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EXHIBIT 10.15
PRODUCT DEVELOPMENT AND LICENSE AGREEMENT
This Product Development and License Agreement ("the Agreement")
entered into on June 28, 1996, is made and entered into by and between Anergen,
Inc., a California corporation, with a principal place of business at 301
Penobscot Drive, Seaport Centre, Redwood City, California 94063, U.S.A.
("ANERGEN"), and N.V. Organon, a company incorporated under the laws of The
Netherlands, having its registered place of business at P.O. Box 20, 5340 BH
Oss, The Netherlands ("ORGANON"), together referred to as "PARTIES", or
individually as a "PARTY."
WHEREAS:
(1) ANERGEN has developed and is developing proprietary Major
Histocompatibility Complex Class II ("MHC II" ) peptide complexes designated for
the treatment of autoimmune disease and has offered rights to its technology to
ORGANON for use in the treatment of rheumatoid arthritis ("RA"); and
(2) ORGANON wishes ANERGEN to conduct feasibility studies leading to
the development of a product or products which incorporate a proprietary ORGANON
peptide epitope for the treatment of RA and makes use of ANERGEN's aforesaid
technology, and wishes to receive a license under ANERGEN's proprietary rights
for the purpose of development, manufacturing and marketing such product or
products; and
(3) The PARTIES wish to enter into a collaboration to develop and
commercialize such product or products in the field of RA, on the terms and
conditions herein.
NOW, THEREFORE, the PARTIES hereby agree as follows:
ARTICLE 1 - DEFINITIONS
In this Agreement, the following terms shall have the following meanings:
1.1 "AFFILIATE" shall mean any corporation or other entity that is directly
or indirectly controlling, controlled by or under common control with a
PARTY. For the purpose of this definition, "control" shall mean the
direct or indirect ownership of more than fifty percent (50%) of the
shares of the subject entity entitled to vote in the election of
directors or other managing authority of such entity.
1.2 "ANERGEN KNOW-HOW" shall mean any and all confidential scientific,
technical and engineering information, experience and know-how relating
to the MHC PEPTIDE TECHNOLOGY that is owned, invented, developed or
acquired (with a right to sublicense) by ANERGEN now or during the term
of the DEVELOPMENT PROGRAM.
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1.3 "ANERGEN PATENTS" shall mean the United States patents and patent
applications listed on Exhibit A, and any patents issuing thereon, and
any corresponding foreign patent applications and patents, and any
division, re-examination, continuation, continuation-in-part,
extension, substitution or reissue of any of the preceding patent
applications and patents.
1.4 "DEVELOPMENT PROGRAM" shall mean the research, scale-up manufacturing,
regulatory and clinical program described in Exhibit B of this
Agreement.
1.5 "EFFECTIVE DATE" shall mean the date this Agreement is entered into.
1.6 "FDA" shall mean the U.S. Food and Drug Administration.
1.7 "FIELD" shall mean the treatment of rheumatoid arthritis.
1.8 "FUTURE PATENTS" shall mean all patent applications in any jurisdiction
made and owned by either PARTY, claiming inventions made by a PARTY or
jointly by the PARTIES during and in connection with the DEVELOPMENT
PROGRAM relating to the MHC PEPTIDE TECHNOLOGY, or the PRODUCT(S) or
the manufacture or use thereof, and any patents issuing thereon, and
any division, re-examination, continuation, continuation-in-part,
extension, substitution and reissue of any of the preceding patent
applications or patents.
1.9 "IND" shall mean an Investigational New Drug Exemption for a PRODUCT,
as defined in the U.S.A. Food, Drug and Cosmetic Act and the
regulations promulgated thereunder, or its equivalent in other
countries.
1.10 "JOINT KNOW-HOW" shall have the meaning set forth in Section 14.3
herein.
1.11 "LAUNCH DATE" shall mean the date on which a PRODUCT is first offered
for commercial sale in any country of the TERRITORY by ORGANON or an
ORGANON AFFILIATE or sublicensee.
1.12 "MAJOR COUNTRY" shall mean any of the United States, Japan, Germany,
the United Kingdom, France or Italy.
1.13 "MHC PEPTIDE TECHNOLOGY" shall mean methods for making and combining a
MHC II heterodimer or a portion thereof, or functional equivalents
thereof, with a peptide capable of forming a complex.
1.14 "NET SALES" shall mean the invoice price billed by ORGANON, its
AFFILIATES or its sublicensees to third parties for the sale of
PRODUCT(S), less the following:
(a) trade and/or quantity discounts actually allowed and taken;
(b) sales, value added, or other excise taxes paid, and duties
actually absorbed, or allowed;
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(c) amounts repaid or credited by reason of purchase chargebacks,
rebates, rejections, defects or return; and
(d) charges for freight, insurance, handling and transportation.
1.15 "ORGANON KNOW-HOW" shall mean any and all confidential scientific,
technical and engineering information, experience and know-how relating
to the PRODUCT(S), that are owned, invented, developed, or acquired
(with a right to sublicense) by ORGANON during the term of the
DEVELOPMENT PROGRAM, including, but not limited to, information, data,
drawings and other materials relating to the development, manufacture,
use and/or sale of the PRODUCT(S).
1.16 "ORGANON PATENTS" shall mean the patent applications and patents listed
on Exhibit C, and any patents issuing thereon, and any division,
re-examination, continuation, continuation- in-part, extension,
substitution or reissue of any of the preceding patent applications and
patents.
1.17 "PAYMENT COMPUTATION PERIOD" shall mean each three (3) month period
ending on March 31st, June 30th, September 30th, and December 31st of a
given year during the term of this Agreement.
1.18 "PLA" shall mean a Product License Application for a PRODUCT, as
defined in the U.S.A. Food, Drug and Cosmetic Act and the regulations
promulgated thereunder, or its equivalent in other countries.
1.19 "PRODUCT," "PRODUCTS," OR PRODUCT(S)" shall mean any pharmaceutical
active composition for the treatment of RA developed in connection with
the DEVELOPMENT PROGRAM, which is derived by the use of the MHC PEPTIDE
TECHNOLOGY and which incorporates one or more specific proprietary
ORGANON epitopes and/or an ANERGEN epitopes selected under 4.5.
1.20 "PROJECT INITIATION DATE" shall mean the date that ORGANON provides
initial quantities of the initial ORGANON epitope to ANERGEN.
1.21 "STEERING COMMITTEE" or "SC" shall mean the joint steering committee
responsible for the management of the initial feasibility stage of the
DEVELOPMENT PROGRAM, described in Article 3 of this Agreement.
1.22 "TERRITORY" shall mean all countries of the world.
ARTICLE 2 - DEVELOPMENT PROGRAM
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2.1 The PARTIES shall conduct the DEVELOPMENT PROGRAM with the goal of
developing a PRODUCT OR PRODUCTS. Each PARTY shall perform its
responsibilities under the DEVELOPMENT PROGRAM in accordance with the
timetables set forth in the development plan.
2.2 The DEVELOPMENT PROGRAM shall have three stages, as follows:
(a) the initial feasibility stage shall consist of
pre-clinical research and development, scale-up manufacture and the
conduct of an initial Phase I/II clinical trial using samples of a
PRODUCT to demonstrate proof of principle in RA, according to criteria
to be established by the SC. The initial feasibility stage shall
commence on the EFFECTIVE DATE and terminate upon the completion of the
first Phase I/II clinical trial of the PRODUCT. For purposes of this
Agreement, a clinical trial shall be deemed completed when all patients
enrolled in such trial have been treated with the PRODUCT, and all
patient case report forms have been submitted to ANERGEN or its
designee and ANERGEN has fully reported to ORGANON in writing its
detailed evaluation of the results of such trial;
(b) the second stage shall commence on the completion of the
initial phase and terminate upon the first approval for the sale of a
PRODUCT in a MAJOR COUNTRY, and shall consist of the conduct of further
clinical trials, including pivotal trials, of the PRODUCT(S), and if
appropriate, further pre-clinical studies with regard to the
PRODUCT(S); and
(c) the third stage shall commence on the completion of the
second phase and shall consist of the conduct of post-approval clinical
studies and PRODUCT commercialization activities.
2.3 Prior to the PROJECT INITIATION DATE, the PARTIES shall agree on a
written development plan for the activities each PARTY will conduct in
connection with the initial feasibility stage of the DEVELOPMENT
PROGRAM. The SC shall review the development plan on an ongoing basis
and from time to time may make changes to the development plan;
provided, however, the development plan shall not be modified except as
agreed in writing by ANERGEN and ORGANON.
2.4 In the event that ORGANON after consideration by the SC and review of
the recommendation of the SC determines that it is [*] FIELD [*] or
[*], ORGANON may [*] subject to the terms and conditions set forth in
this Agreement and provided [*].
* Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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It is understood and agreed that ORGANON [*] the epitope described on
Exhibit D hereto (the "Initial Epitope "). Until the [*] anniversary of
the EFFECTIVE DATE, ORGANON may [*]
(a) [*]
(b) [*]
Notwithstanding the above, it is understood and agreed by PARTIES that
[*]
(c) [*]
(d) [*]
Notwithstanding the above, it is understood and agreed that [*]
[*]
2.5 The DEVELOPMENT PROGRAM shall commence on the date of this Agreement
and shall continue thereafter for a period of at least thirty-six (36)
months from the PROJECT INITIATION DATE. The DEVELOPMENT PROGRAM shall
automatically renew thereafter unless ORGANON gives ANERGEN six (6)
months written notice not to continue the DEVELOPMENT PROGRAM; provided
ORGANON may not give such notice prior to thirty (30) months after the
PROJECT INITIATION DATE and provided any extension of
* Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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the DEVELOPMENT PROGRAM beyond the fifth anniversary of the EFFECTIVE
DATE must be mutually agreed in writing by the PARTIES.
2.6 At least every three (3) months, the SC shall provide each PARTY with a
written report summarizing the activities performed according to the
initial feasibility stage of the DEVELOPMENT PROGRAM, and the costs
incurred in connection with such activities. Periodically, but no less
often than annually, each PARTY shall provide the SC with a written
report summarizing the status of its PATENTS and FUTURE PATENTS
worldwide, and any material scientific or commercial issues relating to
the PRODUCT(S).
2.7 Except as expressly provided in Section 2.8, ORGANON shall be
responsible for all costs projected or approved by the SC to be
incurred in connection with the initial feasibility phase of the
DEVELOPMENT PROGRAM (Exhibit B), including, but not limited to,
pre-clinical research costs, the costs of clinical trials including
product liability insurance, expenses of outside parties assisting in
any such trial, and other clinical trial expenses, costs of toxicology
and pharmacokinetic studies, regulatory filing fees and costs of other
research activities. ORGANON shall pay to ANERGEN quarterly, in
advance, amounts equal to the fully burdened direct and indirect
expenses projected or approved by the SC to be incurred by ANERGEN in
connection with DEVELOPMENT PROGRAM activities in the next quarter.
2.8 In the event that the SC determines that any intellectual property must
be licensed from a third party for the conduct of the DEVELOPMENT
PROGRAM, ORGANON shall be responsible for all license fees and costs
associated with such license; provided, ANERGEN shall [*] of such fees
and costs to ORGANON for a license of any intellectual property
necessary for the use of the MHC PEPTIDE TECHNOLOGY. Unless otherwise
agreed by the PARTIES, ANERGEN shall be the licensee of any
intellectual property necessary for the use of the MHC PEPTIDE
TECHNOLOGY, and ORGANON shall be the licensee of any other third party
intellectual property. If a third party license is obtained by either
PARTY which covers any PRODUCT(S), it is agreed the licensing PARTY
will attempt in good faith to obtain the right to sublicense the same,
and if it obtains such rights, will offer to sublicense such rights to
the other PARTY for consideration equal to a pro rata share of any
license fees, and payments for any amounts owed to the licensor for any
activities conducted by the sublicensee, and on other terms fully
consistent with the license. Any such sublicense will, if possible,
have the same life as the other license rights granted herein. It is
further agreed that each PARTY will attempt to maintain these third
party licenses as long as they are important to the other PARTY and the
sublicensee has not committed any breach of the sublicensed rights.
* Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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ARTICLE 3 - STEERING COMMITTEE
3.1 In order to plan, establish budgets for, and review and monitor
progress with respect to the initial feasibility stage of the
DEVELOPMENT PROGRAM, ANERGEN and ORGANON shall establish a STEERING
COMMITTEE. The SC shall be comprised of three (3) representatives of
each PARTY, such representatives to be selected and replaced by the
respective PARTIES.
3.2 Any approval, determination or other action of the SC must be agreed to
by the representatives of both PARTIES, with each PARTY having one
vote. The SC shall act to resolve, if possible, any disputes between
the PARTIES, and to address other significant matters which may arise
hereunder. In the event of a tie, the matter shall be referred to the
chief executive officers of each PARTY, or their designees, who shall
promptly negotiate in good faith to resolve such dispute. In the event
that such individuals are unable to resolve such dispute, the matter
shall be resolved by binding arbitration pursuant to Section 20.2.
3.3 Each year during the initial feasibility stage of the DEVELOPMENT
PROGRAM, on or before October 31, the SC shall agree on a budget for
the initial feasibility stage of the DEVELOPMENT PROGRAM activities to
be conducted during the next year. Each PARTY shall finally approve the
budget established by the SC for the next year by December 1 of each
year. The PARTIES shall agree on the budget for the first year of the
DEVELOPMENT PROGRAM prior to the PROJECT INITIATION DATE.
3.4 Until the termination of the initial feasibility phase of the
DEVELOPMENT PROGRAM, the SC shall meet at least quarterly, unless
otherwise agreed by the PARTIES, at times and places as agreed upon in
the prior meeting of the SC. The SC shall keep written minutes of its
meetings. ORGANON shall pay all reasonable out-of-pocket expenses,
including, without limitation, travel and lodging expenses, associated
with the attendance of SC representatives at SC meetings. Such
out-of-pocket expenses shall be included as part of the DEVELOPMENT
PROGRAM budget.
ARTICLE 4 - LICENSE GRANTS
4.1 Subject to the terms and conditions of this Agreement, ANERGEN hereby
grants to ORGANON, and ORGANON hereby accepts, the following,
royalty-bearing license under the ANERGEN PATENTS, ANERGEN KNOW HOW,
and ANERGEN's interest in the FUTURE PATENTS and JOINT KNOW-HOW:
(a) to develop, have developed, evaluate, have evaluated, validate
and have validated the PRODUCT(S) in the FIELD;
(b) to conduct clinical and nonclinical studies with respect to
validation, safety and efficacy of the PRODUCT(S) in the
FIELD; and
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(c) subject to Sections 10.1 and 10.3 below, to make, have made,
import, use, offer for sale and sell the PRODUCT(S) in the
FIELD in the TERRITORY.
4.2 ORGANON shall have the right (with the right to sublicense to its
AFFILIATES and other third parties) the right to manufacture, have
manufactured, use and sell the PRODUCT(S) developed in connection with
the DEVELOPMENT PROGRAM, provided that such sublicensees agree in
writing to comply with the terms and conditions of this Agreement and
ANERGEN is an express third party beneficiary of such a sublicense
agreement. The PRODUCT(S) may be sold under ORGANON trademarks;
provided any such PRODUCT(S) shall bear a statement disclosing that any
such PRODUCT(S) was developed in collaboration with and under a license
from ANERGEN.
4.3 ORGANON hereby grants to ANERGEN, and ANERGEN hereby accepts, a
non-exclusive, worldwide, royalty-free license (with the right to grant
sublicenses) to use and practice the ORGANON PATENTS and ORGANON
KNOW-HOW solely for the purpose of conducting the DEVELOPMENT PROGRAM
and fulfilling its obligations under this Agreement.
4.4 Each PARTY shall have the right to practice and commercialize, itself
or with third parties, the JOINT KNOW-HOW and FUTURE PATENTS outside
the FIELD, without the consent of the other PARTY and with no
obligation to account to the other PARTY.
4.5 ORGANON acknowledges that the PRODUCT(S) will contain one or more
proprietary ORGANON epitopes, but that its non-MHC portion will not
contain any ANERGEN epitopes unless the PARTIES agree to amend this
Agreement to include an ANERGEN epitope(s) in which event as part of
such amendment the milestone payment for IND non- rejection in Section
6.2 shall be increased to U.S.[*] and each of the royalty rates in
Section 7.1 shall each be increased by [*] for sales of PRODUCT(S)
using an ANERGEN epitope.
ARTICLE 5 - PROVISIONS ON EXCLUSIVITY IN THE FIELD
5.1 [*]
5.2 After the date set forth in Section 5.1, ANERGEN shall have the right
to enter into an agreement to research, develop and/or commercialize
with third parties (or alone to research, develop and/or
commercialize), products other than the PRODUCT(S) for use in the FIELD
which incorporate the MHC PEPTIDE TECHNOLOGY, provided that such
products do not
* Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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incorporate any ORGANON epitope and/or ANERGEN epitope agreed by the
parties pursuant to Section 4.5. ANERGEN agrees that any exercise of
such retained rights shall not prevent it from performing its
obligations with respect to the DEVELOPMENT PROGRAM. In the event
ANERGEN enters into an agreement with one additional third party and in
connection therewith files a PLA, or if ANERGEN alone files a PLA with
respect to the use of the MHC PEPTIDE TECHNOLOGY in the FIELD,
ORGANON's rights under this Agreement shall be non-exclusive in the
FIELD and the milestone payments and royalties due to ANERGEN
thereafter shall be those set forth in Sections 6.2 (b) and 7.1 (b),
respectively. ANERGEN must notify ORGANON within 10 days of any change
in exclusivity.
ARTICLE 6 - MILESTONE PAYMENTS
6.1 On the EFFECTIVE DATE, ORGANON shall pay to ANERGEN a technology access
fee of [*].
6.2 Within thirty (30) days following the achievement of each of the
following milestones, ORGANON shall pay to ANERGEN the corresponding
milestone payment set forth below.
(a) [*]
(b) [*]
* Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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If ORGANON'S rights become non-exclusive pursuant to Section
5.2 resulting in milestone payments as reflected in Section 6.2(b), because an
ANERGEN or a third party PLA is filed within [*] from the filing of ORGANON'S
PLA, then [*] of the higher milestone amounts paid under Section 6.2 (a) versus
the milestone amounts that would have been paid under Section 6.2 (b) will be
creditable against future royalties to ANERGEN. If the ANERGEN or third party
PLA is filed more than [*] from the filing of ORGANON'S PLA, then [*].
6.3 [*]
ARTICLE 7 - ROYALTIES
7.1 ORGANON will pay running royalties to ANERGEN based on worldwide annual
aggregate NET SALES by ORGANON, its AFFILIATES and sublicensees of all
PRODUCT(S) subject to this Agreement as follows:
(a) [*]
(b) [*]
(c) [*]
* Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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[*]
(d) In the event ANERGEN pursues commercialization of the MHC
PEPTIDE TECHNOLOGY in the FIELD alone or with more than one
additional third party by the filing of more than one PLA with
respect to a product in the FIELD (other than a PRODUCT
subject to this Agreement), then from the time of the filing
of the second PLA for such a product in a MAJOR COUNTRY by the
additional third party or by ANERGEN, the royalty rates in
Section 7 due ANERGEN shall be reduced [*].
7.2 Royalties shall be payable according to Section 7.1, on a
country-by-country and product-by- product basis, from the LAUNCH DATE
in such country until the later of (i) the expiration of all ANERGEN
PATENTS and FUTURE PATENTS covering a particular PRODUCT in such
country, or (ii)[*] following the LAUNCH DATE of such PRODUCT in such
country.
7.3 Within thirty (30) days after the end of each PAYMENT COMPUTATION
PERIOD, ORGANON shall send a written report to ANERGEN stating, on a
country-by-country basis, the NET SALES and the quantity of PRODUCT(S)
sold in the TERRITORY by ORGANON, its AFFILIATES and sublicensees, the
percentage of royalties applicable, and the royalties payable to
ANERGEN. Prior to January 1 of each year ORGANON shall provide to
ANERGEN a copy of ORGANON's internal forecast for sales of PRODUCT(S)
for such year and the blended annual royalty rate that would be payable
for such sales. Royalties payable for the first three PAYMENT
COMPUTATION PERIODS shall use such blended royalty rate. The report for
the period ending March 31st of each year will include a final report
of actual NET SALES for the prior year and the adjustment required in
the final royalty payable for such year. A final report shall also be
submitted within ninety (90) days after termination or expiration of
this Agreement. All royalties, as set forth above, shall be due and
payable to ANERGEN simultaneously with the submission by ORGANON of
each report under this Section 7.4.
7.4 All payments due under this Agreement are quoted in U.S. dollars and
shall be paid to ANERGEN in U.S. dollars via wire transfer to a bank
account designated by ANERGEN. All payments that are not paid on the
date due shall bear interest at the prime rate as reported by the Bank
of America on the date such payment is due, calculated based on the
number of days
* Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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such payment is delinquent, or if such rate is not lawful, at the highest rate
permitted by applicable law.
7.5 NET SALES, and the amounts payable hereunder, shall first be determined
in the currency of the country in which the PRODUCTS were sold, shall
then be converted into Dutch Guilders at the exchange rate used by
ORGANON for consolidation purposes (which shall be closely related to
the market currency exchange rates in effect at the time of each
conversion) and shall then be further converted into an equivalent
amount of U.S. dollars. ORGANON will pay to ANERGEN the amount due in
U.S. dollars by applying the appropriate exchange rate published in The
Wall Street Journal on the last banking day of the relevant PAYMENT
COMPUTATION PERIOD.
7.6 ORGANON and its AFFILIATES and sublicensees shall keep records of the
sales of the PRODUCTS in sufficient detail to permit the determination
of the royalties due and payable to ANERGEN. At the request and expense
of ANERGEN, ORGANON shall permit an independent auditor or certified
public accountant, appointed by ANERGEN and reasonably acceptable to
ORGANON, to examine these records during ordinary business hours to
verify the royalties due and payable to ANERGEN under this Agreement.
Inspections shall be at the expense of ANERGEN, unless there has been
an underpayment of five percent (5%) or more in any reporting period,
in which event the costs of such inspection shall be borne by ORGANON.
The results of any such examination shall be made available to both
ANERGEN and ORGANON. ORGANON's agreements with its AFFILIATES and
sublicensees shall include record keeping provisions and audit rights
on behalf of ANERGEN substantially similar to this Section 7.7.
ARTICLE 8 - TAXES
Each PARTY undertakes to cooperate with the other party to achieve the
tax arrangements which are most favorable for the PARTIES, within the
limits of applicable law. ORGANON may withhold from payments made to
ANERGEN under this Agreement any income taxes required to be withheld
by ORGANON in relation to payments to ANERGEN under the applicable laws
of the relevant countries. Such amount shall be paid to the appropriate
taxing authorities and ORGANON shall provide ANERGEN with official
receipts issued by said taxing authority or such other evidence as is
reasonably available to establish that such taxes have been paid and
are available for credit by ANERGEN for United States income tax
purposes. Notwithstanding the foregoing, ORGANON shall assist ANERGEN
and take all actions reasonably necessary in order to secure a
reduction or elimination of withholding taxes pursuant to any income
tax treaty in force between the United States and the relevant
countries.
ARTICLE 9 - EXCHANGE OF KNOW-HOW
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9.1 Pursuant to the license granted in Article 4, each PARTY shall provide
the other PARTY with all the KNOW-HOW necessary to conduct the
DEVELOPMENT PROGRAM during the term thereof, without unreasonable
delay.
9.2 During the term of this Agreement, each PARTY shall promptly provide to
the other PARTY all safety and efficacy data, information and results
developed or acquired by it with respect to the PRODUCTS; provided
however, neither PARTY shall be obliged to disclose data, information
and results which that PARTY is legally prevented from disclosing. Each
PARTY shall have the right to use such data, information and results
developed by the other PARTY without charge to such PARTY to exercise
its rights and perform its obligations under this Agreement. Each PARTY
shall keep such data, information and results confidential, whether
developed by either PARTY, according to the provisions of Article 12.
9.3 All KNOW-HOW and other INFORMATION (as defined in Article 12) furnished
by one PARTY to the other PARTY hereunder shall remain the property of
the disclosing PARTY.
9.4 Each PARTY will assist the other PARTY in understanding its KNOW-HOW,
as judged useful by the SC.
9.5 ORGANON shall have access to and the right to use, free of any charge,
any parts of the IND and PLA submission dossiers and files prepared by
ANERGEN in connection with any governmental approval of any PRODUCT.
ANERGEN shall have access, free of charge, to such parts of the IND and
PLA submission dossiers and files prepared by ORGANON as is reasonably
required in connection with any governmental approval of any PRODUCT
and, only after the explicit prior written approval of ORGANON (not to
be unreasonably withheld), shall have the right to use such
information. If such use relates to any commercialization, the PARTIES
shall negotiate in good faith a reasonable compensation to ORGANON for
such use.
ARTICLE 10 - SUPPLY OF MATERIALS DURING INITIAL FEASIBILITY PERIOD
10.1 ORGANON shall have the right to make and supply to ANERGEN all peptide
and ANERGEN shall make, or have made, and supply to ORGANON all MHC II
and PRODUCT(S) necessary for development work (including preclinical
and clinical investigation) to be conducted during the DEVELOPMENT
PROGRAM, subject to Section 10.2 below, and ANERGEN's capacity
limitations. ORGANON will reimburse ANERGEN for all fully burdened
direct and indirect costs related to the manufacture and supply of MHC
II and PRODUCT(S) (exclusive of peptide provided by ORGANON) necessary
for the conduct of the DEVELOPMENT PROGRAM. If ORGANON does not provide
the peptide, ANERGEN will procure such peptide from a third party and
be reimbursed the costs thereof.
10.2 The SC shall supply ANERGEN with estimates of the quantities of the MHC
II and/or epitope required during the DEVELOPMENT PROGRAM for
preclinical and clinical
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investigation purposes. Such estimates shall form the basis for orders
to be submitted by ORGANON to ANERGEN for the MHC II and/or epitope and
ANERGEN shall inform ORGANON of the quantity of epitope required, in a
form and subject to a procedure to be agreed between the PARTIES.
ARTICLE 11 - COMMERCIALIZATION
11.1 Following the termination of the initial phase of the DEVELOPMENT
PROGRAM and until the first PLA approval in the United States or a
MAJOR COUNTRY, ORGANON shall use its reasonable best efforts to
complete development of a PRODUCT or PRODUCTS for the use of the
PRODUCT(S) for the treatment of RA. ORGANON shall prepare an annual
development plan and provide a copy of such plan to ANERGEN within
thirty (30) days prior to each calendar year and shall provide ANERGEN
with a copy of any material revisions to such plan during the year. If
pursuant to Section 7.1(d), ANERGEN, alone or with a third party, files
two or more PLAs with respect to products in the FIELD (other than
PRODUCTS subject to this Agreement), as of the date of filing of the
second such PLA ORGANON shall no longer be required to prepare or
provide ANERGEN with an annual development plan.
11.2 Following the first PLA approval, ORGANON shall use its reasonable best
efforts to commercialize the PRODUCT(S) throughout the TERRITORY. After
the first PLA filing with respect to a PRODUCT, ORGANON shall prepare
and provide ANERGEN a reasonable plan for worldwide commercialization,
which may include a staged introduction of the PRODUCT(S) in different
countries. ORGANON shall promptly provide to ANERGEN all material
updates of the plan, as it may be revised from time to time. If
pursuant to Section 7.1(d), ANERGEN, alone or with a third party, files
two or more PLAs with respect to products in the FIELD (other than
PRODUCTS subject to this Agreement), as of the date the filing of the
second such PLA ORGANON shall no longer be required to prepare or
provide ANERGEN with updates to the commercialization plan.
11.3 ANERGEN shall have an exclusive option to co-promote the PRODUCT(S) in
the United States and Canada, together with ORGANON, its AFFILIATES or
sublicensees, under terms and conditions to be mutually agreed. Within
thirty-six (36) months after ANERGEN receives notice from ORGANON of a
PLA filing for the PRODUCT(S) in the United States, ANERGEN shall
notify ORGANON of its intention to exercise such co-promotion right. If
ANERGEN does not exercise such co-promotion right within said
thirty-six (36) month period, the option to co-promote will expire. If
requested by either PARTY, the PARTIES shall negotiate in good faith
the terms of separate agreements for such co-promotion relationship in
the United States and/or Canada, and provided such terms shall reflect
the respective contributions of the PARTIES during the DEVELOPMENT
PROGRAM, including amounts expended by the PARTIES on research and
clinical trial costs, PRODUCT registration fees, patent expenses and
the like. If ANERGEN co-promotes the PRODUCT(S), both PARTIES will
market and conduct sales activities for the PRODUCT(S), and ORGANON
will remunerate ANERGEN for such marketing and sales
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activities, commensurate with the level of effort expended, as mutually
agreed. The PARTIES agree that all PRODUCT(S) sales shall be invoiced
by ORGANON. If during the thirty six (36) month period following notice
from ORGANON of a PLA filing in the United States with respect to a
PRODUCT, ANERGEN, pursuant to Section 7.1(d), alone or with a third
party, files a PLA in the United States with respect to a product in
the FIELD (other than PRODUCT subject to this Agreement), then ANERGEN
shall be required to notify ORGANON of its intention to exercise such
co-promotion right thereto within thirty (30) days of such change.
11.4 Insofar as required to perform co-promotion, in the event that ANERGEN
exercises its option to co-promote, ORGANON shall grant to ANERGEN a
non-exclusive, royalty-free license under the ORGANON PATENTS, ORGANON
KNOW-HOW and ORGANON's interest in and FUTURE KNOW-HOW and FUTURE
PATENTS (with the right to sublicense to an AFFILIATE in the relevant
territory) to offer for sale the PRODUCT(S) in the United States and/or
Canada.
11.5 Prior to the completion of the initial Phase I/II clinical trial of a
PRODUCT, ANERGEN shall disclose to ORGANON all ANERGEN KNOW-HOW
relating to the manufacture of the PRODUCT(S). Prior to the
commencement of the first Phase III clinical trial of a PRODUCT(S), the
PARTIES shall [*]. The PARTIES shall negotiate [*] and/or the
PRODUCT(S) to be sold in certain agreed geographic regions.
11.6 Upon termination of this Agreement with respect to the TERRITORY or a
MAJOR COUNTRY, the PARTIES shall discuss in good faith either (i) a
grant of rights to ANERGEN with respect to any ORGANON manufacturing
technology necessary or useful for the manufacture of the PRODUCT(S)
(including an obligation to transfer such technology and provide
reasonable technical assistance and training with respect thereto and
an interim supply obligation), or (ii) if the PARTIES cannot negotiate
such an agreement, a supply agreement for the PRODUCT(S), pursuant to
reasonable terms and conditions. If pursuant to Section 7.1(d),
ANERGEN, alone or with a third party, files a PLA with respect to
products in the FIELD (other than PRODUCTS subject to this Agreement)
as of the date of filing of such PLA, Section 11.6 shall no longer
apply.
* Certain information on this page has been omitted and filed separately
with the Commission. Confidential treatment has been requested with
respect to the omitted portions.
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ARTICLE 12 - CONFIDENTIALITY
12.1 During the term of this Agreement, and for a period of ten (10) years
after its termination or expiration, each PARTY (the "RECEIVING PARTY")
shall hold in confidence and not disclose to any third party, (except
to AFFILIATES and permitted sublicensees) or use for any purpose other
than as permitted or required by this Agreement, any KNOW-HOW or other
confidential information ("INFORMATION") disclosed by or acquired from
the other PARTY hereto (the "DISCLOSING PARTY") without prior written
consent of the DISCLOSING PARTY. This confidentiality obligation shall
not apply to information which that PARTY (the "RECEIVING PARTY") can
demonstrate to the reasonable satisfaction of the DISCLOSING PARTY:
(a) was in the possession of the RECEIVING PARTY prior to the
disclosure thereof by the DISCLOSING PARTY without a
confidentiality obligation; or
(b) was at the time of disclosure, or thereafter becomes public
knowledge, through no fault of the RECEIVING PARTY; or
(c) is acquired lawfully by the RECEIVING PARTY from a third party
who has no secrecy obligation to the DISCLOSING PARTY; or
(d) is obtained through the PARTY's in-house development,
independent of this Agreement.
12.2 Prior written consent shall be deemed to have been given:
(a) to the disclosure of INFORMATION to any regulatory authority
insofar as necessary in connection with an application for
registration of the PRODUCT in any country of the TERRITORY;
(b) to the disclosure of INFORMATION insofar as necessary in
connection with any clinical trial of the PRODUCT to persons
involved in the conduct of such trial, provided they are bound
by obligations of confidentiality acceptable to the PARTIES;
and
(c) to the disclosure of INFORMATION to employees and consultants
on a "need to know" basis, provided they are bound by
obligations of confidentiality at least equivalent to those in
this Article.
12.3 Any publication or patent applications based on all or any part of the
DEVELOPMENT PROGRAM, or the results of the DEVELOPMENT PROGRAM, shall
be submitted to the other PARTY by the PARTY wishing to publish the
material or file or abandon the patent application as contemplated by
this Agreement. The SC shall make a recommendation
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regarding publication or filing or abandonment of the patent
application as applicable within thirty (30) days after receiving such
request.
12.4 The PARTIES shall not issue any press release concerning this Agreement
or any activities related thereto without consulting with the other;
provided, however that either PARTY may disclose this Agreement or
information regarding the terms of the Agreement which are not
confidential or the activities conducted hereunder from time to time
without the other PARTY's approval, (i) if such approval has been
requested and not received within seventy- two (72) hours and such
PARTY reasonably believes disclosure is required by law or (ii) if such
information has already become publicly available without a breach of
the confidentiality provisions of this Agreement.
12.5 Notwithstanding any other provision of this Article 12, either PARTY
may disclose this Agreement and the terms hereof as required by law,
and to its attorneys and other professional advisors, its investment
bankers, and, subject to obligations of confidentiality at least
equivalent to those of this Article, actual and prospective investors.
ARTICLE 13 - REPRESENTATIONS AND WARRANTIES
ANERGEN and ORGANON specifically disclaim any guarantee that the
DEVELOPMENT PROGRAM will be successful in whole or part. ANERGEN MAKES
NO REPRESEN TATIONS AND WARRANTIES WITH RESPECT TO THE ANERGEN PATENTS,
FUTURE PATENT RIGHTS, PRODUCT, MHC PEPTIDE TECHNOLOGY OR ANERGEN
KNOW-HOW, WHETHER EXPRESS, IMPLIED, OR STATUTORY, INCLUDING BUT NOT
LIMITED TO, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE, VALIDITY, OR NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY
RIGHTS OF THIRD PARTIES. NOTWITH STANDING THE FOREGOING, ANERGEN
REPRESENTS AND WARRANTS THAT: (i) ANERGEN IS THE OWNER OF THE ANERGEN
PATENTS AS OF THE EFFECTIVE DATE; (ii) IT HAS NOT GRANTED TO ANY PARTY
OTHER THAN ORGANON A LICENSE UNDER THE ANERGEN PATENTS WITHIN THE
FIELD, (iii) TO THE BEST OF ANERGEN'S KNOWLEDGE AS OF THE EFFECTIVE
DATE, NO THIRD PARTY CURRENTLY HAS FILED, PURSUED OR MAINTAINED OR HAS
THREATENED TO FILE, PURSUE OR MAINTAIN, ANY CLAIM, CHARGE, COMPLAINT OR
OTHER ACTION ALLEGING THAT THE ANERGEN PATENTS ARE INVALID OR
UNENFORCEABLE AND (iv) TO THE BEST OF ANERGEN'S KNOWLEDGE, AS OF THE
EFFECTIVE DATE, ANERGEN IS NOT AWARE OF ANY POSSIBLE FUTURE
INFRINGEMENT OF THIRD PARTY PATENTS BY ANERGEN IN THE FIELD. IN
ADDITION, ANERGEN IS NOT AWARE OF ANERGEN'S PATENTS OR PATENT
APPLICATIONS LIKELY TO BECOME THE SUBJECT OF INTERFERENCE PROCEEDINGS
WITH THIRD PARTY PATENTS OR PATENT APPLICATIONS IN THE U.S. PATENT
OFFICE.
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ARTICLE 14 - OWNERSHIP OF INTELLECTUAL PROPERTY
14.1 ANERGEN shall retain all right, title and interest in and to any
KNOW-HOW invented, developed or acquired solely by ANERGEN and the
ANERGEN PATENTS.
14.2 ORGANON shall retain all right, title and interest in and to any
KNOW-HOW invented, developed or acquired solely by ORGANON and the
ORGANON PATENTS.
14.3 All right, title and interest in and to KNOW-HOW, whether or not
patentable, that is invented or developed by at least one employee or
agent of ANERGEN and at least one employee or agent of ORGANON in
connection with the DEVELOPMENT PROGRAM shall be owned jointly by
ORGANON and ANERGEN ("JOINT KNOW-HOW"). Inventorship of inventions and
other intellectual property conceived and reduced to practice in
connection with the DEVELOPMENT PROGRAM, and the rights of ownership
with respect to such inventions and other intellectual property,
whether such JOINT KNOW-HOW is patentable or not, shall be determined
in accordance with United States patent law if conceived or reduced to
practice in the USA, and in accordance with Dutch law if conceived and
reduced to practice elsewhere.
ARTICLE 15 - PATENT PROSECUTION AND ENFORCEMENT
15.1 ANERGEN will be responsible for the preparation, prosecution and
maintenance of the ANERGEN PATENTS and FUTURE PATENTS owned solely by
ANERGEN and conducting oppositions, re-examination and interferences
with respect thereto, using patent counsel of its choice and according
to ANERGEN's reasonable business and scientific judgment. ANERGEN will
pay all costs of conducting such activities with respect to such
PATENTS.
15.2 Each PARTY will cooperate with the other as reasonably requested in
obtaining patent protection for JOINT KNOW-HOW and shall agree on which
PARTY shall have principal authority for conducting such activities
with respect to such FUTURE PATENTS. Each PARTY shall keep the other
informed as to material developments in this regard. ANERGEN and
ORGANON shall equally share the expenses related to obtaining and
maintaining patents with regard to any inventions within the JOINT
KNOW-HOW in the names of ANERGEN and ORGANON; provided, with ninety
(90) days notice either PARTY may continue to decline to fund such
activities with regard to any patent application or patent within the
FUTURE PATENTS, and in such event such PARTY shall assign its entire
interest in such patent application or patent to the other PARTY
hereto.
15.3 ANERGEN and ORGANON will immediately inform each other of any actual or
suspected infringement of the ANERGEN PATENTS, ORGANON PATENTS or
FUTURE PATENTS by third parties which such PARTY would reasonably
believe would effect the commercial success of a PRODUCT.
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15.4 Unless otherwise agreed between the PARTIES, ANERGEN shall have the
right, but not the obligation, to bring proceedings against any
infringer of the ANERGEN PATENTS and FUTURE PATENTS owned solely by
ANERGEN, at ANERGEN's risk and expense. ANERGEN shall be entitled to
retain any award or damages obtained in any such suit or proceeding to
the extent of the costs incurred to bring such proceedings, with the
remainder apportioned by good faith negotiation of the PARTIES to
reflect losses suffered. At ANERGEN's request and expense, ORGANON
shall give ANERGEN all reasonable assistance required to institute and
carry on any such suit or proceeding.
15.5 If ANERGEN does not advise ORGANON within two (2) months after receipt
of notice of infringement from ORGANON of ANERGEN's intention to pursue
a commercially significant patent infringement matter relating solely
to an infringement of an ANERGEN PATENT or FUTURE PATENT owned solely
by ANERGEN in the FIELD, ORGANON shall have the right and may elect to
prosecute and fund such matter. If ORGANON has brought an action for
patent infringement at its own expense, ORGANON may keep any judgment
and awards arising from such an action. ANERGEN shall give ORGANON all
reasonable assistance, at ORGANON's request and expense, required to
institute and carry on any such suit or proceeding.
15.6 The PARTIES shall consult and jointly prosecute infringement actions
with respect to jointly owned FUTURE PATENTS and shall share the costs
of such actions and any proceeds thereof, provided if any PARTY elects
not to participate, the other PARTY shall have the right, at its own
expense, to prosecute infringement actions in such patents, without a
duty to account to the other for the proceeds thereof.
ARTICLE 16 - TERM AND TERMINATION
16.1 This Agreement shall become effective as of the EFFECTIVE DATE, and
unless terminated earlier in accordance with this Agreement, shall
continue in full force and effect on a country- by-country basis, as
long as ORGANON is engaged in developing or commercializing a PRODUCT
in such country.
16.2 If a PARTY hereto commits a material breach of any provision of this
Agreement, and fails to remedy such breach within ninety (90) days
after written notice thereof by the other PARTY, in addition to
remedies for damages and/or injunctive relief, the PARTY not in default
may, at its option, terminate this Agreement, and the licenses granted
herein, by giving thirty (30) days prior written notice to the PARTY in
default.
16.3 In addition to the provisions in Section 2.5 affecting the DEVELOPMENT
PROGRAM, ORGANON may terminate this Agreement, and the licenses granted
herein, with respect to any PRODUCT in any country in the TERRITORY by
giving ninety (90) days (except as in Section 16.3(d), in which case it
will be one hundred eighty (180) days or such shorter period as PARTIES
may mutually agree to), prior written notice to ANERGEN:
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(a) if ORGANON determines that the PRODUCT cannot reasonably be
developed or marketed in such country for reasons of safety or
efficacy or for other scientific, medical or commercial
reasons of a compelling nature;
(b) if the PRODUCT cannot be commercially marketed in any such
country as a result of a final written official governmental
unappealable or unappealed order, which ORGANON has used
reasonable efforts to appeal;
(c) if the PRODUCT would infringe patent rights held by third
parties, with the result that the sale and distribution of the
PRODUCT by ORGANON in such country, is or would be likely to
be enjoined or otherwise prohibited; or
(d) if during the DEVELOPMENT PROGRAM it is mutually agreed in
writing by PARTIES following good faith discussions that the
development of the PRODUCT cannot be pursued due to
fundamental medical, scientific, or safety issues.
16.4 ANERGEN may request arbitration to terminate this Agreement with
respect to any PRODUCT in any country in the TERRITORY in which ORGANON
failed to exercise its obligations to commercialize such PRODUCT
pursuant to Article 11.
16.5 In any country in which ORGANON's rights and licenses to the PRODUCT
terminate hereunder, ANERGEN shall have the right to fully exploit the
PRODUCT in such country, itself or with a third party for use within
the FIELD unless ORGANON'S reasons for not exploiting such rights in
that country were for safety, efficacy, regulatory or economic
nonfeasibility (for which ORGANON shall be required to provide a
reasonable basis) reasons rather than solely commercial reasons.
16.6 Any termination of this Agreement shall not affect any accrued rights
or liabilities of either PARTY, without prejudice to its other rights
or remedies at law, or in equity.
16.7 Upon early termination of this Agreement, each PARTY shall return to
the other all KNOW- HOW and other INFORMATION of the other PARTY,
except one copy which may be retained for archival purposes.
16.8 Sections 11.6, 15.2, 15.6, and Articles 7 (as to obligations incurred
prior to termination), 8 (as to obligations incurred prior to
termination), 12, 14, 17, 19, 20 and 21 shall survive the termination
of this Agreement for any reason.
ARTICLE 17 - FORCE MAJEURE
17.1 If either PARTY is affected by circumstances beyond its reasonable
control, such as any Act of God, earthquake, flood, fire, riot, war,
accident, labor disturbance, breakdown of plant or equipment, lack or
failure of transportation facilities, sources of supply or labor, raw
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materials, power or supplies, infectious diseases of animals, or by
reason of any law, order, proclamation, regulation, ordinance, demand
or requirement of any relevant government or any subdivision, authority
or representative thereof ("Force Majeure"), it shall, as soon as
reasonably practicable, notify the other PARTY of the nature and extent
thereof and take all reasonable steps to minimize the loss occasioned
to that other PARTY.
17.2 Neither PARTY shall be deemed to be in breach of this Agreement or
otherwise be liable to the other PARTY by reason of any delay in
performance or nonperformance of any of its obligations hereunder to
the extent that such delay or nonperformance is due to any Force
Majeure of which it has notified the PARTY, and the time for
performance of that obligation shall be extended accordingly.
17.3 If the Force Majeure in question prevails for a continuous period of
more than three (3) months, the PARTIES shall enter into good faith
discussions with a view to alleviating its effect or agreeing upon such
alternative arrangements as may be fair and reasonable. Failure by the
PARTIES to reach a mutually satisfactory agreement within a further
period of three (3) months after entering into such discussions, shall
entitle either PARTY to commence arbitration upon notice in writing.
ARTICLE 18 - ASSIGNMENT
18.1 This Agreement shall not be assigned by either PARTY except that either
PARTY may assign this Agreement to an AFFILIATE, or a successor of all
or substantially all of such PARTY's business or assets.
ARTICLE 19 - INDEMNIFICATION
19.1 ANERGEN shall indemnify ORGANON and its AFFILIATES, and the directors,
officers, employees, agents and counsel of ORGANON and such AFFILIATES,
and the successors and assigns of any of the foregoing (the "ORGANON
Indemnitees"), harmless from and against any and all liabilities,
damages, losses, costs or expenses (including reasonable attorneys' and
professional fees and other expenses of litigation and/or arbitration)
resulting from a claim, suit or proceeding brought by a third party
against a ORGANON Indemnitee, arising from or occurring as a result of
activities performed by ANERGEN in the DEVELOPMENT PROGRAM, or the
manufacture or co-promotion of the PRODUCT(S) by ANERGEN, except to the
extent caused by the negligence or willful misconduct of ORGANON.
19.2 ORGANON shall indemnify ANERGEN and its AFFILIATES and the directors,
officers, employees, agents and counsel of ANERGEN and such AFFILIATES
and the successors and assigns of any of the foregoing (the "ANERGEN
Indemnitees"), from and against any and all liabilities, damages,
losses, costs or expenses (including reasonable attorneys' and
professional
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fees and other expenses of litigation and/or arbitration) resulting
from a claim, suit or proceeding brought by a third party against a
ANERGEN Indemnitee, arising from or occurring as a result of activities
performed by ORGANON in the DEVELOPMENT PROGRAM, or the manufacture or
commercialization of the PRODUCT(S) by ORGANON or its AFFILIATES or
sublicensees, except to the extent caused by the negligence or willful
misconduct of ANERGEN.
19.3 A PARTY (the "Indemnitee") that intends to claim indemnification under
this Article 19 shall promptly notify the other party (the
"Indemnitor") in writing of any loss, claim, damage, liability or
action in respect of which the Indemnitee or any of its AFFILIATES,
Sublicensees or their directors, officers, employees or agents intend
to claim such indemnification, and the Indemnitor shall have the right
to participate in, and, to the extent the Indemnitor so desires, to
assume the defense thereof with counsel mutually satisfactory to the
PARTIES. The indemnity agreement in this Article 19 shall not apply to
amounts paid in settlement of any loss, claim, damage, liability or
action if such settlement is effected without the consent of the
Indemnitor, which consent shall not be withheld unreasonably. The
failure to deliver written notice to the Indemnitor within a reasonable
time after the commencement of any such action, if prejudicial to its
ability to defend such action, shall relieve such Indemnitor of any
liability to the Indemnitee under this Article 19. At the Indemnitor's
request, the Indemnitee under this Article 19, and its employees and
agents, shall cooperate fully with the Indemnitor and its legal
representatives in the investigation of any action, claim or liability
covered by this indemnification and provide full information with
respect thereto.
ARTICLE 20 - GOVERNING LAW AND ARBITRATION
20.1 This Agreement shall be governed by and construed in accordance with
the laws of New York, without reference to principles of conflicts of
law.
20.2 The PARTIES shall attempt in good faith to resolve promptly by
negotiation any dispute which may arise out of or in connection with
this Agreement or the application, interpretation, implementation,
validity, breach or termination of this Agreement, any provision
thereof or any agreement concluded in pursuant of this Agreement.
20.3 If the dispute has not been resolved by negotiation within forty-five
(45) days of the disputing party's notice, or if the PARTIES fail to
meet within twenty (20) days as from such notice, the PARTIES shall
endeavor to settle the dispute by mediation under the current European
CPR Mediation Procedure for Business Disputes. Unless otherwise agreed,
the PARTIES shall select a mediator from the European CPR Panels of
Neutrals.
20.4 If the dispute has not been resolved by non-binding means as provided
in 20.3 above within ninety (90) days of the initiation of such
procedure, the dispute shall be finally and exclusively settled by the
arbitration in New York, New York, under the Uncitral Arbitration Rules
by three (3) arbitrators appointed in accordance with said Rules. The
appointing authority shall
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be the International Chamber of Commerce in Zurich. The language of the
arbitration shall be English. The arbitration shall be in lieu of any
other remedy and the award shall be final, binding and enforceable by
any court having jurisdiction for that purpose.
ARTICLE 21 - MISCELLANEOUS
21.1 Nothing in this Agreement shall be construed as conferring a right to
use in advertising, publicity or otherwise any trademark or trade name
of the other PARTY, without the other PARTY's prior express written
permission.
21.2 No failure or delay by any PARTY in exercising any right or remedy
shall operate as a waiver thereof, nor shall any single or partial
exercise or waiver of any right or remedy preclude its further exercise
or the exercise of any other right or remedy.
21.3 This Agreement shall not constitute either PARTY as the joint venturer,
legal representative or agent of the other PARTY for any purpose
whatsoever. Neither PARTY shall have any right or authority to assume
or create any obligation or responsibility for or on behalf of the
other PARTY, or to otherwise bind the other PARTY.
21.4 Any notice required or permitted to be given under this Agreement shall
be made in writing and shall be deemed to have been sufficiently given,
for all purposes, if mailed by registered or certified mail, return
receipt requested, or by private overnight delivery services, or by
telefax and confirmed by registered or certified mail, addressed to
such other PARTY at its respective address, as follows:
If to: N.V. Organon
P.O. Box 20
5340 BH Oss
The Netherlands
Attention: President
If to: Anergen, Inc.
301 Penobscot Drive
Seaport Centre
Redwood City, California 94063
Attention: President
Either PARTY, from time to time, may change the address to which
notices are given by sending notice of such change to the other PARTY
hereto.
21.5 ORGANON agrees to mark and have its AFFILIATES and sublicensees mark
all PRODUCT sold pursuant to this Agreement in accordance with the
applicable statute or regulations relating to patent marking in the
country or countries of manufacture and sale thereof.
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21.6 The PARTIES recognize that this Agreement is a Master Agreement
covering a number of countries. If, for any country in the TERRITORY,
it becomes necessary to execute a separate instrument for any such
country in order to satisfy local law or regulatory requirements, the
PARTIES agree to execute such further instrument, which shall, to the
extent permitted by the laws of that country, conform to the terms and
conditions of this Agreement.
21.7 This Agreement is in the English language, which language shall be
controlling in all respects, and all versions hereof in any other
language shall be for accommodation only and shall not be binding upon
the PARTIES hereto. All communications and notices to be made or given
pursuant to this Agreement shall be in the English language.
21.8 In the event that any provisions of this Agreement are determined to be
invalid or unenforceable by a court of competent jurisdiction in any
jurisdiction, the remainder of the Agreement shall remain in full force
and effect without said provision in said jurisdiction and such
determination shall not affect the validity or enforceability of such
Article or the Agreement in any other jurisdiction. The PARTIES shall
in good faith negotiate a substitute clause for any provision declared
invalid or unenforceable,, which shall most nearly approximate the
intent of the PARTIES in entering this Agreement.
21.9 This Agreement may not be altered, amended or modified in any way
except by a writing signed by both PARTIES. The failure of a party to
enforce any provision of the Agreement shall not be construed to be a
waiver of the right of such PARTY to thereafter enforce that provision
or any other provision or right.
21.10 NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL,
CONSEQUENTIAL, INCIDENTAL OR INDIRECT DAMAGES ARISING OUT OF THIS
Agreement, HOWEVER CAUSED AND UNDER ANY THEORY OF LIABILITY.
21.11 The PARTIES hereto acknowledge that this Agreement and its Exhibits set
forth the entire agreement and understanding of the PARTIES hereto as
to the subject matter hereof, and supersedes all prior discussions,
agreements and writings in respect hereto.
21.12 THIS Agreement may be executed in two (2) counterparts, each of which
shall be deemed an original but both of which together shall constitute
one and the same instrument.
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IN WITNESS WHEREOF, the PARTIES hereto have caused this Agreement to be
duly executed by their duly authorized officers.
ANERGEN, INC. N.V. ORGANON
By: /s/ JOHN W. VARIAN By: /s/ DRIEK VERGOUWEN
_____________________________ _____________________________
Title: V.P. Finance, C.F.O. Title: Managing Director R&D
__________________________ __________________________
Date: 6/28/96 Date: 6/28/96
___________________________ ___________________________
Exhibit A: ANERGEN PATENTS [*]
B: DEVELOPMENT PROGRAM [*]
C: ORGANON PATENTS [*]
D: ORIGINAL EPITOPE PEPTIDE SEQUENCE [*]
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EXHIBIT A
ANERGEN PATENTS
[ * ]
* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
27
EXHIBIT B
DEVELOPMENT PROGRAM
[*]
* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
28
EXHIBIT C
ORGANON PATENTS
[*]
* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.
29
EXHIBIT D
ORIGINAL EPITOPE PEPTIDE SEQUENCE
[*]
* Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to the
omitted portions.