SALE AND
SUBLICENSE AGREEMENT
BY AND AMONG
MYOGEN, INC.,
WULFING HOLDING GMBH,
WULFING PHARMA GMBH
AND
MYOGEN GMBH
EFFECTIVE AS OF JANUARY 1, 2006
SALE AND SUBLICENSE AGREEMENT
This SALE AND SUBLICENSE AGREEMENT (the "AGREEMENT") executed as of this
27th day of January, 2006 ("EXECUTION DATE") and effective as of the 1st day of
January, 2006 (the "EFFECTIVE DATE"), by and among MYOGEN, INC., a corporation
organized and governed under the laws of Delaware, United States of America
("MYOGEN"), WULFING HOLDING GMBH, a corporation organized and governed under the
laws of the Federal Republic of Germany ("SUBLICENSEE"), WULFING PHARMA GMBH, a
corporation organized and governed under the laws of the Federal Republic of
Germany ("PHARMA") and MYOGEN GMBH, a corporation organized and governed under
the laws of the Federal Republic of Germany and, following the Stock Sale (as
defined below), a wholly-owned subsidiary of Sublicensee ("SUBSIDIARY" and
together with Pharma, the "GUARANTORS"). Myogen, Sublicensee and Guarantors are
sometimes referred to herein individually as a "PARTY" and together as the
"PARTIES."
WHEREAS, Myogen is a biotechnology company that has expertise and
experience in the research and development of compounds for use in treating
cardiovascular disease;
WHEREAS, Myogen has obtained from Sanofi-Aventis ("SANOFI-AVENTIS"), under
the terms of the License Agreement (as defined below), (a) an exclusive
worldwide license under Sanofi-Aventis' patents and know-how to develop and
commercialize Enoximone (as defined below) and (b) all of Sanofi-Aventis' rights
under certain existing trademarks relating to Enoximone in several countries
around the world;
WHEREAS, Sublicensee wishes to acquire Myogen's rights to commercialize and
sell the Product and in connection therewith Myogen and Sublicensee have entered
into that certain Stock Purchase Agreement effective as of January 1, 2006 (the
"PURCHASE AGREEMENT") which contemplates the purchase by Sublicensee of all of
the outstanding capital stock of Myogen GmbH, Myogen's wholly-owned subsidiary
(the "STOCK SALE"); and
WHEREAS, the consummation of the Stock Sale is conditioned upon the
execution and delivery of this Agreement and the grant of the sublicense to
Sublicensee as contemplated herein;
NOW, THEREFORE, in consideration of the foregoing premises and the mutual
covenants and agreements contained herein, the Parties agree as follows:
ARTICLE 1
DEFINITIONS
For purposes of this Agreement, the terms defined in this Article 1 has the
meanings specified below:
1.1 "ADR" has the meaning set forth in Article 11.3.
1.2 "AFFILIATE" means any corporation, firm, partnership or other entity,
whether de jure or de facto, which directly or indirectly owns, is owned or is
under common ownership with a Party to this Agreement to the extent 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
1.
particular jurisdiction) having the power to direct the affairs of the entity
and any person, firm, partnership, corporation or other entity actually
controlled by, controlling or under common control with a Party to this
Agreement. This term does not include those individuals or entities who have
made an equity investment in a Party but who have no significant operational
management with respect to the Party.
1.3 "AUTHORITY" means the United States Food and Drug Administration or any
other equivalent regulatory authority in the Territory, including, without
limitation, the European Medicines Agency (EMEA).
1.4 "BULK ENOXIMONE" mean approximately three hundred (300) kilograms of
bulk Enoximone drug substance in Myogen's existing inventory.
1.5 "COMMERCIALIZATION" or "COMMERCIALIZE" means activities directed to
obtaining pricing and reimbursement approvals, marketing, promoting,
distributing, using, importing, exporting or selling the Product.
Commercialization will not include any activities related to Manufacturing.
1.6 "COMPETITIVE PRODUCT INFRINGEMENT" has the meaning set forth in Article
6.5.1.
1.7 "CONTROL" means possession of the ability to grant a license or
sublicense as provided for herein without violating the terms of any agreement
or other arrangement with or proprietary rights of any Third Party.
1.8 "DRUG APPROVAL APPLICATION" means an application for Regulatory
Approval required before commercial sale or use of a Product as a drug in a
country in the Territory.
1.9 "ENOXIMONE" means 1,3-dihydro-4-methyl-5-[4-(methythio)-benzoyl]-2H-
imidazol-2-one, and all pharmaceutically-acceptable forms (e.g., salts) and all
formulations thereof.
1.10 "ENOXIMONE STARTER MATERIAL" means approximately five hundred (500)
kilograms of each Enoximone starter material (MIA, MTBA) in Myogen's existing
inventory.
1.11 "EUROPE" means, for the purposes of this Agreement, Austria, Belgium,
Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg,
Netherlands, Portugal, Spain, Sweden, and the United Kingdom.
1.12 "EUROPEAN RIGHTS" has the meaning set forth in Article 9.2.
1.13 "FIELD" means the prevention, treatment and/or diagnosis of
cardiovascular diseases and disorders.
1.14 "FINISHED PRODUCT" means that Product in finished saleable form in
Myogen's existing inventory.
1.15 "INFORMATION" means techniques and data including inventions,
practices, methods, assays, knowledge, know-how, skill, experience, marketing,
pricing, distribution, cost,
2.
sales and manufacturing information and test data including pharmacological,
pharmacokinetic, toxicological and clinical data, analytical and quality control
data, stability and integrity data, formulation data, quality control data, and
safety and efficacy data.
1.16 "LIABILITIES" has the meaning set forth in Article 4.7.
1.17 "LICENSE AGREEMENT" means that certain License Agreement, effective as
of October 1, 1998, by and between Hoechst Xxxxxx Xxxxxxx, Inc. ("HMR") and
Myogen as amended by that certain First Amendment to the License Agreement,
effective as of November 23, 1999, by and between HMR and Myogen, that certain
Second Amendment to the License Agreement, effective as of June 2, 2003, by and
between Aventis Pharmaceuticals, Inc. (formerly HMR) ("AVENTIS") and Myogen and
that certain Third Amendment to the License Agreement, dated January 27, 2005,
by and between Aventis (now Sanofi-Aventis) and Myogen as the same may be
further amended from time to time and under which Myogen obtained from
Sanofi-Aventis the exclusive worldwide right to develop and commercialize
Enoximone in the Field.
1.18 "LOSSES" has the meaning set forth in Article 10.1.1.
1.19 "MANUFACTURING" or "MANUFACTURE" means all the activities relating to
production of Product, including without limitation, purchasing raw materials,
quality control and assurance, filling, finishing, labeling, packaging,
qualified person release, holding, shipping, transport and storage and the tests
and analyses conducted in connection therewith. Manufacturing excludes
activities relating to Commercialization.
1.20 "MATERIAL BREACH" has the meaning set forth in Article 9.3.4.
1.21 "MYOGEN DATA" means all Information related to the Product Myogen or
any of its Affiliates has in its possession arising out of all pre-clinical and
clinical research and development conducted by or on behalf of Myogen or its
Affiliates or disclosed Myogen to or its Affiliates by licensors and other
collaborators to the extent not subject to a restrictive confidentiality
arrangement with a Third Party.
1.22 "MYOGEN INDEMNIFIED PARTIES" has the meaning set forth in Article
10.2.1.
1.23 "MYOGEN KNOW-HOW" means Information related to the Product which (i)
Myogen discloses, or is required to disclose, to Sublicensee under this
Agreement and (ii) is within the Control of Myogen and its Affiliates, including
any HMR Know-How (as defined in the License Agreement) which Myogen or its
Affiliates Control pursuant to the License Agreement.
1.24 "NET SALES" means Sublicensee's and/or its Affiliates' and/or all of
its permitted Third Party Sublicensees' gross sales of Products less the sum of
the following, to the extent each is actually incurred and included in the
invoice price and does not exceed the reasonable and customary amount for such
item in the market in which such sales occurred:
(A) discounts, rebates and similar amounts;
3.
(B) sales, tariff duties and/or use taxes directly imposed and
with reference to particular sales;
(C) outbound transportation including packaging, handling and
insurance prepaid or allowed; and
(D) amounts allowed or credited on returns.
No deductions shall be made for commissions paid to individuals
whether they be with independent sales agencies or regularly employed by
Sublicensee and on its payroll, or for cost of collections. Products shall be
considered "sold" when billed out or invoiced. In the event that the sale is
made to an Affiliate, the Net Sale will not be less than an equivalent sale to a
non-Affiliate.
1.25 "PAYMENTS" shall mean those payments from Sublicensee to Myogen set
forth in Article 4.1.
1.26 "PRODUCT" means that intravenous formulation of Enoximone for use in
the Field marketed under the Trademarks.
1.27 "REASONABLE DILIGENCE" shall mean commercially reasonable efforts, as
applicable, to conduct activities relating to the Product in the various
countries in the Territory, consistent with accepted business practices and
legal requirements, and comparable to efforts in the pharmaceutical industry
applicable to the particular activity relating to human pharmaceutical products
at an equivalent stage of development and similar market potential, profit
potential and strategic value in view of conditions then prevailing.
1.28 "REGULATORY APPROVAL" means any approval (including pricing and
reimbursement approvals), product and/or establishment license, registration or
authorization of any Authority or other federal, state or local regulatory
agency, department, bureau or other governmental entity necessary for the
Manufacture and Commercialization of the Product in the Territory.
1.29 "REGULATORY EXPENSES" shall mean any and all expenses, costs and
expenses incurred in obtaining and maintaining Regulatory Approval for the
Product, which expenses are attributable to the Product for use in the Field in
the Territory.
1.30 "REGULATORY FILINGS" shall have the meaning set forth in Article
3.2.2.
1.31 "S-A TERMINATION NOTICE" has the meaning set forth in Article 9.2.
1.32 "SUBLICENSEE DATA" means all Information arising out of all activities
conducted by or on behalf of Sublicensee or its sublicensees, or disclosed to
Sublicensee by its licensors and other collaborators necessary to obtain
Regulatory Approval for marketing of Products in the Territory.
1.33 "SUBLICENSEE INDEMNIFIED PARTIES" has the meaning set forth in Article
10.1.1.
4.
1.34 "SUBLICENSEE KNOW-HOW" means Information related to the Product which
(i) Sublicensee discloses, or is required to disclose, to Myogen under this
Agreement and (ii) is within the Control of Sublicensee, including, without
limitation, all Information developed by or on behalf of Sublicensee relating to
the Product.
1.35 "SUBLICENSEE PATENT" means any and all Patents for inventions made by
Sublicensee personnel on behalf of Sublicensee or its Affiliates which covers
the evaluation, manufacture, use, importation, offer for sale and/or sale of
Enoximone for development by Sublicensee within the Field or Product, which
Patent is owned or Controlled by Sublicensee or its Affiliates.
1.36 "TERM" has the meaning set forth in Article 9.1.
1.37 "TERMINATION EFFECTIVE DATE" has the meaning set forth in Article 9.2.
1.38 "TERRITORY" means the world other than the United States and Canada,
subject to Article 9.2.
1.39 "THIRD PARTY" means any entity other than Myogen or Sublicensee or
their respective Affiliates.
1.40 "THIRD PARTY SUBLICENSEE" has the meaning set forth in Article 2.3.
1.41 "TRADEMARKS" means the trademarks used in connection with the Product
in the Territory as set forth in SCHEDULE 1.41.
1.42 "TRADEMARK COSTS" means the fees and expenses paid to outside counsel
and other Third Parties, direct costs of in-house counsel and filing and
maintenance expenses, incurred in connection with the establishment and
maintenance of rights under the Trademarks applicable to Product in the
Territory, including costs of filing and registration fees, and actions to
enforce or maintain a trademark and other proceedings.
1.43 "TRADEMARK INFRINGEMENT CLAIMS" has the meaning set forth in Article
6.6.1.
1.44 "TRANSITION SERVICES" means Myogen data retrieval at Myogen
facilities, consultation services, transition services and Commercialization
assistance related to the Products.
ARTICLE 2
LICENSE GRANTS & REGULATORY MATTERS
2.1 KNOW-HOW LICENSE TO SUBLICENSEE FOR COMMERCIALIZATION. Upon the terms
and subject to the conditions of this Agreement and the License Agreement,
including, without limitation, the payment obligations herein, Myogen grants to
Sublicensee an exclusive (even as to Myogen and its Affiliates) license under
the Myogen Know-How to conduct Manufacturing, pre-marketing activities,
Commercialization (including the right to make, have made (subject to Article
2.3), use, import (subject to Article 2.3), sell, offer for sale and have sold)
and related
5.
activities in the Territory with respect to the Product in accordance with the
terms of this Agreement.
2.2 KNOW-HOW LICENSE TO CONDUCT REGULATORY APPROVALS. Upon the terms and
subject to the conditions of this Agreement and the License Agreement,
including, without limitation, the payment obligations herein, Myogen grants to
Sublicensee an exclusive license (even as to Myogen and its Affiliates) under
the Myogen Know-How to conduct the Regulatory Approvals in the Territory in
accordance with the terms of this Agreement with respect to the Product for use
in the Field.
2.3 THIRD PARTY SUBLICENSEES. The licenses set forth in Article 2.1 and
Article 2.2 shall include the right to sublicense to Third Party Sublicensees,
but only upon prior written notice to Myogen and prior written consent of
Myogen; provided that that no consent shall be required for Third Party
Sublicensees that are granted only rights to distribute the Product for
Sublicensee in the Territory. Sublicensee may not exercise its "have made" or
"importation" rights under Article 2.1 without first obtaining Myogen's prior
written consent. "THIRD PARTY SUBLICENSEE" means a Third Party that enters into
a sublicense agreement with Sublicensee providing a sublicense to such Third
Party under Sublicensee's license provided by this Agreement.
2.4 LICENSE AGREEMENT. Sublicensee hereby acknowledges that Myogen acts as
licensee under the License Agreement and Third Parties may own the rights to
some or all of the Myogen Know-How and Sublicensee acknowledges that the
sublicense granted hereunder to Sublicensee under the Myogen Know-How is
governed by the terms of the License Agreement. Sublicensee also acknowledges
that Myogen's performance under this Agreement cannot violate any of the terms
of the License Agreement which has been provided to Sublicensee. Sublicensee
agrees to abide by the terms and conditions of the License Agreement, and
perform those obligations of Myogen as if Sublicensee were Myogen where and to
the extent applicable.
2.5 REGULATORY MATTERS AND COMMERCIALIZATION. Sublicensee shall, consistent
with Myogen's obligations under the License Agreement, use Reasonable Diligence
to (a) maintain all Regulatory Approvals and to Manufacture and Commercialize
the Product in the countries in the Territory where Product is distributed as of
the Effective Date and (b) obtain and maintain Regulatory Approvals, and to
Manufacture and Commercialize the Product in the remaining countries in the
Territory where the Product will be distributed by Sublicensee during the Term.
2.6 TRADEMARKS. Subject to the terms and conditions of this Agreement,
Myogen hereby transfers whatever rights it may have under the Trademarks as of
the Effective Date. Sublicensee will, at its own expense, prepare and provide
the documents necessary to transfer the Trademark rights. Myogen will use its
commercially reasonable efforts to assist Sublicensee in the transfer
contemplated hereunder and shall execute such documentation as Sublicensee may
reasonably request in order to effectuate such transfer. As of the Effective
Date, Sublicensee will be responsible for all Trademark Costs.
2.7 TERMINATION OF IMPLIED MYOGEN GMBH SUBLICENSE. Upon the Effective Date,
that certain Sales and Supply Agreement, dated as of February 1, 2000, by and
between Myogen and Subsidiary shall be terminated and of no further force and
effect.
6.
2.8 RIGHT OF FIRST NEGOTIATION.
(A) In the event that Myogen, at any time during the Term,
decides to pursue granting a sublicense to any Third Party to conduct
Manufacturing or Commercialization and related activities outside of the
Territory with respect to the Product (the "NEW TERRITORY"), Myogen will notify
Sublicensee in writing and thereby grant Sublicensee an exclusive option to
negotiate with Myogen for an exclusive license under the Myogen Know-How in the
New Territory in the Field (the "RIGHT OF NEGOTIATION").
(B) Sublicensee must exercise the Right of Negotiation by
providing written notice to Myogen (the "RIGHT OF NEGOTIATION NOTICE") within
sixty (60) days after receiving written notice from Myogen as provided in
Article 2.8(a) of the Right of Negotiation.
(C) If Sublicensee does not submit a Right of Negotiation Notice
to Myogen as provided in Article 2.8(b) prior to the expiration of the sixty
(60) day period referenced in Article 2.8(b), the Right of Negotiation will
immediately terminate at 12:01 a.m. Eastern Standard Time on the calendar day
that is immediately after the last calendar day of such sixty (60) day period
and Myogen will have no further obligation to Sublicensee with respect to the
Right of Negotiation for Product in the New Territory.
(D) If Sublicensee exercises the Right of Negotiation by
providing a Right of Negotiation Notice as provided in Article 2.8(b), Myogen
and Sublicensee will negotiate in good faith, and use their diligent efforts, to
complete a license agreement during the Right of Negotiation Period pursuant to
which Sublicensee would obtain an exclusive license with respect to the Product
under the Myogen Know-How in the New Territory (the "NEW TERRITORY LICENSE
AGREEMENT"). The "RIGHT OF NEGOTIATION PERIOD" will be the period that commences
on the date on which Sublicensee provides Myogen with a Right of Negotiation
Notice as provided in Article 2.8(b) (for the purposes of this Article 2.8(d)
only, the "commencement date") and expires at 12:01 a.m. Eastern Standard Time
on the day immediately following the sixtieth (60th) day after the commencement
date. Such Right of Negotiation Period may be extended upon the mutual written
agreement of Myogen and Sublicensee prior to the expiration thereof as provided
in Article 2.8(e) or earlier terminated by the termination of this Agreement.
(E) In the event Myogen and Sublicensee have not executed the New
Territory License Agreement during the Right of Negotiation Period, after
starting to negotiate the terms and conditions thereof in good faith: (i) Myogen
and Sublicensee may, upon their mutual written agreement prior to the expiration
of the Right of Negotiation Period, extend the Right of Negotiation Period for
successive additional periods of twenty (20) days; or (ii) if not extended by
Myogen and Sublicensee as provided in (i), the Right of Negotiation Period will
expire as provided in Article 2.8(d) and Myogen will have no further obligation
to Sublicensee with respect to the Right of Negotiation or Product in the New
Territory.
7.
ARTICLE 3
REPORTS AND REGULATORY MATTERS
3.1 OBLIGATIONS OF THE PARTIES.
3.1.1. REPORTS. Sublicensee shall submit semi-annual written summary
reports which describe the progress of Commercialization and Regulatory Approval
efforts undertaken by it with regard to the Products under this Agreement
including, without limitation, the progress towards the Commercialization and
Regulatory Approval obligations set forth in this Agreement.
3.1.2. MANUFACTURE AND COMMERCIALIZATION; EXPENSES. During the term of
this Agreement, Sublicensee shall bear its own costs and expenses incurred with
any Manufacturing and Commercialization conducted pursuant to this Agreement.
3.1.3. TRANSITION SERVICES. Myogen will use commercially reasonable
efforts to provide Sublicensee with Transition Services as reasonably requested
by Sublicensee. During the period beginning on the Effective Date and ending six
(6) months thereafter ("TRANSITION PERIOD"), Myogen will provide Transition
Services at no charge to Sublicensee. After expiration of the Transition Period,
Sublicensee will pay Myogen for Transition Services performed by Myogen at two
hundred dollars ($200) per hour. Myogen shall submit written statements on a
quarterly basis to Sublicensee setting forth such expenses incurred by Myogen
for such quarter and Sublicensee shall reimburse Myogen for such expenses within
thirty (30) days thereafter.
3.2 REGULATORY MATTERS.
3.2.1. COMPLIANCE WITH REGULATIONS. Sublicensee and/or Subsidiary, as
applicable, and Myogen to the extent it is providing services, will conduct
its/their efforts hereunder in compliance with all applicable regulatory
requirements of the applicable Authority, including without limitation, the
guidelines of the International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use.
3.2.2. REGULATORY FILINGS. Sublicensee or Subsidiary shall, at its own
expense, prepare and submit all filings with the regulatory authorities with
respect to the Product in each country in the Territory as applicable (the
"REGULATORY FILINGS"), and Sublicensee or Subsidiary shall be responsible for
causing such applications to progress through the approval process in a timely
manner. Regulatory Expenses incurred in obtaining Regulatory Approval for the
Product shall be at the sole cost of Sublicensee or Subsidiary. Sublicensee or
Subsidiary shall, promptly after each such Regulatory Filing, deliver to Myogen
a report with a brief summary of such Regulatory Filing, which shall be held by
Myogen subject to the provisions of Article 5.
3.2.3. MAINTENANCE OF RECORDS. Sublicensee and/or Subsidiary, as
applicable, shall maintain records with respect to activities conducted in
connection with their activities relating to the Product in sufficient detail
and in the manner appropriate for Regulatory Approval purposes and in a manner
which will reflect all clinical and pre-clinical studies conducted, results
achieved and data obtained by Sublicensee or Subsidiary in the course of such
activities.
8.
3.2.4. ADVERSE EVENT REPORTING. Sublicensee and/or Subsidiary, as
applicable, shall be responsible for reporting of adverse experience information
to meet the current requirements for Adverse Drug Reaction reporting to the
applicable Authorities within the Territory. In addition, Sublicensee and/or
Subsidiary, as applicable, shall provide supplemental information at periodic
intervals and/or report adverse events at more frequent intervals if requested
by an applicable Authority. Sublicensee or Subsidiary, as applicable, shall
provide Myogen copies of any reports to the applicable Authorities under this
Article 3.2.4 within forty-eight (48) hours of the submission of such reports to
such applicable Authorities.
To the extent the obligations of this Article 3.2 are undertaken by Subsidiary,
Sublicensee will ensure that Subsidiary complies with such obligations.
3.3 EXISTING INVENTORY. Subject to the terms and conditions set forth in
this Agreement, within forty-five (45) days after the Execution Date, Myogen
shall ship the Bulk Enoximone, the Enoximone Starter Material and the Finished
Product to Sublicensee "Free Carrier," Myogen site (FCA per INCOTERMS, 2000
version).
ARTICLE 4
PAYMENTS AND ROYALTIES
4.1 PAYMENTS. As consideration for the assets transferred to and the rights
granted to Sublicensee by Myogen under this Agreement, Sublicensee shall make
the following Payments to Myogen as promptly as practicable after the Execution
Date and in any event no later than February 10, 2006:
(A) One Hundred Fifty Thousand U.S. Dollars ($150,000) for the
Bulk Enoximone;
(B) Forty Thousand U.S. Dollars ($40,000) for the Enoximone
Starter Material;
(C) One Hundred Seventy-Seven Thousand Three Hundred Ninety-Six
U.S. Dollars ($177,396) for the Finished Product;
(D) Four Million Six Hundred Thousand U.S. Dollars ($4,600,000)
for the CTM Trademark (as identified on Schedule1.41); and
(E) Ten Thousand U.S. Dollars ($10,000) for the Trademarks other
than the CTM Trademark.
4.2 ROYALTIES. Sublicensee will, for use of the rights granted under
Articles 2.1 and 2.2, pay to Myogen on a quarterly basis within forty-five (45)
days after the end of each calendar quarter, periodic payments equal to Eight
Percent (8%) of Net Sales in the Territory that occurred in the immediately
preceding calendar quarter (the "NET SALES ROYALTY PERCENTAGE").
4.3 DURATION OF ROYALTY OBLIGATIONS. If this Agreement is not terminated in
accordance with the other provisions hereof, Sublicensee's obligation to pay
earned royalties
9.
hereunder in a particular country other than the Terminated Countries (as
defined in the License Agreement) shall continue for so long as Myogen is
obligated to pay royalties to Sanofi-Aventis for Net Sales of the Product under
the License Agreement. If this Agreement is not terminated in accordance with
the other provisions hereof, Sublicensee's obligation to pay earned royalties
hereunder in the Terminated Countries (as defined in the License Agreement)
shall continue until October 1, 2011.
4.4 LOSS OF REGISTRATION. Provided that Sublicensee is otherwise in
compliance with the terms and conditions of this Agreement, including, without
limitation, Sublicensee's obligations under Article 3 to update the applicable
regulatory dossier, in the event of a lost or suspended registration of the
Product due to regulatory actions by an applicable Authority in a country set
forth on EXHIBIT A prior to the third anniversary of the Effective Date,
Sublicensee shall be entitled to the following credits:
(A) For each country set forth on EXHIBIT A in which Sublicensee
is required to cease selling the Product during the period commencing on the
Effective Date through the first anniversary of the Effective Date, Sublicensee
shall be entitled to an amount equal to the product of (i) the dollar amount for
such country set forth under the heading "Year 1" on EXHIBIT A multiplied by
(ii) a fraction, the numerator of which is the number of days during such period
in which Sublicensee was actually prohibited from selling the Product and the
denominator of which is 365;
(B) For each country set forth on EXHIBIT A in which Sublicensee
is required to cease selling the Product during the period commencing on the
first anniversary of the Effective Date through the second anniversary of the
Effective Date, Sublicensee shall be entitled to an amount equal to the product
of (i) the dollar amount for such country set forth under the heading "Year 2"
on EXHIBIT A multiplied by (ii) a fraction, the numerator of which is the number
of days during such period in which Sublicensee was actually prohibited from
selling the Product and the denominator of which is 365; and
(C) For each country set forth on EXHIBIT A in which Sublicensee
is required to cease selling the Product during the period commencing on the
second anniversary of the Effective Date through the third anniversary of the
Effective Date, Sublicensee shall be entitled to an amount equal to the product
of (i) the dollar amount for such country set forth under the heading "Year 3"
on EXHIBIT A multiplied by (ii) a fraction, the numerator of which is the number
of days during such period in which Sublicensee was actually prohibited from
selling the Product and the denominator of which is 365.
Each of the payments contemplated under this Article 4.4 shall, at the sole
option of Myogen, be either (i) offset against future payment obligations of
Sublicensee under Article 4.2 in which case Myogen shall provide Sublicensee
written notice of such determination within forty-five (45) days after the end
of the applicable time period under Article 4.4(a), (b) or (c) above or (ii)
paid by Myogen within forty-five (45) days after the end of the applicable time
period under Article 4.4(a), (b) or (c) above.
4.5 ROYALTY PAYMENTS AND REPORTS. Sublicensee shall make royalty payments
under this Agreement to Myogen or its designee along with the report summarizing
the Net Sales
10.
of any Products by Sublicensee, its Affiliates or Third Party Sublicensees, if
any, during the relevant quarter within forty-five (45) days following the end
of each calendar quarter. Such reports will contain Net Sales of all Products
for each country in the Territory. All payments to Myogen shall be in U.S.
currency. For the purpose of calculating payments, the currency exchange rate
for converting any currency to U.S. dollars shall be the exchange rate in the
key currency cross rates table in the final edition of The Wall Street Journal
(U.S. Eastern Edition) or in the case the currency exchange rate is not
published in The Wall Street Journal, the mid-point of the closing bid and ask
price of "Xxxxxx'x 2000 Information Service" historical databases, on the last
business day of each calendar quarter to which such payment relates. A "business
day" is a day on which banks are open for business in the country of the
currency to be translated. Unless Myogen instructs Sublicensee otherwise,
payments pursuant to this Article 4 shall be made by bank wire transfer as
follows:
Myogen, Inc.
Silicon Valley Bank, NA
Account Number: 3300364754
ABA Routing Number: 000000000
4.6 TAXES. Myogen shall pay any and all taxes levied on account of
royalties it receives under this Agreement. If laws or regulations require that
taxes be withheld, then Sublicensee will (a) deduct those taxes from the
remittance royalty, (b) timely pay the taxes to the proper taxing authority and
(c) send proof of payment to Myogen within thirty (30) days following such
payment.
4.7 GUARANTY. Each of the Guarantors hereby jointly, severally and
unconditionally, as primary obligor and not merely as surety, guarantees the
full and prompt performance of the Payments by Sublicensee to Myogen hereunder
(all such obligations being herein collectively call the "LIABILITIES"). Each of
the Guarantors hereby expressly waives (a) notice of the existence or creation
or non-payment of all or any of the Liabilities; (b) any obligation of Myogen to
proceed directly against or exhaust any collateral held by Myogen from
Sublicensee, any other guarantor, or any other person; and (c) any claim or
right which Guarantors may now have or hereafter acquire against Sublicensee or
any other person or entity that arises from the existence, payment, performance
or enforcement of the obligations of Guarantors hereunder, including (without
limitation) any right of subrogation, reimbursement, restitution, exoneration,
contribution or indemnification.
4.8 BLOCKED CURRENCY. In each country where the local currency is blocked
or cannot be removed from such country, Sublicensee will pay the royalty owed on
Net Sales in that country in U.S. currency to Myogen at the exchange rate in
Article 4.5.
4.9 PAYMENTS TO OR REPORTS BY AFFILIATES. Any payment required under any
provision of this Agreement to be made to either Party or any report required to
be made by either Party shall be made to or by an Affiliate of that Party if
designated by that Party as the appropriate recipient or reporting entity.
11.
4.10 NO MULTIPLE ROYALTIES. No multiple royalties shall be payable because
any Product, its manufacture, use, lease or sale are or shall be covered by the
Myogen Know-How licensed under this Agreement.
ARTICLE 5
CONFIDENTIALITY
5.1 CONFIDENTIALITY; EXCEPTIONS. Except to the extent expressly authorized
by this Agreement or otherwise agreed in writing, the Parties agree that, for
the term of this Agreement and for seven (7) years thereafter, the receiving
Party shall keep confidential and shall not publish or otherwise disclose or use
for any purpose other than as provided for in this Agreement any Information
related to the Products and other information and materials furnished to it by
the other Party pursuant to this Agreement, or any provisions of this Agreement
or the License Agreement that are the subject of an effective order of the
Securities and Exchange Commission granting confidential treatment pursuant to
the Securities Exchange Act of 1934, as amended (collectively, "CONFIDENTIAL
INFORMATION"), except to the extent that it can be established by the receiving
Party that such Confidential Information:
(A) was already known to the receiving Party at the time of
disclosure by the other Party;
(B) was generally available to the public or otherwise part of
the public domain at the time of its disclosure to the receiving Party;
(C) became generally available to the public or otherwise part of
the public domain after its disclosure and other than through any act or
omission of the receiving Party in breach of this Agreement;
(D) was disclosed to the receiving Party by a Third Party who had
no obligation to the disclosing Party not to disclose such information to
others; or
(E) was independently developed by the receiving Party without
breach of the provisions of this Agreement (and can be verified by the
disclosing Party as such).
5.2 AUTHORIZED DISCLOSURE. Each Party may disclose Confidential Information
hereunder to the extent such disclosure is reasonably necessary in (a) filing or
prosecuting patent applications, (b) prosecuting or defending litigation, (c)
complying with applicable laws or regulations or (d) conducting pre-clinical or
clinical trials, provided that if a Party is required by law or regulation to
make any such disclosure of the other Party's Confidential Information it will,
except where impracticable for necessary disclosures (e.g., in the event of
medical emergency), give reasonable advance notice to the other Party of such
disclosure requirement and, except to the extent inappropriate in the case of
patent applications, will use its reasonable efforts to secure confidential
treatment of such Confidential Information required to be disclosed. In addition
each Party shall be entitled to disclose, under a binder of confidentiality
containing provisions as protective as those of this Article 5, Confidential
Information to any Third Party for the purpose of carrying out the purposes of
this Agreement. Nothing in this Article 5 shall restrict any Party from using
for any purpose consistent with the terms of this Agreement any
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Information developed by it during the term of this Agreement. When a Party
makes disclosure of Confidential Information to any of its employees, it shall
obtain an acknowledgment and agreement from each such employee that such
employee agrees to be bound by the provisions of Article 5.1 hereof or the
equivalent.
5.3 SURVIVAL. This Article 5 shall survive the termination or expiration of
this Agreement for a period of seven (7) years.
5.4 MANUFACTURING AGREEMENT. All Information exchanged between the Parties
under the Contract Manufacturing Agreement, dated January 31, 2001, by and
between Pharma and Myogen and/or its Affiliates shall be deemed Confidential
Information and shall be subject to the terms of this Article 5, and shall be
included within the definitions of Myogen Know-How and Sublicensee Know-How.
ARTICLE 6
OWNERSHIP OF INTELLECTUAL PROPERTY; ENFORCEMENT
6.1 OWNERSHIP.
6.1.1. As between Myogen and Sublicensee, Myogen shall solely own, and
it alone has the right to apply for patents within and outside of the United
States for any inventions made solely by Myogen's or its licensors' personnel or
consultants in the course of performing work under this Agreement.
6.1.2. As between Myogen and Sublicensee, Sublicensee shall solely
own, and Sublicensee alone has the right to apply for patents within and outside
of the United States for any inventions made solely by Sublicensee's personnel
or consultants in the course of performing work under this Agreement.
6.2 DISCLOSURE OF PATENTABLE INVENTIONS. Each Party shall provide to the
other any invention disclosure submitted in the normal course of performing its
obligations hereunder which discloses an invention related to Enoximone or the
Products in the Field. Such invention disclosures shall be provided to the other
Party promptly after submission and in no event later than ten (10) days after
the end of the calendar quarter in which the disclosure was submitted; provided,
however, that no disclosure is required that would constitute publication prior
to the time a patent issues, and in any case all submissions will be considered
Confidential Information of the Party submitting the invention disclosure.
Sublicensee shall disclose to Myogen any and all Sublicensee Patents,
Sublicensee Know-How and Sublicensee Data.
6.3 LICENSE TO MYOGEN.
6.3.1. LICENSE FOR COMMERCIALIZATION. Upon the terms and subject to
the conditions of this Agreement and subject to payment by Myogen to Sublicensee
of such royalty payments as are mutually agreed upon by Myogen and Sublicensee,
Sublicensee grants to Myogen an exclusive license (even as to Sublicensee and
its Affiliates) under the Sublicensee Patents, Sublicensee Know-How and the
Sublicensee Data to conduct Manufacturing, pre-marketing activities,
Commercialization, to make, have made, use, import, sell, offer for sale and
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have sold and related activities outside the Territory with respect to the
Product in accordance with the terms of this Agreement. Such license shall
include the right to grant sublicenses; provided that such sublicenses are made
subject to the terms of this Agreement and Myogen remains responsible for any
breach by a sublicensee of the sublicense.
6.3.2. LICENSE TO CONDUCT DEVELOPMENT. Upon the terms and subject to
the conditions of this Agreement and subject to payment by Myogen to Sublicensee
of such royalty payments as are mutually agreed upon by Myogen and Sublicensee,
Sublicensee grants to Myogen an exclusive license (even as to Sublicensee and
its Affiliates) under the Sublicensee Patents, Sublicensee Know-How and the
Sublicensee Data to conduct development and Regulatory Approvals outside the
Territory in accordance with the terms of this Agreement with respect to the
Product for use in the Field. Such license shall include the right to grant
sublicenses; provided that such sublicenses are made subject to the terms of
this Agreement and Myogen remains responsible for any breach by a sublicensee of
the sublicense.
6.4 THIRD PARTY PATENT RIGHTS.
6.4.1. Myogen represents and warrants that to its knowledge that there
are no Third Party rights which may be infringed by the manufacture or sale of
any Product, the use of any Myogen Know-How or any other activity contemplated
by this Agreement.
6.4.2. Neither Party makes any representation or warranty to the
other, other than that made in this Article 6.4, with respect to the validity,
enforceability, perfection or dominance of any patent or other proprietary right
or with respect to the absence of rights of Third Parties which may be infringed
by the manufacture or sale of any Product, the use of any Know-How or any other
activity contemplated by this Agreement. Each Party agrees to bring to the
attention of the other Party any patent or patent application it discovers, or
has discovered, and which relates to the subject matter of this Agreement.
6.5 ENFORCEMENT RIGHTS.
6.5.1. GENERAL.
(A) In the event a Third Party, through the actual or proposed
manufacture, export, use, sale or offer for sale of a product in the Territory
competitive with the Product infringes and is reasonably likely to infringe
("COMPETITIVE PRODUCT INFRINGEMENT") any Myogen Know-How, as between Myogen and
Sublicensee, Sublicensee has the sole and exclusive right to institute,
prosecute and control any action or proceeding with respect to such
infringement, and the right to any and all relief, recovery and the like. Myogen
has the right to participate and be represented in such action by counsel of its
own selection at its own expense. Myogen agrees to be joined as a party
plaintiff, if necessary in any such action, and to give Sublicensee reasonable
assistance and any needed authority to control, file and to prosecute such
action, at Sublicensee's expense.
(B) If either Party learns or determines in good faith that there
is or is a likelihood of Competitive Product Infringement of any Myogen Know-How
by a Third Party in the Territory, the Party first having knowledge shall
promptly notify the other Party in writing thereof, which notice shall set forth
the facts of such actual or potential infringement in
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reasonable detail. If Sublicensee, fails to institute and prosecute an action or
proceeding to xxxxx any actual infringement within a period of thirty (30) days
after receiving written notice of actual infringement or otherwise having
knowledge of the actual infringement, then Myogen has the right, but not the
obligation, to bring and prosecute any action and Sublicensee agrees to be
joined as a party plaintiff in such action and to give Myogen all authority to
control, file and prosecute the action as may be necessary; provided, however,
that Sublicensee shall have the right to participate and to be represented in
any such action by counsel of its choice.
(C) The Parties' costs of intellectual property enforcement
(including internal costs and expenses specifically attributable to said patent
enforcement) and related recoveries with respect to actions brought under this
Article 6.5.1 shall be the responsibility and to the benefit of Sublicensee,
except as otherwise noted herein. Any amounts recovered in such action referred
to in this Article 6.5.1 shall be recovered by Sublicensee.
(D) No settlement or consent judgment or other voluntary final
disposition of suit under this Article 6.5.1 may be entered into without the
consent of Myogen, which consent shall not be withheld unreasonably or delayed.
6.5.2. SETTLEMENT OF THIRD PARTY CLAIMS FOR PRODUCTS; ROYALTY
REDUCTION. If a Third Party asserts that a patent or other right owned by it in
the Territory is infringed by the manufacture, use or sale of the Product and if
following the conclusion of proceedings brought as a result of such
infringement, Sublicensee is required to pay the Third Party any payment of any
kind for the right to sell the Product in a particular country, the royalty rate
then payable to Myogen attributable to such country shall be reduced by one-half
(but shall in no event be less than the minimum royalty percentage that Myogen
is required to pay Sanofi-Aventis under the License Agreement). The royalty rate
shall return to its previous level once Sublicensee has fully satisfied the
payment due to the Third Party. In the event Sublicensee is required to pay to
the Third Party a royalty due to an alleged infringement, then the royalty rate
payable to Myogen attributable only to sales in such country in which the
royalty is required to be paid shall be reduced by one-half of the royalty rate
payable to the Third Party (but shall in no event be less than the minimum
royalty percentage that Myogen is required to pay Sanofi-Aventis under the
License Agreement). Such royalty rate shall return to its prior level once the
royalty obligations to the Third Party have been satisfied. No settlement or
consent judgment or other voluntary final disposition of a suit under this
Article 6.5.2 may be entered into without the mutual consent of Myogen and
Sublicensee which shall not be unreasonably withheld or delayed.
6.6 INFRINGEMENT OF TRADEMARKS.
6.6.1. Each Party shall notify the other Party promptly upon learning
of any actual or alleged infringement of any Trademark or of any unfair trade
practices, trade dress imitation, passing off of counterfeit goods, or like
offenses, or any such claims (hereinafter "TRADEMARK INFRINGEMENT CLAIMS")
brought by a Third Party against a Party in connection with the Product in the
Territory. Upon learning of such Trademark Infringement Claim, Sublicensee shall
take all reasonable and appropriate steps to resolve the Trademark Infringement
Claim, with the reasonable cooperation and assistance of Myogen. All of the
reasonable direct costs of in-house counsel, the fees and expenses paid to
outside counsel and other reasonable direct costs incurred in bringing,
maintaining and prosecuting any action described in this Article 6.6.1 shall
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be included in Trademark Costs and shall be borne by Sublicensee, and any
remaining recovery shall be split fifty percent (50%) to Sublicensee and fifty
percent (50%) to Myogen.
6.6.2. Each Party shall notify the other Party promptly upon learning
of any actual or alleged Trademark Infringement Claims brought by a Third Party
against a Party in connection with a Product in the Territory. Upon learning of
such Trademark Infringement Claim, Sublicensee will take all reasonable and
appropriate steps to resolve such Trademark Infringement Claim, with the
reasonable cooperation and assistance of Myogen. All of the reasonable direct
costs of in-house counsel, the fees and expenses paid to outside counsel other
reasonable direct costs incurred in bringing, maintaining and prosecuting any
action described in this Article 6.6.2 shall be borne solely by Sublicensee.
6.7 NO EFFECT OF BANKRUPTCY ON LICENSES. All licenses and grants to a party
under or pursuant to this Agreement by the other party are, and shall otherwise
be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code (11
U.S.C. Section 101 et seq.) (the "BANKRUPTCY CODE"), present conveyances of
"intellectual property" as defined therein. The parties agree that the licensee,
as the owner of such rights, shall retain and may fully exercise all of its
rights and elections under the Bankruptcy Code. The parties further agree that,
in the event that either party ceases to do business in the ordinary course or
if any proceeding is instituted by or against a party seeking to adjudicate it a
bankrupt or insolvent, or seeking liquidation, winding up, reorganization,
arrangement, adjustment, protection, relief or composition of it or its debts
under any law relating to bankruptcy, insolvency or reorganization or relief of
debtors, or seeking an entry of an order for relief or the appointment of a
receiver, trustee or other similar official for it or any substantial part of
its property or it shall take any action to authorize any of the foregoing
actions, the licensee shall have the right to assume, retain and enforce its
rights under this Agreement.
ARTICLE 7
REPRESENTATIONS AND WARRANTIES; EXCLUSIVITY
7.1 REPRESENTATIONS AND WARRANTIES. Each Party hereby represents and
warrants to the other Party that this Agreement is a legal and valid obligation
binding on such Party and enforceable in accordance with its terms, subject to
laws regarding bankruptcy or insolvency generally, provided that the Parties
acknowledge and agree that this Agreement constitutes a license of "intellectual
property" as provided in the Bankruptcy Code. The execution delivery and
performance of the Agreement by such Party does not conflict with any agreement,
instrument or understanding, oral or written, to which it is a Party or by which
it is bound, nor violate any law or regulation of any court, governmental body
or administrative or other agency having jurisdiction over it. Such Party
represents and warrants that it has not, and covenants that during the term of
the Agreement it will not, grant to any Third Party any rights which would
conflict or interfere with or curtail or impair the rights granted to the other
Party hereunder.
7.2 EXCLUSIVITY; NON-COMPETITION WITHIN THE FIELD. During the term of this
Agreement: Myogen and its Affiliates shall not, directly or indirectly, conduct,
have conducted or fund any research, development, regulatory, or
commercialization activity of any intravenous formulation of Enoximone in the
Territory and in the Field other than pursuant to the terms and
16.
conditions of this Agreement. Sublicensee acknowledges that its activities and
operations pursuant to this Agreement shall be the principle mechanism by which
Sublicensee will Commercialize the Products.
ARTICLE 8
INFORMATION & REPORTS
8.1 RECORDS OF REVENUES AND EXPENSES. Sublicensee will maintain complete
and accurate accounts and records of revenues, costs, expenses and payments
earned or made in connection with this Agreement and such records shall be
available for examination at Myogen's expense during Sublicensee's reasonable
business hours for a period of two (2) years from creation of the individual
records. In addition, not more often than once each year, Myogen may designate a
firm of certified public accountants acceptable to Sublicensee to verify the
correctness of calculations and classifications of such revenues, costs,
expenses or payments earned or made in connection with this Agreement. Amounts
that are determined to be due as a result of any variances in revenues, costs,
expenses or payments earned or made in connection with this Agreement discovered
during such audit shall be paid by Sublicensee within thirty (30) days after the
conclusion of the audit (subject to Article 11 hereof). If the audit results in
a variance of more than five percent (5%) in favor of Myogen, the reasonable
audit expenses of Myogen shall be paid by Sublicensee. Any records or accounting
information received from Myogen shall be included within the definition of
Confidential Information for purposes of Article 5.
ARTICLE 9
TERM AND TERMINATION
9.1 TERM. This Agreement shall commence as of the Effective Date and shall
continue unless terminated as provided herein in its entirety ("TERM") or with
respect to certain countries in the Territory as set forth herein.
9.2 TERMINATION OF LICENSE AGREEMENT BY SANOFI-AVENTIS. Subject to Article
9.2 of the License Agreement, Sanofi-Aventis has the right to terminate the
License Agreement in its entirety only during the period prior to the first
Regulatory Approval of an Enoximone product (other than the Product) in the
United States if Myogen shall either (a) discontinue its development obligations
as set forth in Article 3.6.1(a) of the License Agreement or, (b) fails to meet
the milestone set forth in Article 3.6.1(b) of the License Agreement.
Termination of the License Agreement by Sanofi-Aventis must be made pursuant to
a written notice (the "S-A TERMINATION NOTICE") delivered by Sanofi-Aventis to
Myogen within ninety (90) days after the expiration of the time period with
respect to which such notice is being delivered. Such termination shall be
effective as of thirty (30) days following delivery of the S-A Termination
Notice to Myogen (the "TERMINATION EFFECTIVE DATE"). If Sanofi-Aventis
terminates the License Agreement as set forth above, pursuant to the License
Agreement, Myogen may retain all rights granted under Article II of License
Agreement to make, manufacture and commercialize the Product in the Europe only
(the "EUROPEAN RIGHTS"). In the event Sanofi-Aventis does terminate the License
Agreement under Article 9.2 of the License Agreement during the Term of this
17.
Agreement, Myogen will retain the European Rights in accordance with Article 9.2
of the License Agreement and the Territory will then be restricted to Europe as
defined in Article 1, unless Sanofi-Aventis agrees in writing to expand the
Territory to include countries outside of Europe as defined in Article 1.
Notwithstanding the forgoing, the parties acknowledge that Myogen and
Sanofi-Aventis are currently negotiating a fourth amendment to the License
Agreement which would amend Article 9.2 of the License Agreement (the "FOURTH
AMENDMENT"). This Section 9.2 will be void upon execution of the Fourth
Amendment.
9.3 TERMINATION FOR MATERIAL BREACH.
9.3.1. Subject to the provisions of this Article 9.3, if either Party
has committed a Material Breach (as defined below) and such Material Breach
shall remain uncured and shall be continuing for a period of sixty (60) days
following receipt of written notice thereof from the non-breaching Party, then,
in addition to any and all other rights and remedies that may be available, the
non-breaching Party has the right to terminate this Agreement effective upon the
expiration of such sixty (60) day period. Any such written notice of alleged
Material Breach from the non-breaching Party shall include a reasonably detailed
description of all relevant facts and circumstances demonstrating, supporting
and/or relating to each such alleged Material Breach by the breaching Party.
9.3.2. If (i) Sublicensee terminates this Agreement pursuant to the
provisions of this Article 9.3 other than for Material Breach by Myogen of
Myogen's obligations under Article 7.2 or (ii) Myogen terminates this Agreement
pursuant to the provisions of this Article 9.3 and provides Sublicensee notice
of its intention to apply certain of the provisions below, then the following
provisions (or in the case of termination by Myogen under clause (ii) above,
those provisions set forth below which Myogen wishes to enforce as set forth in
Myogen's notice to Sublicensee) will apply:
(A) all licenses and rights in the Myogen Know-How granted to
Sublicensee hereunder shall terminate;
(B) all Confidential Information supplied by each Party to the
other Party shall be promptly destroyed by each Party and each Party shall
certify such destruction to the other, except that each Party may retain one
copy of such information solely for legal archive purposes;
(C) Sublicensee and Subsidiary shall cooperate in the transfer to
Myogen of all NDAs, Drug Approval Applications and Regulatory Approvals related
to the Product, and shall take such other actions and execute such other
instruments, assignments and documents as may be necessary to effect the
transfer of rights hereunder to Myogen; and
(D) effective upon the effective date of termination of the
Agreement by Myogen under Article 9.3, Sublicensee hereby grants to Myogen a
non-exclusive, world-wide, royalty-free license, with the right to grant and
authorize the grant of sublicenses, under the Sublicensee Patents, Sublicensee
Know-How and the Sublicensee Data to (i) conduct Manufacturing, pre-marketing
activities, Commercialization, to make, have made, use, import, sell, offer for
sale and have sold and related activities inside and outside the Territory with
18.
respect to the Product and (ii) conduct Regulatory Approval activities inside
and outside the Territory with respect to the Product for use in the Field.
9.3.3. If Sublicensee terminates this Agreement pursuant to the
provisions of this Article 9.3 due to a Material Breach by Myogen of Myogen's
obligations under Article 7.2 and provides Myogen notice of its intention to
apply certain of the provisions below, then the following provisions (to the
extent they are set forth in Sublicensee's notice to Myogen of such Material
Breach) will apply:
(A) Myogen shall reimburse all Payments effected through the date
of such termination;
(B) Sublicensee's royalty obligations under Article 4.2 shall
cease immediately upon such termination;
(C) effective upon the effective date of such termination, Myogen
hereby grants to Sublicensee a non-exclusive, royalty-free license, with the
right to grant and authorize sublicenses, under the Myogen Know-How to (i)
conduct Manufacturing, pre-marketing activities, Commercialization, to make,
have made, use, import, sell, offer for sale and have sold and related
activities in the Territory with respect to the Product and (ii) conduct
Regulatory Approval activities in the Territory with respect to the Product for
use in the Field; and
(D) all Confidential Information supplied by each Party to the
other Party shall be promptly destroyed by each Party and each Party shall
certify such destruction to the other, except that each Party may retain one
copy of such information solely for legal archive purposes.
9.3.4. For purposes of this Article 9.3, "MATERIAL BREACH" means the
breach or failure to perform, in a material respect, a material obligation under
this Agreement. Without limiting the foregoing and by way of example only, the
term "Material Breach" shall be deemed to include the failure of Sublicensee in
a material respect to meet Sublicensee's payment or non-compete obligations or a
failure of Myogen in a material respect to meet Myogen's non-compete
obligations.
9.3.5. Termination of this Agreement pursuant to this Article 9.3
shall not relieve the breaching Party of any liability, including any obligation
of Sublicensee to make payments hereunder, which accrued hereunder prior to the
effective date of such termination, nor preclude the non-breaching Party from
pursuing all rights and remedies it may have hereunder or at law or in equity
with respect to any breach of this Agreement nor prejudice the non-breaching
Party's right to obtain performance of any obligation. For purposes of this
Article 9.3, any unpaid Payments shall be due and payable upon termination of
this Agreement by Myogen pursuant to this Article 9.3.
9.3.6. The provisions of this Article 9.3 shall survive termination of
this Agreement for a period of seven (7) years.
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9.4 LICENSE OF TRADEMARKS UPON TERMINATION. Should this Agreement terminate
for any reason pursuant to Article 9.3 other than for Material Breach by Myogen
of Myogen's obligations under Article 7.2, promptly after the written request of
Myogen, Sublicensee shall grant or have granted to Myogen an exclusive,
perpetual, irrevocable, transferable, royalty-free license (with the right to
grant sublicenses) to use the Trademarks in connection with the Products in the
Territory.
ARTICLE 10
INDEMNIFICATION
10.1 INDEMNIFICATION BY MYOGEN.
10.1.1. SUBLICENSEE INDEMNIFIED PARTIES. Myogen hereby agrees to
indemnify, save, defend and hold Sublicensee and its Affiliates, officers,
directors, agents and employees (the "SUBLICENSEE INDEMNIFIED PARTIES") harmless
from and against any and all suits, claims, actions, demands, liabilities,
expenses and/or losses, including reasonable legal expense and attorneys' fees
(collectively, "LOSSES"), incurred by or against any Sublicensee Indemnified
Parties, which arise out of any breach of this Agreement by Myogen, or any
negligence or willful misconduct by Myogen, except to the extent such Losses are
attributable to the breach of this Agreement by Sublicensee or any Sublicensee
Indemnified Parties or any negligence or willful misconduct by Sublicensee or
any Sublicensee Indemnified Parties.
10.1.2. NOTICE OF CLAIM. In the event that a Sublicensee Indemnified
Party seeks indemnification under Article 10.1.1, it shall inform Myogen of such
claim as soon as reasonably practicable after it receives notice of the claim
and shall permit Myogen to assume direction and control of the defense of the
claim (including the right to settle the claim solely for monetary
consideration), and shall cooperate as reasonably requested (at the expense of
Myogen) in the defense of the claim.
10.2 INDEMNIFICATION BY SUBLICENSEE.
10.2.1. MYOGEN INDEMNIFIED PARTIES. Sublicensee hereby agrees to
indemnify, save, defend and hold Myogen and its Affiliates, officers, directors,
agents and employees (the "MYOGEN INDEMNIFIED PARTIES") harmless from and
against any and all Losses incurred by or against such Myogen Indemnified
Parties which arise out of (a) any breach of this Agreement by Sublicensee, or
any negligence or willful misconduct by Sublicensee, except to the extent such
Losses are attributable to the breach of this Agreement by Myogen or any Myogen
Indemnified Parties or any negligence or willful misconduct by Myogen or any
Myogen Indemnified Parties, or (b) the design, manufacture, use, handling,
storage, sale or other disposition of Products by Sublicensee, its Affiliates,
agents or sublicensees, except to the extent such Losses also result from the
negligence or willful misconduct of any Myogen Indemnified Parties.
10.2.2. NOTICE OF CLAIM. In the event that any Myogen Indemnified
Party seeks indemnification under Article 10.2.1, it shall inform Sublicensee of
a claim as soon as reasonably practicable after it receives notice of the claim
and shall permit Sublicensee to assume direction and control of the defense of
the claim (including the right to settle the claim solely for monetary
20.
consideration), and shall cooperate as reasonably requested (at the expense of
Sublicensee) in the defense of the claim.
10.3 INSURANCE.
(A) Throughout the Term and thereafter for a period of ten (10)
years (if such insurance is on a claims-made basis), each Party shall carry and
maintain in full force and effect insurance with an insurance company or
companies having a Best's rating of A or higher against clinical trials
liability (with respect to Sublicensee, solely to the extent Sublicensee is
conducting clinical trials), commercial general liability, and/or product
liability with respect to such Product. Such policies may be worldwide blanket
policies.
(B) Such insurance shall be unimpaired by claims, and shall
include indemnity against liability on the part of either Party and any of its
Affiliates, as well as Myogen, as their interests may appear, due to injury,
disability or death of any person or persons, or injury to property, arising
from the manufacture, sale or use of such Product or components thereof in
amounts of not less than Ten Million USD ($10,000,000.00) combined single limit,
bodily injury and property damage. Within thirty (30) days after the Execution
Date, each Party shall furnish the other Party with certificates of insurance
evidencing the aforesaid coverage, which certificates shall describe the
principal terms of such policy or policies and provide that thirty (30) days
prior written notice of cancellation or material changes in said insurance
policies will be given to the other Party.
(C) The indemnification obligations herein shall apply on a first
dollar basis, without limitation or reduction to any deductible or self-insured
retention which the Parties may have under their insurance coverage.
(D) The provisions of this Article 10 shall survive the
expiration or termination of this Agreement for a period of ten (10) years
following the effective date of such expiration or termination.
ARTICLE 11
DISPUTE RESOLUTION
11.1 GENERAL. The Parties recognize that disputes as to certain matters may
from time to time arise during the term of this Agreement which relate to either
Party's rights and/or obligations hereunder. It is the objective of the Parties
to establish procedures to facilitate the resolution of disputes rising under
this Agreement in an expedient manner by mutual cooperation and without resort
to litigation. To accomplish this objective, the Parties agree to follow the
procedures set forth in this Article 11 if and when a dispute arises under this
Agreement.
11.2 NEGOTIATION. Either Party may, by written notice to the other, have
such dispute referred to their respective executive officers designated below or
their successors, for attempted resolution by good faith negotiations within
fourteen (14) days after such notice is received. Said designated officers are
as follows:
FOR SUBLICENSEE: Managing Director
21.
FOR MYOGEN: Chief Executive Officer
In the event the designated executive officers are not able to resolve
such dispute, either Party may at anytime alter the fourteen (14) day period
seek to resolve the dispute through the means provided in Article 11.3.
11.3 ARBITRATION. Any dispute, controversy or claim arising out of or
relating to this Agreement or the validity, construction, enforceability or
performance hereof or thereof, including without limitation disputes relating to
alleged breach or to termination of this Agreement, shall be finally and
exclusively resolved by arbitration by binding Alternative Dispute Resolution
("ADR") pursuant to the Commercial Arbitration Rules and the administration of
the American Arbitration Association for Large, Complex Cases then in effect.
Arbitral proceedings shall be conducted in Denver, Colorado before three (3)
arbitrators. The arbitral panel may award any remedy allowed by law, including
money damages, prejudgment interest and attorneys' fees, and may grant final,
complete, interim, or interlocutory relief, including injunctive relief.
Notwithstanding the foregoing, punitive, exemplary or multiple damages may not
be awarded.
11.3.1. LEGAL FEES. Except as set forth in Article11.3 above, each
Party shall bear its own legal fees and other expenses incurred in connection
with the transactions contemplated hereby.
11.3.2. CONFIDENTIALITY. The ADR proceeding shall be confidential and
the arbitral panel shall issue appropriate protective orders to safeguard each
Party's Confidential Information. Except as required by law, no Party shall make
(or instruct the arbitrator to make) any public announcement with respect to the
proceedings or decision of the arbitrator without prior written consent of each
other Party. The existence of any arbitrated dispute, and the award, shall be
kept in confidence by the Parties and the arbitral panel, except as required in
connection with the enforcement of such award or as otherwise required by
applicable law.
11.4 SURVIVABILITY. Any duty to arbitrate under this Agreement shall remain
in effect and enforceable alter termination of this Agreement for any reason for
the statute of limitations applicable to any disputes arising out of this
Agreement.
11.5 JURISDICTION. For the purpose of this Article 11, each Party agrees to
abide by the award rendered in any arbitration, and the Parties agree to accept
the jurisdiction of any court having jurisdiction over it for the purposes of
enforcing awards entered pursuant to this Article and for enforcing the
agreements reflected in this Article.
ARTICLE 12
MISCELLANEOUS
12.1 ASSIGNMENT; BINDING EFFECT.
12.1.1. ASSIGNMENT TO AFFILIATES. Either Party may assign any of its
rights or obligations under this Agreement in any country in the Territory to
any Affiliates; provided,
22.
however, that such assignment shall not relieve the assigning Party of its
responsibilities for performance of its obligations under this Agreement.
12.1.2. ASSIGNMENT TO NON-AFFILIATES. Myogen may assign any of its
rights or obligations under this Agreement to a non-Affiliate only in connection
with a merger or similar reorganization or the sale of all or substantially all
of its assets to which this Agreement relates, or otherwise with the prior
written consent of Sublicensee. Neither Sublicensee nor any Affiliate of
Sublicensee may assign any of its rights or obligations under this Agreement to
a non-Affiliate (including transfer of the Trademarks to any Third Party)
without Myogen's prior written consent. Subject to the preceding sentence, this
Agreement shall survive any merger or reorganization of either Party with or
into, or such sale of assets to, a Third Party; provided, that in the event of
such merger, reorganization or sale, no intellectual property rights of the
acquiring corporation shall be included in the patents licensed. The foregoing
notwithstanding, Sublicensee may transfer the Trademarks to Third Parties and
lease such Trademarks back from such Third Parties in connection with financing
transactions; provided that such transfer is subject to those licensing
obligations of Sublicensee set forth in Article 9.4.
12.1.3. BINDING EFFECT. This Agreement shall be binding upon and inure
to the benefit of the Parties and their respective successors and permitted
assigns of the Parties. Any assignment not in accordance with this Agreement
shall be void and of no effect.
12.2 CONSENTS NOT UNREASONABLY WITHHELD. Whenever provision is made in this
Agreement for either Party to secure the consent or approval of the other, such
consent or approval shall not unreasonably be withheld or delayed. Whenever
provision is made in this Agreement for one Party to object or to disapprove a
matter, such objection or disapproval shall not be unreasonably exercised.
12.3 FORCE MAJEURE. Except for the payments of amounts due, neither Party
shall lose any rights hereunder or be liable to the other Party for damages or
losses on account of failure of performance by the defaulting Party if the
failure is occasioned by government action, war, fire, explosion, flood, strike,
lockout, embargo, act of God, or any other similar cause beyond the control of
the defaulting Party; provided that the Party claiming force majeure has exerted
all reasonable efforts to avoid or remedy such force majeure; provided, however,
that in no event shall a Party be required to settle any labor dispute or
disturbance. The foregoing shall not affect either Party's rights hereunder to
terminate this Agreement in its entirety or with respect to the Product or
certain countries in the Territory pursuant to the terms hereof.
12.4 FURTHER ACTIONS. Each Party agrees to execute, acknowledge and deliver
such further instruments and do all such other acts, as may be necessary or
appropriate in order to carry out the purposes and intent of this Agreement.
12.5 TRADEMARK RIGHTS. Except as otherwise provided herein or otherwise
agreed to in writing by the Parties, no right, express or implied is granted by
this Agreement to use in any manner the name "Myogen," "Wulfing" or any other
trade name or trademark of the other Party or its Affiliates in connection with
the performance of the Agreement. Notwithstanding the foregoing, subject to the
terms and conditions of this Agreement, for a period of six (6) months beginning
on the Effective Date, Myogen grants to Sublicensee a non-exclusive,
non-transferable
23.
license (without the right to grant sublicenses) to use the trademark and trade
name "Myogen" (including the Myogen logo) ("MYOGEN MARKS") solely in connection
with marketing and selling in the Territory, Products existing in inventory that
are labeled with the Myogen Marks as of the Effective Date. Sublicensee agrees
to state in appropriate places on all materials using the Myogen Marks that the
Myogen Marks are trademarks of Myogen and to include the symbol (TM) or (R) as
appropriate. Myogen grants no rights in the Myogen Marks other than those
expressly granted in this Article 12.5. Sublicensee acknowledges Myogen's
exclusive ownership of the Myogen Marks. Sublicensee agrees not to take any
action inconsistent with such ownership and to cooperate, at Myogen's request
and expense, in any action (including the conduct of legal proceedings) which
Myogen deems necessary or desirable to establish or preserve Myogen's exclusive
rights in and to the Myogen Marks. Sublicensee will not adopt, use, or attempt
to register any trademarks or trade names that are confusingly similar to the
Myogen Marks or in such a way as to create combination marks with the Myogen
Marks. At Myogen's request, Sublicensee will modify or discontinue any use of
the Myogen Marks if Myogen determines that such use does not comply with
Myogen's then-current trademark usage policies and guidelines.
12.6 NOTICES. All notices hereunder shall be in writing and shall be deemed
given if delivered personally or by facsimile transmission (receipt verified),
mailed by registered or certified mail (return receipt requested), postage
prepaid, or sent by a nationally recognized express courier service, to the
Parties at the following address (or at such other address for a Party as shall
be specified by like notice; provided, that notices of a change of address shall
be effective only upon receipt thereof).
IF TO MYOGEN, ADDRESSED TO:
MYOGEN, INC.
0000 X. 000xx Xxxxxx, Xxxxx 000
Xxxxxxxxxxx, Xxxxxxxx 00000-0000
Attention: President (with a copy to the General Counsel)
Telephone: 000-000-0000
Telecopy: 000-000-0000
IF TO SUBLICENSEE, ADDRESSED TO:
Wulfing Holding GmbH
Bethelner Xxxxxxx. 00
00000 Xxxxxx, Xxxxx
Xxxxxxx
Attention: Managing Director
Telephone: 00 (0) 0000 000 000
Telecopy: 00 (0) 0000 000 000
IF TO GUARANTORS, ADDRESSED TO:
MYOGEN GMBH
Rochusstrasse 175-177
24.
53123 Bonn
Germany
Attention: Xxxxx Xxxxxxxxx
Telephone: 00 (0) 000 00000 00
Telecopy: 00 (0) 000 00000 00
WULFING PHARMA GMBH
Bethelner Xxxxxxx. 00
00000 Xxxxxx, Xxxxx
Xxxxxxx
Attention: Managing Director
Telephone: 00 (0) 0000 000 000
Telecopy: 00 (0) 0000 000 000
12.7 WAIVER. Except as specifically provided for herein, the waiver from
time to time by either Party of any of their rights or their failure to exercise
any remedy shall not operate or be construed as a continuing waiver of same or
of any other of such Party's rights or remedies provided in this Agreement. All
such waivers shall be in writing.
12.8 SEVERABILITY. If any term, covenant or condition of this Agreement or
the application thereof to any party or circumstance shall, to any extent, be
held to be invalid or unenforceable, (a) the remainder of this Agreement, or the
application of such term, covenant or condition to the Parties or circumstances
other than those as to which it is held invalid or unenforceable shall not be
affected thereby and each term, covenant or condition of this Agreement shall be
valid and be enforced to the fullest extent permitted by law; and (b) the
Parties hereto covenant and agree to renegotiate any such term, covenant or
application thereof in good faith in order to provide a reasonably acceptable
alternative to the term, covenant or condition of this Agreement or the
application thereof that is invalid or unenforceable, it being the intent of the
Parties that the basic purposes of this Agreement are to be effectuated.
12.9 AMBIGUITIES. Ambiguities, if any, in this Agreement shall not be
construed against either Party, irrespective of which Party may be deemed to
have authored the ambiguous provision.
12.10 GOVERNING LAW. This Agreement shall be governed by and interpreted
under the laws of the State of Delaware, United States of America without regard
to principles of conflicts of law.
12.11 HEADINGS. The Article and paragraph headings contained herein are for
the purposes of convenience only and are not intended to define or limit the
contents of said Articles or paragraphs and do not form a part of this
Agreement.
12.12 COUNTERPARTS. This Agreement may be executed in two counterparts,
each of which shall be deemed an original, but together shall constitute one and
the same instrument.
12.13 ENTIRE AGREEMENT. This Agreement, including all exhibits and
schedules attached hereto, and all documents delivered concurrently herewith,
set forth all the covenants,
25.
promises, agreements, warranties, representations, conditions and understandings
between the Parties hereto with regard to the subject matter herein and
supersede and terminate all prior agreements, warranties, representations,
conditions or understandings, either oral or written, between the Parties
regarding the subject matter hereof other than as specifically set forth herein
and therein. No subsequent alteration, amendment, change or addition to this
Agreement shall be binding upon the Parties hereto unless reduced to writing and
signed by the respective authorized officers of the Parties.
[REMAINDER OF PAGE INTENTIONALLY LEFT BLANK]
26.
IN WITNESS WHEREOF, the Parties have executed this SALE AND SUBLICENSE
AGREEMENT in duplicate originals by theft duly authorized officers as of the
date and year first above written.
MYOGEN, INC.
By: /s/ Xxxx X. Xxxxxx
------------------------------------
Name: Xxxx X. Xxxxxx
----------------------------------
Title: SVP Commercial Development
---------------------------------
WULFING HOLDING GMBH
By: /s/ Xxxx X. Xxxx
------------------------------------
Name: Xxxx X. Xxxx
----------------------------------
Title: Managing Director
---------------------------------
WULFING PHARMA GMBH
By: /s/ Xxxx X. Xxxx
------------------------------------
Name: Xxxx X. Xxxx
----------------------------------
Title: Managing Director
---------------------------------
MYOGEN GMBH
By: /s/ Xxxxxx Xxxxxxxxx
------------------------------------
Name: Xxxxxx Xxxxxxxxx
----------------------------------
Title: Managing Director
---------------------------------
SALE AND SUBLICENSE AGREEMENT
SIGNATURE PAGE
EXHIBIT A
COUNTRY YEAR 1 YEAR 2 YEAR 3
------- ------- ------- -------
United Kingdom 139,709 69,854 69,854
Republic of Ireland 1,762 881 881
France 52,958 26,479 26,479
Germany 195,251 97,625 97,625
Belgium 7,913 3,957 3,957
The Netherlands 252,100 126,050 126,050
Italy 98,207 49,104 49,104
Other Markets 2,100 1,050 1,050
------- ------- -------
750,000 375,000 375,000
======= ======= =======
