<PAGE>
EXHIBIT 10.37
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
LICENSE AGREEMENT
PREAMBLE
THIS
LICENSE AGREEMENT ("Agreement") is entered into as of the 3rd day
of
March, 2006 (the "Effective Date") by and between Myogen, Inc., a
Delaware
corporation, with its principal place of business at 7575 W. 103rd
Avenue,
Westminster, CO 80021-5426 ("Myogen") and GLAXO GROUP LIMITED, a
private limited
company incorporated in England and Wales, having its registered
office at Glaxo
Wellcome House, Berkeley Avenue, Greenford, Middlesex, England UB6
0NN ("GSK").
Myogen and GSK are sometimes collectively referred to herein as the
"Parties"
and separately as a "Party."
WHEREAS, Myogen is the licensee of certain rights in the Abbott
Intellectual Property (as hereinafter defined), and has the right
to grant
certain sublicenses thereunder, relating to Compound (as
hereinafter defined)
and/or Product (as hereinafter defined) in the Field (as
hereinafter defined);
and
WHEREAS, GSK desires to obtain an exclusive sublicense from Myogen
under
the aforesaid Abbott Intellectual Property to make, have made, use,
sell, offer
for sale and import Compound and Product in the Field in the GSK
Territory (as
hereinafter defined), and Myogen is willing to grant to GSK such
sublicense, in
accordance with the terms and conditions of this Agreement; and
WHEREAS, Myogen owns or otherwise controls the Myogen Intellectual
Property
(as hereinafter defined), and has the right to grant certain
licenses
thereunder, relating to Compound and/or Product in the Field;
and
WHEREAS, GSK desires to obtain an exclusive license from Myogen
under the
aforesaid Myogen Intellectual Property to make, have made, use,
sell, offer for
sale and import Compound and Product in the Field in the GSK
Territory, and
Myogen is willing to grant to GSK such license, in accordance with
the terms and
conditions of this Agreement.
NOW,
THEREFORE, in consideration of the mutual covenants and agreements
set
forth herein and other good and valuable consideration, the receipt
and legal
sufficiency of which are hereby mutually acknowledged, Myogen and
GSK hereby
agree as follows:
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
<PAGE>
ARTICLE
I
DEFINITIONS
Section 1.1 Definitions. As used herein, the following capitalized
terms
will have the meanings set forth below when used in this Agreement,
and all
terms defined in the singular will have the same meanings when used
in the
plural (and vice versa), unless otherwise specified.
"Abbott" means Abbott Deutschland Holding GmbH, a German legal
entity, with
its principal office at Max Planck Ring 2, 65205 Wiesbaden,
Germany.
"Abbott Agreement" means the License Agreement by and between
Abbott and
Myogen, dated as of October 8, 2001, and any amendments thereto. A
complete copy
of the Abbott Agreement as of the Effective Date is attached hereto
as Exhibit
A.
"Abbott Intellectual Property" means the Abbott Know-How and Abbott
Patent
Rights, collectively.
"Abbott Know-How" means Know-How that is Controlled by Abbott as of
the
effective date of the Abbott Agreement and which has been licensed
to Myogen in
accordance with the terms and conditions of the Abbott
Agreement.
"Abbott Patent Rights" means the Patent Rights defined in Section
1.16 of
the Abbott Agreement. Myogen has provided to GSK a list of Abbott
Patent Rights
current as of the Effective Date. A list of issued patents and
pending PCT
applications included within the Abbott Patent Rights in the GSK
Territory is
attached hereto as Exhibit B, and Myogen will update such Exhibit
promptly upon
GSK's reasonable written request, which request will not be made by
GSK more
than twice in any Calendar Year during the Term.
An
"Affiliate" of a Party or Person means any Person, whether de jure
or de
facto, that directly or indirectly, controls, is controlled by, or
is under
common control with such Party or Person, as applicable. Solely as
used in this
definition, "control" means (a) direct or indirect ownership of
more than fifty
percent (50%) of the equity (or such lesser percentage which is the
maximum
allowed to be owned by a foreign corporation in a particular
jurisdiction)
having the power to vote on or direct the affairs of such Party or
Person, as
applicable, or (b) the possession, directly or indirectly, of the
power to
direct or cause the direction of the policies and management of
such Party or
Person, as applicable, whether by the ownership of stock, by
contract, or
otherwise.
"Agreement" will have the meaning set forth in the preamble.
"Applicable Law" means all applicable provisions of any and all
supra-national, federal, national, state, provincial, and local
statutes, laws,
rules, regulations, administrative codes, ordinances, decrees,
orders,
decisions, injunctions, awards judgments, permits and licenses of
or from
governmental authorities relating to or governing the use or
regulation of the
subject item.
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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"Assumption of Responsibility Notice" will have the meaning set
forth in
Section 6.1.
"Auditor" will have the meaning set forth in Section 9.3(e).
"Business Day" means any day other than a day which is a Saturday,
a Sunday
or any day banks are authorized or required to be closed in the
United States or
in the United Kingdom.
"Calendar Quarter" means each of the consecutive three (3) month
periods
ending March 31, June 30, September 30, and December 31; provided,
however, that
the first (1st) Calendar Quarter under this Agreement will be the
period
beginning on the Effective Date and ending on the end of the
Calendar Quarter in
which the Effective Date is encompassed.
"Calendar Year" means, for the first Calendar Year, the period
beginning on
the Effective Date and ending December 31, 2006, and for each
Calendar Year
thereafter, each successive period beginning on January 1 and
ending twelve (12)
consecutive calendar months later on December 31; provided,
however, that the
last Calendar Year of the Term will be the period beginning on
January 1 and
ending on the effective date of expiration or termination of the
Term.
"Commercially Reasonable Efforts" means efforts and resources
normally used
by a similarly situated pharmaceutical company in the GSK Territory
or Myogen
Territory, as applicable, in the exercise of its reasonable
business discretion
relating to a prescription pharmaceutical product owned by it or to
which it has
exclusive rights, which is of similar market potential at a similar
stage in its
development or product life, taking into account issues of patent
coverage,
safety and efficacy, product profile, the competitiveness of the
marketplace,
the proprietary position of the compound or product, the regulatory
structure
involved, the profitability of the applicable products (including,
without
limitation, pricing and reimbursement status achieved), and other
relevant
factors, including without limitation technical, legal, scientific,
and/or
medical factors, and provided that all such actions are consistent
in all
material respects with the Development Plan or Global Marketing
Plan, as the
case may be.
"Commercialization" or "Commercialize" means activities directed
to
obtaining pricing and reimbursement approvals, marketing,
promoting,
distributing, using, importing or selling the Product in the
Field.
Commercialization will not include any activities related to
Development or
Manufacturing.
"Common Technical Document" means a harmonized structure and format
for new
drug product applications developed by ICH to be used by the
Parties, as
appropriate and subject to clinical data availability and
Applicable Law in a
country, in connection with Regulatory Approval Applications for
Product in the
European Union, Japan, Canada and the United States.
"Compound" will have the meaning set forth in Section 1.5 of the
Abbott
Agreement.
"Confidential Information" means any and all information disclosed
to or
obtained by Recipient pursuant to or in connection with the
negotiation,
execution, delivery and performance of this Agreement or the
consummation of the
transactions contemplated hereby and any and all information
regarding, related
to, or associated with any or all elements of this Agreement,
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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<PAGE>
including the Development, Manufacture and/or Commercialization of
Product in
the Field or any aspect thereof, or each Party's operations that is
disclosed by
the Disclosing Party to the Recipient; provided, however, that
Confidential
Information will not include information which: (i) at the time of
disclosure is
in the public domain; (ii) after disclosure becomes part of the
public domain,
except through breach of this Agreement; (iii) the Recipient can
demonstrate by
reasonable proof was in its possession prior to the time of
disclosure by the
Disclosing Party hereunder, and was not acquired directly or
indirectly from the
Disclosing Party; (iv) the Recipient can demonstrate by reasonable
proof was
developed by or on behalf of Recipient independent of and without
reference to
the Disclosing Party's Confidential Information; or (v) becomes
available to
Recipient from a Third Party who did not acquire such information
directly or
indirectly from the Disclosing Party and who is not otherwise
prohibited from
disclosing such information.
"Confidentiality Agreement" will have the meaning set forth in
Section
13.1(h).
"Control" means, with respect to the subject item, the ability
and
authority of a Party or its Affiliate, whether arising by
ownership, possession
or pursuant to a license or sublicense, to grant licenses or
sublicenses to the
other Party under or to the subject item as specified in this
Agreement, without
breaching the terms of any agreement with any Third Party and/or
its Affiliates.
"Cure Period" will have the meaning set forth in Section 11.2.
"Development" or "Develop" means non-clinical and clinical research
and
drug development activities related to obtaining and maintaining
Regulatory
Approval (excluding pricing and reimbursement approvals) for
Product in the
Field, including test method development and stability testing,
process
development, formulation development, delivery system development,
quality
assurance and quality control development for clinical supplies,
statistical
analysis, clinical studies (including pre- and post-approval
studies),
regulatory affairs, and Regulatory Approval (excluding regulatory
activities
directed to obtaining pricing and reimbursement approvals) and
clinical study
regulatory activities (excluding regulatory activities directed to
obtaining
pricing and reimbursement approvals).
"Development Information" means any and all information generated
by a
Party (or a Party's Affiliates or any Third Party on behalf of a
Party (i.e.,
including, without limitation, suppliers of starting materials,
excipients and
packaging)) in the Development of Compound and/or Product as
provided in this
Agreement, including, without limitation, information relating to
chemistry
manufacturing and control (CMC), protocols, analysis plans,
annotated case
report forms per study, analysis datasets, programs, raw data and
other relevant
documentation used for the study reporting efforts and minutes from
clinical
advisory boards and investigator meetings.
"Development Plan" means the plan for Development of Product in the
Field
in the United States, Canada and Major European Market Countries,
which will
include, without limitation, the development, operating guidelines
and estimated
filing dates, guidelines for filing Regulatory Approval, any
preclinical and
clinical studies to be conducted (including, without limitation,
[..**..], each
of which the Parties expect to be completed by Myogen according to
the
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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<PAGE>
timelines set forth in the Development Plan.
"Disclosing Party" will have the meaning set forth in Section
13.1(a).
"Dispute" will have the meaning set forth in Section 14.1.
"Dispute Notice" will have the meaning set forth in Section 14.1
hereof.
"Distributor" means a Third Party engaged by a Party or its
Affiliates in a
country in the GSK Territory or Myogen Territory, as applicable,
to
Commercialize Compound and/or Product in such country, who is not a
Sublicensee
or Wholesaler.
"Effective Date" will have the meaning set forth in the
Preamble.
"EMEA" means the European Medicines Agency of the European Union,
or any
successor agency thereto.
"European Commission" means the European Community authority that
has legal
authority to grant marketing authorizations approvals for
pharmaceutical
products on an European Economic Area wide basis following
scientific evaluation
and recommendation from the EMEA or other applicable Regulatory
Authorities.
"European Critical Care Business Unit" means the business unit
within GSK's
European pharmaceutical business unit that is focused on acute
cardiology, the
hospital market and GSK's critical care portfolio in Europe.
"European Economic Area" means those countries forming part of the
European
Economic Area at any time during the Term, including, without
limitation, those
countries in the European Union. The term "European Union" as used
herein and in
the definition of "EMEA" means the countries forming part of the
European Union
at any time during the Term.
"FDA" means the United States Food and Drug Administration or any
successor
agency thereto.
"Field" means any and all therapeutic uses of Compound and/or
Product in
humans for the prevention, palliation or treatment of PAH and
related etiologies
as defined by the World Health Organization (WHO) clinical
classification of
pulmonary hypertension (Venice 2003), a copy of which is attached
hereto as
Exhibit C, but excluding any non-therapeutic or non-human use
(which
non-therapeutic or non-human use shall include, but not be limited
to, imaging,
diagnostics, veterinary medicine, etc.).
"First Commercial Sale" means the date of the first commercial sale
of a
Product in the Field in a country in the Territory or in the GSK
Territory or
Myogen Territory, as applicable, in accordance with the terms of
this Agreement,
by a Party and/or its Affiliates or permitted Sublicensees to
distributors,
wholesalers or other customers in a quantity sufficient for the
distribution of
such Product to pharmacies or other commercial distribution
channels for sale in
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
4
<PAGE>
the Field in such country or GSK Territory or Myogen Territory, as
applicable.
Sales of Product for compassionate use, named patient use, clinical
trial
purposes or other similar uses will not constitute a First
Commercial Sale.
"Force Majeure Event" will have the meaning set forth in Section
15.4(g).
"Generic Equivalent" means, with respect to a particular
Product
Commercialized by GSK, its Affiliates or sublicensees in a given
country in the
GSK Territory, a pharmaceutical composition approved by Regulatory
Authorities
to be sold by a Third Party in such country, which pharmaceutical
composition
contains the Compound as an active ingredient and is bioequivalent
to such
Product with respect to pharmacokinetic properties. For the
avoidance of doubt,
the Generic Equivalent of a particular Product Commercialized by
GSK, its
Affiliates or sublicensees in a given county in the GSK Territory,
may or may
not be in the same Presentation as such Product.
"Global Brand Team" will have the meaning set forth in Section
3.3(a).
"Global Marketing Plan" means the plan for the pre-launch,
launch,
post-launch and ongoing Commercialization activities for the
Product in the
Field in the Territory.
"Good Clinical Practice" means the current good clinical
practice
applicable to the clinical Development of the Product in the Field
under
Applicable Law, to the extent such standards are not less stringent
than the
U.S. current good clinical practice, including the guidelines of
the ICH.
"Good Laboratory Practice" means the current good laboratory
practice
applicable to the Development of the Product in the Field under
Applicable Law,
to the extent such standards are not less stringent than the U.S.
current good
laboratory practice, including 21 C.F.R. Part 58.
"GSK" will have the meaning set forth in the Preamble.
"GSK
Indemnitees" will have the meaning set forth in Section 14.3.
"GSK
Inventions" will have the meaning set forth in Section 10.2.
"GSK
Know-How" means, solely to the extent necessary or useful for
the
purposes of Development, Manufacture and/or Commercialization of
Compound and/or
Product, all Know-How Controlled by GSK, its Affiliate or a Third
Party on
behalf of GSK or its Affiliate at any time during the Term,
excluding any Abbott
Know-How or Myogen Know-How.
"GSK
Intellectual Property" means GSK Know-How and GSK Patent
Rights,
collectively.
"GSK
Marks" will have the meaning set forth in Section 5.2(d).
"GSK
Patent Rights" means Patent Rights, including the interest of
GSK
and/or its
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
5
<PAGE>
Affiliates in Joint Inventions, Controlled by GSK and/or its
Affiliates on the
Effective Date or at any time during the Term, excluding the Abbott
Patent
Rights and the Myogen Patent Rights.
"GSK
Publication" will have the meaning set forth in Section
13.3(b).
"GSK
Sponsored New Development Activity" will have the meaning set forth
in
Section 4.3(d).
"GSK
Territory" means all countries and territories of the world that
are
not included in the Myogen Territory.
"ICH" mean International Committee on Harmonization developed
through a
collaboration between the FDA and regulatory agencies in the
European Union and
Japan to harmonize regulatory requirements to produce marketing
applications
acceptable to the countries of the European Union, Japan and the
United States.
"Indemnitee" will have the meaning set forth in Section 14.4.
"Indemnitor" will have the meaning set forth in Section 14.4.
"Initial Royalty" will have the meaning set forth in Section
9.2(a)(i).
"Joint Inventions" will have the meaning set forth in Section
10.2.
"JNDA" means a Japanese New Drug Application, which is filed with
the MHLW
in order to gain the MHLW's approval to Commercialize a
pharmaceutical product
in Japan for the indications set forth in the Japanese New Drug
Application.
"Joint New Development Activity" will have the meaning set forth in
Section
4.3(b).
"Joint Project Team" will have the meaning set forth in Section
3.2(a).
"Joint Steering Committee" will have the meaning set forth in
Section
3.1(a).
"Know-How" means any proprietary technology, information, methods
of use,
processes, techniques, ideas or inventions (excluding any
inventions disclosed
in any patent or patent application) which are directly related to
or used in
connection with the Compound and/or Product, including any trade
secrets and any
other technical information relating to Development, Manufacture
and/or
Commercialization of the Compound and/or Product, excluding any
Patent Rights.
"Losses" will have the meaning set forth in Section 14.2.
"MAA" means a Marketing Authorization Application, which is filed
with the
EMEA for review and recommendation to the European Commission to
approve such
Marketing Authorization Application for the Commercializing of a
pharmaceutical
product in the European
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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<PAGE>
Economic Area for the indications set forth in the Marketing
Authorization
Application.
"Major Country" means the following countries: [..**..] Australia,
[..**..]
Canada, [..**..] Japan, [..**..].
"Major European Market Countries" means the following countries:
France,
Germany, Italy, Spain and the United Kingdom.
Manufacturing" or "Manufacture" means all the activities relating
to
production of Compound and/or Product, including without
limitation, purchasing
raw materials, quality control and assurance, filling, finishing,
labeling,
packaging, qualified person release, holding, shipping and storage
and the tests
and analyses conducted in connection therewith. Manufacturing
excludes
activities relating to Development or Commercialization.
"MHLW" means the Japanese Ministry of Health, Labour and Welfare or
any
successor agency thereto.
"Milestone Payment" will have the meaning set forth in Section
9.1(a).
"Milestones" will have the meaning set forth in Section 9.1(a).
"Myogen" will have the meaning set forth in the Preamble.
"Myogen Know-How" means, solely to the extent necessary or useful
for
purposes of Development, Manufacture and/or Commercialization of
Compound and/or
Product in the Field, any Know-How that is Controlled by Myogen or
its
Affiliates or a Third Party on behalf of Myogen or its Affiliate on
the
Effective Date or at any time during the Term, including, without
limitation,
Development Information but excluding any Abbott Know-How and GSK
Know-How.
"Myogen Indemnitees" will have the meaning set forth in Section
14.2.
"Myogen Intellectual Property" means Myogen Know-How and Myogen
Patent
Rights, collectively.
"Myogen Inventions" will have the meaning set forth in Section
10.2.
"Myogen Marks" will have the meaning set forth in Section
5.3(d).
"Myogen Patent Rights" means Patent Rights, including the interest
of
Myogen and/or its Affiliates in Joint Inventions, Controlled by
Myogen and/or
its Affiliates on the Effective Date or at any time during the
Term, excluding
the Abbott Patent Rights and GSK Patent Rights. A list of issued
patents and PCT
applications within the Myogen Patent Rights is attached hereto as
Exhibit D,
and Myogen will update such Exhibit at least once each Calendar
Year during the
Term, or promptly after GSK's reasonable written request, which
request will not
be made by GSK more than twice in any Calendar Year during the
Term.
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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<PAGE>
"Myogen Publication" will have the meaning set forth in Section
13.3(a).
"Myogen Sponsored New Development Activity" will have the meaning
set forth
in Section 4.3(c).
"Myogen Territory" means the United States, and any other country
in which
this Agreement is terminated pursuant to Section 6.2, Section 6.5,
Section 11.4
or Section 11.7.
"Myogen Trademarks" means the trademarks set forth on Exhibit E,
attached
hereto and incorporated herein, and Myogen will update such Exhibit
at least
once each Calendar Year during the Term, or promptly after GSK's
reasonable
written request, which request will not be made by GSK more than
twice in any
Calendar Year during the Term.
"NDA" means a New Drug Application, which is filed with the FDA in
order to
gain the FDA's approval to Commercialize a pharmaceutical product
in the United
States for the indications set forth in the New Drug
Application.
"New
Development Activity" will have the meaning set forth in
Section
4.3(a).
"Net
Sales" means the gross sales of Compound and/or Product by GSK,
its
Affiliates or Sublicensees to Third Parties (including, but not
limited to,
pharmaceutical wholesalers, pharmacies, hospitals or dispensing
physicians), in
arm's length transactions for which revenue is actually received by
GSK, its
Affiliates, Sublicensees, less any of the following charges or
expenses that are
incurred in connection with such gross sales:
(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 governmental 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 GSK, its Affiliate or Sublicensee; 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 GSK, its
Affiliates or
Sublicensees.
Any sales of Compound and/or Product between GSK, its Affiliates
and its or
their Sublicensees, for resale, will be excluded from the
computation of Net
Sales; provided, however, that the revenue received from the
subsequent sale of
such Compound and/or Product by GSK, its Affiliates and its or
their Sublicenses
will be included within Net Sales.
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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<PAGE>
"New
Field" will have the meaning set forth in Section 2.3(a).
"New
Field License Agreement" will have the meaning set forth in
Section
2.3(d).
"PAH" means pulmonary arterial hypertension.
"Party" or "Parties" will have the meaning set forth in the
Preamble.
"Patent Prosecution" means, with respect to a Patent Right, (i)
preparing,
filing, prosecuting, maintaining, extending and listing, including
reissue and
reexamination of, such Patent Right (including reissue, continuing,
divisional
and substitute applications and any foreign counterparts thereof)
and (ii)
managing any interference or opposition proceedings relating to the
foregoing.
"Patent Rights" means all patents and patent applications
including
continuations, continuations-in-part, divisions, patents of
addition, patents
issuing from reissue, re-examination, renewal or extension
proceedings, utility
models, all Supplemental Protection Certificates and any foreign
counterparts
thereof, including PCTs existing as of the Effective Date and/or
during the
Term, that generally or specifically claim or cover the making,
having made,
use, sale, offering for sale and import of Compound and/or Product
in the Field
in the Territory.
"Person" means any individual, corporation, partnership, firm,
association,
joint venture, joint stock company, trust or other entity, or any
government or
regulatory administrative or political subdivision or agency,
department or
instrumentality thereof.
"Presentation" means the method of administration of a
pharmaceutical
substance into the human body, including solid oral (including
tablets,
capsules, gelcaps and caplets), other oral (including suspension
and solution),
parenteral (including transdermal, intramuscular, subcutaneous and
intravenous),
suppository, inhaled or intranasal.
"Product" means any pharmaceutical composition containing the
Compound,
whether or not as the sole active ingredient, and regardless of
formulation,
dosage, or form.
"Recipient" will have the meaning set forth in Section 13.1(a).
"Reduced Royalty" will have the meaning set forth in Section
9.2(b)(i).
"Regulatory Approval" means an approval, license, registration,
and/or
authorization necessary for the Development, Manufacture and/or
Commercialization of a prescription pharmaceutical product in the
Territory,
including, without limitation, the Shonin in Japan, but not
including any
approvals for pricing and/or reimbursement.
"Regulatory Approval Applications" means an application for
obtaining a
Regulatory Approval, together with all documents, data, and
information included
with such application.
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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<PAGE>
"Regulatory Authority" means any or all national, supranational,
regional,
state, or local regulatory agency, department bureau, commission,
council, or
other government entity involved in the granting of Regulatory
Approval for a
pharmaceutical product in the Territory.
"Right of Negotiation" will have the meaning set forth in Section
2.3(a).
"Right of Negotiation Notice" will have the meaning set forth in
Section
2.3(b).
"Right of Negotiation Period" will have the meaning set forth in
Section
2.3(d).
"Royalty" or "Royalties" means the Initial Royalty and the Reduced
Royalty,
collectively.
"Sublicensee" means a Third Party to whom a Party or its
Affiliate
sublicenses or otherwise transfers its right to Develop,
Manufacture and/or
Commercialize Compound and/or Product in a country in the GSK
Territory or
Myogen Territory, as applicable in accordance with the terms of
this Agreement,
and in consideration for such transfer of rights, such Third Party
pays such
Party or Affiliate a percentage of, or profit share on, such Third
Party's sales
of Compound and/or Product in such country.
"Supply Agreement" will have the meaning set forth in Section
7.1(g).
"Term" will have the meaning set forth in Section 11.1.
"Territory" means the GSK Territory and Myogen Territory,
collectively.
"Third Party" means any Person other than the Parties or their
respective
Affiliates.
"Third Party Payments" will have the meaning set forth in Section
9.2(c).
"United States" or "U.S." means the fifty (50) states of the United
States
of America, the District of Columbia, Puerto Rico and the
territories and
possessions of the United States.
"Wholesaler" means a Third Party engaged by a Party or its
Affiliates in a
country in the GSK Territory or Myogen Territory, as applicable
under the terms
of this Agreement, whose function is solely to re-sell or
distribute and not in
any way promote Product purchased from such Party to other Third
Party
purchasers.
Section 1.2 Clarification. The word "including" or any variation
thereof
means "including without limitation" and the word "including" or
any variation
thereof will not be construed to limit any general statement which
it follows to
the specific or similar items or matters immediately following it.
The word
"annual" means each period during the Term from January until
December, pro
rated as necessary. The phrase "pricing and/or reimbursement
approval
commercially acceptable to GSK" or similar phrases used in this
Agreement shall
mean pricing and/or reimbursement approval, as applicable, in the
subject
country in the GSK Territory which is commercially acceptable to
GSK, as
determined by GSK in its sole discretion,
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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<PAGE>
provided that any such pricing and/or reimbursement approval shall
be deemed to
be commercially acceptable to GSK if GSK, any of its Affiliates, or
any of its
Sublicensees achieves the First Commercial Sale of the Product in
such country.
ARTICLE II
LICENSE GRANTS
Section 2.1 Grants to GSK Under Abbott and Myogen Intellectual
Property.
(a) License in GSK Territory.
(i) Abbott Intellectual Property. Subject to the terms and
conditions of this Agreement and the Abbott Agreement, including
Abbott's
internal research license as set forth in section 3.2 of the Abbott
Agreement,
Myogen hereby grants to GSK an exclusive sublicense, with the right
to grant
further sublicenses as provided in Section 2.2, under the Abbott
Intellectual
Property to make, have made, use, sell, offer for sale and import
Compound and
Product in the Field in the GSK Territory.
(ii) Myogen Intellectual Property. Subject to the terms and
conditions of this Agreement, Myogen hereby grants to GSK an
exclusive license,
with the right to grant sublicenses as provided in Section 2.2,
under the Myogen
Intellectual Property to make, have made, use, sell, offer for sale
and import
Compound and Product in the Field in the GSK Territory in order for
GSK to
Develop, Manufacture and Commercialize Compound and Product in
accordance with
the terms and conditions of this Agreement.
(iii) Notwithstanding the foregoing or any other provision
contained in this Agreement, Myogen shall retain the right, with
the right to
grant further sublicenses upon obtaining the prior written consent
of GSK, which
consent will not be unreasonably withheld, under the Abbott
Intellectual
Property and the Myogen Intellectual Property, to make, have made
and import
Compound, and make and have made Product, in each case, in the GSK
Territory for
the sole purpose of exporting such Compound and/or Product from the
GSK
Territory for Development, Manufacture and Commercialization of
such Compound
and Product in the Myogen Territory. For the avoidance of doubt,
Myogen will
have no right to use, sell and offer for sale Compound, or use,
sell, offer for
sale and import Product, in each case in the Field in the GSK
Territory (as such
term is defined from time-to-time).
(b) License in Myogen Territory.
(i) Abbott Intellectual Property. Subject to the terms and
conditions of this Agreement and the Abbott Agreement, Myogen
hereby grants to
GSK a non-exclusive sublicense, with the right to grant further
sublicenses as
provided in Section 2.2, under the Abbott Intellectual Property, to
make, have
made and import Compound and to make and have made Product, in each
case in the
Field in the Myogen Territory for the sole purpose of exporting
such Compound
and/or Product from the Myogen Territory for Development,
Manufacture and
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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<PAGE>
Commercialization of such Compound and Product in the Field in the
GSK
Territory. For the avoidance of doubt, GSK shall have no right to
use, sell,
offer for sale or import Compound or Product in the Myogen
Territory.
(ii) Myogen Intellectual Property. Subject to the terms and
conditions of this Agreement, Myogen hereby grants to GSK a
non-exclusive
license, with the right to grant sublicenses as provided in Section
2.2, under
the Myogen Intellectual Property, to make, have made and import
Compound and
make and have made Product, in each case in the Field in the Myogen
Territory
for the sole purpose of exporting such Compound and/or Product from
the Myogen
Territory for Development, Manufacture and Commercialization of
such Compound
and Product in the Field in the GSK Territory.
Section 2.2 GSK's Right to Grant Sublicenses.
(a) GSK will have the right to sublicense any or all of its
rights
under the Abbott Intellectual Property and Myogen Intellectual
Property as
provided in Section 2.1(a) and (b) to its Affiliates, without the
consent of
Myogen.
(b) GSK will have the right to sublicense its rights under the
Abbott
Intellectual Property and Myogen Intellectual Property as provided
in Section
2.1(a) and (b) to Third Parties to make, have made and import
Compound and/or
Product in the Field in the Myogen Territory, for the sole purpose
of exporting
such Compound and/or Product from the Myogen Territory for
Development,
Manufacture and Commercialization of such Compound and Product in
the GSK
Territory in each case upon providing prior written notice to
Myogen. If Myogen
does not object to the sublicense by GSK of its rights as provided
in this
Section 2.2(b), or if Myogen does not provide any response to GSK,
in each case
within [..**..] Business Days after receiving written notice
thereof from GSK,
GSK will be free to sublicense its rights as set forth in this
Section 2.2(b).
If Myogen objects to the sublicense by GSK of its rights as
provided in this
Section 2.2(b) within [..**..] Business Days after receiving
written notice
thereof from GSK, GSK will afford Myogen with a reasonable
opportunity to meet
and discuss with GSK Myogen's objection to such sublicense, which
objection GSK
will consider in good faith but to which GSK will have no
obligation to comply.
(c) GSK will have the right to sublicense any or all of its
other
rights, beyond those set forth in Section 2.2(b) above, under the
Abbott
Intellectual Property and Myogen Intellectual Property as provided
in Sections
2.1(a) as follows:
(i) to any Third Party who GSK may engage to provide services
to
or on behalf of GSK in the GSK Territory relating to this Agreement
(including a
Clinical Research Organization (CRO)), except as otherwise provided
in this
Section 2.2(c), without the consent of Myogen;
(ii) to any Third Party who GSK may engage as a Wholesaler in
the
GSK Territory, without the consent of Myogen;
(iii) to any Third Party who GSK may engage as a Distributor of
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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<PAGE>
Product in a Major European Market Country(ies) or Major
Country(ies), with the
prior written consent of Myogen which consent may be withheld for
any reason in
Myogen's sole discretion;
(iv) to any Third Party who GSK may engage as a Distributor of
Product in a country or countries other than a Major European
Market Country or
Major Country, without the consent of Myogen; and
(v) to any Sublicensee with the prior written consent of
Myogen,
which consent may be withheld for any reason in Myogen's sole
discretion.
Any agreement entered into by GSK pursuant to this Section 2.2(c)
will
automatically terminate as to Product, without any action by GSK or
such Third
Party or Sublicensee, upon the termination of this Agreement or the
Abbott
Agreement.
(d) GSK shall remain responsible for any breach by a Sublicensee
of
the terms of this Agreement or the applicable sublicense agreement.
Any
agreement entered into by GSK with a Third Party pursuant to
Section 2.2(c)
shall be in writing and shall include provisions acknowledging that
such
agreement is subject to the license granted to Myogen under the
Abbott Agreement
and to the license granted to GSK under this Agreement, and with
respect to
agreements entered into pursuant to Section 2.2(c)(v), that each
Sublicensee
shall make reports and keep and maintain records of sales to at
least the same
extent required under this Agreement and the Abbott Agreement,
allowing Myogen
and Abbott the same access and audit rights permitted under this
Agreement and
the Abbott Agreement. GSK shall provide Myogen with a copy of each
agreement
entered into by GSK pursuant to Section 2.2(c)(iii) or (v), which
copy Myogen
may provide to Abbott in accordance with the last sentence in
Section 4.7 of the
Abbott Agreement. Myogen will designate such information as the
Confidential
Information (as defined in Section 1.6 of the Abbott Agreement) of
Myogen and
notify Abbott in writing of its obligation to maintain the
confidentiality of
such agreement in accordance with the terms and conditions of
Section 7 of the
Abbott Agreement. Notwithstanding the foregoing, this Section
2.2(d) will not
apply to, and GSK will have no obligations under this Section
2.2(d) with
respect to, to any agreements with any Third Party covered by
Section 2.2(c)(iv)
above.
Section 2.3 Right of Negotiation for Rights Outside of the
Field.
(a) Each time during the Term that Myogen, on its own or through
any
of its Affiliates or any Third Party, decides to make, have made,
use, sell,
offer for sale and/or import Compound and/or Product for a
therapeutic use
outside of the Field in the GSK Territory (each therapeutic use
referred to as a
"New Field"), Myogen will provide prior written notice to GSK and
thereby grant
to GSK an exclusive option to negotiate with Myogen for an
exclusive license
under the Abbott Intellectual Property and Myogen Intellectual
Property to make,
have made, use, sell, offer for sale and import Compound and
Product in such New
Field (each such notice referred to as a "Right of
Negotiation").
(b) GSK must exercise a Right of Negotiation by providing
written
notice to Myogen (each such notice referred to as a "Right of
Negotiation
Notice") within [..**..] calendar days after receiving written
notice from
Myogen as provided in Section 2.3(a) of such Right of
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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<PAGE>
Negotiation.
(c) If GSK does not submit a Right of Negotiation Notice to Myogen
as
provided in Section 2.3(b) prior to the expiration of the [..**..]
calendar day
period referenced in Section 2.3(b), the corresponding Right of
Negotiation will
immediately terminate at 12:01 a.m. Eastern Standard Time on the
calendar day
that is immediately after last calendar day of such [..**..]
calendar day period
and Myogen will have no further obligation to GSK with respect to
such Right of
Negotiation; provided, however, that in Developing, Manufacturing
and/or
Commercializing Compound and/or Product in such New Field in the
GSK Territory
during the Term, Myogen covenants and agrees that it will not, and
will cause
its Affiliates and any Third Party not to, knowingly, materially
and adversely
affect GSK's right and ability to Develop, Manufacture and
Commercialize Product
in the Field in the GSK Territory.
(d) If GSK exercises a Right of Negotiation by providing a Right
of
Negotiation Notice as provided in Section 2.3(b), the Parties will
in good faith
negotiate during the Right of Negotiation Period a license
agreement pursuant to
which GSK would obtain an exclusive license under the Abbott
Intellectual
Property and Myogen Intellectual Property to make, have made, use,
sell, offer
for sale and import Compound and Product in the New Field in the
GSK Territory
(the "New Field License Agreement"). The "Right of Negotiation
Period" will be
the period that commences on the date on which GSK provides Myogen
with a Right
of Negotiation Notice as provided in Section 2.3(b) (for the
purposes of this
Section 2.3(d) only, the "commencement date") and expires at 12:01
a.m. Eastern
Standard Time on the day immediately following the [..**..] day
after the
commencement date. Each such Right of Negotiation Period may be
extended upon
the mutual written agreement of the Parties prior to the expiration
thereof as
provided in Section 2.3(e) or earlier terminated by the termination
of this
Agreement. Notwithstanding the foregoing, GSK will have the right,
at any time
and for any reason during a Right of Negotiation Period, to
terminate in writing
such Right of Negotiation Period which would terminate the
corresponding Right
of Negotiation.
(e) In the event the Parties have not executed the New Field
License
Agreement during the Right of Negotiation Period, after starting to
negotiate
the terms and conditions thereof in good faith: (i) the Parties
may, upon the
Parties' mutual written agreement prior to the expiration of such
Right of
Negotiation Period, extend such Right of Negotiation Period for
successive
additional periods of [..**..] Business Days; or (ii) if not
extended by the
Parties as provided in (i), such Right of Negotiation Period will
expire as
provided in Section 2.3(d) and Myogen will have no further
obligation to GSK
with respect to such Right of Negotiation or Compound or Product in
such New
Field; provided, however, that in Developing, Manufacturing
and/or
Commercializing Compound and/or Product in such New Field in the
GSK Territory
during the Term, Myogen covenants and agrees it will not, and will
cause its
Affiliates and any Third Party not to, knowingly, materially and
adversely
affect GSK's right and ability to Develop, Manufacture and
Commercialize Product
in the Field in the GSK Territory.
Section 2.4 Grants to Myogen under GSK Intellectual Property.
(a) Subject to the terms and conditions of this Agreement, GSK
hereby
grants to Myogen: (i) a non-exclusive, royalty-free license under
the GSK
Intellectual Property to
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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<PAGE>
make, have made, use, sell, offer for sale and import Compound and
Product in
the Myogen Territory; and (ii) subject to Section 2.3, a
non-exclusive,
royalty-free license under the GSK Intellectual Property to make,
have made,
use, sell, offer for sale and import Compound and Product outside
the Field in
the GSK Territory.
(b) (i) Myogen
will have the right to sublicense any or all of its
rights under the GSK Intellectual Property as provided in Section
2.4(a) to its
Affiliates, without the consent of GSK.
(ii) Myogen will have the right to sublicense its rights under
the GSK Intellectual Property as provided in Section 2.4(a) to
Third Parties to
make, have made and import Compound and/or Product in the Myogen
Territory and
to make, have made and import Compound and/or Product outside of
the Field in
the GSK Territory, in each case upon providing prior written notice
to GSK. If
GSK does not object to the sublicense by Myogen of its rights as
provided in
this Section 2.4(b)(ii), or if GSK does not provide any response to
Myogen, in
each case within [..**..] Business Days after receiving written
notice thereof
from Myogen, Myogen will be free to sublicense its rights as set
forth in this
Section 2.4(b)(ii). If GSK objects to the sublicense by Myogen of
its rights as
provided in this Section 2.4(b)(ii) within [..**..] Business Days
after
receiving written notice thereof from Myogen, Myogen will afford
GSK with a
reasonable opportunity to meet and discuss with Myogen GSK's
objection to such
sublicense, which objection Myogen will consider in good faith but
to which
Myogen will have no obligation to comply.
(iii) Myogen will have the right to sublicense any or all of
its
other rights beyond those set forth in Section 2.4(b)(ii) above
under the GSK
Intellectual Property as provided in Section 2.4(a) to Third
Parties, upon
obtaining the prior written consent of GSK, which consent will not
be
unreasonably withheld. Notwithstanding the foregoing, Myogen will
have the right
at any time during the Term, to sublicense its rights under Section
2.4(a):
(A) to any Third Party who Myogen may engage to provide
services to or on behalf of Myogen relating to this Agreement
(including a
Clinical Research Organization (CRO)), without the consent of
GSK;
(B) to any Third Party who Myogen may engage as a
Wholesaler, without the consent of GSK;
(C) to any Third Party who Myogen may engage as a
Distributor of Product, without the consent of GSK; and
(D) to any Sublicensee with the prior written consent of GSK
which consent may not be unreasonably withheld;
provided, however that, except as set forth in Section 11.9(a)(iv),
any
agreement entered into by Myogen pursuant to this Section
2.4(b)(iii) will
automatically terminate as to Product, without any action by Myogen
or such
Third Party or Sublicensee, upon the termination of this
Agreement.
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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<PAGE>
(iv) Myogen will remain responsible for any breach by a
Sublicensee of the terms of this Agreement or the applicable
sublicense
agreement. Any agreement entered into by Myogen pursuant to this
Section 2.4(b)
will be in writing and will include provisions acknowledging that
such agreement
is subject to the license granted to Myogen under this Agreement
and that such
agreement shall be automatically terminated upon termination of
this Agreement.
Myogen will provide GSK with a copy of each such agreement entered
into by
Myogen pursuant to Section 2.4(b)(iii)(D).
Section 2.5 Affiliates. Notwithstanding anything in this Agreement
to the
contrary, either Party may contract or agree with one or more of
its Affiliates
to have such Affiliate perform any of such Party's obligations
herein. In no
event will such use of an Affiliate be deemed to relieve a Party of
its
liabilities or obligations to the other Party under this Agreement;
provided,
that performance of an obligation hereunder by an Affiliate of a
Party will be
attributed to such Party. Each Party expressly acknowledges and
agrees that it
will remain fully and unconditionally obligated and responsible for
the full and
complete performance of all of its obligations under the terms and
conditions of
this Agreement, whether or not such performance is carried out by
such Party or
any of its Affiliates.
Section 2.6 Abbott Agreement.GSK acknowledges that the sublicense
granted
hereunder to GSK under the Abbott Intellectual Property is governed
by the terms
of the Abbott Agreement. GSK agrees to abide by the terms and
conditions of the
Abbott Agreement, where and to the extent applicable. Further, the
Parties
acknowledge and agree as follows:
(a) Pursuant to Section 3.2 of the Abbott Agreement, Abbott and
its
Affiliates have the right to develop and commercialize the Compound
for [..**..]
(the term [..**..] is defined in Section [..**..] of the Abbott
Agreement).
Subject to any confidentiality restrictions imposed by Abbott,
Myogen will
within five (5) Business Days inform GSK in writing of any
consultation by
Abbott with Myogen regarding Abbott or its Affiliates conducting
any research
and development activities involving the use of Compound in animals
or humans in
which Abbott apprises Myogen of the scope and nature of such
activities.
Further, subject to any confidentiality restrictions imposed by
Abbott, Myogen
will within five (5) Business Days after receipt from Abbott,
provide GSK with
copies of all studies relating to the Compound performed by Abbott
or its
Affiliates, which shall be treated as the Confidential Information
of Myogen and
subject to Article XIII.
(b) To the extent permitted under Applicable Law, pursuant to
Section
4.8 of the Abbott Agreement, in the event that the Abbott Agreement
is
terminated by Abbott for any reason as set forth in Article 8
therein or by
Myogen under Section 8.2 therein, Abbott will have an exclusive
license under
all [..**..] (as such term is defined in Section [..**..] of the
Abbott
Agreement) made solely by GSK and/or its Affiliates.
(c) Myogen will not, and will cause its Affiliates and
Sublicensees
not to: (i) on its or their own or in agreement with Abbott,
terminate the
Abbott Agreement or supplement, amend or modify the Abbott
Agreement in any way
that materially and adversely affects GSK rights under the Abbott
Intellectual
Property or in this Agreement without the prior written
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
16
<PAGE>
consent of GSK; provided, however, that Myogen will provide GSK
with written
notice prior to making any amendment to the Abbott Agreement; (ii)
initiate any
dispute resolution proceedings with Abbott under the Abbott
Agreement without
the prior written consent of GSK, which shall not be unreasonably
withheld; or,
(iii) send written notice to Abbott of any monetary or non-monetary
breach by
Abbott of the Abbott Agreement as provided in Section 8.3 of the
Abbott
Agreement without providing at least ten (10) calendar days' prior
written
notice to GSK.
(d) Within two (2) Business Days of receiving written notice of
a
monetary breach or non-monetary material breach from Abbott as
provided in
Section 8.3 of the Abbott Agreement, Myogen will provide GSK with a
copy of such
notice and meet with GSK upon GSK's request to discuss whether a
material breach
has occurred, whether Myogen should challenge the existence of the
breach by
invoking the ADR (as defined in the Abbott Agreement) procedure set
forth in
Exhibit D of the Abbott Agreement (which Myogen will not do without
prior
consultation with GSK) and the options to cure such breach, if
applicable. GSK
may, in its sole discretion but after consultation with Myogen,
determine to
cure any such breach of Myogen under the Abbott Agreement if Myogen
has not
already done so; provided, however, that (i) if GSK cures any
monetary breach of
Myogen, GSK will have the right to credit all of such amount paid
to Abbott
against any Milestone Payments and/or Royalties owed to Myogen as
provided in
Article IX of this Agreement; and (ii) if GSK cures any
non-monetary breach of
Myogen, GSK will have the right to credit any and all reasonable,
documented
direct costs and expenses incurred by GSK in curing such
non-monetary breach
against any Milestone Payments and/or Royalties owed to Myogen as
provided in
Article IX of this Agreement; however, in the case of (i) and (ii)
above, only
to the extent that such breach was not directly or indirectly a
result of an act
or omission by GSK, its Affiliates or sublicensees, including any
breach of this
Agreement.
Section 2.7 Reservation of Rights. No right or license under
any
intellectual property right Controlled by either Party is granted
or implied
except as expressly granted in this Agreement. Except for the
rights
specifically granted in this Agreement, each Party expressly
reserves all rights
Controlled by it or its Affiliates to all its products and
intellectual
property, and reserves the right to utilize or allow its Affiliates
or Third
Parties to utilize such products and intellectual property rights
in any manner
not inconsistent with the terms of this Agreement.
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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<PAGE>
ARTICLE III
GOVERNANCE
Section 3.1 Joint Steering Committee.
(a) Within fifteen (15) Business Days after the Effective Date,
the
Parties will form a committee (the "Joint Steering Committee"),
which will serve
as a global oversight committee that is responsible for
establishing, reviewing
and revising (i) the overall Development strategy for Compound and
Product in
the Field in the Territory, with input from the Joint Project Team,
including,
without limitation, approval of all updates and revisions to the
Development
Plan as provided in Section 4.1; (ii) the overall Commercialization
strategy for
Compound and Product in the Field in the Territory (other than
pricing and
reimbursement for Product), with input from the Global Brand Team;
and (iii) the
overall Manufacturing strategy for Compound and Product in the
Field in the
Territory. The Joint Steering Committee will oversee the activities
of the Joint
Project Team and Global Brand Team, and will settle unresolved
disputes or
disagreements of the Joint Project Team and Global Brand Team.
(b) Each Party will designate at least three (3) and up to five
(5)
representatives for membership on the Joint Steering Committee.
Each Party's
representatives on the Joint Steering Committee will be employees
from among the
project management, clinical, regulatory, commercial and alliance
management
departments of such Party and will have the authority to make
decisions on
behalf of such Party within the constraints of necessary internal
approvals
(which will have been previously obtained to the extent
practicable). Each Party
will have one (1) vote on each matter brought before the Joint
Steering
Committee. At least three (3) members from each Party (or their
designees with
the authority to make decisions on behalf of such Party) must be
present at a
meeting of the Joint Steering Committee to represent a quorum for
voting
purposes. Each Party may from time to time and in their sole
discretion include
additional non-voting ad-hoc representatives to participate in
Joint Steering
Committee meetings to address specific issues. The Joint Steering
Committee will
be co-chaired by a Myogen member of the Joint Steering Committee
and a GSK
member of the Joint Steering Committee and each Party may, from
time to time and
in its sole discretion, change the member of such Party who serves
as such
Party's designee for co-chairperson of the Joint Steering
Committee.
(c) The first meeting of the Joint Steering Committee may be a face
to
face meeting at a location agreed to by the Parties and will occur
within twenty
(20) Business Days after formation of the Joint Steering Committee;
provided,
however that if the first meeting of the Joint Steering Committee
is not face to
face, the next meeting of the Joint Steering Committee, which must
occur within
the immediately succeeding Calendar Quarter, must be a face to face
meeting at a
location agreed to by the Parties. The purpose of the initial
meeting will be to
agree on an operational charter that will set forth the principles
and
guidelines for the governance and operation of the Joint Steering
Committee
(e.g., how the co-chairs of the Joint Steering Committee will
share
responsibilities for determining meeting agendas and the drafting
of minutes,
etc.). Thereafter, meetings will be held at least once during each
Calendar
Quarter, or more or less frequently as the Joint Steering Committee
members may
agree. The location of
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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such meetings will alternate between sites selected by Myogen and
GSK, unless
otherwise agreed upon between the Parties. Joint Steering Committee
meetings
need not necessarily be face-to-face meetings but, upon the
agreement of both
Parties, can be via other methods of communication such as
teleconferences
and/or videoconference. Each Party will bear all expenses it incurs
in regard to
participating in all meetings of the Joint Steering Committee,
including all
travel and living expenses. Minutes of each Joint Steering
Committee meeting
will be prepared as agreed to by the co-chairpersons and
distributed to the
members of the Joint Steering Committee for review and comment
within twenty
(20) Business Days after each meeting of the Joint Steering
Committee, and will
be approved as the first order of business at the immediately
succeeding Joint
Steering Committee meeting.
(d) All decisions of the Joint Steering Committee will be by
unanimous
vote, which decisions will be final and binding on the Parties.
Should the
members of the Joint Steering Committee become deadlocked on an
issue after a
good faith but unsuccessful effort to break such deadlock, the
issue will be
presented to the senior management of Myogen and GSK as follows for
resolution,
which resolution will be final and binding on the Parties: (i) to
the chief
executive officer of Myogen or his/her designee and the head of
the
cardiovascular therapeutic area within the research and development
organization
at GSK or his/her designee for issues involving the Development of
Compound
and/or Product; and (ii) to the chief executive officer of Myogen
or his/her
designee and the president of pharmaceuticals for Europe at GSK or
his/her
designee for all issues other than those relating to Development of
Compound
and/or Product. If the dispute remains unresolved after thirty (30)
Business
Days following the date on which such dispute is referred to the
senior
management of each Party as provided in this Section 3.1(d), then
(w) Myogen
will make the final and binding decision with respect to any
dispute involving
the Development, Manufacture and Commercialization of Compound
and/or Product in
the Myogen Territory, provided that such decision cannot be
inconsistent with
the terms of this Agreement, the Development Plan and the Global
Marketing Plan,
and such decision cannot materially and adversely affect GSK's
right and ability
to Develop, Manufacture and Commercialize Product in the GSK
Territory; (x) GSK
will make the final and binding decision with respect to any
dispute involving
the Development, Manufacture and Commercialization of Compound
and/or Product in
the GSK Territory, provided that such decision cannot be
inconsistent with the
terms of this Agreement, the Development Plan and the Global
Marketing Plan, and
such decision cannot materially and adversely affect Myogen's right
and ability
to Develop, Manufacture and Commercialize Product in the Myogen
Territory; (y)
any such decision, to the extent not specific to the Myogen
Territory or the GSK
Territory, will be resolved in accordance with Section 14.1; and
(z) any and all
issues relating to safety will be resolved as set forth in Section
3.4.
(e) The
Joint Steering Committee will have only such powers as are
specifically delegated to it in this Agreement, and will have no
power to amend
this Agreement or waive a Party's rights or obligations under this
Agreement.
Section 3.2 Joint Project Team.
(a) Within thirty (30) Business Days after the Effective Date,
the
Parties will form a team (the "Joint Project Team") whose mandate
will be to (i)
make strategic and
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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operational recommendations to the Joint Steering Committee on
matters relating
to the Development of Compound and Product in the Field in the
Territory; (ii)
update the Development Plan during each Calendar Year and obtain
the Joint
Steering Committee's approval of all such updates to the
Development Plan, as
provided in Section 4.1; and (iii) oversee, manage and implement
the Development
of Product in the Field in the Territory as provided in Article 4,
including,
without limitation, appropriate safety reporting systems,
pre-commercial
manufacturing and technology transfer.
(b) Each Party will designate at least three (3), but not more
than
five (5) representatives for membership on the Joint Project Team.
Each Party
may, from time to time and in their sole discretion, determine from
which
departments of such Party (e.g., scientific, clinical development,
commercial
development, regulatory, manufacturing, etc.) representatives on
the Joint
Project Team will come. Each Party will have one (1) vote on each
matter brought
before the Joint Project Team. At least three (3) members from each
Party (or
their designees with the authority to make decisions on behalf of
such Party)
must be present at a meeting of the Joint Project Team to represent
a quorum for
voting purposes. Each Party may from time to time and in their sole
discretion
include additional non-voting ad-hoc representatives to participate
in Joint
Project Team meetings to address specific issues. The Joint Project
Team will be
co-chaired by a Myogen member and a GSK member.
(c) The first meeting of the Joint Project Team may be a face to
face
meeting at a location agreed to by the Parties will occur within
twenty (20)
Business Days after formation of the Joint Project Team; provided,
however that
if the first meeting of the Joint Project Team is not face to face,
the next
meeting of the Joint Project Team, which must occur within the
immediately
succeeding Calendar Quarter, must be a face to face meeting at a
location agreed
to by the Parties. The purpose of the initial meeting will be to
agree on an
operational charter that will set forth the principles and
guidelines for the
governance and operation of the Joint Project Team (e.g., how the
co-chairs of
the Joint Project Team will share responsibilities for determining
meeting
agendas and the drafting of minutes, etc.). Thereafter, meetings
will be held at
least once during each Calendar Quarter, or more or less frequently
as the Joint
Project Team members may agree. The location of such meetings will
alternate
between sites selected by Myogen and GSK, unless otherwise agreed
upon between
the Parties. Joint Project Team meetings need not necessarily be
face-to-face
meetings but, upon the agreement of both Parties, can be via other
methods of
communication such as teleconferences and/or videoconference;
provided, however
that unless otherwise agreed to by the Parties, Joint Project Team
meetings will
be face-to-face meetings not less than twice per year. Each Party
will bear all
expenses it incurs in regard to participating in all meetings of
the Joint
Project Team, including all travel and living expenses. Minutes of
each Joint
Project Team meeting will be prepared as agreed to by the
co-chairpersons and
distributed to the members of the Joint Project Team for review and
comment
within twenty (20) Business Days after each meeting of the Joint
Project Team,
and will be approved as the first order of business at the
immediately
succeeding Joint Project Team meeting.
(d) All decisions of the Joint Project Team will be by unanimous
vote,
which decision will be final and binding on the Parties. Should the
members of
the Joint Project Team become deadlocked on an issue after a good
faith but
unsuccessful effort to break such deadlock,
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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<PAGE>
the issue will be presented to the Joint Steering Committee for
resolution as
set forth in Section 3.1(d).
Section 3.3 Global Brand Team.
(a) Within thirty (30) Business Days after the Effective Date,
the
Parties will form a team (the "Global Brand Team") whose mandate
will be to (i)
make strategic and operational recommendations to the Joint
Steering Committee
on matters relating to the Commercialization of Compound and
Product in the
Field in the Territory; (ii) draft the initial Global Marketing
Plan, and update
such Global Marketing Plan during each Calendar Year and obtain the
Joint
Steering Committee's approval of any such updates to the Global
Marketing Plan,
as provided in Section 5.1; and (iii) oversee the Commercialization
of Product
in the Field in the Territory by the Parties as provided in Article
5.
(b) Each Party will designate at least three (3), but not more
than
five (5) representatives for membership on the Global Brand Team.
Each Party
may, from time to time and in their sole discretion, determine from
which
departments of such Party representatives on the Global Brand Team
will come.
Each Party will have one (1) vote on each matter brought before the
Global Brand
Team. At least three (3) members from each Party (or their
designees with the
authority to make decisions on behalf of such Party) must be
present at a
meeting of the Global Brand Team to represent a quorum for voting
purposes.
Either Party may from time to time and in their sole discretion
include
additional non-voting ad-hoc representatives to participate in
Global Brand Team
meetings to address specific issues. The Global Brand Team will be
co-chaired by
a Myogen member and a GSK member.
(c) The first meeting of the Global Brand Team will be a face to
face
meeting at a location agreed to by the Parties and will occur
within twenty (20)
Business Days after formation of the Global Brand Team. The purpose
of the
initial meeting will be to agree on an operational charter that
will set forth
the principles and guidelines for the governance and operation of
the Global
Brand Team (how the co-chairs of the Global Brand Team will
share
responsibilities for determining meeting agendas and the drafting
of minutes,
etc.). Thereafter, meetings will be held at least once during each
Calendar
Quarter, or more or less frequently as the Global Brand Team
members may agree.
The location of such meetings will alternate between sites selected
by Myogen
and GSK, unless otherwise agreed upon between the Parties. Global
Brand Team
meetings need not necessarily be face-to-face meetings but, upon
the agreement
of both Parties, can be via other methods of communication such
as
teleconferences and/or videoconference. Each Party will bear all
expenses it
incurs in regard to participating in all meetings of the Global
Brand Team,
including all travel and living expenses. Minutes of each Global
Brand Team
meeting will be prepared as agreed to by the co-chairpersons and
distributed to
the members of the Global Brand Team for review and comment within
twenty (20)
Business Days after each meeting of the Global Brand Team, and will
be approved
as the first order of business at the immediately succeeding Global
Brand Team
meeting.
(d) All decisions of the Global Brand Team will be by unanimous
vote,
which decision will be final and binding on the Parties. Should the
members of
the Global Brand Team become deadlocked on an issue after a good
faith but
unsuccessful effort to break such deadlock,
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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the issue will be presented to the Joint Steering Committee for
resolution as
set forth in Section 3.1(d).
Section 3.4 Decisions Relating to Safety Concerns.
(a) Development Activities. If a Party (the "requesting Party")
reasonably believes that patient safety may be compromised in any
ongoing or
proposed or planned Development activity of the other Party
involving a clinical
trial for the Product (the "developing Party"), such requesting
Party may send
written notice to the developing Party requesting that the
developing Party
modify, discontinue or not initiate, as applicable, such
Development activity
(including, without limitation, any clinical trial) in the
Territory. If the
developing Party does not modify or discontinue the conduct or
planning of any
such Development activity within thirty (30) Business Days (or such
shorter
period as may be required by applicable Regulatory Authorities)
after receipt of
written request from the requesting Party as provided in this
Section 3.4(a),
the requesting Party may request that such matter be presented to
an independent
safety board for resolution. The independent safety board panel
will be
comprised of three (3) panelists, one (1) of whom will be selected
by GSK, one
(1) of whom will be selected by Myogen, and one (1) of whom will be
selected by
the two (2) panelists selected by the Parties. No panelist of the
independent
advisory board may be an employee of either Party or shall have had
an
employment or consulting relationship with either Party within five
(5) years of
his/her appointment. Each panelist shall disclose his/her prior
employment and
consulting relationships and must have a background in clinical
safety issues.
Each Party will bear the cost of its own designated panelist on the
independent
safety board and will equally share the cost of the third panelist
selected by
the other panelists. The Parties must present such matter to the
independent
safety board for resolution within thirty (30) Business Days after
a request is
made by the requesting Party, which decision of the independent
safety board
regarding the continuation of any such Development activity must be
agreed to by
a majority of the panelists and will be binding on the Parties.
(b) Commercialization Activities. Without prejudice to the
provisions
contained in Section 8.1(a), if GSK reasonably believes that
patient safety may
be compromised at any time after the First Commercial Sale, GSK may
terminate
this Agreement in accordance with Section 11.3.
(c) Notification of Safety Concerns. After a Party reasonably
believes
that patient safety may be compromised with respect to Product in
the Field in
the Territory as described in Section 3.4(a) or 3.4(b), such Party
will promptly
notify the other Party. Within two (2) Business Days after such
notice is sent
by a Party, the Joint Steering Committee will meet to discuss how
the Parties
will address the patient safety concern, whether as provided in
Sections 3.4(a)
and 3.4(b) or in some other manner.
ARTICLE IV
DEVELOPMENT AND REGULATORY FILINGS
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
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SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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Section 4.1 Development Plan. The initial Development Plan which
has been
agreed to by the Parties as of the Effective Date, has been
exchanged by the
Parties under separate cover. Not later than sixty (60) Business
Days prior to
the end of each Calendar Year during the Term in which the
Development Plan is
applicable, the Joint Project Team will update the Development Plan
as required
and submit the updated Development Plan for review and approval by
the Joint
Steering Committee.
Section 4.2 Clinical/Non-Clinical Development Under the Development
Plan.
(a) Myogen
will be solely responsible for conducting all clinical and
non-clinical Development activities that, as of the Effective Date,
the Parties
believe are required in order for Myogen to obtain and maintain
Regulatory
Approvals for Product in the Field in the United States as set
forth in Section
4.4(b) and that, as of the Effective Date, the Parties believe are
required in
order for GSK or its Affiliates to obtain and maintain Regulatory
Approvals for
Product in the Field in Canada and the European Economic Area as
set forth in
Section 4.4(a), in each case as set forth in the Development Plan
exchanged by
the Parties on the Effective Date and in accordance with this
Agreement, and as
directed by the Joint Project Team. The Development Plan exchanged
by the
Parties on the Effective Date sets forth all such clinical and
non-clinical
Development activities that the Parties believe are required in
order for Myogen
to obtain and maintain Regulatory Approvals for Product in the
Field in the
United States as set forth in Section 4.4(b) and that the Parties
believe are
required in order for GSK or its Affiliates to obtain and maintain
Regulatory
Approvals for Product in the Field in Canada and the European
Economic Area as
set forth in Section 4.4(a), which Development activities will be
conducted by
or on behalf of Myogen at Myogen's sole cost and expense (provided
that Myogen
shall not be required to pay regulatory filing, submission or
similar fees
relating to the GSK Territory). To the extent that Myogen initiates
any such
Development activities after the Effective Date, Myogen will share
the design of
any such Development activities with GSK and provide GSK with a
reasonable
opportunity to review, comment on and modify such design in a
manner consistent
with the requirements necessary for GSK to obtain and maintain
Regulatory
Approval for Product in the Field in the GSK Territory. All
clinical and
non-clinical Development activities other than as set forth in the
Development
Plan exchanged by the Parties on the Effective Date or as provided
in Section
4.4 shall be deemed to be New Development Activities and Myogen and
GSK shall be
responsible for the costs and expenses related to such New
Development
Activities as provided in Section 4.3. Myogen will preserve any and
all raw data
generated from non-Good Laboratory Practices (GLP) studies,
including, without
limitation, pharmacology studies and absorption, distribution,
metabolism and
excretion (ADME) studies, until such time that GSK determines such
raw data is
no longer needed by GSK or its Affiliates to obtain or maintain
Regulatory
Approvals in the GSK Territory as provided in Section 4.4(a). After
such time,
Myogen will notify GSK in writing prior to destroying any such raw
data and
offer GSK an opportunity to retain such raw data at GSK's sole cost
and expense.
(b) Except as otherwise provided in Section 4.2(a) above, GSK will
be
solely responsible for conducting all clinical and non-clinical
Development
activities that are required in order for GSK or its Affiliates to
obtain and
maintain Regulatory Approvals for Product in all countries in the
GSK Territory
in accordance with this Agreement and as directed by the Joint
Project Team.
Such Development activities shall be conducted by or on behalf of
GSK at GSK's
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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sole cost and expense. Notwithstanding the foregoing, Myogen will,
as reasonably
requested by GSK and at Myogen's sole cost and expense (provided
that documented
fees and expenses of any Third Party will be billed at cost to
GSK), provide
support to GSK with respect to clinical and non-clinical
Development activities
required to obtain and maintain Regulatory Approvals for Product in
the GSK
Territory.
(c) Each Party, as applicable, will use Commercially Reasonable
Efforts to execute and to perform, or cause to be performed, their
respective
Development activities set forth in the Development Plan, in each
case, in
compliance with Applicable Law, Good Clinical Practice and Good
Laboratory
Practice. Each Party will at no cost or expense to the other Party
provide such
other Party with copies of or access to any and all Development
Information
generated or otherwise obtained (including information generated or
obtained by
Affiliates or any Third Party on behalf of a Party, provided that
the fees and
expenses of any Third Party will be billed at cost to the
requesting Party) in
the Development of Compound and/or Product as provided in this
Section 4.2
(including Development Information generated or otherwise obtained
by GSK and/or
its Affiliates to support the initial JNDA filing), all of which
Development
Information may be used by or on behalf of each Party in the
Development,
Manufacture and/or Commercialization of Compound and/or Product in
their
respective Territories, including, without limitation, in the
preparation,
submission, filing, prosecution and maintenance of Regulatory
Approvals for
Product in their respective Territories. Moreover, upon reasonable
written
notice from a Party, the other Party will provide Regulatory
Authorities with
access to any Development Information for inspection and/or review
as may be
required under Applicable Law.
Section 4.3 Development Outside of the Development Plan.
(a) If, during the Term, either Party desires to Develop the
Compound
and/or Product in the Field for new indications, new formulations,
publication
purposes or any purpose other than as provided in the Development
Plan (a "New
Development Activity"), such Party must submit its proposed
development plan for
such New Development Activity, including, without limitation the
proposed budget
of all costs thereof, for review and approval by the Joint Steering
Committee.
(b) If the Joint Steering Committee approves the proposed plan
and
budget for a New Development Activity (a "Joint New Development
Activity"), then
prior to the commencement of any such Joint New Development
Activity, the
Parties, through the Joint Project Team, will use Commercially
Reasonable
Efforts to draft and agree to a comprehensive development plan and
budget for
such Joint New Development Activity that are consistent with the
proposed
development plan that was provided to the Joint Steering Committee
as provided
in Section 4.3(a). The Parties acknowledge and agree that (i) each
Party will be
responsible for its own internal costs associated with such Joint
New
Development Activity; (ii) GSK will only be obligated to pay for
those actual
external costs for such Joint New Development Activity that are
equal to the
greater of (A) [..**..] of such actual external costs, or (B) if
sales have
commenced in both the GSK Territory and the Myogen Territory,
[..**..] such
actual external costs [..**..] the gross sales of Product in the
Field in the
GSK Territory for the immediately preceding Calendar Year [..**..]
the gross
sales of Product in the Field in the Territory for the
immediately
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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preceding Calendar Year, in each case calculated by the Parties in
accordance
with generally accepted accounting principles; and (iii) Myogen
will be
obligated to pay for all actual external costs for such Joint New
Development
Activity which GSK is not obligated to pay for as provided in (ii)
above. The
Parties will conduct any Joint New Development Activity in
accordance with the
development plan, the budget prepared as provided in this Section
4.3(b) and the
terms and conditions of this Agreement, and as directed by the
Joint Project
Team and Joint Steering Committee.
(c)
If the Joint Steering Committee does not approve the proposed
plan
and/or budget for a New Development Activity and Myogen nonetheless
desires to
conduct such New Development Activity (a "Myogen Sponsored New
Development
Activity"), Myogen may conduct such Myogen Sponsored New
Development Activity
only within the Myogen Territory; provided, however that Myogen may
conduct
clinical/non-clinical activities relating to such Myogen Sponsored
New
Development Activity in the GSK Territory upon obtaining GSK's
prior written
consent, which will not be unreasonably withheld. Prior to
conducting such
Myogen Sponsored New Development Activity, Myogen will draft a
comprehensive
development plan and budget for such Myogen Sponsored New
Development Activity
that is consistent with the proposed development plan submitted to
the Joint
Steering Committee as provided in Section 4.3(b), which will be
presented to the
Joint Project Team for review and comment. Myogen will conduct any
such Myogen
New Development Activity in accordance with the development plan
and budget
prepared as provided in this Section 4.3(c), the terms and
conditions of this
Agreement. Myogen will be solely responsible for conducting, and
paying all
costs and expenses related to, a Myogen Sponsored New Development
Activity. Upon
Myogen's completion of a Myogen Sponsored New Development Activity,
Myogen will
provide GSK with access to any and all Development Information
generated by or
on behalf of Myogen during such Myogen Sponsored New Development
Activity, all
of which Development Information may be used by or on behalf of GSK
in the
Development, Manufacture and/or Commercialization of Compound
and/or Product in
the Field in the GSK Territory, including, without limitation, in
the
preparation, submission, filing, prosecution and maintenance of
Regulatory
Approvals for Product in the Field in the GSK Territory; provided,
however, that
GSK first pays to Myogen an amount equal to what GSK's funding
contribution
would have been as provided in Section 4.3(b)(i) had the Joint
Steering
Committee approved such New Development Activity, plus [..**..] of
such amount.
(d) If the Joint Steering Committee does not approve the proposed
plan
and/or budget for a New Development Activity and GSK nonetheless
desires to
conduct such New Development Activity (a "GSK Sponsored New
Development
Activity"), GSK may conduct such GSK Sponsored New Development
Activity only
within the GSK Territory; provided, however that GSK may
conduct
clinical/non-clinical activities relating to such GSK Sponsored New
Development
Activity in the Myogen Territory only upon obtaining Myogen's prior
written
consent, which will not be unreasonably withheld. Prior to
conducting such GSK
Sponsored New Development Activity, GSK will draft a comprehensive
development
plan and budget for such GSK Sponsored New Development Activity
that is
consistent with the proposed development plan submitted to the
Joint Steering
Committee as provided in Section 4.3(b), which will be presented to
the Joint
Project Team for review and comment. GSK will conduct any such GSK
New
Development Activity in accordance with the development plan and
budget
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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prepared as provided in this Section 4.3(d), the terms and
conditions of this
Agreement. GSK will be solely responsible for conducting, and
paying all costs
and expenses related to, a GSK Sponsored New Development Activity.
Upon GSK's
completion of a GSK Sponsored New Development Activity, GSK will
provide Myogen
with access to any and all Development Information generated by or
on behalf of
GSK during such GSK Sponsored New Development Activity, all of
which Development
Information may be used by or on behalf of Myogen in the
Development,
Manufacture and/or Commercialization of Compound and/or Product in
the Field in
the Myogen Territory, including, without limitation, in the
preparation,
submission, filing, prosecution and maintenance of Regulatory
Approvals for
Product in the Field in the Myogen Territory; provided, however
that Myogen
first pays to GSK an amount equal to what Myogen's funding
contribution would
have been as provided in Section 4.3(b)(ii) had the Joint Steering
Committee
approved such New Development Activity, plus [..**..] of such
amount.
Section 4.4 Regulatory Approvals.
(a) Subject to Section 6.4, GSK will, in accordance with the
Development Plan and as directed by the Joint Project Team, be
solely
responsible for at its sole expense, using Commercially Reasonable
Efforts, for
the preparation, submission, filing, prosecution and maintenance,
in its own
name or in the name of any of its Affiliates or sublicensees, of
all Regulatory
Approvals for Compound and Product in the Field in the GSK
Territory.
(b) Myogen will, in accordance with the Development Plan and as
directed by the Joint Project Team, be solely responsible for, at
its sole
expense, the preparation, submission, filing, prosecution and
maintenance, in
its own name or in the name of any of its Affiliates or
sublicensees, of all
Regulatory Approvals for Compound and Product in the Field in the
Myogen
Territory.
(c) Notwithstanding the foregoing, each Party agrees and
acknowledges
that it will, as reasonably requested by the other Party from time
to time
during the Term, assist the other Party with the preparation of the
Common
Technical Document. Further, Myogen will, as reasonably requested
by GSK from
time to time during the Term, (i) assist GSK with the preparation
of responses
to questions by Regulatory Authorities regarding Compound and/or
Product in the
Field in the GSK Territory; and (ii) provide support to GSK during
the
preparation, filing, prosecution and maintenance of Regulatory
Approvals for
Compound and Product in the Field in the GSK Territory, in each
case at Myogen's
sole cost and expense; provided, however that the reasonable,
documented direct
fees and expenses of any Third Party incurred by Myogen in
connection with such
assistance will be [..**..] GSK.
(d) Except with respect to a Myogen Sponsored New Development
Activity, unless GSK has paid the funding contribution, if
required, as set
forth in Section 4.3(c), Myogen will promptly furnish GSK with
copies of all
substantive Regulatory Authority outputs relating to the
Development of, and/or
filing of Regulatory Approvals for, Compound and/or Product in the
Myogen
Territory (including, without limitation, all substantive
correspondence with
such Regulatory Authorities, responses from such Regulatory
Authorities,
requests for information from such Regulatory Authorities, briefing
documents
and other materials relating to interactions with such Regulatory
Authorities,
and summaries of outputs resulting from substantive
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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correspondence/ conversations or meetings with such Regulatory
Authorities).
(e) Except with respect to a GSK Sponsored New Development
Activity,
unless Myogen has paid the funding contribution, if required, as
set forth in
Section 4.3(d), GSK will promptly furnish Myogen with copies of all
substantive
Regulatory Authority outputs relating to the Development of, and/or
filing of
Regulatory Approvals for, Compound and/or Product in the GSK
Territory
(including, without limitation, all substantive correspondence with
such
Regulatory Authorities, responses from such Regulatory Authorities,
requests for
information from such Regulatory Authorities, briefing documents
and other
materials relating to interactions with such Regulatory
Authorities, and
summaries of outputs resulting from substantive correspondence/
conversations or
meetings with such Regulatory Authorities).
ARTICLE V
COMMERCIALIZATION
Section 5.1 Global Marketing Plan. As directed by the Joint
Steering
Committee, the Global Brand Team will draft the initial Global
Marketing Plan
and submit the initial Global Marketing Plan to the Joint Steering
Committee for
review and approval. Thereafter, not later than sixty (60) Business
Days prior
to the end of each Calendar Year during the Term, the Global Brand
Team will
update the Global Marketing Plan as required and submit the updated
Global
Marketing Plan for review and approval by the Joint Steering
Committee.
Section 5.2 Commercialization of Product in the GSK Territory.
(a) (i) GSK will have full control, authority and responsibility
for
the Commercialization of Product in the Field in the GSK Territory.
Subject to
Section 6.4, GSK will exercise its Commercially Reasonable Efforts
in
Commercializing Product in countries of the GSK Territory where it
has obtained
Regulatory Approval in a manner consistent with this Agreement and
the Global
Marketing Plan, and, with respect to the Major Countries and Major
European
Market Countries only, as directed by the Global Brand Team.
Notwithstanding
anything in this Section 5.2(a) or in this Agreement to the
contrary, GSK will
have final decision-making authority, in its sole discretion,
relating to the
Commercialization of Product in the Field in the GSK Territory,
including,
without limitation, pricing and reimbursement for Product (as
provided in
Section 5.2(c)), Product advertising and promotional materials,
Product
packaging, sales force training and all interactions with
Regulatory Authorities
regarding the Commercialization of Product in the Field; provided,
however that
any such decisions of GSK relating to the Commercialization of
Product in the
Field in the GSK Territory, to the extent not required by a
Regulatory Authority
or under Applicable Law, will not be inconsistent with the Global
Marketing Plan
or the terms of this Agreement, and will not materially and
adversely affect
Myogen's Development, Manufacture and/or Commercialization of
Product in the
Field in the Myogen Territory, or subject to Section 2.3, Myogen's
retained
right to make, have made, use, sell, offer for sale and/or import
Product
outside of the Field in the GSK Territory.
(ii) If, at any time during the Term, Myogen reasonably
believes
that
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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GSK has failed to use Commercially Reasonable Efforts in
Commercializing Product
in a country in the GSK Territory as set forth in Section
5.2(a)(i), Myogen may
(A) with respect to any Major Country or Major European Market
Country, exercise
its rights under Section 6.2, and (B) with respect to any country
other than a
Major Country or Major European Market Country, exercise its rights
under
Section 11.2 to terminate this Agreement but only with respect to
such affected
country and in such an event, such terminated country will be
removed from the
GSK Territory and included within the Myogen Territory and the
provisions
contained in Section 11.9(a) shall apply to such termination.
(b) GSK will book all sales of Product in the Field in the GSK
Territory and will warehouse and distribute the Product in the
Field in the GSK
Territory; provided, however, that GSK will be permitted to
warehouse Product in
the Field in the Myogen Territory if such Product has been
Manufactured by or on
behalf of GSK in the Myogen Territory. If Myogen receives any
orders for Product
for sale in the Field in the GSK Territory, it will refer such
orders to GSK. If
Product sold in the Field in the GSK Territory is returned to
Myogen, Myogen
will promptly ship such returned Product to a facility designated
by GSK.
(c) Subject to the terms of this Agreement, including, without
limitation, Section 6.4, and the Global Marketing Plan, (i) GSK
will be solely
responsible for, using Commercially Reasonable Efforts, all pricing
and
reimbursement approval proceedings relating to the Product in the
Field in the
GSK Territory, and (ii) GSK will have complete discretion in
setting pricing for
the Product in the Field in the GSK Territory. GSK will be
responsible for
filing and maintenance fees relating to pricing and reimbursement
approvals.
(d) (i) Subject to Applicable Law and the Global Marketing Plan,
GSK
will, in its sole discretion, determine and select all trademarks,
tradenames,
copyrights, logos (collectively, "GSK Marks"), used in connection
with Product
in the Field in the GSK Territory and will, as part of GSK's annual
updates to
the Global Marketing Plan, keep Myogen informed of GSK's plans with
respect to
existing and planned GSK Marks. For the avoidance of doubt, the
term "GSK Marks"
will in no way be deemed to include the Myogen Trademarks.
(ii) Myogen hereby grants to GSK an exclusive, royalty free
license, with the right to grant sublicenses, to use the Myogen
Trademarks to
Develop, Manufacture and Commercialize Compound and/or Product in
the Field in
the GSK Territory during the Term. GSK will use the Myogen
Trademarks solely
with respect to the Development, Manufacture and/or
Commercialization of
Compound and/or Product in the Field and in accordance with the
standards of
quality established or approved in writing by Myogen and provided
to GSK.
Whenever GSK uses the Myogen Trademarks in any manner in connection
with
Product, Myogen will clearly indicate that the Myogen Trademarks
are owned by
Myogen. When using the Myogen Trademarks under this Agreement, GSK
will comply
with all Applicable Law pertaining to the Myogen Trademarks in
force at any time
in the GSK Territory. During the Term, GSK will provide Myogen with
copies of
promotional materials on a periodic basis, as requested by Myogen,
for review of
the use of the Myogen Trademarks by GSK. GSK will use Commercially
Reasonable
Efforts to promptly take any and all actions directed by Myogen
with respect to
GSK's use of the Myogen Trademarks that are reasonably designed to
ensure
compliance with the provisions of this Section 5.2(d)(ii).
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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(A) GSK acknowledges and agrees that Myogen and/or its
Affiliates, is, and at all times will remain the owner of the
Myogen Trademarks.
GSK will not at any time do, cause to be done, or permit any of its
employees,
agents, contractors and subcontractors to commit any act
inconsistent with,
contesting or in any way impairing, or tending to impair, such
ownership. GSK
agrees that all use of the Myogen Trademarks by GSK will inure to
the benefit of
and be on behalf of Myogen or Myogen's Affiliates. GSK acknowledges
that nothing
in this Agreement will give GSK any right, title or interest in the
Myogen
Trademarks other than the right to use the Myogen Trademarks within
the GSK
Territory in accordance with this Agreement. GSK agrees that it
will not
challenge Myogen's or Myogen's Affiliates' title to, or ownership
of, the Myogen
Trademarks, or attack or contest the validity of the Myogen
Trademarks. All
goodwill accruing to the Myogen Trademarks as a result of the use
of the Myogen
Trademarks in the performance of this Agreement will belong solely
to Myogen or
Myogen's Affiliates. In the event that GSK acquires any rights in
the Myogen
Trademarks in connection with GSK's activities pursuant to this
Agreement, GSK
will assign, and hereby does assign, to Myogen or Myogen's
Affiliates all such
rights, including any related goodwill.
(B) GSK is limited to using the Myogen Trademarks in
connection with the Internet as follows:
(1) the use must be in compliance with local rules
regarding advertising of pharmaceuticals on the Internet;
(2) the use of any Myogen Trademarks as a domain name
is limited to the relevant country code domain within the GSK
Territory. No
license is granted to use the ".com generic code domain" or any
other such
top-level domain. All domain names containing the Myogen Trademark
will be
registered and maintained by and in the name of Myogen or its
designee;
(3) the use of any Myogen Trademarks as a domain name
is limited to use on websites with universal resource locaters
using the
relevant country code domain within the GSK Territory and aimed at
audiences in
those countries in the GSK Territory;
(4) appropriate disclaimers must be included in any
website to the effect that it is intended for residents in that
country within
the GSK Territory only; and
(5) in using any of the Myogen Trademarks as a domain
name or on the Internet, GSK will not have and will not represent
in any way
that it has any title or right to the ownership or registration or
their use,
except as provided in this Agreement. GSK will at all times
indicate that each
of the Trademarks is a trademark of Myogen and is used under
license.
(e) Upon GSK's request, the Parties will, through the Global
Brand
Team and
[..**..] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS
DOCUMENT, MARKED
BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE
SECURITIES AND
EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES
EXCHANGE ACT OF
1934, AS AMENDED.
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in the Global Marketing Plan, use good faith efforts to negotiate
ways in which
Myogen may assist GSK in the Commercialization of Product in the
Field in the
GSK Territory during the Term at no cost or expense to GSK except
as agreed in
advance to defer the incremen