ex10-42




THIS EXHIBIT HAS BEEN REDACTED AND IS THE A SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH “*” AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

EXHIBIT 10.42


DIGENE CORPORATION

1201 CLOPPER ROAD

GAITHERSBURG, MARYLAND 20878

(301)944-7000







April 29, 2001



Confidential



Heinrich Dreismann, Ph.D.

President and CEO of Roche Molecular Systems, Inc.

Roche Diagnostics

4300 Hacienda Drive

Pleasanton, CA 94588



            Re:     Strategic Collaboration and Distribution Rights


Dear Heiner:


            We are pleased by your interest in and excited about the prospect of a
strategic collaboration between Roche Molecular Systems, Inc., a Delaware
corporation and an affiliate of F. Hoffmann-La Roche, Ltd., a corporation
organized under the laws of Switzerland (collectively, “Roche”), and Digene
Corporation, a Delaware corporation (“Digene”). This letter agreement sets
forth the understanding between Roche and Digene regarding the sale, marketing
and distribution of Digene’s Hybrid Capture HPV products and the negotiation of
a strategic collaboration and relationship. Upon execution of this letter
agreement below, each of Digene and Roche agree to be bound by the terms and
conditions of this letter agreement (“Agreement”).



	 	 	 
	1.		
Upfront Payment. In consideration of the
promises, covenants and undertakings of Digene provided in
this Agreement, Roche will pay to Digene a non-refundable,
up-front payment of five million dollars ($5,000,000) on April
30, 2001 (the “Upfront Payment”). The Upfront Payment may be
converted into equity of Digene as provided in paragraph 6
below.



 








THIS EXHIBIT HAS BEEN REDACTED AND IS THE A SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH “*” AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



Heinrich Dreismann, Ph.D.

April 29, 2001

Page 2




	 	 	 
	2.		
Abbott. Digene represents to Roche that, on
April 30, 2001, Digene will terminate the Marketing and
Distribution Agreement between Digene and Abbott Laboratories
(“Abbott”), dated as of May 7, 1999 (the “Abbott Agreement”),
with respect to HPV only, all in accordance with Digene’s
rights and pursuant to such agreement.
	 
	3.		
Distribution.





	 	 	 
	(a)		
Appointment. Subject to the
termination of the Abbott Agreement and as of May 1,
2001 until June 30, 2002 (the “Distribution Term”),
Digene hereby appoints Roche and its affiliates as a
co-exclusive distributor of the HPV Products listed on
Schedule A attached hereto in the Territory (defined in
paragraph 3(d) below) and Roche hereby accepts such
appointment. As co-exclusive distributor, Roche will
have the sole and exclusive right to market, promote,
sell and distribute HPV Products in the Territory,
subject only to (i) Abbott’s distribution rights in
accordance with the wind-down provisions of the Abbott
Agreement and (ii) after the expiration of Abbott’s
wind-down period, only if the strategic relationship is
not reached pursuant to paragraph 6, Digene rights to
sell HPV Products on its own. Roche acknowledges that
Abbott will be a non-exclusive existing distributor of
the HPV Products in the Territory in accordance with the
wind-down provisions of the Abbott Agreement.
	 
	(b)		
Wind-Down Period. In the event that
the Distribution Term is not extended by mutual
agreement of Roche and Digene and if Roche has met all
of its obligations under this Agreement (which
obligations do not include a requirement that any
agreement be reached under paragraph 6(a)), there shall
be a wind-down period of six (6) months after June 30,
2002. During the wind-down period, if any, Roche’s
distribution rights in the Territory shall be
non-exclusive and Digene shall be free to engage any
third party to act as a distributor of the HPV Products
in the Territory.
	 
	(c)		
Equipment Buy-Back. In the event
that no agreement is reached under paragraph 6(a) and if
Roche has met all of its obligations under this
Agreement (which obligations do not include a
requirement that any agreement be reached under
paragraph 6(a)), then, within 30 days of December 31,
2002, Digene shall buy back from Roche equipment
purchased by Roche from Digene that is



 








THIS EXHIBIT HAS BEEN REDACTED AND IS THE A SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH “*” AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



Heinrich Dreismann, Ph.D.

April 29, 2001

Page 3




	 	 	 
			
then owned by Roche and is in use for HPV testing in
connection with the HPV Products at Roche’s customers’
laboratories at
[*******************************************************
*******************************************].
	 
	(d)		
Territory. For purposes of this
Agreement, the “Territory” shall mean Europe, the Middle
East and Africa, where “Europe” shall only include
Albania, Andora, Austria, Estonia, Latvia, Lithuania,
Belgium, Belarus, Bosnia, Bulgaria, Commonwealth of
Independent States, Croatia, Cyprus, Czech Republic,
Denmark, Finland, France, Germany, Greece, Greenland,
Hungary, Iceland, Ireland, Italy, Liechtenstein,
Luxembourg, Macedonia, Malta, Moldova, Monaco,
Netherlands, Norway, Poland, Portugal, Romania, Russia,
San Marino, Serbia, Slovenia, Slovakia, Spain, Sweden,
Switzerland, Ukraine, United Kingdom, USSR – all former
countries, Vatican City and Yugoslavia; “Middle East”
shall only include Afghanistan, Algeria, Egypt, Iran,
Iraq, Israel, Jordon, Kuwait, Lebanon, Morocco, Oman,
Qatar, Saudi Arabia, Syria, The Sudan, Tunisia,
Turkey/Kurdistan and United Arab Emirates (UAE); and
“Africa” shall only include all countries in the
continent of Africa excluding Algeria, Egypt, Morocco,
The Sudan and Tunisia.





	 	 	 
	4.		
Obligations of the Parties Related to
Distribution.





	 	 	 
	(a)		
Digene shall supply to Roche the
Digene-labeled HPV Products.
	 
	(b)		
Roche shall pay the transfer price
for the HPV Products set forth on Schedule A attached
hereto. Digene shall apply the pre-paid Period Amount
to the transfer price owed for HPV Products delivered by
Digene to Roche in the Reporting Period related to such
Period Amount, all in accordance with paragraph 5(c).
	 
	(c)		
Promptly after execution of this
Agreement, Digene and Roche shall negotiate detailed
terms and conditions related to the supply and purchase
of HPV Products, including forecasting, delivery,
quality assurance, limitations of warranty,
indemnification and such other provisions that are
standard in the industry for such agreements and that
are no less favorable to the parties than similar terms
found in the Abbott Agreement.



 








THIS EXHIBIT HAS BEEN REDACTED AND IS THE A SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH “*” AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



Heinrich Dreismann, Ph.D.

April 29, 2001

Page 4




	 	 	 
	(d)		
Roche will conduct sales and
marketing efforts, which may include advertising,
presenting educational seminars, participating in
customer visitations and displaying exhibits at trade
shows.
	 
	(e)		
Roche will undertake the sales and
marketing efforts and commitments set forth on Schedule
B attached hereto.
	 
	(f)		
Digene will spend
[**********************************] over the
Distribution Term toward demand creation and market
development efforts for the HPV Products in the
Territory. Digene and Roche will cooperate with each
other for the purpose of coordinating each of their
marketing efforts. On a quarterly basis during the
Distribution Term Digene shall provide to Roche a
description of such market development efforts and the
amounts expended.
	 
	(g)		
Digene Trademarks. Digene grants to
Roche a non-exclusive right to use the trademarks, trade
names and logos listed on Schedule C attached hereto
(“Digene Marks”) in connection with Roche’s sale of the
HPV Products. Other than as expressly set forth in the
preceding sentence, nothing contained in this Agreement
will grant to Roche any right, title or interest in
Digene Marks. Roche recognizes the validity of Digene
Marks and acknowledges the same are the property of
Digene. At no time during or after the Distribution
Term will Roche challenge, or assist others to
challenge, the Digene 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 Digene. All
representations of Digene Marks that Roche intends to
use will first be submitted to Digene for approval
(which will not be unreasonably withheld or delayed) of
design, color and other details or will be exact copies
of those used by Digene. In addition, Roche will follow
the instructions issued by Digene from time to time for
the purposes of protecting the standards of quality
established for the goods and services sold under Digene
Marks.





	 	 	 
	5.		
Minimum Purchase of HPV Products and
Reconciliation.





	 	 	 
	(a)		
Minimum Purchase. During the
Distribution Term, Roche will purchase from Digene a
minimum amount of HPV Products so that the aggregate
purchase price of such HPV Products shall total at



 








THIS EXHIBIT HAS BEEN REDACTED AND IS THE A SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH “*” AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



Heinrich Dreismann, Ph.D.

April 29, 2001

Page 5




	 	 	 
			
least [***************************************] (the
“Minimum Amount”). In the event that Roche does not
actually take delivery of such amount of HPV Products,
Roche will nevertheless pay Digene the Minimum Amount,
subject to the reconsiliations provided in this
agreement. Upon completion of reconciliation for any
Reporting Period pursuant to paragraph 5(d), the
Minimum Amount shall be reduced by the corresponding
Period Amount.
	 
	(b)		
Pre-Payment of the Minimum Amount.
Roche will pre-pay the Minimum Amount by paying the
Period Amount on the Pre-Payment Due Dates, all
according to the schedule set forth below, and shall
submit to Digene a non-cancelable, binding purchase
order, substantially in the form of Schedule D, for such
amount of HPV Products at the time of such pre-payment.





	 	 	 	 	 
	

	Pre-Payment Due Date		Reporting Period		Period Amount
	
	
	
	


	

	[*********]		
[*********]
		$   [*********]
	
	
	
	

	
	
	
	


	

	[*********]		
[*********]
		     [*********]
	
	
	
	

	
	
	
	


	

	[*********]		
[*********]
		     [*********]
	
	
	
	

	
	
	
	


	

	[*********]		
[*********]
		     [*********]
	
	
	
	

	
	
	
	


	

	[*********]		
[*********]
		     [*********]
	
	
	
	

	
	
	
	


	

	Total Minimum Amount		
		$  [**********]
	
	
	
	


	






	 	 	 
	(c)		
Application of the Period Amounts to
Transfer Price Owed. As Digene delivers HPV Products to
Roche in a given Reporting Period, Digene shall prepare
an invoice for such delivered HPV Products and
immediately apply the balance of the Period Amount for
such Reporting Period toward the invoice. In the event
that invoices issued exceed the Period Amount for such
Reporting Period, Roche shall pay the invoiced amount
within 30 days of receipt of the invoice.



 







THIS EXHIBIT HAS BEEN REDACTED AND IS THE A SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH “*” AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION


Heinrich Dreismann, Ph.D.

April 29, 2001

Page 6




	 	 	 
	(d)		
Reconciliation. Within 30 days of
the end of each Reporting Period, Digene shall
distribute, if required, portions of the Period Amount
for such Reporting Period as follows:





	 	 	 
	(i)		
To Roche. If Digene
receives revenues from the sale of all Digene
products by Abbott under the Abbott Agreement in
the Reporting Period (the “Abbott Revenues”), then
Digene shall pay to Roche
[******************************* ********];
provided, however, that if the sum of the Abbott
Revenues plus the revenues received from Roche
under this Agreement for the Reporting Period (the
“Roche Revenues”) exceed the Period Amount for the
Reporting Period, then the amount to be paid to
Roche under this paragraph 5(d)(i) shall
[***************
************************************************
*].
	 
	(ii)		
To Digene. If the sum of
the Abbott Revenues plus the Roche Revenues is
less than the Period Amount for the Reporting
Period, then Digene shall retain from the Period
Amount, an amount equal to [******************************
***************************************************].
	 
	(iii)		
Interest. Digene shall
deposit the Period Amount in an interest-bearing
account and all interest earned through the end of
the Reporting Period on the Period Amount shall be
paid to Roche, regardless of whether the Period
Amount is applied to invoices, paid to Roche or
retained by Digene as outlined in this paragraph
5. Within 30 days of the end of each Reporting
Period, Digene shall pay to Roche the interest
that has accrued on the balance of the Period
Amount (net of distributions made under this
paragraph 5) during the relevant Reporting Period.
	 
	(iv)		
Quarterly Report. At the
time of each reconciliation under this paragraph
5(d), Digene shall provide to Roche a report
showing the Abbott Revenues and the Roche Revenues
for that Reporting Period. If a strategic
relationship between Digene and Roche is not
achieved during the 120-day



 








THIS EXHIBIT HAS BEEN REDACTED AND IS THE A SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH “*” AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



Heinrich Dreismann, Ph.D.

April 29, 2001

Page 7




	 	 	 
			
negotiation period as provided in paragraph 6(a),
Roche retains the right to audit Digene’s
invoices to Abbott.





	 	 	 
	6.		
Negotiation of a Strategic Relationship.





	 	 	 
	(a)		
Negotiations. Subject to termination
of the Abbott Agreement and beginning on May 1, 2001 for
a period of 120 days, Digene and Roche shall negotiate
in good faith all of the concepts raised in Roche’s
letter to Digene, dated April 12, 2001 and attached
hereto as Schedule E (the “April 12 Letter”) with the
purpose of reaching a definitive agreement or an
agreement on a term sheet for a strategic relationship
between Digene and Roche. Such negotiations shall be
exclusive on Digene’s part.
	 
	(b)		
Agreement Reached. If the agreement
reached or agreed-upon term sheet regarding such a
strategic relationship includes the purchase by Roche of
an equity interest in Digene, then the Upfront Payment
shall be converted into such equity or a portion of such
equity on terms and conditions to be negotiated as part
of the strategic relationship agreement.
	 
	(c)		
No Agreement Reached. In the event
that Digene and Roche do not enter into a definitive
agreement or a binding term sheet pursuant to paragraph
6(a) that includes a purchase by Roche of an equity
interest in Digene within the 120-day period (or such
longer period of time that both parties may agree to in
writing) and if Roche has met all of its payment
obligations under paragraphs 1, 4(b) and 5(b) of this
Agreement, then, on July 1, 2002, the Upfront Payment
shall be converted into shares of Common Stock of Digene
at a conversion price of $35 per share pursuant to the
Stock Purchase Agreement attached hereto as Schedule F.
Digene shall not disclose the terms of the equity
purchase by Roche, except as may be required in the
circumstances outlined in paragraph 7(b)(a).





	 	 	 
	7.		
Confidentiality and Publicity.





	 	 	 
	(a)		
Confidentiality. Each of Digene and
Roche acknowledge and agree that during the Distribution
Term, each of them and their affiliates may exchange
information which the disclosing party marks as
“confidential” (“Confidential Information”). Each of
Roche and Digene shall use the Confidential Information
of the



 








THIS EXHIBIT HAS BEEN REDACTED AND IS THE A SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH “*” AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



Heinrich Dreismann, Ph.D.

April 29, 2001

Page 8




	 	 	 
			
other only for the purpose of the activities
contemplated by this Agreement and may only disclose
such Confidential Information on a need-to-know basis
for the purposes of this Agreement to a third party or
employee who is bound by a confidentiality obligation
similar to the terms of this paragraph 7(a). Roche and
Digene shall ensure that their affiliates and such
affiliates’ officers, directors, employees,
representatives and agents shall keep all Confidential
Information exchanged hereunder confidential and treat
such Confidential Information with the same care as it
would exercise in the handling of its own confidential
or proprietary information. This paragraph 7(a) shall
remain in effect for a period of five (5) years after
termination or expiration of this Agreement for all
Confidential Information. “Confidential Information”
shall not include information that:





	 	 	 
	(i)		
is known to the receiving
party and/or its affiliates at the time of the
disclosure, as evidenced by its written records;
	 
	(ii)		
is disclosed to the
receiving party and/or its affiliates by a third
party having a legal right to do so;
	 
	(iii)		
becomes patented,
published or otherwise part of the public domain
through no fault of the receiving party and/or its
affiliates; or
	 
	(iv)		
is independently
developed by or for the receiving party and/or its
affiliates without use of Confidential Information
disclosed hereunder, as evidenced by its written
records.





	 	 	 
	(b)		
Public Announcements. Neither Digene
nor Roche shall make any public announcement concerning
this Agreement, nor make any public statement which
includes the name of the other party or any of its
affiliates, or otherwise use the name of the other party
or any of its affiliates in any public statement or
document without the consent of the other, which consent
shall not be unreasonably withheld, except: (a) as may
be required by law or judicial order, including required
disclosure under the Securities Act of 1933, as amended,
the Securities Exchange Act of 1934, as amended, any
exchange on which either party’s equity securities are
listed, the National Association of Securities Dealers,
Inc. and/or its subsidiaries; (b) as may be contained in
joint marketing materials,



 








THIS EXHIBIT HAS BEEN REDACTED AND IS THE A SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH “*” AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



Heinrich Dreismann, Ph.D.

April 29, 2001

Page 9





	 	 	 
			
presentations and related activities; (c) that Digene
may provide general information, including aggregate
revenue information by region, on a periodic basis and
in response to inquiries; or (d) that either party may
include in a subsequent public statement or document,
information regarding this Agreement which has already
been approved by the other party.





	 	 	 
	8.		
Payments. All payments to be made under
paragraphs 1 and 5(b) shall be made by wire transfer according
to the wire instructions set forth on Schedule G.




            We are very excited about the prospect of a strategic relationship with
Roche. If you are in agreement with the terms and conditions of this
Agreement, please execute this Agreement in the space provided below and return
to me.




	 	Best Regards,

DIGENE CORPORATION





	 	By:   /s/ Evan Jones            
Evan Jones

Chief Executive Officer






AGREED TO BY:

ROCHE MOLECULAR SYSTEMS, INC.




By:   /s/ Heinrich Dreismann            

Heinrich Dreismann, Ph.D.

President and CEO



Attachments


cc:       Morris Cheston, Jr., Esquire


 










THIS EXHIBIT HAS BEEN REDACTED AND IS THE A SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH “*” AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.










September 7, 2001



Confidential



Heinrich Dreismann, Ph.D.

President and CEO

Roche Molecular Systems, Inc.

4300 Hacienda Drive

Pleasanton, CA 94588



            Re:      Amendment to Letter Agreement


Dear Heiner:


            On April 29, 2001, Roche Molecular Systems, Inc., a Delaware corporation
and an affiliate of F. Hoffmann-La Roche, Ltd., a corporation organized under
the laws of Switzerland (“Roche”), and Digene Corporation, a Delaware
corporation (“Digene”) entered into a letter agreement to set forth the
understanding between Roche and Digene regarding the sale, marketing and
distribution of Digene’s Hybrid Capture HPV products and the negotiation of a
strategic collaboration and relationship (the “Letter Agreement”). The purpose
of this letter (the “Amendment”) is to amend certain terms of the Letter
Agreement to reflect our current agreements and understandings. Upon execution
of this Amendment below, each of Digene and Roche agrees to be bound by the
terms and conditions of this Amendment. All capitalized terms used in this
Amendment without definition have the meanings given to such terms in the
Letter Agreement.



	 	 	 
	1.		
Transfer Prices. Paragraph 4(b) of the Letter
Agreement is hereby deleted in its entirety and replaced with
the following: “Roche shall pay the transfer price for the
HPV Products set forth on Schedule A attached hereto during
the Distribution Term.” As of and after the effective date of
this Amendment, Schedule A as attached to this Amendment shall
be Schedule A to the Letter Agreement.
	 
	2.		
Additional Products. In addition to the transfer
price changes made pursuant to paragraph 1 of this Amendment,
Schedule A is amended and restated to include additional HPV
Products to be marketed, distributed and sold by Roche in the
Territory under the Letter Agreement.



 








THIS EXHIBIT HAS BEEN REDACTED AND IS THE A SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH “*” AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



Heinrich Dreismann, Ph.D.

September 7, 2001

Page 2




	 	 	 
	3.		
Marketing Efforts. Schedule B of the Letter
Agreement is deleted in its entirety and replaced with
Schedule B attached to this Amendment.
	 
	4.		
Status of Letter Agreement. On and after the
effective date of this Amendment, the terms and provisions of
the Letter Agreement, except as amended hereby, shall continue
in full force and effect. If a conflict arises between the
terms of this Amendment and the terms of the Letter Agreement,
the terms of this Amendment shall control.




            Please indicate your agreement with the terms and conditions of this
Amendment, by executing this Amendment in the space provided below and
returning a signed version of this Amendment to me.




	 	Best Regards,

DIGENE CORPORATION







	 	By:    /s/ Evan Jones            

Evan Jones

Chief Executive Officer






AGREED TO BY:

ROCHE MOLECULAR SYSTEMS, INC.




By:    /s/ Heinrich Dreismann            

Heinrich Dreismann, Ph.D.

President and CEO



Attachments


cc:       Morris Cheston, Jr., Esquire