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EXHIBIT 10.2
DISTRIBUTION AGREEMENT
Entered into this 1st day of August, 1997
BETWEEN
Digene Corporation, a company organized under the laws of the State of
Delaware, United States of America ("U.S.A.") and having its offices at 0000
Xxxxxxxx Xxxxx Xxxx, Xxxxxxxxxx, Xxxxxxxx 00000, X.X.X. ("Digene");
AND
Murex Diagnostics Corporation, a company organized under the laws of Barbados
and having its headquarters at Xxxxx Xxxx Xxxxx, Xxxxx Xxxx Xxxx, Xxxxxxxxxx
Xxxxxxxx ("MDC").
WITNESSETH
WHEREAS Digene is engaged in the business of developing, manufacturing and
marketing medical diagnostic products; and
WHEREAS MDC desires to acquire from Digene the right to distribute the medical
diagnostic products and biomedical research products identified herein
(collectively, the "Products").
NOW THEREFORE, in consideration of the promises and of the mutual covenants and
obligations hereinafter set forth, the parties hereto agree as follows:
1. DISTRIBUTORSHIP
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1.1 Digene hereby grants MDC the exclusive right to distribute the
Products described in Exhibit A, attached hereto and made a part
hereof during the term of this Agreement, to any testing
location in the Territories described in Exhibit B (the
"Territory"), and subject to the terms and conditions of this
Agreement. No rights whatsoever are granted to distribute
Products outside the Territory, whether directly or indirectly
through purchasers in the Territory for resale or other
distribution outside the Territory. MDC hereby agrees to sell
and promote the sale of the Products in conformity with and
subject to the terms and conditions of this Agreement and
further agrees not to sell or otherwise distribute Products to
purchasers in the Territory for resale or other distribution
outside the Territory. Digene agrees not to sell or otherwise
distribute Products to purchasers outside the Territory for
resale or other distribution in the Territory.
1.2 Products of Others. MDC shall have the right to distribute,
sell or sublicense the products of any manufacturers
provided that such other products are not similar to or
competitive with the Products and provided MDC is not in
competition with Digene. MDC shall be deemed to be in
competition with Digene if MDC, any of its affiliates, parent
companies or respective agents commences the distribution or
sale of a DNA or RNA probe assay or other DNA or RNA based
product for detection of HIV RNA, HBV DNA, or CMV DNA assays
based on Digene Confidential Information. Patent Rights (such
terms as defined in the 1994 Development and License Agreement
dated May 31, 1994) or any pending patent claimed by Digene and
filed by Digene as of the date of this Distribution Agreement,
or any product based in any respect upon Digene's Hybrid
Capture(R), SHARP Signal or Digene's proprietary Hybrid Capture
assay detection formats.
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1.3 If Digene introduces any DNA assay other than a Product into an
active development program, then Digene agrees to notify MDC and
discuss in good faith the distribution of such product with MDC,
but without obligation to reach agreement.
2. RESPONSIBILITIES OF MDC
2.1 MDC Responsibilities. In addition to all other rights and
obligations created by this Agreement and subject to Digene not
limiting MDC from meeting its responsibilities, MDC shall:
2.1.1 Use its reasonable efforts in the Territory to
distribute and support the Products including, without
limitation, the requirement to advertise the Products and
participate and exhibit the Products at major local
exhibitions for infectious disease diagnostics on a
country by country basis each year.
2.1.2 Maintain an adequate and qualified sales force to
accomplish the market objectives for the Products.
2.1.3 Provide adequate and competent technical assistance in
support of any prospective or actual Product sales in the
Territory including training salesmen and end users.
2.1.4 Maintain at all times a stock of Product necessary to
supply reasonable estimated demand therefor with
consideration given to normal time delays.
2.1.5 Provide adequate customer and technical support for the
Products and reasonably assist Digene in the discharge of
obligations to the customer.
2.1.6 Provide to end users written instructions which have been
agreed upon by Digene and MDC as to the usage of each of
the Products.
2.1.7 Deliver Products in the packaging agreed upon by Digene
and MDC. This packaging will include the name and logo
of Digene, as the manufacturer.
2.1.8 Work with Digene quarterly to determine MDC's estimated
Product requirements for the next quarter, marketing
potential, trends and forecasts, competition, marketing
techniques, current developments in the Territory,
changes of regulations governing the sale of Products in
the Territory and amounts of Products sold. MDC expressly
disclaims any liability regarding the information
concerning changes in the regulations.
2.1.9 Comply with and help Digene to comply with all present
and future regulations and/or licensing requirements
promulgated by authorized governmental authorities
effective during the term of this Agreement and required
in order to carry out the terms of this Agreement.
2.1.10 Exhibit C to this Agreement outlines specific support
and promotional activities which MDC agrees to perform
under this Agreement. In addition, Exhibit C outlines
specific undertakings by Murex regarding the
implementation and rules of engagement of this Agreement.
2.2 Scope and Limitations of Authority: This Agreement does not
create an employer-employee relationship between Digene
and MDC, nor an agency, joint venture or
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partnership. Neither party shall have the authority to act for
or bind the other in any way, to execute agreements on behalf of
the other or to represent that either party is in any way
responsible for the acts or omissions of the other. Digene shall
not have the right to direct or control MDC's performance. MDC
shall be an independent contractor only and may not engage
any other entity other than current resellers to carry out any
or all of its undertakings under this Agreement unless such
engagement is agreed to by Digene in writing. MDC shall not
appoint any other firm to sell the Products in the Territory
unless agreed in writing by Digene. A list of current resellers
approved by Digene is provided as Exhibit F.
2.3 Protection of Digene's Licenses: MDC acknowledges and agrees
that all Digene proprietary rights in Products delivered to MDC
by Digene are and shall remain at all times the exclusive
property of Digene and may not be duplicated by MDC or used
except pursuant to this Agreement and that MDC, by taking
delivery of, making payment for, distributing, and selling or
otherwise using or transferring any of the Products, shall not
become entitled to any proprietary rights in any such Products.
MDC shall take all reasonable measures to ensure that all
proprietary rights of Digene in the Products remain with Digene,
except that MDC will not be obligated to institute legal actions
against its customers or take responsibility for their actions.
2.4 Trademark Protection: MDC is hereby granted a non-exclusive
license to use Digene's current and future trademarks solely for
the purposes of promoting the Products and fulfilling its
obligation under the terms of this Agreement. MDC agrees not to
apply for registration of any trademarks used by Digene or
anyone relative to the Products, except where Digene shall be
the owner of such trademarks.
2.5 Confidentiality of Information:
2.5.1 From time to time, Digene may make available to MDC
information of a confidential nature including, but not
limited to, medical and technical data, test and
analysis data, marketing, application, manufacturing,
financial, bookkeeping, business, market and customer
information in a written form or orally. All oral
disclosures will be reduced to writing within thirty
(30) days and all confidential material will be clearly
labeled CONFIDENTIAL. MDC shall not disclose such
information to others or use such information without
the prior written consent of Digene, except to the
extent required by law. All other data or proprietary
information transmitted by Digene to MDC shall be
treated by MDC with the same care as it would exercise
in the handling of its own confidential or proprietary
information and in no event shall such information be
disclosed to any person including employee, consultant
and/or contractor unless such individual is bound by the
terms of this paragraph. Upon termination or
cancellation of this Agreement for any reason, all such
data, proprietary information and confidential
information of Digene shall be immediately returned by
MDC to an officer of Digene and the limitations and
undertakings specified in this paragraph shall remain in
effect for a period of four years from the date of
termination or expiration of this Agreement.
Confidential information as referred to in this Section
2.5 shall not include information (i) which is or
becomes public knowledge through no fault of MDC; (ii)
which is known to MDC at the time of disclosure by
Digene, as evidenced by MDC's written records; (iii)
which is disclosed to MDC on a non-confidential basis by
a third party having no obligation of secrecy to Digene.
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2.5.2. From time to time, MDC may make available to Digene
information of a confidential nature including, but not
limited to, medical and technical data, test and
analysis data, marketing, application, manufacturing,
financial, bookkeeping, business, market and customer
information in a written form or orally. All oral
disclosures will be reduced to writing within thirty
(30) days and all confidential material will be clearly
labeled CONFIDENTIAL. Digene shall not disclose such
information to others or use such information without
the prior written consent of MDC, except to the extent
required by law. All other data or proprietary
information transmitted by MDC to Digene shall be
treated by Digene with the same care as it would
exercise in the handling of its own confidential or
proprietary information and in no event shall such
information be disclosed to any person including
employee, consultant and/or contractor unless such
individual is bound by the terms of this paragraph. Upon
termination or cancellation of this Agreement for any
reason, all such data, proprietary information and
confidential information of MDC shall be immediately
returned by Digene to an officer of MDC and the
limitations and undertakings specified in this paragraph
shall remain in effect for a period of four years from
the date of termination or expiration of this Agreement.
Confidential information as referred to in this Section
2.5 shall not include information (i) which is or
becomes public knowledge through no fault of Digene;
(ii) which is known to Digene at the time of disclosure
by MDC, as evidenced by Digene's written records; (iii)
which is disclosed to Digene on a non-confidential basis
by a third party having no obligation of secrecy to MDC.
2.6 Customer Equipment and Software Validation. The validation of
equipment and software for use on Products shall be jointly
completed by Digene and MDC and shall need a jointly agreed-upon
Validation Protocol. The Validation Protocol shall meet the
standards applied to Digene's development Programs as defined in
the Digene-Murex Development and License Agreement dated April
14, 1993.
MDC shall market and sell only equipment and software to perform
Product assays which have met Validation Protocols (Validated
Equipment and Software). MDC shall use reasonable efforts to
assure that all customers for Products are trained and are
performing assays only on Validated Equipment and Software. If
the customer chooses not to acquire equipment and software from
Digene or MDC, then MDC will use all reasonable efforts to
assure that the customer is nevertheless using Validated
Equipment and Software.
Digene and MDC agree that MDC will use best efforts not to place
Validated Equipment or Software at a customer site which will
not be running Product assays on Validated Equipment and
Software.
The failure by a customer to use Validated Equipment and
Software for running Product assays shall invalidate any
warranty given by Digene as to the accuracy of the results of
the Product assay or as it related to Product performance as
stated in the Agreements.
3. RESPONSIBILITY OF DIGENE
3.1 Support Responsibilities: In addition to other rights and
obligations created by this Agreement, Digene shall:
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3.1.1 Make every reasonable effort to deliver Products set
forth in MDC's orders pursuant to the terms of this
Agreement. Shipments shall be made to MDC not later than
15 days from the date on which the order is received.
Digene reserves the right to immediately cease all
shipments of Product upon the discovery of a
non-conformity to specification in the Product. Digene
shall renew shipment only upon correction of such
non-conformity.
3.1.2 Provide a reasonable quantity of current promotional
material literature relating to the Products; and Digene
shall, at the request of MDC, provide a reasonable
amount of sales and product training to key employees of
MDC for the purpose of training MDC in the proper
support of the Products. MDC agrees to pay all
reasonable travel, travel related, and living expenses
of Digene personnel directly incurred by Digene in
providing such sales and product training at MDC's
request.
3.1.3 Assist MDC, upon request and subject to Digene's
approval, which shall not be unreasonably withheld, in
making presentations to MDC's customers or prospects.
3.2 Digene's Proprietary Marks: Digene may affix its trade name,
service marks or trademarks, now owned or hereafter acquired by
Digene (collectively the "Proprietary Marks"), to any of the
Products. MDC shall not have or acquire any right, title or
interest in the Proprietary Marks, either used alone or in
conjunction with other words or names, or in the good will
thereof, and shall not use any such Proprietary Marks without
the express written consent of Digene. Should MDC, in spite of
this provision, acquire any such title or interest by operation
of law or otherwise, MDC shall immediately notify Digene of that
fact and will, upon request by Digene, assign without
consideration the same to Digene. Upon Termination for cause as
defined in Section 7.2, MDC shall immediately return to Digene
all advertising, sales or promotional material containing
Digene's Proprietary Marks, and a complete list of active
accounts, outstanding quotations and product inquiries received
in the six months preceding termination.
3.3 Digene accepts the responsibility to provide MDC with complete
information regarding limitations to use of the Products,
especially those limitations which are required to be disclosed
under the regulations of the United States Food and Drug
Administration ("FDA"). Digene will work with MDC to gain and
maintain all governmental approvals, except customs and
importation, especially that of the FDA when necessary for MDC
to sell the Products in the Territory. MDC will aid Digene in
obtaining regulatory approval or appropriate government
notifications indicating, if this be the case, that regulatory
approval is not required in Territory countries.
3.4 Digene and MDC shall agree on the Product Claims for each
Product prior to the first delivery of such Product to MDC.
3.5 No amendment may be made by Digene to the Product Specification
or Product Claims without the prior written approval of MDC
except where such amendment is made in compliance with
governmental requirements and MDC has been notified in advance.
3.6 Digene undertakes to ensure that all Products are manufactured,
packaged and supplied in accordance with the Product
Specification and Product Claims.
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3.7 Digene undertakes to provide MDC with complete information regarding any
limitation on the right to use the Products, including any limitations
imposed under any regulations of the FDA, as soon as possible after
becoming aware of such limitation.
3.8 Digene undertakes in respect of each delivery of Products to MDC to give
notice to MDC or such MDC affiliates as shall be designated as the
delivery address in purchase orders for Products placed by MDC or an MDC
affiliate on Digene with such delivery in an agreed form certifying that
the Products in that delivery have been analyzed and meet the Product
Specification as agreed upon jointly in writing between MDC and Digene,
citing the lot number of the Products and the date on which the
shelf-life for such Products expires. All Products will have a minimum
of at least (5) five months shelf life from the date of shipment unless
agreed to in writing between Digene and MDC. Digene agrees to work in
good faith to achieve a (6) six month shelf life remaining from the date
of shipment for all products. MDC will be notified in writing by Digene
as soon as Digene deems that six month dating from the date of shipment
is possible.
3.9 Digene shall notify MDC of the discovery and nature of any non-
conformance of any Product to its Product Specification and/or Product
Claims and keep MDC informed of the progress of corrective actions
instigated by Digene.
3.10 Subject to receiving at least five (5) working days prior notice, Digene
will allow MDC and its duly authorized representatives and the personnel
of appropriate regulatory authorities during normal business hours
access to such premises as are used in the production and testing of the
Products for the purpose of inspection thereof.
3.11 If MDC reasonably considers it necessary in the light of customer
complaints it receives in respect of any Products (or when an
appropriate regulatory authority requires it) Digene shall at MDC's
request instigate a quality control/quality assurance investigation in
respect of the Products and report its findings to MDC as soon as such
findings are available and in any event within one (1) month of MDC's
request.
3.12 If Digene's findings are not in MDC's reasonable opinion considered
adequate to explain and resolve the problem or complaint giving rise to
a request by MDC under Section 3.11 Digene shall allow MDC the right to
raise specific questions about the complaint and the findings and any
other matter pertinent thereto. Digene's relevant personnel shall
provide MDC with such reasonable information and assistance and
pertinent information as MDC may require in this regard.
3.13 Digene undertakes to inform MDC of any material complaints Digene may
receive from its own customers or from any government or regulatory
authority in respect of the Products, their manufacture or constituents,
and Digene's findings in respect thereof. Such information and copies of
any relevant correspondence in relation thereto shall be supplied to MDC
as soon as practicable after receipt or issuance by Digene.
3.14 All packaging and trade dress of the Products including all labels
attached to and/or supplied with the Products shall be agreed between
the parties in writing in advance and shall not be changed except by
agreement, such agreement not to be unreasonably withheld by either
party, and following the procedures agreed between the parties from time
to time. All such packaging and labeling shall comply with any
regulatory requirement relating thereto.
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3.15 Digene's manufacturing process for any Product shall not be
amended in any way that could reasonably be expected to affect
the performance of that Product except with the prior written
agreement of MDC. In the event of such agreed amendment Digene
shall provide reasonable documentation to enable MDC to
appropriately modify the Product Specification and the QA
Specification to be applied to the Product hereunder. For the
avoidance of doubt, it could reasonably be expected that
performance of a Product would be affected by changes including
but not limited to the source of materials, manufacturing
process, labeling and packing components, bottle fill volumes or
adjustment of shelf life.
3.16 Digene agrees to take all reasonable steps to ensure that the
Products comply with all present and future regulations and
licensing requirements issued by any authorized governmental
authority which are effective during the term of this Agreement
where such compliance is required by law to carry out the
distribution and sale of the Products within the Territories.
MDC agrees to provide Digene with reasonable assistance in the
performance of its obligations pursuant to this paragraph.
3.17 Digene will take all steps necessary to gain and maintain all
governmental approvals necessary for the manufacture, marketing,
export, and sale of the Products and without prejudice to the
generality of the foregoing, all FDA approvals for MDC to sell
the Products, in the Territory. MDC shall take all reasonable
steps to assist Digene to obtain such regulatory approvals as
are necessary for marketing and sale of Products in the
Territory.
3.18 Digene agrees to follow FDA approved and inspected procedures to
ensure that the quality of the Products is achieved and
maintained. In the case of complaints from purchasers or other
users of the Products supplied to MDC, Digene will examine
samples retained from each lot in order to verify and/or assess
the cause of such complaints and notify MDC of the details of
such examination.
3.19 Exhibit C to this Agreement outlines specific undertakings by
Digene regarding the implementation and rules of engagement of
this Agreement.
4. PURCHASE OF PRODUCTS
4.1 Products: MDC shall purchase all units of the Products from
Digene and shall retain them in its own Inventory. MDC shall
deliver such units of the Products to its customers and shall be
responsible for sending invoices to such customers and for
collecting any purchase price or other charges due therefor.
MDC acknowledges that Digene manufactures products for in
vitro diagnostics and for biomedical research laboratories.
The Products which Digene agrees to provide are referred to in
Exhibit A. Digene will provide, at Digene's cost, DML-2000
luminometers, rotary shakers, and data analysis systems on
placement guidelines jointly agreed upon between Digene and
MDC. In the event MDC desires to place equipment at accounts or
in territories which are not within the placement guidelines,
then MDC shall have the option to purchase equipment at prices
jointly agreed upon between MDC and Digene. Certain accessories
and laboratory equipment are listed on Exhibit A. MDC shall
have no rights to distribute Digene's biomedical research
products or other in vitro diagnostic products unless
specifically agreed to in writing by Digene.
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4.2 Purchase Prices: MDC acknowledges and agrees that it shall pay the total
purchase price ("Purchase Price") for each Product ordered. The
Purchase Prices shall be paid to Digene as provided for in the Price
List set forth in Exhibit D, Part 1 and Part 2, attached hereto and made
a part hereof. Where MDC and Digene agree that price reductions are
required to achieve increased market penetration, such price reductions
will be negotiated on a country by country basis. Digene agrees to
provide MDC with 60 days advance notice of price changes and to increase
prices no more frequently than once every twelve (12) months. Digene
and MDC agree that kit pricing will be set to provide Digene revenue
equal to 60% of end-user sales. Digene will meet all freight and
insurance costs in delivering Product to Murex European affiliate
companies and MDC will meet all import duty taxes. At the end of each
Digene fiscal year MDC and Digene will work together to adjust the net
purchase price of each class of kits (HIV RNA, CMV DNA, HBV DNA) such
that Digene obtains revenue equal to 60% of MDC's net sales. Net sales
shall be as defined in the 1994 Development and License Agreement
between Digene and MDC dated May 31, 1994.
In addition, Digene shall be liable to pay for any penalty charges
levied by the relevant Government authorities as a result of
non-compliance by Digene of terms and conditions stipulated in
Government tender or contracts or any local purchase order provided that
Digene has previously agreed in writing to be bound by the terms of such
agreement.
4.3 Delivery and Payment. "Delivery" shall take place when shipments are
shipped from Digene in accordance with instructions from MDC. In the
absence of specific routing instructions, Digene reserves the right to
select the carrier and method of conveyance.
4.4 Risk of Loss: Risk of loss shall pass to MDC on shipment. If a
shipment of Products is not accepted by MDC due to failure to meet the
Product Specification, MDC will immediately notify Digene, return a
sample of Product at Digene's request and cost, if the failure is shown
to be a failure by Digene, and provide its reasonable efforts to help
Digene determine the source and nature of the problem. Digene may
request the return of the entire shipment, but will be obligated to pay
all freight and customs fees. The MDC will use its reasonable efforts
to assist Digene in pursuing a claim with the shipper at Digene's
request. Furthermore, if MDC is pursuing a claim with a shipper, Digene
will use its reasonable efforts to assist MDC in pursuing such claim.
4.5 Digene undertakes to supply, free of charge, one (1) kit from each
manufactured batch of Products in the delivery of Products to fill an
order from MDC to enable MDC to ensure that the Product conforms with
the Product Specification.
4.6 As soon as practicable after taking delivery of the Products, MDC shall
carry out an inspection on the Products to determine whether the
Products were shipped with the remaining shelf life specified in the
Product Specification and as defined in Section 3.8 and whether the
correct quantity has been delivered and within two (2) weeks of delivery
shall confirm or dispute the quantity of the Products supplied. Absence
of notification shall signify notification of acceptance.
4.7 Digene agrees to replace any Products not conforming with the Product
Specification, Product Claims or QA Specification within their shelf
life provided that at Digene's option such Product is returned to Digene
within 30 days of discovery and MDC provides Digene with written details
of non-conformance. Digene shall not be liable to replace any Product
which has a non-conformity caused by misuse of the Products
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by the negligence of MDC. Digene agrees to meet all costs
whatsoever incurred in the proper return and/or replacement of
any Product pursuant to this paragraph.
4.8 In the event of any dispute arising between the parties which
they are unable to settle amicably as to the quantity, quality
and/or suitability for use of Products, taking account the
terms of this Agreement and in particular the warranties of
Digene, the matter (including the question of payment for the
relevant Products by MDC) shall be determined in accordance with
Section 8.1.
4.9 MDC reserves the right to reject any Products which have been
supplied in breach of Digene's obligations under this Agreement
notwithstanding that payment has been made. Digene agrees to
replace such Products and to send such replacement Products free
of charge to MDC forthwith by airfreight prepaid to a
destination as instructed by MDC.
4.10 In the event that it is determined that damage to a Product was
caused during shipment by a carrier appointed by MDC and a claim
in respect of such damage is denied by MDC's insurance company
due to an inherent defect in the Product or improper packaging,
where Digene does not have grounds to reasonably object to this
conclusion, Digene shall replace such Products immediately free
of charge to MDC by airfreight prepaid to a destination as
instructed by MDC. MDC shall provide all reasonable assistance
to Digene should Digene pursue any claim against the third party
responsible for the shipment.
4.11 In the event of a recall, market withdrawal or correction of any
Products arising from a defect in the Products, Digene shall
replace the defective Products and deliver these replacements
free of charge as directed by MDC. In the event of a recall,
market withdrawal or correction of any Products which is proven
to be the result of willful fraud or gross negligence of Digene,
Digene shall reimburse MDC for all reasonable documented costs
and expenses associated with such an action save that Digene
shall not reimburse MDC for any costs that are proven to be the
result of willful fraud or gross negligence of MDC.
5. PAYMENT
5.1 Terms: Payment will be due at the end of the month following
the month of the date of invoice. Any invoice amount which is
not paid when due will bear interest at the rate of one and
one-half (1.5) percent per month. No Purchase Price or sums
owed to Digene by MDC shall be subject to set off for claims of
MDC. Digene shall have the right not to make further shipments
to MDC if MDC has any invoices which are more than 90 days in
arrears.
5.2 Taxes and Duties: MDC shall pay any and all applicable sales,
use or excise, state, local, federal or other taxes, Customs
duties, or amounts legally levied with respect to the
transportation, sale, transfer, license, sublicense or use of
Product by MDC, or upon the provision of any services by MDC
with respect to a Product, as such taxes or amounts that may now
or hereafter be imposed under the authority of any nation, group
of nations, state, or local taxing jurisdiction.
6. WARRANTY
6.1 Warranty: Digene agrees to replace any Product not performing
or conforming to the Product Specifications as agreed upon
jointly in writing between MDC and Digene pursuant to Section
3.8 if the nonconforming Product is returned to Digene within
the
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period of the shelf life specified by Digene for each of the
Products and provided that such nonconformity was not caused by
misuse or negligence of MDC. All third party expenses, including
any applicable transportation, handling, Customs and related
costs associated with the return and/or replacement of such
Products, if determined to be non-conforming, shall be paid by
Digene. DIGENE MAKES NO EXPRESS WARRANTY OTHER THAN THOSE
HEREIN, AND EXCLUDES AND DISCLAIMS, TO THE EXTENT PERMITTED BY
APPLICABLE LAW, ANY AND ALL IMPLIED WARRANTIES INCLUDING,
WITHOUT LIMITATION, IMPLIED WARRANTIES IN CONNECTION WITH THE
DESIGN, SALE AND MERCHANTABILITY OR FITNESS OF THE PRODUCTS FOR
ANY PARTICULAR PURPOSE OR USE EXCEPT THAT THE PRODUCTS ARE FREE
FROM MANUFACTURING DEFECTS AND CONFORM TO DIGENE'S PUBLISHED
SPECIFICATIONS AND, WHERE APPROPRIATE, THE REQUIREMENTS OF THE
UNITED STATES FOOD AND DRUG ADMINISTRATION. DIGENE SHALL HAVE NO
LIABILITY WITH RESPECT TO ITS OBLIGATIONS UNDER THIS AGREEMENT
OR OTHERWISE FOR CONSEQUENTIAL, EXEMPLARY, INCIDENTAL OR
PUNITIVE DAMAGES, EVEN IF IT HAS BEEN ADVISED THAT THE
POSSIBILITY OF SUCH DAMAGE EXISTS. While MDC may provide a
warranty for its end user, any warranty provided by MDC is its
own. Digene will make a reasonable effort to provide an initial
response to all customer complaints within five (5) working days
after receipt of said information.
6.2 Digene shall maintain product liability insurance during the
entire term of this Agreement in an amount not less than $1
million. Digene shall include all the Products in such policy.
6.3 Digene warrants that the Products supplied to MDC including the
containerization and packaging therefor shall at the time of
delivery be free from manufacturing defects and conform in all
respects with the Product claims, the requirements of the FDA,
and with International Airfreight Transport Association
requirements in force at that time.
6.4 Digene warrants that it has to the best of its knowledge and
belief supplied to MDC full details of all patents or other
intellectual property rights that are relevant to the sale by
MDC of Products in the Territories and shall notify MDC on
becoming aware of any other such intellectual property rights
from time to time.
6.5 Digene warrants that the Products supplied to MDC shall, subject
to any damage to the Products subsequent to delivery of the
products to MDC, conform in all respects with the Product Claims
and Product Specification during the period of the shelf life of
the Products.
6.6 Digene warrants that the Products supplied to MDC shall have at
least the minimum shelf life as specified in the Product
Specification or as defined in Section 3.8, Product Claims, and
any relevant packaging insert.
6.7 Digene warrants that the tests and quality control procedures
required to have been carried out by Digene prior to delivery
shall have been carried out by Digene to the Products so
delivered prior to delivery.
6.8 Digene warrants that the Products supplied to MDC shall be
manufactured and packaged in accordance with, and will meet, all
applicable USA regulations covering good manufacturing
practices.
6.9 Digene warrants that the Products shall be fit for their
purpose.
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6.10 Digene warrants that the Products shall be of merchantable
quality.
6.11 Digene warrants the Products shall be generally safe for their
intended use.
6.12 Digene warrants the Products shall be free of all liens and
encumbrances of any kind.
6.13 Digene hereby warrants that to the best of its knowledge the
manufacture, marketing, distribution or sale of the Products
does not infringe the intellectual property of any third party
subsisting at the date of this Agreement.
7. TERM AND TERMINATION
7.1 Term: The initial term of the Agreement shall commence on the
date of execution of this Agreement by both parties and will
remain in effect for the initial term of four (4) years and
seven (7) months, unless terminated earlier under the provisions
herein. At the conclusion of the initial term, and provided that
it has not been subject to earlier termination this Agreement
shall be automatically renewed for additional successive
one-year terms unless Digene or MDC chooses to terminate this
Agreement by providing written notice at least 90 days in
advance of the termination date or by providing 90 days notice
at any time after the conclusion of the initial term.
7.2 Termination for Cause: Digene may terminate this Agreement by
sixty (60) days notice to MDC upon the occurrence of any of the
following events should they not be remedied within such sixty
day notice period:
7.2.1 MDC fails to pay an invoice when due.
7.2.2 MDC fails to fulfill one or more of its obligations
under Section 1 or 2.
7.2.3 IMTC becomes bankrupt, insolvent or becomes unable to
pay its obligations when they become due.
7.2.4 MDC fails to substantially perform the specific support
and promotional activities outlined in Exhibit C without
prior written agreement by Digene, such termination to
be on a country by country basis.
7.2.5 One or both of the Development and License Agreements
dated May 31, 1994 or April 14, 1993 between
International Murex Technologies Corp. ("IMTC") and
Digene are terminated by Digene because of a breach by
IMTC.
7.3 Effect of Expiration, Termination: The effect of expiration or
termination of the Agreement is to be as follows:
7.3.1 Upon expiration of this Agreement or upon termination by
either party, Digene undertakes to supply MDC with all
Products required to enable MDC to fulfill its
contractual obligations, including all tenders won or
for which Murex has already bid prior to the date of
such termination.
7.3.2 Upon expiration of this Agreement or upon termination by
either party, Digene may determine, at its option
subject to Section 7.3.1, whether to ship products under
any Product Orders previously submitted by MDC. MDC will
have the right to sell all Products it has in inventory
to the newly appointed Distributor at cost plus any
handling cost or return all outstanding inventory to
Digene at cost plus any handling cost with 1.5%
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interest upon expiration of the served 90 day notice of
termination. All warranties in effect will survive the
termination of this Agreement.
7.3.3 Upon expiration of this Agreement or upon termination,
the terms of paragraph 2.5 will remain in effect for an
additional four years therefrom.
7.3.4 Termination of this Agreement for any reason shall be
without prejudice to any rights of either party against
the other arising out of events occurring prior to that
termination.
7.4 Co-Exclusive Distribution or Wind-Down. Twenty-four (24) months
from the effective date of this Agreement, MDC agrees that
Digene may terminate this Agreement at any time on a country by
country basis by providing 6 months advance notice in writing to
MDC. Effective as of the notification date, Digene shall have
the right to distribute Product directly on a co-exclusive basis
to customers who are not active customers of MDC. At the end of
the 6 month period, Digene will take over direct sales to all
customers in the territories affected by the termination notice.
If MDC has acquired equipment or accessories to support specific
accounts, Digene agrees to acquire from MDC any field
instrumentation in good working order used to support the
Products which MDC desires to sell to Digene (a 3 year
depreciation schedule will be used to calculate equipment
value).
8. MISCELLANEOUS PROVISIONS
8.1 Arbitration: Any controversy or claim arising out of or relating
to this Agreement, or the performance or breach thereof, shall
be settled by arbitration, in accordance with the Commercial
Arbitration Rules of the American Arbitration Association in the
City of Washington, D.C., U.S.A. and judgment upon the award
rendered by the Arbitrator(s) may be entered in any Court having
jurisdiction thereof.
8.2 Assignment: Digene or MDC have the right to assign its rights
and obligations under this Agreement to any of its subsidiaries
and/or affiliates provided that such entity assumes all Digene's
or MDC's obligations under this Agreement. It is understood and
agreed that MDC may not assign in whole or in part any interest
in this Agreement other than as provided in this clause and
Section 2.2 hereof, without the prior written consent of Digene.
Any sale of all or substantially all of the assets or capital
stock of MDC shall not be deemed to be an assignment of this
Agreement. This Agreement shall be binding upon and inure to the
benefit of the heirs, successors and permitted assignees of the
parties hereto.
8.3 Force Majeure: Either party shall be excused from any delay or
failure in performance hereunder caused by any labor dispute,
governmental requirement, act of God, earthquake, inability to
secure materials and transportation facilities, and other causes
beyond its control. If such delay shall continue for more than
90 days, and 135 days in the case of Digene's inability to
deliver Product, the party injured by the inability of the other
to perform shall have the right, upon written notice to the
other party, to terminate this Agreement.
8.4 Entire Agreement. This Agreement sets forth the entire agreement
and understanding between the parties relative to the subject
matter contained herein and supersedes all other agreements,
oral and written, heretofore made between the parties, except
that it shall not relieve either party from making payments
which may be owing under an agreement prior to the date thereof.
Any amendment hereto must be in writing and signed by an
authorized representative of Digene and MDC. Should
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any portion of this Agreement be held invalid, or unlawful, the
remainder of the Agreement shall continue to be binding on both
parties.
8.5 Captions: Section titles or captions contained herein are for
reference only and shall not be considered in construing this
Agreement.
8.6 Notices: All notices and requests required or authorized
hereunder, shall, except where specifically provided otherwise,
be given either in writing by personal delivery to the party to
whom notice is to be given, or sent by registered mail,
addressed to the party intended at the address set forth below.
The date of delivery in the case of personal delivery or the
date upon which it is deposited in the mail in the case of
notice by mail, shall be deemed to be the date of such notice.
Digene: Digene Corporation
0000 Xxxxxxxx Xxxxx Xxxx, Xxxxx 000
Xxxxxxxxxx, XX 00000
Attn: President or Executive Vice President
MDC: Murex Diagnostics Corporation
Xxxxx Xxxx Xxxxx
Xxxxx Xxxx Xxxx
Xxxxxxxxxx
Xxxxxxxx
Attn: General Manager
8.7 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.
8.8 Records: MDC shall keep accurate and detailed records of all
sales of the Products, and MDC shall permit examination and
inspection of such records by authorized representatives of
Digene, upon reasonable notice, during usual business hours. MDC
may limit inspection of such information to an agreed
independent auditor, only to the extent such inspection may
divulge confidential information of MDC. In the event MDC
exercises its right to limit inspection to an auditor, written
records of sales not containing such confidential information
shall be supplied by MDC per the terms of Exhibit C.
8.9 Centralized Shipping: In the event MDC uses centralized ordering
and shipping for products to be delivered to individual
territories, MDC agrees to provide accurate data at the end of
every month (within 15 days) outlining the countries where
products have been shipped and the specific number of units
shipped. If differential pricing is provided in different
countries, MDC will make this information and the numbers of
units to be purchased at each price clear on purchase orders or
order at the price provided on Exhibit D Part 1, or subsequently
agreed to in writing between the parties, in which case, a
rebate will be provided on a monthly basis after the monthly
unit volume by country information has been received.
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8.10 Governing Law
8.10.1 This Agreement, 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.
applicable to Agreements made and to be performed in
that State.
8.10.2 Each of the parties consents to the jurisdiction of the
courts of the State of Maryland, U.S.A. and of the
United States District Courts of Maryland, U.S.A. with
respect to any dispute or controversy arising under or
in connection with this agreement. A summons or
complaint in any such action or proceeding may be served
by mail in accordance with Section 8.6 provided a
reasonable time for response is allowed. This Section is
not intended to limit or amend the terms of Section 8.1
of this Agreement.
8.11 Digene and MDC agree not to announce this Agreement by press
release or other form of communication without the written
approval of the other party. Both parties agree to keep this
Agreement confidential unless required to disclose it by
operation of law.
8.12 Counterparts: Effectiveness of Agreement. This Agreement shall
be executed in counterparts, each of which shall be deemed an
original but both of which together shall constitute the same
instrument. This Agreement shall become effective upon the date
first written on this Agreement.
In consideration of the mutual covenants and conditions herein set forth, the
parties have executed this Agreement as of the day and year above written.
Murex Diagnostics Corporation Digene Corporation
Signature: Signature: /s/ XXXX XXXXX
------------------------- -------------------------
By: Peet Von Jaarsveld By: Xxxx Xxxxx
Title: General Manager Title: President & CEO
Date: Date: August 1, 1997
-------------------------- --------------------------
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EXHIBIT A
Exclusive Products
Digene HIV RNA, CMV DNA, HBV DNA Hybrid Capture II quantitative
chemiluminescent microplate assays (specific part numbers will be added to this
Agreement as the products are formally introduced). Hybrid Capture II Equipment
and accessories will be provided on a non-exclusive basis.
Note: Digene is currently discussing the development of a low-cost qualitative
HBV DNA detection kit for a pharmaceutical company. Such a kit is not to be
considered part of this Agreement.
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EXHIBIT B
Territory
Europe Poland
Austria Czech and Slovak Republics
Belgium Hungary
Denmark Romania
Finland Commonwealth of Independent States
France Bulgaria
Germany Former Yugoslavia
Ireland Estonia
Italy Latvia
Luxembourg Lithuania
Netherlands Middle East
Norway United Arab Emirates
Portugal Saudi Arabia
Spain Lebanon
Sweden Oman
Switzerland Iran
United Kingdom Iraq
Greece Qatar
Jordan
Africa Bahrain
All Countries Syria
Yemen
Israel
Asia/Pacific Egypt
Singapore Malta
Cyprus
Eastern Europe Xxxxxxx Xxxxxxxx xx Xxxxxxxx Xxxxxx
00
00
EXHIBIT C
SPECIFIC SUPPORT AND PROMOTIONAL ACTIVITIES
MDC recognizes that significant market development activities will be required
to build sales volume for Digene's products. MDC agrees to actively promote
the Products to laboratories and end-user clinicians and pathologists. MDC
agrees to execute jointly agreed upon marketing campaigns in the Territory;
these campaigns may involve translation and printing of promotional materials
into brochures, advertisements and mailers. MDC will also undertake
jointly-initiated product promotional campaigns. MDC agrees to conduct these
campaigns with reasonable levels of expenditure consistent with the market
opportunity for the Products, to maintain appropriate organizational staffing
to execute said campaigns and to conduct educational seminars independently and
with Digene representatives.
MDC and Digene further agree to the additional rules of engagement as outlined
below:
1) Since the Products are integrally and strategically linked with other MDC
patient monitoring products MDC will work with Digene to set the strategic
plans for the Products. Digene will then work through Dartford to implement
those plans across the MDC territories. MDC will drive the territory
involvement not Digene.
MDC reserves the right of final say on marketing strategy, including end-user
prices, and tactics for the Products in its territory. If ultimately
differences cannot be resolved then Digene's recourse is to terminate the
Agreement. Digene cannot over-rule MDC on such issues.
2) MDC to respond on what sales and operational reports it can routinely make
available to enable Digene to monitor the implementation of
strategic/tactical plans.
These reports will fall short of providing monthly sales details by customer
for all customers, but MDC will try to address key account focus and to the
extent possible, provide monthly account volume.
Details of Product customers specific account information including average
sell prices and unit volume by customer will be made available on a periodic
basis (at least annually).
Digene will be entering its own lease-financing arrangements for microplate
instruments. Digene shall be provided specific information about the location
and users of such equipment. Digene shall be free to contact such customers
provided that clearance is provided on a local basis in advance by local
Murex management (such clearance not to be unreasonably withheld).
Digene would prefer that instruments placed by MDC are financed by Digene,
with placements being made under pre-agreed rules and guidelines. MDC will
not be required to refer placement decisions to Digene providing the
placements fall within the pre-agreed guidelines.
3) MDC agrees to consider Digene funding additional sales and marketing
resource, including additional sales persons to address a particular
opportunity, if MDC does not believe additional resources are commercially
justified or fit with MDC strategies and plans.
However MDC reserves the right to veto any such additional resource if it is
held to have an adverse effect on MDC's own plans or if implementation would
affect MDC's own activities (e.g. if
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Digene wishes to fund a major trade show but to man the show would take
away a disproportionate amount of MDC reps.)
Digene would have the option to terminate the Agreement if there were
disagreement on these additional resource requests.
4) Digene reserves the right to set the strategy and tactics for
discussing and managing the relationships with Pharmaceutical companies
with potential business in the Territory in respect of the Products.
Any subsequent sales of Product into the Territory will however be
subject to the standard MDC margin. If Digene wishes to refer to any
MDC product or other bundling opportunity with MDC in its discussions
with a pharmaceutical company, then Digene will fully discuss this
with MDC prior to any approach to any such third party. MDC reserves
the right to veto bringing the MDC name or products into any such
discussions.
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EXHIBIT D
Part 1, Part 2
Purchase Prices
Digene HIV RNA, CMV DNA, HBV DNA Hybrid Capture II quantitative
chemiluminescent microplate assays and related accessories (specific prices
will be added to this Agreement as the products are formally introduced).
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EXHIBIT E
Per Attached Packaged Insert
Product specifications will be agreed in writing in advance of the formal
release of the Products by MDC.
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EXHIBIT F
TERRITORY DISTRIBUTOR
--------- -----------
Europe
------
Austria Xxxxx, Vienna
Belgium Murex Diagnostics Benelux B.V.
Denmark Orion Diagnostica A/S, Hellebaek
Finland Orion Diagnostica A/S, Espoo
France Murex Diagnostics France S.a.r.l.
Germany Murex Dianostica GmbH
Ireland Xxxxxx May Xxxxxxx, Dublin (for MDC)
Italy Murex Diagnostici S.p.a.
Luxembourg Murex Diagnostics Benelux B.V.
Netherlands Murex Diagnostics Benelux B.V.
Norway Orion Diagnostica A/S, Asker
Portugal Sipaco, Lisbon
Spain Murex Diagnostica S.A.
Sweden Orion Diagnostica AB, Trosa
Switzerland Murex Diagnostics Benelux B.V. (Schaffhauser
Branch)
United Kingdom and Africa and Middle east Murex Biotech (UK) Ltd
(as defined below)
Greece (for HPV Hybrid Capture products only) Alpha-Medical Ltd, Athens
Africa
------
Botswana Delta Diagnostics
Kenya, Tanzania & Uganda Xxxxxxxx Pharmaceuticals
Namibia Medlab Services
Zambia Africa Health
Zimbabwe Zimpharm
Eastern Europe
--------------
Poland Alexim, Powinska
Czech Interade (for MDC)
Slovek Republic Timed Spol, Bratislava
Hungary Unilab, Budapest
Romania Tamisa Trading, Bucharest
Commonwealth of Independent States Dynatech, Denkendorf (Germany)
Bulgaria Global Medical, Sofia
Estonia Xxxx, Tallin
Middle East
-----------
United Arab Emirates Gulf and World Traders, Dubai
Saudi Arabia Abdulnehman Algosaib GTB, Riyadh
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EXHIBIT G
QUALITY ASSURANCE
INCOMING GOODS AND
PRODUCT RELEASE SPECIFICATIONS
To be agreed upon jointly in writing on a product by product basis at product
release.
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