Exhibit 10.29
JOINDER
This JOINDER, dated as of February 26, 2004, is made by
Bioenvision, Inc., a Delaware corporation
("Bioenvision"), with an address at
509 Madison Avenue, Suite 404, New York,
New York 10022.
The undersigned hereby agrees to be bound by, and subject to,
each of the terms and conditions of the
Manufacturing and Distribution
Agreement, dated and effective as of
December 10, 2001 (the "Effective Date"),
between Stegram Pharmaceuticals Limited
("Stegram") and Arnolds Veterinary
Products, a trading division of Dechra Ltd.
("Arnolds"), as the same may be
amended or restated at any time or from
time to time (the "Agreement"), a copy
of which is attached as Exhibit A hereto:
provided; however, that:
(i)
Arnolds and Stegram agree that, from and after the date hereof
until the termination of or expiration of the Agreement,
Bioenvision shall have the right to receive fifty percent (50%)
of all royalty payments otherwise due and owing by Arnolds to
Stegram pursuant to Section 8.1 of the Agreement, in each case,
on the same terms and provisions as such payments are due to be
paid to Stegram under the Agreement;
(ii) Arnolds
shall not market the Product other than for veterinary
use without the prior written consent of Bioenvision;
(iii) Bioenvision
agrees that it shall not actively promote or supply
trilostane/modrenal into the veterinary market; and
(iv) Arnolds and
Stegram agree that Bioenvision shall be considered a
party to the Agreement from and after the date hereof.
IN WITNESS WHEREOF, Bioenvision has executed this Joinder as of
the date first-above written.
BIOENVISION, INC.
By: /s/ David P. Luci
--------------------------------
Name: David P. Luci
Title: Director of
Finance
AGREED TO AND ACCEPTED (as of
the date first-above written):
STEGRAM PHARMACEUTICAL LIMITED
By: /s/ P.W. Ellson
-------------------------
Name:
P.W. Ellson
Title:
Director
<PAGE>
ARNOLDS VETERINARY PRODUCTS
By: /s/ E. Torr
----------------------
Name:
E. Torr
Title:
Business Development
Director
<PAGE>
DATED:
2001
--------------------------------------------------------------------------------
(1) STEGRAM PHARMACEUTICALS LIMITED
-and-
(2) ARNOLDS VETERINARY PRODUCTS LIMITED
-----------------------
MANUFACTURING AND
DISTRIBUTION AGREEMENT
-----------------------
================================================================================
DLA
Date
of Original: 7
November 2001
Victoria Square House
Date of Version: 10
December 2001
Victoria Square
Draft No: 1
Birmingham B2 4DL
Tel: 08700 111 111
FE Ref. DG
Fax: 0121 262 5794
DP Ref:
STEGRAMAGG.DOC
================================================================================
<PAGE>
TABLE OF CONTENTS
================================================================================
1.
DEFINITIONS............................................................1
2. SUPPLY OF
TRILOSTANE...................................................3
3. SPECIFIC
OBLIGATIONS RELATING TO THE PRODUCT...........................5
4. TECHNICAL
INFORMATION..................................................6
5.
MANUFACTURING AND DISTRIBUTION
LICENSES................................6
6.
IMPROVEMENTS...........................................................7
7. OWNERSHIP
OF IMPROVEMENTS/STEGRAM IPRS.................................7
8.
ROYALTY................................................................8
9.
CONFIDENTIALITY........................................................9
10.
PATENTS...............................................................10
11. OWNERSHIP OF THE
STEGRAM'S IPRS.......................................11
12. TERM AND
TERMINATION..................................................12
13.
GENERAL...............................................................13
JOINDER1...............................................................1
1.
DEFINITIONS............................................................1
2. SUPPLY OF
TRILOSTANE...................................................3
3. SPECIFIC
OBLIGATIONS RELATING TO THE PRODUCT...........................5
4. TECHNICAL
INFORMATION..................................................6
5.
MANUFACTURING AND DISTRIBUTION
LICENSES................................6
6.
IMPROVEMENTS...........................................................7
7. OWNERSHIP
OF IMPROVEMENTS/STEGRAM IPRS.................................7
8.
ROYALTY................................................................8
9.
CONFIDENTIALITY........................................................9
10.
PATENTS...............................................................10
11. OWNERSHIP OF THE
STEGRAM'S IPRS.......................................11
12. TERM AND
TERMINATION..................................................12
13.
GENERAL...............................................................13
21
Options to
acquire Intellectual Property Rights ......................21
APPENDIX..............................................................22
Patents
..............................................................22
<PAGE>
THIS AGREEMENT is made on
2001
BETWEEN
(1) STEGRAM
PHARMACEUTICALS LIMITED (registered in England number 2434770)
whose registered office is at: 44 Broomfield Drive,
Billingshurst,
Sussex: RH14 9TN ("Stegram")
(2) ARNOLDS
VETERINARY PRODUCTS LIMITED (registered in England number
505382) whose registered office is at Dechra House, Jamage
Industrial
Estate, Talke Pits, Stroke on Trent, Staffordshire ST7 LXW
("Arnolds")
BACKGROUND
1. Stegram
produces a chemical substance know as Trilostane (and
hereinafter referred to as "Trilostane") used in the manufacture of
a
veterinary product for the treatment of dogs, horses and other
animals.
2. Arnolds is
engaged in the formulation, manufacture, licensing and
distribution of products for veterinary use.
3. Arnolds
wishes to manufacture, license and distribute the Product (as
defined below) for veterinary use.
OPERATIVE PROVISIONS
1.
DEFINITIONS
1.1 In
this agreement, unless the context otherwise requires, the
following expressions shall have the following meanings:
"Effective Date" means [the date of this agreement];
"Group" means Arnold
and any company which is a subsidiary or the
holding company of Arnolds or any subsidiary of the holding
company of Arnolds (including, without limitation, Dales
Pharmaceuticals Limited);
"Group Company" means any company which is a member of the
Group;
"Improvements" means all improvements, modifications or
adaptations to any part of the Technical Information which
might
reasonably be of commercial interest to either party in the
design, development, manufacture or supply of the Product for
veterinary use or in the operation of the process used in the
manufacture of the Product and which may be made or acquired by
either party during the term of this agreement;
IPRs" means patents, trade marks, service markets, design
rights
(whether registerable or otherwise), applications for any of
the
foregoing, copyright,
1
<PAGE>
database rights know-how, trade or business names and other
similar rights or obligations whether registerable or not in
any
country (including but not limited to the United Kingdom) where
related to veterinary use;
"MA" means any marketing authorization or any other
pharmaceutical or product license consent or approval relating
to
the manufacture or supply by Arnolds of the Product in any
country within the Territory;
"Stegram IPRs" means:
1.1.1.1 the
patents (and applications) short
particulars of which are listed in
schedule 1;
1.1.1.2 all
patent applications that may
hereafter be filed in the Territory by
or on behalf of Stegram which either are
based on or claim priority from any of
the foregoing patents [and applications]
or which are in respect of any
Improvements to which Stegram is
entitled and which Stegram is due to
disclose to Arnolds under this
agreement;
1.1.1.3 all
patents which may be granted
pursuant to any of the foregoing patent
applications; and
1.1.1.4 all
other Intellectual Property Rights
of Stegram and any applications therefor
which relate to the Products or the
"Trilostane" or which relate to or are
used in the design, manufacture,
assembly or supply of Products or the
Trilostane;
"Net Sales Value" means the total value of all sales of the
Products invoiced to third party customers by Arnolds after
deduction of trade discounts, credits and allowances and
exclusive of Value Added Tax;
"Product" means the product sold under the Trade Mark Vetoryl
and
any other product which may be added to Schedule 2 in the
future;
"Trilostane" means the raw materials referred to in schedule 3
[and such other raw materials or compounds which are agreed in
writing to be added to schedule 3];
"Technical Information" means all identifiable know-how,
experience, data, drawings, designs, technical reports,
specifications and all other technical or commercial
information
relating to the Product or the RMs or relating to or used in
the
design, manufacture, assembly, marketing or supply of the
Product
or the RMs (including all know-how and technical information
contained in the Drug Master File relating to the process used
to
manufacture the Product using the RMs) as appropriate for
veterinary use;
2
<PAGE>
"Territory" means the countries listed in schedule 4 and any
other country which is agreed in writing by the parties to be
added to schedule 4;
"Trace Mark" means Vetoryl;
"VMD" means the Veterinary Medicine Directorate.
1.2 In
this agreement any reference to the term "Arnolds" shall
include any other Group Company including, without limitation,
Dales Pharmaceuticals Limited.
1.3 In
this agreement any reference to the term "Stegram" shall
include any subsidiary or holding company of Stegram and any
subsidiary of any holding company of Stegram.
1.4 In
this agreement the terms "subsidiary" and "holding company"
shall have the meanings ascribed to those terms in section 736
of
the Companies Act 1985 (as amended).
1.5 In
this agreement, except where the context otherwise requires:
1.5.1 the use of
the singular includes the plural and vice
versa;
1.5.2 any
reference to "person" or "persons" includes
natural persons, firms, partnerships, companies,
corporations, associations, organizations,
governments, states, foundations and trusts (in each
case whether or not having a separate legal entity).
2. SUPPLY OF
TRILOSTANE
2.1
Arnolds agrees to purchase from Stegram or its designee and
Stegram agrees to sell or cause to be sold to Arnolds
exclusively
all of Arnolds requirements for Trilostane during the terms of
the Agreement. Stegram agrees not to sell or cause to be sold
Trilostane for using in the veterinary field to any party in
the
territory other than Arnolds.
2.2
Stegram and Arnolds agree that either, or both parties shall
seek
to identify an alternative source of Trilostane with the prior
written agreement of the other party.
2.3
Stegram shall comply with all applicable regulations or legal
requirements concerning the manufacture, packaging, packing,
supply and delivery of the Trilostane and the performance of
its
obligations under this agreement.
2.4 The
price of the Trilostane shall be the price specified in
schedule 5 or such other price as shall be agreed in writing by
the parties.
3
<PAGE>
The price of the Trilostane shall be:
2.4.1 exclusive
of any applicable value added tax;
2.4.2 inclusive
of all charges for packaging, packing,
shipping, carriage, insurance and delivery of the
Trilostane to the premises of Arnolds or other Group
Company and any duties or levies other than value
added tax.
2.5 The
Supplier may invoice Arnolds on or at any time after delivery
of the Trilostane. Arnolds shall subject to the terms of this
agreement pay the price invoiced by Stegram in respect of the
Trilostane so delivered within 60 days of the date of Stegram's
invoice.
2.6 The
Trilostane shall be delivered properly packed and secured to
the delivery address specified in Arnolds order and which has
been previously accepted by Stegram by the date requested by
Arnolds during the normal business hours of Arnolds. Arnolds
agrees to provide Stegram each quarter an estimate of its
requirements for Trilostane for the coming 12 months together
with an official order for the first quarter of each 12 month
period so as to allow 90 days for Stegram to complete the
order.
2.7
Arnolds shall be entitled to return at Stegram's expense any
Trilostane delivered which is not in accordance with the
specification.
2.8
Delivery of the Trilostane shall take place when the Trilostane
is delivered at the delivery address specified in Arnolds's
order. Risk of damage to or loss of the Trilostane shall pass
to
Arnolds on delivery to Arnolds in accordance with this clause
2.9.
2.9
Stegram accepts that Arnolds's ability to manufacture or
distribute the Product and to perform its obligations relating
to
the manufacture or distribution of the Product is dependent
upon
the supply of Trilostane in accordance with the terms of this
agreement, including, without limitation, the supply of
Trilostane ordered by Arnolds from time to time.
2.10 Stegram
shall provide such assistance and information as shall be
reasonably requested by Arnolds or required by any competent
regulatory authority including, without limitation, the VMD and
shall cooperate with Arnolds and any competent regulatory
authority and perform such other acts as shall be reasonably
requested by Arnolds or required by any competent regulatory
authority for the purposes of manufacture and distribution of
the
Product.
2.11 Stegram
shall ensure that any Trilostane delivered to Arnolds
shall be free from defects in design, material and workmanship,
will be fit for the purpose of manufacturing the Product in
accordance with the specification for the Product and will
comply
with the specification for the Trilostane agreed in writing by
4
<PAGE>
Stegram and Arnolds and all British standards and applicable
statutes and regulations.
2.12 Stegram
shall inform Arnolds of any modifications to or
improvements in the manufacture of Trilostane (including,
without
limitation, any modification or improvement to the composition
or
formulation of the Trilostane) or their packaging by giving
Arnolds not less than 90 days' prior written notice. Promptly
upon request from Arnolds Stegram shall provide Arnolds with
all
information which is reasonably available to Stegram or of
which
Stegram is aware and all assistance as shall be reasonably
necessary to enable Arnolds to assess the effect of the
modification or improvement upon the Product, its packaging and
its business, to verify with the appropriate governmental or
regulatory agency or authority (including, without limitation,
the VMD) whether or not the modification or improvement affects
any MA or other license relating to the Product and to enable
Arnolds to maintain in force all marketing authorizations,
licensed and consents relating to the Product or its resale in
any part of the Territory and to comply with the terms of this
Agreement. If Stegram gives Arnolds written notification of any
modification to or impr
