Exhibit 10.16
DEVELOPMENT AND LICENSE AGREEMENT
This Development and License Agreement (the "Agreement") is made and shall be
effective as of December 15, 1999 by and between Cephalon, Inc., a Delaware
corporation with its principal place of business located at 000 Xxxxxxxxxx
Xxxxxxx, Xxxx Xxxxxxx, Xxxxxxxxxxxx 00000-0000, X.X.X. ("Cephalon") and Xxxxxxx
Pharma AG, a German corporation with its principal place of business located at
Xxxxxx-Xxxxx-XxxxXx 00, Xxxxxxx am Rhein, X-00000 Xxxxxxx ("Xxxxxxx Pharma").
WITNESSETH:
WHEREAS, Kyowa Hakko Kogyo, Co. Ltd. ("Kyowa") granted to Cephalon the right
to make, develop, use and sell pharmaceutical products containing the
Substances, KT5555,KT6587 and KT8391 (each a derivative of K252a), under the
terms and conditions of a license agreement ("Kyowa License") dated May 15,
1992, as amended; said right, including the right to sublicense in certain
territories, including Europe, Mexico, Canada, the Middle East, Africa, Latin
America, South America, Australia and New Zealand;
WHEREAS, Cephalon wishes to grant, and Xxxxxxx Pharma wishes to accept, a
sublicense as described herein of certain of Cephalon's rights under the Kyowa
License, in that certain territory to be defined herein, to product(s) developed
by Cephalon that contain any of KT5555, KT6587 and KT8391, such product(s) to be
known hereinafter respectively as CEP-701, CEP-751 and CEP-2563;
WHEREAS, Cephalon has developed a chemical platform of [**] compounds
believed to have potential efficacy in treating cancers that rely upon the
family of neurotrophin receptors for survival;
WHEREAS, Cephalon wishes to grant, and Xxxxxxx Pharma wishes to accept, an
exclusive option to license, in that certain territory to be defined herein,
certain fused pyrrolocarbazoles as described herein for use as provided herein;
WHEREAS, Cephalon and Xxxxxxx Pharma desire to enter into a collaboration to
develop and commercialize compounds for uses related to cancer therapeutics; and
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
1
WHEREAS, Cephalon and Xxxxxxx Pharma desire to establish commercial licensing
and supply arrangements under which Cephalon Licensed Products and Kyowa
Licensed Products (as defined below) will be marketed and sold exclusively by
Xxxxxxx Pharma in the Territory (as defined below).
NOW, THEREFORE, for good and valuable consideration, the adequacy of which is
hereby affirmed, the parties hereby agree as follows.
Article 1. Definitions. Terms that are capitalized as defined terms in this
Agreement shall have the meanings set forth below, and defined terms may be used
in their singular and plural sense:
1.1 "Affiliate" shall mean any individual or entity directly or indirectly
controlling, controlled by or under common control with, a Party to this
Agreement. Without limiting the foregoing, the direct or indirect ownership of
fifty percent (50%) or more of the outstanding voting securities of an entity,
or the right to receive fifty percent (50%) or more of the profits or earnings
of an entity, or the right to control the policy decisions of a person or
entity, shall be deemed to constitute control.
1.2 "At Cost" shall mean all direct and indirect expenses incurred which shall
be allocated in a fair and equitable manner in conformance with United States
generally accepted accounting principles ["US GAAP"], consistently applied with
those established with respect to other products, and shall include:
(a) the arms-length transfer price to Cephalon for Compounds and clinical
supplies manufactured by a third party including Cephalon's expenses incurred in
connection with such third party manufacture; such Cephalon expenses include,
but are not limited to, those relating to existing or acquired equipment
(current procedures for such equipment allocations shall be provided within
thirty (30) days of the Effective Date and upon any amendment of such procedures
thereafter), technology transfer, scale-up, validation, quality control and
quality assurance testing, stability testing, storage, regulatory filings,
shipping and import/export services;
(b) all expenses for Compounds and clinical supplies manufactured by
Cephalon including, but not limited to, existing and acquired equipment
(current procedures for such equipment allocations shall be provided within
thirty (30) days of the Effective Date and upon any amendment of such procedures
thereafter), technology transfer, scale-up, validation, quality control and
quality assurance testing, stability testing, storage, regulatory filings,
shipping and import/export services; and
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
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(c) all incremental expenses incurred by or on behalf of Cephalon in the
US Program at the written request of Xxxxxxx Pharma which are not otherwise
required for regulatory or commercial purposes under the US Program but which
specifically support Xxxxxxx Pharma's Development Program.
1.3 "Backup Compounds" shall mean the fused pyrrolocarbazoles known as CEP-
4416, CEP-4715, and CEP-4574 or any other fused pyrrolocarbazoles owned by
Cephalon which inhibit the Target(s) and are selected under the US Program for
clinical development in the Field.
1.4 "Cephalon Licensed Products" shall mean all pharmaceutical products that
contain Backup Compounds.
1.5 "Cephalon Technology" shall mean collectively, Patent Rights, Know-How and
Improvements, including but not limited to technology and data obtained or
licensed from TAP through the US Program, but excluding Kyowa Technology. For
purposes of clarification, the term Cephalon Technology expressly excludes any
Patent Rights and Know-How that Cephalon may license from a third party after
the Effective Date of this Agreement, unless (i) Cephalon is permitted to grant
a sublicense or other rights thereunder to Xxxxxxx Pharma; and (ii) Xxxxxxx
Pharma shall have executed and delivered a sublicense or other agreement in a
form reasonably required in connection therewith. Cephalon Technology includes
the drug development dossier related to the filing of an investigational new
drug application by or on behalf of Cephalon that supports clinical studies of a
Compound; as well as any Patent Rights, Improvements and Know-How to the extent
that it relates to the composition, manufacture, use, and commercialization of
the Compounds in the Field or Licensed Products.
1.6 "Compounds" shall mean the Lead Compound (as defined herein), CEP-751, CEP-
2563 and the Backup Compounds.
1.7 "Development Program" shall mean a program including, but not limited to,
preclinical, clinical and regulatory development of a Compound conducted by
Xxxxxxx Pharma pursuant to this Agreement primarily with the intent, and for the
purpose, of generating data for submission to regulatory authorities in support
of an application for governmental approval necessary to permit the
commercialization of a Licensed Product in the Field within the Territory.
1.8 "Effective Date" shall mean the date hereof.
1.9 "Field" shall mean the treatment of cancer, including but not limited to
prostate cancer and
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
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pancreatic cancer.
1.10 "Improvements" shall have the meaning set forth in Section 11.1.
1.11 "Know-How" shall mean know-how, trade secrets, Targets, technical
information , formulae, processes, expert opinions, data, and other confidential
and proprietary information, other than Kyowa Technology, concerning or relating
to the composition, manufacture, use or commercialization of Compounds or
Licensed Products, including, without limitation, CMC, preclinical, clinical,
and other data generated pursuant to the US Program and the Development Program,
which is owned or controlled by a Party to this Agreement.
1.12 "Kyowa Licensed Products" shall mean all pharmaceutical products that
contain the Lead Compound (as defined herein), CEP-751 or CEP-2563.
1.13 "Kyowa Technology" shall mean: the patent rights, including all patent
applications and issued patents owned, licensed or controlled by Kyowa and/or
its Affiliates anywhere in the world that contain a Valid Claim covering the
composition, manufacture or use of the Lead Compound, CEP-751 or CEP-2563 (as
well as the use of K252a solely in connection with the manufacture of the Lead
Compound, CEP-751 or CEP-2563) including but not limited to any provisionals,
divisionals, continuations, continuations-in-part, reissues, reexaminations,
extensions derived therefrom, as well as all foreign patent applications,
granted foreign patents and all counterparts thereof including, but not limited
to, supplemental protection certificates, administrative protection certificates
(or other governmental actions) which provide exclusive rights to the patent
holders in the patented subject matter; manufacturing rights; and know-how,
trade secrets and technical information relating to K252a and the Lead Compound,
CEP-751 and CEP-2563 only to the extent that such patent rights, manufacturing
rights, know-how, trade secrets or technical information have been granted to
Cephalon pursuant to the Kyowa License. A copy of the Kyowa License, as
amended, is attached hereto as Exhibit D.
1.14 "Lead Compound" shall mean CEP-701. The chemical formula of CEP-701 is
set forth on Exhibit B.
1.15 "Licensed Products" shall mean Cephalon Licensed Products and Kyowa
Licensed Products.
1.16 "Marketing Authorization Application" or "MAA" shall mean an application
seeking the approval of the competent regulatory authority in any country in the
Territory (including, without limitation, the European Medicines Evaluation
Agency or "EMEA") to enable Xxxxxxx Pharma
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
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(or an Affiliate or assignee thereof) to market a Licensed Product(s).
1.17 "Net Sales" shall mean the gross receipts derived in arms-length
transactions from the sale of Licensed Products in the Territory by Xxxxxxx
Pharma (or by its Affiliates, sublicensees), to independent third parties in the
Territory, less the sum of the following items:
a) Import, export, excise and sales taxes and custom duties paid or
allowed by the selling party and any other governmental charges
imposed upon the production, importation, use or sale of Licensed
Products by Xxxxxxx and/or its Affiliates;
b) Credit for returns, refunds, rebates and allowances, or trades to
customers for returned or recalled Licensed Product;
c) Trade, quantity and cash discounts actually allowed;
d) Transportation, freight and insurance allowances; and
e) Rebates actually granted to wholesalers, administrative fees in
lieu of rebates paid to managed care and other similar institutions,
chargebacks and retroactive price adjustments and any other similar
allowances which effectively reduce the net selling price.
Gross and Net Sales shall be calculated according to US GAAP. Sales or
transfers between or among a party to this Agreement and its Affiliates or
sublicensees shall be excluded from the computation of Net Sales except where
such Affiliates or sublicensees are end users, but Net Sales shall include the
subsequent final sales to third parties by such Affiliates or sublicensees.
Where (i) Licensed Products are sold as one of a number of items without a
separate price; or (ii) the consideration for the Licensed Products shall
include any non-cash element; or (iii) the Licensed Products shall be
transferred in any manner other than an invoiced sale, except for Licensed
Products transferred as samples or any other similar transfer for promotional
purposes usually made in the relevant part of the Territory, the gross sales
applicable to any such transaction shall be deemed to be Xxxxxxx Pharma's
average gross sales for the applicable quantity of Licensed Products during the
calendar quarter and in the country in which the transaction occurred. If there
are no independent gross sales of Licensed Products in the country at that time,
then Xxxxxxx Pharma and Cephalon shall mutually agree on a surrogate measure to
be used in lieu thereof.
1.18 "Party" or "Parties" shall mean Cephalon and/or Xxxxxxx Pharma, as the
case may be.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
5
1.19 "Patent Rights" shall mean all patent rights, including but not limited
to, U.S. patent applications (whether in preparation or filed) and issued
patents, owned, controlled or licensed (with the right to assign or sublicense)
by Cephalon (and/or an Affiliate thereof) anywhere in the world covering the
assays, Targets, Improvements, processes, composition, manufacture or use of any
Compound (as well as any Know-How that may be patentable), including but not
limited to any provisionals, divisionals, continuations, continuations-in-part,
reissues, reexaminations, extensions derived therefrom, as well as all foreign
patent applications, granted patents and all counterparts thereof including, but
not limited to, substitutions, confirmations, registrations, revalidations,
supplemental protection certificates, administrative protection certificates (or
other governmental actions) which provide exclusive rights to the patent holders
in the patented subject matter. All such Patent Rights in the Territory for
all Compounds and the filing dates of each, in existence as of the Effective
Date shall be as set forth on Exhibit A hereto.
1.20 "Pivotal Trial" shall mean an adequate and well controlled, clinical
study designed to demonstrate sufficient efficacy and safety to directly support
a regulatory filing for marketing approval by a competent regulatory authority .
1.21 "Reasonable Business Efforts" shall mean necessary and prudent efforts
applied in a prompt, commercially reasonable manner, to the maximum extent
feasible consistent with the exercise of good business judgment for the
attainment of the goals and purposes of this Agreement consistent with current
industry standards and practice.
1.22 "TAP" shall refer to Takeda Xxxxxx Pharmaceutical Holdings Inc., a
Delaware corporation headquartered at 0000 Xxxxxxxx Xxxx, Xxxxxxxxx, Xxxxxxxx
00000.
1.23 "TAP Agreement" means that certain collaborative research, development and
licensing agreement dated May 17, 1994 between Cephalon and TAP as amended. A
copy of the TAP Agreement, as amended as of the date of this Agreement, is
attached hereto as Exhibit C. Any additional amendments to the TAP Agreement
during the term of this Agreement (including any amendments referred to in
Section 16.3 (h)(iv) of this Agreement) will be provided to Xxxxxxx Pharma
promptly and added to Exhibit C.
1.24 "Target" or "Targets" shall mean the [**]
1.25 "Territory" shall mean generally the regions of Europe, Mexico, Canada,
the Middle East, Africa, Latin America and South America (including
specifically, without limitation, the countries within those regions listed in
Exhibit F hereto), as well as the countries of Australia
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
6
and New Zealand.
1.26 "US Program" shall refer to the research and development program through
which TAP, as a licensee and collaborator of Cephalon, bears the primary
responsibility and expenses of preclinical, clinical, regulatory and commercial
development of certain Compounds in the United States, including, the Lead
Compound, CEP-751, CEP-2563 and the Backup Compounds.
1.27 "Valid Claim" shall mean a claim of an issued or granted patent that has
not lapsed or become abandoned or been declared invalid or unenforceable by a
court or agency of competent jurisdiction from which no appeal can be or is
taken.
Article 2. Development Program
2.1 Responsibilities of Xxxxxxx Pharma.
(a) Xxxxxxx Pharma agrees to conduct a Development Program using
Reasonable Business Efforts as to the Lead Compound (or as to CEP-751 or CEP-
2563, or as to one or more Backup Compounds should Xxxxxxx Pharma exercise its
option hereunder), to treat diseases in the Field. Xxxxxxx Pharma shall fund and
conduct all necessary clinical trials of Compounds in the Field within the
Territory and any additional preclinical trials (other than those performed by
Cephalon and TAP in support of regulatory filings outside of the Territory)
required for regulatory purposes in the Field in the Territory. All Know-How
developed solely by or on behalf of Xxxxxxx Pharma resulting from the conduct of
the Development Program will be owned by Xxxxxxx Pharma and made available to
Cephalon as set forth in Article 8. All Know-How developed jointly by or on
behalf of Xxxxxxx Pharma and Cephalon resulting from the conduct of the
Development Program will be jointly owned by Xxxxxxx Pharma and Cephalon and
made available to Cephalon as set forth in Article 8. All Know-How developed by
or on behalf of Xxxxxxx Pharma and a third party will be made available to
Cephalon as set forth in Article 8.
(b) Promptly, but in any event not more than ninety (90) days following
the execution of this Agreement, Xxxxxxx Pharma shall submit to Cephalon a
written plan describing the overall strategy and objectives of the Development
Program to the extent such plan has been formulated (the "Development Plan").
The Development Plan shall take full advantage of the expertise of Xxxxxxx
Pharma with respect to drug development, regulatory practices and
commercialization of such Compounds in the Field. The Development Plan will
define, at a minimum, the following items (to the extent possible consistent
with the current stage of clinical development of any Compound):
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
7
(i) the labeling Xxxxxxx Pharma will seek in the Territory;
(ii) the preclinical and clinical studies reasonably expected to be
necessary to support such labeling;
(iii) an estimate of the schedule of planned preclinical and clinical
studies; and
(iv) synopses of critical clinical studies ( e.g., proof-of-principle
and Pivotal Trials). Such study synopses shall include information that
is appropriate and customary in the industry, including but not limited
to, study design and duration of treatment, the primary endpoints of such
studies, patient numbers, the criteria for selection and exclusion of
such patients, and the power calculations for determining numbers of such
study participants and the estimated primary and secondary analyses.
The Development Plan shall also account for the reasonable expectation of
Xxxxxxx Pharma for receipt of primary data and analyses of the same from time-
sensitive preclinical and clinical studies conducted by or on behalf of TAP
and/or Cephalon in the US Program. It shall be the primary responsibility of
Xxxxxxx Pharma to identify and conduct any preclinical and clinical studies
necessary, in addition to those supplied by Cephalon to Xxxxxxx Pharma from the
US Program, for approval of an MAA and commercialization of a Licensed Product
in the Field in the Territory. Subject to the prior written consent of Cephalon
with respect to the material items in the Development Plan, which consent shall
not be unreasonably withheld or delayed, Xxxxxxx Pharma shall finalize the
Development Plan. Cephalon shall be deemed to have provided its consent if it
has not responded to the material items in such Development Plan within ten (10)
business days of its receipt of the Development Plan from Xxxxxxx Pharma. The
final Development Plan shall be attached to this Agreement as Exhibit E.
(c) Concurrent with its submission of the Development Plan, Xxxxxxx Pharma
shall provide to Cephalon an estimate of its overall budget for implementation
of the Development Plan (the "Development Budget"). The Development Budget will
include fully burdened expenses and will detail the allocation of resources by
Xxxxxxx Pharma necessary for the preclinical and clinical activities performed
by or on behalf of Xxxxxxx Pharma as distributed over each calendar year before
the anticipated first commercial sale of Licensed Product in the Territory. The
Development Budget shall also account for Xxxxxxx Pharma's sole responsibility
for all incremental expenses incurred by or on behalf of Cephalon or TAP that
may be needed for the Development Program, but which are not similarly needed
for the US Program, such
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
8
incremental expenses including, but not limited to, different formulations,
additional studies, study arms or study analyses conducted under the US Program
by or on behalf of Cephalon or TAP. The fully burdened expenses of Xxxxxxx
Pharma to implement and complete the Development Program defined in the
Development Plan will be consistent with a minimum investment by Xxxxxxx Pharma
of [**] dollars [**]. The Development Budget will be treated as Confidential
Information of Xxxxxxx Pharma and shall not be disclosed by Cephalon to any
third party without the consent of Xxxxxxx Pharma.
(d) Xxxxxxx Pharma shall implement the Development Plan consistent with
the Development Budget not later than ninety (90) days following receipt by
Xxxxxxx Pharma of Cephalon's written consent described in Section 2.1(b) and
all required regulatory approvals or expiration of required waiting periods.
Subject to its obligations set forth in Section 5.2, Section 2.3, Section 16.3
and those set forth herein to update and meet with Cephalon, and further subject
to Cephalon's right to consent to material modifications to the Development Plan
and Development Budget pursuant to Section 2.1(e), Xxxxxxx Pharma will manage
and coordinate all development activities undertaken pursuant to the Development
Program, including scheduling preclinical studies and clinical trials for
Compounds; establishing milestones for the completion of Development Program
objectives, including without limitation those relating to anticipated filing
dates for a clinical trial authorization (or its equivalent) filing and an MAA
filing; determining to end the development of a Compound in the Field, within
the Territory; and generally exercising its Reasonable Business Efforts to
undertake and complete in a timely manner the Development Program with respect
to each Compound.
(e) Xxxxxxx Pharma shall periodically review, and modify as may be
necessary and advisable, the preclinical, clinical and commercial objectives of
its Development Program for each Compound. On or before October 1st of each
year following the Effective Date (and for so long as the Development Program
continues), Xxxxxxx Pharma shall provide to Cephalon a written update of the
Development Plan accounting for any proposed modifications in the Development
Program, including but not limited to, alterations in schedule of studies,
design and objectives of studies, and timing of analysis or final reporting of
studies or of regulatory filings in the Territory for the Lead Compound and
plans for clinical development of other Compounds, if appropriate. Any material
modification to the Development Plan shall be subject to the prior written
consent of Cephalon, which consent shall not be unreasonably withheld or
delayed, prior to Xxxxxxx Pharma's implementation of such material
modification. Cephalon shall be deemed to have provided its consent if it has
not responded to such material modifications to the Development Plan within ten
(10) business days of its receipt of such material modifications from Xxxxxxx
Pharma.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
9
2.2 Primary Responsibilities of Cephalon.
(a) Under the terms and conditions of the TAP Agreement, as amended,
Cephalon and TAP collaborate in the conduct of research, preclinical and
clinical studies, regulatory and commercialization strategies for the Lead
Compound, and, potentially, CEP-751, CEP 2563 or Backup Compounds, in the Field
in the United States. Under terms and conditions of an existing Confidential
Disclosure Agreement by and between Cephalon and Xxxxxxx Pharma dated July 13,
1998 as amended on November 6, 1998, Xxxxxxx Pharma has received the necessary
protocols, plans, results, analyses and reports regarding the US Program in
order to determine, using its Reasonable Business Efforts, those additional
requirements that may be needed for development of Compounds within the Field
and commercialization of a Licensed Product in the Territory. Accordingly, all
Know-How resulting from the conduct of the US Program, whether developed by
Cephalon or TAP or jointly by Cephalon and TAP will be provided to Xxxxxxx
Pharma as described in Article 8.
(b) For purposes of generating preclinical and clinical data that will be
mutually acceptable by the regulatory authorities responsible for approving a
Compound under the US Program and under the Development Program, Cephalon shall
facilitate the coordination of the US Program and the Development Program as
follows. Thirty (30) days following receipt of the Development Plan from Xxxxxxx
Pharma or as soon thereafter as practicable, Cephalon shall host the first
meeting of governing members of both the US Program and the Development Program
at a mutually agreeable location. The purpose of such meeting will be to
determine the optimal manner in which Cephalon can coordinate the development of
Compounds in the respective territories. Cephalon's efforts shall include the
following: coordinating the objective of utilizing all preclinical and
clinical trial data for both the US Food and Drug Administration ("FDA") and
EMEA approvals; coordinating the design, primary or secondary endpoints,
treatment regimens, dosing, and indications in proof-of-principle and Pivotal
Trials, and minimizing replication of such preclinical and clinical studies by
TAP and Cephalon in the US Program and by Xxxxxxx Pharma in the Development
Program. In no case, however, shall either Party be required to conduct studies
in its respective Program which would otherwise conflict with its reasonable
business judgment. Cephalon shall be responsible for producing minutes of this
meeting and shall distribute the meeting minutes to Xxxxxxx Pharma as well as to
TAP within thirty (30) days after the meeting.
(c) After the first meeting described above, Cephalon shall continue to
use its Reasonable Business Efforts under the TAP Agreement and under this
Agreement to coordinate and, if possible, and if appropriate, economize the
development efforts and expenditures by TAP
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
10
and Cephalon and by Xxxxxxx Pharma in their respective programs. In order to
achieve this objective, Cephalon will ensure that appropriate representatives of
Xxxxxxx Pharma (not more than three [3] individuals per meeting) shall be
invited as non-voting participants to regular meetings (not less frequently than
once every six [6] months) of the development committee jointly representing
Cephalon and TAP in the US Program and at consultant or investigator meetings
convened to support a Compound under the US Program; conversely, Xxxxxxx Pharma
will ensure that appropriate representatives of TAP and Cephalon (not more than
three [3] individuals per company per meeting) shall be invited to regular
meetings (not less frequently than once every six [6] months) of Xxxxxxx
Pharma's management team for any Compound under the Development Program and at
consultant or investigator meetings convened to support a Compound under the
Development Program. Regardless of the number of individual members of Xxxxxxx
Pharma that may attend and participate in any given meeting or proceeding
organized by TAP and/or Cephalon relating to a Compound, Xxxxxxx Pharma shall
not be entitled to vote on matters relating to the US Program, provided,
however, that Cephalon shall consult with Xxxxxxx Pharma with respect to
critical decisions relating to the development of Compounds under the US Program
and shall give due consideration to the experience and perspective of Xxxxxxx
Pharma. Regardless of the number of individual members of TAP that may attend
and participate in any given meeting or proceeding organized by Xxxxxxx Pharma
relating to a Compound, TAP shall not be entitled to vote on matters relating to
the Development Program. Written minutes of all such meetings shall be prepared
by the host of the meeting and approved by authorized signature of the parties
to the respective agreements only, and copies of these minutes shall be
distributed to the General Counsel of Cephalon, Xxxxxxx Pharma and TAP not later
than thirty (30) days after any such meeting(s). Xxxxxxx Pharma shall have the
right to review and comment upon design and protocols for preclinical and
clinical studies to be conducted in the US Program. Notwithstanding such review
and comment by Xxxxxxx Pharma, but subject to Cephalon's covenants in Section
16.2 (h) and 2.3 of this Agreement, Cephalon and TAP shall have the final
authority on design and implementation of such protocols for the US Program.
2.3 General Responsibilities of the Parties The Parties agree to cooperate
with each other in good faith to work toward the success of the Development
Program. No less frequently than once every six (6) months, the Parties shall
meet at mutually agreed locations (or via videoconference) to update one another
on the progress and any modifications, including Material Modifications, of the
Development Program and the US Program. Each Party agrees that it will not
conduct or allow to be conducted any development activities in its territory
which in its reasonable business judgment would jeopardize regulatory approval
of Licensed Products worldwide. The Parties agree to use Reasonable Business
Efforts to perform their obligations pursuant to this Agreement, including
without limitation the diligence requirements set forth in
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
11
Section 5.2. However, nothing in this Agreement shall give either Party the
authority to control or direct the activities of any employees or agents of the
other Party.
2.4 Term of the Development Program. The Development Program shall continue
for so long as Xxxxxxx Pharma continues development and seeks marketing approval
for not less than one Compound.
2.5 Use of Compounds and Technology. The Parties agree that all compositions,
biological materials and animals used in the Development Program shall be used
in compliance with all applicable laws and regulations. Neither Party shall
provide Lead Compound (or CEP-751, CEP-2563 if under development by Xxxxxxx
Pharma, or Backup Compounds if Xxxxxxx Pharma has exercised its option to the
Backup Compounds) to any third party in the Territory without the prior written
consent of the other Party, which consent shall not be unreasonably withheld or
delayed.
ARTICLE 3. GRANT OF RIGHTS
3.1 SUBLICENSE TO KYOWA LICENSED PRODUCTS. Subject to the terms and conditions
set forth herein, and pursuant to the Kyowa License, Cephalon hereby grants to
Xxxxxxx Pharma its rights under the Kyowa License, except the right to
sublicense, solely to (a) use the Kyowa Technology for development of the Lead
Compound, CEP-751 or CEP-2563 within the Field, and (b) use and sell the
Kyowa Licensed Products in the Territory. Cephalon additionally hereby grants to
Xxxxxxx Pharma the exclusive right in the Territory, without the right to
sublicense, to use the Cephalon Technology solely for the purposes of
development, marketing and sale of Kyowa Licensed Products within the Field.
Xxxxxxx Pharma acknowledges that the rights of Cephalon with regard to Kyowa
Licensed Products under the Kyowa License are exclusive in Europe, Mexico and
Canada, and semi-exclusive as to Kyowa in the remainder of the Territory and,
therefore, that the rights granted hereunder to Xxxxxxx Pharma also are
exclusive in Europe, Mexico and Canada and semi-exclusive as to Kyowa in all
other parts of the Territory. Moreover, Xxxxxxx Pharma hereby agrees to
cooperate with Cephalon so as to ensure continued satisfaction of all those
terms and conditions of the Kyowa License, a copy of which Kyowa License is
attached hereto as Exhibit D. In the event that Cephalon determines to directly
manufacture any of Lead Compound, CEP-751 or CEP-2563 rather than have such
compounds manufactured by a third party manufacturer, then, if that compound is
currently under development by Xxxxxxx Pharma, Cephalon shall promptly notify
Xxxxxxx Pharma and, upon the request of Xxxxxxx Pharma, the Parties shall
discuss the possibility of Cephalon granting manufacturing rights to Xxxxxxx
Pharma to make Compounds for use in the Field within the
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
12
Territory.
3.2 Marketing and Distribution Rights to Kyowa Licensed Products. Subject to
the terms and conditions set forth herein, Xxxxxxx Pharma may market and
distribute Kyowa Licensed Products developed hereunder through the channels
normally used for the Xxxxxxx Pharma product portfolio, including but not
limited to, Affiliates, agents, distributors, joint venture partners and co-
promotion and co-marketing partners (even if any such commercial contract
between Xxxxxxx Pharma and the applicable third party is formally described or
structured as a license). Subject to the written consent of Cephalon, which
consent shall not be unreasonably withheld, Xxxxxxx Pharma may grant rights to
other authorized third parties to market, promote, sell and distribute Kyowa
Licensed Products in any country in the Territory where Xxxxxxx Pharma does not
itself or through its then existing ordinary channels, wish to market Kyowa
Licensed Products. Cephalon shall be deemed to have provided consent if it has
not responded to the suggested authorized third party(ies) within ten (10)
business days after receiving the name of such authorized third parties from
Xxxxxxx Pharma. If Cephalon has established a commercial operation in any of
the following countries: [**] and Xxxxxxx Pharma is not then marketing,
promoting, selling and distributing directly or through an Affiliate or other
channel normally used for the Xxxxxxx Pharma product portfolio in such
countries, then prior to entering into any agreement with any other third party
for such marketing, promotion, selling or distribution rights in such country,
Xxxxxxx Pharma hereby agrees to negotiate in good faith for a period not to
exceed sixty (60) days to grant such rights to Cephalon under terms and
conditions to be mutually agreed upon. If Xxxxxxx Pharma and Cephalon fail to
so reach agreement within such period, then Xxxxxxx Pharma may discuss terms and
conditions with such other third parties but it shall not, within twelve (12)
months of the expiration of the sixty (60) day negotiation period, enter into
any such agreement with a third party on terms and conditions more favorable in
the aggregate to such third party than those offered to Cephalon without first
offering such more favorable terms to Cephalon in accordance with the procedures
set forth herein. If, after complying with the terms of this paragraph, Xxxxxxx
Pharma thereafter enters into such an agreement with a third party, with
Cephalon's consent as described above in this Section 3.2, then such agreement
shall contain terms and conditions customary in the pharmaceutical industry with
respect to such commercial arrangements, including without limitation those
relating to the prompt disclosure of adverse drug experiences, any adverse
regulatory or other governmental actions, or Know-How relating to the Kyowa
Licensed Products.
3.3 Option to Backup Compounds. Subject to the terms and conditions set forth
herein, including payment of all upfront license payments in Section 4.1,
Cephalon hereby grants to Xxxxxxx Pharma a time-limited option to license
exclusively (exclusive even as to Cephalon) under the Cephalon Technology (a)
the right to use and develop the Backup Compounds in the
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
13
Field in the Territory; (b) the right to use and sell Cephalon Licensed Products
in the Territory. The option must be exercised, if at all, in accordance with
the terms and conditions of Section 3.4.
3.4 Option Exercise for Backup Compounds. Subject to the terms and conditions
set forth herein, to exercise the option granted by Cephalon in section 3.3 for
any Backup Compound: (a) Xxxxxxx Pharma must, by the latter of the second
anniversary of the Effective Date or one hundred eighty (180) days after the
filing of an Investigational New Drug Application ("IND") for such Backup
Compound provided such IND is filed on or before the second anniversary of the
Effective Date: (i) give Cephalon not less than thirty (30) days written notice
that it is exercising its option and (ii) provided Cephalon has filed patent
applications for all Backup Compounds no later than thirty (30) days from
receipt of such notice, pay Cephalon [**] dollars [**] within thirty (30) days
of such notice, OR, in the alternative (b) Xxxxxxx Pharma must (i) give Cephalon
not less than thirty (30) days written notice on or before the second
anniversary of the Effective Date that it is extending the time to exercise its
option until the latter to occur of the fourth anniversary of the Effective Date
or sixty (60) days after the filing of an IND for such Backup Compound, (ii)
provided Cephalon has filed patent applications for all Backup Compounds no
later than thirty (30) days from receipt of such notice, pay Cephalon an option
period extension fee of [**] Dollars [**] within thirty days of such notice, and
(iii) if Xxxxxxx Pharma desires to exercise its option, Xxxxxxx Pharma shall
notify Cephalon in writing before the expiration of the extended option period
that it is exercising its option and shall pay Cephalon [**] dollars [**] within
thirty (30) days of such notice. If Xxxxxxx Pharma does not exercise its option
for any Backup Compound within the relevant time periods set forth above, then
such option shall expire and shall be of no further force and effect.
3.5 Marketing and Distribution Rights to Cephalon Licensed Products. From and
after the time Xxxxxxx Pharma exercises its option to take an exclusive license
to the Backup Compounds pursuant to Section 3.4, and subject to the terms and
conditions set forth herein, Xxxxxxx Pharma may market and distribute Cephalon
Licensed Products developed hereunder in the Territory through the channels
normally used for the Xxxxxxx Pharma product portfolio including, but not
limited to, Affiliates, agents, distributors, joint venture partners and co-
promotion and co-marketing partners (even if any such commercial contract
between Xxxxxxx Pharma and the applicable third party is formally described or
structured as a license). Subject to the written consent of Cephalon, which
consent shall not be unreasonably withheld, Xxxxxxx Pharma may grant rights to
other authorized third parties to market, promote, sell and distribute Cephalon
Licensed Products in any country in the Territory, where Xxxxxxx Pharma does not
itself or through its then-existing ordinary channels, wish to market Cephalon
Licensed Products. Cephalon shall be deemed to have provided consent if it has
not responded to the suggested
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
14
authorized third party(ies) within ten (10) business days after receiving the
names of such authorized third parties from Xxxxxxx Pharma. If Cephalon has
established a commercial operation in any of the following countries: [**] and
Xxxxxxx Pharma is not marketing, promoting, selling and distributing directly or
through an Affiliate or other channel normally used for the Xxxxxxx Pharma
product portfolio in such countries, then prior to entering into any agreement
with any other third party for such marketing, promotion, selling or
distribution rights in such country, Xxxxxxx Pharma hereby agrees to negotiate
in good faith for a period not to exceed sixty (60) days to grant such rights to
Cephalon under terms and conditions to be mutually agreed upon. If Xxxxxxx
Pharma and Cephalon fail to so reach agreement within such period, then Xxxxxxx
Pharma may discuss terms and conditions with such other third parties but it
shall not, within twelve (12) months of the expiration of the sixty (60) day
negotiation period, enter into any such agreement with a third party on terms
and conditions more favorable in the aggregate to such third party than those
offered to Cephalon without first offering such more favorable terms to Cephalon
in accordance with the procedures set forth herein. If , after complying with
the terms of this paragraph, Xxxxxxx Pharma thereafter enters into such an
agreement with a third party, with Cephalon's consent as described above in this
Section 3.5, then such agreement shall contain terms and conditions customary in
the pharmaceutical industry with respect to such commercial arrangements,
including without limitation those relating to the prompt disclosure of adverse
drug experiences, any adverse regulatory or other governmental actions, or Know-
How relating to the Cephalon Licensed Products.
3.6 Licensed Products in the United States. If, during the term of this
Agreement, the TAP Agreement is terminated for any reason, Cephalon shall
immediately (and no later than ten [10] business days thereafter) inform Xxxxxxx
Pharma and, provided that Cephalon does not decide to unilaterally assume all
responsibilities and costs of the US Program, then Cephalon shall xxxxx Xxxxxxx
Pharma an exclusive right, exercisable within ninety (90) days of Cephalon's
notification to Xxxxxxx Pharma that the TAP agreement has terminated, upon the
payment of additional consideration to be negotiated in good faith, to share
responsibilities, costs and commercial opportunities, to be agreed upon, of the
US Program. In any event there shall be no such expansion of the Territory
hereunder unless Xxxxxxx Pharma shall have, within ninety (90) days of said
notification to Xxxxxxx Pharma, successfully negotiated additional terms and
conditions with Cephalon concerning said expansion. If in such negotiation
Xxxxxxx Pharma receives exclusive commercialization rights in the United States
then the additional terms set forth below shall be included in any agreement for
territorial expansion:
(a) negotiation of additional reasonable terms giving due regard to the
stage of development of any Compounds in the US Program;
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
15
(b) deletion of all references hereunder to the US Program and to TAP;
(c) diligent conduct of a program for registration and commercialization
of Licensed Product in the US;
(d) payment to Cephalon of a transfer price in the amount of between [**]
percent [**] and [**] percent [**] of the annual Net Sales of such Licensed
Product(s) in the United States; and
(e) payment to Cephalon of the following additional milestone payments not
later than 30 days following completion of each milestone:
(i) [**] dollars [**] upon the submission of the first New Drug
Application ("NDA") for a Licensed Product in the United States; and
(ii) [**] dollars [**] upon the approval of the first NDA for a Licensed
Product in the United States.
If Xxxxxxx Pharma and Cephalon fail to so reach agreement within such ninety-day
period, then Cephalon may discuss terms and conditions with third parties but
it shall not, within twelve (12) months of the expiration of the ninety (90) day
negotiation period, enter into any such agreement with a third party on terms
and conditions more favorable in the aggregate to such third party than those
offered to Xxxxxxx Pharma without first offering such more favorable terms to
Xxxxxxx Pharma in accordance with the procedures set forth herein.
Article 4. License fees, Transfer Pricing and Milestone Payments
4.1 Upfront License Fees and Fees for Option to License to Backup Compounds.
In consideration of Cephalon granting Xxxxxxx Pharma the sublicense to the Kyowa
License to Kyowa Licensed Products (as set forth in Section 3.1) and in
consideration of Cephalon granting Xxxxxxx Pharma the option to exercise an
exclusive license to the Backup Compounds (as set forth in Section 3.3), Xxxxxxx
Pharma shall pay Cephalon (i) on the Effective Date, by wire transfer (or as
otherwise agreed upon by the Parties), an amount equal to [**] dollars [**]; and
(ii) on or before the first anniversary of the Effective Date, by wire transfer
(or as otherwise agreed upon by the Parties) an amount equal to [**] dollars
[**].
4.2 TRANSFER PRICING. Xxxxxxx Pharma shall pay the following amounts to
Cephalon as transfer prices on Net Sales:
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
16
(a) Subject to Section 4.2(e), Xxxxxxx Pharma shall pay to Cephalon (i) a
transfer price in the amount of [**] percent [**] of the annual Net Sales of
Kyowa Licensed Products in the Territory for all annual Net Sales less than [**]
dollars [**]; and (ii) a transfer price in the amount of [**] percent [**] of
the annual Net Sales of Kyowa Licensed Products in the Territory for all annual
Net Sales equal to or greater than [**] dollars [**].
(b) If Xxxxxxx Pharma exercises its option in Section 3.3 to take an
exclusive license to Cephalon Licensed Products in the Territory, subject to
Section 4.2(e), Xxxxxxx Pharma shall pay to Cephalon a transfer price in the
amount of [**] percent [**] of the annual Net Sales of Cephalon Licensed
Products in the Territory.
(c) Notwithstanding the provisions of Sections 4.2(a) and 4.2(b), while
the parties fully expect that the transfer pricing that Cephalon will charge
Xxxxxxx Pharma hereunder for the supply of Licensed Products, which is dependent
upon the price for which Xxxxxxx Pharma will be able to sell Licensed Products
in the Territory, is reasonable and will allow each Party to make an acceptable
return for their efforts, the Parties acknowledge and agree that because the
Licensed Products are still in development and the competitive situation in the
marketplace could change unexpectedly, the transfer pricing hereunder may result
in an undue hardship on one or both of the Parties. Therefore, the parties
agree that if the transfer pricing hereunder results in a situation where
Cephalon is unable to make a fair profit [**] on the sale of Licensed Products
to Xxxxxxx Pharma, and/or in a situation where Xxxxxxx Pharma is unable to make
a fair profit (transfer prices in the ranges set forth in Section 4.2(a), above,
as a percentage of annual Net Sales) on the sale of Licensed Products in the
Territory, the parties agree to renegotiate the transfer price terms in good
faith to allow each party to make an acceptable return.
(d) Xxxxxxx Pharma shall maintain (and shall require its Affiliates,
sublicensees and third party marketers to maintain, if applicable) such records
as it creates in the ordinary course of its business of all sales of Licensed
Products pursuant to the licenses granted hereunder, for a period of not less
than five (5) years from the date of the applicable Net Sales. Cephalon shall
have the right, upon no less than two (2) weeks prior written notice to Xxxxxxx
Pharma, and at its own expense and through a certified public accountant or like
person reasonably acceptable to Xxxxxxx Pharma, to examine such records during
regular business hours during the life of this Agreement and for twelve (12)
months after the later of its termination or the last sale of Licensed Products
by Xxxxxxx Pharma subject to the transfer pricing obligations outlined above;
provided, however, that such examination shall not take place more often than
once a year and shall not cover such records for more than the preceding five
(5) years and provided further that such certified public accountant shall be
subject to the confidentiality provisions of this
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
17
Agreement, shall not retain or make copies of any Xxxxxxx Pharma records, and
shall report to Cephalon only as to the accuracy of said transfer price
statements and payments.
(e) Upon shipment of Licensed Products to Xxxxxxx Pharma, Cephalon shall
immediately invoice Xxxxxxx Pharma in the amount of a provisional transfer price
for the Licensed Products, which amount shall equal the transfer price as set
forth in Sections 4.2(a) and 4.2(b) based upon Xxxxxxx Pharma's Net Sales during
the immediately preceding calendar quarter. With respect to shipments prior to
the first commercial sale of Licensed Products and during the first two calendar
quarters after such first commercial sale only, the provisional transfer price
shall be based upon Xxxxxxx Pharma's best estimates in accordance with its most
recent sales forecasts. Within six (6) months after the first commercial sale
of said Licensed Products, Xxxxxxx Pharma shall conduct an accounting to
determine the actual Net Sales for the first two calendar quarters, and Xxxxxxx
Pharma shall pay to Cephalon within sixty (60) days any understated amounts, or
Cephalon shall pay to Xxxxxxx Pharma any overstated amounts. Thereafter, within
sixty (60) days after the end of each calendar quarter during the pendency of
this Agreement, Xxxxxxx Pharma shall deliver to Cephalon a true accounting of
all Licensed Products sold by Xxxxxxx Pharma (and by its Affiliates,
sublicensees and third party marketers, if applicable) during such calendar
quarter and shall, at the same time, Xxxxxxx Pharma shall pay all additional
transfer prices in excess of the current provisional transfer price due Cephalon
on the basis of the Net Sales attributable thereto or Cephalon shall, within
thirty days after receiving such accounting pay to Xxxxxxx Pharma any
overpayment and the provisional transfer price shall be adjusted accordingly.
Such accounting shall show sales on a country-by country and Licensed Product-
by-Licensed Product basis, and such accounting shall state the Net Sales subject
to transfer pricing under this Article 4, the calculation of transfer pricing
with respect thereto, and shall separately show the calculation of all
adjustments thereto.
4.3 Milestone Payments.
(a) In consideration of the rights granted pursuant to this Agreement and
for so long as this Agreement has not been terminated, Xxxxxxx Pharma shall pay
to Cephalon those amounts set forth below (subject to Section 4.3(b), Section
4.3(c) and Section 4.4 hereof) by wire transfer (or as otherwise agreed by the
parties) not later than thirty (30) days following the completion of the
milestones set forth below:
(i) [**]
(ii) [**]
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
18
(iii) [**]
(iv) [**]
(v) [**]
(b) For each of the milestones set forth in Sections 4.3(a)(i)- (v),
above, Cephalon shall receive payment for any one of the Lead Compound, CEP-751
or CEP-2563 which achieves the individual milestone, and any one of the Backup
Compounds which achieves the individual milestone, without regard to whether the
milestone is achieved in the US Program or the Development Program.
(c) With respect to unpaid milestones under 4.3 (a) (ii) and 4.3 (a) (iv)
relating to any Pivotal Trial(s) the design of which was not accepted in writing
by Xxxxxxx Pharma, but for which Xxxxxxx Pharma receives notice from the EMEA
accepting such MAA, such milestones shall be due and payable immediately (and no
later than thirty [30] days subsequent to the notice from the EMEA of the
validation of such MAA).
4.4 Credits Against Milestone Payments. Milestone payments made by Xxxxxxx
Pharma under the terms of Section 4.3 hereof in connection with the Lead
Compound, CEP-751, CEP-2563 or a Backup Compound that subsequently "fails in
development" (as defined below), or for which Xxxxxxx Pharma otherwise fails to
obtain approval of the applicable MAA, and is subsequently replaced by a Backup
Compound that is so designated by Xxxxxxx Pharma for the same indication, shall
be credited against milestone payments for such Backup Compound. Failure in
development shall mean a) any failure to reach the defined success criteria in
the clinical program of the US Program or the Development Program with respect
to safety and/or efficacy, b) any failure to fulfill clinical or preclinical
regulatory requirements established by the EMEA; c) any failure to meet CMC
standards; and/or d) failure of the Compound to demonstrate a sufficient
competitive profile of safety, efficacy or price to support commercialization.
4.5 Development Budget Variances. Xxxxxxx Pharma shall provide to Cephalon,
upon Cephalon's reasonable request, documentation that supports the expenses
incurred by Xxxxxxx Pharma under the Development Budget. Cephalon shall have
the right, at its own expense and through a certified public accountant or like
person reasonably acceptable to Xxxxxxx Pharma, to audit the records supporting
the Development Budget during regular business hours during the life of this
Agreement and for twelve (12) months after the later of its termination or the
last sale of Licensed Products by Xxxxxxx Pharma. If Xxxxxxx Pharma fails to
spend at least [**]of the
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
19
[**] dollar [**] Development Budget under the Development Plan, then Xxxxxxx
Pharma agrees to pay Cephalon [**] percent [**] of the difference between [**]
dollars [**] and the actual amount Xxxxxxx Pharma spends on the Development
Plan, but in no case more than [**] dollars [**], by the date of the first
commercial sale of Licensed Product. Such payment shall be made by Xxxxxxx
Pharma to Cephalon on or before the date of the first anniversary of the first
commercial sale. If, based on European regulatory requirements or state-of-the-
art medical practice, Xxxxxxx Pharma spends in excess of [**] of the [**] dollar
[**] Development Budget under the Development Plan, then Cephalon agrees to pay
Xxxxxxx Pharma [**] percent [**] of the difference between [**] dollars [**] and
the actual amount Xxxxxxx Pharma spends on the Development Plan, but in no case
more than [**] dollars [**], by the date of the first commercial sale of
Licensed Product, provided, however, that in no event shall Xxxxxxx Pharma
charge any costs to the Development Budget to the extent that such costs were
incurred by Xxxxxxx Pharma because of Xxxxxxx Pharma's gross negligence in the
conduct of the Development Program. Such payment shall be made either as direct
payment or credits against Xxxxxxx Pharma milestone payments, at Xxxxxxx
Pharma's option.
4.6 Taxes. If Xxxxxxx Pharma is required by law to withhold any taxes or
other governmental obligations from the milestone or transfer price obligations
to be paid to Cephalon under the terms of this Article 4, then Xxxxxxx Pharma
shall provide notice to Cephalon of any such requirement. In such event,
Xxxxxxx Pharma may withhold and pay such taxes or obligations on behalf of
Cephalon, provided that Xxxxxxx Pharma sends to Cephalon original receipts of
such payments (or if it is not possible to obtain an original receipt, other
official written confirmation thereof).
4.7 Payments
(a) Currency: All payments due under this agreement shall be payable in
--------
U.S. dollars. Any conversion of Net Sales from local currencies shall be made
at the average rate prevailing for the applicable calendar quarter as published
in The Wall Street Journal.
(b) Other Payments: Cephalon shall invoice Xxxxxxx Pharma for any
--------------
incremental At Cost expenses in the US Program incurred by or on behalf of
Cephalon at Xxxxxxx Pharma's request for support of the Development Program in
the Territory, and such incremental expenses shall be due and payable within
sixty (60) days of invoicing.
(c) Late Payments: Each party agrees to pay interest at the lower of the
-------------
rate of i) one percent (1%) per month compounded daily, or ii) the highest rate
allowable under applicable law, accruing from the due date of such payment, on
any payment due to the other party which is
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
20
more than thirty (30) days overdue.
Article 5. Regulatory Matters
5.1 Regulatory Approvals. Xxxxxxx Pharma shall be responsible for obtaining
and shall own all necessary regulatory and marketing approvals for the use and
sale of Licensed Products in the Territory, unless otherwise agreed to by the
Parties.
5.2 Diligence in Regulatory Submissions and Product Launch. Xxxxxxx Pharma
agrees to prepare and file XXXx for Licensed Products in the Territory using
resources as if said Licensed Products were of Xxxxxxx Pharma origin and have
the same commercial potential. Unless otherwise agreed upon by the Parties,
Xxxxxxx Pharma agrees to file a MAA with the EMEA (or with a regulatory
authority in one of the following countries: [**] within [**] following
successful completion of the Development Program (including all related
activities) for any Kyowa Licensed Products and Cephalon Licensed Products, and
to launch such Licensed Products in the Territory as soon as practicable
following the date of marketing (and, if applicable, pricing and reimbursement)
approval in each country in the Territory, and in a manner at least consistent
with the launch of other products having the same or similar commercial
potential that are marketed and sold by Xxxxxxx Pharma in such country.
Notwithstanding anything to the contrary in this Section 5.2, Xxxxxxx Pharma
agrees to use Reasonable Business Efforts to:
(a) launch the first clinical study(ies) in the Territory within [**] of
the Effective Date of this Agreement and the fulfillment of all applicable
requirements of a competent regulatory authority in the Territory and in
accordance with the Development Plan;
(b) complete the analysis and report on the first proof-of-principle
clinical study(ies) in the Territory within [**] of the Effective Date;
(c) initiate the first Pivotal Trial within [**] of the Effective Date; and
(d) file a MAA with the EMEA (or with a regulatory authority in one of the
following countries: [**] within [**] after the filing by or on behalf of
Cephalon of a NDA with the US Food and Drug Administration for any Licensed
Products, provided that the US NDA filing meets EMEA regulatory requirements, or
otherwise within [**] after completion by Xxxxxxx Pharma of the Pivotal Trial(s)
required to support an EMEA filing.
5.3 Cooperation. Both Parties hereby agree to: (i) cooperate with each other
and render
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
21
assistance in connection with the filing of a MAA (or other application for
regulatory approval) with any governmental authority or agency which may be
required, whether in or outside the Territory, to obtain approval to market
Licensed Products or to obtain pricing and reimbursement approval; and (ii)
execute documents, and provide a letter of authorization or other documentation
to the appropriate regulatory authorities or to any other governmental authority
or agency, as necessary or advisable, to enable either Party to file, refer to
or incorporate by reference all technical information including data on file
with any such agency or authority concerning Licensed Products that may be
contained in a drug master file or otherwise. In the event that any such drug
master file is supplemented or modified, each Party agrees to notify the other
Party promptly that supplements or modifications have been made.
5.4 Product Recalls. If (i) any governmental or regulatory authority issues a
request, directive, or order that any Licensed Product be recalled or withdrawn
from the market, (ii) a court of competent jurisdiction in a final,
nonappealable judgment orders a recall or withdrawal of any Licensed Product, or
(iii) following discussion between the Parties, and giving due consideration to
the views of the other Party, the Party holding the MAA (or analogous marketing
application outside the Territory) for the applicable Licensed Product
determines in its sole discretion that said Licensed Product should be recalled
or withdrawn from one or more countries within its respective territory, then
the Parties together shall take all appropriate corrective actions to effect the
recall or withdrawal. The costs and expenses of notification and destruction or
return of the recalled or withdrawn Licensed Product in the Territory shall be
borne by Xxxxxxx Pharma, provided, however, that in the case of recalls due to
latent defects in a manufacturing lot of Licensed Products which Xxxxxxx Pharma
would not have been reasonably able to detect and reject, Cephalon shall bear
such costs and expenses.
Article 6. Manufacture and Supply of Compounds and Licensed Products
6.1 Supply AgreementS.
(a) Definitive Supply Agreements. The Parties agree to negotiate in good
faith the terms of a definitive supply agreement with regard to pre-commercial
and commercial supply of Compounds (and their associated Licensed Products)
under which Cephalon will manufacture and supply Compounds and Licensed Products
to Xxxxxxx Pharma, which supply agreement shall contain terms and conditions
customary in the industry, including without limitation those relating to GMP
compliance, compliance with product specifications, quality control, records,
storage, inspection, product delivery and acceptance, lead times, firm orders,
forecasts, quantity, inventory requirements, and assurance of supply [**], and
audit rights in favor of Xxxxxxx Pharma. The supply agreement will provide that
Xxxxxxx Pharma shall purchase exclusively
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
22
from Cephalon all of Xxxxxxx Pharma's requirements for Licensed Products during
the term of this Agreement and such supply agreement shall have a term not less
than the term of this Agreement . Xxxxxxx Pharma will be responsible for
packaging and labeling the finished dosage form Licensed Products to be marketed
and sold in the Territory. Xxxxxxx Pharma shall provide to Cephalon samples of
the label, package insert, packaging, advertising and promotional materials for
each Licensed Product, and Cephalon shall, if it has any concerns regarding
compliance of such samples with applicable law as such law relates to Cephalon's
responsibilities as a manufacturer, it shall notify Xxxxxxx Pharma within thirty
(30) days after receipt of the samples.
(b) Preclinical and Clinical Supply. Until the definitive supply agreement
described in Section 6.1(a) has been executed by the parties, Cephalon agrees to
use its Reasonable Business Efforts to supply Xxxxxxx Pharma and Xxxxxxx Pharma
agrees to purchase from Cephalon sufficient quantities of preclinical and
clinical supplies of GMP quality Compounds in order to permit Xxxxxxx Pharma to
conduct the Development Program hereunder. Xxxxxxx Pharma acknowledges that
Cephalon may engage new third party manufacturers (other than those in existence
as of the Effective Date), subject to the prior written approval of Xxxxxxx
Pharma not to be unreasonably withheld or delayed, to produce the Compounds.
Xxxxxxx Pharma shall purchase exclusively from Cephalon all of Xxxxxxx Pharma's
requirements for Compounds during the term of this Agreement. Cephalon shall
provide pre-clinical and clinical supply At Cost. All such supplies shall be
provided in finished dosage form, packaged in bulk containers, ready for final
packaging and labeling. Cephalon shall use its Reasonable Business Efforts to
provide Phase III clinical supplies that either i) consist of final drug product
in the dosage form specified by Xxxxxxx Pharma to be utilized in its applicable
regulatory filing, or, ii) consist of supplies that are bioequivalent to the
final commercial dosage form, provided, however, that if such Phase III clinical
supplies do not consist of final drug product, then Cephalon shall bear any
additional development costs which may be incurred as a result. Cephalon shall
be responsible for timely compliance with all CMC requirements in the Territory,
including, without limitation, development and manufacturing of drug substance
and drug product and qualification and maintenance of manufacturing facilities.
(c) Commercial Supply. Cephalon agrees to use its Reasonable Business
Efforts to supply Xxxxxxx Pharma and Xxxxxxx Pharma agrees to purchase from
Cephalon sufficient quantities of commercial supplies of GMP quality finished
dosage form Licensed Products in the Territory, to be packaged in bulk
containers. Xxxxxxx Pharma acknowledges that Cephalon has engaged and may
engage additional third party manufacturers to produce bulk drug substance
and/or finished dosage form. Xxxxxxx Pharma shall pay Cephalon a transfer price
for finished dosage form as described in Section 4.2. Such finished dosage form
shall in all cases be
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
23
provided in a product format specified by Xxxxxxx Pharma to meet then current
European regulatory requirements specified by the EMEA. Xxxxxxx Pharma shall
purchase exclusively from Cephalon all of Xxxxxxx Pharma's requirements for the
Licensed Products during the term of this Agreement. Xxxxxxx Pharma hereby
grants to Cephalon a right of first negotiation to obtain from Xxxxxxx Pharma
the right to supply Xxxxxxx Pharma with Licensed Products after the expiration
of the term of this Agreement. In the event Xxxxxxx Pharma requires supply of
Licensed Products after the termination of this Agreement, then not less than
[**] prior to the expiration or termination of this Agreement and prior to
negotiating with any third party manufacturer, or manufacturing itself, Xxxxxxx
Pharma shall notify Cephalon of its supply requirements. Cephalon shall have
thirty (30) days thereafter to notify Xxxxxxx Pharma in writing that it is
interested in supplying Xxxxxxx Pharma. If Cephalon so notifies Xxxxxxx Pharma
then the parties shall proceed in good faith to negotiate a supply agreement for
Licensed Products. If Cephalon notifies Xxxxxxx Pharma that it is not interested
in such a supply arrangement, or fails to notify Xxxxxxx Pharma within such
thirty-day period, or fails to reach agreement with Xxxxxxx Pharma on the terms
of such supply arrangement within ninety (90) days after such notification, then
Xxxxxxx Pharma shall be free to negotiate with any third party for supply. In
the event that Cephalon determines to directly manufacture Licensed Products, or
to contract with a new or additional third party manufacturer for supplies of
Licensed Product at any time, then, if that Licensed Product is either currently
under development or being commercialized by Xxxxxxx Pharma, Cephalon shall
promptly notify Xxxxxxx Pharma and, upon the request of Xxxxxxx Pharma, the
parties shall discuss the possibility of Cephalon granting manufacturing rights
to Xxxxxxx Pharma to make Licensed Product for sale in the Territory.
Article 7. Marketing, Promotion and Sale of Product
7.1 MARKETING. Xxxxxxx Pharma agrees to use its Reasonable Business Efforts
to promote the sale of Kyowa Licensed Products and Cephalon Licensed Products in
the Territory and to maximize the Net Sales thereof. In connection with these
efforts, Xxxxxxx Pharma shall regularly prepare and update a commercialization
plan (the "Marketing Plan") for review by Cephalon not less than once per
calendar year following the filing of the first MAA, which Marketing Plan will
set forth the Licensed Product marketing and selling strategies, and will
include an estimated promotional budget, detailing objectives, planned training
and educational programs for its sales force, upcoming symposia, seminars and
professional relations events in the Territory, and other matters appropriate
and customary in the industry for such a Marketing Plan, all of which shall give
due consideration to the experience and perspective of Cephalon with respect to
optimal marketing and selling practices in the Territory. With respect to
Licensed Products, Xxxxxxx Pharma agrees to provide that level of sales and
promotional support which is, in the aggregate, at a level comparable to that
incurred in the industry for pharmaceutical
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
24
products of comparable market potential. All Know-How resulting from
implementation of the Marketing Plan will be owned by Xxxxxxx Pharma and made
available to Cephalon as set forth in Article 8 Notwithstanding Cephalon's
review of the Marketing Plan, Xxxxxxx Pharma shall have the final authority to
determine product positioning, pricing [subject to Section 4.2(c)] and all other
marketing and promotional issues, expenditures and activities. If Xxxxxxx Pharma
determines in good faith that it would not be in the mutual best interests of
the Parties for it to commence (or to continue, as the case may be) marketing
and selling Kyowa Licensed Products or Cephalon Licensed Products in any given
country in the Territory for which it has received marketing approval, then it
will promptly notify Cephalon of such determination and the Parties will discuss
appropriate resolution, which may include the forfeiture of territorial rights
in such countries to Cephalon under terms and conditions to be mutually agreed
upon; provided however, that Xxxxxxx Pharma shall be deemed to be marketing and
selling the applicable Licensed Product in all countries of the European Union
if it is marketing and selling said Licensed Product in each of the following
countries: [**].
7.2 Compliance. Xxxxxxx Pharma shall have obtained and shall maintain in
good standing all required permits, licenses and regulatory approvals necessary
or advisable to market, promote, sell and distribute Licensed Products in the
Territory. Xxxxxxx Pharma shall comply with all local laws, rules, regulations,
and reporting requirements in force in the Territory covering, among other
things, the marketing, promotion and sale, and the payment for, the Licensed
Products.
7.3 Sale of Product. Prior to filing the initial MAA for a Licensed Product in
the Territory, Xxxxxxx Pharma will provide to Cephalon in writing its good faith
non-binding forecast of aggregate Net Sales to be obtained in the Territory for
at least the first three calendar years after the first commercial sale
hereunder, and thereafter shall provide to Cephalon its sales forecasts for such
Licensed Product as generated in the ordinary course of its business ("Annual
Sales Forecasts"). In the event that a Licensed Product has more than one
indication, the Annual Sales Forecasts may include separate minimum Annual Sales
Forecasts for each Licensed Product indication. If, despite its Reasonable
Business Efforts, Xxxxxxx Pharma fails to meet its most recent Annual Sales
Forecasts , then the Parties shall meet to discuss whether such shortfall is due
principally to market conditions beyond the control of Xxxxxxx Pharma, or
whether certain marketing and sales initiatives or other actions should be
taken.
Article 8. Rights to Data and Regulatory Compliance
8.1 Sharing of Data. Subject to the license grants set forth in Article 3,
the Parties shall provide to each other and have reciprocal rights to use, in
connection with the development and
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
25
commercialization of Compounds, all Know-How generated either by or for either
Party, or jointly by or for the Parties, under the Development Program or the US
Program in each of its respective territories. Such Know-How may be used by
Cephalon inside or outside the Territory and inside or outside the Field subject
to the rights of Xxxxxxx Pharma to use all such Know-How set forth herein.
Xxxxxxx Pharma agrees to use Cephalon's Know-How and any other Know-How, to the
extent such Know-How is directly related to Compounds or Licensed Products,
solely for the development of Compounds within the Field and the
commercialization of Licensed Products within the Territory . The Parties shall
agree on a format to be used to enable the Parties to have prompt, electronic
access to all data generated (whether generated jointly or by or on behalf of
either Party separately), subject to appropriate electronic encryption and other
confidentiality requirements to preserve the integrity of each party's
proprietary data.
8.2 Adverse Drug Events. The Parties hereby agree that, not later than sixty
(60) days after the Effective Date, they will establish procedures for the
handling and reporting of adverse events ("AEs"), and that such procedures
shall require that the Parties inform each other in an appropriate and efficient
manner of any such AEs with respect to Compounds and the Licensed Products,
taking into account those procedures used regularly by the Parties and those
requirements of the EMEA, the FDA and other relevant regulatory authorities.
Details of the AE exchange with respect to e.g. form, content, timelines, etc.
will be agreed and documented by the Parties respective drug safety departments.
Notwithstanding the above, Cephalon shall be allowed to retain copies in
electronic or other formats of all information relating to adverse drug events
for any Compound recorded in the Development Program and in the US Program.
8.3 Notice of Governmental Action. During the term of this Agreement, each
Party further agrees to immediately notify the other Party about any information
such Party received regarding any threatened or pending action by a governmental
agency which may involve the safety and efficacy claims of Compounds or Licensed
Products or the continued clinical testing or marketing thereof. Upon receipt
of any such information, Cephalon shall consult with Xxxxxxx Pharma in an effort
to arrive at a mutually acceptable procedure for taking appropriate action;
provided, however, that nothing contained herein shall be construed as
restricting the right of either Party to make a timely report of such matter to
any government agency or take other action that it deems to be appropriate or
required by applicable law or regulation.
Article 9. Limited Liability
OTHER THAN THOSE WARRANTIES SET FORTH IN SECTION 16 BELOW, CEPHALON MAKES NO
WARRANTY (EXPRESS OR IMPLIED) AS TO THE
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
26
COMPOUNDS OR THE LICENSED PRODUCTS. EXCEPT AS OTHERWISE PROVIDED HEREIN, THE
SOLE AND EXCLUSIVE REMEDY OF XXXXXXX PHARMA FOR ANY LIABILITY OF ANY KIND,
INCLUDING LIABILITY BASED ON WARRANTY FOR COMPOUND SUPPLIED TO XXXXXXX PHARMA BY
CEPHALON (EXPRESS OR IMPLIED, WHETHER CONTAINED HEREIN OR ELSEWHERE),
NEGLIGENCE, STRICT LIABILITY, CONTRACT OR OTHERWISE IS LIMITED TO THE
REPLACEMENT OF COMPOUND OR LICENSED PRODUCT (AS THE CASE MAY BE) OR THE REFUND
OF THE SUPPLY PRICE THERFOR. CEPHALON SHALL IN NO CASE BE LIABLE FOR SPECIAL,
INCIDENTAL, OR CONSEQUENTIAL DAMAGES OF ANY KIND, INCLUDING LOST PROFITS.
Article 10. Trademark for Licensed Products
10.1 Selection of Trademarks. The Parties acknowledge that it may be in their
mutual best interests to attempt to develop a single trademark for use within
and outside the Territory for a given Licensed Product, and agree to discuss the
choice and selection of the trademark at an appropriate time prior to commercial
launch. Any single trademark for use within the Territory and within the United
States for a given Licensed Product shall be made in accordance with Section 4.3
of the TAP Agreement. In the event that such trademark is licensed by TAP to
Cephalon, then Cephalon shall grant to Xxxxxxx Pharma a royalty-free, exclusive
sublicense to such trademark for use with the Licensed Products in the
Territory for the term of this Agreement. All other such trademarks in the
Territory shall be owned by, and registered in the name of Xxxxxxx Pharma.
Cephalon agrees that Cephalon will select for its own marketed products
trademarks not confusingly similar to the trademarks chosen for the Licensed
Products.
Article 11. Inventions
11.1 Disclosure of Inventions. During the pendency of this Agreement, the
Parties agree to disclose to each other any and all inventions, discoveries and
improvements that may be conceived, reduced to practice, or made by either Party
while engaged in the performance of this Agreement and that are within the scope
of the licenses granted under Article 3 hereof,]whether patentable or
unpatentable including without limitation any new compositions, formulations,
uses, dosages, methods of formulating, processes, methods of manufacture or the
administration thereof (collectively, "Improvements"). The Parties further
agree to exchange any Know-How related to or covered by the Improvements that is
reasonably necessary in order to utilize such Improvements.
11.2 Inventorship. Inventorship and ownership with respect to all patentable
Improvements
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
27
shall be determined in accordance with U.S. patent law.
11.3 Ownership. All Improvements to the extent directly related to the
Compounds, whether discovered or developed by Cephalon, by Xxxxxxx Pharma or
jointly by Cephalon and Xxxxxxx Pharma in collaboration hereunder, shall be
owned by Cephalon. Cephalon shall xxxxx Xxxxxxx Pharma an option for an
exclusive, royalty-free license to use and sell such Improvements in the
Territory, but only to use and sell Compounds in the Field or Licensed Products
in the Territory. All Improvements discovered or developed solely by Xxxxxxx
Pharma during the performance of this Agreement to the extent that they are not
directly related to the Compounds, shall be owned by Xxxxxxx Pharma. Xxxxxxx
Pharma shall grant Cephalon an option for an exclusive, royalty-free license to
such Improvements outside the Territory , but only to make, have made, use and
sell Compounds or Licensed Products outside the Territory. All Improvements
discovered or developed jointly by Cephalon and Xxxxxxx Pharma during the
performance of this Agreement that are not directly related to the Compounds,
shall be owned jointly by Cephalon and Xxxxxxx Pharma. Each party shall grant
to the other party an option for an exclusive, royalty-free license to such
jointly owned Improvements that are not directly related to the Compounds,
outside the Territory as to Cephalon, and in the Territory as to Xxxxxxx Pharma,
but in each case only to make, have made, use and sell Compounds and Licensed
Products.
Article 12. Patent Rights. Each Party, at its own expense, shall prepare, file,
prosecute and maintain all patents and patent applications for Improvements that
it owns. Each Party shall keep the other Party fully advised of the status of
all such patents and patent applications. In addition, each party shall make
Reasonable Business Efforts to send the other Party advance drafts of any papers
to be filed relating to such patents and patent applications and shall consider
the suggestions of the other Party and its patent counsel with respect to the
prosecution and maintenance of such patents and patent applications. If a Party
fails to prepare, file, prosecute or maintain such patents and patent
applications as required by this Agreement, it shall immediately notify the
other Party and the other Party shall have the right to assume responsibility
and control at its own expense for said preparation, filing, prosecution and
maintenance of such patents and patent applications in the name and on the
account of the original party. Each Party shall cooperate reasonably with the
other upon request in promptly executing any and all such patent applications,
or other instruments deemed necessary or useful by either or both Parties in
connection with the application prosecution or maintenance of such patents or
patent applications.
Cephalon, at its own expense, shall prepare, file, prosecute and maintain
all Patent Rights for Cephalon Technology in the Territory. Cephalon shall keep
Xxxxxxx Pharma fully advised of
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
28
the status of all Patent Rights. In addition, Cephalon shall make commercially
reasonable efforts to send Xxxxxxx Pharma advance drafts of any papers to be
filed relating to Patent Rights in the Territory and shall consider the
suggestions of Xxxxxxx Pharma and its patent counsel with respect to the
prosecution and maintenance of Patent Rights in the Territory. If Cephalon fails
to prepare, file, prosecute or maintain Patent Rights in the Territory as
required by this Agreement, it shall immediately notify Xxxxxxx Pharma and then
Xxxxxxx Pharma shall have the right to assume responsibility and control at its
own expense for said preparation, filing, prosecution and maintenance of any
such Patent Rights in the name and on the account of Cephalon. Each Party shall
cooperate reasonably with the other upon request in promptly executing any and
all patent applications, or other instruments deemed necessary or useful by
either or both Parties in connection with the application, prosecution or
maintenance of Patent Rights in the Territory.
Article 13. Infringement
13.1 Notice Regarding and Authority to Take Action Against Infringers. Each
Party shall promptly notify the other Party of any identified infringement by
third parties of the proprietary rights of either Party with regard to Compounds
and Licensed Products. If any of the Patent Rights are infringed in the any of
the following countries[**], then Cephalon shall have the obligation to
commence appropriate legal action to enjoin such infringement at its sole
expense, and Xxxxxxx Pharma shall provide its complete cooperation to Cephalon
in doing so, at Xxxxxxx Pharma's expense. If any of the Patent Rights are
infringed in any of the remaining countries in the Territory, Cephalon shall
have the right but not the obligation to commence appropriate legal action to
enjoin such infringement at its sole expense, and Xxxxxxx Pharma shall provide
its complete cooperation to Cephalon in doing so, at Xxxxxxx Pharma's expense.
If, in the latter case, Cephalon fails to initiate such action within ninety
(90) days after being notified of the infringement, Xxxxxxx Pharma shall have
the right, but not the obligation, to undertake such action at its own expense,
in the name of Cephalon, and Cephalon agrees to provide its complete
cooperation to Xxxxxxx Pharma, at Cephalon's expense. Any damages or awards
resulting from the prosecution of such claim shall be applied first, to
reimburse the parties pro-rata for their costs and expenses, with any balance to
be shared by the Parties in proportion to their respective economic losses from
such infringement. Notwithstanding the foregoing, the Parties acknowledge that
the Kyowa License, which is attached hereto as Exhibit D, establishes all
applicable procedures and responsibilities for enforcement of rights relating to
the Kyowa Technology.
13.2 Notice of Infringement of Third Party Proprietary Rights. Each Party shall
promptly notify the other Party of any notification received or claim against it
asserting infringement of third party proprietary rights by Licensed Products,
Compounds, Know-How or Improvements.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
29
13.3 Infringement of Third Party Proprietary Rights. If a claim alleging
infringement of third party proprietary rights in the Territory is made against
Xxxxxxx Pharma, then Cephalon may elect to defend against such a claim on behalf
of Xxxxxxx Pharma at the cost and expense (including, without limitation,
attorneys fees) of Cephalon, but Xxxxxxx Pharma may be represented in such event
by legal counsel in an advisory capacity at its own expense. However, if
Cephalon does not elect to defend against such a claim within one hundred twenty
(120) days after receiving notice (whether from Xxxxxxx Pharma or otherwise) of
such claim, Xxxxxxx Pharma has the right, but not the obligation, to defend
against such claim at its own expense. The Party assuming said defense shall
keep the other Party informed of the status of the case. If the Party assuming
said defense determines to file a counterclaim against the third party claiming
infringement, and subsequently prevails in obtaining damages or awards, then
such award or damages shall be divided on the same basis as set forth in Section
13.1, above. Regardless of which Party assumes the defense of any such claim,
if damages are awarded based upon said claim, then the Parties shall allocate
the responsibility for paying said damages in proportion to their respective
economic interests in the country or countries within the Territory as to which
such damage award is based. Notwithstanding the foregoing, the Parties
acknowledge that the Kyowa License, which is attached hereto as Exhibit D,
establishes all applicable procedures and responsibilities for the defense of
infringement claims raised with respect to Kyowa Licensed Products.
Article 14. Term and Termination
14.1 Term of the Agreement. This Agreement shall commence as of the Effective
Date, and will terminate by mutual agreement of the Parties, or otherwise in
accordance with the provisions of this Article 14. The parties obligations with
respect to Sections 4.2 and 4.6 and Article 6 shall expire upon the last to
occur of (i) the expiration date of the last to expire of Valid Claims of Patent
Rights to any Licensed Product; (ii) the end of any period of market exclusivity
under any MAA for any Licensed Product (or under the terms of applicable laws
and regulations); or (iii) that date which is the tenth (10th) anniversary of
the first commercial sale of a Licensed Product by Xxxxxxx Pharma in the
Territory.
14.2 Termination of Development Program for a Compound. All rights to any
Compounds for which development has been discontinued in its entirety by Xxxxxxx
Pharma, including any rights of use to Kyowa Technology and Cephalon Technology
related to such Compound, automatically shall revert to Cephalon, subject to the
terms of this Agreement..
14.3 Termination for Breach by Either Party. Upon breach of any material
provision of
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
30
this Agreement, the breaching Party will be given written notice and ninety (90)
days within which to remedy such breach. Failure to remedy any such breach
within this time period (or if the breach is not capable of remedy in such time
period, to undertake continuous and diligent efforts to remedy such breach) will
constitute sufficient grounds for termination by the other Party without any
further notice. Upon termination of this Agreement due to unremedied breach by
either Party, the breaching Party shall have no liability to the other Party (or
to any third party)for any damages, losses, indemnity, compensation, costs or
expenses of any kind for lost profits or prospective sales, investments made or
expenses incurred in connection with the establishment, development or
maintenance of its business, markets or customers, fees for transferring
Compounds, product registrations, or any similar claims, damages, fees or
payments.
14.4 Termination by Xxxxxxx Pharma. Xxxxxxx Pharma shall have the right to
terminate this Agreement at any time upon no less than (i) six (6) months prior
written notice to Cephalon up until commercial launch of the first Licensed
Product in the Territory or upon (ii) twelve (12) months prior written notice to
Cephalon at any time thereafter.
14.5 Termination for Product Failure. Either Party shall have the right to
terminate this Agreement with respect to a particular Compound or Licensed
Product upon thirty (30) days written notice if nonclinical or clinical evidence
about that Licensed Product demonstrates a sufficiently serious adverse
risk/benefit profile that further development or commercialization of such
Compound or Licensed Products permanently suspended a regulatory authority or
other authority of competent jurisdiction in any Major Country of the Territory.
14.6 Effects of Termination. Upon termination of this Agreement due to
unremedied breach by Xxxxxxx Pharma, unilateral termination by Xxxxxxx Pharma,
or upon termination of this Agreement by the mutual agreement of the Parties,
the following provisions shall apply:
(a) Xxxxxxx Pharma acknowledges that except as provided herein, upon any
such termination it shall have no further rights with respect to the Cephalon
Technology, the Kyowa Technology, the Compounds and the Licensed Products. All
rights granted to Xxxxxxx Pharma under this Agreement shall immediately revert
to Cephalon, except as provided below, and Xxxxxxx Pharma shall immediately
cease its use of Cephalon Technology and Kyowa Technology. To the extent
necessary or advisable, at the request of Cephalon Xxxxxxx Pharma immediately
will grant to Cephalon a perpetual, exclusive (exclusive even as to Xxxxxxx
Pharma), fully-paid, royalty-free license under any Patent Rights, Know-How,
Improvements, trademarks or any other proprietary rights whatsoever held by
Xxxxxxx Pharma necessary to enable Cephalon to make, have made, use and sell
Licensed Products in the Territory, and Xxxxxxx Pharma will execute any
documents necessary to facilitate the intent of this paragraph;
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
31
(b) Any outstanding unpaid invoices shall become due and payable
immediately in lieu of any payment terms previously agreed upon by the Parties;
(c) Xxxxxxx Pharma shall cease use of all Compounds in the Territory, and
shall cease all marketing, sales and distribution of Licensed Products in the
Territory; provided, however, that Xxxxxxx Pharma shall have the right to sell
in accordance with the terms of this Agreement all unsold inventories of any
such Licensed Products in its possession unless Cephalon, at its sole
discretion, shall exercise the option, by written notice to Xxxxxxx Pharma on or
before the effective date of such expiration or termination, to repurchase all
remaining inventory then held by Xxxxxxx Pharma at a purchase price equal to the
cost of Products of such inventory; and
(d) Xxxxxxx Pharma will provide Cephalon with all copies of any MAA (or its
equivalent outside the Territory) for Compounds or Licensed Product and any
accompanying documentation (including without limitation all regulatory agency
correspondence) in its possession or, if such registration application has not
yet been filed in the Territory prior to the date of said termination or
expiration, with all Know-How relating to all Compounds in its possession on
such date. At the request of Cephalon, Xxxxxxx Pharma shall take all steps as
may be required by applicable law to transfer any such registration for
Licensed Products to Cephalon, or otherwise to enable Cephalon to market and
sell Licensed Products in the Territory, and also shall provide full support
to Cephalon to facilitate the prompt execution of such legal transfer. In no
event shall Cephalon be obligated to pay any fee or to make any other payment to
Xxxxxxx Pharma, to the local government in the Territory, or to any third party,
to effect such legal transfer. Except for termination due to unremedied breach
by Xxxxxxx Pharma, the costs incurred in connection with such transfer or
enabling activities shall be shared equally between Xxxxxxx Pharma and Cephalon.
14.7 Bankruptcy. All rights and licenses granted under or pursuant to this
Agreement by Cephalon to Xxxxxxx Pharma, or by Xxxxxxx Pharma to Cephalon are,
and shall otherwise be deemed to be, for purposes of Section 365(n) of the
Bankruptcy Code, licenses of rights to "intellectual property" as defined under
Section 101(52) of the Bankruptcy Code. The parties agree that each of them, as
licensees of such rights under this Agreement, shall retain and may fully
exercise all of its rights and elections under the Bankruptcy Code. The parties
further agree that, in the event of the commencement of a bankruptcy proceeding
by or against either party under the Bankruptcy Code, the party not in
bankruptcy shall be entitled to a complete duplicate of, or complete access to,
as appropriate, any such intellectual property and all embodiments of such
intellectual property, and same, if not already in its possession, shall be
promptly delivered to such party not in bankruptcy (i) upon any such
commencement of a bankruptcy proceeding
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
32
upon written request therefore by the party not in bankruptcy , unless the party
in bankruptcy elects to continue to perform all of its obligations under this
Agreement, or (ii) if not delivered under (i) above, upon the rejection of this
Agreement by or on behalf of the party in bankruptcy upon written request
therefore by the party not in bankruptcy
14.9 Survival of Obligations. All terms and conditions of this Agreement
which the Parties intend to survive the expiration or termination hereof shall
so survive, and shall include without limitation, those terms and conditions
relating to confidentiality, indemnification, intellectual property rights
generally, and rights to payment. More specifically, the termination of this
Agreement shall not relieve the Parties of any obligations accruing prior to
such termination, and any such termination shall be without prejudice to the
rights of either Party against the other, including without limitation the
obligation to pay for Compounds purchased, or transfer prices for Licensed
Products sold prior to said termination.
Article 15. Confidentiality.
15.1 Confidential Information. During the term of this Agreement, and for ten
(10) years after its termination or expiration, each Party shall maintain in
confidence any information concerning the subject matter hereof provided by the
other Party (the "Providing Party"), and that is considered to be confidential
by the Providing Party, regardless of whether provided prior to or after the
Effective Date. Such information, collectively the "Confidential Information"
shall be in writing and includes but is not limited to Know-How, Patent Rights,
Improvements, Cephalon Technology and Kyowa Technology, documentation, business
plans, cost and operational information, whether or not related to Compounds or
Licensed Products. Confidential Information shall not be used or disclosed to
others except for carrying out the purpose of this Agreement. The foregoing
obligation of confidentiality shall not apply to any portion of the Confidential
Information that a Party ("Receiving Party") can demonstrate by written
documentation:
(a) was already known to the Receiving Party;
(b) was generally available to the public or otherwise part of the public
domain at the time of its disclosure;
(c) became generally available to the public or otherwise part of the
public domain after its disclosure to the Receiving Party, other than through
any act or omission of the Receiving Party in breach of this Agreement;
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
33
(d) was subsequently lawfully disclosed to the Receiving Party by a third
party; or
(e) the Receiving Party was compelled to disclose by governmental
administrative agency or judicial requirements; provided however, that any
disclosure under this subsection 15.1(e) shall neither relieve the Receiving
Party from attempting to impose confidentiality obligations on the governmental
administrative agency or judicial body, to the extent feasible, nor shall it
relieve the Receiving Party from maintaining the confidentiality of the
Confidential Information with respect to third parties other than the agency or
body as to which such compelled disclosure has been made.
15.2 Protection of Confidential Information. The Parties shall take all
reasonable steps to eliminate the risk of disclosure of Confidential
Information, including, without limitation, ensuring that only employees,
agents, consultants, and representatives with a need to know the Confidential
Information have access thereto. The Parties acknowledge by the signing of this
Agreement that such employees, agents, and representatives are to be bound by
substantially similar obligations of confidentiality as are established under
this Article 15.
15.3 Presumptive Confidentiality of Information Exchanged. All information
exchanged by the Parties under the terms and conditions of this Agreement shall
be considered Confidential Information and treated as such unless otherwise
specified and agreed upon by the Parties.
15.4 Use for Development Purposes and Following Termination For Breach. During
the term of this Agreement or in the event that this Agreement is terminated for
breach under the terms of Article 14, nothing herein shall be construed so as to
preclude a party (during the Agreement term) or the non-breaching Party (after
termination) from disclosing to a competent regulatory authority or to a third
party, under appropriate confidentiality provisions, any, Know-How,
Improvements or other Confidential Information, that it may deem necessary or
advisable in order to support the further development or commercialization of
Compounds or Licensed Products.
Article 16. Representations, Warranties and Covenants
16.1 General Representations. Each Party hereby represents and warrants to the
other as follows:
(a) Duly Organized. It is a corporation duly organized, validly existing
and in good standing under the laws of the jurisdiction of its incorporation, is
qualified to do business and is in good standing as a foreign corporation in
each jurisdiction in which the conduct of its business or
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
34
the ownership of its properties requires such qualification and has all
requisite power and authority, corporate or otherwise, to conduct its business
as now being conducted, to own, lease and operate its properties and to execute,
deliver and perform this Agreement;
(b) Due Execution. The execution, delivery and performance by it of this
Agreement have been duly authorized by all necessary corporate action and do not
and will not (i) require any consent or approval of its stockholders, (ii)
violate any provision of any law, rule, regulation, order, writ, judgment,
injunction, decree, determination or award presently in effect having
applicability to it or any provision of its charter or by-laws, or (iii) result
in a breach of or constitute a default under any agreement, mortgage, lease,
license, permit, patent or other instrument or obligation to which it is a Party
or by which it or its assets may be bound or affected;
(c) No Third Party Approval. No authorization, consent, approval, license,
exemption of, or filing or registration with, any court or governmental
authority or regulatory body is required for the due execution, delivery or
performance by it of this Agreement;
(d) Binding Agreement. This Agreement is a legal, valid and binding
obligation of such Party, enforceable against it in accordance with its terms
and conditions, except as may be limited by bankruptcy laws or other laws
affecting the rights of creditors generally, and rules of law governing
equitable remedies. Each is not under any obligation to any person, contractual
or otherwise, that is conflicting or inconsistent in any respect with the terms
of this Agreement or that would impede the diligent and complete fulfillment of
its obligations hereunder;
(e) Inventions. It will take all steps reasonably necessary to ensure that
its employees, agents, consultants and representatives convey to it all rights
in and to any and all Improvements, trademark rights or any other proprietary
rights that may be conceived or reduced to practice by said employees, agents,
consultants and representatives;
(f) Debarment. It is not debarred or suspended from receiving contracts
from the United States or German government or other governmental authority or
agency;
(g) Full Disclosure. It has disclosed in good faith any and all material
information related to the subject matter hereof and to the performance of its
obligations hereunder.
16.2 Cephalon Representations, Warranties and Covenants. Cephalon hereby
represents, warrants and covenants to Xxxxxxx Pharma that, as of the Effective
Date:
(a) Cephalon is the sole owner of the entire right, title and interest in
and to those Patent
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
35
Rights which include a Valid Claim for Compounds and the same are free of any
liens, encumbrances, restrictions, licenses and other legal or equitable claims
of any kind or nature;
(b) Cephalon is the sole licensee of the entire right, title and interest
in the part of the Kyowa Technology, which is sublicensed to Xxxxxxx Pharma
under this Agreement and the same are free of any liens, encumbrances,
restrictions, licenses and other legal or equitable claims of any kind or
nature;
(c) It has the right to grant to Xxxxxxx Pharma the licenses provided for
in this Agreement;
(d) To the best of its knowledge and belief, there are no third Party
rights, licenses or patents, other than those granted to Xxxxxxx Pharma
hereunder, which are necessary for Xxxxxxx Pharma's use and enjoyment of the
licenses granted to Xxxxxxx Pharma;
(e) Cephalon has not received any notices from any third party alleging
that Licensed Products or Compounds infringe or would infringe any third party
rights within the Territory. To the best of Cephalon's knowledge, the
manufacture, use and sale of Licensed Product in the Territory will not infringe
any such third party rights;
(f) If Xxxxxxx Pharma has exercised its option to a Backup Compound, and
provided Xxxxxxx Pharma is not in breach of the terms of this Agreement, for the
term of this Agreement, Cephalon shall not [**]. If Xxxxxxx Pharma does not
exercise its option to the Backup Compounds under Section 3.4 herein, and
provided Xxxxxxx Pharma is not in breach of the terms of this Agreement, for a
period of [**], Cephalon shall [**], Cephalon shall [**];
(g) For so long as Xxxxxxx Pharma is undertaking the Development Program
or commercializing a Licensed Product, Cephalon shall [**]; and,
(h) It shall use its Reasonable Business Efforts to:
(i) Conduct outside of the Territory at least one Pivotal Trial with
the Lead Compound (or CEP-751 or CEP-2563 if such Compounds are under
development by Xxxxxxx Pharma in the Territory) in either hormone-dependent
or hormone-independent prostate cancer, the design and execution of which
shall be coordinated with Xxxxxxx Pharma such that the results of such
Pivotal Trials may be used to support marketing approval of an EMEA
regulatory approval under the Development Program;.
(ii) Not conduct or allow to be conducted any development activities
outside the
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
36
Territory which in its reasonable business judgment would jeopardize
regulatory approval of Licensed Products worldwide;
(iii) Install electronic encryption and other confidentiality
requirements to preserve the integrity of Xxxxxxx Pharma's proprietary
data; and
(iv) Amend the TAP Agreement to include the representations set forth
in 16.2(h)(i), (ii) and (iii), above, and to provide to Xxxxxxx Pharma, no
later than the Effective Date of this Agreement, a copy of such amendment.
16.3 Xxxxxxx Pharma Representations and Covenants. Xxxxxxx Pharma hereby
represents and covenants to Cephalon that:
(a) Xxxxxxx Pharma is acknowledged by the authorities in parts of the
Territory as an approved manufacturer and marketer of drugs, and is as such
under the inspection of the competent authorities;
(b) During the term of this Agreement, it will not [**].
(c) It shall use its Reasonable Business Efforts in the Territory to
conduct at least one Pivotal Trial with the Lead Compound (or CEP-751 or CEP-
2563 if such Compounds are under development by Xxxxxxx Pharma in the Territory)
in either hormone-dependent or hormone-independent prostate cancer, the design
and execution of which shall be coordinated with Cephalon and TAP such that the
results of such Pivotal Trials may be used to support marketing approval of an
NDA under the US Program.
16.4 Warranty Disclaimers. Nothing in this Agreement shall be construed as:
(a) a warranty or representation by Cephalon as to the validity or scope of
the Cephalon Technology, other than as specifically provided to the contrary
herein;
(b) a warranty or representation that anything made, used, sold or
otherwise disposed of under this Agreement is or will be free from infringement
of patents, copyrights and trademarks of third Parties;
(c) an obligation to bring or prosecute actions or suits against third
parties for infringement, except as set forth in Section 13.1;
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
37
(d) except as otherwise provided herein, conferring rights to use in
advertising, publicity or otherwise any trademark or the name of Cephalon or
Xxxxxxx Pharma;
(e) any representation by either Party, express or implied, other than as
specifically set forth herein, including representations of merchantability or
fitness for a particular purpose, or that the use, manufacture, sale or
distribution of Licensed Products will not infringe upon any third party patent,
copyright, trademark or other rights.
Article 17. Indemnification
17.1 Xxxxxxx Pharma Indemnitees. Cephalon shall indemnify and hold Xxxxxxx
Pharma, its parent companies, Affiliates and subsidiaries, and the officers,
directors and employees of each of them (the "Xxxxxxx Pharma Indemnitees")
harmless from any and all liability, loss, damages, costs or expenses (including
reasonable attorneys' fees) stemming from third party claims or actions (or the
threat thereof) that are based upon (i) the breach of any material covenant,
representation or warranty of Cephalon contained in this Agreement; (ii) the
manufacture by Cephalon (or any Affiliate, assignee, subcontractor or
sublicensee thereof) of any Compounds or Licensed Products; and (iii) the costs
incurred by Xxxxxxx Pharma in the successful enforcement of its rights under
this Section 17.1. Notwithstanding anything to the contrary herein, Cephalon
shall have no obligation to so indemnify the Xxxxxxx Pharma Indemnitees to the
extent that such losses, liabilities, obligations, claims, fees or expenses are
based upon the conduct of the Xxxxxxx Pharma Indemnitees.
17.2 Cephalon Indemnitees. Xxxxxxx Pharma shall indemnify and hold Cephalon,
its parent companies, Affiliates and subsidiaries, and the officers, directors
and employees of each of them (the "Cephalon Indemnitees") harmless from any and
all liability, loss, damages, costs or expenses (including reasonable attorneys'
fees) stemming from third party claims or actions (or the threat thereof) that
are based upon (i) the breach of any material covenant, representation or
warranty of Xxxxxxx Pharma contained in this Agreement; (ii) the manufacture,
use, marketing, promotion, sale or distribution by Xxxxxxx Pharma (or any
Affiliate, assignee, subcontractor or sublicensee thereof) of any Compounds or
Licensed Products; (iii) the use by any person of any Licensed Products that
were manufactured, marketed, sold or distributed by Xxxxxxx Pharma (or any
Affiliate, assignee, subcontractor or sublicensee thereof), including without
limitation, any claim that said use resulted in personal injury or death; and
(iv) the costs incurred by Cephalon in the successful enforcement of its rights
under this Section 17.2. Notwithstanding anything to the contrary herein,
Xxxxxxx Pharma shall have no obligation to so indemnify the Cephalon Indemnitees
to the extent that such losses, liabilities, obligations, claims, fees or
expenses are
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
38
based upon the conduct of the Cephalon Indemnitees.
17.3 Indemnification Procedures. In the event that one Party receives notice of
a claim, lawsuit, or liability for which it is entitled to indemnification by
the other Party, the Party receiving notice shall give prompt notification to
the indemnifying Party. The Party being indemnified shall cooperate fully with
the indemnifying Party throughout the pendency of the claim, lawsuit or
liability, and the indemnifying Party shall have complete control over the
conduct and disposition of the claim, lawsuit, or liability, except that
indemnifying Party shall have no obligation to provide indemnity with respect to
any amounts paid in settlement of any claims if such settlement is effected
without the prior written consent of the indemnifying Party.
Article 18. General.
18.1 Headings. The headings and captions used herein are for the convenience
of the Parties only and are not to be construed to define, limit, or affect the
construction or interpretation thereof.
18.2 Severability. The provisions of this Agreement are separate and
divisible, and the invalidity or unenforceability of any part shall not affect
the validity or enforceability of any remaining part or parts, all of which
shall remain in full force and effect. However, the Parties agree to
substitute, any invalid or unenforceable provision, by a valid and enforceable
provision which maintains, to the greatest extent possible, the respective
interests of the Parties otherwise established hereunder.
18.3 Entire Agreement. This Agreement contains the entire agreement of the
Parties regarding the subject matter hereof and supersedes all prior agreements,
understandings or conditions (whether oral or written) regarding the same. This
Agreement may not be changed, modified, amended or supplemented except by a
written instrument signed by both Parties.
18.4 Assignability and Sublicenses. Except as otherwise provided herein, this
Agreement shall not be assignable, sublicensable or transferable, either in
whole or in part, by either Party without the prior written consent of the
other, except to an Affiliate or in connection with a merger, consolidation or
sale of all or substantially all of the line of business to which this Agreement
relates. In any event, no such assignment, sublicense or transfer shall relieve
any Party of responsibility for the performance of any accrued obligation which
such Party has then hereunder.
18.5 Publications. The Parties to this Agreement are free to make presentations
and
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
39
publications relating to the results of any activities conducted pursuant to
this Agreement prior to marketing of Cephalon Licensed Product or Kyowa Licensed
Product, but with due regard to the protection of Confidential Information and
proprietary rights and always provided that the other Party has approved the
scientific content of any such presentation or publication. For that purpose,
the Parties agree to provide the other with a copy of any proposed written
presentation, abstract and/or publication relating to the results of such
activities at least thirty (30) days prior to submission thereof for publication
or presentation thereof. Each Party will take due note of any comment by the
other Party and shall respect the response of the other Party. The parties
agree, whenever possible, to mutually develop and adhere to a single uniform
publication policy. In the event that a Party notifies the other Party that it
intends to file patent applications on any of the subject matter of the
presentation or publication, the Party publishing such publication or
presentation shall delay such publication or presentation for a reasonable
period as requested by the notifying party and not to exceed ninety (90) days to
allow the notifying Party to file such applications.
18.6 Public Announcements. Each Party agrees that, except as may be required by
law, it shall not disclose the existence, substance or details of this Agreement
without the prior written consent of the other Party. In cases in which
disclosure is proposed or required by law, the disclosing Party, prior to such
disclosure, will notify the non-disclosing Party of the contents of the proposed
disclosure, provided however, that subsequent disclosure(s) of the same or
substantially similar contents shall not require further consent. The non-
disclosing Party shall have the right to make reasonable changes to the
disclosure to protect its interests. The disclosing Party shall not unreasonably
refuse to include such changes in its disclosure. The parties will agree upon
the text of a joint announcement of this Agreement and, once agreed, the
information contained in that announcement may be used by either party in
subsequent announcements.
18.7 Further Assurances. Each Party hereto agrees to execute, acknowledge and
deliver such further instruments, and to take such other actions, as may be
necessary to appropriate in order to carry out the purposes and intent of this
Agreement.
18.8 Notices and Reports. All notices, consents or approvals required by this
Agreement shall be in writing and sent by courier or by certified or registered
air mail, postage prepaid or by facsimile or courier (confirmed by such
certified or registered mail) to the Parties at the following addresses or such
other addresses as may be designated in writing the respective Parties. Notices
shall be deemed effective on the date of mailing.
If to Cephalon:
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
40
Senior Vice President & General Counsel
Cephalon, Inc.
000 Xxxxxxxxxx Xxxxxxx
Xxxx Xxxxxxx, XX 00000-0000 XXX
Telephone: (000) 000-0000
Facsimile (000) 000-0000
If to Xxxxxxx Pharma:
Xxxxxxx Pharma AG
Xxxxxx-Xxxxx-Xxx. 00
Xxxxxxx xx Xxxxx
X-00000 Xxxxxxx
Telephone: (02173) 48.13.69
Telefax: (02173) 48.10.64
Attn: Head of Legal Affairs
18.9 Waiver. The waiver by either Party of a breach of any provisions
contained herein shall be effective only if made in writing and shall in no way
be construed as a waiver of any succeeding breach of such provision or the
waiver of the provision itself.
18.10 Dispute Resolution. Any dispute concerning or arising out of this
Agreement or concerning the existence or validity hereof, shall be determined by
the following procedure.
(a) Both Parties understand and appreciate that their long term mutual
interest will be best served by affecting a rapid and fair resolution of any
claims or disputes which may arise out of services performed under this contract
or from any dispute concerning the terms of this Agreement. Therefore, both
Parties agree to use their best efforts to resolve all such disputes as rapidly
as possible on a fair and equitable basis. Toward this end both Parties agree
to develop and follow a process for presenting, rapidly assessing, and settling
claims on a fair and equitable basis which takes into account the precise
subject and nature of the dispute.
(b) If any dispute or claim arising under this Agreement cannot be readily
resolved by the Parties pursuant to the process described above, the Parties
agree to refer the matter to a panel consisting of the Chief Executive Officer
("CEO") of each Party for review and resolution. A copy of the terms of this
Agreement, agreed upon facts (and areas of disagreement), and concise summary of
the basis for the contentions of each Party will be provided to both such CEOs
who shall review the same, confer, and attempt to reach a mutual resolution of
the issue.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
41
(c) Any dispute controversy or claim arising out of or relating to the
validity, construction, enforceability or performance of this Agreement,
including disputes relating to an alleged breach or to termination of this
Agreement and including any claim of inducement by fraud or otherwise, but
excluding any dispute, controversy or claim arising out of or relating to the
validity, enforceability, or infringement of any Patent Rights , which cannot be
resolved by good faith negotiation between the parties as set forth in paragraph
18.10(b), above, shall be resolved by arbitration conducted in the English
language in New York, New York before a panel of three arbitrators under the
then current rules and procedures of the International Chamber of Commerce, or
other rules and procedures as the parties may agree. The prevailing party in
any such proceeding shall be entitled to an award of its reasonable attorneys'
fees and other costs, including the fees and expenses of the arbitrators,
provided that the same may be apportioned between the parties by the arbitrators
if they determine that each party has prevailed in part. The arbitral award
shall be binding and conclusive on both parties and may be enforced in any court
of competent jurisdiction. Notwithstanding the foregoing, either party may, on
good cause shown, seek a temporary restraining order and/or a preliminary
injunction from a court of competent jurisdiction, to be effective pending the
institution of the arbitration process and the deliberation and award of the
arbitration panel
(d) This Agreement shall be governed by and construed in accordance with
the substantive laws of the State of New York and of the United States of
America, without regard to the conflicts of laws provision thereof. Judgment
upon any award rendered in such event may be entered in any court having
jurisdiction and the Parties hereby consent to the said jurisdiction and venue,
and further irrevocably waive any objection which either Party may have now or
hereafter to the laying of venue of any proceedings in said courts and to any
claim that such proceedings have been brought in an inconvenient forum, and
further irrevocably agrees that a judgment or order in any such proceedings
shall be conclusive and binding upon the Parties and may be enforced in the
courts of any other jurisdiction thereof.
18.11 Force Majeure. A Party shall not be liable for nonperformance or delay
in performance (other than of obligations regarding any payments or of
confidentiality) caused by any event reasonably beyond the control of such Party
including, without limitation, wars, hostilities, revolutions, riots, civil
disturbances, national emergencies, strikes, lockouts, unavailability of
supplies, epidemics, fires, floods, earthquakes, other forces of nature,
explosions, embargoes, or any other Acts of God, or any laws, proclamations,
regulations, ordinances, or other acts or orders of any court, government or
governmental agency. Any occurrence of Force Majeure shall be reported promptly
to the other Party.
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
42
IN WITNESS THEREOF, the Parties have executed this Agreement by their duly
authorized representatives, as of the day and year first above written.
XXXXXXX PHARMA AG CEPHALON, INC.
By:__________________________ By:__________________________
Xxxxxxx Xxxxxxx-Xxxxxxx Xxxxx X. Xxxxxx,Ph.D.
Chairman of the Executive Board Senior Vice President
Worldwide Business Development
By:__________________________
Xxxx Xxxxx, M.D., Ph.D.
Member of the Executive Board
Research & Development
**Certain portions of this exhibit have been omitted based upon a request for
confidential treatment that has been filed with the Commission. The omitted
portions have been filed separately with the Commission.
43
