EXHIBIT 10.23
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
LICENSE AGREEMENT
This License Agreement ("AGREEMENT") is made as of this 30th day of
June 2003 (the "EFFECTIVE DATE") by and between XXXXXX LABORATORIES, an Illinois
corporation, with its principal office at 000 Xxxxxx Xxxx Xxxx, Xxxxxx Xxxx, XX
00000-0000 ("ABBOTT") and MYOGEN, INC., a Delaware corporation, with its
principal office at 0000 X. 000xx Xxxxxx, Xxxxxxxxxxx, XX 00000-0000 ("MYOGEN").
WITNESSETH
WHEREAS, Abbott is the holder or licensee of certain patent applications and
patents ("Patents," as more fully defined below) relating to Compound (as
defined below);
WHEREAS, Abbott also possesses proprietary Know-How (as defined below) relating
to Compound; and
WHEREAS, Myogen wishes to obtain, and Abbott wishes to grant to Myogen, an
exclusive license in the Myogen Territory (as defined below) under the Abbott
Technology (as defined below) for the development and commercialization of
Product for use in the Field (as defined below).
NOW, THEREFORE, in consideration of the mutual obligations and promises as set
forth herein, the parties do hereby agree as follows:
1. DEFINITIONS
In addition to the terms defined in the other provisions of this
Agreement, as used in this Agreement, the following terms shall have
the following respective meanings:
1.1 "ABBOTT TECHNOLOGY" means the Patents and Know-How, including
all Improvements developed by Abbott and Improvements that are
jointly developed by Abbott and Myogen pursuant to Article 15.
1.2 "AFFILIATE" means any corporation, company, partnership, joint
venture and/or firm, which controls, is controlled by, or is
under common control with either party hereto. For purposes of
this definition, control shall mean direct or indirect
ownership of more than fifty percent (50%) of the stock or
participating shares entitled to vote for the election of
directors (but only as long as such ownership exists).
1.3 "API" means the Compound in an active pharmaceutical form
suitable for manufacture of Product.
1.4 CANCER FIELD means the prophylactic or therapeutic
administration to humans or non-human animals as an agent,
either alone or in combination with other agents, for the
prevention, treatment or palliation of cancer including
neoadjuvant,
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
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RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
adjuvant or supportive care and/or as part of combination with
radiotherapy, surgery, chemo-, biologic- or other therapy
associated with cancer, including, but not limited to, pain
and bone/skeletal complications or indications from bone
metastasis.
1.5 "CO-MARKETING" means the sale by Myogen and Abbott of the same
formulation of a Product independently under separate trade
names in a particular country.
1.6 "COMBINATION PRODUCT" means a pharmaceutical product that is
comprised in part of API and in part of one or more other
pharmaceutically active agents in any configuration,
formulation or combination.
1.7 "COMMERCIALLY REASONABLE EFFORTS" means the level of efforts
and resources required to carry out clinical or regulatory
development, manufacturing, or commercialization, as
applicable, of Product in a manner consistent with the efforts
that a similarly situated pharmaceutical company would
typically devote to a product of similar market potential,
profit potential and strategic value.
1.8 "COMPOUND" means the compound identified as LU 135252
(Darusentan) with the following formula:
[GRAPHIC FORMULA]
and its racemates, isomers, Prodrugs, active metabolites and
any pharmaceutically acceptable salt or complex thereof, in
its current and any other formulation, whether made before or
after the Effective Date.
1.9 "CONFIDENTIAL INFORMATION" means any and all information or
data relating to the Compound and/or Product which a party
discloses to the other party, its employees or
representatives, including information that is conceived or
reduced to practice during the Term by either party or by a
Third Party conducting feasibility and evaluation studies for
Myogen, whether in writing, orally or by observation,
including, without limitation, all scientific, clinical,
technical, commercial, financial and business information and
Know-How, and other information or data that is identified as
confidential at the time it is communicated. Confidential
Information shall not include information or any portion
thereof which:
(a) is known to the receiving party at the time of
disclosure and documented by written records made
prior to the date of this Agreement;
(b) is subsequently disclosed to the receiving party
without any obligations of confidence by an
unaffiliated third person who has not obtained it
directly or indirectly from the other party and who
has the right to make such disclosure;
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 2
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
(c) becomes patented, published or otherwise part of the
public domain; or
(d) is independently developed by or for the receiving
party by person(s) having no knowledge of or access
to such information and without breach of any
confidentiality obligation as evidenced by its
written records.
(e) The contents of and the Exhibits to this Agreement
shall constitute Confidential Information.
1.10 "CO-PROMOTION" means the joint promotion of the Product by the
parties under the same brand name and label.
1.11 "CO-PROMOTION AGREEMENT" means the agreement setting forth the
terms governing the parties Co-Promotion arrangement, to be
negotiated by the Parties upon Xxxxxx'x exercise of the
Co-Promotion Option.
1.12 "CO-PROMOTION OPTION" shall have the meaning ascribed to such
term in Section 3.1 of this Agreement
1.13 "CO-PROMOTION TERRITORY" means any country in the Myogen
Territory where Abbott has entered into a Co-Promotion
Agreement with Myogen.
1.14 "CRD" means the medical condition commonly known as chronic
renal disease.
1.15 "EFFECTIVE DATE" shall have the meaning ascribed to such term
in the opening paragraph of this Agreement.
1.16 "EMEA" means the European Medicines Evaluation Agency, or any
successor thereto.
1.17 "EUROPE" means all members of the European Union as of the
Effective Date.
1.18 "EU Major Markets" means the following countries:
United Kingdom, Spain, France, Italy and Germany.
1.19 "FIELD" means all human and non-human diagnostic, prophylactic
and therapeutic uses of the Compound and/or Product in any
formulation or dosage form for any and all indications except
therapeutic uses and indications in the Cancer Field.
1.20 "FIRST COMMERCIAL SALE" means the first sale of Product in the
Myogen Territory, after Regulatory Approval, by Myogen, any
Affiliates or sublicensees of Myogen, or any contract sales
force of Myogen or its Affiliates, to any unaffiliated Third
Party as evidenced by the selling party's invoice or other
relevant document provided to such Third Party. A sale to an
unaffiliated Third Party shall not include quantities
delivered solely for research purposes, for clinical trials or
quantities distributed as free samples or promotions.
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 3
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
1.21 "IMPROVEMENTS" means all additions, developments,
modifications, enhancements and adaptations (i) which directly
relate to or are used in connection with the Compound and/or
Product, or any formulations thereof or additions,
developments, modifications, enhancements, improvements and
adaptations thereto, and (ii) which are conceived or reduced
to practice during the Term. Ownership of Improvements shall
be as set forth in Article 15 hereof.
1.22 "IND" means an investigational new drug application filed with
the applicable Regulatory Authority in a country of the Myogen
Territory, in order to commence human clinical testing of a
drug. An IND, together with all supplemental filings
referencing the initial IND filing, shall be deemed one and
the same IND for all purposes of this Agreement.
1.23 "KNOW-HOW" means any proprietary technology, information,
method of use, process, technique, idea or invention (other
than the Patents) owned, possessed or used by Abbott or its
Affiliates as of the Effective Date which is directly related
to or used in connection with the Compound and/or Product,
including all trade secrets and any other technical
information relating to development, manufacture, use or sale
of the Compound and/or Product, provided that Abbott continues
to have the right to license and/or sublicense to Myogen.
1.24 "MANUFACTURING AND SUPPLY AGREEMENT" means an agreement
between the parties for the manufacture and supply of Compound
and/or Product as contemplated and described more fully under
Section 6.6(b) below.
1.25 "Myogen Territory" means all countries of the world.
1.26 "MYOGEN TRADEMARK" means any trademark registered, owned or
chosen for Product by Myogen in any country of the Myogen
Territory and the Co-Promotion Territory.
1.27 "NDA" means an application (whether original, supplementary or
abbreviated) to the applicable Regulatory Authority in a
country of the Myogen Territory, for approval by such
Regulatory Authority, necessary for the commercial sale of
Product in such country. An NDA, together with all
supplemental filings referencing the initial NDA filing, shall
be deemed one and the same NDA for all purposes of this
Agreement.
1.28 "NET SALES" means gross sales of the Product invoiced to
unrelated third parties in arm's length transactions, by
Myogen or any Myogen Affiliates or sublicensees of Myogen, or
any contract sales force of Myogen or its Affiliates,
including, but not limited to, pharmaceutical wholesalers,
pharmacies, hospitals or dispensing physicians, less any of
the following charges or expenses that are incurred in
connection with gross sales of the Product during the Term:
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 4
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
(a) discounts, including cash discounts, customary trade
allowances or rebates actually taken, governmental
rebates, chargebacks, commissions, and group
purchasing management fees for formulary access;
(b) credits or allowances given or made for rejection,
recall or return of previously sold Product actually
taken;
(c) any tax or government charge, duty or assessment
(including any tax such as a value added or similar
tax or government charge) levied on the sale,
transportation or delivery of Product when included
on the invoice or other written document between the
parties as payable by the purchaser and collectable
by Myogen, its Affiliate or sub-licensee; and
(d) freight, postage, transportation, insurance and
duties on shipment of Product when included on the
invoice or other written document between the parties
as payable by the purchaser and collectable by
Myogen, its Affiliates or sublicensees.
With respect to a Combination Product, Net Sales of such Combination
Product shall first be calculated in accordance with Net Sales of
Product above, and then the Net Sales of such Combination Product shall
be determined on a country-by-country basis as follows:
(i) by multiplying the Net Sales of such
Combination Product by the fraction A/(A+B), where A is the
average selling price in such country of Product which
contains the Compound as its sole active ingredient and B is
the total of the average selling prices in such country of
pharmaceutical product(s) which contain each of the other
active ingredients as their sole active ingredient; or
(ii) if either the average selling price of the
Product which contains the Compound as its sole active
ingredient or the average selling price of all of the other
pharmaceutical products which contain each of the other active
ingredients in such Combination Product is not available, by
multiplying the Net Sales of such Combination Product by a
percentage, determined by mutual agreement of the parties,
which represents the proportionate economic value of the
Compound relative to the economic value contributed by all
other active ingredients in such Combination Product. If the
parties cannot agree, then the alternative dispute resolution
procedure set forth on Exhibit D shall be used to determine
the matter.
1.29 "PATENTS" means the patent applications and patents listed in
Exhibit A hereto and any patents or patent applications
derived from those listed in Exhibit A in the sense of making
a priority claim to one of those listed patents or patent
applications, including foreign equivalents, and any and all
substitutions, extensions, additions, reissues,
re-examinations, renewals, divisions, continuations,
continuations-in-part or supplementary protection certificates
and any other patent applications and patents owned by or
licensed to (with the right to sublicense) Abbott or its
Affiliates during the Term specifically claiming the Compound
or Product or solely relating to any Improvements to the
Compound derived from Abbott Technology.
1.30 "PRODRUG" means a pharmaceutical compound which, following
administration to a human, is metabolized into the Compound or
an Improvement.
1.31 "PRODUCT" means any formulation containing the Compound or an
Improvement to the Compound as an active ingredient for use in
the Field.
1.32 "REGULATORY APPROVAL" or "RA" means all governmental approvals
and authorizations necessary for the commercial sale of the
Product in a country of the
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 5
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Myogen Territory, including, but not limited to, marketing
authorization, pricing approval and pricing reimbursement, as
applicable.
1.33 "REGULATORY AUTHORITY" means the United States Food and Drug
Administration ("FDA") or any successor entity and its
equivalent in other countries of the Myogen Territory,
including, but not limited to, the EMEA.
1.34 "RESISTANT HYPERTENSION" means the indication in which
elevated blood pressure in a patient population has been
treated with multiple anti-hypertensive therapeutic agents and
where the patients' blood pressure has not been adequately
controlled. This population includes but is not limited to
sub-populations such as patients who also have CRD.
1.35 "ROYALTY PERIOD" shall have the meaning ascribed to such term
in Section 7.4(a) of this Agreement.
1.36 "TERM" means the period commencing on the Effective Date and
terminating as set forth in Article 10 below.
1.37 "THIRD PARTY" means any entity not a party to this Agreement
and not an Affiliate of Myogen or Abbott.
1.38 "VALID CLAIM" means a claim of an unexpired Patent which
covers the manufacture, use or sale of the Product that has
not been withdrawn, canceled or disclaimed nor held to be
invalid or unenforceable by a court or government agency of
competent jurisdiction in an unappealed or unappealable
decision.
1.39 "WORK PLAN" means the preliminary summary of the development
plan for the Product, which preliminary summary is attached
hereto as Exhibit B, and the final version of which will be
completed by Myogen, reviewed by Abbott and attached hereto as
the final version of Exhibit B by December 31, 2003.
2. LICENSE GRANT
Subject to Xxxxxx'x Co-Promotion Rights set out in this Agreement,
Abbott hereby grants to Myogen an exclusive right and license in the
Myogen Territory, under the Abbott Technology, for all uses in the
Field, with the right to grant sublicenses pursuant to Section 6.7
hereof, to (i) research, develop, modify and improve Compound and
Product; (ii) apply for and obtain Regulatory Approvals; and (iii) use,
import/export, market, offer to sell and sell, Product and Compound;
and (iv) make, or have made, the Compound and Product for use in the
Field.
3. XXXXXX'X CO-PROMOTION RIGHTS
3.1 Abbott shall have the right of first negotiation
("CO-PROMOTION OPTION") to participate with Myogen in the
Co-Promotion of Product in the Co-Promotion Territory, under
terms and conditions to be negotiated within [/\#/\] of
Xxxxxx'x exercise of the Co-Promotion Option.
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 6
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
3.2 The Co-Promotion Option shall become effective upon Myogen's
notice to Abbott that it intends to seek a Co-Promotion
arrangement in a particular country or group of countries in
the Myogen Territory and shall remain open for a [/\#/\]
period thereafter ("CO-PROMOTION OPTION PERIOD"). Abbott may
exercise its Co-Promotion Option by providing Myogen with
notice of its intention to exercise its Co-Promotion Option
before the expiration of the Co-Promotion Option Period. The
parties shall have [/\#/\] to conclude the terms of the
Co-Promotion arrangement in the country or countries in
question. If Abbott fails to give notice of its exercise or
its election not to exercise its Co-Promotion Option before
the expiration of the Co-Promotion Option Period, Abbott will
be deemed to have waived all rights under its Co-Promotion
Option. In the event Abbott waives or otherwise fails to
exercise its Co-Promotion Option or if the parties are unable
to conclude an agreement within the [/\#/\] negotiation
period, then Myogen shall be free to enter into such an
arrangement with any Third Party in that country or group of
countries. If Co-Promotion is not legally permitted in any
country of the Co-Promotion Territory, Xxxxxx'x right to
negotiate as set forth in this Section 3.2 will be limited to
Co-Marketing rights in such country or countries, the terms of
which shall be negotiated by the parties.
4. JAPAN OPTION
4.1 JAPAN OPTION. Myogen grants Abbott a right of first
negotiation to become Myogen's exclusive development and
commercialization partner of Product in Japan ("JAPAN
OPTION").
4.2 The Japan Option shall become effective [/\#/\] following the
enrollment of the first patient in the first clinical trial as
outlined in the Work Plan and shall remain open for a sixty
(60) day period thereafter ("JAPAN OPTION PERIOD"). Abbott may
exercise its Japan Option by providing Myogen with notice of
its intention to exercise its Japan Option before the
expiration of the Japan Option Period. The parties shall have
sixty (60) days to conclude the terms of the development and
commercialization arrangement for Japan. If Abbott fails to
give notice of its exercise or its election not to exercise
its Japan Option before the expiration of the Japan Option
Period, Abbott will be deemed to have waived all rights under
its Japan Option. In the event Abbott waives or otherwise
fails to exercise its Japan Option within the Japan Option
Period or if the parties are unable to conclude an agreement
within the sixty (60) day negotiation period, then Myogen
shall be free to enter into such an arrangement with any Third
Party in Japan.
5. INFORMATION
5.1 CONVEYANCE OF INFORMATION/INVENTORY.
(a) By June 30, 2003, Abbott shall convey to Myogen or
its designee all the information under Xxxxxx'x or
its Affiliates' control relating to the
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[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Compound (the "DATA TRANSFER"). Abbott shall use
Commercially Reasonable Efforts to ensure that it has
located and conveyed all of the information under its
and its Affiliates' control and Abbott agrees to
immediately convey to Myogen any information which
Abbott locates after June 30, 2003. The information
to be transferred and conveyed as part of the Data
Transfer includes, but is not limited to: (i) all
information relating to Patents and Know-How; (ii)
worldwide regulatory documentation for the Compound,
including, without limitation, complete copies of all
existing IND filings for any Product, all supplements
thereto and all other regulatory files and FDA
correspondence related to any Product; (iii) clinical
trial protocols, draft and final clinical reports,
case report forms from clinical trials; (iv) safety
data, toxicity study reports; (v) data and
information related to all indications, doses, and
formulations, both actual and proposed, for the
Products; (vi) manufacturing protocols, batch records
and current standard operating procedures, including,
but not limited to, quality analysis and quality
control methodologies and standards; (vii) claims
related to potential violations of any Third Party
rights; and (viii) all collaborative research
agreements; in each case, to the extent in the
control of Abbott, its Affiliates and agents. For
purposes of this Section 5.1, information shall not
be deemed under Xxxxxx'x and its Affiliates' control
if such information is protected by confidentiality
agreements with third parties; provided, however,
that Abbott shall provide Myogen with notice that
such information is subject to third party
confidentiality obligations at the time of its
identification. With respect to such protected
information, Abbott shall use Commercially Reasonable
Efforts to obtain the consent of such third parties
to release the protected information to Myogen.
(b) By June 30, 2003, Abbott will execute and deliver a
letter to the FDA authorizing the transfer of the IND
filing for the Compound to Myogen and authorizing
Myogen to do and take all actions that are necessary
to transfer the IND filings for the Compound in the
name of Myogen. In addition, during the [/\#/\] day
period following the Effective Date Abbott shall
provide at an Abbott location to be identified by
Abbott reasonable assistance to Myogen, [/\#/\] to
Myogen, to affect the orderly transfer of
Product-related development activities and regulatory
documents to Myogen provided that Myogen shall be
responsible for its own out of pocket expenses.
(c) Abbott will complete, at Xxxxxx'x expense, two
ongoing studies nearing completion as of the
Effective Date, [/\#/\]. Abbott will complete, at
Xxxxxx'x option, but subject to Myogen's approval of
the applicable expenditures, any of the pre-clinical
studies identified on
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 8
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
Exhibit C for the Compound, and Myogen will reimburse
Abbott for [/\#/\] associated with such studies.
(d) By June 30, 2003, Abbott shall, for the purposes of
supplying Myogen with Compound for use in conducting
clinical trials and at Myogen's expense, initiate the
process of re-testing and re-qualifying the Compound
and releasing to Myogen the specified quantities of
previously manufactured bulk API (Compound)
consisting of approximately [/\#/\] of Compound
located at Xxxxxx'x Ludwigshafen facility. Xxxxxx
shall convert re-qualified Compound into tablet form
as well as provide matching placebos at Xxxxxx'x
[/\#/\] plus Xxxxxx'x [/\#/\]of Compound in such
tablets [/\#/\] according to a manufacturing,
delivery and payment schedule to be mutually agreed
by the parties. If Xxxxxx is unable to re-qualify the
previously manufactured bulk API, Xxxxxx shall,
within a Commercially Reasonable time, manufacture a
new batch of API sufficient to allow Myogen to
commence its clinical trials at Xxxxxx'x [/\#/\].
Xxxxxx hereby states that its fully burdened costs
for the manufacture of the existing API is [/\#/\].
Xxxxxx shall use commercially reasonable efforts to
maintain the cost of the bulk API at a cost equal to
or less than [/\#/\]. Myogen shall pay Xxxxxx
[/\#/\].
(e) Myogen shall, [/\#/\] identify which batches of the
existing API they wish Xxxxxx to hold for Myogen's
future purchase, and Xxxxxx shall be free to dispose
of all batches not so identified. Myogen may purchase
quantities of API from time to time on an as-needed
basis. Myogen [/\#/\].
(f) Xxxxxx represents and warrants that the Compound,
matched placebo and Product conveyed to Myogen under
Section 5.1(d) has been or shall be manufactured in
accordance with current Good Manufacturing Practices
("CGMP"). Other than the foregoing warranty, any
Compound shall be conveyed "AS IS" and "WITH ALL
FAULTS," WITHOUT ANY OTHER WARRANTY OF ANY KIND
WHATSOEVER, EXPRESS OR IMPLIED, INCLUDING WARRANTIES
OF MERCHANTABILITY AND FITNESS FOR PARTICULAR
PURPOSE. Myogen shall be responsible for all testing,
quality control and certification of such Compound.
6. FEASIBILITY/EVALUATION/DEVELOPMENT/MANUFACTURING/MARKETING/OTHER
6.1 FEASIBILITY/EVALUATION STUDIES. Myogen shall use Commercially
Reasonable Efforts to evaluate the Compound in accordance with
the Work Plan. Myogen shall have sole responsibility for
conducting and/or supervising the feasibility and evaluation
studies on the Compound as set forth in the Work Plan. Myogen
shall provide Xxxxxx with summaries of the feasibility and
evaluation studies conducted
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 9
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
by or on behalf of Myogen, including summaries of reports and
data generated under such studies, on a semi-annual basis
(including at any annual review meeting held pursuant to
Section 6.2 below), and all such information shall be treated
as Myogen's Confidential Information. Recognizing that certain
work to be conducted on behalf of Myogen will be performed by
one or more Third Parties and recognizing that such work
(e.g., formulations) may involve the patented subject matter
of such Third Party, Myogen will use Commercially Reasonable
Efforts to: (a) provide in its license with the Third Party
that the patented subject matter of such Third Party may be
sublicensed to Xxxxxx in the event that the Compound and
Product are returned to Xxxxxx under Sections 6.3(b) and
Article 10; and (b) negotiate a [/\#/\] with such Third Party.
In the event that Myogen is unable to negotiate a royalty-free
license/sublicense, Xxxxxx agrees to [/\#/\] thereunder if it
elects to practice under such license/sublicense following the
return of the Compound and Product under Sections 6.3(b) and
Article 10. Myogen agrees to promptly provide Xxxxxx with
written notice of the terms of any [/\#/\] prior to entering
into any such [/\#/\] with Third Parties, which pertain to the
Compound and/or Product, in order for Xxxxxx to have the
opportunity to comment on said terms and conditions before
Myogen enters into that [/\#/\].
6.2 REVIEW. Beginning six (6) months following the Effective Date
and every six (6) months thereafter while Myogen is developing
the Compound, Myogen shall provide Xxxxxx with a written
report reviewing the progress of the Work Plan and the results
of such work and studies remaining to be completed under the
Work Plan, which report shall be deemed Myogen Confidential
Information. In the event Xxxxxx so requests, the parties
shall meet in person once during each calendar year to discuss
these topics. The meeting shall be held at a mutually
agreeable time at Myogen's headquarters. Each party shall be
responsible for its own costs of attendance.
6.3 CLINICAL DEVELOPMENT.
(a) Myogen shall use Commercially Reasonable Efforts to
develop the Compound in accordance with the Work Plan
and not to materially deviate from the time schedule
stated therein except as may be dictated by valid
scientific, clinical and/or Regulatory circumstances
and shall use Commercially Reasonable Efforts to
maximize the commercial opportunity of the Compound
and Product. Myogen may modify the Work Plan if
required to adjust the Work Plan under such
circumstances and will communicate such modifications
to Xxxxxx. If Myogen requires any other material
modification to the Work Plan, it will so notify
Xxxxxx within a reasonable time. Myogen shall have
sole responsibility for designing, conducting and
paying for the cost of the clinical development of
Product and shall use Commercially Reasonable Efforts
to conduct such
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[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
clinical development as set forth below. Xxxxxx
hereby agrees that [/\#/\].
(b) In the event Myogen breaches a material obligation
under Section 6.3(a) or 6.5(b) of this Agreement,
Xxxxxx may then advise Myogen that Xxxxxx believes
that Myogen has breached such material obligation and
that Xxxxxx is adversely impacted thereby. Upon so
advising Myogen, either Party may initiate an
alternative dispute resolution procedure ("ADR") as
set forth in Exhibit D and request the ADR to rule
upon whether Myogen has breached any such material
obligation. In the event that the neutral conducting
such ADR renders a ruling that Myogen has breached
such material obligation and that Xxxxxx was
adversely impacted thereby, and Myogen fails to
comply with the terms of the neutral's ruling within
the time specified therein for compliance (which in
no event shall be less than ninety (90) days), or if
such compliance cannot be fully achieved by such
date, Myogen has failed to commence compliance and/or
has failed to use diligent efforts to achieve full
compliance as soon thereafter as is reasonably
possible, then Xxxxxx'x sole remedy shall be the
right to terminate this Agreement and the licenses
granted hereunder, and to obtain from Myogen a
license to Improvements under Section 15.
6.4 COMMERCIALIZATION.
(a) Myogen shall use Commercially Reasonable Efforts to
develop, register and commercialize Product in the
U.S. and EU Major Markets. It is the parties'
expectation that Myogen will commercialize Product in
all commercially viable markets in the Myogen
Territories other than the Co-Promotion Territories
within [/\#/\] following First Commercial Sale of the
Product. If, following such [/\#/\] period, there
remain markets outside the Co-Promotion Territories
where Myogen is not commercializing Product which
Xxxxxx, in its reasonable estimation, believes are
commercially viable markets, then the parties shall
meet within thirty (30) days of Xxxxxx'x written
notice for the purpose of developing a mutually
agreeable action plan for such under-served markets.
If the parties are unable to agree on an action plan,
Myogen shall have the option to enlist a marketing
partner to assist Myogen in marketing the Product in
the underserved markets, or to offer to Xxxxxx the
option, for Xxxxxx and its Affiliates, to sell the
Product directly in each such country, by paying to
Myogen or its sublicensees a reasonable royalty to be
mutually agreed by the Parties. Myogen agrees to
provide Product to Xxxxxx and its Affiliates for sale
in
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 11
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
each such country at the same delivered [/\#/\] of
goods (as evidenced by Myogen's internal records)
incurred by Myogen in procuring or manufacturing
Product for its own sales plus [/\#/\] and to
cooperate with Xxxxxx by, among other things, working
with Xxxxxx and its Affiliates to coordinate, in the
relevant country, marketing and sales strategies and
the development of selling and other materials
necessary for the effective sale and marketing of
Product in such country consistent with Myogen's
global Product marketing strategies. The rights and
obligations of the parties with respect to
commercialization within the Co-Promotion Territory
will be as agreed upon and set forth in the
Co-Promotion Agreement.
(b) If there is any material disagreement between the
parties concerning whether a market is commercially
viable such that Myogen should be commercializing
Product in accordance with Section 6.4(a) hereof, or
if Myogen reasonably believes that enlisting a
marketing partner (including Xxxxxx) to assist it in
selling the Product in a particular country will have
a substantial negative impact on Myogen's local,
regional or global commercial efforts, then the
matter may be submitted to ADR. If the neutral
conducting such ADR makes a final determination that
a market is commercially viable and that Myogen
should be commercializing Product in such market, the
neutral shall provide Myogen with the opportunity to
commercialize Product in such market. If Myogen fails
to commercialize Product within the time period
prescribed by the neutral (which in no event shall be
less than ninety (90) days), then the neutral may
issue an order allowing Xxxxxx to terminate Myogen's
license with respect to that country.
6.5 MARKETING/MARKETING PLAN/REGULATORY REVIEWS.
(a) Except as set forth in Articles 3 and 4 above, in the
Myogen Territory and subject to Xxxxxx'x [/\#/\]
rights, if any, Myogen shall have sole responsibility
for marketing Product, including entering into any
co-marketing and/or co-promotion arrangement. Myogen
shall distribute all Product samples in the United
States in accordance with the Prescription Drug
Marketing Act.
(b) Subject to the terms of any [/\#/\] arrangement
between Myogen and Xxxxxx, six months prior to launch
in any of the EU Major Markets, the United States or
Canada (collectively "Key Markets"), Myogen shall
prepare a marketing plan ("Marketing Plan"), with
regard to the marketing and sale of the Product. The
Marketing Plan shall contain a ten year sales
forecast for each indication for the [/\#/\], a
detailed summary of the size of the sales force to be
utilized in the sale of the Product, and detailed
estimate of the promotional spending to be allocated
to the promotion of the Product. Myogen shall on a
commercially reasonable basis enlist the
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 12
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
services of professional consultants normally used in
the development of similar marketing plans for
products similar to Product. Xxxxxx shall have the
opportunity to review said Marketing Plan
sufficiently in advance of its finalization in order
to provide comments to said Marketing Plan. Myogen
shall ensure that the Marketing Plan is sufficient to
maximize the commercial opportunity of Darusentan and
shall use Commercially Reasonable Efforts to
implement such Marketing Plan.
(c) Myogen shall, at its sole expense and consistent with
its obligations under Section 6.4(a), apply for RA's
in all countries in the Myogen Territory for the
purposes of selling the Product.
6.6 MANUFACTURING.
(a) Myogen will be solely responsible for and/or will
arrange for the manufacture of Compound and/or
Product. Xxxxxx shall provide Myogen with the
manufacturing protocol for the Compound and/or
Product, which protocol shall be considered Xxxxxx
Confidential Information. All additional Know-How or
Xxxxxx Confidential Information relating to raw
materials or precursors to the Compound, and all
additional information and documentation in Xxxxxx'x
or its Affiliates' possession, which are necessary to
make Compound and/or Product, shall be transferred to
Myogen by June 30, 2003.
(b) If Myogen elects to negotiate terms and conditions
with a Third Party manufacturer ("TPM") for the
manufacture and supply of the Compound and/or Product
to Myogen, Myogen shall first offer Xxxxxx the
opportunity to negotiate a Manufacturing and Supply
Agreement providing for Xxxxxx to supply Myogen with
its requirements of the Compound and Product. The
parties shall have [/\#/\] to execute a definitive
Manufacturing and Supply Agreement. If the parties
are unable to conclude a definite Manufacturing and
Supply Agreement, then Myogen shall be free to
negotiate such an agreement with a TPM. Myogen shall
be solely responsible for all costs and expenses
necessary to qualify such TPM. Myogen may provide the
manufacturing protocol to the TPM under terms that
provide for the protection of Xxxxxx Confidential
Information.
6.7 SUBLICENSING. Subject to Xxxxxx'x Co-Promotion rights, Myogen
may sublicense its rights under this Agreement, in the Myogen
Territory, without obtaining Xxxxxx'x prior written consent.
Each sublicense shall be in writing and shall include
provisions acknowledging that such sublicense is subject to
the license granted Myogen under this Agreement, that each
sublicensee shall make reports and keep and maintain records
of sales to at least the same extent as required under this
Agreement, allowing Xxxxxx the same access and audit rights as
permitted under this Agreement, and that such sublicense shall
be automatically
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 13
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
terminated upon termination of this Agreement. Myogen shall
remain primarily liable for the performance of sublicensees.
Myogen shall provide Xxxxxx with a copy of each sublicense
agreement.
7. FINANCIALS
7.1 EXECUTION LICENSE FEE. Myogen shall pay to Xxxxxx a
non-refundable payment of Three Million Dollars ($3,000,000)
in cash on the Effective Date.
7.2 SECOND LICENSE FEE PAYMENT. Myogen shall convey to Xxxxxx a
non-refundable payment of Two Million Dollars ($2,000,000) in
cash on or before December 31, 2003.
7.3 MILESTONES. Myogen shall make the following [/\#/\] milestone
payments ("Milestones") to Xxxxxx within [/\#/\] of the
occurrence of the following events with respect to any
Product, regardless of whether or not Myogen has sublicensed
any of its rights under this Agreement:
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 14
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
REGULATORY FILING MILESTONE PAYMENT
Submission of first filing of an NDA in [/\#/\]: [/\#/\]
Submission of first filing seeking Regulatory [/\#/\]
Approval in [/\#/\]:
REGULATORY APPROVAL MILESTONE PAYMENT
First Indication:
Upon Regulatory Approval in [/\#/\]: [/\#/\]
Upon Regulatory Approval of an [/\#/\] filing or approval in
[/\#/\]: [/\#/\]
Upon Regulatory Approval in [/\#/\]: [/\#/\]
Second Indication:
Upon Regulatory Approval in [/\#/\].: [/\#/\]
Upon Regulatory Approval of an [/\#/\] filing or approval in
[/\#/\]: [/\#/\]
Upon Regulatory Approval in [/\#/\]: [/\#/\]
Third Indication:
Upon Regulatory Approval in [/\#/\]: [/\#/\]
Upon Regulatory Approval of an [/\#/\] filing or approval in
[/\#/\]: [/\#/\]
Upon Regulatory Approval in [/\#/\]: [/\#/\]
Each milestone payment will be made only once regardless of how many Products
are developed or commercialized or the number of indications for which a Product
has received Regulatory Approval. The total maximum milestone payments and
license fees due Xxxxxx with respect to any and all Products if all of the
foregoing milestones are met will be [/\#/\].
For purposes of this Section 7.3 the term "Indication" with respect to Second
Indication and Third Indication refers to a new indication for the use of an
existing, approved Product for which (a) an additional clinical trial must be
conducted with the Product in order to obtain Regulatory Approval for such use;
and (b) where such Regulatory Approval results in a Regulatory
Authority-approved label expanding the approved uses of the Product.
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 15
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
7.4 ROYALTY PAYMENTS.
(a) MARGINAL ROYALTY RATE AND ROYALTY PERIOD. Beginning
with the First Commercial Sale by Myogen, any
Affiliates or sublicensees of Myogen, or any contract
sales force of Myogen or its Affiliates, Myogen shall
pay to Xxxxxx a royalty on annual aggregate worldwide
Net Sales of all Product in accordance with the
following schedule:
ANNUAL NET SALES MARGINAL ROYALTY RATE
[/\#/\] [/\#/\]
[/\#/\] [/\#/\]
[/\#/\] [/\#/\]
In those countries where no Valid Claim exists at the
time of launch of the Product covering the Compound
or any Product, Myogen will pay Xxxxxx a royalty of
[/\#/\] of Myogen's Net Sales in such country in
consideration for licenses to Xxxxxx Know-How
relating to the Compound or Product for a period of
not more than [/\#/\] after Regulatory Approval of
the Product in such country; provided however, if
during the Term a Valid Claim comes into existence
for any such country, then the normal royalty rate
shall apply to sales in that country unless generic
competition to the Product exists in that country and
the generic product has at least a [/\#/\] market
share in that country, in which case the reduced
royalty rate shall apply for the [/\#/\] period
described above for so long as the generic product
has a [/\#/\] market share, provided however, if the
market share of the generic product drops below
[/\#/\] during such [/\#/\] period, the normal
royalty rate shall again apply for so long as the
market share of the generic product is below [/\#/\].
The obligation of Myogen to pay a full royalty to
Xxxxxx shall be on a country-by-country basis and
shall continue with respect to Product manufactured
or sold in a country until the expiration of the last
Patent in such country that contains a Valid Claim
(the "ROYALTY PERIOD").
(b) REDUCED ROYALTY. Upon the end of the Royalty Period
in any country of the Myogen Territory on a
country-by-country basis, Myogen shall have an
exclusive, perpetual and irrevocable license under
the Xxxxxx Technology in such country of the Myogen
Territory, with all of the rights granted under
Article 2 hereof, except that, for a period of
[/\#/\] from the expiration of the Valid Claim in
that country, Myogen shall pay to Xxxxxx a reduced
royalty of [/\#/\] of Net Sales of Product in such
country (the "REDUCED ROYALTY PERIOD").
(c) ROYALTY REPORTS AND PAYMENTS. Beginning with the
First Commercial Sale anywhere in the Myogen
Territory, within forty-five (45) days after the end
of each calendar quarter, Myogen shall
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 16
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
prepare and deliver to Xxxxxx a report detailing the
calculation of Net Sales, on a country-by-country
basis, for such just ended quarter along with the
calculation of royalties due thereon pursuant to
Sections 7.4(a) and (b) above. Each report shall be
accompanied by full payment in U.S. dollars of the
royalties shown thereon to be due. In the event that
conversion from foreign currency is required in
calculating a royalty payment hereunder, the exchange
rate used shall be the average of the ratio in effect
on the first business day and the last business day
of the applicable quarter for which royalties are
calculated, as reported at the 9:00 am (Central
Standard Time) exchange rate according to Reuters, or
a substantially similar global publication if Reuters
is no longer published. All such quarterly reports
shall show sales in the currency of the country in
which the sales were made and the currency conversion
rate used to arrive at the US dollar amounts shown in
the quarterly report.
(d) BOOKS AND RECORDS/AUDIT RIGHTS. Myogen shall keep
books and records accurately showing all Products
manufactured, used or sold under the terms of this
Agreement. The relevant portions of such books and
records shall be open to inspection by
representatives of Xxxxxx, at Xxxxxx'x cost, solely
for the purposes of determining the correctness of
the royalties payable under this Agreement. Such
audit, conducted no more than one time per calendar
year, shall be during normal business hours after
reasonable advance notice and subject to suitable
confidentiality provisions. In the event an audit
shows a deficiency to be due, Myogen shall
immediately pay such deficiency along with the
reasonable costs and expenses of the audit if the
deficiency is more than five percent (5%) of the
amount due during such audited period. If the audit
shows that an excess was paid, Myogen shall be
entitled to deduct the amount of such excess from the
payment due for the next calendar quarter. Such books
and records shall be preserved for a period of at
least three (3) years after the date of the royalty
payment to which they pertain, and no audit may be
conducted with respect to royalties due in any
calendar year that is more than two (2) years
preceding the calendar year in which the audit is
being conducted. Books and records for a given
calendar year may only be audited once.
(e) WITHHOLDING TAXES ON ROYALTIES. Where any sum due to
be paid to Xxxxxx hereunder is subject to any
withholding or similar tax, the parties shall use all
reasonable efforts to do all such acts and things and
to sign all such documents as will enable them to
take advantage of any available exemption, applicable
double taxation agreement or treaty. In the event
there is no exemption or applicable double taxation
agreement or treaty, or if an applicable double
taxation agreement or treaty reduces but does not
eliminate such withholding or similar tax, Myogen
shall pay such
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 17
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
withholding or similar tax to the appropriate
government authority, deduct the amount paid from the
amount due Xxxxxx and secure and send to Xxxxxx proof
of such payment, together with copies of all relevant
correspondence with such government authority.
(f) THIRD PARTY ROYALTIES. In the event that Myogen is
required to pay royalties to a Third Party under
patents in any country owned or controlled by such
Third Party, Myogen will be entitled to deduct
[/\#/\] of such Third Party royalties against royalty
payments due to Xxxxxx; provided that royalties due
to Xxxxxx shall not be reduced by greater than
[/\#/\] and provided further that a license under
such Third Party patents is necessary in order to
market any Product in said country. Notwithstanding
the foregoing, prior to the Effective Date, Xxxxxx
has provided to Myogen a list of any known royalties
that are owed to Third Parties as of the Effective
Date along with copies of any agreements with Third
Parties pursuant to which such royalties are owed,
and Myogen shall have no liability with respect to
and shall have no obligation to pay any such Third
Party royalty obligations incurred with respect to
the Product prior to the Effective Date.
(g) LATE PAYMENTS. Any payments due under this Agreement,
which are late, shall bear interest at the rate of
one percent (I%) per month.
8. REPRESENTATIONS/WARRANTIES
8.1 REPRESENTATIONS AND WARRANTIES OF XXXXXX. Xxxxxx represents
and warrants that:
(a) it is duly organized, validly existing and in good
standing under the laws of Illinois, that it has full
corporate power and authority to enter into this
Agreement and to carry out its provisions, and that
there are no outstanding agreements, assignments or
encumbrances in existence that are inconsistent with
the provisions of this Agreement;
(b) it is duly authorized to execute and deliver this
Agreement and to perform its obligations hereunder
and that the execution, delivery and performance of
this Agreement by it does not require the consent,
approval or authorization of or notice, filing or
registration with any governmental agency or
Regulatory Authority;
(c) as of the Effective Date, to the best of Xxxxxx'x
knowledge, (i) it has sufficient rights under the
Xxxxxx Technology necessary to grant the rights
specified in this Agreement and to perform its
obligations hereunder; (ii) there are no claims,
judgments or settlements against or owed by it
relating to the Xxxxxx Technology; (iii) the exercise
of Myogen's rights to
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 18
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
the Compound under this Agreement or Myogen's use of
the Xxxxxx Technology under this Agreement will not
infringe any intellectual property rights of a Third
Party with the exception of infringement arising from
the use of Compound or Xxxxxx Technology in
combination with the technology of a Third Party and
such infringement would have been avoided without
such combination; (iv) the material provided to
Myogen concerning the manufacturing process for the
Compound as it relates to process historical cost,
historical yield and historical quality are accurate
in all material respects; (v) there are no known
adverse events that have not been described in the
documents provided to Myogen or the applicable
Regulatory Authority; (vi) Xxxxxx has exerted
Commercial Reasonable Efforts to gather and convey to
Myogen all documents in Xxxxxx'x or its Affiliates'
possession and notices from Regulatory Authorities as
part of the Data Transfer described in Article 5.1
(a); and (vii) Exhibit A includes the relevant
Patents necessary to market and sell the Product as
contemplated in the Work Plan.
(d) as of the Effective Date, to the best of Xxxxxx'x
knowledge, (i) none of the Patents are invalid or
unenforceable, (ii) it has complied in all material
respects with all applicable laws and regulations in
connection with the preparation and submission of any
filings with any Regulatory Authority; (iii) it has
filed with applicable Regulatory Authorities all
required and material notices, supplemental
applications and annual or other reports, including
adverse experience reports, with respect to the
Compound; and (iv) there is no pending or overtly
threatened action by the Regulatory Authorities that
will have a material adverse effect on the timing of
a Regulatory Approval of the Compound or any
Products.
8.2 REPRESENTATIONS AND WARRANTIES OF MYOGEN. Myogen represents
and warrants that it is duly organized, validly existing and
in good standing under the laws of Delaware, that it has full
corporate power and authority to enter into this Agreement and
to carry out its provisions, and that there are no outstanding
agreements, assignments or encumbrances in existence that are
inconsistent with the provisions of this Agreement. Myogen
further represents and warrants that it is duly authorized to
execute and deliver this Agreement and to perform its
obligations hereunder, and that the execution, delivery and
performance of this Agreement by it does not require the
consent, approval or authorization of or notice, filing or
registration with any governmental agency or Regulatory
Authority.
8.3 INDEMNIFICATION BY MYOGEN. Myogen shall indemnify and hold
Xxxxxx, its Affiliates and their directors, officers,
employees and agents harmless from and against any and all
liabilities, actions, suits, claims, demands, prosecutions,
damages, costs, expenses or money judgments finally awarded
(including
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 19
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
reasonable legal fees) (collectively, "LIABILITIES") incurred
by or instituted or rendered against Xxxxxx to the extent such
Liabilities result from a Third Party claim arising from
product liability claims or from the willful misconduct or the
negligent acts or omissions of Myogen or its Affiliates or
Myogen's material breach of this Agreement, except to the
extent such Third Party claims arise out of the negligence or
willful misconduct of Xxxxxx, its Affiliates and their
directors, officers, employees and agents, or the material
breach of this Agreement or the Manufacturing and Supply
Agreement, if any, by Xxxxxx, its Affiliates and their
directors, officers, employees and agents, and provided that
Xxxxxx gives Myogen prompt notice in writing of any such claim
or lawsuit and permits Myogen to undertake sole control of the
defense and settlement thereof at Myogen's expense. In any
such claim or lawsuit:
(a) Xxxxxx will cooperate in the defense by providing
access to witnesses and evidence available to it.
Xxxxxx shall have the right to participate, at its
expense, in any defense to the extent that in its
reasonable judgment Xxxxxx may be prejudiced by
Myogen's sole defense thereof.
(b) With respect to this Agreement, Xxxxxx shall not
settle, offer to settle or admit liability in any
claim or suit in which Xxxxxx intends to seek
indemnification by Myogen without the written consent
of the CEO, COO or CFO of Myogen.
8.4 INDEMNIFICATION BY XXXXXX. Xxxxxx shall indemnify and hold
Myogen, its Affiliates and their directors, officers,
employees and agents harmless from and against any and all
Liabilities, incurred by or instituted or rendered against
Myogen to the extent such Liabilities result from a Third
Party claim arising from the willful misconduct or the
negligent acts or omissions of Xxxxxx or its Affiliates or
Xxxxxx'x material breach of this Agreement, except to the
extent such Third Party claims arise out of the negligence or
willful misconduct of Myogen, its Affiliates and their
directors, officers, employees and agents, or the material
breach of this Agreement by Myogen, its Affiliates and their
directors, officers, employees and agents, and provided that
Myogen gives Xxxxxx prompt notice in writing of any such claim
or lawsuit and permits Xxxxxx to undertake sole control of the
defense and settlement thereof at Xxxxxx'x expense. In any
such claim or lawsuit:
(a) Myogen will cooperate in the defense by providing
access to witnesses and evidence available to it.
Myogen shall have the right to participate, at its
expense, in any defense to the extent that in its
reasonable judgment Myogen may be prejudiced by
Xxxxxx'x sole defense thereof
(b) With respect to this Agreement, Myogen shall not
settle, offer to settle or admit liability in any
claim or suit in which Myogen intends to seek
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 20
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
indemnification by Xxxxxx without the written consent
of a duly authorized officer of Xxxxxx.
8.5 REPORTABLE OCCURRENCES. Each party warrants that it shall
advise the other promptly of any occurrence, which is reported
or reportable by it to the Regulatory Authorities relating in
any way to the Compound or the Product.
8.6 LIMITATION. EXCEPT FOR THE EXPRESS WARRANTIES IN THIS ARTICLE
8, NEITHER PARTY MAKES ANY WARRANTIES, EXPRESS OR IMPLIED, IN
FACT OR BY OPERATION OF LAW, STATUTORY OR OTHERWISE. EACH
PARTY SPECIFICALLY DISCLAIMS ANY IMPLIED WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. EXCEPT
FOR VIOLATIONS OF ARTICLE 9 AND AMOUNTS FINALLY AWARDED FOR
INDEMNIFICATION FOR THIRD PARTY LIABILITIES UNDER SECTIONS 8.3
AND 8.4 ABOVE, NEITHER PARTY SHALL BE LIABLE TO THE OTHER
PARTY HERETO FOR ANY SPECIAL, CONSEQUENTIAL, EXEMPLARY OR
INCIDENTAL DAMAGES (INCLUDING LOST OR ANTICIPATED PROFITS
RELATING TO THE SAME) ARISING FROM ANY CLAIM RELATING TO THIS
AGREEMENT, WHETHER SUCH CLAIM IS BASED ON CONTRACT, TORT
(INCLUDING NEGLIGENCE) OR OTHERWISE, EVEN IF AN AUTHORIZED
REPRESENTATIVE OF SUCH PARTY IS ADVISED OF THE POSSIBILITY OR
LIKELIHOOD OF SAME.
9. CONFIDENTIALITY AND NON-DISCLOSURE
9.1 NONDISCLOSURE. Neither party shall use or disclose any
Confidential Information received by it from the other party
pursuant to this Agreement without the prior written consent
of the other. This obligation will continue for a period of
seven (7) years after termination of this Agreement or
expiration of the Term, whichever is earlier. Subject to the
exceptions immediately below, Xxxxxx shall hold in confidence
and shall not directly or indirectly disclose or provide to
any Third Party information pertaining to the Compound or
Xxxxxx Technology without Myogen's prior written consent. The
parties recognize that pursuant to Articles 3 and 4, Xxxxxx
may be involved in marketing and selling the Compound and
Product in the Co-Promotion Territory. Xxxxxx shall be
permitted to disclose information pertaining to the Compound
and the Xxxxxx Technology to the extent necessary for Xxxxxx
to perform its obligations under this Agreement, including,
but not limited to, its Co-Promotion activities, and only if
the recipient of such information is under a duty of
confidentiality to Xxxxxx.
9.2 RESTRICTION. Each party shall restrict dissemination of
Confidential Information to those of its employees,
contractors, agents and sublicensees (if any) who have an
actual need to know and have a legal obligation to protect the
confidentiality of such Confidential Information. All
Confidential Information disclosed by one
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 21
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
party to the other shall remain the sole property of the
disclosing party and neither party shall obtain any right of
any kind to the Confidential Information disclosed, except as
granted under this Agreement.
9.3 RESTRICTION EXEMPTIONS. Nothing contained in this Article 9
shall be construed to restrict the parties from using or
disclosing Confidential Information solely to the extent and
solely as required:
(a) for regulatory, tax or customs reasons;
(b) by court order or other governmental order or written
request, provided in each case the party disclosing
information promptly informs the other and uses its
best efforts to limit the disclosure and to maintain
confidentiality to the maximum extent possible and
permits the other party to attempt by appropriate
legal means to limit such disclosure; or
(c) to perform acts permitted by this Agreement,
including (i) disclosure by Myogen to third parties
undertaking feasibility and evaluation studies,
clinical trials and the like on behalf of Myogen, so
long as such third parties are under a legal
obligation to Myogen to protect the confidentiality
of such Confidential Information, or (ii) disclosure
by Myogen to sublicensees, so long as such
sublicensees are under a legal obligation to Myogen
to protect the confidentiality of such Confidential
Information, or (iii) disclosure by Myogen in
connection with the marketing and commercial sale of
Product, or (iv) disclosure by Myogen to the extent
required by law; and (v) disclosure by Xxxxxx in
connection with its Co-Promotion activities, if any.
10. TERM AND TERMINATION
10.1 This Agreement shall continue in effect unless and until
terminated as provided in this Section 10 or in Section
6.3(b). Upon the end of the Royalty Period in any country of
the Myogen Territory, Myogen shall have an exclusive, subject
to Xxxxxx'x Co-Promotion Rights, perpetual and irrevocable
license under the Xxxxxx Technology, with all of the rights
granted under Article 2 hereof, and without any further
obligation to Xxxxxx, except for the payment obligations
accruing prior to such date and the indemnification
obligations under Section 8.3, and except for any obligation
to pay a reduced royalty for the Reduced Royalty Period, as
provided in Section 7.4(b) hereof.
10.2 If, after January 1, 2004, Myogen determines in its reasonable
scientific and commercial judgment that the Compound does not
have an acceptable profile or a reasonable likelihood of
commercial success, or that it is economically or technically
impractical for Myogen to continue developing and marketing
the Product, Myogen shall have the right to terminate this
Agreement upon ninety
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 22
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
(90) days written notice, at the end of which the termination
shall be effective. Upon such termination, Myogen shall pay
all payments and royalties which may have become due prior to
the effective date of such termination, including, but not
limited to, the Second License Fee Payment provided for under
Section 7.2, and Myogen shall assign and deliver, and Xxxxxx
shall be entitled to retain for its own use, all studies and
information relating to the Compound. Myogen shall transfer
all RA's held in its name and Xxxxxx shall be granted a
license to all Improvements as set forth in Section 15 hereof.
In addition, Myogen shall continue to be responsible for any
milestones obtained by Myogen (or its sublicensee) with
respect to the Product thereafter notwithstanding Myogen's
earlier termination under this Section 10.2.
10.3 Either party may terminate this Agreement by giving to the
other party prior written notice of not less than thirty (30)
days in the case of a monetary breach and of not less than
ninety (90) days in the event the other party shall commit a
non-monetary material breach of this Agreement (other than an
alleged breaches of Sections 6.3(a) or 6.5(b) or Section
6.4(a), in which event the provisions of Sections 6.3(b) and
Section 6.4(b), respectively, shall apply), and such breaching
party (or that party's sublicensee) shall fail to cure, or
commence action to cure, such breach during such thirty (30)
or ninety (90) day period, as applicable. In the case of a
non-monetary breach (other than an alleged breaches of
Sections 6.3(a) or 6.5(b) or Section 6.4(a), the cure period
may be extended for such longer period as may reasonably be
necessary if cure is not reasonably possible within the
initial ninety (90) day period, provided the breaching party
continues its diligent efforts to cure. No such cancellation
and termination shall release the breaching party from any
obligations hereunder incurred prior thereto. In the event of
a dispute whether a material breach has occurred, the
existence of material breach shall be determined using the ADR
procedure set forth in Exhibit D. A party's right to terminate
this Agreement shall only apply if the breaching party fails
to cure such breach in the manner required by the final
judgment of the ADR hearing. In the event that this Agreement
is terminated for Myogen's material breach, Xxxxxx shall be
entitled to retain for its own use all funds previously paid
by Myogen, Myogen shall pay all payments and royalties which
may have become due prior to the effective date of such
termination, including, but not limited to, the Second License
Fee Payment provided for under Section 7.2, and Myogen shall
assign and deliver, and Xxxxxx shall be entitled to retain for
its own use, all studies and information relating to the
Compound, Myogen shall transfer all RA's held in its name and
Xxxxxx shall be granted a license to all Improvements
generated hereunder as set forth in Section 15 hereof. In the
event this Agreement is terminated for Xxxxxx'x material
breach, Myogen shall be entitled to retain for its own use all
studies, information and Improvements generated hereunder, no
license to Improvements shall be granted to Xxxxxx under
Section 15 hereof and Xxxxxx shall be obligated pay any
amounts that became payable pursuant to this Agreement prior
to the termination date.
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 23
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
10.4 Either party may terminate this Agreement on thirty (30) days
notice if the other party passes a resolution or the court
makes an order for its winding up; or has a receiver or
administrator appointed over its business or all of its
assets; or is or becomes bankrupt; or ceases its business
operations. In the event that this Agreement is terminated
under this Section 10.4, subject to the other terms of this
Agreement, the terminating party shall be entitled to the
assignment and delivery of, and shall be entitled to retain
for its own use all studies, information and Improvements
(subject to the license set forth in Section 15 as it concerns
Xxxxxx) generated hereunder. Notwithstanding the bankruptcy or
insolvency of Xxxxxx or the impairment of performance by
Xxxxxx of its obligations under this Agreement as a result of
bankruptcy or insolvency of Xxxxxx, Myogen shall be entitled
to retain the licenses granted herein, without any further
obligation to Xxxxxx other than the payment obligations under
Article 7.
10.5 Termination of this Agreement shall be without prejudice to
any rights of either party against the other which may have
accrued up to the date such termination becomes effective.
10.6 All causes of action accruing to either party under this
Agreement shall survive expiration or termination of this
Agreement for any reason.
10.7 Upon any termination or expiration of this Agreement, each
party shall promptly return to the other party all written
Confidential Information of the other party, and all copies
thereof (retaining one copy of the Confidential Information of
the other in its confidential files for archival purposes
only), which is not covered by a paid-up license or other
rights specified herein surviving such termination or
expiration.
10.8 In the event the Myogen license in Article 2 hereof is
terminated for any country due to an uncured material breach
by Myogen, Myogen agrees to provide Product to Xxxxxx and/or
its Affiliates, or their designee, for sale in each such
country at the same fully burdened delivered cost of goods (as
evidenced by Myogen's internal records) incurred by Myogen in
procuring or manufacturing Product for its own sales and to
cooperate with Xxxxxx, or its designee, by, among other
things, coordinating marketing and sales strategies consistent
with Myogen's global Product marketing strategies, clinical
studies and development plans.
11. INFRINGEMENT OF PATENTS BY THIRD PARTY. In the event of an actual or
suspected infringement of a Patent by a Third Party, the following
shall apply:
11.1 NOTICE. Each party shall give the other written notice if one
of them becomes aware of any infringement by a Third Party of
any Patent. Upon notice of any such infringement, the parties
shall promptly consult with one another with a view toward
reaching agreement on a course of action to be pursued.
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 24
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
11.2 XXXXXX'X RIGHT TO BRING INFRINGEMENT ACTION.
(a) ABBOTT ELECTION. If a Third Party infringes any
Patent, Abbott shall have the right, but not the
obligation, to institute and prosecute an action or
proceeding to xxxxx such infringement and to resolve
such matter by settlement or otherwise.
(i) Abbott shall notify Myogen of its intention
to bring an action or proceeding prior to
filing the same and in sufficient time to
allow Myogen the opportunity to discuss with
Abbott the choice of counsel for such
matter. Abbott shall keep Myogen informed of
material developments in the prosecution or
settlement of such action or proceeding.
Abbott shall be responsible for all fees and
expenses of any action or proceeding against
infringes which Abbott initiates. Myogen
shall cooperate fully [/\#/\], including
executing and making available such
documents as Abbott may reasonably request,
and Myogen may, at its option or at the
request of Abbott, join such action as
co-plaintiff or party plaintiff if legally
permissible or if the maintenance of the
action or proceeding requires the same. In
the event Myogen joins such action or
proceeding at its election, or at the
request of Abbott, it may be represented by
its own counsel [/\#/\].
(ii) If Abbott elects not to exercise such right,
and the parties disagree on the utility of
bringing an action against an alleged
infringer, then the parties shall submit
their disagreement to a mutually agreeable
Third Party attorney with experience in
patent litigation in the country of
infringement for resolution. If the Third
Party attorney decides that an infringement
action has a reasonable chance of success,
then Abbott shall be obligated to institute
an action or proceeding in accordance with
Section 11.2(a)(i) above. If the Third Party
attorney decides that an infringement action
does not have a reasonable chance of
success, then no action shall be brought by
either party unless Abbott elects within ten
(10) days of the neutral's decision to
institute such an action or proceeding (or
except as otherwise provided in accordance
with Section 11.2(a)(iii) below).
(iii) If Myogen reasonably believes there is
substantial merit to bringing such an action
notwithstanding the neutral's decision
pursuant to Section 11.2(a)(ii) above; or if
Abbott elects to bring such action but
delegates the authority to institute and
prosecute such action or proceeding to
Myogen, Myogen shall have the right to
institute and prosecute such action or
proceeding to xxxxx such
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 25
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
infringement and to resolve such matter by
settlement or otherwise. Abbott shall
cooperate fully by joining as a party
plaintiff if reasonably requested to do so
by Myogen or if required to do so by law to
maintain such action and by executing and
making available such documents as Myogen
may reasonably request. Abbott may be
represented by counsel in any such action,
[/\#/\].
(b) XXXXXX'X USE OF PROCEEDS. All amounts of
every kind and nature recovered from an
action or proceeding of infringement brought
by Abbott shall belong to Abbott, and shall
be used first to reimburse Abbott for its
documented and actual costs of prosecution,
including attorneys' fees, expert fees and
all other related expenses, second to
reimburse Myogen for its documented and
actual costs if it is represented by counsel
in the proceeding. If such damage award is
based upon a finding of Myogen's lost sales,
the balance of the amount awarded as
compensatory damages shall, beyond the costs
incurred by Abbott and Myogen for their
respective participations in the action or
proceeding, shall first be used to provide
Abbott the royalty it would have received if
the lost sales had been licensed sales of
Myogen under Section 7.4(a) hereinabove, and
then the parties shall [/\#/\] unless the
award is based upon lost profits of Myogen
and Myogen participated as a party. In such
case, Myogen shall be entitled to [/\#/\] of
said remainder. Any exemplary damages
awarded shall be [/\#/\] between Myogen and
Abbott; [/\#/\].
(c) MYOGEN'S USE OF PROCEEDS. All amounts of
every kind and nature recovered from an
action or proceeding of infringement brought
by Myogen [/\#/\], and shall first be used
to reimburse Myogen for its documented and
actual costs of prosecution, second to
reimburse Abbott for its documented and
actual costs if it is represented by counsel
in the proceedings, and the balance shall be
considered Net Sales under this Agreement
and subject to royalty obligation under
Section 7.4.
12. INFRINGEMENT OF THIRD PARTY RIGHTS; MYOGEN DEFENSE OF SUIT. If Abbott,
its Affiliates, Myogen, its Affiliates, sublicensees, distributors or
other customers are sued or threatened with suit by a Third Party
alleging infringement of patents or other intellectual property rights
that are alleged to cover the manufacture, use, sale, import, export or
distribution of one or more Products, Abbott or Myogen, whichever is
relevant, will promptly notify the other in writing and provide a copy
of the lawsuit or claim. Myogen shall control the defense in any such
claim or suit. Myogen shall keep Abbott timely informed of material
developments in the defense of such claim or suit. If Myogen expends
any amounts in connection with any Third Party claim of infringement or
misappropriation, or is required to pay a royalty or other amount to a
Third Party for the manufacture, use, sale, import, export or
distribution of one or more Products in the Myogen Territory as a
result of a final judgment or settlement, such amounts shall be
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 26
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
[/\#/\], but only where such claim, judgment or settlement arises out
of Myogen's practice of a Patent or use of the Abbott Technology
pursuant to the license granted under Article 2 of this Agreement
except where such claim, judgment or settlement alleges an infringement
arising from the practice of a Patent or use of the Abbott Technology
in combination with the technology of a Third Party and such
infringement would have been avoided without such combination. Abbott
shall fully cooperate with Myogen in the defense of any such action at
Xxxxxx'x expense. Myogen shall have the right to settle any such suit,
including the right to grant one or more sublicenses with Xxxxxx'x
prior written approval, which approval shall not unreasonably be
withheld, provided that Myogen shall not otherwise have the right to
surrender, limit or adversely affect any rights to the Patents. The
terms of this Article 12 shall not apply to or affect Xxxxxx'x
indemnity obligation for a breach of Section 8.1(c).
13. PATENT PROSECUTION AND MAINTENANCE; PATENT COSTS: PATENT TERM
EXTENSION.
13.1 DISCLOSURE OF PATENTS/APPLICATIONS TO MYOGEN. Within thirty
(30) days of Myogen's request, Abbott shall provide Myogen a
list of Patents and patent applications in a given Patent
family. If, following Myogen's receipt of such list(s), Myogen
requests additional information, Abbott shall provide to
Myogen the complete text of, and all other information in its
possession or control directly related to (a) all patent
applications included in the given Patent family filed
anywhere in the Territories, and (b) all patents included in
the given Patent family as well as all information in
Xxxxxx'x, its Affiliates and its patent counsel's possession
concerning the institution or possible institution of any
interference, opposition, reexamination, reissue, revocation,
nullification or any official proceeding involving an issued
patent included in the given Patent family a[nywhere in the
Myogen Territory.
13.2 PROSECUTION AND MAINTENANCE. Abbott shall be solely
responsible for the preparation, filing, prosecution and the
associated costs incurred in connection with maintenance of
the Patents (except for the case family including [/\#/\]
which is the responsibility of BASF AG; provided always that
Abbott shall use Commercially Reasonable Efforts to cause BASF
AG to defend or prosecute the case family as necessary) in
Xxxxxx'x name, including oppositions and interferences,
subject to Myogen's right to assume such duties in the event
Abbott reasonably fails to adequately prepare, file, prosecute
and maintain the Patents. By June 30, 2003, Abbott shall
inform BASF AG of Xxxxxx'x desire to have the Patent family
for which BASF AG has responsibility transferred to Abbott and
Abbott shall use commercially reasonable efforts to have BASF
AG agree to such transfer to Abbott within a reasonable time
after the Effective Date, and upon such transfer such Patents
will be subject to the same terms and conditions of this
Agreement as the Patents for which Abbott has responsibility
as of the Effective Date. Abbott and Myogen shall consult and
cooperate with each other, and Abbott shall keep Myogen
reasonably informed with respect to the prosecution
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 27
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
and maintenance of the Patents hereunder, including the case
family which is the responsibility of BASF AG. In this regard
Abbott shall exercise its rights under its license from BASF
AG for this Patent family such that Myogen shall have the
opportunity to participate in the preservation of these Patent
rights if it chooses to do so. In connection with its duties
under this Section 13.2, Abbott will provide Myogen with: (a)
copies of all material documents received or prepared by
Abbott in the prosecution and maintenance of the Patents; (b)
advance written notice to the extent reasonably practical of
any action or proceeding relating to any Patent; and (c) a
bi-annual report on the status of prosecution of all Patents.
Abbott shall provide copies in a timely manner to allow Myogen
an opportunity, if it so elects, to review and comment on
Xxxxxx'x proposed patent strategy. If Myogen determines, upon
advice of its patent counsel, that further prosecution actions
with respect to an existing application within the Patents or
a reexamination, reissue, interference and action under 35 USC
Paragraph 146 or other official proceeding involving an issued
Patent anywhere in the Myogen Territory is required to ensure
the enforceability of such Patent or adequate claim coverage
within such Patents, Abbott shall have the right and sole
responsibility for conducting such prosecution action or
instituting such proceeding. If Abbott elects not to exercise
such right, then Myogen shall have the right and sole
responsibility for the pursuit of such activities, and Abbott
shall cooperate with Myogen and provide Myogen with all
necessary information to conduct such activities. Inasmuch as
the Patents cover other compounds not licensed to Myogen
hereunder, Abbott warrants that it will not take any action
with respect to the Patents, which would have a material
adverse effect on the patent coverage of the Compound.
13.3 PATENT EXTENSIONS. Abbott shall have the right and sole
responsibility for obtaining patent term extensions under the
provisions of 35 USC Paragraph 156 for any U.S. Patent and for
non-U.S. Patents under similar provisions of law of other
countries involving a Product which has obtained Regulatory
Approval. Myogen shall cooperate with Abbott and provide
Abbott with all necessary information to obtain such
extensions. If Abbott elects not to exercise such right,
Myogen may file for such extension at its own expense, and
Abbott shall cooperate with Myogen and provide Myogen with all
necessary information to obtain such extensions.
14. TRADEMARK. Myogen may select any Trademark or Trademarks for the
Product in the Myogen Territory including the Co-Promotion Territory,
("MYOGEN TRADEMARKS"). All costs related to the selection and
maintenance of the Myogen Trademark(s) shall be borne by Myogen. The
Myogen Trademark(s) shall be owned by Myogen, and Abbott shall have no
claims or rights in or to the Myogen Trademark(s), except such right as
may be necessary for Abbott to commercialize Product following a
termination under Sections 10.2, 10.3 or 10.4 above, and/or to fulfill
its Co-Promotion activities in the Co-Promotion Territory.
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 28
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
15. IMPROVEMENTS. All Improvements made solely by Myogen and/or its
Affiliates hereunder shall be the sole and exclusive property of Myogen
("MYOGEN IMPROVEMENTS"). All Improvements made solely by Abbott and/or
its Affiliates ("ABBOTT IMPROVEMENTS") shall become part of the Abbott
Technology, subject to the license to Myogen set forth in Article 2
hereof. All Improvements made jointly by employees or others acting on
behalf of Abbott and Myogen (or their Affiliates) hereunder shall be
jointly owned by Abbott and Myogen ("JOINT IMPROVEMENTS"), without a
duty of accounting to the other, to the extent such individuals would
be considered "joint inventors" within the meaning of the U.S. patent
laws. Each party shall take all necessary actions, including executing
documents of assignment, to vest title to all Joint Improvements
(including all intellectual property rights therein) with both parties.
With respect to patents resulting from Joint Improvements, the parties
shall select a mutually agreeable Third Party attorney to prepare,
file, prosecute and maintain such patents. The Third Party attorney
shall consult and apprise each party equally and both parties shall
share 50/50 the costs and fees of employing such Third Party attorney.
Xxxxxx'x interest in such Joint Improvements shall be subject to the
license granted to Myogen under Article 2 hereof and subject to the
terms and conditions of this Agreement. In the event this Agreement is
terminated by Abbott for any reason, as set forth in Article 10, or by
Myogen under Section 10.2, all Myogen improvements shall be exclusively
licensed to Abbott solely for use with the Compound and Product on a
worldwide basis on terms to be mutually agreed to by the parties after
good faith negotiations, and Myogen retains all rights in and to any
Myogen Improvements for any and all other uses.
16. MISCELLANEOUS.
16.1 FORCE MAJEURE. If the performance by either party of any of
its obligations under this Agreement shall be prevented by
circumstances beyond its reasonable control, which could not
have been avoided by the exercise of reasonable diligence,
then such party shall be excused from the performance of that
obligation for the duration of the event. The affected party
shall promptly notify the other party in writing should such
circumstances arise, give an indication of the likely extent
and duration thereof, and shall use commercially reasonable
efforts to resume performance of its obligations as soon as
practicable.
16.2 NOTICES. Any notice required to be given or made under this
Agreement by one of the parties hereto to the other shall be
in writing, by personal delivery, registered U.S. mail or
overnight courier, addressed to such other party at its
address indicated below, or to such other address as the
addressee shall have last furnished in writing to the
addressor and shall be effective upon the date of receipt.
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 29
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
If to Myogen: Myogen, Inc.
0000 X. 000xx Xxxxxx, #000
Xxxxxxxxxxx, XX 00000-0000
Attn: President
With a copy to: Xxxxxx Godward LLP
000 Xxxxxxxxxxx Xxxxxxxx
Xxxxx 000
Xxxxxxxxxx, XX 00000-0000
Attn: Xxxxxx X. Xxxxxx, Esq.
If to Abbott: Xxxxxx International Ltd.
000 Xxxxxx Xxxx Xxxx
Xxxx. 6WP; Xxxx. XX00
Xxxxxx Xxxx, XX 00000-0000
Attn: Senior Vice President,
International Operations
With a copy to: Xxxxxx Laboratories
000 Xxxxxx Xxxx Xxxx
Xxxx. 364; Bldg. AP6D
Xxxxxx Xxxx, XX 00000-0000
Attn: Senior Vice President, Secretary
and General Counsel
16.3 APPLICABLE LAW/COMPLIANCE. This Agreement shall be governed by
and construed in accordance with the laws of the State of
Illinois, excluding its conflict of laws provision. Each party
hereto shall comply with all applicable laws, rules,
ordinances, guidelines, consent decrees and regulations of any
federal, state or other governmental authority.
16.4 ENTIRE AGREEMENT. This Agreement and the attachments
(Exhibits) contain the entire understanding of the parties
with respect to the subject matter hereof. All express or
implied agreements and understandings, either oral or written,
heretofore made are expressly merged in and made a part of
this Agreement. This Agreement may be amended, or any term
hereof modified, only by a written instrument duly executed by
both parties hereto.
16.5 COUNTERPARTS . This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but
all of which together shall constitute one and the same
instrument.
16.6 SEVERABILITY/HEADINGS. If any provision of this Agreement is
deemed unenforceable, the remainder of the Agreement will not
be affected and, if
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 30
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
appropriate, the parties will attempt to replace the
unenforceable provision with a new provision that, to the
extent possible, reflects the parties' original intent. The
captions and headings used in this Agreement are for reference
only and are not to be construed in any way as terms or used
to interpret the provisions of this Agreement.
16.7 ASSIGNMENT. Neither party may without written approval of the
other assign this Agreement or transfer its interest or any
part thereof under this Agreement to any Third Party except
that (a) either party may assign this Agreement without
consent to a Third Party that acquires all or substantially
all of the business to which this Agreement pertains, or, (b)
either party may assign this Agreement in whole or part to any
Affiliate of that party and such party hereby guarantees the
performance by such Affiliate.
16.8 DISPUTE RESOLUTION. The parties hereto shall attempt to settle
any dispute arising out of or relating to this Agreement in an
amicable way. Except for claims for injunctive or other
equitable relief, which may be brought in any court of
competent jurisdiction, any controversy, claim or right of
termination for cause which may arise under, out of, in
connection with, or relating to this Agreement, or any breach
thereof, shall be settled according to the Alternative Dispute
Resolution provisions attached hereto as Exhibit D.
16.9 INDEPENDENT CONTRACTOR. It is understood that both parties
hereto are independent contractors and engage in the operation
of their own respective businesses and neither party hereto is
to be considered the agent of the other party for any purpose
whatsoever and neither party has any authority to enter into
any contract or assume any obligation for the other party or
to make any warranty or representation on behalf of the other
party. Each party shall be fully responsible for its own
employees, servants and agents, and the employees, servants
and agents of one party shall not be deemed to be employees,
servants and agents of the other party for any purpose
whatsoever.
16.10 SURVIVAL. Sections 8.1, 8.2, 8.3, 8.4 and 8.6, Articles 9, of
this Agreement shall survive the expiration or termination of
this Agreement for any reason for a period of seven (7) years,
Articles 15, 16.8 and 16.10 of this Agreement shall survive
the expiration or termination of this Agreement for any reason
and Article 7 shall survive early termination of this
Agreement for any reason with respect to Product sold prior to
such termination and with respect to Product sold after such
termination if such termination was by Myogen pursuant to
Section 10.2, by Abbott for Myogen's breach pursuant to
Section 10.3, or by Abbott by reason of Myogen's insolvency
under Section 10.4. Nothing contained in the preceding
sentence shall be deemed to entitle Abbott to double recovery
of damages under any patent infringement suit against Myogen.
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 31
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
16.11 PUBLICITY. No press release or other public announcement shall
be made by either party concerning the execution of this
Agreement or the fact that Myogen has licensed the Compound
from Abbott, without the prior written consent of the
non-disclosing party, which consent shall not be unreasonably
withheld. Neither party shall use the name of the other party,
its officers, employees or agents for purposes of any public
commercial activity without the other party's prior written
consent, except where the name of the other party must be
disclosed as a matter of law. Should either party wish to make
a disclosure or be required by law to make a disclosure, the
disclosing party shall submit a copy of the proposed
disclosure to the other party for review. The non-disclosing
party shall have two (2) weeks to review and comment on the
content of such disclosure. In the case of a disclosure
required by law, the disclosing party, subject to legal
requirements, shall use all reasonable efforts to accommodate
the non-disclosing party's comments. For non-routine matters
like an emergency, special circumstance, or other situation
where the law compels a disclosure in less than three (3)
week's time, the non-disclosing party agrees to use
commercially reasonable efforts to provide its review and
comment in order to meet the disclosing party's timetable.
(REMAINDER OF PAGE INTENTIONALLY LEFT BLANK)
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 32
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as
of the Effective Date.
XXXXXX LABORATORIES MYOGEN, INC.
By: /s/ Xxxxxxx X. Leiden By: /s/ J. Xxxxxxx Xxxxxxx
----------------------------------- --------------------------------
Name: Xxxxxxx X. Leiden Name: J. Xxxxxxx Xxxxxxx
--------------------------------- -------------------------------
Its: President & COO Its: President & CEO
---------------------------------- -------------------------------
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 1
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
EXHIBIT A
TO
EXCLUSIVE LICENSE AGREEMENT
BETWEEN
XXXXXX LABORATORIES
AND
MYOGEN, INC.
DATED JUNE 30, 2003
PATENTS AND PATENT APPLICATIONS
NO. PRIORITY DATE WO NUMBER IN-HOUSE NO. TITLE
-------------- ------------------- ------------------------ ----------------- -----------------------------------------------
1 23.04.93 WO 94/25442 43997 3-Het-Arylcarbonsaure-derivate
-------------- ------------------- ------------------------ ----------------- -----------------------------------------------
Verwendung von Carbonsaurederivaten als
2 31.03.94 WO 95/26716 44751 Arzneimittel
-------------- ------------------- ------------------------ ----------------- -----------------------------------------------
3 14.10.94 WO 96/11914 45281 Neue Carbonsaurederivate
-------------- ------------------- ------------------------ ----------------- -----------------------------------------------
4 26.09.97 WO 99/16445 480/1171 Combination of ETRAs plus RAS-inhibitors
-------------- ------------------- ------------------------ ----------------- -----------------------------------------------
5 19.12.96 Germany 480/1174 Combination of ETRAs plus vasodilators
-------------- ------------------- ------------------------ ----------------- -----------------------------------------------
Combination of ETRAs plus
6 30.09.97 WO 99/16444 480/1175 beta-blockers
-------------- ------------------- ------------------------ ----------------- -----------------------------------------------
7 05.12.97 WO 99/29308 480/1181 Use of ETRAs to inhibit obesity
-------------- ------------------- ------------------------ ----------------- -----------------------------------------------
8 30.10.98 WO 2000/026170 00000 Xxxxxxxxx xxx Racematspaltung
-------------- ------------------- ------------------------ ----------------- -----------------------------------------------
9 20.01.00 51096 Enantioselective Synthesevon ETRAs
-------------- ------------------- ------------------------ ----------------- -----------------------------------------------
Combination of ETRAs plus aVb3 zur Behandlung
10 19.09.00 51748 von Restenosis
-------------- ------------------- ------------------------ ----------------- -----------------------------------------------
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 1
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
EXHIBIT B
TO
EXCLUSIVE LICENSE AGREEMENT
BETWEEN
XXXXXX LABORATORIES
AND
MYOGEN, INC.
DATED JUNE 30, 2003
WORK PLAN
(PRELIMINARY)
[/\#/\]
PRELIMINARY DEVELOPMENT TIMELINES
[DRAWING]
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 1
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
EXHIBIT C
TO
EXCLUSIVE LICENSE AGREEMENT
BETWEEN
XXXXXX LABORATORIES
AND
MYOGEN, INC.
DATED JUNE 30, 2003
PRE-CLINICAL STUDIES
[/\#/\]
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 1
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
EXHIBIT D
TO
EXCLUSIVE LICENSE AGREEMENT
BETWEEN
XXXXXX LABORATORIES
AND
MYOGEN, INC.
DATED JUNE 30, 2003
ALTERNATIVE DISPUTE RESOLUTION
The parties recognize that from time to time a dispute may arise
relating to either party's right or obligations under this Agreement. The
parties agree that any such dispute shall be resolved by the Alternative Dispute
Resolution ("ADR") provisions set forth in this Exhibit, the result of which
shall be binding upon the parties.
To begin the ADR process, a party first must send written notice of the
dispute to the other party for attempted resolution by good faith negotiations
between their respective presidents (or their designees) of the affected
subsidiaries, divisions, or business units within twenty-eight (28) days after
such notice is received (all references to "days" in this ADR provision are to
calendar days). If the matter has not been resolved within twenty-eight (28)
days of the notice of dispute, or if the parties fail to meet within such
twenty-eight (28) days, either party may initiate an ADR proceeding as provided
herein. The parties shall have the right to be represented by counsel in such a
proceeding.
1. To begin an ADR proceeding, a party shall provide written notice to the
other party of the issues to be resolved by ADR. Within fourteen (14)
days after its receipt of such notice, the other party may, by written
notice to the party initiating the ADR, add additional issues to be
resolved within the same ADR.
2. Within twenty-one (21) days following receipt of the original ADR
notice, the parties shall select a mutually acceptable neutral to
preside in the resolution of any disputes in this ADR proceeding. If
the parties are unable to agree on a mutually acceptable neutral within
such period, either party may request the President of the CPR
Institute for Dispute Resolution ("CPR"), 000 Xxxxxxx Xxxxxx, 00xx
Xxxxx, Xxx Xxxx, Xxx Xxxx 00000, to select a neutral pursuant to the
following procedures:
(a) The CPR shall submit to the parties a list of not less than
five (5) candidates within fourteen (14) days after receipt of
the request, along with a Curriculum Vitae for each candidate.
No candidate shall be an employee, director, or shareholder of
either party or any of their subsidiaries or affiliates.
(b) Such list shall include a statement of disclosure by each
candidate of any circumstances likely to affect his or her
impartiality.
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 1
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
(c) Each party shall number the candidates in order of preference
(with the number one (1) signifying the greatest preference)
and shall deliver the list to the CPR within seven (7) days
following receipt of the list of candidates. If a party
believes a conflict of interest exists regarding any of the
candidates, that party shall provide a written explanation of
the conflict to the CPR along with its list showing its order
of preference for the candidates. Any party failing to return
a list of preferences on time shall be deemed to have no order
of preference.
(d) If the parties collectively have identified fewer than three
(3) candidates deemed to have conflicts, the CPR immediately
shall designate as the neutral the candidate for whom the
parties collectively have indicated the greatest preference.
If a tie should result between two candidates, the CPR may
designate either candidate. If the parties collectively have
identified three (3) or more candidates deemed to have
conflicts, the CPR shall review the explanations regarding
conflicts and, in its sole discretion, may either (i)
immediately designate as the neutral the candidate for whom
the parties collectively have indicated the greatest
preference, or (ii) issue a new list of not less than five (5)
candidates, in which case the procedures set forth in
subparagraphs 2(a) -2(d) shall be repeated.
3. The ADR proceeding will be governed by and subject to the principles
specified in the "CPR Rules for Non-Administered Arbitration" except to
the extent such rules conflict with any of the provisions of this
Agreement. No earlier than twenty-eight (28) days or later than six (6)
months after selection, the neutral shall hold a hearing to resolve
each of the issues identified by the parties, provided that the parties
agree that stated goal of the parties is to hold such hearing within
fifty-six (56) days after selection. The ADR proceeding shall take
place at a location agreed upon by the parties. If the parties cannot
agree, the neutral shall designate a location other than the principal
place of business of either party or any of their subsidiaries or
affiliates.
4. At least seven (7) days prior to the hearing, each party shall submit
the following to the other party and the neutral:
(a) a copy of all exhibits on which such party intends to rely in
any oral or written presentations to the neutral;
(b) a list of any witnesses such party intends to call at the
hearing, and a short summary of the anticipated testimony of
each witness;
(c) a proposed ruling on each issue to be resolved, together with
a request for a specific damage aware or other remedy for each
issue. The proposed rulings and remedies shall not contain any
recitation of the facts or any legal arguments and shall not
exceed one (1) page per issue.
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 2
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
(d) a brief in support of such party's proposed rulings and
remedies, provided that the brief shall not exceed twenty (20)
pages. This page limitation shall apply regardless of the
number of issues raised in the ADR proceeding.
Except as expressly set forth in subparagraphs 4(a) - 4(d), no
discovery shall be required or permitted by any means, including
depositions, interrogatories, requests for admissions, or production of
documents.
5. The hearing shall be conducted on two (2) consecutive days and shall be
governed by the following rules:
(a) Each party shall be entitled to five (5) hours of hearing time
to present its case. The neutral shall determine whether each
party has had the five (5) hours to which it is entitled.
(b) Each party shall be entitled, but not required, to make an
opening statement, to present regular and rebuttal testimony,
documents or other evidence, to cross-examine witnesses, and
to make a closing argument. Cross-examination of witnesses
shall occur immediately after their direct testimony, and
cross-examination time shall be charged against the party
conducting the cross-examination.
(c) The party initiating the ADR shall begin the hearing and, if
it chooses to make an opening statement, shall address not
only issues it raised but also any issues raised by the
responding party. The responding party, if it chooses to make
an opening statement, also shall address all issues raised in
the ADR. Thereafter, the presentation of regular and rebuttal
testimony and documents, other evidence, and closing arguments
shall proceed in the same sequence.
(d) Except when testifying, witnesses shall be excluded from the
hearing until closing arguments.
(e) Settlement negotiations, including any statements made
therein, shall not be admissible under any circumstances.
Affidavits prepared for purposes of the ADR hearing also shall
not be admissible. As to all other matters, the neutral shall
have sole discretion regarding the admissibility of any
evidence.
6. Within seven (7) days following completion of the hearing, each party
may submit to the other party and the neutral a post-hearing brief in
support of its proposed rulings and remedies, provided that such brief
shall not contain or discuss any new evidence and shall not exceed ten
(10) pages. This page limitation shall apply regardless of the number
of issues raised in the ADR proceeding.
7. The neutral shall rule on each disputed issue within fourteen (14) days
following completion of the hearing. Such ruling shall adopt in its
entirety the proposed ruling and remedy of one of the parties on each
disputed issue but may adopt one party's proposed rulings and remedies
on some issues and the other party's proposed rulings and remedies on
other issues. The neutral shall not issue any written opinion or
otherwise explain the basis of the ruling.
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 3
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
8. The neutral shall be paid a reasonable fee plus expenses. These fees
and expenses, along with the reasonable legal fees and expenses of the
prevailing party (including all expert witness fees and expenses), the
fees and expenses of a court reporter, and any expenses for a hearing
room, shall be paid as follows:
(a) If the neutral rules in favor of one party on all disputed
issues in the ADR, the losing party shall pay 100% of such
fees and expenses.
(b) If the neutral rules in favor of one, party on some issues and
the other party on other issues, the neutral shall issue with
the rulings a written determination as to how such fees and
expenses shall be allocated between the parties. The neutral
shall allocate fees and expenses in a way that bears a
reasonable relationship to the outcome of the ADR, with the
party prevailing on more issues, or on issues of greater value
or gravity, recovering a relatively larger share of its legal
fees and expenses.
9. The rulings of the neutral and the allocation of fees and expenses
shall be binding, non-reviewable, and non-appealable, and may be
entered as a final judgment in any court having jurisdiction.
10. Except as provided in paragraph 9 or as required by law, the existence
of the dispute, any settlement negotiations, the ADR hearing, any
submissions (including exhibits, testimony, proposed rulings, and
briefs), and the rulings shall be deemed Confidential Information. The
neutral shall have the authority to impose sanctions for unauthorized
disclosure of Confidential Information.
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 4
[/\#/\] CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED BY BRACKETS, IS FILED WITH THE
SECURITIES AND EXCHANGE COMMISSION PURSUANT TO
RULE 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
1 ABBOTT
--------------------------------------------------------------------------------
Global Licensing & New Business Development
Xxxxxx Laboratories
000 Xxxxxx Xxxx Xxxx, Xxxx X00X/XX00-0
Xxxxxx Xxxx, Xxxxxxxx 00000
June 27, 2003
Myogen, Inc.
0000 X. 000xx Xxxxxx
Xxxxxxxxxxx, XX 00000-0000
Re: License Agreement Dated June 27, 2003 ("License Agreement") Between
Xxxxxx Laboratories ("Abbott") and Myogen, Inc. ("Myogen")
Dear Sir or Madam:
In the event of a transfer of manufacturing responsibility to a Third Party
Manufacturer for the supply of Compound and/or Product in accordance with
Section 6.6(b) of the License Agreement, Myogen may request the assistance of
Xxxxxx personnel with knowledge and skills in the manufacture of Compound and/or
Product to assist Myogen with such transfer.
Myogen may request such assistance by providing written notice to Abbott
specifying the nature of the assistance requested and suggesting the schedule
for Abbott to provide such assistance. Abbott shall reasonably cooperate with
Myogen's request and assign qualified Xxxxxx personnel to provide such
assistance at a schedule subject to the mutual agreement of the parties.
Myogen shall compensate Abbott for each hour of personnel time spent providing
the assistance at the rate of [/\#/\]. Myogen shall also reimburse Abbott for
all reasonable costs and expenses incurred by such Xxxxxx personnel in
connection with providing the assistance, including reasonable travel and
lodging expenses. The parties agree that Abbott shall not be obligated to supply
more than [/\#/\] of personnel time in response to Myogen's
request.
The parties indicate their agreement to the foregoing understanding by their
signatures below.
XXXXXX LABORATORIES MYOGEN, INC.
By: /s/ Signature Illegible By: /s/J. Xxxxxxx Xxxxxxx
---------------------------------- ---------------------------------
Title: Divisional Vice President Title: President & CEO
------------------------------- ------------------------------
Date: 6-27-03 Date: 6-27-03
-------------------------------- -------------------------------
[/\#/\] CONFIDENTIAL TREATMENT REQUESTED 1
