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Title: |
Agreement |
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Entities: |
AstraZeneca AB; Barclays Bank plc; Salix Pharmaceuticals Ltd.; Shire Pharmaceuticals Group plc; Covington & Burling |
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Date: |
2000 |
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156KB total |
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$59 |
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#327327 |
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DATED 17th May 2000
GLYCYX PHARMACEUTICALS, LTD
-and-
SHIRE PHARMACEUTICALS GROUP PLC
AGREEMENT
THE INFORMATION HEREIN MARKED BY [*] HAS BEEN OMITTED PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT FILED WITH THE SEC.
{PAGE}
CONTENTS
{TABLE}
{CAPTION}
{S} {C} {C}
1. DEFINITIONS............................................................................................2
2. GRANT AND ASSIGNMENT...................................................................................9
3. SUBLICENCES AND ASSIGNMENTS OF PATENTS................................................................11
4 BUSINESS OPPORTUNITIES................................................................................13
5 GLYCYX ASSISTANCE.....................................................................................14
6 MUTUAL COOPERATION....................................................................................15
7 DEVELOPMENT AND MANUFACTURING COMMITTEES..............................................................15
8 TRANSFER BY GLYCYX....................................................................................18
9 PRODUCT REGISTRATIONS.................................................................................19
10 SUPPLY OF PRODUCT.....................................................................................20
11 REPRESENTATIONS AND WARRANTIES........................................................................24
12 PAYMENTS TO GLYCYX....................................................................................29
13 PRODUCT DATABASE AND ADVERSE REACTIONS REPORTING.......................................................3
14 IMPROVEMENTS...........................................................................................4
15 PRODUCT PATENTS, FORMULATION AND USE PATENTS AND TRADEMARKS............................................5
16 CONFIDENTIALITY........................................................................................7
17 INDEMNITY..............................................................................................9
18 WITHHOLDING TAX.......................................................................................11
19 FORCE MAJEURE.........................................................................................12
20 ASSIGNMENT............................................................................................12
21 NOTICES...............................................................................................13
22 ENTIRE AGREEMENT......................................................................................14
23 INDEPENDENT CONTRACTORS...............................................................................15
{/TABLE}
{PAGE}
{TABLE}
{CAPTION}
{S} {C} {C}
24 WAIVER................................................................................................15
25 SEVERABILITY..........................................................................................15
26 GOVERNING LAW.........................................................................................16
27 JURISDICTION..........................................................................................16
{/TABLE}
{PAGE}
This Agreement is made the 17th day of May 2000
B E T W E E N:
(1) GLYCYX PHARMACEUTICALS, LTD. a company incorporated in Bermuda having its
registered office at Milner House, 18 Parliament Street, Hamilton, HM12 Bermuda
("Glycyx"); and
(2) SHIRE PHARMACEUTICALS GROUP PLC a company incorporated in England and Wales
having its registered office at East Anton, Andover, Hampshire, SP10 5RG England
("Shire")
W H E R E A S:
A. Glycyx is the sole and exclusive licensee of all rights in respect of a
pharmaceutical compound, Balsalazide, in respect of the territory of the world
excluding the United States and has itself or through a previous sub-licensee,
AstraZeneca AB, developed such pharmaceutical compound, conducted all clinical
trials and testing required in connection with initial applications for product
registrations within the European Union and applied for and obtained certain
product registrations in respect thereof and marketed such product in certain
European countries.
B. Shire wishes to acquire rights to such pharmaceutical compound in respect of
certain European countries and wishes to acquire product registrations obtained
in respect thereof currently held in the name of AstraZeneca AB and wishes to
effect a smooth transition of the marketing and distribution of such
pharmaceutical product in such countries from AstraZeneca AB.
C. Glycyx has agreed to grant to Shire certain rights and to procure the
assignment to Shire of certain other rights in respect of such
pharmaceutical compound in certain European countries upon the terms
and conditions of this Agreement.
1
{PAGE}
D. [*]
IT IS AGREED AS FOLLOWS:
1. DEFINITIONS
In this Agreement, the following terms and expressions shall have the meanings
specified below:
"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. For
the avoidance of doubt, Salix Pharmaceuticals, Ltd. a company registered in the
British Virgin Islands and Salix Pharmaceuticals Inc, a company registered in
California, USA are both Affiliates of Glycyx.
"API" means the active pharmaceutical ingredient of any Product.
"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 Territory and the approval by the applicable Regulatory Authority of such
country of such Product for reimbursement under its national health and welfare
system and pricing.
"Assignments" means each of and together the Assignment of Patents in the form
contained in Schedule 2 and the Assignment of Trade Marks in the form contained
in Schedule 3.
"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 SE-151 85 Sodertalje, Sweden.
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
2
{PAGE}
"Astra Agreement" means an agreement entered into between Astra and Glycyx dated
22 December 1999.
"Astra Stock" means all Stock in respect of each of Sweden, Denmark and the
United Kingdom in the possession of Astra as at the relevant Transfer Date.
"Astra Termination Letter" means a letter of even date herewith from Glycyx to
Astra in respect of the Astra Agreement.
"Balsalazide" means 5-[4(2-Carboxyethylcarbamoyl)-phenylazo]- salicylic acid
disodium salt dihydrate or other salts and any prodrugs, analogs and isomers
thereof.
"Biorex" means Biorex Laboratories Limited a company incorporated in England and
Wales having its registered office at 2 Crossfield Chambers, Gladbeck Way,
Enfield, Middlesex, EN2 7HT, England.
"Biorex Agreement" means an agreement of even date herewith between Biorex and
Glycyx, relating to the Product Patents, the Trade Marks, the Community Trade
Mark, the Product and Balsalazide.
"CEOs" has the meaning set out in Clause 7.7.
"Clinical Study" has the meaning set out in Clause 9.3.
"Community Trade Marks" means the trademarks "Colazid" and "Colazide" registered
as Community Trade Marks in the name of Biorex under registration numbers
000501759 and 000267930.
"Consideration Shares" has the meaning set out in Clause 12.5.
"Development Committee" has the meaning set out in Clause 7.1.
"Effective Date" means the date of receipt by Glycyx of payment under Clause
12.1.1.
"Excluded Territory" means the world excluding only the Territory.
"Existing Territory" means the United Kingdom, Denmark and Sweden.
3
{PAGE}
"Formulation and Use Patents" means the patents and the patent applications
listed in Schedule 1 and any continuations, continuations-in-part, divisions,
substitutions, renewals, reissues and extensions, including any SPCs obtained in
respect thereof only insofar as they relate to the Territory.
"Glycyx Area" means each of the areas known as Pacific Rim (ie. China, Korea,
Japan, Taiwan and Australasia), South East Asia, Central America, South America,
Eastern Europe and North America (which for the avoidance of doubt shall not
include the Territory or any part thereof).
"Glycyx Manufacturing Technology" means such Manufacturing Technology as is
owned by or within the control of or licensed to Glycyx or its Affiliates as at
the Effective Date including for the avoidance of doubt any obtained by Glycyx
from Astra (whether located in the Territory or elsewhere).
"Glycyx Product Information" means (in written or in any other form, including
electronic format):
(i) all pharmacology, toxicology and other preclinical test
results and, clinical data (including clinical trials data and
results), in respect of Balsalazide and the Product;
(ii) any documents or data filed or required to be filed in
connection with the Product Registrations;
(iii) correspondence with the Regulatory Authorities in the
Territory relating to Balsalazide or the Product;
(iv) marketing information used to support the marketing and
distribution of the Product in the Territory (including,
without limitation, sales training materials, promotional
materials and customer lists);
(v) any database relating to any adverse events in respect of the
Product which relates to the Territory;
4
{PAGE}
owned by or within the control of or licensed to Glycyx or its Affiliates as at
the Effective Date (including for the avoidance of doubt any obtained by Glycyx
from Astra) whether located in the Territory or elsewhere.
"Glycyx' Solicitors" means Covington & Burling Registered Foreign Lawyers and
Solicitors - London of Leconfield House, Curzon Street, London, W1Y 8AS.
"Glycyx Stock" means all Stock manufactured for sale in the Territory which is
within the possession or control of Glycyx at the Effective Date, which is
estimated not to exceed 2.1 million capsules.
"Improvement" means any improvement, modification or adaptation to the
Manufacturing Technology which might reasonably be of commercial interest to the
Parties in the manufacture of Balsalazide or any Product.
"Indemnified Party" has the meaning set out in Clause 17.3.
"Indemnifying Party" has the meaning set out in Clause 17.3.
"Information" has the meaning set out in Clause 11.2.11.
"Infringement" has the meaning set out in Clause 15.5.
"Infringement Claim" means any allegation or claim made against Shire or any
Sublicensee that the development, manufacture, sale or distribution of any
Product within the Territory infringes or is an unauthorised use of the
Intellectual Property Rights of a Third Party.
"Initial Payment " means the Initial Payment to be paid by Shire to Glycyx under
Clauses 12.1.1 and 12.1.2.
"Intellectual Property Rights" means all rights in inventions, patents, SPCs,
designs, copyrights (including rights in software), trade marks, service marks
and databases (whether or not any of those is registered and including
applications for registration of the foregoing) together with all trade secrets,
know-how, other confidential information and all rights or forms of protection
of a similar nature or having equivalent or similar effect to any of those which
may subsist anywhere in the world.
5
{PAGE}
"Liabilities" has the meaning set out in Clause 17.
"Manufacturing Committee" has the meaning set out in Clause 7.4.
"Manufacturing Technology" means all methods, processes, designs, data,
procedures and other information relating to the manufacture of Balsalazide
and/or the Products including, without limitation, final quality assurance,
quality control procedures, manufacturing procedures, product and raw material
specifications, formulation data and other technology related thereto.
"Maximum Quantity" has the meaning set out in Clause 10.11.
"MCA" means Medicines Control Agency, the UK Regulatory Authority established
under Section 6, Medicines Act 1968.
"Net Sales" means with respect to any Product the invoiced sales price of such
Product received from independent customers (including distributors) who are not
an Affiliate or Sublicensee, less, to the extent such amounts are included in
the invoiced sales price: (a) actual credited allowances to such independent
customers for spoiled, damaged, out-dated and returned Product; (b) sales,
value-added and other direct taxes for Product; (c) customs, duties and
surcharges relating to Product; and (d) normal and customary government, trade,
quantity and cash discounts.
"Price" has the meaning set out in Clause 10.11.
"Proceedings" has the meaning set out in Clause 15.5.
"Products" means (a) any products incorporating Balsalazide, or (b) any other
substance or material whose development, manufacture, use, sale or distribution
by an unlicensed Third Party would constitute an infringement of any Valid Claim
of the Product Patents.
"Product Patents " means the patents listed in the Schedule to the Patent
Assignment contained in Schedule 2.
"Product Licence" means the Product Registration for the Product granted by the
MCA in the United Kingdom to Astra numbered 0017/0394.
6
{PAGE}
"Product Registrations" means all product licenses or approvals, marketing
approvals and pricing or reimbursement approvals in respect of any Product
granted to Glycyx or Astra or any Affiliate, licensee or sublicensee of Glycyx
or Astra by any Regulatory Authority prior to the Effective Date and any
applications (whether prepared, but not submitted, pending, withdrawn or
rejected) therefor in respect of the Territory only.
"Regulatory Authority" means any body responsible for the grant of product
licences or approvals, marketing approvals or pricing or reimbursement approvals
within the Territory.
"SPC" means in relation to any Product all Supplementary Protection Certificates
for medicinal products and their equivalents provided under Council Regulation
(EEC) No. 1768/92 of 18th June 1992 and any analogous extensions of patent
protection in any jurisdiction.
"Stock" means all stocks of Product (in whatever form or state of preparation)
which has at the relevant date, at least two thirds of its approved shelf life
unexpired and complies with specifications for the Product as at the relevant
date.
"Sublicence" means any agreement under which Shire grants to a Third Party (the
"Sublicensee") rights to market, promote and/or distribute Products in any part
of the Territory.
"Supply Period" means the period from the Effective Date to 31 December 2001.
"Territory" means Austria, Belgium, Denmark, Finland, France, Germany, Iceland,
Republic of Ireland, Luxembourg, Norway, The Netherlands, Switzerland, Sweden
and the United Kingdom.
"Term" means the term of this Agreement as specified in Clause 2.8.
"Third Party" means any entity other than Shire or Glycyx and their respective
Affiliates.
"Third Party Contractor" means any Third Party manufacturing API or finished
Product for and on behalf of either Party.
"Third Party Recipient" has the meaning set out in Clause 16.3.
7
{PAGE}
"Trade Marks" means the registered trade marks as listed in the Schedule to the
Assignment contained in Schedule 3 including for the avoidance of doubt the
Community Trade Marks.
"Transfer Date" means in respect of each of Sweden, Denmark and the United
Kingdom the date on which the relevant Regulatory Authority effects a transfer
of the relevant Approval into the name of Shire (or as it may direct).
"UK Transfer Date" means the date on which the MCA approves and registers a
transfer of the Product Licence from Astra to Shire.
"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.
1.1 In this Agreement:
1.2.1 The expression "the Parties" shall mean the parties to this Agreement;
1.2.2 Unless the context otherwise requires all references to a
particular clause sub-clause schedule or paragraph shall be a
reference to that clause sub-clause schedule or paragraph in
or to this Agreement as it may be amended from time to time
pursuant to this Agreement;
1.2.3 Headings are for convenience only and shall be ignored in
interpreting this Agreement;
1.2.4 Words importing the singular shall include the plural and vice
versa and words importing the masculine gender shall include
the feminine and vice versa;
1.2.5 The words "including" or "included" are to be construed
without limitation to the generality of the preceding words.
8
{PAGE}
2. GRANT AND ASSIGNMENT
2.1 With effect from the Effective Date, Shire shall have a fully paid
irrevocable, exclusive right and licence to develop, manufacture
(subject only to Clause 2.6), use, sell and have sold and distribute
any Product within the Territory. Glycyx hereby grants to Shire:
2.1.1 a fully paid, irrevocable, exclusive right and licence under
the Formulation and Use Patents (subject always to Clause 2.6)
to develop, manufacture, use, sell and have sold and
distribute any Product within the Territory. The licence
granted in this Clause 2.1.1 shall continue in relation to
each country in the Territory for so long as any Product is
within a Valid Claim of the Formulation and Use Patent which
relates to each such country.
2.1.2 a fully paid, irrevocable, exclusive right and licence
(subject always to Clause 2.6) to use the Glycyx Manufacturing
Technology and the Glycyx Product Information (and any
Intellectual Property Rights therein or relating thereto as at
the Effective Date) and any other Intellectual Property Rights
owned, licensed to or within the control of Glycyx as at the
Effective Date relating exclusively to Balsalazide or the
Product in any of the development, manufacture, use, sale and
distribution of any Product in the Territory. The licence
granted in this Clause 2.1.2 shall continue in force for so
long as the Glycyx Manufacturing Technology or Glycyx Product
Information shall remain confidential or any such Intellectual
Property Rights shall remain valid and enforceable.
2.1.3 the licence granted in Clause 2.1.1 and 2.1.2 shall be
exclusive in the Territory to the exclusion of all other
persons including Glycyx and its Affiliates except that Glycyx
and its Affiliates shall have the rights as specified under
Clause 2.6. The Parties acknowledge that Astra has rights to
distribute the Product in the Existing Territory until each of
the relevant Transfer Dates under and in accordance with the
terms of the Astra Agreement.
9
{PAGE}
2.2 Glycyx hereby agrees to procure the assignment by Biorex to Shire on
the Effective Date of the Product Patents and the Trade Marks and
undertakes to deliver to Shire on the Effective Date the Assignments
duly executed by Biorex.
2.3 Glycyx hereby assigns to Shire the right to recover and take all such
proceedings as may be necessary for the recovery of damages or
otherwise in respect of all infringements of any of the Product Patents
committed prior to the Effective Date.
2.4 Glycyx hereby assigns to Shire all its right, title and interest (if
any) in and to any and all goodwill relating to the Trade Marks.
2.5 Each Party shall do or procure the doing of all such acts and things
and/or execute or procure the execution of all such documents in
connection with the assignment of the Product Patents and the Trade
Marks and the grant of the licenses under Clause 2.1 and the transfer
to Shire of the Product Registrations under Clause 8 or otherwise to
give effect to the terms of this Agreement as may reasonably be
required from time to time by the other Party (including for the
avoidance of doubt all such documents as may be required in connection
with the licence back of the Community Trade Marks under the Trade Mark
Assignment). Each Party shall bear its own costs in connection with any
matter arising under this Clause 2.5.
2.6 It is acknowledged that Glycyx, its Affiliates and/or its sublicensees
shall continue to develop, distribute, market and sell the Product in
the Excluded Territory. Shire acknowledges that notwithstanding the
grant of rights to Shire in respect of the Territory under the terms of
this Agreement, Glycyx and its Affiliates:
2.6.1 shall have a fully paid, non exclusive irrevocable right and
licence with a right to sublicence to make or have made
Balsalazide and/or any Products within the Territory and shall
be entitled to use the Glycyx Manufacturing Technology and the
Glycyx Product Information (and Intellectual Property Rights
therein or relating thereto as at the Effective Date) and any
other Intellectual Property Rights licensed to Shire under
Clause 2.1.2 for this purpose; and
10
{PAGE}
2.6.2 are hereby granted a fully paid, irrevocable right and
non-exclusive licence (with right to sublicense) under the
Product Patents for such purpose only
Provided That any such Balsalazide or Product manufactured within the Territory
shall be for supply to Glycyx, its Affiliates and its sublicensees for
marketing, distribution and sale outside the Territory only.
2.7 For the avoidance of doubt Glycyx hereby grants to Shire a
non-exclusive fully paid up royalty free perpetual licence under the
rights granted in Clause 4.4 of the Astra Agreement in respect of the
Astra Intellectual Property (as defined in the Astra Agreement) which
does not relate exclusively to Balsalazide or the Product to use the
same in the development, manufacture, formulation, use or exploitation
of Balsalazide and/or the Product only.
2.8 Unless otherwise expressly stated, the rights and obligations of each
Party under this Agreement shall continue without limit in time. It is
acknowledged that neither party shall be entitled to terminate this
Agreement and the rights granted hereunder. 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
remedies of specific performance or injunctive relief and neither Party
shall be entitled to rescind or terminate this Agreement in any
circumstances whatsoever.
3. SUBLICENCES AND ASSIGNMENTS OF PATENTS
3.1 The licences granted to Shire under Clauses 2.1 above shall include the
right to grant Sublicences within the Territory (for the avoidance of
doubt, without any further consent or approval) Provided That;
3.1.1 each such Sublicence shall impose obligations on the
Sublicensee which are no less onerous than the terms of
Clauses 6 and 16 of this Agreement, as imposed on Shire; and
3.1.2 Shire undertakes to use all reasonable commercial endeavours
to procure the performance by any Sublicensee of the terms of
each Sublicence; and
11
{PAGE}
3.1.3 notwithstanding any such Sublicence, Shire shall remain solely
liable for the performance of its obligations hereunder; and
3.1.4 Shire shall promptly as soon as reasonably practicable after
execution notify Glycyx in writing of the execution of any
Sublicence and the terms thereof and supply to Glycyx a copy
of each such Sublicence (with commercially sensitive terms
only redacted); and
3.1.5 In the event that any Sublicensee is granted any right under
the Sublicence to develop the Product or conduct clinical
trials, the conduct of any such development or clinical trials
by a Sublicensee shall be subject to the prior written
approval of Shire; and
3.1.6 each Sublicense shall require the Sublicensee in its exercise
of its rights under the Sublicense in respect of the
marketing, sale and distribution of the Product to maintain
standards of quality and performance substantially similar to
those maintained by Shire and its other Sublicensees in
connection with the Product taking into account only
differences in the standards of the pharmaceutical industry in
each country; and
3.1.7 Shire shall not grant to any Sublicensee any right in respect
of the manufacture of Product Provided that this shall not
prevent Shire from subcontracting to a Third Party (who may
also be a Sublicensee) the manufacture of API or Product for
and on behalf of Shire, its Affiliates or Sublicensees; and
3.1.8 Each Sublicence shall require that the Sublicensee disclose
and license Improvements to Shire to the extent necessary to
enable Shire to comply with Clause 14.1.
3.2 Shire shall not (save only in the event of an assignment of this
Agreement and the rights and obligations hereunder in accordance with
Clause 20) without the prior written consent of Glycyx assign to any
Sublicensee any Product Patent.
3.3 In the event that Glycyx shall grant to a Third Party any licence in
respect of Balsalazide or the Products in respect of any Glycyx Area
(or a substantial part thereof) it shall impose on such licensee:
12
{PAGE}
3.3.1 obligations which are no less onerous than those imposed on
Shire under Clauses 6 and 16 of this Agreement;
3.3.2 in respect of Improvements terms as imposed on Shire
substantially in the form of Clause 14; and
3.3.3 in respect of any sublicence granted by such licensee an
obligation to impose on such sublicensee obligations which are
no less onerous than those which Shire is obliged to impose on
any Sublicensee under Clause 3.1.
For the avoidance of doubt Glycyx shall be entitled to grant or assign
to any such licensee in respect of any Glycyx Area (or substantial part
thereof) at least such rights in respect of the relevant Glycyx Area
(or substantial part thereof) equivalent to those granted to Shire in
respect of the Territory. Glycyx undertakes to use all reasonable
commercial endeavours to procure the performance by any licensee of the
terms of any such licence.
3.4 Save only in the event of an assignment of this Agreement and the
rights and obligations hereunder in accordance with Clause 20, Glycyx
shall only assign any Formulation and Use Patents together with all the
other Formulation and Use Patents. In the event of any such assignment,
Glycyx shall notify Shire in writing of such assignment and shall
notify the assignee in writing of the licence granted in favour of
Shire under the Formulation and Use Patents under Clause 2.1.1 of this
Agreement. Any such assignment shall require the assignee to comply
with and adhere to the terms of the licence granted in favour of Shire
under Clause 2.1.1.
4 BUSINESS OPPORTUNITIES
4.1 Glycyx and Shire shall during the period of [*] days
after the Effective Date discuss in good faith the grant to
Shire of rights in respect of Balsalazide and Product in part
or all of the Excluded Territory, excluding only the USA,
Mexico and Canada, such grant to be upon such terms as may be
negotiated in good faith between the Parties during such
[*] day period or thereafter in the event that the Parties
agree to continue discussions thereafter. During that [*] day
period Glycyx agrees not to, and will procure that its
Affiliates will not, enter into or
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
13
{PAGE}
continue discussions with any person other than Shire
regarding the license, sale, disposal or other grant of rights
in respect of Balsalazide or the Product in part or all of the
Excluded Territory excluding only the USA, Mexico and Canada.
For the avoidance of doubt, upon the expiration of such [*]
day period, Glycyx and its Affiliates shall have no further
obligations to Shire in respect of this Clause 4.1.
4.2 During the period of [* (*)] years after the Effective Date
Glycyx shall notify Shire in writing in the event that Glycyx
or any Glycyx Affiliate proposes to license to any Third Party
the right to market, distribute and sell any pharmaceutical
product (other than Product or Balsalazide) in the Territory
or the Excluded Territory (Glycyx acknowledging for the
avoidance of doubt that it has no right to offer any such
licences in respect of Balsalazide or the Product in the
Territory) and in the event that Shire so requires Glycyx and
Shire shall discuss in good faith for a period of [* (*)] days
following the date of such notice the grant to Shire of rights
in respect of such product upon such terms and in respect of
such territories as may be negotiated in good faith between
the Parties during such [* (*)] day period or thereafter in
the event that the Parties agree to continue discussions
thereafter. During that [*] day period Glycyx agrees not
to, and will procure that its Affiliates will not, enter into
or continue discussions with any person other than Shire
regarding such license. For the avoidance of doubt, upon the
expiration of any such [* (*)] day period, Glycyx and its
Affiliates shall have no further obligations to Shire in
respect of this Clause 4.2 in respect of such specified
pharmaceutical product.
5 Glycyx assistance
Glycyx undertakes to provide Shire with reasonable and timely access to
relevant employees of Glycyx and any Glycyx Affiliate (and to use its
reasonable commercial endeavours (which for the avoidance of doubt
shall include taking such steps as may reasonably be required to
enforce the terms of the Astra Agreement) to provide such access to
employees of Astra if and to the extent reasonably required by Shire
and to the extent that Glycyx can provide the same under the terms of
the Astra Agreement)
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND
FILED SEPARATELY WITH THE SEC.
14
{PAGE}
who are familiar with Balsalazide and the Product or otherwise have
material information in connection with the development, formulation,
manufacture, distribution, marketing and sale of Balsalazide and/or any
Product or any Product Registrations to make available to and transfer
to Shire the Glycyx Manufacturing Technology, the Glycyx Product
Information and the Product Registrations or in connection with matters
arising in respect of the Product Registrations. Such access shall be
free of charge except that Shire shall bear any travel, hotel or other
out of pocket expenses reasonably incurred by Glycyx, Glycyx'
Affiliates or by Astra in providing such assistance. Glycyx shall
provide documentary evidence of any such expenses if required by Shire.
6 MUTUAL COOPERATION
6.1 Shire acknowledges that Glycyx, its Affiliates and/or its
sublicensees will continue the development, distribution,
marketing and sales of Product in the Excluded Territory. Each
Party undertakes to and undertakes to procure that its
Affiliates, Sublicensees and sublicensees shall:
6.1.1 comply fully with the adverse reporting provisions
contained in Clause 13;
6.1.2 participate in regular meetings (at intervals to be
agreed) to discuss usage and performance of the
Product and at which information concerning such
matters may be exchanged.
7 DEVELOPMENT AND MANUFACTURING COMMITTEES
7.1 The Parties shall establish a Development Committee with two
representatives of each Party and with such other committee
members as may reasonably be required from time to time. Such
Development Committee shall;
7.1.1 meet and consult as required under Clause 9.3; and
7.1.2 meet and consult as may be agreed to inform each
Party of any clinical trials or clinical development
proposed or undertaken by either Party in accordance
with Clause 7.2.
15
{PAGE}
The Parties shall at all times have an equal number of
representatives on the Development Committee.
7.2 Each Party undertakes to communicate to the Development
Committee its proposals for any clinical trials (with the
exception of the Clinical Study which is dealt with in Clause
9.3) or clinical development of any Product in the Territory
(in respect of Shire) and in the Excluded Territory (in
respect of Glycyx) and shall take into account any reasonable
requests of the other Party in connection with any such
proposals. The Parties may decide, on terms which may be
agreed, to further consult in respect of such clinical trials,
such as by sharing data.
7.3 The Development Committee shall meet alternately in London and
in Palo Alto, California unless otherwise agreed and shall
liaise regularly by telephone and other communication. It is
proposed that the initial members of the Development Committee
shall be:
Shire: Dr Garrick Fiddler, Mike Burkin
Glycyx: Lorin Johnson, John Brough
Each Party shall use reasonable endeavours to maintain
effective membership of the Development Committee and, if a
person shall cease to be a member of the Development
Committee, shall replace him with a suitably qualified
replacement.
7.4 The Parties shall establish a Manufacturing Committee with two
representatives of each Party and with such other committee
members as may reasonably be required from time to time. The
Manufacturing Committee shall liaise as may be agreed from
time to time in connection with;
7.4.1 The supply of API and finished Product to Shire
during the Supply Period under Clause 10;
7.4.2 Subsequently, the economic manufacture and supply of
API to satisfy the forecast requirements of each
Party (and its Affiliates, Sublicensees and
sublicensees) in accordance with the terms of Clause
10;
16
{PAGE}
7.5 The Manufacturing Committee shall meet alternately in London
and in Palo Alto, California unless otherwise agreed and shall
liaise by telephone and other communication as reasonably
required from time to time by either Party. It is proposed
that the initial members of the Manufacturing Committee shall
be:
Shire: Rob Haslam, Jenny Fox
Glycyx: John Brough, Randy Hamilton
Each Party shall use reasonable endeavours to maintain
effective membership of the Manufacturing Committee and, if a
person shall cease to be a member of the Manufacturing
Committee, shall replace him with a suitably qualified
replacement. The Parties shall at all times have an equal
number of representatives on the Manufacturing Committee.
7.6 It is the intention of the Parties that all matters relating
to the further development of the Product and the manufacture
of API and the Product during the Supply Period and thereafter
shall be discussed in good faith and considered by the
Development Committee or the Manufacturing Committee as may be
agreed between the Parties from time to time. Without in any
way limiting the obligations of Glycyx in respect of the
transfer of the Product Registrations to Shire, Shire may
refer matters concerning the detailed arrangements for such
transfer to the Development Committee. Decisions of the
Development Committee and the Manufacturing Committee shall be
valid only if unanimously agreed by the two representatives of
each Party on the committee.
7.7 In the event that either the Development Committee or the
Manufacturing Committee are unable to reach agreement on any
particular issue, either committee may refer the matter for
determination by the Chief Executive Officers of each Party
("CEOs"). In the event of any such referral each Party shall
prepare and submit to the CEOs a memorandum or statement
setting out its position in respect of the matter in dispute
and its reasons for adopting that position and the CEOs shall
consider the dispute in the light of those statements. If the
CEOs agree upon the resolution of the dispute they shall issue
a joint statement setting out the agreed terms and shall
exercise all powers available to them to procure that the
agreed
17
{PAGE}
terms are fully and promptly carried into effect by the
relevant committee and the Parties.
7.8 If the matter is not resolved or disposed of in accordance
with Clause 7.7 the matter shall be referred to an independent
expert (experienced in the manufacture of pharmaceuticals or
the development of pharmaceutical products, as appropriate who
shall act as an expert and not an arbitrator) appointed by the
agreement of the Parties, or in the event that the Parties are
unable to agree on the independent expert, such expert shall
be appointed at the request of either Party by the President
for the time being of the Royal Pharmaceutical Society of
Great Britain who shall have the authority to appoint such an
expert.
8 TRANSFER BY GLYCYX
8.1 Glycyx hereby assigns to Shire (and agrees to procure the
assignment by Astra, as appropriate), free of any charge or
payment (subject only to Clause 8.2) and free of any third
party right, claim or licence in respect of all or any part
thereof, all right title and interest in and to the Product
Registrations and agrees to take such steps as Shire may
request to formally transfer and register the ownership of the
Product Registrations to Shire and to secure approval of a
change to the records of the relevant Regulatory Authorities
recording Shire as owner.
8.2 Shire shall be responsible for the payment of any fee payable
by the transferee on the transfer of any Product Registration
or by the applicant in connection with any application for
Approval filed by or on behalf of Shire after the Effective
Date.
8.3 Glycyx undertakes as soon as practicable and in any event
within 60 (sixty) days of the Effective Date to deliver free
of charge to Shire (or as it may direct) copies of all Glycyx
Product Information and Glycyx Manufacturing Technology.
8.4 Glycyx undertakes at its own cost (subject to Clause 5) to
procure the prompt performance by Astra of Astra's obligations
under the Astra Agreement including taking all such steps as
may be required to enforce the terms of the Astra Agreement
insofar as may be necessary to obtain for Shire the rights
granted under this Agreement.
18
{PAGE}
9 PRODUCT REGISTRATIONS
9.1 Shire shall use all reasonable commercial endeavours to obtain
Approvals in each of France, Germany and the Netherlands as
soon as reasonably practicable.
9.2 Glycyx and Shire will each use their reasonable commercial
endeavours to and Glycyx will use its reasonable commercial
endeavours to procure that Astra will, obtain Transfer Dates
which are as soon after the Effective Date as possible.
9.3 In the event that Shire ascertains that the relevant
Regulatory Authorities require additional clinical data to be
filed before granting Approval in Germany, France and the
Netherlands, Shire may, in its absolute discretion (subject to
Clause 9.1) decide to conduct a clinical study in order to
assist in obtaining an Approval (the "Clinical Study"). Shire
shall communicate such decision and details of the form and
protocol of the Clinical Study to the Development Committee
and Shire shall give due consideration to the views of the
Development Committee in respect of the Clinical Study it
being acknowledged that all decisions in respect of the
Clinical Study are ultimately to be made by Shire acting in
its sole discretion. Subject to clause 9.4, Shire shall be
responsible for the conduct of any such Clinical Study and
will provide all medical resources and clinical study
monitors. Shire shall keep the Development Committee informed
as to the conduct, progress and results of the Clinical Study.
Glycyx shall have prompt and full unrestricted access to the
final report and results of the Clinical Study and shall be
entitled to use such results and disclose the same to Third
Parties for use in connection with the registration,
marketing, sale and use of the Product in the Excluded
Territory only.
9.4 Glycyx shall reimburse to Shire costs incurred by Shire and
payable to Third Parties and all direct internal costs
(including for example, salaries) incurred by Shire in the
conduct of the Clinical Study up to a maximum sum of
(pound)[*] [(*] pounds Sterling). Unless otherwise agreed by
the parties, Glycyx will reimburse Shire for such costs within
30 days of Shire issuing an invoice for such costs incurred
and supplying documentation in support thereof.
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
19
{PAGE}
9.5 Glycyx undertakes to retain cash or cash equivalent balances
of not less than the maximum liability to effect the
reimbursement remaining outstanding from time to time under
Clause 9.4 until the earlier of:-
9.5.1 the reimbursement by Glycyx to Shire of (pound)[*]
([*] pounds Sterling) in total in connection with the
conduct of the Clinical Study in accordance with this
Clause 9;
9.5.2 the grant of first Approval in all of Germany, France
and the Netherlands; and
9.5.3 notification by Shire to Glycyx that it does not
intend carrying out any Clinical Study or otherwise
that Glycyx is released from any obligation to
reimburse Shire under Clause 9.4.
10 SUPPLY OF PRODUCT
10.1 Glycyx will within 5 days of the Transfer Date in respect of a
relevant country purchase from Astra in accordance with the
terms of the Astra Agreement all Astra Stock in respect of
such country.
10.2 Glycyx will sell to Shire and Shire will purchase, within 5
days of each Transfer Date all Astra Stock in respect of the
relevant country at a price of (pound)[*]p (plus VAT if
applicable) per capsule. Payment for such Astra Stock shall be
made within 30 days of the receipt by Shire of the invoice
therefor. If Shire notifies Glycyx in writing prior to the
Transfer Date that it does not want to purchase any of the
Astra Stock Glycyx shall have no obligation to purchase the
Astra Stock under Clause 10.1 and Astra will be entitled to
sell such Astra Stock in the relevant country in the Territory
thereafter in accordance with the terms of the Astra
Agreement.
10.3 Glycyx undertakes to grant to Shire a non exclusive fully paid
up royalty free licence under the rights to be granted to
Glycyx by Astra under Clause 18.4.7 of the Astra Agreement and
under the Astra Termination Letter to use any Astra trade
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
20
{PAGE}
mark, trade name or logo or marking appearing on Astra Stock
sold to Shire under Clause 10.2 for a period reasonably
required by Shire to enable Shire to use and sell such Astra
Stock.
10.4 Shire will within 60 days of the Effective Date place a
written order on Glycyx for the quantity of Glycyx Stock which
Shire wishes to purchase and Glycyx will sell and Shire will
purchase such quantity of Glycyx Stock at a price of
(pound)[*]p (plus VAT if applicable) per capsule. For the
avoidance of doubt Glycyx acknowledges that it has no right to
sell in the Territory any Glycyx Stock which is not purchased
by Shire (other than to Astra). Payment for such Glycyx Stock
shall be made within 30 days of the receipt by Shire of the
invoice therefor.
10.5 Notwithstanding Clause 17, Glycyx agrees to indemnify and hold
Shire and/or its Affiliates harmless from and against any
Liabilities suffered or incurred in connection with Third
Party claims for personal injuries or any Product recall to
the extent caused by any defect in any Astra Stock or Glycyx
Stock purchased by Shire, except to the extent that Shire is
liable in respect thereof under Clause 10.6.
10.6 Notwithstanding Clause 17, Shire agrees to indemnify and hold
Glycyx, its Affiliates and sublicensees harmless from and
against any Liabilities suffered or incurred in connection
with Third Party claims for personal injuries or any Product
recall to the extent caused by:
10.6.1 any amendment or alterations made by Shire (or its
Affiliates or Sublicensees) to any of the Astra Stock
or Glycyx Stock or to any packaging of the Astra
Stock or Glycyx Stock; or
10.6.2 any material supplied by Shire or any Shire Affiliate
or Sublicensee with any Astra Stock or Glycyx Stock
in addition to and together with the Astra Stock or
Glycyx Stock as delivered by Glycyx, upon its sale by
Shire or any Shire Affiliate or Sublicensee; or
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
21
{PAGE}
10.6.3 reason of any sale by Shire (its Affiliates or
Sublicensees) of any Astra Stock or Glycyx Stock
which as at the date of such sale does not comply
with the Product specification current at such date
to the extent such failure to comply is caused by
Shire (its Affiliates or Sublicensees).
10.7 Glycyx agrees to introduce Shire to all Third Party
Contractors manufacturing or preparing to manufacture API
and/or Product for and on behalf of Glycyx as at the Effective
Date.
10.8 For the avoidance of doubt, Shire shall be entitled to procure
and license the manufacture, packaging or distribution (among
other things) of API and/or Product for and on behalf of
Shire, its Affiliates or Sublicensees by such Third Party
Contractors, or in such other manner as it considers
appropriate upon such terms as may be agreed between Shire and
Third Party Contractors subject always to Clauses 10.9, 10.10
and 10.11 and 10.12.
10.9 The Parties shall through the Manufacturing Committee liaise
and consult in identifying and establishing additional Third
Party Contractors for the manufacture and supply of API and
Product.
10.10 At any time when there shall be a shortage of supply of API
and/or Product from Third Party Contractors supplying both
Shire and Glycyx (or their Affiliates, Sublicensees or
sublicensees) sufficient to satisfy the demand for API and/or
Product by either Party (or its Affiliates, Sublicensees or
sublicensees), Glycyx and Shire agree to consult with the
Third Party Contractor and allocate available API and/or
Product quantities between themselves by reference to their
requirements for Product:
10.10.1 calculated by reference to [*] within their
respective territories as specified in [* (*)]; and
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
22
{PAGE}
10.10.2 necessary to maintain existing and forecast sales
levels in the Territory and the Excluded Territory
existing as at the date of the shortage of supply;
and
10.10.3 in respect of the [*] within their respective
markets at the date of any such shortage of supply.
10.11 Shire undertakes to use all reasonable commercial endeavours
to obtain API during the Supply Period at the most economic
price. Shire will use reasonable commercial endeavours to
procure that [*] in respect of its premises at [*] and at [*]
are added on relevant Product Registrations in the Territory
provided that this shall not delay or have any other adverse
impact on the Transfer Date. Notwithstanding that Shire shall
order and obtain API from Third Party Contractors direct on
its own account during the Supply Period, the Parties shall
make such payments as shall ensure that the price borne by
Shire for all quantities of API delivered to Shire during the
Supply Period (up to a maximum aggregate total of [*] [(*)]
tonnes (the "Maximum Quantity")) shall be (pound)[*]p ([*]
pounds Sterling) per kilogram of API (the "Price"). Within 30
(thirty) days of each of 31 December 2000 and 31 December
2001, the Parties shall review the total aggregate quantity
of API delivered to Shire, the price paid by Shire for such
quantity and upon review in December 2001, sums paid by
either Party on the December 2000 reconciliation and upon such
review shall effect such payment taking account of the
aggregate total to the date of the reconciliation and any sums
paid on the previous reconciliation, as may be required to
procure that the price borne by Shire for API shall be the
Price. Any such payment shall be made by Shire to Glycyx in
the event that the actual price paid shall be less than the
Price and shall be made by Glycyx to Shire in the event that
the actual price paid shall be greater than the Price.
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
23
{PAGE}
10.12 Shire shall not enter into any contract with any Third Party
Contractor for the supply of API during the Supply Period
without the prior approval of Glycyx (such approval not to be
unreasonably withheld or delayed subject to Glycyx being
satisfied as to the price of supply and the availability of
supply to meet the demand of both Glycyx and Shire for API
during the Supply Period). In the event that Shire proposes to
obtain its supplies of API during the Supply Period from a
Third Party at a price different from the Price it shall
notify Glycyx and if the price exceeds the Price Shire will
give Glycyx the opportunity to obtain the supply to Shire of
the quantities required to be delivered in the Supply Period
(up to the Maximum Quantity) from such Third Party Contractor
or Third Party as Glycyx may designate.
11 REPRESENTATIONS AND WARRANTIES
11.1 Each Party represents and warrants to the other Party as
follows:-
11.1.1 that it is a duly organized and validly existing
corporation under the laws of its jurisdiction of
incorporation;
11.1.2 that it has full corporate power and authority and
has taken all corporate action necessary to enter
into and perform this Agreement;
11.1.3 that the execution and delivery of this Agreement and
the transactions contemplated herein do not violate,
conflict with or constitute a default under its
charter or similar organization document, its bylaws
or the terms or provisions of any material agreement
or other instrument to which it is a party or by
which it is bound, or any order, award, judgment or
decree to which it is a party or by which it is
bound; and
11.2 Glycyx represents and warrants that:
11.2.1 So far as Glycyx or its Affiliates are aware (without
having made enquiry) no Product manufactured,
distributed, sold or used by Glycyx and/or its
Affiliates and/or its sublicensees prior to the
Effective Date in the Territory infringes, has
24
{PAGE}
infringed, is alleged to infringe or has been alleged
to infringe any Intellectual Property Rights of any
Third Party;
11.2.2 So far as Glycyx or its Affiliates are aware (without
having made enquiry) no Product manufactured sold or
used in accordance with any of the Product Patents
prior to the Effective Date in the Territory
infringes or is alleged to infringe any Intellectual
Property Rights of any Third Party;
11.2.3 Neither Glycyx nor any of its Affiliates has at any
time prior to the Effective Date made any commitment
or incurred any obligation which conflicts with any
licences or other rights granted to Shire under this
Agreement;
11.2.4 So far as Glycyx or its Affiliates are aware (without
having made enquiry) none of its sublicensees has at
any time prior to the Effective Date made any
commitment or incurred any obligation which conflicts
with any licences or other rights granted to Shire
under this Agreement;
11.2.5 There are in respect of the Territory or any part
thereof:-
11.2.5.1 no outstanding orders, judgments,
injunctions, awards or decrees of any court
or arbitrator or any other governmental
regulatory body notified to Glycyx its
Affiliates or Astra relating to Balsalazide
or any Product;
11.2.5.2 no challenges, oppositions, actions, suits,
personal injury or product liability or
other claims, legal, administrative or
arbitral proceedings or investigations
against Glycyx, its Affiliates or Astra
pending or threatened against or relating to
Balsalazide or any Product;
11.2.6 There are in respect of any part of the Excluded
Territory so far as Glycyx is aware without having
made enquiry;
11.2.6.1 no outstanding orders, judgments,
injunctions, awards or decrees of any court
or arbitrator or any other governmental
regulatory body notified to Glycyx, its
Affiliates or sublicensees relating to
Balsalazide or any Product;
25
{PAGE}
11.2.6.2 no challenges, oppositions, actions, suits,
personal injury or product liability or
other claims, legal, administrative or
arbitral proceedings or investigations
against Glycyx, its Affiliates or
sublicensees pending or threatened against
or relating to Balsalazide or any Product
which have had or in the reasonable opinion
of Glycyx may have a material adverse effect
on the development, manufacturing or sale of
the Product in the Territory;
11.2.7 Glycyx has at the Effective Date disclosed to Shire
all licences granted by Glycyx, its Affiliates (and
so far as Glycyx is aware without having made
enquiry, its sublicensees) in relation to the Product
Patents, the Glycyx Product Information and any
Product Registration in the Territory. So far as
Glycyx and its Affiliates are aware there have been
no past breaches of any such licences which in the
reasonable opinion of Glycyx are likely to have a
material adverse effect on the rights granted to
Shire under this Agreement. Save as disclosed in
respect of Astra and in respect of the Biorex
Agreement none of such licences is continuing as at
the Effective Date and so far as Glycyx and its
Affiliates are aware no party to such licences which
remain in force as at the Effective Date has
committed any material breach of the terms of such
licence.
11.2.8 Schedule 5 to this Agreement lists all entities
currently manufacturing API and all entities which
have previously manufactured commercially significant
quantities of API for and on behalf of Glycyx, its
Affiliates or its or their sublicensees anywhere in
the world.
11.2.9 So far as Glycyx and its Affiliates are aware without
having made enquiry the Formulation and Use Patents
are legally and beneficially owned by Glycyx free
from all liens, charges and encumbrances.
11.2.10 So far as Glycyx is aware without having made enquiry
all renewal fees and steps for the maintenance or
protection of the Formulation and Use Patents have
been paid or taken.
26
{PAGE}
11.2.11 Neither Glycyx nor any of its Affiliates nor, so far
as Glycyx and its Affiliates are aware without having
made enquiry, any sublicensee has (except in the
ordinary and normal course of business or under an
obligation of confidence) disclosed or permitted to
be disclosed to any person other than Shire any
material Glycyx Manufacturing Technology or Glycyx
Product Information ("Information"). So far as Glycyx
is aware without having made enquiry, no Third Party
has obtained or is using any such Information
(insofar as such Information is confidential and
proprietary to Glycyx) without the authority of
Glycyx and no Third Party who has obtained any such
Information with the authority of Glycyx is using any
of such Information (insofar as such Information is
confidential and proprietary to Glycyx) otherwise
than as permitted by such authorisation.
11.2.12 So far as Glycyx is aware (without having made any
enquiry), the Product Patents and the Formulation and
Use Patents are valid and enforceable and so far as
Glycyx is aware (without having made enquiry) no act
has been done or omission permitted whereby any of
the Formulation and Use Patents has ceased to be
valid and enforceable and so far as Glycyx is aware
(without having made enquiry) no circumstance exists
which might cause any of the Formulation and Use
Patents to cease to be valid and enforceable.
11.2.13 So far as Glycyx and its Affiliates are aware without
having made enquiry (save of Astra), no Third Party
is infringing or has infringed any of the Product
Patents or any of the Formulation and Use Patents.
11.2.14 Save as acknowledged by Shire in a letter to Glycyx
of even date herewith Glycyx is not aware of any
written communication from or to a Regulatory
Authority which indicates that any Product
Registrations granted are likely to be invalid or
subject to challenge, revocation or withdrawal or
that applications for any Product Registrations are
likely to be rejected.
11.2.15 So far as Glycyx is aware, having enforced the terms
of the Astra Agreement it is in possession of all
documents, material and information that is or are
material in connection with the Product
Registrations. Glycyx has given
27
{PAGE}
Shire full and unrestricted access to all documents
in the possession of Glycyx concerning the Product
Registrations.
11.2.16 So far as Glycyx and its Affiliates are aware without
having made enquiry (save of Astra) no trade marks
other than the Trade Marks have been used in
connection with the Product by Glycyx or its
Affiliates or sublicensees (including Astra) in the
Territory.
11.2.17 So far as Glycyx is aware without having made
enquiry, there are no continuations, continuations in
part, divisions, subdivisions, renewals, reissues,
extensions (including SPCs) relating to the Product
Patents or any patent rights claiming priority from
the Product Patents save as listed in the Schedule to
the Patent Assignment.
11.2.18 As of the Effective Date there are no patents or
patent applications within the Territory, other than
the Product Patents and the Formulation and Use
Patents, related to Balsalazide in the name of either
Glycyx or its Affiliates or Biorex or its Affiliates.
11.3 In this Clause 11, where reference is made to enquiry having
been made of Astra, it is acknowledged that enquiry has only
been made of Mr [*] of Astra in the form of a letter quoting
the terms of Clauses 11.2.13 or 11.2.16 and requesting him to
notify Glycyx if he or Astra is aware of any matter which
might constitute a breach of either or both of these
warranties and Mr [*] replied orally on May 9 2000 that he was
not aware of any such matter, on the basis that neither Mr [*]
nor Astra was liable in any manner whatsoever in respect of
such reply.
11.4 Save to the extent provided in this Clause 11, Glycyx makes no
representations, extends no warranties of any kind, either
express or implied, with respect to the manufacture, use,
sale, or other disposition by Shire or its Sublicensees or
other transferees of the Products. THE WARRANTIES EXPRESSLY
SET FORTH IN THIS CLAUSE 11 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.
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
28
{PAGE}
11.5 EACH PARTY ACKNOWLEDGES THAT IN ENTERING INTO THIS AGREEMENT
IT DOES NOT DO SO ON THE BASIS OF AND DOES NOT RELY ON ANY
REPRESENTATION OR WARRANTY OR OTHER PROVISION (EXCEPT AS
EXPRESSLY PROVIDED HEREIN) AND ALL CONDITIONS, WARRANTIES OR
OTHER TERMS IMPLIED BY STATUTE OR COMMON LAW ARE HEREBY
EXCLUDED TO THE FULLEST EXTENT PERMITTED BY LAW.
12 PAYMENTS TO GLYCYX
12.1 In consideration of the rights granted to Shire under the
terms of this Agreement Shire shall pay to Glycyx:
12.1.1 Subject to Clause 12.5 on the date hereof by
telegraphic transfer to Glycyx' Solicitors the sum of
(pound)7,828,000 (the "First Payment"); and
12.1.2 Subject to Clause 12.5 within 5 working days of the
UK Transfer Date, by telegraphic transfer to Glycyx'
Solicitors the sum of (pound)[*] (the "Second
Payment"). The First and Second Payments are together
referred to as the "Initial Payment"; and
12.1.3 Within 30 days of the grant of first Approval in
Germany (if any), the sum of(pound)[*]; and
12.1.4 Within 30 days of grant of first Approval in France
(if any), the sum of(pound)[*]; and
12.1.5 Within 30 days of the grant of first Approval in The
Netherlands (if any), the sum of(pound)[*]; and
12.1.6 On or before 1st February 2004 the sum of (pound)[*],
such sum to be payable only in the event that the
aggregate total Net Sales of all sales of the Product
made by or on behalf of Shire its Affiliates or
Sublicensees in the
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
29
{PAGE}
United Kingdom in the period from the UK Transfer
Date to 31st December 2003 shall exceed
(pound)[*]
Provided Always That in the event that Shire sells Product in
any of France, Germany or the Netherlands without having
obtained Approval in respect of any such country the payments
due in accordance with Clauses 12.1.3, 12.1.4 and 12.1.5 above
shall be payable on the first sale of Product in such country.
12.2 [*]
12.2.1 [*
*
*
*]
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
30
{PAGE}
[*]
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION
OMITTED AND FILED SEPARATELY WITH THE SEC
31
{PAGE}
[*]
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC
32
{PAGE}
Table 1 of Target Sales (GPB (pound))
{TABLE}
{CAPTION}
------------------------------------------------------------------------------------------------------------
Country Year
-----------------------------------------------------------------------------------------
2001 2002 2003 2004 2005
------------------------------------------------------------------------------------------------------------
All GBP
------------------------------------------------------------------------------------------------------------
{S} {C} {C} {C} {C} {C}
UK [* * * * *
------------------------------------------------------------------------------------------------------------
Austria * * * * *
------------------------------------------------------------------------------------------------------------
Belgium * * * * *
------------------------------------------------------------------------------------------------------------
Denmark * * * * *
------------------------------------------------------------------------------------------------------------
Finland * * * * *
------------------------------------------------------------------------------------------------------------
France * * * * *
------------------------------------------------------------------------------------------------------------
Germany * * * * *
------------------------------------------------------------------------------------------------------------
Iceland * * * * *
------------------------------------------------------------------------------------------------------------
Ireland * * * * *
------------------------------------------------------------------------------------------------------------
Luxembourg * * * * *
------------------------------------------------------------------------------------------------------------
Netherlands * * * * *
------------------------------------------------------------------------------------------------------------
Norway * * * * *
------------------------------------------------------------------------------------------------------------
Sweden * * * * *
------------------------------------------------------------------------------------------------------------
Switzerland * * * * *
------------------------------------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------
TOTAL * * * * *]
------------------------------------------------------------------------------------------------------------
{/TABLE}
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
33
{PAGE}
12.2.2 [*]
12.2.3 [*]
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
34
{PAGE}
[*]
12.2.4 [*]
12.2.5 [*]
12.2.6 [*]
12.2.7 [*]
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
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[*]
12.3 All payments due under this Clause 12 shall be made through
the banking system on or before the due date into such bank
account as Glycyx shall designate in writing from time to time
for the receipt of such payments.
12.4 If Shire or Glycyx fails to pay any sums due under this
Agreement by the due date, it shall pay interest on the amount
from time to time outstanding (before and after any expiry of
this Agreement and any judgement), from the date that the same
became due until actual payment, at a rate of 2% above the
base rate from time to time of Barclays Bank plc.
12.5 Shire may at its option (to the extent permitted by law) pay
up to (pound)1,600,000 (one million six hundred thousand
pounds Sterling) of the First Payment and up to (pound)600,000
(six hundred thousand pounds Sterling) of the Second Payment
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:-
12.5.2 the Consideration Shares shall be allotted to Glycyx
(or as it may direct) within 15 days of the Effective
Date in respect of First Payment and within 15 days
of the UK Transfer Date in respect of the Second
Payment; and
12.5.3 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 First Payment and
the UK Transfer Date in respect of the Second
Payment; and
12.5.4 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
12.5.5 the Consideration Shares shall on allotment be
admitted to the Official List of the London Stock
Exchange and may be traded freely upon allotment.
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
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12.6 It is acknowledged that Glycyx shall receive part of the
payments under Clause 12.1 for and on behalf of Biorex in
consideration of the Assignments.
12.7 Save for the payments received under Clause 12.6, and the sum
of (pound)[*] in respect of the licence of the Formulation and
Use Patents insofar as they relate to the United Kingdom, the
Parties acknowledge that Glycyx is being paid in consideration
of the development of Balsalazide and Product (which
development includes all necessary pre-clinical and clinical
studies conducted prior to the Effective Date and the
preparation and filing of a dossier and the grant of Approval
in the United Kingdom) and the exclusive right to market and
sell Product in the Territory transferred under this
Agreement.
13 PRODUCT DATABASE AND ADVERSE REACTIONS REPORTING
13.1 The determination of whether an event amounts to a serious or
unexpected adverse event will be assessed in accordance with
the approved labelling in the country in which the event
occurred.
13.2 Shire shall maintain a database of all adverse and other
reactions or events occurring in connection with the Product
in any part of the Territory and shall use reasonable
endeavours to procure that any such adverse and other
reactions are notified to it in a timely manner by any
Sublicensee and/or distributor of the Product.
13.3 Glycyx shall maintain a database of all adverse and other
reactions or events occurring in connection with the Product
in any part of the Excluded Territory and shall use reasonable
endeavours to procure that any such adverse and other
reactions are notified to it in a timely manner by any
sublicensee and/or distributor of the Product.
13.4 On at least an annual basis a meeting will be held between
representatives of both Shire and Glycyx to review and if
necessary reconcile the data contained in the Shire and Glycyx
reaction databases.
[*] CONFIDENTIAL TREATMENT REQUESTED; CERTAIN INFORMATION OMITTED AND FILED
SEPARATELY WITH THE SEC.
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13.5 Each Party undertakes:-
13.5.1 to notify the other Party by telephone, or facsimile
transmission or electronic mail within 24 hours of
becoming aware of any serious or unexpected adverse
reaction or contra indication to the Product, such
notification to include a summary of such event.
Written documentation of any such event must be
received by the other Party on a CIOMS form along
with an analysis of similar events within 3 (three)
working days of verbal notification;
13.5.2 to use reasonable efforts to provide to the other
Party, as appropriate, follow-up safety information
regarding any such reaction or event using a CIOMS
form;
13.5.3 to notify the other Party within 3 (three) months, on
a quarterly basis, of other adverse reactions or
contra indications to the Product other than stated
under 13.5.1;
13.5.4 to provide to the other Party in a timely manner
copies of all safety reports submitted to any
Regulatory Authority in the Territory or the Excluded
Territory, as appropriate; and
13.5.5 to notify the other Party regarding sales volumes, by
providing in writing quarterly unit sales figures by
reference to each part of the Territory or Excluded
Territory, as appropriate. Such information will be
used by the other Party to generate "increased
frequency" data for periodic safety reporting to the
appropriate Regulatory Authority in the Territory or
Excluded Territory, as appropriate.
14 IMPROVEMENTS
14.1 In the event that either Party or any Affiliate, Sublicensee
or (to the extent such sublicence agreement provides therefor)
sublicensee of either Party shall develop, identify or create
any Improvement it shall promptly notify the Manufacturing
Committee and shall grant to the other Party an irrevocable,
non-exclusive, fully paid up licence (with the right to
sublicense) to develop, use, manufacture, have
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manufactured, exploit, market and sell any such Improvement in
connection only with the manufacture of the Product or
Balsalazide in the Territory or the Excluded Territory as
appropriate.
14.2 In the event that either Party or any Affiliate or Sublicensee
or sublicensee of either Party shall develop, identify or
create any improvement or amendment to the Product or
Balsalazide it may in its sole discretion notify the other
Party and may in its sole discretion enter into negotiations
concerning the grant of a licence to the other Party in
respect of such improvement or amendment upon such terms as it
thinks fit.
15 PRODUCT PATENTS, FO