exv10w1



 





EXHIBIT 10.1




AMENDED AND RESTATED RESELLER AGREEMENT




     THIS AGREEMENT is made as of the 10th day of December, 2003, by Applera
Corporation, a Delaware corporation, acting through its Applied Biosystems
Group (“Applied Biosystems”), with a principal place of business at 35 Wiggins
Avenue, Bedford, Massachusetts 01730, U.S.A., and Digene Corporation, a
Delaware corporation (“Digene”), with its principal place of business at 1201
Clopper Road, Gaithersburg, Maryland 20878, U.S.A.



RECITALS




     The parties desire that the product of Applied Biosystems listed on
Schedule A hereto (“Product”) shall be purchased by Digene and that Digene
shall resell the Product, all upon the terms and conditions set forth herein.
The definitions of capitalized terms used but not otherwise defined herein are
set forth in Schedule C hereto.



     The parties, in consideration of the mutual obligations hereinafter set
forth and intending to be legally bound, hereby agree as follows:




	1.	 	Appointment as Reseller





     1.1 Subject to the warranties, restrictions, and obligations set forth in
this Agreement, Applied Biosystems hereby appoints Digene as its nonexclusive
reseller for the sale, distribution and promotion of the Product, and Digene
accepts such appointment. Schedule A may be amended in writing from time to
time as appropriate to reflect any additional products and applications which
the parties have agreed to include in this Agreement.



     1.2 Subject to the warranties, restrictions, and obligations set forth in
this Agreement, Digene may only resell the Product (i) under Digene’s label or
a joint Digene/Digene distributor label and (ii) only as a component of Digene
products (and only Digene products) manufactured by or for Digene which
incorporate both the Product and Digene’s proprietary Hybrid Capture® system
and improvements thereto for use in human in vitro diagnostics. In the
event that during the term of this Agreement, Digene develops one or more
products for the non-human diagnostic markets such as food and environmental
testing and/or for the human diagnostic markets not covered in this Agreement,
and can demonstrate to Applied Biosystems reasonable satisfaction that
commencement of commercial sales is imminent, at Digene’s request the parties
will negotiate in good faith a Reseller Agreement for the Product for use in
such Digene products for the non-human diagnostic markets and/or human
diagnostic markets not covered in this Agreement. Applied Biosystems
obligation in such event shall be limited to negotiating such a Reseller
Agreement in good faith and nothing contained herein shall impose any
obligation on Applied Biosystems with respect thereto other than to so
negotiate in good faith.



 









 





     1.3 In the event Digene proposes to resell Product under the label of a
third party, for use in human in vitro diagnostics or pharmaceutical
therapeutics research and development, but otherwise in accordance with Section
1.2 and 1.4, at Digene’s request Applied Biosystems will negotiate in good
faith a Reseller Agreement with such third party for the Product to be sold
under such third party’s label. Applied Biosystems obligation in such event
shall be limited to negotiating such a Reseller Agreement in good faith and
nothing contained herein shall impose any obligation on Applied Biosystems with
respect thereto other than to so negotiate in good faith.



     1.4 In no event shall Digene (a) dilute or alter the Product, (b) resell
the Product in the research market or (c) resell the Product for use in
membrane-based assays.



     1.5 Digene shall not resell any of the Product in conjunction with or for
use with any substrate or enhancer purchased from a source other than Applied
Biosystems. Substrate and enhancer, as supplied by Applied Biosystems, are
unique and specifically designed for use with the Product. Product
serviceability, as and to the extent warranted hereunder, cannot be maintained
when used in conjunction with substrate or enhancer purchased other than from
Applied Biosystems. Use of Product with substrates or enhancers purchased from
a source other than Applied Biosystems, unless such other source is selling
Applied Biosystems substrate or enhancer, shall void any Product warranty
hereunder.



     1.6 To the extent Applied Biosystems grants to any unrelated third party
the right to resell an improved formulation of the Product at any time during
the term of this Agreement, Applied Biosystems shall notify Digene of such
improved formulation of the Product. Upon notification, Digene shall have the
option of purchasing such improved formulation of the Product at a purchase
price to be agreed upon by the parties. Digene recognizes and agrees that any
new, improved or substitute dioxetane products and any new, improved or
substitute enhancer products manufactured, marketed and/or sold by Applied
Biosystems will not constitute an improved formulation of the Product and that
this Agreement does not provide Digene with any right to any new, improved or
substitute dioxetanes or enhancers.




	2.	 	Digene’s Obligations and Representations In addition to Digene’s
obligations set forth elsewhere in this Agreement, Digene shall from and after
the date of this Agreement:





     2.1 Use reasonable commercial efforts to promote, develop a market for and
sell DNA probe assays, utilizing the Product, for human in vitro
diagnostics;



     2.2 Promptly respond to all customer complaints about the Product, and
promptly notify Applied Biosystems of any recall or complaints; and



     2.3 Obtain, at its own expense, any import or export license, foreign
exchange license, foreign exchange permit, or other permit or approval it may
need for the resale of Product hereunder and otherwise comply with all
applicable Federal, state, local and foreign laws, regulations, directives,
rules and requirements governing the sale of the Product; provided,



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however, that, at the request and expense of Digene, Applied Biosystems
will aid Digene in gaining regulatory approvals where help and information
relating to the Product is required.




	3.	 	Prices and Terms of Sale





     3.1 The prices for the Product are set forth in Schedule B. Such prices
are F.O.B. Applied Biosystems shipping facility, currently in Bedford,
Massachusetts. Applied Biosystems may adjust the price list once per year
beginning July 1, 2004 as provided in Schedule B. Applied Biosystems will
notify Digene not later than thirty (30) days prior to the effective date of
any such price increase.



     3.1A No later than June 30 of each year, and subject to compliance with
the Minimum Annual Purchases set forth on Schedule A hereto, Digene shall
deliver to Applied Biosystems a non-binding forecast of the quantity of Product
it estimates it will purchase under this Agreement during the upcoming fiscal
year of Applied Biosystems ending June 30. The prices for the Product invoiced
for such fiscal year, as such prices are set forth on Schedule B, shall be
based upon the assumption that Digene in fact will purchase the forecasted
quantity during such fiscal year. If Digene in fact purchases less than the
quantity of Product it forecasted it would purchase during such fiscal year,
within thirty (30) days after the conclusion of such fiscal year, Digene shall
pay to Applied Biosystems the difference, if any, between the aggregate
purchase price paid by Digene for Product purchased during such fiscal year and
the aggregate purchase price Digene should have paid for the Product purchased
during such fiscal year based upon the quantities actually purchased, and if
Digene in fact purchases more than the quantity of Product it forecasted it
would purchase during such fiscal year, within thirty (30) days after the
conclusion of such fiscal year, Applied Biosystems shall pay to Digene the
difference between the aggregate purchase price paid by Digene for Product
purchased during such fiscal year and the aggregate purchase price Digene
should have paid for the Product purchased during such fiscal year based upon
the quantities actually purchased.



     3.1B In addition, Digene shall deliver to Applied Biosystems on each April
1, July 1, October 1, and January 1 a non-binding rolling four (4) quarter
forecast of the quantity of Product it estimates it will purchase under this
Agreement.



     3.1C If this Agreement shall expire or terminate other than at a fiscal
year end, for purposes of determining any amounts payable pursuant to the
preceding paragraph, the quantities of Product purchased during such fiscal
year in which the date of expiration or termination occurs be annualized, and
within thirty (30) days after the date of such expiration or termination,
Digene shall make the payment to Applied Biosystems or Applied Biosystems shall
make the payment to Digene, as the case may be, contemplated by this Section
3.1 based upon such annualization.



     3.1D In addition to providing the non-binding forecasts described in this
Section 3.1, Digene shall deliver binding purchase orders to Applied Biosystems
to purchase Product as contemplated by Section 4 hereof. For purposes of
determining compliance with the “Minimum Annual Purchase” under this Agreement,
and as used in Sections 3.1A and 3.1C, and for the



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purposes of Schedule B, a Product shall be deemed “purchased” on the date
of delivery to Applied Biosystems of a binding, non-cancellable purchase order
if the delivery date designated in such purchase order is equal to or less than
forty-five (45) days from the date of order; otherwise Product is deemed
“purchased” on the delivery date specified in the purchase order.



     3.2 All shipments will be invoiced at the time of shipment, including
partial shipments. Title and risk of loss shall pass to Digene when Product is
delivered to a common carrier FOB factory. Digene assumes and agrees to pay
and hold Applied Biosystems harmless from all export or import duties,
regulatory obligations (except as set forth in Section 2.3) fees or other
charges, all sales, use, excise, value added or other taxes or assessments
applicable to any sale under this Agreement (but excluding taxes, together with
any interest or penalties imposed in connection therewith, on Applied
Biosystems gross revenues or profits), and all costs and charges for
transportation, brokerage, handling and insurance of the Product from the point
of shipment.



     3.3 Except for the royalties pursuant to Section 3.4, all payments
required hereunder are due within thirty (30) days of invoicing. All payments
shall be in U.S. Dollars, without deduction or offset (except as expressly
authorized herein or in writing in advance by Applied Biosystems). If Applied
Biosystems at any time has reasonable concern about security or timeliness of
payments, it may decline to make shipments until receipt of payment or
establishment of a letter of credit or other arrangement securing payment.
Applied Biosystems may impose interest on overdue payments at the lesser of
(i)1-1/2 % per month or (ii) the maximum legal rate of interest.



     3.4 In addition to the price listed on Schedule B, Digene shall pay
Applied Biosystems royalties as set forth in Schedule B, payable with each
report submitted pursuant to Section 3.6.



     3.5 Digene shall keep, in a mutually acceptable accounting format,
complete and accurate books of account containing all particulars that may be
necessary for the purpose of showing the amounts payable to Applied Biosystems
hereunder. Said books of account shall be kept at Digene’s principal place of
business or the principal place of business of the appropriate division of
Digene to which this Agreement relates, or at off-site storage facilities as
consistent with Digene’s document retention procedures. Said books and the
supporting data shall be open for five (5) years following the end of the
fiscal year to which they pertain, to the inspection of Applied Biosystems or
its agents for the purpose of verifying Digene’s royalty statements or
compliance in other respects with this Agreement during Digene’s ordinary
business hours, not more than once in any 12-month period. Should such
inspection lead to the discovery of more than a 10% discrepancy, Digene shall
pay all third party costs incurred by Applied Biosystems related to such
inspection. After such five- (5-) year period, Applied Biosystems shall have
no further right of inspection or investigation with respect to amounts paid to
Applied Biosystems during such fiscal year. In addition, once Applied
Biosystems has exercised its right of inspection hereunder with respect to any
particular fiscal year, Applied Biosystems shall not be entitled to an
additional review of such year once the inspection is completed.



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     3.6 Within forty-five (45) days after each March 31, June 30, September 30
and December 31, Digene shall deliver to Applied Biosystems a report for the
quarter just ended stating: (a) the number of Tests sold (or otherwise disposed
of in a transaction which generated Net Sales) by Digene; (b) Net Sales of
Tests; (c) applicable deductions; (d) total royalties due and payable, and (e)
such other information regarding Digene’s business under this Agreement as
Applied Biosystems shall reasonably request. If no royalties shall be due,
Digene shall so report. “Tests” and “Net Sales” shall have the meanings set
forth on Schedule C.



     3.7 Minimum Annual Purchases are set forth in Schedule A. If Digene fails
to make Minimum Annual Purchases for any applicable fiscal year set forth in
Schedule A, Applied Biosystems may terminate this Agreement as set forth in
Section 5.3(d).




	4.	 	Orders and Shipping





     4.1 Digene shall submit orders at least forty-five (45) days prior to the
requested delivery dates on a purchase order referencing this Agreement.
Digene shall purchase at least the Minimum Annual Purchase amounts per fiscal
year as set forth in Schedule A hereto.



     4.2 Applied Biosystems may specify a different ship date by written notice
within seven (7) days after receipt of an order but otherwise will use
commercially reasonable efforts to ship orders by the requested date. Shipments
shall be in accordance with Digene’s instructions, but unless other written
instructions are provided by Digene, Applied Biosystems will select the common
carrier and shall prepay freight, insurance, and other reasonable and customary
or necessary charges and invoice them to Digene. All Product will be properly
packed. Applied Biosystems shall make reasonable efforts, but not be required
to ship Product earlier than forty-five (45) days after receipt of a purchase
order.



     4.3 The terms and provisions herein shall govern all orders and purchases
notwithstanding any inconsistent or additional terms on purchase orders or
other sales documents and forms, which inconsistent or additional terms shall
have no force or effect whatsoever as between the parties even if Applied
Biosystems might be deemed to have accepted same by reason of its execution or
acknowledgment thereof.



     4.4 In the event Applied Biosystems is unable to supply Product to Digene
or determines that it is unable to do so and such failure to supply continues
for a period of four (4) consecutive months during the term of this Agreement,
thereafter, subject to the terms and conditions of this Section 4.4, Digene
shall have the right to manufacture Product during such time as Applied
Biosystems is unable to supply Product to Digene.



     4.4A Applied Biosystems shall notify Digene in writing as soon as
practicable if Applied Biosystems is unable or anticipates it will be unable to
provide sufficient quantities of Product for any four (4) month period as a
result of a condition described above in this Section 4.4. Upon receipt of
such notification, Digene shall work with Applied Biosystems, if appropriate,
to resolve the failure to supply. If such failure to supply has not been
resolved in the reasonable good faith judgment of Digene, which judgment shall
not be unreasonably withheld,



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within the four (4) month period referred to above, Digene shall have the
right to manufacture for it Product during the period beginning with the first
day after the end of such four (4) month period and ending at such time as
Applied Biosystems notifies Digene in writing in good faith that Applied
Biosystems is able to resume supplying Product to Digene.



     4.4B In the event Digene exercises its right to manufacture Product
pursuant to this Section 4.4, Applied Biosystems shall, solely during the
period during which Digene has a right to manufacture Product pursuant to this
Section 4.4, license to Digene pursuant to “Exhibit B — Terms and Conditions of
License” (the “Terms and Conditions of License”) the Licensed Intellectual
Property Rights (as defined in the Terms and Conditions of License). During
the three month period commencing with the Date of Grant (as such term is
defined in the Terms and Conditions of License), upon Digene’s reasonable
request, Applied Biosystems will provide up to eighty (80) hours of on-site and
telephonic reasonable assistance to Digene in implementing the manufacture of
the Product, at a time or times agreed upon by the parties, to assist Digene in
learning how to manufacture the Product substantially in the manner known to
and used by Applied Biosystems at such time. The parties agree that during
such three (3) month period: (i) Applied Biosystems will devote up to sixty
(60) hours of training on contiguous business days if requested by Digene; and
(ii) Digene’s requests for follow-up assistance shall be requested in no less
than 1 (one) eight (8) hour day increments for on-site assistance. Digene
shall pay Applied Biosystems for such assistance at Applied Biosystems then
commercial rates on a time and materials basis (or if no such rates exist, at
reasonable retail rates), and will reimburse Applied Biosystems for its
reasonable lodging, meal and travel expenses incurred in the performance of
such services, within thirty days of receipt of an invoice therefor. Digene
shall defend, indemnify and hold harmless Applied Biosystems, from and against
any and all claims and liabilities that may arise from the manufacture, supply
or use of Product manufactured by Digene as set forth in the Terms and
Conditions of License. Digene shall use all Licensed Intellectual Property
Rights only for the manufacture of the Product in accordance with this Section
4.4 and not for any other purpose.



     4.4C Notwithstanding any license to Digene granted under Section 4.4B,
Applied Biosystems shall be permitted to cure any condition causing the failure
to supply Product. In the event Applied Biosystems cures any inability to
supply Digene with Product at any time after Digene’s exercise of its right to
manufacture the Product, at Applied Biosystems’ election, Digene shall return
to Applied Biosystems all tangible materials previously transferred pursuant to
this Section, and the license and other rights granted pursuant to Section 4.4B
shall terminate, and Applied Biosystems shall resume the supply of the Product.



     4.5 The parties will use commercially reasonable efforts to comply with
the terms and provisions of “Exhibit A – Quality Terms and Conditions” in all
material respects during the term of this Agreement.




	5.	 	Term and Termination





     5.1 This Agreement shall commence on the date first set forth above and
shall extend until June 30, 2015, subject to earlier termination as provided
herein. The parties may renew this



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Agreement after the initial term or any extended term upon express mutual
agreement in writing (which writing shall designate the expiration date of any
extended term) at least six (6) months prior to the expiration of the initial
term, but if they do not, this Agreement shall automatically expire at the end
of the initial or any renewal term. Notwithstanding the foregoing, Applied
Biosystems may terminate this Agreement effective on any date after June 30,
2011 upon not less than twelve (12) months written notice to Digene if Applied
Biosystems determines that it will no longer manufacture Product for commercial
sale to third parties after the effective date of termination set forth in such
notice; provided that any such termination shall be subject to the provisions
of Section 5.4 hereof.



     5.2 In addition to the renewal rights set forth in Section 5.1, (a) if
prior to sixty (60) days before the end of the initial term or any extended
term of this Agreement Digene offers in a written notice delivered to Applied
Biosystems to extend the term of this Agreement, on the same terms and
conditions as set forth in this Agreement, for a period of at least one year,
and (b) if Applied Biosystems does not accept such offer on or before
the last day of the term of this Agreement in which such notice is delivered to
Applied Biosystems by delivering written notice of acceptance to Digene,
and (c) if at all times during the six month period ending with the last
day of such term Digene offered for commercial sale at least one product that
incorporates both the Product and Digene’s proprietary Hybrid Capture® system
for use in in vitro human diagnostics with respect to which approval for
sale had been obtained from the U.S. Food & Drug Administration (“FDA”), then,
at the expiration of the term of this Agreement, Digene shall acquire from
Applied Biosystems the license described in Section 5.4 hereof, the terms of
which are set forth in the Terms and Conditions of License attached hereto as
Exhibit B, to manufacture the Product. Any such license shall be subject to
the provisions of Section 5.4 hereof and the Terms and Conditions of License.



     5.3 Notwithstanding anything herein contained to the contrary, and in
addition and without prejudice to any other rights or remedies, the parties
shall have the right to terminate this Agreement as follows:




        (a) Applied Biosystems may terminate this Agreement effective
immediately upon written notice if Digene fails to make any payment due
hereunder within ten (10) days after the date such payment was due and
the payment has not been made within twenty (20) days after Applied
Biosystems delivers written notice to Digene of such failure;




        (b) if one party is in material breach of the terms hereof, upon
written notice specifying the breach, provided, however, that if the
first such breach is capable of remedy, termination shall be effective
forty-five (45) days after notice specifying the breach and the remedy
for the breach if the breach shall not have been remedied within such
forty-five (45) day period, and provided further, that the foregoing
provisions permitting cure shall not apply to any breach of Section 1.2,
1.5, 8, 9, or 10 of this Agreement;



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        (c) either party may terminate this Agreement effective immediately
upon written notice if (i) all or a substantial portion of the assets of
the other party are transferred to an assignee for the benefit of
creditors, a receiver, or a trustee in bankruptcy, (ii) a proceeding is
commenced by or against the other party for relief under bankruptcy or
similar laws and such proceeding is not dismissed within thirty (30)
days, (iii) the other party is adjudged insolvent or bankrupt; or (iv) if
the other party shall cease to carry on business; and




        (d) Applied Biosystems may terminate this Agreement upon written
notice to Digene in the event Digene fails to make the Minimum Annual
Purchases set forth on Schedule A for any fiscal year; provided however
that Applied Biosystems shall first notify Digene of its intent to
terminate the Agreement for such purpose and Digene shall then have
forty-five (45) days to order and pay Applied Biosystems for Product
necessary to achieve the Minimum Annual Purchase amount for such fiscal
year, and if Digene does so, Applied Biosystems may not then terminate
this Agreement on the basis of such notice of intent (but all other
rights of termination shall remain in full force and effect). Reference
is made to Section 3.1D for a definition of the term “purchase.” Minimum
Annual Purchases means the purchase by Digene of at least the number of
liters of Product set forth on Schedule A during a twelve month period
beginning July 1.



     5.4 Upon the termination of this Agreement (a) by Applied Biosystems
pursuant to the last sentence of Section 5.1 hereof, (b) by Applied Biosystems’
failing to accept an offer made by Digene to extend the Term of this Agreement
pursuant to Section 5.2 hereof, or (c) by Digene because of (i) an uncured
breach by Applied Biosystems pursuant to Section 5.3(b) hereof, or (ii) the
bankruptcy or insolvency of Applied Biosystems pursuant to Section 5.3(c)
hereof, if requested by Digene in writing either prior to, or in no event later
than sixty (60) days after the effective date of any such expiration or
termination, Digene shall then have a perpetual (except as set forth in the
Terms and Conditions of License), non-exclusive license to and under the
Licensed Intellectual Property Rights (as defined in the Terms and Conditions
of License) to manufacture the Product to include in only Digene products
manufactured by or for Digene that incorporate both the Product and Digene’s
proprietary Hybrid Capture® system for use in in vitro human diagnostics
with respect to which approval for sale had been obtained from the FDA, or
which are then in clinical trials related to an FDA approval process, prior to
such expiration or termination. The Terms and Conditions of License attached
hereto as Exhibit B shall survive any such expiration or termination of this
Agreement if and to the extent Digene is granted such license rights pursuant
to this Agreement and such Terms and Conditions of License.



     5.4A If, pursuant to this Section 5.4, Digene is licensed the Licensed
Intellectual Property Rights pursuant to the Terms and Conditions of License,
during the three (3) month period commencing no later than the date of
expiration or termination of this Agreement and, if reasonably possible, three
(3) months prior to such date of expiration or termination if the provisions of
this Section 5.4 are implicated by the termination of this Agreement pursuant
to the last sentence of Section 5.1 or pursuant to Section 5.2 (for purposes of
this Section 5.4, the “Date of Grant”), upon Digene’s reasonable request,
Applied Biosystems will provide up to eighty (80)



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hours of reasonable assistance to Digene in implementing the manufacture
of the Product, at a time or times agreed upon by the parties, to assist Digene
in learning how to manufacture the Product substantially in the manner known to
and used by Applied Biosystems at such time. The parties agree that: (i)
Applied Biosystems will devote up to sixty (60) hours of training on contiguous
business days if requested by Digene and (ii) Digene requests for follow-up
assistance shall be requested in not less than one (1) eight (8) hour day
increments for on-site assistance. Digene shall pay Applied Biosystems for
such assistance at Applied Biosystems then commercial rates on a time and
materials basis (or if no such rates exist, at reasonable retail rates), and
will reimburse Applied Biosystems for its reasonable lodging, meal and travel
expenses incurred in the performance of such services, within thirty days of
receipt of an invoice therefor.



     5.4B Digene shall defend, indemnify and hold harmless Applied Biosystems,
from and against any and all claims and liabilities that may arise from the
manufacture, supply or use of Products manufactured by Digene as set forth in
the Terms and Conditions of License.



     5.4C Digene shall use all Licensed Intellectual Property Rights only for
the manufacture of the Product in accordance with this Section 5.4 and the
Terms and Conditions of License, and not for any other purpose. In addition,
and without limiting the foregoing, Digene shall have the right, prior to any
expiration or termination of this Agreement, to provide Applied Biosystems with
a forecast of Digene’s expected requirements of the Product for use during the
period between the expiration or termination of this Agreement and Digene’s
receipt of the necessary validation from the FDA to manufacture the Product
pursuant to the foregoing license. Applied Biosystems shall use commercially
reasonable efforts to deliver Product to meet such forecast prior to expiration
or termination of the Agreement and Digene shall pay for such Product pursuant
to this Agreement. All information that Digene receives from Applied
Biosystems is Proprietary Information and can only be used by Digene and only
for the purposes of manufacturing Product by Digene for use with Digene
products in compliance with the terms of this Agreement.



     5.5 The parties each acknowledge that, except as contemplated by Section
5.4 and the Terms and Conditions of License, this Agreement shall, unless the
parties mutually agree otherwise, continue only until the expiration of the
term. With such knowledge in mind, Digene has agreed to the pricing structure
provided for in this Agreement as full, fair and sufficient compensation for
all efforts and services to be performed by Applied Biosystems. Accordingly,
in the event of termination or expiration in accordance with this Agreement
neither party shall be entitled to any indemnity, compensation, damages, loss
of profits or prospective profits, or payment in respect of investments made or
goodwill or clientele established during the continuance of this Agreement.



     5.6 The obligations and covenants of Digene under Sections 3.5, 6.5, 8, 9,
10 and 12, and the obligation of Digene to make payments pursuant to Section 3
for Product delivered or Net Sales of Tests made prior to termination or
expiration of this Agreement, or to pay royalties pursuant to the Terms and
Conditions of License, shall not be affected by termination or expiration of
this Agreement. The obligations and covenants of Applied Biosystems under



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Sections 4.4, 5.1, 5.2 and 5.4 (in each event, to the extent applicable
post termination or expiration), 6, 10 and 12 shall not be affected by
termination or expiration of this Agreement.





	6.	 	Applied Biosystems Limited Product Warranties





     6.1 Applied Biosystems sole warranties are that each Product supplied to
Digene will, for the period specified in the official applicable Product
Specifications set forth in Schedule D hereof, conform in all material respects
to the Product Specifications. Applied Biosystems will provide a Certificate
of Analysis with each shipment. Applied Biosystems makes the foregoing
warranties to and for the benefit of Digene only, and they may not be assigned
to any other party.



     6.2 If any Product does not conform with the foregoing warranties, Applied
Biosystems sole obligation and Digene’s sole remedy with respect thereto shall
be to replace such Product without charge or expense to Digene or, at Applied
Biosystems option, to credit Digene for the amount paid by Digene to Applied
Biosystems for such Product.



     6.3 The above warranties are contingent upon the proper use, storage and
shipment of the Product and shall be void with respect to defects or failures
due to disaster, accident, neglect, misuse, or improper storage or shipment (in
each case not attributable to Applied Biosystems).



     6.4 EXCEPT AS EXPRESSLY SET FORTH IN SECTION 6.1, THERE ARE NO WARRANTIES,
EXPRESS OR IMPLIED, BY OPERATION OF LAW OR OTHERWISE, WITH RESPECT TO THE
PRODUCTS, AND APPLIED BIOSYSTEMS EXPRESSLY DISCLAIMS ALL IMPLIED WARRANTIES AND
WARRANTIES ARISING BY OPERATION OF LAW INCLUDING BUT NOT LIMITED TO ANY
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. NO
REPRESENTATION OR OTHER AFFIRMATION OF FACT, INCLUDING BUT NOT LIMITED TO
STATEMENTS REGARDING CAPACITY, SUITABILITY FOR USE OR PERFORMANCE OF PRODUCTS,
WHETHER MADE BY APPLIED BIOSYSTEMS EMPLOYEES OR OTHERWISE, WHICH IS NOT
CONTAINED IN THIS AGREEMENT SHALL BE DEEMED TO BE A WARRANTY BY APPLIED
BIOSYSTEMS FOR ANY PURPOSE OR GIVE RISE TO ANY LIABILITY OF APPLIED BIOSYSTEMS
WHATSOEVER. WITHOUT LIMITATION OF THE FOREGOING, APPLIED BIOSYSTEMS IS NOT
EXTENDING ANY REPRESENTATION OR WARRANTY THAT THE PRODUCTS, ALONE OR IN
COMBINATION WITH OTHER PRODUCTS, WILL NOT INFRINGE THE PATENTS OR OTHER RIGHTS
OF THIRD PARTIES. IN NO EVENT SHALL APPLIED BIOSYSTEMS BE LIABLE FOR INDIRECT,
INCIDENTAL, CONSEQUENTIAL OR SPECIAL DAMAGES, INCLUDING WITHOUT LIMITATION LOST
BUSINESS PROFITS, REGARDLESS WHETHER THE ACTION IS IN CONTRACT, TORT (INCLUDING
NEGLIGENCE), BREACH OF WARRANTY OR OTHERWISE, EVEN IF APPLIED BIOSYSTEMS HAS
BEEN ADVISED AS TO THE POSSIBILITY THEREOF.



     6.5 If Digene makes any warranty or representation inconsistent with or in
addition to the foregoing warranties or any Product instructions, Digene shall
defend and hold Applied Biosystems harmless from any claim to the extent based
thereon.



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     6.6 Applied Biosystems shall maintain policies of comprehensive general
liability insurance, including product liability insurance, with limits of at
least Five Million Dollars ($5,000,000).




	7.	 	Digene Warranties and Agreements





     7.1 Digene warrants, represents, and agrees that it is solely responsible
for complying with all applicable Federal, state, local and foreign laws,
regulations and directives including, but not limited to, the Federal Food Drug
and Cosmetic Act and the regulations promulgated thereunder, as such laws and
regulations apply to Digene’s storage, sale, use, labeling, shipment, or
distribution of in vitro diagnostic tests incorporating Product. Digene
acknowledges and agrees that it is solely liable for the advertising,
promotion, and sale of Product, and warrants that all such efforts shall be in
compliance with all applicable Federal, state, local and foreign laws,
regulations and directives.



     7.2 Digene warrants that it possesses the capability to qualify the
suitability of Product for use in in vitro diagnostic tests. In so
warranting, Digene acknowledges that it is solely responsible for qualifying
and validating the suitability of Product for any use in diagnostic tests that
Digene may develop from time to time. Digene further acknowledges that Applied
Biosystems, by having provided Product to Digene under this Agreement, has in
no way agreed to, endorsed or otherwise approved of Digene’s determination that
Product is in any way suitable for use in any such diagnostic tests developed,
advertised, promoted, sold or distributed by Digene.




	8.	 	Trademarks and Trade Names





     8.1 Subject to Section 8.2, Applied Biosystems grants to Digene a
non-exclusive right to use the Marks, trade names and logos that Applied
Biosystems may adopt from time to time with respect to the Product (“Applied
Biosystems Marks”) in connection with Digene’s sale and distribution of
Product. Digene will indicate clearly in any and all materials in which Tests
utilizing the Product are advertised, marketed, sold or otherwise distributed
that such Tests utilize Product obtained by Digene from Applied Biosystems.
Except as set forth in this Section 8, nothing contained in this Agreement will
grant to Digene any right, title or interest in Applied Biosystems Marks.
Digene recognizes the validity of Applied Biosystems Marks and acknowledges the
same are the property of Applied Biosystems. At no time during or after the
term of this Agreement will Digene challenge or assist others to challenge
Applied Biosystems Marks or the registration thereof or attempt or assist
others to attempt to register any trademarks, marks, trade names or logos
confusingly similar to those of Applied Biosystems.



     8.2 All representations of Applied Biosystems Marks that Digene intends to
use will first be submitted to Applied Biosystems for approval (which will not
be unreasonably withheld) of design, color, and other details or will be exact
copies of those used by Applied Biosystems. In addition, Digene shall follow
the instructions issued by Applied Biosystems from time to time for the purpose
of protecting the standards of quality established for the goods and services
sold under Applied Biosystems Marks.



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     8.3 Digene acknowledges and agrees that the use of Applied Biosystems
Marks as set forth in Section 8.1, and any review or approval by Applied
Biosystems as set forth in Section 8.2 do not represent the endorsement or
approval by Applied Biosystems of Digene’s storage, sale, use, labeling,
shipment, promotion, or distribution of Product, in any form. Digene agrees
that nothing in this Section 8 in any way affects or alters its responsibility
for complying with all applicable laws and regulations, as set forth in Section
7.1 hereof.




	9.	 	Patent Marking





     Digene shall properly affix the statutory patent notice as set forth in
Schedule E to all Product or, where that is impractical, to labels or boxes for
such Product. Digene may deplete its current inventory of labels for such
Product (which include patent markings) before implementing the statutory
patent notice as set forth in Schedule E.




	10.	 	Confidential Information





     Each party shall treat accordingly all verbal and written communications
from the other party which are designated, or which should reasonably be
regarded, in the normal commercial view, as constituting business secrets or
proprietary information (“Proprietary Information”). Each party shall refrain
from using, disclosing or making available to any third party any of the other
party’s Proprietary Information except for the purposes of implementing this
Agreement and shall impose upon its employees and agents the same obligations
with respect to the other party’s Proprietary Information as it employs with
respect to its own confidential information but in no event shall such
obligations be less than what is reasonable in accordance with good commercial
practice. No such obligations of confidence shall extend to information which
(a) is publicly available through no fault of the receiving party; (b) is
already in the receiving party’s possession; (c) is rightfully received from a
third party; or (d) is required by law to be disclosed, but solely to the
extent of such requirement, and in such event, the party required to disclose
shall identify information so disclosed as the confidential information of the
other party, shall give written notice of such requirement to the other party
as long as possible prior to such disclosure, and shall use all reasonable
efforts to cause, or to assist the other party to cause, such government,
agency or organization to protect such information as confidential.




	11.	 	Notices





     Any notice under this Agreement or provided for in this Agreement shall be
in English and shall be effective when delivered to the address of such party
set out above (or to such other address as either party may specify by notice
given to the other party), addressed in the case of Applied Biosystems to:



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David Hicks

Senior Director

Cell Biology and Functional Proteomics

Applied Biosystems

500 Old Connecticut Path

Framingham, MA 01701




with a copy to

Applied Biosystems Legal Liaison

Applied Biosystems

35 Wiggins Avenue

Bedford, MA 01730



in the case of Digene to:




	 	 	 
	Evan Jones

	 	General Counsel
	President & CEO

	 	Morris Cheston, Jr.
	Digene Corporation

	 	Ballard Spahr Andrews & Ingersoll, LLP
	1201 Clopper Road

	 	1735 Market Street, 51st Floor
	Gaithersburg, Maryland 20878

	 	Philadelphia, Pennsylvania 19103








	12.	 	Dispute Resolution





     Any dispute relating to the interpretation, performance, or damages
resulting from improper termination, of this Agreement shall be resolved, at
either party’s written request, through final, binding arbitration; provided,
however, that nothing contained herein shall be construed to prevent either
party from terminating this Agreement or from bringing an action in any court
of competent jurisdiction to compel the other party to comply with orders or
awards of the arbitrator(s) in the nature of injunctive or provisional relief
during the pendency of the arbitration proceedings. Such arbitration shall be
conducted in Boston, Massachusetts, in accordance with the Commercial
Arbitration Rules and (if applicable) Supplementary Procedures for
International Commercial Arbitration, both as modified from time to time, of
the American Arbitration Association (“AAA”). The arbitrator (or at least one
of the arbitrators if there are three) shall be an experienced business
attorney skilled in the subject matter of the dispute. The arbitrator(s) shall
assess the fees and expenses of the AAA and the arbitrator(s) between the
parties in such proportions as the arbitrator(s) deem equitable. Punitive
damages (including multiple damages) may not be awarded in any arbitration
hereunder. If judicial enforcement or review of the arbitrator(s)’ award is
sought by either party, judgment may be entered upon such award in any court of
competent jurisdiction.




	13.	 	Miscellaneous





     13.1 All obligations of Applied Biosystems under this Agreement shall be
subject to the U.S. export laws, and Applied Biosystems shall not be liable for
any failure to perform hereunder if such performance is at that time prohibited
by the U.S. export laws.



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     13.2 If Digene learns of any infringement of Applied Biosystems patents,
Applied Biosystems Marks or other intellectual property rights associated with
the Product, Digene shall promptly inform Applied Biosystems in writing of all
known information relating thereto and shall cooperate fully with Applied
Biosystems, at Applied Biosystems’ expense, in any reasonable efforts
undertaken by Applied Biosystems to challenge or prosecute such infringement.



     13.3 This Agreement may not be assigned or transferred by Digene without
the prior written consent of Applied Biosystems; provided, however, that the
foregoing shall not be deemed to prohibit any assignment of this Agreement by
Digene in connection with a sale or other transfer of all or a substantial
portion of its business relating to any Product or to a corporation or other
entity into which Digene is merged or consolidated, provided that Digene gives
Applied Biosystems not less than thirty (30) days prior written notice.



     13.4 No modification or waiver of any terms or conditions hereof shall be
of any force or effect unless in writing and signed by each party’s authorized
officer. Either party’s failure to enforce any provision shall not be deemed to
be a waiver of such provision or such party’s right thereafter to enforce such
provision.



     13.5 Digene shall act as an independent contractor and shall not be deemed
to be an employee, agent, or legal representative of Applied Biosystems for any
purpose hereunder. Digene shall not be entitled to enter into any contracts in
the name of or on behalf of Applied Biosystems, nor to pledge the credit of
Applied Biosystems in any way or hold itself out as having authority to do so.



     13.6 This Agreement, along with the attachments referenced herein,
embodies the final, complete and exclusive understanding between the parties,
and supersedes all previous agreements, understandings and arrangements between
the parties with respect to the subject matter contained herein.



     13.7 If any provision of this Agreement is held illegal, invalid or
unenforceable, all other provisions hereof shall remain in full force and
effect as if such provision were not a part hereof.



     13.8 Except as otherwise specifically provided herein, this Agreement
shall be governed by and construed according to the laws of Massachusetts,
U.S.A., excluding both its choice of law provisions and the United Nations
Convention on Contracts for the International Sale of Goods. The official text
of the Agreement and any Schedules, and any notices given or accounts or
statements required hereby shall be in English.



     13.9 Except as otherwise provided herein, if the performance of this
Agreement or any obligation hereunder (other than the making of payments
hereunder) is prevented, restricted or interfered with by reason of any event,
act or condition beyond the reasonable control of the affected party, the party
so affected, upon written notice to the other party, shall be excused from such
performance to the extent of such prevention, restriction or interference.



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     13.10 The headings and captions in this Agreement are for convenience only
and are not part of this Agreement.



     13.11 The following attachments are incorporated in and made a part of
this Agreement:




	(i)	 	Schedule A: Product and Minimum Annual Purchase
Requirements
	 
	(ii)	 	Schedule B: Prices and Royalties
	 
	(iii)	 	Schedule C: Definitions
	 
	(iv)	 	Schedule D: Product Specifications
	 
	(v)	 	Schedule E: Statutory Patent Notice
	 
	(vi)	 	Exhibit A: Quality Terms and Conditions
	 
	(vii)	 	Exhibit B: Terms and Conditions of License





     IN WITNESS WHEREOF, the undersigned have executed and delivered this
Agreement by their duly authorized representatives as of the date first shown
above.



	 	 	 
	APPLERA CORPORATION,

	 	DIGENE CORPORATION
	acting through its Applied Biosystems
	 	 
	Group
	 	 







	 	 	 
	By: /s/ Laura Lauman

	 	By: /s/ Evan Jones
	 
	 	 
	Name: Laura Lauman 

	 	Name: Evan Jones 
	 
	 	 
	Title: Vice President 

	 	Title:  Chairman & CEO 
	 
	 	 
	Date: December 13, 2003 

	 	Date:  December 8, 2003 
	 
	 	 








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