REDACTED VERSION
[CONFIDENTIAL TREATMENT HAS BEEN
REQUESTED FOR PORTIONS OF
THIS EXHIBIT]
LICENSE AGREEMENT
by and between
X.XXXXXXXX-XX XXXXX Xxx, Xxxxxxxxxxxxx.000, XX-0000 Xxxxx, Xxxxxxxxxxx
and
ROCHE MOLECULAR SYSTEMS, INC., 0000 X.X. Xxxxxxx 000, Xxxxxxxxxx, X.X.
00000, XXX (hereinafter jointly referred to as "ROCHE") and
LIFECODES CORPORATION (hereinafter referred to as "LIFECODES").
PREAMBLE
ROCHE and its Affiliates own certain inventions and patent rights relating
to the Polymerase Chain Reaction (PCR) technology and to the reverse
transcription of nucleotides.
LC intends to market products for HLA typing in the field of tissue and
organ transplantation, some of which products and/or their use are covered
by ROCHE's patent rights.
ROCHE is willing to grant to LIFECODES a non-exclusive license under its
patent rights in order to allow LIFECODES to market such HLA typing
products.
1. Definitions
In this Agreement, unless the context otherwise requires:
1.1 "Affiliate" shall mean any corporation, partnership or other business
organization which either party directly or indirectly controls or any
company by which either party is controlled by or is under common control
with or any organization the majority ownership of which is directly or
indirectly common to the majority ownership of a party hereto. For the
purpose of this Agreement "control" shall mean the holding of 50% (fifty
percent) or more of the voting stock or other ownership interests of the
corporation or business entity involved.
1.2 "HLA Typing" shall mean genotyping of specific HLA loci in order to assess
the probability of acceptance of a transplant of a human organ or tissue.
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1.3 "Licensed Patents" shall mean the patents and patent applications as
specified in Schedule A as well as any addition, continuation (but not
continuation-in-part), division, extension, reissue, re-examination,
application or substitution with respect thereto, or the equivalent of any
of the foregoing.
1.4 "Licensed Products" shall mean those products the manufacture, use or sale
of which are covered by one or more Valid Claim(s) of Licensed Patents and
which Products are listed in Schedule B. Each such Product will be clearly
identified and distinguished in the market as being a LIFECODES Product. If
LIFECODES desires to add a new product to the list of Licensed Product or
to change any Licensed Product listed in Schedule B, LIFECODES shall submit
to ROCHE the labels and package insert for such product together with its
request for modification of Schedule B. If ROCHE determines that such new
or changed product is clearly identified as a LIFECODES product and that
such product is clearly identified to be used only for HLA-typing, ROCHE
will confirm, within a reasonable time period after receipt of the above
mentioned labels and package inserts, its consent to the modification of
Schedule B in writing.
1.5 "Net Sales" shall mean the gross invoice price for sales or transfers to
final users less deductions for returns (including withdrawals and
recalls), sales rebates (price reduction), volume (quantity) discounts,
sales taxes and other taxes directly linked to sales in the countries
concerned. In addition to this above computed adjusted gross invoice price,
all other expenses like custom duties, transportation costs and other
direct expenses shall be covered by a lump deduction of six percent (6 %).
In the event LIFECODES is unable to account for sales to end users, the Net
Sales shall be calculated as the sales price to distributors, agents or
wholesalers multiplied by 1.67, which factor represents a 40% margin.
Sales to a third party enjoying a special course of dealing with LIFECODES,
or transfers to Lifecodes' HLA testing laboratory, shall be determined by
reference to price for the product sold or transferred which would be
applicable in an arm's length transaction with an unrelated third party.
In the event that a Licensed Product is sold or transferred in such a way
that the sales price for such a Licensed Product does not fairly represent
an actual independent arms-length transaction price for such Licensed
Product, such as for example because of the transfer of any other product
or service to the purchaser, directly or indirectly, by the Licensee, for
the calculation of royalties hereunder, Net Sales will be determined by
applying the average transaction price for Licensed Products in an
at-arms-length transaction or, if no such at-arms-length transactions are
performed, at the average transaction price of products directly competing
with such Licensed Product.
1.6 "Territory" shall mean the territory of the countries defined in Schedule
C.
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1.7 "Valid Claim" shall mean a legally enforceable claim in any unexpired
Licensed Patent which has not been disclaimed or held invalid by an
unappealed or unappealable decision of a court of competent jurisdiction or
is not otherwise unenforceable.
2. License
ROCHE hereby grants to LIFECODES and its current Affiliates and LIFECODES
and its Affiliates hereby accept a non-exclusive and non-transferable
license under Licensed Patents in the Territory to manufacture, have
manufactured, use and/or sell, including through distributors, Licensed
Products strictly for the purpose of performing HLA Typing.
3. Royalty
3.1 In consideration of the license granted as per Article 2 of this Agreement,
LIFECODES undertakes to pay to ROCHE:
a) a license issuance fee of CHF [_______________] to be paid within
thirty (30) days upon signature of this Agreement.
b) a royalty of [____________] on its Net Sales of Licensed Products;
3.2 No royalties shall be paid on sales of Licensed Products between LIFECODES
and its Affiliates, but in such event royalty shall be due and payable on
the sales of such Licensed Products by such Affiliate to third parties.
3.3 Royalty shall be payable hereunder on Net Sales in each country of the
Territory starting from the first selling of Licensed Products covered by a
Valid Claim of Licensed Patents in such country or, as the case may be, not
covered by a Valid Claim of Licensed Patents in the country of sale but
manufactured in and imported from a country of the Territory covered by a
Valid Claim of Licensed Patents, and shall continue to be payable as long
as the making, using or selling of Licensed Products is covered by a Valid
Claim of Licensed Patents in effect in the respective country of the
Territory.
3.4 Furthermore, the Parties further understand and agree that the royalty rate
provided in subsection 3.1 b) above shall apply only for so long as any
claim of U.S. Patent No. 4,683,195 and 4,683,202 (Amplification Process
Patents listed in Schedule A), or any claim of corresponding foreign patent
rights, shall be in force. Thereafter, the Parties shall negotiate in good
faith a reduced royalty rate for products licensed hereunder.
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4. Reports, Times of Payment and Taxes
4.1 LIFECODES shall, within sixty (60) days after December 31 and June 30 of
each year, provide ROCHE with an account of Net Sales of Licensed Products
on a U.S./ex U.S. basis and of the royalty due in respect to the preceding
calendar half-year and will at the time, when it delivers such account,
make payment of the amount shown to be due.
4.2 Royalty payable hereunder shall be made without any deductions, except for
withholding tax or any other fiscal deductions from time to time required
by the government of any country. All such payments shall be made in Swiss
francs or in such other currency as ROCHE may from time to time direct (so
far as legally permissible). Any necessary currency conversion shall be at
the rate for buying funds as quoted by the Wall Street Journal for the last
business day of the period to which such payments relate.
4.3 Withholding tax, if any, levied by a government of any country of the
Territory on payments made by LIFECODES to ROCHE hereunder shall be borne
by ROCHE. LIFECODES will pay such withholding tax to the respective taxing
authorities and will deduct such amount from the royalty due to ROCHE.
LIFECODES shall use its best efforts to enable ROCHE to claim exception
therefrom under any double taxation or similar agreement in force and shall
produce to ROCHE proper evidence of payments of all withholding taxes.
4.4 LIFECODES shall keep such records as may under recognized accounting
practice enable royalty due under this Agreement to be accurately
determined. LIFECODES shall permit a firm of certified public accountants,
selected by ROCHE and acceptable to LIFECODES, upon request of ROCHE and to
examine such records no more than once in each calendar year during normal
business hours for the purpose of verifying LIFECODES's reports and
accounting hereunder and determining the correctness of said accountings
and the royalty payments made by LIFECODES to ROCHE.
Such examination will be at the cost of ROCHE unless the accountant
concludes that the royalty due has been understated by 5% or more, in which
case the examination will be paid by LIFECODES.
4.5 If LIFECODES should fail to pay any amount specified under this Agreement
at the due date thereof, the amount owed shall bear interest at one and a
half (1.5%) percent per month from the due date until paid.
5. Term and Termination
5.1 The license under this Agreement shall become effective as of April 1, 1997
and, unless terminated sooner as provided hereinbelow or by mutual
agreement, shall remain in effect until the last Licensed Patent having a
Valid Claim will have expired.
5.2 Failure by either party to this Agreement to comply with any of the
obligations and conditions
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contained herein shall entitle the other party to give the party in default
written notice requiring it to make good such default. If the default is
not remedied within sixty (60) days after receipt of such notice, the
notifying party shall be entitled, without prejudice to any of its other
rights conferred on it by this Agreement, to terminate the entire Agreement
by giving notice to take effect immediately. The parties understand and
agree in particular that the manufacture, use or sale of a product not
listed in Schedule B which is covered by Licensed Patents is a material
default.
5.3 Either party may terminate this Agreement upon thirty (30) days written
notice if, at any time, the other party shall file a petition in bankruptcy
or insolvency before the courts or apply for an arrangement or for the
appointment of a receiver or trustee for all of its assets or any part
thereof, or if the other party proposes a written agreement of composition
or extension of its debts or if the other party shall be served with an
involuntary petition against it, filed in any insolvency proceeding, and
such petition shall not be dismissed within sixty (60) days after its
filing, or if the other party shall propose or be a party to any
dissolution or liquidation, or if the other party shall make an assignment
for the benefit of creditors.
5.4 Furthermore, ROCHE shall have the right to terminate this Agreement giving
sixty (60) days written notice, if a controlling interest (i.e. a legal
interest which gives the holder effective management control) of LIFECODES
is acquired by a third party having itself or through an Affiliate thereof,
a business in in-vitro human diagnostics.
5.4 Termination of this Agreement for any reason shall be without prejudice to
any other remedies to which either party is or thereafter becomes entitled
hereunder and shall not affect any obligations or rights accrued before
termination hereunder.
5.5 Upon termination of this Agreement, LIFECODES shall notify ROCHE of the
stock of Licensed Products it has on hand and LIFECODES shall pay the
royalty upon the sale thereof. .
6. Labelling
LIFECODES undertakes to clearly identify each Product as being a LIFECODES
product and to xxxx each Product as follows:
"The use of this product is covered by a license of X.Xxxxxxxx-Xx
Xxxxx Ltd and Roche Molecular Systems, Inc."
7. Negation of Warranties and Indemnity
7.1 Nothing in this Agreement shall be construed as:
a) a warranty or representation by ROCHE as to the validity or scope of
any Licensed Patent;
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c) a warranty or representation that the sale of Licensed Products by
LIFECODES and/or the use of such Licensed Products by LIFECODES's
customers is or will be free from infringement of patents not licensed
hereunder;
d) an obligation to bring or prosecute actions or suits against third
parties for infringement of Licensed Patents. However, it is
understood that it is in the best interest of both parties that third
parties' infringement which have a significant impact on the market,
will be prosecuted by ROCHE;
e) conferring by implication or otherwise any license or rights under any
patents, know-how or other industrial property rights of ROCHE other
than expressly granted hereunder.
8.1 Most Favored Licensee
If after the signature of this Agreement, ROCHE grants to any unrelated
third party a license of substantially the same scope as granted to
LIFECODES herein but under more favorable royalty rates than those given to
LIFECODES under this Agreement, ROCHE shall promptly notify LIFECODES of
said more favorable royalty rates, and LIFECODES shall have the right and
option to elect within thirty (30) days such more favorable royalty rates.
LIFECODES's right to said more favorable royalty rates shall extend only
for so long as and shall be conditioned on LIFECODES's acceptance of all
the same conditions, favorable or unfavorable, under which such more
favorable royalty rates shall be available to such other third party. Upon
LIFECODES's acceptance of all such terms of said third-party agreement, the
more favorable royalty rates shall be effective as to LIFECODES on the
effective date of such other third party license agreement. Notwithstanding
the foregoing, in the event that ROCHE shall receive substantial other
nonmonetary consideration, for example, such as intellectual property
rights, as a part of the consideration for its granting of such license to
a third party, then this Section 8 shall not apply.
9. Miscellaneous
9.1 This Agreement and the license herein granted shall be personal to
LIFECODES and, unless agreed otherwise in writing, shall not be assignable
or otherwise inure to the benefit of successors of LIFECODES or to an
assignee of all or part of the good-will or other assets of LIFECODES.
9.2 This Agreement supersedes all previous agreements, whether written or oral,
with respect to the subject matter hereof.
9.3 No amendments or alterations of this Agreement shall be binding upon either
party unless in writing and duly signed by both parties.
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9.4 All titles and captions in this Agreement are for convenience only and
shall not be interpreted as having any substantive meaning.
9.5 Both parties hereby expressly state that it is the intention of neither
party to violate any rule, law or regulations. In the event that a court of
competent jurisdiction holds that a particular provision or requirement of
this Agreement is in violation of any law, such provision or requirement
shall not be enforced but replaced by a valid and enforceable provision or
requirement which will achieve as far as possible the economic business
intentions of the parties. All other provisions and requirements of this
Agreement, however, shall remain in full force and effect.
9.6 Neither party will issue any press release or other public announcement
relating to this Agreement without obtaining the other party's written
approval, which will not be unreasonably withheld.
9.7 LIFECODES hereby warrants that it shall not, and shall cause each of its
Affiliates not to, arrange sales of LIFECODES Licensed Products or
definitions relating thereto to reduce in bad faith the amounts for which
royalties are payable by LIFECODES hereunder.
10. Notices
Any notice required or permitted to be given under this Agreement shall be
considered properly given, upon receipt, if sent by registered air mail,
telecopier transmission or personal courier delivery to the respective
address of each party as follows:
Lifecodes: Lifecodes Corporation
000 Xxxx Xxxxxx
Xxxxxxxx, Xxxxxxxxxxx 00000
Attn: Xxxx Xxxxxxxx, Vice President,
Sales and Marketing
ROCHE: X.XXXXXXXX-XX XXXXX Ltd
Attn: Corporate Law
Xxxxxxxxxxxxx. 000
XX - 0000 Xxxxx, Xxxxxxxxxxx
with a copy to: ROCHE MOLECULAR SYSTEMS, INC.
0000 Xxxxxxxx Xxxxxx
Xxxxxxx, XX 00000
Attn: Licensing
11. Arbitration and Governing Law
11.1 Governing Law
This Agreement and its effect are subject to and shall be construed and
enforced in accordance with
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the law of the State of New Jersey, U.S.A., except as to any issue which by
the law of New Jersey depends upon the validity, scope or enforceability of
any patent within Licensed Patent Rights which issue shall be determined in
accordance with the applicable patent laws of the United States or the
relevant foreign jurisdiction.
The Parties agree that for any dispute or controversy arising from this
Agreement, the exclusive jurisdiction and venue for any such dispute or
controversy shall be in the United States District Court for the District
of New Jersey if federal jurisdiction exists, and if no federal
jurisdiction exists, then in the Superior Court of New Jersey.
11.2 Arbitration
Notwithstanding the provisions of Section 11.1 above, any dispute
concerning solely the determination of facts and which dispute does not
involve a question of law, shall be settled by final and binding
arbitration at a mutually convenient location in the State of New Jersey
pursuant to the commercial arbitration rules of the American Arbitration
Association in accordance with the following procedural process:
(a) The arbitration tribunal shall consist of three arbitrators. Each
party shall nominate in the request for arbitration and the answer
thereto one arbitrator and the two arbitrators so named will then
jointly appoint the third arbitrator within sixty (60) days of the
filing of the answer, said third arbitrator being the chairman of the
arbitration tribunal.
(b) The decision of the arbitration tribunal shall be final and judgment
upon such decision may be entered in any competent court for juridical
acceptance of such an award and order of enforcement.
Each party hereby submits itself to the jurisdiction of the courts of the
place of arbitration, but only for the entry of judgment with respect to
the decision of the arbitrators hereunder.
11.3 Nothing in this Agreement shall be construed so as to require the
commission of any act contrary to law, and wherever there is any conflict
between any provision of this Agreement or concerning the legal right of
the parties to enter into this Agreement and any statute, law, ordinance or
treaty, the latter shall prevail, but in such event the affected provisions
of the Agreement shall be curtailed and limited only to the extent
necessary to bring it within the applicable legal requirements.
11.4 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 possible. In any event, all
other provisions of this Agreement shall be deemed valid and enforceable to
the full extent possible
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X.XXXXXXXX-XX XXXXX Ltd LIFECODES CORPORATION
By:_____________________________ By: ________________________________
Name:___________________________ Name:_______________________________
Place/Date: ____________________ Place/Date: ________________________
ROCHE MOLECULAR SYSTEMS, INC.
By:_____________________________
Name: __________________________
Place/Date: ____________________
S C H E D U L E A
Licensed Patents
Amplification Process Patents:
U.S. Patent # 4,683,195 and corresponding foreign patent rights
U.S. Patent # 4,683,202 and corresponding foreign patent rights
HLA Patents
U.S. Patent # 5,110920
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S C H E D U L E B
Licensed Products
The following products will be offered under this license:
1) Kit I (20 probes)
2) Kit II (22 probes)
3) Kit III (25 probes)
4) Kit IV (31 probes)
5) Kit V (37 probes)
Each kit will include Taq polymerase, PCR buffer, dNTP's, primers, hybe
solution, SSC, Quick-Light buffer, chemiluminescent substrate and development
folders.
S C H E D U L E C
Territory
Worldwide
