1
Exhibit 10.9
[Note: Certain portions of this document have been marked "[c.i.]" to indicate
that confidentiality has been requested for this confidential information.] [The
confidential portions have been omitted and filed separately with the Securities
and Exchange Commission.]
LICENSE AGREEMENT
BETWEEN
CORANGE INTERNATIONAL LIMITED
AND
ALTEON INC.
DATED AS OF
DECEMBER 30, 1994
2
Exhibit 10.9
TABLE OF CONTENTS
Page
----
ARTICLE 1 - DEFINITIONS.................................................... 1
1.1 "Affiliate"................................................. 1
1.2 "AGE(s)".................................................... 1
1.3 "Combination Product"....................................... 2
1.4 "Commercial Product"........................................ 2
1.5 "Commercial Sale"........................................... 2
1.6 "Commodity Product"......................................... 2
1.7 "Effective Date of this Agreement".......................... 2
1.8 "Far East Countries"........................................ 2
1.9 "FDA"....................................................... 2
1.10 "Field"..................................................... 2
1.11 "510(k)".................................................... 2
1.12 "Licensed Patents".......................................... 2
1.13 "Licensed Technology"....................................... 3
1.14 "NDA"....................................................... 3
1.15 "Net Sales"................................................. 3
1.16 "Party"..................................................... 4
1.17 "Picower"................................................... 4
1.18 "PMA"....................................................... 4
1.19 "Product"................................................... 4
1.20 "Reagents".................................................. 4
1.21 "Research Product".......................................... 4
1.22 "Territory"................................................. 4
1.23 "Valid Claim"............................................... 4
1.24 "Yamanouchi"................................................ 5
ARTICLE 2 - LICENSE GRANT.................................................. 5
2.1 Grant of License............................................ 5
2.2 Reservation of Rights....................................... 5
ARTICLE 3 - MILESTONE, ROYALTY AND OTHER PAYMENTS.......................... 5
3.1 Initial Payment............................................. 5
3.2 Running Royalties........................................... 5
3.3 Obligation to Pay Royalties................................. 6
ARTICLE 4 - PAYMENTS AND REPORTS........................................... 6
4.1 Payment..................................................... 6
4.2 Mode of Payment............................................. 6
4.3 Records Retention........................................... 6
4.4 Audit Request............................................... 7
i
3
Exhibit 10.9
4.5 Cost of Audit............................................... 7
4.6 Taxes....................................................... 7
4.7 No Non-Monetary Consideration for Sales..................... 7
4.8 Affiliate's Right to Pay.................................... 7
4.9 Sublicense of Affiliates.................................... 8
ARTICLE 5 - DEVELOPMENT OBLIGATIONS AND COMMERCIAL COOPERATION............. 8
5.1 Product Development - Research Assays....................... 8
5.2 Product Development and Registration Milestones -
Commercial Assays........................................... 9
5.3 Development of Additional Assays............................ 9
5.4 Conduct of Development Programs by CIL...................... 11
5.5 Collaboration in the Development Process.................... 11
5.6 Joint Inventions............................................ 12
5.7 Collaborative Marketing of AGE Mechanism.................... 13
ARTICLE 6 - RIGHT OF FIRST REFUSAL......................................... 13
6.1 Grant of Right.............................................. 13
6.2 Exercise of Right........................................... 14
6.3 Effect of Exercise.......................................... 14
6.4 Effect of Failure to Exercise............................... 14
ARTICLE 7 - PATENT PROSECUTION, ENFORCEMENT AND INFRINGEMENT............... 14
7.1 Patent Prosecution and Maintenance.......................... 14
7.2 Notification of Infringement................................ 14
7.3 Patent Enforcement.......................................... 14
7.4 Third Party Licenses........................................ 15
7.5 Infringement Action by Third Parties........................ 15
ARTICLE 8 - CONFIDENTIALITY................................................ 16
8.1 Confidential Information.................................... 16
8.2 Confidentiality; Exceptions................................. 17
8.3 Third Party Information..................................... 17
ARTICLE 9 - INDEMNIFICATION................................................ 18
9.1 Indemnification by CIL...................................... 18
9.2 Indemnification by ALTEON................................... 18
9.3 Notice...................................................... 18
ARTICLE 10 - TERM; TERMINATION............................................. 18
10.1 Term........................................................ 18
10.2 Effect of Expiration of Term................................ 19
10.3 Breach...................................................... 19
ii
4
Exhibit 10.9
10.4 Termination by CIL.......................................... 19
10.5 Discontinuance of Sales..................................... 19
10.6 Election Not to Develop Product............................. 19
10.7 Right to Sell Stock on Hand................................. 20
10.8 Termination of Sublicenses.................................. 20
10.9 Effect of Termination....................................... 20
10.10 Surviving Rights............................................ 20
10.11 Accrued Rights, Surviving Obligations....................... 20
ARTICLE 11 - MISCELLANEOUS PROVISIONS...................................... 20
11.1 Relationship of Parties..................................... 20
11.2 Interest on Late Payments................................... 21
11.3 Assignment.................................................. 21
11.4 Disclaimer of Warranties.................................... 21
11.5 Representations and Warranties.............................. 21
11.6 Further Actions............................................. 21
11.7 Patent Marking.............................................. 21
11.8 Sharing of Information...................................... 21
11.9 Force Majeure............................................... 22
11.10 No Trademark Rights......................................... 22
11.11 Public Announcements........................................ 22
11.12 Notices..................................................... 22
11.13 Amendment................................................... 23
11.14 Waiver...................................................... 23
11.15 Counterparts................................................ 23
11.16 Descriptive Headings........................................ 23
11.17 Governing Law............................................... 23
11.18 Alternative Dispute Resolution.............................. 23
11.19 Severability................................................ 24
11.20 Compliance with Law......................................... 24
11.21 Entire Agreement of the Parties............................. 24
iii
5
Exhibit 10.9
EXHIBIT A: U.S. and Foreign Patents and Patent Applications
Relating to the Licensed Technology
EXHIBIT B: List of Countries Where Patents Will Be Filed
and Maintained
EXHIBIT C: Rockefeller Agreements
EXHIBIT D: Picower Agreements
(iv)
6
Exhibit 10.9
LICENSE AGREEMENT
LICENSE AGREEMENT, dated as of December 30, 1994 (this "Agreement"),
between ALTEON INC., a Delaware corporation, ("ALTEON") and CORANGE
INTERNATIONAL LIMITED, a Bermuda corporation ("CIL").
PRELIMINARY STATEMENTS
A. ALTEON has acquired, and possesses the right to license, worldwide
proprietary rights to a range of health care related technologies discovered at
The Rockefeller University, The Picower Institute of Medical Research or at
ALTEON, relating to the inhibition or reversal of damage to cells, tissues and
organs caused by the formation and cross-linking of advanced glycosylation
endproducts, including certain diagnostic technology to measure such endproducts
as a marker of disease and dysfunction associated with diabetic complications,
aging and related conditions.
B. CIL is a common parent company to each of Boehringer
Mannheim Corporation and Boehringer Mannheim GmbH.
B. CIL and/or its Affiliates have expertise in developing and marketing
diagnostic products and wishes to develop and market diagnostic products which
utilize such proprietary technology in conjunction with CIL's and/or its
Affiliates' proprietary immunodiagnostic kits and instrumentation.
C. CIL desires to obtain, and ALTEON is willing to grant, a
license to ALTEON's diagnostic technology.
NOW, THEREFORE, in consideration of the various promises and undertakings
set forth herein, the Parties agree as follows:
ARTICLE 1 - DEFINITIONS
As used herein, capitalized terms shall have the following meanings:
1.1 "Affiliate", with respect to any Party, shall mean any person or
entity controlling, controlled by, or under common control with, such Party. For
these purposes, "control" shall refer to (i) the possession, directly or
indirectly, of the power to direct the management or policies of a person or
entity, whether through the ownership of voting securities, by contract or
otherwise or (ii) the ownership, directly or indirectly, of at
-1-
7
Exhibit 10.9
least 50% of the voting securities or other ownership interest of a person or
entity (or such lesser percentage which is the maximum allowed to be owned by a
foreign corporation in a particular jurisdiction).
1.2 "AGE(s)" shall mean advanced glycosylation endproducts and any similar
biologic or physiologic reference including, but not limited to, Millard
reaction products, non-enzymatic glycation products, and like terminology
functioning in a substantially similar mechanistic way to such advanced
glycosylation endproducts.
1.3 "Combination Product" shall mean a Product that is formulated in
combination with one or more active components not in the Field.
1.4 "Commercial Product" shall mean any Product which is not a Research
Product.
1.5 "Commercial Sale" shall mean any sale which transfers to a purchaser
physical possession and title to any Products in any country in the Territory by
CIL or an Affiliate or sublicensee of CIL.
1.6 "Commodity Product" shall mean a diagnostic product sold by a
non-Affiliate or sublicensee of CIL which utilizes technology similar to the
Licensed Technology, the sale of which does not infringe a Valid Claim, and
which is interchangeable in the marketplace with a Commercial Product.
1.7 "Effective Date of this Agreement" shall mean the date first written
above.
1.8 "Far East Countries" shall mean Japan, Korea, Taiwan and The People's
Republic of China.
1.9 "FDA" shall mean the United States Food and Drug Administration, or
any successor thereto.
1.10 "Field" shall mean the use of in-vitro medical diagnostic and
analytical chemistry for the detection, monitoring and measurement of the
presence of AGEs.
1.11 "510(k)" shall mean an application filed with the FDA prior to the
introduction or delivery for introduction of a medical device pursuant to the
provisions of Section 510(k) of the Federal Food, Drug and Cosmetic Act (21
U.S.C. Section 321, et seq.) and the regulations promulgated thereunder.
-2-
8
Exhibit 10.9
1.12 "Licensed Patents" shall mean any current and future patent or patent
application owned by or licensed to ALTEON during the term of this Agreement
relating to the Licensed Technology in the Field throughout the Territory,
including any substitutions, extensions, renewals, continuations,
continuations-in-part, divisions, patents of additions, and/or reexaminations or
reissues thereof, and any current and future patent or patent application which
is a foreign counterpart in any country in the Territory to any of the
foregoing, including any substitutions, extensions, renewals, continuations,
continuations-in-part, divisions, patents- of-additions, and/or reexaminations
or reissues thereof. ALTEON's current U.S. and foreign patents and patent
applications which exist on the Effective Date of this Agreement are set forth
on Exhibit A.
1.13 "Licensed Technology" shall mean any and all proprietary information,
and all patentable and non-patentable inventions, improvements, discoveries,
claims, formulae, processes, methods, trade secrets, technologies, data and
know-how owned or exclusively licensed to ALTEON or to which ALTEON has the
right to grant licenses or sublicenses before or during the term of this
Agreement which identifies or measures the presence or quantity of AGE's as a
biological marker for disease and dysfunction associated with diabetic
complications, aging and other related conditions. Licensed Technology must not
be publicly available, unless it is made publicly available by, on behalf of, or
with the consent of CIL.
1.14 "NDA" shall mean a New Drug Application filed with the FDA for
marketing approval for a drug pursuant to the Federal Food, Drug and Cosmetic
Act (21 U.S.C. Section 321, et seq.) and the regulations promulgated thereunder.
1.15 "Net Sales" shall mean the gross amount invoiced for all Products
sold by CIL and its Affiliates and sublicensees in arm's length sales to
unrelated third parties, less deductions for:
(a) trade, quantity and cash discounts or rebates, credits,
allowances or refunds given or made for rejected, outdated or returned Products
and the like;
(b) any tax or government charge (other than an income tax)
levied on the sale, transportation or delivery of a Product and borne by the
seller thereof;
(c) any charges for freight, postage, shipping, import
or export taxes, insurance or charges for returnable containers;
and
-3-
9
Exhibit 10.9
(d) the actual full cost of financing or servicing of an
analyzer or device, in the event that the Product is sold as part of a lease or
rental agreement with the customer, whereby an analyzer or other device is
placed with the customer and the financing or servicing of such analyzer or
device is included in the price of the Product.
With respect to the deductions set forth in Sections 1.15(a), (b) or (c),
CIL may elect, for any calendar year during the term of this Agreement, to
deduct a lump sum of five percent (5%) of Net Sales to cover such items in lieu
of taking the deductions set forth in such Sections.
In the case of sales of a Combination Product, Net Sales shall be
determined by multiplying the Net Sales, as defined above, of such Combination
Product by a fraction, the numerator of which shall be the per unit current
stand-alone selling price of the component of such Combination Product that
would be a Product if sold separately (determined in accordance with generally
accepted accounting principles), and the denominator of which shall be the total
per unit current stand-alone selling price of all diagnostic technologies and
ingredients in such Combination Product, including the price of the component of
such Combination Product that would be a Product if sold separately. If there is
no established current stand-alone selling price for any component of a
Combination Product, the Parties shall negotiate in good faith a formula for
determining Net Sales of such Combination Product, taking into account (i) the
sales volume of such Combination Product; (ii) the profitability of such
Combination Product; and (iii) the proprietary nature and importance of each
component of such Combination Product.
1.16 "Party" shall mean ALTEON or CIL and, when used in the plural, shall
mean ALTEON and CIL.
1.17 "Picower" shall mean The Picower Institute for Medical Research.
1.18 "PMA" shall mean an application for premarket approval of a medical
device filed with the FDA pursuant to Section 515(b) of the Federal Food, Drug
and Cosmetic Act (21 U.S.C. Section 321, et seq.) and the regulations
promulgated thereunder.
1.19 "Product" shall mean any product in the Field, the manufacture, use
or sale of which: (i) uses Licensed Technology; and/or (ii) is covered by one or
more Licensed Patents which, but for the license granted hereunder, would
infringe a Valid Claim.
-4-
10
Exhibit 10.9
The term "Product" includes all Commercial Products, all Research Products, and
all Reagents.
1.20 "Reagents" shall mean chemical and biological materials which (i) use
Licensed Technology or are covered by one or more Licensed Patents and, but for
the license granted hereunder, would infringe a Valid Claim, and (ii) are
required for sample preparation or the performance of an AGE specific assay,
including but not limited to polyclonal or monoclonal antibodies, clones,
antigens, sera, diluents, solution, binding materials and the like.
1.21 "Research Product" shall mean any Product which is sold as an assay
for use by research investigators interested in AGE technology for which
premarket regulatory approval has not been granted and for which no diagnostic
efficacy claims have been made.
1.22 "Territory" shall mean all countries of the world, except the Far
East Countries.
1.23 "Valid Claim" shall mean a claim of any issued and unexpired Licensed
Patent which has not been held invalid or unenforceable by final decision of a
court or other governmental agency of competent jurisdiction, unappealable or
unappealed within the time allowed for appeal, and which is not admitted to be
invalid or unenforceable through reissue, disclaimer or otherwise.
1.24 "Yamanouchi" shall mean Yamanouchi Pharmaceutical Co., Ltd.
ARTICLE 2 - LICENSE GRANT
2.1 Grant of License. Subject to the terms and conditions of this
Agreement, ALTEON grants to CIL an exclusive license throughout the Territory,
with the right to grant sublicenses, to make, have made, use, sell and have sold
Products in the Field, under the Licensed Technology and Licensed Patents.
2.2 Reservation of Rights. The license granted in Section 2.1 is exclusive
to CIL, except that:
(a) ALTEON reserves the rights granted by ALTEON to The
Rockefeller University ("Rockefeller") or Picower, or reserved by Rockefeller or
Picower, pursuant to the agreements attached as Exhibit C and Exhibit D,
respectively; and
(b) ALTEON reserves the right, on behalf of itself, Rockefeller
and Picower, to use the Licensed Technology and the
-5-
11
Exhibit 10.9
Licensed Patents without cost to CIL and subject to the confidentiality
provisions of this Agreement, solely for internal research and development
purposes on a non-commercial basis.
ARTICLE 3 - MILESTONE, ROYALTY AND OTHER PAYMENTS
3.1 Initial Payment. As partial consideration to ALTEON for the licenses
and other rights granted to CIL under this Agreement, CIL shall pay to ALTEON
the sum of [C.I.] upon the execution of this Agreement. Such sum shall be
non-refundable.
3.2 Running Royalties. As further consideration of the license and other
rights granted to CIL under this Agreement, CIL shall pay to ALTEON a royalty,
commencing on the first Commercial Sale of a Research Product or a Commercial
Product, as the case may be, by CIL, its Affiliates or its sublicensees, as
follows:
(a) A royalty in the amount of [C.I.] of Net Sales of Research
Products sold in any country in the Territory if the sale would, but for the
license granted hereunder, infringe a Valid Claim.
(b) A royalty in the amount of [C.I.] of Net Sales of Commercial
Products sold in any country in the Territory if the sale would, but for the
license granted hereunder, infringe a Valid Claim and where Commodity Products
are not sold in such country.
(c) A royalty in the amount of [C.I.] of Net Sales of Commercial
Products sold in any country in the Territory if the sale would, but for the
license granted hereunder, infringe a Valid Claim in the event a Commodity
Product is sold in such country that does not infringe a Valid Claim.
(d) A royalty in the amount of [C.I.] of Net Sales of all
Products will be paid on the sale in any country of the Territory if such sale
is not covered by subparagraphs (a), (b) or (c) above.
(e) If any country restricts the royalty rate or amount payable
on account of sales of Products in such country, the royalties payable under
this Agreement with respect to such country shall be automatically adjusted so
as not to exceed the maximum amount payable under applicable laws, regulations
or administrative rulings of such country.
-6-
12
Exhibit 10.9
3.3 Obligation to Pay Royalties. The obligation to pay royalties to ALTEON
under this ARTICLE 3 is imposed only once with respect to the same unit of
Product regardless of the number of Licensed Patents or Licensed Technology
pertaining thereto. There shall be no obligation to pay royalties to ALTEON
under this ARTICLE 3 on sales of Products among CIL, its Affiliates and its
sublicensees, but in such instances the obligation to pay royalties shall arise
upon the sale of Products by CIL, its Affiliates or its sublicensees to
unrelated third parties. Payments of running royalties due under this ARTICLE 3
based on Net Sales shall be deemed to accrue when Products are shipped or
billed, whichever event shall first occur.
ARTICLE 4 - PAYMENTS AND REPORTS
4.1 Payment. All running royalty payments due hereunder shall be paid
annually. Royalties accruing on Net Sales in the United States shall be paid by
January 31st following the end of each calendar year. All other royalties
accruing on Net Sales in other countries in the Territory shall be paid by March
31st following the end of each calendar year. Each such payment shall be
accompanied by a statement of the amount of Net Sales during such year, on a
quarter-by-quarter, Product-by-Product and country- by-country basis, the amount
of royalties due on such Net Sales, and the amount of any credits being applied
to such royalties.
4.2 Mode of Payment. CIL shall make all payments required under this
Agreement in the United States in United States Dollars. The royalty payments
due on the sale of Products outside the United States shall be translated at the
rate of exchange at which United States Dollars are listed in The Wall Street
Journal for the currency of the country in which the royalty is accrued for the
last business day of the calendar quarter in which such sales were made.
4.3 Records Retention. CIL and its Affiliates and sublicensees shall keep
complete and accurate records pertaining to the sale of Products in the
Territory and covering all transactions from which Net Sales are derived for a
period of three calendar years after the year in which such sales occurred, and
in sufficient detail to permit ALTEON to confirm the accuracy of royalty
calculations hereunder.
4.4 Audit Request. At the request and expense of ALTEON, CIL and its
Affiliates and sublicensees shall permit an independent, certified public
accountant appointed by ALTEON and acceptable to CIL or its Affiliate or
sublicensee, at reasonable
-7-
13
Exhibit 10.9
times and upon reasonable notice, to examine those records and all other
material documents relating to or relevant to Net Sales in the possession or
control of CIL or its Affiliates or sublicensees, for a period of two years
after such royalties have accrued, as may be necessary to: (i) determine the
correctness of any report or payment made under this Agreement; or (ii) obtain
information as to the royalties payable for any calendar year in the case of
CIL's failure to report or pay pursuant to this Agreement. Said accountant shall
not disclose to ALTEON any information other than information relating to said
reports, royalties, and payments. Results of any such examination shall be made
available to both Parties.
4.5 Cost of Audit. ALTEON shall bear the full cost of the performance of
any such audit, unless such audit discloses a variance resulting in underpayment
by CIL of more than 10% of the actual amount due. In such case, CIL shall bear
the full reasonable cost of the performance of such audit.
4.6 Taxes. In the event that CIL or its Affiliates are required to
withhold any tax to the revenue authorities in any country in the Territory
regarding any payment to ALTEON due to the laws of such country, such amount
shall be deducted by CIL or its Affiliates, and it shall notify ALTEON and
promptly furnish ALTEON with copies of any tax certificate or other
documentation evidencing such withholding. All taxes levied on ALTEON's income
arising from this Agreement shall be borne by ALTEON. The Parties shall take
steps, consistent with current commercial practices, to: (i) avoid or minimize
any such withholding; and (b) take advantage of such double taxation avoidance
agreements as may be available.
4.7 No Non-Monetary Consideration for Sales. Without the prior written
consent of ALTEON, CIL and its Affiliates and sublicensees shall not accept or
solicit any non-monetary consideration in the sale of any Product other than as
would be reflected in Net Sales. The use by CIL of a commercially reasonable
amount of Product for promotional sampling shall not violate this prohibition.
4.8 Affiliate's Right to Pay. ALTEON agrees that any Affiliate of CIL may
pay, on behalf of CIL, any obligation of CIL under this Agreement and that such
payment shall be received in lieu of payment by CIL in satisfaction of such
obligation under this Agreement. Said Affiliate shall make payment to ALTEON in
U.S. Dollars pursuant to Section 4.2. Said Affiliate shall use its best efforts
to convert the royalties payable on sales in any country to U.S. Dollars;
provided, however, that if conversion to and transfer of U.S. Dollars cannot be
made in any country for any
-8-
14
Exhibit 10.9
reason, payment of royalties may be made in the currency of the country in which
such sales are made, deposited in ALTEON's name in a bank designated by ALTEON
in any such country.
4.9 Sublicense of Affiliates. Upon written request of CIL, ALTEON will
contract directly with any Affiliate of CIL and provide to said Affiliate the
right and license granted hereunder in any country in the Territory on
substantially the same terms and conditions as those contained herein, provided
that CIL shall guarantee to ALTEON performance of such Affiliates' duties and
obligations under such contract.
ARTICLE 5 - DEVELOPMENT OBLIGATIONS AND COMMERCIAL COOPERATION
5.1 Product Development - Research Assays.
(a) During the first calendar quarter of 1995, CIL will initiate
the development of a Hemoglobin-AGE assay for research kits using a microtiter
plate format. Assuming continued demonstration of the utility of the AGE
mechanism and ALTEON's positive clinical experience (e.g., from short-term
trials such as a cholesterol and Lipid-AGE placebo control study and an
Hb-AGE/A1c comparison study), CIL will also develop two additional research
assays for research kits using a microtiter plate format. The order of priority
for development of the assays will be:
(1) AGE-LDL - first; and
(2) AGE-serum protein/peptide - second.
The parties contemplate that CIL will initiate development of the AGE-LDL assay
in the third calendar quarter of 1995, subsequent to ALTEON's planned
commencement of a short term cholesterol and Lipid-AGE placebo control study in
humans. Continued development of such AGE-LDL assay will be based upon such
clinical data as ALTEON may learn and communicate to CIL. CIL will initiate
development of the AGE-serum protein/peptide assay in calendar year 1996 as
ALTEON develops or communicates information supporting such development.
(b) In addition, in the event that (i) Yamanouchi elects not to
accept for development a license of the Licensed Technology and the Licensed
Patents in the Field in the Far East Countries and CIL acquires such rights
pursuant to the exercise of its Rights under Article 6, and (ii) the Parties
agree that a format other than the one developed or being developed pursuant to
Section 5.1(a) (e.g. a radioimmune assay) is required in the Far
-9-
15
Exhibit 10.9
East Countries taking into consideration input the Parties receive from
Yamanouchi or any other ALTEON licensee of AGEs for therapeutic use in Japan,
then, if commercially reasonable, CIL shall also develop (or cause a sublicensee
to develop) the three (3) research assays listed in Section 5.1(a) for research
kits using such different format.
5.2 Product Development and Registration Milestones -
Commercial Assays.
(a) On execution of this Agreement, CIL will prepare a
development plan and schedule for the development of commercial (automated)
assays, on a platform to be determined by CIL, taking into account such factors
as potential market size, frequency of testing and location of testing (i.e.
reference laboratories, etc.) for the assays listed in Section 5.1 (the "Plan").
The Plan will detail assay development milestones and timing which have been
mutually agreed upon by the Parties. The Parties agree that the Plan shall be
consistent with CIL's internal "New Product Commercialization Process
Guideline," as in effect from time to time, a copy of the current version of
which has been provided to ALTEON. The development milestones to be agreed upon
shall include, without limitation, (i) the timing for the initiation of each
assay development, (ii) the timing for the filing of a PMA or 510(k), and (iii)
the timing of commercial launch following regulatory approval. Such Plan shall
include development milestones that are consistent with the intent of the
Parties as set forth in Sections 5.2(b) and 5.2(c). Proposals for such Plan
shall be submitted to ALTEON for its review and comment. Such Plan shall be
subject to the approval of ALTEON, which will not be unreasonably withheld.
(b) It is the intention of the Parties that CIL will commence
the development of a commercial automated Hemoglobin-AGE assay prior to or at
the time that ALTEON generates data from its Phase III nephropathy clinical
trials for pimagedine, or such other clinical trials for pimagedine that ALTEON
is conducting, that indicate therapeutic efficiency for pimagedine. In order to
allow CIL to budget and plan for such assay development, ALTEON currently
anticipates filing for NDA approval of pimagedine between the second quarter of
1997 and the second quarter of 1998. ALTEON will advise CIL from time to time as
to delays or other changes in this expectation.
(c) Further, it is the intention of the Parties that, at a
minimum, CIL shall develop a commercial automated Hemoglobin-AGE assay in a
time frame which would permit PMA or 510(k) approval of a commercial assay at
the same time as ALTEON obtains NDA
-10-
16
Exhibit 10.9
approval for pimagedine, thereby making the Hemoglobin-AGE assay commercially
available contemporaneous with the commercial launch of pimagedine as an AGE
inhibitor for the treatment/prevention of one or more complications of diabetes.
In order to allow CIL to budget and plan for such assay development, ALTEON
currently anticipates receiving NDA approval of pimagedine during 1999. ALTEON
will advise CIL from time to time as to delays or other changes in this
expectation.
5.3 Development of Additional Assays. CIL will have a right of first
refusal to develop additional AGE-analytes. These assays will include (but are
not limited to) assays to detect: (i) AGE-urine, (ii) AGE-tissue, (iii)
AGE-amyloid protein, (iv) AGE-immunoglobulin, (v) pimagedine and similar drug
compounds in patient samples, and (vi) triazine and other pimagedine-blocked
products in patient samples. With respect to each assay, the following terms
will apply:
(a) When ALTEON has sufficient information necessary to permit
CIL or a third party to determine the business and technical feasibility of
developing an assay, ALTEON will notify CIL in writing of the availability of
such information. If CIL desires to conduct due diligence with respect to such
assay, CIL shall notify ALTEON of its interest in same within thirty (30) days
after receipt of notice from ALTEON regarding such assay. CIL will then have six
months from the date of ALTEON's initial notice (or until ALTEON receives NDA
approval of pimagedine, whichever is longer) to conduct due diligence to
determine whether to proceed with the development of such assay.
(b) No later than the end of the due diligence period with
respect to any assay, CIL may elect to proceed with the development of such
assay by sending written notice of such election to ALTEON together with payment
to ALTEON, for each additional assay it elects to develop, of the sum of [C.I.]
[C.I.]. Such sums shall be non-refundable. Products using such assays shall
thereafter be subject to all of the terms of this Agreement applicable to
Products, including the royalty rates set forth in Section 3.2. CIL will then
prepare a development plan and schedule for the development of such assays, on a
platform to be determined by CIL, taking into account such factors as potential
market size, frequency of testing and location of testing (i.e. reference
laboratories, etc.) for the elected assay(s). The Parties agree that any such
plan shall be consistent with CIL's internal "New Product Commercialization
Process Guideline," as in effect from time to time. Proposals for such plan
shall be submitted to ALTEON for its review and comment. Such
-11-
17
Exhibit 10.9
plan shall be subject to the approval of ALTEON, which will not be unreasonably
withheld.
(c) In the event that CIL declines to conduct such due diligence
with respect to an assay pursuant to Section 5.3(a) or does not reply to
ALTEON's notice within the thirty (30) day period, and if ALTEON identifies a
third party willing to develop such assay, CIL will grant an exclusive
sublicense of proprietary rights granted hereunder to enable such third party to
develop and commercialize such assay on terms consistent with this Agreement;
provided, however, that nothing in this Agreement shall be construed to obligate
CIL to assist with or collaborate in the development of such assay. In lieu of
the royalty rates set forth in Section 3.2, CIL shall pay fifty percent (50%) of
the royalties and other payments received by CIL from such third party
sublicensee to ALTEON within thirty (30) days after receipt of such payments.
5.4 Conduct of Development Programs by CIL. CIL shall:
(a) Use its reasonable best commercial efforts and proceed
diligently to perform the work set out in the plan for each assay being
developed;
(b) Conduct the development programs in good scientific manner,
and in compliance in all material respects with all requirements of applicable
laws, rules and regulations, and all other requirements of any applicable good
laboratory practices to attempt to achieve its objectives efficiently and
expeditiously;
(c) During the term of the development programs and promptly
following the expiration or termination of each development program, cause
appropriate representatives of CIL to meet with representatives of ALTEON, at
mutually agreeable times and places or by telephone conference, but at least
quarterly, to discuss the progress and developments of any development programs
relating to AGE diagnostics. Such meetings shall include, without limitation,
the following:
(1) Providing ALTEON access to data and progress
notes concerning CIL's diagnostic development programs and the opportunity to
discuss such data and progress notes with appropriate CIL personnel, in order to
assist ALTEON in determining the progress being made and in evaluating the
viability, utility and acceptability of future AGE-diagnostics pursuits;
(2) Providing ALTEON with reports summarizing all
activities under the development programs during the period since
-12-
18
Exhibit 10.9
the last meeting, which reports shall be in writing if requested by ALTEON; and
(3) At least twice per calendar year, re-evaluating each
development plan and, if necessary, proposing modifications to such plan to
ALTEON for its review and approval; and
(d) Allow representatives of ALTEON, upon reasonable notice and
during normal business hours, to (1) visit the facilities where the development
programs are being conducted, and (2) consult informally, during such visits and
by telephone, with CIL personnel performing work on the development programs.
5.5 Collaboration in the Development Process.
(a) ALTEON will provide CIL with access to ALTEON's assay
development personnel who will provide a reasonable amount of time, as
determined by ALTEON, to assist CIL throughout the development process.
(b) ALTEON will use its best efforts to cause Picower to provide
CIL with access to appropriate scientists on AGE-related diagnostic and medical
knowledge throughout the development process in accordance with the terms of its
agreement with Picower, as well as access to individuals at Picower who consult
for ALTEON.
(c) Subject to the terms of the existing collaborative agreement
between ALTEON and Marion Merrell Dow Inc., ALTEON will provide CIL, at the
quarterly meetings to be held pursuant to Section 5.4(c), access to data and
progress notes concerning ALTEON's AGE therapeutic clinical trials and the
opportunity to discuss such data and progress notes with appropriate ALTEON
personnel, in order to assist CIL in determining the progress being made and in
evaluating the viability, utility and acceptability of future AGE-diagnostics
pursuits.
(d) ALTEON will provide CIL with a reasonable amount of clinical
samples for CIL to use for test development purposes only, as such samples are
available.
(e) CIL hereby grants ALTEON the right to continue to perform
AGE assays on clinical trial samples using its in-house reagents until such time
as CIL can supply research grade diagnostic tests to ALTEON which have been
appropriately validated pursuant to a criterion mutually agreed upon by the
Parties. Thereafter, ALTEON will purchase its requirements of the assay(s) for
clinical trial purposes from CIL at CIL's list price for the
-13-
19
Exhibit 10.9
assay(s), provided that the use of the CIL assay would not invalidate ALTEON's
findings or prior diagnostic results. CIL, however, will provide ALTEON at no
cost a reasonable quantity of research assays for ALTEON to use for its
preclinical testing and validation purposes. Such test kits will not be included
in Net Sales and CIL's provision of test kits to ALTEON at no cost shall not be
deemed to violate Section 4.7 of this Agreement.
5.6 Joint Inventions.
(a) Any inventions made jointly by CIL and ALTEON that are
within the Field shall be jointly owned, but shall be subject to the exclusive
license granted hereunder to CIL and subject to all of the terms of CIL's
license hereunder.
(b) ALTEON will have the right of first refusal to acquire an
exclusive license for any inventions made jointly by the Parties relating to
therapeutic aspects of the Licensed Technology in accordance with the following
terms:
(1) CIL shall give written notice to ALTEON of its interest
in entering into a licensing arrangement for any such joint invention, together
with sufficient information regarding such joint invention which is reasonably
necessary for ALTEON to make an informed decision regarding such arrangement,
including, without limitation, the commercial terms upon which CIL is interested
in offering an exclusive license for such joint invention. ALTEON shall have
ninety (90) days after receipt of such notice and information to decide whether
or not it wishes to accept such offer.
(2) In the event that ALTEON declines to accept such offer
with respect to such joint invention or does not reply to CIL's notice within
the ninety (90) day period, and if CIL identifies a third party willing to enter
into a licensing arrangement for such joint invention on terms no less
advantageous to CIL than those offered to ALTEON for such joint invention,
ALTEON will, together with CIL, grant an exclusive license of such joint
invention to such third party. ALTEON shall collect all royalties from such
third party and shall pay fifty percent (50%) of such royalties and other
payments received by ALTEON from such third party to CIL within thirty (30) days
after receipt of such payments.
(3) In no event may CIL conclude any transaction with any
third party on terms less advantageous to CIL than those offered to ALTEON
without first offering said less advantageous terms to ALTEON in compliance with
this Section 5.6(b).
-14-
20
Exhibit 10.9
(c) Any other joint inventions outside the Field which do not
relate to therapeutic aspects of the Licensed Technology will be jointly owned,
and CIL and ALTEON will negotiate in good faith to determine how best to
recognize the value of each party's contribution to the joint invention, taking
into account (i) the relative efforts by CIL and ALTEON in developing such joint
invention; (ii) whether products developed from such joint invention are covered
by a valid claim of a patent; (iii) the potential sales volume and profitability
of such products; and (iv) the projected expenses of marketing such products.
5.7 Collaborative Marketing of AGE Mechanism. ALTEON and CIL will develop
and carry forward an AGE mechanism marketing plan intended to educate medical
and clinical laboratory practitioners regarding the utility of the AGE marker
and to establish demand for Products and understanding of the clinical and
therapeutic utility of the AGE mechanism in general. Following regulatory
approval of Products, CIL will actively promote and sell Products in the
Territory. On approval of ALTEON's AGE inhibitor agent or other AGE therapeutic
products, provided the commercial availability and regulatory claims approved
for the use of Products, ALTEON will promote their use in AGE diagnostics and as
a diagnostic tool to be used as part of an overall therapy program.
ARTICLE 6 - RIGHT OF FIRST REFUSAL
6.1 Grant of Right. Subject to the terms and conditions of this Agreement,
ALTEON grants to CIL a right of first refusal to expand the Territory to include
the Far East Countries (the "Right") in the event that Yamanouchi elects not to
accept for development a license of the Licensed Technology and the Licensed
Patents in the Field pursuant to an agreement by and between Alteon and
Yamanouchi, such that Yamanouchi retains or receives no financial benefit,
either directly or indirectly, from such license (other than the indirect
benefit to Yamanouchi sales of therapeutic products by virtue of having
commercial assays available).
6.2 Exercise of Right. The Right may be exercised, during the term of this
Agreement, for a period of thirty (30) days following ALTEON's notice to CIL of
Yamanouchi's election not to accept such license (the "Exercise Period"). CIL
may exercise the Right at any time during the Exercise Period by sending to
Alteon written notice of the exercise of the Right. CIL will then prepare a
development plan and schedule for the development of all assays which CIL is
then developing pursuant to Section 5.1 or 5.3 for the Far East Countries, on a
platform to be determined by CIL, taking into account such factors as potential
market size, frequency of
-15-
21
Exhibit 10.9
testing and location of testing (i.e. reference laboratories, etc.) for such
assay(s). Proposals for such plan shall be submitted to ALTEON for its review
and comment. Such plan shall be subject to the approval of ALTEON, which will
not be unreasonably withheld.
6.3 Effect of Exercise. Upon exercise of the Right and agreement on
appropriate development milestones for Products in the Far East Countries, the
Territory shall be expanded to include the Far East Countries and shall be
subject to all of the terms and conditions contained in this Agreement
applicable thereto.
6.4 Effect of Failure to Exercise. In the event that CIL declines to
exercise its Right or does not reply to ALTEON's notice within the Exercise
Period, ALTEON shall be free to negotiate a license for the Products in the
Field in the Far East Countries with a third party.
ARTICLE 7 - PATENT PROSECUTION, ENFORCEMENT AND INFRINGEMENT
7.1 Patent Prosecution and Maintenance. ALTEON agrees to take all actions
reasonably necessary to diligently prosecute and maintain any patents or patent
applications relating to the Licensed Technology and ALTEON's AGE technology for
therapeutic applications in the countries listed on Exhibit B, which may be
modified by mutual agreement of the parties. ALTEON and CIL shall mutually
determine the additional countries, if any, where patent applications will be
filed and prosecuted, and where the patents will be maintained. The Parties
acknowledge and agree that they intend for ALTEON to be required to file and
prosecute patent applications and maintain patents in all major commercial
markets where viable patent protection is available. If the laws affecting
patent protection or maintenance costs change in any such country, the Parties
shall reassess the need to continue to file and prosecute patent applications
and maintain patents in such country.
7.2 Notification of Infringement. If either Party learns of an
infringement or threatened infringement by a third party of any Licensed Patent
granted hereunder within the Territory, such Party shall promptly notify the
other Party and shall provide such other Party with available evidence of such
infringement.
7.3 Patent Enforcement. ALTEON shall have the first right, but not the
duty, to institute patent infringement actions against third parties based on
any Licensed Patent under this Agreement. If ALTEON does not institute an
infringement proceeding against an offending third party within one-hundred
twenty (120) days after receipt of notice from CIL, CIL shall have the right,
but not the duty, to institute such an action. The costs and
-16-
22
Exhibit 10.9
expenses of any such action (including fees of attorneys and other
professionals) shall be borne by the Party instituting the action, or, if the
Parties elect to cooperate in instituting and maintaining such action, such
costs and expenses shall be borne by the Parties in such proportions as they may
agree in writing. Each Party shall execute all necessary and proper documents
and take such actions as shall be appropriate to allow the other Party to
institute and prosecute such infringement actions. Any award paid by third
parties as a result of such an infringement action (whether by way of settlement
or otherwise) shall be paid to the Party who instituted and maintained such
action, or, if both Parties instituted and maintained such action, such award
shall be allocated among the Parties in proportion to their respective
contributions to the costs and expenses incurred in such action.
7.4 Third Party Licenses.
(a) If either Party identifies an infringement or potential
infringement of a third party's patent(s) based upon the use of any Licensed
Technology to make, use or sell any Product in any country in the Territory,
such Party shall promptly notify the other Party and shall provide such other
Party with available evidence of such potential infringement.
(b) In such event, and during the period prior to the
institution of a suit by such third party, ALTEON shall have the first right to
obtain, at ALTEON's expense, a license from such third party in such country
with respect to such infringing Product.
(c) If ALTEON does not obtain a license from such third party in
such country with respect to such infringing Product within 120 days after
ALTEON receives notice of such potential infringement pursuant to Section
7.4(a), CIL may seek to do so prior to the institution of a suit by such third
party. If CIL obtains a license from such third party, CIL shall be entitled to
a credit against the payments due hereunder for such Product in such country of
an amount equal to the royalty paid to such third party, but in no event shall
such credit exceed fifty percent (50%) of such payments due hereunder in any
calendar year for such Product in such country which is the subject of such
potential infringement.
7.5 Infringement Action by Third Parties.
(a) In the event of the institution of any suit by a third party
against CIL or its Affiliates, sublicensees, distributors or customers for
patent infringement involving the
-17-
23
Exhibit 10.9
manufacture, use, distribution, marketing or sale of any Product in the
Territory, CIL shall promptly notify ALTEON in writing of such suit. CIL shall
have the right to defend such suit at its own expense, and ALTEON hereby agrees
to assist and cooperate with CIL, at its own expense, to the extent necessary in
the defense of such suit. During the pendency of such action, CIL shall either,
at its option: (i) continue to make all payments due under this Agreement to
ALTEON, or (ii) make one-half of all payments due under this Agreement resulting
from the Product(s) in the country or countries which are the subject of such
action into an escrow account at a bank mutually agreed to by the Parties, and
continue to make the balance of all payments due under this Agreement to ALTEON.
The costs of creating such escrow account shall be deemed to be costs incurred
in connection with such action, subject to credit or refund as set forth in
Section 7.5(b) or (c), if applicable.
(b) If CIL finally prevails because it is held not to be
infringing any patents or trademarks belonging to such third party or because
such third party's patent is held invalid, CIL shall continue to pay the
royalties as set forth in Section 3.2, but shall be entitled to a credit against
such payments or a refund from the escrow account (or, if the escrow account is
not sufficient to cover the amount due, a credit against such payments), as the
case may be, of an amount equal to one-half of the reasonable costs actually
incurred in such action, but in no event shall such refund or credit be more
than 50% of such payments due hereunder in any calendar year for Products in
such country which is the subject of such action.
(c) If CIL finally loses, whether by judgment, award, decree or
settlement, and is required to pay a royalty to such third party, CIL shall
continue to pay the royalties for such Products in the country which is the
subject of such action, but shall be entitled to a credit against such payments
or a refund from the escrow account (or, if the escrow account is not sufficient
to cover the amount due, a credit against such payments), as the case may be, of
an amount equal to the royalty paid to such third party, but in no event shall
such refund or credit be more than 50% of the payments due hereunder in any
calendar year for Products in such country which is the subject of such action.
In addition, if CIL incurs litigation expenses or is required to pay damages to
such third party, CIL shall be entitled to a refund from the escrow account (or,
if the escrow account is not sufficient to cover the amount due, a credit
against such payments) of an amount equal to one-half of the reasonable costs
actually incurred in such action plus one-half of the damages, but in no event
shall the total refund or credit provided herein be
-18-
24
Exhibit 10.9
more than 50% of the payments due hereunder in any calendar year for Products in
such country which is the subject of such action.
ARTICLE 8 - CONFIDENTIALITY
8.1 Confidential Information. It is contemplated that in the course of the
performance of this Agreement each Party will, from time to time, disclose
proprietary and confidential information to the other. "Information" shall
include all disclosures made pursuant to this Agreement in writing and
identified as being confidential or, if disclosed orally, is reduced to writing
within thirty (30) days of such oral disclosure and identified as being
confidential.
8.2 Confidentiality; Exceptions. Except to the extent expressly authorized
by this Agreement or otherwise agreed in writing, the Parties agree that, for
the term of this Agreement and for five (5) years thereafter, the receiving
Party shall keep confidential, and shall take such reasonable measures to
maintain such Information as confidential as it takes to protect its own
proprietary information, and shall not publish or otherwise disclose and shall
not use for any purpose any Information furnished to it by the other Party
pursuant to this Agreement, except to the extent that it can be established by
the receiving Party by competent proof that such Information:
(a) was already known to the receiving Party, other T 21 than
under an obligation of confidentiality, at the time of disclosure by the other
Party;
(b) was generally available to the public or otherwise part of
the public domain at the time of its disclosure to the receiving Party;
(c) became generally available to the public or otherwise part
of the public domain after its disclosure and other than through any act or
omission of the receiving Party in breach of this Agreement;
(d) was disclosed to the receiving Party by a third party who
had no obligation to the disclosing Party not to disclose such Information to
others.
(e) was independently developed by the receiving Party by
persons who did not have access to the Information.
-19-
25
Exhibit 10.9
Each Party may disclose the other's Information to the extent such
disclosure is reasonably necessary in filing or prosecuting patent applications,
prosecuting or defending litigation, complying with applicable governmental
regulations, undertaking basic research with outside collaborators, or
conducting preclinical or clinical trials, provided that if a Party is required
to make any such disclosure of the other Party's secret or confidential
Information it will, except where impracticable for necessary disclosures, for
example to physicians conducting studies or to health authorities, give
reasonable advance notice to the other Party of such disclosure requirement and,
except to the extent inappropriate in the case of patent applications, will use
its best efforts to secure confidential treatment of such Information required
to be disclosed.
8.3 Third Party Information. The Parties recognize that ALTEON may have
development and marketing partners and/or licensees or sublicensees for the
research, development and marketing of AGE-related therapeutic products. CIL
hereby grants ALTEON the right to share data and information disclosed by CIL
relating to AGEs with such third parties, subject to appropriate confidentiality
agreements; provided, however, that ALTEON shall not share such data and
information with any other licensees of the Licensed Technology in the Field.
ARTICLE 9 - INDEMNIFICATION
9.1 Indemnification by CIL. CIL shall defend, indemnify and hold ALTEON,
its directors, officers and employees, harmless from and against any and all
claims, suits or demands for liability, damages, losses, costs and expenses
(including the costs and expenses of attorneys and other professionals) arising
out of third party claims or suits resulting from the manufacture, use or sale
of Products by CIL, its Affiliates or its sublicensees pursuant to this
Agreement, including, without limitation, promotion and advertising of Products
and/or interactions and communications with governmental authorities, physicians
or other third parties.
9.2 Indemnification by ALTEON. ALTEON shall defend, indemnify and hold
CIL, its directors, officers, employees, Affiliates and sublicensees harmless
from and against any and all claims, suits, or demands for liability, damages,
losses, costs and expenses (including the costs and expenses of attorneys and
other professionals) arising out of third party claims or suits resulting from
the (i) manufacture, use or sale of ALTEON's AGE inhibitor agent or other AGE
therapeutic products and (ii) the promotion of Products outside the scope of
regulatory claims approved for
-20-
26
Exhibit 10.9
Products, by ALTEON, its Affiliates and its licensees or sublicensees,
including, without limitation, promotion and advertising of ALTEON's AGE
inhibitor agent or other AGE therapeutic products and/or interactions and
communications with governmental authorities, physicians or other third parties.
9.3 Notice. In the event that a Party (an "Indemnitee") seeks
indemnification under this ARTICLE 9, the Indemnitee agrees to: (i) promptly
inform the other Party (the "Indemnitor") of any claim, suit or demand
threatened or filed, (ii) permit the Indemnitor to assume direction and control
of the defense or claims resulting therefrom (including the right to settle it
at the sole discretion of the Indemnitor), and (iii) cooperate as requested (at
the expense of the Indemnitor) in the defense of the claim.
ARTICLE 10 - TERM; TERMINATION
10.1 Term. This Agreement shall commence as of the Effective Date of this
Agreement and, unless sooner terminated as provided hereunder, shall terminate
as follows:
(a) As to each Product and as to each country in the Territory:
(i) if such Product is covered by Section 3.2(a), (b) or (c), this Agreement
shall terminate upon the expiration of the last to expire of the Valid Claims
necessary for the use and sale of such Product in such country; and (ii) as to
any Product which is covered by Section 3.2(d), this Agreement shall terminate
fifteen (15) years from the first Commercial Sale of such Product.
(b) This Agreement shall terminate in its entirety upon its
termination as to all Products in all countries in the Territory.
10.2 Effect of Expiration of Term. Following expiration of the term of
this Agreement, in whole or in part, pursuant to Section 10.1, CIL shall have
the royalty-free non-exclusive right and license, within the Field, to continue
to make, use and sell the Products as to which this Agreement is terminated,
including the right to grant sublicenses therefor, as previously licensed in
ARTICLE 2.
10.3 Breach. Failure by CIL to comply with any of the material obligations
contained in this Agreement shall entitle ALTEON to give notice to CIL
specifying the nature of the default and requiring it to cure such default. If
such default is not cured within sixty (60) days after the receipt of such
notice (or, if such default cannot be cured within such sixty (60) day period,
-21-
27
Exhibit 10.9
if CIL does not commence and diligently continue actions to cure such default),
ALTEON shall be entitled, without prejudice to any of its other rights conferred
on it by this Agreement, in addition to any other remedies available to it by
law or in equity, to terminate this Agreement by giving written notice to take
effect immediately. The right of ALTEON to terminate this Agreement, as
hereinabove provided, shall not be affected in any way by its waiver or failure
to take action with respect to any previous default.
10.4 Termination by CIL. CIL shall have the right to terminate the
licenses granted herein, in whole or as to any Product in any country in the
Territory, at any time, and from time to time, by giving notice in writing to
ALTEON. Such termination shall be effective ninety (90) days from the date such
notice is given, and all CIL's rights and duties associated therewith shall
cease as of that date, subject to Section 10.7.
10.5 Discontinuance of Sales. ALTEON may terminate the license granted
herein, in whole or as to any Product licensed under this Agreement to CIL in
any country in the Territory in which CIL voluntarily discontinues Commercial
Sales of such Products for any reason other than as set forth in Section 11.9 or
that CIL is legally barred from selling such Products and fails to start selling
such Products again in such country within one hundred eighty (180) days after
delivery of written notice from ALTEON to CIL of such discontinuance.
10.6 Election Not to Develop Product. If CIL elects not to initiate a
development program, or has not commenced a program, that is designed to develop
and register Product(s) with regulatory agencies in the major markets included
in the Territory in accordance with the milestones agreed upon pursuant to
Section 5.1, ALTEON, at its sole option, shall have the right to terminate the
license granted herein, and this Agreement, by giving notice in writing to CIL
of its decision. Such termination shall be effective ninety (90) days from the
date such notice is given (unless CIL commences such program within such ninety
(90) day period) and, except as otherwise provided in this Agreement, all CIL's
rights and duties associated therewith shall cease as of that date.
10.7 Right to Sell Stock on Hand. Upon the termination of any license
granted herein, in or whole or as to any Product in any country in the
Territory, for any reason other than a failure to cure a material breach of the
Agreement by CIL, CIL and its Affiliates and sublicensees shall have the right
for six (6) months or such longer period as the Parties may reasonably agree to
-22-
28
Exhibit 10.9
dispose of all Product or substantially completed Product then on hand to which
such termination applies, and royalties shall be paid to ALTEON with respect to
such Product as though this Agreement had not terminated.
10.8 Termination of Sublicenses. Upon any termination of this Agreement,
all sublicenses granted by CIL under this Agreement shall terminate
simultaneously, subject, nevertheless, to Section 10.7.
10.9 Effect of Termination. Upon the termination of any license granted
herein as to any Product in any country in the Territory other than pursuant to
Section 10.1, CIL and its sublicensees shall promptly return to ALTEON all
relevant records, materials or confidential information concerning the Licensed
Patents and Licensed Technology relating to such Product in such country in the
possession or control of CIL or any of its sublicensees.
10.10 Surviving Rights. Termination of this Agreement shall not terminate
CIL's obligation to pay all royalties which shall have accrued hereunder. The
Parties' obligations under ARTICLES 4, 7, 8, 9 and 10 and Sections 11.17 and
11.18 shall survive termination.
10.11 Accrued Rights, Surviving Obligations. Termination, relinquishment
or expiration of this Agreement for any reason shall be without prejudice to any
rights which shall have accrued to the benefit of either Party prior to such
termination, relinquishment or expiration. Such termination, relinquishment or
expiration shall not relieve either Party from obligations which are expressly
indicated to survive termination or expiration of this Agreement.
ARTICLE 11 - MISCELLANEOUS PROVISIONS
11.1 Relationship of Parties. Nothing in this Agreement is intended or
shall be deemed to constitute a partnership, agency, employer-employee or joint
venture relationship between the Parties. No Party shall incur any debts or make
any commitments for the other, except to the extent, if at all, specifically
provided herein.
11.2 Interest on Late Payments. Any payments required under this Agreement
that are not made when due shall accrue interest at the rate of one percent (1%)
per month from the date such payment is due. The Party making such payment shall
make the payment together with any accrued interest thereon through the date
such payment is made.
-23-
29
Exhibit 10.9
11.3 Assignment. Except as otherwise provided herein, neither this
Agreement nor any interest hereunder shall be assignable by any Party without
the prior written consent of the other; provided, however, that either Party may
assign this Agreement to any wholly-owned subsidiary, to any Affiliate (provided
that such Affiliate is, directly or indirectly, under 100% common ownership with
such Party), or to any successor by merger or sale of substantially all of its
assets to which this Agreement relates in a manner such that the assignor shall
remain liable and responsible for the performance and observance of all its
duties and obligations hereunder. This Agreement shall be binding upon the
successors and permitted assigns of the parties and the name of a Party
appearing herein shall be deemed to include the names of such Party's
successor's and permitted assigns to the extent necessary to carry out the
intent of this Agreement. Any assignment not in accordance with Section 11.3
shall be void.
11.4 Disclaimer of Warranties. The parties expressly disclaim any
warranties as to validity or enforceability of Licensed Patents, or
non-infringement of third party patents.
11.5 Representations and Warranties. Each Party represents and warrants
that, to the best of its knowledge: (i) it is free to enter into this Agreement;
and (ii) in so doing will not violate any other agreement to which it is a
party.
11.6 Further Actions. Each Party agrees to execute, acknowledge and
deliver such further instruments, and to do all such other acts, as may be
necessary or appropriate in order to carry out the purposes and intent of this
Agreement.
11.7 Patent Marking. At ALTEON's request, CIL shall mark in an appropriate
manner all containers or packages of Products sold by CIL with the appropriate
statutory patent notice for the jurisdiction in which the Product is to be sold
to indicate patent coverage has been obtained or patents are pending.
11.8 Sharing of Information. ALTEON and CIL shall keep each other
currently informed of relevant progress, plans and information concerning the
development, manufacture, use and sale of Products and ALTEON's products to the
extent such are reasonably relevant to the work of the other Party.
11.9 Force Majeure. Neither Party shall be liable to the other for loss or
damages or shall have any right to terminate this Agreement for any default or
delay attributable to any act of God, flood, fire, explosion, strike, lockout,
labor dispute, shortage of
-24-
30
Exhibit 10.9
raw materials, casualty or accident, war, revolution, civil commotion, act of
public enemies, blockage or embargo, injunction, law, order, proclamation,
regulation, ordinance, demand or requirement of any government or subdivision,
authority or representative of any such government, or any other cause beyond
the reasonable control of such Party, if the Party affected shall give prompt
notice of any such cause to the other Party. The Party giving such notice shall
thereupon be excused from such of its obligations hereunder as it is thereby
disabled from performing for so long as it is so disabled and for thirty (30)
days thereafter. Notwithstanding the foregoing, nothing in this Section 11.9
shall excuse or suspend the obligation to make any payment due hereunder in the
manner and at the time provided.
11.10 No Trademark Rights. Except as otherwise provided herein, no right,
express or implied, is granted by this Agreement to use in any manner the name
"CIL" or "ALTEON" or any other trade name or trademark of the other party in
connection with the performance of this Agreement.
11.11 Public Announcements. Except as required by law, neither Party shall
make any public announcement concerning this Agreement or the subject matter
hereof without the prior written consent of the other. In the event of a
required public announcement, the Party making such announcement shall provide
the other with a copy of the proposed text prior to such announcement.
11.12 Notices. All notices and other communications hereunder shall be in
writing and shall be deemed given if delivered personally or by facsimile
transmission (receipt verified), telexed, mailed by registered or certified mail
(return receipt requested), postage prepaid, or sent by express courier service,
to the parties at the following addresses (or at such other address for a party
as shall be specified by like notice; provided, that notices of a change or
address shall be effective only upon receipt thereof):
(a) If to ALTEON, addressed to:
Alteon Inc.
170 Williams Drive
Ramsey, New Jersey 07446-2907
Attention: Chief Executive Officer
Telephone No.: (201) 934-5000
Facsimile No.: (201) 934-8880
-25-
31
Exhibit 10.9
(b) If to CIL, addressed to:
Corange International Limited
c/o Boehringer Mannheim Corporation
9115 Hague Road
Indianapolis, Indiana 46250
Attention: Legal Department
Telephone No.: (317) 845-2000
Facsimile No.: (317) 576-3082
11.13 Amendment. No amendment, modification or supplement of any provision
of this Agreement shall be valid or effective unless made in writing and signed
by a duly authorized officer of each Party.
11.14 Waiver. No provision of this Agreement shall be waived by any act,
omission or knowledge of a Party or its agents or employees except by an
instrument in writing expressly waiving such provision and signed by the waiving
Party.
11.15 Counterparts. This Agreement may be executed simultaneously in two
counterparts, either one of which need not contain the signature of more than
one party but both such counterparts taken together shall constitute one and the
same agreement.
11.16 Descriptive Headings. The descriptive headings of this Agreement are
for convenience only, and shall be of no force or effect in construing or
interpreting any of the provisions of this Agreement.
11.17 Governing Law. This Agreement shall be governed by and interpreted
in accordance with the laws of the State of New Jersey, applicable to contracts
executed and performed wholly within the State of New Jersey. The English
original of this Agreement shall prevail over any translation hereof.
11.18 Alternative Dispute Resolution.
(a) Except with respect to breaches for which a Party is seeking
injunctive relief, all disputes between the Parties relating to this Agreement
or the subject matter hereof which cannot be resolved by the Parties, shall,
upon written notice by one Party to the other, be submitted for settlement by
means of alternative dispute resolution, which can include moderated settlement,
minitrial, use of expert advisor mediation or non- binding arbitration, as
provided in the New Jersey Alternative Procedure for Dispute Resolution Act,
N.J.S.A. 2A:23A-1 et seq.
-26-
32
Exhibit 10.9
(the "Act"). All proceedings for the alternative resolution of a dispute (an
"ADR Proceeding") shall be designed to conclude within four (4) months of the
original notice and shall be held at a mutually agreeable location or in New
York City. If the parties cannot agree on the form of ADR Proceeding to be used,
then mediation, with an independent mediator acceptable to both Parties, shall
be used. All fees and expenses associated with the ADR Proceeding shall be
divided equally between the parties; provided that each party shall be
responsible for such party's own attorneys' fees and disbursements. The Act
shall govern the procedures and methods for any ADR Proceeding demanded or
undertaken pursuant to this Agreement.
(b) Each person selected for any ADR Proceeding shall be
knowledgeable as to the diagnostic industry and will be instructed to consider,
in making any determination or recommendation, the customary practices in the
diagnostic industry to the extent such practices exist. The Parties will
cooperate with each other in causing the ADR Proceeding to be held in as
efficient and expeditious a manner as practicable.
(c) At the conclusion of the ADR Proceeding, either Party shall
have the right to a trial de novo by a court of competent jurisdiction.
11.19 Severability. Whenever possible, each provision of this Agreement
will be interpreted in such manner as to be effective and valid under applicable
law, but if any provision of this Agreement is held to be prohibited by or
invalid under applicable law, such provision will be ineffective only to the
extent of such prohibition or invalidity, without invalidating the remainder of
this Agreement.
11.20 Compliance with Law. Nothing in this Agreement shall be deemed to
permit a Party to export, reexport or otherwise transfer any Licensed Technology
or Licensed Patents transferred hereunder or Products manufactured therefrom
without compliance with applicable laws.
11.21 Entire Agreement of the Parties. This Agreement constitutes and
contains the entire understanding and agreement of the Parties and cancels and
supersedes any and all prior negotiations, correspondence, understandings and
agreements, whether oral or written, between the Parties respecting the subject
matter hereof.
-27-
33
Exhibit 10.9
IN WITNESS WHEREOF, each of the Parties has caused this Agreement to be
executed by its duly authorized officer as of the day and year first above
written.
ALTEON INC.
By: /s/ James J. Mauzey
------------------------------------------
Name: James J. Mauzey
----------------------------------------
Title: Chairman, Chief Executive Officer
----------------------------------------
CORANGE INTERNATIONAL LIMITED
By: /s/ William Petravic
------------------------------------------
Name: William Petravic
----------------------------------------
Title: Treasurer
----------------------------------------
-28-
34
EXHIBIT A
U.S. AND FOREIGN PATENTS AND PATENT APPLICATIONS
RELATING TO THE LICENSED TECHNOLOGY
1) Immunochemical Detection of AGE's (Methods and Test Kits for
Measuring AGE's by ELISA Assay)
U.S. Application #07/956,849 - filed October 1, 1992
P.C.T. Application US92/11158 - filed December 21, 1992
National Phase filings proceeding via a European
Patent Application and in Australia, Canada, Japan and
Korea
Additional filings made in People's Republic of China,
Portugal and Taiwan
2) AGE-Lipid Oxidation - Methods of Measuring
U.S. Application #08/029,417 - filed March 11, 1993
P.C.T. Application US93/10880 - filed November 12, 1993
3) Improved Method of Detecting Hb-AGE & Diagnostic Methods
U.S. Application #08/236,416 - filed April 29, 1994
Decision on PCT filing is pending
4) Monoclonal Antibody specific for AGE's in Biological Samples
U.S. Application #08/ , - filed December , 1994
Decision on PCT filing is pending
5) FFI - Diagnostic Divisional - Immunochemical Test for
Detecting AGE's Using FFI as an Indicator
U.S. Patent #4,761,368 - issued August 2, 1988
European Patent #0322402 - filed February 11, 1989 (Issued in
Germany, France and Great Britain)
35
6) Additional Patents and Patent Applications
U.S. Patent Application #07/749,438 - filed August 23, 1991
(no foreign counterpart) (Liver-Derived Receptors for AGEs and
Uses Thereof)
U.S. Patent #5,202,424 - issued April 13, 1993 (no foreign
counterpart) (Meangial-Cell Derived Receptors for AGEs and
Uses Thereof)
U.S. Patent #5,316,754 - issued May 31, 1994 (no foreign
counterpart) (Meangial-Cell Derived Receptors for AGEs and
Uses Thereof)
U.S. Patent #5,108,930 - issued April 28, 1992 (no foreign
counterpart) (Aminoguanidine Assay and Applications Thereof)
36
EXHIBIT B
LIST OF COUNTRIES
WHERE PATENTS WILL BE FILED AND MAINTAINED
I. BASE COUNTRIES*
United States of America
Canada
Japan
Germany
France
Great Britain
Italy
Spain
II. ADDITIONAL COUNTRIES SUBJECT TO MUTUAL AGREEMENT OF ALTEON AND
CIL*
Mexico
Australia
Others to be determined
37
* applicable to patents/applications covering broad AGE diagnostic technology,
novel antibodies and significant commercial improvements thereto.
38
EXHIBIT C
ROCKEFELLER AGREEMENTS
[Filed as Exhibits 10.4 and 10.5 to the Form 10-K.]
39
EXHIBIT D
PICOWER AGREEMENTS
[Filed as Exhibit 10.7 to the Form 10-K]