EXHIBIT 10.18
*** 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 406 OF THE
SECURITIES ACT OF 1933, AS AMENDED.
LICENSE AGREEMENT
This License Agreement ("AGREEMENT") is made as of this 8th day of
October, 2001 (the "EFFECTIVE DATE") by and between XXXXXX DEUTSCHLAND HOLDING
GmbH, a German legal entity, with its principal office at Xxx Xxxxxx Xxxx 0,
00000 Xxxxxxxxx, Xxxxxxx ("ABBOTT") and MYOGEN, INC., a Delaware corporation,
with its principal office at 0000 X. 000xx Xxxxxx, Xxxxxxxxxxx, XX 00000-0000
("MYOGEN").
WITNESSETH
WHEREAS, Abbott is the holder or licensee of certain patent
applications and patents ("Patents," as more fully defined below) relating to
Compound (as defined below);
WHEREAS, Abbott also possesses proprietary Know-How (as defined below)
relating to Compound; and
WHEREAS, Myogen wishes to obtain, and Abbott wishes to grant to Myogen,
an exclusive license in the Territory (as defined below) under Xxxxxx'x
Technology (as defined below) for the development and commercialization of
Product for Pharmaceutical Uses (as defined below).
NOW THEREFORE, in consideration of the mutual obligations and promises
as set forth herein, the parties do hereby agree as follows:
1. DEFINITIONS. As used in this Agreement, the following terms shall have the
following respective meanings:
1.1 "XXXXXX'X TECHNOLOGY" means the Patents and Know-How, including all
Improvements developed by Abbott and Improvements that are jointly developed by
Abbott and Myogen pursuant to Article 13.
1.2 "AFFILIATE" means any corporation, company, partnership, joint
venture and/or firm which controls, is controlled by, or is under common control
with either party hereto. For purposes of this definition, control shall mean
direct or indirect ownership of more than fifty percent (50%) of the stock or
participating shares entitled to vote for the election of directors (but only as
long as such ownership exists).
1.3 "CHF" means the indication commonly known as chronic heart failure.
1.4 "COMBINATION PRODUCT" means a pharmaceutical product that is
comprised in part of Product and in part of one or more other active agents in
any configuration, formulation or combination.
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1.5 "COMPOUND" means the endothelin receptor antagonist compound
identified as BSF 208075 (ambrisentan) with the following formula:
[GRAPHIC FORMULA]
and the chemical name,(+)-(S)-2-(4,6-Dimethyl-pyrimidin-2-yloxy)-3-methoxy-3,3-
diphenyl propionic acid, its racemates, isomers, Prodrugs, active metabolites
and any pharmaceutically acceptable salt or complex thereof, in its current and
any other formulation, whether made before or after the Effective Date.
1.6 "CONFIDENTIAL INFORMATION" means any and all information or data
relating to the Compound and/or Product which a party discloses to the other
party, its employees or representatives, or is conceived or reduced to practice
during the Term by either party or by a third party conducting feasibility and
evaluation studies for Myogen, whether in writing, orally or by observation,
including, without limitation, all scientific, clinical, technical, commercial,
financial and business information and Know-How, and other information or data
considered confidential in nature. Confidential Information shall not include
information or any portion thereof which:
(a) is known to the receiving party at the time of disclosure
and documented by written records made prior to the date of this Agreement;
(b) is subsequently disclosed to the receiving party without
any obligations of confidence by an unaffiliated third person who has not
obtained it directly or indirectly from the other party and who has the right to
make such disclosure;
(c) becomes patented, published or otherwise part of the
public domain; or
(d) is independently developed by or for the receiving party
by person(s) having no knowledge of or access to such information and without
breach of any confidentiality obligation as evidenced by its written records.
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The contents of and the Exhibits to this Agreement shall constitute Confidential
Information.
1.7 "CRF" means the indication commonly known as chronic renal failure.
1.8 "EFFECTIVE DATE" shall have the meaning ascribed to such term in
the opening paragraph of this Agreement.
1.9 "FIRST COMMERCIAL SALE" means the first sale of Product in the
Territory, after Regulatory Approval, by Myogen, any Affiliates or sublicensees
of Myogen, or any contract sales force of Myogen or its Affiliates, to any
unaffiliated third party as evidenced by the selling party's invoice or other
relevant document provided to such third party. A sale to an unaffiliated third
party shall not include quantities delivered solely for research purposes, for
clinical trials or quantities distributed as free samples or promotions.
1.10 "IMPROVEMENTS" means all additions, developments, modifications,
enhancements and adaptations (i) which directly relate to or are used in
connection with the Compound and/or Product, or any formulations thereof or
additions, developments, modifications, enhancements, improvements and
adaptations thereto, and (ii) which are conceived or reduced to practice during
the Term. Ownership of Improvements shall be as set forth in Article 13 hereof.
1.11 "IND" means an investigational new drug application filed with the
applicable Regulatory Authority in a country of the Territory, in order to
commence human clinical testing of a drug. An IND, together with all
supplemental filings referencing the initial IND filing, shall be deemed one and
the same IND for all purposes of this Agreement.
1.12 "KNOW-HOW" means any proprietary technology, information, methods
of use, processes, techniques, ideas or inventions (other than the Patents)
owned, possessed or used by Abbott as of the Effective Date which is directly
related to or used in connection with the Compound and/or Product, including all
trade secrets and any other technical information relating to development, use
or sale of the Compound and/or Product, provided that Abbott has the right to
license and/or sublicense to Myogen.
1.13 "MANUFACTURING DEVELOPMENT AND SUPPLY AGREEMENT" means an
agreement between the parties for the manufacture and supply of Compound and/or
Product as contemplated and described more fully under Section 4.6(a) below.
1.14 "NDA" means an application (whether original, supplementary or
abbreviated) to the applicable Regulatory Authority in a country of the
Territory, for approval by such Regulatory Authority, necessary for the
commercial sale of Product in
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such country. An NDA, together with all supplemental filings referencing the
initial NDA filing, shall be deemed one and the same NDA for all purposes of
this Agreement.
1.15 "NET SALES" means gross sales of the Product to unrelated third
parties, in arm's length transactions, for which revenue is actually received by
Myogen, by any Affiliates or sublicensees of Myogen, or any contract sales force
of Myogen or its Affiliates, including, but not limited to, pharmaceutical
wholesalers, pharmacies, hospitals or dispensing physicians, less any of the
following charges or expenses that are incurred in connection with gross sales
of the Product during the Term:
(a) discounts, including cash discounts, customary trade
allowances or rebates actually taken, governmental rebates, chargebacks,
commissions, and group purchasing management fees for formulary access;
(b) credits or allowances given or made for rejection, recall
or return of previously sold Product actually taken;
(c) any tax or government charge, duty or assessment
(including any tax such as a value added or similar tax or government charge)
levied on the sale, transportation or delivery of Product when included on the
invoice or other written document between the parties as payable by the
purchaser and collectable by Myogen, its Affiliate or sub-licensee; and
(d) freight, postage, transportation, insurance and duties on
shipment of Product when included on the invoice or other written document
between the parties as payable by the purchaser and collectable by Myogen, its
Affiliates or sublicensees.
With respect to a Combination Product, Net Sales of such
Combination Product shall first be calculated in accordance with Net Sales of
Product above, and then the Net Sales of such Combination Product shall be
determined on a country-by-country basis as follows:
(i) by multiplying the Net Sales of such Combination Product
by the fraction A/(A+B), where A is the average selling price in such country of
Product which contains the Compound as its sole active ingredient and B is the
total of the average selling prices in such country of pharmaceutical product(s)
which contain each of the other active ingredients as their sole active
ingredient; or
(ii) if either the average selling price of the Product which
contains the Compound as its sole active ingredient or the average selling price
of all the other pharmaceutical products which contain each of the other active
ingredients in such Combination Product is not available, by multiplying the Net
Sales of such Combination Product by a percentage, determined by mutual
agreement of the parties, which represents the proportionate economic value of
the Compound relative to the economic value contributed by all other active
ingredients in such Combination Product. If the parties cannot agree, then the
alternative dispute resolution procedure set forth on Exhibit D shall be used to
determine the matter.
1.16 "PATENTS" means the patent applications and patents listed in
Exhibit A hereto and any and all other patent applications and patents and
amendments thereto, including foreign equivalents, and any and all
substitutions, extensions, additions, reissues, re-examinations, renewals,
divisions, continuations, continuations-in-part or supplementary protection
certificates owned by or licensed to (with the right to sublicense) Abbott or
its Affiliates during the Term relating to the Compound, Product or any
Improvements.
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1.17 "PAH" means the indication commonly known as pulmonary arterial
hypertension.
1.18 "PHARMACEUTICAL USES" means any therapeutic use in humans of the
Compound and/or Product in any formulation or dosage form for the management or
treatment or prevention of a disease or condition of the human body, including,
but not limited to, chronic heart failure (CHF), chronic renal failure (CRF) and
pulmonary arterial hypertension (PAH), but excluding any non-therapeutic use or
non-human use (which non-therapeutic or non-human use shall include, but not be
limited to, imaging, diagnostics, veterinary medicine, etc.).
1.19 "PRODRUG" means different pharmaceutical compounds which,
following administration, are converted into structurally similar active
metabolites.
1.20 "PRODUCT" means any formulation containing the Compound or any
Improvement as an active ingredient for Pharmaceutical Uses.
1.21 "REGULATORY APPROVAL" means all governmental approvals and
authorizations necessary for the commercial sale of the Product in a country of
the Territory, including, but not limited to, marketing authorization, pricing
approval and pricing reimbursement, as applicable.
1.22 "REGULATORY AUTHORITY" means the United States Food and Drug
Administration or any successor entity and its equivalent in other countries of
the Territory, including, but not limited to, EMEA.
1.23 "ROYALTY PERIOD" shall have the meaning ascribed to such term in
Section 5.4(a) of this Agreement.
1.24 "TERM" means the period commencing on the Effective Date and
terminating as set forth in Article 8 below.
1.25 "TERRITORY" means the entire world.
1.26 "TRADEMARK" means any trademark registered, owned or chosen for
Product by Myogen in any country of the Territory.
1.27 "VALID CLAIM" means a claim of an unexpired Patent that has not
been withdrawn, canceled or disclaimed nor held to be invalid or unenforceable
by a court or government agency of competent jurisdiction in an unappealed or
unappealable decision.
1.28 "WORK PLAN" means the summary of the current development plan for
BSF 208075, which summary is attached hereto as Exhibit B.
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2. LICENSE GRANT.
2.1 Abbott hereby grants to Myogen an exclusive right and license in
the Territory, under Xxxxxx'x Technology, for all Pharmaceutical Uses, with the
right to grant sublicenses pursuant to Section 4.7 hereof, to (i) research,
develop, modify and improve Compound and Product; (ii) apply for and obtain
Regulatory Approvals; and (iii) use, import/export, market, offer to sell and
sell, Product and Compound.
2.2 In the event Myogen exercises its rights under Section 4.6(a) or
Section 4.6(c) hereof to self-manufacture Compound and/or Product, then the
exclusive license granted under Section 2.1 above shall be deemed to include the
rights to make Compound and Product.
2.3 In the event Myogen exercises its rights under Section 4.6(b) or
Section 4.6(c) hereof to qualify a second source (including itself) to
manufacture Product or to engage a third party manufacturer for finishing
Compound and/or Product, then the exclusive license granted under Section 2.1
above shall be deemed to include the rights to make or have made Compound and
Product, as the case may be.
3. INFORMATION; EXCLUSIVITY.
3.1 CONVEYANCE OF INFORMATION/INVENTORY.
(a) Within thirty (30) days following the Effective Date, Abbott
and Myogen shall work together to (i) identify information and documents under
Xxxxxx'x and its Affiliates' control involving the Compound that will be useful
to Myogen in the transfer of development activities hereunder and (ii) establish
a timeline for delivery of such information and documents. Abbott shall convey
such information to Myogen in accordance with such timeline, but in no event
later than ninety (90) days following its identification by the parties. For
purposes of this Section 3.1, information shall not be deemed under Xxxxxx'x and
its Affiliates' control if such information is protected by confidentiality
agreements with third parties; provided, however, that Abbott shall provide
Myogen with notice that such information is subject to third party
confidentiality obligations at the time of its identification. With respect to
such protected information, Abbott shall use reasonable efforts to obtain the
consent of such third parties to release the protected information to Myogen.
(b) [***], Abbott shall convey the quantities of Product and
matched placebo specified on Exhibit E which are currently in inventory. Abbott
shall supply Myogen with the balance of Product and matched placebos necessary
to achieve the required quantities specified on Exhibit E [...***...]. Abbott
expects that it will be able to communicate such [...***...] cost to Myogen
within ninety (90) days of the Effective Date. Abbott shall utilize [...***...]
of Compound currently in inventory to manufacture such Product and [...***...]
Myogen for the cost of [...***...] of Compound. In the event any excess Compound
remains after the manufacture of the
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Product as provided herein, such excess shall be conveyed to Myogen [...***...].
If additional Compound greater than [...***...] is needed to manufacture the
Product quantities specified on Exhibit E or if Myogen requests additional
Compound, Myogen shall pay Abbott or its designated Affiliate [...***...].
(c) Abbott represents and warrants that the Compound, matched
placebo and Product conveyed to Myogen under Section 3.1(b) has been or shall be
manufactured in accordance with current Good Manufacturing Practices ("cGMP").
Other than the foregoing warranty, any Compound shall be conveyed "AS IS" and
"WITH ALL FAULTS," WITHOUT ANY OTHER WARRANTY OF ANY KIND WHATSOEVER, EXPRESS OR
IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY AND FITNESS FOR PARTICULAR
PURPOSE. Myogen shall be responsible for all testing, quality control and
certification of such Compound.
3.2 ABBOTT EXCLUSIVITY. During the Term, and except as described in
Section 4.3(a), neither Abbott nor its Affiliates, shall directly or through
intermediaries, undertake any development or commercialization activities
related to Pharmaceutical Uses, [...***...]
4. FEASIBILITY/EVALUATION/DEVELOPMENT/MANUFACTURING/MARKETING/OTHER.
4.1 FEASIBILITY/EVALUATION STUDIES. Myogen shall use commercially
reasonable efforts to evaluate the Compound in accordance with the Work Plan.
For purposes of this Agreement, the term "commercially reasonable efforts" shall
mean, in the case of Myogen, those efforts that would be expected in the
pharmaceutical industry of a company substantially similar to Myogen and, in the
case of Abbott, those efforts that would be expected in the pharmaceutical
industry of a company substantially similar to Xxxxxx Laboratories, its parent
company. Myogen shall have sole responsibility for conducting and/or supervising
the feasibility and evaluation studies on the Compound as set forth in the Work
Plan. Myogen shall provide Abbott with summaries of the feasibility and
evaluation studies conducted by or on behalf of Myogen, including summaries of
reports and data generated under such studies, on a semi-annual basis (including
at any annual review meeting held pursuant to Section 4.2 below), and all such
information shall be treated as Myogen's Confidential Information.
Notwithstanding the foregoing, Abbott agrees to use commercially reasonable
efforts to complete, on behalf of Myogen, those feasibility and evaluation
studies listed on Exhibit C [...***...]. For all such studies that will be
performed by Abbott on behalf of Myogen, Myogen shall have the right to review
and approve all trial plans and protocols prior to initiation of any study, and
Myogen shall receive regular reports regarding the progress of such studies.
Periodically, as the progress of the studies may dictate, the Work Plan may be
amended upon mutual written agreement of the parties, and such amendments shall
be reflected in an amended Exhibit B. Recognizing that certain work to be
conducted on behalf of Myogen will be performed by one or more third parties and
recognizing that such work
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(e.g., formulations) may involve the patented subject matter of such third
party, Myogen will use commercially reasonable efforts to (i) provide in its
license with the third party that the patented subject matter of such third
party may be sublicensed to Abbott in the event that the Compound and Product
are returned to Abbott under Sections 4.3(b) and 4.8; and (ii) negotiate a
[...***...] license/sublicense with such third party. In the event that Myogen
is unable to negotiate a [...***...] license/sublicense, Abbott agrees to assume
the [...***...] obligations thereunder if it elects to practice under such
license/sublicense following the return of the Compound and Product under
Sections 4.3(b) and 4.8. Myogen agrees to promptly provide Abbott with written
notice of the terms of any licenses entered into with third parties which
pertain to the Compound and/or Product.
4.2 REVIEW. Beginning one month following the Effective Date and every
six (6) months thereafter while Myogen is developing the Compound, Myogen shall
provide Abbott with a written report reviewing the progress of the Work Plan and
the results of such work and studies remaining to be completed under the Work
Plan, which report shall be deemed Myogen Confidential Information. In the event
Abbott so requests, the parties shall meet in person once during each calendar
year to discuss these topics. The meeting shall be held at a mutually agreeable
time and location. Each party shall be responsible for its own costs of
attendance.
4.3 CLINICAL DEVELOPMENT.
(a) Myogen shall use commercially reasonable efforts to
develop the Compound in accordance with the Work Plan. Myogen shall have sole
responsibility for designing, conducting and paying for the cost of the clinical
development of Product and shall use commercially reasonable efforts to conduct
such clinical development as set forth below. Except as set forth in Section 3.2
above, Abbott hereby agrees that it shall not undertake any research or
development related to Pharmaceutical Uses of the Compound during the Term,
except as may be necessary following the license granted to Abbott under Section
4.8 in the event of a termination of this Agreement under Sections 8.2, 8.3 or
8.4.
(b) In the event Myogen breaches a material obligation under
this Agreement, Abbott may then advise Myogen that Abbott believes that Myogen
has breached such material obligation and that Abbott is adversely impacted
thereby. Upon so advising Myogen, Abbott may initiate an alternative dispute
resolution procedure ("ADR") as set forth in Exhibit D, and request the ADR to
rule upon whether Myogen has breached any such material obligation. In the event
that the neutral party conducting such ADR renders a ruling that Myogen has
breached such material obligation and that Abbott was adversely impacted
thereby, and Myogen fails to comply with the terms of the neutral's ruling
within the time specified therein for compliance, or if such compliance cannot
be fully achieved by such date, Myogen has failed to commence
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compliance and/or has failed to use diligent efforts to achieve full compliance
as soon thereafter as is reasonably possible, then Xxxxxx'x sole remedy shall be
(i) the right to terminate this Agreement and the licenses granted hereunder,
and to obtain from Myogen a license to Improvements under Section 4.8.
4.4 COMMERCIALIZATION.
(a) Myogen shall use commercially reasonable efforts to
develop, register and commercialize Product in at least the following major
countries: United States, Japan, U.K., Germany, Spain, Italy and France (each a
"MAJOR COUNTRY"), using at least that level of effort standard in the
pharmaceutical industry that a pharmaceutical company of Myogen's general size
would use to commercialize a product similar to the Product. It is the parties'
expectation that Myogen will commercialize Product in all commercially viable
markets in addition to Major Countries within [...***...] following First
Commercial Sale of the Product. If, following such [...***...] period, there
remain markets where Myogen is not commercializing Product which Abbott, in its
reasonable estimation, believes are commercially viable markets, then the
parties shall meet within thirty (30) days of Xxxxxx'x written notice for the
purpose of developing a mutually agreeable action plan for such under-served
markets. If the parties are unable to agree on an action plan, Abbott and its
Affiliates shall have the right, upon notice to Myogen, to sell the Product
directly in each such country, by paying to Myogen or its sublicensees
[...***...] to which Abbott would otherwise be entitled if Myogen were marketing
the Product in such country. Myogen agrees to provide Product to Abbott and its
Affiliates for sale in each such country [...***...] and to cooperate with
Abbott by, among other things, working with Abbott and its Affiliates to
coordinate marketing and sales strategies consistent with Myogen's global
Product marketing strategies, clinical studies and the development of selling
and other materials necessary for the effective sale and marketing of Product in
a country.
(b) If there is any material disagreement between the parties
concerning whether commercially reasonable efforts towards commercialization
have been made with respect to a particular indication after Regulatory Approval
in a Major Country, then the matter may be submitted to ADR. If the neutral
party conducting such ADR makes a final determination that Myogen has failed to
use commercially reasonable efforts to develop, register and/or commercialize
Product in a Major Country, the neutral party shall provide Myogen with the
opportunity to undertake such activities and expenses as needed to correct the
failure. If Myogen fails to correct the failure within the time period
prescribed by the neutral party, then the neutral party may provide remedies for
failure to expend such efforts, which could include a requirement for Myogen to
expend additional efforts to make up for any failures, the grant of rights to
Abbott to sell Product in the under-served country, damages and/or termination
of the license rights in the applicable country.
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(c) If there is any material disagreement between the parties
concerning whether a market that is not a Major Country is commercially viable
such that Myogen should be commercializing Product in accordance with Section
4.4(a) hereof, or if Myogen reasonably believes that Xxxxxx'x selling of Product
in a particular country will have a substantial negative impact on Myogen's
local, regional or global commercial efforts, then the matter may be submitted
to ADR. If the neutral party conducting such ADR makes a final determination
that a market that is not a Major Country is commercially viable and that Myogen
should be commercializing Product in such market, the neutral party shall
provide Myogen with the opportunity to commercialize Product in such market. If
Myogen fails to so commercialize Product within the time period prescribed by
the neutral party, then the neutral may xxxxx Xxxxxx the right to sell Product
in the under-served country if the neutral party concludes that such sales
efforts by Abbott will not have a substantial negative impact on Myogen's local,
regional or global commercial efforts.
4.5 MARKETING. Except as set forth in Section 4.4 above, Myogen shall
have sole responsibility for marketing Product, including entering into any
co-marketing and/or co-promotion arrangements. Myogen shall distribute all
Product samples in the United States in accordance with the Prescription Drug
Marketing Act.
4.6 MANUFACTURING:
(a) As of the Effective Date, the parties contemplate
that Abbott or an Abbott Affiliate will manufacture Compound and/or Product and
supply Myogen with its requirements of Compound and/or Product during the Term
pursuant to a definitive Manufacturing Development and Supply Agreement to be
executed by the parties, subject to Myogen's right to qualify a second source to
manufacture Compound and/or Product and to receive up to [...***...] of its
annual requirements of Compound and/or Product from such second source and to
engage a third party manufacturer for finishing Compound and/or Product supplied
by Abbott in bulk form, as provided in Section 4.6(c) below. The Manufacturing
Development and Supply Agreement shall cover the manufacture and supply of
pre-clinical, clinical and/or commercial bulk active Compound and/or Product.
If, following good faith negotiations, the parties are unable to execute a
definitive Manufacturing Development and Supply Agreement within ninety (90)
days of the commencement of their negotiations, and Myogen elects to
self-manufacture Compound and/or Product, then the exclusive license granted
under Section 2.1 above shall be deemed to include the additional rights set
forth in Section 2.2 above. In such event, Abbott shall provide Myogen with the
manufacturing protocol for the Compound and/or Product, which protocol shall be
considered Abbott Confidential Information. All additional Know-How or Abbott
Confidential Information relating to raw materials or precursors to the
Compound, and all additional information and documentation, which are necessary
to make Compound and/or Product, shall be transferred in a timely fashion to
Myogen as mutually agreed by the parties [...***...].
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(b) If the parties are unable to negotiate a definitive
Manufacturing Development and Supply Agreement as provided above and Myogen
elects to negotiate terms and conditions with a third party manufacturer of
Compound and/or Product, Myogen shall, prior to executing a definitive agreement
with such third party, provide Xxxxxx with a summary of the material terms and
conditions and allow Xxxxxx the opportunity to meet or beat such terms and
conditions, taken as a whole, with all such material terms and conditions
considered. If Xxxxxx fails to meet or beat such terms and conditions within
thirty (30) days of its receipt, Myogen shall be free to execute a definitive
agreement for the manufacture and supply of Compound and/or Product with such
third party and, in such event, the additional rights set forth in Section 2.3
above shall be granted to Myogen for the purpose of allowing the third party to
manufacture and supply Compound and/or Product to Myogen. In addition, Xxxxxx
shall provide Myogen with the manufacturing protocol for the Compound and/or
Product, which protocol shall be considered Xxxxxx Confidential Information. All
additional Know-How or Xxxxxx Confidential Information relating to raw materials
or precursors to the Compound, and all additional information and documentation,
which are necessary to have made Compound and/or Product, shall be transferred
in a timely fashion to Myogen as mutually agreed by the parties [...***...].
Myogen may provide the manufacturing protocol to the third party manufacturer
under terms which provide for the protection of such Xxxxxx Confidential
Information.
(c) Myogen shall have the right, at any time, to qualify a
second source (including itself) to manufacture up to [...***...] of its annual
requirements of Compound and/or Product and to engage a third party manufacturer
for finishing Compound and/or Product supplied by Xxxxxx in bulk form. In either
event, the additional rights set forth in Sections 2.2 and 2.3 above shall be
granted to Myogen solely for purposes of allowing such additional sources to
manufacture and/or finish Compound and/or Product for Myogen, as the case may
be. Myogen shall be solely responsible for all costs and expenses necessary to
qualify such second source. Xxxxxx shall provide Myogen with the manufacturing
protocol for the Product, which protocol shall be considered Xxxxxx Confidential
Information. All additional Know-How or Xxxxxx Confidential Information relating
to raw materials or precursors to the Compound, and all additional information
and documentation, which are necessary to make or have made Compound and/or
Product, shall be transferred in a timely fashion to Myogen as mutually agreed
by the parties and at no cost to Myogen. Myogen may provide the manufacturing
protocol to the second manufacturing source under terms which provide for the
protection of such Xxxxxx Confidential Information.
4.7 SUBLICENSING. Myogen may sublicense its rights under this
Agreement, without obtaining Xxxxxx'x prior written consent. Each sublicense
shall be in writing and shall include provisions acknowledging that such
sublicense is subject to the license granted Myogen under this Agreement, that
each sublicensee shall make reports and keep
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and maintain records of sales to at least the same extent as required under this
Agreement, allowing Xxxxxx the same access and audit rights permitted under this
Agreement, and that such sublicense shall be automatically terminated upon
termination of this Agreement. Myogen shall remain primarily liable for the
performance of sublicensees. Myogen shall provide Xxxxxx with a copy of each
sublicense agreement.
4.8 IMPROVEMENTS. All Improvements and all new patents which relate to
the Compound or the Product which come into existence during the Term and which
relate to or are derived from work conducted by or on behalf of Myogen or its
Affiliates or sublicensees relating to the Compound without any contribution by
Xxxxxx, its Affiliates, contractors, or agents, shall be deemed the property of
Myogen. Provided, however, in the event this Agreement is terminated by Xxxxxx
for any reason, as set forth in Article 8, or by Myogen under Section 8.2, all
such Improvements shall be exclusively licensed to Xxxxxx solely for use with
the Compound and Product [...***...] and Myogen retains all rights in and to any
such Improvements for any and all other uses.
5. FINANCIALS.
5.1 DEVELOPMENT COST REIMBURSEMENT. Myogen shall reimburse Xxxxxx for
[...***...] of the development costs incurred by Xxxxxx and its Affiliates. Such
reimbursement shall be made over a [...***...] as follows: (i) a payment of
[...***...]; (ii) a payment of [...***...] on [...***...], together with accrued
interest from and after the Effective Date at [...***...]; and (iii) a payment
of [...***...] on [...***...], together with accrued interest from and after the
Effective Date at [...***...].
5.2 EXECUTION FEE. Myogen shall pay to Xxxxxx [...***...] on the
Effective Date.
5.3 MILESTONES. Myogen shall make the following milestone payments to
Xxxxxx within twenty (20) days of the occurrence of the following events,
regardless of whether or not Myogen has sublicensed any of its rights under this
Agreement:
MILESTONE PAYMENT
--------- -------
Initiation of Phase III Clinical Study* [...***...]
NDA Filing in U.S.* [...***...]
NDA Filing in [...***...] Major Countries [...***...] [...***...]
*If CHF is the first indication where a Phase III Clinical Study is initiated or
an NDA is filed, the full payment amounts indicated above shall be due with
respect to CHF. If a Phase III Clinical Study is initiated or an NDA is filed
for CRF, PAH or any other indication before CHF, then the payment amounts due
shall be one-half the amounts
CONFIDENTIAL TREATMENT REQUESTED
*** TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
indicated above for each such indication, subject in all cases to a maximum
total payment of (i) [...***...] for initiation of Phase III Clinical Studies
for all indications; (ii) [...***...] for NDA filings in the U.S. for all
indications; and (iii) [...***...] for NDA filings in [...***...] Major
Countries [...***...] for all indications.
MILESTONE PAYMENT
--------- -------
Regulatory Approval in U.S. for CHF [...***...]
Regulatory Approval in U.S. for CRF [...***...]
Regulatory Approval in U.S. for PAH [...***...]
If Regulatory Approval is obtained in the U.S. for any other indication prior to
obtaining Regulatory Approval for CHF, CRF and PAH, then the milestone payable
for each such other indication shall be [...***...], provided that the maximum
total milestone payments for obtaining U.S. Regulatory Approval for all
indications shall not exceed [...***...].
MILESTONE PAYMENT
--------- -------
Regulatory Approval in [...***...] Major Countries
[...***...] for CHF** [...***...]
Regulatory Approval in [...***...] Major Countries
[...***...] for CRF** [...***...]
Regulatory Approval in [...***...] Major Countries
[...***...] for PAH** [...***...]
** In the event a centralized filing and Regulatory Approval process has
replaced the requirement to file in and receive Regulatory Approval from each
Major Country [...***...], then such a single filing, and receipt of Regulatory
Approval from [...***...], together with receipt of pricing approval in
[...***...] Major Countries [...***...], shall supercede the requirement to
obtain Regulatory Approval in [...***...] Major Countries [...***...].
If Regulatory Approval is obtained in [...***...] Major Countries [...***...]
(or through a single filing as set forth in the preceding paragraph) for any
other indication prior to obtaining Regulatory Approval for CHF, CRF and PAH,
then the milestone payable for each such other indication shall be [...***...],
provided that the maximum total milestone payments for obtaining [...***...]
Regulatory Approval for all indications shall not exceed [...***...].
CONFIDENTIAL TREATMENT REQUESTED
*** TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
THE MAXIMUM TOTAL MILESTONE PAYMENTS DUE XXXXXX IF ALL OF THE FOREGOING
MILESTONES ARE MET WILL TOTAL [...***...].
5.4 ROYALTY PAYMENTS.
(a) ROYALTY RATE AND ROYALTY PERIOD. Beginning with the First
Commercial Sale by Myogen, any Affiliates or sublicensees of Myogen, or any
contract sales force of Myogen or its Affiliates, Myogen shall pay to Xxxxxx a
royalty on annual aggregate worldwide Net Sales of all Product for all
Pharmaceutical Uses in accordance with the following schedule:
ANNUAL NET SALES ROYALTY
---------------- -------
[...***...] [...***...]
The obligation of Myogen to pay a full royalty to Xxxxxx shall be on a
country-by-country basis and shall continue with respect to Product manufactured
or sold in a country until such time as the last Patent included in the Xxxxxx
Technology covering such Product has expired and/or is invalidated in such
country such that none of the Product, its approved use, method of manufacture
or the sale thereof is covered by a Valid Claim ("ROYALTY PERIOD"). A given
Product shall not be considered "covered by a Valid Claim" such that a full
royalty shall be due on its Net Sales if none of the activities involved in the
manufacturing, marketing or use of that particular Product are subject to a
Valid Claim. For instance, if a given Product is sold into a country in which
there is no longer coverage of the indication or use for which it is sold by
Myogen, and neither the composition of that particular Product or Compound
included in that particular Product nor the method of manufacture of that
particular Product is subject to a Valid Claim in either the country of
manufacture or the country of sale, then the Net Sales of that particular
Product in that country shall not be subjected to a full royalty.
(b) REDUCED ROYALTY PERIOD. Upon the end of the Royalty Period
in any country of the Territory on a country-by-country basis, Myogen shall have
an exclusive, perpetual and irrevocable license under Xxxxxx'x Technology in
such country of the Territory, with all of the rights granted under Article 2
hereof, except that, for so long as Product continues to be sold in such country
by Myogen, Myogen shall pay to Xxxxxx a reduced royalty equal to [...***...] of
the royalty that would otherwise be due during the Royalty Period (the "REDUCED
ROYALTY PERIOD").
The royalty payable for the Reduced Royalty Period shall be calculated by
[...***...]
(c) ROYALTY REPORTS AND PAYMENTS. Beginning with the First
Commercial Sale anywhere in the Territory, within forty-five (45) days after the
end of each calendar quarter, Myogen shall prepare and deliver to Xxxxxx a
report detailing the calculation of Net Sales in the Territory, on a
country-by-country basis, for such just ended quarter along with the calculation
of royalties due thereon pursuant to Sections 5.4(a) and (b) above. Each report
shall be accompanied by full payment in U.S. dollars of the royalties shown
thereon to be due. In the event that conversion from foreign currency is
required in calculating a royalty payment hereunder, the exchange rate used
shall be the ratio in effect at the end of the last business day of the
applicable quarter for which royalties are calculated, as reported by The Wall
Street Journal, or a substantially similar global publication if The Wall Street
Journal is no longer published.
(d) BOOKS AND RECORDS/AUDIT RIGHTS. Myogen shall keep books
and records accurately showing all Products manufactured, used or sold under the
terms of this Agreement. The relevant portions of such books and records shall
be open to inspection by representatives of Xxxxxx, at Xxxxxx'x cost, solely for
the purposes of determining the correctness of the royalties payable under this
Agreement. Such audit, conducted no more than one time per calendar year, shall
be during normal business
CONFIDENTIAL TREATMENT REQUESTED
*** TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
hours after reasonable advance notice and subject to suitable confidentiality
provisions. In the event an audit shows a deficiency to be due, Myogen shall
immediately pay such deficiency along with the reasonable costs and expenses of
the audit if the deficiency is more than five percent (5%) of the amount due
during such audited period. If the audit shows that an excess was paid, Myogen
shall be entitled to deduct the amount of such excess from the payment due for
the next calendar quarter. Such books and records shall be preserved for a
period of at least three (3) years after the date of the royalty payment to
which they pertain, and no audit may be conducted with respect to royalties due
in any calendar year that is more than two (2) years preceding the calendar year
in which the audit is being conducted. Books and records for a given calendar
year may only be audited once.
(e) WITHHOLDING TAXES ON ROYALTIES. Where any sum due to be
paid to Xxxxxx hereunder is subject to any withholding or similar tax, the
parties shall use all reasonable efforts to do all such acts and things and to
sign all such documents as will enable them to take advantage of any applicable
double taxation agreement or treaty. In the event there is no applicable double
taxation agreement or treaty, or if an applicable double taxation agreement or
treaty reduces but does not eliminate such withholding or similar tax, Myogen
shall pay such withholding or similar tax to the appropriate government
authority, deduct the amount paid from the amount due Xxxxxx and secure and send
to Xxxxxx the best available evidence of such payment sufficient to enable
Xxxxxx to obtain a deduction for such withheld taxes or obtain a refund thereof.
6. REPRESENTATIONS/WARRANTIES.
6.1 REPRESENTATIONS AND WARRANTIES OF XXXXXX. Xxxxxx represents and
warrants that:
(a) it is duly organized, validly existing and in good
standing under the laws of Germany, that it has full corporate power and
authority to enter into this Agreement and to carry out its provisions, and that
there are no outstanding agreements, assignments or encumbrances in existence
that are inconsistent with the provisions of this Agreement;
(b) it is duly authorized to execute and deliver this
Agreement and to perform its obligations hereunder and that the execution,
delivery and performance of this Agreement by it does not require the consent,
approval or authorization of or notice, filing or registration with any
governmental agency or Regulatory Authority;
(c) as of the Effective Date, to the best of Xxxxxx'x
knowledge, (i) it has sufficient rights under the Xxxxxx Technology necessary to
grant the rights specified in this Agreement and to perform its obligations
hereunder; (ii) there are no claims,
CONFIDENTIAL TREATMENT REQUESTED
*** TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
judgments or settlements against or owed by it relating to the Xxxxxx
Technology; and (iii) the exercise of Myogen's rights to the Compound under this
Agreement or Myogen's use of the Xxxxxx Technology under this Agreement will not
infringe any intellectual property rights of a third party; and
(d) as of the Effective Date, to the best of Xxxxxx'x
knowledge, (i) none of the Patents are invalid or unenforceable, (ii) it has
complied in all material respects with all applicable laws and regulations in
connection with the preparation and submission of any filings with any
Regulatory Authority; (iii) it has filed with applicable Regulatory Authorities
all required and material notices, supplemental applications and annual or other
reports, including adverse experience reports, with respect to the Compound; and
(iv) there is no pending or overtly threatened action by the Regulatory
Authorities that will have a material adverse effect on the Regulatory Approval
of the Compound or any products.
6.2 REPRESENTATIONS AND WARRANTIES OF MYOGEN. Myogen represents and
warrants that it is duly organized, validly existing and in good standing under
the laws of Delaware, that it has full corporate power and authority to enter
into this Agreement and to carry out its provisions, and that there are no
outstanding agreements, assignments or encumbrances in existence that are
inconsistent with the provisions of this Agreement. Myogen further represents
and warrants that it is duly authorized to execute and deliver this Agreement
and to perform its obligations hereunder, and that the execution, delivery and
performance of this Agreement by it does not require the consent, approval or
authorization of or notice, filing or registration with any governmental agency
or Regulatory Authority.
6.3 INDEMNIFICATION BY MYOGEN. Myogen shall indemnify and hold Xxxxxx,
its Affiliates and their directors, officers, employees and agents harmless from
and against any and all liabilities, actions, suits, claims, demands,
prosecutions, damages, costs, expenses or money judgments finally awarded
(including reasonable legal fees) (collectively, "LIABILITIES") incurred by or
instituted or rendered against Xxxxxx to the extent such Liabilities result from
a third party claim arising from product liability claims or from the willful
misconduct or the negligent acts or omissions of Myogen or its Affiliates or
Myogen's material breach of this Agreement, except to the extent such third
party claims arise out of the negligence or willful misconduct of Xxxxxx, its
Affiliates and their directors, officers, employees and agents, or the material
breach of this Agreement or the Manufacturing Development and Supply Agreement
by Xxxxxx, its Affiliates and their directors, officers, employees and agents,
and provided that Xxxxxx gives Myogen prompt notice in writing of any such claim
or lawsuit and permits Myogen to undertake sole control of the defense and
settlement thereof at Myogen's expense. In any such claim or lawsuit:
CONFIDENTIAL TREATMENT REQUESTED
*** TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
(a) Xxxxxx will cooperate in the defense by providing access
to witnesses and evidence available to it. Xxxxxx shall have the right to
participate, at its expense, in any defense to the extent that in its reasonable
judgment Xxxxxx may be prejudiced by Myogen's sole defense thereof.
(b) With respect to this Agreement, Xxxxxx shall not settle,
offer to settle or admit liability in any claim or suit in which Xxxxxx intends
to seek indemnification by Myogen without the written consent of a duly
authorized officer of Myogen.
6.4 INDEMNIFICATION BY XXXXXX. Xxxxxx shall indemnify and hold Myogen,
its Affiliates and their directors, officers, employees and agents harmless from
and against any and all Liabilities, incurred by or instituted or rendered
against Myogen to the extent such Liabilities result from a third party claim
arising from the willful misconduct or the negligent acts or omissions of Xxxxxx
or its Affiliates or Xxxxxx'x material breach of this Agreement, except to the
extent such third party claims arise out of the negligence or willful misconduct
of Myogen, its Affiliates and their directors, officers, employees and agents,
or the material breach of this Agreement by Myogen, its Affiliates and their
directors, officers, employees and agents, and provided that Myogen gives Xxxxxx
prompt notice in writing of any such claim or lawsuit and permits Xxxxxx to
undertake sole control of the defense and settlement thereof at Xxxxxx'x
expense. In any such claim or lawsuit:
(a) Myogen will cooperate in the defense by providing access
to witnesses and evidence available to it. Myogen shall have the right to
participate, at its expense, in any defense to the extent that in its reasonable
judgment Myogen may be prejudiced by Xxxxxx'x sole defense thereof.
(b) With respect to this Agreement, Myogen shall not settle,
offer to settle or admit liability in any claim or suit in which Myogen intends
to seek indemnification by Xxxxxx without the written consent of a duly
authorized officer of Xxxxxx.
6.5 REPORTABLE OCCURRENCES. Each party warrants that it shall advise
the other promptly of any occurrence which is reported or reportable by it to
the Regulatory Authorities relating in any way to the Compound or the Product.
6.6 LIMITATION. EXCEPT FOR THE EXPRESS WARRANTIES IN THIS ARTICLE 6,
NEITHER PARTY MAKES ANY WARRANTIES, EXPRESS OR IMPLIED, IN FACT OR BY OPERATION
OF LAW, STATUTORY OR OTHERWISE. EACH PARTY SPECIFICALLY DISCLAIMS ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. EXCEPT FOR
VIOLATIONS OF ARTICLE 7 AND AMOUNTS
CONFIDENTIAL TREATMENT REQUESTED
*** TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
FINALLY AWARDED FOR INDEMNIFICATION FOR THIRD PARTY LIABILITIES UNDER SECTIONS
6.3 AND 6.4 ABOVE, NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY HERETO OR TO
ANY THIRD PARTY FOR ANY SPECIAL, CONSEQUENTIAL, EXEMPLARY OR INCIDENTAL DAMAGES
(INCLUDING LOST OR ANTICIPATED PROFITS RELATING TO THE SAME) ARISING FROM ANY
CLAIM RELATING TO THIS AGREEMENT, WHETHER SUCH CLAIM IS BASED ON CONTRACT, TORT
(INCLUDING NEGLIGENCE) OR OTHERWISE, EVEN IF AN AUTHORIZED REPRESENTATIVE OF
SUCH PARTY IS ADVISED OF THE POSSIBILITY OR LIKELIHOOD OF SAME.
7. CONFIDENTIALITY AND NON-DISCLOSURE.
7.1 NONDISCLOSURE. Neither party shall use or disclose any Confidential
Information received by it from the other party pursuant to this Agreement
without the prior written consent of the other. This obligation will continue
for a period of seven (7) years after termination of this Agreement or
expiration of the Term, whichever is earlier. Subject to the exception
immediately below, Xxxxxx shall hold in confidence and shall not directly or
indirectly disclose or provide to any third party information pertaining to the
Compound or Xxxxxx Technology without Myogen's prior written consent. The
parties recognize in Section 3.2 of this Agreement that Xxxxxx may be utilizing
Compound and Xxxxxx Technology in certain limited circumstances, including, but
not limited to, non-Pharmaceutical Uses and for internal research purposes.
Xxxxxx shall be permitted to disclose information pertaining to the Compound and
the Xxxxxx Technology in such circumstances only if the recipient of such
information is under a duty of confidentiality to Xxxxxx, and further, provided
that no such disclosure of such information shall be made for Pharmaceutical
Uses, nor shall Confidential Information of Myogen be disclosed.
7.2 RESTRICTION. Each party shall restrict dissemination of
Confidential Information to those of its employees, contractors, agents and
sublicensees (if any) who have an actual need to know and have a legal
obligation to protect the confidentiality of such Confidential Information. All
Confidential Information disclosed by one party to the other shall remain the
sole property of the disclosing party and neither party shall obtain any right
of any kind to the Confidential Information disclosed, except as granted under
this Agreement.
7.3 RESTRICTION EXEMPTIONS. Nothing contained in this Article 7 shall
be construed to restrict the parties from using or disclosing Confidential
Information solely to the extent and solely as required:
(a) for regulatory, tax or customs reasons;
CONFIDENTIAL TREATMENT REQUESTED
*** TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
(b) by court order or other governmental order or request. provided
in each case the party disclosing information promptly informs the other and
uses its best efforts to limit the disclosure and to maintain confidentiality to
the maximum extent possible and permits the other party to attempt by
appropriate legal means to limit such disclosure; or
(c) to perform acts permitted by this Agreement, including (i)
disclosure by Myogen to third parties undertaking feasibility and evaluation
studies, clinical trials and the like on behalf of Myogen, so long as such third
parties are under a legal obligation to Myogen to protect the confidentiality of
such Confidential Information, or (ii) disclosure by Myogen to sublicensees, so
long as such sublicensees are under a legal obligation to Myogen to protect the
confidentiality of such Confidential Information, or (iii) disclosure by Myogen
in connection with the marketing and commercial sale of Product, or (iv)
disclosure by Myogen to the extent required by law.
8. TERM AND TERMINATION.
8.1 This Agreement shall continue in effect unless and until terminated
as provided in this Section 8 or in Section 4.3(b). Upon the end of the Royalty
Period in any country of the Territory, Myogen shall have an exclusive,
perpetual and irrevocable license under Xxxxxx'x Technology, with all of the
rights granted under Article 2 hereof, and without any further obligation to
Xxxxxx, except for the payment obligations accruing prior to such date and the
indemnification obligations under Section 6.3, and except for any obligation to
pay [...***...], as provided in Section 5.4(b) hereof.
8.2 If Myogen determines in its reasonable scientific and commercial
judgment that the Compound does not have an acceptable profile or a reasonable
likelihood of commercial success, or that it is economically or technically
impractical for Myogen to continue developing and marketing the Product, Myogen
shall have the right to terminate this Agreement upon ninety (90) days written
notice, at the end of which the termination shall be effective. Upon such
termination, Myogen shall pay all payments and royalties which may have become
due prior to the effective date of such termination, and Myogen shall assign and
deliver, and Xxxxxx shall be entitled to retain for its own use, all studies and
information relating to the Compound and shall be granted a license to all
Improvements as set forth in Section 4.8 hereof.
8.3 Either party may terminate this Agreement by giving to the other
party prior written notice of not less than thirty (30) days in the case of a
monetary breach and of not less than ninety (90) days in the event the other
party shall commit a non-monetary material breach of this Agreement, and such
breaching party shall fail to cure, or commence action to cure, such breach
during such thirty (30) or ninety (90) day period, as applicable. In the case of
a non-monetary breach, the cure period may be extended for such longer period as
may reasonably be necessary if cure is not reasonably possible
CONFIDENTIAL TREATMENT REQUESTED
*** TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
within the initial ninety (90) day period, provided the breaching party
continues its diligent efforts to cure. No such cancellation and termination
shall release the breaching party from any obligations hereunder incurred prior
thereto. In the event of a dispute whether a material breach has occurred, the
existence of material breach shall be determined using the ADR procedure set
forth in Exhibit D. A party's right to terminate this Agreement shall only apply
if the breaching party fails to cure such breach in the manner required by the
final judgment of the ADR hearing. In the event that this Agreement is
terminated for Myogen's material breach, Xxxxxx shall be entitled to retain for
its own use all funds previously paid by Myogen, and Myogen shall assign and
deliver, and Xxxxxx shall be entitled to retain for its own use, all studies and
information relating to the Compound and Xxxxxx shall be granted a license to
all Improvements generated hereunder as set forth in Section 4.8 hereof. In the
event that this Agreement is terminated for Xxxxxx'x material breach, Myogen
shall not be liable for payments not yet due and payable under Article 5 hereof,
and Myogen shall be entitled to retain for its own use all studies, information
and Improvements generated hereunder and no license to Improvements shall be
granted to Abbott under Section 4.8 hereof.
8.4 Either party may terminate this Agreement on thirty (30) days
notice if the other party passes a resolution or the court makes an order for
its winding up; or has a receiver or administrator appointed over its business
or all of its assets; or is or becomes bankrupt; or ceases its business
operations. In the event that this Agreement is terminated under this Section
8.4, subject to the other terms of this Agreement, the terminating party shall
be entitled to the assignment and delivery of, and shall be entitled to retain
for its own use all studies, information and Improvements (subject to the
license set forth in Section 4.8 as it concerns Abbott) generated hereunder.
Notwithstanding the bankruptcy or insolvency of Abbott or the impairment of
performance by Abbott of its obligations under this Agreement as a result of
bankruptcy or insolvency of Abbott, Myogen shall be entitled to retain the
licenses granted herein, without any further obligation to Abbott other than the
payment obligations under Article 5.
8.5 Termination of this Agreement shall be without prejudice to any
rights of either party against the other which may have accrued up to the date
such termination becomes effective.
8.6 All causes of action accruing to either party under this Agreement
shall survive expiration or termination of this Agreement for any reason.
8.7 Upon any termination or expiration of this Agreement, each party
shall promptly return to the other party all written Confidential Information of
the other party, and all copies thereof (retaining one copy of the Confidential
Information of the other in its confidential files for archival purposes only),
which is not covered by a paid-up license or other rights specified herein
surviving such termination or expiration.
CONFIDENTIAL TREATMENT REQUESTED
*** TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
9. INFRINGEMENT OF PATENTS BY THIRD PARTY. In the event of an actual or
suspected infringement of a Patent by a third party, the following shall apply:
9.1 NOTICE. Each party shall give the other written notice if one of
them becomes aware of any infringement by a third party of any Patent. Upon
notice of any such infringement, the parties shall promptly consult with one
another with a view toward reaching agreement on a course of action to be
pursued.
9.2 XXXXXX'X RIGHT TO BRING INFRINGEMENT ACTION.
(a) ABBOTT ELECTION. If a third party infringes any Patent,
Abbott shall have the right, but not the obligation, to institute and prosecute
an action or proceeding to xxxxx such infringement and to resolve such matter by
settlement or otherwise.
(i) Abbott shall notify Myogen of its intention to
bring an action or proceeding prior to filing the same and in sufficient time to
allow Myogen the opportunity to discuss with Abbott the choice of counsel for
such matter. Abbott shall keep Myogen timely informed of material developments
in the prosecution or settlement of such action or proceeding. Abbott shall be
responsible for all fees and expenses of any action or proceeding against
infringers which Abbott initiates. Myogen shall cooperate fully [...***...] by
joining as a party plaintiff if reasonably requested to do so by Abbott, if
Myogen elects to join as a co-plaintiff or party plaintiff, or if required to do
so by law to maintain such action or proceeding and by executing and making
available such documents as Abbott may reasonably request. Myogen may be
represented by counsel in any such legal proceedings, [...***...].
(ii) If Abbott elects not to exercise such right, and
the parties disagree on the utility of bringing an action against an alleged
infringer, then the parties shall submit their disagreement to a mutually
agreeable third party attorney for resolution. If the third party attorney
decides that an action should be brought, then Abbott shall be obligated to
institute an action or proceeding in accordance with Section 9.2(a)(i) above. If
the third party attorney decides that an action should not be brought, then no
action shall be brought by either party unless Abbott later elects to institute
such an action or proceeding (or Abbott delegates such right to Myogen in
accordance with Section 9.2(a)(iii) below).
(iii) If Abbott so elects, Abbott may delegate to
Myogen the right to institute and prosecute an action or proceeding to xxxxx
such infringement and to resolve such matter by settlement or otherwise. Abbott
shall cooperate fully by joining as a party plaintiff if reasonably requested to
do so by Myogen or if required to do so by law to maintain such action and by
executing and making available such documents as Myogen may reasonably request.
Abbott may be represented by counsel in any such action, at its own expense.
CONFIDENTIAL TREATMENT REQUESTED
*** TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
(b) XXXXXX'X USE OF PROCEEDS. All amounts of every kind and
nature recovered from an action or proceeding of infringement brought by Abbott
shall belong to Abbott, and shall be used first to reimburse Abbott for its
documented and actual costs of prosecution, including attorneys' fees, expert
fees and all other related expenses, second to reimburse Myogen for its
documented and actual costs if it is represented by counsel in the proceeding.
The balance of the amount shall belong to Abbott if the amount awarded
represents a royalty, except to the extent that the royalty is in excess of the
royalty payable to Abbott under Section 5.4(a) hereof, in which case such excess
shall be split by the parties 50/50. Notwithstanding the foregoing, if the
balance of the amount awarded represents lost profits, and if Myogen joined as a
co-plaintiff or a party plaintiff to the action or proceeding of infringment
brought by Abbott pursuant to Section 9.2(a)(i) above, then Myogen shall be
entitled to the amount of damages allocated as lost profits, and the balance
shall belong to Abbott. Any exemplary or other damages awarded shall belong to
Abbott.
(c) MYOGEN'S USE OF PROCEEDS. All amounts of every kind and
nature recovered from an action or proceeding of infringement brought by Myogen
shall belong to Myogen, and shall first be used to reimburse Myogen for its
documented and actual costs of prosecution, second to reimburse Abbott for its
documented and actual costs if it is represented by counsel in the proceedings,
and the balance shall be considered Net Sales under this Agreement and subject
to royalty obligation under Section 5.4.
10. INFRINGEMENT OF THIRD PARTY RIGHTS; MYOGEN DEFENSE OF SUIT. If Abbott, its
Affiliates, Myogen, its Affiliates, sublicensees, distributors or other
customers are sued or threatened with suit by a third party alleging
infringement in one or more countries of the Territory of patents or other
intellectual property rights that are alleged to cover the manufacture, use,
sale, import, export or distribution of one or more Products, Abbott or Myogen,
whichever is relevant, will promptly notify the other in writing and provide a
copy of the lawsuit or claim. Myogen shall control the defense in any such claim
or suit. Myogen shall keep Abbott timely informed of material developments in
the defense of such claim or suit. If Myogen expends any amounts in connection
with any third party claim of infringement or misappropriation, or is required
to pay a royalty or other amount to a third party for the manufacture, use,
sale, import, export or distribution of one or more Products in the Territory as
a result of a final judgment or settlement, such amounts shall be fully
deductible by Myogen from the milestones and/or royalties payable and accruing
to Abbott thereafter under Section 5.4, but only where such claim, judgment or
settlement arises out of Myogen's practice of a Patent or use of the Abbott
Technology pursuant to the license granted under Article 2 of this Agreement.
Abbott shall fully cooperate with Myogen in the defense of any such action at
Xxxxxx'x expense. Myogen shall have the right to settle any such suit, including
the right to grant one or more sublicenses with Xxxxxx'x prior written approval,
which approval shall not unreasonably be withheld, provided that Myogen shall
not otherwise have the right to surrender, limit
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*** TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
or adversely affect any rights to the Patents. The terms of this Article 10
shall not apply to or affect Xxxxxx'x indemnity obligations for a breach of
Section 6.1(c).
11. PATENT PROSECUTION AND MAINTENANCE; PATENT COSTS; PATENT TERM EXTENSION.
11.1 DISCLOSURE OF PATENTS/APPLICATIONS TO MYOGEN. Within thirty (30)
days of Myogen's request, Abbott shall provide Myogen a list of Patents and
patent applications in a given Patent family. If, following Myogen's receipt of
such list(s), Myogen requests additional information, Abbott shall provide to
Myogen the complete text of, and all other information in its possession or
control directly related to (a) all patent applications included in the given
Patent family filed anywhere in the Territory; and (b) all patents included in
the given Patent family as well as all information in Xxxxxx'x, its Affiliates
and its patent counsel's possession concerning the institution or possible
institution of any interference, opposition, reexamination, reissue, revocation,
nullification or any official proceeding involving an issued patent included in
the given Patent family anywhere in the Territory.
11.2 PROSECUTION AND MAINTENANCE. Abbott shall be solely responsible
for the preparation, filing, prosecution and maintenance of the Patents (except
for the case family including [...***...] which is the responsibility of BASF
AG) in Xxxxxx'x name, including oppositions and interferences, subject to
Myogen's right to assume such duties in the event Abbott reasonably fails to
adequately prepare, file, prosecute and maintain the Patents. Abbott and Myogen
shall consult and cooperate with each other, and Abbott shall keep Myogen
reasonably informed with respect to the prosecution and maintenance of the
Patents hereunder, including the case family which is the responsibility of BASF
AG. In this regard Abbott shall exercise its rights under its license from BASF
AG for these patent rights such that Myogen shall have the opportunity to
participate in the preservation of these patent rights if it chooses to do so.
Abbott will provide Myogen with copies of all material documents received or
prepared by Abbott in the prosecution and maintenance of the Patents. Abbott
shall provide copies in a timely manner to allow Myogen an opportunity, if it so
elects, to review and comment on Xxxxxx'x proposed patent strategy. Inasmuch as
the Patents cover other compounds not licensed to Myogen hereunder, Abbott
warrants that it will not take any action with respect to the Patents which
would have a material adverse effect on the patent coverage of the Compound.
11.3 PATENT EXTENSIONS. Abbott shall have the right and sole
responsibility for obtaining patent term extensions under the provisions of 35
USC Paragraph 156 for any U.S. Patent and for non-U.S. Patents under similar
provisions of law of other countries involving a Product which has obtained
Regulatory Approval. Myogen shall cooperate with Abbott and provide Abbott with
all necessary information to obtain such extensions.
12. TRADEMARK. Myogen may select any Trademark or Trademarks for the Product in
the Territory. All costs related to the selection and maintenance of the
Trademark(s)
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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
shall be borne by Myogen. The Trademark(s) shall be owned by Myogen, and Abbott
shall have no claims or rights in or to the Trademark(s), except such right as
may be necessary for Abbott to commercialize Product following a termination
under Sections 8.2, 8.3 or 8.4 above.
13. IMPROVEMENTS. All Improvements made solely by Myogen and/or its Affiliates
hereunder shall be the sole and exclusive property of Myogen. All Improvements
made solely by Abbott and/or its Affiliates shall become part of Xxxxxx'x
Technology, subject to the license to Myogen set forth in Article 2 hereof. All
Improvements made jointly by employees or others acting on behalf of Abbott and
Myogen (or their Affiliates) hereunder shall be jointly owned by Abbott and
Myogen, without a duty of accounting to the other, to the extent such
individuals would be considered "joint inventors" within the meaning of the U.S.
patent laws. Each party shall take all necessary actions, including executing
documents of assignment, to vest title to all jointly owned Improvements
(including all intellectual property rights therein) with both parties. With
respect to patents resulting from Improvements made jointly by the parties, the
parties shall select a mutually agreeable third party attorney to prepare, file,
prosecute and maintain such patents. The third party attorney shall consult and
apprise each party equally and both parties shall share 50/50 the costs and fees
of employing such third party attorney. Xxxxxx'x interest in such Improvements
shall be subject to the license granted to Myogen under Article 2 hereof and
subject to the terms and conditions of this Agreement. The provisions of this
Article 13 are subject to the rights of the terminating party under Article 8
hereof.
14. MISCELLANEOUS.
14.1 FORCE MAJEURE. If the performance by either party of any of its
obligations under this Agreement shall be prevented by circumstances beyond its
reasonable control which could not have been avoided by the exercise of
reasonable diligence, then such party shall be excused from the performance of
that obligation for the duration of the event. The affected party shall promptly
notify the other party in writing should such circumstances arise, give an
indication of the likely extent and duration thereof, and shall use commercially
reasonable efforts to resume performance of its obligations as soon as
practicable.
14.2 NOTICES. Any notice required to be given or made under this
Agreement by one of the parties hereto to the other shall be in writing, by
personal delivery, registered U.S. mail or overnight courier, addressed to such
other party at its address indicated below, or to such other address as the
addressee shall have last furnished in writing to the addressor and shall be
effective upon the date of receipt.
If to Myogen: Myogen, Inc.
0000 X. 000xx Xxxxxx
Xxxxxxxxxxx, XX 00000-0000
Attn: President
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UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
With a copy to: Xxxxxx Godward LLP
000 Xxxxxxxxxxx Xxxxxxxx
Xxxxx 000
Xxxxxxxxxx, XX 00000-0000
Attn: Xxxxxx X. XxXxxx, Esq.
If to Xxxxxx: Xxxxxx Laboratories
000 Xxxxxx Xxxx Xxxx
Xxxx. 309; Bldg. AP30
Xxxxxx Park, IL 60064-3537
Attn: Senior Vice President,
Pharmaceutical Operations
With a copy to: Xxxxxx Laboratories
000 Xxxxxx Xxxx Xxxx
Xxxx. 364; Bldg. AP6D
Xxxxxx Xxxx, XX 00000-0000
Attn: Senior Vice President,
Secretary and General Counsel
14.3 APPLICABLE LAW/COMPLIANCE. This Agreement shall be governed by and
construed in accordance with the laws of the State of
Illinois, excluding its
conflict of laws provision. Each party hereto shall comply with all applicable
laws, rules, ordinances, guidelines, consent decrees and regulations of any
federal, state or other governmental authority.
14.4 ENTIRE AGREEMENT. This Agreement and the attachments (Exhibits)
contain the entire understanding of the parties with respect to the subject
matter hereof. All express or implied agreements and understandings, either oral
or written, heretofore made are expressly merged in and made a part of this
Agreement. This Agreement may be amended, or any term hereof modified, only by a
written instrument duly executed by both parties hereto. The Heads of Agreement
between Myogen and Xxxxx XX (predecessor in interest to Abbott) dated November
14, 2000, is hereby terminated upon mutual execution of this Agreement.
14.5 COUNTERPARTS. This Agreement may be executed in two or more
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
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UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
14.6 SEVERABILITY/HEADINGS. If any provision of this Agreement is
deemed unenforceable, the remainder of the Agreement will not be affected and,
if appropriate, the parties will attempt to replace the unenforceable provision
with a new provision that, to the extent possible, reflects the parties'
original intent. The captions and headings used in this Agreement are for
reference only and are not to be construed in any way as terms or used to
interpret the provisions of this Agreement.
14.7 ASSIGNMENT. Neither party may without written approval of the
other assign this Agreement or transfer its interest or any part thereof under
this Agreement to any third party except that (i) either party may assign this
Agreement without consent to a third party that acquires all or substantially
all of the business to which this Agreement pertains, or, (ii) either party may
assign this Agreement in whole or part to any Affiliate of that party and such
party hereby guarantees the performance by such Affiliate.
14.8 DISPUTE RESOLUTION. The parties hereto shall attempt to settle any
dispute arising out of or relating to this Agreement in an amicable way. Except
for claims for injunctive or other equitable relief, which may be brought in any
court of competent jurisdiction, any controversy, claim or right of termination
for cause which may arise under, out of, in connection with, or relating to this
Agreement, or any breach thereof, shall be settled according to the Alternative
Dispute Resolution provisions attached hereto as Exhibit D.
14.9 INDEPENDENT CONTRACTOR. It is understood that both parties hereto
are independent contractors and engage in the operation of their own respective
businesses and neither party hereto is to be considered the agent of the other
party for any purpose whatsoever and neither party has any authority to enter
into any contract or assume any obligation for the other party or to make any
warranty or representation on behalf of the other party. Each party shall be
fully responsible for its own employees, servants and agents, and the employees,
servants and agents of one party shall not be deemed to be employees, servants
and agents of the other party for any purpose whatsoever.
14.10 PUBLICITY. No press release or other public announcement shall be
made by either party concerning the execution of this Agreement or the fact that
Myogen has licensed the Compound from Abbott, without the prior written consent
of the non-disclosing party, which consent may be withheld in the non-disclosing
party's sole discretion. Neither party shall use the name of the other party,
its officers, employees or agents for purposes of any public commercial activity
without the other party's prior written consent, except where the name of the
other party must be disclosed as a matter of law. Should either party wish to
make a disclosure or be required by law to make a disclosure, the disclosing
party shall submit a copy of the proposed disclosure to the other party for
review. The non-disclosing party shall have three (3) weeks to review and
comment on the content of such disclosure. In the case of a disclosure required
by law, the disclosing party, subject to legal requirements, shall use all
reasonable efforts to
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UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
accommodate the non-disclosing party's comments. For non-routine matters like an
emergency, special circumstance, or other situation where the law compels a
disclosure in less than three (3) week's time, the non-disclosing party agrees
to use commercially reasonable efforts to provide its review and comment in
order to meet the disclosing party's timetable.
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CONFIDENTIAL TREATMENT REQUESTED
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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as
of the Effective Date.
XXXXXX DEUTSCHLAND MYOGEN, INC.
HOLDING GmbH
By: /s/ Xxxxxxxx Xxxxxxxx By: /s/ J. Xxxxxxx Xxxxxxx
--------------------------- --------------------------
Name: Xxxxxxxx Xxxxxxxx Name: J. Xxxxxxx Xxxxxxx
--------------------------- --------------------------
Its: General Manager Its: President
--------------------------- --------------------------
CONFIDENTIAL TREATMENT REQUESTED
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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
EXHIBIT A
TO
EXCLUSIVE
LICENSE AGREEMENT
BETWEEN
XXXXXX LABORATORIES
AND
MYOGEN, INC.
DATED OCTOBER ____, 2001
Patents and Patent Applications
NO. PRIORITY DATE WO NUMBER IN-HOUSE NO. TITLE
--- ------------- -------------- ------------ -----
1 23.04.93 WO 94/25442 43997 3-Het-Arylcarbonsaure-derivate
2 31.03.94 WO 95/26716 44751 Verwendung von
Carbonsaurederivaten als
Arzneimittel
3 14.10.94 WO 96/11914 45281 Neue Carbonsaurederivate
4 26.09.97 WO 99/16445 480/1171 Combination of ETRAs plus
RAS-inhibitors
5 30.09.97 WO 99/16446 480/1172 Combination of ETRAs plus
calcium antagonists
6 19.12.96 Germany 480/1174 Combination of ETRAs plus
vasodilators
7 30.09.97 WO 99/16444 480/1175 Combination of ETRAs plus
beta-blockers
8 02.10.97 WO 99/17756 480/1176 Use of ETRAs to inhibit organ
transplant rejections
9 05.12.97 WO 99/29308 480/1181 Use of ETRAs to inhibit
obesity
10 30.10.98 WO 2000/026170 00000 Xxxxxxxxx xxx Racematspaltung
11 20.01.00 51096 Enantioselective Synthesevon
ETRAs
12 19.09.00 51748 Combination of ETRAs plus
aVb3 zur Behandlung von
Restenosis
CONFIDENTIAL TREATMENT REQUESTED
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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
EXHIBIT B
TO
EXCLUSIVE
LICENSE AGREEMENT
BETWEEN
XXXXXX LABORATORIES
AND
MYOGEN, INC.
DATED OCTOBER ____, 2001
WORK PLAN
[...***...]
CONFIDENTIAL TREATMENT REQUESTED
*** TEXT OMITTED AND FILED SEPARATELY
CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
EXHIBIT C
TO
EXCLUSIVE
LICENSE AGREEMENT
BETWEEN
XXXXXX LABORATORIES
AND
MYOGEN, INC.
DATED __________, 2001
FEASIBILITY AND EVALUATION STUDIES TO BE PERFORMED BY XXXXXX LABORATORIES
STUDY STATUS START DATE TARGET COMPLETION ESTIMATED COST*
----- ------ ---------- ----------------- ---------------
[...***...]
CONFIDENTIAL TREATMENT REQUESTED
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CONFIDENTIAL TREATMENT REQUESTED
UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
EXHIBIT D
TO
EXCLUSIVE
LICENSE AGREEMENT
BETWEEN
XXXXXX LABORATORIES
AND
MYOGEN, INC.
DATED OCTOBER ____, 2001
ALTERNATIVE DISPUTE RESOLUTION
The parties recognize that from time to time a dispute may arise
relating to either party's right or obligations under this Agreement. The
parties agree that any such dispute shall be resolved by the Alternative Dispute
Resolution ("ADR") provisions set forth in this Exhibit, the result of which
shall be binding upon the parties.
To begin the ADR process, a party first must send written notice of the
dispute to the other party for attempted resolution by good faith negotiations
between their respective presidents (or their designees) of the affected
subsidiaries, divisions, or business units within twenty-eight (28) days after
such notice is received (all references to "days" in this ADR provision are to
calendar days). If the matter has not been resolved within twenty-eight (28)
days of the notice of dispute, or if the parties fail to meet within such
twenty-eight (28) days, either party may initiate an ADR proceeding as provided
herein. The parties shall have the right to be represented by counsel in such a
proceeding.
1. To begin an ADR proceeding, a party shall provide written notice to the
other party of the issues to be resolved by ADR. Within fourteen (14)
days after its receipt of such notice, the other party may, by written
notice to the party initiating the ADR, add additional issues to be
resolved within the same ADR.
2. Within twenty-one (21) days following receipt of the original ADR
notice, the parties shall select a mutually acceptable neutral to
preside in the resolution of any disputes in this ADR proceeding. If
the parties are unable to agree on a mutually acceptable neutral within
such period, either party may request the President of the CPR
Institute for Dispute Resolution ("CPR"), 000 Xxxxxxx Xxxxxx, 00xx
Xxxxx, Xxx Xxxx, Xxx Xxxx 00000, to select a neutral pursuant to the
following procedures:
(a) The CPR shall submit to the parties a list of not less than
five (5) candidates within fourteen (14) days after receipt of
the request, along with a Curriculum Vitae for each candidate.
No candidate shall be an
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UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
employee, director, or shareholder of either party or any of
their subsidiaries or affiliates.
(b) Such list shall include a statement of disclosure by each
candidate of any circumstances likely to affect his or her
impartiality.
(c) Each party shall number the candidates in order of preference
(with the number one (1) signifying the greatest preference)
and shall deliver the list to the CPR within seven (7) days
following receipt of the list of candidates. If a party
believes a conflict of interest exists regarding any of the
candidates, that party shall provide a written explanation of
the conflict to the CPR along with its list showing its order
of preference for the candidates. Any party failing to return
a list of preferences on time shall be deemed to have no order
of preference.
(d) If the parties collectively have identified fewer than three
(3) candidates deemed to have conflicts, the CPR immediately
shall designate as the neutral the candidate for whom the
parties collectively have indicated the greatest preference.
If a tie should result between two candidates, the CPR may
designate either candidate. If the parties collectively have
identified three (3) or more candidates deemed to have
conflicts, the CPR shall review the explanations regarding
conflicts and, in its sole discretion, may either (i)
immediately designate as the neutral the candidate for whom
the parties collectively have indicated the greatest
preference, or (ii) issue a new list of not less than five (5)
candidates, in which case the procedures set forth in
subparagraphs 2(a) - 2(d) shall be repeated.
3. No earlier than twenty-eight (28) days or later than fifty-six (56)
days after selection, the neutral shall hold a hearing to resolve each
of the issues identified by the parties. The ADR proceeding shall take
place at a location agreed upon by the parties. If the parties cannot
agree, the neutral shall designate a location other than the principal
place of business of either party or any of their subsidiaries or
affiliates.
4. At least seven (7) days prior to the hearing, each party shall submit
the following to the other party and the neutral:
(a) a copy of all exhibits on which such party intends to rely in
any oral or written presentations to the neutral;
(b) a list of any witnesses such party intends to call at the
hearing, and a short summary of the anticipated testimony of
each witness;
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UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
(c) a proposed ruling on each issue to be resolved, together with
a request for a specific damage aware or other remedy for each
issue. The proposed rulings and remedies shall not contain any
recitation of the facts or any legal arguments and shall not
exceed one (1) page per issue.
(d) a brief in support of such party's proposed rulings and
remedies, provided that the brief shall not exceed twenty (20)
pages. This page limitation shall apply regardless of the
number of issues raised in the ADR proceeding.
Except as expressly set forth in subparagraphs 4(a) - 4(d), no
discovery shall be required or permitted by any means, including
depositions, interrogatories, requests for admissions, or production of
documents.
5. The hearing shall be conducted on two (2) consecutive days and shall be
governed by the following rules:
(a) Each party shall be entitled to five (5) hours of hearing time
to present its case. The neutral shall determine whether each
party has had the five (5) hours to which it is entitled.
(b) Each party shall be entitled, but not required, to make an
opening statement, to present regular and rebuttal testimony,
documents or other evidence, to cross-examine witnesses, and
to make a closing argument. Cross-examination of witnesses
shall occur immediately after their direct testimony, and
cross-examination time shall be charged against the party
conducting the cross-examination.
(c) The party initiating the ADR shall begin the hearing and, if
it chooses to make an opening statement, shall address not
only issues it raised but also any issues raised by the
responding party. The responding party, if it chooses to make
an opening statement, also shall address all issues raised in
the ADR. Thereafter, the presentation of regular and rebuttal
testimony and documents, other evidence, and closing arguments
shall proceed in the same sequence.
(d) Except when testifying, witnesses shall be excluded from the
hearing until closing arguments.
(e) Settlement negotiations, including any statements made
therein, shall not be admissible under any circumstances.
Affidavits prepared for purposes of the ADR hearing also shall
not be admissible. As to all other matters,
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UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
the neutral shall have sole discretion regarding the
admissibility of any evidence.
6. Within seven (7) days following completion of the hearing, each party
may submit to the other party and the neutral a post-hearing brief in
support of its proposed rulings and remedies, provided that such brief
shall not contain or discuss any new evidence and shall not exceed ten
(10) pages. This page limitation shall apply regardless of the number
of issues raised in the ADR proceeding.
7. The neutral shall rule on each disputed issue within fourteen (14) days
following completion of the hearing. Such ruling shall adopt in its
entirety the proposed ruling and remedy of one of the parties on each
disputed issue but may adopt one party's proposed rulings and remedies
on some issues and the other party's proposed rulings and remedies on
other issues. The neutral shall not issue any written opinion or
otherwise explain the basis of the ruling.
8. The neutral shall be paid a reasonable fee plus expenses. These fees
and expenses, along with the reasonable legal fees and expenses of the
prevailing party (including all expert witness fees and expenses), the
fees and expenses of a court reporter, and any expenses for a hearing
room, shall be paid as follows:
(a) If the neutral rules in favor of one party on all disputed
issues in the ADR, the losing party shall pay 100% of such
fees and expenses.
(b) If the neutral rules in favor of one party on some issues and
the other party on other issues, the neutral shall issue with
the rulings a written determination as to how such fees and
expenses shall be allocated between the parties. The neutral
shall allocate fees and expenses in a way that bears a
reasonable relationship to the outcome of the ADR, with the
party prevailing on more issues, or on issues of greater value
or gravity, recovering a relatively larger share of its legal
fees and expenses.
9. The rulings of the neutral and the allocation of fees and expenses
shall be binding, non-reviewable, and non-appealable, and may be
entered as a final judgment in any court having jurisdiction.
10. Except as provided in paragraph 9 or as required by law, the existence
of the dispute, any settlement negotiations, the ADR hearing, any
submissions (including exhibits, testimony, proposed rulings, and
briefs), and the rulings shall be deemed Confidential Information. The
neutral shall have the authority to impose sanctions for unauthorized
disclosure of Confidential Information.
CONFIDENTIAL TREATMENT REQUESTED
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UNDER 17 C.F.R. SECTIONS 200.80(b)(4)
AND 230.406
EXHIBIT E
TO
EXCLUSIVE
LICENSE AGREEMENT
BETWEEN
XXXXXX LABORATORIES
AND
MYOGEN, INC.
DATED OCTOBER ____, 2001
PRODUCT AND MATCHED PLACEBOS REQUIRED FOR AMBRISENTAN PHASE II CLINICAL TRIALS
[...***...]
CONFIDENTIAL TREATMENT REQUESTED