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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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Size: |
Preview shows 11KB of 52KB total |
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Price: |
$44 |
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ID: |
#327328 |
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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.
{PAGE}
CONTENTS
--------
{TABLE}
{CAPTION}
PAGE
----
{S} {C} {C}
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 MARK ASSIGNMENT
{/TABLE}
2
{PAGE}
This Agreement is made the 17th day of May 2000
B E T W E E N:
(1) 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"); and
(2) Glycyx Pharmaceuticals, Ltd. a company incorporated in Bermuda having
its registered office at Milner House, 18 Parliament Street, Hamilton,
HM12 Bermuda ("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
{PAGE}
(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
{PAGE}
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 SE-151 85
Sodertalje, Sweden.
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 mark "Colazide"
registered number 267930 and the community trade mark "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 Covington & Burling, Registered Foreign
Lawyers and Solicitors - London of Leconfield House, Curzon Street,
London, W1Y 8AS.
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
{PAGE}
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 Section 6, Medicines Act 1968.
1.16 "Milestone Sums" shall be as defined in Clause 5.3.1.
1.17 "National Trade Marks" means the trade mark "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
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