10 Maintenance of Confidentiality
------------------------------
Each Party shall keep in strict confidence and secrecy all of the
Confidential Information of another Party and shall not disclose the same to any
Person whatsoever during the term of this Agreement or at any time thereafter,
unless such Confidential Information becomes public knowledge through no act or
fault on the part of such Party and a Party may disclose Confidential
Information or any part thereof:
(a) to the Therapeutic Product Directorate, Health Canada, to the
Food and Drug Administration, US, or to another regulatory body,
in connection with the development and implementation of clinical
trials program, a request for regulatory clearance or an
application for regulatory approval;
23
(b) subject to the limitations set forth below, to its officers,
directors, employees and agents for the purpose of performing its
obligations hereunder; or
(c) pursuant to compulsory legal process or as may otherwise be
required by applicable law, but only after having notified the
other Parties in writing, as far in advance as may be practicable
so as to provide them with a reasonable opportunity to seek to
prevent such disclosure or to seek to obtain a protective order
for such Confidential Information. Failing such protective order,
it shall use reasonable efforts to secure the court's or other
appropriate governmental entity's order to (i) limit production,
use and disclosure of said information for the purposes of the
proceeding and to the narrowest class of disclosure practicable
under the circumstances and (ii) hold all proceedings in camera
with a sealed record.
Each Party agrees to limit the above-contemplated disclosure of Confidential
Information to only those of its directors, officers, employees and authorized
agents whose need to know and whose access to such information is necessary for
the proper discharge of such Party's functions and responsibilities under this
Agreement and further agrees to take all reasonable safeguards so as to protect
the secret and proprietary nature of such information and to prevent the
unauthorized use, reproduction, disclosure or other dissemination thereof. Prior
to disclosing any Confidential Information of a Party, or any part thereof, to
any of its authorized agents, the Party intending to make such disclosure shall
obtain from each such Person an agreement in which such Person agrees to keep in
strict confidence and secrecy all of the information disclosed to him or her
under the provisions of this clause. Each Party shall be responsible for the
disclosure of any Confidential Information contrary to the provisions of this
Article 12 by its directors, officers, employees and authorized agents.
12.11 Exceptions
----------
The provisions of Section 12.10 shall not apply to the extent and
upon the occurrence of any one of the following events: (a) the information is
subsequently otherwise legally acquired by a Party from a Third Party whose
disclosure thereof is not in any breach of any applicable confidentiality
obligation; or (b) the information is in or comes into the public domain or is
or becomes generally known in the industry otherwise than by a breach of this
Agreement or any other applicable confidentiality obligation. In the event that
any material disclosure under (a) or (b) occurs, each Party shall after
receiving knowledge thereof promptly notify the other Party of the occurrence of
such event.
12.12 Non-disclosure of Agreement
---------------------------
Neither party shall disclose any material information about this
Agreement without the prior written consent of the other. Consent shall not be
required, however, for disclosures to tax authorities, provided that in
connection with such disclosure, each party agrees to use its reasonable efforts
to secure confidential treatment of such information. In the event a disclosure
is required to underwriters, investment or merchant or commercial bankers and
financial, legal and other advisors in connection with due diligence
investigations of the party, the written consent of the other party shall be
required, but the parties understand and agree that time is of the essence and
such consent from such other party shall be given within a reasonable delay,
i.e. within 48hrs following receipt of proper information from the first party
explaining the intended disclosure. Consent and information might be provided
24
via e-mails or facsimile. Each party shall have the further right to disclose
the terms of this Agreement (a) as required by applicable law, including the
rules and regulations promulgated by the Ontario Securities Commission, the U.S.
Securities and Exchange Commission, the Autorite des Marches Financiers du
Quebec or The Toronto Stock Exchange and similar authorities, provided the
disclosing party provides to the other party a copy of the information to be
disclosed and, subject to the remainder of this Section 12.12, an opportunity to
comment thereon not less than five days, or such shorter period as may be
available under applicable law, prior to such disclosure. Any copy of this
Agreement required to be disclosed pursuant to clause (a) of the preceding
sentence shall be edited to delete pricing and other Confidential Information to
the maximum extent permitted by law or the rules of the organizations referred
to therein. If either party determines that a release of such information to the
public other than as a result of the disclosure referred to above or to any
regulatory body is required by law, it shall, to the extent practicable in light
of legal requirements relating to such release, notify the other in writing as
soon as practicable prior to the time of the proposed release. At the other
party's request and before the release (if time permits under applicable law),
the party seeking disclosure shall consult with the other on the necessity for
the disclosure and shall consult with the other on the necessity for the
disclosure and the text for the proposed release. Nothing in this Section 12.12
shall preclude the disclosure of this Agreement or the transactions contemplated
hereby to the respective boards of directors of the parties for the purpose of
obtaining corporate authorization of this Agreement and such transactions.
12.13 Compliance with Confidentiality Obligations
-------------------------------------------
Each Party represents and warrants to the other that neither the
execution and delivery of this Agreement by such Party nor the performance of
such Party's obligations hereunder does or will conflict with or result in a
breach or violation of any agreement or undertaking of confidentiality to which
such Party is a signatory or by which such Party is bound.
12.14 Injunction
----------
Each Party acknowledges that any violation by it of its obligations
under this Article 12 may cause irreparable injury to the other Party for which
damages may not be adequate compensation. Therefore, in addition to all other
remedies available at law or in equity, the non-violating Party will be entitled
to seek injunctive relief in the event of a violation or threatened violation of
this Article 12 by the other Party.
ARTICLE 13
----------
FORCE MAJEURE
-------------
13.1 Force Majeure
-------------
In case of Force Majeure preventing or hindering either Party from
performing its obligations under this Agreement, the Party prevented or hindered
from performing (the "Affected Party") may give written notice to the other (the
"Non-Affected Party") containing reasonable particulars of the Force Majeure in
question and the effect of such Force Majeure as it relates to the obligations
25
of the Affected Party and such Force Majeure shall not constitute a default
under this Agreement, provided that the Affected Party works diligently to
correct the reason for such delay and excuses performance by the Non-Affected
Party during the period of such delay, which shall not be longer than 180 days
from the first occurrence of the Force Majeure. For the purpose of this
Agreement, "Force Majeure" shall mean any of the following events beyond the
control of the Affected Party:
(a) lightning, storms, earthquakes, landslides, floods, washouts and other
acts of God;
(b) substantial or material fires, explosions, breakage of or accidents to
plant, machinery, equipment and storage of the Affected Party;
(c) strikes or other industrial disturbances of the Affected Party;
(d) civil disturbances, sabotage, war, blockades, insurrections,
vandalism, riots, epidemics;
(e) inability to obtain transportation or electric power, water, fuel or
other utilities, or services necessary to operate a substantial
portion of the facilities of the Affected Party; and
(f) any similar material event that is beyond the control of the Affected
Party;
but shall not include the inability of either Party to obtain financing or any
other financial inability on the part of either Party.
ARTICLE 14
----------
TERM AND EARLY TERMINATION
--------------------------
14.1 Termination of Agreement
------------------------
This Agreement will continue in full force until the last to expire
of any Commercialization Phase or upon the third anniversary date of this
Agreement if no Workplan is initiated and ongoing. This Agreement may also be
terminated by mutual written agreement of the Parties, effective as of the time
specified in such written agreement. Upon any termination of this Agreement for
any reason, neither Party will be relieved of any obligations incurred prior to
such termination.
14.2 This Agreement may be unilaterally terminated without penalty by
Hemosol or ProMetic (in each case a "Terminating Party") in the manner set forth
in Section 14.3 if there is the occurrence of any of the circumstances or events
described below with respect to (i) if the Terminating Party is Hemosol,
ProMetic, and (ii) if the Terminating Party is ProMetic, Hemosol (in each case,
a "Terminated Party"):
(a) any regulatory or court order is issued under or pursuant to any
applicable law of any jurisdiction in which the Terminated Party
conducts a substantial portion of its business, which operates to
prevent the Terminated Party from performing its obligations
under this Agreement in a material respect and such order is not
26
stayed or rendered ineffective within 90 days of its issuance, or
a Third Party encumbrancer takes possession of all or a
substantial part of the properties and assets of Hemosol, or if a
distress or execution or any similar process is levied or
enforced against Hemosol which affects such properties and assets
and remains unsatisfied for 90 days;
(b) any order to cease or suspend trading in any securities of
Hemosol Corp, or prohibiting or restricting the distribution of
any of Hemosol Corp's shares is made by any securities regulatory
authority, including the TSX, NASDAQ or any other competent
authority in any jurisdiction where Hemosol Corp is a reporting
issuer (or the equivalent thereof) provided that: (i) the
delisting of the securities of Hemosol from the NASDAQ national
or small capital markets shall not constitute a ground of
termination under this Section 14.2 if the listing of such
securities on another recognized exchange is maintained; (ii)
such order is not made as a result of a take-over bid or another
acquisition of a controlling interest in Hemosol by a Third
Party; (iii) such order has been effective for a period in excess
of 30 days and has not been stayed or otherwise rendered
ineffective; and (iv) ProMetic has served a notice of termination
to Hemosol in accordance with Section 14.4 within 90 days of the
issuance of such order and while such order was in effect;
(c) if the Terminated Party is prevented from complying, either
totally or in part, with any of the terms or provisions of this
Agreement by reason of Force Majeure for a period longer than 180
days or the Terminated Party has failed to meet its obligations
hereunder;
(b) if the Terminated Party institutes any proceeding or takes any
action or executes any agreement to authorize its participation
in or commencement of any proceeding, or if any bona fide
proceeding is commenced by a Third Party against or affecting the
Terminated Party and such proceeding is not discharged within 30
days from the commencement thereof, seeking (i) to adjudicate it
a bankrupt or insolvent, (ii) liquidation, dissolution,
winding-up, reorganization, arrangement, protection, relief or
composition of it or any of its property or debt, (iii) a
proposal with respect to it under any law relating to bankruptcy,
insolvency, liquidation, reorganization or compromise of debts or
other similar laws (including, without limitation, the Companies'
Creditors Arrangement Act (Canada), the Bankruptcy and Insolvency
Act (Canada), the Winding-Up and Restructuring Act (Canada) or
any similar statute of any jurisdiction, including any statute
governing the existence of the Terminated Party) or (iv) the
appointment of a receiver, trustee, manager, liquidator, interim
receiver or manager, agent, custodian or other official with
similar powers or functions for it or for any substantial part of
its properties and assets (including without limitation, with
respect to Hemosol, the Production Facility and, with respect to
ProMetic, the Cascade Process or the intellectual property
related to the production of Resin).
27
14.3 Termination of Development or Commercialization Phase of a System
-----------------------------------------------------------------
(a) In the event of a material breach by either Party of its
obligations under this Agreement or a Workplan during the
Development Phase or the Commercialization Phase with respect to
a System, the non-breaching Party may give the breaching Party
written notice thereof (a "Notice of Breach"), which notice must
state the nature of the breach in reasonable details and, in the
reasonable opinion of the non-breaching Party, the proposed steps
to cure the breach. If the breaching Party fails to cure such
material breach, the non-breaching Party may terminate the
Development Phase or the Commercialization Phase, as applicable,
with respect to such System by written notice to the breaching
Party delivered not earlier than 60 days after receipt by the
breaching Party of the Notice of Breach.
(b) During the Development Phase or the Commercialization Phase of
any System, upon 30 day prior written notice, either Party may
elect, in its sole discretion, to terminate its participation in
the Development Phase or Commercialization Phase of such System,
provided that a Party may not terminate for convenience within 60
days following the delivery of a Notice of Breach by the other
Party in accordance with paragraph (a) above.
(c) If the termination of the Development Phase or the
Commercialization Phase of any System results from a material
breach or termination for convenience by Hemosol, then:
(i.) ProMetic shall have the exclusive right to develop, make,
have made, use, license, sell, have sold or otherwise
commercialize the affected System and related System
Products, provided for greater certainty that Hemosol shall
not have further obligations with respect to such System and
the related System Products; and
(ii.) Hemosol shall not have the right to develop, make, have
made, use, license, sell, have sold or otherwise
commercialize the affected System and related System
Products provided that such termination shall not affect the
rights and obligations of each Party then arising under the
License Agreement except to the extent such rights or
obligations relate or would relate but for the termination,
to the specific System being terminated and the related
System Products.
28
(d) If the termination of the Development Phase or the
Commercialization Phase of any System results from a material
breach or termination for convenience by ProMetic, then:
(i.) Hemosol shall have the exclusive right to continue to
develop, make, have made, use, license, sell, have sold or
otherwise commercialize the affected System and the related
System Products, provided for greater certainty that
ProMetic shall not have further obligations with respect to
such System and the related System Products except as
provided in paragraph (ii) below and any use of a System in
connection with the Cascade Process, shall continue to be
subject to the terms and conditions of the License
Agreement.
(ii.) with respect to Resin to be used by Hemosol in connection
with such Systems, ProMetic shall supply the same to Hemosol
on terms not less favourable to Hemosol than the best terms
that are made available by ProMetic to its most favoured
customer and, if no such customer exists, on terms
representing the reasonable costs to ProMetic for
manufacturing the same plus a commercially reasonable profit
margin. If possible, exact pricing will be set forth in each
Workplan. Any use of a Resin in connection with a System
used in connection with the Cascade Process, shall continue
to be subject to the terms and conditions of the License
Agreement and termination hereunder shall not affect rights
and obligations set forth in the License Agreement.
(iii.) ProMetic shall not have the right to develop, make, have
made, use, license, sell, have sold, or otherwise
commercialize the affected System and related System
Products, provided that such termination shall not affect
the rights and obligations of each Party then arising under
the License Agreement except to the extent such rights or
obligations relate, or would relate but for the termination,
to the specific System being terminated and the related
System Products.
14.4 Notice of Termination
---------------------
A Terminating Party seeking to terminate this agreement in accordance
with this Section 14 shall serve a notice of termination in writing and
termination shall be effective immediately upon confirmation of such receipt by
a facsimile confirmation sheet, courier documents or similar materials from the
Terminated Party, unless the Terminated Party wishes to submit the matter to
arbitration in accordance with this Agreement.
ARTICLE 15
----------
DISPUTE RESOLUTION
------------------
15.1 By Arbitration
--------------
Any dispute arising in connection with this Agreement, including any
question regarding its existence, validity or termination, is to be referred to
and finally resolved by arbitration in accordance with the Arbitration Act, 1991
(Ontario), and except (a) as provided in Section 15.2, (b) for proceedings
commenced to enforce an arbitration award, and (c) for proceedings commenced for
29
specific performance of Article 12, each Party hereby irrevocably waives its
right to commence any proceeding in any court with respect to any matter arising
under this Agreement. The tribunal shall consist of three arbitrators, one of
whom shall be appointed by each Party and the third arbitrator shall be
appointed jointly by the first two. The place of arbitration shall be Toronto
(Canada) if the arbitration is requested by ProMetic and if the arbitration is
requested by Hemosol, the place of arbitration shall be Montreal (Canada) or
such other location as the Parties shall agree. The language of the arbitration
shall be English. No arbitrator shall be an affiliate, employee, officer or
director of either Party or of their respective affiliates, nor shall any
Arbitrator have any interest that would be affected in any material respect by
the outcome of the dispute. The decision of a majority of the arbitrators shall
be final and binding on the Parties and their respective successors and assigns.
The decision shall not be subject to appeal or judicial review except in
circumstances of fraud or as otherwise permitted by applicable law. The tribunal
shall determine the proportions in which the Parties shall pay the costs of the
arbitration and related proceedings.
15.2 Injunction
----------
Nothing set out in this Article 15 shall prevent either Party from
seeking an injunction in any appropriate court.
ARTICLE 16
----------
APPLICABLE LAW
--------------
16.1 Governing Law
-------------
Any controversy arising under or in relation to this Agreement shall
be governed by and construed in accordance with the laws of the Province of
Ontario and the federal laws of Canada applicable therein without regard to
conflicts of law doctrines, except (a) that questions affecting the construction
and effect of any Patent shall be determined by the law of the country in which
the Patent was granted, (b) if any issue is to be determined by reference to the
interpretation of or compliance with the regulatory requirements of any country
and there is conflict between the interpretation of or compliance with such
regulatory requirements under Ontario law and the laws of such country, the
issue of the interpretation of or compliance with such regulatory requirements
shall be made in accordance with the laws of such country, and (c) to the extent
that matters relating to the internal affairs and corporate status of the
Parties are governed as a matter of controlling law by the laws of the
jurisdictions of incorporation of the respective Parties, such laws shall govern
such matters.
16.2 Scope of Authority and Relationship
-----------------------------------
The relationship between each Party is that of independent
contractors and neither this Agreement nor any act of the Parties hereunder or
in accordance herewith creates or shall create any relationship of agency,
master and servant, employment or partnership between the Parties hereto or
between a Party and the employees of the other. Neither Party shall act or
attempt to act, or represent itself, directly or by implication, as agent, or
representative of the other or in any manner assume or attempt to assume or
create any obligation or liability of any kind, nature or sort, express or
implied, on behalf of or in the name of the other.
30
16.3 Assignment; Successors and Assigns
----------------------------------
(a) Neither this Agreement nor any rights of a Party hereunder shall
enure to the benefit of, and the same shall be fully opposable to, enforceable
against and not terminable by, any trustee in the bankruptcy, receiver, interim
receiver, manager, interim manager, creditor, liquidator or trustee of the
business of such Party without the prior written consent of the other Party,
which such other Party may grant or withhold in its sole discretion.
(b) Hemosol acknowledges and agrees that ProMetic is contemplating a
reorganisation of its corporate structure and this Agreement may be assigned,
together with all of ProMetic's rights in the Cascade Process and all
intellectual property relating to the Resin to give effect to such
reorganisation, provided that ProMetic hereby covenants and agrees that ProMetic
shall be unconditionally and irrevocably liable to Hemosol for the timely
performance of the obligations of such assignee unless such assignee is a
purchaser of all or substantially all of the assets or all of the shares of
ProMetic.
(c) Except as provided in this Section 16.3, neither Party shall
delegate duties of performance or assign, in whole or in part any rights or
obligations under this Agreement without the prior written consent of the other
Party, and any attempted delegation or assignment without such written consent
shall be void and of no force or effect. Subject to the restrictions contained
in the preceding sentence, this Agreement shall be binding upon and enure to the
benefit of the Parties and their permitted successors and assigns.
16.4 Extended Meanings
-----------------
Words importing the singular number include the plural and vice versa
and words importing gender include all genders.
16.5 Headings
--------
The division of this Agreement into Sections and the insertion of
headings are for convenience of reference only and shall not affect the
construction or interpretation of this Agreement.
16.6 Language
--------
This Agreement is drawn up in the English language. If this Agreement
is translated into another language, the English language text shall prevail.
Les Parties reconnaissent qu'il est de leur volonte expresse que cette
convention soit redigee uniquement en langue anglaise.
31
16.7 Entire Agreement
----------------
This Agreement, together with the License Agreement, constitutes the
entire agreement of the Parties with respect to the subject matter hereof and
thereof and supersedes all prior or contemporaneous agreements and
understandings of the Parties in connection therewith, including but not limited
to the memorandum of understanding dated December 3, 2003 and the
confidentiality agreement dated July 11, 2003 between the Parties. In the event
of any inconsistency or conflict between (i) this Agreement and a Workplan
approved hereunder, the terms and conditions of such Workplan shall prevail, and
(ii) this Agreement (or any Workplan) and the License Agreement, the terms and
conditions of the License Agreement shall prevail.
16.8 Currency
--------
Unless otherwise specifically provided in this Agreement, all
references to dollar amounts or other money amount are expressed in terms of
lawful money of Canada.
16.9 Notices
-------
(a) Any notice or other documents required or permitted to be given
under this Agreement shall be in writing and shall be delivered or sent by fax
addressed to the Party to whom it is to be given at the address shown below or
at such other address or addresses as the Party to whom such notice or document
is to be given shall have last notified the other Party in accordance with the
provisions of this subsection:
(i.) if to Hemosol at:
Hemosol LP
0000 Xxxxxxxxxx Xxxx.
Xxxxxxxxxxx, XX X0X 0X0
Fax: (000) 000-0000
Attention: President
(ii.) if to ProMetic at:
ProMetic Biosciences Inc.
0000 Xxxxxxxxxx
Xxxxxxxx, Xxxxxx
X0X 0X0
Fax: (000) 000-0000
Attention: President with a courtesy copy to
Dr. Xxxxx Xxxxxx and the General Counsel
(b) Any such notice or other document shall:
(i.) if delivered in person, be deemed to have been received at
the place of receipt on the date of delivery, provided that
if such date is a day other than a business day in the place
of receipt, such notice or document shall be deemed to have
been given and received at the place of receipt on the first
business day thereafter in the place of receipt; and
(ii.) if transmitted by fax, be deemed to have been received at
the place of receipt on the next business day in the place
of receipt, following the day of sending.
32
16.10 Amendment of Agreement
----------------------
None of the terms, conditions or provisions of this Agreement shall
be held to have been changed, waived, varied, modified or altered by any act or
knowledge of either Party, their respective agents, servants or employees,
unless done so in writing signed by both Parties.
16.11 Waiver and Notice of Breach
---------------------------
No waiver on behalf of either Party of any breach of the provisions
hereof shall be effective or binding on such Party unless the same shall be
expressed in writing and any waiver so expressed shall not limit or affect such
Party's rights with respect to any future breach of any of the provisions in
this Agreement.
16.12 Further Assurances
------------------
Each of the Parties covenants and agrees that it and its successors
and permitted assigns will execute such further reasonable documents and do and
perform or cause to be done and performed such further and other reasonable acts
as may be necessary or desirable from time to time in order to give full effect
to the provisions of this Agreement.
16.13 Third Parties
-------------
Nothing in this Agreement, whether expressed or implied, is intended
to confer nor shall confer upon any Person other than the Parties hereto (and
with respect to the indemnification provisions herein, to the respective
directors, officers or employees referred to in such indemnification provisions)
any rights, benefits or remedies of any nature whatsoever under or by reason of
this Agreement.
16.14 Costs of Operations
-------------------
Except as otherwise provided herein, all costs and expenses of
whatever kind or nature incurred by either Party in the conduct of its
operations or the performance of its responsibilities in connection with or
pursuant to this Agreement shall be for the account of and shall be paid by such
Party, and such Party shall not be entitled to reimbursement therefor from the
other Party, whether upon the expiration or earlier termination of this
Agreement or otherwise.
33
16.15 Severability
------------
If any provision of this Agreement is determined to be invalid,
illegal or unenforceable, the remaining provision of this Agreement to the
extent permitted by law shall remain in full force and effect. To the fullest
extent permitted by law, the Parties to the same extent waive any provision of
law that renders any provision hereof prohibited or unenforceable in any
respect.
16.16 Counterparts and Fax Signatures.
--------------------------------
This Agreement may be executed in any number of counterparts, and
each such counterpart will be deemed an original instrument, but all such
counterparts together will constitute but one agreement. The Parties agree that
signatures delivered via fax shall be binding as if they were original
signatures.
IN WITNESS WHEREOF the Parties have duly executed this Agreement on
the date first above written .
PROMETIC BIOSCIENCES INC.
by "Xxxxxx Xxxxxx"
------------------------------------
Name: President
Title: Xxxxxx Xxxxxx
"Xxxxxxxx Xxxxxxxxxxx"
------------------------------------
Name:
Title: VP Finance & Administration
HEMOSOL LP.
by "Xxx Xxxxxxxx"
-----------------------------------
Name: Xxx Xxxxxxxx
Title: President/CEO
"Xxxx Xxxxxx"
-----------------------------------
Name: Xxxx Xxxxxx
Title: VP Operations
34
INTERVENTION BY PROMETIC BIOSCIENCES LTD.
-----------------------------------------
ProMetic Biosciences Ltd. ("PBL") hereby intervenes to this Alliance
Agreement to agree in favour of Hemosol LP (Hemosol) and ProMetic BioSciences
Inc. (PBI) (which shall include, for the purposes of this Intervention, any
assignee or successor of PBI under the Alliance Agreement) that from and after
the date hereof, at all times during which the Alliance Agreement (which shall
include, for the purposes of this Intervention, any amendment, modification,
supplement or restatement thereof agreed upon solely between PBI and Hemosol) is
in effect, PBL agrees that whenever PBI and Hemosol identify resources,
intellectual property and comnutments from PBL that could be required to develop
a System, or part of a System, it shall enter into good faith discussion with
PBI to provide such services or resources.
In connection with this Intervention, PBL hereby represents and
warrants to PBI and Hemosol as follows:
(a) it is a corporation duly organized, validly existing, and in good
standing under the laws of its jurisdiction of incorporation;
(b) its execution, delivery and performance of this Intervention: (i) are
within its corporate power; (ii) have been duly authorized by all
necessary or proper corporate action; (iii) are not in contravention
of any provision of its certificate of incorporation or by-laws; (iv)
do not violate any law or regulation or any order or decree of any
court or governmental instrumentality; (v) do not violate the terms of
any indenture, mortgage, deed of trust, lease, agreement, instrument
or any other commercial agreement to which it is a party or by which
it or any of its property is bound; and (vi) do not require any filing
or registration with or the consent or approval of, any governmental
body, agency, authority or any other Person, which has not been made
or obtained previously; and
(c) this Intervention has been duly executed and delivered by it and
constitutes its legal, valid and binding obligation, enforceable
against it in accordance with its terms.
This Intervention shall be governed by the laws of the Province of
Ontario and the federal laws of Canada applicable therein.
IN WITNESS WHEREOF PBL has duly executed this Agreement for the
purposes of this Intervention on the date first above written .
PROMETIC BIOSCIENCES LTD.
by "Xxxxxx Xxxxxx"
----------------------------------
Name: Xxxxxx Xxxxxx
Title: President
35
SCHEDULE 1.1
ADDITIONAL PRIMARY STEPS
------------------------
[Intentionally left blank; signature of each party will be required for
each Additional Primary Steps to be described herein from time to time]
SCHEDULE 3.1
PROJECT LEADERS
---------------
Representative of ProMetic: Xxxxxxxxxxx Xxxxxx
Representative of Hemosol: Xxxx Xxxxxx
