DATED 17th May 2000
-------------------
Biorex Laboratories Limited
-and-
Glycyx Pharmaceuticals, Ltd
AGREEMENT
THE INFORMATION HEREIN MARKED BY [*] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT FILED WITH THE SEC.
CONTENTS
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PAGE
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1. DEFINITIONS............................................................................................2
2. REPRESENTATIONS AND WARRANTIES.........................................................................6
3. GRANT AND ASSIGNMENT...................................................................................7
4. SURVIVAL OF ORIGINAL AGREEMENT.........................................................................9
5. PAYMENTS TO BIOREX....................................................................................11
6. CONFIDENTIALITY.......................................................................................17
7. INDEMNITY.............................................................................................19
8. FORCE MAJEURE.........................................................................................21
9. ASSIGNMENT............................................................................................21
10. MISCELLANEOUS.........................................................................................21
SCHEDULE 1...................................................................................PATENT ASSIGNMENT
SCHEDULE 2...............................................................................TRADE XXXX ASSIGNMENT
2
This Agreement is made the 17th day of May 0000
X X X X X X X:
(1) Biorex Laboratories Limited a company incorporated in England and Wales
having its registered office at 2 Crossfield Xxxxxxxx, Gladbeck Way,
Enfield, Middlesex, EN2 7HT, England ("Biorex"); and
(2) Glycyx Pharmaceuticals, Ltd. a company incorporated in Bermuda having
its registered office at Xxxxxx Xxxxx, 00 Xxxxxxxxxx Xxxxxx, Xxxxxxxx,
XX00 Xxxxxxx ("Glycyx").
W H E R E A S:
A. By an agreement dated 17th September 1992 between Biorex and Glycyx
(the "Original Agreement"), Biorex granted to Glycyx an exclusive
licence to make, have made, use and sell and have sold certain products
throughout the entire world excluding the United States of America,
Japan, Korea and Taiwan.
B. Shire Pharmaceuticals Group plc ("Shire") wishes to acquire a fully
paid up right to manufacture, market and sell products licensed to
Glycyx under the Original Agreement in certain European countries as
specified in this Agreement (the "Shire Territory").
C. Accordingly, Glycyx and Biorex wish to amend the Original Agreement to
remove the Shire Territory from the scope of the Original Agreement and
to enter into this Agreement in respect of the Shire Territory.
D. Under this Agreement, in return for a share of the consideration to be
paid by Shire to Glycyx, Biorex is willing to agree to:-
(i) assign to Shire its relevant patents and supplementary
protection certificate subsisting in the Shire Territory;
1
(ii) assign to Shire relevant national trade marks subsisting in
the Shire Territory;
(iii) assign to Shire relevant Community Trade Marks subject to a
licence back in respect of the European Union countries
outside the Shire Territory, to enable Biorex to sublicence
the same to Glycyx; and
(iv) license to Glycyx certain know-how in the Shire Territory to
enable Glycyx to sub-license the same to Shire.
NOW IT IS HEREBY AGREED AS FOLLOWS:
1. DEFINITIONS
For the purposes of this Agreement, the terms defined in this Clause
shall have the meanings specified below:
1.1 "Affiliate" means any corporation or other entity which controls, is
controlled by, or is under common control with, a party to this
Agreement. A corporation or other entity shall be regarded as in
control of another corporation or entity if it owns or directly or
indirectly controls more than fifty percent (50%) of the voting stock
or other ownership interest of the other corporation or entity, or if
it possesses, directly or indirectly, the power to direct or cause the
direction of the management and policies of the corporation or other
entity.
1.2 "Approval" means the grant by the relevant regulatory authority of a
marketing authorisation permitting the commercial marketing of a
Product in a country in the Shire Territory and the approval by the
applicable regulatory authority of such country of the Product for
reimbursement under its national health and welfare system and pricing.
1.3 "Assignment" means each of the assignment of the Patents in the form
contained in Schedule 1 and the assignment of the Trade Marks and the
Community Trade Marks in the form contained in Schedule 2 and
"Assignments" means both such assignments.
2
1.4 "Astra" means AstraZeneca AB (previously known as Astra AB) a company
incorporated under the laws of Sweden (company registration number
556011-7482) and whose principal place of business is at XX-000 00
Xxxxxxxxxx, Xxxxxx.
1.5 "Balsalazide" means 5-[4(2-Carboxyethylcarbamoyl)-phenylazo]- salicylic
acid disodium salt dihydrate or other salts and any prodrugs, analogs
and isomers thereof.
1.6 "Biorex Initial Fees" shall be as defined in Clause 5.2.1.
1.7 "Biorex Transfer Fees" shall be as defined in Clause 5.2.2.
1.8 "Community Trade Marks" means the community trade xxxx "Colazide"
registered number 267930 and the community trade xxxx "Colazid"
registered number 000501759 both registered in the name of Biorex.
1.9 "Consideration Shares" shall be as defined in Clause 5.2.3.
1.10 "Cost of Goods Payments" shall be as defined in Clause 5.6.
1.11 "Effective Date" means the date of receipt by Glycyx' Solicitors of the
Initial License Fees from Shire.
1.12 "Glycyx' Solicitors" means Xxxxxxxxx & Xxxxxxx, Registered Foreign
Lawyers and Solicitors - London of Xxxxxxxxxx Xxxxx, Xxxxxx Xxxxxx,
Xxxxxx, X0X 0XX.
1.13 "Initial License Fees" shall be as defined in Clause 5.2.1.
1.14 "Manufacturing Technology" means all methods, processes, designs, data,
procedures and other information owned by or licensed to Biorex or its
Affiliates during the term of this Agreement that are reasonably
required for pilot production or commercial manufacturing of Products,
including, without limitation, final quality assurance-quality control
procedures, manufacturing procedures (including conditions, times,
temperatures, pressures and rates), product and raw material
specifications, and other
3
technology related thereto, including all patent and other intellectual
property rights thereto.
1.15 "MCA" means Medicines Control Agency, the UK Regulatory Authority
established under Xxxxxxx 0, Xxxxxxxxx Xxx 0000.
1.16 "Milestone Sums" shall be as defined in Clause 5.3.1.
1.17 "National Trade Marks" means the trade xxxx "Colazide" and other marks
used in connection with the Product in the Shire Territory and
registered in the name of Biorex as trade marks within the Shire
Territory as listed in schedule 1 to the Assignment contained in
Schedule 2 of this Agreement, excluding the Community Trade Marks.
1.18 "Original Agreement" means the agreement dated 17 September 1992
between Biorex and Glycyx as subsequently amended by the written
agreement of both parties prior to the date of this Agreement.
1.19 "Patents" means the patents listed in the Schedule to the Patent
Assignment contained in Schedule 1.
1.20 "Products" means products incorporating Balsalazide, whether or not
such products are covered by the Patents, or any other material whose
manufacture, use or sale by an unlicensed Third Party would constitute
an infringement of any Valid Claim.
1.21 "Proprietary Information" shall have the meaning given to it in Clause
6.1.
1.22 "Retained European Territory" means all member states for the time
being of the European Union excluding the Shire Territory.
1.23 "Retained Milestone Sums" shall be as defined in Clause 5.3.1
4
1.24 "RetainedSums" means the sum of (pound)[*] retained by Glycyx from sums
received from Shire under the terms of Clause 5.4.
1.25 "Shire" means Shire Pharmaceuticals Group plc, a company incorporated
in England having its registered office at East Anton, Andover,
Hampshire, SP10 5RG, England.
1.26 "Shire Agreement" means the agreement of even date herewith between
Glycyx and Shire for the grant by Glycyx to Shire of certain rights in
respect of the Products in the Shire Territory as such agreement may be
amended or replaced by the parties thereto from time to time.
1.27 "Shire Territory" means Austria, Belgium, Denmark, Finland, France,
Germany, Iceland, Republic of Ireland, Luxembourg, Norway, The
Netherlands, Switzerland, Sweden and the United Kingdom.
1.28 "Technical Information" means all formulae, raw material and product
specifications, designs and procedures, formulation data, processes and
methods, pharmacology, toxicology and other preclinical tests results,
clinical trials data and results, know-how, trade secrets, inventions
and other scientific, medical, technical and marketing data and
information, including all patent and other intellectual property
rights thereto, which:
(a) are owned or controlled by, or licensed to, Biorex or its
Affiliates during the term of this Agreement, and
(b) that are reasonably necessary for the development,
manufacture, sale or use of Products.
Technical Information shall include information and methods
relating to the characterisation, synthesis, formulation,
stability, manufacture or assay of Balsalazide.
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
5
1.29 "Third Party" means any entity other than Glycyx or Biorex and their
respective Affiliates.
1.30 "Trade Marks" means the National Trade Marks and the Community Trade
Marks.
1.31 "Transfer Date" means the date on which the MCA approves and registers
a transfer from Astra to Shire of the product registration granted in
the United Kingdom to Astra numbered 0017/0394.
1.32 "Transfer Fees" shall be as defined in Clause 5.2.2.
1.33 "Valid Claim" means a claim of any issued and unexpired Patent, which
has not been held permanently revoked, unenforceable or invalid by a
decision of a court or other governmental agency of competent
jurisdiction, unappealable or unappealed within the time allowed for
appeal, and which has not been admitted to be invalid or unenforceable
through reissue or disclaimer or otherwise.
1.34 "Working Day" means any day which is not a Saturday, a Sunday or a bank
or public holiday in England, and "Working Days" shall be construed
accordingly.
2. REPRESENTATIONS AND WARRANTIES
2.1 Authorisation
Biorex represents and warrants that (i) it has the full right and
authority to grant the licenses and execute the Assignments provided in
this Agreement and to perform its obligations hereunder; (ii) to the
best of Biorex's knowledge, Glycyx may exercise the licenses granted to
it under this Agreement without conflict with or infringement of any
rights or alleged rights of any person or entity; (iii) Biorex has not
made, and will not make during the term of this Agreement, any
commitment or incur any obligation in conflict with the licenses
granted in this Agreement; and (iv) as of the date of this Agreement,
Biorex and its Affiliates have no patents or patent applications
6
within the Shire Territory, other than the Patents, related to
Balsalazide, or to prodrugs, analogs or isomers thereof, or
improvements to any of the foregoing.
2.2 No Other Representations
Except to the extent provided in this Clause 2, Biorex makes no
representations, extends no warranties of any kind, either express or
implied, with respect to the use, sale, or other disposition by Glycyx
or its sublicensees or other transferees of Products incorporating or
made by use of subject matter licensed under this Agreement. THE
WARRANTIES EXPRESSLY SET FORTH IN THIS CLAUSE 2 BY EITHER PARTY ARE
EXCLUSIVE AND NO OTHER WARRANTY, WRITTEN OR ORAL, INCLUDING WARRANTIES
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, IS EXPRESSED OR
IMPLIED.
3. GRANT AND ASSIGNMENT
3.1 Grant
Biorex hereby grants to Glycyx for the duration set out in Clause 3.3
(and subject to the Patents assigned to Shire), a fully paid,
irrevocable, exclusive right and license (with the full and free right
to sublicense) under the Technical Information and the Manufacturing
Technology to develop, have developed, make, have made, use, sell and
have sold Products within the Shire Territory.
3.2 Assignment
On the Effective Date Biorex shall, by executing the Assignments,
assign to Shire the Patents, the National Trade Marks and the Community
Trade Marks subject to a licence back to use and sublicense the
Community Trade Marks in the Retained European Territory.
3.3 Term
7
3.3.1 This Agreement shall commence on the Effective Date and shall
expire on which ever is the later of (i) the date on which the
last of the Patents ceases to be in force and (ii) the date on
which the last payment due to Biorex under this Agreement has
been made by Glycyx.
3.3.2 For the avoidance of doubt, on expiry of this Agreement (and
subject to the Patents assigned to Shire), Glycyx shall have a
perpetual, irrevocable, non-exclusive, royalty-free license
(with the right to sublicense) under the Technical Information
and Manufacturing Technology to make, have made, use, sell and
have sold Products in the Shire Territory.
3.3.3 Neither party shall be entitled to terminate this Agreement
and the rights granted hereunder in any circumstances
whatsoever. In the event of any breach of the terms of this
Agreement by either party the rights of the other party in
respect of such breach shall be limited to damages or the
equitable remedies of specific performance or injunctive
relief and neither party shall be entitled to rescind or
terminate this Agreement in any circumstances whatsoever.
3.4 Documentation
Each Party undertakes to execute (and Glycyx undertakes to procure
execution by Shire) of such further documents in connection with the
assignment of the Patents, the assignment of the National Trade Marks
and the assignment and licence back of the Community Trade Marks or
otherwise in connection with the licenses granted herein as may
reasonably be required from time to time by the other party and to
satisfy any requirements of national patent and trade xxxx xxxx to
procure the same.
3.5 Shire Agreement
3.5.1 Glycyx undertakes to use all reasonable commercial efforts to
ensure that Shire complies with all of Shire's obligations
under or in connection with the Shire Agreement, including but
not limited to:-
8
3.5.1.1 using all reasonable commercial endeavours to obtain
Approvals in each of France, Germany and the
Netherlands, as soon as reasonably practicable; and
3.5.1.2 making payment in full of all sums due to Glycyx
under the Shire Agreement.
3.5.2 Glycyx shall within three Working Days of the Effective Date
provide to Biorex a true and complete copy of the Shire
Agreement as executed by the parties thereto and shall
promptly notify Biorex of any changes or additions made to the
Shire Agreement thereafter.
4. SURVIVAL OF ORIGINAL AGREEMENT
4.1 The provisions of the Original Agreement shall be varied as follows:-.
4.1.1 The definition of Territory at Article 1.23 of the Original
Agreement shall be amended and shall read as follows:
"Territory" means the entire world, but excluding the
following countries: United States (including its territories,
possessions and the Commonwealth of Puerto Rico), Japan,
Korea, Taiwan, Austria, Belgium, Denmark, Finland, France,
Germany, Iceland, Republic of Ireland, Luxembourg, Norway, The
Netherlands, Switzerland, Sweden and the United Kingdom.
Subject to the terms of the Canada - Mexico Agreement, Canada
and Mexico are included in this Agreement.
4.1.2 The definition of Principal Markets at Article 1.14 of the
Original Agreement shall be amended and shall read as follows:
"Principal Markets" means South Africa, Australia, New
Zealand, Canada, Italy and Spain.
9
4.1.3 Exhibit A of the Original Agreement shall be amended to
exclude the Patents to read as follows:
Patent Patent Number
-----------------------------------
Italy 1,138,450
4.1.4 Exhibit C of the Original Agreement shall be amended to
exclude the National Trade Marks and the Community Trade
Marks.
4.1.5 The definitions of Community Trade Marks, Retained European
Territory and Shire at Clauses 1.8, 1.22 and 1.25 respectively
of this Agreement shall be included as new Articles 1.28, 1.29
and 1.30 respectively of the Original Agreement. Articles
6.3.1 to 6.3.4 of the Original Agreement shall be amended to
read as follows:
"6.3.1 Subject to the provisions of this Agreement, Biorex
hereby grants to Glycyx the exclusive right and
licence to use the Trade Xxxx in connection with the
exploitation of the Products in the Territory and the
Community Trade Marks in connection with the
exploitation of the Products in the Retained European
Territory throughout the term of this Agreement."
"6.3.2 Glycyx shall have the right to grant Sublicensees the
right to use the Trade Xxxx in connection with the
exploitation of the Products in the Territory and the
Community Trade Marks in connection with the
exploitation of the Products in the Retained European
Territory throughout the term of this Agreement,
subject to the provisions of this Agreement."
"6.3.3 Subject to the laws of the country concerned, Glycyx
shall have an exclusive right to institute and pursue
actions to prevent misuse of (i) the Trade Xxxx
throughout the Territory and (ii) the Community Trade
Marks throughout the Retained European Territory."
10
"6.3.4 Glycyx's rights under the Community Trade Marks shall
be subject to Shire (or Shire's assignees or
sublicencees) maintaining the Community Trade Marks"
4.2 For the avoidance of doubt, and subject to Clause 3.5, any liability of
Glycyx under the Original Agreement to make any payment to Biorex in
respect of any part of the Shire Territory is hereby expressly
terminated and waived.
4.3 Subject to Glycyx's obligations set out in Clause 3.5, Biorex and
Glycyx hereby further agree that all development and commercialisation
obligations of Biorex and Glycyx arising under the Original Agreement
are hereby deemed to have been fully satisfied insofar as such
obligations relate to the Shire Territory.
4.4 The Original Agreement as amended pursuant to this Clause 4 shall
continue in full force and effect.
5. PAYMENTS TO BIOREX
5.1 Biorex Fees
In consideration of the grant by Biorex to Glycyx of the rights and
licenses under this Agreement and the execution of the Assignments
Glycyx shall, in accordance with Clause 5.2 pay to Biorex certain sums
in respect of Initial License Fees and Transfer Fees received by Glycyx
and shall make further payment (if any) in respect of the Retained
Milestone Sums under Clause 5.3 and the Retained Sums under Clause 5.4.
Any such payment shall be made through the banking system into such
bank account as Biorex shall designate in writing from time to time for
the receipt of such payments. Payments made to Biorex shall be made in
Pounds Sterling.
5.2 Payment of Biorex Initial Fees and Biorex Transfer Fees
In accordance with the terms of the Shire Agreement:
11
5.2.1 Glycyx' Solicitors shall receive from Shire the sum of
(pound)7,828,000 (the "Initial License Fees") on the Effective
Date and Glycyx shall, having retained sums in accordance with
Clause 5.4 below, and subject to Clause 5.2.3, procure that
within one Working Day of receipt by Glycyx' Solicitors of the
Initial License Fees there shall be paid to Biorex the sum of
(pound)[*] (the "Biorex Initial Fees").
5.2.2 Glycyx' Solicitors shall receive from Shire the sum of
(pound)[*] (the "Transfer Fees") within 5 Working Days
of the Transfer Date and Glycyx shall subject to Clause 5.2.3,
procure that within 3 Working Days of receipt by Glycyx'
Solicitors of the Transfer Fees there shall be paid to Biorex
the sum of (pound)[*] (the "Biorex Transfer Fees").
5.2.3 Glycyx may, at its option, to the extent permitted by law
procure the payment of up to (pound)1,600,000 of the Biorex
Initial Fees and up to (pound)600,000 of the Biorex Transfer
Fees by the allotment of fully paid Ordinary Shares of
(pound)0.05p each in the capital of Shire Pharmaceuticals
Group plc (the "Consideration Shares") upon terms whereby:
5.2.3.1 the Consideration Shares shall be allotted to Biorex
within 15 days of the Effective Date in respect of
the Biorex Initial Fees and within 15 days of the
Transfer Date in respect of the Biorex Transfer Fees;
and
5.2.3.2 the number of Consideration Shares shall be
calculated by reference to the mid-market quotation
as derived from the London Stock Exchange daily
Official List of Ordinary Shares in Shire
Pharmaceuticals Group plc averaged over the period of
5 (five) trading days immediately preceding the
Effective Date in respect of the Biorex Initial Fees
and the Transfer Date in respect of the Biorex
Transfer Fees; and
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
12
5.2.3.3 the Consideration Shares shall rank pari passu in all
respects with the other Ordinary Shares in issue in
the capital of Shire Pharmaceutical Group plc; and
5.2.3.4 the Consideration Shares shall on allotment be
admitted to the Official List of the London Stock
Exchange and may be traded freely upon allotment.
5.3 Milestone Sums
5.3.1 In accordance with Clauses 12.1.3, 12.1.4, 12.1.5 and 12.1.6
of the Shire Agreement certain sums are payable by Shire to
Glycyx on the occurrence of certain events (the "Milestone
Sums"). [******] Biorex further acknowledges that Glycyx is
required to retain cash or cash equivalent balances of not
less than the maximum liability to effect reimbursement to
Shire remaining outstanding from time to time under Clause
12.2 of the Shire Agreement (the "Retained Milestone Sums")
during the period to whichever is the earlier of the date of
payment (if any) of any reimbursement due in respect of the
year to 31 December 2005 and 30 April 2006.
5.3.2 Glycyx shall pay to Biorex [*]% of the balance (if any) of the
Milestone Sums remaining after any reimbursement to Shire in
accordance with the provisions of the Shire Agreement, within
three Working Days of the date upon which Glycyx is no longer
required under the Shire Agreement to retain the Retained
Milestone Sums.
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
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5.4 Retained Sums
Biorex acknowledges that under the terms of the Shire Agreement, Glycyx
has assumed an obligation to pay (up to a maximum of (pound)[*]) the
cost of any clinical trial effected in order to obtain Approval of a
Product in France, Germany and/or The Netherlands. Glycyx shall retain
the sum of (pound)[*] from the Initial License Fees received by it from
Shire ("the Retained Sums"). Under the terms of the Shire Agreement
Glycyx is required to retain cash or cash equivalent balances of not
less than the maximum liability to effect reimbursement remaining
outstanding from time to time until the earlier of:
5.4.1 the reimbursement by Glycyx to Shire of (pound)[*] ([*] pounds
Sterling) in total in connection with the conduct of such
clinical trial;
5.4.2 the grant of the first Approval in all of Germany, France and
the Netherlands; and
5.4.3 the notification by Shire to Glycyx that it does not intend
carrying out such clinical trial or otherwise that Glycyx is
released from any obligation to reimburse Shire in respect of
such clinical trial.
Within three Working Days of the date on which Glycyx is no longer
required under the Shire Agreement to retain the Retained Sums, Glycyx
shall pay to Biorex [*]% of the balance of the Retained Sums (if any)
remaining after payment of the cost of such clinical trial.
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
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5.5 Interest
Glycyx shall keep any and all cash or cash equivalent balances required
under the terms of the Shire Agreement to be maintained by Glycyx in
relation to the Retained Milestone Sums and the Retained Sums in an
account whereby such sums shall earn a commercial rate of interest. On
payment to Biorex of any part of the Retained Milestone Sums or
Retained Sums Glycyx shall in addition pay to Biorex [*]% of all
interest earned on the Retained Milestone Sums and the Retained Sums.
5.6 Cost of Goods Payments
5.6.1 In the Shire Agreement, Glycyx has undertaken to procure that
the cost of goods to Shire in respect of Balsalazide ordered
and delivered to Shire in the period from the Effective Date
to 31 December 2001 (up to a maximum quantity of [*] ([*])
tonnes)) shall be (pound)[*] per kg (the "Maximum Price") and
that in the event that Shire is required to pay in excess of
the Maximum Price to suppliers of Balsalazide, Glycyx shall
reimburse to Shire the aggregate total excess (the "Cost of
Goods Payment").
5.6.2 In the event that under the Shire Agreement Glycyx is required
to make and makes any Cost of Goods Payment to Shire it shall
notify Biorex in writing and Biorex shall within 30 days of
receipt of any such notification pay to Glycyx [*]% of any
such Cost of Goods Payment.
5.6.3 Glycyx shall in accordance with the terms of the Shire
Agreement endeavour to minimise any Cost of Goods Payment that
it is required to make to Shire.
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
15
5.7 Late Payments
Any payments that are not paid on or before the date such payments are
due under this Agreement shall bear interest at the rate of two per
cent above the base lending rate for the time being of Barclays Bank
Plc, London calculated on the number of days such payment is
delinquent. This Clause 5.7 shall in no way limit any other remedy
available to either party.
5.8 Withholding Tax
5.8.1 All sums due hereunder shall be paid without deduction or
withholding in respect of duties, taxes, taxation or charges
otherwise of a taxation nature unless the deduction or
withholding is required by law. In the event that such
deductions or withholdings are required by law, the payer
shall:-
5.8.1.1 ensure that the deduction or withholding does not
exceed the minimum amount legally required;
5.8.1.2 account to the relevant taxation or other authorities
within the period for payment permitted by the
applicable law the full amount of the deduction or
withholding; and
5.8.1.3 furnish to the payee within the period for payment
permitted by the relevant law either an official
receipt of the relevant taxation authorities involved
in respect of all amounts so deducted or withheld or
if such receipts are not issued by the taxation
authorities concerned a certificate of deduction or
equivalent evidence of the relevant deduction or
withholding.
5.8.2 For the purpose of calculating the share of the Retained Sums
and the Milestone Sums due to Biorex under this Agreement,
Glycyx shall be deemed to have received payment in full from
Shire of the Milestone Sums and the Retained Sums under the
Shire Agreement without any deduction or
16
withholding by Shire, in respect of duties, taxes or other
charges of a taxation nature.
5.8.3 If Biorex is unable to claim credit or relief from double
taxation for any amounts withheld or deducted from any sums
due to Biorex under this Agreement, Glycyx shall on receipt of
notification by Biorex, pay to Biorex a payment equal to the
amount necessary to ensure that Biorex receives such sums as
it would have received in the absence of any such deduction or
withholding by Glycyx.
5.8.4 Without prejudice to the provisions of Clause 5.8.1 above, the
parties shall co operate and use reasonable commercial efforts
to ensure that the amount of any deductions or withholdings
required by law are kept to a minimum
5.9 The parties will negotiate in good faith the apportionment of the
consideration payable under this Agreement between the assignment of
the Patents, the assignment of the National Trade Marks and the
Community Trade Marks, and the variation to the licence of the
Technical Information and Manufacturing Technology.
6. CONFIDENTIALITY
6.1 General
Except as expressly otherwise provided in this Agreement, each party
shall hold in confidence and not use or disclose to any Third Party
(other than employees, consultants, advisors, sublicensees and Third
Parties with whom such party is considering entering into a business
relationship who are similarly bound in writing) any product,
technical, manufacturing, process, marketing, financial, business or
other information, ideas, or know-how of the other party that is
identified in writing by the other party as confidential or has, under
the provisions of the Original Agreement, been so identified
("Proprietary Information") at the time of its disclosure or within
thirty (30) days thereafter provided, however, that Proprietary
Information of a party shall not include:
17
6.1.1 items which at the time of disclosure are published or
otherwise generally available to the public;
6.1.2 items which, after disclosure to the other party, are
published or become generally available to the public through
no breach of this Agreement by the other party or the other
party's employees or agents; or
6.1.3 items which the other can document were or are (i) legally in
its possession at the time of disclosure, free of any
obligation of confidentiality, and not acquired directly or
indirectly from such party; or (ii) independently developed.
6.2 Exceptions
A party may disclose Proprietary Information of the other:
6.2.1 In connection with, and in such manner as may be required by,
law or any relevant regulatory authority, or in compliance
with laws or regulations relating to registrations or sale of
securities or product approval;
6.2.2 If such information is also rightfully acquired from a Third
Party who, to the best of such party's knowledge and belief,
is entitled to rightfully make such disclosure, but only to
the extent such party complies with any restrictions imposed
by the Third Party;
6.2.3 To business advisers and any Third Party with whom such Party
proposes to enter into a business relationship and to its
advisers, investors or potential investors (collectively
"Third Party Recipients") Provided That any such disclosure
shall be limited only to such Proprietary Information as is
absolutely necessary and that the disclosing party shall
procure that any Third Party Recipient shall be bound by
obligations of confidentiality substantially equivalent to the
provisions of this Clause 6.
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6.2.4 After five (5) years from the date such information (other
than Manufacturing Technology and Technical Information) is
disclosed to it.
6.3 Licensed Information
Any Proprietary Information of or used by Biorex which is or may be
subject to an exclusive licence to Glycyx hereunder, shall not be
disclosed by Biorex to any Third Party for use in the Shire Territory.
6.4 Terms of this Agreement
Glycyx and Biorex agree not to disclose the financial terms or
conditions of this Agreement to any Third Party without the prior
written consent of the other party hereto (which consent shall not be
unreasonably withheld), except as required by applicable law, or to
professional advisers, or to persons with whom Biorex or Glycyx has
entered into or proposes to enter into a business relationship for the
purposes of raising capital to run their business, and then only under
conditions of confidentiality.
7. INDEMNITY
7.1 Glycyx
Subject to Biorex's compliance with its obligations set forth in Clause
7.2 below, Glycyx agrees to indemnify and hold Biorex, its Affiliates
and their employees and agents harmless from and against any losses,
claims, damages, liabilities or actions (including reasonable
attorneys' fees and court and other expenses of litigation)
(collectively, the "Liabilities") suffered or incurred in connection
with Third Party claims for personal injuries or any product recall to
the extent caused by: (a) any failure to test for or provide adequate
warnings of adverse side effects to the extent such failure arises out
of acts or omissions in connection with preclinical or clinical testing
carried out in respect of the Product by or on behalf of Shire in the
Shire Territory; (b) any manufacturing defect in any Product or other
material manufactured by Glycyx, its sublicensees, any subcontractor of
Glycyx or its sublicensees or Shire or its sublicensees in the Shire
Territory; or (c) any other act or omission (without regard to culpable
conduct) of Glycyx, its sublicensees any subcontractor of Glycyx or its
sublicensees or Shire
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or its sublicensees in connection with the activities contemplated
under this Agreement in the Shire Territory, except to the extent such
Liabilities resulted from negligence, recklessness or intentional
misconduct of Biorex.
7.2 Procedure
In the event that Biorex intends to claim indemnification under this
Clause 7 it shall promptly notify Glycyx in writing of any loss, claim,
damage, liability or action in respect of which Biorex or any of its
Affiliates, employees or agents intend to claim such indemnification,
and Glycyx shall have the right to participate in, and, to the extent
Glycyx so desires, jointly with any other indemnifying party similarly
noticed, to assume the defence thereof with counsel mutually
satisfactory to the parties; provided, however, that Biorex shall have
the right to retain its own counsel, with the fees and expenses to be
paid by Biorex, if representation of Biorex by the counsel retained by
Glycyx would be inappropriate due to actual or potential differing
interests between Biorex and any other party represented by such
counsel in such proceedings. The indemnity agreement in this Clause 7
shall not apply to amounts paid in settlement of any loss, claim,
damage, liability or action if such settlement is effected without the
consent of Glycyx, which consent shall not be withheld unreasonably.
The failure to deliver written notice to Glycyx within a reasonable
time after the commencement of any such action, if prejudicial to its
ability to defend such action, shall relieve Glycyx of any liability to
Biorex under this Clause 7, but the omission so to deliver written
notice to Glycyx shall not relieve it of any liability that it may have
to Biorex otherwise than under this Clause 7. Biorex, its employees and
agents, shall cooperate fully with Glycyx and its legal representatives
in the investigation of any action, claim or liability covered by this
indemnification.
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8. FORCE MAJEURE
Neither party shall be held liable or responsible to the other party
nor be deemed to have defaulted under or breached this Agreement for
failure or delay in fulfilling or performing any term of this Agreement
when such failure or delay is caused by or results from causes beyond
the reasonable control of the affected party or from fire, floods,
embargoes, war, acts of war (whether war be declared or not),
insurrections, riots, civil commotions, strikes, lockouts or other
labour disturbances, acts of God or acts, omissions or delays in acting
by any governmental authority or the other party.
9. ASSIGNMENT
9.1 This Agreement may not be assigned or otherwise transferred, nor,
except as expressly provided hereunder, may any right or obligation
hereunder be assigned or transferred, by either party without the
written consent of the other party; provided, however that either
Biorex or Glycyx may, without such consent, assign this Agreement and
its rights and obligations hereunder in connection with the transfer or
sale of all or substantially all of its business, if such assets
include substantially all of the assets relating to its performance of
its respective obligations hereunder, or in the event of its merger or
consolidation with another company at any time during the term of this
Agreement. Any purported assignment in violation of the preceding
sentence shall be void. Any permitted assignee shall assume all
obligations of its assignor under this Agreement. No assignment shall
relieve either party of responsibility for the performance of any
accrued obligation which such party then has hereunder.
9.2 If Shire assigns the Shire Agreement to any third party, any reference
to Shire in this Agreement shall, where appropriate, be deemed to refer
to the third party assignee.
10. MISCELLANEOUS
10.1 Notices
Any notice required or permitted to be given or made under this
Agreement by one of
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the parties hereto to the other shall be in writing, delivered
personally or by facsimile (and promptly confirmed by personal delivery
or courier) or courier, postage prepaid, addressed to such other party
at its address indicated below, or to such other address as the
addressee shall have last furnished in writing to the addressor and
shall be effective upon receipt by the addressee.
Glycyx Pharmaceuticals Ltd
Xxxxxx Xxxxx, 00 Xxxxxxxxxx Xxxxxx
Xxxxxxxx XX00 Xxxxxxx
Attention: President
Biorex Laboratories, Ltd
0 Xxxxxxxxxx Xxxxxxxx
Xxxxxxxx Xxx
Xxxxxxx, Xxxxxxxxx XX0 0XX
Attention: Managing Director
10.2 Applicable Law
This Agreement shall be governed by and construed in accordance with
the laws of England, without regard to conflicts of laws provisions and
the parties hereby submit to the exclusive jurisdiction of the English
Courts.
10.3 No Consequential Damages
EXCEPT AS PROVIDED IN CLAUSE 7, IN NO EVENT SHALL EITHER GLYCYX OR
BIOREX OR THEIR AFFILIATES BE LIABLE FOR SPECIAL, INDIRECT, INCIDENTAL
OR CONSEQUENTIAL DAMAGES (INCLUDING WITHOUT LIMITATION DAMAGES FOR LOSS
OF PROFITS, PRODUCTION, USE OR SALES) BASED ON CONTRACT, TORT OR ANY
OTHER LEGAL THEORY.
10.4 Entire Agreement
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This Agreement contains the entire understanding of the parties with
respect to the subject matter hereof in respect of the Shire Territory.
All express or implied agreements and understandings, either oral or
written, heretofore made in relation to any part of the Shire Territory
(including without limitation those set out in the Original Agreement
to the extent they relate to any part of the Shire Territory,) are
expressly excluded. This Agreement may be amended, or any term hereof
modified, only by a written instrument duly executed by both parties
hereto.
10.5 Headings
The captions to the several Clauses and Sections hereof are not a part
of this Agreement, but are merely guides or labels to assist in
locating and reading the several Clauses and sections hereof.
10.6 Independent Contractors
It is expressly agreed that Glycyx and Biorex shall be independent
contractors and that the relationship between the two parties shall not
constitute a partnership, joint venture or agency. Neither Glycyx nor
Biorex shall have the authority to make any statements, representations
or commitments of any kind, or to take any action, which shall be
binding on the other, without the prior written authorisation of the
other party to do so.
10.7 Waiver
The waiver by either party of any right hereunder or of the failure to
perform or of a breach by the other party shall not be deemed a waiver
of any other right hereunder or of any other breach or failure by said
other party whether of a similar nature or otherwise.
10.8 Further Assurances
Glycyx shall use commercially reasonable efforts to ensure that each of
its sublicensees and sub contractors shall observe and perform all the
obligations and
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restrictions applicable to it under this Agreement.
10.9 Severability
In case any one or more of the provisions contained in this Agreement
shall for any reason be held to be invalid, illegal or unenforceable in
any respect, such invalidity, illegality or unenforceability shall not
affect any other provisions hereof, but this Agreement shall be
construed as if such invalid or illegal or unenforceable provisions had
never been contained herein.
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AGREED by the parties through their duly authorised representatives on the date
written at the top of the first page of this Agreement:-
For and on behalf of For and on behalf of
Biorex Laboratories Limited Glycyx Pharmaceuticals, Ltd
Signed .......................... Signed ..........................
Full Name .......................... Full Name ..........................
Title .......................... Title ..........................
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