EXHIBIT 4.30
LICENSE AGREEMENT
PROMETIC BIOSCIENCES INC.
- and -
HEMOSOL LP
------------------------
June 1st, 2004
------------------------
TABLE OF CONTENTS
ARTICLE 1
DEFINITIONS
-----------
1.1 Defined Terms.........................................................................................1
ARTICLE 2
GRANT OF LICENSE AND IMPLEMENTATION
-----------------------------------
2.1 Grant.................................................................................................8
2.2 Implementation of the Cascade Process.................................................................9
ARTICLE 3
LICENSES IN THE TERRITORY AND DISTRIBUTORS
------------------------------------------
3.1 Licenses in the Territory............................................................................10
3.2 Distributors.........................................................................................12
3.3 Limitation...........................................................................................13
ARTICLE 4
IMPROVEMENTS
------------
4.1 Disclosure...........................................................................................13
4.2 Improvements.........................................................................................13
ARTICLE 5
PAYMENTS AND ROYALTIES
----------------------
5.1 License Fees.........................................................................................14
5.2 Estimated timing for completion......................................................................15
5.3 Share Restrictions...................................................................................15
5.4 Royalties............................................................................................16
5.5 Payment Period.......................................................................................16
5.6 Interest on Late Payments............................................................................16
5.7 Exchange Rate........................................................................................16
5.8 Withholding Taxes....................................................................................17
ARTICLE 6
LICENSOR'S OBLIGATIONS
----------------------
6.1 Supply Personnel and Technical Assistance............................................................17
6.2 Assistance regarding Production Facility.............................................................17
6.3 Ownership of Cascade Process.........................................................................18
6.4 Approvals and Business Conduct.......................................................................18
6.5 Provision of Materials and Intellectual Property.....................................................18
6.6 Supply of Resin......................................................................................18
6.7 Protection of Territory..............................................................................18
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ARTICLE 7
LICENSEE'S OBLIGATIONS
----------------------
7.1 Compliance with Local Laws...........................................................................19
7.2 Manufacturing Requirements...........................................................................19
7.3 Resins and Raw Material..............................................................................21
7.4 Performance Thresholds...............................................................................21
ARTICLE 8
BOOKS AND RECORDS
-----------------
8.1 Non-Financial Records................................................................................22
8.2 Financial Records....................................................................................22
8.3 quarterly Statement..................................................................................22
8.4 Annual Statement.....................................................................................22
8.5 Audit Rights.........................................................................................23
ARTICLE 9
REPRESENTATIONS AND WARRANTIES
------------------------------
9.1 By the Licensor......................................................................................23
9.2 By the Licensee......................................................................................25
9.3 No Other Representations or Warranties...............................................................27
9.4 Survival of Representation and Warranties............................................................27
ARTICLE 10
PATENTS AND TRADEMARKS
----------------------
10.1 Watch Service........................................................................................27
10.2 Infringement of Patents or Trademarks................................................................27
10.3 Description as Authorized Licensee...................................................................28
ARTICLE 11
INDEMNIFICATION
---------------
11.1 General Indemnification..............................................................................28
11.2 Patent Indemnity.....................................................................................29
11.3 Notice of Claim......................................................................................29
11.4 Direct Claims........................................................................................29
11.5 Third Party Claims...................................................................................30
11.6 Settlement of Third Party Claims.....................................................................30
11.7 Cooperation..........................................................................................31
11.8 Insurance............................................................................................31
11.9 Survival.............................................................................................32
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ARTICLE 12
PATENT AND PATENT APPLICATION FILINGS,
--------------------------------------
PROSECUTION, REGISTRATION AND MAINTENANCE
-----------------------------------------
12.1 Prosecution of Registration..........................................................................32
12.2 Abandonment of Patents...............................................................................32
12.3 Assistance to Prosecution............................................................................33
12.4 Transfer to Licensor.................................................................................33
ARTICLE 13
COMPLAINTS AND CORRECTIVE ACTIONS
---------------------------------
13.1 Complaints...........................................................................................33
13.2 Certain Corrective Actions...........................................................................33
ARTICLE 14
CONFIDENTIALITY
---------------
14.1 Maintenance of Confidentiality.......................................................................34
14.2 Exceptions...........................................................................................35
14.3 Non-disclosure of Agreement..........................................................................35
14.4 Compliance with Confidentiality Obligations..........................................................36
14.5 Injunction...........................................................................................36
ARTICLE 15
FORCE MAJEURE
-------------
15.1 Force Majeure........................................................................................36
ARTICLE 16
TERM AND EARLY TERMINATION
--------------------------
16.1 Term.................................................................................................37
16.2 Termination Events...................................................................................37
16.3 Notice of Termination................................................................................38
ARTICLE 17
RIGHTS AND OBLIGATIONS UPON TERMINATION
---------------------------------------
17.1 Generally............................................................................................39
17.2 Exceptions...........................................................................................40
17.3 Survival of Certain Rights and Obligations...........................................................41
ARTICLE 18
CONFORMITY WITH LOCAL LAWS
--------------------------
18.1 Recording of Agreement...............................................................................41
ARTICLE 19
DISPUTE RESOLUTION
------------------
19.1 By Arbitration.......................................................................................41
19.2 Injunction...........................................................................................41
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ARTICLE 20
APPLICABLE LAW
--------------
20.1 Governing Law........................................................................................42
20.2 Scope of Authority and Relationship..................................................................42
20.3 Assignment; Successors and Assigns...................................................................42
20.4 Extended Meanings....................................................................................43
20.5 Headings.............................................................................................43
20.6 Language.............................................................................................43
20.7 Entire Agreement.....................................................................................43
20.8 Currency.............................................................................................43
20.9 Notices..............................................................................................43
20.10 Amendment of Agreement...............................................................................44
20.11 Waiver and Notice of Breach..........................................................................44
20.12 Further Assurances...................................................................................45
20.13 Third Parties........................................................................................45
20.14 Severability.........................................................................................45
20.15 Costs of Operations..................................................................................45
20.16 Counterparts and Fax Signatures......................................................................46
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LICENSE AGREEMENT
THIS AGREEMENT is made as of the 1st day of June, 2004 between:
PROMETIC BIOSCIENCES INC., a corporation existing under the
laws of Canada
(the "Licensor"),
- and --
HEMOSOL LP, a limited partnership existing under the laws of
the Province of Ontario
(the "Licensee"),
WHEREAS:
(a) the Licensor has the exclusive right to license an improved plasma
protein recovery technology defined hereunder as the Cascade Process,
and wishes to grant certain rights in such technology to the Licensee
in order to allow the Licensee to manufacture proteins and related
products, all in accordance with the terms and conditions hereof (such
technology is also described in Schedule A but for illustration
purposes only);
(b) the Licensee is the owner of a manufacturing facility built to handle
the manufacturing of blood products and wishes to implement, in
collaboration with the Licensor, such technology, subject to the terms
and conditions hereof;
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
DEFINITIONS
-----------
1.1 Defined Terms
-------------
In this Agreement the following terms shall have the following
meanings, respectively:
1.1.1 "A1PI" means alphaone protease inhibitor derived from Raw Material;
1.1.2 "A1PI Primary Step" means the use of a Resin for the capture of A1PI
from Raw Material;
1.1.3 "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 1.1.3;
1.1.4 "Additional Production Facility" means any facility, in addition to
the Production Facility, to be established or used by the Licensee to
implement the Cascade Process;
1.1.5 "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;
1.1.6 "Affected Party" has the meaning set out in Section 15.1;
1.1.7 "Agreement" means this license agreement, including all schedules
attached hereto, as modified, amended, supplemented or restated from
time to time;
1.1.8 "APO-A-1" means apolipoprotein derived from Raw Material;
1.1.9 "APO-A-1 Primary Step" means the use of a Resin for the capture of
APO-A-1 from Raw Material;
1.1.10 "ARC" means the American National Red Cross, a nonprofit corporation
chartered by an act of Congress of January 5, 1905, as amended,
codified at, 36 U.S.C. ss. 300101 et. seq., also known as the
American Red Cross, and any successor thereto;
1.1.11 "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 Target Proteins Recovery
Percentages, and also including: all Additional Primary Steps,
Improvements, and Intellectual Property developed or to be developed
by the Licensor (alone or with any other licensees of Cascade
Process, its affiliates or the ARC) and owned by, or under exclusive
rights in favour of, the Licensor;
1.1.12 "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 and the documentation referred to in Schedule 2.2(b);
1.1.13 "cGMP" means current good manufacturing practices as defined in
guidelines published from time to time by the FDA;
1.1.14 "Claim" has the meaning set out in Section 11.3;
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1.1.15 "Commercial Scale" means the operation of the Cascade Process in the
Production Facility at a batch size sufficient to permit the
processing of 200,000 litres of Raw Material on a 12 month basis;
1.1.16 "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
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 written 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 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;
1.1.17 "Costs" means any and all direct costs incurred by the Licensor or
the Licensee directly attributable to the business development or
licensing activities of the Cascade Process (alone or combined with
one or more Secondary Processes), or patent prosecution and other
documented expenses in connection with the transfer of rights in the
Cascade Process (alone or combined with one or more Secondary
Processes,) and ongoing support to Third Party Licensees, and any and
all sum, i.e. royalty, commissions or other fees, payable to a Third
Party supplier of intellectual property, equipment or services in
connection with the Cascade Process (alone or combined with one or
more Secondary Processes) or the transfer of rights therein, as
reasonably documented by the party incurring such Costs;
1.1.18 "Direct Claim" has the meaning set out in Section 11.3;
1.1.19 "End-Users" means Third Parties who use Proteins, Additional Proteins
or Products purchased by them for any purpose other than resale;
1.1.20 "FDA" means the United States Food and Drug Administration and any
successor thereto;
1.1.21 "Fibrinogen" means fibrinogen derived from Raw Material;
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1.1.22 "Fibrinogen Primary Step" means the use of a Resin for the capture of
Fibrinogen from Raw Material;
1.1.23 "First IND for Clinical Trial Supply" means the date a first
investigational new drug application in respect of a Protein
manufactured by the Licensee using the Cascade Process is cleared
with the FDA;
1.1.24 "Force Majeure" has the meaning set out in Section 15.1;
1.1.25 "FVIII" means haemophillic factor VIII derived from Raw Material;
1.1.26 "hSA" means serum albumin derived from Raw Material;
1.1.27 "hSA Primary Step" means the use of a Resin for the capture of hSA
from Raw Material;
1.1.28 "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;
1.1.29 "Indemnified Party" has the meaning set out in Section 11.3;
1.1.30 "Indemnifying Party" has the meaning set out in Section 11.3;
1.1.31 "Infringer" has the meaning set out in Section 10.2;
1.1.32 "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, relating
to the Cascade Process;
1.1.33 "Intellectual Property Claim" has the meaning set out in Section
11.2;
1.1.34 "Intermediates" means residual depleted plasma concentrate obtained
by the Licensee following the extraction of one or more Proteins or
Additional Proteins from the Raw Material through the use of one or
more Primary Steps or Additional Primary Steps or the entire Cascade
Process;
1.1.35 "IVIG" means intravenous immunoglobulin derived from Raw Material;
1.1.36 "IVIG Primary Step" means the use of a Resin for the capture of IVIG
from Raw Material;
1.1.37 "Know-How" means the technical information, standard operating
procedures, trade secrets, methods, and other information and
specifications relating to the Cascade Process;
1.1.38 "Licensee's Developments" shall have the meaning set forth in Section
4.2;
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1.1.39 "Licensing Revenues" shall mean all revenues collected from a Third
Party Licensee pertaining to the granting of rights in the Cascade
Process and the transfer of Secondary Processes as contemplated in
Section 3.1, less (i) Licensor's Costs (as reduced by Licensee's
Costs pursuant to Section 3.1, as the case may be) and (ii)
Licensor's development fees and expenses as contemplated in Section
3.1 (vi);
1.1.40 "Licensure of First Product" means receipt of all required clearances
of the FDA for the commercial sale of a first Protein, Additional
Protein or Product in the United States of America;
1.1.41 "Losses" has the meaning set out in subsection 11.1(a);
1.1.42 "Net Sales" means, in respect of any particular calendar quarter, the
amount actually received by the Licensee from Resellers and End-Users
with respect to sales of Proteins, Additional Proteins and Products
during such quarter for such items sold by the Licensee to Third
Parties during such quarter, less, without duplication and with
respect to such quarter:
(i) normal and customary returns and normal and customary
trade, quantity or other cash discounts granted by the
Licensee with respect to such items;
(ii) the amount of all applicable sales, value-added and other
taxes to be paid or withheld by the Licensee with respect
to such items; and
(iii) amounts owed by Resellers and End-Users to the Licensee
not paid when due during such quarter,
provided that:
(iv) sales of Proteins, Additional Proteins or Products between
or among the Licensee and its affiliates, collaborators,
agents, consultants, co-marketers and distributors shall
be excluded from the computation of Net Sales;
(v) Net Sales shall include the first sale of such items to
Third Parties by any such affiliates, collaborators,
agents, consultants, co-marketers and distributors (and
provided, for greater certainty, that the references to
the Licensee in the deductions described in paragraphs (i)
to (iii) above shall be deemed to include such affiliates,
collaborators, agents, consultants, co-marketers and
distributors); and
(vi) where (i) the consideration for the sale of any of the
Proteins, Additional Proteins or Products includes any
non-cash element or (ii) any of the Proteins, Additional
Proteins or Products are sold in any manner other than an
invoiced sale, the Net Sales for such transaction shall be
calculated in accordance with a mutually agreeable
formulae;
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1.1.43 "Non-Affected Party" has the meaning set out in Section 15.1;
1.1.44 "Other Territories" means each country in the world, other than the
Territory;
1.1.45 "Patent Interest" has the meaning set out in Section 12.2;
1.1.46 "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, which are necessary in order to use the
Cascade Process under this Agreement, and as of the date hereof, the
Patents include the patents and patent applications listed in
Schedule 1.1.46 and their status as stated in said Schedule;
1.1.47 "PBL" means ProMetic Biosciences Ltd., a corporation existing under
the laws of the Isle of Man, and any successor thereto;
1.1.48 "Person" means any individual, corporation, cooperative organization,
company, partnership, unincorporated association or entity, trust,
joint venture, estate, governmental or regulatory body or authority,
judicial entity or authority or legal entity;
1.1.49 "Preferred Sequence" means the preferred sequence of Primary Steps
transferred in accordance with Section 2.2 (b) for the capture of
Proteins from the Raw Material in a successive manner;
1.1.50 "Primary Step" means any of the A1PI Primary Step, the IVIG Primary
Step, the Fibrinogen Primary Step, the APO-A-1 Primary Step, the hSA
Primary Step, the VWF/FVIII Primary Step, and "Primary Steps" means
all of them;
1.1.51 "Production Facility" means the manufacturing facility of the
Licensee located at ▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇., ▇▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇ ▇▇▇
▇▇▇;
1.1.52 "Production of Conformance Lots" means the sequential production at
Commercial Scale of three identical production lots consistently
meeting the applicable Target Protein Recovery Percentage and the
production specifications set forth in a first initial new drug
application for the contemplated Product;
1.1.53 "Production of Consistency Lots" means establishing the
reproducibility of the manufacturing process to consistently produce
materials for clinical trial requirements;
1.1.54 "Products" means all products that include, incorporate or are
derived from any Proteins or Additional Proteins manufactured by the
Licensee under the Cascade Process;
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1.1.55 "Proteins" shall mean each of the Fibrinogen, APO-A-1, VWF/FVIII,
hSA, AlPI, IVIG, in bulk active form, which can be isolated from the
Raw Material using the Cascade Process;
1.1.56 "Raw Material" means human blood plasma recovered from whole blood
donations or sourced by plasmapharesis procedures;
1.1.57 "Regulatory Body" means the FDA, the TPD, the World Health
Organization and any other agency or organization responsible in the
Territory for the regulation of medicinal products derived from human
plasma or having authority in the Territory over the testing and
marketing of pharmaceutical and biological products generally;
1.1.58 "Resellers" means Third Parties who purchase one or more Proteins,
Additional Proteins or Products for the purpose of resale;
1.1.59 "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 the Proteins and the Additional
Proteins;
1.1.60 "Royalty" has the meaning set out in Section 5.4;
1.1.61 "Secondary Processes" means 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 or Products are, or are intended to be used in humans,
whether arising by law, regulations, directives, norms, guidelines,
market practices or under any regulatory approvals;
1.1.62 "Site Master File" means the documentation required as part of the
licensing procedures (market authorization) by any Regulatory Body
having jurisdiction over such licensing, for the Proteins, the
Additional Proteins and the Products, including, without limitation,
details of the manufacturing building, location, construction,
service facilities and environment, which is kept in an independent
file;
1.1.63 "Target Protein Recovery Percentages" shall have the meaning
described in Schedule 1.1.63;
1.1.64 "Technical Working Group" means the working group established by the
technical and engineering personnel of the Licensor to implement the
Cascade Process which, as of the date hereof, includes the
individuals named on Schedule 1.1.64;
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1.1.65 "Technical Working Group Records" means all records, minutes of
meetings, correspondence and any other documentation relating to the
Technical Working Group;
1.1.66 "Term" shall have the meaning set out in Section 16.1;
1.1.67 "Terminated Party" has the meaning set out in Section 16.2;
1.1.68 "Terminating Party" has the meaning set out in Section 16.2;
1.1.69 "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;
1.1.70 "Third Party" means any Person other than the Licensor and the
Licensee and includes, for greater certainty, the ARC and any
affiliates of the Licensee or the Licensor, and "Third Parties" has a
similar meaning;
1.1.71 "Third Party Licensee" means any Third Party other than the ARC with
whom Licensor enters into a license or other type of agreement for
the use of the Cascade Process or whereby such Third Party agrees to
in-license the Cascade Process.
1.1.72 "Third Party Claim" has the meaning set out in Section 11.3;
1.1.73 "TPD" means the Therapeutic Products Directorate, Health Canada;
1.1.74 "Trademarks" means any trademarks or service marks relating to the
Cascade Process owned by Licensor or which the Licensor has a right
to use in the Territory and to license to Hemosol in the manner
contemplated hereunder. ;
1.1.75 "VWF" means Von Willebrand Factor derived from Raw Material; and
1.1.76 "VWF/FVIII Primary Steps" means the use of a Resin for the capture of
a combination of VWF and FVIII from Raw Material.
ARTICLE 2
GRANT OF LICENSE AND IMPLEMENTATION
-----------------------------------
2.1 Grant
-----
(a) Subject to the terms and conditions set forth in this
Agreement, the Licensor hereby grants to the Licensee the
exclusive right to use the Cascade Process, or part
thereof to manufacture in the Production Facility and any
Additional Production Facilities in the Territory, and
distribute and sell in the Territory, the Proteins,
Additional Proteins and Products. For greater certainty,
and without limiting the generality of the foregoing, the
right to use the Cascade Process also includes the
exclusive right to use a limited number of Primary Steps,
or an alternative sequence.
8
(b) In the event Improvements or Additional Primary Steps are
in-licensed or acquired by the Licensor from a Third Party
(other than an affiliate, or the ARC) during the term of
this Agreement for use in connection with the Cascade
Process in the Territory, then such right shall
automatically be subject to the rights granted under
Section 2.1 (a), but on a non-exclusive basis only and
shall be subject to the terms and conditions set forth
hereunder and those of any agreement with the Third Party;
and
(c) Notwithstanding Subsection 2.1(a) and (b) above, with
respect to Improvements and Additional Primary Steps
in-licensed or acquired from a Third Party (other an
affiliate or the ARC), Licensor shall not be obligated to
grant any right therein to the Licensee if the grant
implies or operation of such grant of rights would require
that the Licensor makes any payments to such Third Party
except such payments as the Licensee shall agree to
reimburse to the Licensor.
2.2 Implementation of the Cascade Process
-------------------------------------
(a) Beginning no later than seven days following the date of
this Agreement and at all time during which this Agreement
is in effect, representatives of the Licensee designated
by it shall join the Technical Working Group to form an
expanded Technical Working Group.
(b) Upon signature of this Agreement, Licensor shall remit to
Licensee the list of document mentioned in Schedule 2.2
(b) and within fifteen days following the date of this
Agreement and promptly thereafter upon the Licensor
obtaining possession or knowledge of, or access to, same,
the Licensor shall provide to the Licensee all other
Cascade Process Documentation in its possession or
knowledge, or to which it has access, in order for the
Licensee to use the Cascade Process and achieve the Target
Protein Recovery Percentage for each Protein.
(c) Within fifteen days following the date of this Agreement,
the expanded Technical Working Group shall meet to
allocate specific responsibilities among the individuals
composing the expanded Technical Working Group with
respect to consultation, development work, coordinated
planning and modifications to the Production Facility
required to implement the Cascade Process.
(d) The expanded Technical Working Group shall meet on a
regular basis to review interim progress made by the
parties and discuss the implementation of the Cascade
Process.
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ARTICLE 3
LICENSES IN THE TERRITORY AND DISTRIBUTORS
------------------------------------------
3.1 Licenses in the Territory
-------------------------
(a) Licensee hereby agrees that the rights granted hereunder
shall become non-exclusive upon the earlier of (i) the
achievement of the First IND for Clinical Trial Supply;
(ii) April 1st, 2007; (iii) such earlier date as agreed
upon in writing by the parties or (iv) at any time if a
milestone payment is due under Section 5.1 hereof but not
paid to ProMetic in accordance with such Section.
Exceptions: 1) In the event on or before the First IND for
Clinical Trial Supply, Licensee and Licensor have agreed
in writing on mutually agreeable performance thresholds
sufficient to maintain exclusivity in the whole Territory,
such as but not limited to proper market penetration in
the Territory, expansion of the Production Facility or
setting up of Additional Production Facilities to enable
such market penetration, and minimum royalty payments per
year, the exclusivity granted under Section 2.1 in the
whole Territory shall remain and any out-licensing
activities shall then require the consent of each party as
with regard to applicable terms and conditions of any
license to a Third Party Licensee and shall take into
account the provisions of this Section 3.1. 2) Regardless,
for so long as the Licensee meets its obligation as set
forth in sections 5.1 and 5.2, the exclusivity of the
right granted hereunder for any jurisdiction within
Canada, shall always remain.
Upon the occurrence of any event set forth above that
triggers the non-exclusivity status of the right granted
hereunder, Licensor shall have the right to license-out
the Cascade Process to a Third Party. However, when
discussing a potential out-licensing of the Cascade
Process to a Third Party, the Licensor agrees to inform
Licensee in writing of such business opportunity, to work
closely with the Licensee and get its input and opinion
from time to time as to key elements of the proposed
license such as the choice of the proposed Third Party
Licensee, proposed market to be addressed by such
licensee, and to address with Licensee potential
collaboration and assistance that could emerge from the
contemplated license agreement, including technology
transfer programs, collaboration to expand and/or
facilitate market penetration in the Territory, and such
issues that are reasonably deemed by Licensee to affect
the financial aspects of its operations under the Cascade
Process. Licensee's input and opinion will not be
unreasonably withheld.
(b) In the event Licensor enters into an agreement with a
Third Party Licensee with respect to the Cascade Process,
and at the time of such agreement, the following
conditions are met: (1) Licensee has developed one or more
Secondary Processes, alone or in collaboration with the
Licensor under a mutually agreeable development program,
(2) such Secondary Processes are reduced in writing under
such forms or instructions to enable the Third ▇▇▇▇▇
Licensee to use and reproduce them ("Secondary Process
Documentation") and are ready to pass on to the Production
of Consistency Lots, (3) if such developed Secondary
Processes are transferred to the Third Party Licensee,
10
they are provided with Licensee's Development, related
Secondary Process Documentation and reasonable technical
support, and (4) the Licensee is in compliance in all
material respects with its obligations hereunder (provided
that this condition shall not apply if the Licensor is not
in compliance in all material respects with its
obligations hereunder and such non compliance of the
Licensor has caused such default on the part of the
Licensee) and has paid, subject to subparagraph (v) below,
all of the milestones payments set forth in Section 5.1
(a) to (e) hereunder, then the Licensor agrees with the
following:
(i) It will pay to the Licensee 50% of the
Licensing Revenues as and when collected by
Licensor if at the time of the agreement with
the Third Party Licensee, three or more
Secondary Processes are developed by Licensee
in the manner set forth above, alone or in
collaboration with the Licensor;
(ii) It will pay to the Licensee 33% of the
Licensing Revenues as and when collected by
Licensor if at the time of the agreement with
the Third Party Licensee, two Secondary
Processes are developed by Licensee in the
manner set forth above, alone or in
collaboration with the Licensor;
(iii) It will pay to the Licensee 16.5% of the
Licensing Revenues as and when collected by
Licensor if at the time of the agreement with
the Third Party Licensee, one Secondary Process
is developed by Licensee in the manner set
forth above, alone or in collaboration with the
Licensor;
(iv) In the event the Licensee has incurred some
Costs in relation to the out-licensing
activities contemplated in this subparagraph
(b), Licensee agrees to send to Licensor an
invoice with reasonable documentation for such
Costs, and Licensor's Costs shall be reduced by
the amount of such Licensee's Costs in the
computation of Licensing Revenues;
(v) With regard to item (4) of subsection 3.1 (b)
above, in the event a Third Party Licensee is
appointed before such milestones payments set
forth in Section 5.1 (a) to (e) have been paid
by Licensee, Licensee shall have the option, in
order to receive its share of Licensing
Revenues as described above, to pay such
milestones payments in full to the Licensor or
request in writing that the Licensor (a) retain
an amount equal to such milestone payments from
the share of the Licensing Revenues payable by
the Licensor to the Licensee if three Secondary
Processes have been developed; (b) retain an
11
amount equal to 50% of such milestone payments
from the share of the Licensing Revenues
payable by the Licensor to the Licensee if two
Secondary Processes have been developed and pay
the remaining portion to Licensor or (c) retain
an amount equal to 25% of such milestone
payments from the share of the Licensing
Revenues payable by the Licensor to the
Licensee if one Secondary Process has been
developed and pay the remaining portion to
Licensor. In the event such offsetting
mechanism has been all exhausted, but Licensee
has still not achieved all of its milestones
upon such event, then its right to share in the
Licensing Revenues shall be suspended until
such time those milestones events have been
achieved.; and
(vi) In the event the Secondary Processes
transferred to the Third Party Licensor are not
those developed by Licensee (whether alone or
in collaboration with the Licensor), Licensor
shall have the right to recoup any development
fees incurred to develop such Secondary
Processes effectively transferred to the Third
Party Licensee, from the Licensing Revenues
before apportioning such Licensing Revenues in
the manner set forth above.
(c) Nothing herein shall prevent either party, at any time,
from carrying out business development and marketing
activity in relation to the Cascade Process in the
Territory.
3.2 Distributors
------------
The Licensee may appoint one or more Third Parties as distributor of
Proteins, Additional Proteins and Products in the Territory, provided that:
(a) notwithstanding such appointment of the distributor the
Licensee shall remain responsible to the Licensor for the
timely performance of all obligations of the Licensee
hereunder;
(b) only distribution rights (and in particular no rights to
the Cascade Process) shall be provided to the distributor;
(c) the distributor shall not be provided with any
Confidential Information of the Licensor unless such
distributor will be required to be designated on, or be a
party to, a regulatory filing, approval or other similar
process as a requirement to distribute a Protein,
Additional Protein or Product and as part of such
requirement, access to such Confidential Information is
necessary, in which case, before any Confidential
Information is provided to the distributor, the Licensor's
consent, not to be unreasonably withheld, must be obtained
to the provision of the Confidential Information to the
distributor and the distributor must enter into a
confidentiality agreement in favour of the Licensee
satisfactory to the Licensor acting reasonably;
(d) the Licensee agrees to cause each distributor it appoints
to diligently promote the sale of and use all reasonable
commercial efforts to fully and diligently market the
Proteins, Additional Proteins or Products throughout the
Territory for which the distributor has been appointed a
distributor; and
12
(e) the distribution agreement shall be immediately terminable
by the Licensor at its option in the event of the
termination of this Agreement pursuant to Section 16.2
provided that (i) the Licensor shall not be entitled to
notify any distributor directly of any termination of the
distribution agreement unless the Licensee has not
notified such distributor of such termination (with a
contemporaneous copy of such notice provided to the
Licensor) within the reasonable period specified in the
Licensor's request to the Licensee to do so which shall be
in accordance with Section 16.3, and (ii) if the Licensor
does not terminate the distribution agreement as mentioned
in this paragraph 3.2(e) upon the termination of this
Agreement pursuant to Section 16.2, the distributor shall
thereafter become a direct distributor of the Licensor on
the terms and conditions set out in such distribution
agreement and the Licensor shall thereafter be subject to
the rights and obligations of the Licensee under such
distribution agreement.
3.3 Limitation
----------
Each of the Licensor and the Licensee agrees not to grant any license
or otherwise grant or transfer rights in the Cascade Process and not to appoint
any distributors of the Proteins, Additional Proteins or Products other than
pursuant to and in accordance with the provisions of this Article 3.
ARTICLE 4
IMPROVEMENTS
------------
4.1 Disclosure
----------
Each party agrees to promptly disclose to the other material
technical data and information relating to material developments with respect to
the Cascade Process, including specifically with respect to Improvements
(whether or not patentable), that it may develop or acquire during the term of
this Agreement and shall promptly provide to the other a copy of all
documentation relating to such developments.
4.2 Improvements
------------
(a) Licensee shall have the right not to implement any Improvement in
its sole discretion, provided it so informs Licensor via a written notice as set
forth herein with explanations for such rejection.
(b) The Licensor acknowledges and agrees that the Licensee possesses
skills and experience relating to the engineering, design, implementation and
operation of manufacturing facilities dedicated to the bio-manufacturing and
production of blood-related products. The Licensor and the Licensee agree that
the Licensee will be vested with all right, title and interest in engineering
plans, diagrams, methodologies, operational parameters and other similar
information that are authored, created or developed during the Term and are
related primarily to the engineering of the Production Facility or any
Additional Production Facility ("Licensee's Developments").
13
(c) With respect to all Licensee's Developments developed solely by
the Licensee or jointly by the Licensor and the Licensee (with or without the
ARC), the following terms shall apply:
(i) Licensee hereby grants the Licensor an
exclusive license in and outside the Territory
to make, have made, use, sell, distribute and
sublicense (subject to terms and conditions set
forth in Section 3.1) such Licensee's
Developments and any products derived therefrom
as and when developed, provided that such
license shall not be automatically granted if
the grant or operation of such license would
require the Licensee to make any payments to
any Third Parties except such payments as the
Licensor shall agree to make to such Third
Parties or reimburse to the Licensee, and
provided that such right shall not affect
Licensee's right to use such Licensee's
Developments in the Production Facility or any
Additional Production Facility;
(ii) upon payment of the consideration to be agreed
upon between the Licensee and the Licensor,
acting reasonably, and any relevant Third
Parties, the right, title and interest of the
Licensee in such Licensee's Developments shall
be assigned to the Licensor and, if applicable,
such Third Parties (provided that, unless
otherwise agreed upon, the rights of the
Licensee under this Agreement shall continue in
full force and effect in favour of the Licensee
with respect to such Licensee's Developments);
and
(iii) Licensee shall use its reasonable commercial
efforts to protect such Licensee's Developments
at its own expense and to reasonably enforce
the related intellectual property rights and
report from time to time to the Licensor the
progress of such efforts.
(d) Notwithstanding any of the foregoing, with respect to any
Improvement developed by Licensee or jointly by the Licensee and the Licensor
during this Agreement relating to the Cascade Process in whole or in part, such
Improvement shall become the exclusive property of Licensor. Licensee shall have
access to such Improvement in accordance with the terms and conditions of this
Agreement.
(e) Each of the parties agrees to sign and execute and cause any of
its affiliates, employees, consultants and sublicensees to sign and execute any
document reasonably required to give effect to the foregoing.
ARTICLE 5
PAYMENTS AND ROYALTIES
----------------------
5.1 License Fees
------------
The Licensee agrees to pay the following license fees to the Licensor
upon the achievement of the following milestones provided, for further
certainty, that the Licensee shall have no obligations to pay the fees for any
applicable milestones that are not achieved:
14
(a) upon the execution and delivery of this Agreement and the
documents set forth in Schedule 2.2 (b):
(i) $1,500,000; and
(ii) the issue of 1,000,000 common shares of Hemosol
Corp. to the Licensor;
(b) upon the attainment of 30 litre batch size of Raw Material
with the Cascade Process that consistently attains the
Target Protein Recovery Percentages, $4,000,000;
(c) upon issuance of the First IND for Clinical Trial Supply
for the eventual Licensure of First Product, $2,500,000;
(d) upon the completion of the Production of Conformance Lots,
$2,500,000; and
(e) upon the completion of the Licensure of First Product,
$5,000,000.
5.2 Estimated timing for completion
-------------------------------
The estimated timing for the completion of the milestones set forth
in Section 5.1 (b) to (e) are as follows: For the milestone referred to in 5.1
(b), the expected timing for completion is December 2004; For the milestone set
forth in Section 5.1 (c), the expected timing for completion is December 2005;
For the milestone referred to in Section 5.1 (d), the expected timing for
completion is December 2006; and for the milestone referred to in Section 5.1
(e), the expected timing for completion is December 2007.
The parties agree that aside for the timeline set forth in Section
5.1 (b), circumstances outside the control of the Licensee might affect the
timely performance of the milestones set forth in Section 5.1 (c) to (d) and
therefore, those expected timelines are provided for guidelines purposes only.
If any of such expected timing is missed despite Licensee's commercially
reasonable efforts to do so, Licensee shall have a reasonable opportunity within
thirty (30) days of the applicable missed expected timing to submit a reasonable
development plan for meeting such expected timing and any subsequent timing
within a reasonable period of time under the circumstances. Such new expected
timings shall also extend the due dates for all corresponding milestone payments
accordingly, both parties acting reasonably. The parties agree and acknowledge
that the milestones 5.1 (c) to (d) requires the involvement of a third party and
consequently that Hemosol will not have absolute control over their timely
performance. Hemosol however agrees to use its reasonable commercial efforts to
do whatever is under its control to achieve these estimated timing.
5.3 Share Restrictions
------------------
(a) The Licensor hereby agrees that all issuance of common shares by
Hemosol Corp. to the Licensor (including any shares issued prior to the date
hereof) shall be subject to all applicable legal and regulatory restrictions
(including any hold periods) and approvals, including without limitation the
restrictions applicable under the securities laws and other requirements in
force in the provinces of Ontario and Quebec and those maintained from time to
time by any stock exchange on which such shares are listed for trading.
15
(b) If the Licensor wishes to sell or transfer any common shares of
the Hemosol Corp. at any time and from time to time during a twelve month period
commencing on the date of the issuance of such common shares, it shall, prior to
such sale or transfer, (i) give written notice thereof to the Licensee at least
30 days but not more than 45 days prior to the proposed sale, (ii) cooperate
with the Licensee to ensure that such sale or transfer is conducted in an
orderly manner and (iii) use all reasonable commercial efforts to avoid any
material negative impact on the trading price of Hemosol Corp.'s shares as a
result of such sale or transfer.
5.4 Royalties
---------
In addition to the obligations of the Licensee under Section 5.1, the
Licensee agrees to pay the Licensor during the term of this Agreement an ongoing
royalty (the "Royalty") equal to the sum of:
(a) an amount equal to 8% of Net Sales to Resellers in the
Territory; and, without duplication,
(b) an amount equal to 5% of Net Sales to End-Users in the
Territory.
5.5 Payment Period
--------------
The Royalty shall be calculated and payable quarterly on or before
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,
to Net Sales from prior periods and (b) annual adjustments to the Royalty shall
be made following the end of each calendar year to reflect final adjustments to
Net Sales 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.
5.6 Interest on Late Payments
-------------------------
Interest on all Royalty payments shall be charged by the Licensor 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 until payment is received.
5.7 Exchange Rate
-------------
Except as otherwise specified in this Agreement, all milestones
payments required to be made by or on behalf of the Licensee under this
Agreement, other than any payment in common shares, shall be paid in Canadian
dollars. Any royalty or other payments payable by the Licensee or the Licensor
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
16
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.
5.8 Withholding Taxes
-----------------
Any payments to be made hereunder, will be made in accordance with
applicable legal requirements, including applicable withholding tax provisions.
Both parties agree to collaborate to apply for or otherwise take advantage of
any income tax credit, tax deduction, tax refund or similar benefit in respect
of any payment made or to be made by any party to the other hereunder.
ARTICLE 6
LICENSOR'S OBLIGATIONS
----------------------
6.1 Supply Personnel and Technical Assistance
-----------------------------------------
From time to time, the Licensee may request the Licensor to furnish
technical assistance through making available to the Licensee, at the Production
Facility or any Additional Production Facility, such number of the Licensor's
technical personnel as the Licensee may reasonably request for the
implementation of the Cascade Process and, to the extent known by the Licensor,
the Secondary Processes, and the Licensor shall use its commercially reasonable
efforts to accommodate such request. The Licensor shall be responsible for the
travel, living and related expenses of its personnel during their visits to or
stationing at the Production Facility or any Additional Facility. The Licensor's
employees shall, while so visiting or stationed at the Production Facility or
any Additional Production Facility, remain employees, and subject to the
supervision and control, of the Licensor and shall not be or be deemed to become
employees of the Licensee.
6.2 Assistance regarding Production Facility
----------------------------------------
The Licensor shall provide commercially reasonable support and
assistance to the Licensee (i.e. knowledge, making staff available to Licensee
if requested by Licensee and helping in compiling data) for the purposes of
obtaining validation and licensing of the Production Facility and any Additional
Production Facilities by the FDA, the TPD and any other applicable Regulatory
Body in the Territory and, to the extent the Licensee is involved in any
countries outside of the Territory, such other countries where the Licensee
intends to sell or distribute Proteins, Additional Proteins and Products, which
support and assistance shall include, without limitation, the Licensor
providing, to the extent reasonably required, the Cascade Process Documentation
to each relevant Regulatory Body.
17
6.3 Ownership of Cascade Process
----------------------------
The Licensor shall ensure that all present and future right, title
and interest of (i) affiliates of the Licensor or (ii) any other Person
inventing or developing any of the same for, in collaboration with or on behalf
of the Licensor, in the Cascade Process are owned or under control of the
Licensor (alone or jointly with the ARC) and are licensed to the Licensee in
accordance with this Agreement.
6.4 Approvals and Business Conduct
------------------------------
The Licensor shall procure and maintain all approvals, licenses,
permissions, permits and other rights necessary to the performance of its
obligations under this Agreement, including without limitation, the grants with
respect to the Cascade Process to the Licensee hereunder and shall conduct its
business in a manner so as to not bring discredit upon the reputation of the
Cascade Process, the Proteins, Additional Proteins, Products or the Licensee.
6.5 Provision of Materials and Intellectual Property
------------------------------------------------
The Licensor agrees to promptly provide to the Licensee all
documents, materials and other information relating to the Cascade Process,
Secondary Processes, Proteins, Additional Proteins and Products that are or
become in the Licensor possession or knowledge or to which the Licensor has or
obtains access from time to time and, with respect to Secondary Processes,
Proteins, Additional Proteins and Products, which Licensor -has right to
disclose to Licensee.
6.6 Supply of Resin
----------------
The Licensor shall provide to the Licensee and Licensor shall be the
exclusive supplier of all Resin requested by the Licensee for the manufacture of
the Proteins and the Additional Proteins on commercially reasonable terms and in
quantities sufficient to meet the requirements of the Licensee from time to
time. All Resin supplied by the Licensor to the Licensee shall comply with the
specifications and requirements of each Regulatory Body having jurisdiction over
the supply thereof by the Licensor or the use thereof by the Licensee and shall
be fit for use in the Cascade Process to consistently achieve the Target Protein
Recovery Percentages.
The Licensor agrees to use its commercially reasonable efforts to
implement a dual site (two appointed manufacturing sites) for the supply of
Resin to the Licensee for use with the Cascade Process, including securing the
right of such alternative manufacturing supplier to continue its operations in
the event of a bankruptcy of Licensor or its appointed manufacturing site.
6.7 Protection of Territory
-----------------------
(a) Except to the extent specifically permitted in Section 3.1, the
Licensor shall not cause, facilitate or allow any Third Party other than the
Licensee to use the Cascade Process or manufacture, sell, distribute or
otherwise commercialize any of the Proteins, Additional Proteins, Products or
Intermediates deriving from the Cascade Process or any portion thereof within
the Territory and, upon becoming aware of same, shall use its commercial
reasonable efforts to ensure that any such use, manufacture, sale, distribution
or other benefit by any such Third Party is terminated forthwith.
18
(b) Subject to the non-exclusivity provisions set forth in Section
3.1, any license or agreement with a Third Party Licensee permitting the use of
the Cascade Process or the sale or distribution of Proteins, Additional Proteins
or Products shall include provisions to the effect that:
(i) such Third Party Licensee shall not engage in
any activity nor facilitate, promote or
participate in any activity directly or
indirectly intended to, or resulting in, such
Third Party Licensee being able to sell,
distribute or market any of the Proteins,
Additional Proteins or Products in any way
anywhere inside the Territory;
(ii) such Third Party Licensee shall not enter into
any agreement or relationship with any Person
which results in a breach of the provisions
described in paragraph (i); and
(iii) all agreements between the Licensor and such
Third Party Licensee permitting such Third
Party Licensee to use the Cascade Process or
sell, distribute or otherwise commercialize or
benefit from any products derived therefrom
shall automatically terminate if such Third
Party Licensee does not comply with the
provisions described in paragraphs (i) or (ii).
ARTICLE 7
LICENSEE'S OBLIGATIONS
----------------------
7.1 Compliance with Local Laws
--------------------------
The Licensee shall comply with all laws and regulations as may apply
in the Territory in relation to the manufacture, sale and distribution of
Proteins, Additional Proteins or Products. The Licensee shall procure and
maintain all approvals, licenses, authorizations, permits and other rights
necessary to the performance of its obligations under this Agreement and conduct
its business in a manner so as to not bring discredit upon the reputation of the
Cascade Process, the Proteins, the Additional Proteins, the Products or the
Licensor.
7.2 Manufacturing Requirements
--------------------------
The Licensee shall:
(a) proceed with any modifications to the Production Facility
or any Additional Production Facility, if applicable, as
may be commercially reasonable to implement the Cascade
Process;
(b) identify equipment to be fully and exclusively dedicated
to the activities described herein and use such equipment
only in relation to the Cascade Process;
19
(c) develop and when applicable in accordance with regulatory
requirements, maintain a plasma master file (for quality
assurance, safety and traceability of Raw Material);
(d) develop and when applicable in accordance with regulatory
requirements, including those applicable to Third Party
Licensees or any clients of the Licensees or Third Party
Licensees, maintain a Site Master File for the Production
Facility and, if applicable, any Additional Production
Facility;
(e) apply for and when applicable in accordance with
regulatory requirements, including those applicable to
Third Party Licensees or any clients of the Licensees or
Third Party Licensees, maintain a cGMP equipment
certification and a cGMP plant certification for the
Cascade Process for the Production Facility and, if
applicable, any Additional Production Facility;
(f) adhere to cGMP and other obligations required by the FDA
and any other Regulatory Body for the manufacturing and
quality control of the Proteins, the Additional Proteins
and the Products;
(g) when applicable in accordance with regulatory
requirements, including those applicable to Third Party
Licensees or any clients of the Licensees or Third Party
Licensees, standardize biological methods required in the
characterization of in-process and final Proteins,
Additional Proteins and Products;
(h) act diligently to prepare any other documentation
reasonably required to apply for approval by any
Regulatory Body of the Proteins, the Additional Proteins,
the Products, or the Production Facility (as a
manufacturing plant for any of the foregoing);
(i) insert in any agreement with End-Users or Resellers,
including the ARC, (hereinafter collectively referred to
as "Client") the following obligation for the Licensee or
any such similar obligation as deemed acceptable by
Licensor: Develop and comply with a quality assurance
program acceptable to Client, to ensure that all work
complies with all applicable laws, standards and
applicable specifications, and the terms and conditions of
this Agreement ("Quality Assurance Program"). Licensee
shall make the Quality Assurance Program and related
procedures available to Client upon reasonable request in
connection with an audit or examination. As part of the
Quality Assurance Program Licensee shall maintain records
evidencing all quality systems concerning the matters
contemplated by this Agreement and the results of their
implementation; Licensee shall review with Client any
material issues of or relating to its compliance with
applicable laws or other regulatory issues related to this
Agreement in any context (including, but not limited to,
during an audit or examination) or that are identified by,
or reportable to, the FDA or TPD. Licensee shall notify
Client in writing fifteen (15) days of all corrective or
20
preventive actions taken or that are planned to be taken
in response to any of the foregoing issues that may have a
bearing on its ability to perform its obligations under
this Agreement or otherwise comply with the terms and
conditions of this Agreement or that may impair Client's
ability to perform its own obligations. Licensee shall
provide Client with (i) correction reports related to any
field for any corrective or preventive actions, (ii)
reports related to product discards or losses, and (iii)
biologic product deviation reports;
(j) Nothing contained herein shall be interpreted as
preventing Licensee to enter into any other commercial
arrangements with a Person, but Licensee hereby agrees and
undertake not to enter into any commercial agreement or
any type of arrangement that would, compromise or cause
delay to the timely completion or the due performance of
Licensee's obligations hereunder, including, without
limitation to the foregoing, the achievement of any
milestones set forth in Section 5.1. Licensees agrees and
undertakes to commit its core manufacturing area to the
implementation and running of the Cascade Process, along
with all human resources and capital expenditures
necessary to move this project forward and meet the agreed
milestones, time being the essence. In this regard,
Licensee agrees to use its reasonable commercial efforts
to prepare its Site Master File and CMC section, and
develop and implement QC testing for the eventual
Licensure of First Product, the whole within a reasonable
timeframe allowing the timely completion of the milestone
set forth in Section 5.1 (c) the filing of a first IND
within the expected timing set forth in Section 5.2 by a
client; and
(k) Nothing in this Agreement shall create any obligation for
the Licensee to develop final formulation and proceed with
filling steps required for the sale of Proteins,
Additional Proteins or Products.
7.3 Resins and Raw Material
-----------------------
Subject to compliance by the Licensor with its obligations under
Section 6.6, the Licensee shall purchase from the Licensor all Resin to be used
in the Primary Steps and Secondary Processes. For greater certainty, the
reference to Resin in the context of Secondary Processes may include
bioseparation media not under proprietary rights of the Licensor, but commonly
available within the industry. In such a case, there is no obligation for the
Licensee to purchase such media from the Licensor. Notwithstanding the
foregoing, the Licensee shall be permitted to obtain the Raw Material to be used
in connection with the Cascade Process from any source worldwide, in its sole
discretion.
7.4 Performance Thresholds
----------------------
The Licensee shall implement production scale capacity in the
Production Facility permitting the Licensee to process not less than 500,000
litres of Raw Material per year following the achievement of the Production of
Conformance Lots.
21
ARTICLE 8
BOOKS AND RECORDS
-----------------
8.1 Non-Financial Records
---------------------
The Licensee shall keep at its principal place of business records
accurate in all material respects relating to the Cascade Process and all
products manufactured therewith, including without limitation manufacturing
records, test records and, where applicable, clinical records (including adverse
events) in accordance with Licensee's 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 in the Territory. The Licensee shall permit the
Licensor's representatives to inspect all such records at all reasonable times
on reasonable prior notice.
8.2 Financial Records
-----------------
The Licensee shall keep at its principal place of business financial
records accurate in all material respects relating to sale of the Proteins,
Additional Proteins and Products, in accordance with the Licensee's 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 in
the Territory, of the Proteins, Additional Proteins and Products manufactured by
or on behalf of the Licensee, as well as cost of sales and quantity of Proteins,
Additional Proteins and Products manufactured in the Production Facility and
each Additional Facility, in sufficient detail to enable the payments due under
this Agreement to be correctly ascertained in all material respects. The
Licensor shall keep at its principal place of business financial records
accurate in all material respects relating to the Licensing Revenues, in
accordance with the Licensee's customary practices, but in any event for a
minimum of five years from the date of their origin, in sufficient detail to
enable any payments due under section 3.1 to be correctly ascertained in all
material respects.
8.3 Quarterly Statement
-------------------
On or before the twenty-fifth day of the month following the end of
each calendar quarter, the Licensee shall supply the Licensor with a statement
of the Licensee's chief executive or chief financial officer, certifying the
quantity of the Proteins, Additional Proteins and Products manufactured, and
amount of gross sales and Net Sales related thereto, as well as the deductions
from gross sales to reach Net Sales and the Royalty payable under this Agreement
with respect to the calendar quarter just ended. Beginning on the date a Third
Party Licensee is appointed and provided that any amount is owed to Licensee
under section 3.1, the Licensor shall, on or before the twenty-fifth day of the
month following the end of each calendar quarter, supply the Licensee with a
statement of the Licensor's chief executive or chief financial officer,
certifying the amount of Licensing Revenues and the amount payable under this
Agreement with respect to the calendar quarter just ended.
22
8.4 Annual Statement
----------------
On or before April 30 of each year, the Licensee shall supply the
Licensor with a statement of the Licensee's regular auditors or in the
Licensee's discretion of the Licensee's chief financial officer, certifying the
quantity of the Proteins, Additional Proteins and Products manufactured, the
amount of gross sales and Net Sales for such items, 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 payable under this Agreement with
respect to the prior calendar year. Beginning on the date a Third Party Licensee
is appointed and provided that any amount is owed to Licensee under section 3.1,
the Licensor shall, on or before April 30 of each year, supply the Licensee with
a statement of the Licensor's regular auditors or in the Licensor's discretion
of the Licensor's chief financial officer, certifying the amount of Licensing
Revenues and the amount payable under this Agreement with respect to the prior
calendar year.
8.5 Audit Rights
------------
The Licensor shall be entitled to appoint accountants acceptable to
the Licensee acting reasonably to audit on an annual basis the records for the
sale of Proteins, Additional Proteins and Products and the Licensee 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 Licensor in the statement referred to in Section 8.4 for
the year in question, then the Licensee shall promptly pay to the Licensor the
amount owing together with interest thereon calculated from the dates the
amounts were due at the rate specified in Section 5.6 and, if such payment
exceeds $50,000, the cost of such audit. Beginning on the date a Third Party
Licensee is appointed, the Licensee shall be entitled to appoint accountants
acceptable to the Licensor acting reasonably to audit on an annual basis the
records for the Licensing Revenues and the Licensor 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
Licensee, then the Licensor shall promptly pay to the Licensee the amount owing
together with interest thereon calculated from the dates the amounts were due at
the rate specified in Section 5.6 and, if such payment exceeds $50,000, the cost
of such audit. The rights of each party under this Section 8.5 shall survive the
termination of this Agreement.
ARTICLE 9
REPRESENTATIONS AND WARRANTIES
------------------------------
9.1 By the Licensor
---------------
The Licensor hereby represents and warrants to the Licensee as
follows and acknowledges that the Licensee is relying upon such representations
and warranties in entering into this Agreement:
(a) PBL has (alone or jointly with the ARC) the exclusive
ownership of, free and clear of any encumbrances, all of
the Cascade Process and all intellectual property relating
to the Resin, and PBL has licensed to the Licensor on an
exclusive basis all of the right, title and interest of
PBL in the Cascade Process; Licensor has the sole and
exclusive right to grant the rights contemplated in this
Agreement to the Licensee and have manufactured and
supplied Resin to the Licensee as provided for in this
Agreement, and in particular does not require the consent
of the ARC to do so, and to the best of the Licensor's
knowledge, after due inquiry, no Third Party has any
license, claim or other right, interest or lien in or to
the Cascade Process or any portion thereof;
23
(b) there is no Intellectual Property relating to the Cascade
Process and its components other than the Patents and
Know-How and the Licensor has sufficient rights in and to
such Intellectual Property and all intellectual property
relating to the Resin (i) for use in connection with the
business it currently carries on (consisting primarily of
the development of Resin and isolation and purification
steps), (ii) to grant the rights granted to the Licensee
under this Agreement and (iii) to manufacture and sell
Resin to the Licensee as contemplated by this Agreement;
and such Intellectual Property is sufficient for the use
by the Licensee of the Cascade Process;
(c) to the extent that any of the Intellectual Property is
Know-How, the Licensor is in legal possession of all
information relating to such Know-How and all Persons
having knowledge or access to such Know-How, including
without limitation the ARC, have executed valid and
enforceable confidentiality agreements with the Licensor
and are under a written obligation not to disclose such
Know-How to any Third Party and not to make, use, sell or
otherwise exploit such Know-How;
(d) the Licensor has in place sufficient security measures,
policies, procedures and agreements to maintain any and
all Know-How confidential and within the exclusive
ownership and control of the Licensor;
(e) all registrations of any rights in any Intellectual
Property are in good standing to preserve the rights
thereto and, to the knowledge of the Licensor, all such
registrations have been filed, prosecuted and obtained in
accordance with all applicable legal requirements and are
currently in effect and in compliance with all applicable
legal requirements;
(f) to the Licensor's knowledge, all of the Patents are valid
and enforceable. Neither the Licensor nor, to the
knowledge of the Licensor, the ARC has received any
professional opinion, whether preliminary in nature or
qualified in any other manner, which concludes that a
challenge to the validity or enforceability of any Patent
may succeed;
(g) to the Licensor's knowledge, the Intellectual Property in
respect of which the Patents have been issued or, where
patent applications have not yet been filed, with respect
to the Intellectual Property relating to such patent
applications, is novel and not obvious within the meaning
of the applicable patent legislation at the relevant time
under such legislation, and, to the Licensor's knowledge,
there is no prior art of which the Licensor is aware that
was not disclosed during the application for or
prosecution of any such Patent and which, if such prior
art had been disclosed, may have affected the scope of the
patent claims ultimately granted in respect thereof;
24
(h) neither Licensor nor its affiliates has received any
communication alleging that the Licensor or any of its
affiliates has violated, and has no knowledge that the
Licensor or any of its affiliates has violated, the
intellectual property rights of any Person;
(i) the Licensor (i) is a corporation duly organized, validly
existing, and in good standing under the laws of its
jurisdiction of incorporation with its respective
principal place of business located in Montreal, Canada ,
and (ii) 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;
(j) the execution, delivery and performance of this Agreement
by the Licensor and all documents to be delivered by the
Licensor hereunder: (i) are within the corporate power of
the Licensor; (ii) have been duly authorized by all
necessary or proper corporate action; (iii) are not in
contravention of any provision of the certificate of
incorporation or by-laws of the Licensor; (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 the Licensor is a party or
by which the Licensor 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;
(k) this Agreement has been duly executed and delivered by the
Licensor and constitutes a legal, valid and binding
obligation of the Licensor, enforceable against the
Licensor in accordance with its terms; and
(l) the employees, consultants, advisors, contractors, and
other Persons associated with the performance of this
Agreement by the Licensor 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 the Cascade
Process developed or invented by them in the course of
their functions with the Licensor have been and will, if
developed after the date of this Agreement, be assigned to
the Licensor.
9.2 By the Licensee
---------------
The Licensee represents and warrants to the Licensor as follows and
acknowledges that the Licensor is relying upon such representations and
warranties in entering into this Agreement:
(a) the Licensee has the right and the ability to use the
Production Facility and any Additional Production
Facility, as and when used by the Licensee, in order to
manufacture the Proteins, Additional Proteins and Products
upon receipt of all required regulatory approvals
therefor;
25
(b) the Licensee has the ability, expertise, infrastructure
and assets (Production Facility and equipments therein) to
perform its implementation and manufacturing obligations
hereunder and except as set forth in Schedule 9.2 (b) such
infrastructure, equipments and other assets are free from
any liens or encumbrances; Such list is provided as of the
date hereof. Any future material liens or encumbrances
will be disclosed in a separate schedule as and when
applicable.
(c) the Licensee has, or will have when such obligations are
to be performed, the ability and resources to distribute
and market the Proteins, Additional Proteins and Products
in accordance with its obligations under this Agreement in
each of the Territory where, when and if applicable, a
final regulatory approval from the Regulatory Body is
obtained;
(d) the Licensee (i) is a corporation duly organized, validly
existing, and in good standing under the laws of the
Province of Ontario with its respective principal place of
business located at the Production Facility; and (ii) 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;
(e) the execution, delivery and performance of this Agreement
by the Licensee and all documents to be delivered by the
Licensee hereunder: (i) are within the corporate power of
the Licensee; (ii) have been duly authorized by all
necessary corporate action; (iii) are not in contravention
of any provision of the certificate of incorporation or
by-laws of the Licensee, and (iv) based on the
representations and warranties of the Licensor hereunder,
do not violate any law or regulation or any order or
decree of any court or governmental instrumentality, do
not violate the terms of any indenture, mortgage, deed of
trust, lease, agreement, instrument or any other
commercial agreement to which the Licensee is a party or
by which the Licensee or any of its property is bound, and
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;
(f) this Agreement has been duly executed and delivered by the
Licensee and constitutes a legal, valid and binding
obligation of the Licensee, enforceable against the
Licensee in accordance with its terms; and
(g) the Licensee's employees, consultants, advisors,
contractors and other Persons associated with the
performance of this Agreement by the Licensee have
executed agreements whereby all right, title and interest
of such employees, consultants, advisors, contractors and
other Persons in any technology and inventions to the
Cascade Process developed or invented by them in the
course of their functions with the Licensee have been and,
if developed after the date hereof, will be assigned to
the Licensee.
26
9.3 No Other Representations or Warranties
--------------------------------------
Except as otherwise expressly set forth in this Article 9, neither
the Licensor nor the Licensee makes any representations and extends any
conditions or warranties of any kind, either express or implied, in relation to
itself.
9.4 Survival of Representation and Warranties
-----------------------------------------
The representations and warranties of the parties in this Article 9
shall be deemed to be repeated on each day during which this Agreement is in
effect and shall survive the termination of this Agreement.
ARTICLE 10
PATENTS AND TRADEMARKS
----------------------
10.1 Watch Service
-------------
The Licensor shall maintain, in a reasonable manner, a watch service
to detect patents, patent applications, trademarks and other Intellectual
Property relating to the Cascade Process in the Territory and particularly those
that conflict with or relate to the Patents, Trademarks or Know-How and shall
promptly report any potential or actual conflicts or relationships with the
Patents, Trademarks or Know-How to the Licensee.
10.2 Infringement of Patents or Trademarks
-------------------------------------
If the Licensee or the Licensor becomes aware of any infringement of
any Patent or other Intellectual Property right relating to the Cascade Process
in the Territory, the Licensee or the Licensor, as the case may be, shall
promptly notify the other party thereof. If requested by the Licensee to do so,
the Licensor 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
Licensor, the Licensee shall agree to be joined or to join as a party in such
suit. If the Licensee elects to do so, the Licensee may be represented in such
proceedings by its own counsel at its own expense. In every case of reported
infringement or passing off, the Licensor 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 Licensor 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 Licensee shall have the
right during the term of this Agreement to ▇▇▇ in its own name or, with the
approval of the Licensor or if necessary to the suit, jointly with the Licensor,
for present and past infringement or passing off. The Licensor shall be kept
informed at all times of all such proceedings taken by the Licensee. If the
Licensor elects to do so, the Licensor may be represented in such proceedings by
its own counsel at its own expense. The party bringing the action shall bear all
27
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 as a result of
the infringing or passing off conduct, 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 party having carriage of the
action shall be responsible for paying any costs which may be awarded to the
successful defendant.
10.3 Description as Authorized Licensee
----------------------------------
During the term of this Agreement, the Licensee shall, where required
by law, refer, describe and advertise itself only as a licensee of the Cascade
Process, provided that the Licensee is not obligated to describe, refer to and
advertise itself as a licensee of the Licensor for the manufacture and sale of
the Proteins, Additional Proteins and Products in the Territory.
ARTICLE 11
INDEMNIFICATION
---------------
11.1 General Indemnification
-----------------------
(a) By the Licensor: The Licensor hereby agrees to indemnify and hold
harmless the Licensee and its directors, officers, employees, affiliates 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 manufacture,
use, handling, storage, sale or other
disposition or shipment by the Licensor of any
Resin or any use by the Licensee of the
Intellectual Property provided by the Licensor,
except if Licensee has misused such Resin or
Intellectual Property or where such use has
been made in contravention of this Agreement or
any other written agreement between the
parties; or
(ii) any misrepresentation made by the Licensor
herein, or any breach by the Licensor of or
failure by the Licensor to perform its
obligations under, this Agreement;
provided, however, that the Licensor's obligations to indemnify the Licensee and
hold it harmless shall not include any loss or liability against which the
Licensee is obligated to indemnify and hold the Licensor harmless hereunder.
(b) By the Licensee: The Licensee hereby agrees to indemnify and hold
harmless the Licensor and its directors, officers, employees and affiliates from
and against all 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 manufacture,
use, handling, storage, sale or other
disposition or shipment of Proteins, Additional
Proteins and Products by the Licensee; or
28
(ii) any misrepresentation made by the Licensee
herein, or any breach by the Licensee of or
failure by the Licensee to perform its
obligations under, this Agreement;
provided, however, that the Licensee's obligations to indemnify the Licensor and
hold it harmless shall not include any Losses against which the Licensor is
obligated to indemnify and hold the Licensee harmless hereunder.
11.2 Patent Indemnity
----------------
The Licensor hereby agrees to indemnify and hold harmless the
Licensee and its directors, officers, employees, affiliates and distributors
from and against all Losses (which shall include for the purposes of this
Section 11.2 any running or other royalties or other payments, however
characterized, paid under any agreement or arrangement entered into by the
Licensee in accordance with Section 11.6 subject to Licensor's consent, 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") related to the use of the
Cascade Process as permitted herein.
11.3 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 11 except where, and
solely to the extent that, such failure actually prejudices the rights of such
Indemnifying Party.
11.4 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
the Indemnified Party as the Indemnifying Party may reasonably request. If both
29
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.
11.5 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.
11.6 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).
30
11.7 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.
11.8 Insurance
---------
The Licensor and the Licensee shall each maintain insurance against
such risks as may relate to or arise from the transactions contemplated by this
Agreement (including but not limited to fire and extended risk insurance on
their respective production facilities and insurance against product liability),
subject to availability and affordability, including for the Licensee:
(a) a commercial general liability policy including broad form
contractual liability coverage in an amount not less than
US $10,000,000 for each occurrence and US $20,000,000
annual aggregate;
(b) professional liability insurance in an amount not less
than US $10,000,000 per occurrence and US $20,000,000
annual aggregate specifically insuring claims arising from
the manufacturing of Proteins, Additional Proteins and
Products, including but not limited to coverage for all
expenses, attorneys' fees, and costs incurred in the
investigation, negotiation, arbitration, and defense of
any suit or claim for damages;
(c) products and completed operations liability coverage
applicable to the manufacture of any Proteins, Additional
Proteins and Products in an amount not less than US
$25,000,000 for each claim and $50,000,000 annual
aggregate; and
(d) clinical trials liability as and when applicable in an
amount not less than US $5,000,000 each claim and
$10,000,000 annual aggregate insuring claims arising from
the performance of clinical trials related to the
Proteins, Additional Proteins and Products which shall be
maintained from the earlier of the commencement of
clinical trials or the enrolment of the first participant
in clinical trials.
For purposes of this Section 11.8, product liability insurance shall
be "affordable" if it is available at premium costs comparable to the premiums
for insurance against similar risks generally insured by prudent
biopharmaceutical companies. Maintenance of such insurance and the performance
by a party of its obligations under this Section 11.8 shall not relieve the
party of liability under its indemnity obligations set out in this Agreement.
31
11.9 Survival
--------
This Article 11 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 11 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 11 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 11 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.
ARTICLE 12
PATENT AND PATENT APPLICATION FILINGS,
--------------------------------------
PROSECUTION, REGISTRATION AND MAINTENANCE
-----------------------------------------
12.1 Prosecution of Registration
---------------------------
Throughout the term of this Agreement the Licensor shall prepare,
file and prosecute the Patents in the Territory and use its reasonable
commercial efforts to prepare, file and prosecute in the Territory any patent
applications with respect to the Cascade Process. The Licensor shall also use
its reasonable commercial efforts to prepare, file and prosecute in the
Territory any new trademarks relating to the Cascade Process. Such preparation,
filing and prosecution shall in all cases be at the cost and. expense of the
Licensor. The Licensee and Licensor shall be kept fully informed of such
preparations, filings and prosecutions, and, upon request of a party, the other
party will provide reasonable assistance with respect thereto, at its own
expense. The Licensor shall be responsible for the payment of maintenance fees
on all Patents and patent applications, and patents granted with respect to such
patent applications, and on all Trademarks and new trademarks relating to the
Cascade Process.
12.2 Abandonment of Patents
----------------------
If either the Licensor or the Licensee intends to dispose of or
abandon any Patent, right in a Patent, patent application, patent or the right
to file for a foreign patent (the "Patent Interest") which would be covered by
this Agreement, it shall notify the other party of such intention and, to the
extent practicable, give such other party sufficient notice to permit it to take
all steps necessary to preserve such Patent Interest. Such notified party shall
then have the right during the 60 day period commencing with such notification
to assume any such Patent Interest which the notifying party intends to dispose
of or abandon and to undertake the procuring or preserving of such Patent
Interest to itself. The notifying party will co-operate with the other party in
such endeavour (including making an assignment of its full right, title and
interest in the Patent Interest) provided that such other notified party shall
bear all the costs (including any tax liability) in connection therewith.
32
12.3 Assistance to Prosecution
-------------------------
Subject to Section 12.1 hereof, each of the Licensee and the Licensor
shall render all reasonable assistance if so requested by the other in the
prosecution of any present or future patent applications in the Territory. Each
party also shall render all reasonable assistance, if so requested by the other
party, in connection with and in support of any application for the extension of
the terms of any patent, free of charge. Any reasonable costs and expenses
incurred by the Licensee in providing any assistance requested by the Licensor
pursuant to this Section 12.3 shall be reimbursed by the Licensor forthwith upon
request thereof by the Licensee.
12.4 Transfer to Licensor
--------------------
Should the laws or regulations of any country in the Territory vest
the Licensee with any property rights to any of the Trademarks or Patents, or to
any new patents, patent applications or trademarks, the Licensee shall promptly,
freely and co-operatively relinquish to the Licensor (or, if relinquishment is
not possible, grant for the life of such Trademarks or Patents an exclusive
royalty-free license to the Licensor, of) any and all such rights upon
termination of this Agreement for any reason, without recourse or cost to the
Licensor, and shall thereafter refrain from any further usage of the said
trademarks or patents. This obligation shall survive the termination of this
Agreement.
ARTICLE 13
COMPLAINTS AND CORRECTIVE ACTIONS
---------------------------------
13.1 Complaints
----------
Each party shall maintain a record of all complaints it receives with
respect to the Cascade Process, Proteins, Additional Proteins and Products. Each
party shall notify the other of any material complaint received by it in
sufficient detail and within ten days after the receipt thereof.
13.2 Certain Corrective Actions
--------------------------
In the event that any Regulatory Body having jurisdiction in the
Territory shall order any change or corrective action, including a recall, with
respect to any of the Proteins, Additional Proteins or Products then being
manufactured, sold or distributed by the Licensee or if, notwithstanding that
any such change or corrective action shall not have been ordered, the Licensee
acting reasonably and in good faith believes, based on appropriate expert
evidence or advice, that absent such change or corrective action it will be in
violation of a rule of law or other regulatory requirement in any of the
Territory applicable to it as the manufacturer or distributor of any of the
Proteins, Additional Proteins and Products, then the Licensee, as the
responsible product manufacturer with respect to such Proteins, Additional
Proteins and Products in the applicable Territory, shall have sole authority to
determine the nature and extent of its compliance with such order or any action,
including a recall, to be taken notwithstanding the absence of any such order,
as the case may be, provided that any such order relating to the safety or
integrity of the Proteins, Additional Proteins and Products shall be resolved to
33
the satisfaction of the regulatory authority issuing such order. Without
limiting the generality of the foregoing, before responding to any such order or
taking any such action, the Licensee shall consult with the Licensor with
respect to any such order, its compliance therewith, or any action to be taken
with respect to such order, and the Licensee shall advise the Licensor as
promptly as practicable of the issuance of any such order against it and of the
steps being taken to resolve the matter or the taking of such action. Should the
Licensor reasonably consider that the Licensee's actions taken with respect to
any order received from the Regulatory Body is not appropriate and does not
adequately protect the reputation of the Cascade Process or the Licensor, or the
effectiveness or quality of the Cascade Process, the Licensor may take an active
role in responding to such order or in the corrective order to be taken, the
whole at its own cost. The parties agree to collaborate in good faith to find an
acceptable corrective action or appropriate response should the Licensor take
such an active role.
ARTICLE 14
CONFIDENTIALITY
---------------
14.1 Maintenance of Confidentiality
------------------------------
Each of the Licensor and the Licensee 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 TPD, to the FDA 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;
(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
34
unauthorized use, reproduction, disclosure or other dissemination thereof. Prior
to disclosing any Confidential Information of a party hereto, 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 14 by its directors, officers, employees and
authorized agents.
14.2 Exceptions
----------
The provisions of Section 14.1 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 hereto 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, the Licensor or the Licensee
(as applicable) shall after receiving knowledge thereof promptly notify the
other party of the occurrence of such event.
14.3 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 (a) 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
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 14.3, 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 14.3
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.
35
14.4 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.
14.5 Injunction
----------
Each party acknowledges that any violation by it of its obligations
under this Article 14 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 14 by the other party.
ARTICLE 15
FORCE MAJEURE
-------------
15.1 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
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;
36
(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 16
TERM AND EARLY TERMINATION
--------------------------
16.1 Term
----
Subject to the provisions of this Article 16, this Agreement shall
remain in full force and effect for a term (the "Term") expiring on the later to
occur of (i) 45 years from the date of this Agreement or (ii) the last to expire
of the Patents.
16.2 Termination Events
------------------
This Agreement may be unilaterally terminated without penalty by the
Licensee or the Licensor (in each case a "Terminating Party") in the manner set
forth in Section 16.3 if there is the occurrence of any of the circumstances or
events described below with respect to (i) if the Terminating Party is the
Licensee, the Licensor, and (ii) if the Terminating Party is the Licensor, the
Licensee (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 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 the
Licensee, or if a distress or execution or any similar
process is levied or enforced against the Licensee which
affects such properties and assets and remains unsatisfied
for 90 days;
(b) any order to cease or suspend trading in any securities of
the Licensee, or prohibiting or restricting the
distribution of any of the Licensee's shares is made by
any securities regulatory authority, including the TSX,
NASDAQ or any other competent authority in any
jurisdiction where the Licensee's is a reporting issuer
(or the equivalent thereof) provided that: (i) the
delisting of the securities of the Licensee from the
NASDAQ national or small capital markets shall not
constitute a ground of termination under this Section 16.2
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 the Licensee's 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) the Terminating Party has served a
notice of termination to the Licensee in accordance with
Section 16.3 within 90 days of the issuance of such order
and while such order was in effect;
37
(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 under Article 15;
(d) in the event that, the performance thresholds set forth in
Section 7.4 are not met by the Licensee, unless such non
performance is caused by a default of the Licensor
hereunder and Licensor has been notified of such default
and has not cured the same in accordance with the terms
and conditions set forth hereunder;
(e) 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 the Licensee, the Production Facility) and,
with respect to the Licensor , the Cascade Process or the
intellectual property related to the production of Resin);
or
(f) in any other circumstances not covered by subsections (a)
to (e) of this Section 16.2, if, while the Terminating
Party is in compliance in all material respects with its
obligations under this Agreement, the Terminated Party
defaults in any material respect in the performance of its
obligations under this Agreement and fails to cure that
default within 30 days following written notice thereof
from the Terminating Party.
16.3 Notice of Termination
---------------------
A Terminating Party seeking to terminate this agreement in accordance
with this Article 16 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.
38
ARTICLE 17
RIGHTS AND OBLIGATIONS UPON TERMINATION
---------------------------------------
17.1 Generally
---------
If this Agreement is terminated pursuant to Article 16, then except
as provided in the remaining provisions of this Article 17, or as required by
those provisions of this Agreement specified in Section 17.3 which shall survive
any such termination:
(a) this Agreement shall terminate provided the Licensee shall
be permitted to (i) sell and distribute all Proteins,
Additional Proteins and Products manufactured prior to the
termination, provided that such sales are subject to the
payment of the Royalty as set out in this Agreement and
(ii) to return to Licensor or any Third Party designated
by Licensor, the Resin in accordance with the agreed terms
and conditions of any supply arrangement entered into
between the parties with respect with Resin requirements;
(b) except to the extent necessary to exercise its rights
under subsection 17.1(a), the Licensee shall turn over to
the Licensor all sales inquiries and unfilled orders, and
the parties shall negotiate in good faith the amount of
compensation, if any, which the Licensee may receive
therefor and, if the parties are unable to agree thereon
either party may submit the determination of the amount of
compensation to dispute resolution pursuant to Article 19
of this Agreement;
(c) if the Licensee is the Terminated Party, the parties shall
use commercially reasonable efforts to negotiate in good
faith with respect to the assumption by the Licensor, or a
Person designated by it, of the Licensee's obligations
under any agreements obligating the Licensee to supply
Proteins, Additional Proteins and Products or to purchase
Raw Material;
(d) each party shall make any payments then due hereunder to
the other party that accrued prior to the effective date
of termination, and except as provided in this Agreement
with respect to amounts due hereunder from either party to
the other, no further payments or other amounts shall be
due from the Licensee to the Licensor or the Licensor to
the Licensee;
(e) the Licensor shall refrain from using the Confidential
Information of the Licensee and the Licensee shall refrain
from using the Confidential Information of the Licensor;
(f) if the Licensor is the Terminating Party, the Licensee
shall cease using and shall deliver and relinquish to the
Licensor all of the right, title and interest of the
Licensee in the Cascade Process under this Agreement
including any and all information, master files, reports,
and other documents required for the continued supply of
Proteins, Additional Proteins and Products in the
Territory or for installation and qualification of the
Cascade Process with a Third Party (provided that Licensee
shall be entitled to payment by the Licensor of reasonable
consideration for any of such information, master files,
39
reports, and other documents), whether such information
and documentation is developed solely by Licensee,
Licensor or jointly, except to the extent that any of such
matters are required to be retained by the Licensee for
the purposes referred to subsection 17.1(a) above, in such
a case, Licensee shall have the right to keep a copy of
such documentation and information for the purpose set for
in such section 17.1 (a). Notwithstanding the foregoing,
any Licensee's Developments developed solely by the
Licensee or jointly by the Licensor and the Licensee
shall, upon payment by the Licensor to the Licensee of
reasonable consideration to be agreed upon by the parties,
acting reasonably, be transferred to the Licensor; and
(g) except as may be required by applicable law, neither party
shall disclose to any Third Party the reasons or basis of
any termination without the express written consent of the
other party and the parties shall agree on statements for
public disclosure, such consent and agreement not to be
unreasonably withheld or delayed. This provision shall
survive the termination of this Agreement.
17.2 Exceptions
----------
Notwithstanding Section 17.1:
(a) if the Licensor is entitled to terminate this Agreement
under subsection 16.2(d) or 16.2(f), the Licensor shall be
entitled, in its discretion, acting reasonably, to either
remove elements of the exclusivity of the License (in
respect of the affected specific Proteins, Additional
Proteins, Products or Territory or terminate this
Agreement;
(b) if the Licensee is entitled to terminate this Agreement
under Section 16.2 (a), (c) or (e) or upon a definitive
ruling being issued by an arbitrator confirming that the
Licensee is entitled to terminate this Agreement under
Section 16.2(f), then the ARC shall thereafter
automatically maintain and support the rights of the
Licensee in and to the Cascade Process under Section 2.1
(a) and (b) of this Agreement only, provided that the
Licensee shall make any payments as and when due to
Licensor hereunder to the ARC, that ARC shall have no
other obligations under this Agreement and that the
Licensee shall thereafter obtain Resin from any available
source; and
(c) the parties shall use their reasonable commercial efforts
and negotiate in good faith to include provisions in this
Agreement within 6 months following the signature of this
Agreement, that will, to the fullest extent that is
commercially reasonable having regard to all relevant
commercial considerations and circumstances, preserve and
facilitate the continued commercial activity of a party in
the event that the other party is unable to, or will
imminently be unable to provide materials or services that
are material to the ongoing exploitation of this Agreement
(e.g. supply of Resin in case of termination events
affecting Licensor or its appointed manufacturing site,
and continued operations at the Production Facility in
case of termination events affecting Licensee).
40
17.3 Survival of Certain Rights and Obligations
------------------------------------------
The rights and obligations of the parties under the following
provisions of this Agreement shall survive the expiry or any termination hereof:
Sections 4, 5, 8, 11, 14 and 19.1 (with respect to arbitration of any claims of
non-performance of a party's obligations under any surviving provision referred
to in this Section 17.3), and any other provision of this Agreement which states
that it survives the expiry or termination of this Agreement.
ARTICLE 18
CONFORMITY WITH LOCAL LAWS
--------------------------
18.1 Recording of Agreement
----------------------
The Licensee may at its expense take such steps as may be deemed
necessary or useful by the Licensee to satisfy the laws and requirements of the
Territory with respect to declaring, recording or otherwise rendering this
Agreement valid or perfecting or registering the rights of the Licensee
hereunder. Any such declaration or recording shall be be made in a form that has
been approved by the Licensor, acting reasonably.
ARTICLE 19
DISPUTE RESOLUTION
------------------
19.1 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 19.2, (b) for proceedings
commenced to enforce an arbitration award, and (c) for proceedings commenced for
specific performance of Article 14, 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 of the Licensor and the Licensee 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 the Licensor and if
the arbitration is requested by Licensee, 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.
19.2 Injunction
----------
Nothing set out in this Article 19 shall prevent either party from
seeking an injunction in any appropriate court.
41
ARTICLE 20
APPLICABLE LAW
--------------
20.1 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.
20.2 Scope of Authority and Relationship
-----------------------------------
The relationship between the Licensee and the Licensor 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 the Licensee nor the
Licensor 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.
20.3 Assignment; Successors and Assigns
----------------------------------
(a) Except as provided in Article 3 hereof with respect to
distributors, neither this Agreement nor any of the rights or duties of the
Licensee shall be assigned, transferred or conveyed by the Licensee, by
operation of law or otherwise, nor shall this Agreement or any rights of the
Licensee enure to the benefit of any successor to the Licensee's business or of
its property, whether by operation of law or otherwise, or to a purchaser of all
of the shares of the Licensee or to a purchaser of any part of the business or
assets of the Licensee, without the prior written consent of the Licensor,
acting reasonably;
(b) The Licensor may assign this Agreement, together with all of the
Licensor's rights in the Cascade Process and all intellectual property relating
to the Resin with the prior written consent of the Licensee, which consent shall
not be unreasonably withheld, provided however, that Licensor may assign this
Agreement, any part of its rights and obligations hereunder or Licensor's rights
in the Cascade Process and all intellectual property relating to the Resin to
any affiliate without obtaining the consent of Licensee, provided that any such
assignment shall not relieve Licensor of any of its obligations hereunder.
42
(c) Neither this Agreement nor any rights 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 a party without the prior written consent of the other party, which
such other party may grant or withhold in its sole discretion.
20.4 Extended Meanings
-----------------
Words importing the singular number include the plural and vice versa
and words importing gender include all genders.
20.5 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.
20.6 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.
20.7 Entire Agreement
----------------
This Agreement, together with the Alliance 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 Licensee and the
Licensor. In the event of any inconsistency or conflict between this Agreement
and the Alliance Agreement, the terms and conditions of this Agreement shall
prevail. 20.8 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.
20.9 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:
43
(i) if to the Licensee at:
Hemosol LP
▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇.
▇▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇ ▇▇▇
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: President
(ii) if to the Licensor at:
ProMetic Biosciences Inc.
▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇
▇▇▇ ▇▇▇
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
Attention: President with a courtesy copy to
the General Counsel and Dr. ▇▇▇▇▇ ▇▇▇▇▇▇
(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.
20.10 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.
20.11 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.
44
20.12 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.
20.13 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.
20.14 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. In the event of
any such determination, the parties agree to negotiate in good faith to modify
this Agreement to fulfil as closely as possible the original intent and purposes
hereof. 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.
20.15 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 termination of this Agreement or otherwise.
45
20.16 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 one and the same 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 "▇▇▇▇▇▇ ▇▇▇▇▇▇"
---------------------------------------
Name: ▇▇▇▇▇▇ ▇▇▇▇▇▇
Title: CEO
"▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇"
---------------------------------------
Name:
Title: VP Finance & Administration
HEMOSOL LP
by "▇▇▇ ▇▇▇▇▇▇▇▇"
---------------------------------------
Name: ▇▇▇ ▇▇▇▇▇▇▇▇
Title: President/CEO
"▇▇▇▇ ▇▇▇▇▇▇"
---------------------------------------
Name: ▇▇▇▇ ▇▇▇▇▇▇
Title: VP Operations
46
INTERVENTION BY PROMETIC BIOSCIENCES LTD.
-----------------------------------------
For good and valuable consideration (the receipt and sufficiency of
which are hereby acknowledged), ProMetic Biosciences Ltd. ("PBL") hereby
intervenes to this License Agreement to agree in favour of the Licensor (which
shall include, for the purposes of this Intervention, any assignee or successor
of the Licensor under the License Agreement) that from and after the date
hereof, at all times during which the License Agreement (which shall include,
for the purposes of this Intervention, any amendment, modification, supplement
or restatement thereof agreed upon solely between the Licensor and the Licensee)
is in effect, PBL:
(a) shall not terminate or revoke the exclusive license
granted to the Licensor in all of its rights, title and
interest in the Cascade Process in the Territory without
the prior written consent of the Licensee, which shall not
be unreasonably withheld unless such assignment is part of
a corporate reorganisation;
(b) shall not transfer, encumber, charge or otherwise grant
any rights in the Cascade Process to any Third Party
without the prior written consent of the Licensee in its
sole discretion; and
(c) agrees to promptly provide to the Licensor and Licensee
all documents, materials and other information relating to
the Cascade Process, Secondary Processes, Proteins,
Additional Proteins and Products that are or become in the
Licensor possession or knowledge or to which PBL has or
obtains access from time to time and, with respect to
Secondary Processes, Proteins, Additional Proteins and
Products, which PBL has right to disclose to Licensor or
Licensee.
In connection with this Intervention, PBL hereby represents and
warrants to the Licensee as follows and acknowledges that the Licensee is
relying upon such representations and warranties in entering into the License
Agreement with the Licensor and accepting this Intervention from PBL:
(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) all representations and warranties made by the Licensor in
Section 9.1 of the License Agreement are exact, valid and
true.
(d) 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 "▇▇▇▇▇▇ ▇▇▇▇▇▇"
------------------------------
Name: ▇▇▇▇▇▇ ▇▇▇▇▇▇
Title: President
"▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇"
------------------------------
Name: ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇
Title: VP Finance &
Administration
INTERVENTION BY PROMETIC LIFE SCIENCES INC.
-------------------------------------------
For good and valuable consideration (the receipt and sufficiency of
which are hereby acknowledged), ProMetic Life Sciences Inc. ("PLSI") hereby
intervenes to this License Agreement to agree in favour of the Licensee (which
shall include, for the purposes of this Intervention, any assignee or successor
of the Licensee under the License Agreement) that from and after the date
hereof, at all times during which the License Agreement (which shall include,
for the purposes of this Intervention, any amendment, modification, supplement
or restatement thereof agreed upon solely between the Licensor and the Licensee)
is in effect, PLSI shall:
(a) ensure that the financial condition of each of the
Licensor and PBL is such that the Licensor is in a
position to meet all of its obligations under the License
Agreement and that PBL is in a position to meet all of its
obligations under its Intervention and, to the extent
required, provide adequate financial support and resources
to each of the Licensor and PBL to enable it to meet all
of such obligations; and
(b) cause each of its affiliates, including Licensor, not to
institute any proceeding or take or omit to take any
action or execute any agreement to authorize the
participation of the Licensor or PBL in or the
commencement of any proceeding against or affecting the
Licensor or PBL, or facilitate any proceeding by a Third
Party against or affecting the Licensor or PBL, seeking
(i) to adjudicate the Licensor or PBL bankrupt or
insolvent, (ii) liquidation, dissolution, winding-up,
protection, relief or composition of the Licensor or PBL
or any of its property or debt, (iii) a proposal with
respect to the Licensor or PBL 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 Licensor or PBL) 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 the
Licensor or PBL or for any substantial part of its
properties and assets (including without limitation the
Cascade Process or the intellectual property rights
relating to Resin).
In connection with this Intervention, PLSI hereby represents and
warrants to the Licensee as follows and acknowledges that the Licensee is
relying upon such representations and warranties in entering into the License
Agreement with the Licensor and accepting this Intervention from PLSI:
(a) it owns and controls all of the outstanding shares,
warrants and other securities of each of the Licensor and
PBL, free and clear of any encumbrance, lien, security
interest, hypothec or other charge;
(b) it is a corporation duly organized, validly existing, and
in good standing under the laws of its jurisdiction of
incorporation;
(c) 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-law;
(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;
(d) 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; and
The foregoing representations and warranties shall be in effect until
such a time the Licensor is no longer a subsidiary (as defined in the Business
Corporation Act (Ontario) as presently in force, or the Licensor is cash flow
positive during three consecutive financial years. This Intervention shall be
governed by the laws of the Province of Ontario and the federal laws of Canada
applicable therein.
IN WITNESS WHEREOF PLSI has duly executed this Agreement for the
purposes of this Intervention on the date first above written.
PROMETIC LIFE SCIENCES INC.
by "▇▇▇▇▇▇ ▇▇▇▇▇▇"
------------------------------
Name: ▇▇▇▇▇▇ ▇▇▇▇▇▇
Title: President
"▇. ▇▇▇▇▇▇▇▇"
------------------------------
Name: ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Title: Secretary
INTERVENTION BY AMERICAN NATIONAL RED CROSS
-------------------------------------------
The American National Red Cross (the "ARC") hereby intervenes to this
License Agreement to agree in favour of the Licensee (which shall include, for
the purposes of this Intervention, any assignee or successor of the Licensee
under this License Agreement) that, (i) it has read this License Agreement; and
(ii) it agrees with and will abide by the terms and conditions of Subsection
17.2 (b), provided that Licensee also complies with its obligations thereunder.
Any amendment, modification, supplement or restatement of this Agreement shall
not affect the rights and obligations of the ARC under this Intervention unless
it is made in writing and signed by the ARC.
In connection with this Intervention, the ARC hereby consents to the
granting of rights in the Cascade Process by the Licensor to the Licensee under
the License Agreement and, represents and covenants in favour of the Licensee
that upon the occurrence of any event giving effect to the obligations of the
ARC under Section 17.2 (b), it will have sufficient rights to maintain and
support the rights of the Licensee under Section 2.1 (a) and (b) the License
Agreement.
This Intervention has been duly executed and delivered by the ARC and
constitutes its legal, valid and binding obligation, enforceable against it in
accordance with its terms.
The foregoing representations and covenants shall be deemed to be
repeated on each day during which the License Agreement is in effect and shall
survive the termination of the License Agreement. This Intervention shall be
governed by the laws of the State of Delaware, US.
This Intervention, along with the Intervention dated December 3, 2003
made to the Memorandum of Understanding between Hemosol Inc. and ProMetic
BioSciences Ltd constitute the entire commitment of the ARC with respect to the
subject matter hereof.
IN WITNESS WHEREOF the ARC has duly executed this Agreement for the
purposes of this Intervention on the date first above written.
AMERICAN NATIONAL RED CROSS
by
------------------------------
Name:
Title:
------------------------------
Name:
Title:
INTERVENTION BY HEMOSOL CORP
----------------------------
For good and valuable consideration (the receipt and sufficiency of
which are hereby acknowledged), Hemosol Corp. ("HCorp") hereby intervenes to
this License Agreement to agree in favour of the Licensor (which shall include,
for the purposes of this Intervention, any assignee or successor of the Licensor
under the License Agreement) that from and after the date hereof, at all times
during which the License Agreement (which shall include, for the purposes of
this Intervention, any amendment, modification, supplement or restatement
thereof agreed upon solely between the Licensor and the Licensee) is in effect,
HCorp shall:
(a) ensure that the financial condition of the Licensee is
such that the Licensee is in a position to meet all of its
obligations under the License Agreement and, to the extent
required, provide adequate financial support and resources
to the Licensee to enable it to meet all of such
obligations; and
(b) cause each of its affiliates, including the Licensee not
to, institute any proceeding or take or omit to take any
action or execute any agreement to authorize the
participation of the Licensee in or the commencement of
any proceeding against or affecting the Licensee, or
facilitate any proceeding by a Third Party against or
affecting the Licensee, seeking (i) to adjudicate the
Licensee bankrupt or insolvent, (ii) liquidation,
dissolution, winding-up, reorganization, arrangement,
protection, relief or composition of the Licensee or any
of its property or debt, (iii) a proposal with respect to
the Licensee 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 Licensee) 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 the Licensee
or for any substantial part of its properties and assets.
In connection with this Intervention, HCorp hereby represents and
warrants to the Licensor and PLSI as follows and acknowledges that the Licensor
and PLSI are relying upon such representations and warranties in entering into
the License Agreement with the Licensee and accepting this Intervention from
HCorp:
(a) it owns as general partner a 93% interest in the Licensee,
free and clear of any encumbrance, lien, security
interest, hypothec or other charge;
(b) it is a corporation duly organized, validly existing, and
in good standing under the laws of its jurisdiction of
incorporation;
(c) 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-law;
(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;
(d) 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; and
This intervention is irrevocable for as long as the License
Agreement, or any part thereof, exists, is valid or is in effect and until all
obligations of the Licensee have been fully executed and performed in accordance
with the terms of the License Agreement.
This Intervention shall be governed by the laws of the Province of
Ontario and the federal laws of Canada applicable therein.
IN WITNESS WHEREOF HCorp has duly executed this Agreement for the
purposes of this Intervention on the date first above written.
HEMOSOL CORP
by "▇▇▇ ▇▇▇▇▇▇▇▇"
-----------------------------
Name: ▇▇▇ ▇▇▇▇▇▇▇▇
Title: President/CEO
"▇▇▇▇ ▇▇▇▇▇▇"
-----------------------------
Name: ▇▇▇▇ ▇▇▇▇▇▇
Title: VP Operations
53
SCHEDULE A
VISUAL AID FOR THE CASCADE PROCESS, SECONDARY PROCESSES AND DRUG DEVELOPMENT
Note : This Schedule A is provided for illustration purposes only and shall have
no legal or binding effect between the parties.
Under License Others
Cascade Process Secondary Drug Development/Clinical
Processes Trials
[Object omitted] [Object omitted] Protein 1 Product 1
[Object omitted] [Object omitted] Protein 2 Product 2
[Object omitted] [Object omitted] Protein 3 Product 3
[Object omitted] [Object omitted] Protein 4 Product 4
[Object omitted] [Object omitted] Protein 5 Product 5
[Object omitted] [Object omitted] Protein 6 Product 6
SCHEDULE 1.1.3
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]
55
SCHEDULE 1.1.46
PATENTS AND PATENT APPLICATIONS
[attached hereto.]
Patents and Patent Applications
PA-0001-PBL Affinity Ligands (PBL with Novo Nordisk)
------------------------------------------------------------------------------------------------------------------------------------
Title Country FileDate Status
----- ------- -------- ------
Novel Affinity Ligands and Their Use Canada 1996-09-19 Pending
CA 2,232,626
Novel Affinity Ligands and Their Use PCT 1996-09-19 National Phase
PCT/DK96/00399
Triazine Based Ligands and Use Thereof United States 1998-05-01 Issued
US 6,117,996
PA-0004-PBL 3D Triazine Library (PBL)
------------------------------------------------------------------------------------------------------------------------------------
Title Country FileDate Status
----- ------- -------- ------
Multidimensional Libraries United States 2003-01-28 Lapsed
US 60/443,092
▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇-▇▇-▇▇ Filed
PCT/GB03/05368
PA-0028b-PBL API Purification (ARC-118)
------------------------------------------------------------------------------------------------------------------------------------
Title Country FileDate Status
----- ------- -------- ------
Method for Purification of United States 1998-09-24 Issued
Alpha-1 Proteinase Inhibitor US 6,093,804
▇▇-▇▇▇▇-▇▇▇ ▇▇▇▇▇▇ Proteins Ligands (ARC-191)
------------------------------------------------------------------------------------------------------------------------------------
Title Country FileDate Status
----- ------- -------- ------
Plasma Protein-Binding Ligands PCT 2003-04-14 Published
▇▇▇/▇▇▇▇/▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇▇▇-▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇ 2003-04-14 Filed
US 10/414,524
PA-0047-PBL Preferred Sequence(s) (PBL with ARC)
------------------------------------------------------------------------------------------------------------------------------------
Title Country FileDate Status
----- ------- -------- ------
Definitive title to be confirmed Canada In preparation
Definitive title to be confirmed PCT To be filed based on priority appl. (CA)
PA-New-PBL Other Resin for use in conjunction with Preferred Sequence(s) (PBL)
------------------------------------------------------------------------------------------------------------------------------------
Title Country FileDate Status
----- ------- -------- ------
Definitive title to be confirmed Canada In preparation
Definitive title to be confirmed PCT To be filed based on priority appl. (CA)
SCHEDULE 1.1.51
PRODUCTION RELEASE REQUIREMENTS
-------------------------------
[Intentionally omitted at time of execution]
SCHEDULE 1.1.63
TARGET PROTEIN RECOVERY PERCENTAGES
-----------------------------------
Target Protein Recovery Percentages obtained from the Raw Material using
the Cascade Process, i.e. before Secondary Processes
FVIII/vonWilberbrand Factor >40%
Apolipoprotein - %
Plasminogen >70%
Fibrinogen >70%
Albumin >80%
Immunoglobulin >80%
Alpha-1 Porteinase Inhibitor >80%
SCHEDULE 1.1.64
TECHNICAL WORKING GROUP
-----------------------
▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇ (Project Director PPPS, PBL)
Dev ▇▇▇▇▇▇ (PBL)
▇▇▇ ▇▇▇▇ (ARC)
▇▇▇ ▇▇▇▇▇ (ARC)
▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇ (consultant, PBL)
▇▇▇▇ Curling (consultant, PBL)
SCHEDULE 2.2 (b)
LIST OF DOCUMENTS PROVIDED ON THE DATE OF SIGNATURE
(attached hereto)
The list attached hereto, the documents listed and their content are
Confidential Information of Licensor, except for patents and published patent
applications which are deemed to be non-confidential of the Licensor.
The analytical SOPs listed in the attached list are draft versions and represent
early research and development phase assays. These SOPs will likely not
represent the final version of each assay used to produce clinical material, and
should be optimized and qualified for their intended use. Assay validation
should occur at Production Facility and only after the Secondary Processes
development is initiated by Licensee.
Documents provided on the date of signature of License Agreement
----------------------------------------------------------------
Patents and patent applications:
--------------------------------
1. Novel Affinity Ligands and Their Use, Canadian patent application No.
2,232,626
2. Triazine based Ligands and Use Thereof, US Patent No. 6,117,996
3. Method for the Purification of Alpha-1 Protease Inhibitor, US Patent No.
6,093,804
4. Plasma Protein-Binding Ligands, US patent application No. 10/414,524
5. Plasma Protein-Binding Ligands, PCT patent application No. PCT/US03/11798
Preferred Sequences
-------------------
6. PPPS - Cascade sequences variations
Analytical Chemistry:
---------------------
7. Summary Chart - Core Assays for Process Development
MAbsorbent(TM) A2P:
-------------------
8. Column Packing SOP
9. Technical Report on Detection of leachates (HPLC)
Mimetic Blue(TM) SA:
--------------------
10. Mimetic Blue SA P6XL -- Data Sheet and Column Packing SOP
11. SOP for Detection of leachates (ELISA)
SCHEDULE 9.2 (B)
----------------
LIENS AND ENCUMBRANCES
----------------------
(attached hereto)
SCHEDULE 9.2(b)
---------------
LIENS AND ENCUMBRANCES
----------------------
1. Easement registered on June 6, 1963 as No. TT154986 in favour of
Trans-Canada PipeLines Limited.
2. Restrictions registered on February 6, 1964 as No. TT162545Z in favour of
Her Majesty the Queen in Right of the Province of Ontario as represented by
the Minister of Highways restricting access to ▇▇▇▇▇▇▇ ▇▇. ▇▇▇ from the
lands relating to the Production Facility which appear to be perpetual.
3. Notice registered on February 12, 1973 as No. VS248789 being an amendment
of the Toronto-Malton Airport Zoning Regulations and amended further by a
notice registered on March 27, 2000 as No. LT2057426 by Her Majesty the
Queen in Right of the Department of Transport Canada which restrict the
height of buildings and structures that can be erected on the lands
relating to the Production Facility.
4. Financial Agreement registered on December 14, 1989 as No. LT1082614
between Runnymede Development Corporation Limited, The Corporation of the
City of Mississauga and The Regional Municipality of Peel, as amended by an
agreement registered on November 14, 2001 as ▇▇. ▇▇▇▇▇▇▇▇ between Hemosol
Inc., The Regional Municipality of Peel and Runnymede Development
Corporation Limited.
5. Easement registered on December 14, 1989 as No. ▇▇▇▇▇▇▇▇▇ in favour of
Mississauga Hydro-Electric Commission and ▇▇▇▇ Canada.
6. Easement registered on August 1, 1991 as No. LT1241703 in favour of The
Regional Municipality of Peel.
7. Charge registered on November 22, 2002 as No. PR 351375 in favour of The
Bank of Nova Scotia in the original principal amount of $25,000,000.
8. Charge/Mortgage of land registered on April 30, 2004 as No. PR631467 in
favour of The Bank of Nova Scotia in the original principal amount of
$25,000,000.
9. All reservations and conditions expressed in the initial grant from the
Crown.
10. The priority of any liens under the Construction Lien Act (Ontario) (the
"Act") to the extent of any deficiency in the holdbacks required to be made
under the Act or to the extent provided by Section 78(3) of the Act.
11. Any municipal by-laws or regulations affecting the Production Facility or
its use and any other municipal land use instruments including, without
limitation, official plans and zoning and building by-laws, as well as
decisions of the Committee of Adjustment or any other competent authority
permitting variances therefrom, and all applicable building codes.
12. Any and all interests (including liens, charges, adverse claims, security
interests or other encumbrances) of any nature whatsoever now or hereafter
claimed or held by Her Majesty the Queen in Right of Canada, Her Majesty
the Queen in Right of any province of Canada, or by any other governmental
department, agency or authority under or pursuant to any applicable
legislation, statute or regulation which, in each and every case, are not
registered in the Land Titles Office.
13. Any and all licences, easements, rights-of-way, rights in the nature of
easements and agreements with respect thereto including, without
limitation, agreements, easements, licences, rights-of-way and interests in
the nature of easements for sidewalks, public ways, sewers, drains,
utilities, gas, steam and water mains or electric light and power, or
telephone and telegraphic conduits, poles, wires and cables which, in each
and every case, are not registered in the Land Titles Office.
14. The exceptions and qualifications set out in Section 44(1) of the Land
Titles Act (Ontario).
15. The encumbrances and other liens evidenced by the registrations described
in the Personal Property Security Act (Ontario) enquiry response
certificates with a file currency date of May 16, 2004 against Hemosol
Inc., the Licensee, LPBP Inc. and Hemosol Corp., copies of which have been
provided by the Licensee to the Licensor.