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THIS EXHIBIT HAS BEEN REDACTED AND IS THE 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 10.39
LICENSE AGREEMENT
Agreement made this 5th day of April, 2000, by and between INSTITUT PASTEUR, a
Foundation existing under the laws of France, 25-28 rue du Docteur Roux, 75724
Paris Cedex 15 and DIGENE CORPORATION, 1201 Clopper Road, Gaithersburg, Maryland
20878, U.S.A., a corporation incorporated under the laws of Delaware.
WITNESSETH
WHEREAS, INSTITUTE PASTEUR, hereinafter "IP", is the co-owner together
with INSERM of US patent No. 5.981.173 relating to two novel genital Human
Papillomavirus (HPV) types, HPV68 and HPV70;
WHEREAS, IP and INSERM are also co-owners of Biological Material of the
cloned genome of the Human Papillomavirus type HPV68, deposited by IP at the
Collection Nationale de Culture de Micro-organismes (CNCM) (National Collection
for Microorganisms Culture) on February 16, 1995, with accession No. I-1540;
WHEREAS, DIGENE CORPORATION, hereinafter "LICENSEE", is desirous to
obtain exclusive licenses under said patent and said Biological Material
relating to the Licensed Product, as hereinafter defined;
WHEREAS, IP is willing to grant to LICENSEE exclusive licenses under said
patent and Biological Material to make, have made, use and sell Licensed
Product;
WHEREAS, INSERM, by letter dated January 27, 2000, has agreed that IP may
enter into an exclusive license agreement with LICENSEE.
NOW, THEREFORE, for good and valuable consideration, receipt of which is
hereby acknowledged, it is agreed:
ARTICLE I
DEFINITIONS
1.1 "Affiliate(s)" means any corporation, partnership or other
business entity which LICENSEE directly or indirectly controls or any company by
which LICENSEE is controlled or is under common control with.
For the purpose of the Agreement, "control" shall mean the holding of
fifty percent (50%) or more of the voting stock or other ownership interest of
the corporation, partnership, or other business entity involved.
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
Notwithstanding the above, in the event LICENSEE is precluded by local
government laws or regulations from owning or controlling fifty percent (50%) of
an entity, such entity shall be deemed to be an Affiliate if LICENSEE owns or
controls the maximum permissible portion of that entity under applicable laws or
regulations.
1.2 "Biological Material" means biological material accession No.
I-1540 of the cloned genome of the Human Papillomavirus type 68 (HPV68).
1.3 "Field" means HPV in vitro human diagnostics and HPV in vitro
pre-clinical and clinical diagnostic testing for HPV vaccine and therapeutic
discovery and development.
1.4 "HPV" means Human Papillomavirus.
1.5 "Licensed Product" means HPV Hybrid Capture(R) II (HPV HCII)
and/or any other product using the Licensed Patent and/or the Biological
Material or fragments thereof, or derived biological material from Biological
Material or fragments thereof, or a synthetic molecule corresponding to said
Biological Material or to derived Biological Material or to fragments of both
thereof.
In addition, Licensed Product also includes any final product,
manufacture, sale or use of any significant part of which would constitute an
infringement of the Licensed Patent but for the licenses granted in Article 2
hereunder.
1.6 "Licensed Patent" means US patent No. 5.981.173 relating to Two
Novel Genital Human Papillomavirus (HPV) types, HPV68 and HPV70, related to the
Potentially Oncogenic HPV39 attached hereto in Exhibit 1 and all
continuations-in-part as the case may be.
1.7 "Net Sales" means the gross invoice price of Licensed Product sold
by LICENSEE and/or its Affiliates to Third Parties, less any sales tax,
packaging, shipping, insurance charges, returns and allowances, and any normal
rebates, credits and discounts to the extent they are factually applicable and
are reflected in the gross invoice price. In no event shall the deductions for
usual sales expenses exceed [*******] percent ([***]%) of the gross invoice
price. No deduction from the gross invoice price shall be made for any item of
cost incurred by the seller in its own operations incident to the manufacture,
sale or shipment of the Licensed Product. Sales between or among LICENSEE and
its Affiliates shall be excluded from the computation of Net Sales except when
such Affiliates are end users.
In the event Licensed Product is sold by LICENSEE or its Affiliates in
combination with other products which do not include HPV types and which have
commercial utility other than use in combination with such Licensed Product
(together, a "Combination Package"), for purpose of royalty payments Net Sales
of such Licensed Product shall be calculated as follows. Net Sales of such
Licensed Product shall be the gross invoice price of such Combination Package
containing other products billed to customers by LICENSEE or its Affiliates,
less the
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
deductions referred to above, multiplied by the fraction A/(A+B), where A is the
gross selling price of the Licensed Product sold separately in arms length
transactions with Third Parties during the period in question, and B is the
gross selling price of such other products sold separately in arms length
transactions with Third Parties during the period in question; provided further,
that if any Combination Package is sold by LICENSEE or its Affiliates and the
gross selling price for the Licensed Product of such other products when sold
separately is not determinable, then the gross amount billed or invoiced to
Third Parties for the sale of such Licensed Product shall be deemed to be an
amount equal to the percentage of the gross sales price, less the deductions
referred to above, for the Combination Package which is equal to the percentage
of the fair market value of the Licensed Product and the other products in the
Combination Package represented by the fair market value of the Licensed
Product.
LICENSEE and its Affiliates shall, in their sole discretion, determine
the gross invoice price of Licensed Product sold by LICENSEE and its Affiliates
to Third Parties; provided, however, that any discount offered with respect to
Licensed Product shall be consistent with the overall discounting policies of
LICENSEE in connection with the sale of its diagnostic products and, when
considered in relation to the percentage discount applicable to any of
LICENSEE's other diagnostic products which are sold together with or in
combination with the Licensed Product, shall not materially adversely affect Net
Sales.
1.8 "Third Party(ies)" means any person or entity other than IP, any
Affiliates of IP, LICENSEE or any Affiliates of LICENSEE.
ARTICLE II
LICENSE GRANT
2.1 Upon the terms and subject to the conditions of this Agreement, IP
grants to LICENSEE, and LICENSEE accepts from IP a worldwide, royalty-bearing
exclusive license under the Licensed Patent and the Biological Material within
the Field to make, have made, use and sell Licensed Product. The license does
not include a sublicense right to Third Parties.
2.2 LICENSEE expressly acknowledges and agrees that this exclusive
license is personal to LICENSEE alone and LICENSEE shall have no right to assign
or otherwise transfer or share its rights except with its Affiliates; provided,
however, that LICENSEE may assign any or all of its rights, interests or
obligations hereunder to any successor to the LICENSEE in a merger or to any
other purchaser of substantially all of the assets of LICENSEE's business
related to its HPV business, provided such purchaser assumes all of LICENSEE's
obligations hereunder.
2.3 IP hereby agrees during the term of this Agreement to maintain and
keep in effect the Licensed Patent without prejudice to Section 3.1(e). Should
IP decide to abandon the registration of the Licensed Patent, IP will promptly
notify LICENSEE of such decision. Upon receipt of IP's notice, LICENSEE shall
have the right, but not the obligation, by notice to IP, to require IP to
maintain and keep in effect the Licensed Patent, in which event LICENSEE shall
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
reimburse IP for all of its out-of-pocket costs thereafter incurred with respect
to such patent maintenance. Effective as of the date of the abandonment of the
Licensed Patent or, if notice of IP's decision to abandon the Licensed Patent is
provided by IP to LICENSEE as required above, and LICENSEE decides to reimburse
IP for all of its out of pocket costs as provided above, the date LICENSEE sends
IP notice of such decision, the royalty rate set forth in Section 3.1(b) shall
be reduced to [******] percent ([***]%).
ARTICLE III
FINANCIAL CONDITIONS
3.1 For the rights and privileges granted to LICENSEE under Section
2.1 hereabove, LICENSEE shall pay to IP:
(a) a non-refundable license issuance fee in the amount of U.S.
$[*******], $[*******] of which has been paid upon the execution of the "Term
Sheet" entered into prior to this Agreement and the remaining U.S. $[*******] of
which shall be paid upon execution of this Agreement;
(b) royalties of [*****] percent ([***]%) of LICENSEE's and its
Affiliates' Net Sales in the U.S. (exclusive of U.S. sales to be shipped outside
of the U.S. territory) of Licensed Product payable from the date of first sale
of Licensed Product in the U.S.;
(c) royalties of [*****] percent ([***]%) of LICENSEE's and its
Affiliates' Net Sales of Licensed Product outside the U.S. payable from the date
of the first sale of Licensed Product outside the U.S.;
(d) in case of future determination of invalidity of the
Licensed Patent in the U.S. by a definitive decision of the relevant authority,
the royalty for Net Sales in the U.S. of Licensed Product will be reduced to
[*****]percent ([***]%) starting from the date of such definitive decision of
invalidity and for the commercial life of the Licensed Product;
(e) for calendar year 1999 LICENSEE shall reimburse IP for
[******] of its out-of-pocket patent maintenance costs relating to the Licensed
Patent up to U.S. $[*****]. Commencing January 1, 2000 LICENSEE shall reimburse
IP for its out-of-pocket patent maintenance costs relating to the Licensed
Patent up to U.S. $[*****] per year. By April 15, 2000 and by February 15 of
each year thereafter, IP shall provide LICENSEE with an accounting, and
appropriate back-up documentation, of the relevant patent maintenance costs paid
by IP in the prior calendar year. LICENSEE shall made payment of its
reimbursement obligation set forth above within thirty (30) days of its receipt
of such accounting provided, that within such thirty (30) day period LICENSEE
shall be entitled to request reasonable additional documentation with respect to
such costs; and provided, further, that LICENSEE shall make such payment within
fifteen (15) days of its receipt of such additional documentation, subject in
all cases to LICENSEE's rights under Section 10.2.
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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
3.2 LICENSEE shall, within sixty (60) days after the first day of
January and July of each year, provide IP with a true and accurate account of
Net Sales in the Territory with a break down per country and for each Licensed
Product and royalty due in respect to the preceding six calendar months and will
at the time when it delivers such account make payment of the amount of royalty
shown to be due (Attn: Direction de la Valorisation of IP). If no royalties are
due, it shall be so reported. The correctness and completeness of each such
account shall be attested to in writing by the responsible financial officer of
LICENSEE.
If royalties payable hereunder are in arrears, IP shall be entitled to
apply to LICENSEE a penalty equal to the relevant minimum legally applicable
rate under the French law, as published by Decree of the Ministry of Economy,
Finances and Industry in the French Official Gazzette, increased with 2%,
beginning on the 60th day after the end of the applicable royalty period.
3.3 Royalties payable hereunder shall be made without any deductions
whatsoever except for withholding tax. Such payments shall be made in U.S.
dollars by check sent to Direction de la Valorisation, INSTITUTE PASTEUR 25-28
rue du Docteur Roux, 75724 Paris Cedex 15 - France.
3.4 The withholding tax (if any) levied by the U.S. authorities on
payments made by LICENSEE to IP hereunder shall be borne by IP.
LICENSEE shall use reasonable efforts to help IP to claim exemption
therefrom under any double taxation or similar agreement in force and shall
produce to IP proper evidence of payment of all withholding tax.
3.5 LICENSEE shall keep or cause to be kept complete and accurate
records of the Net Sales of Licensed Product in accordance with U.S. generally
accepted accounting procedures. Such records shall be accessible, not more than
once a year at any reasonable time during business hours within five (5) years
after the end of the royalty period to which such records relate, to an
independent accountant selected by IP for the purpose of verifying Net Sales and
any royalty due pursuant to this Agreement. If in dispute, such records shall be
kept until the dispute is settled. Such accountant shall keep confidential all
information provided to it by LICENSEE, except that it may disclose to IP,
subject to its agreement of confidentiality set forth in Section 8.4,
information relating to the accuracy of the records and payments made.
The cost of such inspection shall be borne by LICENSEE if any error or
discrepancy is shown by which the royalty amount to which IP is entitled is
increased by 5% or more of the amount shown in LICENSEE's account.
ARTICLE IV
PERFORMANCE
LICENSEE will use reasonable commercial efforts to commercialize the
Licensed Product worldwide in the main countries. The "main countries" shall
mean the developed,
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
commercially viable countries with a per capita gross national product of
greater than U.S. $[******] per year. In the event LICENSEE has sales of
Licensed Product in a "main country" for a one year period below U.S. $[******]
and provided that such amount corresponds to a rate of penetration of the
potential market for Licensed Product for the said country of less than
[******]%, IP will notify LICENSEE in writing and give LICENSEE a six month cure
period. At the end of such cure period, if the sales of Licensed Product in such
main country have remained below the above-mentioned thresholds, the license in
that country will become non-exclusive and the royalty rate shall be reduced by
[******]%, unless LICENSEE is using commercially reasonable efforts to sell
Licensed Product in such country.
ARTICLE V
PATENTMARKING
Nothing in this Agreement shall be construed as conferring upon either
party or its Affiliates any right to include in advertising, packaging or other
commercial activities related to Licensed Product, any reference to the other
party, its trade names, trademarks or service marks in a manner which would be
likely to cause confusion or to indicate that such Licensed Product is in any
way certified by the other party.
In order to indicate the origin of the license, LICENSEE shall be
entitled, but is not required, without obtaining the prior consent of IP, to
affix the following mention on the Licensed Product: "U.S. Patent No.
5-981-173". If LICENSEE wants to add the mention "Licensed by Institut Pasteur",
LICENSEE will submit to IP the proposed packaging and/or booklets or any other
document with the mention "Licensed by Institut Pasteur" for IP prior written
authorizations which shall not be unreasonably withheld according to IP general
policy on the use of the name Pasteur. This authorization shall in no way be
construed to constitute a license of any Institut Pasteur's trademarks or other
signs or to be a violation of the first paragraph of this Article V.
ARTICLE VI
TERMINATION
The License granted hereunder shall begin on June 1, 1999 and shall
continue for the life of the Licensed Patent or for the commercial life of the
Licensed Product in the countries where there is no Licensed Patent and for the
U.S. in case of invalidity of the Licensed Patent by a national authority, or
unless sooner terminated as provided in the following:
6.1 Failure by either party to comply with any respective obligations
and conditions contained in this Agreement shall entitle the other party to give
to the party in default notice requiring it to remedy such default. If such
default is not remedied within sixty (60) days after receipt of such notice by
the party in default, the notifying party shall be entitled (without prejudice
to any of its other rights conferred on it by this Agreement) to automatically
terminate this Agreement by giving notice to take effect immediately upon
receipt by the defaulting party.
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
The right of either party to terminate this Agreement as hereinabove
provided shall not be affected in any way by its waiver of, or failure to take
action with respect to any previous default. Should either party terminate this
Agreement according to its terms, all licenses granted hereunder shall cease.
6.2 Any rights and obligations accrued prior to termination or
expiration of this Agreement shall not be affected by such termination or
expiration. By way of illustration but not of limitation, termination or
expiration of this Agreement shall not relieve LICENSEE of any obligation
hereunder to:
(i) pay royalties to IP for sales made prior to the date of
said termination or for sales made after termination of Licensed Product
manufactured by LICENSEE and its Affiliates prior to termination,
(ii) keep records as provided herein.
6.3 Effect of termination on LICENSEE:
LICENSEE shall, on the effective date of termination for whatever reason,
cease or have ceased any manufacture of the Licensed Product. Notwithstanding
such termination, LICENSEE and its Affiliates shall be entitled to sell at
normal prices the quantity of Licensed Product in their existing inventory for a
three (3) month period after the effective date of termination; provided that
the breach giving rise to the termination did not consist of a default of
payment of royalty as provided in Section 3.2 hereof; and provided that LICENSEE
shall remain obligated to pay royalties accrued and unpaid for all sales of
Licensed Product through the end of such three (3) month period.
LICENSEE and its Affiliates shall, on the effective date of termination,
for whatever reason, return to IP the Biological Material No. I-1540 and its
progenes in their possession.
ARTICLE VII
NEGATION OF WARRANTIES AND INDEMNITY
IP MAKES NO WARRANTY OF ANY KIND EITHER EXPRESS OR IMPLIED RELATING TO
THE LICENSED PRODUCT INCLUDING WITHOUT LIMITATION ANY WARRANTY REGARDING SAFETY,
EFFICACY, OR PERFORMANCE, ANY WARRANTY OF MERCHANTABILITY OR ANY WARRANTY OF
FITNESS FOR ANY PARTICULAR PURPOSE.
LICENSEE shall take all reasonable precautions to prevent death, personal
injury, illness and property damage from the use of Licensed Product and/or
Biological Material and/or derived Biological Material or fragment hereunder.
LICENSEE shall assume full responsibility for its use or its Affiliates' use of
Licensed Patent thereof and shall defend, indemnify and hold IP harmless from
and against all liability, demands, damages, expenses (including reasonable
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
attorneys' fees) and losses arising from death, personal injury, illness,
property damage or any other injury or damage resulting therefrom, unless such
damage is solely attributable to the fault of IP.
Nothing in this Agreement shall be construed as a warranty that the
Licensed Patent is valid or enforceable. IP informs LICENSEE that to its
knowledge the exercise of the Licensed Patent does not infringe any patent
rights of a Third Party.
Nothing in this Agreement shall be construed as an obligation on the part
of either party to bring or prosecute actions or suits against Third Parties for
infringement.
Nothing in this Agreement shall be construed as conferring by implication
or otherwise any license or rights under any patents, know-how or other
industrial property rights of IP other than expressly granted hereunder.
In the event that IP or LICENSEE becomes aware of actual or threatened
infringement of the Licensed Patent, that party shall promptly notify the other
party in writing. IP and LICENSEE hereby agree that IP, at its sole cost and
expense, shall have the first right, but not the obligation, to attempt to stop
any such alleged infringement by taking such action as IP, in its sole judgment,
deems appropriate, including prosecution of a lawsuit. LICENSEE shall have the
right, at its sole cost and expense, to join in any such infringement suit which
IP elects to institute. The parties hereby agree that all recoveries and awards
that may be obtained as a result of any action taken by IP at its expense with
respect to any such alleged infringement, including any settlement thereof,
shall be owned entirely by IP, except that LICENSEE shall retain such recoveries
and awards which may be specifically allocated to LICENSEE by the court or the
settlement. In the event IP fails to take any action against the alleged
infringer within sixty (60) days of issuance of any notice referred to in the
first sentence of this paragraph, LICENSEE, thereafter, shall have the right,
but not the obligation, at its sole cost and expense, to attempt to stop such
alleged infringement by taking such action as LICENSEE, in its sole judgment,
deems appropriate, including prosecution of a lawsuit. The parties hereby agree
that all recoveries and awards that may be obtained as a result of any action
authorized to be taken by LICENSEE with respect to such alleged infringement,
including any settlement thereof, shall be owned entirely by LICENSEE.
The party conducting such action shall have full control over its
conduct, including settlement thereof. In any event, IP and LICENSEE shall
assist one another and reasonably cooperate in any such litigation at the
other's request and at the expense of the requesting party.
ARTICLE VIII
GENERAL
8.1 If any provision of this Agreement is held to be unenforceable for
any reason, it shall be adjusted rather than voided, if possible, in order to
achieve the intent of the parties to the extent legally possible.
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REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
8.2 This Agreement may be modified or amended only in writing by
authorized officers of the parties.
8.3 Except as otherwise specifically provided in Article V, LICENSEE
agrees to obtain IP's approval before distributing any written information,
including but not limited to promotional and sales materials relating to the
Licensed Product, to Third Parties which contains or refers to IP or this
Agreement. IP's approval shall not be unreasonably withheld or delayed and, in
any event, IP's decision shall be rendered within three (3) weeks of receipt of
the written information. If no reply is received from IP within three (3) weeks,
IP agreement is to be assumed. Once approved, such materials, or abstracts of
such materials, which do not materially alter the context of the material
originally approved may be reprinted during the term of the Agreement without
further approval by IP unless IP has notified LICENSEE in writing of its
decision to withdraw permission for such use.
8.4.1 Both parties agree to keep confidential and proprietary and not to
disclose any information obtained from the other under this Agreement to any
Third Party during the term of this Agreement as well as for a period of five
(5) years thereafter and will not use it other than as permitted under this
Agreement.
The above obligations of confidentiality shall not apply to:
(a) information which at the time of disclosure is available to
the public; or
(b) information which the receiving party can show by written
records was in its possession at the time of disclosure and was not acquired
directly or indirectly from the disclosing party; or
(c) information which after disclosure is published or becomes
part of the knowledge available to the public through no act or failure to act
on the part of the receiving party; or
(d) information which is hereafter received by the receiving
party from a third party who does not require that such information be
maintained in confidence; and
(e) information which is independently developed by the
receiving party without use of or access to information disclosed by the
disclosing party.
8.4.2 Exceptions:
Notwithstanding Section 8.4.1, and subject to Section 8.4.3, any party
may disclose information disclosed to it by the other party hereto:
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
(a) to the extent, and only to the extent, such disclosure is
necessary for such party to comply with applicable governmental laws or
regulations (the party that desires to so disclose information shall give the
other party reasonable advance notice of any such proposed disclosure pursuant
to such compliance with law or regulation, shall use its best efforts to secure
confidential treatment of the information thus disclosed, and shall advise the
other party in writing of the manner in which that was done),
(b) to technical or medical personnel engaged by the receiving
party to achieve regulatory approval to the extent necessary for their efforts
to achieve regulatory approval, and
(c) in connection with labeling as defined under the United
States Federal Food, Drug and Cosmetic Act or equivalent foreign labeling
regulations and submissions to governments authorities, or in connection with
the sales promotion and use of the Licensed Product (for example, disclosing
such information to customers, advertising agencies or appropriate consultants),
but only to the extent necessary.
8.4.3 Neither party shall make any public announcement concerning this
Agreement, nor make any public statement which includes the name of the other
party, or otherwise use the name of the other party in any public statement or
document without the consent of the other party, 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, or the National Association of Securities
Dealers, Inc. and/or its subsidiaries; (b) that LICENSEE may provide general
information, including aggregate revenue information by region, on a periodic
basis and in response to inquiries; and (c) 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.
8.4.4 LICENSEE shall seek confidential treatment for the terms and
conditions of this Agreement to the fullest extent permitted by the Securities
and Exchange Commission (the "SEC") and any other governmental agency or
self-regulatory organization to which LICENSEE is required to provide a copy of
this Agreement. Prior to seeking confidential treatment from the SEC or any
other governmental agency or self-regulatory organization for this Agreement,
LICENSEE shall consult with IP and IP's counsel and provide it with a reasonable
opportunity to request the inclusion of specified provisions in any request by
LICENSEE for confidential treatment.
8.5 Captions and paragraph headings are for convenience only and shall
not form an interpretative part of this Agreement. Unless otherwise specifically
provided, all references to an Article incorporates all sections or subsections
thereunder. This Agreement has been prepared jointly and shall not be strictly
construed against either party hereto. The feminine and masculine pronouns are
interchangeable hereunder as the context may require. The plural shall
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be substituted for the singular number in any place in which the context may
require such substitution.
8.6 Any notice or communication authorized or required to be given
hereunder or for the purpose hereof shall be in writing and shall be (a)
delivered personally; (b) mailed by registered or certified mail, postage
prepaid and return receipt requested; (c) sent by overnight courier; or (d) sent
by facsimile or express mail as follows:
- if to IP:
Anne Bellod
Direction de la Valorisation et des Partenariats Industriels
INSTITUT PASTEUR
25-28, rue du Docteur Roux
75724 Paris Cedex 15
France
with a copy to:
Legal Department
INSTITUT PASTEUR
25-28, rue du Docteur Roux
75724 Paris Cedex 15
France
- If to LICENSEE:
DIGENE CORPORATION
1201 Clopper Road
Gaithersburg, MD 20878
U.S.A.
with a copy to:
Ballard Spahr Andrews & Ingersoll, LLP
1735 Market Street, 51st Floor
Philadelphia, PA 19103
U.S.A.
Attention: Morris Cheston, Jr., Esq.
or to such other address or person as a party may designate by notice.
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SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
ARTICLE IX
ASSIGNMENT
Except as set forth in Section 2.2., this Agreement is not assignable
without the written consent of the non assigning party, which consent shall not
unreasonably be withheld.
ARTICLE X
GOVERNING LAW / ARBITRATION
10.1 This Agreement is governed by the Laws of the Republic of France.
10.2 In case of controversies which cannot be settled amicably, such
issues shall be settled by final and binding arbitration pursuant to the
Rules of Conciliation and Arbitration of the International Chamber of Commerce
(Paris) as hereinafter provided:
(a) The Arbitration Tribunal shall consist of three (3)
arbitrators. Each party shall nominate in the request for arbitration and the
answer thereto one (1) arbitrator and the two arbitrators so named will then
jointly appoint the third arbitrator as chairman of the Arbitration Tribunal
with sixty (60) days of the appointment of the second arbitrator. If one party
fails to nominate its arbitrator or if the parties'arbitrators cannot agree on
the person to be named as chairman, the Court of Arbitration of the
International Chamber of Commerce shall make the necessary appointments for
arbitrator or chairman.
(b) The place of arbitration shall be in Paris and the
arbitration proceedings shall be held in English and French without obligation
for translation. The binding version of the award shall be the French text.
(c) The award of the Arbitration Tribunal shall be final and
binding and judgment upon such an award may be entered in any competent court
for juridical acceptance of such an award and order of enforcement.
12
<PAGE> 13
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT
REQUEST. REDACTED MATERIAL IS MARKED WITH "*" AND BRACKETS AND HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
In Witness whereof the parties have caused this Agreement to be executed
in duplicate by their duly authorized officers.
by: INSTITUT PASTEUR
/s/ Jean Castex
----------------------------------------------
Jean Castex
Title: Director General Adjoint
Christian Policard
Title: Directeur de la Valorisation et des Partenariats Industriels
by: DIGENE CORPORATION
/s/ Evan Jones
--------------------------------------------
Evan Jones
Title: Chairman and CEO
<PAGE> 14
THIS EXHIBIT HAS BEEN REDACTED AND IS THE 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 1 TO THE AGREEMENT ENTERED INTO BETWEEN INSTITUT PASTEUR
AND DIGENE CORPORATION ON APRIL 5, 2000
Se-Dossier 258150 DE 01 CLONAGE DE GENCHE DE VIRUS NPVSS
No. D.I 195005 CLONAGE DE GENCHE DE VIRUS NPVSS
No. D.I 195004 NPVTO
<TABLE>
<CAPTION>
NO. SE-DOSSIER PAYS NO. DEPOT DATE DEPOT TYPE DE LIEN TITULAIRE OFFICIAL
<S> <C> <C> <C> <C>
----- -- -- STATS-UNIS UE011650 14/02/1996 INSERM
250159 US 03 STATS-UNIS US815667 11/02/1997 INSERM
<CAPTION>
NO. SE-DOSSIER TITULAIRE OFFICE2 TITULAIRE OFFICE3 NO DELIVERANCE DATE
<S> <C> <C> <C>
----- -- -- INSTITUT PASTEUR
250159 US 03 INSTITUT PASTEUR 5981173 9/11/1999
</TABLE>
** Fin d'Edition **
