1
EXHIBIT 10.3
FIRST AMENDMENT TO THE DISTRIBUTION AGREEMENT
This First Amendment (the "First Amendment") to the Distribution Agreement
between Digene Diagnostics, Inc. (now known as Digene Corporation) ("Digene")
and Murex Biotech Limited ("MBL") dated February 28, 1996 (the "Distribution
Agreement") serves to record certain changes mutually agreed between Digene and
MBL with respect to their respective performance under the Distribution
Agreement. Each of Digene and MBL may hereinafter be referred to as a "Party"
and collectively as the "Parties". This Agreement shall be effective as of
February 1, 1997.
1. Definitions.
1.1 "Affiliate" shall mean any Person that controls, is controlled
by or is under common control with MBL or Digene, as the
context may require. For purposes of this definition "control"
shall mean: (a) in the case of corporate entities, direct or
indirect ownership of at least fifty percent (50%) of the
stock or shares entitled to vote for the election of
directors; and (b) in the case of non-corporate entities,
direct or indirect ownership of at least fifty percent (50%)
of the equity interest with the power to direct the management
and policies of such non-corporate entities.
1.2 "Agency and Sales Representation Agreement" shall mean the
Agency and Sales Representation Agreement dated of even date
herewith between Digene Corporation and Murex Diagnostics
Corporation.
1.3 "Customer" shall mean any Person who purchases Exclusive
Products from MBL or any of its Affiliates in the Territory or
purchases Non-Exclusive Products from MBL or any of its
Affiliates in the Territory for HPV-testing purposes.
1.4 "Digene/Murex Agreements" shall mean the following agreements:
(i) the Distribution Agreement dated May 19, 1992 between
Digene Diagnostics, Inc. and International Murex Technologies
Corporation ("IMTC"), as amended May 26, 1993 and April 4,
1996; (ii) the Development and License Agreement dated April
14, 1993 between Digene Diagnostics, Inc. and IMTC; and (iii)
the Development and License Agreement dated May 31, 1994
between Digene Diagnostics, Inc. and IMTC.
1.5 "Effective Date" shall be the date first set forth herein.
1.6 "Exclusive Products" shall mean the exclusive Products listed
on Schedule 1 attached hereto.
1.7 "HPV" shall mean Human Papillomavirus.
2
1.8 "Non-Exclusive Products" shall mean the non-exclusive Products
listed on Schedule 1 attached hereto.
1.9 "Person" shall mean an individual, a corporation, a
partnership, an association, a joint stock company, a trust,
any unincorporated organization or a government or political
subdivision thereof.
1.10 "Products" shall mean the Exclusive Products and the
Non-Exclusive Products.
1.11 "Territory" shall mean the countries listed on Schedule II
attached hereto.
2. Cessation of Product Sales and Distribution.
2.1 Except as set forth in the Agency and Sales Representation
Agreement and except as set forth in this Section 2, MBL and
its Affiliates will cease in the Territory, from the Effective
Date, the distribution and sale under the Distribution
Agreement of the Exclusive Products and the sale or other
distribution of the Non-Exclusive Products in connection with
the HPV Products or to Customers who intend to use such
Non-Exclusive Products for HPV-testing purposes. Nothing
contained herein, or in the Agency and Sales Representation
Agreement shall be deemed to terminate or otherwise reduce the
rights of MBL or any of its Affiliates to (i) sell or
otherwise distribute any of the Non-Exclusive Products in the
Territory in connection with non-HPV Digene products,
including to HPV Exclusive Product customers, or to non-HPV
Exclusive Products customers as such rights are set forth in
the Digene/Murex Agreements, or (ii) to sell or otherwise
distribute Products outside of the Territory pursuant to such
Digene/Murex Agreements.
2.2 Digene is also hereby granted the right to request that MBL
cease the distribution and sale of the Products listed in
Schedule I attached hereto in any of the remaining territories
as listed in Exhibit B of the Distribution Agreement, provided
that Digene provides six (6) months advance notice to MBL of
the exercise of such right and further provided that such
request shall not conflict with the terms and provisions in
effect as of the Effective Date in any existing agency or
distribution agreement MBL or its Affiliates utilize to sell
or distribute the Products. In the event MBL or its Affiliates
elect to enter into any new agency or distribution agreement
with respect to the Products, MBL shall first notify Digene in
writing in advance. After such notification, Digene shall have
the right to accept or reject MBL's (or such MBL's
Affiliates') execution of such agreement. Digene shall have
the right to review the agreement or other arrangement between
MBL and such distributor or agent in order to confirm that
Digene's interests will be protected, and if necessary, in
Digene's sole discretion, provide for Digene to enter into an
2
3
agreement directly with such agent or distributor. In such
event, MBL and MBL's Affiliates will have no obligation to
provide agency or other services under any agreements with
Digene or its Affiliates for servicing such distributor or
agent, except for services provided, at Digene's cost, to
reasonably support Digene during a transition period.
3. Digene is relieved of any obligation under Sections 1.3 and 1.4 of the
Distribution Agreement.
4. Miscellaneous
4.1 Arbitration. Subject to the provisions of the Federal
Arbitration Act, 9 U.S.C. Section 1 et. seq., any claim,
controversy or dispute arising out of or relating to this
Agreement or any interpretation or breach thereof or
performance thereunder, including without limitation any
dispute concerning the scope of this arbitration provision,
shall be settled by submission to final and binding
arbitration ("Arbitration") for determination, without any
right by any Party to a trial de novo in a court of competent
jurisdiction. The Arbitration and all pre-hearing, hearing,
post-hearing arbitration procedures shall be conducted in
accordance with the Commercial Arbitration Rules (the
"Commercial Rules") of the American Arbitration Association
(herein referred to as the "Association") as supplemented
hereby. The Arbitration hearing shall take place in
Washington, D.C. All pre-hearing and post-hearing matters and
procedures shall take place at such place and manner,
including telephonically, as shall be agreed by the Parties.
In the event the parties fail to reach agreement regarding the
foregoing, the chair of the Arbitration panel shall determine
the manner and location of such matters. In addition to the
Commercial Rules, the Parties shall also follow the procedures
described below:
4.1.1 The Party seeking Arbitration shall give notice of a
demand to arbitrate (herein referred to as the
"Demand") to the other Party and to the Association.
The Demand shall include (i) the nature of the claim
that is being asserted and the remedy or relief that
is requested, or the issues to be determined if no
claim is being asserted, (ii) a copy of this
arbitration provision, and (iii) unless the Parties
shall have otherwise agreed upon the mutual selection
of a single arbitrator, the designation of one
arbitrator, who shall have no prior or existing
personal or financial relationship with the
designating Party.
4.1.2 Within thirty (30) days after receipt of the Demand,
the other Party shall give notice (herein referred to
as the "Response") to the Party that demanded
arbitration, and to the Association, of (i) any
additional issues to be arbitrated, (ii) its answer
to the claims or issues raised by
3
4
the Party that sent the Demand, and (iii) its
designation of a second arbitrator, who shall have no
prior or existing personal or financial relationship
with the designating Party.
4.1.3 If a Response designating a second arbitrator is not
received within the above-mentioned thirty (30) day
period, the Association shall immediately designate
the second arbitrator.
4.1.4 The two arbitrators as designated pursuant to the
foregoing provision shall then designate a third
arbitrator within ten (10) days after the designation
of the second arbitrator. If the two arbitrators
cannot agree on the designation of the third
arbitrator within the ten (10) day period allotted,
the Association shall designate the third arbitrator.
Such third arbitrator designated pursuant to this
Section 4.1.4 shall be the chair of the Arbitration
panel.
4.1.5 The Arbitration panel as designated above shall
proceed with the Arbitration by giving notice to all
Parties of its proceedings and hearings in accordance
with the Association's applicable procedures. Within
15 days after all three arbitrators have been
appointed or at such other time as shall be agreed by
the Parties, an initial meeting among the chair of
the Arbitration panel and counsel for the Parties
shall be held for the purpose of establishing a plan
for administration of the Arbitration, including: (i)
definition of issues; (ii) scope, timing and type of
discovery, which may at the discretion of the
arbitrators include production of documents in the
possession of the Parties, but may not, without the
consent of the Parties, include depositions; (iii)
exchange of documents and filing of detailed
statements of claims and pre-hearing memoranda; (iii)
schedule and place of hearings; and (iv) any other
matters that may promote the efficient, expeditious
and cost-effective conduct of the proceeding. The
substantive law of the State of Maryland shall be
applied by the arbitrators to the resolution of the
dispute, provided that the arbitrators shall base
their decision on the express terms, covenants and
conditions of this Agreement. The arbitrators shall
be bound to make specific findings of fact and reach
conclusions of law, based upon the submissions and
evidence of the Parties, and shall issue a written
decision explaining the basis for the decision and
award.
4.1.6 The Parties agree that the arbitrators shall have no
power to alter or modify any express provision of
this Agreement or to render any award which, by its
terms, effects any such alteration or modification.
4
5
4.1.7 Upon written demand to any Party to the Arbitration
for the production of documents and things (including
computer discs and data) reasonably related to the
issues being arbitrated, the Party upon which such
demand is made shall promptly produce, or make
available for inspection and copying, such documents
or things without the necessity of any action by the
arbitrators, provided, however, that no such demand
shall be effective if made within the twenty (20) day
period prior to the first day of the Arbitration
hearing.
4.1.8 Subject to the limitations imposed by Section 4.1.5,
the arbitrators shall have the power to grant any and
all relief and remedies, whether at law or in equity,
including provisional relief, that the courts in the
State of Maryland may grant and such other relief as
may be available under the Commercial Rules, other
than punitive damages. Any award of the arbitrators
shall include pre-award and post-award interest at
the applicable rate or rates under Maryland law. The
decision of the arbitrators shall be final and as an
"award" within the meaning of the Commercial Rules
and the Federal Arbitration Act and judgment upon the
arbitration award may be entered in the United States
District Courts of Maryland ("Maryland District
Courts") or any other court having jurisdiction, as
if it were a judgment of that court. The Parties to
this Agreement expressly consent to the jurisdiction
of the Association, including, without limitation,
reasonable attorney's fees and the Parties waive any
objection they may have as to jurisdiction and venue
regarding the Maryland District Courts.
4.1.9 The Arbitration panel is specifically authorized to
award attorney's fees and expenses to the prevailing
Party, as determined by the Arbitration panel.
4.2 Entire Agreement.
This First Amendment, along with the Distribution Agreement,
as amended by this First Amendment thereto, set forth the
entire agreement and understanding between the Parties
relative to the subject matter contained herein and therein
and supersede all other agreements, oral and written,
heretofore made between the Parties, with respect to the
subject matter contained herein and therein. Any amendment
hereto must be in writing and signed by an authorized
representative of each of Digene and MBL.
4.3 Captions. Section titles or captions contained herein are for
reference only and shall not be considered in construing this
Agreement.
5
6
4.4 Notices. All notices and requests required or authorized
hereunder, shall, except where specifically provided
otherwise, be given in writing, and delivered either by
personal delivery to the Party to whom notice is to be given,
or sent by registered mail or by an internationally recognized
express delivery service, addressed to the Party intended at
the address set forth below. The date of delivery in the case
of personal or mail delivery or the date upon which it is
deposited with the express delivery service in the case of
notice by express delivery service, shall be deemed to be the
date of such notice.
Digene: Digene Corporation
0000 Xxxxxxxx Xxxxx Xxxx
Xxxxxxxxxx, XX 00000
Attn: President or Executive Vice President
MBL: Murex Biotech Limited
Xxxxxxx Xxxx
Xxxxxx Xxxx, Xxxxxxxx, Xxxx XX0 0XX
Attn: Vice President and General Manager
4.5 Waivers. The waiver by either Party of any breach or alleged
breach of any provision hereunder shall not be construed to be
a waiver of any concurrent, prior or succeeding breach of said
provision or any other provision herein. Any waiver must be in
writing.
4.6 Governing Law. This First Amendment, and all of the rights and
duties in connection therewith, shall be governed by and
construed under the law of the State of Maryland, U.S.A.,
without regard to conflicts of laws principles, applicable to
agreements made and to be performed in that State.
4.7 Press Release and Other Permitted Disclosures Regarding the
First Amendment.
4.7.1 Press Releases. Each of Digene and MBL agree not to
announce this First Amendment by press release or
other form of communication without the written
approval of the other Party.
4.7.2 Permitted Disclosure. The Parties agree to keep the
terms of this First Amendment confidential with
exception of such information which in the opinion of
counsel to the disclosing party is required to be
disclosed by applicable law, rule, regulation or
generally accepted accounting practice, including any
rules of applicable stock exchanges and other
self-regulatory authorities or organizations on which
the Parties or their Affiliates are listed. Provided,
however, that in the event a Party or its
6
7
Affiliates shall be required to disclose any of the
terms of this First Amendment, whether pursuant to
subpoena, deposition, interrogatory, or otherwise, or
a Party or its Affiliates shall otherwise propose to
disclose any of the terms of this First Amendment
(except in connection with such Party's or such
Affiliates' required disclosure under any applicable
securities laws, the rules of any applicable stock
exchange or other self regulatory authority or
organization or other reporting requirements) such
disclosing Party shall provide the other Party with
prompt written notice of such requirement so that the
other Party may seek a protective order or other
appropriate remedy and/or waive compliance with the
terms of this First Amendment. Notwithstanding the
foregoing, except as otherwise required by the
provisions of Section 4.7.1 hereof, (i) no prior
written notice shall be required in connection with
any Party's (or its Affiliates') required compliance
with applicable securities laws, the rules of any
applicable stock exchange or other self-regulatory
authority or organization or other reporting
requirements; and (ii) any Party shall be permitted
to submit this First Amendment as evidence in any
proceeding in connection with any dispute between the
Parties. The provisions of this Section 4.7.2 shall
not restrict a Party or its Affiliates from making
any disclosure of any terms of this First Amendment
to the extent such terms become generally available
to the public (other than as a result of a disclosure
by such Party in violation of this First Amendment),
or restrict the ability of the Parties and their
Affiliates from making disclosure to the extent such
disclosure is required for the effective undertaking
by the Parties of their respective rights and
obligations hereunder. By way of example and not in
limitation of the foregoing, MBL shall be entitled to
disclose to proposed customers the fact that it is
acting as an authorized distributor of the Products
or agent of Digene.
4.8 Counterparts. This First Amendment shall be executed in
counterparts, each of which shall be deemed an original but
both of which together shall constitute the same instrument.
4.9 All references to "Digene Diagnostics, Inc." under the
Distribution Agreement shall hereafter be changed to
references to "Digene Corporation".
4.10 Conflict; Effectiveness of Distribution Agreement. In the
event of conflict between the provisions of this First
Amendment and the Distribution Agreement with respect to the
subject matter herein, this First Amendment shall control. All
other terms and provisions of the Distribution Agreement
remain in full force and effect.
7
8
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
8
9
In consideration of the mutual covenants and conditions herein set
forth, the Parties have executed this First Amendment as of the Effective Date.
Accepted and agreed for and on behalf of Digene Corporation
By /s/ XXXX XXXXX Date 3/3/97
-------------------------------------- --------------------
Print Name Xxxx Xxxxx
------------------------------
Accepted and agreed for and on behalf of Murex Biotech Limited
By /s/ R. XXXXX XXXXXXXXX Date 2/1/97
--------------------------------------- ---------------------
Print Name R. Xxxxx Xxxxxxxxx
-------------------------------
9
10
SCHEDULE I - PRODUCTS
EXCLUSIVE PRODUCTS
Digene Part
Exclusive Product Description Number*
----------------------------- -------
HUMAN PAPILLOMAVIRUS DETECTION KIT
Human Papillomavirus (HPV) DNA Assay (6/11/42/43/44 and 4401-1030
16/18/31/35/45/51/52/56)
HPV DNA Test Panel 4401-1024
Digene Specimen Collection Kit 4203-0020
Digene Sample Transport Medium 4203-1030
Human Papillomavirus (HPV) Target: LI Region (Consensus) 4603-1100
Probe Groups (6/11/42/43/44 and
16/18/31/35/39/45/51/52/56/68)
INDIVIDUAL HPV PROBE PACKS:
HPV Type 6/11 4401-1611
HPV Type 16 4401-1016
HPV Type 18 4401-1018
HPV Type 31 4401-1031
HPV Type 33 4401-1033
HPV Type 35 4401-1035
HPV Type 42 4401-1042
HPV Type 43 4401-1043
HPV Type 44 4401-1044
HPV Type 45 4401-1045
HPV Type 51 4401-1051
HPV Type 52 4401-1052
HPV Type 56 4401-1056
NON-EXCLUSIVE PRODUCTS
Digene Part
Non-Exclusive Product Description Number*
--------------------------------- -------
HYBRID CAPTURE SYSTEM EQUIPMENT AND ACCESSORIES
DCR-1 Luminometer 4300-1010
Rotary Shaker Assembly (22v) 4300-1025
Printer Paper (DCR-1 Compatible) 4300-1012
Wash Apparatus 4301-1001
Decanting Racks 4301-1002
Hybridization Rack 4301-1003
Disposable Transfer Pipettes 4301-1500
Luminometer Validation Reagents 0000-0000
Xxxxxxxxxxxxx Tube Caps (red) 4400-1040
Hybridization Tube Caps (green) 4400-1041
SHARP Signal System Assay 4600-1192
--------
* Represents all current products within such part number category.
11
SCHEDULE II - TERRITORY
EUROPE
Germany
Switzerland
Austria
Belgium
Netherlands
Luxembourg
France
Italy
Spain
United Kingdom
EASTERN EUROPE
Poland
Czech and Slovak Republics
Hungary
Romania
Commonwealth of Independent States
Bulgaria
Estonia
Slovenia
Croatia
Macedonia
Lithuania
