EXHIBIT 10.17
[*#*] 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
(ENOXIMONE)
BY AND BETWEEN
HOECHST XXXXXX XXXXXXX, INC.
AND
MYOGEN, INC.
EFFECTIVE AS OF OCTOBER 1, 1998
TABLE OF CONTENTS
PAGE
ARTICLE 1 DEFINITIONS.................................................................................1
1.1 "Affiliate".....................................................................................1
1.2 "Control".......................................................................................1
1.3 "Development"...................................................................................1
1.4 "Development Expenses"..........................................................................2
1.5 "Development Plans".............................................................................2
1.6 "Drug Approval Application".....................................................................2
1.7 "Enoximone".....................................................................................2
1.8 "Europe"........................................................................................2
1.9 "Equity payments"...............................................................................2
1.10 "FDA"...........................................................................................2
1.11 "Field".........................................................................................2
1.12 "HMR Data"......................................................................................2
1.13 "HMR Know-how"..................................................................................2
1.14 "HMR Patent"....................................................................................2
1.15 "HMR Trademark".................................................................................3
1.16 "IND"...........................................................................................3
1.17 "Information"...................................................................................3
1.18 "Joint Patent"..................................................................................3
1.19 "Major Market Country"..........................................................................3
1.20 "Material Breach"...............................................................................3
1.21 "Milestone Payments"............................................................................3
1.22 "Myogen Data"...................................................................................3
1.23 "Myogen Know-how"...............................................................................3
1.24 "Myogen Patent".................................................................................3
1.25 "NDA" or "New Drug Applications"................................................................4
1.26 "Net Sales".....................................................................................4
1.27 "Patent"........................................................................................4
1.28 "Patent Expenses"...............................................................................4
1.29 "Product".......................................................................................4
1.30 "Q & A".........................................................................................5
1.31 "Regulatory Approval"...........................................................................5
1.32 "Regulatory Filings"............................................................................5
1.33 "Signing Fees"..................................................................................5
1.34 "Sublicensee"...................................................................................5
1.35 "Sublicense Fees"...............................................................................5
1.36 "Terminated Countries"..........................................................................5
1.37 "Termination Effective Date"....................................................................5
1.38 "Territory".....................................................................................5
1.39 "Third Party"...................................................................................5
1.40 "Transfer Date".................................................................................5
1.41 "UTC"...........................................................................................5
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TABLE OF CONTENTS
(CONTINUED)
PAGE
1.42 "Written Disclosure"............................................................................5
ARTICLE 2 LICENSE GRANTS..............................................................................5
2.1 Patent and Know-how License to Myogen to Conduct Development....................................5
2.2 Patent and Know-how License to Myogen for Commercialization.....................................5
2.3 Sublicenses.....................................................................................6
ARTICLE 3 DEVELOPMENT.................................................................................6
3.1 Scope...........................................................................................6
3.2 Conduct of Development..........................................................................6
3.3 U.S. Compassionate Trials.......................................................................6
3.4 Development Plans...............................................................................7
3.5 Status Meetings.................................................................................7
3.6 Obligations of the Parties......................................................................7
3.7 Existing Inventory..............................................................................8
3.8 Regulatory Matters..............................................................................9
ARTICLE 4 MILESTONES AND ROYALTIES....................................................................9
4.1 Europe.........................................................................................10
4.2 Territory other than Europe....................................................................10
4.3 Duration of Royalty Obligations................................................................10
4.4 Royalty Rate if Generics Introduced............................................................11
4.5 Sales by Sublicensees..........................................................................11
4.6 Royalty Payments and Reports...................................................................11
4.7 Taxes..........................................................................................11
4.8 Blocked Currency...............................................................................12
4.9 Payments to or Reports by Affiliates...........................................................12
4.10 No Multiple Royalties..........................................................................12
ARTICLE 5 CONFIDENTIALITY............................................................................12
5.1 Confidentiality; Exceptions....................................................................12
5.2 Authorized Disclosure..........................................................................12
5.3 Survival.......................................................................................13
5.4 Termination of Prior Agreement.................................................................13
5.5 Publications...................................................................................13
ARTICLE 6 OWNERSHIP OF INTELLECTUAL PROPERTY AND PATENT RIGHTS.......................................13
6.1 Ownership......................................................................................13
6.2 Disclosure of Patentable Inventions............................................................14
6.3 Patent Filings.................................................................................14
6.4 Third Party Patent Rights......................................................................15
6.5 Enforcement Rights.............................................................................15
6.6 Assignment of Joint Patents....................................................................16
ARTICLE 7 REPRESENTATIONS AND WARRANTIES; EXCLUSIVITY................................................17
7.1 Representations and Warranties.................................................................17
7.2 Exclusivity; Non-competition Within The Field..................................................17
ARTICLE 8 INFORMATION & REPORTS......................................................................17
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TABLE OF CONTENTS
(CONTINUED)
PAGE
8.1 Records of Revenues and Expenses...............................................................17
8.2 Publicity Review...............................................................................18
ARTICLE 9 TERM AND TERMINATION.......................................................................18
9.1 Term...........................................................................................18
9.2 Termination by HMR For Myogen's Failure to Meet Milestones or Discontinuing
Development....................................................................................18
9.3 Termination by HMR For Myogen's Failure to Commercialize or Market Products in
the Territory..................................................................................19
9.4 Termination for Material Breach by Myogen......................................................21
9.5 Termination Without Cause......................................................................22
9.6 Termination for Material Breach by HMR.........................................................23
ARTICLE 10 INDEMNIFICATION............................................................................24
10.1 Indemnification by HMR.........................................................................24
10.2 Indemnification by Myogen......................................................................24
ARTICLE 11 DISPUTE RESOLUTION.........................................................................25
11.1 General........................................................................................25
11.2 Negotiation....................................................................................25
11.3 Arbitration....................................................................................25
11.4 Survivability..................................................................................26
11.5 Jurisdiction...................................................................................26
ARTICLE 12 MISCELLANEOUS..............................................................................26
12.1 Assignment; Binding Effect.....................................................................26
12.2 Research and Development Entities..............................................................27
12.3 Consents Not Unreasonably Withheld.............................................................27
12.4 Force Majeure..................................................................................27
12.5 Further Actions................................................................................27
12.6 No Trademark Rights............................................................................27
12.7 Notices........................................................................................27
12.8 Waiver.........................................................................................28
12.9 Severability...................................................................................28
12.10 Ambiguities....................................................................................28
12.11 Governing Law..................................................................................28
12.12 Headings.......................................................................................28
12.13 Counterparts...................................................................................28
12.14 Entire Agreement...............................................................................28
12.15 Additional Agreements..........................................................................29
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LICENSE AGREEMENT
LICENSE AGREEMENT (the "Agreement") effective as of October 1, 1998
(the "Effective Date"), by and between MYOGEN, INC., a
Delaware corporation
("Myogen") and HOECHST XXXXXX XXXXXXX, INC., a
Delaware corporation ("HMR").
Myogen and HMR are sometimes referred to herein individually as a "Party" and
together as the "Parties."
W I T N E S S E T H:
WHEREAS, HMR is a leading multinational health care company with a
broad product portfolio of drugs for the treatment of human diseases;
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 desires to obtain an exclusive worldwide license from
HMR for the right to develop and commercialize Enoximone (as defined in Article
1.8) on the terms and subject to the conditions set forth in this Agreement.
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 I
shall have the meanings specified below:
1.1 "AFFILIATE" shall mean 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 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.
1.2 "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.
1.3 "DEVELOPMENT" shall mean all activities relating to obtaining
Regulatory Approval of a Product, Product line extensions, alternative delivery
systems and new indications therefor and all activities relating to developing
the ability to manufacture the same. This includes pre-clinical testing,
toxicology, formulation, bulk product, fill/finish, manufacturing
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process development, manufacturing and quality assurance technical support,
clinical studies, regulatory affairs and outside counsel regulatory legal
services.
1.4 "DEVELOPMENT EXPENSES" shall mean any and all Patent Expenses,
costs and expenses incurred in obtaining Regulatory Approval for the Product and
the expenses incurred by Myogen in accordance with the Development Plan, which
expenses are attributable to Development of the Products for use in the Field.
1.5 "DEVELOPMENT PLANS" shall mean the Development Plans referred to in
Article 3.4.
1.6 "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.
1.7 "ENOXIMONE" shall mean
1,3-dihydro-4-methyl-5-[*#*]-2H-imidazol-2-one, and all
pharmaceutically-acceptable forms (e.g., salts) and all formulations thereof,
including, without limitation, that formulation developed by HMR and marketed
under the trade name of Perfan in Europe.
1.8 "Europe" shall mean the following countries Austria, Belgium,
Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the
Netherlands, Portugal, Spain Sweden, and the United Kingdom.
1.9 "EQUITY PAYMENTS" shall have the meaning set forth in Article
2.3.2.
1.10 "FDA" means the United States Food and Drug Administration or any
other equivalent regulatory authority in the Territory.
1.11 "FIELD" means the prevention, treatment and/or diagnosis of
cardiovascular diseases and disorders.
1.12 "HMR DATA" means all Information related to the Product HMR 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 HMR or its
Affiliates or disclosed to HMR or its Affiliates by licensors and other
collaborators to the extent not subject to a restrictive confidentiality
arrangement with a Third Party.
1.13 "HMR KNOW-HOW" means Information which (i) HMR discloses, or is
required to disclose, to Myogen under this Agreement and (ii) is within the
Control of HMR and its Affiliates. Notwithstanding anything herein to the
contrary, HMR Know-how shall exclude any HMR Patent.
1.14 "HMR PATENT" means any and all Patents which cover the discovery,
evaluation, manufacture, use or importation, offer for sale and/or sale of
Enoximone in the Field or Product, which Patent is owned or Controlled by HMR or
any of its Affiliates as listed in Schedule 1.14, including HMR's or any of its
Affiliates' interest in any Joint Patent. HMR will promptly notify Myogen of any
HMR Patents that are issued or applied for hereafter.
1.15 "HMR TRADEMARK" means the trademark Perfan in Europe and any other
trademarks or tradenames used by HMR to market Enoximone in any country in the
Territory.
1.16 "IND" shall mean an Investigational New Drug Application.
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1.17 "INFORMATION" means techniques and data including inventions,
practices, methods, assays, knowledge, know-how, skill, experience, marketing,
pricing, distribution, cost, 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.
1.18 "JOINT PATENT" shall have the meaning set forth in Article 6.3.1.
1.19 "MAJOR MARKET COUNTRY" means each of Argentina, Brazil, Mexico,
Canada, United States, Germany, France, Italy, Spain, United Kingdom, Australia,
Japan, Korea, Belgium, Austria.
1.20 "MATERIAL BREACH" shall have the meaning set forth in Article 9.4
(d).
1.21 "MILESTONE PAYMENTS" shall have the meaning set forth in Article
2.3.2.
1.22 "MYOGEN DATA" means all Information arising out of all Development
(as defined in Article III) conducted by or on behalf of Myogen or its
sublicensees, or disclosed to Myogen by its licensors and other collaborators
necessary to obtain Regulatory Approval for marketing of Products in the
Territory.
1.23 "MYOGEN KNOW-HOW" means Information which (i) Myogen discloses, or
is required to disclose, to HMR under this Agreement and (ii) is within the
Control of Myogen, including, without limitation, all Information developed by
or on behalf of Myogen relating to the Product. HMR hereby acknowledges that
University Technology Corporation (UTC) may own the rights to some or all of
Myogen's Patents and Know-how and that there are agreements between UTC and
Myogen whereby Myogen has exclusively licensed, or has the right to exclusively
license, UTC's rights subject to rights for research and education. HMR also
acknowledges that Myogen's performance under this Agreement cannot violate any
of the terms of those agreements between Myogen and UTC which have been provided
to HMR set out as Schedule 1.23. Notwithstanding anything herein to the
contrary, Myogen Know-how shall exclude any Myogen Patents.
1.24 "MYOGEN PATENT" means any and all Patents for inventions made
solely by Myogen personnel on behalf of Myogen or its Affiliates which covers
the evaluation, manufacture, use, importation, offer for sale and/or sale of
Enoximone for development by Myogen within the Field or Product, which Patent is
owned or Controlled by Myogen or its Affiliates, including Myogen's interest in
any Joint Patent. HMR hereby acknowledges that University Technology Corporation
(UTC) may own the rights to some or all of Myogen's Patents and Know-how and
that there are agreements between UTC and Myogen whereby Myogen has exclusively
licensed, or has the right to exclusively license, UTC's rights subject to
rights for research and education. HMR also acknowledges that Myogen's
performance under this Agreement cannot violate any of the terms of those
agreements between Myogen and UTC which have been provided to HMR set out as
Schedule 1.23. Myogen shall-promptly notify HMR of any Myogen Patents which are
issued or applied for hereafter.
1.25 "NDA" OR "NEW DRUG APPLICATIONS" shall mean any and all
applications submitted to the FDA under Sections 505, 507, or 512 of the Federal
Food, Drug and Cosmetic Act and any applicable regulations related to any
Products, including without limitation, full NDAs, "paper" NDAs and abbreviated
NDAs (ANDAs) and all amendments and supplements or equivalents in the Territory.
1.26 "NET SALES" of Myogen and/or its sublicensee shall mean such
party's gross sales of Products produced hereunder 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;
(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;
(d) amounts allowed or credited on returns.
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No deductions shall be made for commissions paid to individuals whether
they be with independent sales agencies or regularly employed by Myogen 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.
1.27 "PATENT" means an (i) United States patent, continuation,
continuation-in-part, division, patent of addition, reexamination, reissue,
renewal, extension, term restoration and foreign counterpart thereof, including
a supplementary protection certificate and other administrative protection, and
(ii) application for a United States patent and foreign counterpart thereof; in
either case, which claim the manufacture, sale or use of Enoximone or a Product,
or formulations or manufacture thereof, for use in the Field. Any other compound
or use outside of the Field disclosed or claimed in such patent or patent
application is not within this definition of "Patent."
1.28 "PATENT EXPENSES" means the fees and expenses of outside counsel
and payments to Third Parties incurred after the Effective Date in connection
with the preparation, filing, prosecution and maintenance of Myogen Patents and
HMR Patents, including the costs of patent interference and opposition
proceedings.
1.29 "PRODUCT" shall mean any finished pharmaceutical composition
containing Enoximone as a pharmaceutically active ingredient (either alone or in
combination with one or more other pharmaceutically active ingredients), for use
in the Field.
1.30 "Q & A" shall have the meaning set forth in Article 8.2.
1.31 "REGULATORY APPROVAL" means any approval (including pricing and
reimbursement approvals), product and/or establishment license, registration or
authorization of any federal, state or local regulatory agency, department,
bureau or other governmental entity necessary for the manufacture, use, storage,
import, export, transport or sale of a Product.
1.32 "REGULATORY FILINGS" shall have the meaning set forth in Article
3.8.2.
1.33 "SIGNING FEES" shall have the meaning set forth in Article 2.3.2.
1.34 "SUBLICENSEE" shall have the meaning set forth in Article 2.3.2.
1.35 "SUBLICENSE FEES" shall have the meaning set forth in Article
2.3.2.
1.36 "TERMINATED COUNTRIES" shall have the meaning set forth in Article
9.3.1.
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1.37 "TERMINATION EFFECTIVE DATE" shall have the meaning set forth in
Article 9.2.
1.38 "TERRITORY" means all countries and territories of the world
provided that any country(ies) in which this Agreement is terminated shall be
removed from the scope of this definition.
1.39 "THIRD PARTY" means any entity other than Myogen or HMR or their
respective Affiliates.
1.40 "TRANSFER DATE" shall have the meaning set forth in Article 4.1
(c).
1.41 "UTC" means University Technology Corporation, a not for profit
Colorado Corporation, having its principle place of business at 0000 Xxxx
Xxxxxx, Xxxxx 000, Xxxxxxx, Xxxxxxxx 00000.
1.42 "WRITTEN DISCLOSURE" shall have the meaning set forth in Article
8.2.
ARTICLE 2
LICENSE GRANTS
2.1 PATENT AND KNOW-HOW LICENSE TO MYOGEN TO CONDUCT DEVELOPMENT. Upon
the terms and subject to the conditions of this Agreement, HMR grants to Myogen
an exclusive license (even as to HMR and its Affiliates) under the HMR Patents
and HMR Know-how, and Joint Patents, if any, to conduct Development in the
Territory in accordance with the terms of this Agreement with respect to
Enoximone for use in the Field; [*#*]
2.2 PATENT AND KNOW-HOW LICENSE TO MYOGEN FOR COMMERCIALIZATION. Upon
the terms and subject to the conditions of this Agreement, including, without
limitation, the royalty payment obligations herein, HMR grants to Myogen an
exclusive (even as to HMR and its Affiliates) license under the HMR Patents and
HMR Know-how to conduct manufacturing, pre-marketing activities,
commercialization (including the right to make, have made, use, import, sell,
offer for sale and have sold) and related activities in the Territory with
respect to Enoximone and any Product in accordance with the terms of this
Agreement; [*#*]
2.3 SUBLICENSES.
2.3.1 APPROVAL REQUIRED. The foregoing license shall include the right
to sublicense, but only upon prior written notice to HMR.
2.3.2 SUBLICENSE FEES AND PAYMENTS. At such time that the aggregate of
sublicensee fees, signing and payments (including equity payments) to Myogen
from all sublicenses exceed [*#*], Myogen shall pay to HMR [*#*] of such fees
and payments in excess of the initial [*#*]. Such payments to HMR shall be made
by Myogen within [*#*] days of Myogen's receipt of the corresponding payment
from the applicable sublicensee. "Sublicense fees" shall mean any lump sum fees
paid by Sublicensee to Myogen, but shall not mean any royalties on sales of
Product received by Myogen from the sublicensee. "Signing fees" shall mean fees
received by Myogen from the sublicensee upon signing of the sub
license
agreement. "Milestone payments" shall mean payments received by Myogen from the
sublicensee that are payable upon achievement of a particular milestone or goal.
"Equity payments" shall mean amounts received by Myogen for investments by the
sublicensee in Myogen to obtain an equity position in Myogen in connection with
its Myogen sublicensing activity. "Sublicensee" means a Third Party that enters
into a sub
license agreement with Myogen providing a sublicense to such Third
Party under Myogen's license provided by this Agreement.
ARTICLE 3
DEVELOPMENT
3.1 SCOPE. Myogen shall conduct a development program with respect to
Products with the objective of obtaining Regulatory Approval and commercializing
a Product as set forth in this Agreement.
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3.2 CONDUCT OF DEVELOPMENT. Myogen will be solely responsible for
carrying out Development of Products. Throughout the term hereof, Myogen shall
have the right to engage Third Parties to perform its research, development and
commercialization activities pursuant to this Agreement, provided such Third
Party agrees to be bound by Article V hereof or the equivalent. Notwithstanding
any other provision hereof, Myogen shall have sole control and authority over
all aspects of Development and commercialization of Products in the Territory,
and HMR shall not have any liability with respect thereto.
3.3 U.S. COMPASSIONATE TRIALS Promptly after the date of execution of
this Agreement, Myogen shall assume full responsibility for all aspects of U.S.
compassionate trials under the IND for Enoximone that was submitted to the FDA.
HMR will transfer all records and study data relating to the Compassionate
trials to Myogen. Myogen and HMR will cooperate to ensure an orderly and clear
transfer of responsibility.
3.4 DEVELOPMENT PLANS. Development of Products pursuant to this Article
III shall be governed by a separate written plan attached as Exhibit 3.4 hereto
("Development Plan") which, together with updates, shall be prepared by Myogen
and submitted to HMR for its information. Each Development Plan will describe
the proposed overall program of development for Products, including, process
development, clinical studies and regulatory plans and other elements of
obtaining Regulatory Approval. Each Development Plan will set forth key
objectives. Each Development Plan will be updated annually by Myogen and,
together with any updates thereto, be provided to HMR for its information.
3.5 STATUS MEETINGS. Representatives from HMR and Myogen will meet at
least two (2) times annually to discuss development and commercialization of
Products for use in the Field for purposes of HMR's information and to monitor
Myogen's compliance with the provisions of this Agreement. The location of such
meetings will alternate between Myogen's facilities and HMR's facilities. Each
Party will bear its own travel and related costs. Myogen shall provide HMR all
Information reasonably requested by HMR during the term hereof relating to the
development and commercialization of Products for use in the Field and Products.
3.6 OBLIGATIONS OF THE PARTIES.
3.6.1 MYOGEN'S OBLIGATIONS.
(a) Myogen shall use reasonable commercial diligence,
consistent with accepted business practices and legal requirements relating to
pharmaceutical drug development and within the general guidelines as set forth
in the Development Plans and any updates thereto, to continue Development of
Products in the Territory, devoting the same degree of attention and diligence
to such development efforts as similar companies devote to development
activities for potential drug products of comparable market potential.
(b) Myogen shall initiate a Phase III study for the purpose of
obtaining FDA Regulatory Approval of a Product after regulatory consultation
with the FDA within 3 years after the Effective Date; provided that in the event
Myogen experiences any delays in complying with this Section 3.6.1(b) that are
caused by parties or events outside of the control of Myogen, including, without
limitation, any additional requirements imposed by the FDA beyond those
specified in the Development Plan, the date by which Myogen is required to
initiate a Phase III study as required herein shall automatically be extended by
the period of such delay. As used in this Section 3.6.1(b), the "Initiation of a
Phase III study" shall be deemed to have occurred when the first patient is
enrolled in such study.
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(c) In the event Myogen fails to meet the commercial diligence
requirements of this Article 3.6.1, HMR may in its discretion terminate this
Agreement as provided in Article IX herein.
3.6.2 HMR'S OBLIGATIONS.
(a) Within 120 days after execution of this Agreement, HMR
shall transfer to Myogen the IND for Enoximone, shall deliver to Myogen all HMR
Data in the form in which it is currently available in order to facilitate
commencement of Development hereunder, and thereafter shall provide such
additional HMR Data or data subsequently developed by HMR and its Affiliates
reasonably requested by Myogen.
(b) It is expressly understood that HMR has no obligation to
finalize clinical reports but that HMR shall deliver to Myogen the raw data and,
if available, the final clinical reports.
3.6.3 DEVELOPMENT REPORTS. Myogen shall submit semi-annual written
summary reports which describe the progress of development efforts undertaken by
it, if any, under this Agreement. Summary reports shall include, without
limitation, a description and statement of purpose of each study in progress,
and with respect to clinical trials, the number of patients which enrolled in,
dropped from, or completed the study, as well as any side effect or unexpected
data, and the progress towards the diligence obligations set forth in Article
3.6.1.
3.6.4 DEVELOPMENT AND COMMERCIALIZATION EXPENSES.
(a) During the term of this Agreement, (i) Myogen shall bear
its own costs and expenses incurred with any development and commercialization
conducted pursuant to this Agreement, and (ii) Myogen will reimburse HMR for
efforts and costs related to HMR data retrieval at HMR facilities, for
consultation services and commercialization assistance which HMR performs at the
rates as set forth on Schedule 3.6.4 attached hereto. HMR shall submit written
statements on a quarterly basis to Myogen setting forth such expenses incurred
by HMR for such quarter and Myogen shall reimburse HMR for such expenses within
thirty (30) days thereafter.
(b) In the event of termination pursuant to Article IX, Myogen
shall bear its own costs and expenses incurred in connection with any
development and commercialization conducted by it pursuant to this Agreement.
3.7 EXISTING INVENTORY.
(a) Within 120 days after the date of execution of the
Agreement, Myogen shall purchase from HMR and HMR shall deliver to Myogen,
approximately [*#*] active ingredient to be used by Myogen for Development.
(b) Upon the Transfer Date (as defined in Section 4.1 hereof),
Myogen shall purchase from HMR and HMR shall deliver to Myogen, that number of
kilograms of Enoximone active ingredient [*#*] as shall be determined by
Myogen in its sole discretion upon the Transfer Date.
(c) [*#*] of Enoximone active ingredient purchased under
this Section 3.7, payment of which shall be made by Myogen within ten (10)
business days after the relevant shipment has been dispatched by HMR. HMR will
ship the Enoximone "Free Carrier, HMR site Midland, MI, (FCA per INCOTERMS, 1990
version)".
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3.8 REGULATORY MATTERS.
3.8.1 COMPLIANCE WITH REGULATIONS. Myogen, and HMR to the
extent it is providing services will conduct their efforts hereunder in
compliance with all applicable regulatory requirements, including without
limitation, the FDA's Good Clinical Practice, Good Laboratory Practice and Good
Manufacturing Practice regulations and the guidelines of the International
Conference on Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use.
3.8.2 REGULATORY FILINGS. After transfer of the IND for
Enoximone that was submitted to the FDA and HMR Data to Myogen, Myogen shall, at
its own expense, prepare and submit all filings with the regulatory authorities
with respect to Enoximone in each Major Market Country (the "Regulatory
Filings"), and Myogen shall be responsible for causing such applications to
progress through the approval process in a timely manner. [*#*] Myogen shall,
promptly after each such Regulatory Filing, deliver to HMR a report with a brief
summary of such Regulatory Filing, which shall be held by HMR subject to the
provisions of Article V.
3.8.3 MAINTENANCE OF RECORDS. Myogen shall maintain records
with respect to activities conducted in connection with the Development of
Enoximone 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 Myogen in
the course of such Development.
3.8.4 ADVERSE EVENT REPORTING. After transfer of the IND for
Enoximone that was submitted to the FDA to Myogen, Myogen shall be responsible
for reporting of adverse experience information to meet the current requirements
for Adverse Drug Reaction reporting to the FDA. The parties recognize that the
holder of a IND may be required to submit information regarding adverse events
concerning the Product to various governmental agencies. In addition,
supplemental information may be required to be provided at periodic intervals
and adverse events may be required to be reported at more frequent intervals
depending on the severity of the event.
ARTICLE 4
MILESTONES AND ROYALTIES
4.1 Europe. As consideration for the rights granted to Myogen by HMR
under this Agreement for Europe Myogen shall make the following payments to HMR:
(a) Myogen will pay to HMR [*#*] upon signing of this
Agreement;
(b) Myogen will pay to HMR [*#*] upon the earlier of (i) the approval
by the FDA for Myogen to proceed with Phase III clinical studies with the oral
Formulation of a product or (ii) six (6) months after the Effective Date;
(c) On a date no later than one (1) year from the date of
signing (the "Transfer Date"), Myogen shall pay to HMR [*#*] Upon the Transfer
Date (i) HMR shall transfer to
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[*#*]CONFIDENTIAL TREATMENT REQUESTED
Myogen any and all of its rights and obligations for Enoximone and Product
commercialization activities in Europe except as specified in this Section
4.1(c), and (ii) HMR shall transfer whatever rights it may have under the
existing HMR Trademarks in the countries listed in Exhibit 4.1.(c). Myogen will
[*#*] prepare and provide the documents necessary to transfer the HMR Trademark
rights. HMR is not transferring, and Myogen does not accept any liabilities
caused by or arising from the manufacture, use, commercialization or sale of the
Product incurred or arising prior to the Transfer Date. All accounts payable or
receivable existing as of the Transfer Date or relating to any periods prior to
the Transfer Date shall remain the accounts payable or receivable of HMR. All
reporting, tax and other responsibilities and obligations relating to the
Enoximone or Product for periods prior to the Transfer Date shall remain with
HMR. All returns of Enoximone or Product shipped prior to the Transfer Date
shall be the responsibility of HMR;
(d) On the first anniversary of the Transfer Date, Myogen
shall pay to HMR [*#*]
(e) On the second anniversary of the Transfer Date, Myogen
shall pay to HMR [*#*]
(f) Beginning on the first day of the calendar quarter in
which the second anniversary of the Transfer Date falls, Myogen will pay to HMR
for a period of ten (10) years, on a quarterly basis within 60 days after the
end of each calendar quarter, periodic payments equal to [*#*] that occurred in
the immediately preceding calendar quarter;
(g) The payments in Article 4.1(a)-(e) shall be allocated
between HMR and its Affiliates. HMR shall receive sixty percent (60%) of these
payments. HMR's European Affiliates shall receive forty percent (40%). HMR will
retain one hundred percent (100%) of the royalties in Article 4.1(f) and Article
4.2.
4.2 TERRITORY OTHER THAN EUROPE. With respect to markets in the
Territory excluding Europe and in consideration of the rights granted by HMR
under this Agreement, Myogen shall pay to HMR, on a quarterly basis within sixty
(60) days after the end of each calendar quarter, periodic payments equal to
[*#*] in such markets that occurred in the immediately preceding calendar
quarter.
4.3 DURATION OF ROYALTY OBLIGATIONS. If this Agreement is not
terminated in accordance with the other provisions hereof, Myogen's obligation
to pay earned royalties hereunder in a particular country shall continue until
the termination of this Agreement for so long as Myogen by its activities would,
but for the license granted herein, infringe a valid claim of an unexpired HMR
Patent in such country covering said activity. From and after the expiration of
such claims, all royalty amounts shall be reduced by [*#*] but shall in no event
be less than [*#*] until the tenth (10) anniversary of the first commercial sale
of the relevant Product in such country after which time all royalty obligations
shall cease entirely.
4.4 ROYALTY RATE IF GENERICS INTRODUCED. In the event that a generic
version of a Product is marketed in any country of the Territory where no
relevant Patents within the HMR Patents or Joint Patents have issued, the
royalty rate in that country will be reduced to [*#*] of the applicable
royalty provided in Articles 4.1 and 4.2 but shall in no event be less than
three and [*#*]
4.5 SALES BY SUBLICENSEES. In the event Myogen grants licenses or
sublicenses to others to make or sell Products, such licenses or sublicenses
shall include an obligation for the
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licensee or sublicensee to account for and report to Myogen its Net Sales of
such Products on the same basis as if such Net Sales were sales by Myogen, and
Myogen shall pay royalties to HMR as if the Net Sales of the sublicensee were
sales of Myogen. Amounts payable by the sublicensee to Myogen on account of the
sublicense shall not be included in amounts deducted from gross sales in
arriving at Net Sales.
4.6 ROYALTY PAYMENTS AND REPORTS. Royalty payments under this Agreement
shall be made to HMR or its designee along with the report summarizing the Net
Sales of any Products by Myogen, its Affiliates or Sublicensees during the
relevant quarter within sixty (60) days following the end of each calendar
quarter. All payments to HMR 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 HMR
instructs Myogen otherwise payments pursuant to this Article V shall be made by
bank wire transfer as follows:
Citibank, New York
Hoechst Xxxxxx Xxxxxxx, Inc.
[*#*]
4.7 TAXES. HMR 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 Myogen will (i) deduct those taxes from the remittance
royalty, (ii) timely pay the taxes to the proper taxing authority and (iii) send
proof of payment to HMR within thirty (30) days following such payment.
4.8 BLOCKED CURRENCY. In each country where the local currency is
blocked or cannot be removed from such country, Myogen will pay the royalty owed
on Net Sales in that country in US currency to HMR at the exchange rate in
Article 4.6.
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.
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 more than one HMR Patent or HMR Know-how licensed under this Agreement.
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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 [*#*] 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 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
(i) filing or prosecuting patent applications, (ii) prosecuting or defending
litigation, (iii) complying with applicable laws or regulations or (iv)
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 V, Confidential Information to any Third Party for the purpose
of carrying out the purposes of this Agreement. Nothing in this Article V shall
restrict any Party from using for any purpose consistent with the terms of this
Agreement any 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
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
agreement from each such employee that such employee agrees to be bound by the
provisions of Article 6.1 hereof or the equivalent.
5.3 SURVIVAL. This Article V shall survive the termination or
expiration of this Agreement for a period of [*#*] years.
5.4 TERMINATION OF PRIOR AGREEMENT. All Information exchanged between
the Parties under the Confidentiality Agreement between Myogen and HMR, dated as
of February 4, 1997, as amended, shall be deemed Confidential Information and
shall be subject to the terms of this Article V, and shall be included within
the definitions of Myogen Know-how and HMR Know-how.
5.5 PUBLICATIONS. Except as required by law, each Party agrees that it
shall not publish or present Information or Confidential Information without the
opportunity for prior review by the other Party. Each Party shall provide to the
other the opportunity to review and approve any proposed publications or
presentations (including information to be presented verbally) which relate to
Enoximone or the Products or otherwise constitutes Confidential Information as
early as reasonably practical, but at least four weeks prior to their intended
submission for publication (except, where applicable, with the written consent
of an appropriate officer of the other Party) and such submitting Party agrees,
upon written request from the other Party, not to submit such abstract or
manuscript for publication or to make such presentation until the other Party
consents. It is understood and agreed that the provisions of this Article 5.5
are directed to publications and presentations that may be made to the general
public, including the relevant scientific communities, and that nothing herein
will prevent or limit Myogen from preparing materials that may contain
Information or Confidential Information and making presentations with respect
thereto that are private in nature.
ARTICLE 6
OWNERSHIP OF INTELLECTUAL PROPERTY AND PATENT RIGHTS
6.1 OWNERSHIP.
6.1.1 HMR shall solely own, and it alone shall have the right
to apply for Patents within and outside of the United States for any inventions
made solely by HMR's personnel or consultants in the course of performing work
under this Agreement.
6.1.2 Myogen and/or UTC shall solely own, and Myogen alone
shall have the right to apply for Patents within and outside of the United
States for any inventions made solely by Myogen's personnel or consultants, or
substantially by Myogen with insignificant contribution from HMR, in the course
of performing work under this Agreement.
6.1.3 Inventions made jointly by personnel or consultants of
Myogen and HMR, so long as both Parties have made substantial contribution to
the inventions, shall be owned jointly, without accounting, by Myogen and/or UTC
and HMR. The law of joint ownership of inventions of the United States shall
apply to any joint ownership of patents within the United States claiming joint
inventions of the Parties.
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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 the Enoximone
in the Field or the Products. 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.
6.3 PATENT FILINGS.
6.3.1 MYOGEN AND JOINT PATENTS. Myogen shall prepare, file,
and prosecute Patents for (i) inventions relating to Enoximone that are made
pursuant to Section 6.1.2 hereof by Myogen personnel and consultants (all of
which shall be issued in Myogen's and/or UTC's name and shall be Myogen
Patents), and (ii) inventions relating to Enoximone that are made jointly
pursuant to Section 6.1.3 hereof by personnel and consultants of Myogen and HMR
in the course of the performance of the Parties' obligations under this
Agreement (which shall be issued in HMR's and Myogen's and/or UTC joint name and
shall be "Joint Patents"), and will use reasonable efforts to file initially all
such applications in the United States. With respect to Joint Patents only (A)
the determination of the countries outside of the United States in which to file
patent applications shall be made by Myogen and, if appropriate, UTC; (B) Myogen
shall keep HMR informed of the status of such Patents and shall seek the advice
of HMR with respect to such Patent strategy and draft applications and shall
give reasonable consideration to any suggestions or recommendation of HMR
concerning the preparation, filing, prosecution and maintenance thereof; and (C)
the Parties shall cooperate in good faith in the prosecution of such Patents and
shall share all material Information relating thereto promptly after receipt of
such Information.
6.3.2 HMR PATENTS. HMR shall file, prosecute and be entitled
to be issued in its name Patents to cover inventions relating to Enoximone that
are made solely by HMR personnel and consultants (all of which will be HMR
Patents), and will use reasonable efforts to file initially all such
applications in the United States. The determination of the countries outside of
the U.S. in which to file shall be made by mutual agreement of the Parties. If,
however, there is a dispute as to where to file, the more comprehensive filing
shall be made. HMR shall keep Myogen informed of the status of each HMR Patent
and shall seek the advice of Myogen with respect to HMR Patent strategy and
draft applications and shall give reasonable consideration to any suggestions or
recommendations of Myogen concerning the preparation, filing, prosecution and
maintenance thereof. The Parties shall cooperate reasonably in the prosecution
of all applications for HMR Patents and shall share all material Information
relating thereto promptly after receipt of such Information. If, during the term
of this Agreement, HMR intends to allow any HMR Patent under which Myogen has a
license under this Agreement, to lapse or become abandoned without having first
filed a substitute, HMR shall, whenever practicable, notify Myogen of such
intention at least sixty (60) days prior to the date upon which such HMR Patent
shall lapse or become abandoned, and Myogen shall thereupon have the right, but
not the obligation, to assume responsibility for the prosecution and maintenance
thereof (and Patent Expenses shall continue to be shared).
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[*#*]CONFIDENTIAL TREATMENT REQUESTED
6.4 THIRD PARTY PATENT RIGHTS.
(a) HMR 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 Patent, Know-how or any other activity
contemplated by this Agreement.
(b) Neither Party makes any representation or warranty to the
other, other than that made in this Section 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 Patent, 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, import, use, sale or offer for sale of a product competitive with a
Product being developed or commercialized under this Agreement infringes or is
reasonably likely to infringe ("Competitive Product Infringement") any Myogen
Know-how, Myogen Patent, HMR Know-how, HMR Patents, or Joint Patents, Myogen
and/or UTC shall have the 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. HMR has the right to participate and be
represented in such action by counsel of its own selection at its own expense.
HMR agrees to be joined as a party plaintiff, if necessary in any such action,
and to give Myogen reasonable assistance and any needed authority to control,
file and to prosecute such action.
(b) If either Party learns or determines in good faith that
there is or is a reasonable likelihood of Competitive Product Infringement of
any Myogen Patents, HMR Patents, or Joint Patents by a Third Party, 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 reasonable detail. If Myogen or HMR, as the case may be, fails to institute
and prosecute an action or proceeding to xxxxx any actual infringement within a
period of ninety (90) days after receiving written notice of actual infringement
or otherwise having knowledge of the actual infringement, then the other Party
shall have the right, but not the obligation, to bring and prosecute any action
and the Party which failed to bring such action agrees to be joined as a party
plaintiff in such action and to give the Party bringing such action reasonable
assistance and all authority to control, file and prosecute the action as may be
necessary; provided, however, that the Party which failed to bring the action
shall have the right to participate and to be represented in any such action by
counsel of its choice; provided, further, that HMR's right to bring such an
action may be limited if the Myogen Patent at issue is owned by UTC (HMR hereby
acknowledges that UTC has the first right to bring an action against an
infringer in the case of a Myogen Patent owned by UTC and licensed to Myogen).
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(c) [*#*] and related recoveries with respect to actions
brought under this Article 6.5.1 shall be [*#*] to the benefit of Myogen,
except as otherwise noted herein. Any amounts recovered in such action referred
to in this Article 6.5.1 shall be recovered by Myogen.
(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
joint consent of Myogen and HMR, which consents shall not be withheld
unreasonably or delayed, except with respect to Myogen Patents owned by UTC.
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 is
infringed by the manufacture, use or sale of any Product and if following the
conclusion of proceedings brought as a result of such alleged infringement,
Myogen is required to pay the Third Party any payment of any kind for the right
to sell a Product in a particular country, the royalty rate then payable to HMR
attributable only to sales in such country shall be reduced by [*#*] The royalty
rate shall return to its previous level once Myogen has fully satisfied the
payment due to the Third Party. [*#*] 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 HMR which shall not be
unreasonably withheld or delayed.
6.5.3 PATENT PROSECUTION RIGHTS. Notwithstanding the
provisions of Article 6.5.1, a Party shall not file or prosecute any action for
infringement of a Patent for which the other Party has the primary
responsibility if the other Party having primary responsibility is prosecuting
at least one such action for infringement of such Patent, without the agreement
of the other Party, which agreement shall not be unreasonably withheld.
6.6 ASSIGNMENT OF JOINT PATENTS. Neither Party may assign its rights
under any Joint Patent except with the prior written consent of the other Party;
provided, however, that either party may assign such rights without consent to
an Affiliate or other permitted assignee under this Agreement in connection with
a merger or similar reorganization or sale of all or substantially all of its
assets.
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 Section 365(n) of the U.S. 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
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[*#*]CONFIDENTIAL TREATMENT REQUESTED
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: HMR and its Affiliates shall not, directly or indirectly,
conduct, have conducted or fund any research, development, regulatory, or
commercialization activity of Enoximone or the Products within the Field other
than pursuant to the terms and conditions of this Agreement, and Myogen
acknowledges that its activities and operations pursuant to this Agreement shall
be the principal mechanism by which Myogen will commercialize the Products. HMR
may terminate this Agreement for cause pursuant to Article 9.4 hereof in the
event of the material breach of this paragraph 7.2 by Myogen or its Affiliates.
ARTICLE 8
INFORMATION & REPORTS
8.1 RECORDS OF REVENUES AND EXPENSES. Myogen 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 HMR's expense during Myogen'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, HMR may designate a firm of certified public
accountant acceptable to Myogen 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
Myogen within thirty (30) days of the conclusion of the audit (subject to
Article XIII hereof). If the audit results in a variance of more than 5% in
favor of HMR, the reasonable audit expenses of HMR shall be paid by Myogen. Any
records or accounting information received from Myogen shall be included within
the definition of Confidential Information for purposes of Article VI. In the
event the provisions of Section 9.5.3 apply, the provisions of this Section 8.1
shall apply to HMR.
8.2 PUBLICITY REVIEW. Subject to the provisions of this Article 8.2, no
Party shall originate any written publicity, news release, or other public
announcement relating to this Agreement or the performance hereunder or the
existence of an arrangement between the Parties (collectively, "Written
Disclosure"), without the prior prompt review and written approval of the other,
which approval shall not be unreasonably withheld. In addition, each Party
agrees to submit to the other Party, for prompt review and written approval, any
question and answer sheet or similar materials ("Q & A") prior to using such
materials in connection with oral disclosures. With regard to any proposed
Written Disclosure or Q & A by Myogen, HMR shall take into consideration that
Myogen is a specialized privately held company and as such will find it
important to provide ongoing information about this Agreement and the status of
the Collaboration Agreement to investors or potential investors. Recognizing
that it is impractical to have each oral disclosure reviewed in advance, the
Parties agree that oral disclosures by any Party of information which is
immaterial and which relates to this Agreement, or to performance
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[*#*]CONFIDENTIAL TREATMENT REQUESTED
hereunder or the existence of an arrangement between the Parties, shall be
generally consistent with previously approved Written Disclosures or Q & A's.
Notwithstanding the foregoing provisions of this Article 8.2, any Party may make
any public Written Disclosure it believes in good faith is required by
applicable law or any listing or trading agreement concerning its
publicly-traded securities based upon the written advice of counsel, provided
that prior to making such Written Disclosure, the disclosing Party shall provide
the other Party with an opportunity to promptly review the proposed Written
Disclosure. To the extent that the reviewing Party reasonably requests that any
information in the proposed Written Disclosure be deleted, the disclosing Party
shall take reasonable action to avoid disclosure, where possible, including
requesting confidential treatment of such information pursuant to Rule 406 of
the Securities Act of 1933 or Rule 26b-2 of the Securities Exchange Act of 1934,
as applicable (or any other applicable regulation relating to the confidential
treatment of information).
ARTICLE 9
TERM AND TERMINATION
9.1 TERM. This Agreement shall commence as of the Effective Date and
shall terminate as provided herein in its entirety or with respect to certain
countries in the Territory as set forth herein.
9.2 TERMINATION BY HMR FOR MYOGEN'S FAILURE TO MEET MILESTONES OR
DISCONTINUING DEVELOPMENT. HMR shall have the right to terminate this Agreement
in its entirety under this Section 9.2 only during the period prior to the first
Regulatory Approval of a product (other than Perfan) in the United States if
Myogen shall either: (a) discontinue Development of Product as set forth in
Article 3.6.1(a) or, (b) fails to meet the milestone set forth in 3.6.1(b).
Termination of this Agreement shall be made pursuant to a written notice (the
"Termination Notice") delivered by HMR 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 Termination Notice to Myogen (the "Termination Effective Date").
If HMR terminates this Agreement as set forth above, Myogen may retain all
rights granted under Article II herein to make, manufacture and commercialize
intravenous Product sold under the trade name Perfan in Europe only ( the
"European Rights") paying a royalty rate of [*#*] to HMR for the duration of the
HMR Patents or for ten (10) years from the Transfer Date whichever is longer;
provided however, that Myogen satisfies all payment requirements of Article 4.1.
In the event HMR terminates this Agreement under this Section 9.2 and Myogen
elects not to retain European Rights, then Myogen shall return to HMR or
destroy, at HMR's discretion, all unused Enoximone at its own expense and all
rights granted under Article II of this Agreement shall terminate.
9.2.1 TERMINATION EFFECTIVE DATE. If HMR terminates this
Agreement pursuant to this Section 9.2, the Parties shall continue to perform
their obligations under this Agreement pending the winding down of operations on
the Termination Effective Date (other than with respect to the European Rights
as provided in this Section 9.2). Upon the Termination Effective Date:
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(a) all licenses and rights of Myogen to HMR Patents and HMR
Know- how hereunder shall terminate in their entirety with respect to Enoximone
and Product except with respect to the European Rights as provided in this
Section 9.2;
(b) all HMR Confidential Information and HMR Data shall be
returned to HMR (except with respect to the European Rights as provided in this
Section 9.2), except Myogen may retain one copy of such information solely for
legal archive purposes;
(c) Myogen shall transfer to HMR all INDs, Drug Approval
Applications and Regulatory Approvals related to Enoximone and Product(s) and
shall take such other actions and execute such other instruments, assignments
and documents as may be necessary to effect the transfer of such rights
hereunder to HMR (except with respect to the European Rights as provided in this
Section 9.2); and
(d) all Confidential Information of Myogen, excluding that
information transferred pursuant to Article 9.2 (c) above, shall be promptly
destroyed by HMR and HMR shall certify to Myogen such destruction, except HMR
may retain one copy of such information solely for legal archive purposes.
(e) Myogen shall return to HMR or destroy, at HMR's
discretion, any unused Enoximone obtained from HMR pursuant to Article 3.7 at
its own expense provided, however, that in the event Myogen retains the European
Rights, as provided in this Section 9.2, Myogen shall not be obligated to return
any unused Enoximone.
9.3 TERMINATION BY HMR FOR MYOGEN'S FAILURE TO COMMERCIALIZE OR MARKET
PRODUCTS IN THE TERRITORY.
9.3.1 FAILURE TO COMMERCIALIZE IN MAJOR MARKET COUNTRIES. With
respect to each Major Market Country, if Myogen, (i) discontinues Development
(i.e. does not fulfill the criteria set forth in Article 3.6.1(a)) in any such
country, or (ii) does not Commercialize the Product in any such country within
12 months after obtaining Regulatory Approval in such country, then HMR shall
have the right to terminate this Agreement with respect to such Major Market
Countries (such countries shall be referred to as "Terminated Countries") and
the definition of the Territory shall thenceforth exclude such countries. HMR
shall provide written notification to Myogen of its intent to deem a particular
country a Terminated Country, and Myogen shall have ninety (90) days following
receipt of such written notice in which to respond to such proposed action. If
Myogen shall in good faith dispute such intention to deem a particular country a
Terminated Country, the Parties shall submit such matter to arbitration pursuant
to the terms of Article XI hereof. As used in this Section 9.3, "Commercialize"
means to commence the commercial sale or commercial distribution of the Product.
9.3.2 FAILURE TO COMMERCIALIZE IN OTHER COUNTRIES. If Myogen
commercializes a product in all of the Major Market Countries within 12 months
after obtaining relevant Regulatory Approval in each of these countries, then
Myogen shall have an additional two years to commercialize the Product in other
countries in the Territory. HMR shall have the right, at its option, to
terminate Myogen's rights hereunder with respect to those countries where a
Product has not been commercialized as set forth above (any such countries
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[*#*]CONFIDENTIAL TREATMENT REQUESTED
shall also be referred to as "Terminated Countries"), and the definition of the
Territory shall thenceforth exclude such countries. HMR shall provide written
notification to Myogen of its intent to deem a particular country a Terminated
Country, and Myogen shall have ninety (90) days following receipt of such
written notice in which to respond to such proposed action. If Myogen shall in
good faith dispute such intention to deem a particular country a Terminated
Country, the Parties shall submit such matter to arbitration pursuant to the
terms of Article XI hereof.
9.3.3 EFFECT OF TERMINATED COUNTRIES. If HMR terminates this
Agreement with respect to a Terminated Country, then the following provisions
shall apply:
(a) HMR shall receive an exclusive (even as to Myogen but
subject to the existing rights of Third Parties and if necessary, subject to the
approval of UTC) right and license in the Terminated Countries with the right to
grant sublicenses, to all Myogen Patents, Myogen Know-how and all of Myogen's
interest in trademarks in the Terminated Countries related to Enoximone, to
make, have made, import, use, sell, offer for sale and have sold Products,
subject to the royalty obligations set forth below in Article 9.3.3(c), and
shall have the exclusive right (but not the obligation) to enforce the Patents
against Competitive Product Infringement in the Terminated Countries, except in
cases where UTC reserves this right, and the exclusive right (but not the
obligation) to enforce the trademark rights related to Enoximone against
infringers in the Terminated Countries.
(b) Myogen shall transfer all INDs, Drug Approval Applications
and Regulatory Approvals related to Enoximone in the Terminated Countries to
HMR, and take such other actions and execute such other instruments, assignments
and documents as may be necessary to transfer the rights hereunder in the
Terminated Countries to HMR.
(c) Subject to Myogen's performance of the provisions of this
Article 9.3.3 and Myogen's fulfillment of its obligations for payments due under
Article 4.1, Myogen shall be entitled to receive royalties with respect to the
Net Sales by HMR or its sublicensees of Products in those Terminated Countries
under Article IX at a rate of [*#*]
9.4 TERMINATION FOR MATERIAL BREACH BY MYOGEN.
(a) Subject to the provisions of this Article 9.4, if Myogen
shall have committed a Material Breach (as defined below) and such Material
Breach shall remain uncured and shall be continuing for a period of ninety (90)
days following receipt of written notice thereof from HMR, then, in addition to
any and all other rights and remedies that may be available, HMR shall have the
right to terminate this Agreement effective upon the expiration of such ninety
(90) day period. Any such written notice of alleged Material Breach from HMR
shall include a reasonably detailed description of all relevant facts and
circumstances demonstrating, supporting and/or relating to each such alleged
Material Breach by Myogen.
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[*#*] CONFIDENTIAL TREATMENT REQUESTED
(b) If HMR terminates this Agreement pursuant to the
provisions of this Article 9.4, then the following provisions shall apply:
(i) HMR shall receive an exclusive (even as to Myogen
but subject to the existing rights of Third Parties and if necessary, subject to
the approval of UTC) right and license in the Terminated Countries with the
right to grant sublicenses, to all Myogen Patents, Myogen Know-how and all of
Myogen's interest in trademarks in the Terminated Countries related to
Enoximone, to make, have made, import, use, sell, offer for sale and have sold
Products, subject to the royalty obligations set forth above in Article
9.3.3(c), and shall have the exclusive right (but not the obligation) to enforce
the Patents against Competitive Product Infringement in the Terminated Countries
at its sole expense, except in cases where UTC, reserves this right, and the
exclusive right (but not the obligation) to enforce the trademark rights related
to Enoximone against infringers in the Terminated Countries.
(ii) all licenses and rights in the HMR Patents, HMR
Know- how and HMR Trademarks granted to Myogen hereunder shall terminate;
(iii) 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;
(iv) Myogen shall cooperate in the transfer to HMR of
all NDAs, Drug Approval Applications and Regulatory Approvals related to
Enoximone, 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 HMR.
(c) Termination of this Agreement pursuant to this Article 9.4
shall not relieve Myogen of any liability, including any obligation to make
payments hereunder, which accrued hereunder prior to the effective date of such
termination, nor preclude HMR 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 HMR's right to obtain performance of any obligation.
(d) For purposes of this Article 9.4 and Article 9.6,
"Material Breach" shall mean 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 Myogen in a material respect to meet Myogen's payment
or non-compete obligations. In no event shall a failure to meet timelines
specified in any Research and Development Plan, in and of itself, be deemed to
constitute a Material Breach in the event such failure is caused by parties or
events outside the control of Myogen, including, without limitation, any
additional requirements imposed by the FDA.
(e) The provisions of this Article 9.4 shall survive
termination of this Agreement for a period of [*#*].
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[*#*]CONFIDENTIAL TREATMENT REQUESTED
9.5 TERMINATION WITHOUT CAUSE.
9.5.1 TERMINATION WITHOUT CAUSE (INCLUDING DENIAL OF PHASE III
TRIALS). Myogen shall have a continuing right, subject to this Article 9.5, to
terminate this Agreement, (a) without cause, effective upon six (6) month
advance written notice to HMR, or (b) upon written notice to HMR, if within six
(6) months after the Effective Date Myogen has not received necessary consent or
the like from the FDA to proceed to Phase III clinical trials for Enoximone
((a), (b), or both (a) and (b), "Termination Without Cause").
9.5.2 EFFECT OF TERMINATION WITHOUT CAUSE. If Myogen
terminates pursuant to this Article 9.5, then:
(a) all licenses and rights in the HMR Patents, HMR Know-how
and HMR Trademarks granted to Myogen hereunder shall terminate;
(b) all Confidential Information supplied by HMR to Myogen
shall be returned to HMR, except Myogen may retain one copy of such information
solely for legal archive purposes;
(c) Myogen shall cooperate in the transfer of all NDAs, Drug
Approval Applications and Regulatory Approvals related to Enoximone to HMR, 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
HMR.
9.5.3 ROYALTY UPON TERMINATION WITHOUT CAUSE. Notwithstanding
anything in this Article 9.5 to the contrary, if, and only if, (i) Myogen
terminates this Agreement pursuant to this Article 9.5 subsequent to the filing
by Myogen of an NDA covering the use of Enoximone in the Field but prior to the
completion of Myogen's due diligence obligations set forth in Article III of
this Agreement, (ii) HMR or any of its sublicensees completes the development
and commercialization of Enoximone and (iii) Myogen fulfills all of its
obligations for payments due under Article 4.1, then Myogen shall be entitled to
a royalty of [*#*] of Net Sales of any Product incorporating Enoximone.
9.5.4 TERMINATION DUE TO EXPIRATION OF ROYALTY OBLIGATIONS.
Unless earlier terminated, this Agreement shall terminate on a country by
country basis upon expiration of Myogen's obligation to pay royalties in such
countries pursuant to this Agreement.
9.5.5 TERMINATION BY MUTUAL CONSENT. This agreement may be
terminated by the mutual written consent of the parties.
9.5.6 ACCRUED RIGHTS, SURVIVING OBLIGATIONS. Termination,
relinquishment or expiration of the Agreement or any portion hereof for any
reason shall be without prejudice to any rights which shall have accrued to the
benefit of either Party prior to such termination, relinquishment or expiration,
including damages arising from any breach hereunder. Such termination,
relinquishment or expiration shall not relieve either Party from obligations
which are expressly indicated to survive termination or expiration of this
Agreement.
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[*#*]CONFIDENTIAL TREATMENT REQUESTED
9.6 TERMINATION FOR MATERIAL BREACH BY HMR.
(a) Subject to the provisions of this Article 9.6, if HMR
shall have committed a Material Breach (as defined below) and such Material
Breach shall remain uncured and shall be continuing for a period of ninety (90)
days following receipt of written notice thereof from Myogen, then, in addition
to any and all other rights and remedies that may be available to Myogen, Myogen
shall have the right to terminate this Agreement effective upon the expiration
of such ninety (90) day period. Any such written notice of alleged Material
Breach from Myogen shall include a reasonably detailed description of all
relevant facts and circumstances demonstrating, supporting and/or relating to
each such alleged Material Breach by HMR.
(b) If Myogen terminates this Agreement pursuant to the
provisions of this Article 9.6, the following provisions apply:
(i) all licenses and rights in the HMR Patents, HMR
Know-how and HMR Patents granted to Myogen hereunder shall [*#*]
(ii) all Confidential Information supplied by Myogen
to HMR shall be promptly returned to Myogen, except that HMR may retain one copy
of such information solely for legal archive purposes.
(c) Termination of this Agreement pursuant to this Article 9.6
shall not relieve HMR of any liability hereunder which accrued prior to the
effective date of such termination, nor preclude Myogen 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 Myogen's right to obtain performance of
any obligation.
(d) For purposes of this Article 9.6, "Material Breach" shall
have the same meaning as it does for Article 9.4. By way of example only, the
term "Material Breach" shall be deemed to include the violation of the exclusive
nature of the grant of licenses and rights to Myogen under this Agreement, the
failure of HMR to supply the HMR Data, the failure of HMR to transfer the IND,
and the failure of HMR to transfer its rights pursuant to 4.1(c).
9.7 TRANSFER OF TRADEMARK UPON TERMINATION. Should the agreement
terminate for any reason pursuant to this Article IX, other than pursuant to
section 9.6, at the written request of HMR, Myogen shall transfer to HMR its
rights under the HMR Trademarks previously assigned to it by HMR under section
4.1(c) hereof.
ARTICLE 10
INDEMNIFICATION
10.1 INDEMNIFICATION BY HMR.
10.1.1 MYOGEN INDEMNIFIED PARTIES. HMR hereby agrees to
indemnify, save, defend and hold Myogen and its agents and employees (the
"Myogen Indemnified Parties")
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[*#*]CONFIDENTIAL TREATMENT REQUESTED
harmless from and against any and all suits, claims, actions, demands,
liabilities, expenses and/or loss, including reasonable legal expense and
attorneys' fees (collectively, "Losses"), incurred by or against any Myogen
Indemnified Parties, which arise out of the breach of this Agreement by HMR, or
any negligence or willful misconduct by HMR, 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.
10.1.2 NOTICE OF CLAIM. In the event that a Myogen Indemnified
Party seeks indemnification under Article 10.1.1, it shall inform HMR of such
claim as soon as reasonably practicable after it receives notice of the claim
and shall permit HMR 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 HMR) in the defense
of the claim.
10.2 INDEMNIFICATION BY MYOGEN.
10.2.1 HMR INDEMNIFIED PARTIES. Myogen hereby agrees to
indemnify, save, defend and hold HMR and its agents and employees (the "HMR
Indemnified Parties") harmless from and against any and all Losses incurred by
or against such HMR Indemnified Parties which (i) arise out of the 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 HMR or any HMR Indemnified Parties or any negligence or willful
misconduct by HMR or any HMR Indemnified Parties , or (ii) arise out of the
design, manufacture, use, handling, storage, sale or other disposition of
Products by Myogen, its agents or sublicensees, except to the extent such Losses
also result from the negligence or willful misconduct of any HMR Indemnified
Parties
10.2.2 NOTICE OF CLAIM. In the event that any HMR Indemnified
Party seeks indemnification under Article 10.2.1, it shall inform Myogen of a
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.
10.2.3 INSURANCE.
(a) Throughout the Term and thereafter for a period of ten
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, commercial general liability, and/or product liability with respect
to such Product. Each Party shall include the other Party as an additional
insured under such Insurance policies. 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 HMR, 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
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[*#*]CONFIDENTIAL TREATMENT REQUESTED
amounts of not less than [*#*] million combined single limit, bodily injury
and property damage. Within 30 days after the date hereof, each Party shall
furnish the other Party with certificates of insurance evidencing the aforesaid
coverage and naming the other Party as an additional insured thereunder, which
certificates shall describe the principal terms of such policy or policies and
provide that 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 X shall survive the
expiration or termination of this Agreement for a period of ten 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 XI 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 HMR: Head of Business Development and Strategic Planning
FOR MYOGEN: Chief Executive Officer
In the event the designated executive officers are not able to resolve such
dispute, either Party may at anytime after 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, but excluding any dispute,
controversy or claim arising out of or relating to the validity, enforceability
or infringement of any Patent, 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 Kansas City, Missouri,
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[*#*]CONFIDENTIAL TREATMENT REQUESTED
if requested and begun by Myogen and in Denver, Colorado if requested and begun
by HMR, 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 Article 11.3 above,
each Party shall bear its own legal fees.
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 after 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 XI, 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, 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. Either Party may assign
any of its rights or obligations under this Agreement or its ownership interest
in Joint Patents to a non-Affiliate only in connection with a merger or similar
reorganization or the sale of all or substantially all of its assets, or
otherwise with the prior written consent of the other Party. This Agreement
shall survive any such merger or reorganization of either Party with or into, or
such sale of assets to, a Third Party and no consent for such merger,
reorganization or sale shall be required hereunder; 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.
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[*#*]CONFIDENTIAL TREATMENT REQUESTED
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 RESEARCH AND DEVELOPMENT ENTITIES. Either Party may assign its
rights and obligations under this Agreement to an entity or entities (e.g.,
partnership or corporation) that are specifically formed for financial purposes
and that finance research and development performed by such Party; provided,
however, that such assignment shall not relieve the assigning Party of
responsibility for performance of its obligations under this Agreement.
12.3 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.
12.4 FORCE MAJEURE. 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.
12.5 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.
12.6 NO 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," "HMR" or any
other trade name or trademark of the other Party or its Affiliates in connection
with the performance of the Agreement.
12.7 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).
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[*#*]CONFIDENTIAL TREATMENT REQUESTED
IF TO MYOGEN, ADDRESSED TO: MYOGEN, INC.
Xxxxxxxxxxx Xxxx. 000, X.X. Xxx 0000
Xxxxxx, Xxxxxxxx 00000-0000
Attention: President
Telephone: (000) 000-0000
Telecopy: (000) 000-0000
IF TO HMR, ADDRESSED TO: HOECHST XXXXXX XXXXXXX, INC.
Xxxxx 000-000, X.X. Xxx 0000
Xxxxxxxxxxx, XX 00000-0000
Attention: Vice President, General Counsel
Legal Department
Telephone: (000) 000-0000
Telecopy: (000) 000-0000
12.8 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.
12.9 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, (i) 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 (ii) 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.
12.10 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.
12.11 GOVERNING LAW. This Agreement shall be governed by and
interpreted under the laws of the State of
Delaware, without regard to
principles of conflicts of law.
12.12 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.
12.13 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.
12.14 ENTIRE AGREEMENT. This Agreement and the Confidentiality
Agreement, including all Exhibits attached hereto and thereto, and all documents
delivered concurrently
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[*#*]CONFIDENTIAL TREATMENT REQUESTED
herewith, set forth all the covenants, promises, agreements, warranties,
representations, conditions and understandings between the Parties hereto and
supersede and terminate all prior agreements, warranties, representations,
conditions or understandings, either oral or written, between the Parties 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.
12.15 ADDITIONAL AGREEMENTS. The Parties agree that after the execution
of this Agreement they will enter into to good faith negotiations with respect
to an Interim Supply Agreement and a Technical Agreement for Product supply by
HMR.
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[*#*]CONFIDENTIAL TREATMENT REQUESTED
IN WITNESS WHEREOF, the Parties have executed this Agreement in
duplicate originals by their duly authorized officers as of the date and year
first above written.
MYOGEN, INC. HOECHST XXXXXX XXXXXXX, INC.
By: /s/ J. Xxxxxxx Xxxxxxx By: /s/ M A Xxxxxxx
------------------------------------------- ------------------------------------------
Name: J. Xxxxxxx Xxxxxxx Name: Xxxxxxx X. Xxxxxxx
----------------------------------------- ----------------------------------------
Title: President & CEO Title: Vice President, Licensing & Alliances
---------------------------------------- ---------------------------------------
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[*#*]CONFIDENTIAL TREATMENT REQUESTED
SCHEDULE 1.14
RPT-CASELIST-RPT
09/29/1998
CASE SERIES REPORT
TITLE: ENHANCEMENT OF PRAZOSIN
ABSTRACT: THIS INVENTION RELATES TO THE SYNERGISTIC ENHANCEMENT OF CERTAIN
ANTIHYPERTENSIVES BY THE CONJUNCTIVE USE OF CERTAIN CARDIOTONIC AGENTS. MORE
SPECIFICALLY, THIS INVENTION RELATES TO THE ENHANCEMENT OF THE BLOOD PRESSURE
LOWERING EFFECT ACHIEVED WITH ALPHAl-ADRENOCEPTOR ANTAGONISTS BY THE
CONJUNCTIVE ADMINISTRATION OF CARDIOTONIC AGENTS POSSESSING THE ABILITY TO
SPECIFICALLY INHIBIT CYCLIC AMP-PHOSPHODIESTERASE.
INVTRS: XXXX XXXXXXX C
CASE NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
00000 XX G 278440/87 2612175 11/05/2007
11/05/1987 02/27/1997 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
35262 KR G 87-12354 96662 11/15/2010
11/04/1987 03/06/1996 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
35262 LU G 0268146 11/04/2007
11/04/1987 01/09/1991 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
00000 XX G 0268146 11/04/2007
11/04/1987 01/09/1991 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
35262 PH G 36022 23818 11/23/2006
11/04/1987 11/23/1989 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
00000 XX X 87116236.8 0268146. 11/04/2007
11/04/1987 01/09/1991 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
35262 TW G 76106585 31295 01/21/2004
11/02/1987 05/25/1989 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
35262 us I 927785
11/05/1986 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
35262 ZA G 87/8182 87/8182 10/30/2007
10/30/1987 06/29/1988 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
-31-
RPT-CASELIST-RPT
09/29/1998
CASE SERIES REPORT
TITLE: ENHANCEMENT OF PRAZOSIN
ABSTRACT: THIS INVENTION RELATES TO THE SYNERGISTIC ENHANCEMENT OF CERTAIN
ANTIHYPERTENSIVES BY THE CONJUNCTIVE USE OF CERTAIN CARDIOTONIC AGENTS. MORE
SPECIFICALLY, THIS INVENTION RELATES TO THE ENHANCEMENT OF THE BLOOD PRESSURE
LOWERING EFFECT ACHIEVED WITH ALPHAl-ADRENOCEPTOR ANTAGONISTS BY THE
CONJUNCTIVE ADMINISTRATION OF CARDIOTONIC AGENTS POSSESSING THE ABILITY TO
SPECIFICALLY INHIBIT CYCLIC AMP-PHOSPHODIESTERASE.
INVTRS: XXXX XXXXXXX C
CASE NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
35262A US G 153542 4868182 11/05/2006
02/03/1988 09/19/1989 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
-32-
RPT-CASELIST-RPT
09/29/1998
CASE SERIES REPORT
TITLE: NOVEL 4-AROYLIMIDAZOL-2- ONES
ABSTRACT:
INVTRS: DAGE XXXXXXX X XXXXXX J XXXXXX
XXXXXXXXXX XXXXXXX A
CASE NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
MOO964 us I 49808
06/18/1979 Assignee: XXXXXXXXXX XXXXXXX INC
-33-
RPT-CASELIST-RPT
09/29/1998
CASE SERIES REPORT
TITLE: NOVEL 4-AROYLIMIDAZOL-2- ONES
ABSTRACT: NOVEL 4-AROYLIMIDAZOL-Z-ONES ARE USEFUL AS
ANTIHYPERTENSIVES, CARDIOTONICS AND ANTITHROMBOTICS.
THE AROYL GROUP CAN BE A 2-FURYL, 2-THIENYL OR
OPTIONALLY SUBSTITUTED PHENYL.
INVTRS: DAGE XXXXXXX X XXXXXX J XXXXXX
XXXXXXXXXX XXXXXXX A
CASE NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
M00964A AT G 3142/80 375349 12/15/2001
06/13/1980 05/15/1984 Assignee: XXXXXXXXXX XXXXXXX INC
M00964A AU G 59118/80 532783 06/06/2000
06/06/1980 03/14/1984 Assignee: XXXXXXXXXX XXXXXXX INC
M00964A BE G 201057 883856 06/17/2000
06/17/1980 07/15/1980 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964A CA G 354197 1132554 09/28/1999
06/17/1980 09/28/1982 Assignee: MERRELL PHARMACEUTICALS INC
M00964A CH G 4627/80 646155 06/16/2000
06/16/1980 11/15/1984 Assignee: XXXXXXXXXX XXXXXXX INC
M00964A DE G 3021792.6 3021792 06/11/2000
06/11/1980 08/10/1989 Assignee: XXXXXXXXXX XXXXXXX INC
M06964A DK G 2590/80 160269 06/17/2000
06/17/1980 07/22/1991 Assignee: XXXXXXXXXX XXXXXXX INC
M00964A ES G 492255 492255 04/27/2001
06/09/1980 04/27/1981 Assignee: XXXXXXXXXX XXXXXXX INC
M00964A FR G 8013434 8013434 06/17/2000
06/17/1980 09/12/1983 Assignee: XXXXXXXXXX XXXXXXX INC
M00964A GB G 8019898 2055364 06/18/2000
06/18/1980 06/08/1983 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964A HK G 614 06/18/2000
08/21/1986 Assignee: XXXXXXXXXX XXXXXXX INC
M00964A HU G 1506/80 186736 06/17/2000
06/17/1980 01/21/1985 Assignee: XXXXXXXXXX XXXXXXX INC
M00964A HU G 4624/84 192634 06/17/2000
A 12/12/1984 12/22/1986 Assignee: XXXXXXXXXX XXXXXXX INC
M00964A IE G 1162/80 50646 06/05/2000
06/05/1980 09/17/1986 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
-34-
RPT-CASELIST-RPT
09/29/1998
CASE SERIES REPORT
TITLE: NOVEL 4-AROYLIMIDAZOL-2- ONES
ABSTRACT: NOVEL 4-AROYLIMIDAZOL-2-ONES ARE USEFUL AS
ANTIHYPERTENSIVES, CARDIOTONICS AND ANTITHROMBOTICS.
THE AROYL GROUP CAN BE A 2-FURYL, 2-THIENYL OR
OPTIONALLY SUBSTITUTED PHENYL.
INVTRS: DAGE XXXXXXX X XXXXXX J XXXXXX
XXXXXXXXXX XXXXXXX A
CASE NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
M00964A IL G 60243 60243 06/06/2000
06/06/1980 05/01/1987 Assignee: XXXXXXXXXX XXXXXXX INC
M00964A IT G 48997A/80 1143922 06/17/2000
06/17/1980 10/29/1986 Assignee: XXXXXXXXXX XXXXXXX INC
M00964A JP G 81495/80 1600613 06/18/2000
06/18/1980 01/31/1991 Assignee: XXXXXXXXXX XXXXXXX
M00964A MAYA G 709 06/18/2000
12/16/1986 Assignee: XXXXXXXXXX XXXXXXX INC
M00964A NL F 8003498
06/17/1980 Assignee: XXXXXXXXXX XXXXXXX INC
M00964A NO G 801796 152841 06/17/2000
06/17/1980 11/27/1985 Assignee: XXXXXXXXXX XXXXXXX INC
M00964A NZ G 193935 193935 06/04/2000
06/04/1980 10/09/1985 Assignee: XXXXXXXXXX XXXXXXX INC
M00964A PH G 24143 18683 08/29/2002
06/16/1980 08/29/1985 Assignee: XXXXXXXXXX XXXXXXX INC
M00964A PH I 32264 02/11/1991
A 04/19/1985 Assignee: XXXXXXXXXX XXXXXXX 'INC
M00964A RU G 2942302 1217255 07/07/2000
07/07/1980 03/07/1986 Assignee: XXXXXXXXXX XXXXXXX INC
M00964A SABA G 13 06/18/2000
01/15/1987 Assignee: XXXXXXXXXX XXXXXXX INC
M00964A XXXX G 2949 06/18/2000
08/20/1986 Assignee: XXXXXXXXXX XXXXXXX INC
M00964A SE G 8004253.4 8004253 06/06/2000
06/06/1980 02/05/1987 Assignee: XXXXXXXXXX.XXXXXXX INC
M00964A SE G 8501452 8501452 06/06/2000
A 03/25/1985 09/19/1991 Assignee: XXXXXXXXXX XXXXXXX INC
-35-
RPT-CASELIST-RPT
09/29/1998
CASE SERIES REPORT
TITLE: NOVEL 4-AROYLIMIDAZOL-2- ONES
ABSTRACT: NOVEL 4-AROYLIMIDAZOL-2-ONES ARE USEFUL AS
ANTIHYPERTENSIVES, CARDIOTONICS AND ANTITHROMBOTICS.
THE AROYL GROUP CAN BE A 2-FURYL, 2-THIENYL OR
OPTIONALLY SUBSTITUTED PHENYL.
INVTRS: DAGE XXXXXXX X XXXXXX J XXXXXX
XXXXXXXXXX XXXXXXX A
CASE NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
M00964A SG G 2055364 8690467-g 06/18/2000
12/26/1986 Assignee: XXXXXXXXXX XXXXXXX INC
M00964A US I 119207
02/07/1980 Assignee: XXXXXXXXXX XXXXXXX INC
M00964A ZA G 80/3332 80/3332 06/04/2000
06/04/1980 01/21/1981 Assignee: XXXXXXXXXX XXXXXXX INC
-36-
RPT-CASELIST-RPT
09/29/1998
CASE SERIES REPORT
TITLE: NOVEL 4-AROYLIMIDAZOL-2- ONES
ABSTRACT: NOVEL 4-AROYLIMIDAZOL-2-ONES ARE USEFUL AS
ANTIHYPERTENSIVES, CARDIOTONICS AND ANTITHROMBOTICS.
THE AROYL GROUP CAN BE A 2-FURYL, 2-THIENYL OR
OPTIONALLY SUBSTITUTED PHENYL.
INVTRS: DAGE XXXXXXX X XXXXXX J XXXXXX
XXXXXXXXXX XXXXXXX A
CASE NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
M00964AEXT BE G 201057 883856 06/17/2002
06/17/1980 07/15/1980 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964AEXT FR G 8013434 92C0319 10/27/2004
05/26/1992 09/11/1992 Assignee: XXXXXXXXXX XXXXXXX INC
M00964AEXT GB G 8019898 2055364 10/27/2002
06/18/1980 06/08/1983 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964AEXT IE F 1162/80
06/05/1980 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964AEXT IT G 48997A/80 1143922 03/09/2011
06/17/1980 lo/2911986 Assignee: XXXXXXXXXX XXXXXXX INC
M00964AEXT NL F 8003498
06/17/1980 Assignee: XXXXXXXXXX XXXXXXX INC
-37-
RPT-CASELIST-RPT
09/29/1998
CASE SERIES REPORT
TITLE: NOVEL 4-AROYLIMIDAZOL-2- ONES
ABSTRACT:
INVTRS: DAGE XXXXXXX X XXXXXX J XXXXXX
XXXXXXXXXX XXXXXXX A
CASE NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
M00964B US I 159048
06/13/1980 Assignee: XXXXXXXXXX XXXXXXX INC
-38-
RPT-CASELIST-RPT
09/29/1998
CASE SERIES REPORT
TITLE: NOVEL 4-AROYLIMIDAZOL-2-ONES
ABSTRACT: NOVEL 4-AROYLIMIDAZOL-2-ONES ARE USEFUL AS
ANTIHYPERTENSIVES, CARDIOTONICS AND ANTITHROMBOTICS.
THE AROYL GROUP CAN BE A 2-FURYL, 2-THIENYL OR
OPTIONALLY SUBSTITUTED PHENYL. ADDED: Xl CAN ALSO BE AN
ALKYL-SULFONE OR -SULFOXIDE.
INVTRS: DAGE XXXXXXX X XXXXXX J XXXXXX
XXXXXXXXXX XXXXXXX A
CASE NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
M00964C AT G 0058435 02/18/2002
02/18/1982 12/30/1986 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MOO964C AU G 80486/82 558789 02/15/2002
02/15/1982 05/25/1987 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C BE G 0058435 02/18/2002
02/18/1982 12/30/1986 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C CA G 396247 1173047 08/21/2001
02/15/1982 08/21/1984 Assignee: MERRELL PHARMACEUTICALS INC
M00964C CH G 0058435 02/18/2002
02/18/1982 12/30/1986 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C DE G 3274855.8 0058435 02/18/2002
02/18/1982 12/30/1986 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C DK G 675/82 161250 02/16/2002
02/16/1982 12/09/1991 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C EP I 82101233.3 0058435 02/18/2002
02/18/1982 12/30/1986 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C ES G 509636 509636 04/26/2003
02/16/1982 04/26/1983 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MOO964C FR G 0058435 02/18/2002
02/18/1982 12/30/1986 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C GB G 8204721 2093031 02/17/2002
02/17/1982 10/24/1984 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C GR G 67318 76025 02/15/2002
02/15/1982 08/03/1984 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C HK G 615 02/17/2002
08/21/1986 Assignee: MERRELL PHARMACEUTICALS INC
-39-
RPT-CASELIST-RPT
09/29/1998
CASE SERIES REPORT
TITLE: NOVEL 4-AROYLIMIDAZOL-2-ONES
ABSTRACT: NOVEL 4-AROYLIMIDAZOL-2-ONES ARE USEFUL AS
ANTIHYPERTENSIVES, CARDIOTONICS AND ANTITHROMBOTICS.
THE AROYL GROUP CAN BE A 2-FURYL, 2-THIENYL OR OPTIONALLY
SUBSTITUTED PHENYL. ADDED: Xl CAN ALSO BE AN
ALKYL-SULFONE OR -SULFOXIDE.
INVTRS: DAGE XXXXXXX X XXXXXX J XXXXXX
XXXXXXXXXX XXXXXXX A
CASE NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
M00964C IE G 333/82 52422 02/16/2002
02/16/1982 02/03/1988 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C IL G 65010 65010 02/14/2002
02/14/1982 09/01/1986 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C IT G 20134/BE/87 0058435 02/18/2002
02/18/1982 12/30/1986 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C JP G 22154/82 1740674 02/16/2002
02/16/1982 03/15/1993 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C KR G 82-715 22212 02/18/2002
02/18/1982 12/03/1986 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C LU G 0058435 02/18/2002
02/18/1982 12/30/1986 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C MAYA G 710 02/17/2002
12/16/1986 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C NL G 0058435 02/18/2002
02/18/1982 12/30/1986 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C NO G 820495 156527 02/17/2002
02/17/1982 10/07/1987 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MOO964C NZ G 199733 199733 02/15/2002
02/15/1982 01/20/1986 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C PH I 26861 18106 03/21/2002
02/12/1982 03/21/1985 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C SABA G 323 02/17/2002
12/01/1986 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C XXXX G 2947 02/17/2002
08/20/1986 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
-40-
RPT-CASELIST-ROT
09/29/1998
CASE SERIES REPORT
TITLE: NOVEL 4-AROYLIMIDAZOL-2-ONES
ABSTRACT: NOVEL 4-AROYLIMIDAZOL-2-ONES ARE USEFUL AS
ANTIHYPERTENSIVES, CARDIOTONICS AND ANTITHROMBOTICS.
THE AROYL GROUP CAN BE A 2-FURYL, 2-THIENYL OR
OPTIONALLY SUBSTITUTED PHENYL. ADDED: Xl CAN ALSO BE AN
ALKYL-SULFONE OR -SULFOXIDE.
INVTRS: DAGE XXXXXXX X XXXXXX J XXXXXX
XXXXXXXXXX XXXXXXX A
CASE NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
M00964C SE G 82101233.3 0058435 02/18/2002
02/18/1982 12/30/1986 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C SG I 466 06/16/1995
12/26/1986 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C TW I 7110919 17847 10/16/1997
03/16/1982 02/07/1983 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M00964C US I 235453
02/18/1981 Assignee: XXXXXXXXXX XXXXXXX INC
M00964C ZA G 82/0969 82/0969 02/15/2002
02/15/1982 09/28/1983 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
-41-
RPT-CASELIST-RPT
09/29/1998
CASE SERIES REPORT
TITLE: NOVEL 4-AROYLIMIDAZOL-Z-ONES
ABSTRACT: NOVEL 4-AROYLIMIDAZOL-Z-ONES WHEREIN THE AROYL GROUP
CAN BE FURYL, THIENYL OR PHENYL GROUP. THE PHENYL GROUP
MAY BE SUBSTITUTED WITH ALKYL, ALKOXY, HYDROXY, HALO,
ALKYLTHIO, ALKYLSULFOXIDE, ALKYLSULFONE, CF3,
AMINOSULPHONYL, AMINO, PYRROLIDINO, PIPERIDINO,
MORPHALINE OR PIPERAZINO GROUP. THE COMPOUNDS ARE
USEFUL AS CARDIOTONIC AGENTS.
INVTRS: DAGE XXXXXXX X XXXXXX J XXXXXX
XXXXXXXXXX XXXXXXX A
CASE NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
M00964D US I 373457
4/30/1982 Assignee: XXXXXXXXXX XXXXXXX INC
-42-
RPT-CASELIST-RPT
09/29/1998
CASE SERIES REPORT
TITLE: NOVEL 4-AROYLIMIDAZOL-2-ONES
ABSTRACT: NOVEL 4-AROYLIMIDAZOL-2-ONES ARE USEFUL AS
ANTIHYPERTENSIVES, CARDIOTONICS, ANTITHROMBOTICS,
BRONCHODILATORS AND UTEROSPASMOLYTICS. THE AROYL GROUP
CAN BE A 2-FURYL, Z-THIENYL OR PHENYL, OPTIONALLY
SUBSTITUTED WITH ALKYL, ALKOXY, ALKYLTHIO, HALOGEN,
HYDROXY, METHYLENEDIOXY, ALKYLSULFOXIDE, ALKYLSULFONE,
AMINO, CYCLIC AMINO, TRIFLUOROMETHYL OR SULFONAMIDO.
COVERS CARDIOTONIC COMPUND MDL-17043.
INVTRS: DAGE XXXXXXX X XXXXXX J XXXXXX
XXXXXXXXXX XXXXXXX A
CASE NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
M00964E US G 417805 4405635 09/20/2000
09/13/1982 09/20/1983 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
-43-
RPT-CASELIST-RPT
09/29/1998
CASE SERIES REPORT
TITLE: PHARMACEUTICAL COMPOSITION FOR 4-AROYLIMIDAZOL-2-ONES
ABSTRACT: THE PRESENT INVENTION PROVIDES A LIQUID PHARMACEUTICAL
COMPOSITION COMPRISING A) AN EFFECTIVE AMOUNT OF A
4-AROYLIMIDAZOL-2-ONE, OR A PHARMACEUTICALLY ACCEPTABLE
SALT THEREOF, AND B) ONE OR MORE PHARMACEUTICALLY ACCEPTABLE
NONIONIC SURFACTANTS IN AN AMOUNT FROM ABOUT
30 PERCENT TO ABOUT 99 PERCENT BY WEIGHT OF THE
COMPOSITION, AND OPTIONALLY FURTHER COMPRISES ONE OR
MORE PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS OTHER THAN
NONIONIC SURFACTANTS IN A TOTAL AMOUNT UP TO ABOUT 45
PERCENT BY WEIGHT OF THE COMPOSITION.
INVTRS: XXXXXXXXX XX DOMET J
CASE NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
MO1308 AR G 313066 241632 10/30/2007
01/25/1989 10/30/1992 Assignee: MEKRELL DOW PHARMACEUTICALS INC
MO1308 AT G 0326103 01/25/2009
01/25/1989 07/15/1992 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 AU G 28768/89 611757 01/25/2009
01/25/1989 10/14/1991 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 BE G 0326103 01/25/2009
01/25/1989 07/15/1992 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 CA I 588904 05/03/1993
01/23/1989 Assignee: XXXXXXX XXX PH+RMACEUTICALS(CANADA)
MO1308 CH G 0326103 01/25/2009
01/25/1989 07/15/1992 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 CN I 89100532
01/28/1989 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 DE G 68902056.2 0326103 01/25/2009
01/25/1989 07/15/1992 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 DK G 375/89 169566 01/27/2009
01/27/1989 12/05/1994 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 EP I 89101268.4 0326103 01/25/2009
01/25/1989 07/15/1992 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 ES G 0326103 01/25/2009
01/25/1989 07/15/1992 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
M01308 FI I 01/04/1989
Assignee: XXXXXXX XXX PHARMACEUTICALS INC
-44-
RPT-CASELIST-RPT
09/29/1998
CASE SERIES REPORT
TITLE: PHARMACEUTICAL COMPOSITION FOR 4-AROYLIMIDAZOL-2-ONES
ABSTRACT: THE PRESENT INVENTION PROVIDES A LIQUID PHARMACEUTICAL
COMPOSITION COMPRISING A) AN EFFECTIVE AMOUNT OF A
4-AROYLIMIDAZOL-2-ONE, OR A PHARMACEUTICALLY ACCEPTABLE
SALT THEREOF, AND B) ONE OR MORE PHARMACEUTICALLY
ACCEPTABLE NONIONIC SURFACTANTS IN AN AMOUNT FROM ABOUT
30 PERCENT TO ABOUT 99 PERCENT BY WEIGHT OF THE
COMPOSITION, AND OPTIONALLY FURTHER COMPRISES ONE OR
MORE PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS OTHER THAN
NONIONIC SURFACTANTS IN A TOTAL AMOUNT UP TO ABOUT 45
PERCENT BY WEIGHT OF THE COMPOSITION.
INVTRS: XXXXXXXXX XX DOMET J
CASE NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
MO1308 FR G 0326103 01/25/2009
01/25/1989 07/15/1992 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 GB G 0326103 01/25/2009
01/25/1989 07/15/1992 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 GR G 920402114 0326103 01/25/2009
01/25/1989 07/15/1992 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
~01308 HU I 428/89 08/18/1992
01/27/1989 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 IE G 275/89 62426 01/27/2009
01/27/1989 01/18/1995 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 IL F 89049
01/24/1989 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 IT G 25467/BE/92 0326103 01/25/2009
01/25/1989 07/15/1992 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 JP I 16542/89
01/27/1989 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 KR I 89-960
01/28/1989 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 LU G 0326103 01/25/2009
01/25/1989 07/15/1992 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 NL G 0326103 01/25/2009
01/25/1989 07/15/1992 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 NO I 01/04/1989
Assignee: XXXXXXX XXX PHARMACEUTICALS INC
-45-
RPT-CASELIST-RPT
09/29/1998
CASE SERIES REPORT
TITLE: PHARMACEUTICAL COMPOSITION FOR 4-AROYLIMIDAZOL-2-ONES
ABSTRACT: THE PRESENT INVENTION PROVIDES A LIQUID PHARMACEUTICAL
COMPOSITION COMPRISING A) AN EFFECTIVE AMOUNT OF A
4-AROYLIMIDAZOL-2-ONE, OR A PHARMACEUTICALLY ACCEPTABLE
SALT THEREOF, AND B) ONE OR MORE PHARMACEUTICALLY
ACCEPTABLE NONIONIC SURFACTANTS IN AN AMOUNT FROM ABOUT
30 PERCENT TO ABOUT 99 PERCENT BY WEIGHT OF THE
COMPOSITION, AND OPTIONALLY FURTHER COMPRISES ONE OR
MORE PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS OTHER THAN
NONIONIC SURFACTANTS IN A TOTAL AMOUNT UP TO ABOUT 45
PERCENT BY WEIGHT OF THE COMPOSITION.
INVTRS: XXXXXXXXX XX DOMET J
CASE NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
MO1308 NZ G 227700 227700 01/24/2009
01/24/1989 02/04/1991 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 PH I 38117 07/15/1993
01/29/1989 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 PT G 89561 89561 01/27/2009
01/27/1989 07/07/1993 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 SE G 89101268.4 0326103 01/25/2009
01/25/1989 07/15/1992 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 TW I 78100532 06/28/1991
01/25/1989 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 US I 149803
01/29/1988 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
MO1308 ZA G 89/0552 89/0552 01/24/2009
01/24/1989 10/25/1989 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
-46-
RPT-CASELIST-RPT
09/29/1998
CASE SERIES REPORT
TITLE: PHARMACEUTICAL COMPOSITION FOR 4-AROYLIMIDAZOL-2-ONES
ABSTRACT: THE PRESENT INVENTION PROVIDES A LIQUID PHARMACEUTICAL
COMPOSITION COMPRISING A) AN EFFECTIVE AMOUNT OF A
4-AROYLIMIDAZOL-2-ONE, OR A PHARMACEUTICALLY ACCEPTABLE
SALT THEREOF, AND B) ONE OR MORE PHARMACEUTICALLY
ACCEPTABLE NONIONIC SURFACTANTS IN AN AMOUNT FROM ABOUT
30 PERCENT TO ABOUT 99 PERCENT BY WEIGHT OF THE
COMPOSITION, AND OPTIONALLY FURTHER COMPRISES ONE OR
MORE PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS OTHER THAN
NONIONIC SURFACTANTS IN A TOTAL AMOUNT UP TO ABOUT 45
PERCENT BY WEIGHT OF THE COMPOSITION.
INVTRS: XXXXXXXXX XX DOMET J
CASE NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
M01308A US I 327399
03/21/1989 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
-47-
RPT-CASELIST-RPT
09/29/1998
CASE SERIES REPORT
TITLE: PHARMACEUTICAL COMPOSITION FOR 4-AROYLIMIDAZOL-2-ONES
ABSTRACT: THE PRESENT INVENTION PROVIDES A LIQUID PHARMACEUTICAL
COMPOSITION COMPRISING A) AN EFFECTIVE AMOUNT OF A
4-AROYLIMIDAZOL-2-OnE, OR A PHARMACEUTICALLY ACCEPTABLE
SALT THEREOF, AND B) ONE OR MORE PHARMACEUTICALLY
ACCEPTABLE NONIONIC SURFACTANTS IN AN AMOUNT FROM ABOUT
30 PERCENT TO ABOUT 99 PERCENT BY WEIGHT OF THE
COMPOSITION, AND OPTIONALLY FURTHER COMPRISES ONE OR
MORE PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS OTHER THAN
NONIONIC SURFACTANTS IN A TOTAL AMOUNT UP TO ABOUT 45
PERCENT BY WEIGHT OF THE COMPOSITION.
INVTRS: XXXXXXXXX XX DOMET J
CASE NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
M01308B US I 511811
04/17/1990 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
-48-
RPT-CASELIST-RPT
09/29/1998
CASE SERIES REPORT
TITLE: PHARMACEUTICAL COMPOSITION FOR 4-AROYLIMIDAZOL-2-ONES
ABSTRACT: THE PRESENT INVENTION PROVIDES A LIQUID PHARMACEUTICAL
COMPOSITION COMPRISING A) AN EFFECTIVE AMOUNT OF A
4-AROYLIMIDAZOL-Z-ONE, OR A PHARMACEUTICALLY ACCEPTABLE
SALT THEREOF, AND B) ONE OR MORE PHARMACEUTICALLY
ACCEPTABLE NONIONIC SURFACTANTS IN AN AMOUNT FROM ABOUT
30 PERCENT TO ABOUT 99 PERCENT BY WEIGHT OF THE
COMPOSITION, AND OPTIONALLY FURTHER COMPRISES ONE OR
MORE PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS OTHER THAN
NONIONIC SURFACTANTS IN A TOTAL AMOUNT UP TO ABOUT 45
PERCENT BY WEIGHT OF THE COMPOSITION.
INVTRS: XXXXXXXXX XX DOMET J
CASE NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
MO 1308C US I 811897
12/20/1991 Assigde: XXXXXXX XXX PHARMACEUTICALS INC
-49-
RPT-CASELIST-RPT
09/29/1998
CASE SERIES REPORT
TITLE: PROCESS FOR THE PRODUCTION OF IMIDAZOLONES
ABSTRACT: THE PRESENT INVENTION PERTAINS TO A PROCESS FOR
PRODUCING A 2-IMIDAZOLONE FROM A UREIDOACETAL. THE
UREIDOACETAL IS SUBJECTED TO AN ACID CATALYZED
CONDENSATION IN ORDER TO PRODUCE THE 2-IMIDAZOLONE. THE
REACTION IS CONDUCTED IN AN ALCOHOLIC SOLVENT IN ORDER
TO MINIMIZE THE PRODUCTION OF A POLYMERIC BY-PRODUCT.
INVTRS: XXXXX XX XXXXX XX
XXXX NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
MO1331 US I 181015
04/13/1988 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
-50-
RPT-CASELIST_RPT
09/29/1998
CASE SERIES REPORT
TITLE: PROCESS FOR THE PRODUCTION OF IMIDAZOLONES
ABSTRACT: THE PRESENT INVENTION PERTAINS TO A PROCESS FOR
PRODUCING A 2-IMIDAZOLONE FROM A UREIDOACETAL. THE
UREIDOACETAL IS SUBJECTED TO AN ACID CATALYZED
CONDENSATION IN ORDER TO PRODUCE THE 2-IMIDAZOLONE. THE
REACTION IS CONDUCTED IN AN ALCOHOLIC SOLVENT IN ORDER
TO MINIMIZE THE PRODUCTION OF A POLYMERIC BY-PRODUCT.
INVTRS: XXXXX XX XXXXX XX
XXXX NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
M01331A US I 379730
07/14/1989 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
-51-
RPT-CASELIST_RPT
09/29/1998
CASE SERIES REPORT
TITLE: PROCESS FOR THE PRODUCTION OF 2-IMIDAZOLONES
ABSTRACT: THE PRESENT INVENTION PERTAINS TO A PROCESS FOR
PRODUCING A 2-IMIDAZOLONE FROM A UREIDOACETAL. THE
UREIDOACETAL IS SUBJECTED TO AN ACID CATALYZED
CONDENSATION IN ORDER TO PRODUCE THE 2-IMIDAZOLONE. THE
REACTION IS CONDUCTED IN AN ALCOHOLIC SOLVENT IN ORDER
TO MINIMIZE THE PRODUCTION OF A POLYMERIC BY-PRODUCT.
INVTRS: XXXXX XX XXXXX XX
XXXX NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
M01331B US I 511870
04/20/1990 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
-52-
RPT-CASELIST_RPT
09/29/1998
CASE SERIES REPORT
TITLE: PROCESS FOR THE PRODUCTION OF 2-IMIDAZOLONES
ABSTRACT: THE PRESENT INVENTION PERTAINS TO A PROCESS FOR
PRODUCING A 2-IMIDAZOLONE FROM A UREIDOACETAL. THE
UREIDOACETAL IS SUBJECTED TO AN ACID CATALYZED
CONDENSATION IN ORDER TO PRODUCE THE 2-IMIDAZOLONE. THE
REACTION IS CONDUCTED IN AN ALCOHOLIC SOLVENT IN ORDER
TO MINIMIZE THE PRODUCTION OF A POLYMERIC BY-PRODUCT.
INVTRS: XXXXX XX XXXXX XX
XXXX NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
M0133lC US I 639392
01/10/1991 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
-53-
RPT-CASELIST_RPT
09/29/1998
CASE SERIES REPORT
TITLE: PROCESS FOR THE PRODUCTION OF 2-IMIDAZOLONES
ABSTRACT: THE PRESENT INVENTION PERTAINS TO A PROCESS FOR
PRODUCING A 2-IMIDAZOLONE FROM A UREIDOACETAL. THE
UREIDOACETAL IS SUBJECTED TO AN ACID CATALYZED
CONDENSATION IN ORDER TO PRODUCE THE 2-IMIDAZOLONE. THE
REACTION IS CONDUCTED IN AN ALCOHOLIC SOLVENT IN ORDER
TO MINIMIZE THE PRODUCTION OF A POLYMERIC BY-PRODUCT.
INVTRS: XXXXX XX XXXXX XX
XXXX NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
M01331D US I 751596
08/21/1991 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
-54-
RPT-CASELIST_RPT
09/29/1998
CASE SERIES REPORT
TITLE: PROCESS FOR THE PRODUCTION OF 2-IMIDAZOLONES
ABSTRACT: THE PRESENT INVENTION PERTAINS TO A PROCESS FOR
PRODUCING A 2-IMIDAZOLONE FROM A UREIDOACETAL. THE
UREIDOACETAL IS SUBJECTED TO AN ACID CATALYZED
CONDENSATION IN ORDER TO PRODUCE THE 2-IMIDAZOLONE. THE
REACTION IS CONDUCTED IN AN ALCOHOLIC SOLVENT IN ORDER
TO MINIMIZE THE PRODUCTION OF A POLYMERIC BY-PRODUCT.
INVTRS: XXXXX XX XXXXX XX
XXXX NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
M01331E US I 818510
01/08/1992 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
-55-
RPT-CASELIST_RPT
09/29/1998
CASE SERIES REPORT
TITLE: PROCESS FOR THE PRODUCTION OF 2-IMIDAZOLONES
ABSTRACT: THE PRESENT INVENTION PERTAINS TO A PROCESS FOR
PRODUCING A 2-IMIDAZOLONE FROM A UREIDOACETAL. THE
UREIDOACETAL IS SUBJECTED TO AN ACID CATALYZED
CONDENSATION IN ORDER TO PRODUCE THE 2-IMIDAZOLONE. THE
REACTION IS CONDUCTED IN AN ALCOHOLIC SOLVENT IN ORDER
TO MINIMIZE THE PRODUCTION OF A POLYMERIC BY-PRODUCT.
INVTRS: XXXXX XX XXXXX XX
XXXX NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
M0133lF US I 902437
06/18/1992 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
-56-
RPT-CASELIST_RPT
09/29/1998
CASE SERIES REPORT
TITLE: PROCESS FOR THE PRODUCTION OF Z-IMIDAZOLONES
ABSTRACT: THE PRESENT INVENTION PERTAINS TO A PROCESS FOR
PRODUCING A 2-IMIDAZOLONE FROM A UREIDOACETAL. THE
UREIDOACETAL IS SUBJECTED TO AN ACID CATALYZED
CONDENSATION IN ORDER TO PRODUCE THE 2-IMIDAZOLONE. THE
REACTION IS CONDUCTED IN AN ALCOHOLIC SOLVENT IN ORDER
TO MINIMIZE THE PRODUCTION OF A POLYMERIC BY-PRODUCT.
INVTRS: XXXXX XX XXXXX XX
XXXX NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
M01331G US I 971713
11/04/1992 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
-57-
RPT-CASELIST_RPT
09/29/1998
CASE SERIES REPORT
TITLE: PROCESS FOR THE PRODUCTION OF 2-IMIDAZOLONES
ABSTRACT: THE PRESENT INVENTION PERTAINS TO A PROCESS FOR
PRODUCING A 2-IMIDAZOLONE FROM A UREIDOACETAL. THE
UREIDOACETAL IS SUBJECTED TO AN ACID CATALYZED
CONDENSATION IN ORDER TO PRODUCE THE 2-IMIDAZOLONE. THE
REACTION IS CONDUCTED IN AN ALCOHOLIC SOLVENT IN ORDER
TO MINIMIZE THE PRODUCTION OF A POLYMERIC BY-PRODUCT.
INVTRS: XXXXX XX XXXXX XX
XXXX NO. STATUS SN/FILED XXX/ISSUED EXPIRES
------------------- ------ ---------- ---------- ----------
M01331H US G 39539 5338862 08/16/2011
03/29/1993 08/16/1994 Assignee: XXXXXXX XXX PHARMACEUTICALS INC
137 TOTAL RECORDS REPORTED
-58-
SCHEDULE 1.23
UNIVERSITY TECHNOLOGY CORPORATION
INTELLECTUAL PROPERTY
LICENSE AGREEMENT
FILED SEPARATELY AS AN EXHIBIT TO THE COMPANY'S
REGISTRATION STATEMENT OF FORM S-1.
--------------------------------------------------------------------------------
----------
-31-
[*#*]CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT 3.4
DEVELOPMENT PLAN
[*#*]
-32-
[*#*]CONFIDENTIAL TREATMENT REQUESTED
SCHEDULE 3.6.4
Non-exempt personnel: [*#*] per hour
Exempt personnel: [*#*] per hour
-33-
[*#*]CONFIDENTIAL TREATMENT REQUESTED
EXHIBIT 4.1 (c)
PERFAN - ALL ACTIVE TRADEMARKS
09/28/98
APPLICATION FILING REGISTRATION REGISTRATION
COUNTRY NAME TRADEMARK STATUS NUMBER DATE NUMBER DATE OWNER NAME
------------ --------- ------ ----------- ------ ------------ ------------ ----------
ARGENTINA PERFAN REGISTERED 1592937 24-Apr-87 1370311 27-Dec-89 MERRELL PHARMACEUTICALS INC.
AUSTRALIA PERFAN REGISTERED 416268 02-Oct-84 A416268 02-Oct-84 MERRELL PHARMACEUTICALS INC.
AUSTRIA PERFAN REGISTERED 313144 20-Jan-82 467190 20-Jan-82 XXXXXX XXXXXXX DOW EUROPE AG
BENELUX PERFAN REGISTERED 676376 25-Jul-85 410845 25-Jul-85 MERRELL PHARMACEUTICALS INC.
BENELUX PERFAN REGISTERED 313144 20-Jan-82 467190 20-Jan-82 XXXXXX XXXXXXX DOW EUROPE AG
BRAZIL PERFAN REGISTERED 811775259 08-Nov-84 811775259 10-Jun-86 MERRELL PHARMACEUTICALS INC.
CANADA PERFAN REGISTERED 537872 06-Mar-85 314937 06-Jun-86 MERRELL PHARMACEUTICALS INC.
COLOMBIA PERFAN REGISTERED 205478 07-Oct-81 168,141 28-Sep-94 MERRELL PHARMACEUTICALS INC.
CZECH REPUBLIC PERFAN REGISTERED "" 27-Dec-90 169460 11-Mar-92 MERRELL PHARMACEUTICALS INC.
DENMARK PERFAN REGISTERED 7175 28-Sep-89 20 03-Jan-92 MERRELL PHARMACEUTICALS INC.
ECUADOR PERFAN REGISTERED 8123 13-Apr-87 1105-94 07-Jun-88 MERRELL PHARMACEUTICALS INC.
EGYPT PERFAN REGISTERED 64782 16-Oct-84 64782 16-Oct-84 MERRELL PHARMACEUTICALS INC.
FINLAND PERFAN REGISTERED 1691 14-Apr-87 107970 20-Jul-90 MERRELL PHARMACEUTICALS INC.
FRANCE PERFAN REGISTERED 313144 20-Jan-82 467190 00-Xxx-00 XXXXXX XXXXXXX XXX XXXXXX XX
XXXX XXXX PERFAN REGISTERED 3652 19-Nov-84 A568/1986 19-Nov-84 MERRELL PHARMACEUTICALS INC.
HUNGARY PERFAN REGISTERED 313144 20-Jan-82 467190 20-Jan-82 XXXXXX XXXXXXX DOW EUROPE AG
HUNGARY PERFAN REGISTERED 54491 01-Feb-91 140265 01-Feb-91 MERRELL PHARMACEUTICALS INC.
ICELAND PERFAN REGISTERED 797 29-Sep-89 58/1990 10-Jan-90 MERRELL PHARMACEUTICALS INC.
INTERNATIONAL
REGISTRATION PERFAN REGISTERED 313144 20-Jan-82 467190 20-Jan-82 XXXXXX XXXXXXX DOW EUROPE AG
ISRAEL PERFAN REGISTERED 73516 24-Aug-89 73516 24-Aug-89 XXXXXXX XXX PHARMACEUTICALS INC.
ITALY PERFAN REGISTERED 313144 20-Jan-82 467190 20-Jan-82 XXXXXX XXXXXXX DOW EUROPE AG
JAPAN PERFAN REGISTERED 106578 05-Oct-84 2713480 30-Apr-96 MERRELL PHARMACEUTICALS INC.
MEXICO PERFAN REGISTERED 141586 09-Jun-92 431168 18-Feb-93 MERRELL PHARMACEUTICALS INC.
MOROCCO PERFAN REGISTERED 313144 20-Jan-82 467190 20-Jan-82 XXXXXX XXXXXXX DOW EUROPE AG
NEW ZEALAND PERFAN REGISTERED 155097 03-Oct-84 A155097 03-Oct-84 MERRELL PHARMACEUTICALS INC.
NORWAY PERFAN REGISTERED 1426 09-Apr-87 134067 03-Nov-88 MERRELL PHARMACEUTICALS INC.
PAKISTAN PERFAN REGISTERED 84192 14-Oct-84 84192 14-Oct-84 MERRELL PHARMACEUTICALS INC.
PARAGUAY PERFAN REGISTERED 5128 06-Oct-84 193934 26-Aug-86 MERRELL PHARMACEUTICALS INC.
PERU PERFAN REGISTERED 86791 14-Feb-85 63566 27-Jan-87 XXXXXXX XXX PHARMACEUTICALS INC.
POLAND PERFAN REGISTERED 96447 07-Feb-91 70227 07-Feb-91 MERRELL PHARMACEUTICALS INC.
PORTUGAL PERFAN REGISTERED 313144 20-Jan-82 467190 00-Xxx-00 XXXXXX XXXXXXX XXX-XXXXXXXXX
XXXXXXXX XX XXXXXXX PERFAN REGISTERED 2997 02-Oct-84 A112660 02-Oct-84 MERRELL PHARMACEUTICALS INC.
ROMANIA PERFAN REGISTERED 23963 05-Aug-91 17660 12-Mar-91 XXXXXXX XXX PHARMACEUTICALS INC.
ROMANIA PERFAN REGISTERED 14795 09-Jan-85 33362 09-Jan-85 XXXXXXX XXX PHARMACEUTICALS INC.
RUSSIAN FEDERATION PERFAN REGISTERED 131175 24-Jan-91 98646 09-Sep-91 MERRELL PHARMACEUTICALS INC.
SINGAPORE PERFAN REGISTERED S/5468 19-Oct-84 5468/84 19-Oct-84 MERRELL PHARMACEUTICALS INC.
SOUTH AFRICA PERFAN REGISTERED 7446 07-Oct-81 81/7446 07-Oct-81 MERRELL PHARMACEUTICALS INC.
SWEDEN PERFAN REGISTERED 2968 13-Apr-87 215664 02-Feb-90 XXXXXXX XXX PHARMACEUTICALS INC.
SWITZERLAND PERFAN REGISTERED 4022 23-Jul-81 313144 23-Jul-81 DOW EUROPE S.A.
TURKEY PERFAN REGISTERED 6611 01-Feb-88 "" MERRELL PHARMACEUTICALS INC.
UNITED KINGDOM PERFAN REGISTERED 1318243 07-Aug-87 1318243 07-Aug-87 DOWELANCO
URUGUAY PERFAN REGISTERED 239743 11-Sep-90 239743 27-May-91 MERRELL PHARMACEUTICALS INC.
VENEZUELA PERFAN PENDING 20272 21-Nov-90 "" MERRELL PHARMACEUTICALS INC.
YUGOSLAVIA PERFAN REGISTERED 313144 20-Jan-82 467190 20-Jan-82 XXXXXX XXXXXXX DOW EUROPE AG
YUGOSLAVIA PERFAN REGISTERED Z-91/98 10-Jan-91 38374 08-Sep-94 MERRELL PHARMACEUTICALS INC.
-34-
[*#*] CONFIDENTIAL TREATMENT REQUESTED
First Amendment
to the
License Agreement
(Enoximone)
By and Between
Hoechst Xxxxxx Xxxxxxx, Inc.
and
Myogen, Inc.
This First Amendment is effective this 23rd day of November 1999, by
and between Hoechst Xxxxxx Xxxxxxx, Inc., ("HMR") a
Delaware corporation and
Myogen, Inc. ("Myogen") a
Delaware corporation, generally referred to as a
"Party" and together as the "Parties."
BACKGROUND
HMR and Myogen entered into a
License Agreement dated October 1, 1998
(the "
License Agreement"). The Parties now wish to amend the
License Agreement
to change the Milestone and Royalty obligations, the Transfer Date and to add
Co-Marketing rights.
NOW, THEREFORE, in consideration of the mutual promises and agreements
set forth herein, the Parties hereto agree as follows:
1.
[*#*] CONFIDENTIAL TREATMENT REQUESTED
1. Capitalized terms not otherwise defined herein shall have the meanings set
forth in the License Agreement.
2. ARTICLE I, section 1.40 "Transfer Date" is deleted entirely and replaced
with the following:
1.40 "Transfer Date" shall mean the actual date that the transfer of
European rights from HMR to Myogen commences, but in no event later than
[*#*].
3. ARTICLE II is amended to add a new section 2.4.
2.4 Co-Marketing Rights. After the Transfer Date, [*#*] to HMR, Myogen
grants to HMR the right to co-market in Europe, under terms and conditions
to be negotiated in good faith which are consistent with standards for the
pharmaceutical industry, the oral Enoximone product being developed by
Myogen. If additional studies are required for European registration and HMR
elects to perform these studies then the terms of the co-marketing agreement
will be adjusted accordingly to reflect HMR's contribution to the
development of European Enoximone. If HMR exercises its right to co-market,
HMR shall market the oral Enoximone product under HMR's trade name.
4. ARTICLE III, section 3.7(c) is amended to read in its entirety:
(c) HMR shall invoice and charge Myogen [*#*] per kilogram of
Enoximone active ingredient purchased under this Section 3.7, payment of
which shall be made by Myogen in four quarterly payments beginning on
[*#*]. HMR will ship the Enoximone [*#*].
2.
[*#*] CONFIDENTIAL TREATMENT REQUESTED
5. ARTICLE IV, section 4.1(c) is amended by deleting the first sentence only
and adding in its place:
(c) [*#*], Myogen shall pay to HMR [*#*] payable in quarterly
payments of [*#*] due no later than the first day of each calendar
quarter.
6. ARTICLE IV, sections 4.1 (d) and 4.1 (e) are deleted entirely and replaced
with the following:
(d) [*#*], Myogen shall pay to HMR [*#*] payable in quarterly
payments of [*#*] due no later than the first day of each calendar
quarter.
(e) [*#*], Myogen shall pay to HMR [*#*] payable in quarterly
payments of [*#*] due no later than the first day of each calendar
quarter.
7. ARTICLE IV section (f) is amended by deleting [*#*] and adding in its
place [*#*].
8. ARTICLE IV, section 4.3 is amended to change the last sentence to read:
...From and after the expiration of such claims, all royalty amounts,
excluding those [*#*] shall be reduced by [*#*] but shall in no event be
less than [*#*] until the tenth (10) anniversary of the first commercial
sale of the relevant Product in such country after which time all royalty
obligations shall cease entirely.
3.
[*#*] CONFIDENTIAL TREATMENT REQUESTED
Except as amended hereby, the License Agreement shall remain unchanged and in
full force and effect.
IN WITNESS WHEREOF, the Parties have caused this First Amendment to be
executed by their duly authorized representatives as of this date set forth
above.
HOECHST XXXXXX XXXXXXX, INC. MYOGEN, INC.
By: /s/ Signature Illegible By: /s/ J. Xxxxxxx Xxxxxxx
------------------------------ -----------------------------
Title: Title: President and CEO
---------------------------- ---------------------------
4.
[*#*] CONFIDENTIAL TREATMENT REQUESTED
SECOND AMENDMENT TO THE LICENSE AGREEMENT (ENOXIMONE)
BY AND BETWEEN
AVENTIS PHARMACEUTICALS INC.
(FORMERLY HOECHST XXXXXX XXXXXXX, INC.)
AND
MYOGEN, INC.,
This Second Amendment to the License Agreement (Enoximone) by and
between Aventis Pharmaceuticals Inc. (formerly Hoechst Xxxxxx Xxxxxxx, Inc.) and
Myogen, Inc., effective October 1, 1998 ("Second Amendment" and "License
Agreement," respectively) is effective this ____ day of May 2003 ("Effective
Date"), by and between Aventis Pharmaceuticals Inc., a
Delaware corporation with
a principal office at 000 Xxxxxxxx Xxxxxxxxx Xxxx, Xxxxxxxxxxx, Xxx Xxxxxx 00000
("Aventis"), and Myogen, Inc., a
Delaware corporation with a principal office at
0000 X. 000xx Xxxxxx, xxxxx 000, Xxxxxxxxxxx, XX 00000-0000 ("Myogen") (each
individually a "Party" and collectively "Parties").
BACKGROUND
Aventis and Myogen entered into the License Agreement on October 1,
1998, and subsequently amended it for the first time on November 25, 1999
("First Amendment"). Among other changes to the License Agreement, the First
Amendment added Section 2.4 Co-Marketing Rights, whereby Myogen granted to
Aventis the right to co-market the oral Enoximone product in Europe. The Parties
now wish to modify the terms of the First Amendment to terminate all such rights
granted to Aventis under the First Amendment to co-market the oral Enoximone
product in Europe; and, in consideration for the termination of the co-marketing
rights, to amend the License Agreement to provide for a royalty to be paid by
Myogen to Aventis if the Net Sales of the oral Enoximone product in Europe reach
or exceed the threshold described below.
NOW, THEREFORE, in consideration of the mutual promises and agreements
set forth in this Second Amendment, the Parties agree as follows:
1. GRANT BACK OF CO-MARKETING RIGHTS RELATING TO ORAL ENOXIMONE PRODUCT.
(a) The license granted by Myogen to Aventis in Paragraph 3 of the
First Amendment (which added a new Section 2.4 to Article II
of the License Agreement) to co-market in Europe the oral
Enoximone product being developed by Myogen is hereby
terminated. Accordingly, Section 2.4 of the License Agreement
is hereby deleted in its entirety.
(b) It is understood that notwithstanding anything contained in
the License Agreement to the contrary, Aventis shall not have
any obligation of any
1 [/\#/\] CONFIDENTIAL TREATMENT REQUESTED
kind, financial or otherwise, with respect to the development
or co-marketing in Europe of the oral Enoximone product being
developed by Myogen.
2. Section 4.1(f) is amended and restated as follows:
(f) Beginning on the first day of the calendar quarter in which the
second anniversary of the Transfer Date falls, Myogen will pay to Aventis for a
period of ten (10) years on a quarterly basis within sixty (60) days after the
end of each calendar quarter, periodic payments equal to the following
percentage of Net Sales in Europe that occurred during the immediately preceding
calendar quarter:
(1) [/\#/\] of Net Sales in Europe less than [/\#/\] in a
calendar year; and,
(2) [/\#/\] of the incremental Net Sales in Europe that equal
or exceed [/\#/\] in a calendar year.
3. MISCELLANEOUS.
(a) Capitalized terms not otherwise defined in this Second
Amendment shall have the meaning set forth in the License
Agreement.
(b) Except as expressly modified by this Second Amendment, the
terms and conditions of the License Agreement (as previously
amended by the First Amendment) shall remain unchanged and in
full force and effect.
(REMAINDER OF PAGE INTENTIONALLY LEFT BLANK)
2 [/\#/\] CONFIDENTIAL TREATMENT REQUESTED
IN WITNESS WHEREOF, the Parties have caused this Second Amendment to be
executed by their duly authorized representatives as of the Effective Date set
forth above.
AVENTIS PHARMACEUTICALS INC. MYOGEN, INC.
By: /s/ Xxxxxxx X. Xxxxxxx, Ph.D. By: /s/ J. Xxxxxxx Xxxxxxx
---------------------------------- ---------------------------------
Title: VP, Head of Global Business Title: President & CEO
------------------------------- ------------------------------
Development
-------------------------------
Date: 6/12/03 Date: 5/6/03
------------------------------- -------------------------------
3 [/\#/\] CONFIDENTIAL TREATMENT REQUESTED
